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Cancidas (Caspofungin MSD) (caspofungin) – Package leaflet - J02AX04

Updated on site: 05-Oct-2017

Medication nameCancidas (Caspofungin MSD)
ATC CodeJ02AX04
Substancecaspofungin
ManufacturerMerck Sharp

Package Leaflet: Information for the user

Cancidas 50 mg powder for concentrate for solution for infusion

Caspofungin

Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.

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

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

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

What is in this leaflet

1.What Cancidas is and what it is used for

2.What you need to know before you are given Cancidas

3.How to use Cancidas

4.Possible side effects

5.How to store Cancidas

6.Contents of the pack and other information

1.What Cancidas is and what it is used for

What Cancidas is

Cancidas contains a medicine called caspofungin. This belongs to a group of medicines called anti- fungals.

What Cancidas is used for

Cancidas is used to treat the following infections in children, adolescents and adults:

serious fungal infections in your tissues or organs (called ‘invasive candidiasis’). This infection is caused by fungal (yeast) cells called Candida.

People who might get this type of infection include those who have just had an operation or those whose immune systems are weak. Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection.

fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis’) if other anti-fungal treatments have not worked or have caused side effects. This infection is caused by a mould called Aspergillus.

People who might get this type of infection include those having chemotherapy, those who have had a transplant and those whose immune systems are weak.

suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic. People who are at risk of getting a fungal infection include those who have just had an operation or those whose immune systems are weak.

How Cancidas works

Cancidas makes fungal cells fragile and stops the fungus from growing properly. This stops the infection from spreading and gives the body’s natural defences a chance to completely get rid of the infection.

2. What you need to know before you are given Cancidas

Do not use Cancidas

-if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in

section 6).

If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you are given Cancidas if:

you are allergic to any other medicines

you have ever had liver problems - you might need a different dose of this medicine

you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.

if you have ever had any other medical problem.

If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.

Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Cancidas

Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Cancidas can affect the way some other medicines work. Also some other medicines can affect the way Cancidas works.

Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

cyclosporin or tacrolimus (used to help prevent organ transplant rejection or to suppress your immune system) as your doctor may need to run extra blood tests during your treatment

some HIV medicines such as efavirenz or nevirapine

phenytoin or carbamazepine (used for the treatment of seizures)

dexamethasone (a steroid)

rifampicin (an antibiotic).

If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.

Cancidas has not been studied in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.

Women given Cancidas should not breast-feed.

Driving and using machines

There is no information to suggest that Cancidas affects your ability to drive or operate machinery.

Cancidas contains sucrose

Cancidas contains sucrose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor, nurse or pharmacist before you are given this medicine.

3.How to use Cancidas

Cancidas will always be prepared and given to you by a healthcare professional. You will be given Cancidas:

once each day

by slow injection into a vein (intravenous infusion)

over about 1 hour.

Your doctor will determine the duration of your treatment and how much Cancidas you will be given each day. Your doctor will monitor how well the medicine works for you. If you weigh more than 80 kg, you may need a different dose.

Children and adolescents

The dose for children and adolescents may differ from the adult dose.

If you have been given more Cancidas than you should

Your doctor will decide how much Cancidas you need and for how long each day. If you are worried that you may have been given too much Cancidas, tell your doctor or nurse straight away.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse straight away if you notice any of the following side effects – you may need urgent medical treatment:

rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine.

difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.

cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.

rash, skin peeling, mucous membrane sores, hives, large areas of peeling skin.

As with any prescription medicine, some side effects may be serious. Ask your doctor for more information.

Other side effects in adults include

Common: may affect up to 1 in 10 people:

Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells

Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood

Headache

Inflammation of the vein

Shortness of breath

Diarrhoea, nausea or vomiting

Changes in some laboratory blood tests (including increased values of some liver tests)

Itching, rash, skin redness or sweating more than usual

Joint pain

Chills, fever

Itching at the injection site.

Uncommon: may affect up to 1 in 100 people:

Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)

Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood

Disorientation, feeling nervous, being unable to sleep

Feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy, change in the way things taste, tingling or numbness

Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes

Sensation of fast or irregular heart beats, rapid heart beat, irregular heart beat, abnormal heart rhythm, heart failure

Flushing, hot flush, high blood pressure, low blood pressure, redness along a vein which is extremely tender when touched

Tightening of the bands of muscle around the airways resulting in wheezing or coughing, fast breathing rate, shortness of breath that wakes you up, shortage of oxygen in the blood, abnormal breath sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain

Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly

Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical, liver disorder

Abnormal skin tissue, generalised itching, hives, rash of varying appearance, abnormal skin, red often itchy spots on your arms and legs and sometimes on the face and the rest of the body

Back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness

Loss of kidney function, sudden loss of kidney function

Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site

Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system

Chest discomfort, chest pain, feeling of body temperature change, generally feeling unwell, general pain, swelling of the face, swelling of the ankles, hands or feet, swelling, tenderness, feeling tired.

Side effects in children and adolescents

Very common: may affect more than 1 in 10 people:

Fever

Common: may affect up to 1 in 10 people:

Headache

Fast heart beat

Flushing, low blood pressure

Changes in some laboratory blood tests (increased values of some liver tests)

Itching, rash

Catheter site pain

Chills

Changes in some laboratory blood tests.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse 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 Cancidas

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

Do not use this medicine after the expiry date which is stated on the carton and the vial (the first two numbers are the month; the next four numbers are the year). The expiry date refers to the last day of that month.

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

Once Cancidas has been prepared, it should be used straight away. This is because it does not contain any ingredients to stop the growth of bacteria. Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Cancidas”).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Cancidas contains

The active substance is caspofungin. Each vial of Cancidas contains 50 mg of caspofungin.

The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide (please see section 2. What you need to know before you are given Cancidas).

What Cancidas looks like and contents of the pack

Cancidas is a sterile, white to off-white compact powder.

Each pack contains one vial of powder.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Limited

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

 

or

 

Laboratories Merck Sharp & Dohme- Chibret

 

Route de Marsat-RIOM

 

63963 Clermont-Ferrand Cedex 9

 

France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel.: +370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel.: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com

Eλλάδα

MSD Α.Φ.Β.Ε.Ε

Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: + 33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited Tel.: 8007 4433 (+ 356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: + 386 1 5204201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0) 9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 5700488 medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224 msd_lv@merck.com

This leaflet was last revised in

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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:

Instructions of how to reconstitute and dilute CANCIDAS:

Reconstitution of CANCIDAS

DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CANCIDAS is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products. Visually inspect the infusion solution for particulate matter or discolouration.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of conventional vials

To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentrations of the reconstituted vials will be 5.2 mg/ml.

The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25°C.

Step 2 Addition of reconstituted CANCIDAS to patient infusion solution

Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer’s solution. The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses. Do not use if the solution is cloudy or has precipitated.

PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS

DOSE*

Volume of recon-

Standard preparation

Reduced volume

 

stituted

(reconstituted

infusion

 

CANCIDAS for

CANCIDAS added to

(reconstituted

 

transfer to

250 ml) final

CANCIDAS added to

 

intravenous bag or

concentration

100 ml) final

 

bottle

 

concentration

50 mg

10 ml

0.20 mg/ml

-

50 mg at reduced

10 ml

-

0.47 mg/ml

volume

 

 

 

35 mg for moderate

 

 

 

hepatic impairment

7 ml

0.14 mg/ml

-

(from one 50 mg vial)

 

 

 

DOSE*

Volume of recon-

Standard preparation

Reduced volume

 

stituted

(reconstituted

infusion

 

CANCIDAS for

CANCIDAS added to

(reconstituted

 

transfer to

250 ml) final

CANCIDAS added to

 

intravenous bag or

concentration

100 ml) final

 

bottle

 

concentration

35 mg for moderate

 

 

 

hepatic impairment

7 ml

-

0.34 mg/ml

(from one 50 mg vial) at

 

 

 

reduced volume

 

 

 

* 10.5 ml should be used

for reconstitution of all

vials

 

INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for paediatric dosing

Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller2 Formula)

Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)

1.Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA

(as calculated above) and the following equation: BSA (m2) X 70 mg/m2 = Loading Dose

The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.

2.Equilibrate the refrigerated vial of CANCIDAS to room temperature.

3.Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of 5.2 mg/ml.

4.Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle)

containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C.

Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)

1.Determine the actual daily maintenance dose to be used in the paediatric patient by using the

patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose

The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.

2.Equilibrate the refrigerated vial of CANCIDAS to room temperature.

3.Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of 5.2 mg/ml.

4.Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or

bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers

2 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)

Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C.

Preparation notes:

a The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.

b Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.

c CANCIDAS is formulated to provide the full labelled vial dose (50 mg) when 10 ml is withdrawn from the vial.

Package Leaflet: Information for the user

Cancidas 70 mg powder for concentrate for solution for infusion

Caspofungin

Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.

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

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

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

What is in this leaflet

1.What Cancidas is and what it is used for

2.What you need to know before you are given Cancidas

3.How to use Cancidas

4.Possible side effects

5.How to store Cancidas

6.Contents of the pack and other information

1. What Cancidas is and what it is used for

What Cancidas is

Cancidas contains a medicine called caspofungin. This belongs to a group of medicines called anti- fungals.

What Cancidas is used for

Cancidas is used to treat the following infections in children, adolescents and adults:

serious fungal infections in your tissues or organs (called ‘invasive candidiasis’). This infection is caused by fungal (yeast) cells called Candida.

People who might get this type of infection include those who have just had an operation or those whose immune systems are weak. Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection.

fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis’) if other anti-fungal treatments have not worked or have caused side effects. This infection is caused by a mould called Aspergillus.

People who might get this type of infection include those having chemotherapy, those who have had a transplant and those whose immune systems are weak.

suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic. People who are at risk of getting a fungal infection include those who have just had an operation or those whose immune systems are weak.

How Cancidas works

Cancidas makes fungal cells fragile and stops the fungus from growing properly. This stops the infection from spreading and gives the body’s natural defences a chance to completely get rid of the infection.

2. What you need to know before you are given Cancidas

Do not use Cancidas

-if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in

Section 6).

If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you are given Cancidas if:

you are allergic to any other medicines

you have ever had liver problems - you might need a different dose of this medicine

you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.

if you have ever had any other medical problem.

If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.

Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Cancidas

Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Cancidas can affect the way some other medicines work. Also some other medicines can affect the way Cancidas works.

Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

cyclosporin or tacrolimus (used to help prevent organ transplant rejection or to suppress your immune system) as your doctor may need to run extra blood tests during your treatment

some HIV medicines such as efavirenz or nevirapine

phenytoin or carbamazepine (used for the treatment of seizures)

dexamethasone (a steroid)

rifampicin (an antibiotic).

If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.

Pregnancy and breastfeeding

Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.

Cancidas has not been studied in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.

Women given Cancidas should not breast-feed.

Driving and using machines

There is no information to suggest that Cancidas affects your ability to drive or operate machinery.

Cancidas contains sucrose

Cancidas contains sucrose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor, nurse or pharmacist before you are given this medicine.

3. How to use Cancidas

Cancidas will always be prepared and given to you by a healthcare professional. You will be given Cancidas:

once each day

by slow injection into a vein (intravenous infusion)

over about 1 hour.

Your doctor will determine the duration of your treatment and how much Cancidas you will be given each day. Your doctor will monitor how well the medicine works for you. If you weigh more than 80 kg, you may need a different dose.

Children and adolescents

The dose for children and adolescents may differ from the adult dose.

If you have been given more Cancidas than you should

Your doctor will decide how much Cancidas you need and for how long each day. If you are worried that you may have been given too much Cancidas, tell your doctor or nurse straight away.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse straight away if you notice any of the following side effects – you may need urgent medical treatment:

rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine.

difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.

cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.

rash, skin peeling, mucous membrane sores, hives, large areas of peeling skin.

As with any prescription medicine, some side effects may be serious. Ask your doctor for more information.

Other side effects in adults include

Common: may affect up to 1 in 10 people:

Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells

Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood

Headache

Inflammation of the vein

Shortness of breath

Diarrhoea, nausea or vomiting

Changes in some laboratory blood tests (including increased values of some liver tests)

Itching, rash, skin redness or sweating more than usual

Joint pain

Chills, fever

Itching at the injection site.

Uncommon: may affect up to 1 in 100 people:

Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)

Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood

Disorientation, feeling nervous, being unable to sleep

Feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy, change in the way things taste, tingling or numbness

Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes

Sensation of fast or irregular heart beats, rapid heart beat, irregular heart beat, abnormal heart rhythm, heart failure

Flushing, hot flush, high blood pressure, low blood pressure, redness along a vein which is extremely tender when touched

Tightening of the bands of muscle around the airways resulting in wheezing or coughing, fast breathing rate, shortness of breath that wakes you up, shortage of oxygen in the blood, abnormal breath sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain

Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly

Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical, liver disorder

Abnormal skin tissue, generalised itching, hives, rash of varying appearance, abnormal skin, red often itchy spots on your arms and legs and sometimes on the face and the rest of the body

Back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness

Loss of kidney function, sudden loss of kidney function

Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site

Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system

Chest discomfort, chest pain, feeling of body temperature change, generally feeling unwell, general pain, swelling of the face, swelling of the ankles, hands or feet, swelling, tenderness, feeling tired.

Side effects in children and adolescents

Very common: may affect more than 1 in 10 people:

Fever

Common: may affect up to 1 in 10 people:

Headache

Fast heart beat

Flushing, low blood pressure

Changes in some laboratory blood tests (increased values of some liver tests)

Itching, rash

Catheter site pain

Chills

Changes in some laboratory blood tests.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse 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 Cancidas

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

Do not use this medicine after the expiry date which is stated on the carton and the vial (the first two numbers are the month; the next four numbers are the year). The expiry date refers to the last day of that month.

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

Once Cancidas has been prepared, it should be used straight away. This is because it does not contain any ingredients to stop the growth of bacteria. Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Cancidas”).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Cancidas contains

The active substance is caspofungin. Each vial of Cancidas contains 70 mg of caspofungin.

The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide (please see section 2. What you need to know before you are given Cancidas).

What Cancidas looks like and contents of the pack

Cancidas is a sterile, white to off-white compact powder.

Each pack contains one vial of powder.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Limited

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

 

or

 

Laboratories Merck Sharp & Dohme- Chibret

 

Route de Marsat-RIOM

 

63963 Clermont-Ferrand Cedex 9

 

France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel.: +370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel.: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com

Eλλάδα

MSD Α.Φ.Β.Ε.Ε

Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: + 33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited Tel.: 8007 4433 (+ 356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: + 386 1 5204201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0) 9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 5700488 medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224 msd_lv@merck.com

This leaflet was last revised in

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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:

Instructions of how to reconstitute and dilute CANCIDAS:

Reconstitution of CANCIDAS

DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CANCIDAS is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products. Visually inspect the infusion solution for particulate matter or discolouration.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of conventional vials

To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentrations of the reconstituted vials will be: 7.2 mg/ml.

The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25°C.

Step 2 Addition of reconstituted CANCIDAS to patient infusion solution

Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer’s solution. The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses. Do not use if the solution is cloudy or has precipitated.

PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS

DOSE*

Volume of

Standard

Reduced volume

 

reconstituted

preparation

infusion

 

CANCIDAS for

(reconstituted

(reconstituted

 

transfer to

CANCIDAS added to

CANCIDAS added to

 

intravenous bag or

250 ml) final

100 ml) final

 

bottle

concentration

concentration

70 mg

10 ml

0.28 mg/ml

Not Recommended

70 mg

 

 

 

(from two 50-mg

14 ml

0.28 mg/ml

Not Recommended

vials)**

 

 

 

35 mg for moderate

 

 

 

hepatic impairment

5 ml

0.14 mg/ml

0.34 mg/ml

(from one 70 mg vial)

 

 

 

*10.5 ml should be used for reconstitution of all vials

**If 70 mg vial is not available, the 70 mg dose can be prepared from two 50-mg vials

INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for paediatric dosing

Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)

Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of age (using a 70-mg vial)

1.Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA

(as calculated above) and the following equation: BSA (m2) X 70 mg/m2 = Loading Dose

The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.

2.Equilibrate the refrigerated vial of CANCIDAS to room temperature.

3.Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of 7.2 mg/ml.

4.Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle)

containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C.

Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a 70-mg vial)

1.Determine the actual daily maintenance dose to be used in the paediatric patient by using the

patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose

The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.

2.Equilibrate the refrigerated vial of CANCIDAS to room temperature.

3.Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of 7.2 mg/ml.

4.Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or

bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C.

Preparation notes:

a The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.

b Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.

c CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.

3 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)

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