Venofer (iron (III) hydroxide sucrose complex) 20mg/ml 5ml 5 ampoules

The composition and form of issue: 

The intravenous solution 20 mg/ml. 1 ml contains active substance:

iron (III) hydroxide sucrose complex 540 mg (equivalent iron content 20 mg) excipients: sodium hydroxide water for injection to 1 ml

2 or 5 ml in colorless, transparent glass ampoules (type I according to European Pharmacopoeia) in a contour acheikova package 5 ampoules, in a cardboard pack 1 pack.

Description pharmaceutical form:

The aqueous solution brown.

Pharmacokinetics:

After a single on/in the introduction of the drug Venofer containing 100 mg of iron, Cmax of iron, 538,memoli achieved after 10 min after injection. Vd of the Central chamber is almost completely corresponds to the volume of serum (about 3 years).

T1/2 of about 6 h. the Vss is approximately 8 l (indicating a low iron distribution in liquid media the organism). Due to the low stability of iron saharata in comparison with transferrin is observed in competitive exchange of iron to transferrin favor. The result of 24 hours over about 31 mg of iron.

Release of iron by the kidneys the first 4 h after injection is less than 5% of total clearance. After 24 h serum iron level returns to the original (before the introduction) value, and approximately 75% of the sucrose leaves the bloodstream.

Description pharmacological action:

Multicore centers iron (III) hydroxide is surrounded outside by many non-covalent associated molecules of sucrose. The result is a complex, molecular weight of approximately 43 KD, resulting in its excretion via the kidneys in unchanged form is not possible. This complex is stable in physiological conditions does not emit ions of iron. The iron in this complex is associated with structures similar to the natural San.

Indications:

• Treatment of iron-deficiency States in the following cases:
• the need for rapid replenishment of iron deficiency
• patients who can not tolerate oral iron or fail to comply with treatment
• if you have an active inflammatory bowel disease when oral iron preparations are ineffective.

Contraindications:

• hypersensitivity to drug or its components Venofer
• anemia not associated with iron deficiency
• signs of iron overload (hemosiderosis, hemochromatosis) or violation of the process of its utilization
• The first trimester of pregnancy.

With caution: asthma, eczema, polyvalent Allergy, allergic reactions to other parenteral iron preparations, low iron binding capacity the ability of serum and/or folic acid deficiency, hepatic failure, acute or chronic infectious diseases (due to the fact that parenterally administered iron may have an adverse effect in the presence of a bacterial or viral infection) and individuals who have elevated indicators of ferritin in blood serum.

Application of pregnancy and breast-feeding:

Limited experience of the drug Venofer pregnant patients showed no undesirable effects of saharat iron on pregnancy and health of the fetus/newborn. Up to the present time have not been conducted well-controlled studies in pregnant women. The results of reproduction studies in animals revealed no direct or indirect harmful effects on the development of the embryo/fetus, childbirth or postnatal development. However, the need for further study of the ratio risk/benefit.

Admission nematerializiranih saharata of iron in breast milk is unlikely. Thus, Venofer is not dangerous for infants who are breastfed.

Side effects:

Currently known about the following adverse events having a temporal and possible causal relationship to administration of the drug of Venofer. All symptoms were very rare (frequency of occurrence less than 0.01% and greater than or equal to 0,001%).

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

From the CCC: palpitations, tachycardia, decreased blood pressure, kollaptoidnoe state, feeling heat, tides blood to a person, peripheral edema.

From the side of respiratory system: bronchospasm, shortness of breath.

Gastrointestinal: bottled abdominal pain, epigastric pain, diarrhea, dysgeusia, nausea, vomiting.

With the skin: erythema, pruritus, rash, pigmentation disorders, increased sweating.

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

The immune system: allergic, anaphylactoid reactions, including swelling of the face, swelling of the larynx.

Violations of a General nature and reactions at the injection site: asthenia, chest pain, feeling of heaviness in the chest, weakness, pain and swelling at the injection site (especially when ekstrawazalnoe hit of a drug), a sense of malaise, pallor, fever, chills.

Drug interactions:

Venofer should not be administered concurrently with medicinal forms of iron intake because it promotes the reduction of iron absorption from the gastrointestinal tract. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection.

Venofer can be mixed in the same syringe only sterile saline solution. No other solution for I/V administration and therapeutic products add not allowed because there is a risk of precipitation and/or other pharmaceutical interaction. Compatibility with containers of other materials than glass, PE and PVC has not been studied.

Method of application and dose:

/V. Venofer introduced only in/in slow struino or drip, as well as in the venous phase of dialysis system and not intended for the/m introduction. Unacceptable simultaneous introduction of full therapeutic doses of the drug.

Before the introduction of the first therapeutic dose is necessary to assign a test dose. If during the observation period appeared the phenomenon of intolerance, the drug should be discontinued immediately. Before opening, ampoules should examine her for possible sediment and damage. You can use only a brown solution without sediment.

Drip: Venofer preferable to introduce in the course of drip infusion in order to reduce the risk of pronounced blood pressure reduction and the risk of contact with okolovenoznoe space. Just before infusion of Venofer should be diluted with 0.9% sodium chloride solution in ratio of 1:20, e.g. 1 ml (20 mg iron) in 20 ml of 0.9% solution of sodium chloride. The resulting solution is introduced with the following speed: 100 mg of iron at least 15 minutes 200 mg iron for 30 minutes 300 mg of iron during 1.5 h 400 mg iron for 2.5 h 500 mg iron for 3.5 h. The introduction of the maximum tolerated dose, estimated at 7 mg iron/kg should be made for at least 3.5 h, regardless of the total dose.

Before the first drip introduction the therapeutic dose of Venofer you must enter test dose: 20 mg of iron for adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron/kg) — for children with body weight less than 14 kg, for 15 min. in the absence of undesirable phenomena, the remaining solution should be administered with the recommended speed.

Bolus: drug Venofer you can also enter in the form of undiluted solution in/in slow speeds (norm) 1 ml of Venofer (20 mg iron) in min, t O. 5 ml of Venofer (100 mg iron) injected at least 5 min. Maximum volume should not exceed 10 ml of Venofer (200 mg iron) per 1 injection.

Before the first jet introduction the therapeutic dose of Venofer assign test dose: 1 ml of Venofer (20 mg iron) in adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron/kg) for children weighing less than 14 kg over 1-2 min If no adverse effects during subsequent 15 min of observation the remainder of the solution should be administered with the recommended speed. After injection, the patient is recommended some time to fix arm in extended position.

Introduction to dialysis system: Venofer possible to enter directly into the venous phase of dialysis system, strictly observing the rules outlined for intravenous injection.

Calculation of dose: the dose is calculated individually, in accordance with the common iron deficiency according to the formula:

Total iron deficit in mg = body weight in kg ? (normal level Hb ? the Hb level of the patient), g/l ? 0,24* + deposited iron, mg.

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

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

*Coefficient of 0.24 = 0,0034?0,07?1000 (iron content Hb=0.34 percent blood volume = 7% of body weight factor 1000 = the “g” in “mg”).

The total amount of drug Venofer that you want to enter (in ml) = total iron deficit (mg)/20 mg/ml (see table).

Table

The total amount of drug for the treatment of Venofer

Body weight, kGThe cumulative therapeutic dose of Venofer for the introductionHb 60 гg/lHb 75 g/lHb 90 g/lHb 105 g/lmg Femlmg Femlmg Femlmg Feml51608140712061005103201628014240122201115480244202738019320162064032560285002542027258004070035620315202630960488404274037640323512606311405710005088044401360681220611080549404745148074132066114057980495015807914007012206110405255168084150075130065110055601800901580791360681140576519009516808414407212006070202010117608815007512606375212010618609315807913206680222011119409716608313606885234011720401021720861420719024401222120106180090148074

In the case when the total therapeutic dose exceeds the maximum allowed single dose, it is recommended that the fractional drug.

If after 1-2 weeks after the start of drug treatment of Venofer is no improvement of hematological parameters, it is necessary to reconsider the initial diagnosis.

Calculation of doses to replenish iron levels after blood loss or even autologous blood

The dose of Venofer is calculated by the following formula:

– if the amount of blood lost is known: in/with the introduction of 200 mg iron (10 ml of Venofer) leads to the same increase in the concentration of Hb and the transfusion of 1 unit of blood (400 ml with the concentration of Hb=150 g/l).

The amount of iron that need to be replaced (mg) = number of units blood lost x 200

or

The required amount of drug Venofer (ml) = number of blood units lost x 10.

– a reduction in Hb level: use the previous formula, provided that the depot iron Supplement is required.

The amount of iron that must be replaced (mg) = body weight in kg ? 0,24 ? (normal level Hb ? the Hb level of the patient), g/l.

For example: weight 60 kg, Hb deficit = 10 g/l “the required amount of iron” 150 mg ” the required volume of Venofer = 7.5 ml.

Standard dosage

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

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

The maximum tolerated single dose

Adults and elderly patients:

– for jet injection: 10 ml of Venofer (200 mg iron), the duration of injection at least 10 min.

for intravenous injection: depending on indications, a single dose can be 500 mg of iron. The maximum allowable single dose of 7 mg/kg, and is injected 1 once a week, but it should not exceed 500 mg of iron. Time of administration of the drug and the method of dilution, see above.

Overdose:

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

Treatment: it is recommended to use a symptomatic treatment and, if necessary, substances that bind iron (chelates), such as deferoxamine.

Special instructions:

Venofer should be administered only to patients in whom the diagnosis of anaemia is confirmed by corresponding laboratory data (e.g. the results of determining serum ferritin or hemoglobin and hematocrit, number of erythrocytes and their parameters — average corpuscular volume, average content of hemoglobin in the erythrocyte).

I/iron preparations can cause allergic or anaphylactoid reactions that can be potentially life-threatening.

Should strictly observe the rate of administration of Venofer (with the rapid introduction of the drug may drop BP). A higher incidence of undesirable side effects (especially a decrease in blood pressure), which can also be severe and associated with increasing doses. Thus, the time of administration of the drug contained in the section “Method of application and dosage” should be strictly adhered to, even if the patient receives the drug at the maximum tolerated dose.

Studies conducted in patients who have hypersensitivity reactions to iron dextran showed no complications on the background of drug treatment of Venofer.

Avoid penetration of the drug into okolovenoznoe space, since getting Venofer beyond the vessel leading to tissue necrosis and brown staining of the skin. In the case of this complication to speed up the excretion of iron and prevent its further penetration into the surrounding tissue, it is recommended that application to the injection site geparinoterapii preparations (gel or ointment is applied lightly, not rubbing).

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

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

Influence on ability to driving and working with machinery

It is unlikely that the drug Venofer may have an adverse effect on the ability to drive a car or work with mechanisms.

Storage conditions:

In original package (do not freeze).