Davita Fevit (Food supplement)

Print
(Food supplement)
Barcode: 8935206006827
Description

INFORMATION FOR MEDICAL STAFF

COMPOSITION:
Ferrous fumarate .........................162 mg
(Equivalent to 53.25 mg of elemental iron)
Folic acid ................................... 0.75 mg
Vitamin B12 ...............................7.5 mcg
Excipients q.s........................... 1 capsule
(DL-Tocopheryl acetate, white beeswax, lecithin, palm oil, soy-bean oil, gelatin 150 bloom, glycerin, sorbitol solution, potassium sorbate, ponceau color, titanium dioxide, glycine, citric acid monohydrate).
PHARMACEUTICAL FORM: Soft capsule.
PHARMACODYNAMIC PROPERTIES:
ATC code: B03AE01
Iron is necessary for the formation of haemoglobin, myoglobin and cytochrome C respiratory enzymes.
Folic acid is an indispensable element in the synthesis of nucleoprotein and normal erythropoiesis. Deficiency of folic acid causes megaloblastic anaemia (like anemia due to vitamin B12 deficiency).
Vitamin B12 has hematopoietic effect. When vitamin B12 levels are not enough, function of several types of folic acid has been reported to decline.
PHARMACOKINETIC PROPERTIES:
Folic acid is normally absorbed from the duodenum and jejunum. Iron is stored in the body in two forms: ferritin and hemosiderin. About 90% of iron entered into the body is excreted in the feces.
Folic acid is absorbed, mainly from the proximal part of the small intestine. The drug is mainly stored in the liver and is actively concentrated in the cerebrospinal fluid. Every day around 4 - 5 mcg of folic acid is excreted in urine.
Vitamin B12 is absorbed through the intestine, mainly in the ileum. After absorption, vitamin B12 links transcobalamin II and is rapidly removed from plasma to distribute priority in the liver parenchyma. The liver is a store of vitamin B12 to other tissues. Vitamin B12 is excreted in the bile.
PRESENTATIONS: Box of 3 blisters x 10 soft capsules.
THERAPEUTIC INDICATIONS:
Treatment of iron deficiency anemia in pregnant women, children, adolescents, or adults with internal bleeding such as intestinal bleeding or colon cancer and bleeding ulcers, and in patient taking hemodialysis or gastric surgery.
Prophylaxis of iron and folic acid deficiency in children, young women during the menstrual period, women in reproductive age with blood loss and pregnant women who need more iron to increase blood volume and fetus development.
DOSAGE & ADMINISTRATION:
1 capsule once to twice daily after meals.
Or as directed by the physician.
CONTRAINDICATIONS:
A history of hypersensitivity to any component of the medication.
Malignancy; haemochromatosis: hemochromatosis, haemosiderosis, and hemolytic anemia.
PRECAUTIONS: Caution should be exercised in patients who may suffer from folate dependent tumors, allergy to soybeans, peanuts, ponceau, fructose intolerance.
Pregnancy and lactation: Bofit F can be used during pregnancy and lactation.
Effects on works: No studies have been shown on drivers, machinery users, height workers, and other cases.
INTERACTIONS:
Concurrent use of the drug and sulfasalazine, anticonvulsants, cotrimoxazole should be taken caution.
Avoid concomitant use of the drug with quinolone, tetracycline antibiotics; penicillamine, carbidopa/levodopa, methyldopa, parathyroid hormones, zinc salts, tea and antacids such as calcium carbonate, sodium carbonate, magnesium trisilicate.
UNDESIRABLE EFFECTS:
The side effects relate to gastrointestinal tract: epigastric pain, nausea, vomiting, constipation.
OVERDOSE:
Toxic dose may cause a moderate poisoning at dose of below 30 mg of Fe2+ per kg body-weight and a severe poisoning at dose of above 60 mg of Fe2+ per kg body-weight. Fatal dose may be from 80 to 250 mg of Fe2+ per kg body-weight. Minimum fatal dose in children is reported 650 mg of Fe2+.
Symptoms: abdominal pains, nausea, vomiting, bleeding diarrhea, dehydration, acidosis, doze-accompanied shock. There are periods which seem recoverable with no symptoms; but after 6 to 24 hours the symptoms reappear including hemopexis and cardiovascular collapse. Some manifestations including high fever, hypoglycemia, liver poisoning, renal impairment, convulsions, and coma are reported.
Management: Firstly, gastric lavage with milk (or carbonate solution) is immediately employed, then pumping deferoxamine solution. Blood pressure is, if necessary, increased by dopamine. Dialysis is indicated in case of renal impairment. Adjustment of acid-base and electrolyte equilibrium and rehydration are advised.
Read the directions carefully before use.
For more information, please consult a physician.
STORAGE CONDITIONS:
Store in dry places, not exceeding 30oC, protect from light.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT:      INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.
Keep out of reach of children
Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Ferrous fumarate ........................ 162 mg
(Equivalent to 53.25 mg of elemental iron)
Folic acid ................................... 0.75 mg
Vitamin B12 ...............................7.5 mcg
Excipients q.s........................... 1 capsule
(DL-Tocopheryl acetate, white beeswax, lecithin, palm oil, soy-bean oil, gelatin 150 bloom, glycerin, sorbitol solution, potassium sorbate, ponceau color, titanium dioxide, glycine, citric acid monohydrate).
PRODUCT DESCRIPTION:
Long, red, soft capsules containing brown drug solution.
PRESENTATION:
Box of 3 blisters x 10 soft capsules.
WHAT THE DRUG IS USED FOR:
Treatment of iron deficiency anemia in pregnant women, children, adolescents, or adults with internal bleeding such as intestinal bleeding or colon cancer and bleeding ulcers, and in patient taking hemodialysis or gastric surgery.
Prophylaxis of iron and folic acid deficiency in children, young women during the menstrual period, women in reproductive age with blood loss and pregnant women who need more iron to increase blood volume and fetus development.
HOW TO TAKE THIS MEDICINE:
1 capsule once to twice daily after meals.
Or as directed by the physician.
WHEN SHOULD YOU NOT TAKE THIS MEDICINE:
A history of hypersensitivity to any component of the medication.
Malignancy; haemochromatosis: hemochromatosis, haemosiderosis, and hemolytic anemia.
UNDESIRABLE EFFECTS:
The side effects relate to gastrointestinal tract: epigastric pain, nausea, vomiting, constipation.
Inform your physician about any adverse effects occur during the treatment.
WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:
Concurrent use of the drug and sulfasalazine, anticonvulsants, cotrimoxazole should be taken caution.
Avoid concomitant use of the drug with quinolone, tetracycline antibiotics; penicillamine, carbidopa/levodopa, methyldopa, parathyroid hormones, zinc salts, tea and antacids such as calcium carbonate, sodium carbonate, magnesium trisilicate.
WHAT SHOULD YOU DO IF YOU MISS A DOSE:
The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.
HOW TO STORE THIS MEDICINE:
Store in dry places, not exceeding 30oC, protect from light.
SIGNS AND SYMPTOMS OF DRUG OVERDOSE:
Toxic dose may cause a moderate poisoning at dose of below 30 mg of Fe2+ per kg body-weight and a severe poisoning at dose of above 60 mg of Fe2+ per kg body-weight. Fatal dose may be from 80 to 250 mg of Fe2+ per kg body-weight. Minimum fatal dose in children is reported 650 mg of Fe2+.
Symptoms: abdominal pains, nausea, vomiting, bleeding diarrhea, dehydration, acidosis, doze-accompanied shock. There are periods which seem recoverable with no symptoms; but after 6 to 24 hours the symptoms reappear including hemopexis and cardiovascular collapse. Some manifestations including high fever, hypoglycemia, liver poisoning, renal impairment, convulsions, and coma are reported.
WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:
Management: Firstly, gastric lavage with milk (or carbonate solution) is immediately employed, then pumping deferoxamine solution. Blood pressure is, if necessary, increased by dopamine. Dialysis is indicated in case of renal impairment. Adjustment of acid-base and electrolyte equilibrium and rehydration are advised.
WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE:
Caution should be exercised in patients who may suffer from folate dependent tumors, allergy to soybeans, peanuts, ponceau, fructose intolerance.
Pregnancy and lactation:
Bofit F can be used during pregnancy and lactation.
Effects on works:
No studies have been shown on drivers, machinery users, height workers, and other cases.
WHEN SHOULD YOU CONSULT YOUR DOCTOR, PHARMACIST:
If you need further information, please consult your doctor or pharmacist.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT:

Reviews

There are yet no reviews for this product.