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 solution for oral administration 15ml No. 20
Dosage
800 mg/15 ml
Active substance
Iron protein succinylate
Manufacturer
Italpharmaco S.p.A. (Spain)
Shelf life
2 years
Storage conditions
At a temperature not exceeding 25 °C
Registration certificate number
P N013855/01 dated 03/28/2017
Pharmacological actions
Replenishes iron deficiency and substrate stimulates heme synthesis.
Instructions
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.
Indications
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.
Contraindications
Hypersensitivity, hemosiderosis, hemochromatosis, aplastic, hemolytic and sideroblastic anemia, chronic pancreatitis, liver cirrhosis.
Directions for use and doses
Orally, before meals, adults - 1-2 bottles (amount equivalent to 40-80 mg of ferric iron) per day in 2 divided doses; children - 1.5 ml/kg/day (an amount equivalent to 4 mg/kg/day of ferric iron) in 2 divided doses. The course is no more than 6 months (except for cases of ongoing bleeding, menorrhagia and pregnancy).
Side effects
Epigastric pain, nausea, constipation, diarrhea.
Interaction
They interfere with the absorption of tetracyclines in the gastrointestinal tract. Absorption is increased by ascorbic acid (at a dose of over 200 mg); antacids reduce it. Chloramphenicol slows down the development of the effect (stimulation of erythropoiesis).
Overdose
Symptoms:
in the first 6–8 hours - epigastric pain, nausea, vomiting (including blood), diarrhea, drowsiness, pallor, shock, coma.
Treatment:
emetics, gastric lavage, adequate supportive therapy.
Pharmgroups
Hematopoiesis stimulants
Pharmaceutical actions
hematopoietic, antianemic
