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Venofer solution for intravenous administration 20 mg/ml ampoules of 5 ml 5 pcs.

The drug Venofer is administered only intravenously: by drip infusion, or slow injection, or directly into the venous section of the dialysis system. Before use, ampoules/vials should be inspected for sediment or damage. Only use ampoules/vials containing a homogeneous, sediment-free, brown solution. Each ampoule/vial of Venofer is intended for single use only. Any remaining unused medicinal product or waste should be disposed of in accordance with local requirements. The administration of the drug Venofer should be carried out under the supervision of medical personnel experienced in the diagnosis and treatment of anaphylactic reactions, in a specialized department. It should be possible to carry out anti-shock therapy, including a 0.1% solution of epinephrine (adrenaline), antihistamines and/or corticosteroids. The test dose is not a reliable predictor of the subsequent development of hypersensitivity reactions, and therefore its preliminary administration is not recommended. During the administration of the drug and immediately after administration, patients should be under medical supervision. When the first signs of anaphylactic reactions appear, the use of the drug should be stopped immediately. It is necessary to monitor each patient for at least 30 minutes after each administration of Venofer at a therapeutic dose to ensure the absence of adverse events. Intravenous drip infusion. Venofer is diluted only with sterile 0.9% (w/v) sodium chloride (NaCl) solution. The diluted solution should be transparent and brown in color. Dilution should be made immediately before infusion. Intravenous injection. Venofer can be administered by slow intravenous injection at a rate of 1 ml of undiluted solution per minute and its dose should not exceed 10 ml (200 mg of iron) per injection. Injection into the venous portion of the dialysis system. Venofer can be administered during a hemodialysis session directly into the venous section of the dialysis system under the same conditions as for intravenous injection. Doses. For each patient, the cumulative dose of Venofer should be individually calculated and should not be exceeded. Standard doses. Adult and elderly patients. 5-10 ml of Venofer (100-200 mg iron) 1-3 times a week. Children. There is only a moderate amount of research data on the use of the drug in children. In case of clinical need for use, it is not recommended to exceed a dose of 0.15 ml of Venofer (3 mg of iron) per kg of body weight no more than 3 times a week.

Venofer solution d/iv injected 20 mg 5 ml No. 5

Compound

Active substance: iron (III) hydroxide sucrose complex 540 mg, which corresponds to an iron content of 20 mg.
Excipients: sodium hydroxide, water for injection - up to 1 ml.

Pharmacokinetics

Distribution

After a single intravenous administration of the drug Venofer® containing 100 mg of iron, Cmax of iron, on average 538 μmol, is achieved 10 minutes after injection.

The Vd of the central chamber almost completely corresponds to the volume of the serum - about 3 liters.

Vd at steady state is approximately 8 L (which indicates a low distribution of iron in body fluids). Due to the low stability of iron saccharate compared to transferrin, competitive iron metabolism is observed in favor of transferrin. As a result, about 31 mg of iron (III) is transferred in 24 hours.

Removal

T1/2 - about 6 hours. In the first 4 hours, less than 5% of iron from the total clearance is excreted by the kidneys. After 24 hours, the serum iron level returns to its original (pre-administration) value, and approximately 75% of sucrose leaves the vascular bed.

Indications for use

Venofer® is used to treat iron deficiency conditions in the following cases:

with a clinical need for rapid replenishment of iron reserves;
in patients who cannot tolerate oral iron supplements or do not comply with treatment regimen;
in the presence of active inflammatory bowel disease, when oral iron supplements are ineffective.

Contraindications

Anemia not associated with iron deficiency;
signs of iron overload (hemosiderosis, hemochromatosis);
disruption of the iron utilization process;
I trimester of pregnancy;
hypersensitivity to the components of the drug.

The drug is prescribed with caution to patients with bronchial asthma, eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations; patients with low serum iron-binding capacity and/or folic acid deficiency; patients with liver failure, with acute or chronic infectious diseases, with elevated serum ferritin levels due to the fact that parenteral iron may have an adverse effect in the presence of a bacterial or viral infection.

Directions for use and doses

Venofer is administered only intravenously (slowly drip or stream) or into the venous section of the dialysis system. Not intended for intramuscular administration. Simultaneous administration of the full therapeutic dose of the drug is unacceptable.

Before administering the first therapeutic dose, a test dose must be prescribed. If during the observation period phenomena of intolerance occur, administration of the drug should be stopped immediately. Before opening the ampoule, you should inspect it for possible sediment and damage. Only brown solution without sediment can be used.

Drip administration: Venofer® is preferably administered by drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of the solution entering the perivenous space. Immediately before infusion, Venofer® should be diluted with 0.9% sodium chloride solution in a ratio of 1:20, for example, 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution. The resulting solution should be administered at the following speed: 100 mg of iron - no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - within 1.5 hours; 400 mg of iron - within 2.5 hours; 500 mg of iron - over 3.5 hours. The maximum tolerated single dose of 7 mg iron/kg should be administered over a minimum of 3.5 hours, regardless of the total dose of the drug.

Before the first drip administration of a therapeutic dose of Venofer®, it is necessary to administer a 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 weighing less than 14 kg, for 15 minutes. In the absence of adverse events, the remainder of the solution should be administered at the recommended rate.

Injection: Venofer® can also be administered as an undiluted IV solution slowly, at a rate (norm) of 1 ml of Venofer® (20 mg iron) per minute; 5 ml of Venofer® (100 mg iron) should be administered at least 5 minutes before. The maximum volume of the drug should not exceed 10 ml of Venofer® (200 mg iron) per 1 injection.

Before the first jet injection of a therapeutic dose of Venofer®, a test dose should be prescribed: 1 ml of Venofer® (20 mg iron) for 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 within 1-2 minutes. If there are no adverse events during the next 15 minutes of observation, the remaining part of the solution should be administered at the recommended rate. After the injection, the patient is recommended to fix his arm in an extended position for a while.

Introduction to Dialysis System

Venofer® can be administered directly into the venous portion of the dialysis system, strictly following the rules described for intravenous injection.

Dose calculation: the dose is calculated individually in accordance with the general iron deficiency in the body using the formula:

General iron deficiency (mg) = body weight (kg) × [normal Hb level - patient’s Hb level] (g/l) × 0.24* + deposited iron (mg).

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

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

*Coefficient 0.24 = 0.0034×0.07×1000 (iron content in Hb=0.34%; blood volume = 7% of body weight; coefficient 1000 = conversion from “g” to “mg”).

The total volume (ml) of Venofer® that must be administered = total iron deficiency (mg)/20 mg/ml (Tables 1 and 2).

Table 1

Body weight (kg)	Cumulative therapeutic dose of Venofer® for administration
	Hb 60 g/l		Hb 75 g/l
	mg Fe	ml	mg Fe	ml
5	160	8	140	7
10	320	16	280	14
15	480	24	420	21
20	640	32	560	28
25	800	40	700	35
30	960	48	840	42
35	1260	63	1140	57
40	1360	68	1220	61
45	1480	74	1320	66
50	1580	79	1400	70
55	1680	84	1500	75
60	1800	90	1580	79
65	1900	95	1680	84
70	2020	101	1760	88
75	2120	106	1860	93
80	2220	111	1940	97
85	2340	117	2040	102
90	2440	122	2120	106

table 2

Body weight (kg)	Cumulative therapeutic dose of Venofer® for administration
	Hb 90 g/l		Hb 105 g/l
	mg Fe	ml	mg Fe	ml
5	120	6	100	5
10	240	12	220	11
15	380	19	320	16
20	500	25	420	21
25	620	31	520	26
30	740	37	640	32
35	1000	50	880	44
40	1080	54	940	47
45	1140	57	980	49
50	1220	61	1040	52
55	1300	65	1100	55
60	1360	68	1140	57
65	1440	72	1200	60
70	1500	75	1260	63
75	1580	79	1320	66
80	1660	83	1360	68
85	1720	86	1420	71
90	1800	90	1480	74

In cases where the total therapeutic dose exceeds the maximum permissible single dose, split administration of the drug is recommended. If after 1–2 weeks. after starting treatment with Venofer®, there is no improvement in hematological parameters, it is necessary to reconsider the initial diagnosis.

Dose calculation for replenishing iron levels after blood loss or autologous blood donation

The dose of Venofer® is calculated using the following formula:

If the amount of blood lost is known: intravenous administration of 200 mg of iron (10 ml of Venofer®) leads to the same increase in Hb concentration as the transfusion of 1 unit of blood (= 400 ml with Hb concentration = 150 g/l).

The amount of iron that needs to be replenished (mg) = the number of units of blood lost × 200 or the required volume of Venofer® (ml) = the number of units of blood lost × 10.

If Hb levels decrease: the previous formula should be used, provided that the iron depot does not need to be replenished.

The amount of iron (mg) that needs to be replenished = body weight (kg) × 0.24 × [normal Hb level - patient Hb level] (g/l).

For example: body weight 60 kg, Hb deficiency = 10 g/l: the required amount of iron is approximately 150 mg, and the required volume of Venofer® = 7.5 ml.

Standard dose

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

There are only limited data on the use of the drug in children under 3 years of age. If necessary, it is recommended to administer no more than 0.15 ml of Venofer® (3 mg iron) per kg of body weight 1-3 times a week, depending on the hemoglobin level.

Maximum tolerated single dose

Adults and elderly patients: for jet administration - 10 ml of Venofer® (200 mg iron), duration of administration of at least 10 minutes; for drip administration, depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg/kg and is administered once a week, but it should not exceed 500 mg of iron. The time of administration of the drug and the method of dilution are as indicated above.

Storage conditions

The drug should be stored out of the reach of children, in its original packaging, at a temperature of 4° to 25°C; do not freeze.

Best before date

3 years.
Do not use after the expiration date. Shelf life after dilution with saline: chemical and physical stability after dilution at room temperature is 12 hours. From a microbiological point of view, the drug should be used immediately. If the drug is not used immediately after dilution, the user is responsible for the conditions and storage time, which in any case should not exceed 3 hours at room temperature if the dilution was carried out under controlled and guaranteed aseptic conditions.

special instructions

Venofer® should be prescribed only to those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data (for example, the results of determining serum ferritin or hemoglobin and hematocrit levels, the number of erythrocytes and their parameters - the average volume of an erythrocyte, the average hemoglobin content in an erythrocyte).

IV iron supplements may cause allergic or anaphylactoid reactions, which can be potentially life-threatening.

The rate of administration of Venofer® should be strictly observed (with rapid administration of the drug, blood pressure may decrease). A higher incidence of undesirable side effects (especially decreased blood pressure), which can also be severe, is associated with an increase in dose. Therefore, the recommended dosing time should be strictly followed, even if the patient is not receiving the drug at the maximum tolerated single dose.

Studies conducted in patients with hypersensitivity reactions to iron dextran showed no complications during treatment with Venofer®.

Penetration of the drug into the perivenous space should be avoided, because Venofer entering outside the vessel leads to tissue necrosis and brown discoloration of the skin. If this complication develops, to accelerate the removal of iron and prevent its further penetration into surrounding tissues, it is recommended to apply heparin-containing drugs to the injection site (gel or ointment is applied with light movements, without rubbing).

From a microbiological point of view, the drug should be used immediately.

Description

Hematopoiesis stimulating iron drug.

Pharmacodynamics

Iron supplement. The polynuclear iron(III) hydroxide centers are surrounded on the outside by many non-covalently bound sucrose molecules. As a result, a complex is formed, the molecular weight of which is approximately 43 kDa, as a result of which it is impossible to excrete it unchanged by the kidneys. This complex is stable and does not release iron ions under physiological conditions. The iron in this complex is bound to structures similar to natural ferritin.

Side effects

Side effects likely related to the administration of Venofer® were observed very rarely (<0.01% and ≥0.001%).

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

From the cardiovascular system: palpitations, tachycardia, decreased blood pressure, collapsed states, feeling of heat, “flushes” of blood to the face.

From the respiratory system: bronchospasm, shortness of breath.

From the digestive system: diffuse abdominal pain, pain in the epigastric region, diarrhea, taste disturbance, nausea, vomiting.

From the skin: erythema, itching, rash, pigmentation disorders, increased sweating.

From the musculoskeletal system: arthralgia, back pain, joint swelling, myalgia, pain in the extremities.

Allergic reactions: anaphylactoid reactions, facial swelling, laryngeal swelling.

Local reactions: pain and swelling at the injection site (especially if the drug enters extravasally).

General disorders: asthenia, chest pain, feeling of heaviness in the chest, weakness, peripheral edema, feeling of malaise, pallor, fever, chills.

Use during pregnancy and breastfeeding

Contraindicated in the first trimester of pregnancy.

Limited experience with the use of Venofer® in pregnant patients has shown the absence of undesirable effects of iron sucrose on the course of pregnancy and the health of the fetus/newborn. To date, there have been no well-controlled studies in pregnant women. Experimental studies of the effect on reproduction in animals did not reveal direct or indirect harmful effects on the development of the embryo/fetus, childbirth or postnatal development. However, further study of the relationship between the expected benefit of therapy for the mother and the possible risk for the fetus is required.

It is unlikely that unmetabolized iron sucrose passes into breast milk. Thus, Venofer® does not pose a danger to breastfed infants.

Interaction

The drug should not be prescribed simultaneously with dosage forms of iron for oral administration, because absorption of iron from the gastrointestinal tract decreases. Treatment with oral iron supplements can be started no earlier than 5 days after the last injection.

Pharmaceutical interactions

Venofer® can be mixed in one syringe only with saline solution. No other IV solutions or therapeutic agents may be added due to the risk of precipitation and/or other pharmaceutical interactions. Compatibility with containers made of materials other than glass, polyethylene and polyvinyl chloride has not been studied.

Overdose

Symptoms: hemosiderosis due to acute overload.

Treatment: symptomatic therapy is recommended and, if necessary, the use of drugs that bind iron (chelates), for example, intravenous deferoxamine.

Impact on the ability to drive vehicles and operate machinery

It is unlikely that the drug Venofer® may have an undesirable effect on the ability to drive vehicles and operate machinery.

Venofer®

IV, IV drip and by injection into the venous section of the dialysis system. Not intended for intramuscular administration. It is unacceptable to administer the full therapeutic dose of the drug at once. Before opening the ampoule, it is necessary to inspect for the presence of sediment and damage; only a clear brown solution can be used. The drug, diluted with 0.9% sodium chloride solution, should be used within 12 hours when stored at a temperature of 4 to 25 ° C in daylight. Before starting treatment, it is necessary to administer a test dose in the same way as it is intended to be used during treatment: (1-2.5 ml = 20-50 mg iron) for adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron/kg ) children weighing less than 14 kg. If no adverse events develop within at least 15 minutes of observation, the remainder of the treatment dose can be administered. Drip administration: it is preferable to administer by drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of the solution entering the perivenous space. Immediately before infusion, the drug must be diluted with 0.9% sodium chloride solution in a ratio of 1:20 (for example, 1 ml - 20 mg Fe in 20 ml of 0.9% sodium chloride solution). The resulting solution is administered at the following speed: 100 ml - no less than 15 minutes; 200 ml - within 30 minutes; 300 ml - within 1.5 hours; 400 ml - within 2.5 hours; 500 ml - over 3.5 hours. Jet administration: it is also possible to administer it in the form of an undiluted solution slowly intravenously, at a rate of no more than 1 ml/min (20 mg iron/min). The maximum volume of the drug should not exceed 10 ml. After administration, the patient is recommended to fix his arm in an extended position for a while. Introduction to the dialysis system: it is possible to administer directly into the venous portion of the dialysis system, strictly following the rules described for intravenous injection. Dose calculation: the dose is calculated individually in accordance with the general iron deficiency in the body using the formula: General Fe deficiency (mg) = body weight (kg) x (normal Hb - patient’s Hb (g/l) x 0.24 + deposited iron (mg) For for patients with a body weight of less than 35 kg and a normal hemoglobin (Hb) = 130 g/l, the amount of deposited iron is 15 mg/kg of body weight. For patients with a body weight of more than 35 kg and a normal Hb = 150 g/l, the amount of deposited iron equals 500 mg Coefficient 0.24 = 0.0034 x 0.07 x 1000 (iron concentration in Hb - 0.34%; blood volume - 7% of body weight; coefficient 1000 - conversion of g to mg) In the case where the total therapeutic dose exceeds the maximum permissible single dose , fractional administration of the drug is recommended. If, 1-2 weeks after the start of treatment with the drug, there is no improvement in hematological parameters, it is necessary to reconsider the initial diagnosis. Calculation of the dose to replenish iron content after blood loss: the dose required to compensate for iron deficiency is calculated using the following formula: Amount iron that needs to be replenished (mg) = number of units of blood lost x 200 or Volume of drug required (ml) = number of units of blood lost x 10 (1 unit of blood = 400 ml with an Hb value of 150 g/l; IV administration of 200 mg of iron (10 ml) leads to the same increase in Hb as a transfusion of 1 unit of blood). When Hb decreases: it is necessary to use the previous formula, provided that the iron depot does not need to be replenished. The amount of iron that needs to be replenished (mg) = body weight (kg) x 0.24 x (normal Hb - patient’s Hb (g/l). Standard dosage: adults and elderly patients - 5-10 ml (100-200 mg iron) 1-3 times a week depending on the hemoglobin level. Children: there is only limited data on the use of the drug in children. If necessary, it is recommended to administer no more than 0.15 ml/kg body weight (3 mg iron/kg) 1-3 times a week depending on the Hb indicator. Maximum single dose: adults and elderly patients (for jet administration) - 10 ml (200 mg of iron), duration of administration of at least 10 minutes. For drip administration: depending on the indications, a single dose (administered 1 time per week) may be increased to 0.35 ml/kg body weight (7 mg iron/kg), but should not exceed 500 mg iron.In general, larger doses are associated with a higher incidence of adverse events.

FERINJECT

Directions for use and doses

Intravenous - stream or drip (infusion) and by direct injection into the venous section of the dialysis system.
Before use, bottles should be inspected for possible sediment and damage. Only a homogeneous solution without sediment can be used.

Ferinject® should be used in departments that have the necessary equipment to provide emergency medical care in the event of anaphylactic reactions. Each patient should be observed for the development of signs or symptoms of hypersensitivity reactions for at least 30 minutes after each administration of iron carboxymaltose solution (see section "Special Instructions").

Intravenous infusion:

Ferinject® can be administered intravenously by drip (infusion) in a maximum single dose of up to 1000 mg of iron (up to 20 mg of maximum iron/kg body weight). You cannot administer 1000 mg of iron (20 ml Ferinject®) intravenously (infusion) more than once a week. Immediately before infusion administration, the drug must be diluted with a sterile 0.9% sodium chloride solution for injection in the ratios indicated in the table:

Guidelines for dilution of Ferinject® for infusion

Ferinject®	Iron	Amount of sterile 0.9% sodium chloride solution for injection1	Minimum administration time
> 2 to 4 ml	>100 to 200 mg	50 ml	—
> 4 to 10 ml	>200 to 500 mg	100 ml	6 min.
> 10 to 20 ml	> 500 to 1000 mg	250 ml	15 minutes.

Note:

1 To maintain the stability of the drug, dilution to concentrations less than 2 mg of iron/ml is not allowed (the volume of the Ferinject® solution is not taken into account).

Jet injection:

Ferinject® can be administered intravenously as a bolus in a maximum single dose of up to 4 ml (200 mg of iron) per day, but not more than 3 times a week.

Determination of cumulative iron dose

The cumulative dose for iron replenishment with iron carboxymaltose is determined based on the patient's body weight and hemoglobin (Hb) level and should not be exceeded. The table below should be used to determine your cumulative iron dose.

Cumulative iron dose based on patient weight and hemoglobin (Hb) level

Hb (g/dl)	Patients weighing between 35 and <70 kg	Patients weighing ≥70 kg
<10	1500 mg	2000 mg
≥10	1000 mg	1500 mg

Note: In patients weighing less than 35 kg, the cumulative iron dose should not exceed 500 mg.

When determining iron requirements in overweight patients, it should be based on the normal ratio of body weight to blood volume.

Patients with an Hb value ≥ 14 g/dL should be given an initial dose of 500 mg iron and iron levels should be checked before subsequent administrations.

After repletion, regular assessments should be performed to ensure that iron levels are normalized and maintained.

Maximum tolerated single dose:

A single dose of the drug should not exceed 1000 mg of iron (20 ml) per day or 20 mg of iron (0.4 ml) per kg of body weight. A dose of 1000 mg iron (20 ml) should not be administered more than once a week.

Use of the drug for chronic kidney disease requiring hemodialysis

The maximum daily dose of 200 mg should not be exceeded in patients with chronic kidney disease requiring hemodialysis.