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
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. |
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 |
5 ml clear glass ampoules in packs of 5 ampoules.
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
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
| Drug | Countries | |
|---|---|---|
| RAUTEVENE | South Africa |
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