Hiberix

hiberix prescribing information

1. HIGHLIGHTS OF PRESCRIBING INFORMATION . These highlights do not include all the information needed to use HIBERIX safely and effectively. See full prescribing information for

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Hiberix Clinical Review

Hiberix BLA Clinical Review Page - 1 - DEPARTMENT OF HEALTH & HUMAN SERVICES FDA/CBER/OVRR/DVRPA Date: July 8, 2009 From: Karen M. Farizo, M.D. Medical Officer, Clinical Review Branch 1 Through: *Douglas Pratt, M.D. Chief, Clinical Review Branch 1 Subject:* Clinical Review of Biologics License ...

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HIBERIX® PRODUCT INFORMATION

HIBERIX ® PRODUCT INFORMATION Haemophilus influenzae type b (Hib) vaccine DESCRIPTION HIBERIX is a non-infectious vaccine containing purified polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of Haemophilus influenzae type b covalently bound to tetanus toxoid.

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How HIBERIX is given The doctor or nurse will give HIBERIX as an injection. If you have any concerns about how this vaccine is to be given, talk to your doctor

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SUBJECT: New Haemophilus influenzae type b (Hib) Vaccine ...

Hiberix On August 19, 2009, the Food and Drug Administration approved Hiberix, a new Haemophilus Influenzae type b (Hib) vaccine indicated for the booster dose of the Hib series in children 15 months-4 years of age.

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1. Trade name of Medicinal Product

1 DATA SHEET Name of Medicinal Product . Hiberix ® Haemophilus influenzae type b (Hib) vaccine. Presentation. Hiberix is a lyophilised vaccine of purified polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of Hib, covalently bound to tetanus toxoid.

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SAFETY DATA SHEET

HIBERIX 1361 Approved/Revised 26-Jan-2009 Material SDS Number Version 9 SAFETY DATA SHEET * 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Material HIBERIX Synonym(s) HIBERIX VACCINE * NDC NO: 58160-806-01 * NDC NO: 58160-806-05 * HAEMOPHILUS TYPE B CONJUGATE ...

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FIGURE 1: Recommended immunization schedule for persons aged ...

Hiberix should only be used for the booster (final) dose in children aged 12 months through 4 years. 5. Pneumococcal vaccines. (Minimum age: 6 weeks for pneumococcal conjugate

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Booster Dose of HIBERIX

Pediatric Safety and Utilization Review: Booster Dose of HIBERIX® Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Pediatric Advisory Committee Meeting

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The Advisory Committee on Immunization Practices ACIP is a ...

Iowa Department of Public Health Division of Acute Disease Prevention & Emergency Response Immunization Program - 1-800-831-6293 November 9, 2009 Vaccines for Children (VFC) Program Haemophilus influenzae Type b (Hib) Vaccine Summary Hiberix November 2, 2009 Iowa Vaccines for Children Program ...

www.idph.state.ia.us

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