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MabCampath (alemtuzumab) – Package leaflet - L01XC04

Updated on site: 08-Oct-2017

Medication nameMabCampath
ATC CodeL01XC04
Substancealemtuzumab
ManufacturerGenzyme Europe B.V.

PACKAGE LEAFLET: INFORMATION FOR THE USER

MabCampath 10 mg/ml concentrate for solution for infusion

Alemtuzumab

Read all of this leaflet carefully before you start using this medicine.

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

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.

 

 

longer

WHAT MABCAMPATH IS AND WHAT IT IS USED FOR

MabCampath is used to treat patients with chronic lymph cytic leukaemia (CLL), a cancer of the

lymphocytes (a type of white blood cell). It is used in patients f

whom treatment combinations

including fludarabine (another medicine used in leukaemia) are n

t appropriate.

 

 

no

 

 

The active substance in MabCampath, alemtuzumab, is a monoclonal antibody. A monoclonal

antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific

 

are

ergicproductto alemtuzumab or to proteins of a similar origin or to any of the other ingredients of

structure (called an antigen) that is found in cer ain cells in the body. In CLL, too many lymphocytes

are produced. Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with

sugar molecules) that is found on the surfa e of lymphocytes. As a result of this binding, the

lymphocytes die, and this helps to ontrol the CLL.

 

 

2.

BEFORE YOU USE MABCAMPATH

 

 

Do not use MabCam ath if you:

 

 

Medicinal

 

 

 

M bC mp th (see section 6 “Further Information”). Your doctor will inform you accordingly

h ve

infection

 

 

 

have HIV

 

 

 

have an active second malignancy

 

 

 

are pregnant (see also “Pregnancy”).

 

 

Take special care with MabCampath:

When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “Possible side effects”). These effects will gradually reduce as treatment is continued.

You may also be given

steroids, antihistamines or analgesics (treatment for fever) to help reduce some of the side effects.

The dosage of MabCampath will not be increased until the effects are reduced.

 

MabCampath treatment may reduce your natural resistance to infections

 

 

antibiotics and antivirals may be given to provide you with extra protection.

You will be examined for symptoms of a certain type of viral infection called CMV (cytomegal vi us)

during your MabCampath therapy and for at least 2 months afterwards.

 

Your doctor will monitor you carefully if you

 

 

 

have heart disease or chest pains and/or you are receiving treatment to red ce high blood

 

pressure, as MabCampath may make these conditions worse.

authorised

 

Patients with these conditions may be at higher risk of a heart attack.

 

 

 

have been treated in the past with chemotherapies or general m dications that have a high risk

 

of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart

 

rate, body weight) while receiving MabCampath.

 

 

 

have other side effects, most often blood disorders fr m taki MabCampath.

 

Your doctor will be monitoring the effects of treatment and your progress carefully by

 

examining you and by taking blood samples for ana ysis a regular basis.

 

 

longer

 

are over 65 years of age as you may be m re i t lerant to the medicine than other patients.

no You may experienceproductan allergic or hyperse si ivity reaction to MabCampath solution, especially

against the protein contained in it, while he infusion is given to you. Your doctor will treat you for this, if this happens.

Because of the potential for a fatal reaction to transfusion of any blood products following treatment with MabCampath, it is recommen ed that you speak to your doctor regarding the irradiation of blood products prior to eceiving the transfusion. You should inform your doctor if you experience any unusual symptoms after a transfusion.

MabCampath is not recommended in children below 17 years of age or in patients who have kidney or

liver disorders.

MedicinalTaki g other medicines

You should form your doctor if you are taking or have recently taken any other medicines, even those not prescribed.

In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer agents.

Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment. Speak to your doctor before receiving any vaccinations.

Pregnancy

MabCampath must not be administered to patients who are pregnant, therefore if you:

Driving or using machines
Breast-feeding

are pregnant or you think you may be pregnant, you should tell your doctor immediately.

are a woman of childbearing potential or a fertile man, then you should use effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.

on the matter.

You should stop breast-feeding when you start your treatment and you should notauthorisedbegin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor

No studies of the effects of MabCampath on the ability to drive and use machines have been performed. However you should be cautious as confusion and sleepiness have been seen. You ould ask your doctor for advice.

3. HOW TO USE MABCAMPATH

MabCampath is administered into one of your veins via alongerdrip (see also ‘info mation intended for medical or healthcare professionals’).

Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.

MabCampath treatment may continue for up to 12 weeks depending your progress.

During the first week, your doctor will increasenothe d se of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.

MabCampath to give you during yo whole treatment period.

If you experienceproductearly side effects the ini ial smaller doses may be repeated until the effects go away or reduce. The doctor will carefully monitor you and decide what are the appropriate amounts of

If more MabCampath is given than recommended

Your doctor will treat y u, as appropriate, if you have any side effects.

4. POSSIBLE SIDE EFFECTS

MedicinalLike all medicines, MabCampath can cause side effects, although not everybody gets them.

Your doctor may give you other medicines or change your dose to help reduce any side effects (see se t on 2 “Take Special care”).

Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome. Diseases related to an overactive immune system where your immune system attacks your own body can lead to low red blood cells, low blood platelets and/or low white blood cells, and nerve disorders, and these can also be fatal. Tell your doctor immediately if you experience any of these side effects.

In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.

51

Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):

Usually one or more of these effects happen during the first week after the start of treatment:

 

fever, shivering/chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low

 

white/red blood cell levels, infections including pneumonia and blood poisoning, irritation

 

and/or blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red

 

raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.

They are usually only mild or moderate problems and they gradually diminish during the course of

treatment.

 

 

 

 

 

 

Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):

 

high blood pressure, fast or slow heart rate, feeling your heart racing, blood vessel spasm

 

becoming red in the face, bruising of the skin

 

 

 

 

taste changes

 

 

 

 

 

 

decreased sense of touch

 

 

 

 

 

dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless

 

eye inflammation (e.g. conjunctivitis)

 

 

 

authorised

 

pins and needles or burning sensation of the skin

 

 

 

 

abnormal liver function, constipation, indigestion, passing abdominal gas

 

 

inflammation, irritation and/or tightness of the lungs, throat a d/or sinuses, too little oxygen

 

reaching the body organs, coughing, coughing up of blood

 

abdominal bleeding (e.g. in the stomach and intestine)

 

 

injection site reactions including redness, swelling, pain, bruising, inflammation

 

generally feeling unwell, weakness, pain in vari

us parts of the body (muscle, back, chest,

 

bones, joints, stomach and intestine)

 

 

longer

 

weight loss, dehydration, thirst, swelli g f the l

wer legs, temperature change sensation, low

 

calcium or sodium blood levels

no

 

 

flu-like symptoms

 

 

 

 

abscess, skin redness or allergic skin reaction, blistering of the skin

 

 

confusion, anxiety, depression, sleeplessness

 

 

 

Uncommon side effects (affects 1 to 10 patients in every 1,000 patients treated in clinical trials):

 

bone marrow dis de s

 

 

 

 

 

heart disorde s (hea

stopping, heart attack, heart congestion, irregular heart rate)

 

blood disorders (abnormal clotting, decreased protein, low potassium levels)

 

high b ood sugar, worsening diabetes

 

 

 

 

 

bleeding ndproductinflammation of the gums, blisters on the tongue, nosebleeds

 

fluid

the lungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal

 

f di

gs in the lungs, lymph gland disorders

 

 

 

ervousness, abnormal thinking

 

 

 

 

 

swelling around the eye

 

 

 

 

 

ringing sound in the ears, deafness

 

 

 

 

 

hiccups, burping

 

 

 

 

 

 

hoarseness

 

 

 

 

 

 

abnormal kidney function

 

 

 

 

 

paralysis of the small bowel

 

 

 

 

 

impotence

 

 

 

 

 

Medicinal

 

 

 

 

 

 

unsteadiness, increased muscle tone

 

 

 

 

 

unusual increased or altered sensitivity to touch

 

 

 

 

abnormal sensation/feeling or movement

 

 

 

pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence

tumour lysis syndrome (a metabolic disorder, which may begin with pains in the side and blood in the urine)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

5. HOW TO STORE MABCAMPATH

Keep out of the reach and sight of children.

 

Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and e

ampoule label. The expiry date refers to the last day of that month.

authorised

Store in a refrigerator (2 C-8 C).

Do not freeze.

Store in the original packaging in order to protect from light.

 

 

longer

Medicines should not be disposed of via wastewater r h usehold waste. Your healthcare professional

will dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

no

 

product

 

 

MabCampath should be used within 8 hours after dilution. During that time the solution may be stored at 15°C-30°C or refrigerated.

Do not use MabCampath if you notice any signs of particu ate matter or discolouration prior to administration.

What MabCampath contains

The active substance is alemtuzumab.

One ml contains 10 mg f alemtuzumab. Each ampoule contains 30 mg of alemtuzumab.

The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen

phosphate, sodium chloride, dibasic sodium phosphate and water for injections.

MedicinalWhat bC mpath looks like and contents of the pack

MabCampath is a concentrate for solution for infusion that comes in a glass ampoule.

Ea h pack of MabCampath contains 3 ampoules.

Marketing Authorisation Holder

Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands

Manufacturer

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom

Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.

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

Authorisation Holder.

België/Belgique/Belgien/

 

Italia/Malta

authorised

 

 

Luxemburg/ Luxembourg

 

Genzyme Srl (Italia/Italja),

 

Genzyme Belgium N.V.,

 

Tel: +39 059 349 811

 

Tél/Tel: + 32 2 714 17 11

 

 

 

България

 

 

Magyarország

 

Джензайм ЕООД

 

 

Genzyme Europe B.V. Képviselet

Тел. +359 2 971 1001

 

Tel: +36 1 310 7440

 

Česká Republika/Slovenská Republika/

 

Nederland

 

Slovenija

 

 

Genzyme Europe B.V.,

 

Genzyme Czech s.r.o.

 

Tel: +31 35 699 1200

 

Tel: +420 221 722 511

 

longer

 

Danmark/Norge/Sverige/Suomi/Finland/

 

 

 

Österreich

 

Ísland

 

 

Genzyme Austria GmbH,

 

Genzyme A/S, (Danmark/Tanska/Danmörk),

Tel: + 43 1 774 65 38

 

Tlf/Puh./Sími: + 45 32712600

 

 

 

Deutschland

 

 

Polska/Eesti/Latvija/Lietuva

 

Genzyme GmbH,

 

 

Genzyme P ska Sp. z .o.

 

Tel: +49 610236740

 

(P la/P lija/Lenkija),

 

 

 

 

Tel: + 48 22 246 0900

 

Ελλάδα/Κύπρος

product

 

Portugal

 

 

 

Tel: +44 1865 405200

 

Genzyme Hellas Ltd. (Ελλάδα)

noGenzyme Portugal S.A.

 

Τηλ: +30 210 99 49 270

 

Tel: +351 21 422 0100

 

España

 

 

România

 

sanofi-aventis, S.A.

 

Genzyme Biopharma SRL

 

Tel: +34 93 485 94 00

 

Tel: +40 212 43 42 28

 

France

 

 

United Kingdom/Ireland

 

Genzyme S.A.S,

 

 

Genzyme Therapeutics Ltd. (United

Tél: + 33 (0) 825 825 863

 

Kingdom),

 

Medicinal

 

 

 

 

Th s leaflet was last approved in

 

 

 

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

The following information is intended for medical or healthcare professionals only:

During the first week, 3 mg of MabCampath is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3, depending on tolerability. MabCampath will be given at 30 mg three times per calendar week on alternate days, for up to 12 weeks.

infused though the same intravenous line.

 

 

authorised

The ampoule contents should be inspected for particulate matter and discolouration prior to

 

administration. If particulate matter is present or the solution is coloured, then the ampoule should not

be used.

 

 

 

 

 

 

MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath

should be prepared for intravenous infusion using aseptic techniques and that the diluted soluti

n f

infusion should be administered within 8 hours after preparation and protected from light. The

 

required amount of the ampoule contents should be added, via a sterile, low-protein binding, n

n-fibre

5 μm filter, to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%)

 

solution for infusion. The bag should be inverted gently to mix the solution. Care sho

ld be aken to

ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.

Other medicinal products should not be added to the MabCampath infusion solution

simultaneously

 

 

 

longer

 

 

 

Caution should be exercised in the handling and preparation of the MabCampath solution. The use of

latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the ampoule

or other accidental spillage. Women who are pregnant or tryi to become pregnant should not handle

MabCampath.

 

 

 

 

 

 

Procedures for proper handling and disposal should be

bserved. Any spillage or waste material

should be disposed of by incineration.

no

 

 

 

 

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

 

 

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

MabCampath 30 mg/ml concentrate for solution for infusion

Alemtuzumab

Read all of this leaflet carefully before you start using this medicine

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

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.

 

 

longer

WHAT MABCAMPATH IS AND WHAT IT IS USED FOR

MabCampath is used to treat patients with chronic lymph cytic leukaemia (CLL), a cancer of the

lymphocytes (a type of white blood cell). It is used in patients f

whom treatment combinations

including fludarabine (another medicine used in leukaemia) are n

t appropriate.

 

 

no

 

 

The active substance in MabCampath, alemtuzumab, is a monoclonal antibody. A monoclonal

antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific

 

are

ergicproductto alemtuzumab or to proteins of a similar origin or to any of the other ingredients of

structure (called an antigen) that is found in cer ain cells in the body. In CLL, too many lymphocytes

are produced. Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with

sugar molecules) that is found on the surfa e of lymphocytes. As a result of this binding, the

lymphocytes die, and this helps to ontrol the CLL.

 

 

2.

BEFORE YOU USE MABCAMPATH

 

 

Do not use MabCam ath if you:

 

 

Medicinal

 

 

 

M bC mp th (see section 6 “Further Information”). Your doctor will inform you accordingly

h ve

infection

 

 

 

have HIV

 

 

 

have an active second malignancy

 

 

 

are pregnant (see also “Pregnancy”).

 

 

Take special care with MabCampath:

When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “Possible side effects”). These effects will gradually reduce as treatment is continued.

You may also be given

steroids, antihistamines or analgesics (treatment for fever) to help reduce some of the side effects.

The dosage of MabCampath will not be increased until the effects are reduced.

MabCampath treatment may reduce your natural resistance to infections

 

antibiotics and antivirals may be given to provide you with extra protection.

You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus)

during your MabCampath therapy and for at least 2 months afterwards.

 

Your doctor will monitor you carefully if you

 

 

have heart disease or chest pains and/or you are receiving treatment to reduce high bl

 

pressure, as MabCampath may make these conditions worse.

 

 

Patients with these conditions may be at higher risk of a heart attack.

 

 

have been treated in the past with chemotherapies or general medications that have high risk

 

of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart

 

rate, body weight) while receiving MabCampath.

authorised

 

 

have other side effects, most often blood disorders from taking MabCampath.

 

Your doctor will be monitoring the effects of treatment and your progr ss carefully by

 

examining you and by taking blood samples for analysis a re ular basis.

 

are over 65 years of age as you may be more intolera t to the medicine than other patients.

You may experience an allergic or hypersensitivity reactionlongerto MabCampath solution, especially against the protein contained in it, while the infusinois given to you. Your doctor will treat you for this, if this happens.

blood products prior to receiving the transfusion. You should inform your doctor if you experience any unusual symptoms after a transf sion.

MabCampath is not recommen ed in children below 17 years of age or in patients who have kidney or liver disorders.

Taking other medicines

Because of the potentialproductfor a fatal reac ion ra sfusion of any blood products following treatment with MabCampath, it is recommended hat you speak to your doctor regarding the irradiation of

You should inform your doctor if you are taking or have recently taken any other medicines, even Medicinalthose not prescribed.

In part cular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer age ts.

Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment. Speak to your doctor before receiving any vaccinations.

Pregnancy

MabCampath must not be administered to patients who are pregnant, therefore if you:

are pregnant or you think you may be pregnant, you should tell your doctor immediately.

Driving or using machines

are a woman of childbearing potential or a fertile man, then you should use effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.

Breast-feeding

on the matter.

You should stop breast-feeding when you start your treatment and you should notauthorisedbegin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor

No studies of the effects of MabCampath on the ability to drive and use machines have been performed. However you should be cautious as confusion and sleepiness have been seen. Y s uld ask your doctor for advice.

3. HOW TO USE MABCAMPATH

Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.

MabCampath is administered into one of your veins vialongera drip (see also ‘info mation intended for medical or healthcare professionals’).

MabCampath treatment may continue for up to 12 weeks depending your progress.

no If you experienceproductearly side effects the ini ial smaller doses may be repeated until the effects go away or reduce. The doctor will carefully moni or you and decide what are the appropriate amounts of

During the first week, your doctor will increase the d se of MabCampath slowly to reduce the possibility of you having side effects and to all w y ur b dy to tolerate MabCampath better.

MabCampath to give you during your whole treatment period.

If more MabCampath is given than recommended

Your doctor will treat y u, as appropriate, if you have any side effects.

4. POSSIBLE SIDE EFFECTS

MedicinalLike all medicines, MabCampath can cause side effects, although not everybody gets them.

Your doctor m y give you other medicines or change your dose to help reduce any side effects (see sect on 2 “Take Special care”).

Ser ous side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome. Diseases related to an overactive immune system where your immune system attacks your own body can lead to low red blood cells, low blood platelets and/or low white blood cells, and nerve disorders, and these can also be fatal. Tell your doctor immediately if you experience any of these side effects.

In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.

Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):

Usually one or more of these effects happen during the first week after the start of treatment:

 

fever, shivering/chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low

 

white/red blood cell levels, infections including pneumonia and blood poisoning, irritation

 

and/or blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red

 

raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.

They are usually only mild or moderate problems and they gradually diminish during the course of

treatment.

 

 

 

Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):

 

high blood pressure, fast or slow heart rate, feeling your heart racing, blood vessel spasm

 

becoming red in the face, bruising of the skin

 

 

taste changes

 

 

 

decreased sense of touch

 

 

 

dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless

 

eye inflammation (e.g. conjunctivitis)

 

authorised

 

pins and needles or burning sensation of the skin

 

 

abnormal liver function, constipation, indigestion, passing abdominal gas

 

 

inflammation, irritation and/or tightness of the lungs, throat and/or sinus s, too little oxygen

 

reaching the body organs, coughing, coughing up of blood

 

abdominal bleeding (e.g. in the stomach and intestine)

 

 

injection site reactions including redness, swelling, pain, bruising, inflammation

 

generally feeling unwell, weakness, pain in various parts f the body (muscle, back, chest,

 

bones, joints, stomach and intestine)

 

 

 

weight loss, dehydration, thirst, swelling f the l werlongerlegs, temperature change sensation, low

 

calcium or sodium blood levels

 

 

flu-like symptoms

 

 

 

abscess, skin redness or allergic skin reaction, blistering of the skin

 

 

 

 

no

 

confusion, anxiety, depression, sleeplessness

 

Uncommon side effects (affects 1 to 10 in every patients in 1,000 patients treated in clinical trials):

 

bone marrow dis rders

 

 

 

heart disorde s (hea st pping, heart attack, heart congestion, irregular heart rate)

 

blood disorde s (abno mal clotting, decreased protein, low potassium levels)

 

high b ood sugar, worsening diabetes

 

 

 

bleeding and inflammation of the gums, blisters on the tongue, nosebleeds

 

fluid

product

 

 

the ungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal

 

fi di

gs in the lungs, lymph gland disorders

 

ervousness, abnormal thinking

 

 

 

swelli

g around the eye

 

 

 

ringing sound in the ears, deafness

 

 

 

hiccups, burping

 

 

 

hoarseness

 

 

 

abnormal kidney function

 

 

 

paralysis of the small bowel

 

 

 

impotence

 

 

Medicinalunsteadiness, increased muscle tone

 

 

unusual increased or altered sensitivity to touch’

abnormal sensation/feeling or movement

pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence

tumour lysis syndrome (a metabolic disorder, which may begin with pains in the side and blood in the urine)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

5. HOW TO STORE MABCAMPATH

Keep out of the reach and sight of children.

Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the vial label. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C-8 C).

authorised

Do not freeze.

Store in the original packaging in order to protect from light.

 

MabCampath should be used within 8 hours after dilution. During that time the solution may be stored

at 15°C-30°C or refrigerated.

 

Do not use MabCampath if you notice any signs of particulate matter or discolouration prior to

administration.

 

The active substance is alemtuz mab.

Medicines should not be disposed of via wastewater or h useh ld waste. Your healthcare professional

will dispose of medicines no longer required. These measures will help protect the environment.

 

no

longer

6. FURTHER INFORMATION

 

What MabCampath contains

 

product

 

 

One ml contains 30 mg of alemtuzumab. Each vial contains 30 mg of alemtuzumab.

The other ingredients a e dis dium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chlo ide, dibasic sodium phosphate and water for injections.

What MabCam ath looks like and contents of the pack

MedicinalMabC mp th is concentrate for solution for infusion that comes in a glass vial.

Ea h pack of MabCampath contains 3 vials.

Marketing Authorisation Holder

Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands

Manufacturer

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom

Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.

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

Authorisation Holder.

België/Belgique/Belgien/

Italia/Malta

 

Luxemburg/ Luxembourg

Genzyme Srl (Italia/Italja),

authorised

Genzyme Belgium N.V.,

Tel: +39 059 349 811

 

Tél/Tel: + 32 2 714 17 11

 

 

България

 

Magyarország

 

Джензайм ЕООД

 

Genzyme Europe B.V. Képviselet

Тел. +359 2 971 1001

Tel: +36 1 310 7440

 

Česká Republika/Slovenská Republika/

Nederland

 

Slovenija

 

Genzyme Europe B.V.,

 

Genzyme Czech s.r.o.

Tel: +31 35 699 1200

 

Tel: +420 221 722 511

 

 

Danmark/Norge/Sverige/Suomi/Finland/

Österreich

 

Ísland

 

Genzyme Austria GmbH,

 

Genzyme A/S, (Danmark/Tanska/Danmörk),

Tel: + 43 1 774 65 38

 

Tlf/Puh./Sími: + 45 32712600

 

 

Deutschland

 

Polska/Eesti/Latvija/Lietuva

 

Genzyme GmbH,

 

Genzyme P lska Sp. z .o.

 

Tel: +49 610236740

(Poo a/P ija/Lenkija),

 

 

 

Tel: + 48 22 246 0900

 

Ελλάδα/Κύπρος

 

no

 

 

P rtugallonger

 

Genzyme Hellas Ltd. (Ελλάδα)

Ge zyme Portugal S.A.

 

Τηλ: +30 210 99 49 270

Tel: +351 21 422 0100

 

España

product

România

 

 

 

sanofi-aventis, S.A.

Genzyme Biopharma SRL

 

Tel: +34 93 485 94 00

Tel: +40 212 43 42 28

 

France

 

United Kingdom/Ireland

 

Genzyme S.A.S,

 

Genzyme Therapeutics Ltd. (United

Tél: + 33 (0) 825 825 863

Kingdom),

 

Medicinal

 

Tel: +44 1865 405200

 

 

 

 

This le flet w s last approved in

 

 

Deta led formation on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

The following information is intended for medical or healthcare professionals only:

During the first week, 3 mg of MabCampath is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3, depending on tolerability. MabCampath will be given at 30 mg three times per calendar week on alternate days, for up to 12 weeks.

The vial contents should be inspected for particulate matter and discolouration prior to administration. If particulate matter is present or the solution is coloured, then the vial should not be used.

MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for

infusion should be administered within 8 hours after preparation and protected from light. The

required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%)

solution for infusion or glucose (5%) solution for infusion. The bag should be inverted gently to mix

the solution. Care should be taken to ensure the sterility of the prepared solution particularly as it

contains no antimicrobial preservatives.

authorised

 

Other medicinal products should not be added to the MabCampath infusion solution or simultaneously

infused though the same intravenous line.

 

Caution should be exercised in the handling and preparation of the MabCampath solution. The use f latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial other accidental spillage. Women who are pregnant or trying to become pregnant should not andle MabCampath.

Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of by incineration.

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

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