ADENOHARDT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ADENOSINE

Available from:

PROPHARM LTD

ATC code:

C01EB10

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ADENOSINE 3 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CP PHARMACEUTICALS LTD, U.K.

Therapeutic area:

ADENOSINE

Therapeutic indications:

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

Authorization date:

2021-12-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Adenohardt
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6 mg of adenosine per 2 ml (3 mg/ml).
Excipient(s) with known effect
Each 2 ml vial contains 7.08 mg (3.56 mg/ml) of sodium equivalent to
0.3 mmol (0.15
mmol/ml) of sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution free from visible particles.
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
Adenohardt 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.
Adenohardt 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 ADULTS
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
intravenous bolus.
Additional or higher doses are not recommended.
CHILDREN
No controlled pediatric study has been undertaken.
The level of evidence does not allow a recommended posology.
ELDERLY
See dosa