GARDASIL 9 Suspension for injection Ref.[28336] Active ingredients: L1 protein of human papillomavirus type 11 L1 protein of human papillomavirus type 16 L1 protein of human papillomavirus type 18 L1 protein of human papillomavirus type 31 L1 protein of human papillomavirus type 33 L1 protein of human papillomavirus type 45 L1 protein of human papillomavirus type 52 L1 protein of human papillomavirus type 58 L1 protein of human papillomavirus type 6

Posology

Individuals 9 to and including 14 years of age at time of first injection

Gardasil 9 can be administered according to a 2-dose (0,6-12 months) schedule (see section 5.1). The second dose should be administered between 5 and 13 months after the first dose. 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 (0, 2, 6 months) schedule. The second dose should be administered at least one 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 given within a 1-year period.

Individuals 15 years of age and older at time of first injection

Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.

The second dose should be administered at least one 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 given within a 1-year period.

The use of Gardasil 9 should be in accordance with official recommendations.

It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9 (see section 4.4).

The need for a booster dose has not been established.

Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for Gardasil 9.

Subjects previously vaccinated with a 3-dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9 (see section 5.1). qHPV vaccine was also known as Silgard in some countries.

Paediatric population (children <9 years of age)

The safety and efficacy of Gardasil 9 in children below 9 years of age have not been established. No data are available (see section 5.1).

Method of administration

The vaccine should be administered by intramuscular injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.

Gardasil 9 must not be injected intravascularly, subcutaneously or intradermally. The vaccine should not be mixed in the same syringe with any other vaccines and solution.

For instructions on the handling of the vaccine before administration, see section 6.6.

No cases of overdose have been reported.

3 years.

Gardasil 9 suspension for injection:

Store in a refrigerator (2°C-8°C).

Do not freeze. Keep the vial in the outer carton in order to protect from light.

Gardasil 9 should be administered as soon as possible after being removed from the refrigerator.

Stability data indicate that the vaccine components are stable for 96 hours when stored at temperatures from 8°C to 40°C or for 72 hours when stored at temperatures from 0°C to 2°C. At the end of this period Gardasil 9 should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Gardasil 9 suspension for injection in a pre-filled syringe:

Store in a refrigerator (2°C-8°C).

Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

Gardasil 9 should be administered as soon as possible after being removed from the refrigerator.

Stability data indicate that the vaccine components are stable for 96 hours when stored at temperatures from 8°C to 40°C or for 72 hours when stored at temperatures from 0°C to 2°C. At the end of this period Gardasil 9 should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Gardasil 9 suspension for injection:

0.5 ml suspension in a vial (glass) with stopper (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1.

Gardasil 9 suspension for injection in a pre-filled syringe:

0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconised FluroTec-laminated bromobutyl elastomer) and a tip cap (synthetic isoprene-bromobutyl blend) in pack sizes of 1 or 10 with needles or in a pack size of 10 without needles.

Not all pack sizes may be marketed.

Gardasil 9 suspension for injection:

• Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation.
• Shake well before use to make a suspension. After thorough agitation, it is a white, cloudy liquid.
• Inspect the suspension visually for particulate matter and discolouration prior to administration. Discard the vaccine if particulates are present and/or if it appears discoloured.
• Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
• Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
• The vaccine should be used as supplied. The full recommended dose of the vaccine should be used.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Gardasil 9 suspension for injection in a pre-filled syringe:

• Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation.
• Shake well before use, the pre-filled syringe, to make a suspension. After thorough agitation, it is a white, cloudy liquid.
• Inspect the suspension visually for particulate matter and discolouration prior to administration. Discard the vaccine if particulates are present and/or if it appears discoloured.
• Choose an appropriate needle to ensure an intramuscular (IM) administration depending on your patient’s size and weight.
• In packs with needles, two needles of different lengths are provided per syringe.
• Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.
• Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
• The vaccine should be used as supplied. The full recommended dose of the vaccine should be used.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.