Table 1.
Product information.
| Name of the medicinal product | Cervarix® | Gardasil®/Silgard® | ||||||
|---|---|---|---|---|---|---|---|---|
| Producer | GlaxoSmithKline Biologics | Sanofi Pasteur MSD/Merck Sharp & Dohme | ||||||
| Qualitative and Quantitative composition | 1 dose (0.5 ml) contains | 1 dose (0.5 ml) contains approximately | ||||||
| Human papillomavirus type 16 L1 protein | 20 micrograms | Human papillomavirus type 6 L1 protein | 20 micrograms | |||||
| Human papillomavirus type 18 L1 protein | 20 micrograms | Human papillomavirus type 11 L1 protein | 40 micrograms | |||||
| 2 adjuvanted by AS04 containing: 3-O-desacyl-4’- monophosphoryl lipid A (MPL) | 50 micrograms | Human papillomavirus type 16 L1 protein | 40 micrograms | |||||
| Adsorbed on aluminium hydroxide, hydrated (Al(OH)3) | 0.5 milligrams Al3+ in total | Human papillomavirus type 18 L1 protein | 20 micrograms | |||||
| Adsorbed on amorphous aluminium hydroxyphosphate sulfate adjuvant. | 0.225 milligrams Al | |||||||
| Pharmaceutical form | Suspension for injection. Turbid white suspension. | Suspension for injection. After thorough agitation, it is a white, cloudy liquid | ||||||
| Posology: age at the time of first injection and immunization schedule | EMA | FDA | TGA | PHAC | EMA | FDA | TGA | PHAC |
| 9 to and including 14 years = Two doses each of 0.5 ml at 0, 6 months From 15 years and above = Three doses each of 0,5 ml at 0, 1, 6 months |
9 – 25 years of age = Three doses each of 0.5 ml at 0, 1, 6 months | Female from 10 – 45 years of age = Three doses each of 0.5 ml at 0, 1, 6 months | Recommended for females aged 9 – 26 years of age; may be administered to female over 26 years of age = Three doses each of 0.5 ml at 0, 1, 6 months | 9 to and including 13 years of age = Two doses each of 0.5 ml at 0, 6 months From 14 years and above = Three doses each of 0,5 ml at 0, 2, 6, months |
9 – 26 year of age = Three doses each of 0.5 ml at 0, 2, 6 months | Females aged 9 – 45 years and males aged 9 – 26 years = Three doses each of 0.5 ml at 0,2,6 months | Recommended for: females aged 9 – 26 years of age, males between 9 and 26 years of age. May be administered to female over 26 years of age = Three doses each of 0.5 ml at 0, 2, 6 months | |
| Method of administration | Intramuscular injection | Intramuscular injection | ||||||
| Contraindications | Hypersensitivity to the active substances or to any of the excipients | Hypersensitivity to the active substances or to any of the excipients | ||||||
EMA: European medicines agency; FDA: US food and drug administration; PHAC: Public health agency of Canada; TGA: Australian government department of Health - therapeutic goods administration.