Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
Human Papillomavirus Type 11 L1 Protein; Human Papillomavirus Type 16 L1 Protein; Human Papillomavirus Type 18 L1 Protein; Human Papillomavirus Type 6 L1 Protein
MSD PHARMA (SINGAPORE) PTE. LTD.
J07BM01
40 mcg
SOLUTION, STERILE
Human Papillomavirus Type 11 L1 Protein 40 mcg; Human Papillomavirus Type 16 L1 Protein 40 mcg; Human Papillomavirus Type 18 L1 Protein 20 mcg; Human Papillomavirus Type 6 L1 Protein 20 mcg
INTRAMUSCULAR
Prescription Only
MERCK SHARP & DOHME LLC
ACTIVE
2006-12-05
Copyright© 2013 Merck Sharp & Dohme, a subsidiary of Merck & Co. Inc., Whitehouse Station, NJ, USA. All Rights Reserved. SG-V501-I-112013 PRODUCT CIRCULAR GARDASIL™ [QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE] I. THERAPEUTIC CLASS GARDASIL is a recombinant, quadrivalent vaccine that protects against Human Papillomavirus (HPV). II. INDICATIONS GARDASIL is a vaccine indicated in girls and women aged 9 through 26 years for the prevention of cervical, vulvar and vaginal cancer, premalignant genital lesions (cervical, vulvar and vaginal), HPV infection, cervical adenocarcinoma _in situ_ (AIS) and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL PHARMACOLOGY. GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of HPV infection caused by HPV types 6, 11, 16 and 18 and genital warts (condyloma acuminata) caused by HPV types 6 and 11. For efficacy data, see section XIV CLINICAL PHARMACOLOGY. GARDASIL is also indicated in individuals 9 through 26 years of age for the prevention of anal cancer and premalignant lesions due to HPV types 6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL PHARMACOLOGY. III. DOSAGE AND ADMINISTRATION _Dosage _ GARDASIL should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule: First dose: at elected date Second dose: 2 months after the first dose Third dose: 6 months after the first dose Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administer Διαβάστε το πλήρες έγγραφο
SG-V501-I-012021 PRODUCT CIRCULAR GARDASIL™ [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] I. THERAPEUTIC CLASS GARDASIL is a recombinant, quadrivalent vaccine that protects against Human Papillomavirus (HPV). II. INDICATIONS GARDASIL is a vaccine indicated in girls and women aged 9 through 26 years for the prevention of cervical, vulvar and vaginal cancer, premalignant genital lesions (cervical, vulvar and vaginal), HPV infection, cervical adenocarcinoma in situ (AIS) and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL PHARMACOLOGY. GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of HPV infection caused by HPV types 6, 11, 16 and 18 and genital warts (condyloma acuminata) caused by HPV types 6 and 11. For efficacy data, see section XIV CLINICAL PHARMACOLOGY. GARDASIL is also indicated in individuals 9 through 26 years of age for the prevention of anal cancer and premalignant lesions due to HPV types 6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL PHARMACOLOGY. III. DOSAGE AND ADMINISTRATION Dosage GARDASIL should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule: First dose: at elected date Second dose: 2 months after the first dose Third dose: 6 months after the first dose Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Alternatively, in individuals 9 through 13 years of age, GARDASIL can be administered according to a 2-dose (0, 6 months) schedule. The use of GARDASIL should be in accordance with of Διαβάστε το πλήρες έγγραφο