Patient leaflet - Silgard
What Silgard is and what it is used for
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 pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); pre-cancerous lesions of the anus and genital warts in males and females; cervical and anal cancers. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases, 75–80% of anal cancer cases; 70% of HPV-related pre-cancerous lesions of the vulva and vagina; 75% of HPV related pre-cancerous lesions of the anus. 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 individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, in individuals who are already infected with one or more of the vaccine HPV types, Silgard can still protect against diseases 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 HPV 6-, 11-, 16-, and 18-related diseases in women 16–45 years of age and in men 16–26 years of age. The vaccine also produces type-specific antibodies in 9– to 15-year-old children and adolescents.
Silgard should be used in accordance with official guidelines.
2. What you need to know before you receive SilgardDo not receive Silgard if: you or your child is allergic (hypersensitive) to any of the active substances or any of the other
ingredients of Silgard (listed under “other ingredients”- see section 6).
- you or your child developed an allergic reaction after receiving a dose of Silgard.
- you or your child suffer 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before vaccination if you or your child
- 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, HIV infection or
medicines that affect the immune system.
Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.
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 Papillo
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 you or your child know about Silgard
studies are ongoing to
The duration of protection is currently unknown. Longer term determine whether a booster dose is needed.
Other medicines or vaccines and Silgard
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.
aceptives (e.g. the pill) did not reduce the protection obtained by
Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Silgard may be given to women who are breast-feeding or intend to breast-feed.
ing and using machines
o studies on the effects on the ability to drive and use machines have been performed.
-
3. How Silgard is given
Silgard is given as an injection by your doctor. Silgard is intended for adolescents and adults from 9 years of age onwards.
If you are from 9 to and including 13 years of age
Silgard can be administered according to a 2-dose schedule:
- First injection: at chosen date
- Second injection: 6 months after first injection
Alternatively, Silgard can be administered according to a 3-dose schedule:
First injection: at chosen date
Second injection: 2 months after first injection
Third injection: 6 months after first injection
The second dose should be administered at least one month after the first dose and the third do should be administered at least 3 months after the second dose. All three doses should be given a 1-year period. Please speak to your doctor for more information.
If you are from 14 years of age
Silgard should be administered according to a 3-dose schedule:
First injection: at chosen date
Second injection: 2 months after first injection
Third injection: 6 months after first injection
The second dose should be administered at least one month after th should be administered at least 3 months after the second dose. All a 1-year period. Please speak to your doctor for more information.
se and the third dose ses should be given within
It is recommended that individuals who receive a first dose with Silgard.
ard complete the vaccination course
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 s
ringe with any other vaccines and solutions.
If you forget one dose of Silgar
If you miss a scheduled injecti
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 completion of the vaccination course
should be done with
and not with another HPV vaccine.
r questions on the use of this medicine, ask your doctor or pharmacist.
If you have a
4.
le side effects
ines and medicines, Silgard can cause side effects, although not everybody gets them.
e 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. Headache was also seen.
Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity. Fever and nausea have also been reported.
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); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barre Syndrome, acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.
Reporting of side effects
If you get any side effects, talk to your doctor 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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Silgard
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the vial label and the outer carton (after
EXP). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C)y^\^
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
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. Conte
the pack and other information
What Silgard contains
The active substances are: highly purified non-infectious protein for each of the Human
Paillomavirus types (6, 11, 16, and 18).
ose (0.5 ml) contains approximately:
Human Papillomavirus Type 6 L1 protein2,3
20 micrograms
40 micrograms
40 micrograms
20 micrograms
Human Papillomavirus Type 11 L1 protein2,3
Human Papillomavirus Type 16 L1 protein2,3
Human Papillomavirus Type 18 L1 protein2,33adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams 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.
contact the local representative of the
Lietuva
UAB Merck Sharp & Dohme
Tel. + 370 5 278 02 47
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 vials.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Merck Sharp and Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
The Netherlands
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K v O
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This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:.
The following information is intended for medical or healthcare professionals only:
The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. Any unused product or waste material should be disposed of in accordance with local requirements.
Shake well before use. Thorough agitation immediately before administration is necessary to suspension of the vaccine.
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.