Feroksid solution for infection. 20mg/ml amp. 5 ml No. 5

Solution Feroksid is applied to injections at indications which are provided below.

Deficiency of iron at patients to whom oral iron preparations or in case of their inefficiency in the following circumstances cannot be appointed:

• intolerance of oral iron preparations;
• presence of inflammatory diseases of digestive tract (for example ulcer colitis) which can become aggravated at therapy by oral iron preparations;
• iron deficiency states resistant to therapy in case control of these states oral iron preparations is insufficient.

Structure

Active ingredient: gland (ІІІ) hydroxide saccharose complex (1 ml of iron (ІІІ) hydroxide of a saccharose complex equivalent to iron (ІІІ) 20 mg).

Excipients: sodium hydroxide, water for injections.

Contraindication

• anemia which is not tied with deficiency gland (for example hemolytic anemia, megaloblastny anemia owing to insufficiency of B12 vitamin, violation of an erythrogenesis, a marrow hypoplasia, the anemia caused by poisoning with lead);
• a disease, followed by glut of an organism iron (hemosiderosis, hemochromatosis) or inherited disorders of process of utilization of iron (for example sideroakhrestichesky anemia, skin porphyria, thalassemia);
• hypersensitivity to active agent or other components of medicine is available;
• I pregnancy trimester.

Feroksid is entered by

only intravenously. It is possible to execute input by means of a slow injection, drop infusion or direct introduction to the venous site of a dialysis system. Means is not intended for intramuscular or hypodermic introduction.

to

In case the full necessary dose exceeds most resolved single dose of 200 mg (for an injection) or 500 mg (for infusion), recommends fractional introduction of medicine.

In time and after use of the medicine "Feroksid" should watch

patients concerning signs and symptoms of reactions of hypersensitivity. It is necessary to provide performing the corresponding emergency treatment.

Cumulative dose of medicine should be calculated for each patient individually and not to exceed it. The dose is calculated, considering the body weight of the patient and an indicator of level of hemoglobin.

Intravenous drop administration

Feroksid is entered by drop infusion to reduce risk of developing arterial hypotension and danger of hit of solution in perivenous space.

Just before introduction to sterile 0.9% chloride sodium solution in the ratio 1:20, for example - 1 ml of the medicine "Feroksid" (20 mg of iron) in at most 20 ml of sterile 0.9% of solution of sodium of chloride.

For ensuring stability of solution the cultivation of the medicine "Feroksid" in big, than is recommended, volumes of normal saline solution it is not allowed.

Intravenous jet administration

Feroksid can be entered slowly in the form of undiluted solution with a speed of 1 ml a minute (5 ml of the medicine "Feroksid" (100 mg of iron) are entered in 5 minutes), but the maximum volume of solution should not exceed 10 ml of the medicine "Feroksid" (200 mg of iron) for one injection.

After an injection to the patient should straighten a hand. It is necessary to avoid paravenous leak of medicine as it can lead to developing of pain, inflammation, necrosis of fabrics and long brown coloring of skin in this place.

Injection introduction into the venous site of a dialysis system

Feroksid can be entered directly into the venous site of a dialysis system during the hemodialysis session, strictly following the rules described for an intravenous injection.

General dose of the medicine "Feroksid" equivalent to the general deficiency of iron (mg) is defined by

with an indicator of level of hemoglobin (Hb) and body weight. The dose is calculated individually according to the general deficiency of iron in the patient's organism on a formula Ganzoni^ the general deficiency of iron (mg) = the body weight (kg) x (the normal Hb level (g/l) - the Hb level of the patient (g/l)) × 0.24 + the deposited iron (mg).

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

For patients with body weight more than 35 kg: the normal Hb level - 150 g/l, amount of the deposited iron - 500 mg.

Total amount of the medicine "Feroksid" which needs to be entered (into ml) = the general deficiency of iron (mg) of/20 (mg/ml).

Calculation of a dose for completion of level of iron after blood loss or donorship

Dose of the medicine "Feroksid" necessary for compensation of deficiency of iron, is determined by a formula:

• if knows amount of the lost blood: intravenous administration of 200 mg of iron (10 ml of the medicine "Feroksid") leads to the same increase in concentration of Hb, as well as transfusion of one unit of blood (400 ml with concentration of Hb of 150 g/l); amount of iron which needs to be compensated (mg) = the number of units of the lost blood × 200 or the necessary volume of the medicine "Feroksid" (ml) = the number of units of the lost blood × 10;
• at decrease in the Hb level to use the previous formula, but it must be kept in mind that the depot of iron does not need to be filled up. Amount of iron which needs to be compensated (mg) = the body weight (kg) x 0.24 x (the normal Hb level (g/l) - the Hb level of the patient) (g/l).

Standard dosage

Adults and patients of advanced age: 5-10 ml of the medicine "Feroksid" (100-200 mg of iron) 1-3 times a week depending on the Hb level.

Children of 3 years: there are only limited data on use of medicine to children. In case of clinical need it is recommended to enter no more than 0.15 ml of the medicine "Feroksid" (3 mg of iron) on 1 kg of body weight no more than 3 times a week.

Maximum tolerable single or week dose (adults and patients of advanced age)

For injections the maximum tolerable dose - 10 ml of the medicine "Feroksid" (200 mg of iron), no more than 3 times a week, duration of introduction is not less than 10 minutes.

For infusion the maximum tolerable dose - no more once a week:

• to patients with body weight more than 70 kg: 500 mg of iron (25 ml of the medicine "Feroksid") within not less than 3.5 hours;
• to patients with the body weight of 70 kg and below: 7 mg of iron on body weight kg within not less than 3.5 hours.

Should observe strictly infusion introduction time even if the patient does not receive the most tolerable single dose.

In case improvement of hematologic indicators is not observed (increase in level of hemoglobin approximately on 1 g/l of blood a day or approximately on 10-20 g/l in 1-2 weeks after an initiation of treatment), it is necessary to revise the initial diagnosis of the patient and to exclude existence of steady blood loss.

Pregnant

Perhaps use of medicine in II and III trimesters of pregnancy is only strict

Feature of application

Cannot exclude influence of the iron arriving with breast milk of mother on the newborn/baby therefore it is necessary to estimate a ratio risk/advantage.

Children

Are only limited data on use of medicine for children. To appoint to children only according to vital indications (for fast replenishment of an organism iron).

Drivers

Corresponding researches are absent. Influence on ability to steer motor transport or other mechanisms is improbable. But in case of development of side reactions, such as dizziness, confusion of consciousness, it is necessary to refrain from control of motor transport or work with other mechanisms before disappearance of symptoms.

Overdose can result

in acute glut of an organism iron that can be shown as a hemosiderosis. In case of overdose it is recommended to apply symptomatic means and if it is necessary, the substances connecting iron (chelates).

Side effects

Most widespread undesirable reaction to medicine about which the dizgevziya was reported, is. Nausea, arterial hypotension, arterial hypertension, pain in the place of infusion which arose with a frequency from 1st to 2 events at 100 people belong to frequent undesirable reactions.

reactions of hypersensitivity which arose with a frequency of 0.25 events at 100 people during clinical trials belong To the most important serious side reactions which emergence was associated with use of medicine.

Interaction

Feroksid can be mixed only from sterile 0.9% chloride sodium solution. No other solutions for intravenous administration and therapeutic medicines can be added as there is a risk of precipitation and/or other pharmaceutical interaction. The compatibility with containers from polyethylene and polyvinylchloride is not studied.

to Store

in original packing at a temperature not above 25 °C, out of children's reach. Not to freeze.

Expiration date - 3 years.

After opening of an ampoule from the microbiological point of view medicament should be used immediately.

After cultivation by normal saline solution physical and chemical stability at the room temperature makes 12 hours.