Instructions for use RANFERON-12 (RANFERON-12)

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pharmachologic effect

Fersinol is used to treat iron deficiency anemia.
When iron enters the body, it enters the liver system, spleen and bone marrow, and becomes part of transferrin and apoferritin.

Iron combines with hemoglobin, myoglobin and iron-containing enzymes, and is also in the form of ferritin.

It has no effect on erythropoiesis, nor does it have a therapeutic effect for anemia that has a different etiology.

A small amount of iron is excreted from the body.

Indications for use

Used as replacement therapy for severe iron deficiency.

For the purpose of treatment and prevention of iron deficiency in cases where taking oral medications is impossible or does not have the desired effect:

  • resistance to oral iron supplements;
  • iron malabsorption;
  • patient's reluctance to take iron orally;
  • for acute diseases of the digestive tract.

Mode of application

Intramuscular administration only.
Before complete administration, a test is carried out. And if there is no change in the patient’s condition within half an hour, the drug is administered completely.

The dose of the drug is calculated by the doctor depending on the degree of iron deficiency.

For children:

Up to 5 kg – one fourth ampoule/day,

5–10 kg – half an ampoule/day,

10–45 kg – 1 ampoule/day.

Adults weighing more than 45 kg – 2 ampoules/day.

The course dose does not exceed the calculated number of ampoules.

Side effects

Side effects are manifested by the following symptoms:

  • skin color changes, pain and inflammation appear at the injection site;
  • joint pain;
  • swollen lymph nodes;
  • increased body temperature;
  • headache, general weakness;
  • manifestations of impaired gastrointestinal function;
  • allergic manifestations.

Treatment is symptomatic.

Contraindications

Contraindications are:

  • Individual iron intolerance.
  • Anemia of another origin.
  • Hemosiderosis or hemochromatosis.
  • Lack of iron absorption.
  • Osler-Rendu-Weber syndrome, acute kidney infection, uncompensated liver cirrhosis, chronic polyarthritis, bronchial asthma, infectious hepatitis.

Pregnancy

Do not use Fersinol during the first trimester of pregnancy.
At a later date, it is prescribed by the attending physician when the benefit of taking it outweighs the risk.

Drug interactions

Do not use with iron preparations that are intended for oral administration, as there is a decrease in their absorption from the gastrointestinal tract.
ACE inhibitors increase the effect of iron.

It is not allowed to mix the drug in the same syringe with other agents, with the exception of a sterile isotonic sodium chloride solution

Overdose

Manifests itself as hemosiderosis or hemochromatosis.
Therapy is symptomatic.

Release form

Ampoules 2 ml/100 mg, pack of five pieces

Storage conditions

Storage temperature should be below 25 degrees Celsius

Compound

1 ampoule:
Main substance:

Iron (III) hydroxide polymaltose complex – 100 mg;

Excipient: water for injection.
Attention! The description of the drug on this page is simplified. Before purchasing and using the drug, consult your doctor or pharmacist, and also read the instructions approved by the manufacturer. Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. ATTENTION! This section is provided for informational purposes only and is not a catalog or price list of our company. To obtain information about the availability of drugs, call + 99871 202 0999 Pharmacy Network Helpline 999.

Instructions for use RANFERON-12 (RANFERON-12)

Antianemic drug. Complex of vitamins with microelements. Anemia often occurs in women of childbearing age, young children, pregnancy and lactation, as well as in the elderly. Causes of anemia include iron deficiency and, less commonly, folic acid or cyanocobalamin deficiency.

Iron

is an integral part of heme and plays a significant role in oxygen transport, as well as in oxidative metabolic reactions and other metabolic processes. With increased loss of iron or insufficient intake from food, the body's iron supply is gradually depleted, iron deficiency occurs, and as a result, anemia. The need for iron increases in early childhood, during puberty, pregnancy and lactation. The most common cause of iron deficiency in adult men and postmenopausal women is chronic blood loss (usually from the gastrointestinal tract).

The use of iron supplements for iron deficiency anemia is very effective, and, as a rule, dosage forms of iron salts are prescribed for oral administration.

To prevent iron deficiency anemia in predisposed patients, diet therapy with a high iron content in food, biologically active food supplements or medications containing iron salts is used, as well as sanitation of foci of chronic infection. Carrying out preventive measures is necessary during pregnancy, during menorrhagia, after gastrectomy and in pediatric practice when managing infants who had low birth weight.

Ranferon-12 in capsule form contains ferrous fumarate in an amount that allows the drug to be used for the treatment of iron deficiency anemia, as well as ascorbic acid, which significantly improves iron absorption.

Folic acid

and
cyanocobalamin
are representatives of the B vitamins and play a significant role in various metabolic processes. Deficiency of these vitamins can lead to the development of megaloblastic anemia and severe neurological disorders. Folic acid is necessary for the normal course of pregnancy and fetal development (protects against the formation of defects in the development of the neural tube). Ranferon-12 contains cyanocobalamin and folic acid in an amount that allows for the prevention of megaloblastic anemia.

Zinc

is part of many enzymatic systems and is present in all tissues of the body. The need for zinc increases during pregnancy and lactation. Zinc in multivitamin preparations is recommended for use during pregnancy (especially in women at risk or who do not receive adequate nutrition). Ranferon-12 contains zinc in an amount sufficient to meet the increased need for this microelement in various patients, incl. during pregnancy and lactation.

Fersinol-Z No. 30 caps.

FERSINOL Composition: Each capsule contains 150 mg of dried iron sulfate, 0.5 mg of folic acid, 10 mcg of cyanocobalamin, 100 mg of ascorbic acid. Excipients: dibasic calcium phosphate, purified talc, starch, polyvinyl pyrolidone, white beeswax, glyceryl monosterate, polyethylene glycol 6000. Pharmacological actions: Fersinol is a complex antianemic drug containing divalent iron in the form of a simple ferrous sulfate salt, vitamin B12, folic and ascorbic acid, intended for the treatment of iron deficiency conditions. The iron sulfate contained in Fersinol replenishes iron deficiency in the body. It is a constituent of hemoglobin, myoglobin and various other enzymes. Being a structural component of heme, it takes part in erythropoiesis. Ascorbic acid improves the absorption of iron in the intestines. Vitamin B12 and folic acid are involved in the formation and maturation of red blood cells. The active components of the drug Fersinol are located in a special neutral shell, which ensures their absorption, mainly from the upper part of the small intestine. The absence of local irritation on the gastric mucosa contributes to the good tolerability of Fersinol from the gastrointestinal tract. Indications: • Treatment of anemia caused by combined deficiency of iron, folic acid and vitamin B12, occurring against the background of chronic blood loss (gastrointestinal bleeding, bleeding from the bladder, bleeding from hemorrhoids, menopause and metrorrhagia), as well as against the background of chronic alcoholism , infectious diseases, taking anticonvulsants and oral contraceptives; • Treatment of anemia that occurs during pregnancy and lactation; • Prevention of iron and folic acid deficiency in the II and III trimesters of pregnancy, in the postpartum period, during lactation. Contraindications: • Anemia not associated with iron deficiency (hemolytic anemia, megaloblastic anemia associated with isolated vitamin B12 deficiency); • Increased iron content in the body (hemosiderosis); • Impaired iron utilization mechanisms (anemia caused by lead poisoning, sideroachrestic anemia). Side effects: From the digestive system: rarely - epigastric pain, diarrhea, constipation. Other: in some cases - allergic reactions. Pregnancy and lactation: Fersinol is prescribed during pregnancy and lactation as prescribed. Special instructions: During the period of taking the drug Fersinol, a dark coloration of the stool may be observed, which is due to the excretion of unabsorbed iron and has no clinical significance. Overdose: Symptoms: epigastric pain, nausea, vomiting, diarrhea, drowsiness, pale skin. Treatment: gastric lavage, symptomatic therapy. The antidote is desferroxamine. Interaction with other drugs: Organic acids, calcium salts, phosphates, phytin, cholestyramine, as well as antacid drugs containing aluminum, magnesium, calcium interfere with the absorption of iron due to the formation of insoluble complexes. Iron salts interfere with the absorption of tetracycline antibiotics in the gastrointestinal tract. Preparations containing pancreatic enzymes may reduce iron absorption. With simultaneous use of the drug Fersinol with phenobarbital, carbamazepine, sodium valproate, sulfasalazine, hormonal contraceptives, folic acid antagonists, trimethoprim, pyrimethamine, triamethren, the absorption of folic acid is reduced. Dosage regimen: For mild anemia, Fersinol is prescribed 1 caps. 1-2 times/day for 3-4 weeks; for moderate anemia – 1 caps. 1-2 times/day for 8-12 weeks; for severe anemia – 2 caps. 2 times/day for 16 weeks or more. To prevent iron and folic acid deficiency during pregnancy and lactation, Fersinol is prescribed 1 caps. 2 times a day in the II and III trimesters and in the postpartum period during breastfeeding. Fersinol capsules should be taken after meals. Storage conditions: Store at a temperature not exceeding 25o C. Keep out of the reach of children. Release form: Box containing 20 capsules.

Fersinol 100 mg/2 ml No. 5 solution d/in.amp.

Instructions for medical use of the drug Fersinol Trade name Fersinol International nonproprietary name No Dosage form Solution for injection 100 mg/2 ml Composition 2 ml of solution contain the active substance - iron (III) hydroxide polymaltose complex 333.33 mg (in terms of iron 100 mg ), excipient - water for injection. Description Dark reddish-brown homogeneous liquid Pharmacotherapeutic group Hematopoiesis stimulants. Fe +++ preparations for parenteral use. ATC code B03AC Pharmacological properties Pharmacokinetics Iron (III) hydroxide polymaltose complex contains as an active substance a nonionic iron compound based on a hydroxide-polymaltose complex of ferric iron equal to 100 mg of elemental iron. This combination is as close as possible to the structure of natural iron compounds with ferritin in serum and is designed for the prevention and treatment of iron deficiency conditions. With intramuscular injection, iron quickly enters the bloodstream: 15% of the dose after 15 minutes, 44% after 40 minutes. Cmax in blood plasma is achieved 24 hours after injection. Plasma protein binding – 90%. In the bloodstream it binds to transferrin, in tissues it is deposited as part of ferritin, and is used in the process of erythropoiesis. In the reticuloendothelial system, the complex is broken down into iron hydroxide and polymaltose (metabolized by oxidation). In small quantities, the unchanged complex can pass through the placental barrier and small amounts pass into breast milk. Iron bound to ferritin or transferrin can cross the placental barrier and, as part of lactoferrin, enters breast milk in small quantities. Following intramuscular administration, polymaltose iron(III) hydroxide complex as the active ingredient is absorbed primarily by the liver. There it is included in hemoglobin, myoglobin and other iron-containing enzymes, and is also found in the body in the form of ferritin. The half-life is 22.4 hours, the volume of distribution is 2.93 liters. Less than 1% of the total dose of the drug is excreted through the kidneys. Pharmacodynamics Fersinol is developed for the treatment and prevention of iron deficiency conditions. Iron is an essential trace element that is necessary for the normal functioning of the body: it is part of the hemoglobin of erythrocytes, myoglobin and many enzymes involved in the processes of tissue respiration and hematopoiesis, and regulates immunity. In the preparation, iron is in the form of a complex compound of iron (III) hydroxide with polymaltose. This complex is stable and does not release iron in the form of free ions. After intramuscular administration, iron is quickly used in the synthesis of hemoglobin and myoglobin or transferred to iron-containing depots, resulting in regression of clinical and laboratory symptoms of iron deficiency. Indications for use Fersinol is indicated for the treatment and prevention of iron deficiency anemia and all types of iron deficiency of various origins; for rapid and effective replacement therapy - severe iron deficiency (for example, after blood loss) - ineffectiveness of oral iron due to impaired absorption from the gastrointestinal tract, various types of blood loss leading to post-hemorrhages - intolerance to oral iron-containing drugs - iron deficiency resistant to therapy with other drugs Fersinol is administered only for iron deficiency conditions confirmed by appropriate laboratory tests. Method of administration and dosage: Used only intramuscularly, and only with deep injection! After opening the ampoule, the solution should be administered immediately. Before injection, perform a sensitivity test (0.5 ml I/M). For adults, the daily dose is 100 mg (1 ampoule). For children, the dose is calculated depending on the age and body weight of the child. The course of parenteral treatment is determined by the attending physician taking into account the hemoglobin level; if necessary, therapy is continued with oral iron supplements. Maximum daily doses: Children weighing up to 5 kg ¼ ampoules (0.5 ml = 25 mg iron) Children weighing from 5 to 10 kg ½ ampoule (1 ml = 50 mg iron) Adults 2 ampoules (4 ml = 200 mg iron) When normalization of clinical and laboratory symptoms of iron deficiency, use the drug for a month to replenish the iron reserve in the body. If a precipitate forms in the ampoule, the solution is not suitable for use. Do not mix with other medications. Side effects - if the injection technique is incorrect - skin coloring, pain, inflammation at the injection site, infiltrates, abscesses Rarely - arthralgia, myalgia, swollen lymph nodes, fever, malaise - decreased blood pressure - headache, dizziness - shortness of breath - metallic taste in the mouth , nausea, vomiting, constipation, dark discoloration of stool Very rarely - urticaria, skin rash, itching or anaphylactic reactions Contraindications - hypersensitivity to iron or other components of the drug - anemia not associated with iron deficiency (hemolytic, megaloblastic, caused by vitamin B12 deficiency ) - impaired erythropoiesis, bone marrow hypoplasia - excess iron in the body (hemochromatosis, hemosiderosis) - impaired iron utilization mechanisms (sideroachrestic anemia, lead anemia) - Osler-Rendu-Weber syndrome - bronchial asthma - Crohn's disease - pregnancy (I trimester) - Liver cirrhosis in the stage of decompensation Drug interactions ACE inhibitors enhance systemic effects. It should not be used simultaneously with oral iron-containing drugs (iron absorption from the gastrointestinal tract is reduced), therefore treatment with oral iron-containing drugs should begin no earlier than 1 week after the last injection. With intramuscular administration of the drug Fersinol, no interactions were observed that develop when taking ferrous iron preparations simultaneously with certain foods and medications (for example, tetracyclines). Special instructions When administered intramuscularly, the patient may develop anaphylactic reactions caused by hypersensitivity. Therefore, parenteral iron therapy should only be used in patients for whom oral therapy is insufficient and/or impossible. Before use, it is advisable to conduct a sensitivity test (test dose: 0.5 ml IM). In case of an allergic reaction, epinephrine and glucocorticoids may be used. Only undamaged ampoules can be used. If a precipitate forms, the solution is not suitable for use. After opening the ampoule, the solution should be administered immediately. In case of anemia that occurs against the background of malignant tumors or infectious diseases, iron is deposited in the RES (reticulo-endothelial system), from where it can be mobilized and used only after the underlying disease has been cured. Prescribe with caution to patients with liver and kidney failure, cardiovascular and allergic diseases. In children, parenteral iron supplements can negatively affect the course of the infectious process. In the event of the development of moderately severe allergic reactions, antihistamines are recommended; in the event of a severe anaphylactic reaction, immediate administration of adrenaline. Cardiopulmonary resuscitation must be available. Only undamaged ampoules can be used. If a precipitate forms, the solution is not suitable for use. After opening the ampoule, the solution should be administered immediately. Should not be mixed with other therapeutic drugs. Pregnancy and lactation Contraindicated in the first trimester of pregnancy. Use in the second and third trimesters is possible only in cases where the result of treatment outweighs the potential risk to the fetus. In small quantities, unchanged iron from the polymaltose complex can pass into breast milk, but adverse effects are unlikely to occur in breastfed infants. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. The use of this drug does not affect the ability to drive a car or other mechanisms. Overdose Symptoms: Overdose can cause acute iron oversaturation, which is manifested by hemosiderosis syndromes. Chronic excess iron leads to the development of hemochromatosis. Treatment is symptomatic. In case of iron poisoning, prescribe desferroxamine or calcium disodium ethylenediamine tetraacetic acid - EDTA. Desferroxami (chelating agent) has teratogenic properties. Release form and packaging 2 ml of the drug in dark glass ampoules with a precise break point. 5 ampoules are placed in a plastic blister pack. 1 contour package together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box. Storage conditions Store at temperatures up to 25 0C. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription, Turkey, under the license "Bilim Ilach Sanayi ve Ticaret A.S.", Turkey Holder of the registration certificate "World Medicine", Great Britain Packer Idol Ilach Dolum San. ve Tij. A.Sh.”, Turkey, under the license “Bilim Ilach Sanayi ve Tijaret A.Sh.”, Turkey Address of the organization that accepts claims from consumers on the quality of products (products) of the Republic of Kazakhstan in the territory of the Republic of Kazakhstan, Almaty, Suyunbay Ave. 222 B Tel/fax: 8(7272)529090 www.worldmedicine.kz

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