GARDASIL® 9 (Slovakian)

GARDASIL® 9 is a 9-valent recombinant vaccine designed to protect against nine types of Human Papillomavirus (HPV), including types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It is approved for use in girls and women as well as boys and men aged 9 to 45 years to prevent HPV-related diseases. These include cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers, as well as genital warts and various precancerous lesions.

The vaccine is administered as a suspension for intramuscular injection and provides high efficacy rates, especially when administered before exposure to the virus. It is not a treatment for existing HPV infections or related diseases and does not eliminate the need for routine screening in women. The product is manufactured using recombinant DNA technology in Saccharomyces cerevisiae (yeast).

GARDASIL® 9 must be administered intramuscularly, typically into the deltoid or anterolateral thigh. Dosing depends on patient age.

Key Features:

• Administered in 0.5 mL doses.
  
• Protocol varies by age group.
  

Administration Schedule:

• Ages 9–14:
  
  • 2-dose: 0, 6–12 months
    
  • 3-dose: 0, 2, 6 months (if second dose <5 months after the first)
    
• Ages 15–45:
  
  • 3-dose: 0, 2, 6 months
    
• Instructions:
  • Shake well before use
    
  • Inspect for particulates and discoloration
    
  • Use single-dose vial or prefilled syringe
    
  • Observe patients for 15 minutes post-injection

GARDASIL® 9 is indicated for the prevention of various HPV-related diseases in both sexes, from age 9 to 45.

Indications:

• Cancers: Cervical, vulvar, vaginal, anal, oropharyngeal, and head & neck (HPV types 16, 18, 31, 33, 45, 52, 58)
  
• Genital warts: HPV types 6 and 11
  
• Precancerous lesions: CIN 1/2/3, AIS, VIN 2/3, VaIN 2/3, AIN 1/2/3
  

Contraindications:

• Severe allergic reaction to yeast or any previous dose
  
• Hypersensitivity to vaccine components
  

Side Effects:

• Injection-site reactions (pain, swelling, erythema)
  
• Systemic reactions (fever, headache, fatigue)
  
• Rare: syncope, hypersensitivity, or serious adverse events

Each 0.5 mL dose contains:

• HPV L1 proteins:
  
  • Type 6: 30 mcg
    
  • Type 11: 40 mcg
    
  • Type 16: 60 mcg
    
  • Type 18: 40 mcg
    
  • Types 31, 33, 45, 52, 58: 20 mcg each

• Adjuvant: 500 mcg of amorphous aluminum hydroxyphosphate sulfate (AAHS)
  
• Other components:
  
  • Sodium chloride (9.56 mg)
    
  • L-histidine (0.78 mg)
    
  • Polysorbate 80 (50 mcg)
    
  • Sodium borate (35 mcg)
    
  • Yeast protein (<7 mcg)
    
  • Water for injection

The vaccine is available in two formats:

• 0.5 mL single-dose vial
  
• 0.5 mL prefilled syringe (without attached needle)
  

Each unit contains a sterile, white, cloudy suspension for intramuscular injection. The packaging includes instructions for proper handling and administration.

Yes, GARDASIL® 9 may cause local and systemic side effects. Most are mild to moderate and resolve on their own.

Most Common Side Effects (≥10%):

• Injection-site pain (up to 90%)
  
• Swelling and erythema (up to 48%)
  
• Headache (11–15%)
  
• Fever (up to 10.4%)
  

Other Possible Side Effects:

• Nausea, dizziness, fatigue
  
• Syncope (fainting)
  
• Hypersensitivity reactions
  
• Rare: Autoimmune or neurological conditions

Storage Conditions:

• Store refrigerated at 2–8°C
  
• Do not freeze; discard if frozen
  
• Protect from light
  
• Use immediately after opening single-dose vial or syringe
  

Additional Notes:

• Shake well before use
  
• Inspect for particulate matter and discoloration prior to injection