Tetagam P, prefilled syringeSolution for injection for intramuscular use

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Human plasma protein

Disponible des:

CSL Behring GmbH

Codi ATC:

J06BB; J06BB02

Designació comuna internacional (DCI):

Human plasma protein

Dosis:

250 international unit(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Specific immunoglobulins; tetanus immunoglobulin

Estat d'Autorització:

Not marketed

Data d'autorització:

2014-10-17

Informació per a l'usuari

PACKAGE INSERT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
– Keep this leaflet. You may need to read it again.
– If you have further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you. 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 gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
TETAGAM
®
P
Solution for injection for intramuscular use
ACTIVE INGREDIENT:
Human tetanus immunoglobulin
PHARMACOTHERAPEUTIC GROUP
Immune sera and immunoglobulins, human tetanus immunoglobulin,
ATC-code: J06B B02
THERAPEUTIC INDICATIONS
POSTEXPOSURE PROPHYLAXIS
Immediate prophylaxis after tetanus prone injuries in patients
• not adequately vaccinated
• whose immunisation status is not known with certainty
• with severe deficiency in antibody production
THERAPY OF CLINICALLY MANIFEST TETANUS
Tetanus immunoglobulin should always be administered in conjunction
with an active tetanus vaccination unless there are contraindications
or
confirmation of adequate vaccination.
WHO guidelines and other official guidance regarding the use of human
tetanus immunoglobulin for intramuscular use should be observed.
CONTRAINDICATIONS
Known hypersensitivity to any of the components of the product.
Known hypersensitivity to human immunoglobulins.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not inject intravascularly! Ensure that Tetagam P is not
administered into a
blood vessel because of the risk of shock.
True hypersensitivity reactions are rare. Tetagam P contains a small
quantity of
IgA. Individuals who are deficient in IgA have the potential for
developing IgA
antibodies and may have anaphylactic reactions after administration of
blood
components containing IgA. The physician must therefore weigh the
benefit of
treatment with Tetagam P against the potential risks of
hypersensitivity
reactions.
Rarely human tetanus immunoglobulin can in

Fitxa tècnica

Health Products Regulatory Authority
01 March 2019
CRN008VDV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tetagam P, prefilled syringeSolution for injection for intramuscular
use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Human tetanus immunoglobulin
1 ml solution contains:
Human protein 100 – 170 mg thereof immunoglobulins at least 95 %
with antibodies to tetanus toxin at least 250 IU
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection for intramuscular use.
Tetagam P is a clear solution. The colour can vary from colourless to
pale-yellow up to light brown during shelf life.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_POSTEXPOSURE PROPHYLAXIS_
Immediate prophylaxis after tetanus prone injuries in patients
- not adequately vaccinated
- whose immunisation status is not known with certainty
- with severe deficiency in antibody production
_THERAPY OF CLINICALLY MANIFEST TETANUS_
Tetanus immunoglobulin should always be administered in conjunction
with an active tetanus vaccination unless there are
contraindications or confirmation of adequate vaccination.
WHO guidelines and other official guidance regarding the use of human
tetanus immunoglobulin for intramuscular use should
be observed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Children and adults are to receive the same dose.
_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 case of:
– 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)
– burns, congelations
– tissue necrosis
– septicaemic abortion
– adults weighing more than the average.
In case of extensive burns it is advisable to administer a second
injection of 250 IU Tetagam P after the exsudative phase of the
burn has subsided (abo