Human Tetanus Immunoglobulin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

INACTIVATED STRAIN, FLURY LEP

Available from:

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

ATC code:

J06BB02

INN (International Name):

INACTIVATED STRAIN FLURY LEP 100 IU/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INACTIVATED STRAIN FLURY LEP 100 IU/ml

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Withdrawn

Authorization date:

2007-10-04

Patient Information leaflet

BPL 0793 
6.07.12 PROOF: 
FOUR 90 x 290MM
COLOURS:  Black 
BPL PO No.: 261148

PMS 273

PMS 430
PATIENT INFORMATION LEAFLET
HUMAN TETANUS 
IMMUNOGLOBULIN
100 IU/ML SOLUTION FOR INJECTION
STDNL2
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 Tetanus Immunoglobulin is and what it is used for
2.  Before you are given Human Tetanus Immunoglobulin
3.  How you are given Human Tetanus Immunoglobulin
4.  Possible side effects
5.  How to store Human Tetanus Immunoglobulin
6. Further information
1. WHAT HUMAN TETANUS IMMUNOGLOBULIN IS 
AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of tetanus
antibodies. 
It is prepared from blood plasma from screened donors.
Human Tetanus 
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 you against tetanus and is normally given with tetanus
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 to tetanus, or have not
been properly 
vaccinated, or do not know whether you have been vaccinated to
tetanus 
but may have recently been exposed to tetanus because you have been 
wounded e.g by a cut, bite or pierced by a foreign body
•  you have had a full course of vaccination to tetanus but have
recently had a 
severe injury with a h

Summary of Product characteristics

Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF PRODUCT 

Human Tetanus Immunoglobulin. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Human Tetanus Immunoglobulin Ph.Eur. * 

Human  Tetanus  Immunoglobulin  is  presented  as  a  vial  size  of  250  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 100 iu of tetanus antibody. 

3. 
PHARMACEUTICAL FORM 

Solution for injection. 

4. 
CLINICAL PARTICULARS 

4.1 
Therapeutic indications 

Human  Tetanus  Immunoglobulin  is  used  in  the  treatment  of  tetanus  and  for  passive 
immunisation  against  tetanus,  in  conjunction  with  a  tetanus  vaccine,  in  the  treatment  of 
tetanus-prone wounds. 

The following are considered tetanus-prone wounds: 

a)

Any  wound  or  burn  sustained  more  than  six  hours  before  surgical  treatment  of  the 
wound. 

b) 
Any wound or burn at any interval after injury that shows one or more of the following 
characteristics: 
i.  
A significant degree of devitalised tissue. 
ii.  
Puncture-type wound. 
iii. 
Contact with soil or manure likely to harbour tetanus organisms. 
iv. 
Clinical evidence of sepsis. 

Thorough  surgical  cleansing  of  the  wound  is  essential  whatever  the  tetanus  immunisation 
history of the patient. 

Specific anti-tetanus treatment is as follows: 

IMMUNISATION STATUS 
TYPE OF WOUND 

CLEAN 
TETANUS PRONE 
After only 2 doses of a 3 
dose course of vaccination 
Nil 
A reinforcing dose of adsorbed 
vaccine given 6 weeks�