Gardasil 9 suspension for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Gardasil 9 suspension for injection in a pre-filled syringe

Recombinant, adsorbed, nonavalent human papillomavirus vaccine

Read the entire leaflet carefully before you or your child is vaccinated, because it contains important information for you or your child.

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

Leaflet contents:

1. What Gardasil 9 is and what it is used for
2. What you need to know before you or your child receive Gardasil 9
3. How Gardasil 9 is administered
4. Possible side effects
5. How to store Gardasil 9
6. Contents of the pack and other information

1. What Gardasil 9 is and what it is used for

Gardasil 9 is a vaccine indicated for children and adolescents from 9 years of age and adults. It is administered to protect against diseases caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

These diseases include precancerous lesions and cancers of the female genitals (cervix, vulva, and vagina); precancerous lesions and anal cancers, and genital warts in both men and women.

Gardasil 9 has been studied in males aged 9 to 26 years and females aged 9 to 45 years.

Gardasil 9 protects against the HPV types that cause the majority of cases of these diseases.

Gardasil 9 is indicated for the prevention of these diseases. The vaccine is not used to treat HPV-related diseases. Gardasil 9 has no effect in individuals who already have a persistent infection or disease associated with any of the HPV types included in the vaccine. However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil 9 may still provide protection against diseases associated with the other HPV types covered by the vaccine.

Gardasil 9 cannot cause HPV-related diseases. When an individual is vaccinated with Gardasil 9, the immune system (the body's natural defense system) is stimulated to produce antibodies against the 9 HPV types contained in the vaccine, to help protect against diseases caused by these viruses.

It is recommended that if you or your child received a first dose of Gardasil 9, you complete the vaccination schedule with Gardasil 9.

If you or your child have already received an HPV vaccine, ask your doctor whether Gardasil 9 is suitable for you.

Gardasil 9 should be used in accordance with official recommendations.

2. What you need to know before you or your child receive Gardasil 9

Do not receive Gardasil 9 if you or your child:

• are allergic to any of the active substances or to any of the other ingredients of this vaccine (listed in “Other ingredients” – see section 6).
• have had an allergic reaction after receiving a dose of Gardasil (HPV types 6, 11, 16, and 18) or Gardasil 9.

Warnings and precautions

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

• have a bleeding disorder (a condition that causes excessive bleeding), such as haemophilia.
• have a weakened immune system, for example due to a genetic defect, HIV infection, or medicines that affect the immune system.
• have an illness with a high fever. However, a mild fever or a respiratory tract infection (such as a cold) does not justify delaying vaccination.

Fainting (syncope) may occur following any injection with a needle, particularly in adolescents, sometimes accompanied by brief seizure-like activity. Therefore, inform your doctor or nurse if you or your child has previously fainted after an injection.

As with any vaccine, Gardasil 9 may not fully protect all individuals who receive it.

Gardasil 9 does not protect against all types of Human Papillomavirus (HPV). Therefore, appropriate measures to prevent sexually transmitted infections should still be used.

Vaccination does not replace routine cervical screening. If you are a woman, you should continue to follow your doctor’s advice regarding Papanicolaou (Pap) tests/cervical cytology and other preventive and protective measures.

Other important information you or your child should know about Gardasil 9

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

Use of Gardasil 9 with other medicines or vaccines

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

Gardasil 9 may be administered at the same visit as a combined diphtheria (d), tetanus (T), acellular pertussis (ap), and/or inactivated poliomyelitis (IPV) booster vaccine (dTap, dT-IPV, dTap-IPV), provided that the injections are given at different injection sites (e.g., the other arm or leg).

Gardasil 9 may not have an optimal effect if used together with medicines that suppress the immune system.

Oral contraceptives (e.g., the pill) did not reduce the protection provided by Gardasil 9.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Data from women who received Gardasil 9 during pregnancy do not show an increased risk of spontaneous abortions or congenital malformations.

However, if you are pregnant or become pregnant during the vaccination schedule, it is recommended to postpone or interrupt vaccination until pregnancy ends.

Gardasil 9 can be given to women who are breastfeeding or who are planning to breastfeed.

Driving and use of machines

Gardasil 9 may have a slight and temporary effect on the ability to drive and use machines (see section 4, "Possible side effects").

Gardasil 9 contains sodium chloride

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

3. How Gardasil 9 is administered

Your doctor will administer Gardasil 9 by injection.

Gardasil 9 is indicated in adolescents and adults aged 9 years and older.

If you are between 9 and 14 years of age (inclusive) at the time of the first injection

Gardasil 9 may be administered according to a 2-dose schedule:

• First injection: on a scheduled date
• Second injection: administered between 5 and 13 months after the first injection.

If the second dose is administered earlier than 5 months after the first dose, a third dose should be given.

Gardasil 9 may also be administered according to a 3-dose schedule:

• First injection: on a scheduled date
• Second injection: 2 months after the first injection (not earlier than 1 month after the first dose)
• Third injection: 6 months after the first injection (not earlier than 3 months after the second dose)

All three doses should be administered within a 1-year period. Consult your doctor for further information.

If you are 15 years of age or older at the time of the first injection

Gardasil 9 should be administered according to a 3-dose schedule:

• First injection: on a scheduled date
• Second injection: 2 months after the first injection (not earlier than 1 month after the first dose)
• Third injection: 6 months after the first injection (not earlier than 3 months after the second dose)

All three doses should be administered within a 1-year period. Consult your doctor for further information.

Individuals who received an initial dose of Gardasil 9 are recommended to complete the vaccination series with Gardasil 9.

Gardasil 9 will be given as an intramuscular injection (through the skin into the muscle), preferably in the upper arm or thigh muscle.

If you miss a dose of Gardasil 9

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 appointments for subsequent doses. If you miss an appointment or are unable to visit your doctor at the scheduled time, consult your doctor. If your first vaccine dose received is Gardasil 9, the vaccination series should be completed with Gardasil 9 and not with another HPV vaccine.

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

4. Possible adverse effects

Like all vaccines and medicines, this vaccine may cause adverse effects, although not everyone will experience them.

The following adverse effects may occur after the use of Gardasil 9:

Very common (may affect more than 1 in 10 people): injection site reactions (pain, swelling, redness) and headache.

Common (may affect up to 1 in 10 people): injection site reactions (bruising, itching), fever, tiredness (fatigue), dizziness, and nausea.

Uncommon (may affect up to 1 in 100 people): swollen lymph nodes (in neck, armpits or groin), hives (urticaria), fainting sometimes accompanied by tremors or stiffness, vomiting, joint pain, muscle pain, unusual tiredness or weakness, chills, general malaise, lump (nodule) at injection site.

Rare (may affect up to 1 in 1,000 people): allergic reactions.

Frequency not known (frequency cannot be estimated from available data): severe allergic reactions (anaphylactic reaction).

When Gardasil 9 is administered together with a combined booster vaccine containing diphtheria, tetanus, pertussis (acellular component), and poliomyelitis (inactivated) during the same visit, increased cases of swelling at the injection site have been observed.

Fainting has been reported, sometimes accompanied by tremors or stiffness. Although episodes of fainting are uncommon, patients should be observed for 15 minutes after receiving the HPV vaccine.

The following adverse effects have been reported with GARDASIL or SILGARD and may also be observed after receiving GARDASIL 9:

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

As with other vaccines, adverse effects reported during general use include: muscle weakness, abnormal sensations, tingling in arms, legs and upper body, or confusion (Guillain-Barré syndrome, acute disseminated encephalomyelitis); bleeding or bruising more easily than normal, and skin infection at the injection site.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gardasil 9

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

Do not use this vaccine after the expiry date stated on the carton and on the syringe label after EXP or CAD. The expiry date refers to the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Gardasil9

The active substances are: highly purified non-infectious proteins for each type of Human Papillomavirus (6, 11, 16, 18, 31, 33, 45, 52 and 58).

1 dose (0.5 ml) contains approximately:

Human Papillomavirus1 L1 protein Type 62,3 30 micrograms
Human Papillomavirus1 L1 protein Type 112,3 40 micrograms
Human Papillomavirus1 L1 protein Type 162,3 60 micrograms
Human Papillomavirus1 L1 protein Type 182,3 40 micrograms
Human Papillomavirus1 L1 protein Type 312,3 20 micrograms
Human Papillomavirus1 L1 protein Type 332,3 20 micrograms
Human Papillomavirus1 L1 protein Type 452,3 20 micrograms
Human Papillomavirus1 L1 protein Type 522,3 20 micrograms
Human Papillomavirus1 L1 protein Type 582,3 20 micrograms

1 Human Papillomavirus = HPV
2 L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (strain 1895)) using recombinant DNA technology.
3 adsorbed on amorphous aluminium hydroxyphosphate sulfate as adjuvant (0.5 milligrams of Al).

Amorphous aluminium hydroxyphosphate sulfate is included in the vaccine as an adjuvant. Adjuvants are included to enhance the immune response to vaccines.

The other components of the vaccine suspension are: sodium chloride, histidine, polysorbate 80 (E 433), borax (E 285), and water for injections.

Appearance of the product and contents of the pack

1 dose of Gardasil 9 injectable suspension contains 0.5 ml.

Before shaking, Gardasil 9 may appear as a clear liquid with a white deposit. After vigorous shaking, it becomes a white, cloudy liquid.

Gardasil 9 is available in packs of 1 or 10 pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of last review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Gardasil 9 injectable suspension in a pre-filled syringe:

• Prior to agitation, Gardasil 9 may appear as a clear liquid with a white precipitate.

• Shake the pre-filled syringe well before use to form a suspension. After vigorous shaking, it is a white, cloudy liquid.

• Visually inspect the suspension for the presence of particles and discoloration before administration. Discard the product if particles and/or discoloration are present.

• Select the most appropriate needle to ensure intramuscular (IM) administration based on the individual's size and weight.

• In packages containing needles, 2 needles of different lengths are supplied per syringe.

• Attach the needle by rotating clockwise until the needle is securely fitted onto the syringe. Administer the full dose according to standard protocol.

• Inject immediately via the intramuscular (IM) route, preferably in the deltoid region of the upper arm or the anterolateral upper thigh.

• The vaccine should be administered as supplied. The complete recommended dose of the vaccine must be used.

Any unused medicine and materials that have come into contact with it should be disposed of in accordance with local regulations.