M-M-R II- measles, mumps, and rubella virus vaccine live injection, powder, lyophilized, for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN (UNII: MFZ8I7277D) (MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN - UNII:MFZ8I7277D), MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN (UNII: 47QB6MX9KU) (MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN - UNII:47QB6MX9KU), RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (UNII: 52202H034Z) (RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN - UNII:52202H034Z)

Διαθέσιμο από:

A-S Medication Solutions

Οδός χορήγησης:

SUBCUTANEOUS

Θεραπευτικές ενδείξεις:

M-M-R® II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubella-containing vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to neomycin [see Description (11)]. Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this population, disseminated mumps and rubella vacc

Περίληψη προϊόντος:

Product: 50090-1860

Καθεστώς αδειοδότησης:

Biologic Licensing Application

Αρχείο Π.Χ.Π.

M-M-R II- MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE INJECTION,
POWDER,
LYOPHILIZED, FOR SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
M-M-R II SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR M-M-R II.
M-M-R II (MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE) SUSPENSION
FOR SUBCUTANEOUS
INJECTION
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
M-M-R II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella
in individuals 12 months of age and older. (1)
DOSAGE AND ADMINISTRATION
Administer a 0.5-mL dose of M-M-R II subcutaneously. (2.1)
The first dose is administered at 12 to 15 months of age. (2.1)
The second dose is administered at 4 to 6 years of age. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection (0.5-mL dose) supplied as a lyophilized
vaccine to be reconstituted using
accompanying sterile diluent. (3)
CONTRAINDICATIONS
Hypersensitivity to any component of the vaccine. (4.1)
Immunosuppression. (4.2)
Moderate or severe febrile illness. (4.3)
Active untreated tuberculosis. (4.4)
Pregnancy. (4.5, 8.1)
WARNINGS AND PRECAUTIONS
Use caution when administering M-M-R II to individuals with a history
of febrile seizures. (5.1)
Use caution when administering M-M-R II to individuals with
anaphylaxis or immediate hypersensitivity
following egg ingestion. (5.2)
Use caution when administering M-M-R II to individuals with a history
of thrombocytopenia. (5.3)
Evaluate individuals for immune competence prior to administration of
M-M-R II if there is a family
history of congenital or hereditary immunodeficiency. (5.4)
Immune Globulins (IG) and other blood products should not be given
concurrently with M-M-R II. (5.5,
7.2)
ADVERSE REACTIONS
See full prescribing information for adverse reactions occurring
during clinical trials or the post-marketing
period. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK SHARP & DOHME
CORP., A
SUBSIDIARY OF MERCK