Cavintonum 10 mg / 2 ml 10s solution for injection in ampoules

The instruction for medical use


of Kavinton® medicine

the Trade name
of Kavinton®

the International unlicensed



name Vinpocetine Dosage Form Solution for injections of 10 mg / 2 ml

Structure
of 2 ml of solution contains
active agent - a Vinpocetine of 10 mg,
excipients: ascorbic acid, sodium metabisulphite, tartaric acid, benzyl alcohol, sorbite, water for injections.

Description
Colourless or slightly greenish transparent solution

Pharmacotherapeutic group
of Psikhoanaleptiki. Psychostimulants and nootropa. Psychostimulants and nootropa others. The Vinpocetine
the ATX N06BX18 Code

the Pharmacological

Pharmacokinetics At properties intravenous administration in the course of metabolism of primary passing through a liver of 25-30% of a Vinpocetine turns into the apo-vinkaminovy acid (AVA). Diseases of a liver and kidneys do not influence metabolism of a Vinpocetine. Linking with blood proteins makes 66%. The volume of distribution of 246.7±88.5 l that indicates good distribution in fabrics. The value of clearance of a Vinpocetine (66.7 l/h) exceeds values in plasma and in a liver (50 l/h) that indicates extrahepatic metabolism of connection.
Well gets into various fabrics and liquids of an organism, including liquor. Time of semi-removal is 4.83±1.29 h. It is removed by kidneys and through digestive tract. Removal of apovinkaminovy acid is carried out by glomerular filtration. Time of semi-removal depends on a dose of a Vinpocetine and the mode of dosing.
Advanced age: elderly and young patients have no essential differences in drug kinetics, drug does not kumulirutsya. The patient with chronic diseases of a liver and kidneys drug is appointed in a usual dose, the lack of cumulation allows to conduct long courses of treatment.
The pharmacodynamics
the Vinpocetine represents connection with the complex mechanism of action which renders favorable effect on metabolism of a brain and improves its blood supply and also improves rheological properties of blood.
Neuroprotective action of a Vinpocetine is connected with blockade a voltage - dependent tubules of Na + both Sa2 + and protection of neurons against inflow of Na, inadequate in the conditions of a hypoxia, + and the excess receipt of Sa2 caused by it + in a cell. Interaction of a Vinpocetine with receptors of the glyutamat protects neurons from cytotoxic action of the glyutamat and N-methyl-D-aspartate, and also alpha amino-3-hydroxy-5-methyl-4-izoksazol-propionic acid.
The Vinpocetine strengthens neuroprotective action of adenosine, blocking its utilization. Has direct antioxidant effect, interfering with formation of reactive substances.
The Vinpocetine stimulates cerebral metabolism: drug increases capture of glucose and oxygen, increasing consumption of these substances brain tissue. Drug increases resistance of a brain to a hypoxia, increases glucose transport – an exclusive power source for a brain – through a blood-brain barrier, shifts glucose metabolism of energetically more favorable aerobic way aside, selectively inhibits Ca2+-calmodulin-dependent enzyme tsGMF-phosphodiesterase (FDE), increases the tsAMF and tsGMF level in a brain. Drug increases concentration of ATP and a ratio of ATF/AMF, strengthens a turn of noradrenaline and serotonin in a brain, stimulates the ascending noradrenergichesky system, has antioxidant activity, as a result of action of all above-mentioned effects the Vinpocetine has tserebroprotektivny effect.
The Vinpocetine improves microcirculation in a brain: drug inhibits aggregation of thrombocytes, reduces patholologically the increased viscosity of blood, increases deformability of erythrocytes and inhibits capture of adenosine, improves O2 transport in fabrics by decrease in affinity of O2 to erythrocytes.
The Vinpocetine selectively increases a blood stream in a brain: drug increases cerebral fraction of warm emission, reduces vascular resistance in a brain, without affecting parameters of system circulation (arterial blood pressure, warm emission, pulse rate, the general peripheric resistance), drug does not cause effect of burglarizing. Moreover, against the background of drug the intake of blood in damaged (but yet not nekrotizirovanny) sites of ischemia with low perfusion (converse effect of burglarizing) improves.
As a result of such difficult mechanism of action the Vinpocetine accelerates regress of all-brain and focal symptomatology, improves memory, attention, intellectual productivity.

Indications
- tranzitorny ischemia of a brain
- a cerebral ischemic stroke
- states after a cerebral stroke
- dementia, owing to the multiple centers of a brain damage
- atherosclerosis of vessels of a brain
- posttraumatic and hypertensive encephalopathy
- vertebrobazilyarny insufficiency
- the mental and neurologic disorders caused by cerebrovascular insufficiency
- the ophthalmologic diseases of mesh and vascular covers (caused by atherosclerosis, arterial or venous thromboses and embolisms, a vasomotor spasm)
- diseases of an inner ear (decrease in hearing owing to vascular diseases or toxic influences (including iatrogenic), Menyer's disease, sonitus

the Route of administration and doses
Is intended for intravenous infusion, to enter slowly (speed of infusion should not exceed 80 thaws/min.!).
It is forbidden to enter intramusculary and in the concentrated look intravenously!
For preparation of infusion it is possible to use the normal saline solution or infusion solutions containing glucose (Salsol, Ringer, Rindexum, Reomakrodex). Infusion solution with Kavintonom® should be used in the first 3 hours after preparation.
Initial daily dose: 20 mg (2 in ampoules) in 500 ml of infusion solution for intravenous administration. Depending on shipping of the patient it is possible to increase a dose within 2-3 days, but no more than up to 1 mg/kg of body weight. An average course of treatment of 10-14 days, an average daily dose of 50 mg at the body weight of 70 kg (5 in ampoules in 500 ml of infusion solution).
Patients with diseases of a liver and kidneys can appoint in the same doses.
Upon termination of a course of intravenous therapy it is recommended to continue treatment by the tablets Kavinton® Forte (on 1 tablets 3 times a day) or the tablets Kavinton® (on 2 tablets 3 times a day)

Side effects
Infrequently (& gt, 1/1000 & lt, 1/100)
- feeling of heat
- a lowering of arterial pressure
- euphoria
Seldom (& gt, 1/10000 & lt, 1/1000)
- a headache, dizziness, drowsiness, concern, a hemiparesis
- a hearing disorder, a hyperacusia, a gipoakuziya
- an ischemia/myocardial infarction, an angina of exertion, arrhythmia, bradycardia, tachycardia, premature ventricular contraction, heartbeat
- hemorrhage in an anterior chamber of an eye, a hypermetropia, decrease in visual acuity, shortsightedness
- increase in arterial blood pressure, lengthening of an interval QT, ST segment depression on the ECG
- inflows, an asthenia, discomfort in a breast, fibrinferments in the place of an injection
- nausea, dryness in a mouth, discomfort in a stomach
- an erythema, a hyperhidrosis, urticaria
- thrombocytopenia, agglutination of erythrocytes
- a hypercholesterolemia, diabetes
- increase in concentration of urea in blood
is Very rare (& lt, 1/10000)
- anemia
- a depression, a tremor, a loss of consciousness, a preunconscious state
- anorexia, vomiting, saliva hypersecretion
- heart failure, fibrillation of auricles, lengthening of an interval of PR on the ECG
- thrombophlebitis
- conjunctiva hyperaemia, a papilledema, a diplopia
- sonitus
- a skin itching, dermatitis
- increase in activity of a lactate dehydrogenase

of the Contraindication
- hypersensitivity to any component of drug
- the acute stage of a cerebral hemorrhage
- heavy coronary heart disease
- heavy disturbances of a warm rhythm
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years
- persons with hereditary intolerance of fructose

Medicinal interactions
Kavintona® Solution is chemically incompatible with heparin therefore their introduction in one syringe is forbidden.
Kavintona® solution is chemically incompatible with the infusion solutions containing amino acids therefore they cannot be used for cultivation of the injection Kavintona® form.
Simultaneous use of a Vinpocetine and alpha Methyldopums can cause strengthening of hypotensive effect therefore at their combined use the regular control of blood pressure is required.
Despite the lack of these clinical trials confirming a possibility of interaction it is recommended to show care at co-administration of a Vinpocetine with the drugs operating on the central nervous system, antiarrhythmic means and anticoagulants. At the same time, in case of need, simultaneous use of anticoagulants and Kavintona® is admissible.

Special instructions
in case of increase in intracranial pressure, reception of antiarrhythmic means, disturbance of a warm rhythm or lengthening of an interval of QT, Kavinton® it is appointed after careful assessment of expected advantage and potential risk for the patient.
Existence of a syndrome of the prolonged interval QT and a concomitant use of the drugs causing lengthening of QT demand carrying out periodic control of the electrocardiogram.
Injection Kavintona® solution contains sorbitol (160 mg / 2 ml) therefore in the presence at sick diabetes the control of level of sugar in blood is necessary.
In case of intolerance of fructose or deficit 1.6 diphosphatases of fructose use of drug it is necessary to avoid.

There is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of the Data confirming adverse influence of a Vinpocetine on ability to drive the car and potentially dangerous mechanisms, but considering a possibility of development of such side effects as dizziness, drowsiness, it is necessary to be careful.

Overdose
Symptoms: are unknown, emergence of side effects is possible.
Treatment: symptomatic

the Form of release and packing
On 2 ml of solution place in glass ampoules of brown color with a white dot for a break. On 5 ampoules place in a plastic pallet.
On 2 pallets put in a cardboard box together with the instruction for medical use in the state and Russian languages.


To Store storage conditions in the place protected from light at a temperature from 15ºС to 25 °C.
To store out of children's reach!



Not to use a period of storage of 5 years after expiry date.

Prescription status
According to the prescription

the Name and the country
of the JSC Gideon Richter manufacturing organization,
1103 Budapest, Dyomryoi St., 19-21, Hungary

the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
E-mail:
Phone number: 8-(727) 258-26-22, 8-(727) 258-26-23






To develop info@richter.kz