Instruction for use: Venofer

Dosage form: Solution for intravenous administration

Active substance: Ferri (III) hydroxidum saccharosum complexum

ATX

B03AC02 Iron oxide saccharate

Pharmacological groups

Macro and microelements

Iron preparation [Stimulators of hemopoiesis]

The nosological classification (ICD-10)

D50 Iron deficiency anemia: Iron deficiency in food; Anemia due to violations of hemoglobin synthesis and iron metabolism; Anemia of iron deficiency; Iron / folic deficiency anemia; Iron deficiency anemia

E61.1 Insufficiency of iron: Insufficient food intake of iron; Iron deficiency; Iron deficiency in women during pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency after surgery; Latent iron deficiency; Lack of iron during pregnancy and lactation; Inadequate intake of iron from food; Increased need for iron; Increased need for iron during menstruation; Disturbances of iron absorption from the digestive tract; Severe iron deficiency

Composition

Solution for intravenous administration - 1 ml

active substance: Iron (III) hydroxide sucrose complex 540 mg

(Equivalent to an iron content of 20 mg)

Auxiliary substances: sodium hydroxide; Water for injection - up to 1 ml

Description

The aqueous solution is brown.

Pharmachologic effect

Mode of action - Replenishing iron deficiency, anti-anemia.

Pharmacodynamics

Multinucleated centers of iron (III) hydroxide are surrounded from the outside by a multitude of non-covalently bound sucrose molecules. As a result, a complex is formed, the molecular mass of which is approximately 43 kD, as a result of which its excretion through the kidneys in an unchanged form is impossible. This complex is stable and under physiological conditions does not release iron ions. Iron in this complex is associated with structures similar to natural ferritin.

Pharmacokinetics

After a single intravenous injection of the preparation of VenoferŪ containing 100 mg of iron, Cmax of iron, on average 538 μmol, is reached 10 minutes after the injection. Vd of the central chamber almost completely corresponds to the volume of the serum (about 3 liters).

T1 / 2 - about 6 hours Vss is about 8 liters (which indicates a low distribution of iron in the body fluids). Due to the low stability of iron, sugar in comparison with transferrin there is a competitive exchange of iron in favor of transferrin. As a result, about 31 mg of iron is transferred within 24 hours.

The excretion of iron by the kidneys within the first 4 hours after the injection is less than 5% of the total clearance. After 24 hours, the serum iron level returns to its original (before administration) value, and about 75% sucrose leaves the vascular bed.

Indication of the drug Venofer

Treatment of iron deficiency in the following cases:

The need to quickly fill iron deficiency;

In patients who do not tolerate oral iron preparations or do not comply with the treatment regimen;

In the presence of active inflammatory bowel diseases, when oral iron preparations are ineffective.

Contraindications

Increased sensitivity to the preparation of VenoferŪ or its components;

Anemia not related to iron deficiency;

Signs of iron overload (hemosiderosis, hemochromatosis) or disruption of its utilization;

I trimester of pregnancy.

With caution: bronchial asthma, eczema, polyvalent allergy, allergic reactions to other parenteral iron preparations, low serum iron binding ability and / or folic acid deficiency; Hepatic insufficiency, acute or chronic infectious diseases (due to the fact that parenterally administered iron can have an adverse effect in the presence of a bacterial or viral infection) and individuals who have increased serum ferritin levels.

Application of pregnancy and breastfeeding

Limited experience with the use of VenoferŪ in pregnant women showed no adverse effect of iron sugarate on the course of pregnancy and fetal / newborn health. To date, there have not been well-controlled studies in pregnant women. The results of reproduction studies in animals showed no direct or indirect adverse effects on embryo / fetal development, childbirth, or postnatal development. Nevertheless, further investigation of the risk / benefit relationship is required.

The intake of unmetabolized iron sugarate in breast milk is unlikely. Thus, VenoferŪ does not pose a hazard to infants who are breastfeeding.

Side effects

Currently, there are known about the following undesirable phenomena, having a temporary and possible causal relationship to the administration of the preparation VenoferŪ. All the symptoms were very rare (incidence less than 0.01% and greater than or equal to 0.001%).

From the nervous system: dizziness, headache, loss of consciousness, paresthesia.

On the part of the CVS: palpitations, tachycardia, lowering blood pressure, collapoid conditions, a feeling of heat, flushing of the blood to the face, peripheral edema.

On the part of the respiratory organs: bronchospasm, dyspnea.

From the gastrointestinal tract: diffuse pain in the abdomen, pain in the epigastric region, diarrhea, taste distortion, nausea, vomiting.

From the skin: erythema, itching, rash, pigmentation, increased sweating.

From the musculoskeletal system: arthralgia, back pain, swelling of the joints, myalgia, pain in the limbs.

From the side of the immune system: allergic, anaphylactoid reactions, incl. Swelling of the face, swelling of the larynx.

General disorders and reactions at the injection site: asthenia, chest pain, a feeling of heaviness in the chest, weakness, pain and swelling at the injection site (especially with extravasal ingestion of the drug), a feeling of malaise, pallor, fever, chills.

Interaction

VenoferŪ should not be given concomitantly with the medicinal forms of iron for oral administration. Helps to reduce the absorption of iron from the digestive tract. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection.

VenoferŪ can be mixed in a single syringe only with sterile saline. No other solutions for intravenous administration and therapeutic drugs are added, since there is a risk of precipitation and / or other pharmaceutical interactions. Compatibility with containers of other materials than glass, PE and PVC has not been studied.

Dosing and Administration

IV.

VenoferŪ is administered only IV - slowly struining or dripping, and also into the venous section of the dialysis system - and is not intended for intravenous administration. Impossible simultaneous introduction of the full therapeutic dose of the drug.

Before the introduction of the first therapeutic dose, a test dose should be administered. If during the observation period there were intolerance phenomena, the drug should be discontinued immediately. Before opening the ampoule, it should be inspected for possible sediment and damage. You can use only a brown solution without sediment.

Drip introduction: VenoferŪ is preferable to be administered during drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of getting the solution into the circumveneous area. Just prior to infusion, VenoferŪ should be diluted with 0.9% sodium chloride solution in a ratio of 1:20, for example 1 ml (20 mg iron) in 20 ml of 0.9% sodium chloride solution. The resulting solution is introduced at the following rate: 100 mg of iron - not less than 15 minutes; 200 mg of iron - for 30 minutes; 300 mg of iron - for 1.5 hours; 400 mg of iron - for 2.5 hours; 500 mg of iron for 3.5 hours. The maximum tolerated single dose of 7 mg of iron / kg should be administered for a minimum of 3.5 hours, regardless of the total dose of the drug.

Before the first dropping of the therapeutic dose of the preparation of VenoferŪ, a test dose should be administered: 20 mg of iron for adults and children weighing more than 14 kg and half of the daily dose (1.5 mg of iron / kg) for children weighing less than 14 kg , For 15 min. In the absence of adverse events, the remainder of the solution should be administered at the recommended rate.

Stream injection: the preparation of VenoferŪ can also be administered as a undiluted I / O solution slowly, at a rate (norm) of 1 ml of the preparation of VenoferŪ (20 mg of iron) per minute, i.e. 5 ml of the preparation VenoferŪ (100 mg of iron) is introduced for at least 5 minutes. The maximum volume should not exceed 10 ml of the preparation VenoferŪ (200 mg of iron) per 1 injection.

Prior to the first jet administration of the therapeutic dose of the preparation VenoferŪ, a test dose should be given: 1 ml of the preparation VenoferŪ (20 mg iron) - for adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron / kg) for children weighing Body less than 14 kg within 1-2 minutes. In the absence of adverse events for the next 15 minutes of observation, the remainder of the solution should be administered at the recommended rate. After injection, the patient is recommended to fix his hand for a while in the extended position.

Introduction to the dialysis system: VenoferŪ can be administered directly to the venous site of the dialysis system, strictly following the rules described for IV injection.

Calculation of the dose: the dose is calculated individually, according to the total iron deficiency in the body according to the formula:

Total iron deficiency, mg = body weight, kg × (normal Hb level - patient's Hb level), g / l × 0.24 * + deposited iron, mg

For patients weighing less than 35 kg: a normal level of Hb = 130 g / l, the amount of deposited iron = 15 mg / kg.

For patients weighing more than 35 kg: a normal level of Hb = 150 g / l, the amount of deposited iron = 500 mg.

* Coefficient 0.24 = 0.0034 × 0.07 × 1000 (iron content in Hb = 0.34%, blood volume = 7% of body weight, coefficient 1000 = conversion from "g" to "mg").

The total volume of the preparation of VenoferŪ, which must be entered (in ml) = total iron deficiency (mg) / 20 mg / ml (see Table).

Table

The total volume of the preparation VenoferŪ for treatment

In the case where the total therapeutic dose exceeds the maximum allowable single dose, fractional administration of the drug is recommended.

If, 1-2 weeks after starting the treatment with VenoferŪ, there is no improvement in hematologic parameters, it is necessary to revise the initial diagnosis.

Calculation of the dose for replenishment of the level of iron after blood loss or delivery of autologous blood

The dose of VenoferŪ is calculated by the following formula:

- if the amount of blood lost is known: iv injection of 200 mg of iron (10 ml of the preparation of venoferŪ) leads to the same increase in Hb concentration as the transfusion of 1 unit of blood (400 ml with a concentration of Hb = 150 g / l).

The amount of iron that must be replenished (mg) = number of units of lost blood × 200

or

The required volume of the preparation VenoferŪ (ml) = the number of units of the lost blood × 10

- if the Hb level is lowered: use the previous formula, provided that the iron depot is not needed to replenish.

The amount of iron to be replenished (mg) = body weight, kg × 0.24 × (normal Hb level - patient's Hb level), g / l.

For example: body weight 60 kg, deficiency Hb = 10 g / l "necessary amount of iron" 150 mg "required volume of preparation VenoferŪ = 7.5 ml.

Standard dosage

Adults and elderly patients: 5-10 ml of VenoferŪ (100-200 mg of iron) 1-3 times a week, depending on the level of hemoglobin.

Children: there are only limited data on the use of the drug in children under 3 years of age. The recommended dose for children of other age groups is not more than 0.15 ml (3 mg of iron) per kg of body weight 1-3 times a week, depending on the level of hemoglobin.

The maximum tolerable single dose

Adults and elderly patients:

- for jet injection: 10 ml of VenoferŪ preparation (200 mg of iron), duration of administration is at least 10 min.

- for drip introduction: depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg / kg and is administered once a week, but it should not exceed 500 mg of iron. The time of administration and the method of dilution are described above.

Overdose

Overdose can cause acute overload with iron, which is manifested by symptoms of hemosiderosis.

Treatment: it is recommended to use symptomatic agents and, if necessary, iron-binding substances (chelates), for example deferoxamine IV.

Special instruction

VenoferŪ should be administered only to those patients who are diagnosed with anemia with appropriate laboratory data (for example, the serum ferritin or hemoglobin and hematocrit, the number of red blood cells and their parameters, the mean red blood cell volume, the mean hemoglobin in the erythrocyte).

IV iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life-threatening.

It is necessary to strictly adhere to the speed of administration of the preparation VenoferŪ (with rapid administration of the drug, blood pressure can decrease). A higher incidence of undesirable side effects (in particular, lowering blood pressure), which may also be severe, is associated with an increase in dose. Thus, the time of administration of the drug given in the section "Method of administration and dose" should be strictly observed, even if the patient does not receive the drug in the maximum tolerable single dose.

Studies conducted in patients with hypersensitivity reactions to iron dextran showed no complications during the treatment with VenoferŪ.

Avoid penetration of the drug into the circumvallic space, because The entry of VenoferŪ outside the vessel results in tissue necrosis and brown staining of the skin. If this complication develops, to accelerate the excretion of iron and prevent its further penetration into surrounding tissues, it is recommended to apply heparin-containing preparations to the injection site (gel or ointment is applied lightly without rubbing).

Shelf life after the first opening of the container: from a microbiological point of view, the drug should be used immediately.

Shelf life after dilution with physiological saline: the chemical and physical stability after dilution at room temperature is maintained for 12 hours. From a microbiological point of view, the solution should be used immediately. If the product has not been used immediately after dilution, the user is responsible for the storage conditions and time, which in any case should not exceed 3 hours at room temperature if the dilution was performed in controlled and guaranteed aseptic conditions.

Influence on the ability to drive a car and work with mechanisms. It is unlikely that the preparation VenoferŪ can have an undesirable effect on the ability to drive a car and work with mechanisms.

Release Form

Solution for intravenous administration, 20 mg / ml: in colorless, clear glass ampoules (type I, European Pharmacopoeia) 2 or 5 ml; In the package outline, 5 amp; In a pack of cardboard 1 package.

Manufacturer

Vifor C.A. Ruth de Moncor, 10, SN-1752, Villars-sur-Glane, Switzerland.

The owner of the registration certificate. Vifor (International) Inc. Rehenhstrasse, 37, SN-9014, Art. Gallen, Switzerland.

Organization that accepts claims Vifor (International) Inc. 125047, Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Venofer

At a temperature of 4-25 ° C. In the original packaging (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Venofer

3 years.

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