MENVEO meningococcal (Groups A, C, W

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Diphtheria CRM197 protein, Quantity: 16.7 microgram; Meningococcal oligosaccharide group A, Quantity: 10 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Diphtheria CRM197 protein,Meningococcal oligosaccharide group A,Meningococcal oligosaccharide group C,Meningococcal oligosacchar

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sucrose; monobasic potassium phosphate

Administration route:

Intramuscular

Units in package:

single dose pack 1 x MenA Lyo vial / 1 x MenCWY syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y. The use of this vaccine should be in accordance with official recommendations.

Product summary:

Visual Identification: WHITE CAKE; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
MENVEO (MENINGOCOCCAL (GROUPS A, C, W-135 AND Y) OLIGOSACCHARIDE
CRM197)
POWDER AND SOLUTION FOR SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Meningococcal (Groups A, C, W-135 and Y) Oligosaccharide CRM
197
Conjugate
Vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENVEO powder and solution for solution for injection
MENVEO consists of one vial containing the lyophilised Meningococcal
Group A
(MenA) Conjugate Component plus excipients, and one syringe or vial
containing the
liquid Meningococcal Groups C, W-135 and Y (MenCWY) Conjugate
Component plus
excipients. The reconstituted sterile liquid vaccine is administered
by intramuscular
injection and contains meningococcal serogroup A, C, W-135 and Y
oligosaccharides
conjugated individually to
_Corynebacterium diphtheriae_
CRM
197
protein. The
polysaccharides are produced from fermentation and purification of
_Neisseria _
_meningitidis_
(serogroups A, C, W-135 or Y). MenA, MenW-135 and MenY
polysaccharides are purified by several extraction and precipitation
steps. MenC
polysaccharide is purified by a combination of chromatography and
precipitation steps.
The protein carrier (CRM
197
) is produced by bacterial fermentation and is purified by a
series of chromatography and ultrafiltration steps.
The oligosaccharides are prepared by hydrolysis, sizing, activation
and conjugation.
Each oligosaccharide is covalently linked to the CRM
197.
The resulting glycoconjugates
are purified to yield the four drug substances, which compose the
final vaccine. No
preservative or adjuvant is added during manufacturing. The vaccine
contains no
thiomersal.
3.
PHARMACEUTICAL FORM
MENVEO is presented as meningococcal group A (MenA) lyophilised
conjugate
component and a meningococcal group C, W-135 and Y (MenCWY) liquid
conjugate
component.
2
The MenA conjugated component is a white to off-white powder for
injection and
MenCWY conjugated component is a colourless clear solution for
injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MENVEO