Velferrum - Instructions For Use, The Price Of Ampoules, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Welferrum

Welferrum: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Velferrum

ATX code: B03AC

Active ingredient: iron (III) hydroxide sucrose complex [Ferric (III) hydroxide sacharose complex]

Manufacturer: Velpharm, LLC (Russia)

Description and photo update: 2020-04-07

Prices in pharmacies: from 2026 rubles.

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Welferrum is an iron preparation used in the treatment of iron deficiency states.

Release form and composition

Dosage form - solution for intravenous (i / v) administration: dark brown, colloidal (in a cardboard box 1 or 2 cell contour packs, each containing 5 ampoules of light-shielding glass containing 5 ml of solution, complete with an ampoule scarifier or without it, if the ampoule has a fracture ring or an incision with a dot. Each pack also contains instructions for the use of Velferrum).

Composition of 5 ml solution:

• active substance: concentrate of iron [III] hydroxide of the sucrose complex - 2678.57 mg (which corresponds to the content of 100 mg of iron);
• auxiliary components: water for injection, sodium hydroxide.

Pharmacological properties

Pharmacodynamics

The multinuclear centers present in iron hydroxide are surrounded on the outside by a large number of non-covalently bound sucrose molecules, as a result of which a complex with a molecular weight of approximately 43 kDa is formed. Due to this, the excretion of the substance through the kidneys in an unchanged form becomes impossible. The complex is stable and does not release iron ions under physiological conditions.

The structure of the multinucleated iron-containing nucleus is similar to that of the ferritin nucleus (physiological iron depot). This complex is designed to create a controlled source of utilizable iron for ferritin and transferrin, which are responsible for the storage and transport of iron in the body. After intravenous administration, the iron contained in the complex is captured by the bone marrow, spleen and liver, and then either stored in the liver in the form of ferritin, or is used for the synthesis of myoglobin, hemoglobin and other iron-containing enzymes.

Pharmacokinetics

After a single intravenous injection of a Velferrum solution containing 100 mg of iron, the maximum concentration of the substance is noted after 10 minutes and is 538 μmol (on average). The volume of distribution of the central chamber is almost completely equal to the volume of serum and is about 3 liters.

The half-life of the drug from the plasma is 6 hours. In the equilibrium state, the volume of its distribution is almost 8 liters, which indicates a low distribution of iron in the body fluids. Since the stability of iron in saccharate in comparison with transferrin is low, there is a competitive exchange of iron in favor of the latter. As a result, approximately 31 mg of iron is transferred in 24 hours.

4 hours after injection, renal excretion of the substance is less than 5% of the total clearance. After 24 hours, the serum iron level returns to the initial value (value before administration). Almost 75% of sucrose leaves the vascular bed.

Indications for use

Solution for IV administration Velferrum is prescribed for the treatment of iron deficiency states in the presence of the following diseases / conditions:

• active inflammatory bowel pathologies in which oral dosage forms of iron are ineffective;
• intolerance to oral iron preparations or non-adherence to treatment;
• the need for fast iron replacement.

Contraindications

Absolute:

• anemia not associated with iron deficiency;
• the presence of signs of iron overload (hemochromatosis, hemosiderosis) or a violation of the process of its utilization;
• I trimester of pregnancy;
• established hypersensitivity to the components of the drug.

Relative (the introduction of Velferrum requires special care and careful medical supervision):

• liver failure;
• bronchial asthma;
• polyvalent allergy;
• acute or chronic infectious pathologies;
• allergic reactions to other parenteral iron preparations;
• eczema;
• low serum iron-binding capacity and / or folic acid deficiency;
• increased serum ferritin levels.

Velferrum, instructions for use: method and dosage

Solution Velferrum in ampoules is intended for intravenous slow jet or drip. Also, the drug can be injected into the venous area of the dialysis system. It cannot be administered intramuscularly.

It is important to take into account that the simultaneous administration of the full therapeutic dose is unacceptable.

A test dose should be administered before the first therapeutic dose is administered. If signs of intolerance are detected during the observation period, treatment with Velferrum is immediately stopped.

Before opening the ampoule, inspect it for damage and possible sediment. Only a solution without brown sediment is allowed for use.

It is preferable to administer the drug by drip infusion. This allows you to reduce the likelihood of a pronounced decrease in blood pressure and the risk of the solution entering the peri-venous space.

Immediately before the introduction, Welferrum is diluted with 0.9% sodium chloride solution in a ratio of 1:20 [for example, 1 ml (20 mg of iron) in 20 ml of solvent]. The rate of administration of the resulting solution depends on the dose of iron:

• 100 mg: 15 minutes (not less);
• 200 mg: 30 min;
• 300 mg: 90 min;
• 400 mg: 150 min;
• 500 mg: 210 min.

The injection of the maximum tolerated single dose (7 mg of iron per 1 kg of body weight) is carried out for 210 minutes (at least), regardless of the total dose of Velferrum.

Before the first drip of a therapeutic dose of a drug, a test dose is administered, namely:

• adults and children weighing more than 14 kg: 20 mg for 15 minutes;
• children weighing less than 14 kg: half the daily dose (1.5 mg iron per 1 kg of body weight) for 15 minutes.

If, after applying the test dose, no undesirable effects are noted, the remainder of the solution can be administered at the recommended rate.

Also, Velferrum can be administered undiluted intravenously slowly at a rate of 1 ml (20 mg of iron) in 1 min (normal); 5 ml (100 mg iron) is injected over a minimum of 5 minutes.

No more than 10 ml of the drug (200 mg of iron) can be administered per injection.

Before the first jet injection of a therapeutic dose of Velferrum, a test dose is used, namely:

• adults and children weighing more than 14 kg: 1 ml (20 mg of iron) for 1-2 minutes;
• children weighing less than 14 kg: half the daily dose (1.5 mg of iron per 1 kg of body weight) for 1–2 minutes.

If, after using the test dose, side effects are not observed, the remainder of the solution can be injected at the recommended rate. After injection, patients are advised to fix the arm in an extended position for some time.

It is allowed to inject the solution directly into the venous section of the dialysis system. In this case, it is necessary to strictly follow the rules described for intravenous injection. The doctor individually, in accordance with the general iron deficiency in the body, sets the dose of Welferrum according to the following formula: total iron deficiency (mg) = weight (kg) x (normal level of Hb - Hb of the patient) (g / l) x 0.24 + deposited iron (mg).

The normal Hb level and the amount of deposited iron for patients weighing less than 35 kg are 130 g / l and 15 mg per 1 kg of body weight, respectively; more than 35 kg - 150 g / l and 500 mg, respectively.

The coefficient 0.24 is obtained by multiplying the iron content in Нb (0.34%), blood volume (7% of body weight) and the coefficient 1000 (conversion from g to mg) (0.24 = 0.0034 x 0.07 x 1000).

The total volume of the drug that is recommended to be administered (in ml) is equal to the total iron deficiency (mg) (20 mg / ml).

The cumulative therapeutic dose of the solution in ml or iron in mg, depending on the patient's weight and Hb 60/75/90/105 g / l, respectively, is:

• 5 kg: 8/7/6/5 ml or 160/140/120/100 mg;
• 10 kg: 16/14/12/11 ml or 320/280/240/220 mg;
• 15 kg: 24/21/19/16 ml or 480/420/380/320 mg;
• 20 kg: 32/28/25/21 ml or 640/560/500/420 mg;
• 25 kg: 40/35/31/26 ml or 800/700/620/520 mg;
• 30 kg: 48/42/37/32 ml or 960/840/740/640 mg;
• 35 kg: 63/57/50/44 ml or 1260/1140/1000/880 mg;
• 40 kg: 68/61/54/47 ml or 1360/1220/1080/940 mg;
• 45 kg: 74/66/57/49 ml or 1480/1320/1140/980 mg;
• 50 kg: 79/70/61/52 ml or 1580/1400/1220/1040 mg;
• 55 kg: 84/75/65/55 ml or 1680/1500/1300/1100 mg;
• 60 kg: 90/79/68/57 ml or 1800/1580/1360/1140 mg;
• 65 kg: 95/84/72/60 ml or 1900/1680/1440/1200 mg;
• 70 kg: 101/88/75/63 ml or 2020/1760/1500/1260 mg;
• 75 kg: 106/93/79/66 ml or 2120/1860/1580/1320 mg;
• 80 kg: 111/97/83/68 ml or 2220/1940/1660/1360 mg;
• 85 kg: 117/102/86/71 ml or 2340/2040/1720/1420 mg;
• 90 kg: 122/106/90/74 ml or 2440/2120/1800/1480 mg.

If the total therapeutic dose is higher than the maximum allowable single dose, the drug is administered fractionally.

In the absence of improvement in hematological parameters after 7-14 days from the start of therapy, it is important to revise the initial diagnosis.

The dose of Velferrum required to compensate for iron deficiency is calculated using the following formula:

• when the amount of lost blood is known: the amount of iron required for replenishment (mg) = the number of units of lost blood x 200, or the required volume of the drug Velferrum (ml) = the number of units of lost blood x 10. In / in injection of 200 mg of iron (10 ml of solution) increases the concentration of Hb in the same way as a transfusion of 1 unit of blood (0.4 l with an Hb concentration of 150 g / l);
• when an increase in Hb is required: the above formula is applied, provided that it is not required to replenish the iron depot; the amount of iron required for replenishment (mg) = body weight (kg) x 0.24 x (normal Hb level - the patient's Hb level g / l). For example, the patient's weight is 60 kg, and the Hb deficiency = 10 g / l, which means that the required amount of iron is 150 mg, and the Velferrum solution is 7.5 ml.

At a standard dosage, adults and elderly patients use 5-10 ml of solution (100-200 mg of iron) 1 to 3 times a week, depending on the level of hemoglobin.

Data on drug use in children under 3 years of age are limited. Children of other age groups are prescribed no more than 0.15 ml of the drug (3 mg of iron) per 1 kg of weight from 1 to 3 times a week, depending on the level of hemoglobin.

The maximum tolerated single dose of Velferrum in adults and elderly patients is:

• jet injection: 10 ml (200 mg iron); duration of administration - at least 10 minutes;
• drip administration: the dose can reach 500 mg of iron, depending on the indication. The maximum permissible single dose is 7 mg of iron per 1 kg of body weight (but not more than 500 mg of iron), it is administered once a week.

Side effects

During therapy with iron [III] hydroxide of the sucrose complex, the most common adverse events were nausea, injection site reactions, chills, pyrexia, decreased blood pressure, and changes in taste.

Possible side effects of Welferrum (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; the frequency cannot be determined from the available data - with an unspecified frequency):

• immune system: rarely - anaphylactoid reactions;
• nervous system: often - disturbances in taste; infrequently - headache, dizziness; rarely - loss of consciousness, fainting, paresthesia; with an unknown frequency - confusion, decreased level of consciousness;
• heart: infrequently - palpitations, tachycardia; with an unknown frequency - bradycardia;
• vessels: infrequently - vascular collapse, decreased blood pressure; rarely - increased blood pressure;
• respiratory organs, chest cavity and mediastinum: infrequently - shortness of breath, bronchospasm;
• gastrointestinal tract: infrequently - diarrhea, abdominal pain, vomiting, nausea;
• skin and subcutaneous tissues: infrequently - erythema, rash, urticaria, itching;
• musculoskeletal system and connective tissue: infrequently - muscle pain; rarely - joint pain, joint swelling;
• general disorders and disorders at the injection site: often - reactions at the injection / infusion site; infrequently - hyperhidrosis, chest pain, hot flashes, chills, pyrexia, hyperemia, peripheral edema; rarely - chromaturia, edema, fever, general malaise, asthenia, fatigue, angioedema; very rarely - back pain, hyperhidrosis; with an unknown frequency - thrombophlebitis.

Overdose

Possible symptoms: Acute iron overload, which is manifested by signs of hemosiderosis.

Therapy: the appointment of symptomatic agents and, if necessary, iron-binding substances (chelates), for example, intravenous administration of deferoxamine.

special instructions

Velferrum in ampoules should be used only in those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data (for example, determination of the level of hemoglobin and hematocrit or serum ferritin, the number of erythrocytes and their parameters - the average concentration of hemoglobin in the erythrocyte, the average hemoglobin content in the erythrocyte or average erythrocyte volume).

Iron preparations for intravenous administration can lead to the development of anaphylactoid and allergic reactions, which are potentially life-threatening.

It is important to strictly observe the rate of administration of the solution; with quick injections, blood pressure may decrease. A higher incidence of side effects (in particular a decrease in blood pressure), which can also be severe, was observed with increasing doses. The recommended time of administration of the drug should be strictly observed, even if the patient is not administered the maximum tolerated single dose.

Studies conducted in persons with hypersensitivity to iron dextran have shown no complications during therapy with iron [III] preparations of sucrose hydroxide complex.

After opening the container, Welferrum should be used immediately from a microbiological point of view.

Influence on the ability to drive vehicles and complex mechanisms

During the period of therapy with Velferrum, it is forbidden to drive vehicles, as well as perform other work related to increased attention, in cases where the patient develops undesirable phenomena in the form of a semi-faint, confusion or dizziness.

Application during pregnancy and lactation

In the first trimester of pregnancy, Velferrum is not prescribed.

Well-controlled studies of the use of the drug during pregnancy have not been conducted. The limited data available indicate that there is no adverse effect of iron sucrose on pregnancy and fetal / newborn health. Animal reproduction studies have shown no direct or indirect adverse effects on embryo / fetal development, labor or postnatal development.

Passage of unmetabolized iron sucrose into breast milk is considered unlikely. Velferrum can be used during lactation as it does not pose a danger to breastfed babies.

Pediatric use

The safety and efficacy profile of Velferrum in children under 3 years of age has not been studied.

For violations of liver function

Liver failure is a relative contraindication to the use of Velferrum.

Drug interactions

Velferrum cannot be used in combination with oral dosage forms of iron, as this leads to a decrease in the absorption of iron from the gastrointestinal tract. Therapy with such agents can be started at least 5 days after the last injection.

Welferrum can be mixed in one syringe only with a sterile 0.9% sodium chloride solution.

The drug is incompatible with other solutions for intravenous administration and therapeutic drugs due to the likelihood of precipitation and / or other pharmaceutical interactions.

Compatibility studies with containers made of materials other than glass (PVC, polyethylene) have not been carried out.

Analogs

The analogues of Velferrum are Ferrum Sandoz, Vialfer, Argeferr, Likferr 100, Irondext, Iron [III] hydroxide sucrose complex, Binnoferum, FerMed, Irongard, Venofer, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Velferrum

There are few reviews about Velferrum, testifying to its effectiveness.

Price for Velferrum in pharmacies

The approximate price for Velferrum (in a package of 5 ampoules of 5 ml of solution) is 2,184 rubles.

Welferrum: prices in online pharmacies

Drug name Price Pharmacy

Welferrum 20 mg / ml solution for injection 5 ml 5 pcs. 2026 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!