Silgard, suspension for injection in a pre-filled syringe.Human Papillomavirus Vaccine [Types 6, 11, 16, 18](Recombinant, adsorbed)

Silgard is a vaccine. Vaccination with Silgard is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.

These diseases include cervical cancer; pre-cancerous lesions of the female genitals (cervix, vulva and vagina); and genital warts. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases and 70% of HPV-related pre-cancerous lesions of the vulva and vagina. HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.

Silgard is intended to prevent these diseases. The vaccine is not used to treat HPV related diseases. Silgard does not have any effect in females who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, in females who are already infected with one or more of the vaccine HPV types, Silgard can still protect against disease associated with the other HPV types in the vaccine.

Silgard cannot cause the diseases it protects against.

Silgard produces type-specific antibodies and has been shown in clinical trials to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-45 years of age. The vaccine also produces antibodies in 9- to 15-year-old children and adolescents. Whether these type-specific antibodies prevent disease in adult males has not been evaluated.

Silgard should be used in accordance with official guidelines.

Do not use Silgard if:

the person to be vaccinated

• is allergic (hypersensitive) to any of the active substances or any of the other ingredients of 70

Silgard (listed under ?other ingredients?? see section 6).

• has developed an allergic reaction after receiving a dose of Silgard.
• suffers from an illness with high fever. However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.

Take special care with Silgard:

You should tell your doctor if the person to be vaccinated:

• has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
• has a weakened immune system, for example due to a genetic defect or HIV infection

As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.

Silgard will not protect against every type of Human Papillomavirus. Therefore appropriate precautions against sexually transmitted disease should continue to be used.

Silgard will not protect against other diseases that are not caused by Human Papillomavirus.

Vaccination is not a substitute for routine cervical screening . You should continue to follow your doctor?s advice on cervical smear/Pap tests and preventative and protective measures.

What other important information should I know about Silgard?

The duration of protection is currently unknown. Longer term follow-up studies are ongoing to determine whether a booster dose is needed.

Taking other medicines:

Silgard can be given with a Hepatitis B vaccine or with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.

Silgard may not have an optimal effect if:

• used with medicines that suppress the immune system.

In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Silgard.

Please tell your doctor or pharmacist if the person for whom the vaccine is intended is taking or has recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding:

Consult your doctor if the person to be vaccinated is pregnant, trying to become pregnant or becomes pregnant during the course of vaccination.

Silgard may be given to women who are breast-feeding or intend to breast-feed.

Driving and using machines:

There is no information to suggest that Silgard affects your ability to drive or use machinery.

Silgard is given as an injection by your doctor. Silgard is intended for adolescents from 9 through 15 years of age and females 16 years of age onwards. The person to be vaccinated will receive three doses of the vaccine.

First injection: at chosen date
Second injection: ideally 2 months after first injection
Third injection: ideally 6 months after first injection

If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Please speak to your doctor for more information.

The person to be vaccinated should complete the three-dose vaccination course; otherwise the person to be vaccinated may not be fully protected.

Silgard will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).

The vaccine should not be mixed in the same syringe with any other vaccines and solutions.

If you forget to take Silgard:

If you miss a scheduled injection, your doctor will decide when to give the missed dose. It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses. If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice. When Silgard is given as your first dose, the following two doses to complete the 3-dose vaccination course should also be Silgard, and not another HPV vaccine.

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

Like all vaccines and medicines, Silgard can cause side effects, although not everybody gets them.

The following side effects can be seen after the use of Silgard:

Very commonly (more than 1 in 10 patients), side effects found at the injection site include: pain, swelling and redness. Fever was also seen.

Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity.

Rarely (less than 1 in 1000 patients): hives (urticaria).

Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.

When Silgard was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.

Side effects that have been reported during marketed use include:

Fainting, sometimes accompanied by shaking or stiffening, has been reported. Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.

Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported. Some of these reactions have been severe.

As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, and bleeding or bruising more easily than normal.

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

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

The vaccine should not be used after the expiry date which is stated on the syringe label and the outer carton (after EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2ºC - 8ºC). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

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.