HAVRIX 1440

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HEPATITIS A VIRUS ANTIGEN, INACTIVATED

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J07BC02

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

HEPATITIS A VIRUS ANTIGEN, INACTIVATED 1440 E.L.U/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE BIOLOGICALS S.A

Therapeutic group:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Therapeutic area:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Therapeutic indications:

Active immunisation against infections caused by Hepatitis A virus.The vaccine is particularly indicated for those at increased risk of infection or transmission.

Authorization date:

2021-06-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
20
רבמבונב
2013
םש
רישכת
תילגנאב
רפסמו
םושירה
H AVRIX 1440 101-61-28393
םש
לעב
םושירה
GLAXOSMITHKLINE (ISRAEL) LTD :
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
אפורל ןולעב
אפורל ןולעב
תורמחהה
תושקובמה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
CONTRAINDICATIONS
Hypersensitivity
to any component
of the vaccine.
Severe febrile
illness
.
Hypersensitivity to the active substance,
to any of the excipients listed in section
6.1, or to neomycin (present at traces)
.
EFFECTS ON ABILITY TO
DRIVE AND USE
MACHINES
Not applicable
No studies of the effects of Havrix 1440
on the ability to drive and use machines
have been performed. However, some of
the effects mentioned under section 4.8
“Undesirable effects” may temporarily
affect the ability to drive or use
machines
.
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
)ןולעב(
עבצב
קורי
.

Summary of Product characteristics

Page 1 of 9
Havrix 1440
1
NAME OF THE MEDICINAL PRODUCT
Havrix 1440
Suspension for injection in a pre-filled syringe
Suspension for injection in a vial
Hepatitis A antigen (inactivated) vaccine (adsorbed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1.0 mL) contains:
Hepatitis A virus
antigen (inactivated)
1,2
1440 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium
(as aluminium
hydroxide
)
Total: 0.50 milligrams Al
3+
Havrix
1440
vaccine may contain traces of neomycin B sulfate, which is used during
the
manufacturing process (see section 4.3).
Excipient(s) with known effect:
This vaccine contains phenylalanine 166 micrograms per dose (see
section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Suspension for injection.
Turbid liquid suspension.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Active immunisation against infections caused by hepatitis A virus.
The vaccine is
particularly indicated for those at increased risk of infection or
transmission. For example,
immunisation should be considered for the following risk groups:
Travellers visiting areas of medium or high endemicity, i.e., anywhere
outside northern or
western Europe, Australia, North America and New Zealand.
Military and diplomatic personnel.
Persons for whom hepatitis A is an occupational hazard or for whom
there is an increased risk
of transmission. These include employees in day care centres, nursing,
medical and
paramedical personnel in hospitals and institutions, especially
gastroenterology and paediatric
units, sewage workers and food packagers or handlers.
Haemophiliacs.
Page 2 of 9
Intravenous drug abusers.
Homosexual men.
Patients with chronic liver disease (including alcoholic cirrhosis,
chronic hepatitis B, chronic
hepatitis C, autoimmune hepatitis, primary biliary cirrhosis).
Since virus shedding from infected persons may occur for a prolonged
period, active
immunisation of close contacts may be considered.
In addition, there may be other groups at risk or specific
c