KAMRAB

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

HUMAN-RABIES IMMUNOGLOBULIN

Saatavilla:

KAMADA LTD, ISRAEL

ATC-koodi:

J06BB05

Lääkemuoto:

SOLUTION FOR INJECTION

Koostumus:

HUMAN-RABIES IMMUNOGLOBULIN 150 IU/ML

Antoreitti:

I.M

Prescription tyyppi:

Required

Valmistaja:

KAMADA LTD, ISRAEL

Terapeuttinen ryhmä:

RABIES IMMUNOGLOBULIN

Terapeuttinen alue:

RABIES IMMUNOGLOBULIN

Käyttöaiheet:

KamRAB IM is indicated for passive, transient post-exposure prevention of rabies infection when given immediately to individuals in cases of contact with rabid or possibly rabid animal.

Valtuutus päivämäärä:

2023-06-30

Pakkausseloste

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_______________
13-11-13
________
םש
רישכת
תילגנאב
רפסמו
םושירה
______
KAMRAB 138- 88-31771-
00
__
םש
לעב
םושירה
___
KAMADA LTD
_________________________________
דבלב תורמחהה טורפל דעוימ הז ספוט
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
QALITATIVE
AND
QUANTITATIVE
COMPOSITION
Human rabies immunoglobulin (for
intramuscular or subcutaneous use
only)
.
Human rabies immunoglobulin
)
עיפומ
טוריפב
ףיעסב
Method of
(administration
INDICATION
Human rabies immunoglobulin must always
be used in combination with a rabies
vaccine as part of the post-exposure
prophylaxis of rabies infection in patients
exposed to animals suspected of being rabid,
provided the patient was not previously
vaccinated with rabies vaccine.
Rabies virus is usually transmitted by the
bite of a rabid animal but can occasionally
penetrate abraded skin contaminated with
the saliva of infected animals. Progress of
the virus after exposure is believed to
follow a neural pathway and the time
between exposure and clinical rabies is a
function of the proximity of the bite (or
abrasion) to the central nervous system and
the dose of virus injected. The incubation is
usually 2-6 weeks but can be longer. After
severe bites about the face and neck and
arms, it may be as short as 10 days. After
initiation of the vaccine series it takes
approximately one week for development
of immunity to rabies; therefore, the value
of immediate passive immunization with
rabies antibodies in the form of rabies
immune globulin (human) cannot be
overemphasized
.
תת לטוב
ףיעס
RATIONALE OF TREATMENT, TABLE A1
.
Human rabies immunoglobulin must
always be used in combination with a
rabies vaccine as part of the post-
exposure prophylaxis of rabies
i

Valmisteyhteenveto

1
FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Kam
_RAB_
, Human-Rabies Immunoglobulin (HRIG) 150 IU/mL, Solution for i.m.
Injection.
2
THERAPEUTIC INDICATIONS
Passive, transient post-exposure prophylaxis of rabies infection, when
given immediately to
individuals in cases of contact with rabid or possibly rabid animal.
Human rabies immunoglobulin must always be used in combination with a
rabies vaccine as part
of the post-exposure prophylaxis of rabies infection in patients
exposed to animals suspected of
being rabid.
Local or state public health officials should be consulted if
questions arise about the need for
rabies prophylaxis.
Recommendations for passive and/or active immunization after exposure
to an animal suspected
of having rabies have been outlined, among others by the World Health
Organization (WHO)
and by the U.S. public health Advisory Committee on Immunization
Practices (ACIP).
3
DOSAGE AND ADMINISTRATION
POSOLOGY
Post-exposure prophylaxis consists of a regimen of one dose of
immunoglobulin and full courses
of rabies vaccination. Rabies immunoglobulin and the first dose of
rabies vaccine should be
given as soon as possible after exposure. Additional doses of rabies
vaccine should be given
according to official guidelines or the manufacturer’s instructions.
Rabies prophylaxis exclusively with simultaneous vaccination:
recommended dose of rabies
immunoglobulin is 20 IU/kg body weight, preferably at the time of the
first vaccine dose. It may
also be given through the seventh day after the first dose of vaccine
is given.
Kam
_RAB_
should never be administered in the same syringe or into the same
anatomical site as
the vaccine.
Because of the risk of interference with antibody production related
to vaccination, neither the
dose should be increased, nor a repeated rabies immunoglobulin dose be
given (even if the onset
of the simultaneous prophylaxis is delayed).
METHOD OF ADMINISTRATION
Human rabies immunoglobulin should be administered via the
intramuscular route.
If a large volume (>2