ACT-HIB

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

HAEMOPHILUS B

Διαθέσιμο από:

MEDICI MEDICAL LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

J07AG01

Φαρμακοτεχνική μορφή:

LYOPHILIZED POWDER FOR INJECTION

Σύνθεση:

HAEMOPHILUS B 10 MCG / 0.5 ML

Οδός χορήγησης:

S.C, I.M

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

SANOFI PASTEUR, FRANCE

Θεραπευτική περιοχή:

HEMOPHILUS INFLUENZAE B, PURIFIED ANTIGEN CONJUGATED

Θεραπευτικές ενδείξεις:

Prevention in infants of invasive diseases caused by Haemophilus influenzae type B ( meningitis septicemia cellulitis arthritis epiglotitis).

Ημερομηνία της άδειας:

2023-06-30

Αρχείο Π.Χ.Π.

ACT-HIB 10 MICROGRAMS/0.5 ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION IN
A PRE-FILLED SYRINGE
Haemophilus Influenzae type b vaccine (conjugated)Sanofi Pasteur Inc.
1
INDICATIONS AND USAGE
This vaccine is indicated for the prevention of Haemophilus influenzae
type b invasive infections
(meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.)
in children from the age of 2 months.
This vaccine does not provide protection against infections due to
other types of Haemophilus influenzae
or against cases of meningitis of other origins.
Under no circumstances can the tetanus protein contained in this
vaccine be used to replace the usual
tetanus vaccination.
2
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR OR DEEP SUBCUTANEOUS ROUTE USE ONLY
The recommended injection sites are the antero-lateral aspect of the
thigh (middle third) for infants
and toddlers and the deltoid region for older children.
Do not inject by the intravascular route
2.1
IMMUNIZATION SERIES
•
Before 6 months of age, 3 successive doses of 0.5 ml administered one
or two months apart, followed by
a booster injection (fourth dose) one year after the third injection.
•
Between 6 and 12 months of age, 2 doses of 0.5 ml administered one
month apart, followed by a booster
injection (0.5 ml) at 18 months of age.
•
From 1 to 5 years of age, a single dose of 0.5 ml.
For contact cases: in the event of contact with a case of invasive
Haemophilus influenzae type b disease
(family or childcare), vaccination should be implemented according to
the schedule for the contact case’s
age.
The index case should also be vaccinated
2.2
RECONSTITUTION
ActHIB vaccine is a solution for injection supplied as single-dose
vials of lyophilized vaccine to be
reconstituted only with the accompanying saline diluent (0.4% Sodium
Chloride). To reconstitute
ActHIB vaccine, withdraw 0.6 mL of saline diluent and inject into the
vial of lyophilized ActHIB
vaccine. Agitate the vial to ensure complete reconstitution. The
reconstituted ActHIB vaccine will
appear
clear
and