ACT-HIB 10mcg/0.5m Microgram/ML Pdr+Solv for Soln for Inj

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

HAEMOPHILUS INFLUENZAE TYPE B, CONJUGATE WITH TETANUS PROTEIN

Inapatikana kutoka:

Sanofi Pasteur

ATC kanuni:

J07AG51

INN (Jina la Kimataifa):

HAEMOPHILUS INFLUENZAE TYPE B, CONJUGATE WITH TETANUS PROTEIN

Kipimo:

10mcg/0.5m Microgram/ML

Dawa fomu:

Pdr+Solv for Soln for Inj

Dawa ya aina:

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

Eneo la matibabu:

Hemophilus influenzae B vaccines

Idhini hali ya:

Authorised

Idhini ya tarehe:

2016-11-25

Taarifa za kipeperushi

PATIENT INFORMATION LEAFLET
ACT-HIB
®
powder and solvent for solution for injection
_Haemophilus influenzae _type b Conjugate Vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED.

Keep this leaflet. You may need to read it again.

If you have any other questions, ask your doctor or pharmacist.

This vaccine has been prescribed for your child. Do not pass it on to
others.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Act-HIB is and what it is used for
2.
Before Act-HIB is given
3.
How Act-HIB is given
4.
Possible side effects
5.
How to store Act-HIB
6.
Further information
1.
WHAT ACT-HIB IS AND WHAT IT IS USED FOR
Act-HIB is a vaccine. It is used to protect against diseases caused by
a bacteria
called _Haemophilus influenzae _type b.
These diseases include:

Meningitis - swelling of the outer covering of the brain. This can
cause
high temperature, very severe headaches, twitching of the muscles in
the
neck and back, a rash, fits, being sick and delirium. It can sometimes
be
fatal.

Sepsis - a very serious generalised infection of the body. This can
cause
high temperature and low blood pressure. This may lead to fainting.

Cellulitis - redness and swelling of the skin and the tissues under
the skin.
This also occurs when a cut has become infected.

A type of arthritis (swelling of the joints), that is often associated
with a
high temperature. The larger joints (e.g. knee, elbow, shoulder, hip)
are
usually affected, these joints become swollen and painful.

Epiglottitis - swelling of part of the back of the throat. This can
cause
difficulty in swallowing and breathing.
Act-HIB is used to prevent your child from getting these diseases by
protecting
them against these diseases before they come into contact with the
bacteria.
IMPORTANT INFORMATION ABOUT THE PROTECTION PROVIDED

Act-HIB will only help prevent these diseases if they are caused by
the
bact

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Act-HIB
powder and solvent for solution for injection
_Haemophilus influenzae_ type b conjugate vaccine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 ml dose of reconstituted vaccine contains:
_Haemophilus influenzae_ type b polysaccharide
(polyribosylribitol phosphate)
10 micrograms
Conjugated to tetanus toxoid as a carrier
18 – 30 micrograms
Excipient(s):
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White powder in a vial and colourless solvent in a syringe.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Act-HIB is indicated for active immunisation against
invasive diseases caused by_ Haemophilus influenzae_ type b in
infants and children from the age of 2 months.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Infants from 2 to 12 months:_
Three doses each of 0.5 ml separated by intervals of at least 4 weeks
according to national vaccination policies.
The vaccine would normally be administered at the same time as
diphtheria, tetanus, pertussis and polio vaccination.
Conjugate vaccine from the same manufacturer should be used for the
whole primary course.
_Children from 12 months and over:_
A single dose of 0.5 ml, which may be administered simultaneously with
measles, mumps and rubella vaccine but at a
different site.
_Booster dose:_
After completion of a 3-dose primary series in infancy an additional
booster dose of Hib conjugate vaccine may be
administered in accordance with official guidance.
_Adults and the elderly:_
Not recommended.
Method of administration
Act-HIB should be administered by intramuscular or deep subcutaneous
injection.
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