Maltofer - instructions for use, dose, side effects, contraindications

After intramuscular injection, iron released from the active component - iron (III) hydroxide of polymaltose, is absorbed mainly by the liver.Then it is included in the composition of hemoglobin, myoglobin and iron-containing enzymes, and also stored in the body in the form of ferritin. Response from the blood indicators for parenteral administration of iron occurs no faster than with the intake of iron salts in patients in whom they are effective. Like other iron preparations, Maltofer^® does not affect erythropoiesis and is ineffective in anemia not associated with iron deficiency.

Pharmacokinetics:

After intramuscular injection, the complex enters the bloodstream through the lymphatic system. The maximum concentration of iron in the blood plasma is reached approximately 24 hours after the injection. From the blood plasma macromolecular complex enters the reticulo-endothelial system, where it is split into constituents, multinucleated iron hydroxide and polymaltose (metabolized by oxidation). The slow release of iron is the reason for its good tolerability. In the bloodstream, iron binds to transferrin, is stored in tissues in ferritin, in the bone marrow is included in hemoglobin and participates in the process of erythropoiesis. Excreted from the body are only small amounts of iron.

In small quantities, the unaltered complex can pass through the placental barrier, and small amounts of it enter the breast milk. Iron associated with transferrin can pass through the placental barrier, and in the lactoferrin enters the breast milk in small amounts.

There are no data on the pharmacokinetics of the drug in patients with iron deficiency anemia.

It is well known that the absorption of iron depends on the severity of iron deficiency anemia. It is intense in the case of low hemoglobin and decreases with the normalization of hemoglobin.

The degree of iron utilization can not be higher than the iron-binding capacity of transport proteins.

Influence of renal and hepatic insufficiency on the pharmacological properties of iron (III) of the polymaltozate hydroxide are not known. The toxicity of the drug is very low. LD₅₀, determined for white mice with intravenous administration of the preparation Maltofer^®, was> 2500 mg of iron per kilogram of body weight, which is 100 times lower than for simple iron salts.

Indications:

Iron deficiency anemia with ineffectiveness or inability to take iron preparations inside (including patients with diseases of the gastrointestinal tract (GI tract) and with malabsorption syndrome).

The drug is administered intramuscularly only when confirmed by an appropriate iron deficiency state (for example, by measuring serum ferritin, hemoglobin (Hb), hemocrit or the number of erythrocytes, as well as their parameters - the average volume of erythrocyte, average content Hb in erythrocyte or medium concentration Hb in the erythrocyte).

Contraindications:

Application of the preparation Maltofer^® contraindicated in the event that:

there is an increased sensitivity to the components of the drug;
anemia not related to iron deficiency (hemolytic anemia, megaloblastic anemia caused by vitamin B deficiency₁₂);
disorders of erythropoiesis, bone marrow hypoplasia;
there are signs of iron overload (hemosiderosis, hemochromatosis) or disruption of its utilization (sidero-sacrificial anemia, thalassemia, lead anemia, late porphyria of the skin),
Osler-Randu-Weber syndrome, chronic polyarthritis, bronchial asthma, infectious diseases of the kidneys in the acute stage; uncontrolled hyperparathyroidism, decompensated liver cirrhosis, infectious hepatitis;
I trimester of pregnancy;
use for intravenous use;
children's age up to 4 months (experience of using the drug is limited).

Carefully:Impaired renal and / or liver function.

Pregnancy and lactation:

Clinical data on the use of the drug in pregnant women, is currently insufficient. In animal studies, the reproductive toxicity of the drug has not been studied. In pregnancy, the drug should be used only if the intended benefit to the mother exceeds the potential risk to the fetus and / or the child.

In small quantities, unaltered iron from the polymaltose complex can penetrate into breast milk. If you need to use the drug during lactation, breastfeeding should be discontinued.

Contraindicated to apply the drug in I trimester of pregnancy.

Dosing and Administration:

Intramuscularly.

Before the first administration of the initial dose of the drug, Maltofer^®, it is necessary to carry out a test: the drug is injected intramuscularly - from ¼ to ½ of the drug dose (from 25 to 50 mg of iron (0.5-1 ml)) is administered to the adult, and from the last 4 months half the daily dose. In the absence of adverse reactions within 15 minutes after administration, the remainder of the initial dose of the drug can be administered.

Calculation of dose

The dose of the drug is calculated individually and adapted to the overall iron deficiency according to the following formula:

Total iron deficiency (mg) = body weight (kg) x (normal level Hb -level Hb patient) (g / l) x 0.24^* + iron stocks (mg).

At a body weight of the patient up to 34 kg: normal level Hb = 130 g / l, which corresponds to the iron reserves = 15 mg / kg body weight.

At a body weight of the patient over 34 kg: normal level Hb = 150 g / l, which corresponds to the iron reserves = 500 mg.

^* Factor 0.24 = 0.0034 x 0.07 x 1000 (iron content in hemoglobin = 0.34% / volume of blood @7% of body weight / factor 1000 = transfer from g to mg)

Total number of ampoules for administration = Total iron deficiency (mg) / 100 mg

Body mass kg	Hb 60 g / l		Hb 75 g / l		Hb 90 g / l		Hb 105 g / l
Body mass kg	ml	amp.	ml	amp.	ml	amp.	ml	amp.
5	3	1,5	3	1,5	3	1,5	2	1
10	6	3	6	3	5	2,5	4	2
15	10	5	9	4,5	7	3,5	6	3
20	13	6,5	11	5,5	10	5	8	4
25	16	8	14	7	12	6	11	5,5
30	19	9,5	17	8,5	15	7,5	13	6,5
35	25	12,5	23	11,5	20	10	18	9
40	27	13,5	24	12	22	11	19	9,5
45	30	15	26	13	23	11,5	20	10
50	32	16	28	14	24	12	21	10,5
55	34	17	30	15	26	13	22	11
60	36	18	32	16	27	13,5	23	11,5
65	38	19	33	16,5	29	14,5	24	12
70	40	20	35	17,5	30	15	25	12,5
75	42	21	37	18,5	32	16	26	13
80	45	22,5	39	19,5	33	16,5	27	13,5
85	47	23,5	41	20,5	34	17	28	14
90	49	24,5	43	21,5	36	18	29	14,5

if the required dose exceeds the maximum daily dose, the administration of the drug should be fractional.

standard dose

adults: 1 ampoule daily (2.0 ml = 100 mg iron)

children from 4 months: the dosage is determined depending on the body weight.

maximum permissible daily doses

children with a body weight of up to 5 kg: ¼ ampoule (0.5 ml = 25 mg iron)

children with a body weight of 5 to 10 kg: ½ ampoule (1.0 ml = 50 mg iron)

children with a body weight of 10 to 45 kg: 1 ampoule (2.0 ml = 100 mg of iron)

adults: 2 ampoules (4.0 ml = 200 mg of iron)

if the response from the hematological parameters is absent after 1-2 weeks (for example, an increase in the level hb approximately 0.1 g / dl per day), the initial diagnosis should be reviewed. The total dose of the drug for the course of treatment should not exceed the calculated number of ampoules.

injection technique (see pictures)

The technique of injection is crucial. as a result of improper administration of the drug, pain and staining of the skin at the injection site may occur. the technique of ventro-gluteal injection described below is recommended instead of the generally accepted one - in the upper outer quadrant of the gluteus maximus muscle.

1) the length of the needle should be at least 5-6 cm. The lumen of the needle should not be too wide. for children, as well as for adults with a small body weight, needles should be shorter and thinner.

2) the injection site is defined as follows (see Figure 1): fix the point a along the line of the spinal column at the level corresponding to the lumbar-iliac articulation. if the patient lies on the right side, place the middle finger of the left hand at point a. Leave your index finger from the middle so that it is under the iliac crest line at point c.The triangle located between the proximal phalanges, the middle and index fingers is the injection site (see Figure 2).

3) tools are disinfected by the usual method. before inserting the needle, slide the skin about 2 cm (see Figure 3) in order to close the puncture hole well after removing the needle. this prevents the penetration of the injected solution into the subcutaneous tissues and the dyeing of the skin.

4) position the needle vertically with respect to the skin surface, at a greater angle to the point of the iliac joint than to the point of the femoral joint (see Figure 4).

5) after the injection, slowly remove the needle and press the area of the skin adjacent to the injection site with your finger for approximately one minute.

6) After the injection, the patient needs to move.

opening of ampoules with a point and a notch

The diagrams below illustrate the method of opening ampoules with a dot and a notch.

Side effects:

In rare cases, arthralgia, lymphadenopathy, fever, headache, dyspepsia (nausea, vomiting) may occur.

Very rarely allergic or anaphylactic reactions can develop.

Local reactions (with the wrong technique of drug administration): dyeing of the skin, soreness at the injection site, inflammation.

Overdose:

To date, there have been no reports of an overdose of iron.

With the introduction of the drug Maltofer^® in high doses, the complex can not be removed by hemodialysis because of its high molecular weight. Periodic monitoring of serum ferritin can help in the timely recognition of progressive accumulation of iron.

Overdose can cause acute overload with iron, which manifests itself as symptoms of hemosiderosis. In case of overdose, it is recommended to use symptomatic agents and, if necessary, iron-binding substances (chelates), for example deferoxamine in / in.

Interaction:

Like all other parenteral iron preparations, Maltofer^® Do not use simultaneously with iron-containing medications for oral administration, since absorption of the latter from the gastrointestinal tract decreases. Therefore, treatment with iron-containing medications for oral administration should begin no earlier than 1 week after the last injection of the drug Maltofer^®.

Simultaneous administration of angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) can cause an increase in the systemic effects of parenteral iron preparations.

Special instructions:

Maltofer® should only be given to patients who are diagnosed with anemia with appropriate laboratory data (for example, serum ferritin or hemoglobin and hematocrit, the number of erythrocytes and their parameters-the mean erythrocyte volume, mean hemoglobin in erythrocyte, or the mean concentration of hemoglobin in the erythrocyte) .

Before use, the ampoule should be inspected for sediment and damage.

Use only ampoules without sediment and damage.

After opening the ampoule, the preparation Maltofer® should be administered immediately.

Maltofer® should not be mixed with other medications.

Parenteral iron preparations can cause allergic and anaphylactic reactions. In the case of moderate allergic reactions, antihistamines should be prescribed; with the development of severe anaphylactic reaction requires the immediate introduction of epinephrine (adrenaline).The means of cardiopulmonary resuscitation should be available.

Care should be taken when administering the drug to patients with allergies, as well as hepatic and renal insufficiency.

Side effects that occur in patients with cardiovascular diseases may aggravate the course of the underlying disease.

Patients with bronchial asthma or having a low iron-binding capacity of blood serum and / or deficiency of folic acid belong to a group at high risk of developing allergic or anaphylactic reactions.

Introduction to children under 4 months of age is not recommended due to lack of experience. In children, parenteral iron preparations can adversely affect the course of the infectious process.

Effect on the ability to drive transp. cf. and fur:

The effect on the ability to drive vehicles and mechanisms has not been studied.

Form release / dosage:

Solution for intramuscular injection 50 mg / ml.

Packaging:

2 ml of the preparation in colorless, transparent glass ampoules (type I according to the European Pharmacopoeia), having a notch and technical color marks in the form of a rim and points on the neck of the ampoule.

5 ampoules in a contour acrylic packaging made of polyvinyl chloride.

For 1 or 20 packs of cells, together with instructions for medical use in a cardboard box.

Storage conditions:

In the original packaging in a dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011981 / 02

Date of registration:21.07.2008 / 16.02.2018

Expiration Date:Unlimited