MENJUGATE 10micrograms suspension for injection, syringes

Land: Storbritannien

Språk: engelska

Källa: myHealthbox

Aktiva substanser:

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

Tillgänglig från:

Novartis Vaccines and Diagnostics

ATC-kod:

J07AH

INN (International namn):

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

Dos:

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

Läkemedelsform:

Suspension for injection

Administreringssätt:

Intramuscular injection

Enheter i paketet:

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

Receptbelagda typ:

POM - Prescription Only Medicine

Tillverkad av:

Novartis Vaccines and Diagnostics

Terapeutisk grupp:

Meningococcal vaccines

Terapeutiska indikationer:

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

Bemyndigande status:

Authorised

Tillstånd datum:

2015-03-31

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER 

MENJUGATE KIT 10 MICROGRAMS POWDER AND SOLVENT FOR 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. 

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

1. 
WHAT MENJUGATE KIT IS AND WHAT IT IS USED FOR  

Menjugate Kit 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 of age, adolescents and adults and it 
can only protect against meningococcal group C bacteria. It cannot
protect against other groups (strains) of_ _
meningococcal bacteria or against other causes of meningitis and
septicaemia (blood poisoning). If at any 
time you or your child experiences neck pain, neck stiffness or a
disl

Produktens egenskaper

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 (syringe): 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