GARDASIL® 9 (Slovakian)

Description

Name: GARDASIL® 9 (Slovakian)
Manufacturer: MSD
Active Substance(s): HPV PROTEINS
Strength: 0.5ml
Pack Size: 1 pre-filled syringe of 1ml
Accessories: 1 x 0.5ml Vial, 1 x Pre-Filled Syringe

GARDASIL® 9 is a recombinant vaccine designed for the prevention of diseases caused by Human Papillomavirus (HPV). It protects against nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58), which are linked to cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers, as well as genital warts. The vaccine is approved for girls and women aged 9-45 years and boys and men aged 9-45 years.

Key Features:

• Comprehensive Protection: Covers nine HPV types, preventing related cancers and genital warts.
• Age-Adapted Dosage: Administered as a two-dose regimen for ages 9-14 years and a three-dose regimen for ages 15-45 years.
• Clinically Proven Efficacy: Demonstrated to provide high effectiveness in preventing HPV-related diseases.

GARDASIL® 9 is available in 0.5 mL single-dose vials and prefilled syringes for intramuscular injection.

Ingredients:

• HPV L1 Virus-Like Particles (VLPs): Derived from HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
• Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS): 500 mcg per dose as an adjuvant.
• Sodium Chloride (9.56 mg), L-Histidine (0.78 mg), Polysorbate 80 (50 mcg), Sodium Borate (35 mcg), and Water for Injection.
• No preservatives or antibiotics.

GARDASIL® 9 is indicated for girls and women (9-45 years) and boys and men (9-45 years) for the prevention of:

• Cervical, vulvar, vaginal, 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.
• Precancerous lesions: Cervical intraepithelial neoplasia (CIN 1/2/3), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN 2/3), vaginal intraepithelial neoplasia (VaIN 2/3), and anal intraepithelial neoplasia (AIN 1/2/3).

Contraindications:

• Severe allergic reactions to yeast or any component of the vaccine.
• Hypersensitivity reactions after a previous dose of GARDASIL® 9.

Side Effects:

• Common (≥10%): Injection-site pain (89.9%), swelling (40.0%), erythema (34.0%), headache (14.6%).
• Less Common: Fever, dizziness, nausea, fatigue.
• Rare but serious: Anaphylactic reactions, syncope (fainting requiring observation for 15 minutes post-vaccination).

GARDASIL® 9 is administered as a 0.5 mL intramuscular injection in the deltoid or anterolateral thigh.

Dosage Schedule:

• Ages 9-14 years: Two-dose regimen (0 and 6-12 months). If the second dose is given before 5 months, a third dose is required.
• Ages 15-45 years: Three-dose regimen (0, 2, and 6 months).

Storage Recommendations:

• Store at 2-8°C (refrigerated).
• Do not freeze; discard if frozen.
• Protect from light; keep in the original packaging.

By following proper administration and storage guidelines, GARDASIL® 9 provides effective protection against HPV-related diseases.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.