Gardasil 0.5 ml/pre-filled syringe IM Injection

✔️ Directions for Use:

• For intramuscular use only
• Shake well before administration to ensure proper suspension
• Do not dilute or mix with other vaccines
• After agitation, the vaccine appears as a white, cloudy suspension
• Inspect visually for particulate matter or discoloration prior to use
• Inject into the deltoid muscle or the anterolateral thigh
• Due to the risk of syncope, observe vaccine recipients for 15 minutes post-vaccination

✔️ Gardasil is indicated for the prevention of diseases caused by Human Papillomavirus (HPV) types included in the vaccine.

Girls and Women (9–26 years)

Prevention of:

Cervical, vulvar, vaginal, and anal cancers associated with HPV types 16 and 18

Genital warts (condyloma acuminata) caused by HPV types 6 and 11

Prevention of HPV-related precancerous or dysplastic lesions:

Cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3

Cervical adenocarcinoma in situ (AIS)

Vulvar intraepithelial neoplasia (VIN) grades 2 and 3

Vaginal intraepithelial neoplasia (VaIN) grades 2 and 3

Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Boys and Men (9–45 years)

Prevention of:

Anal, oropharyngeal, and other head and neck cancers associated with HPV types 16, 18, 31, 33, 45, 52, and 58

Genital warts caused by HPV types 6 and 11

Prevention of:

Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন

Pharmacology

HPV infects only humans. Gardasil contains virus-like particles (L1 VLPs) that stimulate the immune system to produce neutralizing antibodies. Protection against HPV-related diseases is believed to be mediated through vaccine-induced humoral immune responses, although the precise mechanism has not been fully established.

Dosage Schedule

Ages 9–14 years

2-dose schedule: 0 and 6–12 months

If the second dose is given less than 5 months after the first, a third dose is required at least 4 months later

3-dose schedule: 0, 2, and 6 months

Ages 15–45 years

3-dose schedule: 0, 2, and 6 months

* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন

✔️ Drug Interactions

Immunosuppressive treatments (e.g., chemotherapy, radiotherapy, high-dose corticosteroids) may reduce the immune response to Gardasil.

✔️ Contraindications:

Known hypersensitivity to any component of the vaccine, including yeast

Severe allergic reaction following a previous dose of Gardasil

✔️ Adverse Reactions

Common (≥10%) adverse effects include:

Injection-site pain, swelling, and erythema

Headache

Incidence varies by age and gender, with injection-site pain being the most frequently reported reaction across all groups.

✔️ Pregnancy & Lactation

Pregnancy Category B

Animal studies show no evidence of fetal harm; however, adequate human studies are lacking

Use during pregnancy only if clearly needed

Caution is advised during breastfeeding, as excretion in human milk is unknown

✔️ Precautions & Warnings

Syncope and, rarely, seizure-like activity may occur after vaccination; patients should remain seated or supine during observation

Tonic-clonic movements associated with syncope are usually transient and resolve with appropriate positioning

✔️ Storage:

Store at 2–8°C

Do not freeze

Protect from light

Administer as soon as possible after removal from refrigeration