Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
HPV Type 18 L1 Protein, Quantity: 20 microgram; HPV Type 16 L1 Protein, Quantity: 20 microgram
GlaxoSmithKline Australia Pty Ltd
HPV Type 16 L1 Protein,HPV Type 18 L1 Protein
Injection, suspension
Excipient Ingredients: water for injections; sodium chloride; 3-O-desacyl-4'-monophosphoryl lipid A; monobasic sodium phosphate; aluminium hydroxide hydrate
Intramuscular
100 vials, 1 vial, 10 vials
(S4) Prescription Only Medicine
CERVARIX is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18. Immunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations. (See Precautions and Clinical Trials). CERVARIX is indicated in females from 10 to 45 years for the prevention of Cervical Cancer by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and CIN 3) caused by human papillomavirus types 16 and 18. Immunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations.
Visual Identification: Tubid liquid after shaking. White deposit and colourless supernatant after sedimentation; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2007-05-18
1 AUSTRALIAN PRODUCT INFORMATION CERVARIX HUMAN PAPILLOMAVIRUS VACCINE TYPES 16 AND 18 (RECOMBINANT, AS04 ADJUVANTED) SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Human Papillomavirus Vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CERVARIX contains recombinant C-terminally truncated L1 proteins from human papillomavirus (HPV) type-16 and type-18 each assembled as virus-like particles (VLPs). The HPV-16 and HPV-18 L1 antigens are prepared by recombinant DNA technology using a Baculovirus expression system in Trichoplusia ni cells. HPV-16 and HPV-18 L1 antigens in CERVARIX are adjuvanted with AS04. This AS04 adjuvant system comprises aluminium hydroxide hydrate (Al(OH)3) and 3-O-desacyl-4’- monophosphoryl lipid A (MPL). The MPL within AS04 enhances the initiation of the immune response through the activation of innate immunity, leading to an improved cellular and humoral adaptive immune response. Each 0.5 mL dose of CERVARIX contains 20 micrograms each of HPV-16 L1 and HPV-18 L1 proteins, 0.5 milligrams of Al(OH)3 and 50 micrograms of MPL. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Suspension for injection. CERVARIX is presented as a turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed. This does not constitute a sign of deterioration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CERVARIX is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18. Immunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations. (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials). 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage The vaccination schedule depends on the age of the Baca dokumen lengkapnya