PROQUAD measles mumps rubella and varicella virus vaccine live injection powder lyophilized for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN (UNII: MFZ8I7277D) (MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN - UNII:MFZ8I7277D)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN

Composition:

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

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

PROQUAD- MEASLES, MUMPS, RUBELLA AND VARICELLA VIRUS VACCINE LIVE
INJECTION, POWDER,
LYOPHILIZED, FOR SUSPENSION
MERCK SHARP & DOHME CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROQUAD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PROQUAD.
PROQUAD®
MEASLES, MUMPS, RUBELLA AND VARICELLA VIRUS VACCINE LIVE
SUSPENSION FOR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
ProQuad is a vaccine indicated for active immunization for the
prevention of measles, mumps, rubella, and varicella in
children 12 months through 12 years of age. (1)
DOSAGE AND ADMINISTRATION
A 0.5-mL dose for subcutaneous injection only. (2.1)
The first dose is usually administered at 12 to 15 months of age.
(2.1)
A second dose, if needed, is usually 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 only accompanying
sterile diluent. (2.2, 3)
CONTRAINDICATIONS
History of anaphylactic reaction to neomycin or hypersensitivity to
gelatin or any other component of the vaccine. (4.1)
Primary or acquired immunodeficiency states. (4.2)
Family history of congenital or hereditary immunodeficiency. (4.2)
Immunosuppressive therapy. (4.2, 7.3)
Active untreated tuberculosis or febrile illness (>101.3°F or
>38.5°C). (4.3)
Pregnancy. (4.4, 8.1, 17)
WARNINGS AND PRECAUTIONS
Administration of ProQuad (dose 1) to children 12 to 23 months old who
have not been previously vaccinated against
measles, mumps, rubella, or varicella, nor had a history of the
wild-type infections, is associated with higher rates of
fever and febrile seizures at 5 to 12 days after vaccination when
compared to children vaccinated with M-M-R® II and
VARIVAX® administered separately. (5.1, 6.1, 6.3)
Use caution when administering ProQuad to children with a history of
cerebral injury or seizures or any other condition
in which stress due to fever should be avo