Menjugate 10 micrograms suspension for injection Meningococcal group C conjugate vaccine

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Meningococcal group c oligosaccharide; Corynebacterium diphtheriae crm197 protein

Beszerezhető a:

GSK Vaccines S.r.l.

ATC-kód:

J07AH; J07AH05

INN (nemzetközi neve):

Meningococcal group c oligosaccharide; Corynebacterium diphtheriae crm197 protein

Adagolás:

10

Gyógyszerészeti forma:

Suspension for injection in pre-filled syringe

Az alkalmazás módja:

Intramuscular injection

db csomag:

Pack size of 1, 5 or 10 syringes filled with 0,6 ml of vaccine

Recept típusa:

Product subject to prescription which may not be renewed (A)

Gyártó:

Novartis Vaccines and Diagnostics

Terápiás csoport:

Meningococcal vaccines

Terápiás terület:

Meningococcal vaccines; other meningococcal polyvalent purified polysaccharides antigen

Terápiás javallatok:

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

Engedélyezési státusz:

Authorised

Engedély dátuma:

2015-05-08

Betegtájékoztató

491650
MENJUGATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR
CHILD START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
- 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.
- If you or your child get 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 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 dislike of light (photophobia), drowsiness or confusion,
red or purple bruise-like spots that do not fade under
pressure you must contact your doctor or local Accident
and Emergency Department immediately.
THIS VACCINE CANNOT CAUSE MENINGITIS C
(MENINGOCOCCAL GROUP C DISEASE).
• have an INFECTIOUS ILLNESS OR HIGH FEVER. In this

Termékjellemzők

Health Products Regulatory Authority
05 November 2021
CRN00CLN6
Page 1 of 8
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
1 dose (0.5 ml) contains:
Neisseria meningitidis group C (strain C11) oligosaccharide
10 micrograms
conjugated to
Corynebacterium diphtheriae CRM197 protein1
12.5 to 25.0 micrograms
adsorbed on aluminium hydroxide
0.3 to 0.4 mg Al 3+
1CRM197 (Cross Reacting Material 197)
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
between the doses (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 need for booster doses in subjects primed with a single dose (i.e.
aged 12 months or more when first immunised) has not
yet been established (see section 5.1).
_Adolescents and adults_
Me