HIBERIX (haemophilus b conjugate vaccine- tetanus toxoid conjugate kit

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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)

Beszerezhető a:

GlaxoSmithKline Biologicals SA

INN (nemzetközi neve):

HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Összetétel:

HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL

Terápiás javallatok:

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.

Termék összefoglaló:

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.

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

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