PRIORIX- measels, mumps, and rubella vaccine, live kit

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED CHICK EMBRYO FIBROBLASTS LIVE ANTIGEN (UNII: YRF2UZG52M) (MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED CHICK EMBRYO FIBROBLASTS LIVE ANTIGEN - UNII:YRF2UZG52M), MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK EMBRYO FIBROBLASTS LIVE ANTIGEN (UNII: 566FJ5L8R4) (MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK EMBRYO FIBROBLASTS LIVE ANTIGEN - UNII:566FJ5L8R4), RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (UNII: 52202H034Z) (RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN - UNII:52202H034Z)

Verfügbar ab:

GlaxoSmithKline Biologicals SA

Anwendungsgebiete:

PRIORIX 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 PRIORIX to individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine [see Description (11)] . Due to the risk of disseminated vaccine virus infection, do not administer PRIORIX to individuals with severe humoral or cellular (primary or acquired) immunodeficiency. Do not administer PRIORIX to individuals who are pregnant. Pregnancy should be avoided for 1 month after vaccination [see Use in Specific Populations (8.1)] . Risk Summary PRIORIX contains live attenuated measles, mumps, and rubella viruses. The vaccine is contraindicated for use in pregnant women because infection during pregnancy with the wild-type viruses is associated with maternal and fetal adverse outcomes. Pregnancy should be avoided for 1 month after vaccination [see Contraindications (4.3), Patient Counseling Information (17)]. Reports have indicated that contracting wild-type measles during pregnancy enhances fetal risk, including increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects.2,3 Wild-type mumps virus infection during the first trimester of pregnancy may increase the rate of spontaneous abortion. Pregnant women infected with wild-type rubella virus are at increased risk for miscarriage or stillbirth, and their infants are at risk for congenital rubella syndrome.1 Available data on inadvertent administration of PRIORIX to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. There are no animal studies with PRIORIX to inform use during pregnancy. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary It is not known whether the vaccine components of PRIORIX are excreted in human milk. Data are not available to assess the effects of PRIORIX on the breastfed infant or on milk production/excretion. Studies have shown that lactating postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast‑fed infants.4,5 In the breast-fed infants with serological evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.6,7 The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PRIORIX and any potential adverse effects on the breastfed child from PRIORIX or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. Safety and effectiveness of PRIORIX in infants younger than 12 months have not been established. Clinical studies of PRIORIX did not include participants 65 years of age and older to determine whether they respond differently from younger participants.

Produktbesonderheiten:

PRIORIX is supplied in a box (NDC 58160-824-15) containing: After reconstitution, each vial contains one dose (approximately 0.5 mL) of PRIORIX. Vials of lyophilized antigen component: Store refrigerated between 36° and 46°F (2° and 8°C). Protect vials from light. Prefilled ungraduated syringes of sterile water diluent: Store refrigerated between 36° and 46°F (2° and 8°C) or at controlled room temperature up to 77°F (25°C). Do not freeze lyophilized antigen component or sterile water diluent. Administer PRIORIX immediately after reconstitution. If not used immediately, store refrigerated between 36° and 46°F (2° and 8°C) and administer within 8 hours. Discard reconstituted vaccine if not used within 8 hours. Do not freeze. Discard if the reconstituted vaccine has been frozen.

Berechtigungsstatus:

Biologic Licensing Application

Fachinformation

PRIORIX- MEASELS, MUMPS, AND RUBELLA VACCINE, LIVE
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRIORIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRIORIX.
PRIORIX (MEASLES, MUMPS, AND RUBELLA VACCINE, LIVE), SUSPENSION FOR
SUBCUTANEOUS
INJECTION
INITIAL U.S. APPROVAL: 2022
INDICATIONS AND USAGE
PRIORIX 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 SUBCUTANEOUS INJECTION ONLY.
Each dose is approximately 0.5 mL.
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DOSAGE FORMS AND STRENGTHS
PRIORIX is a suspension for injection supplied as a single-dose vial
of lyophilized antigen component to be
reconstituted with the accompanying prefilled syringe of sterile water
diluent component. A single dose
after reconstitution is approximately 0.5 mL. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common solicited adverse reactions in clinical trials
participants:
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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The first dose is administered at 12 through 15 months of age. (2.1)
The second dose is administered at 4 through 6 years of age. (2.1)
Severe allergic reaction (e.g., anaphylaxis) to any component of
PRIORIX, or after a previous dose of
any measles, mumps, and rubella virus-containing vaccine. (4.1)
Severe immunodeficiency. (4.2)
Pregnancy. (4.3, 8.1)
There is a risk of febrile seizure following administration of
PRIORIX. (5.2)
Thrombocytopenia and thrombocytopenic purpura have been reported
following vaccination with
PRIORIX. (5.3)
Syncope (fainting) can occur in association with administration of
injectable vaccines, including
PRIORIX. Procedures should be in place to avoid injury from fainting.
(5.4)
The tip caps