RABIPUR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RABIES, INACTIVATED, WHOLE VIRUS

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J07BG01

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

RABIES, INACTIVATED, WHOLE VIRUS 2.5 IU/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE VACCINES GMBH, GERMANY

Therapeutic group:

RABIES, INACTIVATED, WHOLE VIRUS

Therapeutic area:

RABIES, INACTIVATED, WHOLE VIRUS

Therapeutic indications:

Rabipur is indicated for active immunization against Rabies in individuals of all ages.

Authorization date:

2014-04-30

Patient Information leaflet

רבמטפס
2019
:ןודנה
RABIPUR
/
רופיבר
FOR INJECTION
POWDER AND SOLVENT FOR SOLUTION
ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
תרבח
ג
ןיילקתימסוסקל
) מ"עב לארשי
GSK ןוכדע לע עידוהל תשקבמ (
רישכתה לש אפורל ןולעה
RABIPUR /
רופיבר
. םג ללוכ ןולעה ןוכדע
:םיאבה תא
-
דבלב חוסינה טושיפ ךרוצל רישכתה תיוותה
חסונ ןוכדע
- :ןונימ רטשמ תפסוה
ACCELERATED PREP (PRE-EXPOSUREPROPHYLAXIS) רמוח
:ליעפ היוותהה תרשואמה תינכדעה
רישכתל
:לארשיב
Rabipur is indicated for active immunization against rabies in
individuals of all ages. See Sections 4.2 and 5.1 for
detailed information about pre- and post-exposure prophylaxis.
Rabipur should be used in accordance with official recommendations. העדוהב
יוצמ וז םיני ןולעל ועצובש םייונישה
.
:םינמוסמה םינוכדעל ארקמ
תפסות
–
םודא בתכ
הקיחמ
-
הקיחמ וק םע לוחכ בתכ
םינוכדיעה ןלהל
םייתוהמה
:אפורל ןולעב ושענש
MARKED UPDATE
SECTION
Rabipur is indicated for Active immunization against Rabies in
individuals of all ages.
This includesSee Sections 4.2 and 5.1 for detailed information about
pre-exposure
prophylaxis (i.e. before possible risk of exposure to rabies), in both
primary series and
booster dose, and post-exposure prophylaxis (i.e. after suspected or
proven exposure to
rabies)..
Rabipur is toshould be used on the basis ofin accordance with official
recommendations.
4.1
THERAPEUTIC
INDICATIONS
_Dosage in adults and children _
The recommended single intramuscular (IM) dose for both primary
immunization and
boosters is 1.0 ml in individuals of all ages.
_Pre-exposure prophylaxis _
(PrEP)
_ _
_Primary immunization _
In previously unvaccinated individuals, an initial course of
pre-exposure prophylaxis
consists of three doses (each of 1.0 ml)should be administered IM
onaccording t

Summary of Product characteristics

1
The format of this leaflet was determined by the Ministry of Health
and its content was checked and
approved in September 2019.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rabipur
Powder and solvent for solution for injection
Rabies vaccine (inactivated).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 vial (1.0 ml) contains:
Rabies virus* (Inactivated, strain Flury
LEP)……………………… ≥ 2.5 IU
* produced on purified chick embryo cells (PCEC)
This vaccine contains residues of chicken proteins (e.g., ovalbumin),
human serum albumin, and
may contain traces of neomycin, chlortetracycline and amphotericin B.
See section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white.
The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rabipur is indicated for Active immunization against Rabies in
individuals of all ages.
See Sections 4.2 and 5.1 for detailed information about pre- and
post-exposure prophylaxis.
Rabipur should be used in accordance with official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for both primary immunization and boosters is 1.0
ml
_Pre-exposure prophylaxis _
Rabipur_Vila_Amoules_SPC_V4.1_Update_09-2019
_Primary immunization _
In previously unvaccinated individuals, three doses should be
administered according to the
conventional or rapid regimen as shown in Table 1.
Table 1 Primary immunization regimens
_ _
_Conventional regimen _
_Rapid regimen* _
1
st
dose
Day 0
Day 0
2
nd
dose
Day 7
Day 3
3
rd
dose
Day 21 (or 28)
Day 7
THE CONVENTIONAL REGIMEN OF DAYS 0,7,21 (OR 28) IS THE PREFERABLE
REGIMEN.
*The rapid regimen
should only be considered for adults aged 18-65 years not able to
complete the
conventional pre-exposure prophylaxis regimen within 21 or 28 days
before protection is required.
_Booster doses _
Booster doses are generally recommended every 2-5 years. Timing for
b