Elovac - B - Hepatitis B Vaccine B.p(R Dna) Page 3

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PRODUCT
RANGE
-
The vaccine should be shaken well to obtain a homogenous turbid white suspen
nization should start immediately after birth and preferably use 0, 1 and 2 months
sion.
schedule.
-
The vaccine should be used as supplied and no dilution is necessary.
-
Chronic haemodialysis Patients
®
-
The vaccine should be inspected visually for particulate material or discolouration
The recommended dosage of Elovac-B
vaccine is 40 mcg (2ml) using a 0,1,2,
prior to administration.
6 months vaccination schedule. Anti-HBs surveillance every 3-6 months is war
-
Sterile needle and syringe should be used for withdrawal of vaccine.
ranted so as to maintain the accepted protective level of 10mlU/ml.
-
Aseptic techniques should be followed.
-
Any vaccine remaining in a single dose vial should be discarded.
PRESENTATION
Immunization Regimen:
Elovac-B
®
is presented as a sterile ready to use slightly turbid white suspension for
Primary immunization with Elovac-B
®
consists of three intramuscular doses. The
intra-muscular administration.
second dose given one month after the first and the third dose administered at least
Elovac-B
®
is marked as:
four months after the second dose of Elovac-B
®
-
0.5ml and 1ml single dose vial.
-
5.0ml and 10.0ml Multi-dose Vial.
Immunization Schedule:
STORAGE:
Protect form light.
1st dose
Given on fixed date
DO NOT GREEZE. Discard vial if contents are frozen.
2nd dose
4-10 weeks after the 1st dose
Elovac-B
®
Must be stored and transported between +2
o
C & + 8
o
C.
3rd dose
4-20 weeks after the 2nd dose
®
Elovac-B
Must not be diluted to administer.
A booster dose is recommended 12 months
after the 1st dose.
A second booster dose may be required after
8 years in the high risk population if the
antibody titre falls below 10 mIU/ml.
Immunization in special situations
-
Known/presumed exposure to HBV
First dose of Elovac-B
®
vaccine can be administered simultaneously with Hepa
titis B immunoglobulin, which however must be given at a separate injection site.
-
Neonates born to HBV carrier Mother
®
First dose of Elovac-B
vaccine can be administered simultaneously with Hepa
titis B immunoglobulin, which must be given at separate injection site. The immu
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