Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN (UNII: MFZ8I7277D) (MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN - UNII:MFZ8I7277D)
Merck Sharp & Dohme Corp.
MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN
MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN 1000 [TCID_50] in 0.5 mL
Biologic Licensing Application
PROQUAD- MEASLES, MUMPS, RUBELLA AND VARICELLA VIRUS VACCINE LIVE INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION MERCK SHARP & DOHME CORP. ---------- 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 Läs hela dokumentet