DEXISUN Concentrated solution for infusion Ref.[50700] Active ingredients: Dexmedetomidine

Source: Health Products Regulatory Authority (ZA)  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext 1, Roodepoort, 1724, South Africa

Product name and form

DEXISUN Concentrated solution for intravenous infusion.

Pharmaceutical Form

A clear, colourless solution, free from visible extraneous matter.

Qualitative and quantitative composition

Each 1 ml of sterile solution contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.

Contains sodium chloride (9,0 mg/ml).

For full list of excipients, see section 6.1

Sugar free.

Active Ingredient Description
Dexmedetomidine

Dexmedetomidine is a selective alpha-2 receptor agonist with a broad range of pharmacological properties. It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings. The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus, situated in the brainstem.

List of Excipients

Sodium chloride
Water for injections

Pack sizes and marketing

DEXISUN is packed in a 2 ml tubular, USP type 1 flint glass vial, with a 13 mm Teflon coated grey rubber stopper and a 13 mm pink aluminium flip-off seal, in a outer carton. Each carton contains 1 or 5 vials.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext 1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

54/2.9/0218

21 June 2022

Drugs

Drug Countries
DEXISUN South Africa

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