SYTRON Oral solution Ref.[27557] Active ingredients: Sodium feredetate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

Product name and form

Sytron 27.5 mg iron per 5 ml Oral Solution.

Pharmaceutical Form

Oral solution.

Clear, red syrup, free of particles.

Qualitative and quantitative composition

Each 5 ml of oral solution contains 207.5 mg of sodium feredetate trihydrate equivalent to 27.5 mg of iron.

Excipients with known effect:

Each 5 ml of Sytron solution contains: 5 mg of Methyl hydroxybenzoate (E218), 1 mg of Propyl Hydroxybenzoate (E216), 11.4 mg of sodium, 1400 mg of sorbitol, 0.015 ml of ethanol and 0.35 mg of Ponceau 4R (E124) - please refer to section 4.4 for further details.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sodium feredetate

Sodium feredetate is used for iron deficiency anaemia. After absorption, elemental iron is available for haemoglobin regeneration and reversal of anaemia associated with iron-deficient states.

List of Excipients

Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Citric acid monohydrate
Saccharin sodium
Glycerol
Sorbitol solution
Ethanol 96%
Black cherry flavour
Ponceau 4R (E124)
Potable water

Pack sizes and marketing

Sytron is supplied in round amber glass bottles with a CRC cap. Each bottle contains either 125ml or 500ml or 2250ml of Sytron.

Not all pack sizes may be marketed.

Marketing authorization holder

Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

Marketing authorization dates and numbers

PL 16508/0059

13 October 1993/18 February 2004

Drugs

Drug Countries
SYTRON Estonia, United Kingdom

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