Fersinol
(Ferrous sulfate / Folic acid / Vit. B12 / Vit. C)




COMPOSITION

Each ampoule (2 ml) contains ferric (III) hydroxide polymaltose complex 100 mg.

THERAPEUTIC INDICATIONS

- Severe posthemorrhagic anemia;
- Iron deficiency anemia of different genesis in adults and children in cases where the treatment with oral iron-containing preparations is ineffective or impossible (including the treatment of patients with gastrointestinal diseases and malabsorption syndrome).
Fersinol is administered only in iron-deficient states which are confirmed by appropriate laboratory tests.

CONTRAINDICATIONS

- Hypersensitivity;
- Kinds of anemia which are not associated with iron deficiency (hemolytic, megaloblastic, associated with vitamin B12 deficiency);
- Erythropoietic disturbances, bone marrow hypoplasia;
- Iron loading (hemochromatosis, hemosiderosis);
- Iron utilization disturbances (sideroachrestic anemia, thalassemia, lead anemia, porphyria cutanea tarda hereditaria);
- Osler-Rendu-Weber disease;
- Chronic polyarthritis;
- Bronchial asthma;
- Infectious renal diseases in acute stage;
- Uncontrollable hyperparathyroidism;
- Decompensated hepatic cirrhosis;
- Infancy (children under 4 months);
- Pregnancy (the first trimester);
- Infectious hepatitis (because of drug accumulation in reticuloendothelial system).

ADVERSE EFFECTS

Rare – arthralgia, lymphoid nodular hyperplasia, fever, headache, malaise, dyspepsia (nausea, vomiting), metallic taste in the mouth; very rare – allergic reactions.
Local reactions (resulting from an incorrect injection technique): skin coloration, painfulness, inflammation.

DOSAGE AND ADMINISTRATION

The preparation is administered by deep intramuscular injection.

The daily dose for adults is 1 ampoule (100 mg).
For children lower doses are recommended depending on the age and weight.
The period of parenteral iron therapy is determined by the physician by observing the hemoglobin levels.

Maximum daily dose:

For children up to 5 kg 0.5 ml (1/4 ampoule, 25 mg elementary iron)
For children between 5-10 kg 1.0 ml (1/2 ampoule, 50 mg elementary iron)
Adults 4.0 ml (2 ampoules, 200 mg elementary iron)

During pregnancy: 27 mg/daily. During lactation – under 18 years – 10 mg/day; 18 years and older – 9 mg/day.

DRUG INTERACTIONS

ICE inhibitors enhance systemic effects. Concomitant treatment with iron-containing preparations is not recommended (iron absorption from gastrointestinal tract is decreased), thus, the treatment with oral iron-containing preparations should not be started earlier than 1 week after the last injection.

PREGNANCY AND LACTATION

Drug application is contraindicated in the first trimester of pregnancy and possible in the second and the third trimesters. Small quantity of unchanged iron from polymaltose complex is excreted with breast milk, however, the development of adverse effects in nursing infants is hardly possible.

MANUFACTURED FORM

Solution for injections. 5 amber glass ampoules in a plastic strip. Each ampoule contains 2 ml of solution. 1 plastic strip in a carton box with enclosed leaflet.

Blood & Blood Forming Organs

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Fersinol
Fersinol-Z

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