AMIODACORE INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

SANOFI ISRAEL LTD

ATC code:

C01BD01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

AMIODARONE HYDROCHLORIDE 50 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic group:

AMIODARONE

Therapeutic area:

AMIODARONE

Therapeutic indications:

Treatment should be initiated and normally monitored only under hospital or specialist supervision. Amiodacore injection is indicated for Corronary insufficiency, arrhythmias resistant to other treatments, wolf parkinson white syndrome.Amiodacore intravenous can be used where a rapid response is required or where oral administration is not possible.

Authorization date:

2014-05-31

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
4.2015
םש
רישכת
תילגנאב
AMIODACORE INJECTION
רפסמ
:םושיר
043-04-23211-00
םש
לעב
םושירה
SANOFI AVENTIS ISRAEL LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
!דבלב
םירכזומ
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םהב
השענ
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תוחיטב
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עדימ
אלמ
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תושקובמה
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טסקט
רסוהש
ןמוסמ
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יחכונ
טסקט
שדח
4.4. SPECIAL
WARNINGS AND
PRECAUTIONS FOR
USE
…..
DRUG INTERACTIONS (SEE SECTION 4.5) ….
Severe bradycardia and heart block have been reported in patients
taking amiodarone and Harvoni, or amiodarone and a combination of
Sovaldi and Daklinza. Of 8 cases reviewed up to April 2015, one case
resulted in fatal cardiac arrest and two required pacemaker
intervention.
Onset of bradycardia was within 24 hours of initiating hepatitis C
treatment in 6 cases and within 2 to 12 days in the other 2 cases.
Rechallenge in the context of continued amiodarone treatment
resulted in recurrence of symptomatic bradycardia in 2 cases.
Recurrence was also seen on rechallenge with the antivirals 8 days
after stopping amiodarone, but not 8 weeks after stopping.
Amiodarone should only be initiated in patients treated with Harvoni,
or Sovaldi plus Daklinza, if other antiarrhythmics are
contra-indicated
or not tolerated.
If concomitant use with amiodarone is unavoidable, patients should
be closely monitored, particularly during the first weeks of
treatment.
Those at high risk of bradyarrhythmia should be monitored in an
appropriate clinical setting for 48 hours after starting concomitant
treatment.
SEVERE BULLOUS REACTIONS (SEE SECTION 4.8)
Life-threatening or even fatal cutaneous reactions Steven

Summary of Product characteristics

1
_AMIO-INJ-SPC-24.0 July 2022 _
1. NAME OF THE MEDICINAL PRODUCT
AMIODACORE INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 ml ampoule contains 150 mg amiodarone hydrochloride.
Excipient(s) with known effect
Benzyl alcohol 60 mg in each 3 ml ampoule (see section 4.4)
For excipients, see section 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.
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 m