B12 ANKERMANN tablets p/o 1000mcg № 25×4

Name:
B12 Ankermann. Forms of release Tablets. MNN cyanocobalamin.
Description:
Round biconvex white tablets. Qualitative and quantitative composition One coated tablet contains: Active substance: cyanocobalamin (vitamin B 12) 1000 mcg Excipients, the presence of which must be taken into account in the composition of the drug: lactose, sucrose. See section 6.1 for a complete list of excipients. Indications for use Vitamin B12 deficiency leading to impaired maturation of red blood cells and manifested by megaloblastic anemia and neurological disorders such as funicular myelosis (spinal cord injury). Vitamin B12 deficiency may be due to long-term malnutrition (eg, a vegan diet), malabsorption from food (malabsorption due to inadequate production of intrinsic factor), disease of the terminal ileum (eg, Sprue disease), helminthic infestation, caecum syndrome, or a congenital disorder. transport of vitamin B12. Route of administration and doses In the presence of severe neurological symptoms, it is preferable to start parenteral administration of vitamin B12. Dosing depends on the symptoms. Symptoms of vitamin B12 deficiency Initial therapy Maintenance therapy Patients with hematological and additionally severe neurological symptoms Parenteral administration 1-2 coated tablets daily Patients with isolated severe hematological and / or neurological symptoms Parenteral administration 1-2 coated tablets daily Patients with haematological and/or neurological symptoms 2 coated tablets x 2 times a day 1-2 coated tablets daily Patients without haematological and neurological symptoms 2 coated tablets x 1-2 times a day 1-2 tablets, coated, daily Condition after gastrectomy or other symptoms of malabsorption 1-2 coated tablets daily 1-2 coated tablets daily Dietary deficiency (for example, vegetarian diet, etc.) 1-2 coated tablets, daily 1-2 film-coated tablets daily The film-coated tablets are taken with a small amount of liquid, without chewing, preferably in the morning on an empty stomach. Children over 14 years of age For children, the use of vitamin B12 in daily doses up to 1000 mcg is recommended as an alternative to parenteral therapy for vitamin B12 deficiency. Elderly patients For elderly patients, the usual dosing regimens are recommended. Patients with impaired renal function In patients with moderate renal insufficiency B12 Ankermann can be used at the usual dose. In cases of severe renal insufficiency, dose reduction is recommended and serum vitamin B12 concentrations should be checked regularly. Patients with hepatic impairment Pharmacokinetic data and clinical experience in patients with hepatic impairment are not available. Safety and efficacy in patients with hepatic impairment have not been established. Duration of treatment Duration of use, especially the duration of the initial treatment of patients with pernicious anemia, is determined by the attending physician (usually 4 weeks). It depends on the therapeutic effect, which must be constantly monitored (see 4.4. “Special instructions and warnings”). Initial therapy is carried out until clinical and hematological remission is achieved, then – maintenance therapy. Missing a dose If you forget to take Ankermann® B12, take it as soon as you remember. Do not take a double dose to make up for a missed tablet. ContraindicationsIncreased individual sensitivity to the active substance or auxiliary components of the drug (see 6.1). Patients at high risk of developing Leber’s optic atrophy, tobacco and alcohol amblyopia. Special instructions or warnings In the presence of hematological and / or neurological disorders, it should be borne in mind that: The severity of the disease and its possible consequences in case of inadequate treatment or failure to comply with the oral therapy regimen dictates the need for careful monitoring of the effect of therapy. 7 days after the start of therapy, it is recommended to evaluate the dynamics of the symptoms of the disease, to count the reticulocytes, to perform a complete blood count (including determining the values of hemoglobin and hematocrit), and also to control the red blood cell volume (MCV). In the future, an assessment of symptoms, blood tests and MCV should be carried out every 4 weeks during the first three months of treatment, then with good adherence to treatment 1 time for 6-12 months. If insufficient adherence is suspected, monitoring may be more frequent. Patients with rare congenital galactose intolerance, lactase deficiency, glucose-galactose malabsorption, congenital fructose intolerance or sucrase-isomaltase deficiency should not take Ankermann® B12. Drug interactions and other interactions Vitamin B12 absorption is impaired by colchicine, aminoglycosides, neomycin, aminosalicylic acid, antiepileptic drugs, biguanides, chloramphenicol, cholestyramine, potassium salts, methyldopa, and acid depressants (eg, omeprazole, cimetidine), and also in the presence of alcohol. Taking oral contraceptives can help reduce the concentration of cyanocobalamin in the blood serum. This decrease, however, does not lead to clinically significant consequences. Antimetabolites and most antibiotics interfere with the analysis of vitamin B12 by microbiological methods. Fertility, pregnancy and lactation Fertility Limited data suggest no teratogenic effect. Pregnancy and lactation The recommended daily intake of vitamin B12 during pregnancy and lactation is 4 micrograms. Vitamin B12 passes into breast milk. Experience to date does not indicate the development of adverse effects when taking higher doses of vitamin B12 on a fetus or a breast-fed child. Influence on the ability to drive vehicles or other mechanisms There are no restrictions on the appointment of the drug to drivers of vehicles and persons working with potentially dangerous mechanisms. Side effects When assessing side effects, their frequency is determined as follows: Very often (≥ 1/10) Often (≥ 1/100, but <1/10) Infrequently (≥ 1/1000, but <1/100) Rarely (≥ 1/10) 10,000 but <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders: Uncommon: severe hypersensitivity reactions that may manifest as urticaria, rash or itching over large areas of the body. Frequency unknown: acne in the form of a rash on the skin. General disorders and reactions at the injection site: Frequency unknown: fever. Reporting adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse drug reaction and drug failure reporting systems. The patient, if he experiences any adverse reactions, should consult a doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Overdose Vitamin B12 has a great therapeutic breadth. Poisoning or overdose symptoms are not known. In case of accidental overdose, symptomatic treatment should be carried out. Pharmacological propertiesPharmacodynamic propertiesPharmacotherapeutic group: antianemic agents, vitamin B12 ATC code: B03BA01 Vitamin B12 is part of the prosthetic group methylmalonyl - coenzyme A-isomerase, necessary for the conversion of propionic acid to succinic. In addition, Vitamin B12, along with folic acid, is involved in the formation of labile methyl groups, which are transferred to other methyl acceptor proteins through transmethylation processes. Vitamin B12 affects the synthesis of nucleic acids, especially in the processes of hematopoiesis and cell maturation in general. Occurrence and requirement Vitamin B12 is used therapeutically in the form of cyanocobalamin and/or hydroxocobalamin (-acetate). Both of these forms are prodrugs that are converted in the body into active forms - methyl- and 5-adenosylcobalamin. The human body is not able to synthesize vitamin B12 and must cover its need in the composition of food. Rich in vitamin B12 liver, kidneys, heart, fish, oysters, milk, egg yolk and meat. Absorption of vitamin B12 occurs primarily in the small intestine. Two absorption mechanisms are known. One active, in which vitamin B12 binds to the glycoprotein formed in the stomach, an internal factor, which ensures the absorption process; another mechanism is passive, which, in the absence of an internal factor, ensures the absorption of large doses ingested by the oral route. Vitamin B12 is stored in the body. The daily requirement is about 1 mcg. Manifestations of vitamin B12 deficiency Years of inadequate intake of vitamin B12 leads to manifestations of its insufficiency when its content in blood plasma falls below 200 pg / ml. The hematological manifestation of insufficiency is megaloblastic anemia. Neurological manifestation of vitamin B12 deficiency is a disorder of the peripheral and central nervous system. The phenomena of polyneuropathy can be accompanied by damage to long spinal tracts and be combined with mental disorders. Vitamin B12 deficiency is most commonly manifested by nonspecific symptoms such as weakness, pallor, tingling and numbness in the arms and legs, unsteady gait, and decreased exercise tolerance. Symptoms caused by vitamin B12 deficiency can only be corrected with supplemental vitamin B12 intake. To date, it has been proven that high oral doses of vitamin B12 (³1000 µg/day) can be successfully used to achieve and maintain remission of symptoms caused by vitamin B12 deficiency. Pharmacokinetic properties Absorption of vitamin B12 occurs in two ways: in a bound state with intrinsic factor, vitamin B12 is actively absorbed in the duodenum and small intestine. The subsequent intake of vitamin B12 into tissues is carried out with the help of transcobalamin, which belongs to the group of plasma beta-globulins. Vitamin B12 can enter the bloodstream independently of intrinsic factor by passive diffusion through the mucosa of the gastrointestinal tract. 1-3% of orally ingested vitamin B12 enters the systemic circulation, and this intake is dose-dependent. When taking high doses (1000 mcg / day), even in patients with the absence of intrinsic factor, absorption occurs in sufficient quantities. The physiological intake of vitamin B12, independent of the intrinsic factor, is dose-dependent. The absolute amount of vitamin B12 intake increases with increasing dose (table). Table. The amount of absorbed vitamin B12 depending on the dose taken The amount of absorbed vitamin B12 (mcg) Dose (mcg) Total active passive 10 1.38 1.3 0.08 100 2.365 1.477 0.887 1000 10.484 1.498 8.99 10000 91.486 1.499 81286 Vitamin B The body is stored in depots, of which the liver is the most important. The daily intake of vitamin B12 is very small at about 1 mcg, the turnover rate is about 2.5 mcg. The biological half-life is about a year. At the same time, 2.55 mcg of vitamin B12, or 0.051% of the body's content, is consumed daily. Vitamin B12 is excreted primarily in the bile; reabsorbed by the enterohepatic route about 1 μg. Excess ingested and non-deposited vitamin B12 is excreted in the urine. The plasma half-life of vitamin B12 is about 5-10 hours. After taking 1 mg of vitamin B12, about 5% of the dose is excreted in the urine. From the liver, vitamin B12 enters the intestine with bile, where it undergoes enterohepatic circulation. The main storage site for vitamin B12 is the liver. The total reserves of vitamin B12 in the body of an adult are about 2-5 mg. Due to the enterohepatic circulation, the metabolism of vitamin B12 is very slow. The half-life of vitamin B12 in the liver is about 12 months. It takes about 3-5 years for the development of vitamin B12 deficiency with a reduced intake of it in the body. In case of insufficient intake of vitamin B12 in a healthy body, clinical manifestations of vitamin B12 deficiency appear after 3-5 years. Preclinical Safety Data Animal studies with vitamin B12, even at very high doses, have not shown any toxicity. There are no reports of adverse reactions related to the use of vitamin B12 in pre - and postnatal development and no reports of teratogenic, mutagenic or carcinogenic effects. Composition of excipients Lactose monohydrate, povidone K 30, stearic acid, croscarmellose sodium; Shell composition: gum arabic, calcium carbonate, macrogolglycerol hydrostearate, macrogol 6000, sucrose, talc, titanium dioxide, kaolin, sodium lauryl sulfate, aquapolish® P white*, montan glycol wax. (*Composition of Aquapolish® P white: hypromellose, hydroxypropyl cellulose, stearic acid, talc, medium chain triglycerides, titanium dioxide.) Storage conditions and shelf life 2 years. Do not use after the expiry date stated on the package. Stored at a temperature not exceeding 25°C. Keep out of the reach of children. Packing: 25 tablets in a blister made of PVC / PVDC film and aluminum foil, 2 (No. 50 (25x2)) or 4 (No. 100 (25x4)) blister packs together with instructions for use in a cardboard box. Conditions for dispensing from pharmaciesWithout a doctor's prescription. Buy B12 ANKERMANN tablets p/o 1000 mcg No. 25x4