Instruction

Trade name: FERINJECT ^® / FERINJECT ^®

Grouping (chemical) name: ferric carboxymaltose

Dosage form: solution for intravenous administration 50 mg/ml

Indications for use: Treatment of iron deficiency (including iron deficiency anemia) when oral iron preparations are ineffective or cannot be prescribed. The diagnosis must be confirmed by laboratory tests; treatment of iron deficiency when rapid replenishment of iron levels is needed.

Contraindications: The use of Ferinject ^® is contraindicated in the following cases: hypersensitivity to iron carboxymaltose complex, iron carboxymaltose solution or to any of the components of the drug; anemia not associated with iron deficiency, such as other microcytic anemia; signs of iron overload or impaired iron utilization; pregnancy (I trimester); children's age up to 14 years.

With caution: Ferinject ^® should be used with caution in patients with hepatic and renal insufficiency, acute or chronic infection, asthma, eczema or atopic allergies. It is recommended to control the use of the drug Ferinject ^® in pregnant women (II-III trimester).

Side effects: adverse reactions reported during clinical trials, as well as in the post-marketing period, which are common (≥ 1/100 and < 1/10): hypophosphatemia (based on laboratory tests), headache, dizziness , "rush" of blood to the face, arterial hypertension, nausea, reactions in the injection / infusion area.

Pregnancy, lactation:There are limited clinical data from controlled studies on the use of Ferinject in pregnant women (see “Clinical efficacy”). A careful benefit / risk benefit assessment is necessary before administration during pregnancy since hypersensitivity reactions may result in a particular risk to the mother and child (see “Warnings and precautions”). Ferinject is contraindicated during the first trimester of pregnancy (see “Contradictions”), and should only be used during the 2nd and 3rd trimester if the indication is compelling; in this context, body weight before the onset of pregnancy should be used to calculate the required quantity of iron, to avoid a potential overdose. Particularly careful monitoring for the signs of hypersensitivity reactions should be undertaken when administering during pregnancy.

*Full information is contained in the instructions for use.