Infanrix-Hib vaccine

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Diphtheria toxoid, adsorbed 30 [iU] (> or =); Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Tetanus toxoid 40 [iU] (> or =); Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (as PRP (target fill 10mcg + 2.5mcg overage)); Diphtheria toxoid, adsorbed 30 [iU] (> or =); Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Tetanus toxoid 40 [iU] (> or =)

Verfügbar ab:

GlaxoSmithKline NZ Limited

INN (Internationale Bezeichnung):

Detoxified pertussis toxin 25 µg

Darreichungsform:

Suspension for injection

Zusammensetzung:

Active: Diphtheria toxoid, adsorbed 30 [iU] (> or =) Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Tetanus toxoid 40 [iU] (> or =) Excipient: Aluminium hydroxide Sodium chloride Water for injection Active: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (as PRP (target fill 10mcg + 2.5mcg overage)) Excipient: Lactose monohydrate Sodium chloride Water Active: Diphtheria toxoid, adsorbed 30 [iU] (> or =) Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Tetanus toxoid 40 [iU] (> or =) Excipient: Aluminium hydroxide Phenoxyethanol Sodium chloride Water for injection

Einheiten im Paket:

Syringe, 0.5 mL

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

GlaxoSmithKline Biologicals SA

Anwendungsgebiete:

INFANRIXTM-Hib is indicated for active immunisation against diphtheria, tetanus, pertussis (DTP) and Haemophilus influenzae type b (Hib) infection in all children from 15 months of age.

Produktbesonderheiten:

Package - Contents - Shelf Life: Syringe, - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 10 x 0.5ml - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Berechtigungsdatum:

1996-06-17

Fachinformation

1
DATA SHEET
NAME OF MEDICINAL PRODUCT
INFANRIX-HIB, POWDER AND SUSPENSION FOR INJECTION
DIPTHERIA, TETANUS, ACELLULAR PERTUSSIS AND ADSORBED CONJUGATED
_HAEMOPHILUS INFLUENZAE _TYPE B VACCINE.
PRESENTATION
After reconstitution, 1 dose (0.5 ml) contains:
Diphtheria toxoid
 30 IU
Tetanus toxoid
 40 IU
Pertussis antigens
Pertussis toxoid
25 micrograms
Filamentous Haemagglutinin
25 micrograms
Pertactin
8 micrograms
_Haemophilus influenzae _type b polysaccharide
10 micrograms
conjugated to tetanus toxoid 
20-40 micrograms
The diphtheria and tetanus toxins obtained from cultures
of _Corynebacterium _
_diphtheriae _and _Clostridium tetani _are detoxified and purified.
 The acellular pertussis 
vaccine components (PT, FHA and pertactin) are prepared by growing
phase I 
_Bordetella pertussis _from which the PT and FHA and pertactin are
extracted, purified 
and irreversibly detoxified.
The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine
components are 
adsorbed on aluminium salts.  The final vaccine is formulated in
saline and contains 
2-phenoxyethanol as preservative.
The Hib polysaccharide is prepared from Hib, strain 20,752 and coupled
to tetanus 
toxoid.  After purification the conjugate is lyophilised in the
presence of lactose as 
stabiliser.
INFANRIX
TM
-HIB meets the World Health Organisation requirements for 
manufacture of biological substances, of Hib conjugate vaccines and of
diphtheria, 
tetanus, pertussis and combined vaccines.
2
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
The diphtheria, tetanus, acellular pertussis component is a turbid
white suspension.
The lyophilised _Haemophilus influenzae _type b (Hib) component is
a white powder.
CLINICAL PARTICULARS
_THERAPEUTIC INDICATIONS_
INFANRIX
TM
-HIB IS INDICATED FOR ACTIVE IMMUNISATION AGAINST DIPHTHERIA,
TETANUS, PERTUSSIS 
(DTP) AND _HAEMOPHILUS INFLUENZAE _TYPE B (HIB) INFECTION IN ALL
CHILDREN FROM 15 MONTHS OF 
AGE.
INFANRIX
TM
-HIB does not protect against diseases