CAPVAXIVE SOLUTION FOR INJECTION [SIN17471P]
Active ingredients: CAPVAXIVE SOLUTION FOR INJECTION
Product Info
CAPVAXIVE SOLUTION FOR INJECTION
[SIN17471P]
Product information
Active Ingredient and Strength | (MBC) PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 - 4 MCG/0.5 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | MSD INTERNATIONAL GMBH - IRELAND |
Registration Number | SIN17471P |
Licence Holder | MSD PHARMA (SINGAPORE) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07AL02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
1. INDICATIONS AND USAGE
CAPVAXIVE is indicated for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older.
CAPVAXIVE will only protect against S. pneumoniae serotypes as indicated above.
CAPVAXIVE should be used in accordance with official recommendations.
Dosing
2. DOSAGE AND ADMINISTRATION
2.1 General
Dosage
Administer a single 0.5 mL dose of CAPVAXIVE intramuscularly.
Method of Administration
For intramuscular injection only. Do not inject intravascularly.
2.2 Adults
One single dose.
2.3 Vaccination of Individuals Previously Vaccinated with One or More Doses of Other Pneumococcal Vaccines
Administer a single dose of CAPVAXIVE to adults 18 years of age and older previously vaccinated with one or more doses of other pneumococcal vaccines. The dose of CAPVAXIVE should be administered at least 8 weeks after the last dose of the prior pneumococcal vaccine.
Contraindications
4. CONTRAINDICATIONS
CAPVAXIVE is contraindicated in individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including diphtheria toxoid. [See Pharmaceutical Particulars (15.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]
