FERMED 20 mg
.Name of the medicinal product
FERMED 20 mg iron / ml, solution for injection or concentrate for solution for infusion.
Qualitative and quantitative composition
One millilitre of solution contains 20 mg of iron as iron sucrose (iron(III)-hydroxide sucrose complex).
Each 5 ml ampoule of FERMED contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).
For a full list of excipients,
Pharmaceutical form
Solution for injection or concentrate for solution for infusion.
FERMED is a dark brown, non transparent, aqueous solution ,free from sediments
Clinical particulars
Therapeutic indications
FERMED is indicated for the treatment of iron deficiency in the following indications:
• where there is a clinical need to deliver iron rapidly to iron stores,
• in patients who cannot tolerate oral iron therapy or who are non-compliant,
• in active inflammatory bowel disease where oral iron preparations are ineffective.
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, serum iron, etc.).
Contraindications
The use of FERMED is contraindicated in cases of:
• known hypersensitivity to FERMED or any of its excipients
• anaemias not attributable to iron deficiency
• iron overload or disturbances in utilisation of iron
• patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions
• pregnancy first trimester.
Pregnancy and lactation
Data on a limited number of exposed pregnancies indicated no adverse effects of FERMED on pregnancy or on the health of the foetus/newborn child. No well-controlled studies in pregnant women are available to date. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Nevertheless, risk/benefit evaluation is required.
FERMED should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put the mother or foetus at risk.
Pregnancy first trimester: see contraindications.
Non metabolised FERMED is unlikely to pass into the mother’s milk. No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.
Effects on ability to drive and use machines
In the case of symptoms of dizziness, confusion or light headedness following the administration of FERMED, patients should not drive or use machinery until the symptoms have ceased.
Overdose
Overdosage can cause acute iron overloading which may manifest itself as haemosiderosis. Overdosage should be treated, if required, with an iron chelating agent.
Pharmaceutical particulars
List of excipients
Water for injections
Sodium hydroxide
Incompatibilities
FERMED must only be mixed with sterile 0.9% m/V sodium chloride solution. No other solutions and therapeutic agents should be used as there is the potential for precipitation and/or interaction. The compatibility with containers other than glass, polyethylene and PVC is not known.
Shelf life
Shelf life of the product as packaged for sale:
2 years.
Shelf life after first opening of the container:
From a microbiological point of view, the product should be used immediately.
Shelf life after dilution with sterile 0.9% m/V sodium chloride solution:
From a microbiological point of view, the product should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.
Special precautions for storage
Store in original carton. Do not store above 30°C. Do not freeze.
Nature and contents of container
5 ml solution in one ampoule (type I glass) in pack sizes of 5 AMPOULES.
Marketing authorisation holder
Manufactured by Sunny pharmaceutical
Badr city –cairo/ Egypt
Under License of Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn / Germany
SUMMARY OF PRODUCT CHARACTERISTICS for FERCAYL
Sunnypyramid Injection Qualitative and quantitative composition
SUNNYFUNGAL NAME OF THE MEDICINAL PRODUCT
Peptrelif Injection 50 mg/2ml NAME OF
FERMED 20 mg .Name of the
Etasylsunny 250/2ml solution for IV injection
