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), 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), VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (UNII: GPV

Available from:

Merck Sharp & Dohme LLC

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

Administration route:

SUBCUTANEOUS

Therapeutic indications:

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. Do not administer ProQuad to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {1} or to a previous dose of M-M-R II (Measles, Mumps, Rubella, Live), ProQuad or VARIVAX (Varicella Virus Vaccine Live) vaccine, or any other measles, mumps, and rubella or varicella-containing vaccine. Do not administer ProQuad to individuals with a history of anaphylaxis to neomycin [see Description (11)] . Do not administer ProQuad vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Measles inclusion body encephalitis {2} (MIBE), pneumonitis {3} 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 mump

Product summary:

ProQuad is supplied as follows: (1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4171-00 (package A) (2) a separate package of 10 prefilled syringes of sterile diluent, NDC 0006-4175-88 (package B) OR a separate package of 10 vials of sterile diluent, NDC 0006-4309-00 (package B) Storage Vaccine Vial To maintain potency, ProQuad must be stored frozen between -58°F and +5°F (-50°C to -15°C). Use of dry ice may subject ProQuad to temperatures colder than -58°F (-50°C). Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between −58 °F and +5 °F ( −50 °C and −15 °C) for up to 18 months. Any freezer (e.g ., chest, frost-free) that reliably maintains an average temperature between −58 °F and +5 °F ( −50 °C and −15 °C) and has a separate sealed freezer door is acceptable for storing ProQuad. Routine defrost cycling of a frost-free freezer is acceptable. ProQuad may be stored at refrigerator temperature (36° to 46°F, 2° to 8°C) for up to 72 hours prior to reconstitution. Discard any ProQuad vaccine stored at 36° to 46°F which is not used within 72 hours of removal from 5°F (-15°C) storage. Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses. Sterile Diluent The sterile diluent should be stored at room temperature (68° to 77°F, 20° to 25°C), or in a refrigerator (36° to 46°F, 2° to 8°C). IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES. DO NOT FREEZE RECONSTITUTED VACCINE. For information regarding the product or questions regarding storage conditions, call 1-800-637-2590.

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 LLC
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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 INTRAMUSCULAR OR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Dosage and Administration
Dose and Schedule (2.1)
02/2023
Preparation for Administration (2.2)
08/2023
Administration (2.3)
02/2023
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
For intramuscular or subcutaneous injection only. (2.1, 2.3)
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. (2.2, 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
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. Exercise
caution when administering ProQuad to persons with an individual or
family history of febrile seizures.
(5.1, 6.1, 6.3)
Use caution when administering ProQuad to children w