Adsine

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Compra

Scheda tecnica Scheda tecnica (SPC)
07-03-2023

Principio attivo:

Adenosine 3 mg/mL;  ;  

Commercializzato da:

Baxter Healthcare Ltd

INN (Nome Internazionale):

Adenosine 3 mg/mL

Dosaggio:

6 mg/2mL

Forma farmaceutica:

Solution for injection

Composizione:

Active: Adenosine 3 mg/mL     Excipient: Sodium chloride Water for injection

Tipo di ricetta:

Prescription

Prodotto da:

Xinxiang Tuoxin Biochemical Technology & Science Co Ltd

Indicazioni terapeutiche:

Therapeutic Indications Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White syndrome). Diagnostic Indications Aid to diagnosis of broad or narrow QRS complex supraventricular tachycardias. Although Adenosine-Claris 6 mg/2 ml is not effective in converting 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.

Dettagli prodotto:

Package - Contents - Shelf Life: Vial, glass, sulfur-treated Ph Eur type I clear 2 mL with teflon-coated rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 30°C. Do not refrigerate - Vial, glass, sulfur-treated Ph Eur type I clear 2 mL with teflon-coated rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 30°C. Do not refrigerate - Vial, glass, sulfur-treated Ph Eur type I clear 2 mL with teflon-coated rubber stopper - 25 dose units - 24 months from date of manufacture stored at or below 30°C. Do not refrigerate

Data dell'autorizzazione:

2016-12-19

Scheda tecnica

                                NEW ZEALAND DATA SHEET
ADSINE Data Sheet 8 November 2022
Page 1 of 8
Baxter Healthcare Ltd
1 ADSINE (6mg/2mL, solution for injection)
ADSINE 6mg/2mL solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE INGREDIENT _
ADSINE solution for injection contains 6mg/2mL adenosine (equivalent
to 3mg/mL).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for
injection.
Clear, colourless to almost colourless solution essentially 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 bypass tracts (Wolff
‐
Parkinson
‐
White syndrome).
_DIAGNOSTIC INDICATIONS _
Aid to diagnosis of broad or narrow QRS complex supraventricular
tachycardias. Although ADSINE 6mg/2mL is
not effective in converting 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
Dose and method of administration
ADSINE 6mg/2mL should be used only in hospitals, with monitoring and
cardiorespiratory resuscitation
equipment available for immediate use if necessary. 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,
it should be administered either directly into a vein or into an IV
line. If administered via an IV line it should be
injected as proximally as possible, and followed by a rapid saline
flush.
ADSINE 6mg/2mL 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.
_THERAPEUTIC DOSE _
_Adults _
_Initial dose:_ 3mg given as a rapid intravenous bolus (over 2
seconds).
_Second dose:_ If the first dose does not result in the elimination of
supraventricular tac
                                
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