ADENOCOR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ADENOSINE

Available from:

SANOFI - AVENTIS ISRAEL LTD

ATC code:

C01EB10

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ADENOSINE 6 MG / 2 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SANOFI AVENTIS, FRANCE

Therapeutic group:

ADENOSINE

Therapeutic area:

ADENOSINE

Therapeutic indications:

Rapid conversion to a normal sinus rhythm of paroxysmal supraventicular tachycardias including those associated with accessory bypass tracts (wolf parkinson-white syndrome).

Authorization date:

2013-06-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
04.2013
םש
רישכת
תילגנאב
ADENOCOR
רפסמ
םושיר
1284929054 םושירה לעב םש
SANOFI-AVENTIS ISRAEL LTD
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.2 POSOLOGY AND
METHOD OF
ADMINISTRATION
טסקט ,בוהצב ןמוסמ ףסוהש שדח טסקט
חסונ יוניש ,הקיחמ וק םע םודאב ןמוסמ
רסוהש
עיפומ הז קרפ לש אלמ טסקט .קוריב םינמוסמ
םכרושיאל החלשנש ןולע תעצהב
THERAPEUTIC DOSE
Adult:
Initial dose: 3mg given as a rapid intravenous bolus
(over 2 seconds).
Second dose: If the first dose does not result in
elimination of the supraventricular tachycardia within 1
to 2 minutes, 6mg should be given also as a rapid
intravenous bolus, followed by a rapid saline flush
….
Children
No controlled pediatric study has been undertaken.
Published uncontrolled studies show similar effects of
adenosine in adults and children: effective doses for
children were between 0.0375 and 0.25mg/kg.
The level of evidence does not allow a recommended
posology.
…………………………..
Hepatic / Renal impairment
As adenosine requires no hepatic or renal function for
its activation or inactivation, hepatic and/or renal failure
would not be expected to alter efficacy or tolerance
.
4.4 SPECIAL WARNINGS
AND SPECIAL
PRECAUTIONS FOR USE
רסוהש טסקט ,בוהצב ןמוסמ ףסוהש שדח טסקט
םינמוסמ חסונ יוניש ,הקיחמ וק םע םודאב
ןמוסמ
ןולע תעצהב עיפומ הז קרפ לש אלמ טסקט
.קוריב
.םכרושיאל החלשנש
Due to the possibility of transient cardiac arrhythmias
arising during conversion of the supraventricular
tachycardia to normal sinus rhythm, administration
should be carried out in hospital with
electrocardiographic monitoring…�

Summary of Product characteristics

1
ADENOCOR
1. NAME OF THE MEDICINAL PRODUCT
Adenocor
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6 mg of adenosine per 2 ml (3 mg/ml).
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular
tachycardias including those associated with accessory by-pass tracts
(Wolff-
Parkinson-White syndrome).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adenocor is intended for hospital use only with monitoring and
cardiorespiratory resuscitation
equipment available for immediate use.
METHOD OF ADMINISTRATION
It should be administered by rapid IV bolus injection according to the
ascending dosage
schedule below. To be certain the solution reaches the systemic
circulation administer either
directly into a vein or into
an IV line. If given into an IV line it should be injected as
proximally as
possible, and followed by a rapid saline flush.
Adenocor should only be used when facilities exist for cardiac
monitoring. Patients who develop
high-level AV block at a particular dose should not be given further
dosage increments.
POSOLOGY
Adult:
_Initial dose: _
3 mg given as a rapid intravenous bolus (over 2 seconds).
_Second dose:_
If the first dose does not result in elimination of the
supraventricular
tachycardia within 1 to 2 minutes, 6 mg should be given also as a
rapid
intravenous bolus.
_Third dose:_
If the second dose does not result in elimination of the
supraventricular
tachycardia within 1 to 2 minutes,12 mg should be given also as a
rapid
2
intravenous bolus.
Additional or higher doses are not recommended.
Children:
The level of evidence does not allow a recommended posology.
Elderly:
See dosage recommendations for adults.
Hepatic / Renal impairment:
As adenosine requires no hepatic or renal function for its activation
or inactivation, hepatic
and/or renal failure would not be expected to alter efficacy or
tolerance.
4.3 CONTRAINDICATIONS