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1. Drug name
Frizovit
2. Drug formula ingredients
Each 5 ml contains: Elemental iron (as Iron(III) hydroxide polymaltose complex) 50mg
3. Dosage form
Oral solution
4. Route of administration
Oral route.
5. Indications
- Prevention and treatment of iron deficiency anemia:
- Pregnant women
- Breastfeeding women
- Malnourished people
- Patients after surgery
6. Administration, dosage
Dosage and duration of drug use depend on the level of iron deficiency of each patient.
Adults and children over 12 years old: Take 1 tube each time x 2 times/day.
Children under 12 years old: Use as directed by a physician.
Dosage should be divided into small portions for use throughout the day.
7. Contraindications
Do not use the drug for people who are hypersensitive to any ingredient of the drug.
Patients with anemia not caused by iron deficiency include hemolytic anemia, reduced bone marrow production, and disordered erythropoiesis.
8. Special warnings and precautions for use
Overuse of medicine can cause poisoning in children. Therefore, caution should be exercised during use.
Do not abuse the drug and use according to the recommended dosage.
Be cautious when using for subjects including: People with allergies, people with gastrointestinal diseases, patients with liver or kidney failure.
9. Fertility, pregnancy and lactation
The medicine can be used for pregnant women and breastfeeding mothers to supplement iron in the body. However, it should be used according to the dosage prescribed by your doctor.
10. Effects on ability to drive and use machines
The drug does not affect the ability to drive and operate machinery.
11. Drug interactions and incompatibilities
Use iron 2 hours apart when being treated with tetracycline, Chloramphenicol , Levodopa , fluoroquinolone, Methyldopa , penicillamine and Levothyroxine .
Do not use antacids within 2 hours of taking the medicine.
12. Undesirable effects
The drug is well tolerated, side effects are less frequent than with preparations containing inorganic iron.
If you experience any of the following unwanted effects, notify your doctor for timely treatment:
13. Overdose and treatment
There have been no reports of drug overdose. However, if an overdose occurs, the patient should be taken to a medical facility for timely treatment.
14. Pharmacodynamic properties
Pharmacological group: Medicines to treat anemia, oral preparations containing iron (III), iron complex with isomaltose.
ATC code: B03AB05
Iron salts play an important role in the prevention and treatment of iron deficiency anemia. Normally, the body will store iron in the form of ferritin and hemosiderin to synthesize hemoglobin. Iron (III) is less able to diffuse across mucosal membranes than iron (II) due to its large molecular mass. Because there is no free iron ion, IPC complex (iron (III) hydroxide polymaltose) has high safety and lower toxicity than iron (II), thereby causing less irritation and increasing patient tolerance. .
The use of IPC in the prevention and treatment of iron deficiency cases with clinically proven effectiveness, hemoglobin values can increase up to 0.8mg/dl per week.
15. Pharmacokinetic properties
Iron absorption in the body is a physiological process. After contacting the iron binding site on the mucosal surface, IPC will release iron (III), at which time iron (III) will be actively transported and in mucosal cells. Here, it will bind to ferritin and transferrin. The bioavailability of the drug does not depend on the presence of food.
The half-life of iron is about 90 minutes. The iron in preparations is usually iron(II), so iron(II) absorption is passive and uncontrolled. Unlike iron (II), IPC has higher safety, causes less stomach irritation, and rarely interacts with other substances.
16. Packaging specifications
Box of 20 tubes x 5 ml with instructions for use.
17. Storage conditions, expiration date, and quality standards of the drug
Storage conditions: Cool and dry place, protected from light, temperature not exceeding 30 o C.
Expiry date: 24 monthsfrom the date of manufacture.
Quality standards of drugs: IN HOUSE
18. Name and address of the drug manufacturing facility
Euro Santé Pharmaceutical Joint Stock Company
Song Cung industrial site, Dong Thap commune, Dan Phuong district, Hanoi city, Vietnam.
