NIMENRIX

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE; NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE; NEISSERIA MENINGITIDIS GROUP W - 135 POLYSACCHARIDE; NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE

Inapatikana kutoka:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC kanuni:

J07AH02

Dawa fomu:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Tungo:

NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE 5 MCG; NEISSERIA MENINGITIDIS GROUP W - 135 POLYSACCHARIDE 5 MCG; NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE 5 MCG; NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE 5 MCG

Njia ya uendeshaji:

I.M

Dawa ya aina:

Required

Viwandani na:

PFIZER MANUFACTURING BELGIUM NV, BELGIUM

Kundi la matibabu:

OTHER MENINGOCOCCAL MONOVALENT PURIFIED POLYSACCHARIDES ANTIGEN

Eneo la matibabu:

OTHER MENINGOCOCCAL MONOVALENT PURIFIED POLYSACCHARIDES ANTIGEN

Matibabu dalili:

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135 and Y.

Idhini ya tarehe:

2018-08-31

Taarifa za kipeperushi

NIMENRIX, PIL, CC TC 170722
2022-0079800
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
NIMENRIX
®
, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Each dose (0.5 ml) contains:
_Neisseria meningitidis_ group A polysaccharide
1
5 micrograms
_Neisseria meningitidis _group C polysaccharide
1
5 micrograms
_Neisseria meningitidis_ group W-135 polysaccharide
1
5 micrograms
_Neisseria meningitidis_ group Y polysaccharide
1
5 micrograms
1
conjugated to tetanus toxoid carrier protein
44 micrograms
Inactive ingredients and allergens: see section 2 under “Important
information about some of this
medicine’s ingredients” and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Nimenrix is intended for active immunization of children aged 6 weeks
and older and adults against
an invasive meningococcal disease caused by bacteria called _Neisseria
meningitidis_ types A, C, W-
135 and Y.
THERAPEUTIC GROUP: meningococcal vaccine
Nimenrix helps your body to produce its own protection (antibodies)
against the bacteria. These
antibodies help protect you against meningococcal disease.
Nimenrix will only help protect against infections caused by the
bacteria _Neisseria meningitidis_ types
A, C, W-135 and Y.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You or your child are sensitive (allergic) to the active ingredient or
to any of the other
ingredients in this medicine (see section 6).
Signs of an allergic reaction may include itchy skin rash, difficulty
breathing, swelling of
the face or tongue. SEE YOUR DOCTOR IMMEDIATELY IF YOU

Tabia za bidhaa

Nimenrix, LPD, CC 040822
2021-0074656
Page 1 of
26
®
Nimenrix
1.
NAME OF THE MEDICINAL PRODUCT
Nimenrix powder and solvent for solution for injection in pre-filled
syringe
.
Meningococcal groups A, C, W-135
and Y conjugate vaccine
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
_Neisseria meningitidis_
group A polysaccharide
1
5 micrograms
_Neisseria meningitidis _
group C polysaccharide
1
5 micrograms
_Neisseria meningitidis_
group W-135
polysaccharide
1
5 micrograms
_Neisseria meningitidis_
group Y polysaccharide
1
5 micrograms
1
conjugated to tetanus toxoid carrier protein
44 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder or cake is white.
The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nimenrix is indicated for active immunisation of individuals from the
age of 6 weeks against invasive
meningococcal disease caused by
_Neisseria meningitidis_
groups A, C, W-135 and Y.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Nimenrix should be used in accordance with available official
recommendations.
_Primary immunisation _
Infants from 6 weeks to less than 6 months of age: two doses, each of
0.5 ml, should be administered with
an interval of 2
months between doses.
Infants from 6 months of age, children, adolescents and adults: a
single 0.5 mL dose should be
administered.
An additional primary dose of Nimenrix may be considered appropriate
for some individuals (see section
4.4).
_Booster doses _
After completion of the primary immunisation course in infants 6 weeks
to less than 12 months of age, a
booster dose should be given at 12 months of age with an interval of
at least 2 months after the last
Nimenrix vaccination (see section 5.1).
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2021-0074656
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In previously vaccinated individuals 12 months of age and older,
Nimenrix may be given as a booster
dose if they have received primary vaccination wit