If you have any further questions on Silgard after reading this leaflet, please ask your doctor or pharmacist.
What Silgard contains
The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
1 dose (0.5 ml) contains approximately:
Human Papillomavirus1Human Papillomavirus1 Type 6 L1 protein2,3 Type 11 L1 protein2,3 Human Papillomavirus1Human Papillomavirus1 Type 16 L1 protein2,3 Type 18 L1 protein2,3 20 micrograms 40 micrograms 40 micrograms 20 micrograms
1Human Papillomavirus HPV 2L1 protein in the form of virus like particles produced in yeast cells Saccharomyces cerevisiae CANADE 3C-5 Strain 1895 by recombinant DNA technology. 3adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant 225 micrograms Al.
The other ingredients in the vaccine suspension are:
Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
What Silgard looks like and contents of the pack
1 dose of Silgard suspension for injection contains 0.5 ml.
Prior to agitation, Silgard may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid.
Silgard is available in packs of 1, 10 or 20 pre-filled syringes.
Not all pack sizes are marketed.
Marketing Authorisation Holder: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien Merck Sharp Dohme B.V., TélTel 32 0 2 373 42 11 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V., TélTel 32 0 2 373 42 11 MSDBelgiuminfomerck.com
. 359 2 819 3740 info-msdbgmerck.com Magyarország MSD Magyarország Kft Tel. 36.1.888.5300 hungarymsdmerck.com
eská republika Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420.233.010.111 msdcrmerck.com Malta Merck Sharp Dohme ME Ltd. Tel 357 22866700 infocyprusmerck.com
Danmark Merck Sharp Dohme, Tlf 45 43 28 77 66 dkmailmerck.com Nederland Merck Sharp Dohme B.V. Tel 31 0 23 5153153 msdbvnlmerck.com
Deutschland MSD SHARP DOHME GmbH, Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS, Tlf 47 32 20 73 00 msdnorgemsd.no
Eesti Merck Sharp Dohme OÜ Tel 372.613.9750 msdeestimerck.com Österreich Merck Sharp Dohme GmbH, Tel 43 0 1 26 044 msd-medizinmerck.com
.. 30.210.8009111 Mailboxvianex.gr Polska MSD Polska Sp. z o.o. Tel. 48.22.549.51.00 msdpolskamerck.com
España Merck Sharp Dohme de España, S.A., Tel 34 91 321 06 00 Silgardmsd.es Portugal Merck Sharp Dohme, Lda, Tel 351 21 4465700 informacaodoentemerck.com
France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com
Slovenija Merck Sharp Dohme, d.o.o. Tel 386.1.520.4201 msdsloveniamerck.com Ireland Merck Sharp Dohme Ireland Human Health Limited, Tel 353 01 2998771 medinfoirelandmerck.com
Ísland Icepharma hf. Sími 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel 421.2.58282010 msdskmerck.com
Italia Merck Sharp Dohme Italia S.p.A., Tel 39 06 361911 doccenmerck.com SuomiFinland MSD Finland Oy, PuhTel 358 0 9 804650 infomsd.fi
Merck Sharp Dohme ME Ltd. 357 22866700 infocyprusmerck.com Sverige Merck Sharp Dohme Sweden AB, Tel 46 0 8 626 1400 medicinskinfomerck.com
Latvija SIA Merck Sharp Dohme Latvija Tel 371.7364.224 msdlvmerck.com. United Kingdom Merck Sharp and Dohme Limited, Tel 44 0 1992 467272 medinfoukmerck.com
Lietuva
UAB Merck Sharp & Dohme
Tel.: +370.5.2780.247
msd_lietuva@merck.com
This leaflet was last approved in:
- Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
- If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient?s size and weight. 75
- Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Discard the product if particulates are present or if it appears discoloured. Any unused product or waste material should be disposed of in accordance with local requirements.
Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.