Gardasil 9 suspension for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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 given
4. Possible side effects
5. How to store Gardasil 9
6. Contents of the pack and other information

• is allergic to any of the active substances or any of the other ingredients of this vaccine (listed under “other ingredients”, in section 6).
• developed an allergic reaction after receiving a dose of Gardasil or Silgard (HPV types 6, 11, 16, and 18) or Gardasil 9.

Talk to your doctor, pharmacist or nurse 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;
• suffer from an illness with high fever. However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination.

Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection. Therefore tell the doctor or nurse if fainting occurred with a previous injection.

As with any vaccine, Gardasil 9 may not fully protect all of those who get the vaccine.

Gardasil 9 will not protect against every type of Human Papillomavirus. Therefore appropriate precautions against sexually transmitted disease should continue to be used.

Vaccination is not a substitute for routine cervical screening. If you are a woman, you should continue to follow your doctor’s advice on cervical smear/Pap tests and preventative and protective measures.

The duration of protection is not yet known. Longer term follow-up studies are ongoing to determine whether a booster dose is needed.

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

Gardasil 9 can be given 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, for example the other arm or leg) during the same visit.

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

Hormonal contraceptives (for example the pill) did not reduce the protection obtained by Gardasil 9.

If you are pregnant, think that you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine. Information from pregnant women vaccinated with Gardasil 9 does not show a higher risk for miscarriages or babies with birth defects.

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

Gardasil 9 may be given to women who are breast-feeding or intend to breast-feed.

Gardasil 9 may slightly and temporarily affect the ability to drive or use machines (see section 4 “Possible side effects”).

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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

• First injection: at chosen date
• Second injection: given between 5 and 13 months after first injection

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

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

• First injection: at chosen date
• Second injection: 2 months after first injection (not earlier than one month after the first dose)
• Third injection: 6 months after first injection (not earlier than 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.

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

• First injection: at chosen date
• Second injection: 2 months after first injection (not earlier than one month after the first dose)
• Third injection: 6 months after first injection (not earlier than 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.

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

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

If a scheduled injection is missed, your doctor will decide when to give the missed dose.

It is important that you follow your doctor or nurse’s instructions 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 Gardasil 9 is given as your first dose, the completion of the vaccination course should be done with Gardasil 9, and not another HPV vaccine.

Allergic reactions have been reported. Some of these reactions have been severe. Symptoms may include difficulty breathing and wheezing.

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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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

1 dose (0.5 ml) contains approximately:

Human Papillomavirus¹ Type 6 L1 protein^2,3 30 micrograms

Human Papillomavirus¹ Type 11 L1 protein^2,3 40 micrograms

Human Papillomavirus¹ Type 16 L1 protein^2,3 60 micrograms

Human Papillomavirus¹ Type 18 L1 protein^2,3 40 micrograms

Human Papillomavirus¹ Type 31 L1 protein^2,3 20 micrograms

Human Papillomavirus¹ Type 33 L1 protein^2,3 20 micrograms

Human Papillomavirus¹ Type 45 L1 protein^2,3 20 micrograms

Human Papillomavirus¹ Type 52 L1 protein^2,3 20 micrograms

Human Papillomavirus¹ Type 58 L1 protein^2,3 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 sulfate adjuvant (0.5 milligrams Al).

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

The other ingredients in the vaccine suspension are: sodium chloride, histidine, polysorbate 80 (E433), borax (E285) and water for injections.

1 dose of Gardasil 9 suspension for injection contains 0.5 ml.

Prior to agitation, Gardasil 9 may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid.

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

Not all pack sizes may be marketed.

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Manufacturer

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