RAPIBLOC Powder for solution for infusion Ref.[9871] Active ingredients: Landiolol

Source: European Medicines Agency (EU) 

Product name and form

Rapibloc 300 mg powder for solution for infusion.
Rapibloc 600 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

White to almost white powder.

Qualitative and quantitative composition

A vial contains 300 mg or 600 mg landiolol hydrochloride which is equivalent to 280 mg or 560 mg landiolol.

After reconstitution (see section 6.6), each ml contains 6 mg or 12 mg landiolol hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Landiolol

Landiolol is a highly 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. Landiolol, as other beta-blockers, is thought to reduce the sympathetic drive, resulting in reduction in heart rate, decrease in spontaneous firing of ectopic pacemakers, slowing the conduction and increase the refractory period of the AV node.

List of Excipients

Mannitol E421
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Colourless glass (Type 1) 50 ml vial with a bromobutyl rubber stopper and an aluminium flip-off seal.

Pack size of 1 vial includes 300 mg (the colour code of the flip-off seal is yellow) or 600 mg (the colour code of the flip-off seal is red) powder for solution for infusion.

Not all pack sizes may be marketed.

Drugs

Drug Countries
RAPIBLOC Austria, Finland, France, Croatia, Netherlands, Romania

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.