The instruction for medical use of Ronocit medicine the Trade name of Ronocit the International unlicensed name Tsitikolin Lekarstvennaya a form Solution for injections, 500 mg and 1000 mg, 4 ml Structure 1 ampoule contains active agent – a tsitikolin of sodium of 522.52 mg and 1045.04 mg (it is equivalent a tsitikolina 500.0 and 1000.0), excipients: 1 M acid chlorohydrogen ** or 1 M hydroxide sodium solution **, water for injections ** – Is used by 1 M solution of sodium of hydroxide or 1 M acid chlorohundred-hydrogen. Description Transparent colourless or brownish-yellow color solution. Pharmacotherapeutic group Nervous system. Psychoanaleptics. The psychostimulants applied at deficit of attention and hyperactivity (ADHD-Attention deficit hyperactivity disorder) and nootropic means. Other psychogogic and nootropic means. Tsitikolin. The ATX N06BX06 code the Pharmacological Pharmacokinetics Tsitikolin properties is well absorbed at intravenous and intramuscular administration. It is metabolized in a liver with formation of sincaline and cytidine. After parenteral administration the concentration of sincaline in blood plasma significantly increases. Tsitikolin is substantially distributed in structures of a brain, with rapid implementation of fractions of sincaline in structural phospholipids and fractions of cytidine – in cytidine nucleotides and nucleic acids. Only 15% of the entered dose of a tsitikolin are brought out of a human body: less than 3% – kidneys and about 12% – with the exhaled carbon dioxide. A pharmacodynamics Tsitikolin, being a predecessor of key ultrastructural components of a cellular membrane (mainly phospholipids), possesses a broad spectrum of activity: promotes restoration of the damaged cell membranes, inhibits action of phospholipases, interfering with excess education of free radicals and also prevents death of cells, influencing apoptosis mechanisms. In an acute period of a stroke tsitikolin reduces brain tissue defeat volume, improves cholinergic transfer. In a craniocereberal injury reduces duration of a posttraumatic coma and expressiveness of neurologic symptoms. In case of a chronic hypoxia of a brain tsitikolin it is effective at treatment of such cognitive disorders as a memory impairment, lack of initiative, difficulties arising during the performing of daily actions and self-service. Perhaps long-term treatment by drug as tsitikolin does not influence breath, pulse and arterial blood pressure. Indications – a stroke, a sharp phase and its neurologic complications – traumatic injury of a brain and its neurologic complications the Route of administration it is possible to administer the Drug intramusculary, intravenously slowly (from 3 to 5 minutes, depending on a dose) or in the form of intravenous drop infusion. At introduction in the form of intravenous drop infusion the speed of perfusion has to be from 40 to 60 drops a minute. The composition of this drug allows, if necessary, oral administration. Contents of an ampoule can be accepted directly or to dissolve in half of glass of water (120 ml). Solution for injections in an ampoule is intended for single use. After opening of an ampoule, solution should be used immediately. Unused drug has to be thrown out. Drug is compatible to all types of intravenous isotonic solutions. It can also be mixed with hypertonic salt solution of glucose. Adults the Recommended dose makes from 500 mg to 2000 mg a day depending on weight of a state. Elderly patients any specific dose adjustment for this age group is not required. Children Experience of use for children is limited. Therefore drug should be used only if the expected advantage exceeds any possible risk. Side effects the Frequency of undesirable reactions very rare (& lt, 1/10000) (including individual cases): – hallucinations – a headache, dizziness – arterial hypertension, arterial hypotension – short wind – nausea, vomiting, diarrhea – reddening, a small tortoiseshell, a dieback, a purpura – a fever, hypostasis of the Message about the suspected undesirable reactions of the Message about the suspected undesirable reactions after registration of medicine are important. At identification at the patient of serious undesirable reaction to medicine or emergence of the new undesirable reaction which is not described in this section we ask to inform according to the National system of pharmacovigilance. Contraindications – hypersensitivity to a tsitikolin or to any of auxiliary components of drug – patients with a hypertension of parasympathetic nervous system Medicinal interactions Tsitikolin enhances effects of the drugs containing a levodopa. It is not necessary to appoint drug along with the medicines containing centrofenoksin or Meclofenoxatum. Special instructions Intravenous administration has to be slow (from 3 to 5 minutes, depending on a dose). At introduction in the form of intravenous drop infusion the speed of perfusion has to be from 40 to 60 drops a minute. In case of persistent intracraneal hemorrhage it is recommended not to exceed a dose of 1000 mg a day at very slow intravenous administration (30 drops a minute). Use in pediatrics the Experience of use for children is limited. Therefore drug should be used only if the expected advantage exceeds any possible risk. Use at pregnancy and a lactation Use of drug at pregnancy is possible only when the advantage for mother exceeds potential risk for a fruit. In need of use of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination. Influence on ability to driving of motor transport and to control of mechanisms: drug does not affect ability to driving of motor transport and control of the mechanisms demanding the increased speed of psychomotor reactions. The overdose of Cases of intoxication is not expected in connection with hypotoxicity of drug, even at exceeding therapeutic dosed At accidental overdose symptomatic therapy is appointed. The form of release and packing On 4.0 ml of drug spill in ampoules from colourless glass. On 5 ampoules place in blister strip packagings from polyvinylchloride. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack cardboard. To Store storage conditions at a temperature not higher than 25 wasps. To store out of children’s reach! Not to apply a period of storage of 5 years after an expiration date. Prescription status According to the prescription the San Idol Producer Ilach Dolum. ve Tidzh. A.Sh Topkapy, Davutpasha Dzhad., Dzhebealibey Juice., No. 20, Stambul, Turkey the Holder of the registration certificate of ROTAFARM ILACHLARY LIMITED SHIRKETI Stambul, Turkey the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of TROKA-S PHARMA LLP, RK, Almaty, Turksibsky district, Suyunbaya Ave., 222 Ph. / fax: 8 (7272) 529090 www.worldmedicine.kz the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222b Cellular ph. +7 701 786 33 98, (24-hour access). e-mail: email@example.com
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