PRESENTATION: Cap (soft-gelatin) 3 x 10’s. Syrup 120 ml
DESCRIPTION: Each capsule contains the following: Ferrous gluconate 250 mg, manganese sulfate monohydrate 0.2 mg, copper sulfate 0.2 mg, vitamin C (ascorbic acid) 50 mg, folic acid 1 mg, vitamin B12 (cyanocobalamin) 7.5 mcg. Each 5-ml syrup contains the following: Ferrous
gluconate 129.5 mg, vitamin B1 (thiamine HCl) 1 mg, vitamin B2 (riboflavin) 1 mg, vitamin B6
(pyridoxine HCl) 1.5 mg, nicotinamide 15 mg and biotin 0.3 mg
ACTIONS: Pharmacology: Vltamin B1: Thiamine or thiamin is essential for normal growth and development and helps to maintain proper functioning of the heart and the nervous and digestive systems. Thiamine is water-soluble and cannot be stored in the body; however, once absorbed, the vitamin is concentrated in muscle tissue. Vitamin B2• Riboflavin is required for a wide variety of cellular processes. Like the other B-vitamins, it plays a key role in energy metabolism and is required for the metabolism of fats, carbohydrates and proteins,
Vitamin B6: Vitamin B6 is a cofactor in many reactions of amino acid metabolism, including transamination, deamination and decarboxylation. Pyridoxal phosphate (PLP) is also necessary for the enzymatic reaction governing the release of glucose from glycogen,Vitamin B12:Cyanocobalamin is important for the normal functioning of the brain and nervous system and for the formation of blood It is involved in the metabolism of every cell of the body, especially affecting the DNA synthesis and regulation, Cyanocobalamin is also involved in fatty acid synthesis and energy production, Its effects are still not completely known .Folic Acid: Folic acid and folate (the anion form) are necessary for the production and maintenance of new cells. This is especially imponant during periods of rapid cell division and growth e.g., infancy and pregnancy. Folate is needed to replicate DNA. Both adults and children need folate to make normal red blood cells and to prevent anemia. Manganese: Manganese is an essential trace nutrient; in the presence of oxygen, it deals with the toxic effects of superoxide, formed from the 1-electron reduction of dioxygen.
Pharmacokinetics: Absorption: The absorption is increased when iron stores are depleted or red blood cell production is increased. Conversely, high iron-blood concentrations decrease absorption. The average dietary intake of iron is 18-20 mg/day. Approximately 10% of this iron is absorbed in healthy individuals and about 20-30% in iron-deficient individuals.
Orally administered iron is absorbed most efficiently when it is administered between meals. However, conventional iron preparations frequently cause gastric irritation when taken on an empty stomach. Although food can decrease the absorption of iron by 40-56%; gastric intolerance may necessitate administering the drug with food.
Distribution: Ferrous iron passes through gastrointestinal mucosal cells directly into the blood and is immediately bound to transferrin. Transferrin, a glycoprotein b1-globulin, transports iron to the bone marrow where it is incorporated into the hemoglobin. Small excesses of iron within the villous epithelial cells are oxidized to the ferric state. Ferric iron combines with the protein apoferritin to yield ferritin and is stored in mucosal cells which are exfoliated at the end of their lifespan and excreted in the feces.
INDICATIONS: Capsules: indicated for the following traumatic endogenous hemorrhages and anemia, during pregnancy, old age and convalescence. Secondary anemia due to infections, intoxications and tumors.Macrocytlc hyperchromic anemias, for instance during pregnancy, in sprue or parasitosis.Alimentary anemias due to general dietary insufficiency and poorly balanced food. Anemia prophylaxis in blood donors.
Syrup: Iron deficiency anemia in children. Latent insufficiencies of iron and the B—vitamins contain Sangobion syrup during the growth period. Iron deficiencies after loss of blood in chronic illness and during convalescence.
DOSAGE & ADMINISTRATION: Capsule: Unless otherwise prescribed by the physician, initially 1cap during or after the meal is administered 3 times. With increased improvement of the blood the daily dose may be reduced to 3 times 1cap or according to the physician’s prescription.
Syrup: Iron and Vitamin Supplement, or as Pro-phylaxis Against Iron and Vitamin E Deficiencies: 1 teaspoon daily.
Therapy for Iron Deficiencies: 3-S teaspoonful daily. It is advisable to correlate the therapeutic does to the acuteness of the deficiency (with or without deficiency) and to the age ofthe child. The treatment should be continued until the red blood count, iron content in the serum and the binding capacity iron has normalized. Afterwards, the medicine can continued for 1-2 months to replenish the iron reserves.
OVERDOSAGE: Acute over dosage of iron may cause nausea and vomiting, and in severe cases cardiovascular collapse and death. The lethal dose of orally ingested elemental iron is estimated to be 180-300 mg/kg of body weight.
CONTRAINDICATIONS: Hypersensitivity to any of components of Sangobion capsule and syrup: patients with thalassemia, sideroblastic anemia, hemochromatosis and hemosiderosis; rare instance of hypersensitivity to folic acid.
PRECAUTIONS: Where anemia exists, its nature should be established and underlying causes determined. Concomitant parenteral therapy with vitamin B12 may be necessary in patients with deficiency of vitamin B12.Pernicious anemia is rare in women of childbearing age and the likelihood of its occurrence along with pregnancy is reduced by the impairment of fertility associated with vitamin B12 deficiency.
Caution should be exercised when dosing ascorbic acid in patients with chronic renal failure and in patients with chronic renal failure and in patient receiving acetylsalicylic acid.
Use in lactation: Folic acid, ascorbic acid and complex vitamins are excreted in breast milk.
ADVERSE REACTIONS: Allergic sensitization has been reported following oral and parenteral administration of folic acid.Allergic reactions, including rash, pruritusanaphylaxis have been reported with vitamin use.
INTERACTIONS: Eggs inhibit iron absorption. Col-fee meal and tea consumed with a meal or 1 hr after meal may significantly inhibit the absorption of dietary iron. Its clinical significance has not been determined. Oral iron preparations should not be taken within 1 hr or 2 hrs after ingestion of the abovementioned food products.
STORAGE: Capsules: Store at B°-15°Cfrom sunlight and humidity.
Syrup: Store below 30°C. Protect from light and heat.
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