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Velcade (bortezomib) – Package leaflet - L01XX32

Updated on site: 10-Oct-2017

Medication nameVelcade
ATC CodeL01XX32
Substancebortezomib
ManufacturerJanssen-Cilag International NV

Package leaflet: Information for the user

VELCADE 1 mg powder for solution for injection

Bortezomib

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What VELCADE is and what it is used for

2.What you need to know before you use VELCADE

3.How to use VELCADE

4.Possible side effects

5.How to store VELCADE

6.Contents of the pack and other information

1.What VELCADE is and what it is used for

VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells.

VELCADE is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years:

-alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.

-in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.

-in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).

VELCADE is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.

2. What you need to know before you use VELCADE

Do not use VELCADE

-if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6)

-if you have certain severe lung or heart problems.

Warnings and precautions

You should tell your doctor if you have any of the following:

low numbers of red or white blood cells

bleeding problems and/or low number of platelets in your blood

diarrhoea, constipation, nausea or vomiting

fainting, dizziness or light-headedness in the past

kidney problems

moderate to severe liver problems

numbness, tingling, or pain in the hands or feet (neuropathy) in the past

heart or blood pressure problems

shortness of breath or cough

seizures

shingles (localised including around the eyes or spread across the body)

symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath

memory loss, trouble thinking, difficulty with walking or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.

You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.

If you have mantle cell lymphoma and are given the medicine rituximab with VELCADE you should tell your doctor:

if you think you have hepatitis infection now or have had it in the past. In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal. If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.

You must read the package leaflets of all medicinal products to be taken in combination with VELCADE for information related to these medicines before starting treatment with VELCADE. When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).

Children and adolescents

VELCADE should not be used in children and adolescents because it is not known how the medicine will affect them.

Other medicines and VELCADE

Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are using medicines containing any of the following active substances:

-ketoconazole, used to treat fungal infections ritonavir, used to treat HIV infection

-rifampicin, an antibiotic used to treat bacterial infections

-carbamazepine, phenytoin or phenobarbital used to treat epilepsy

-St. John’s Wort (Hypericum perforatum), used for depression or other conditions

-oral antidiabetics

Pregnancy and breast-feeding

You should not use VELCADE if you are pregnant, unless clearly necessary.

Both men and women receiving VELCADE must use effective contraception during and for up to

3 months after treatment. If, despite these measures, pregnancy occurs, tell your doctor immediately.

You should not breast-feed while using VELCADE. Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.

Thalidomide causes birth defects and foetal death. When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).

Driving and using machines

VELCADE might cause tiredness, dizziness, fainting, or blurred vision. Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.

3.How to use VELCADE

Your doctor will work out your dose of VELCADE according to your height and weight (body surface area). The usual starting dose of VELCADE is 1.3 mg/m2 body surface area twice a week.

Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).

Progressive multiple myeloma

When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period’ without treatment. This 21-day period (3 weeks) corresponds to one treatment cycle. You might receive up to 8 cycles (24 weeks).

You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.

When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.

You might receive up to 8 cycles (24 weeks).

When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the VELCADE, 21-day treatment cycle.

You might receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma

If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE intravenously together with two other medicines; melphalan and prednisone.

In this case, the duration of a treatment cycle is 42 days (6 weeks). You will receive 9 cycles (54 weeks).

In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.

In cycles 5 to 9, VELCADE is administered once weekly on days 1, 8, 22 and 29.

Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.

If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.

You will receive 4 cycles (12 weeks).

When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).

Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if

tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.

You might receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone. VELCADE is given intravenously on days 1, 4, 8 and 11, followed by a ‘rest period’ without treatment. The duration of a treatment cycle is 21 days (3 weeks). You might receive up to 8 cycles (24 weeks).

The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:

Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2. Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the VELCADE treatment cycle.

How VELCADE is given

This medicine is for intravenous use only. VELCADE will be administered by a health care professional experienced in the use of cytotoxic medicines.

VELCADE powder has to be dissolved before administration. This will be done by a healthcare professional. The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.

If you are given too much VELCADE

As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. In the unlikely event of an overdose, your doctor will monitor you for side effects.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious.

If you are given VELCADE for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms:

-muscle cramping, muscle weakness

-confusion, visual loss or disturbances, blindness, seizures, headaches

-shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting

-coughing and breathing difficulties or tightness in the chest.

Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood. Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly. You may experience a reduction in the number of:

-platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver)

-red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness

-white blood cells may make you more prone to infections or flu-like symptoms.

If you are given VELCADE for the treatment of multiple myeloma the side effects you may get are listed below:

Very common side effects (may affect more than 1 in 10 people)

Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage

Reduction in the number of red blood cells and or white blood cells (see above)

Fever

Feeling sick (nausea) or vomiting, loss of appetite

Constipation with or without bloating (can be severe)

Diarrhoea: if this happens, it is important that you drink more water than usual. Your doctor may give you another medicine to control diarrhoea

Tiredness (fatigue), feeling weak

Muscle pain, bone pain

Common side effects (may affect up to 1 in 10 people)

Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting

High blood pressure

Reduced functioning of your kidneys

Headache

General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness

Shivering

Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness

Shingles (localised including around the eyes or spread across the body)

Chest pains or shortness of breath with exercise

Different types of rash

Itching of the skin, lumps on the skin or dry skin

Facial blushing or tiny broken capillaries

Redness of the skin

Dehydration

Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach

Alteration of liver functioning

A sore mouth or lip, dry mouth, mouth ulcers or throat pain

Weight loss, loss of taste

Muscle cramps, muscle spasms, muscle weakness, pain in your limbs

Blurred vision

Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)

Nose bleeds

Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood, restlessness or agitation, changes in your mental status, disorientation

Swelling of body, to include around eyes and other parts of the body

Uncommon side effects (may affect up to 1 in 100 people)

Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate

Failing of your kidneys

Inflammation of a vein, blood clots in your veins and lungs

Problems with blood clotting

Insufficient circulation

Inflammation of the lining around your heart or fluid around your heart

Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis

Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina

Cerebrovascular disorders

Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching

Arthritis, including inflammation of the joints in the fingers, toes, and the jaw

Disorders that affect your lungs, preventing your body from getting enough oxygen. Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing

Hiccups, speech disorders

Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention

Altered levels of consciousness, confusion, memory impairment or loss

Hypersensitivity

Hearing loss, deafness or ringing in the ears, ear discomfort

Hormone abnormality which may affect salt and water absorption

Overactive thyroid gland

Inability to produce enough insulin or resistance to normal levels of insulin

Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, discharge from the eyes, abnormal vision, bleeding of the eye

Swelling of your lymph glands

Joint or muscle stiffness, sense of heaviness, pain in your groin

Hair loss and abnormal hair texture

Allergic reactions

Redness or pain at the injection site

Mouth pain

Infections or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestines, sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood

Skin infections

Bacterial and viral infections

Tooth infection

Inflammation of the pancreas, obstruction of the bile duct

Genital pain, problem having an erection

Weight increase

Thirst

Hepatitis

Injection site or injection device related disorders

Skin reactions and disorders (which may be severe and life threatening), skin ulcers

Bruises, falls and injuries

Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots (usually on the legs) to large bruise-like patches under the skin or tissue

Benign cysts

A severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.

Rare side effects (may affect up to 1 in 1,000 people)

Heart problems to include heart attack, angina

Flushing

Discoloration of the veins

Inflammation of the spinal nerve

Problems with your ear, bleeding from your ear

Underactivity of your thyroid gland

Budd–Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)

Changes in or abnormal bowel function

Bleeding in the brain

Yellow discolouration of eyes and skin (jaundice)

Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse

Breast disorders

Vaginal tears

Genital swelling

Inability to tolerate alcohol consumption

Wasting, or loss of body mass

Increased appetite

Fistula

Joint effusion

Cysts in the lining of joints (synovial cysts)

Fracture

Breakdown of muscle fibers leading to other complications

Swelling of the liver, bleeding from the liver

Cancer of the kidney

Psoriasis like skin condition

Cancer of the skin

Paleness of the skin

Increase of platelets or plasma cells (a type of white cell) in the blood

Abnormal reaction to blood transfusions

Partial or total loss of vision

Decreased sex drive

Drooling

Bulging eyes

Sensitivity to light

Rapid breathing

Rectal pain

Gallstones

Hernia

Injuries

Brittle or weak nails

Abnormal protein deposits in your vital organs

Coma

Intestinal ulcers

Multi-organ failure

Death

If you are given VELCADE together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:

Very common side effects (may affect more than 1 in 10 people)

Pneumonia

Loss of appetite

Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage

Nausea and vomiting

Diarrhoea

Mouth ulcers

Constipation

Muscle pain, bone pain

Hair loss and abnormal hair texture

Tiredness, feeling weak

Fever

Common side effects (may affect up to 1 in 10 people)

Shingles (localized including around the eyes or spread across the body)

Herpes virus infections

Bacterial and viral infections

Respiratory infections, bronchitis, coughing with phlegm, flu like illness

Fungal infections

Hypersensitivity (allergic reaction)

Inability to produce enough insulin or resistance to normal levels of insulin

Fluid retention

Difficulty or problems in sleeping

Loss of conciousness

Altered level of consciousness, confusion

Feeling dizzy

Increased heartbeat, high blood pressure, sweating,

Abnormal vision, blurred vision

Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate

High or low blood pressure

Sudden fall of blood pressure upon standing which may lead to fainting

Shortness of breath with exercise

Cough

Hiccups

Ringing in the ears, ear discomfort

Bleeding from your bowels or stomach

Heartburn

Stomach pain, bloating

Difficulty swallowing

Infection or inflammation of the stomach and intentines

Stomach pain

Sore mouth or lip, throat pain

Alteration of liver function

Itching of skin

Redness of skin

Rash

Muscle spasms

Infection of the urinary tract

Pain in limbs

Swelling of body, to include eyes and other parts of the body

Shivering

Redness and pain at injection site

General ill feeling

Weight loss

Weight increase

Uncommon side effects (may affect up to 1 in 100 people)

Hepatitis

Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse

Movement disorders, paralysis, twitching

Vertigo

Hearing loss, deafness

Disorders that affect your lungs, preventing your body from getting enough oxygen. Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing

Blood clots in your lungs

Yellow discoloration of the eyes and skin (jaundice)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store VELCADE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and the carton after EXP.

Do not store above 30 C. Keep the vial in the outer carton in order to protect from light.

The reconstituted solution should be used immediately after preparation. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the reconstituted solution is stable for 8 hours at 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.

VELCADE is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What VELCADE contains

-The active substance is bortezomib. Each vial contains 1 mg of bortezomib (as a mannitol boronic ester). After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.

-The other ingredients are mannitol (E421) and nitrogen.

What VELCADE looks like and contents of the pack

VELCADE powder for solution for injection is a white to off-white cake or powder.

Each carton of VELCADE 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.

Marketing Authorisation Holder

JANSSEN-CILAG INTERNATIONAL NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél + 32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5-Smíchov Tel: +420 227 012 227

Danmark

Janssen Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

España

Janssen-Cilag, S.A.

E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / + 33 1 55 00 40 03

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: + 32 14 64 94 11

Magyarország

Janssen Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: + 31 76 711 1111

Norge

Janssen-Cilag AS.

Postboks 144

NO-1325-Lysaker

Tlf: + 47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel:+43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: + 48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

Hrvatska

România

Johnson & Johnson S.E. d.o.o.

Johnson & Johnson România SRL

Oreškovićeva 6h

Str. Tipografilor nr. 11-15

10010 Zagreb

Clădirea S-Park, Corp B3-B4, Etaj 3

Tel: +385 1 6610 700

013714 Bucureşti, ROMÂNIA

 

Tel: +40 21 207 1800

Ireland

Slovenija

Janssen-Cilag Ltd.

Johnson & Johnson d.o.o.

50-100 Holmers Farm Way

Šmartinska cesta 53

High Wycombe

SI-1000 Ljubljana

Buckinghamshire HP12 4EG

Tel. +386 1 401 18 30

United Kingdom

 

Tel: +44 1 494 567 444

 

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02/2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

This leaflet was last revised in

 

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

1.RECONSTITUTION FOR INTRAVENOUS INJECTION

Note: VELCADE is a cytotoxic agent. Therefore, caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended.

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF VELCADE SINCE NO PRESERVATIVE IS PRESENT.

1.1Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a 1 ml syringe without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.

The concentration of the resulting solution will be 1 mg/ml. The solution will be clear and colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.

1.2Before administration, visually inspect the solution for particulate matter and discolouration. If any discolouration or particulate matter is observed, the solution should be discarded. Confirm concentration on vial to ensure that the correct dose is being given for the intravenous route of administration (1 mg/ml).

1.3The reconstituted solution is preservative free and should be used immediately after preparation. However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

It is not necessary to protect the reconstituted medicinal product from light.

2.ADMINISTRATION

Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.

Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).

Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.

Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.

VELCADE 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY. Do not give by other routes. Intrathecal administration has resulted in death.

3.DISPOSAL

A vial is for single use only and the remaining solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.

Package leaflet: Information for the user

VELCADE 3.5 mg powder for solution for injection

Bortezomib

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What VELCADE is and what it is used for

2.What you need to know before you use VELCADE

3.How to use VELCADE

4.Possible side effects

5.How to store VELCADE

6.Contents of the pack and other information

1. What VELCADE is and what it is used for

VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells.

VELCADE is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years:

-alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.

-in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.

-in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).

VELCADE is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.

2. What you need to know before you use VELCADE

Do not use VELCADE

-if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6)

-if you have certain severe lung or heart problems.

Warnings and precautions

You should tell your doctor if you have any of the following:

low numbers of red or white blood cells

bleeding problems and/or low number of platelets in your blood

diarrhoea, constipation, nausea or vomiting

fainting, dizziness or light-headedness in the past

kidney problems

moderate to severe liver problems

numbness, tingling, or pain in the hands or feet (neuropathy) in the past

heart or blood pressure problems

shortness of breath or cough

seizures

shingles (localised including around the eyes or spread across the body)

symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath

memory loss, trouble thinking, difficulty with walking or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.

You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.

If you have mantle cell lymphoma and are given the medicine rituximab with VELCADE you should tell your doctor:

if you think you have hepatitis infection now or have had it in the past. In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal. If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.

You must read the package leaflets of all medicinal products to be taken in combination with VELCADE for information related to these medicines before starting treatment with VELCADE. When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).

Children and adolescents

VELCADE should not be used in children and adolescents because it is not known how the medicine will affect them.

Other medicines and VELCADE

Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are using medicines containing any of the following active substances:

-ketoconazole, used to treat fungal infections ritonavir, used to treat HIV infection

-rifampicin, an antibiotic used to treat bacterial infections

-carbamazepine, phenytoin or phenobarbital used to treat epilepsy

-St. John’s Wort (Hypericum perforatum), used for depression or other conditions

-oral antidiabetics

Pregnancy and breast-feeding

You should not use VELCADE if you are pregnant, unless clearly necessary.

Both men and women receiving VELCADE must use effective contraception during and for up to

3 months after treatment. If, despite these measures, pregnancy occurs, tell your doctor immediately.

You should not breast-feed while using VELCADE. Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.

Thalidomide causes birth defects and foetal death. When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).

Driving and using machines

VELCADE might cause tiredness, dizziness, fainting, or blurred vision. Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.

3. How to use VELCADE

Your doctor will work out your dose of VELCADE according to your height and weight (body surface area). The usual starting dose of VELCADE is 1.3 mg/m2 body surface area twice a week.

Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).

Progressive multiple myeloma

When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period’ without treatment. This 21-day period (3 weeks) corresponds to one treatment cycle. You might receive up to 8 cycles (24 weeks).

You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.

When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.

You might receive up to 8 cycles (24 weeks).

When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the VELCADE, 21-day treatment cycle.

You might receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma

If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE together with two other medicines; melphalan and prednisone.

In this case, the duration of a treatment cycle is 42 days (6 weeks). You will receive 9 cycles (54 weeks).

In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.

In cycles 5 to 9, VELCADE is administered once weekly on days 1, 8, 22 and 29.

Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.

If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.

You will receive 4 cycles (12 weeks).

When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).

Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.

You might receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.

VELCADE is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period’ without treatment. The duration of a treatment cycle is 21 days (3 weeks). You might receive up to 8 cycles (24 weeks).

The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:

Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2. Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the VELCADE treatment cycle.

How VELCADE is given

This medicine is for intravenous or subcutaneous use. VELCADE will be administered by a health care professional experienced in the use of cytotoxic medicines.

VELCADE powder has to be dissolved before administration. This will be done by a healthcare professional. The resulting solution is then either injected into a vein or under the skin. Injection into a vein is rapid, taking 3 to 5 seconds. Injection under the skin is in either the thighs or the abdomen.

If you are given too much VELCADE

As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. In the unlikely event of an overdose, your doctor will monitor you for side effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious.

If you are given VELCADE for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms:

-muscle cramping, muscle weakness

-confusion, visual loss or disturbances, blindness, seizures, headaches

-shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting

-coughing and breathing difficulties or tightness in the chest.

Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood. Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly. You may experience a reduction in the number of:

-platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver)

-red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness

-white blood cells may make you more prone to infections or flu-like symptoms.

If you are given VELCADE for the treatment of multiple myeloma the side effects you may get are listed below:

Very common side effects (may affect more than 1 in 10 people)

Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage

Reduction in the number of red blood cells and or white blood cells (see above)

Fever

Feeling sick (nausea) or vomiting, loss of appetite

Constipation with or without bloating (can be severe)

Diarrhoea: if this happens, it is important that you drink more water than usual. Your doctor may give you another medicine to control diarrhoea

Tiredness (fatigue), feeling weak

Muscle pain, bone pain

Common side effects (may affect up to 1 in 10 people)

Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting

High blood pressure

Reduced functioning of your kidneys

Headache

General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness

Shivering

Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness

Shingles (localised including around the eyes or spread across the body)

Chest pains or shortness of breath with exercise

Different types of rash

Itching of the skin, lumps on the skin or dry skin

Facial blushing or tiny broken capillaries

Redness of the skin

Dehydration

Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach

Alteration of liver functioning

A sore mouth or lip, dry mouth, mouth ulcers or throat pain

Weight loss, loss of taste

Muscle cramps, muscle spasms, muscle weakness, pain in your limbs

Blurred vision

Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)

Nose bleeds

Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood, restlessness or agitation, changes in your mental status, disorientation

Swelling of body, to include around eyes and other parts of the body

Uncommon side effects (may affect up to 1 in 100 people)

Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate

Failing of your kidneys

Inflammation of a vein, blood clots in your veins and lungs

Problems with blood clotting

Insufficient circulation

Inflammation of the lining around your heart or fluid around your heart

Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis

Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina

Cerebrovascular disorders

Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching

Arthritis, including inflammation of the joints in the fingers, toes, and the jaw

Disorders that affect your lungs, preventing your body from getting enough oxygen. Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing

Hiccups, speech disorders

Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention

Altered levels of consciousness, confusion, memory impairment or loss

Hypersensitivity

Hearing loss, deafness or ringing in the ears, ear discomfort

Hormone abnormality which may affect salt and water absorption

Overactive thyroid gland

Inability to produce enough insulin or resistance to normal levels of insulin

Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, discharge from the eyes, abnormal vision, bleeding of the eye

Swelling of your lymph glands

Joint or muscle stiffness, sense of heaviness, pain in your groin

Hair loss and abnormal hair texture

Allergic reactions

Redness or pain at the injection site

Mouth pain

Infections or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestines, sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood

Skin infections

Bacterial and viral infections

Tooth infection

Inflammation of the pancreas, obstruction of the bile duct

Genital pain, problem having an erection

Weight increase

Thirst

Hepatitis

Injection site or injection device related disorders

Skin reactions and disorders (which may be severe and life threatening), skin ulcers

Bruises, falls and injuries

Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots (usually on the legs) to large bruise-like patches under the skin or tissue

Benign cysts

A severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.

Rare side effects (may affect up to 1 in 1,000 people)

Heart problems to include heart attack, angina

Flushing

Discoloration of the veins

Inflammation of the spinal nerve

Problems with your ear, bleeding from your ear

Underactivity of your thyroid gland

Budd–Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)

Changes in or abnormal bowel function

Bleeding in the brain

Yellow discolouration of eyes and skin (jaundice)

Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised

lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse

Breast disorders

Vaginal tears

Genital swelling

Inability to tolerate alcohol consumption

Wasting, or loss of body mass

Increased appetite

Fistula

Joint effusion

Cysts in the lining of joints (synovial cysts)

Fracture

Breakdown of muscle fibers leading to other complications

Swelling of the liver, bleeding from the liver

Cancer of the kidney

Psoriasis like skin condition

Cancer of the skin

Paleness of the skin

Increase of platelets or plasma cells (a type of white cell) in the blood

Abnormal reaction to blood transfusions

Partial or total loss of vision

Decreased sex drive

Drooling

Bulging eyes

Sensitivity to light

Rapid breathing

Rectal pain

Gallstones

Hernia

Injuries

Brittle or weak nails

Abnormal protein deposits in your vital organs

Coma

Intestinal ulcers

Multi-organ failure

Death

If you are given VELCADE together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:

Very common side effects (may affect more than 1 in 10 people)

Pneumonia

Loss of appetite

Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage

Nausea and vomiting

Diarrhoea

Mouth ulcers

Constipation

Muscle pain, bone pain

Hair loss and abnormal hair texture

Tiredness, feeling weak

Fever

Common side effects (may affect up to 1 in 10 people)

Shingles (localized including around the eyes or spread across the body)

Herpes virus infections

Bacterial and viral infections

Respiratory infections, bronchitis, coughing with phlegm, flu like illness

Fungal infections

Hypersensitivity (allergic reaction)

Inability to produce enough insulin or resistance to normal levels of insulin

Fluid retention

Difficulty or problems in sleeping

Loss of conciousness

Altered level of consciousness, confusion

Feeling dizzy

Increased heartbeat, high blood pressure, sweating,

Abnormal vision, blurred vision

Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate

High or low blood pressure

Sudden fall of blood pressure upon standing which may lead to fainting

Shortness of breath with exercise

Cough

Hiccups

Ringing in the ears, ear discomfort

Bleeding from your bowels or stomach

Heartburn

Stomach pain, bloating

Difficulty swallowing

Infection or inflammation of the stomach and intentines

Stomach pain

Sore mouth or lip, throat pain

Alteration of liver function

Itching of skin

Redness of skin

Rash

Muscle spasms

Infection of the urinary tract

Pain in limbs

Swelling of body, to include eyes and other parts of the body

Shivering

Redness and pain at injection site

General ill feeling

Weight loss

Weight increase

Uncommon side effects (may affect up to 1 in 100 people)

Hepatitis

Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse

Movement disorders, paralysis, twitching

Vertigo

Hearing loss, deafness

Disorders that affect your lungs, preventing your body from getting enough oxygen. Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing

Blood clots in your lungs

Yellow discoloration of the eyes and skin (jaundice)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store VELCADE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and the carton after EXP.

Do not store above 30 C. Keep the vial in the outer carton in order to protect from light.

The reconstituted solution should be used immediately after preparation. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the reconstituted solution is stable for 8 hours at 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.

VELCADE is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What VELCADE contains

-The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).

-The other ingredients are mannitol (E421) and nitrogen.

Intravenous reconstitution:

After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.

Subcutaneous reconstitution:

After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.

What VELCADE looks like and contents of the pack

VELCADE powder for solution for injection is a white to off-white cake or powder.

Each carton of VELCADE 3.5 mg powder for solution for injection contains a glass 10 ml vial with a royal blue cap, in a transparent blister pack.

Marketing Authorisation Holder

JANSSEN-CILAG INTERNATIONAL NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél + 32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5-Smíchov Tel: +420 227 012 227

Danmark

Janssen Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: + 32 14 64 94 11

Magyarország

Janssen Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: + 31 76 711 1111

Norge

Janssen-Cilag AS.

Postboks 144

NO-1325-Lysaker

Tlf: + 47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel:+43 1 610 300

España

Janssen-Cilag, S.A.

Paseo de las Doce Estrellas, 5-7 E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / + 33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h

10010 Zagreb

Tel: +385 1 6610 700

Ireland

Janssen-Cilag Ltd.

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Tel: +44 1 494 567 444

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: + 48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

România

Johnson & Johnson România SRL Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800

Slovenija

Johnson & Johnson d.o.o. Šmartinska cesta 53 SI-1000 Ljubljana

Tel. +386 1 401 18 30

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02/2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

This leaflet was last revised in

 

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

1. RECONSTITUTION FOR INTRAVENOUS INJECTION

Note: VELCADE is a cytotoxic agent. Therefore, caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended.

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF VELCADE SINCE NO PRESERVATIVE IS PRESENT.

1.1Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a syringe of the appropriate size without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.

The concentration of the resulting solution will be 1 mg/ml. The solution will be clear and colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.

1.2Before administration, visually inspect the solution for particulate matter and discolouration. If any discolouration or particulate matter is observed, the solution should be discarded. Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).

1.3The reconstituted solution is preservative free and should be used immediately after preparation. However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

It is not necessary to protect the reconstituted medicinal product from light.

2. ADMINISTRATION

Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.

Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).

Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.

Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.

VELCADE 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE. Do not give by other routes. Intrathecal administration has resulted in death.

3. DISPOSAL

A vial is for single use only and the remaining solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.

The following information is intended for healthcare professionals only:

Only the 3.5 mg vial can be administered subcutaneously, as described below.

1.RECONSTITUTION FOR SUBCUTANEOUS INJECTION

Note: VELCADE is a cytotoxic agent. Therefore, caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended.

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF VELCADE SINCE NO PRESERVATIVE IS PRESENT.

1.1Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a syringe of the appropriate size without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.

The concentration of the resulting solution will be 2.5 mg/ml. The solution will be clear and colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.

1.2Before administration, visually inspect the solution for particulate matter and discolouration. If any discolouration or particulate matter is observed, the solution should be discarded. Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).

1.3The reconstituted product is preservative free and should be used immediately after preparation. However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

It is not necessary to protect the reconstituted medicinal product from light.

2. ADMINISTRATION

Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.

Confirm the dose and concentration in the syringe prior to use. (check that the syringe is marked as subcutaneous administration).

Inject the solution subcutaneously, under a 45-90°angle.

The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).

Injection sites should be rotated for successive injections.

If local injection site reactions occur following VELCADE injection subcutaneously, either a less concentrated VELCADE solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.

VELCADE 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE. Do not give by other routes. Intrathecal administration has resulted in death.

3. DISPOSAL

A vial is for single use only and the remaining solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.

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