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Cubicin (daptomycin) – Package leaflet - J01XX09

Updated on site: 06-Oct-2017

Medication nameCubicin
ATC CodeJ01XX09
Substancedaptomycin
ManufacturerMerck Sharp

Package leaflet: Information for the patient

Cubicin 350 mg powder for solution for injection or infusion daptomycin

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 nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

What is in this leaflet

1.What Cubicin is and what it is used for

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

3.How Cubicin is given

4.Possible side effects

5.How to store Cubicin

6.Contents of the pack and other information

1.What Cubicin is and what it is used for

The active substance in Cubicin powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Cubicin is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a bacterium called Staphylococcus aureus and to treat infections in the blood caused by the same bacterium when associated with skin or heart infection.

Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Cubicin.

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

You should not be given Cubicin

If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.

Warnings and precautions

Talk to your doctor or nurse before you are given Cubicin.

-If you have, or have previously had kidney problems. Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).

-Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin. The symptoms generally go away within a few days of stopping Cubicin.

-If you are very overweight. There is a possibility that your blood levels of Cubicin could be higher than those found in persons of average weight and you may need careful monitoring in

case of side effects.

If any of these applies to you, tell your doctor or nurse before you are given Cubicin.

Tell your doctor straight away if you develop any of the following symptoms:

-Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Cubicin. Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information).

-Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment.

-Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.

-New or worsening fever, cough or difficulty breathing. These may be signs of a rare but serious lung disorder called eosinophilic pneumonia. Your doctor will check the condition of your lungs and decide whether or not you should continue Cubicin treatment.

Cubicin may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is no problem. Therefore it is important that your doctor takes into account that you are receiving Cubicin. Please inform your doctor that you are on treatment with Cubicin.

Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.

Children and adolescents

Cubicin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.

Use in elderly

People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

Other medicines and Cubicin

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention the following:

-Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Cubicin. Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.

-Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These could interfere with the effects of Cubicin in the kidney.

-Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting. It may be necessary for your doctor to monitor your blood clotting times.

Pregnancy and breast-feeding

Cubicin is not usually given to pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could

affect the baby.

Driving and using machines

Cubicin has no known effects on the ability to drive or use machines.

3.How Cubicin is given

Cubicin will usually be given to you by a doctor or a nurse.

The dose will depend on how much you weigh and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well.

Children and adolescents (1 to 17 years of age)

The dose for children and adolescents (1 to 17 years of age) being treated for skin infection will depend on the age of patient. The recommended doses based on age are shown in the table below:

Age group

Dosage

Duration of treatment

12 to 17 years

5 mg/kg once every 24 hours infused over

 

 

30 minutes

 

7 to 11 years

7 mg/kg once every 24 hours infused over

 

 

30 minutes

Up to 14 days

2 to 6 years

9 mg/kg once every 24 hours infused over

 

 

60 minutes

 

1 to < 2 years

10 mg/kg once every 24 hours infused over

 

 

60 minutes

 

If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day. If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.

A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated.

Detailed instructions for use and handling are given at the end of the leaflet.

4.Possible side effects

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

The most serious side effects are described below:

Very rare serious side effects (may affect up to 1 in 10,000 people)

A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of Cubicin. This serious allergic reaction needs immediate medical attention. Tell your doctor or nurse straight away if you experience any of the following symptoms:

-Chest pain or tightness,

-Rash with blistering, sometimes affecting the mouth and genitals,

-Swelling around throat,

-Rapid or weak pulse,

-Wheezing,

-Fever,

-Shivering or trembling,

-Hot flushes,

-Dizziness,

-Fainting,

-Metallic taste.

Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness. In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.

Serious side effects with frequency not known (frequency cannot be estimated from the available data)

A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given Cubicin, mostly after more than 2 weeks of treatment. The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever. If you experience these symptoms, tell your doctor or nurse straight away.

If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.

The most frequently reported side effects are described below:

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

-Fungal infections such as thrush,

-Urinary tract infection,

-Decreased number of red blood cells (anaemia),

-Dizziness, anxiety, difficulty in sleeping,

-Headache,

-Fever, weakness (asthenia),

-High or low blood pressure,

-Constipation, abdominal pain,

-Diarrhoea, feeling sick (nausea) or being sick (vomiting),

-Flatulence,

-Abdominal swelling or bloating,

-Skin rash or itching,

-Pain, itchiness or redness at the site of infusion,

-Pain in arms or legs,

-Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).

Other side effects which may occur following Cubicin treatment are described below:

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

-Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells),

-Decreased appetite,

-Tingling or numbness of the hands or feet, taste disturbance,

-Trembling,

-Changes in heart rhythm, flushes,

-Indigestion (dyspepsia), inflammation of the tongue,

-Itchy rash of skin,

-Muscle pain or weakness, inflammation of the muscles (myositis), joint pain,

-Kidney problems,

-Inflammation and irritation of the vagina,

-General pain or weakness, tiredness (fatigue),

-Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts.

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

-Yellowing of the skin and eyes,

-Prothrombin time prolonged.

Frequency not known (frequency cannot be estimated from the available data) Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Cubicin

- 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 label after EXP. The expiry date refers to the last day of the month.

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

6. Contents of the pack and other information

What Cubicin contains

-The active substance is daptomycin. One vial of powder contains 350 mg daptomycin.

-The other ingredient is sodium hydroxide.

What Cubicin looks like and contents of the pack

Cubicin powder for solution for injection or infusion is supplied as a pale yellow to light brown cake or powder in a glass vial. It is mixed with a solvent to form a liquid before it is administered.

Cubicin is available in packs containing 1 vial or 5 vials.

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Manufacturer

MSD Italia S.r.l.

Via Fontana del Ceraso 7 03012 - Anagni (FR) Italy

Laboratories Merck Sharp & Dohme Chibret

Route de Marsat

Riom

63963, Clermont Ferrand Cedex 9

France

For any information about this medicine, 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.: +361 888 53 00

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: +45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000 (+31 23 5153153)

e-mail@msd.de

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@ msd.no

Ελλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Polska

Merck Sharp & Dohme de España, S.A.

MSD Polska Sp.z o.o.

Tel: +34 91 321 06 00

Tel.: +48 22 549 51 00

msd_info@merck.com

msdpolska@merck.com

France

Portugal

MSD France

Merck Sharp & Dohme, Lda

Tél: + 33 (0) 1 80 46 40 40

Tel: +351 21 4465700

 

clic@merck.com

Hrvatska

România

Merck Sharp & Dohme d.o.o.

Merck Sharp & Dohme Romania S.R.L.

Tel: + 385 1 6611 333

Tel: +40 21 529 29 00

croatia_info@merck.com

msdromania@merck.com

Ireland

Slovenija

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 299 8700 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

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com.

This leaflet was last revised in

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201 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 804650 info@msd.fi

Sverige

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

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 healthcare professionals only

Important: Please refer to the Summary of Product Characteristics before prescribing.

Instructions for use and handling

350 mg presentation:

Daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as an injection over 2 minutes. Preparation of the solution for infusion requires an additional dilution step as detailed below.

Cubicin given as an intravenous infusion over 30 or 60 minutes

A 50 mg/ml concentration of Cubicin for infusion can be achieved by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.

To prepare Cubicin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.

1.The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

2.The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.

3.Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

4.The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

5.Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.

6.The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).

7.Invert the vial in order to allow the solution to drain towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.

8.Replace needle with a new needle for the intravenous infusion.

9.Expel air, large bubbles, and any excess solution in order to obtain the required dose.

10.The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.

Cubicin is not physically or chemically compatible with glucose-containing solutions. The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.

The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C

must not exceed 12 hours (24 hours if refrigerated).

Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration at 2°C – 8°C.

Cubicin given as 2-minute intravenous injection (adult patients only)

Water should not be used for reconstitution of Cubicin for intravenous injection. Cubicin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).

A 50 mg/ml concentration of Cubicin for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.

To prepare Cubicin for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.

1.The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

2.The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.

3.Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

4.The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

5.Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.

6.Invert the vial in order to allow the solution to drain towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.

7.Replace needle with a new needle for the intravenous injection.

8.Expel air, large bubbles, and any excess solution in order to obtain the required dose.

9.The reconstituted solution should then be injected intravenously slowly over 2 minutes.

Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C – 8°C).

However, from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.

Cubicin vials are for single-use only. Any unused portion remaining in the vial should be discarded.

Package leaflet: Information for the patient

Cubicin 500 mg powder for solution for injection or infusion daptomycin

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 nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

What is in this leaflet

1.What Cubicin is and what it is used for

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

3.How Cubicin is given

4.Possible side effects

5.How to store Cubicin

6.Contents of the pack and other information

1. What Cubicin is and what it is used for

The active substance in Cubicin powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Cubicin is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a bacterium called Staphylococcus aureus and to treat infections in the blood caused by the same bacterium when associated with skin or heart infection.

Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Cubicin.

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

You should not be given Cubicin

If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.

Warnings and precautions

Talk to your doctor or nurse before you are given Cubicin.

-If you have, or have previously had kidney problems. Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).

-Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin. The symptoms generally go away within a few days of stopping Cubicin.

-If you are very overweight. There is a possibility that your blood levels of Cubicin could be higher than those found in persons of average weight and you may need careful monitoring in

case of side effects.

If any of these applies to you, tell your doctor or nurse before you are given Cubicin.

Tell your doctor straight away if you develop any of the following symptoms:

-Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Cubicin. Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information).

-Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment.

-Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.

-New or worsening fever, cough or difficulty breathing. These may be signs of a rare but serious lung disorder called eosinophilic pneumonia. Your doctor will check the condition of your lungs and decide whether or not you should continue Cubicin treatment.

Cubicin may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is no problem. Therefore it is important that your doctor takes into account that you are receiving Cubicin. Please inform your doctor that you are on treatment with Cubicin.

Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.

Children and adolescents

Cubicin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.

Use in elderly

People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

Other medicines and Cubicin

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention the following:

-Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Cubicin. Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.

-Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These could interfere with the effects of Cubicin in the kidney.

-Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting. It may be necessary for your doctor to monitor your blood clotting times.

Pregnancy and breast-feeding

Cubicin is not usually given to pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could

affect the baby.

Driving and using machines

Cubicin has no known effects on the ability to drive or use machines.

3. How Cubicin is given

Cubicin will usually be given to you by a doctor or a nurse.

The dose will depend on how much you weigh and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well.

Children and adolescents (1 to 17 years of age)

The dose for children and adolescents (1 to 17 years of age) being treated for skin infection will depend on the age of patient. The recommended doses based on age are shown in the table below:

Age group

Dosage

Duration of treatment

12 to 17 years

5 mg/kg once every 24 hours infused over

 

 

30 minutes

 

7 to 11 years

7 mg/kg once every 24 hours infused over

 

 

30 minutes

Up to 14 days

2 to 6 years

9 mg/kg once every 24 hours infused over

 

 

60 minutes

 

1 to < 2 years

10 mg/kg once every 24 hours infused over

 

 

60 minutes

 

If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day. If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.

A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated.

Detailed instructions for use and handling are given at the end of the leaflet.

4. Possible side effects

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

The most serious side effects are described below:

Very rare serious side effects (may affect up to 1 in 10,000 people)

A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of Cubicin. This serious allergic reaction needs immediate medical attention. Tell your doctor or nurse straight away if you experience any of the following symptoms:

-Chest pain or tightness,

-Rash with blistering, sometimes affecting the mouth and genitals,

-Swelling around throat,

-Rapid or weak pulse,

-Wheezing,

-Fever,

-Shivering or trembling,

-Hot flushes,

-Dizziness,

-Fainting,

-Metallic taste.

Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness. In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.

Serious side effects with frequency not known (frequency cannot be estimated from the available data)

A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given Cubicin, mostly after more than 2 weeks of treatment. The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever. If you experience these symptoms, tell your doctor or nurse straight away.

If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.

The most frequently reported side effects are described below:

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

-Fungal infections such as thrush,

-Urinary tract infection,

-Decreased number of red blood cells (anaemia),

-Dizziness, anxiety, difficulty in sleeping,

-Headache,

-Fever, weakness (asthenia),

-High or low blood pressure,

-Constipation, abdominal pain,

-Diarrhoea, feeling sick (nausea) or being sick (vomiting),

-Flatulence,

-Abdominal swelling or bloating,

-Skin rash or itching,

-Pain, itchiness or redness at the site of infusion,

-Pain in arms or legs,

-Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).

Other side effects which may occur following Cubicin treatment are described below:

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

-Blood disorders (e.g increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells),

-Decreased appetite,

-Tingling or numbness of the hands or feet, taste disturbance,

-Trembling,

-Changes in heart rhythm, flushes,

-Indigestion (dyspepsia), inflammation of the tongue,

-Itchy rash of skin,

-Muscle pain or weakness, inflammation of the muscles (myositis), joint pain,

-Kidney problems,

-Inflammation and irritation of the vagina,

-General pain or weakness, tiredness (fatigue),

-Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts.

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

-Yellowing of the skin and eyes,

-Prothrombin time prolonged.

Frequency not known (frequency cannot be estimated from the available data) Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Cubicin

- 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 label after EXP. The expiry date refers to the last day of the month.

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

6. Contents of the pack and other information

What Cubicin contains

-The active substance is daptomycin. One vial of powder contains 500 mg daptomycin.

-The other ingredient is sodium hydroxide.

What Cubicin looks like and contents of the pack

Cubicin powder for solution for injection or infusion is supplied as a pale yellow to light brown cake or powder in a glass vial. It is mixed with a solvent to form a liquid before it is administered.

Cubicin is available in packs containing 1 vial or 5 vials.

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Manufacturer

MSD Italia S.r.l.

Via Fontana del Ceraso 7 03012 - Anagni (FR) Italy

Laboratories Merck Sharp & Dohme Chibret

Route de Marsat

Riom

63963, Clermont Ferrand Cedex 9

France

For any information about this medicine, 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.: +361 888 53 00

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: +45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000 (+31 23 5153153)

e-mail@msd.de

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@ msd.no

Ελλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Polska

Merck Sharp & Dohme de España, S.A.

MSD Polska Sp.z o.o.

Tel: +34 91 321 06 00

Tel.: +48 22 549 51 00

msd_info@merck.com

msdpolska@merck.com

France

Portugal

MSD France

Merck Sharp & Dohme, Lda

Tél: + 33 (0) 1 80 46 40 40

Tel: +351 21 4465700

 

clic@merck.com

Hrvatska

România

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)1 299 8700 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

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com.

This leaflet was last revised in

Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201 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 804650 info@msd.fi

Sverige

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

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 healthcare professionals only

Important: Please refer to the Summary of Product Characteristics before prescribing.

Instructions for use and handling

500 mg presentation:

Daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as an injection over 2 minutes. Preparation of the solution for infusion requires an additional dilution step as detailed below.

Cubicin given as an intravenous infusion over 30 or 60 minutes

A 50 mg/ml concentration of Cubicin for infusion can be achieved by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.

To prepare Cubicin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.

1.The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

2.The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.

3.Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

4.The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

5.Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.

6.The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).

7.Invert the vial in order to allow the solution to drain towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.

8.Replace needle with a new needle for the intravenous infusion.

9.Expel air, large bubbles, and any excess solution in order to obtain the required dose.

10.The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.

Cubicin is not physically or chemically compatible with glucose-containing solutions. The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.

The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C

must not exceed 12 hours (24 hours if refrigerated).

Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration at 2°C – 8°C.

Cubicin given as 2 -minute intravenous injection (adult patients only)

Water should not be used for reconstitution of Cubicin for intravenous injection. Cubicin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).

A 50 mg/ml concentration of Cubicin for injection is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.

To prepare Cubicin for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.

1.The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

2.The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.

3.Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

4.The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

5.Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.

6.Invert the vial in order to allow the solution to drain towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.

7.Replace needle with a new needle for the intravenous injection.

8.Expel air, large bubbles, and any excess solution in order to obtain the required dose.

9.The reconstituted solution should then be injected intravenously slowly over 2 minutes.

Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C – 8°C).

However, from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.

Cubicin vials are for single-use only. Any unused portion remaining in the vial should be discarded.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for daptomycin, the scientific conclusions of CHMP are as follows:

A cumulative review of post-marketing data revealed that there were a total of 17 cases where the reporter described organising pneumonia associated with daptomycin therapy without reporting an associated diagnosis of pulmonary eosinophilia or eosinophilic pneumonia. The majority describe probable or possible organising pneumonia based on a radiographic presentation compatible with eosinophilic pneumonia. Definite cases with both histopathological and radiographic descriptions appeared to be consistent with the known presentation of eosinophilic pneumonia, but the diagnosis was not initially recognised. Organising pneumonia is therefore to be added to section 4.4 of the EU SmPC (special warnings and precautions) and to section 4.8 (undesirable effects) as an adverse reaction of not known frequency under respiratory, thoracic and mediastinal disorders. No changes to the package leaflet are required.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the Marketing Authorisation(s)

On the basis of the scientific conclusions for daptomycin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing daptomycin is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.

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