Universal reference book for medicines
Name of the preparation: MALTOFER® (MALTOFER)
ATC codes: B03AC04

Type: Antianemic drug for parenteral use

Registration number: П N011981 / 02-2001

Solution for injection is brown.

1 ml of 1 amp.
Excipients: sodium hydroxide, purified water.
2 ml - ampoules of colorless glass (5) - packs of cardboard.



Description of the preparation is based on an approved instruction for use and approved by the manufacturer for the 2013 edition.


PHARMACHOLOGIC EFFECT



The preparation of iron.
After the / m introduction of iron (III) hydroxide polymaltozate enters the bloodstream through the lymphatic system. From the plasma macromolecular complex enters the reticulo-endothelial system, where it is split into ferric hydroxide and polymaltose. The slow release of iron is the reason for its good tolerability. In the liver is included in the composition of hemoglobin, myoglobin and iron-containing enzymes, and is also deposited in the body in the form of ferritin. In the blood, iron binds to transferrin, in the bone marrow is included in the hemoglobin and used in the process of erythropoiesis.
It is well known that the inclusion of iron in protoporphyrin depends on the severity of iron deficiency anemia.
It is intense in the case of a low level of hemoglobin and decreases as the hemoglobin level normalizes.
The response from the blood indicators for parenteral administration of iron occurs no faster than with the oral administration of iron salts in patients in whom they are effective.

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

The effect of renal and hepatic insufficiency on the pharmacological properties of iron (III) polymethyltosate hydroxide is not known.

Like other iron preparations, Maltofer ® has no effect on erythropoiesis and is ineffective in anemia not associated with iron deficiency.

The toxicity of the drug is very low.
With IV injection of the preparation Maltofer ® LD 50 in white mice was> 2500 mg of iron per kg of body weight, which is 100 times lower than for simple iron salts.
PHARMACOKINETICS



Suction and distribution

After an IM injection, C max iron is reached after about 24 hours.

In the blood, iron binds to transferrin, in tissues is deposited in the ferritin, in the bone marrow is included in the hemoglobin.

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

From the plasma macromolecular complex enters the reticulo-endothelial system, where it is split into components, iron hydroxide and polymaltose.

Excreted from the body are only small amounts of iron.

Polymaltose is metabolized by oxidation or excreted.

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

INDICATIONS



Treatment of iron deficiency in case of insufficient efficiency, inefficiency or impossibility of oral intake of iron-containing preparations, including:

- with malabsorption;

- in patients who do not agree to use oral iron preparations for a long time and regularly;

- in patients with gastrointestinal diseases (for example, ulcerative colitis), in which iron preparations for oral administration can provoke an exacerbation of the disease.

Maltofer ® for injection is used only if the iron deficiency state is confirmed by appropriate studies (for example, serum ferritin, hemoglobin, hematocrit or erythrocyte count, as well as their mean erythrocyte volume, mean hemoglobin content in erythrocyte).

DOSING MODE



The drug is given in / m.

Before the first administration of a therapeutic dose, an IM test should be performed: adults are injected from 1/4 to 1/2 of the drug dose (25 to 50 mg of iron), and children receive 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.
During the injection, it is necessary to ensure the availability of funds for the provision of emergency care in the development of anaphylactic shock.

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)?
(normal level of Hb is the patient's Hb level) (g / l)? 0.24 * + iron stocks (mg)
With a body weight of less than 35 kg: normal Hb = 130 g / l, which corresponds to the deposited iron = 15 mg / kg body weight

At a body weight of more than 35 kg: a normal level of Hb = 150 g / l, which corresponds to the deposited iron = 500 mg

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

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

Body weight (kg) Total number of ampoules for administration

Hb 60 g / l Hb 75 g / l Hb 90 g / l Hb 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 required dose exceeds the maximum daily dose, then the administration of the drug should be fractional.

Adults appoint 1 ampoule daily (2.0 ml = 100 mg of iron).

For children, the dose is determined depending on the body weight.

Maximum permissible daily doses:

Children with a body weight of up to 6 kg 1/4 ampoule (0.5 ml = 25 mg iron)

Children with a body weight of 5 to 10 kg 1/2 ampoule (1.0 ml = 50 mg iron)

Adult 2 ampoules (4.0 ml = 200 mg of iron)

If the therapeutic response from the hematological parameters is absent after 1-2 weeks (for example, an increase in the Hb level by about 0.1 g / dl per day), then 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.
The technique of injection

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 described below for ventro-gluteal injection is recommended instead of the generally accepted (in the upper outer quadrant of the gluteus maximus muscle).
The length of the needle should be at least 5-6 cm. The needle clearance should not be wide.
For children, as well as for adults with a small body weight, the needles should be shorter and thinner.
Tools are disinfected using the usual method.


According to the recommendations of Hochstetter, the injection site is determined as follows (Figure 1): on the line of the spinal column at the level corresponding to the lumbosacral articulation, fix the point A. If the patient lies on the right side, then place the middle finger of the left hand at the point A. Hold the index finger from the middle so that it is below the iliac crest line at point B.


The triangle, located between the proximal phalanges, the middle and index fingers, is the injection site (Figure 2).


Before inserting the needle, you should move the skin about 2 cm (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.

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

After the injection, slowly take out the needle and press with your finger the skin area adjacent to the injection site, for about 5 minutes.

After the injection, the patient needs to move.

SIDE EFFECT



On the part of the body as a whole: rarely - joint pain, enlarged lymph nodes, fever, headaches, malaise;
very rarely - allergic or anaphylactic reactions.
From the digestive system: rarely - nausea, vomiting (stop with symptomatic therapy).

Local reactions: violation of the technique of drug administration can lead to skin staining, the appearance of soreness and inflammation at the injection site.

CONTRAINDICATIONS



- Anemia not related to iron deficiency (eg, hemolytic anemia, megaloblastic anemia caused by vitamin B deficiency, 12 disorders of erythropoiesis, bone marrow hypoplasia);

- excess iron (ie hemochromatosis, hemosiderosis);

- impairment of iron utilization (eg, 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 cirrhosis of the liver;

- infectious hepatitis;

- I trimester of pregnancy;

- IV introduction;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION



Category C. An experimental study of the effect on reproductive performance as well as controlled studies in pregnant women with this drug has not been conducted.
Therefore, the use of the drug Maltofer ® is possible only in those cases when the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
In small quantities, unaltered iron from the polymaltose complex can penetrate into breast milk.
It is unlikely that taking the drug causes undesirable effects in children who are breastfeeding.
SPECIAL INSTRUCTIONS



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). With the introduction it is necessary to ensure the availability of cardiopulmonary resuscitation.
With caution, the drug should be administered to patients with allergies, as well as hepatic and renal insufficiency.

Side effects, which occur in patients with cardiovascular diseases, can aggravate the course of the underlying disease.

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

Before using the drug, the ampoule should be inspected for sediment and damage.
Use only ampoules without sediment and damage. After opening the ampoule, the injection solution should be administered immediately.
Maltofer ® for injection should not be mixed with other therapeutic drugs.

Use in Pediatrics

In children, the parenteral use of iron preparations can adversely affect the course of the infection process.

It is not recommended to prescribe the drug to children under 4 months due to lack of experience in this category of patients.

Impact on the ability to drive vehicles and manage mechanisms

Influence on the ability to drive vehicles or work with mechanisms is unlikely.

OVERDOSE



To date, no cases of an overdose of iron have been reported.

Symptoms: with an overdose, there may be acute gland overload, which is manifested by symptoms of hemosiderosis.
Chronic excess iron leads to the development of hemochromatosis. This can occur when an erroneous diagnosis of iron deficiency anemia in the case of treatment-resistant anemia.
Treatment: hemochromatosis should be treated as well as thalassemia - with / in the administration of deferoxamine.

Complex iron (III) hydroxide polymaltose is not excreted from the body during hemodialysis due to high molecular weight.
Periodic monitoring of serum ferritin can help in the timely recognition of progressive accumulation of iron.
DRUG INTERACTION



Like all other parenteral iron preparations, Maltofer ® should not be used concomitantly with oral iron preparations, since absorption of the latter from the gastrointestinal tract decreases.
Therefore, oral iron therapy should be started no earlier than 1 week after the last injection.
Simultaneous administration of ACE inhibitors (eg, enalapril) may cause an increase in the systemic effects of parenteral iron preparations.

STORAGE CONDITIONS AND SHELF LIFETIME



List B. The drug should be stored out of the reach of children, protected from light in the original packaging at a temperature of no higher than 25 ° C;
Do not freeze. Shelf life - 5 years.


The information is provided for your information, do not self-medicate, it is dangerous for your health.

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