Venofer in ampoules instructions for use
Venofer - antianemic drug for parenteral administration.
Release form and composition
Venofer is available in the form of an injection solution, in 5 ml ampoules. Ampoules with the instruction are placed in a carton (5 ampoules per pack).
The main active ingredient is iron III sucrose complex. 1 ml contains 540 mg of a sucrose complex (corresponding to 20 mg of iron). That is, the drug ampoule contains 100 mg of iron.
Auxiliary components: sodium hydroxide, water for injection (up to 1 ml).
Pharmacodynamics. Venofer belongs to the group of iron preparations used in the treatment of iron deficiency states.
Pharmacokinetics. 10 minutes after the intravenous administration of Venofer, the maximum plasma concentration of iron is reached. The half-life is 6 hours. During the first four hours less than 5% of iron is excreted by the kidneys. About 24% of sucrose is eliminated within 24 hours, iron is completely eliminated.
Indications for use
Venofer is prescribed for conditions involving iron deficiency in the body. Namely:
- for rapid recovery of iron concentration;
- in case of intolerance to oral iron supplements or non-compliance with the prescribed treatment regimen;
- with the ineffectiveness of iron-containing oral agents due to the presence of intestinal diseases.
Venofer is contraindicated in:
- violations of the process of utilization of iron;
- symptoms of iron overload (hemochromatosis, hemosiderosis);
- individual intolerance to the components of the drug;
- in the first trimester of pregnancy.
Dosing and Administration
The solution is injected only intravenously (drip / jet) or into the venous area of the dialysis system.
The solution is not intended for intramuscular injections.
The full therapeutic dose of the drug can not be administered simultaneously.
Ampoules before opening must be checked for damage, and the solution - for the presence of sediment. It is possible to apply only solution of brown color without any foreign particles and inclusions.
Before the first injection of Venofer, a test dose is administered: 20 mg of iron (1 ml) is administered to adults and children weighing more than 14 kg or 1.5 mg / kg to children weighing less than 14 kg. When this infusion lasts at least 15 minutes. In the event of intolerance reactions, the administration immediately stops. If undesirable side effects do not develop, the remaining solution is injected at the recommended rate.
Immediately before the infusion, Venofer is diluted with a 0.9% solution of sodium chloride in the ratio of 1:20 (20 ml of sodium chloride per 1 ml of the preparation).
The infusion rate is determined by the dosage of iron: 100 mg of iron is administered at least 15 minutes, 200 mg of iron - for 30 minutes, 300 mg of iron - 1.5 hours, 400 mg - 2.5 hours, 500 mg - 3.5 hours.
The maximum tolerated single dose is 7 mg of iron per 1 kg of body weight, a minimum of 3.5 hours is administered, regardless of the total dosage of the drug.
Jet injection of Venofer
Venofer may be administered neat, slowly intravenously at a rate of 1 ml of solution per minute. 5 ml of solution injected for at least 5 minutes. Per 1 injection allowed the introduction of not more than 200 mg of iron (10 ml). After insertion, the patient's arm should remain extended.
Introduction to the dialysis system
The solution is allowed to enter directly into the venous area of the dialysis system.
Calculation of doses Venofer
In conditions involving iron deficiency in the body, the dose of the drug is calculated individually for each patient based on the indicators of total iron deficiency using the formula: total volume of Venofer's solution, which must be entered = total iron deficiency / 20 mg / ml.
To restore the iron content after blood loss or blood donation (if the amount of blood lost is known), the dose of Venofer is calculated by the formula: the required volume of Venofer (ml) = the number of units of lost blood * 10.
Venofer Standard Dosages
Adults and elderly patients are usually prescribed 100–200 mg of iron (5–10 ml of solution) from 1 to 3 times a week (based on hemoglobin levels).
Maximum tolerable single dose
For a single jet administered 10 ml of the drug (200 mg of iron) is prescribed, the speed of administration is at least 10 minutes.
For a single drip, a single dosage is 500 mg of iron (5 ampoules of the drug). The solution is diluted and injected as described in the instructions above.
Venofer is generally well tolerated by patients. In rare cases, undesirable side effects may occur:
- on the part of the musculoskeletal system - swelling of the joints, arthralgia and myalgia, pain in the back and limbs;
- on the part of the cardiovascular system - increased heart rate, tachycardia , sensation of heat, flushing of the face, pronounced decrease in blood pressure, up to the collaptoid state;
- on the part of the nervous system - paresthesia, dizziness and headache, loss of consciousness;
- on the part of the respiratory system - shortness of breath, bronchospasm;
- on the part of the digestive system - abdominal pain, epigastric pain, change in taste, nausea, vomiting, diarrhea;
- dermatological reactions - itching, rash, erythema, disturbed pigmentation, increased sweating;
- allergic reactions - anaphylactoid reactions, swelling of the face / larynx;
- general reactions - pain and heaviness in the chest, asthenia, weakness, paleness of the skin, chills and fever, peripheral edema;
- local reactions - swelling pain in the area of injection / infusion.
With an overdose of the drug, hemosiderosis develops due to acute overload. Symptomatic therapy is carried out to eliminate the symptoms of poisoning. If necessary, prescribed iron-binding drugs (deferoxamine intravenously).
When applying Venofer, it is important to consider the following points:
- Venofer is prescribed only in cases where the diagnosis of anemia is confirmed by appropriate laboratory parameters;
- Venofer, like other intravenous iron preparations, can cause life-threatening allergic / anaphylactoid reactions;
- during treatment, the rate of solution administration must be strictly observed, since rapid administration may cause severe hypotension;
- in patients with intolerance to iron dextran, no complications were observed during treatment with Venofer;
- with the introduction of the solution, it is important to avoid its penetration into the near-venous space - this can cause tissue necrosis and brown skin pigmentation (with the development of such complications, creams, ointments or gels with heparin are applied to the injection site);
- the solution for infusion should be prepared immediately before use (in exceptional cases, the diluted solution can be stored at room temperature for no longer than 3 hours, provided that the dilution was carried out under controlled and aseptic conditions).
With care, Venofer is prescribed for:
- bronchial asthma;
- lack of folic acid;
- acute and chronic infections;
- elevated serum ferritin concentrations;
- liver failure;
- polyvalent allergies;
- allergic reactions to other iron preparations.
- treatment with iron preparations for oral administration is allowed to begin only 5 days after the last injection / infusion of Venofer;
- the drug can only be diluted with saline;
- Do not mix the solution with any other drugs.
Pregnancy and lactation
In the first trimester of pregnancy, Venofer is contraindicated.
Well-controlled studies of the use of Venofer in the II and III trimesters has not been conducted. In experimental studies, the teratogenic effects of the drug on the fetus were not identified. Therefore, during these periods of pregnancy, the drug can be administered, but only after a balanced assessment of the ratio of the expected benefits to the mother and the potential hazard to the fetus.
The drug is not excreted in breast milk, therefore safe for breastfed babies.
Influence on reaction speed and ability to concentrate
Does not affect.
Complete structural analogs of Venofer, containing an identical active ingredient, are the preparations: Likferr, Argeferr.
Terms and conditions of storage
Venofer ampoules are stored protected from sunlight, out of the reach of children at a temperature of 4 ° C to 25 ° C. The solution can not be frozen! The shelf life of the drug is 3 years. Do not enter the solution after the expiration date indicated on the package.
Venofer solution for intravenous injection of 20 mg / ml 5 ml, 5 pcs. - 2200-2800 rub.