GARDASIL 9 INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Gardasil9 injectable suspension in a pre-filled syringe

Nonavalent vaccine against Human Papillomavirus (Recombinant, adsorbed)

Read all of this leaflet carefully before you or your child is 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, pharmacist, or nurse.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Gardasil 9 is a vaccine that is 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 genital area (cervix, vulva, and vagina); precancerous lesions and cancers of the anus and genital warts in men and women.

Gardasil 9 has been studied in males from 9 to 26 years of age and females from 9 to 45 years of age.

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

Gardasil 9 is indicated to prevent these diseases. The vaccine is not used to treat HPV-related diseases. Gardasil 9 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 9 may still protect against diseases associated with the other HPV types in 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) stimulates the production of antibodies against the 9 HPV types 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 regimen with Gardasil 9.

If you or your child have already received an HPV vaccine, ask your doctor if 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 receives Gardasil 9

You or your child should not receive Gardasil 9 if:

• you are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in "the other ingredients are" - see section 6).
• you developed an allergic reaction after receiving a dose of Gardasil (HPV types 6, 11, 16, and 18) or Gardasil 9.

Warnings and precautions

Consult your doctor, pharmacist, or nurse if you or your child:

• have a coagulation disorder (a disease that makes you bleed more than normal), such as hemophilia.
• have a weakened immune system, such as due to a genetic disorder, HIV infection, or medications that affect the immune system.
• have a high fever. However, moderate fever or upper respiratory tract infection (such as a cold) does not justify delaying vaccination.

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 9 does not guarantee complete protection of the vaccinated individuals.

Gardasil 9 does not protect against all types of Human Papillomavirus. Therefore, appropriate measures to prevent sexually transmitted diseases should continue to be used.

Vaccination is not a substitute for routine cervical cancer screening. If you are a woman, you shouldfollow your doctor's advice about Pap smear/cervical cytology tests and other preventive and protective measures.

What other important information should you or your child know about Gardasil 9?

The duration of protection is currently unknown. Long-term follow-up studies are ongoing to determine if a booster dose would be necessary.

Use of Gardasil 9 with other medicines or vaccines

Inform your doctor or pharmacist if you or your child are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Gardasil 9 can be administered with a combined booster vaccine of diphtheria (d) and tetanus (T) with pertussis (acellular) (ap) and/or poliomyelitis (inactivated) (IPV) (dTap, dT-IPV, dTap-IPV vaccines) during the same visit, at a different injection site (another part of the body, for example, the other arm or leg).

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

Oral contraceptives (such as the pill) did not reduce the protection obtained with Gardasil 9.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Information from women who have been vaccinated with Gardasil 9 during pregnancy does not show an increased risk of spontaneous abortions or babies with congenital malformations.

However, if you are pregnant or become pregnant during the vaccination regimen, it is recommended to postpone or interrupt vaccination until you are no longer pregnant.

Gardasil 9 can be administered to women who are breastfeeding or will be breastfeeding.

Driving and using machines

Gardasil 9 may temporarily and mildly affect 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; this is essentially "sodium-free".

3. How Gardasil 9 is administered

Your doctor will administer Gardasil 9 by injection.

Gardasil 9 is indicated for adolescents and adults from 9 years of age and older.

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

Gardasil 9 can be administered following a 2-dose schedule:

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

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

Gardasil 9 can be administered following a 3-dose schedule:

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

The three doses should be administered within a period of 1 year. Consult your doctor for more information.

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

Gardasil 9 should be administered following a 3-dose schedule:

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

The three doses should be administered within a period of 1 year. Consult your doctor for more information.

It is recommended that individuals who received a first dose of Gardasil 9 complete the vaccination regimen with Gardasil 9.

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

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 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 dose of vaccine you receive is Gardasil 9, the completion of the vaccination regimen should be done 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 side effects

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

The following side effects may appear after the use of Gardasil 9:

Very common(may affect more than 1 in 10 people), local side effects at the injection site: (pain, swelling, and redness) and headache.

Common(may affect up to 1 in 10 people), local side effects at the injection site: (bruising and itching), fever, fatigue, dizziness, and nausea.

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

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

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

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

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

The following side 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, side effects that have been reported during general use include: muscle weakness, abnormal sensations, tingling in the 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 that appears on the carton and on the label of the syringe after CAD or EXP. The expiry date is 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 no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Gardasil Composition9

The active ingredients are: highly purified non-infectious protein 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 Type 6 L1 protein2,3 30 micrograms

Human Papillomavirus1 Type 11 L1 protein2,3 40 micrograms

Human Papillomavirus1 Type 16 L1 protein2,3 60 micrograms

Human Papillomavirus1 Type 18 L1 protein2,3 40 micrograms

Human Papillomavirus1 Type 31 L1 protein2,3 20 micrograms

Human Papillomavirus1 Type 33 L1 protein2,3 20 micrograms

Human Papillomavirus1 Type 45 L1 protein2,3 20 micrograms

Human Papillomavirus1 Type 52 L1 protein2,3 20 micrograms

Human Papillomavirus1 Type 58 L1 protein2,3 20 micrograms

1Human Papillomavirus = HPV

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

3adsorbed on amorphous aluminum hydroxyphosphate sulfate as an adjuvant (0.5 milligrams of Al).

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

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

Product Appearance and Package Contents

1 dose of Gardasil 9 injectable suspension contains 0.5 ml.

Before shaking, Gardasil 9 may appear as a clear liquid with a white precipitate. After vigorous shaking, it is a white and turbid liquid.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:{MM/AAAA}.

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

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This information is intended only for healthcare professionals:

Gardasil 9 injectable suspension in pre-filled syringe:

• Before shaking, Gardasil 9 may appear as a clear liquid with a white precipitate.

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

• Visually inspect the suspension for particulate matter and discoloration prior to administration. Discard the product if it contains particulate matter and/or discoloration.

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

• In packages with needles, 2 needles of different lengths are provided per syringe.

• Attach the needle by twisting it clockwise until it is securely attached to the syringe. Administer the full dose according to the standard protocol.

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

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

Disposal of unused medicinal products and all materials that have come into contact with them should be done in accordance with local regulations.