iron III hydroxide polymaltozat | Ferrum Lek solution for in / mouse. 50 mg / ml 2 ml ampoules 5 pcs.

Latin name

Ferrum Lek

Release form

Solution for i / m administration.

Packing

2 ml ampoules, in a box of 5 ampoules.

Pharmacological action

Antianemic drug.

In the preparation, iron is in the form of a complex compound of iron (III) hydroxide polyisomaltosate. This macromolecular complex is stable and does not release iron in the form of free ions. The complex is similar in structure to the natural iron compound ferritin. Iron (III) hydroxide polyisomaltosate does not have the prooxidant properties that are inherent in iron (II) salts.

Iron, which is part of the drug, quickly compensates for the lack of this element in the body (including with iron deficiency anemia), restores hemoglobin (Hb) levels.

When using the drug, there is a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory symptoms of iron deficiency.

Indications

for the treatment of iron deficiency conditions requiring fast and reliable replacement of iron loss in the body (severe posthemorrhagic anemia)

impaired iron absorption impossibility of full absorption of iron from the gastrointestinal tract malabsorption syndrome, ulcerative colitis and some other gastrointestinal diseases

intolerance to oral iron preparations

ineffectiveness of treatment of iron deficiency anemia with oral iron preparations.

Contraindications

hypersensitivity to the components of the

drug excess iron in the body (hemochromatosis, hemosiderosis)

impaired iron utilization mechanisms (lead anemia, siderochrestic anemia, thalassemia)

iron anemia (e.g. megaloblastic, caused by a lack of cyanocobalamin).

I trimester of pregnancy

Osler-Rendu-Weber syndrome

acute infectious kidney disease

uncontrolled hyperparathyroidism

decompensated liver cirrhosis

infectious hepatitis.

Caution should be used in bronchial asthma, chronic polyarthritis, cardiovascular insufficiency, low ability to bind iron and / or folic acid deficiency, in children under 4 months of age.

Use in case of impaired liver function

The use of the drug in decompensated cirrhosis of the liver, infectious hepatitis is contraindicated.

Use in case of impaired renal function

The use of the drug is contraindicated in infectious diseases of the kidneys in the acute stage.

Use in children

Caution is advised to use the drug in pediatric patients up to 4 months of age.

Use during pregnancy and lactation

Parenteral administration of the drug is contraindicated in the first trimester of pregnancy. In the II and III trimesters of pregnancy and during breastfeeding, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or baby.

Composition

1 ml 1 amp.

iron (III) hydroxide polyisomaltose 50 mg100 mg

Excipients: sodium hydroxide, hydrochloric acid (concentrated), water d / and.

Dosage and administration

The drug in the form of a solution can be entered only in / m. In / in the introduction of the drug is not allowed!

Before administering the first therapeutic dose, each patient should be given a test dose of 1 / 4-1 / 2 ampoules (25-50 mg of iron) for an adult and 1/2 daily dose for children. In the absence of adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered.

Dosages of Ferrum Lek® are selected individually according to the total iron deficiency calculated according to the following formula:

Total iron deficiency (mg) = body weight (kg)? (calculated Hb level (g / l) - detected Hb (g / l))? 0.24 + deposited iron (mg).

With a body weight of up to 35 kg: calculated level of Hb = 130 g / l, deposited iron = 15 mg / kg of body weight.

With a body weight of more than 35 kg: calculated level of Hb = 150 g / l, deposited iron = 500 mg.

Factor 0.24 = 0.0034? 0. 07? 1000 (iron content in Hb = 0.34%, total blood volume = 7% of body weight, factor 1000 - transfer from g to mg).

Calculation of the total number of drug ampoules based on the detected hemoglobin level and body weight

Body weight (kg) Total number of ampoules at Hb level

60 g / l75 g / l90 g / l105 g / l

51.51.51.51

10332.52

1554.53.53

206.55.554

258765.5

309.58.57.56.5

3512.511.5109

4013.512119.5

45151311.510

5016141210.5

5517151311

60181613.511.5

651916.514.512

702017.51512.5

752118.51613

8022.519.516.513.5

8523.520.51714

9024.521.51814.5

If the total number of ampoules that must be entered exceeds the maximum allowable daily dose, then the total number of ampoules should be divided by the required number of days. If the hematological parameters do not improve 1-2 weeks after the start of treatment, the diagnosis should be clarified again.

Calculation of the total dosage to compensate for iron due to blood loss

With a known amount of blood i / m, the administration of 200 mg of iron (2 ampoules) leads to an increase in hemoglobin equivalent to 1 blood unit (400 ml with a hemoglobin content of 150 g / l).

Amount of iron to be reimbursed (mg) = number of blood units lost x 200 or required number of ampoules = number of blood units lost x 2

With the known final hemoglobin level, the above formula is used taking into account that the deposited iron does not need to be replenished.

Amount of iron, to be compensated (mg) = body weight (kg)? (calculated Hb level (g / l) - detected Hb level (g / l)) x 0.24

Usual doses of Ferrum Lek®

Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules) depending on the level of hemoglobin for children - 3 mg / kg / day (0.06 ml / kg body weight / day).

The maximum daily dose for adults is 200 mg (2 ampoules) for children - 7 mg / kg / day (0.14 ml / kg body weight / day).

Rules for the administration of the drug

The drug is administered deeply / m alternately in the right and left buttocks.

In order to reduce pain and avoid staining the skin, the following rules should be followed:

- the drug should be injected into the upper outer quadrant of the buttock, using a

5-6 cm long needle - before injection after skin disinfection, subcutaneous tissues should be moved down 2 cm to prevent subsequent

drug leakage - after administration of the drug, subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 min .

Before using the solution for v / m injection, ampoules should be carefully examined. Only ampoules containing a homogeneous solution without sediment should be used. Solution for intramuscular injection should be used immediately after opening the ampoule.

Side effects

From the digestive system: nausea, vomiting.

From the side of the central nervous system: headache, dizziness.

Local reactions: with the wrong technique of drug administration it is possible to stain the skin, the appearance of soreness and inflammatory reaction at the injection site.

Other: arterial hypotension, arthralgia, swollen lymph nodes, fever, malaise are extremely rare - allergic or anaphylactic reactions.

Drug Interaction

Ferrum Lec® for injection should not be used concomitantly with iron for oral administration.

Concomitant administration of Ferrum Lek® with ACE inhibitors may cause an increase in systemic effects of parenteral iron preparations.

overdose

Symptoms: An overdose of iron can lead to acute iron overload and hemosiderosis.

Treatment: symptomatic therapy. As an antidote, it is given slowly / slowly (15 mg / kg / h) of Deferoxamine depending on the severity of the overdose, but not more than 80 mg / kg / day. Hemodialysis is ineffective.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 РC. Do not freeze.

Expiration

5 years.

Deystvuyuschee substances

iron III hydroxide polymaltozat

Pharmacy

pharmacy prescription

dosage form

dosage form

injection

sandoz, switzerland