Gardasil (HPV Vaccine) (cont.)

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PREPARATIONS: Injection: 0.5 ml single-dose vial and pre-filled syringe

STORAGE: Gardasil should be stored refrigerated at 2 to 8 C (36 to 46 F) and should be protected from light and not frozen.

PRESCRIBED FOR: Gardasil is used for the prevention of infection with HPV types 6, 11, 16, and 18 in girls and women 9 to 26 years of age.

It also is approved for preventing genital warts caused by HPV types 6 and 11 and anal cancer caused by HPV types 16 and 18 in males 9 to 26 years old.

Gardasil protects against cervical cancer (cancer of the lower end of the uterus or womb); abnormal and precancerous cervical lesions; abnormal and precancerous vaginal lesions; abnormal and precancerous vulvar lesions; precancerous anal lesions and genital warts.

Gardasil does not treat active cervical cancer, active genital warts, or other active genital lesions caused by HPV.

Individuals with a compromised immune system will not respond as well to Gardasil as individuals with a normal immune system.

Women should continue cervical cancer screening even after receiving vaccination with Gardasil.

DOSING: Gardasil 0.5 ml is injected intramuscularly as three separate doses. The first dose is administered at the patient's convenience, the second dose two months after the first dose, and the third dose six months after the first dose.

DRUG INTERACTIONS: Gardasil may be administered concomitantly (at different sites) with hepatitis B vaccine, Menactra (Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine), and Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed). The use of immunosuppressive drugs reduces the efficacy of Gardasil. Hormonal contraceptives do not interact with Gardasil.

PREGNANCY: Gardasil has not been adequately evaluated in pregnant women. It should only be used in pregnant women if it is clearly needed.

NURSING MOTHERS: It is not known whether Gardasil or the antibodies induced by Gardasil are excreted in breast milk.

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