Products

PrSIBBORAN®

landiolol hydrochloride for injection

Powder for solution, 300 mg/vial Intravenous Beta-adrenergic receptor blocking agent

The information on this page is intended for Canadian healthcare professionals.

Indication

SIBBORAN (landiolol hydrochloride) is indicated for the short-term reduction of ventricular rate in patients with supraventricular tachycardia including atrial fibrillation and atrial flutter in perioperative, postoperative, or other acute circumstances where short-term control of the ventricular rate with a short acting agent is desirable.

SIBBORAN is not intended for use in chronic settings.

Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use.

About SIBBORAN

Landiolol is a selective beta-1-adrenoreceptor antagonist that inhibits the positive chronotropic effects of the catecholamines adrenaline and noradrenaline on the heart, where beta-1-receptors are predominantly located.

SIBBORAN is supplied as a powder for solution. Each vial contains 300 mg landiolol hydrochloride, which is equivalent to 280 mg landiolol. SIBBORAN is intended for intravenous use in a monitored setting and should be administered by a qualified health care professional.

Serious warnings and precautions

During the administration of SIBBORAN (landiolol hydrochloride), patients should be carefully monitored, with particular attention to heart rate and blood pressure.

Prescribing information

For complete prescribing information, including contraindications, warnings and precautions, please consult the Product Monograph, available from Health Canada’s Drug Product Database.

Product Monograph (PDF) ↗

Date of initial authorization: November 20, 2023 · Manufacturer: AOP Orphan Pharmaceuticals GmbH, Vienna, Austria

Medical information
medical [at] enoumenatx.com
Adverse events & product quality complaints
pv [at] enoumenatx.com

You may also report a suspected side effect to the Canada Vigilance Program (Health Canada).

Partnership

Commercialized in Canada by Enoumena Therapeutics, in partnership with AOP Health.

AOP Health

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