ADRENALINE TEVA

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

EPINEPHRINE

Beschikbaar vanaf:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC-code:

R03AA01

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

EPINEPHRINE 1 MG/ML

Toedieningsweg:

I.M, I.V, S.C, INTRACARDIAC

Prescription-type:

Required

Geproduceerd door:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutische categorie:

EPINEPHRINE

Therapeutisch gebied:

EPINEPHRINE

therapeutische indicaties:

Adrenaline Teva Solution for Injection is indicated in the following situations:– Spasm of the airways in acute asthma attacks.– Rapid relief of allergic reactions to drugs or other substances.– Emergency treatment of anaphylactic shock.– Cardiac arrest and cardiopulmonary resuscitation (physical measures should be used first).

Autorisatie datum:

2013-01-31

Bijsluiter

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
___________
DECEMBER 26, 2012
_________
םש
רישכת
תילגנאב
_
_
ADRENALINE INJECTION 1MG/1ML
רפסמ
םושיר
_
027
62
21638
21
םש
לעב
םושירה
Teva Pharmaceutical Industries Ltd. ,P.O. Box 3190 Petach Tikva
.
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNINGS
(
see also Precautions)
Use with caution in patients with ventricular fibrillation,
prefibrillatory rhythm, tachycardia, myocardial infarction,
phenothiazine induced circulatory collapse and prostatic
hypertrophy (1).
Adrenaline is ordinarily administered with extreme caution
to patients who have a heart disease. Use of adrenaline with
drugs that may sensitise the heart to arrhythmias, e.g.,
digitalis, mercurial diuretics, or quinidine, ordinarily is not
recommended. Anginal pain may be induced by adrenaline in
patients with coronary insufficiency (3).
Administer slowly with caution to elderly patients and to
patients with hypertension, diabetes mellitus,
hyperthyroidism and psychoneurosis. Use with extreme
caution in patients with long-standing bronchial asthma and
emphysema who have developed degenerative heart disease
(1, 2) (see also Contraindications) .
Adrenaline may delay the second stage of labour by
inhibiting contractions of the uterus (1).
Syncope has occurred following administration to asthmatic
children (1).
In patients with Parkinsonian syndrome the drug increases
rigidity and tremor. Intra-arterial administration should be
avoided since marked vasoconstriction may result in
gangrene (1).
Intramuscular injection into the buttocks should be avoided
as gas gangrene is a possibility (1).
Accidental injection into the hands or feet may result in loss
of blood flow to the affected area and should be avoided. If
there is an accidental injection into these areas, advise the
patient to go immediately to the

Productkenmerken

Adrenaline Teva FW Minor Updated 05‐2021
ADRENALINE TEVA 1 MG/ML (1:1,000)
SOLUTION FOR S.C., I.M., I.V. OR INTRACARDIAC INJECTION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Adrenaline Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains:
Adrenaline (Epinephrine) 1 mg
Excipients with known effect
Sodium metabisufite (E223) 1.5 mg/ml
Sodium 3.3mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adrenalin Teva Solution for Injection is indicated in the following
situations:
–
Spasm of the airways in acute asthma attacks.
–
Rapid relief of allergic reactions to drugs or other substances.
–
Emergency treatment of anaphylactic shock.
–
Cardiac arrest and cardiopulmonary resuscitation (physical measures
should be used
first).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adrenaline Teva 1mg/ml Solution for Injection can be administered by
intramuscular (I.M.),
subcutaneous (S.C.) and intravenous (I.V.) injection, and in extremely
serious cases and if the
intravenous route is not practicable, via the intracardiac route.
The intravenous and intracardiac routes must be used in the hospital
setting, after dilution of
the solution in 0.9% sodium chloride solution and under cardiac
monitoring. Adrenaline Teva
will be administered by healthcare personnel. Adrenaline Teva 1mg/ml
(1:1,000) must be
Adrenaline Teva FW Minor Updated 05‐2021
diluted in 0.9% sodium chloride solution to 1:10,000 before I.V. or
intracardiac administration.
To prevent degradation by light or oxidation, it is recommended that
the product be used
immediately after dilution. The dosage and route of administration
depend on the diagnosis
and the clinical condition of patients. In an emergency situation, a
rapid route of absorption
should be used.
Acute asthma attacks, allergic reactions and anaphylactic shock
The usual dose for the treatment of acute asthma