The instruction for medical use of medicine Kalyminum of 60 N the Trade name Kalyminum of 60 N the International unlicensed name of Pyridostigmine bromide the Dosage form of the Tablet Structure One Tablet contains active agent – pyridostigmine bromide of 60.0 mg, excipients: microcrystalline cellulose, potato starch, PVP K 25, silicon the dioxide besieged, the water purified silicon dioxide colloidal anhydrous, magnesium stearate, glutaminic acid a hydrochloride. The description White, biconvex, oblong tablets, with risky for a break on one party. Pharmacotherapeutic group Drugs for treatment of diseases of nervous system others. Parasympathomimetics. Antikholinesterazny drugs. Pyridostigmine bromide. The ATX N07AA02 code the Pharmacological Pharmacokinetics At properties oral administration of pyridostigmine bromide reaches the maximum concentration in blood plasma in 1.5 – 3 hours. Biological availability of pyridostigmine of bromide after oral administration makes from 8 to 20%. At patients with a heavy myasthenia it can decrease less than by 4%. Speed and volume of absorption differ in big individual variability. Pyridostigmine bromide does not get through a blood-brain barrier. After intravenous administration the elimination half-life of pyridostigmine of bromide makes about 1.5 hours, after oral administration it can increase in 2 – 2½ time. It is partially metabolized in a liver to inactive metabolites. Removal of medicinal substance in not changed look and in the form of metabolites happens mainly through kidneys. The Pyridostigmine pharmacodynamics bromide inhibits cholinesterase and belongs to group of parasympathomimetic means of indirect action. The inhibition of enzyme promotes accumulation of acetylcholine on receptors in the field of cholinergic synapses, it leads to stronger and long action of acetylcholine. Pyridostigmine bromide has primary impact on peripheral nervous system. It has no effect on function of the central nervous system since in connection with low solubility in lipids does not get through a blood-brain barrier. Characteristic of medicine is its gradually coming, uniform, long and slowly weakening action. Indications – gravis myasthenia – a myasthenic syndrome (Lambert-Eaton-Rooke syndrome) as a part of combination therapy using guanidine accept the Route of administration and doses of the Tablet inside, washing down with a small amount of liquid (half of a glass of water). Tablets have a dividing mark, and can are divided into two equal parts. Therefore there is a possibility of reception of a half of a tablet. gravis myasthenia Adult for symptomatic treatment of a disease appoint 1 – 3 tablet Kalyminum of 60 N 3-4 times a day (180 mg – at most 720 mg a day). At treatment of a myasthenia of gravis the dosage of Kalyminum of 60 N is defined individually, depending on severity of a disease and response of the patient to such treatment. The maximum daily dose Kalyminum of 60 N should not exceed 720 mg. Kalyminum 60 N adult appoint a myasthenic syndrome (Lambert-Eaton-Rooke syndrome) on 1 – 3 tablets 3-4 times a day (180 mg-720 mg a day). In case of lack of satisfactory result at specified dosages, treatment 375-1000 mg of a daily dose of the guanidine accepted in intervals between intake of pyridostigmine can be added. The dosage of medicine is defined individually, depending on response of the patient. The patients having a renal failure At patients with the broken renal function or a renal failure action Kalyminum 60H can be longer as drug mostly is removed by kidneys practically in not changed look (75%). At creatinine content in plasma of 2 mg/dl, the maintenance dose can be halved or the interval between administration of drug doubles. Special attention is paid to the fact that the dose is defined on the basis of individual response of the patient to this treatment. Therefore, stringent medical control is shown to the patients having a renal failure. Side effects – perspiration, the increased salivation and dacryagogue, the strengthened secretion of bronchial glands – the nausea, vomiting, a diarrhea, a paroxysmal abdominal pain (caused by the raised intestines vermicular movement) – frequent desires on urination – a muscular tremor, a spasm of muscles, muscle weakness – spasms – accommodation disturbance, a miosis – bradycardia, disturbances of a heart rhythm, hypotension – an enanthesis. Contraindications – hypersensitivity to active ingredient or to drug components – a myatonia – obturatsionny intestinal impassability – a spasm of bilious and urinary tract – spastic conditions of bodies of digestive tract – shock in the postoperative period – bronchial asthma – obstructive bronchitis – an iritis (inflammation of eyes, inflammation of an iris of the eye of an eye) – use in a combination with the depolarizing muscle relaxants (for example, suktsinilkholin)) – the lactation period Medicinal interactions Antibiotics from group of aminoglycosides (such as streptomycin, Neomycinum, Kanamycinum, gentamycin) and such antibiotics as polymyxin, colistin, Oxytetracyclinum, clindamycin, lincomycin and also m – cholinolytics, ganglioblokator, quinidine, procaineamide, local anesthetics, tricyclic antidepressants, antiepileptic and protivoparkinsonichesky medicines reduce effect of pyridostigmine of bromide. Atropine is capable to neutralize m – cholinergic effect of pyridostigmine (but not its influence on skeletal muscles). Pyridostigmine bromide enhances effect of derivatives of morphine, barbiturates and the depolarizing muscle relaxants. It is incompatible with ethanol. Carefully Kalyminum 60 N apply special instructions at patients with the bradycardia, Parkinson’s disease, diabetes, diseases of kidneys (if necessary korrigirut a drug dose) postponed liver diseases after digestive tract surgeries. At patients with the postponed diseases of a liver it is necessary to control function of a liver regularly. Only after careful comparison of risk of intervention and the expected favorable effect Kalyminum of 60 N is applied in stomach ulcer, dekompensirovanny heart failure, a myocardial infarction, a thyrotoxicosis. During treatment by Kalyminum 60H patients have to refuse alcohol intake since at the same time mutual strengthening of action and side effects can be noted. In particular at patients with a heavy myasthenia the concomitant use of alcohol can lead to breath difficulty. It is recommended to choose time of intake of pyridostigmine of bromide so that its maximum effect matched a cycle of physical activity of the patient. It is necessary to remember that the lack of the expected treatment response can be a consequence of overdose. Use for patients with a renal failure by the Patient with a renal failure a necessary dose of drug is chosen individually for each patient depending on effect of drug and a functional condition of kidneys as pyridostigmine bromide in not changed look is removed from an organism, generally by kidneys. Use in pediatrics Due to the high content of active ingredient use for children of this dosage form (Kalyminum of 60 N) is not recommended. Pregnancy and a lactation On use during pregnancy the sufficient therapeutic experience was not accumulated yet. The risk of premature births increases at intake of pyridostigmine bromide in the last trimester. Therefore during pregnancy medicine should be applied only after strict comparison of advantage and risk. As pyridostigmine bromide passes into maternal milk, during drug treatment it is necessary to stop breastfeeding. Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms At insufficient compensation of a basic disease or at cholinergic effects after relative overdose of medicine at patients the ability to react quickly to unexpected events can weaken therefore it cannot be run vehicles or potentially dangerous mechanisms. Overdose Symptoms: the increased salivation and dacryagogue, erubescence, perspiration, feeling of fatigue, sharp weakness, strong narrowing of pupils, disorders of vision, feeling of dizziness, nausea, vomiting, an involuntary otkhozhdeniye of urine and a calla, intestinal colic, paralysis of muscles (on the basis of neuromuscular blockade), a bronchospasm, a fluid lungs, hypotonia up to vascular collapse, bradycardia up to full cardiac arrest, sometimes the reflex tachycardia, cholinergic crisis (expressed or the accruing muscle weakness up to approach of paralysis of muscles, including paralysis of respiratory muscles). Treatment: gastric lavage and use of activated carbon. As specific antidote serves Atropini sulfas which is entered slowly intravenously in a dose of 1 – 2 mg. Drug is dosed on its action, in need of dependence on pulse rate the initial dose is entered in 2 – 4 hours repeatedly. Watch that airways were free, if necessary carry out artificial respiration. In cardiac arrest do cardiac massage. The form of release and packing On 100 tablets place in a bottle from dark glass with a polyethylene stopper. 1 bottle together with the instruction for medical use in the state and Russian languages is put in a cardboard pack. To Store storage conditions at a temperature not above 30 °C. To store out of children’s reach! 3 years not to use a period of storage after an expiration date. Prescription status According to the prescription Producer Klocke Pharma Service Gmbh, Appenweier, Germany Straburger Str.77, 77767 Appenweier, Germany the Packer of Klocke Verpackungs-Service GmbH, Weingarten, Germany Max-Becker-Str.6, 76356, Weingarten, Germany the Releasing control of Merckle Gmbh, Blaubeuren, Germany the Owner of the registration certificate of Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Ratiofarm Kazakhstan LLP, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, BC Nurly-Tau, 5B, 6 floor. Phone number: (727) 3251615 The address of the organization, in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: Ratiofarm Kazakhstan LLP, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, BC Nurly-Tau, 5B, 6 floor. Phone number: (727) 3251642, mobile +7(701)9240368, e-mail:
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