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

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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)

Доступно од:

Merck Sharp & Dohme LLC

INN (Међународно име):

MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN

Састав:

MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN 1000 [TCID_50] in 0.5 mL

Пут администрације:

SUBCUTANEOUS

Терапеутске индикације:

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 vaccin

Резиме производа:

M-M-R II vaccine is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00 (2) a box of 10 prefilled syringes of sterile diluent, NDC 0006-4175-88 (package B) OR a box of 10 vials of sterile diluent, NDC 0006-4309-00 (package B) Storage Vaccine Vial Exposure to light may inactivate the vaccine viruses. To maintain potency, M-M-R II must be stored between -58°F and +46°F (-50°C to +8°C). Use of dry ice may subject M-M-R II to temperatures colder than -58°F (-50°C). Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F (2°C to 8°C). Sterile Diluent The sterile diluent should be stored in the refrigerator (36°F to 46°F, 2°C to 8°C) or at room temperature (68°F to 77°F, 20°C to 25°C). Do not freeze the sterile diluent . Administer M-M-R II vaccine immediately after reconstitution. If not administered immediately, reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours. For information regarding the product or questions regarding storage conditions, call 1-800-637-2590.

Статус ауторизације:

Biologic Licensing Application

Карактеристике производа

M-M-R II- MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE INJECTION,
POWDER,
LYOPHILIZED, FOR SUSPENSION
STERILE DILUENT- STERILE WATER INJECTION
MERCK SHARP & DOHME LLC
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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 INTRAMUSCULAR
OR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 1978
RECENT MAJOR CHANGES
Dosage and Administration
Dose and Schedule (2.1)
02/2023
Administration (2.2)
08/2023
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
For intramuscular or subcutaneous injection only. (2.1, 2.2)
A single dose is approximately 0.5 mL.
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 (approximately 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 REACTION