MALTAZAM

Each ampoule contains:

active substance: iron (III) hydroxide sucrose complex (expressed as iron (III)) – 100 mg.

excipients: sodium hydroxide, water for injections

Treatment of iron deficiency conditions in the following cases:

— need for rapid iron replenishment;

— in patients who do not tolerate oral iron preparations or do not comply with the treatment regimen;

— in active inflammatory bowel disease when oral preparations are ineffective;

— in chronic kidney disease when oral preparations are less effective.

Diagnosis of deficiency: Hb, serum ferritin, TSAT, serum iron, etc.

(Hemoglobin Hb, transferrin saturation TSAT).

IV. Maltazam is administered only intravenously – by slow injection or drip, and also into the venous limb of the dialysis system – and is not intended for intramuscular use. The full therapeutic dose must not be administered at once. A test dose must be given before the first therapeutic dose. If intolerance occurs during the observation period, administration must be stopped immediately. Before opening, the ampoule should be inspected for possible sediment and damage. Only a brown solution without sediment may be used.

Drip infusion: Maltazam is preferably administered as a drip infusion in order to reduce the risk of a marked drop in blood pressure and the risk of the solution entering the perivenous space. Immediately before infusion, Maltazam must be diluted with 0.9% sodium chloride solution in a ratio of 1:20, e.g. 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution. The resulting solution is administered at the following rate: 100 mg of iron – over at least 15 min; 200 mg of iron – over 30 min; 300 mg of iron – over 1.5 h; 400 mg of iron – over 2.5 h; 500 mg of iron – over 3.5 h. The maximum tolerated single dose of 7 mg of iron/kg should be administered over at least 3.5 h, regardless of the total dose.

Slow injection: Maltazam can also be administered as an undiluted solution intravenously, slowly, at a rate (norm) of 1 ml of Maltazam (20 mg of iron) per minute, i.e. 5 ml of Maltazam (100 mg of iron) is administered over at least 5 min. The maximum volume must not exceed 10 ml of Maltazam (200 mg of iron) per injection.

Administration into the dialysis system: Maltazam can be administered directly into the venous limb of the dialysis system, strictly following the rules described for intravenous injection.

Standard dosage:

Adults and elderly patients: 5 ml of Maltazam (100 mg of iron) 1-3 times a week, depending on the hemoglobin level.

Children: there are only limited data on the use of the medicine in children under 3 years. The recommended dose for children of other age groups is no more than 0.15 ml (3 mg of iron) per kg of body weight 1-3 times a week, depending on the hemoglobin level.

Maximum tolerated single dose:

Adults and elderly patients:

For slow injection: 5 ml of Maltazam (100 mg of iron), administered over at least 5 min.

For drip infusion: depending on the indications, a single dose may reach 500 mg of iron. The maximum permissible single dose is 7 mg/kg, administered once a week, but it must not exceed 500 mg of iron. For administration time and dilution method, see above.