Universal reference book for medicines
Product name: FERRUM LEK ® (FERRUM LEK)

Active substance: nonappropriate

Type: Anti-anemic drug

Manufacturer: LEK dd (Slovenia)
Composition, form of production and packaging
The solution for the / m introduction is
brown, opaque, with practically no visible particles.

1 ml of 1 amp.

iron (III) hydroxide polyisomaltozate 50 mg 100 mg

Auxiliary substances: sodium hydroxide, hydrochloric acid (concentrated), water d / u.

2 ml - ampoules (5) - blisters (1) - packs of cardboard.

2 ml - ampoules (10) - blisters (5) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Anti-anemic drug.

In the preparation, iron is in the form of a complex iron (III) compound, polyisomaltosate hydroxide.
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 polyisomaltozate does not possess pro-oxidant properties, which are inherent in iron (II) salts.
Iron, which is part of the drug quickly replenishes the lack of this element in the body (including with iron deficiency anemia), restores the level of hemoglobin (Hb).

With the use of the drug, a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory symptoms of iron deficiency occur.

PHARMACOKINETICS

Suction

After the / m introduction of the drug, iron quickly enters the bloodstream: 15% of the dose - after 15 minutes, 44% of the dose - after 30 minutes.

Iron in a complex with transferrin is transferred to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes.

Excretion

T 1/2 - 3-4 days.
Complex iron (III) hydroxide polyisomaltozate is sufficiently large and therefore not excreted through the kidneys, the compound is stable and under physiological conditions does not release iron ions.
INDICATIONS

Treatment of all conditions of iron deficiency, requiring its rapid replenishment:

- severe iron deficiency due to blood loss;

- violation of iron absorption in the intestine;

- the conditions under which treatment with iron for oral administration is ineffective or unworkable.

DOSING MODE

The drug in the form of a solution can be administered only in / m.
Not allowed in / in the introduction of the drug!
Before the introduction of the first therapeutic dose, each patient should be given a test dose of 1 / 4-1 / 2 ampoules (25-50 mg iron) for an adult and 1/2 day dose forchildren .
In the absence of adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered.
The doses of the preparation 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 (g / l) - detected Hb (g / l))? 0.24 + deposited iron (mg).
With a body weight of up to 35 kg: a calculated level of Hb = 130 g / l, deposited iron = 15 mg / kg of body weight.

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

The factor is 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 ampoules of the drug based on the detected level of hemoglobin and body weight

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

60 g / l 75 g / l 90 g / l 105 g / l

5 1.5 1.5 1.5 1

10 3 3 2.5 2

15 5 4.5 3.5 3

20 6.5 5.5 5 4

25 8 7 6 5.5

30 9.5 8.5 7.5 6.5

35 12.5 11.5 10 9

40 13.5 12 11 9.5

45 15 13 11.5 10

50 16 14 12 10.5

55 17 15 13 11

60 18 16 13.5 11.5

65 19 16.5 14.5 12

70 20 17.5 15 12.5

75 21 18.5 16 13

80 22.5 19.5 16.5 13.5

85 23.5 20.5 17 14

90 24.5 21.5 18 14.5

If the total number of ampoules you need to enter exceeds the maximum allowable daily dose, then the total number of ampoules should be divided by the required number of days.
If hematological parameters do not improve after 1-2 weeks after the start of treatment, the diagnosis should be clarified once again.
Calculation of the total dosage for iron compensation due to blood loss

With a known amount of lost blood, the introduction 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).

The amount of iron that must be refunded (mg) = number of lost blood units x 200 or the required number of ampoules = number of lost blood units x 2

At a known final level of hemoglobin, the above formula is used, given that the deposited iron is not required to be replenished.

The amount of iron that needs to be reimbursed (mg) = body weight (kg)?
(calculated level of Hb (g / l) - detected level of Hb (g / l)) x 0.24
The usual doses of Ferrum Lek ®

Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules), depending on the level of hemoglobin;
Children - 3 mg / kg / day (0.06 ml / kg body weight / day).
The maximum daily intake for adults is 200 mg (2 ampoules);
for children - 7 mg / kg / day (0.14 ml / kg of body weight / day).
Rules of drug administration

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

In order to reduce pain and avoid dyeing of the skin, the following rules should be observed:

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

- before injection after skin disinfection, move the subcutaneous tissue downwards by 2 cm to prevent subsequent outflow of the drug;

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

Before applying the solution for the / m injections of the ampoule should be carefully examined.
Use only ampoules containing a homogeneous solution without sediment. A solution for intravenous injections should be used immediately after opening the ampoule.
SIDE EFFECT

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 - dyeing of the skin, the appearance of pain and inflammation at the injection site.

Other: arterial hypotension, arthralgia, enlarged lymph nodes, fever, malaise;
extremely rarely - allergic or anaphylactic reactions.
CONTRAINDICATIONS

- excess iron in the body (hemosiderosis, hemochromatosis);

- violations of the mechanisms of iron incorporation into hemoglobin (anemia caused by lead poisoning, sideroachrestic anemia, thalassemia);

- Anemia, not associated with iron deficiency;

- Osler-Randu-Weber Syndrome;

- infectious diseases of the kidneys in the acute stage;

uncontrolled hyperparathyroidism;

Decompensated cirrhosis of the liver;

- infectious hepatitis;

- I trimester of pregnancy;

- Hypersensitivity to the components of the drug.

With caution should be used in patients with bronchial asthma, chronic polyarthritis, cardiovascular insufficiency, low ability to bind iron and / or deficiency of folic acid, in children of up to 4 months.

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 exceeds the potential risk to the fetus or baby.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated use of the drug in infectious diseases of the kidneys in the acute stage.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated use of the drug in decompensated liver cirrhosis, infectious hepatitis.

APPLICATION FOR CHILDREN

With caution should be used in children in children up to 4 months.

SPECIAL INSTRUCTIONS

The drug should be used only in a hospital.

When appointing Ferrum Lek ®, it is mandatory to conduct laboratory tests: a general clinical blood test and determination of serum ferritin level;
it is necessary to exclude the violation of iron absorption.
Treatment with oral forms of iron-containing preparations should be started no earlier than 5 days after the last injection of Ferrum Lek ® .

The contents of the ampoules should not be confused with other drugs.

OVERDOSE

Symptoms: an overdose of iron preparations can lead to an acute overload with iron and hemosiderosis.

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

Ferrum Lek ® for I / m injections should not be used concomitantly with iron preparations for oral administration.

Simultaneous application of the preparation of Ferrum Lek ® with ACE inhibitors can cause an increase in the systemic effects of parenteral iron preparations.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C;
Do not freeze. Shelf life - 5 years. Do not use after the expiration date.
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