Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
HPV-16 L1; HPV-18 L1
GLAXOSMITHKLINE PTE LTD
J07BM02
20 μg/0.5ml
INJECTION, SUSPENSION
HPV-16 L1 20 μg/0.5ml; HPV-18 L1 20μg/0.5ml
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals s.a.
ACTIVE
2007-11-22
1 _CERVARIX_ _™_ _ _ 1. NAME OF THE MEDICINAL PRODUCT _Cervarix_ _TM_ _ _ Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 section 5.1) 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cervarix is a vaccine indicated in females from 9 to 25 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by Human Papillomavirus (HPV) Types 16 & 18. See sections 4.4 and 5.1 for important information on the data regarding HPV-16 and/or HPV-18, and other oncogenic HPV types that support this indication. The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 9-25 years. The use of Cervarix should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The vaccination schedule depends on the age of the subject. From age 9 to and including 14 years of age at the time of the first injection, Cervarix can be administered as either a 2 or 3 dose schedule. From age 15 years and above, only the 3-dose schedule is recommended. 2-dose schedule: the vaccination sc Soma hati kamili
1 CERVARIX_ _ 1. NAME OF THE MEDICINAL PRODUCT Cervarix_ _ Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted) Suspension for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 section 4.1)_ 3. CLINICAL INFORMATION 3.1 THERAPEUTIC INDICATIONS Cervarix is a vaccine indicated in females from 9 to 25 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by Human Papillomavirus (HPV) Types 16 & 18. See sections 3.4 and 4.1 for important information on the data regarding HPV-16 and/or HPV-18, and other oncogenic HPV types that support this indication. The indication is based on the demonstration of efficacy in women aged 15 to 25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 9 to 25 years. The use of Cervarix should be in accordance with official recommendations. 3.2 POSOLOGY AND METHOD OF 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* or Three doses each of 0.5 ml at 0, 1, 6 months** 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 5th month after the first dose, a third dose should always be administered. **If flexibility in the vaccination s Soma hati kamili