ROTARIX- rotavirus vaccine, live, oral kit ROTARIX- rotavirus vaccine, live, oral solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN (UNII: KZ3L01D2PC) (HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN - UNII:KZ3L01D2PC)

Available from:

GlaxoSmithKline Biologicals SA

INN (International Name):

HUMAN ROTAVIRUS A TYPE G1P STRAIN RIX4414 LIVE ANTIGEN STRAIN RIX4414 LIVE ANTIGEN - UNII:KZ3L01D2PC)

Composition:

HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN 1000000 [CCID_50] in 1 mL

Therapeutic indications:

ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)] . ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age. A demonstrated history of hypersensitivity to any component of the vaccine. Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of ROTARIX should not receive further doses of ROTARIX. Infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant for intussusception should not receive ROTARIX. Infants with a history of intussusception should not receive ROTARIX [see Warnings and Precautions (5.5)] . In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see Adverse Reactions (6.2)] . Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive ROTARIX. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having SCID [see Adverse Reactions (6.2)] . Safety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated. The effectiveness of ROTARIX in pre-term infants has not been established. Safety data are available in pre-term infants (ROTARIX = 134, placebo = 120) with a reported gestational age ≤36 weeks. These pre-term infants were followed for SAEs up to 30 to 90 days after Dose 2. SAEs were observed in 5.2% of recipients of ROTARIX as compared with 5.0% of placebo recipients. No deaths or cases of intussusception were reported in this population.

Product summary:

The ROTARIX vial and oral dosing applicator presentation is supplied as single-dose vials of lyophilized vaccine component, accompanied by a prefilled oral dosing applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution. Supplied as an outer package of 10 doses (NDC 58160-854-52) containing: Storage before Reconstitution Storage after Reconstitution ROTARIX (vial and oral dosing applicator presentation) should be administered within 24 hours of reconstitution. After reconstitution, store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Discard the reconstituted vaccine in biological waste container if not used within 24 hours. Do not freeze. Discard if the reconstituted vaccine has been frozen. ROTARIX oral dosing applicator only presentation is supplied as a single, 1.5-mL dose in a prefilled oral dosing applicator with a plunger stopper (NDC 58160-740-02) in a carton of 10 (NDC 58160-740-21). Storage Store refrigerated at 2° to 8℃ (36° to 46°F). Do not freeze. Discard if the vaccine has been frozen. Keep in original package to protect from light.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ROTARIX- ROTAVIRUS VACCINE, LIVE, ORAL
ROTARIX- ROTAVIRUS VACCINE, LIVE, ORAL SOLUTION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROTARIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROTARIX.
ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL)
SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
ROTARIX is a vaccine indicated for the prevention of rotavirus
gastroenteritis caused by G1 and non-G1
types (G3, G4, and G9). ROTARIX is approved for use in infants 6 weeks
and up to 24 weeks of age. (1)
DOSAGE AND ADMINISTRATION
FOR ORAL USE ONLY.
ROTARIX is supplied as either:
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•
Schedule
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•
DOSAGE FORMS AND STRENGTHS
Suspension for oral use.
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CONTRAINDICATIONS
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•
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Common (≥5%) solicited adverse reactions included
fussiness/irritability, cough/runny nose, fever, loss of
appetite, and vomiting. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
Vial and oral dosing applicator presentation: The vial contains the
lyophilized vaccine component and
the oral dosing applicator contains the diluent. The contents of the
vial must be reconstituted with the
diluent to form ROTARIX prior to administration (2.1), or
Oral dosing applicator only presentation: The oral dosing applicator
contains ROTARIX and does NOT
require reconstitution or dilution before use. (2.1)
Administer first dose to infants beginning at 6 weeks of age. (2.3)
Administer second dose after an interval of at least 4 weeks and up to
24 weeks of age. (2.3)
Vial and oral dosing applicator presentation: a single dose is 1 mL.
(3)
Oral dosing applicator only presentation: a single dose is 1.5 mL. (3)
A demonstrated history of hypersensitivity to the vaccine or any
component of the vaccine. (4.