Adenocor 6mg/2ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Adenosine

Available from:

Sanofi

ATC code:

C01EB10

INN (International Name):

Adenosine

Dosage:

3mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200; GTIN: 5000283101086

Patient Information leaflet

ADENOCOR 3MG/ML SOLUTION
FOR INJECTION
Adenosine
The following information is extracted from the SPC.
TECHNICAL INFORMATION FOR THE ADMINISTRATION OF
ADENOCOR 3MG/ML SOLUTION FOR INJECTION
1.
TRADE NAME OF MEDICINAL PRODUCT
Adenocor 3mg/ml Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6mg of adenosine per 2ml
(3mg/ml).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
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:
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.
Third dose:
If the second dose does not result in
elimination of the supraventricular
tachycardia within 1 to 2 minutes. 12mg
should be given also as a rapid
intravenous bolus.
Additional or higher doses are not recommended.
Paediatric population
During administration of adenosine cardio-respiratory
resuscitation equipment must be available for
immediate use if necessary.
Adenosine is intended for use with continuous
monitoring and ECG recording during administration.
The dosing recommended for the treatment of
paroxysmal supraventricular tachycardia in the
paediatric populat

Summary of Product characteristics

OBJECT 1
ADENOCOR
Summary of Product Characteristics Updated 20-Nov-2013 | SANOFI
1. Name of the medicinal product
Adenocor
2. Qualitative and quantitative composition
Each vial contains 6mg of adenosine per 2ml (3mg/ml).
For excipients, see 6.1
3. Pharmaceutical form
Solution for injection
Clear, colourless 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).
Paediatric population
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardia in children aged 0
to 18 years.
Diagnostic Indications
Aid to diagnosis of broad or narrow complex supraventricular
tachycardias. Although Adenocor will not
convert atrial flutter, atrial fibrillation or ventricular tachycardia
to sinus rhythm, the slowing of AV
conduction helps diagnosis of atrial activity.
Sensitisation of intra-cavitary electrophysiological investigations.
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:
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.
Third dose:
If the second dos