Human Hepatitis B Immunoglobulin

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

IMMUNOGLOBULIN ANTIHEPATITIS

Prieinama:

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

ATC kodas:

J06BB04

INN (Tarptautinis Pavadinimas):

IMMUNOGLOBULIN ANTIHEPATITIS B 100 IU/ml

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

IMMUNOGLOBULIN ANTIHEPATITIS B 100 IU/ml

Recepto tipas:

POM

Gydymo sritis:

IMMUNE SERA AND IMMUNOGLOBULINS

Autorizacija statusas:

Withdrawn

Leidimo data:

2007-10-01

Pakuotės lapelis

BPL 0792 
18.05.12 PROOF: 
THREE 90 x 290MM
COLOURS:  Black 
BPL PO No.: 261148

PMS 273

PMS 430
PATIENT INFORMATION LEAFLET
HUMAN HEPATITIS B 
IMMUNOGLOBULIN
100 IU/ML STERILE SOLUTION
SHDNL2
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 Hepatitis B Immunoglobulin is and what it is used for
2.  Before you are given Human Hepatitis B Immunoglobulin
3.  How you are given Human Hepatitis B Immunoglobulin
4.  Possible side effects
5.  How to store Human Hepatitis B Immunoglobulin
6. Further information
1. WHAT HUMAN HEPATITIS B IMMUNOGLOBULIN 
IS AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of hepatitis B
antibodies. 
It is prepared from blood plasma from screened donors. 
Human Hepatitis B Immunoglobulin is given by injection into a
muscle 
(intramuscular) such as the buttock or thigh. Your doctor or nurse
will give you 
the injection. It is used to protect against infection by the
hepatitis B virus and 
is normally given with hepatitis B vaccine. Your doctor will explain
further why 
this medicine has been given to you.
This product is usually given to you if:
•  you have not had previous vaccination, or have not been
properly 
vaccinated, to hepatitis B and have been accidentally exposed to
infection 
by skin pricks, cuts, spillage into the eye or mouth, from infectious
material 
such as blood, or from bites.
•  you are having kidney dialysis while waiting for vaccination to
be fully

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF PRODUCT 

Human Hepatitis B Immunoglobulin. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Human Hepatitis B Immunoglobulin Ph.Eur. * 

Human  Hepatitis  B  Immunoglobulin  is  presented  as  two  vial  sizes  of  200  iu  and  500  iu.

Each  millilitre  contains:  10-100  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 100 iu of hepatitis
B antibody. 

3. 
PHARMACEUTICAL FORM 

Solution for injection. 

4. 
CLINICAL PARTICULARS 

4.1 
Therapeutic indications 

Human Hepatitis B Immunoglobulin is indicated for: 

i. 
Post  exposure  prophylaxis  in  persons  who  have  not  received  prior  vaccination,  or 
whose vaccination regimen is  incomplete, or when the antibody level  is  inadequate 
(i.e. <10 iu/L). 

ii. 
The passive immunisation of people at increased risk of exposure should be used in 
combination with hepatitis B vaccination. 

iii. 
Accidental  exposure  (skin  pricks,  contamination  of  abrasions,  spillage  into  eye  or 
mouth,  bites  or  scratches)  to  blood  or  other  material  containing  HBsAg.

Contamination of intact skin is not included unless there is heavy contamination of a 
large area. 

iv. 
Sexual contacts of patients with acute hepatitis B. 

v. 
Non-immune  staff  and  patients  of  dialysis  units  for  temporary  protection  after  a 
patient in the unit is found to be HBsAg positive, and for haemodialysis patients and 
recipients of certain blood products unable to develop
adequate protec