Tetagam P Solution for Injection for intramuscular use 250IU/ml

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

IMMUNOGLOBULIN TETANUS, HUMAN

Disponible des:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

Codi ATC:

J06BB02

Designació comuna internacional (DCI):

IMMUNOGLOBULIN TETANUS, HUMAN 250 IU

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

IMMUNOGLOBULIN TETANUS, HUMAN 250 IU

tipo de receta:

POM

Área terapéutica:

IMMUNE SERA AND IMMUNOGLOBULINS

Estat d'Autorització:

Authorised

Data d'autorització:

2018-08-03

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

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tetagam

P
Solution 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.
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7
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 (about
36 hours after