Gardasil 9 suspension inyectable en jeringa precargada

Label: Information for the User

Gardasil9 Suspension for Injection in Pre-filled Syringe

Nonavalent Vaccine against Human Papillomavirus (Recombinant, Adsorbed)

Read this label carefully before you or your child is vaccinated,because it contains important information for you or your child.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse,even if they are not listed in this label. See section4.

Gardasil9 is a vaccinethat is indicated forchildren andadolescents starting from 9years ofage andadults.It is administeredto protect against diseases caused by the types6, 11, 16, 18, 31, 33,45, 52and 58of Human Papillomavirus (HPV).

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

Gardasil9 has been studiedin men aged 9 to 26years andwomen aged 9to 45years.

Gardasil9 protects against the types of HPV that cause the majority of cases of these diseases.

Gardasil9 is indicated to prevent these diseases. The vaccine is not used to treat diseases related to HPV. Gardasil9 has no effect on individuals who already have a persistent infection or disease associated with any of the types of HPV in the vaccine. However, in individuals who are already infected with one or more of the types of HPV in the vaccine, Gardasil9 may still protect against diseases associated with the other types of HPV in the vaccine.

Gardasil9 cannot cause diseases related to HPV.

When an individual is vaccinated with Gardasil9, the immune system (the body's natural defense system) stimulates the production of antibodies against the 9types of HPV contained in the vaccine, to help protect against diseases caused by these viruses.

It is recommended that if you or your child received the first dose of Gardasil9, complete the vaccination regimen with Gardasil9.

If you or your child have already received the HPV vaccine, ask your doctor if Gardasil9 is suitable for you.

Gardasil9 should be used in accordance with official recommendations.

You or your child should not receive Gardasil9if

• you are allergic to any of the active ingredients or to any of the other components of this vaccine (listed in “other components are” – see section6).
• you developed an allergic reaction after receiving a dose of Gardasil (types of HPV6, 11, 16, and 18) or Gardasil9.

Warnings and precautions

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

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

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

As with any vaccine, Gardasil9 does not provide complete protection for the vaccinated.

Gardasil9 does not protect against all types of Human Papillomavirus. Therefore, you should continue to use appropriate measures to prevent sexually transmitted diseases.

Vaccination is not a substitute for routine cervical examination. If you are a womanyou shouldfollow your doctor's advice about the Papanicolau test/cervical cytology and other preventive and protective measures.

What else you or your child should know about Gardasil9

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

Use of Gardasil9 with other medications or vaccines

Inform your doctor or pharmacist if you or your child are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Gardasil9 can be administered with a combined booster vaccine for diphtheria(d) and tetanus(T) with pertussis (acellular) (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, for example, the other arm or leg).

Gardasil9 may not have an optimal effect if used with medications that suppress the immune system.

Oral contraceptives (for example, the pill) did not reduce the protection obtained with Gardasil9.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Information from pregnant women vaccinated with Gardasil9 does not show a higher risk of spontaneous abortions or congenital malformations.

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

Gardasil9 can be administered to women who are breastfeeding or plan to breastfeed.

Driving and operating machinery

Gardasil9may affecttemporarilyandslightlyyour ability to drive and operate machinery(see section4"Possible side effects").

Gardasil9 containssodium chloride

This medication containsless than 1mmolof sodium (23mg) per dose; it is essentially"sodium-free".

Your doctor will administer Gardasil 9 through an injection.

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

If you are 9 to 14 years old (inclusive) at the time of the first injection

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

• First injection: on a specified 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 must be administered.

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

• First injection: on a specified date
• Second injection: 2 months after the first injection (not before one month after the first dose)
• Third injection: 6 months after the first injection (not before three months after the second dose)

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

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

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

• First injection: on a specified date
• Second injection: 2 months after the first injection (not before one month after the first dose)
• Third injection: 6 months after the first injection (not before three months after the second dose)

The three doses must 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 cycle with Gardasil 9.

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

If you forgot a dose of Gardasil 9

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

It is essential to follow the instructions of your doctor or nurse regarding visits for the administration of the following doses. If you forget or cannot attend your doctor at the scheduled time, consult your doctor. If the first dose of vaccine you receive is Gardasil 9, the completion of the vaccination regimen must be done with Gardasil 9 and not with another HPV vaccine.

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

Like all vaccines and medications, this vaccinemay cause side effects, although not everyone will experience them.

The following side effects may appear after using Gardasil9:

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

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

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

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

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

When Gardasil9 is administered with a combined booster vaccine that contains diphtheria, tetanus, pertussis (acellular component), and inactivated poliomyelitis, in the same visit, more cases of swelling at the injection site have been observed.

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

The following side effectshave been reported withGARDASILor SILGARDand mayalsobe observedafter receivingGARDASIL9:

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

Like other vaccines, side effects 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); easy bruising or bleeding, or skin infection at the injection site.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccineafter the expiration date that appears on the box and on the syringe label after CAD or EXP. The expiration date is the last day of the month indicated.

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

Do not freeze.

Keepthe syringein the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe containers and medicines that you no longerneed.By doing so, you will help protect the environment.

Composition of Gardasil9

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

1dose (0.5ml) contains approximately:

Human Papillomavirus L1 protein1Type 62,330micrograms

Human Papillomavirus L1 protein1Type 112,340micrograms

Human Papillomavirus L1 protein1Type 162,360micrograms

Human Papillomavirus L1 protein1Type 182,340micrograms

Human Papillomavirus L1 protein1Type 312,320micrograms

Human Papillomavirus L1 protein1Type 332,320micrograms

Human Papillomavirus L1 protein1Type 452,320micrograms

Human Papillomavirus L1 protein1Type 522,320micrograms

Human Papillomavirus L1 protein1Type 582,320micrograms

1Virus of Human Papillomavirus = HPV

2Protein L1 in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiaeCANADE3C-5 (Strain1895)) by recombinant DNA technology.

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

This vaccine includes amorphous aluminum hydroxide phosphate sulfate as an adjuvant. Adjuvants are included to improve the immune response of vaccines.

The other components of the vaccine in suspension are: sodium chloride, histidine, polisorbate80(E433), boric acid(E285) and water for injection.

Aspect of the product and content of the package

1dose of Gardasil9 injectable suspension contains 0.5ml.

Before shaking, Gardasil9 may appear as a transparent liquid with a white precipitate. After a vigorous shaking, it is a white and turbid liquid.

Gardasil9 is available in packages of 1 or 10pre-filled syringes.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

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

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:{MM/AAAA}.

For detailed information about this medicine, please visit the website of the European Medicines Agencyhttps://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Gardasil9 injectable suspension in pre-filled syringe:

• Before shaking, Gardasil9may appear asa transparent liquid witha white precipitate.

• Shake the pre-filled syringe well before use to make a suspension.

• Examine the suspension visually to discard the presence of particles and discoloration before administration. Discard the product if it presents particles and/or discoloration.

• Choose the needle most appropriate to ensure an intramuscular (IM) administration in accordance with the size and weight of the individual..

• Available in packages with needles, 2needles of different lengths are supplied per syringe.

• Insert the needle by rotating it in the direction of the clock until it securely fits into 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 superior region of the thigh.

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

The disposal of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.