Menitorix vaccine powder and solvent for solution for injection 0.5ml vials

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Neisseria meningitidis group C strain C11 capsular polysaccharide tetanus toxoid conjugate; Haemophilus influenzae type b polysaccharide tetanus toxoid conjugate

Disponible desde:

GlaxoSmithKline UK Ltd

Código ATC:

J07AG53

Designación común internacional (DCI):

Neisseria meningitidis group C strain C11 capsular polysaccharide tetanus toxoid conjugate; Haemophilus influenzae type b polysaccharide tetanus toxoid conjugate

formulario farmacéutico:

Powder and solvent for solution for injection

Vía de administración:

Intramuscular

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 14040000; GTIN: 5000123112159

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
MENITORIX
®
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
_HAEMOPHILUS _TYPE B AND _MENINGOCOCCAL_ GROUP C CONJUGATE VACCINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING
THIS VACCINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This vaccine has been prescribed for your child only. Do not pass it
on to others.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Menitorix is and what it is used for
2 What you need to know before your child receives Menitorix
3 How Menitorix is given
4 Possible side effects
5 How to store Menitorix
6 Contents of the pack and other information
1
WHAT MENITORIX IS AND WHAT IT IS USED FOR
Menitorix is a vaccine that can be given to children after the age of
2 months up to 2 years to
prevent infectious diseases caused by_ Haemophilus influenzae _type b
(Hib) and _Neisseria _
_meningitidis _group C (MenC) bacteria. The vaccine works by causing
the body to produce its
own protection (antibodies) against these bacteria. The vaccine cannot
cause Hib and MenC.
•
_HAEMOPHILUS INFLUENZAE _TYPE B (HIB): Hib bacteria most frequently
cause meningitis
(inflammation of the coverings of the brain and spinal cord). Even
after recovery from Hib
meningitis there can be complications such as mental retardation,
spastic paralysis,
deafness or epilepsy. Hib infection can also cause a life-threatening
inflammation of the
throat with severe swelling that can cause suffocation. Less commonly,
the bacteria can
infect other parts of the body, particularly the lungs (causing
pneumonia) and the bones
and joints.
•
_NEISSERIA MENINGITIDIS _GROUP C (MENC): Like Hib bacteria, MenC
bacteria most
frequently cause meningitis. They may also cause severe blood
infections and spread
t

Ficha técnica

OBJECT 1
MENITORIX
Summary of Product Characteristics Updated 08-Mar-2016 |
GlaxoSmithKline UK
1. Name of the medicinal product
Menitorix - Powder and solvent for solution for injection
_Haemophilus _type b and _Meningococcal_ group C conjugate vaccine
2. Qualitative and quantitative composition
After reconstitution, each 0.5 ml dose contains:
_Haemophilus _type b polysaccharide
(polyribosylribitol phosphate)
5 micrograms
conjugated to tetanus toxoid as carrier protein
12.5 micrograms
_Neisseria meningitidis_ group C (strain C11) polysaccharide
5 micrograms
conjugated to tetanus toxoid as carrier protein
5 micrograms
Excipients with known effect:
This product contains sodium 75 micromol per dose (see section 4.4)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection
White powder and a clear colourless solvent.
4. Clinical particulars
4.1 Therapeutic indications
Active immunization of infants from the age of 2 months and toddlers
up to the age of 2 years for the
prevention of invasive diseases caused by _Haemophilus influenzae_
type b (Hib) and _Neisseria _
_meningitidis_ group C (MenC).
See also section 4.4.
4.2 Posology and method of administration
Posology
Menitorix should be used in accordance with official recommendations.
_Primary vaccination in infants:_
Alternative vaccination schedules in infants are available with
Menitorix.
_Three dose primary series_
The vaccination schedule consists of three primary doses, each of 0.5
ml which should be administered
from 2 months up to 12 months of age with an interval of at least 1
month between doses (see section
5.1).
_Two-dose primary series_
The vaccination schedule, consisting of two primary doses, each of 0.5
ml, may be given from 3 months
up to 12 months of age with an interval of at least 2 months between
doses (see section 5.1).
_Preterm infants born between 25 weeks and 36 weeks of gestational
age_
Three primary doses, each of 0.5 ml, should be administered from 2
months up to 12 months of age