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AstraZeneca

Cubicin
daptomycin

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.


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.


Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39

2031 BN Haarlem The Netherlands


Manufacturer FAREVA Mirabel 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

MSD Belgium

Tél/Tel: +32(0)27766211

dpoc_belux@merck.com

Lietuva

UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47

msd_lietuva@merck.com


България

Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737

info-msdbg@merck.com


Luxembourg/Luxemburg

MSD Belgium

Tél/Tel: +32(0)27766211

dpoc_belux@merck.com


Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111

dpoc_czechslovak@merck.com


Magyarország

MSD Pharma Hungary Kft. Tel.: +361 888 53 00

hungary_msd@merck.com


Danmark

MSD Danmark ApS Tlf: +45 4482 4000

dkmail@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)

malta_info@merck.com


Deutschland

MSD Sharp & Dohme GmbH

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

e-mail@msd.de

Nederland

Merck Sharp & Dohme B.V.

Tel: 0800 9999000 (+31 23 5153153)

medicalinfo.nl@merck.com


Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200

msdeesti@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00

msdnorge@ msd.no


Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300

dpoc_greece@merck.com


Österreich

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

Tel: +43 (0) 1 26 044

msd-medizin@merck.com


España

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

Polska

MSD Polska Sp.z o.o. Tel.: +48 22 549 51 00


France

MSD France

Tél: + 33 (0) 1 80 46 40 40


Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700

inform_pt@merck.com


Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333

croatia_info@merck.com

România

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

msdromania@merck.com


Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 299 8700

medinfo_ireland@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201

msd_slovenia@merck.com


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010

dpoc_czechslovak@merck.com


Ιtalia

MSD Italia S.r.l.

Tel: +39 06 361911

medicalinformation.it@merck.com


Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0) 9 804650

info@msd.fi


Κύπρος

Merck Sharp & Dohme Cyprus Limited

Τηλ: 800 00 673 (+357 22866700)

cyprus_info@merck.com


Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488

medicinskinfo@merck.com


Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224

msd_lv@merck.com.

United Kingdom (Northern Ireland)

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

medinfoNI@msd.com


This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.



Important: Please refer to the Summary of Product Characteristics before prescribing. Instructions for use and handling

350 mg presentation:


In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Unlike in adults, daptomycin should not be administered by injection over a 2-minute period in paediatric patients. Paediatric patients 7 to 17 years old should receive daptomycin infused over 30 minutes. In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 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 or dilute lyophilised Cubicin. For Reconstitution:

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


For Dilution:

  1. Slowly remove the appropriate reconstituted liquid (50 mg daptomycin/ml) from the vial using a new sterile needle that is 21 gauge or smaller in diameter by inverting the vial in order to allow the solution to drain towards the stopper. Using a 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 the required solution from the inverted vial.

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

  3. Transfer the required reconstituted dose into 50 ml sodium chloride 9 mg/ml (0.9 %).

  4. 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.