Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
SMITHKLINE BEECHAM PHARMACEUTICALS - Indonesia
HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
20 MCG /20 MCG
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 1 DOSIS (0,5 ML)
GlaxoSmithKline Biologicals SA - Belgium
2022-03-04
ERS_leaCERinj_PI update GDS27 IPI21_circ2_28Jun22 Page 1 of 10 _ _ _ _ CERVARIX HUMAN PAPILLOMAVIRUS VACCINE TYPES 16 AND 18 (RECOMBINANT, AS04 ADJUVANTED) QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection 1 dose (0.5 mL) contains: Human Papillomavirus type 16 L1 protein 1 20 micrograms Human Papillomavirus type 18 L1 protein 1 20 micrograms 3-_O_-desacyl-4’- monophosphoryl lipid A (MPL) 2 50 micrograms Aluminium hydroxide, hydrated 2 0.5 milligrams Al 3+ 1 L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system 2 The GlaxoSmithKline proprietary AS04 adjuvant system is composed of aluminium hydroxide and 3-_O_-desacyl-4’- monophosphoryl lipid A (MPL) (see _Pharmacodynamics_) CLINICAL INFORMATIONS INDICATIONS _CERVARIX_ is indicated in females from 9 through 25 years of age for the prevention of persistent infection, premalignant cervical lesions and_ _cervical cancer (squamous cell carcinoma and adenocarcinoma) caused by oncogenic Human Papillomavirus (HPV) types 16, and 18 (see _Warnings and _ _Precautions and _ _Pharmacodynamics_ sections for more information on HPV 16, 18 and other oncogenic types). DOSAGE AND ADMINISTRATION The vaccination schedule depends on the age of the subject. AGE AT THE TIME OF THE FIRST INJECTION IMMUNIZATION AND SCHEDULE 9 to and including 14 years* Two doses each of 0.5 mL. The second dose given between 5 and 13 months after the first dose From 15 years and above Three doses each of 0.5 mL at 0, 1, 6 months** *If the second vaccine dose is administered before the 5 th month after the first dose, a third dose should always be administered. **If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose. _ _ Although the necessity for a booster dose has not been established, an anamnestic response has been observed after the adminis Lugege kogu dokumenti