RAUTEVENE Solution for injection Ref.[51237] Active ingredients: Iron sucrose

Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Gen-Eye (Pty) Ltd<sup>1</sup>, Unit 7, Royal Palm Business Estate, 646 Washington Street, Halfway House, Midrand, 1685, Gauteng, South Africa 1 Company Registration number: 2009/009360/07

Product name and form

Rautevene solution for injection/concentrate for solution for infusion.

Pharmaceutical Form
Solution for injection/concentrate for solution for infusion. Dark brown colloidal solution in 5 ml clear glass ampoules.

Qualitative and quantitative composition

Each 5 ml ampoule contains 100 mg iron in the form of iron (III)-hydroxide sucrose complex, 20 mg iron per ml.

Excipient: Water for injection.

Osmolarity: Approximately 1250 mOsmol/l.

Contains no preservatives.

Contains sugar (approximately 30% sucrose).

Active Ingredient	Description
Iron sucrose	Iron sucrose is composed of a polynuclear iron(III)-hydroxide core surrounded by a large number of non-covalently bound sucrose molecules. The polynuclear iron core has a structure similar to that of the core of the physiological iron storage protein ferritin. The complex is designed to provide, in a controlled manner, utilisable iron for the iron transport and storage proteins in the body (i.e., transferrin and ferritin, respectively).

List of Excipients
Water for injection

Pack sizes and marketing

5 ml clear glass ampoules in packs of 5 ampoules.

Marketing authorization holder

Gen-Eye (Pty) Ltd¹, Unit 7, Royal Palm Business Estate, 646 Washington Street, Halfway House, Midrand, 1685, Gauteng, South Africa

¹ Company Registration number: 2009/009360/07

Marketing authorization dates and numbers

46/8.3/0849

Date of registration: 05 December 2013
Date of the most recently revised package insert as approved by SAHPRA: 09 February 2022

Drugs

Drug	Countries
RAUTEVENE	South Africa

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