Composition, form of production and packaging
Solution for oral administration.
The solution for oral administration is transparent, brownish, with a pleasant characteristic cherry smell.
1 f.
iron protein succinylate 800 mg,
which corresponds to the content of Fe 3+ 40 mg
Auxiliary substances: sorbitol, propylene glycol, sodium methylparahydroxybenzoate, sodium propylparahydroxybenzoate, cherry flavoring (black cherry concentrated concentrate, vanillin, amyl acetate, small amounts of other ethers, benzaldehyde, clove bud oil, propylene glycol, diethylene glycol monoethyl ether, water), sodium saccharinate, purified water.
Powder for preparation of oral solution of white with a yellowish shade of color, odorless (in a sealed cap-dispenser [cap-container]).
100 mg
calcium folinate pentahydrate 235 Ојg,
which corresponds to a calcium content of folinate of 200 Ојg
or corresponds to a folinic acid content of 185 Ојg
Excipients: mannitol.
15 ml - polyethylene bottles (10) with a container cap containing 100 mg of powder - packs of cardboard.
15 ml - polyethylene bottles (20) with a container cap containing 100 mg of powder - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Anti-anemic drug. Contains iron and calcium folinate. Replenishes the lack of iron and folate in the body.
The main function of iron is the transfer of oxygen to the tissues. Iron is a part of hemoglobin, myoglobin, iron-containing cytochrome enzymes, carries electrons and acts as a catalyst for oxidation, hydroxylation and other metabolic processes.
Ferlatum Foul contains iron-protein succinylate, which is a complex compound, where the trivalent iron atoms are surrounded by a semisynthetic protein carrier, which prevents damage to the gastric mucosa. The protein carrier dissolves in the duodenum, releasing iron at the site of optimal absorption.
From the intestine to the blood, trivalent iron comes through active absorption, which explains the impossibility of overdose and poisoning.
Calcium folinate is the calcium salt of folic acid, which compensates for the lack of folate in the body.
PHARMACOKINETICS
Data on the pharmacokinetics of the drug are not available.
INDICATIONS
- treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia) and folate;
- Prevention of iron deficiency and folate during pregnancy, lactation, active growth, after prolonged bleeding, against a background of inadequate and unbalanced nutrition.
DOSING MODE
Ferlatum Fole should be taken orally before or after a meal.
Adults 1-2 vials / day in 2 divided doses (in an amount equivalent to 40-80 mg trivalent iron and 0.235-0.470 mg calcium folinate pentahydrate) or in accordance with the doctor's recommendations.
Children (from the neonatal period) at 1.5 ml / kg / day (in an amount equivalent to 4 mg / kg / day of ferric iron and 0.0235 mg / kg / day calcium folinate) in 2 divided doses or in accordance with the doctor's recommendations.
1 bottle (15 ml) contains: iron protein succinylate 800 mg (equivalent to 40 mg ferric iron) and 0.235 mg calcium folinate pentahydrate (equivalent to 0.185 mg folinic acid).
Pregnant for the prevention of iron deficiency anemia - 1 bottle / day. For treatment of latent or clinically pronounced iron deficiency - 1-2 vials / day in 2 divided doses.
After reaching the normal values ​​of serum iron and hemoglobin, the treatment is continued in a maintenance dose for at least 8-12 weeks.
Rules for the preparation of solution
To prepare a solution for oral administration, press forcefully onto the perforator of the dispenser cover so that the powder spills into the solution in the vial. Then vigorously shake the contents of the vial, remove the dosing lid and drink the solution from the vial.
SIDE EFFECT
Rarely: the appearance of gastrointestinal disorders that disappear when the dose is reduced or the drug is withdrawn.
CONTRAINDICATIONS
- hemochromatosis;
- violation of iron utilization (including lead anemia, sidero-anh- mastic anemia);
- non-iron deficiency anemia (including hemolytic anemia, megaloblastic anemia, caused by a lack of vitamin B 12 );
- chronic pancreatitis;
- cirrhosis of the liver;
- Hypersensitivity to the components of the drug.
With caution , the drug should be used for peptic ulcer of the stomach and duodenum, impaired absorption in the pathology of the small intestine (including enteritis, malnutrition syndrome, resection of the small intestine, resection of the stomach according to Billroth II with the inclusion of the duodenum).
PREGNANCY AND LACTATION
The use of Ferlatum Fole is especially recommended for the prevention and treatment of iron deficiency and folate, which develops during pregnancy and during breastfeeding.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug for cirrhosis.
APPLICATION FOR CHILDREN
Children (from the neonatal period) at 1.5 ml / kg / day (in an amount equivalent to 4 mg / kg / day of ferric iron and 0.0235 mg / kg / day calcium folinate) in 2 divided doses or in accordance with the doctor's recommendations.
SPECIAL INSTRUCTIONS
The continuous period of application of the drug Ferlatum Fall should not exceed 6 months, except for cases of chronic hemorrhage (including menorrhagia, hemorrhoids) and pregnancy.
Due to the possible development of allergic reactions, caution should be given to patients with intolerance to milk protein.
Ferlatum Foul contains sorbitol, so do not use the drug in patients with hereditary intolerance to fructose.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the employment of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (including driving vehicles).
OVERDOSE
To date, no signs of intoxication and excessive supply of the Ferlatum Fole drug have been described.
DRUG INTERACTION
With simultaneous application, no interaction of the Ferlatum Foul with other drugs was noted.
The absorption of iron can be increased by the simultaneous use of the drug Ferlatum Fole with ascorbic acid at a dose> 200 mg.
Absorption of iron can be reduced with the simultaneous use of the drug Ferlatum Foul with antacids.
Chloramphenicol causes a delayed response to iron therapy.
Pharmacological interaction with the simultaneous application of the Forlatum Foll preparation with antagonists of histamine H2-receptors is absent.
Some antitumor and antileukemic drugs (including aminopterin, methotrexate and other pterin derivatives) exhibit the properties of folate antagonists.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
