Ferlatum Foul
Ferlatum Fol (iron protein succinylate + calcium folinate pentahydrate) is an antianemic drug, a stimulator of hematopoiesis. Compensates for deficiency of iron and folic acid salts. The main task of iron is to transport oxygen to tissues and cells. This trace element is a component of hemoglobin, myoglobin (oxygen-binding protein of striated muscles and myocardium), and cytochrome enzymes. Iron works as a carrier of electrons to places where they are in demand, stimulates the occurrence of redox reactions, hydroxylation reactions and other metabolic processes. The protein succinylate contained in the drug ferlatum fol is a complex compound in which a semi-synthetic protein carrier is “encrusted” with ferric iron atoms. The protein carrier is hydrolyzed in the duodenum, releasing iron in the place most convenient for its absorption. In addition, it prevents possible damage to the gastric mucosa. The entry of ferric iron from the intestines into the blood is carried out through active absorption, which virtually eliminates the risk of overdose and poisoning. The second component of ferlatum foul - calcium folinate - replenishes folate deficiency in the body. This is a calcium salt of folinic acid, which is two orders of magnitude more active than folic acid.
Ferlatum foul has a combined release form: an oral solution containing iron protein succinylate, and a powder for preparing an oral solution containing calcium folinate pentahydrate. It is recommended to take the drug before or after meals. The daily dose for adults is 1-2 bottles in 2 doses, for children (including newborns) - 1.5 ml per 1 kg of body weight in the same 2 doses. The doctor may recommend other doses of the drug. To prevent the development of iron deficiency, pregnant women are recommended to take 1 bottle per day. For the treatment of latent or clinically pronounced iron deficiency anemia, they are prescribed 1-2 bottles per day for 2 doses.
After normalization of iron and hemoglobin levels, maintenance therapy is continued for at least another 2-3 months. A solution of ferlatum foul for oral administration is prepared as follows: press the perforator of the dispenser cap (for this you need to apply a certain force) so that the powder pours into the solution in the bottle, then vigorously shake the resulting suspension until the contents are homogenized. Then remove the dispenser cap and drink the resulting solution. The maximum duration of continuous use of ferlatum foul is 6 months. In case of chronic blood loss (for example, hemorrhoids, menorrhagia) and pregnancy, the duration of the pharmacotherapeutic course may be increased. Due to the risk of developing allergic reactions in persons with milk protein intolerance, such patients should be especially careful when using the drug. Ferlatum foul contains sorbitol, which excludes the possibility of its use by persons with genetically determined fructose intolerance. To date, the medical literature and periodicals have not described a single case of poisoning from excessive intake of ferlatum foul into the body. There have also been no descriptions of adverse drug interactions between this drug and other drugs when used together. The absorption of iron in the digestive tract increases when ferlatum foul is combined with vitamin C at a dose of over 200 mg. The opposite situation is observed when taking the drug together with drugs that reduce gastric acidity. Some cytotoxic and antileukemic drugs exhibit folate antagonism.
The effectiveness of ferlatum foul in the correction of iron deficiency conditions in pregnant women compared to traditional iron monotherapy was confirmed in a multicenter randomized clinical trial, the results of which concluded that the combination drug was superior.
Ferlatum, 20 pcs., 15 ml, 800 mg/15 ml, oral solution
INSTRUCTIONS FOR MEDICAL USE OF THE DRUG FERLATUM (FERLATUM)
APPROVED BY THE PHARMACOLOGICAL COMMITTEE OF THE RUSSIAN MINISTRY OF HEALTH ON APRIL 12, 2001. PROTOCOL No. 6
Registration number: p No. 013855/01–2002
Trade name of the drug: Ferlatum
International nonproprietary name: Protein iron succinylate
Dosage form: Oral solution
COMPOUND
1 bottle (15 ml) contains:
Active substance
: protein iron succinylate - 800 mg (equivalent to 40 mg Fe3+).
Excipients
: sorbitol; propylene glycol; sodium methyl p-hydroxybenzoate; sodium propyl parahydroxybenzoate; Morella flavoring agent; sodium saccharin; purified water.
Pharmacotherapeutic group
Antianemic drug. Iron supplement.
pharmachologic effect
The ferric iron contained in the drug replenishes the lack of iron in the body, in particular in case of iron deficiency anemia.
INDICATIONS FOR USE
— Treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia).
— Preventive therapy for iron deficiency during pregnancy.
CONTRAINDICATIONS
- Hypersensitivity to the drug.
— Excess iron in the body (hemosiderosis).
— Impaired iron utilization (lead anemia, sideroachrestic anemia).
- Non-iron deficiency anemia (hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).
- Chronic pancreatitis.
- Cirrhosis of the liver.
METHOD OF APPLICATION AND DOSES
Ferlatum is taken orally, preferably before meals.
Adults: 1–2 bottles per day (equivalent to 40–80 mg Fe3+), or as recommended by a physician, in two divided doses.
Children: 1.5 ml/kg/day (equivalent to 4 mg/kg/day Fe3+), in two divided doses or as recommended by a physician.
SIDE EFFECT
Gastrointestinal disorders (including diarrhea, constipation, nausea and epigastric pain) may occur when using increased doses of Ferlatum, which disappear when the dose is reduced or the drug is discontinued.
If side effects associated with taking the drug occur, you should inform your doctor.
OVERDOSE
The first 6–8 hours after using an excessive dose of the drug are characterized by the appearance of epigastric pain, nausea, vomiting (sometimes mixed with blood), diarrhea, in some cases accompanied by drowsiness, pallor of the skin, shock, even coma. Emergency treatment measures before qualified medical care are provided include gastric lavage.
INTERACTIONS WITH OTHER MEDICINES
Iron derivatives contribute to disruption of the absorption processes of tetracyclines in the gastrointestinal tract; therefore, their simultaneous use should be avoided.
Iron absorption can be increased with simultaneous administration of more than 200 mg of ascorbic acid and reduced with the use of antacids. Chloramphenicol causes a delayed response to iron therapy.
There was a lack of pharmacological interaction with concomitant treatment with H2 receptor antagonists.
USE IN PREGNANT AND NURSING WOMEN
Ferlatum is indicated for iron deficiency conditions that develop during pregnancy and lactation.
INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND WORK WITH MECHANISMS
No decrease in patient reactions was noted during the use of the drug (including driving vehicles and working with mechanical equipment).
SPECIAL INSTRUCTIONS
The total period of use of Ferlatum should not exceed 6 months, with the exception of cases of chronic blood loss (menorrhagia, hemorrhoids, etc.) and pregnancy.
RELEASE FORM
An oral solution containing 800 mg of protein ferrous succinylate is packaged in 15 ml plastic bottles.
The cardboard box contains 10 plastic bottles of 15 ml each.
STORAGE CONDITIONS
Store at a temperature not exceeding 25°C out of the reach of children.
BEST BEFORE DATE
2 years. Do not use a drug that has expired.
CONDITIONS OF VACATION FROM PHARMACIES
By doctor's prescription.
Ferlatum Fol solution for oral administration 15 mg fl PE 100 mg powder N10
Registration Certificate Holder
ITALFARMACO (Italy)
Dosage form
Medicine - Ferlatum FOL (Ferlatum FOL)
Description
Oral solution.
The solution for oral administration is transparent, brownish in color, with a pleasant characteristic cherry odor.
1 fl.
iron protein succinylate 800 mg, which corresponds to Fe3+ content 40 mg
Excipients
: sorbitol, propylene glycol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, cherry flavor (concentrated wild black cherry flavor, vanillin, amyl acetate, small amounts of other esters, benzaldehyde, clove bud oil, propylene glycol, diethylene glycol monoethyl ether, water), sodium saccharinate, purified water .
Powder for the preparation of oral solution is white with a yellowish tint, odorless (in a sealed dispenser cap [container cap]).
100 mg
calcium folinate pentahydrate 235 mcg, which corresponds to the content of calcium folinate 200 mcg or equivalent to the content of folinic acid 185 mcg
Excipients
: mannitol.
15 ml - polyethylene bottles (10) with a container cap containing 100 mg of powder - cardboard packs. 15 ml - polyethylene bottles (20) with a container cap containing 100 mg of powder - cardboard packs.
Indications
- treatment of latent and clinically significant iron deficiency (iron deficiency anemia) and folate;
- prevention of iron and folate deficiency during pregnancy, lactation, active growth, after prolonged bleeding, against the background of inadequate and unbalanced nutrition.
Contraindications for use
- hemochromatosis;
- violation of iron utilization (including lead anemia, sideroachrestic anemia);
- non-iron deficiency anemia (including hemolytic anemia, megaloblastic anemia caused by a lack of vitamin B12);
- chronic pancreatitis;
- cirrhosis of the liver;
- hypersensitivity to the components of the drug.
Carefully _
the drug should be used for peptic ulcers of the stomach and duodenum, malabsorption in pathologies of the small intestine (including enteritis, malabsorption syndrome, resection of the small intestine, gastric resection according to Billroth II with the inclusion of the duodenum).
pharmachologic effect
Antianemic drug. Contains iron and calcium folinate. Replenishes the lack of iron and folate in the body.
The main function of iron is to transport oxygen to tissues. Iron is part of hemoglobin, myoglobin, iron-containing cytochrome enzymes, transfers electrons and works as a catalyst for oxidation reactions, hydroxylation and other metabolic processes.
Ferlatum Fol contains iron-protein succinylate, which is a complex compound where ferric iron atoms are surrounded by a semi-synthetic protein carrier that prevents damage to the gastric mucosa. The protein carrier dissolves in the duodenum, releasing iron at the site of optimal absorption.
Ferric iron enters the blood from the intestines through active absorption, which explains the impossibility of overdose and poisoning.
Calcium folinate is the calcium salt of folinic acid, which replenishes the lack of folate in the body.
Drug interactions
With simultaneous use, there was no interaction of the drug Ferlatum Fol with other drugs.
Iron absorption can be increased with simultaneous use of Ferlatum Fol with ascorbic acid in a dose of >200 mg.
Iron absorption may be reduced when Ferlatum Fol is used concomitantly with antacids.
Chloramphenicol causes a delayed response to iron therapy.
There is no pharmacological interaction with the simultaneous use of Forlatum Fol with histamine H2 receptor antagonists.
Some antitumor and antileukemic drugs (including aminopterin, methotrexate and other pterin derivatives) exhibit folate antagonist properties.
Dosage regimen
Ferlatum Fol should be taken orally before or after meals.
For adults
1-2 bottles/day in 2 doses (in an amount equivalent to 40-80 mg of ferric iron and 0.235-0.470 mg of calcium folinate pentahydrate) or as recommended by a doctor.
Children (from the neonatal period)
1.5 ml/kg/day (in an amount equivalent to 4 mg/kg/day ferric iron and 0.0235 mg/kg/day calcium folinate) in 2 divided doses or as recommended by a physician.
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 the treatment of latent or clinically pronounced iron deficiency
- 1-2 bottles/day in 2 divided doses.
After achieving normal levels of serum iron and hemoglobin, treatment is continued at a maintenance dose for at least 8-12 weeks.
Rules for preparing the solution
To prepare the solution for oral administration, press firmly on the perforator of the dispenser cap so that the powder pours into the solution in the bottle. Then you should vigorously shake the contents of the bottle, remove the dispenser cap and drink the solution from the bottle.
Overdose
To date, no signs of intoxication or excessive intake of the drug Ferlatum Fol into the body have been described.
Side effect
Rarely:
the appearance of gastrointestinal disorders that disappear when the dose is reduced or the drug is discontinued.
special instructions
The continuous period of use of the drug Ferlatum Fol should not exceed 6 months, with the exception of cases of chronic blood loss (including menorrhagia, hemorrhoids) and pregnancy.
Due to the possible development of allergic reactions, the drug should be prescribed with caution to patients with milk protein intolerance.
Ferlatum Fol contains sorbitol, so the drug should not be used in patients with hereditary fructose intolerance.
Effect on the ability to drive vehicles and operate machinery
The drug does not affect the performance of potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles).
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
Shelf life: 2 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - No restrictions. Restrictions when breastfeeding - No restrictions.
The use of Ferlatum Fol is especially recommended for the prevention and treatment of iron and folate deficiency that develops during pregnancy and breastfeeding.
Use for liver dysfunction
Restrictions for liver dysfunction - Contraindicated.
The use of the drug is contraindicated for liver cirrhosis.
Use in children
Restrictions for children - No restrictions.
Children (from the neonatal period)
1.5 ml/kg/day (in an amount equivalent to 4 mg/kg/day ferric iron and 0.0235 mg/kg/day calcium folinate) in 2 divided doses or as recommended by a physician.
Terms of sale
The drug is available with a prescription.
Contacts for inquiries
ITALFARMACO S.p.A. (Italy)
ITALFARMACO SpA
Representative office in Russia ITF LLC 115432 Moscow Andropov Avenue, 18, bldg. 6, off. 4-01 Tel. Fax
