Injection Venofer 20 mg / ml 5ml ampoules 5 pcs

Description

Composition
Active substance:
1 ml contains: iron (III) 20 mg in the form of iron (III) hydroxide sucrose complex 510-570 mg.
Excipients:
Sodium hydroxide 0-5 mg of 10% sodium hydroxide solution q.s. to adjust to pH 10,5-11,0 water for injection 580-640 mg.
Description:
The aqueous solution was brown.
Product form:
A solution for intravenous administration of 20 mg / ml. 5 ml of the drug in the colorless, transparent glass vials (type I Eur. F.) having a notch on the neck of the ampoule and technical colored marks in the form of one or two collars and the point. 5 ml of the drug in the colorless, transparent glass vials (type I Eur. F.), closed elastic stopper and an aluminum cap with tear-off element. 5 ampoules or vials in blisters of PVC together with instructions for use packed in a cardboard box.
Contraindications
Use of the drug Venofer® contraindicated in the following cases: increased sensitivity to iron-sucrose complex, a solution of iron-sucrose complex or any of the components of the drug; anemia not caused by iron deficiency; signs of iron overload or inborn errors of its recycling processes; I trimester of pregnancy.
Carefully
Patients with asthma, eczema, polyvalent allergy, allergic reactions to other parenteral iron preparations and persons with low iron binding capacity of serum and / or folic acid deficiency Venofer® need to be used with caution. Also, care is required when administered iron preparations to patients with liver failure, acute or chronic infectious disease and individuals who have serum ferritin indicators increased due to the fact that iron can be parenterally administered adversely effect the presence of bacterial or viral infection.
Dosage
20 mg / ml
Indications
Venofer® is used to treat iron deficiency in the following cases: when the clinical need for a rapid replenishment of iron stores; in patients who can not tolerate oral iron supplements do not observe or treat mode; in the presence of active inflammatory bowel disease where oral iron preparations are ineffective.
Interaction with other drugs
As with all parenteral iron preparations, the drug is not recommended Venofer® simultaneously with oral iron preparations, since oral absorption of iron may decrease, therefore therapy with oral iron preparations should begin no sooner than 5 days after the last injection.
Venofer® may be mixed only with sterile 0.9% (w / v) sodium chloride solution. When mixed with other solution or medicaments there is a risk of precipitation and / or interaction. Compatibility with containers of other materials, in addition to glass, polyethylene and polyvinyl chloride, have not been studied.
Overdose
Overdose can cause iron overload, which can manifest symptoms of hemosiderosis. Overdose should be treated with a chelating agent for iron binding or according to medical practice standards.
pharmachologic effect
Pharmacological group:
Antianemic means iron preparation for parenteral administration.
Pharmacodynamics:
The mechanism of action of the drug active ingredient is Venofer® – an iron-sucrose complex – multi-core consists of a core of iron hydroxide (III), surrounded by a large number of non-covalently linked molecules of sucrose. The average molecular weight of this complex 2 is about 43 kDa. Polynuclear iron core structure similar to that of ferritin protein core – physiological depot iron. This system is designed to create a controllable source of iron utilized for proteins responsible for the transport and deposition of iron in the body (transferrin and ferritin, respectively). After intravenous administration of iron-core multicore this complex mostly captured by the reticuloendothelial system of the liver, spleen and bone marrow. In the next step the iron used for the synthesis of hemoglobin, myoglobin and other iron-containing enzymes, or stored in the liver mainly in the form of ferritin.
Pharmacokinetics:
Distribution
Ferrokinetika iron-sucrose complex, and labeled with 52Fe 59Fe, was evaluated in patients with anemia and chronic renal failure. During the first 6-8 hours 52Fe entrapped by the liver, spleen and bone marrow. It is believed that grip spleen radiolabel rich in macrophages, it is typical of iron capture by the reticuloendothelial system. After intravenous administration of a single dose Venofer® containing 100 mg iron in healthy volunteers maximum total serum iron concentration achieved within 10 minutes after injection, with an average concentration of 538 μmol / L. The volume of distribution of the central chamber is fully consistent plasma volume (about 3 liters).
biotransformation
After injection sucrose mostly decomposed, and iron-core multicore advantageously captured by the reticuloendothelial system of the liver, spleen and bone marrow. After 4 weeks after the administration of red blood cells is utilization of iron from 59 to 97%.
breeding
The average molecular weight of the iron-sucrose complex is approximately 43 kDa, which is pretty much in order to prevent removal by the kidneys. Iron excretion by the kidneys during the first 4 hours after bolus injection Venofer® preparation containing 100 mg iron was less than 5% of the administered dose. After 24 hours, the total concentration of iron in serum was decreased to a level before administration. Renal excretion of sucrose was about 75% of the administered dose.
Pregnancy and breast-feeding
A moderate amount of data on the drug Venofer® pregnant women in II and III trimester of pregnancy has not revealed any risk to the mother or the newborn. However, Venofer® should be used during the II and III trimester of pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. Use of the drug in the first trimester of pregnancy is contraindicated. Animal studies did not reveal any direct or indirect harmful effects on pregnancy, embryo / fetal development, birth or postnatal development. The amount of data in separation of iron from human breast milk after intravenous administration of iron-sucrose complex is limited. Within a small clinical study healthy lactating mothers with iron deficiency was obtained 100 mg of iron as iron-sucrose complex. 4 days after treatment the iron content in human breast milk is not increased, and the difference compared with the control group (n = 5) was not observed. We can not exclude the fact that the iron from drug Venofer® may enter the newborn / infant with mother’s milk, so you should assess the risk-benefit ratio.
Conditions of supply of pharmacies
On prescription.
side effects
The most frequent adverse events (NLR) recorded in clinical trials Venofer® preparation was the change in taste, which was observed with a frequency of 4.5 to 100 subjects phenomenon. The most important serious adverse drug reactions associated with drug Venofer®, hypersensitivity reactions were observed in clinical trials with a frequency of 0.25 phenomena on 100 subjects.
Below are unwanted drug reactions registered after treatment Venofer® in clinical studies as well as in post-registration period (frequency * contains manifestations in packing preparation instruction)
Disorders of immune system: hypersensitivity, anaphylactoid reactions, angioedema
Disorders of the nervous system: taste disturbance, headache, dizziness, paresthesia, hypoesthesia, syncope, somnolence, decreased level of consciousness, confusion, loss of consciousness, anxiety, tremor
Violations by Heart: palpitations, bradycardia, tachycardia
Disturbances from vessels: reduced blood pressure, hypertension, flushing, phlebitis, vascular collapse, thrombophlebitis
Violations of the respiratory system, thorax and mediastinum, dyspnea, bronchospasm
Violations by the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea, constipation
Violations of the skin and subcutaneous tissue disorders: pruritus, rash, urticaria, erythema
Violations by musculoskeletal and connective tissue disorders: muscle cramps, myalgia, arthralgia, pain in extremity, back pain
Violations of the kidneys and urinary tract: chromaturia
General disorders and at the injection site: injection site reactions / infusion (injection-site pain / infusion extravasation at the injection / infusion, irritation at the injection / infusion site reaction injection / infusion, changes in skin coloring at the injection / infusion bruising at the injection / infusion, itching at the injection / infusion), chills, fatigue, fatigue, peripheral edema, pain, chest pain, rash, pyrexia, cold sweats, malaise, pallor
Laboratory and instrumental data: gammaglutamiltransferazy increase in activity, increased alanine aminotransferase activity, increased aspartate aminotransferase activity, increased levels of ferritin in the blood plasma, increased lactate dehydrogenase activity in the blood.
special instructions
Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which can be potentially fatal, so should be available allergy medications, as well as equipment for cardiopulmonary resuscitation and related procedures. After parenteral administrations preceding uncomplicated iron complexes have also been reported hypersensitivity reactions. After each injection, the drug Venofer® all patients should be monitored for the absence of adverse effects for at least 30 minutes. Patients with a history of bronchial asthma, eczema, other types of atopic allergies or allergic reactions to other parenteral iron preparations, Venofer® drug should be used with caution, as these patients may have a particular risk of developing an allergic reaction. Patients with impaired liver function parenteral iron should only be applied after careful assessment of the risk-benefit ratio. Patients with impaired liver function, where iron overload is a precipitating factor should not be used parenteral iron. In order to avoid iron overload, it is recommended to closely monitor the level of iron in the body. Parenteral iron should be used with caution in the presence of acute or chronic infection. Patients with bacteremia is advisable to discontinue use of the drug Venofer®. In patients with chronic infection should assess the risk-benefit ratio. Avoid penetration of the drug in okolovenoznoe space, as it can lead to pain, inflammation development and coloring of the skin brown. In cases of unintentional penetration of the drug into the space okolovenoznoe treatment should be carried out according to the standards of medical practice. Venofer® should be used only in cases where the indication for use is confirmed by results of relevant studies (eg, serum ferritin, transferrin saturation, hemoglobin (Hb), erythrocyte indices – MCV, MCH, MCHC).
Shelf life after the first opening of the container from the microbiological point of view, the preparation should be used immediately
Shelf life after mixing 0.9% sodium chloride (NaCl) Chemical and physical stability after reconstitution at room temperature (15-25 ° C) is 12 hours. However, from the microbiological point of view, the preparation should be used immediately after dilution. If the drug was not used immediately should not after reconstitution, one who uses the active solution, is responsible for conditions and storage time after dilution, which in any case exceed 3 hours at room temperature, except when the dilution was performed in controlled and appropriate aseptic conditions.
Effects on ability to drive vehicles or work with other mechanisms of the effects of these on the ability to drive or operate are not available with other mechanisms. However, some adverse reactions (such as dizziness, confusion, and other (refer to “Side effects”)) may adversely affect the ability to drive or work with other mechanisms. Patients who have marked adverse reaction data, it is recommended to refrain from driving vehicles or using other mechanisms to complete disappearance of these symptoms.
Storage conditions
The original package at a temperature not higher than 25 ° C. The preparation is not subject to freezing. Keep out of the reach of children.
Dosing and Administration
application
The drug is administered only intravenously Venofer®: by drip infusion, injection or slow, or directly into the venous portion of the dialysis system. Before using ampoules / vials should be visually inspected for the absence of sediment or damage. Use should only ampoules / vials homogeneous solution containing no brown precipitate. Each vial / bottle of the drug Venofer® designed solely for one-time use. Any remaining unused medicament or waste must be disposed of in accordance with local requirements. The introduction of Venofer® drug should be administered under the supervision of medical personnel with experience in the diagnosis and treatment of anaphylactic reactions in a specialized department. It shall be possible therapy of antishock comprising 0.1% solution of epinephrine (adrenaline), antihistamines and / or corticosteroids. Test dose is not a reliable predictor of the subsequent hypersensitivity reaction, and therefore it is not recommended prior administration. At the time of drug administration and directly after injection, patients should be under the supervision of a physician. At the first signs of anaphylactic reactions the use of the preparation should be discontinued immediately. It is necessary to observe each patient for at least 30 minutes after each injection of the drug in a therapeutic dose of Venofer® for the absence of adverse effects.
Intravenous drip infusion
Venofer® only diluted with sterile 0.9% (w / v) sodium chloride (NaCl) Sodium. Diluted solution should be clear, brown. Breeding must be carried out immediately before infusion, and the resulting solution should be administered as follows: 1. The dose of drug Venofer® (mg iron) -100 mg dose Venofer® preparation (preparation ml Venofer®) -5 ml, the maximum volume dilution of sterile 0.9 % (w / v) NaCl-solution 100 ml, the minimum infusion time 15 minutes 2. Venofer® drug dose (mg iron) -200 mg dose Venofer® drug (drug Venofer® ml) -10 ml, the maximum volume of sterile dilution 0.9% (w / v) NaCl-solution 200 ml, the minimum infusion time of 30 minutes 3. dose etc. eparata Venofer® (mg iron) -300 mg dose Venofer® drug (drug Venofer® ml) -15 ml, the maximum volume dilution of sterile 0.9% (w / v) NaCl-solution 300 ml, the minimum infusion time-1, 5 chasa 4. Venofer® dose drug (mg iron) -400 mg dose Venofer® drug (drug Venofer® ml) -20 ml, the maximum volume dilution of sterile 0.9% (w / v) NaCl-solution 400 ml, min time 2.5 hour-infusion 5. Venofer® dose drug (mg iron) -500 mg dose Venofer® drug (drug Venofer® ml) -25 ml, the maximum volume of sterile dilution 0.9% (w / v) NaCl-solution of 500 ml min-infusion time 3.5 hours
Dilution of the drug to lower the iron concentration is unacceptable for reasons of stability of the solution.
Intravenous injection Venofer® may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and the dose should not exceed 10 ml (200 mg of iron) per injection.
Injection in a venous system portion Venofer® dialysis can be administered during hemodialysis session directly into the venous portion of the dialysis system during the same conditions as for intravenous injection.
Dose for each patient should be individually calculate the cumulative dose of the drug Venofer®, which should not be exceeded.
Dose calculation *
The total cumulative dose of drug Venofer® equivalent total iron deficiency (mg) is determined based on hemoglobin (Hb) and body weight (BW). Дозу препарата Венофер® следует индивидуально рассчитывать для каждого пациента в соответствии с общим дефицитом железа *Формулы расчета изложены в инструкции по применению.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist