Human Rabies Immunoglobulin

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

IMMUNOGLOBULIN RABIES, HUMAN

Saatavilla:

Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom

ATC-koodi:

J06BB05

INN (Kansainvälinen yleisnimi):

IMMUNOGLOBULIN RABIES, HUMAN 150 IU/ml

Lääkemuoto:

SOLUTION FOR INJECTION

Koostumus:

IMMUNOGLOBULIN RABIES, HUMAN 150 IU/ml

Prescription tyyppi:

POM

Terapeuttinen alue:

IMMUNE SERA AND IMMUNOGLOBULINS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2007-10-04

Pakkausseloste

BPL 0791 
28.05.12 PROOF: 
THREE 90 x 290MM
COLOURS:  Black 
BPL PO No.: 261148

PMS 273

PMS 430
PATIENT INFORMATION LEAFLET
HUMAN RABIES
IMMUNOGLOBULIN
NOT LESS THAN 150 IU/ML SOLUTION FOR INJECTION
SRCNL2
PLEASE READ ALL OF THIS LEAFL ET CAREFULLY BEFORE USING THIS
MEDICINE.
•  Keep this leafl et. You may need to read it again.
•  If you have any further questions, please ask your doctor.
•  This medicine has been prescribed for you personally. Do not
pass it on to 
others. It may harm them, even if their symptoms are the same as
yours.
•  If any of the side effects get serious, or if you notice any
side effects not 
listed in this leafl et, please tell your doctor.
Is this leafl et hard to see or read? Phone 
020 8258 2200.
IN THIS LEAFL ET:
1.  What Human Rabies Immunoglobulin is and what it is used for
2.  Before you are given Human Rabies Immunoglobulin
3.  How you are given Human Rabies Immunoglobulin
4.  Possible side effects
5.  How to store Human Rabies Immunoglobulin
6. Further information
1. WHAT HUMAN RABIES IMMUNOGLOBULIN IS 
AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of rabies
antibodies. It is 
prepared from blood plasma from screened donors.
Human Rabies Immunoglobulin is given by injection around the wound
and 
into the muscle at the side of the thigh (intramuscular). Your doctor
or nurse 
will give you the injection. It is used to protect you against rabies
and is given 
with fi rst dose of rabies vaccine, or not more than 7 days
later. Your doctor will 
explain further why this medicine has been given to you.
This product is usually given to you if:
•  you have been bitten, scratched or received any other injury
from a 
suspected rabid animal or you may have swallowed or breathed in
tissue 
such as saliva from a suspected rabid animal.
2. BEFORE YOU ARE GIVEN 
HUMAN RABIES IMMUNOGLOBULIN
SPECIAL CARE MUST BE TAKEN WITH HUMAN RABIES IMMUNOGLOBULIN IF YOU:
•  DEVELOP AN

Valmisteyhteenveto

_  _
_ _
_  _

_ _
_ _
_  _
Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF PRODUCT: 

Human Rabies Immunoglobulin 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION: 

Human Rabies Immunoglobulin Ph.Eur.* 
Human Rabies Immunoglobulin is presented as a vial size of 500 iu. Each millilitre contains: 
40-180  mg/ml  human  protein  of  which  at  least  95%  are  gammaglobulins.    This  product  is 
prepared from plasma from screened donors. Donors are selected from the USA. 
* One millilitre contains not less than 150 iu of rabies antibody. 

3. 
PHARMACEUTICAL FORM: 

Solution for injection. 

4. 
CLINICAL PARTICULARS: 

4.1 
THERAPEUTIC INDICATIONS 

The  use  of  Human  Rabies  Immunoglobulin  is  specified  in  the  World  Health  Organisation 
(WHO) guidelines for specific systemic treatment.  These guidelines are outlined in the table 
below: 

STATUS OF BITING ANIMAL 
(IRRESPECTIVE OF ANY 
EARLIER VACCINATION) 
NATURE OF EXPOSURE 
AT TIME OF 
EXPOSURE 
DURING NEXT 
10 DAYS
 A

RECOMMENDED 
TREATMENT 
Healthy 

None 
Healthy 
None 
Contact, but no lesions; 
indirect contact; non contact  Suspected as rabid
 b

Rabid 
None 
Healthy 
None 
Healthy 
Rabid 
Start vaccination 
schedule
 c

Suspected as rabid
 b

Healthy 
Start vaccination 
schedule; stop 
treatment if animal 
remains healthy for 5 
days
 a, d

Licks on the skin; scratches 
or abrasions; Minor bites 
(on covered areas of arms, 
trunk and legs) 

Rabid 
Start vaccination 
schedule; upon positive 
diagnosis, complete the 
course of vaccine 
_  _
_ _
_  _

_ _
_ _
_  _
Page 2 of 6 
Rabid; wild animal
 e

or animal 
unavailable for 
observation 

Give complete course 
of vaccination 
Licks of mucosa; major 
bites�