M-M-R II Lyophilized Powder for Injection (IM/SC)

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Live Measles, Mumps and Rubella Vaccine

Available from:

Merck Sharp & Dohme (I.A.) LLC; Distributor: Merck Sharp & Dohme (I.A.) LLC

INN (International Name):

Live Measles, Mumps and Rubella Vaccine

Dosage:

Formulation: After reconstitution, one dose (0.5 mL) contains: Measles virus? Enders' Edmonston strain (live, attenuated).. Mumps virus! Jeryl Lynn TM (B Level) strain (live, attenuated) ...... Rubella virus? Wistar RA 27/3 strain (live, attenuated) .... .... .. .NLT 1,000 CCID 50 ..NLT 12,500 CCID 50 ....NLT 1,000 CCID 50 () Produced in chick embryo cells. (2) Produced in WI-38 human diploid lung fibroblasts.

Pharmaceutical form:

Lyophilized Powder for Injection (IM/SC)

Units in package:

Single dose. Clear and colorless glass vial x 3 mL + Type I pre-filled glass syringe (diluent) (0.75 ml water for injection) x 1 mL + 2 separate needles in a sealed clear plastic tray (Box of 10's), Single dose. Clear and colorless glass vial x 3 mL + Type I pre-filled glass syringe (diluent) (0.75 ml water for injection) x

Manufactured by:

Merck Sharp and Dohme Corp., USA

Product summary:

Formulation: After reconstitution, one dose (0.5 mL) contains: Measles virus? Enders' Edmonston strain (live, attenuated).. Mumps virus! Jeryl Lynn TM (B Level) strain (live, attenuated) ...... Rubella virus? Wistar RA 27/3 strain (live, attenuated) .... .... .. .NLT 1,000 CCID 50 ..NLT 12,500 CCID 50 ....NLT 1,000 CCID 50 () Produced in chick embryo cells. (2) Produced in WI-38 human diploid lung fibroblasts.

Authorization date:

2022-08-09