SUMMARY OF PRODUCT CHARACTERISTICS
for
FERCAYL 100mg/2ml
solution for infusion and injection
NAME OF THE MEDICINAL PRODUCT
FERCAYL 100mg/2ml solution for infusion and injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml ampoule containing 100 mg iron(III) as Iron(III)-hydroxide dextran complex
Each ml contains 50 mg Iron (III).
,
PHARMACEUTICAL FORM
Solution for infusion and injection
A dark brown solution.
CLINICAL PARTICULARS
Therapeutic indications
– For adults only
Fercayl® is indicated for the treatment of iron deficiency in the following indications:
– When oral iron preparations cannot be used, e.g. due to intolerance, or in case of demonstrated lack
of effect of oral iron therapy
– Where there is a clinical need to deliver iron rapidly to iron stores.
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Serum ferritin, serum iron, transferrin saturation and hypochromic red cells).
Contraindications
– Non-iron deficiency anaemia (e.g. haemolytic anaemia).
– Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis).
– Patients with a history of asthma, allergic eczema or other atopic allergy should not be treated by intravenous injection.
– Drug hypersensitivity including iron mono- or disaccharide complexes and dextran.
– Decompensated liver cirrhosis and hepatitis.
– Acute or chronic infection, because parenteral iron administration may exacerbate bacterial or viral
infections.
– Rheumatoid arthritis with symptoms or signs of active inflammation.
– Acute renal failure.
Pregnancy and lactation
There are no adequate data from the use of Fercayl® in pregnant women. Studies in animals have shown reproductive toxicity
Fercayl® should not be used during the first trimester of
pregnancy. If the benefit of Fercayl®-treatment is judged to outweigh the potential risk to the foetus, it is recommended that treatment, should be confined to the second and third trimester, if treatment is clearly necessary.
It is unknown whether the complex iron-dextran is excreted in human or animal breast milk. It is preferable to not use Fercayl® during breast-feeding.
Pharmacodynamic properties
Fercayl® solution for infusion and injection contains iron as a stable iron(III)-hydroxide dextran complex, which is analogous to the physiological form of iron, ferritin (ferric hydroxide phosphate protein complex).The iron is available in a non-ionic water-soluble form. It has a very low toxicity and can be given in large doses.
Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Fercayl® and slowly returns to baseline after about 3 weeks.
Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelia cells.
List of excipients
Sodium chloride
Water for injection
Licensor :
Laboratoires STEROP, avenue de Scheut 46-50, 1070 Brussels, Belgium.
Manufacturer:
Sunny pharmaceutical
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
