FERRUM CHAT (The solution for the / m)

Active material: gland [III] hydroxide poliizomaltozat
When ATH: B03AC04
CCF: Antianemic drug
ICD-10 codes (testimony): D50, E61.1
When CSF: 19.02.01.02
Manufacturer: LEK d.d. (Slovenia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

The solution for the / m Brown color, opaque, practically free of visible particles.

Excipients: Sodium hydroxide, hydrochloric acid (Concentrated), water d / and.

2 ml – ampoule (5) – blisters (1) – packs cardboard.
2 ml – ampoule (10) – blisters (5) – packs cardboard.

Pharmacological action

Antianemic drug.

The preparation of the iron is in the form of complex compounds of iron (III) hydroxide with poliizomaltozoy. This macromolecular complex is stable and does not emit in the form of free iron ion. The complex is similar in structure to naturally iron compound – ferritin. Gland (III) poliizomaltozny hydroxide complex does not have pro-oxidant properties, inherent iron salts (II).

Iron, part of the drug quickly compensates for the deficiency of this element in the body (incl. when iron deficiency anemia), restores the level of hemoglobin (Hb).

In applying the drug is a gradual regression of clinical (weakness, fatiguability, dizziness, tachycardia, soreness and dryness of the skin) and laboratory symptoms of iron deficiency.

Pharmacokinetics

Absorption

After the / m of iron preparations quickly enters the bloodstream: 15% dose – through 15 m, 44% dose – through 30 m.

Iron in complex with transferrin transferred to the cells of the organism, which is used for the synthesis of hemoglobin, myoglobin and some enzymes.

Deduction

T_1/2 – 3-4 d. The iron complex (III) poliizomaltozoy hydroxide with sufficiently large and therefore is not output from the kidney, and the compound is stable in physiological conditions does not emit iron ions.

Testimony

The treatment of iron deficiency states, requiring its rapid replenishment:

- Severe iron deficiency due to blood loss;

- Violation of iron absorption in the intestine;

- State, in which treatment with oral iron is ineffective or impractical.

Dosage regimen

A preparation in the form of a solution can only enter / m. Not permitted in / in a preparation!

Before administration of the first therapeutic dose for each patient should introduce a test dose, component 1/4-1/2 ampoule (25-50 Iron mg) to Adult and 1/2 daily dose children. In the absence of side reactions during 15 minutes after administration, the residue was administered starting daily dose.

Doses of the drug Ferrum Lek^® selected individually according to the general iron deficiency, calculated by the following formula:

Total iron deficiency (mg) = Body weight (kg) x (the calculated level of Hb (g / l) – Hb found (g / l)) x 0.24 + deposited iron (mg).

At weighing up 35 kg: the calculated level of Hb = 130 g / l, deposited iron = 15 mg / kg body weight.

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

Factor 0.24 = 0.0034 x 0.07 x 1000 (the iron content of Hb = 0.34%, total blood volume = 7% body weight, factor 1000 – translation of Mr. mg).

Calculation of the total amount of drug vials based on the detected level of hemoglobin and body weight

If the total number of vials, to be introduced, exceeds the maximum daily dose, the total number of vials to be divided into the required number of nights. If after 1-2 weeks after initiation of treatment did not improve hematologic parameters, should again clarify the diagnosis.

Calculate the total dose to compensate the iron due to blood loss

When a certain amount of blood lost / m introduction 200 Iron mg (2 ampoule) It leads to an increase in hemoglobin, эkvyvalentnomu 1 blood unit (400 ml containing hemoglobin 150 g / l).

The amount of iron, you want to compensate (mg) = Number of blood units lost x 200 or the required number of vials = number of blood units lost x 2

When hemoglobin is used prior the above formula given, that the deposited iron is not required to fill.

The amount of iron, you want to compensate (mg) = Body weight (kg) x (the calculated level of Hb (g / l) – the detected level of Hb (g / l)) x 0.24

Usual dose Ferrum Lek^®

Adults and elderly patients appointed 100-200 mg (1-2 ampoule) depending on the level of hemoglobin; children – 3 mg / kg / day (0.06 ml / kg body weight / day).

The maximum daily dose Adult – 200 mg (2 ampoule); to children – 7 mg / kg / day (0.14 ml / kg body weight / day).

Rules of administration

The drug is injected deep into the / m alternately in the right and left buttock.

For, to reduce the sense of combat and prevent staining of the skin, should observe the following rules:

- The drug should be injected into the upper outer quadrant of the buttocks, using a needle length 5-6 cm;

- Before injection after skin disinfection should be shifted subcutaneous tissue down 2 cm to prevent subsequent leakage of the drug;

- After injection subcutaneous tissue should be released, and the injection press and hold this position for 1 m.

Before applying the solution for i / m injection ampoules should carefully examine the. Only use ampoule, containing homogeneous solution, no precipitate. Solution for i / m injection should be used immediately after opening the ampoule.

Side effect

From the digestive system: nausea, vomiting.

CNS: headache, dizziness.

Local reactions: by improper injection technique may – coloration of the skin, appearance of pain and inflammation at the injection site.

Other: hypotension, arthralgia, swollen lymph nodes, temperature rise, malaise; rarely – allergic or anaphylactic reactions.

Contraindications

- An excessive content of iron in the body (hemosiderosis, gemoxromatoz);

- Violation of the mechanisms of inclusion of iron in hemoglobin (anemia, caused by lead poisoning, sideroahresticheskaya anemia, Thalassemia);

- Anemia, not associated with iron deficiency;

- Rendu-Osler-Weber;

- Infectious kidney disease in the acute stage;

- Uncontrolled hyperparathyroidism;

- Decompensated cirrhosis;

- Infectious hepatitis;

- I trimester of pregnancy;

- Hypersensitivity to the drug.

FROM caution use in patients with asthma, chronic polyarthritis, cardiovascular disease, low ability to bind iron and / or folic acid deficiency, in pediatric patients under 4 months.

Pregnancy and lactation

Parenteral administration of the drug is contraindicated in the I trimester of pregnancy. In II and III trimesters of pregnancy and lactation the drug is prescribed only in case, if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Cautions

The drug should be used only in a hospital.

In the appointment of Ferrum Lek^® be sure to laboratory analysis: overall clinical analysis of blood and determination of serum ferritin levels; necessary to eliminate the violation of iron absorption.

Treatment with oral forms of iron supplements should be started no earlier than, than later 5 days after the last injection, Ferrum Lek^®.

The contents of ampoules should not be mixed with other drugs.

Overdose

Symptoms: overdose of iron supplements can lead to severe iron overload and hemosiderosis.

Treatment: simptomaticheskaya therapy. As an antidote is administered in / slow (15 mg / kg / hr) deferoxamine, depending on the severity of the overdose, but not more 80 mg / kg / day. Hemodialysis nyeeffyektivyen.

Drug Interactions

Ferrum Lek^® for i / m injection should not be used simultaneously with iron preparations for oral administration.

Simultaneous use of the drug Ferrum Lek^® with ACE inhibitors may cause a strengthening of the systemic effects of parenteral iron preparations.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C; Do not freeze. Shelf life – 5 years. Do not use after the expiry date, on the package.