Multi-iron centers (III) hydroxide are surrounded by a variety of outside non-covalently bound nandrolone phenylpropionate side effects molecules. The result is a complex having a molecular weight of approximately 43 kD, whereby its excretion by the kidneys in an unmodified form is not possible. This complex is stable under physiological conditions and does not release iron ions. The iron in this complex is associated with a structure similar to a natural ferritin.
After a single intravenous administration of the drug Venofer ® , containing 100 mg of iron, maximum concentration of iron, on average 538 μmol achieved 10 minutes after injection. The volume of distribution of the central chamber virtually completely corresponds to the volume of serum (about 3 L).The half-life of about 6 hours. The volume of distribution at steady state is about 8 liters, indicating a low iron distribution in body fluids. Due to the low stability in comparison with iron saccharate transferrin observed competitive exchange in favor of transferrin iron and as a result, for about 24 hours transferred to 31 mg iron.
Iron Isolation kidneys 4 hours after the first injection is less than 5% of the total clearance. After 24 hours, serum iron is returned to the original (before the administration) value, and about 75% of nandrolone phenylpropionate side effects leaves the bloodstream.
Indications for use : Venofer ® is used to treat iron deficiency in the following cases:
- if necessary, the rapid replenishment of iron;
- in patients who can not tolerate oral iron supplements or do not comply with the treatment regimen;
- in the presence of active inflammatory bowel disease where oral iron preparations are ineffective.
Contraindications : The use of Venofer product ® is contraindicated in the following cases:
- anemia is not associated with iron deficiency;
- there are signs of iron overload (hemo-siderosis, hemochromatosis) or a violation of its recycling process;
- there is an increased sensitivity to the drug Venofer ® and its components;
- I trimester of pregnancy.
Precautions : 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 ® should be used with caution. Also, care is required when administered iron preparations with hepatic failure patients with acute or chronic infectious disease and individuals who have serum ferritin indicators increased due to the fact that iron can be parenterally administered to adversely effect the presence of bacterial or viral infection.
Use during pregnancy and lactation : Limited experience with the drug Venofer ® in pregnant patients showed no undue influence iron nandrolone phenylpropionate side effects on pregnancy and the fetus / newborn health. So far, not been well-controlled studies in pregnant women. Results reproduction studies in animals did not reveal any direct or indirect harmful effects on the development of the embryo / fetus, birth or postnatal development. Nevertheless, requires an assessment of risk / benefit ratio.
Receipt unmetabolized iron nandrolone phenylpropionate side effects in breast milk is unlikely. Therefore, Venofer ® is not dangerous for infants who are breastfed.
Dosing and Administration : Introduction : Venofer ® is administered only intravenously – slow bolus or infusion, as well as in the venous portion of the dialysis system and is not intended for intramuscular administration. It is unacceptable the introduction of a one-time full therapeutic dose. Before the introduction of the first therapeutic dose, it is necessary to appoint a test dose. If during follow any intolerance phenomena, the introduction of the drug should be discontinued immediately. Before opening the vial should be inspected for possible damage and sediment. You can only use brown clear solution. Drip introduction : Venofer ® is preferably added in the drip infusion in order to reduce the risk of significant decrease in blood pressure and the risk of falling into the solution okolovenoznoe space. Immediately before the infusion of Venofer ® should be diluted with 0.9% sodium chloride solution 1:20 [for example, 1 ml (20 mg iron) in 20 ml of 0.9% sodium chloride]. The resulting solution was added with the following rate of 100 mg of iron – not less than 15 minutes; 200 mg of iron – 30 minutes; -to 300 mg of iron for 1.5 hours; 400 mg of iron – 2.5 hours; 500 mg of iron – for 3.5 hours. Introduction of the maximum tolerated single dose of 7 mg of iron / kg body weight, should be carried out for at least 3.5 hours, regardless of the total dose. Before the first administration of the therapeutic dose drip drug Venofer ® necessary to introduce a test dose of 20 mg iron adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron / kg), children having a body weight less than 14 kg, for 15 minutes. If no adverse events, the remainder of the solution should be administered at the recommended speed. Stream introduction: preparation Venofer ® can also be administered in the form of undiluted solution by slow intravenous injection, to the speed (rate) 1 ml Venofer ® (20 mg iron), one minute (5 ml drug Venofer ® (100 mg iron) is injected at least 5 minutes). The maximum amount of drug should not exceed 10 ml of the drug Venofer ® (200 mg iron) per injection. Before the introduction of the first jet of a therapeutic dose of the drug Venofer ®, should be assigned to a test dose of 1 ml of the product 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 having a body weight less than 14 kg over 1-2 minutes. If no adverse events for the next 15 minutes of observation, the remainder of the solution should be administered at the recommended speed. After injection, the patient is recommended for some time to fix the arm in the extended position. Introduction to the dialysis system : Venofer ® . May be administered directly into the venous portion of the dialysis system, strictly observing the rules described for intravenous injection dose Calculation : The dose is calculated individually in accordance with the general deficits iron in the body by the formula: Total iron deficiency (mg) = body weight (kg) × (normal level of Hb – Hb patient) (g / l) × 0,24 * + iron deposited (mg). C For patients weighing less than 35 kg: normal level of Hb = 130 g / l, the amount of deposited iron = 15 mg / kg body weight. For patients weighing more than 35 kg: normal level of Hb = 150 g / l, the amount of deposited iron = 500 mg. The coefficient 0,24 = 0,0034 × 0,07 × 1000 (The iron content in the Hb = 0,34%; blood volume = 7% of body weight; ratio of 1000 = “d” in translation “mg”).
|The total amount of the drug Venofer ® ,
which must be entered (in ml)
|=||Total iron deficiency (mg)|
|20 mg / ml|
|Body weight [kg]||The cumulative therapeutic dose of the drug Venofer ® for administration:|
|Hb 60 g / l||Hb 75 g / l||Hb 90 g / l||105 g Hb / l|
|mg Fe||ml||mg Fe||ml||mg Fe||ml||mg Fe||ml|
In the case where the total therapeutic dose exceeds the maximum allowed single dose, it is recommended fractional administration of the drug.
If after 1-2 weeks after initiation of treatment with Venofer ® is no improvement in hematological parameters, the initial diagnosis should be reviewed.
Calculation of the dose to make up for the iron level after blood loss or delivery of autologous blood :
The dose of the drug Venofer ® , required to compensate the iron deficit is calculated according to the following formula:
- If the amount of blood lost known:
intravenous injection of 200 mg iron (= 10 mL drug Venofer ® ) results in the same increased concentrations of Hb, as transfusion 1 unit of blood (= 400 ml with the concentration of Hb 150 g / L).
Iron amount that needs to be addressed (mg) =
number of units of blood lost × 200 or the required amount of the drug Venofer ® (ml) = the number of units of blood lost × 10
- By reducing the level of Hb: Use the previous formula, provided that the depot iron does not need to replenish
the amount of iron, which is necessary to compensate [mg] = body weight [kg] × 0,24 × (normal level of Hb – level of patient Hb) (g / l )
For example, the body weight of 60 kg, the shortage of Hb = 10 g / l => required amount of iron ≡ 150 mg => the required volume of product Venofer ® = 7.5 ml
Standard dosage :
Adults and elderly patients: 5-10 ml Venofer ® (100-200 mg iron) 1-3 times a week depending on the hemoglobin level. Children: There is limited data on the use of the drug in children under 3 years. The recommended dose for children ages rest – not more than 0.15 ml of the preparation Venofer ® (iron 3 mg) per kg body weight 1-3 times per week depending on the hemoglobin level.
The maximum tolerated single dose:
adults and elderly patients: for inkjet administration of 10 ml of the drug Venofer ® . (200 mg iron), the duration of administration for at least 10 minutes
to drip depending on the indication unit dose may reach 500 mg of iron. The maximum allowable single dose of 7 mg of iron per kg body weight and is administered once a week, but it should not exceed 500 mg of iron. Time of administration and method of breeding, see “Dosage and administration”.
Side effects :
It is now known about the following adverse events with temporal and causal relationship possible with the introduction of the drug Venofer ® . All the symptoms were very rare (incidence of less than 0.01% and greater than or equal to 0.001%) of the nervous system – dizziness, headache, loss of consciousness, paraesthesia Cardio-vascular system – palpitations, tachycardia, decreased blood pressure, kollaptoidnye state, feeling hot, “tides” of blood to the face, and peripheral edema. On the part of the respiratory system. bronchospasm, shortness of breath. On the part of the gastrointestinal tract – spilled abdominal pain, epigastric pain, diarrhea, dysgeusia, nausea, vomiting. For the skin – erythema, pruritus, rash, pigmentation disorders, increased sweating. On the part of the musculoskeletal system – arthralgia, back pain, joint swelling, myalgia, pain in the limbs. On the part of the immune system – allergy, anaphylactoid reaction, including swelling of the face, swelling of the throat. Violations of a general nature, and injection site reactions – fatigue, chest pain, feeling of heaviness in the chest, weakness, pain and swelling at the injection site (particularly when extravasal contact with the drug), malaise, pallor, increased temperature, chills
Overdose (intoxication) drug :
Overdose can cause acute iron overload, manifested symptoms of hemosiderosis. In overdose recommended symptomatic agents, and if necessary, binders iron (chelates) such as deferoxamine / in.
Interaction with other drugs : Venofer ® should not be administered concurrently with medicinal iron forms for oral administration, since it helps reduce the absorption of iron from the gastrointestinal tract.Treatment with oral iron preparations can begin no earlier than 5 days after the last injection of
Venofer ® can be mixed in the same syringe only with sterile saline. No other solutions for intravenous administration, and the therapeutic agents are not allowed to add, as there the risk of precipitation and / or another pharmaceutical interactions. Compatibility with containers of other materials than glass, polyethylene and poly vinyl chloride has not been studied.
Cautions : Venofer ® should be administered only to those patients who have a diagnosis of anemia confirmed by the relevant laboratory data (eg, results of determination of serum ferritin and hemoglobin and hematocrit, red blood cell count and their parameters – mean corpuscular volume, average content of hemoglobin in the red blood cell, or an average concentration hemoglobin in the erythrocyte).Intravenous iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life threatening.
It is necessary to strictly observe the rate of administration of the drug Venofer ® (with the rapid introduction of the drug may reduce blood pressure). The higher incidence of adverse side effects (in particular – BP reduction), which may also be heavy and is associated with increasing dose. Thus, the time of administration, driven in the “Dosage and administration” must be strictly observed, even if the patient does not receive the drug at the maximum tolerated single dose. Studies in patients with hypersensitivity to iron dextran reaction showed no complications during treatment with the drug Venofer ® . Avoid penetration of the drug into the space okolovenoznoe because Venofer hit outside of the vessel leads to tissue necrosis and brown skin coloring. In the case of this complication to accelerate the removal of iron and prevent its further penetration into the surrounding tissue, it is recommended applying to the injection of heparin-containing medicines (gel or ointment applied lightly, without rubbing).
Shelf life after first opening the container : From a microbiological point of view, the drug should be used immediately.
Shelf life after saline dilution : Chemical and physical stability after reconstitution at room temperature is 12 hours. From a microbiological point of view, the drug should be used immediately. If the drug was not used immediately after reconstitution, the user is responsible for the storage conditions and time, which in any case should not exceed 3 hours at room temperature when the dilution was performed in a controlled aseptic conditions and guaranteed.
Effects on ability to drive a car and operate machinery
is unlikely that the drug Venofer ® may have an adverse effect on the ability to drive a car and operate machinery
Product form : solution for intravenous administration of 20 mg / ml to 5 ml or 2 ml of the drug in the colorless, transparent glass vials (Type I according to European Pharmacopoeia) having a notch on the neck of the ampoule and technical colored marks, in the form of the rim and the points.
In 5 ampoules in blisters of PVC, which, together with instructions for use are packed in a cardboard box. anabolic steroids for sale online buy testosterone cypionate buy anabolic steroids uk online