The instruction for medical use
of Fersinol Torgovoye medicine a name
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
Solution for injections of 100 mg / 2 ml
of 2 ml of solution contain
active agent – iron (III) hydroxide a polymaltose
complex of 333.33 mg (in terms of iron of 100 mg),
excipient – water for injections.
Dark henna-red homogeneous liquid
hematopoiesis Stimulators. The drugs Fe +++ for parenteral use.
The ATX B03AC code
Iron Pharmacokinetics properties (III) hydroxide a polymaltose complex contains in quality of active agent not ionic compound of iron on a basis hydroxide – a polymaltose complex of the trivalent iron equal to 100 mg of elementary iron. Such combination is as close as possible to structure of natural compounds of iron with ferritin in serum and is developed for prevention and treatment of iron deficiency states.
At an intramuscular injection iron quickly gets to a blood stream: 15% of a dose – in 15 minutes, 44% – in 40 minutes. Cmax in blood plasma is reached in 24 hours after an injection. Linking with proteins of plasma – 90%. In a blood-groove contacts transferrin, in fabrics it is deposited as a part of ferritin, used in the course of an erythrogenesis.
In a reticuloendothelial system the complex is split on ferrous hydroxide and a polymaltose (it is metabolized by oxidation).
In small quantities not changed complex can pass through a placental barrier and its insignificant quantities get to breast milk. The iron connected with ferritin or transferrin can pass through a placental barrier, and as a part of lactoferrin gets to breast milk in small amounts.
After intramuscular introduction, the polymaltose complex of ferrous hydroxide (III) in the form of active ingredient is absorbed, mainly, by a liver. There it is included hemoglobin, a myoglobin and other ferriferous enzymes and also is in an organism in the form of ferritin.
Elimination half-life makes 22.4 hours, distribution volume 2.93 liters. Less than 1% of the general dose of drug are removed through kidneys.
Fersinol is developed for therapy and prevention of iron deficiency states.
Iron is the major microelement which is necessary for normal activity of an organism: is a part of hemoglobin of the erythrocytes, a myoglobin and many enzymes participating in processes of tissue respiration and blood formation regulates immunity.
In drug iron is in a type of complex compound of iron (III) hydroxide with a polymaltose. This complex is stable and does not emit iron in the form of free ions.
After intramuscular introduction, iron is quickly used in synthesis of hemoglobin and a myoglobin or transferred to ferriferous depots, regression of clinical and laboratory symptoms of the zhelezodefitsit is as a result reached.
Fersinol is shown to the indication to use for therapy and prevention of an iron deficiency anemia and all types of deficiency of iron of various genesis, for fast and effective replacement therapy
– serious deficiency of iron (for example, after blood loss)
– inefficiency of oral iron owing to disturbance of absorption from digestive tract, the different types of blood losses leading to post-hemorrhages
– intolerance of oral ferriferous drugs
– the deficiency of iron resistant to therapy
is entered by other drugs Fersinol only at the iron deficiency states confirmed with the corresponding laboratory researches.
The route of administration and doses
Is applied only intramusculary, and only at deep introduction!
After opening of an ampoule, solution should be entered immediately.
Before an injection to carry out the sensitivity test (0.5 ml of I/M).
For adults the daily dose makes 100 mg (1 ampoule).
For children the dose is calculated depending on age and the body weight of the child.
The course of parenteral treatment is defined by the attending physician with hemoglobin level, if necessary therapy continues oral iron preparations.
Maximum daily doses:
Children weighing up to 5 kg
¼ ampoules (0.5 ml = 25 mg of iron)
Children weighing from 5 to 10 kg
½ ampoules (1 ml = 50 mg of iron)
2 ampoules (4 ml = 200 mg of iron)
At normalization of clinical and laboratory symptoms of deficiency of iron to use drug within a month for completion of a reserve of iron in an organism.
At formation of a deposit in an ampoule solution is not suitable for use. Not to mix with other medicines.
– at the wrong technology of introduction – coloring of skin, morbidity,
inflammation in the place of an injection, infiltrates, abscesses
– arthralgias, myalgias, a hyperadenosis, fever,
– a lowering of arterial pressure
– a headache, dizziness
– short wind
– metal smack in a mouth, nausea, vomiting, a constipation, coloring a calla in
– urticaria, skin rash, an itching or anaphylactic reactions
of the Contraindication
– hypersensitivity to iron or other components of drug
– the anemias which are not connected with deficiency of iron (hemolytic,
megaloblastny, caused by a lack of B12 vitamin)
– disturbance of an erythrogenesis, a marrow hypoplasia
– excess of iron in an organism (hemochromatosis, a hemosiderosis)
– disturbance of mechanisms of utilization of iron (sideroakhrestichesky anemia,
– Osler’s syndrome – Randyu – Weber
– bronchial asthma
– Crohn’s disease
– pregnancy (I trimester)
– cirrhosis in a decompensation stage
APF Inhibitors enhance system effects. It is not necessary to apply along with oral ferriferous drugs (absorption of iron from a GIT decreases) therefore treatment by oral ferriferous drugs should be begun not earlier than in 1 week after the last injection.
At intramuscular administration of the drug Fersinol, interactions which develop at a concomitant use of drugs of bivalent iron with some food and medicinal substances were not observed (for example, tetracyclines).
At intramuscular introduction at the patient can develop the anaphylactic reactions caused by hypersensitivity. Thus, therapy by iron at parenteral administration has to be performed only at patients for whom therapy at intake is insufficient and/or impossible. Before use it is desirable to carry out the sensitivity test (a test dose: 0.5 ml in oil). In case of allergic reaction epinephrine and glucocorticoids can be applied.
It is possible to use only the intact ampoules. At formation of a deposit, solution is not suitable for use. After opening of an ampoule, solution should be entered immediately.
In the anemia which arose against the background of malignant tumors or infectious diseases, iron is deposited with RES (retikulo – an endothelial system) from where it can be mobilized and used only after treatment of a basic disease.
With care appoint to patients with a liver and renal failure, cardiovascular and allergic diseases. At children parenteral iron preparations can negatively influence a course of infectious process. In case of development of moderate allergic reactions, antihistaminic drugs are recommended, at development of heavy anaphylactic reaction — immediate administration of adrenaline. Means of cardiopulmonary resuscitation have to be available. It is possible to use only the intact ampoules. At formation of a deposit, solution is not suitable for use. After opening of an ampoule, solution should be entered immediately. It is not necessary to mix with other therapeutic drugs.
Pregnancy and the period of a lactation
It is contraindicated in the I trimester of pregnancy
Use in II and III trimesters perhaps only when the treatment outcome exceeds potential risk for a fruit.
In small quantities not changed iron from a polymaltose complex can get into breast milk, however emergence of undesirable effects at the children who are on breastfeeding is improbable.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Use of this drug does not influence ability to drive the car and other mechanisms.
Symptoms: The overdose can cause acute glut iron which is shown by hemosiderosis syndromes. The chronic excess of iron leads to development of hemochromatosis.
Treatment is symptomatic. In poisoning with iron to appoint desferroksamin or calcium disodium salt ethylene diamine of tetraacetic acid – EDTA. Desferroksami (chelate agent) has teratogenic properties.
A form of release and packing
On 2 ml of drug in ampoules of dark glass with the place of an exact break.
On 5 ampoules put in blister strip packaging from plastic.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a box of cardboard.
To Store storage conditions at a temperature up to 25 of 0C.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
According to the prescription
“Idol Ilach Dolum Sang. ve Tidzh. A.Sh.”, Turkey, according to the license “Bilim Ilach Sanayi ve A.Sh. Tidzharet”, Turkey
the Owner of the registration certificate
“Uorld Meditsin”, Great Britain
the Packer Idol Ilach Dolum Sang. ve Tidzh. A.Sh.”, Turkey, according to the license “Bilim Ilach Sanayi ve A.Sh. Tidzharet”, Turkey
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from the consumer on quality of products (goods) of RK, Almaty, Suyunbaya 222 BTel Ave. / fax: 8 (7272) 529090www.worldmedicine.kz