אמיודקור זריקות

Country: Israel

Language: Hebrew

Source: Ministry of Health

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

SANOFI ISRAEL LTD

ATC code:

C01BD01

Pharmaceutical form:

תמיסה להזרקה

Composition:

AMIODARONE HYDROCHLORIDE 50 MG / 1 ML

Administration route:

תוך-ורידי

Prescription type:

מרשם נדרש

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic group:

AMIODARONE

Therapeutic area:

AMIODARONE

Therapeutic indications:

Corronary insufficiency, arrhythmias resistant to other treatments, wolf parkinson white syndrome.

Authorization date:

2014-05-31

Summary of Product characteristics

1
1. NAME OF THE MEDICINAL PRODUCT
Amiodacore Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 ml ampoule contains 150 mg amiodarone hydrochloride.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Amiodacore Injection is indicated for coronary insufficiency,
arrhythmias resistant to other treatments,
Wolff-Parkinson-White syndrome.
Amiodacore Intravenous can be used where a rapid response is required
or where oral administration is
not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Amiodacore Injection should only be used when facilities exist for
cardiac monitoring, defibrillation,
and cardiac pacing.
Amiodacore Injection may be used prior to DC cardioversion.
The standard recommended dose is 5 mg/kg bodyweight given by
intravenous infusion over a period of
20 minutes to 2 hours. This should be administered as a dilute
solution in 250 ml 5% dextrose. This
may be followed by repeat infusion of up to 1200 mg (approximately 15
mg/kg bodyweight) in up to
500 ml 5% dextrose per 24 hours, the rate of infusion being adjusted
on the basis of clinical response
(see section 4.4).
In extreme clinical emergency the drug may, at the discretion of the
clinician, be given as a slow
injection of 150 - 300 mg in 10 - 20 ml 5% dextrose over a minimum of
3 minutes. This should not be
repeated for at least 15 minutes. Patients treated in this way with
Amiodacore Injection must be closely
monitored, e.g. in an intensive care unit
(see section 4.4).
After dilution in 5% dextrose solution, the diluted solution should be
used immediately.
2
Changeover from Intravenous to Oral therapy
As soon as an adequate response has been obtained, oral therapy should
be initiated concomitantly at
the usual loading dose (i.e. 200 mg three times a day). Amiodacore
Injection should then be phased out
gradually.
Paediatric population
The safety and efficacy of amio