Menveo Powder and Solution for Solution for Injection

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

(MenA Lyo) Meningococcal Group A oligosaccharide conjugated to CRM197 protein; (MenCWY) Meningococcal Group C oligosaccharide conjugated to CRM197 protein; (MenCWY) Meningococcal Group W-135 oligosaccharide conjugated to CRM197 protein; (MenCWY) Meningococcal Group Y oligosaccharide conjugated to CRM197 protein

Հասանելի է:

GLAXOSMITHKLINE PTE LTD

ATC կոդը:

J07AH08

Դոզան:

10 microgram conjugated to 16.7-33.3 microgram

Դեղագործական ձեւ:

INJECTION, POWDER, FOR SOLUTION

Կազմը:

(MenA Lyo) Meningococcal Group A oligosaccharide conjugated to CRM197 protein 10 microgram conjugated to 16.7-33.3 microgram; (MenCWY) Meningococcal Group C oligosaccharide conjugated to CRM197 protein 5 microgram conjudated to 7.1-12.5 microgram; (MenCWY) Meningococcal Group W-135 oligosaccharide conjugated to CRM197 protein 5 microgram conjugated to 3.3-8.3 microgram; (MenCWY) Meningococcal Group Y oligosaccharide conjugated to CRM197 protein 5 microgram conjugated to 5.6-10 microgram

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

GSK Vaccines S.r.l. (MenCWY Liquid)

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2012-01-20

Տեղեկատվական թերթիկ

 
1. 
NAME OF THE MEDICINAL PRODUCT 
Menveo powder and solution for solution for injection 
Meningococcal Group A, C, W135 and Y conjugate vaccine 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One dose (0.5 ml of the reconstituted vaccine) contains: 

(Originally contained in the powder) 
• 
Meningococcal group A oligosaccharide_ _  

10 micrograms 
Conjugated to _Corynebacterium diphtheriae_ CRM
197
 protein  
16.7 to 33.3 micrograms 

(Originally contained in the solution) 
• 
Meningococcal group C oligosaccharide_  _  

5 micrograms 
Conjugated to _Corynebacterium diphtheriae_ CRM
197
 protein  
7.1 to 12.5 micrograms 

• 
Meningococcal group W135 oligosaccharide_   _
          5 micrograms 
Conjugated to _Corynebacterium diphtheriae_ CRM
197
 protein  
3.3 to 8.3 micrograms 

• 
Meningococcal group Y oligosaccharide_  _
                   5 micrograms 
Conjugated to _Corynebacterium diphtheriae _CRM
197
 protein       5.6 to 10.0 micrograms  

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Powder and solution for solution for  injection (powder and solution
for injection). 
The powder is a white to off- white cake.  
The solution is a colourless clear solution. 

4. 
CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Menveo is indicated for active immunization of adolescents (from 11
years of age) and 
adults at risk of exposure to _Neisseria meningitidis_ groups A, C,
W135 and Y, to prevent 
invasive disease. 
The use of this vaccine should be in accordance with official
recommendations. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

Adults 
Menveo should be administered as a single 0.5 ml injection.  

Paediatric population 

Menveo is indicated from the age of 11 years and above and should
be administered as a 
single 0.5 ml injection. 

Elderly 
There are l

Ապրանքի հատկությունները

1.
NAME OF THE MEDICINAL PRODUCT
Meningococcal Group A, C, W-135 and Y conjugate vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml of the reconstituted vaccine) contains:
(Originally contained in the powder)
•
Meningococcal group A oligosaccharide
10 micrograms
Conjugated to _Corynebacterium diphtheriae _CRM
197
protein
16.7 to 33.3
micrograms
(Originally contained in the solution)
•
Meningococcal group C oligosaccharide
5 micrograms
Conjugated to _Corynebacterium diphtheriae _CRM
197
protein
7.1 to 12.5
micrograms
•
Meningococcal group W-135 oligosaccharide
5 micrograms
Conjugated to _Corynebacterium diphtheriae _CRM
197
protein
3.3 to 8.3 micrograms
•
Meningococcal group Y oligosaccharide
5 micrograms
Conjugated to _Corynebacterium diphtheriae _CRM
197
protein
5.6 to 10.0
micrograms
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solution for solution for injection.
The powder is a white to off-white cake.
The solution is a colourless clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Menveo is indicated for active immunization of children (from 2 months
of age),
adolescents and adults at risk of exposure to _Neisseria meningitidis
_groups A, C, W-135
and Y, to prevent invasive disease.
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology

Vaccine schedule for children from 2 to 23 months of age
Infants initiating vaccination from 2 to 6 months of age
First three doses of Menveo, each of 0.5 ml, should be given with an
interval of at least 2
months; the fourth dose should be administered during the second year
of life (at 12 to 16
months).
Alternatively, when Menveo is given as part of a routine infant
immunisation programme
or according to a national recommendation, a series consisting of
three doses, each of
0.5ml, may be given. The first dose should be administered from the
age of 2 months, with
a second dose 2 months later. The third dose should be adm