EPIPEN JUNIOR AUTO-INJECTOR INJECTION

Երկիր: Հարավաֆրիկյան Հանրապետություն

Լեզու: անգլերեն

Աղբյուրը: South African Health Products Regulatory Authority (SAHPRA)

Հասանելի է:

Mylan Pharmaceuticals (Pty) Ltd

Դոզան:

See ingredients

Դեղագործական ձեւ:

INJECTION

Կազմը:

EACH 0,3 ml SOLUTION CONTAINS ADRENALINE 0,15 mg

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2006-07-07

Ապրանքի հատկությունները

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Page 1 of 4
CLEAN COPY OF ENGLISH PACKAGE INSERT
SCHEDULING STATUS:
S4
PROPRIETARY NAME (and dosage form):
EPIPEN
®
AUTO-INJECTOR
EPIPEN
® JR AUTO-INJECTOR
COMPOSITION:
Each 0,3 ml of EPIPEN
® Auto-injector contains:
Adrenaline 0,3 mg
Sodium Metabisulfite (Antioxidant)
Each 0,3 ml of EPIPEN
® JR Auto-injector contains:
Adrenaline 0,15 mg
Sodium Metabisulfite (Antioxidant)
PHARMACOLOGICAL CLASSIFICATION:
A 5.1 Adrenomimetics (sympathomimetics)
PHARMACOLOGICAL ACTION:
Adrenaline is a sympathomimetic agent.
INDICATIONS:
Use as an adjunct in the treatment of severe anaphylactic or
life-threatening reactions. EPIPEN
® and
EPIPEN
® JR are to be used only when prescribed by a doctor for patients who
are highly allergic and in
danger of developing a life-threatening reaction. EPIPEN
® and EPIPEN
® JR are intended as emergency
treatment and should not substitute any medical care to be implemented
at a later stage.
CONTRA-INDICATIONS:
Sensitivity to any of the ingredients including sensitivity to
sulphites.
WARNINGS:
The Adrenaline solution should be checked every 14 days for any brown
discolouration.
If there is any such discolouration or if any turbidity has formed,
the solution should not be used.
Should the patient accidentally inject him or herself, in the hands,
feet, fingers or toes; immediate
hospitalisation together with the appropriate treatment is
recommended.
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Page 2 of 4
INTERACTIONS:
Interaction with monoamine oxidase inhibitors and alpha and
betablockers may occur.
DOSAGE AND DIRECTIONS FOR USE:
EPIPEN
® or EPIPEN
® JR should be administered immediately in the case of the development
of a life-
threatening reaction.
EPIPEN
® is intended for the treatment of adults and children with a body mass
of more than 45 kg.
EPIPEN
® JR is intended for the treatment of children with a body mass of less
than 45 kg.
EPIPEN
® and EPIPEN
® JR are for single dose administration only and the unused portion
must be
discarded.
Never put thumb, fingers or hand over orange tip. The needle comes out
of the ora