Menitorix

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Haemophilus influenzae type b PRP 5ug (conjugated with 12.5 mcg tetanus toxoid);  ; Neisseria meningitidis Group C polysaccharide 5ug (5 mcg Men C polysaccharide conjugated to 5 mcg tetanus toxoid)

Disponible desde:

GlaxoSmithKline NZ Limited

Designación común internacional (DCI):

Haemophilus influenzae type b PRP 5 µg (conjugated with 12.5 mcg TT)

Dosis:

0.5 mL

formulario farmacéutico:

Injection with diluent

Composición:

Active: Haemophilus influenzae type b PRP 5ug (conjugated with 12.5 mcg tetanus toxoid)   Neisseria meningitidis Group C polysaccharide 5ug (5 mcg Men C polysaccharide conjugated to 5 mcg tetanus toxoid) Excipient: Sodium chloride Sucrose Tetanus toxoid Trometamol hydrochloride Sodium chloride Water for injection

Unidades en paquete:

Syringe, glass, Diluent, Type I with or without needles, 0.5 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

GlaxoSmithKline Biologicals SA

indicaciones terapéuticas:

MENITORIX is indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroup C (MenC).

Resumen del producto:

Package - Contents - Shelf Life: Syringe, glass, Diluent, Type I with or without needles - 0.5 mL - 60 months from date of manufacture stored at or below 25°C - Syringe, glass, Diluent, 10x0.5 mL Type I with or without needles - 10 dose units - 60 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Powder for Injection, Type I with bromobutyl rubber stopper - 3 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, Powder for Injection, 10x3 mL Type I with bromobutyl rubber stopper - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Fecha de autorización:

2006-08-18

Ficha técnica

1 

DATA SHEET 

NAME OF THE MEDICINAL PRODUCT 
MENITORIX
®

_Haemophilus _type b and _Neisseria meningitidis_ group C conjugate
vaccine

PRESENTATION 
MENITORIX

is presented as a powder and diluent for reconstitution for
intramuscular 
injection. 

Each 0.5ml dose of the reconstituted vaccine contains 5 micrograms
of _Haemophilus _type 
b polysaccharide (polyribosylribitol phosphate) conjugated to 12.5
micrograms of tetanus 
toxoid as a carrier protein and 5 micrograms of _Neisseria
meningitidis _serogroup C (strain 
C11) polysaccharide conjugated to 5 micrograms of tetanus toxoid as a
carrier protein. 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
MENITORIX is indicated for the prevention of invasive diseases caused
by _Haemophilus _
_influenzae_ type b (Hib) and _Neisseria meningitidis_ serogroup C
(MenC).
_ _
_ _
_POSOLOGY AND METHOD OF ADMINISTRATION_ 
Primary vaccination in infants from 6 weeks up to 12 months of age: 

Three doses, each of 0.5 ml, should be given with an interval of at
least 1 month between 
doses. 

Booster vaccination of children primed in infancy with Hib and MenC
conjugate vaccines: 

After primary vaccination against Hib and MenC in infancy, a booster
dose is 
recommended to ensure long-term protection.  The booster dose should
be administered 
from the age of 12 months onwards and before the age of 2 years. 

A single (0.5 ml) dose of MENITORIX may be used to boost immunity to
Hib and MenC in 
children who have previously completed a primary immunisation series
with MENITORIX 
or with other Hib or MenC conjugate vaccines.  The timing of the
booster dose of 
MENITORIX should be in accordance with available official
recommendations and would 
usually be given from the age of 12 months onwards and at least 6
months after the last 
priming dose.  The need for booster doses in subjects primed with a
single dose of MenC 
conjugate (i.e. aged 12 months or more when first immunised) has not
been established.