GARDASIL Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Gardasil injectable suspension in a pre-filled syringe

Human Papillomavirus [Types 6, 11, 16, 18] (Recombinant, adsorbed) vaccine

Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you or your child experience any side effects, talk to your doctor, pharmacist or nurse, even if you think the side effects are not serious, or if they are listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Gardasil and what is it used for
2. What you need to know before you or your child receive Gardasil
3. How Gardasil is administered
4. Possible side effects
5. Storage of Gardasil
6. Contents of the pack and further information

1. What is Gardasil and what is it used for

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

These diseases include precancerous lesions of the female genital area (cervix, vulva, and vagina); precancerous lesions of the anus and genital warts in men and women; anal and cervical cancer. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases; 75-80% of anal cancer cases; 70% of vulvar and vaginal precancerous lesions related to HPV; 80% of anal precancerous lesions related to HPV. HPV types 6 and 11 are responsible for approximately 90% of genital warts cases.

Gardasil is indicated to prevent these diseases. The vaccine is not used to treat HPV-related diseases. Gardasil has no effect on 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 HPV types in the vaccine, Gardasil may still protect against diseases associated with the other HPV types in the vaccine.

Gardasil cannot cause the diseases it protects against.

Gardasil induces the production of specific antibodies and has been shown in clinical trials to prevent HPV 6, 11, 16, and 18-related diseases in women aged 16-45 and men aged 16-26. The vaccine also induces the production of specific antibodies in children and adolescents aged 9-15.

Gardasil should be used according to official recommendations.

2. What you need to know before you or your child receive Gardasil

You or your child should not receive Gardasil if:

• you or your child are allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed in "other ingredients" - see section 6).
• you or your child have developed an allergic reaction after receiving a dose of Gardasil.
• you or your child have a high fever. However, moderate fever or upper respiratory tract infection (e.g., a cold) does not justify delaying vaccination.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before vaccination if you or your child:

• have a bleeding disorder (a disease that makes you bleed more than normal), e.g., hemophilia.
• have a weakened immune system, e.g., due to a genetic disorder, HIV infection, or medications that affect the immune system.

After any injection with a needle, fainting may occur, mainly in adolescents, sometimes accompanied by falling. Therefore, inform your doctor or nurse if you have fainted after any previous injection.

As with any vaccine, Gardasil does not provide 100% complete protection in all vaccinated individuals.

Gardasil does not protect against all types of Human Papillomavirus. Therefore, appropriate measures to prevent sexually transmitted diseases should continue to be used.

Gardasil does not protect against other diseases not caused by Human Papillomavirus.

Vaccination is not a substitute for routine cervical screening. Do not stop following your doctor's advice about Pap tests/cervical cytology and other preventive and protective measures.

What other important information should you or your child know about Gardasil

Long-term follow-up studies have been conducted to determine the duration of protection. The need for a booster dose has not been established.

Use of Gardasil with other medicines or vaccines

Gardasil can be administered with a Hepatitis B vaccine or with a combined booster vaccine of diphtheria (d) and tetanus (T) with pertussis (acellular component) (ap) and/or poliomyelitis (inactivated) (IPV) (dTap, dT-IPV, dTap-IPV vaccines) during the same visit, in a different injection site (another part of the body, e.g., the other arm or leg).

Gardasil may not have an optimal effect if:

• used with medicines that suppress the immune system.

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

Tell your doctor or pharmacist if you or your child are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Gardasil can be administered to women who are breastfeeding or will be breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Gardasil contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How Gardasil is administered

Your doctor will administer Gardasil by injection. Gardasil is indicated in adolescents and adults from 9 years of age

If you are 9 to 13 years old (inclusive)

Gardasil can be administered following a 2-dose schedule:

• First injection: on a given date.
• Second injection: 6 months after the first injection.

If the second dose is administered before 6 months after the first dose, a third dose should be administered.

Alternatively, Gardasil can be administered following a 3-dose schedule:

• First injection: on a given date.
• Second injection: 2 months after the first injection.
• Third injection: 6 months after the first injection.

The second dose should be administered at least 1 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 administered within a 1-year period. Consult your doctor for more information.

If you are 14 years old or older

Gardasil should be administered following a 3-dose schedule:

• First injection: on a given date.
• Second injection: 2 months after the first injection.
• Third injection: 6 months after the first injection.

The second dose should be administered at least 1 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 administered within a 1-year period. Consult your doctor for more information.

It is recommended that individuals who received a first dose of Gardasil complete the vaccination regimen with Gardasil.

Gardasil is administered by intramuscular injection through the skin into the muscle (preferably into the muscle of the upper arm or thigh).

The vaccine should not be mixed in the same syringe with any other vaccine or solution.

If you miss a dose of Gardasil

If you miss a scheduled injection, your doctor will decide when to administer the missed dose.

It is important that you follow your doctor's or nurse's instructions regarding visits for the administration of the next doses. If you miss them or cannot attend your doctor's office at the scheduled time, consult your doctor. If the first vaccine dose you receive is Gardasil, the completion of the vaccination regimen should also be done with Gardasil and not with another HPV vaccine.

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

4. Possible side effects

As with all vaccines, this vaccine can cause side effects, although not everybody gets them.

The following side effects may appear after use of Gardasil:

Very common(may affect more than 1 in 10 patients), local side effects at the injection site, including: pain, swelling, and redness. Headache has also been reported.

Common(may affect more than 1 in 100 patients), local side effects at the injection site, including: bruising, itching, pain in the arm or leg. Fever and nausea have also been reported.

Rare(may affect less than 1 in 1,000 patients), hives.

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

More cases of headache and swelling at the injection site have been observed when Gardasil and a combined booster vaccine of diphtheria, tetanus, pertussis (acellular component), and poliomyelitis (inactivated) are administered during the same visit.

Side effects that have been reported during the marketing of Gardasil include:

Fainting, sometimes accompanied by shaking or stiffness. Although fainting episodes are rare, patients should be observed for 15 minutes after receiving the HPV vaccine.

Allergic reactions, which can include difficulty breathing, wheezing, hives, and rash. Some of these reactions have been severe.

As with other vaccines, side effects that have been reported during general use include: swollen lymph nodes (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body, or confusion (Guillain-Barré syndrome, acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, muscle pain, unusual tiredness or weakness, chills, general feeling of being unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think the side effects are not serious, or if they are listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gardasil

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 label and carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep the syringe in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Gardasil composition

The active ingredients are: highly purified non-infectious protein for each type of Human Papillomavirus (6, 11, 16, and 18).

1 dose (0.5 ml) contains approximately:

1 Human Papillomavirus = HPV

2 L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiaeCANADE 3C-5 (Strain 1895)) by recombinant DNA technology.

3 Adsorbed on amorphous aluminum hydroxyphosphate sulfate as an adjuvant (0.225 milligrams of Al).

Amorphous aluminum hydroxyphosphate sulfate is included in the vaccine as an adjuvant. Adjuvants are included in some vaccines to accelerate, enhance, and/or prolong the immune response of the vaccines.

The other components of the vaccine suspension are:

Sodium chloride, histidine, polysorbate 80, borax, and water for injectable preparations.

Product appearance and container contents

1 dose of Gardasil injectable suspension contains 0.5 ml.

Before shaking, Gardasil may appear as a clear liquid with a white precipitate. After vigorous shaking, it is a white and turbid liquid.

Gardasil is available in packs of 1, 10, or 20 pre-filled syringes.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this prospectus: {MM/AAAA}

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended for healthcare professionals only:

• Gardasil is available in a pre-filled syringe ready for use by intramuscular (IM) injection, preferably in the deltoid region of the upper arm.
• If the container contains 2 needles of different lengths, choose the most suitable one to ensure IM administration based on the individual's size and weight.
• Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration. Discard the product if it contains particles or appears discolored. Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Shake well before use. Fix the needle by rotating it clockwise until it is securely attached to the syringe. Administer the full dose according to the standard protocol.