Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: C9R35M8XV6) (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN - UNII:C9R35M8XV6)
GlaxoSmithKline Biologicals SA
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX [see Description (11)] . Safety and effectiveness of HIBERIX in children younger than 6 weeks and in children aged 5 to 16 years have not been established.
HIBERIX Vial and Vial presentation is supplied in a carton packaged without syringes or needles (NDC 58160-818-11) containing: HIBERIX Vial and Prefilled Syringe Presentation is supplied in a carton (NDC 58160-726-15) containing: TIP-LOK syringes are to be used with Luer Lock compatible needles. The stopper of the vial containing Lyophilized Antigen Component or Sterile Saline Diluent and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex. Lyophilized Antigen Component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Sterile Saline Diluent prefilled syringes and vials: Store refrigerated or at controlled room temperature between 2° and 25°C (36° and 77°F). Do not freeze. Discard if the diluent has been frozen.
Biologic Licensing Application
HIBERIX- HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) GLAXOSMITHKLINE BIOLOGICALS SA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HIBERIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HIBERIX. HIBERIX [HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)] FOR INJECTION, FOR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 2009 RECENT MAJOR CHANGES Dosage and Administration (2) 12/2023 INDICATIONS AND USAGE HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by _Haemophilus influenzae _type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). (1) DOSAGE AND ADMINISTRATION FOR INTRAMUSCULAR ADMINISTRATION ONLY. A 4-dose series (either 0.5 mL or approximately 0.5 mL each, depending on the presentation) given by intramuscular injection (2.1): • • HIBERIX is supplied in 2 presentations: • • DOSAGE FORMS AND STRENGTHS Solution for injection. • • CONTRAINDICATIONS Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any _H. influenzae_ type b- or tetanus toxoid-containing vaccine or any component of HIBERIX. (4) WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT 1-888-825-5249 OR Primary series: One dose each at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Booster: One dose at 15 through 18 months of age. Vial and vial presentation: vial of Lyophilized Antigen Component and vial of Sterile Saline Diluent. (2.2) Vial and prefilled syringe presentation: vial of Lyophilized Antigen Component and prefilled syringe of Sterile Saline Diluent. (2.2) Vial and vial presentation: a single dose after reconstitution is 0.5 mL. (3) Vial a Aqra d-dokument sħiħ