Venofer in ampoules instruction manual
Venofer is an anti-anemic drug for parenteral administration.
Form of issue and composition
The venofer is available in the form of an injection solution, in 5 ml ampoules. Ampoules with the instruction are placed in a cardboard package (5 ampoules per pack).
The main active ingredient is iron III sucrose complex. In 1 ml contains 540 mg of a sucrose complex (corresponding to 20 mg of iron). That is, the 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, it is used in the therapy of iron deficiency states.
Pharmacokinetics. 10 minutes after 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. For 24 hours, about 75% of sucrose is removed, the iron is removed completely.
Indications for use
Venofer is prescribed for conditions accompanied by iron deficiency in the body. Namely:
- To quickly restore the concentration of iron;
- With intolerance of oral iron or non-compliance with the prescribed treatment regimen;
- When iron-containing oral agents are ineffective due to the presence of intestinal diseases.
Contraindicated Venofer at:
- Violations of the process of iron utilization;
- Symptoms of an excess of iron (hemochromatosis, hemosiderosis);
- Individual intolerance to the components of the drug;
- In the first trimester of pregnancy.
Dosing and Administration
The solution is administered only intravenously (by drip / jet) or into the venous section of the dialysis system.
The solution is not intended for intramuscular injection.
A complete therapeutic dose of the drug can not be administered concurrently.
Ampoules must be checked for damage before opening and the solution for sediment. Use only a brown solution without any foreign particles and inclusions.
Before the first administration of Venofer, a test dose is given: 20 mg of iron (1 ml) is administered to adults and children weighing more than 14 kg or 1.5 mg / kg for children weighing less than 14 kg. The infusion lasts no less than 15 minutes. When intolerance reactions occur, the administration is immediately stopped. If unwanted side effects do not develop, the remaining solution is administered at the recommended rate.
Immediately prior to infusion, the venofer is diluted with 0.9% sodium chloride solution in a ratio of 1:20 (per 1 ml of the drug, 20 ml of sodium chloride).
The rate of infusion 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 for 1.5 hours, 400 mg for 2.5 hours, 500 mg for 3.5 hours.
The maximum tolerable single dose is 7 mg of iron per kg of body weight, administered at least 3.5 hours, regardless of the total dosage of the drug.
Injection of a Venofer
The venofert can be administered undiluted, slowly intravenously at a rate of 1 ml of solution per minute. 5 ml of the solution is injected for at least 5 minutes. For 1 injection, the administration of not more than 200 mg of iron (10 ml of solution) is allowed. After administration, the patient's arm should remain elongated.
Introduction to the dialysis system
The solution is allowed to enter directly into the venous section of the dialysis system.
Calculation of the doses of Venofer
In conditions accompanied by a lack of iron in the body, the dose of the drug is calculated individually for each patient based on the total iron deficiency by the formula: the total volume of the venofer solution to be introduced = total iron deficiency / 20 mg / ml.
To restore the content of iron after blood loss or blood donation (if the amount of blood lost is known), the Venofer dose is calculated using the formula: necessary volume of Venofer (ml) = number of units of lost blood * 10.
Standard dosages of the VENOFER
Adults and elderly patients are usually prescribed 100-200 mg of iron (5-10 ml of solution) from 1 to 3 times per week (based on the hemoglobin content).
Maximum tolerable single dose
For a single bladder administration, 10 ml of the drug (200 mg of iron) are prescribed, the rate of administration is at least 10 minutes.
For a single drop administration, a single dosage is 500 mg of iron (5 ampoules of the drug). The solution is diluted and injected as indicated in the instructions above.
Usually Venofer is well tolerated by patients. In rare cases, undesirable side effects may occur:
- From the musculoskeletal system - edema of the joints, arthralgia and myalgia, back and limb pain;
- From the cardiovascular system - increased heart rate, tachycardia , a feeling of heat, flushes of blood to the face, a pronounced lowering of blood pressure, down to the collapoid state;
- From the side of the nervous system - paresthesia, dizziness and headache, loss of consciousness;
- On the part of the respiratory organs - dyspnea, bronchial spasm;
- On the part of the digestive system - abdominal pain, epigastric pain, taste changes, nausea, vomiting, diarrhea;
- Dermatological reactions - itching, rash, erythema, pigmentation disorders, increased sweating;
- Allergic reactions - anaphylactoid reactions, edema of the face / larynx;
- General reactions - pain and heaviness in the chest, asthenia, weakness, pale skin, chills and fever, peripheral edema;
- Local reactions - edema of pain in the area of injection / infusion.
When an overdose of the drug due to acute overload develop hemosiderosis. Symptomatic therapy is used to eliminate symptoms of poisoning. If necessary, iron-binding drugs are prescribed (deferoxamine intravenously).
When using Venofer, it is important to consider the following points:
- The venofer is prescribed only in cases when the diagnosis of anemia is confirmed by appropriate laboratory parameters;
- Venofer, like other iron preparations for intravenous administration, can cause life-threatening allergic / anaphylactoid reactions;
- During the treatment, the rate of administration of the solution must be strictly observed, since rapid administration can cause severe hypotension;
- In patients with intolerance to dextran iron, no complications were observed with Venofer;
- When introducing a solution, it is important to avoid its penetration into the circumveneal area - 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 infusions 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 guaranteed aseptic conditions).
Caution The venofer is assigned when:
- Bronchial asthma;
- Lack of folic acid;
- Acute and chronic infections;
- Increased ferritin concentration in serum;
- Hepatic insufficiency;
- Allergies are polyvalent;
- Allergic reactions to other iron preparations.
- Treatment with iron for oral administration is allowed to begin only 5 days after the last injection / infusion of Venofer;
- The drug can be diluted only with saline solution;
- Do not mix the solution with any other medicines.
Pregnancy and lactemia
In the first trimester of pregnancy, Venofer is contraindicated.
Well-controlled studies of the use of Venofer in the II and III trimesters have not been conducted. In experimental studies, there was no teratogenic effect of the drug on the fetus. Therefore, during this period of pregnancy, the drug can be prescribed, but only after a weighted assessment of the ratio of expected benefits to the mother and the potential hazard to the fetus.
The drug is not excreted in breast milk, therefore it is safe for children who are breastfeeding.
Effect on reaction speed and concentration ability
Does not affect.
The Venofer counterparts
The complete structural analogues of Venofer, containing an identical active substance, are preparations: Likferr, Argeferr.
Terms and conditions of storage
Venofer ampoules are stored in a place protected from sunlight and inaccessible to children at a temperature of 4 ° C to 25 ° C. The solution can not be frozen! Shelf life of the drug is 3 years. Do not inject the solution after the expiry date indicated on the package.
The Venofer price
Venofer solution for intravenous injection 20 mg / ml 5ml, 5 pcs. - 2200-2800 rub.