CERVARIX human papillomavirus vaccine types 16 and 18 [recombinant, AS04 adjuvanted] suspension for injection vial

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

HPV Type 18 L1 Protein, Quantity: 20 microgram; HPV Type 16 L1 Protein, Quantity: 20 microgram

Disponibbli minn:

GlaxoSmithKline Australia Pty Ltd

INN (Isem Internazzjonali):

HPV Type 16 L1 Protein,HPV Type 18 L1 Protein

Għamla farmaċewtika:

Injection, suspension

Kompożizzjoni:

Excipient Ingredients: water for injections; sodium chloride; 3-O-desacyl-4'-monophosphoryl lipid A; monobasic sodium phosphate; aluminium hydroxide hydrate

Rotta amministrattiva:

Intramuscular

Unitajiet fil-pakkett:

100 vials, 1 vial, 10 vials

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2007-05-18

Karatteristiċi tal-prodott

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