Sertozin 1000 mg / 4 ml 5's solution for injection in ampoules

The instruction for medical use of Sertozin Torgovoye medicine a name Sertozin Mezhdunarodnoye the unlicensed name Tsitikolin Lekarstvennaya a form Solution for injections of 500 mg / 4 ml, 1000 mg / 4 ml 1 ampoule of drug contains Structure: active agent – a tsitikolina of sodium (it is equivalent to a tsitikolin of 500.0 mg or 1000.0 mg) – 522.52 mg or 1045.04 mg excipient – sodium hydroxide, Acidum hydrochloricum, water for injections the Description Transparent, colourless or fulvous solution Pharmacotherapeutic group Psychostimulants and the nootropic drugs ATX N06BX06 Code Pharmacological Pharmacokinetics Properties. Absorption Tsitikolin is well absorbed, bioavailability after intravenous administration and intake approximately identical. Metabolism. Drug is metabolized in intestines and in a liver with formation of sincaline and cytidine. After reception concentration of sincaline in plasma significantly raise. Distribution. 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. Tsitikolin gets into a brain and is actively built in cellular, cytoplasmic and mitochondrial membranes, forming a part of fraction of structural phospholipids. Removal. Only 15% of the entered dose of a tsitikolin are brought out of a human body: less than 3% - kidneys and through intestines and about 12% with the exhaled CO2 (carbon dioxide). In excretion of a tsitikolin with urine it is possible to allocate 2 phases: the first phase lasting about 36 hours during which clearance rate decreases and the second phase during which the speed of excretion decreases much more slowly. The same is observed with the exhaled CO2 - clearance rate quickly decreases approximately in 15 hours, and then decreases much more slowly. Pharmacodynamics. Tsitikolin stimulates biosynthesis of structural phospholipids in a membrane of neurons that promotes improvement of functions of membranes, including functioning of ion-exchange pumps and neuroceptors. Thanks to the stabilizing action on a membrane tsitikolin has antiedematous properties therefore reduces wet brain. Tsitikolin oppresses activity of some phospholipases, interferes with residual release of free radicals, prevents damage of membrane systems and provides preservation of a protective antioxidant system. Tsitikolin reduces the volume of the damaged fabric, preventing death of cells, affecting apoptosis mechanisms, and improves cholinergic transfer. Tsitikolin also has preventive neurotyre-tread effect in focal strokes of a brain. Tsitikolin promotes fast functional rehabilitation of patients in acute disorders of cerebral circulation, reducing ischemic defeat of tissues of brain that is confirmed by results of X-ray inspections. In craniocereberal injuries tsitikolin reduces duration of the recovery period and reduces intensity of a posttraumatic syndrome. Tsitikolin promotes increase in level of brain activity, reduces amnesia level, improves a state at cognitive, sensitive and motor disturbances which are observed in brain ischemia. Indications an acute period of a stroke the recovery period of an ischemic and hemorrhagic stroke a craniocereberal injury, the acute and recovery period the cognitive, sensitive and motive neurologic disorders caused by degenerative changes and vascular disorders of a brain the Route of administration and doses For intravenous or intramuscular administration. Intravenously appoint in the form of a slow intravenous injection (within 5 minutes) or drop intravenous injection (40-60 drops a minute). During an acute period of a stroke and craniocereberal injury treatment there begin with intravenous administration of drug in a dosage 1000 – 2000 mg, daily, depending on disease severity within two weeks with the subsequent transition to intramuscular introduction 1-2 injections (500 – 2000 mg) a day or intake by a course up to 45 – 90 days. The dose and a course of administration of drug can be changed according to the recommendation of the attending physician. Side effects Side reactions arise very seldom (& lt, 1/10000), including isolated cases. allergic reactions, a small tortoiseshell, a dieback, erubescence up to purple coloring, a skin itching, hypostases, development of an acute anaphylaxis a headache, dizziness, hallucinations, excitement, insomnia, temperature increase, feeling of heat, a tremor dispnoe nausea, vomiting, diarrhea increase or short-term lowering of arterial pressure of the Contraindication - hypersensitivity to drug components is possible. - the raised tone of parasympathetic nervous system. Medicinal interactions Tsitikolin enhances effect of a levodopa. It is not necessary to appoint along with the medicines containing Meclofenoxatum. Special instructions in case of permanent intracraneal hemorrhage it is not necessary to exceed a dose of 1000 mg a day and speed of intravenous administration of 30 drops a minute. Drug is used right after opening of an ampoule. The ampoule with drug is intended only for single use. Residues of drug need to be destroyed. Use during pregnancy and a lactation. There are not enough data on Sertozin's use to pregnant women. Data on excretion of a tsitikolin in breast milk and its action on a fruit are not known. Therefore during pregnancy or feeding a breast drug is appointed only when the expected advantage for mother exceeds potential risk for a fruit. Use in pediatrics is Not enough data on Sertozin's use to children. Drug is used in urgent cases when the expected advantage of use exceeds potential risk. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms In some cases some side reactions from the central nervous system can affect ability to run motor transport and to work with difficult mechanisms. Overdose Cases of overdose are not described. In case of emergence, symptoms of overdose are shown by strengthening of side effect of drug. Treatment: symptomatic. The form of release and packing On 4 ml of drug spill in ampoules from colourless glass. On 5 ampoules place in blister strip packaging. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. Storage conditions In the dry, protected from light place at a temperature not above 25 °C. 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. Producer FarmaVizhn San. ve Tidzh. A.Sh, Turkey the Owner of the registration certificate of Dr Sertus Ilach Sanayi Ve Tidzharet Limited Shirketi, Turkey the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b