GARDASIL® 9 (Slovakian)

Each dose of Gardasil 9 is 0.5 mL. Administer Gardasil 9 as follows:

*If the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose.

1. GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:

   • Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
   • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.

2. GARDASIL 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:

   • Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
   • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.

3. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

4. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The L1 proteins are produced by separate fermentations using recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS). The 9-valent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer.

• Do not dilute or mix GARDASIL 9 with other vaccines.
• Shake well immediately before use to maintain suspension of the vaccine.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored. After thorough agitation, GARDASIL 9 is a white cloudy liquid.
• Administer intramuscularly in the deltoid or anterolateral area of the thigh.
• Observe patients for 15 minutes after administration.
• Single-Dose Vial Use: Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly. Discard vial after use.
• Prefilled Syringe Use: This package does not contain a needle. Shake well before use. Attach a needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol. Discard syringe after use.

Contraindications

• Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL®.

After-care

• Vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL 9 should continue to undergo cervical cancer screening per standard of care.
• Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.
• GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
• Since syncope has been reported following HPV vaccination sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.