Tetanus immunoglobulin human 250unit solution for injection vials

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Tetanus immunoglobulin human

Dostopno od:

Bio Products Laboratory Ltd

Koda artikla:

J06BB02

INN (mednarodno ime):

Tetanus immunoglobulin human

Odmerek:

250unit

Farmacevtska oblika:

Solution for injection

Pot uporabe:

Intramuscular

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 14050200; GTIN: 5019943000362

Navodilo za uporabo

PATIENT INFORMATION LEAFLET
HUMAN TETANUS
IMMUNOGLOBULIN
100 IU/ML SOLUTION FOR INJECTION
STDNL5
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 [phone].
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 and
virally-inactivated
during manufacture. 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 high risk of being infected by tetanus germs
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.
2. BEFORE YOU ARE GIVEN
HUMAN TETANUS IMMUNOGLOBULIN
You must not be given this medicine if you are:
•
SUFF

Lastnosti izdelka

OBJECT 1
HUMAN TETANUS IMMUNOGLOBULIN
Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Human Tetanus Immunoglobulin, 100 IU/ml sterile solution
2. Qualitative and quantitative composition
Human Tetanus Immunoglobulin Ph.Eur. contains human protein, 40-180
g/L of which at least 95% is
IgG. The concentration of specific IgG to tetanus toxin is not less
than 100 IU/ml in nominal 250 IU vials.
The correct volume to give the stated potency is overprinted on the
label.
This product is prepared from plasma from screened donors. Donors are
selected from the USA.
For excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
POST-EXPOSURE PROPHYLAXIS:
Immediate prophylaxis after tetanus prone injuries in patients not
adequately vaccinated, in patients
whose immunisation status is not known with certainty, and in patients
with severe deficiency in antibody
production or vaccinated patients with high risk wounds.
4.2 Posology and method of administration
4.2.1 POSOLOGY
Prophylaxis of tetanus prone wounds:
• 250 IU, unless the risk is thought to be extremely high
• The dose may be increased to 500 IU in:
• Infected wounds, where surgically appropriate treatment cannot be
achieved within 24 hours
• Deep or contaminated wounds with tissue damage and reduced oxygen
supply, as well as foreign
body injury (e.g. bites, stings or shots)
The volume of solution that needs to be administered to give 250 IU is
stated on the label.
DO NOT EXCEED THE RECOMMENDED DOSE.
4.2.2 METHOD OF ADMINISTRATION
Human Tetanus Immunoglobulin should be administered via the
intramuscular route.
If a large volume (> 2mL for children or > 5 mL for adults) is
required, it is recommended to administer
this in divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the
vaccine should be administered
at two different sites.
If intramuscular administration is contra-ind