MENJUGATE 10micrograms suspension for injection in vials

Țară: Regatul Unit

Limbă: engleză

Sursă: myHealthbox

Ingredient activ:

Neisseria meningitidis group C (strain C11) oligosaccharide, Corynebacterium diphtheriae CRM197 protein , adsorbed on Aluminium

Disponibil de la:

Novartis Vaccines and Diagnostics

Codul ATC:

J07AH

INN (nume internaţional):

Neisseria meningitidis group C (strain C11) oligosaccharide, Corynebacterium diphtheriae CRM197 protein , adsorbed on Aluminium

Dozare:

10micrograms, 12.5 to 25.0micrograms, 0.3 to 0.4mg Al 3+

Forma farmaceutică:

Suspension for injection

Calea de administrare:

Intramuscular injection

Unități în pachet:

Pack size of 1, 5 or 10 single doses in vials

Tip de prescriptie medicala:

POM - Prescription Only Medicine

Produs de:

Novartis Vaccines and Diagnostics

Grupul Terapeutică:

Meningococcal vaccines

Indicații terapeutice:

Active immunisation of children from 2 months of age, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis group C.

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-03-31

Prospect

Novartis Vaccines and Diagnostics S.r.l. 

Menjugate 
March 2015 
Confidential 
Page 7 of 13 

PACKAGE LEAFLET 
Novartis Vaccines and Diagnostics S.r.l. 

Menjugate 
March 2015 
Confidential 
Page 8 of 13 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

MENJUGATE 10 MICROGRAMS SUSPENSION FOR INJECTION  
Meningococcal group C conjugate vaccine 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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 or nurse. 
- 
This vaccine has been prescribed for you or your child only. Do not
pass it on to others. It 
may harm  them, even if their signs of illness are the
same as yours or of your child. 
- 
If you or your child gets any side effects, talk to your doctor
or nurse. This includes any 
possible side effects not listed in this leaflet. See section
4. 

WHAT IS IN THIS LEAFLET:  
1. 
What Menjugate is and what it is used for 
2. 
What you need to know before you or your child use Menjugate  
3. 
How to use Menjugate  
4. Possible 
side 
effects 
5. 
How to store Menjugate  
6. 
Content of the pack and other information 

1. 
WHAT MENJUGATE IS AND WHAT IT IS USED FOR  

Menjugate is a vaccine that is used to prevent
disease caused by a bacterium named _Neisseria _
_meningitidis_ group C (also referred to as meningococcal group C
bacteria). The vaccine works by 
causing your body to make its
own protection (antibodies) against these meningococcal group C 
bacteria. 

_Neisseria meningitidis_ group C bacteria can cause serious and
sometimes life-threatening infections 
such as meningitis and septicaemia (blood poisoning). 

This vaccine is used for active immunisation of children
from 2 months

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
MENJUGATE 10 micrograms suspension for injection  

Meningococcal group C conjugate vaccine 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 0.5 ml dose of the vaccine contains: 
_Neisseria meningitidis_ group C (strain C11) oligosaccharide 

10 micrograms 
Conjugated to   
_Corynebacterium diphtheriae_ CRM197 protein    

   12.5 to 
25.0 micrograms 
adsorbed on Aluminium hydroxide          

0.3 to 0.4 
mg Al
 3+

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Suspension for injection.  

Suspension (vial): white opalescent 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Active immunisation of children from 2 months of age, adolescents
and adults, for the 
prevention of invasive disease caused by _Neisseria
meningitidis_ group C. 
The use of Menjugate should be determined on the basis of
official recommendations. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 

_Paediatric population_ 

Primary immunisation 
Infants from 2 months of age up to 12 months: two doses, each
of 0.5 ml, should be 
given with an interval of at least 2 months (See section 4.5
regarding co-
administration of Menjugate with other vaccines). 

Children over the age of 12 months: a single dose of 0.5 ml. 

The safety and efficacy of Menjugate in children aged less than
2 months have not 
been established. No data are available. 

Booster doses 
It is recommended that a booster dose should be given after
completion of the 
primary immunisation series in infants. The timing of this dose
should be in 
accordance with available official recommendations. Information on
responses to 
booster doses and on co-administration with other childhood
vaccines is given in 
sections 5.1 and 4.5, respectively.  
The n