The instruction for medical use
of Ferkayl® medicine
the Trade name
the International unlicensed name
Is not present
the Dosage form
Solution for injections 100mg/2ml in ampoules
of iron a dextran 100.00 mg
sodium excipients chloride 18.00 mg
water for injections to 2 ml
Solution of dark brown color
Iron preparations trivalent for parenteral use
the Code of automatic telephone exchange B03A C06
Pharmacokinetics At properties intramuscular administration of iron of a dextran absorption happens in the place of an injection through lymphatic system. Distribution happens as follows: the most part of iron of a dextran, after an injection, is soaked up within 72 hours. The rest of iron of a dextran is soaked up within 3-4 weeks.
Such Pharmacokinetics of iron of a dextran causes indications of this drug at clinical need of fast transport of iron for its depot and also at inefficiency or impossibility of absorption of orally used iron preparations in digestive tract. Small amounts of iron are removed with a stake and urine.
Iron is necessary for normal functioning of various humic and negeminovy substrates: hemoglobin, a myoglobin, cytochromes, peroxidases and catalases which participate in oxygen transport, tissue respiration and removal of the peroxides which are formed in the course of free radical reactions. Adequate amounts of iron are necessary for an effective erythrogenesis – a gemoglobinization of erythroblasts. Iron transfer to the ripened erythrocytes comes generally by release from transferritin in a receptor on a membrane predecessor.
The drug Ferkayl® contains gland a dextran which is an analog of a physiologic form of iron – ferritin (proteinaceous hydroxide – an iron-phosphatic complex). Iron is available in the form of not ionic, water-soluble form. Cells of reticuloendothelial system (RES) slowly release iron which divides an iron dextran into its components – iron and a dextran. Iron contacts protein threads at once, forming hemosiderin or ferritin – physiologic forms of iron, or, to a lesser extent – transferrin. This iron which is exposed to physiological control raises hemoglobin and fills up the exhausted iron reserves.
Appointment as his patient from (miss) immune disturbances or inflammatory processes (for example, a system lupus erythematosus, a pseudorheumatism) can cause allergic reaction on type III.
– treatment and prevention of an iron deficiency anemia of various genesis at
adults and children
– the increased need of an organism for iron at pregnancy,
a lactation, donorship, active growth of children, teenagers
– insufficiency of intake of iron with food
– disturbance of absorption of iron from digestive tract.
Route of administration and doses
Adult: the general dose applied intramusculary has to be determined depending on body weight and the level of initial hemoglobin by the following formula: a dose (ml) = 0.0476 x P x (14.8-N) + 1 ml on each 5 kg of body weight of the patient (at most 14 ml) where
P – the body weight of the patient,
14.8 – normal concentration
of hemoglobin H – observed concentration of hemoglobin (/100 ml)
This formula is applied by kg to calculation of a dose of Ferkayl® (in ml) for restoration of normal concentration of hemoglobin (the 1st member of the equation: 0.0476 x P x (14.8 – N)) and restoration of reserves of iron in an organism (the 2nd member of the equation: 1 ml on each 5 kg of body weight of the patient of at most 14 ml). Number 0.0476 includes iron content in Ferkayl® (50mg/ml), iron content in hemoglobin (0.34%) and the blood volume (7% of body weight).
To children (since 4 months): for children weighing over 15 kg the dose as for adults is appointed. To children up to 15 kg the general dose applied intramusculary is calculated by the following formula: a dose (ml) = 0.0476 x P x (12-N) + 1 ml on each 5 kg of weight the patient’s body.
The general dose applied at the rate of daily injections following:
– to children up to 5 kg – 0.5 ml
– to children weighing from 5 to 10 kg – 1 ml
– children weighing over 15 kg and adult – 2 ml.
The table is developed for convenience of definition of a course of treatment.
The course dose of drug is defined in a zavismost from body weight and the level of initial hemoglobin in milliliters. The number of ampoules is defined on a course of treatment by division of a course dose into 2 ml as each ampoule of drug contains 2 ml of solution. The drug is administered deeply intramusculary once a day. Before introduction of the main dose of drug, carrying out a test dose is necessary.
The COURSE DOSE of the DRUG FERKAYL®
DEPENDING ON WEIGHT AND the LEVEL of INITIAL HEMOGLOBIN, In ML *
NV (/100 ml)
12,0 11,0 10,0 9,0 8,0 7,0 6,0 5,0 4,0 3,0 5 1,2 1,5 1,7 2,0 2,2 3,4 4,7 6,0 7,2 8,4 10 2,5 2,9 3,4 3,9 4,4 4,9 5,4 5,8 6,3 6,8 15 3,7 4,4 5,1 5,85 6,6 7,3 8,0 8,7 9,4 10,1 20 4,95 5,9 6,9 7,8 8,8 9,7 10,7 11,6 12,6 13,5 25 6,2 7,4 8,6 9,8 11,0 12,1 13,3 14,5 15,7 16,9 30 7,4 8,9 10,3 11,7 13,2 14,6 16,0 17,4 18,9 20,3 35 8,7 10,3 12,0 13,7 15,4 17,0 18,7 20,4 22,0 23,7 40 9 12 14 16 17 19 21 23 25 27 50 12 15 17 19 21,5 24 26 28 31 33 60 15 18 21 24 26,5 29 32 35 38 41 70 17 21 24 27 30,5 34 37 40 44 47 80 20 23 27 31 35 39 43 46 50 54 90 22 27 31 35 39,5 44 48 52 57 61 100 25 30 34 39 44 49 54 58 63 68
* the number of days of treatment is twice less than a course dose
– the undesirable phenomena and complications can arise at the patient at individual intolerance and hypersensitivity to iron preparations
– the supersensitivity in the form of skin rash and an itching
– joint pains, muscular pain and heat of unknown origin is seldom possible. Pain can be shown during the period from several hours to several days after an injection which passes after prescribing of sedatives. Patients with rheumatic arthritis can have a deterioration in articulate symptoms
– anaphylactoid reactions meet extremely seldom and can be shown in the form of the complicated breath and lowering of blood pressure. Symptoms can appear in a few minutes after an injection. In these cases the administration of drug of Ferkayl® has to be immediately stopped.
– supersensitivity to iron preparations and in cases
of asthmatic or allergic states in an aggravation stage
– a pseudorheumatism
– an acute renal failure
– a heavy liver failure
– the anemia which is not caused by deficiency of iron (for example, hemolytic anemia)
– excess of iron or disturbance of its removal (hemochromatosis,
Pharmaceutical: simultaneous use of the drug Ferkayl® with oral ferriferous drugs or additives is undesirable because of a possibility of overdose.
Solution for injections of Ferkayl® contains iron in a stable dekstranovy complex which is similar to physiologic forms of iron, ferritin. Sterile solution has neutral rn, about 5.2 – 6.5. Solution does not contain preservatives. Dekstranovy complexes of iron for parenteral administration differ in the stability and speed of release in serum.
Pharmakodinamicheskiye: it is not necessary to appoint an injection of Ferkayla® in parallel with other orally taken iron preparations, it can cause decrease in absorption of oral iron. Intake of orally taken iron preparations has to begin not earlier than
five days after acceptance of the last injection of the drug Ferkayl®. At simultaneous use of iron preparations and Ferkayla® synergism can be shown. It is necessary to inform in due time the attending physician and/or the druggist of any other medicines which you apply or recently applied even if you bought them independently.
Pharmacokinetic: in an organism, use of high doses of a dextran of iron (5 ml and more) can give brown color to the serum, in blood samples
taken in four hours after drug acceptance. Medicine can become the reason of mistakenly increased content of bilirubin and reduced content of calcium in blood serum.
of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Data on influence on ability to run the vehicle or potentially dangerous mechanisms are not present.
Prevention: during drug treatment it is necessary to refrain from alcohol intake.
is not revealed
the Form of release and packing
Solution 100mg/2ml in ampoules from brown glass on 2 ml No. 5, 2 of ml No. 10х10.
5 or 10х10 ampoules in a container for ampoules, in cardboard packing together with the instruction for use.
To Store storage conditions in the dry, protected from light place, at a temperature from +18 ° to +25 °C.
To store out of children’s reach!
A period of storage
not to use drug after an expiration date.
According to the prescription
the Company Producer Laboratories STEROP s.a., Belgium
Laboratories STEROP s.a. av.
To Develop De Scheut 46-50 Scheutlaan Brussel 1070 Bruxelles