Rotarix, información del fabricante

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) Oral Suspension Initial U.S. Approval: 2008 ---------------------------RECENT MAJOR CHANGES -------------------Contraindications (4.1) 1/2010----------------------------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 to 24 weeks of age. (1) ----------------------- DOSAGE AND ADMINISTRATION ---------------FOR ORAL USE ONLY. (2.1) • Each dose is 1-mL administered orally. (2.2) • Administer first dose toinfants beginning at 6 weeks of age. (2.2) • Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age. (2.2) --------------------- DOSAGE FORMS AND STRENGTHS -------------• Vial of lyophilized vaccine to be reconstituted with a liquid diluent in a prefilled oral applicator. (3) • Each 1-mL dose contains a suspension of at least 106.0 median Cell Culture Infective Dose(CCID50) of live, attenuated human G1P[8] rotavirus after reconstitution. (3)

-------------------------------CONTRAINDICATIONS-----------------------• A demonstrated history of hypersensitivity to the vaccine or any component of the vaccine including latex rubber (contained in the oral applicator). (4.1, 11) • History of uncorrected congenital malformation of the gastrointestinal tract thatwould predispose the infant to intussusception. (4.2) ----------------------- WARNINGS AND PRECAUTIONS ---------------• Administration of ROTARIX in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness of ROTARIX in infants with chronic gastrointestinal disorders have not been evaluated. (5.1) • Since ROTARIX is a live virus, safety and effectiveness ininfants with known primary or secondary immunodeficiencies have not been evaluated. (5.2) ------------------------------ ADVERSE REACTIONS ----------------------Common (≥5%) solicited adverse events 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 orwww.vaers.hhs.gov. See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling. Revised: January 2010 RTX:5PI

FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Reconstitution Instructions for Oral Administration 2.2 Recommended Dose and Schedule Infant Feeding 2.3 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Hypersensitivity4.2 Gastrointestinal Tract Congenital Malformation 5 WARNINGS AND PRECAUTIONS Gastrointestinal Disorders 5.1 5.2 Altered Immunocompetence 5.3 Shedding and Transmission Intussusception 5.4 5.5 Post-Exposure Prophylaxis 6 ADVERSE REACTIONS Clinical Trials Experience 6.1 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Concomitant Vaccine Administration 7.2 Immunosuppressive Therapies

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USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.4 Pediatric Use DESCRIPTION CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility 13.1 CLINICAL STUDIES 14.1 Efficacy Studies 14.2 Efficacy Through Two Rotavirus Seasons 14.3 Efficacy Against Specific Rotavirus Types REFERENCES HOWSUPPLIED/STORAGE AND HANDLING 16.1 Storage Before Reconstitution 16.2 Storage After Reconstitution PATIENT COUNSELING INFORMATION 17.1 Patient Advice 17.2 FDA-Approved Patient Labeling

*Sections or subsections omitted from the full prescribing information are not listed.

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