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Servitel

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Producer: BELUPO, Pharmaceuticals & Cosmetics, d.d. Republic of Croatia

Code of automatic telephone exchange: N05AH04

Release form: Firm dosage forms. Tablets.

Indications to use: Schizophrenia. Maniacal syndrome (Mania).


General characteristics. Structure:

Active agent: a kvetiapina гемифумарат 28,78 mg (25 mg of a kvetialin are equivalent)  

Excipients: a gipromelloza — 1,4 mg, hydrophosphate calcium a dihydrate — 3,5 mg, lactoses monohydrate — 7 mg, starch corn — 13,82 mg, sodium carboxymethylstarch — 3,5 mg, magnesium stearate — 0,89 mg, MKTs — 7,94 mg, talc — 1,75 mg, silicon dioxide colloid — 1,42 mg 
 
Cover film Opadry of pink 02B34304 — 2 mg (dye ferrous oxide red (E172) — 0,031 mg, dye ferrous oxide yellow (E172) — 0,028 mg, a gipromelloza of 2910 (E464) — 1,25 mg, titanium dioxide (E171) — 0,56 mg, a macrogoal of 400 — 0,125 mg, Sunset dye yellow (E110) — 0,003 mg)  

Active agent: a kvetiapina гемифумарат 115,13 mg (100 mg of a kvetiapin are equivalent)  

Excipients: a gipromelloza — 5,6 mg, hydrophosphate calcium a dihydrate — 14 mg, lactoses monohydrate — 28 mg, starch corn — 55,27 mg, sodium carboxymethylstarch — 14 mg, magnesium stearate — 3,56 mg, MKTs — 31,75 mg, talc — 7 mg, silicon dioxide colloid — 5,69 mg 
 
Cover film Opadry of yellow 02B32696 — 8 mg (dye ferrous oxide yellow (El72) — 0,25 mg, a gipromelloza of 2910 (E464) — 5 mg, titanium dioxide (E171) — 2,25 mg, a macrogoal of 400 — 0,5 mg)  
 
Active agent: a kvetiapina гемифумарат 230,27 mg (200 mg of a kvetiapin are equivalent)  

Excipients: a gipromelloza — 11,2 mg, hydrophosphate calcium a dihydrate — 28 mg, lactoses monohydrate — 56 mg, starch corn — 110,54 mg, sodium carboxymethylstarch — 28 mg, magnesium stearate — 7,11 mg, MKTs — 63,5 mg, talc — 14 mg, silicon dioxide colloid — 11,38 mg  

Cover film Opadry: white 20A28735 — 12 mg (a hypro rod (E463) — 3,59 mg, a gipromelloza of 2910 (E464) — 3,59 mg, titanium dioxide (E171) — 3,51 mg, talc — 1,31mg).




Pharmacological properties:

Kvetiapin is atypical antipsychotic drug. Kvetiapin and his active metabolite N-dezalkil кветиапин interact with neytrotransmitterny receptors of a brain. Kvetiapin and N-dezalkil кветиапин show high affinity to ssrotoninovy receptors of type 5HT2 and dopamine receptors of the D1 and D2 types of a brain. Higher selectivity to serotoninovy receptors of type 5HT2, than to dopamine receptors of the D2 type, causes the main clinical antipsychotic properties of a kvetiapin and low frequency of development of extrapyramidal side effects. Besides, N-dezalkil кветиапин shows high affinity to noradrenaline carrier. Kvetiapin and N-dezalkil кветиапин have high affinity to histamine and to alfa1-adrenoceptors and smaller affinity in relation to alfa2-adrenoceptors and serotoninovy receptors of type 5HT1. Kvetiapin does not show appreciable affinity to cholinergic muskarinovy and benzodiazepine receptors. In standard tests кветиапин shows antipsychotic activity. The specific contribution of a metabolite of N-dezalkil of a kvetiapin to pharmacological activity of a kvetiapin is not established.

Results of studying of ekstraiiramidny symptoms (EPS) at animals revealed that кветиапин causes a weak katalepsy in the doses which are effectively blocking dopamine D2 receptors. Kvetiapin causes the selection reduction of activity of mesolimbic A10-dofaminergichesky neurons in comparison with A9-nigrostriatnymi the neurons involved in motor function.

During clinical trials (at use of a kvetiapin in a dose of 75-750 mg/days) distinctions between kvetiapiny and placebo in the frequency of emergence of extrapyramidal symptoms and the accompanying use of anticholinergic drugs are not revealed. Kvetiapin does not cause long increase in concentration of prolactin in a blood plasma.

Kvetiapin is effective at treatment of both positive, and negative symptoms of schizophrenia. It is long supports clinical improvement at those patients at whom the positive effect developed in the initiation of treatment. Duration of impact of a kvetiapin on receptors 5HT2 and D2 makes less than 12 hours after administration of drug.

Pharmacokinetics. At oral administration кветиапин it is well soaked up from digestive tract and actively metabolized in a liver. Meal significantly does not influence bioavailability of a kvetiapin. About 83% of a kvetiapin contact proteins of a blood plasma.

Equilibrium molar concentration of an active metabolite of N-dezalkil of a kvetiapin makes 35% of equilibrium molar concentration of a kvetiapin. The period of an ioluvyvedeniye of a kvetiapin and N-dezalkil of a kvetiapin makes about 7 and 12 hours, respectively. The pharmacokinetics of a kvetiapin and N-dezalkil of a kvetiapin linear, distinctions of pharmacokinetic indicators at men and women is not observed. It is established that CYP3A4 is a key isoenzyme of metabolism of the kvetiapin mediated by P450 cytochrome. N-dszalkil кветиапин is formed with participation of an isoenzyme of CYP3A4.

The average clearance of a kvetiapin at elderly patients is 30-50% less, than at patients aged from 18 up to 65 years.

The average plasma clearance of a kvetiapin decreases approximately by 25% at patients with a heavy renal failure (clearance of creatinine less than 30 ml/min. / 1,73 sq.m), but individual indicators of clearance are in limits of the values corresponding to healthy volunteers. At patients with an abnormal liver function (for example, the compensated alcoholic cirrhosis) the average plasma clearance of a kvetiapin is reduced approximately by 25%. As кветиапин it is intensively metabolized in a liver, at patients with a liver failure increase in plasma concentration of a kvetiapin is possible that demands correction of a dose.

On average less than 5% of a molar dose of fraction of a free kvetiapin and N-dezalkil of a kvetiapin of plasma are removed with urine. About 73% of a kvetiapin are removed by nights and 21% - through intestines. Less than 5% of a kvetiapin are not exposed to metabolism and is removed in an invariable look by kidneys or through intestines.

In a research of pharmacokinetics of a kvetiapin in various dose use of a kvetiapin before reception of a ketokonazol or along with ketokonazoly, led to increase, on average, in the maximum concentration (Cmax) and the area under a curve "concentration time" (AUC) of a kvetiapin of 235% and 522% respectively, and also to reduction of clearance of a kvetiapin, on average, for 84%. The elimination half-life of a kvetiapin increased, but the average time of achievement of the maximum concentration (tmax) did not change. Kvetiapin and some of his metabolites, including N-dezalkil кветиапин, have the weak inhibiting activity in relation to isoenzymes of P450 1A2, 2C9, 2C19, 2D6 and ZA4 cytochrome, but only at concentration at 10-50 times of the exceeding concentration, observed at usually used effective dose of 300-450 mg/days. Based on results of in vitro, it is not necessary to expect that simultaneous use of a kvetiapin with other drugs will lead to clinically expressed inhibition of the metabolism of other medicines mediated by P450 cytochrome.


Indications to use:

— for treatment of schizophrenia;
— for treatment of maniacal episodes in structure of bipolar disorder.
Drug is not shown for prevention of maniacal episodes at bipolar disorder.


Route of administration and doses:

Inside, irrespective of meal.
Adults
Treatment of schizophrenia. Сервитель® appoint 2 times a day. The daily dose for the first 4 days of therapy makes: the 1st day — 50 mg, the 2nd day — 100 mg, the 3rd day — 200 mg, the 4th day — 300 mg. Since 4th day, the dose has to be selected to clinically effective dose which usually is ranging from 300 to 450 mg/days. Depending on clinical effect and individual portability the patient, the dose can vary ranging from 150 to 750 mg/days. The maximum recommended daily dose makes 750 mg.

Treatment of maniacal episodes in structure of bipolar disorder. Сервитель® it is applied as monotherapy or as adjuvant therapy to stabilization of mood.

Сервитель® appoint 2 times a day. The daily dose for the first 4 days of therapy makes: the 1st day — 100 mg, the 2nd day — 200 mg, the 3rd day — 300 mg, the 4th day — 400 mg. Further, by 6th day of therapy the daily dose of drug can be increased to 800 mg. Increase in a daily dose should not exceed 200 mg a day.

Depending on clinical effect and individual portability the patient, the dose can vary ranging from 200 to 800 mg/days. Usually effective dose makes from 400 to 800 mg/days. The maximum recommended daily dose makes 800 mg.

Elderly patients
At elderly patients the initial dose of a kvetiapin makes 25 mg/days. The dose should be increased daily by 25–50 mg before achievement of an effective dose which it is probable, will be less, than at young patients.

Patients with a renal and liver failure

At patients with a renal or liver failure it is recommended to begin therapy kvetiapiny with 25 mg/days. It is recommended to increase a dose daily by 25–50 mg before achievement of an effective dose.


Features of use:

During therapy kvetiapiny drowsiness and the related symptoms, for example, sedation can be noted. In clinical trials with participation of patients with a depression in structure of bipolar disorder, drowsiness, as a rule, developed during the first three days of therapy. Expressiveness of this side effect, generally was insignificant or moderate. At development of the expressed drowsiness more frequent visits to the doctor within 2 weeks from the moment of emergence of drowsiness can be required by patients with a depression in structure of bipolar disorder or before reduction of expressiveness of symptoms. In certain cases the therapy termination kvetiapiny can be required. Patients with cardiovascular diseases

It is necessary to be careful at purpose of a kvetiapin to patients with cardiovascular and cerebrovascular diseases, and other states contributing to hypotension. Against the background of therapy kvetiapiny there can be orthostatic hypotension, especially during an initial stage of selection of a dose (at elderly patients it is observed more often than at young people). When developing orthostatic hypotension the dose decline or its slower titration can be required. Lengthening of an interval of QT

The interrelation between reception of a kvetiapin and increase in QT of an interval is not revealed. However, lengthening of an interval of QT was noted at drug overdose.

It is necessary to be careful at purpose of a kvetiapin to patients with cardiovascular diseases and earlier noted lengthening of an interval of QT, and also at simultaneous use with the drugs extending QT interval, other neuroleptics, especially at elderly people, patients with a syndrome of inborn lengthening of an interval there is QT, chronic heart failure, a myocardium hypertrophy, a hypopotassemia or a hypomagnesiemia.

Late dyskinesia

At prolonged use of a kvetiapin there is potentiality of development of late dyskinesia. At emergence of symptoms of late dyskinesia it is recommended to lower a dose of drug or gradually to cancel it. The expressed neutropenia

In clinical trials of a kvetiapin cases of the expressed neutropenia were infrequently noted (quantity of neutrophils <0,5*109/l). The majority of cases of the expressed nsytropeniya arose in several months after the beginning of therapy kvetiapiny. The dozozavisimy effect was not revealed. The leukopenia and/or a neutropenia was resolved after the treatment termination kvetiapiny. Possible risk factor for emergence of a neutropenia is the previous reduction in the amount of leukocytes and cases lekarstvenno of the induced neutropenia in the anamnesis. At patients with quantity of neutrophils <1,0*109/l reception of a kvetiapin should be stopped. The patient should be observed for identification of possible symptoms of an infection and to control the level of neutrophils (before increase in level 1,5*109/l).

Hyperglycemia

Against the background of reception of a kvetiapin development of a hyperglycemia or an aggravation of a diabetes mellitus in patients with a diabetes mellitus in the anamnesis is possible. Clinical observation of patients with a diabetes mellitus and patients with risk factors of development of a diabetes mellitus is recommended.

Level of lipids

Against the background of reception of a kvetiapin increase in concentration of triglycerides and cholesterol is possible.

Elderly patients with dementia

Kvetiapin is not shown for treatment of the psychoses connected with dementia. Some atypical neuroleptics in randomized placebos - controlled researches increased risk of development of cerebrovascular complications in patients with dementia. The mechanism of this increase in risk is not studied. The similar risk of increase in frequency of cerebrovascular complications cannot be excluded for other antipsychotic medicines or other groups of patients. Kvetiapin has to be applied with care at patients with risk of development of a stroke.

The analysis of use of atypical neuroleptics for treatment of the psychoses connected with dementia at elderly patients revealed increase in death rate in group of the patients receiving drugs of this group in comparison with group of placebo. Relationship of cause and effect between treatment kvetiapiny and risk of increase in mortality at elderly patients with dementia is not revealed.

Convulsive attacks

Distinctions in the frequency of development of spasms in the patients accepting кветиапин or placebo are not revealed. However, also as well as at therapy by other antipsychotic drugs, it is recommended to be careful at treatment of patients with existence of convulsive attacks in the anamnesis. Malignant antipsychotic syndrome

Against the background of reception of antipsychotic drugs, including a kvetiapin, the malignant antipsychotic syndrome can develop. Clinical manifestations of a syndrome include a hyperthermia, the changed mental status, muscular rigidity, instability of the autonomic nervous system, increase in concentration of a kreatinfosfokinaza. In such cases кветиапин it is necessary to cancel and carry out the corresponding treatment.

The acute reactions connected with drug withdrawal

At sharp cancellation of a kvetiapin the following acute reactions (a syndrome of "cancellation") - nausea, vomiting, sleeplessness, a headache, dizziness and irritability can be observed. Therefore drug withdrawal is recommended to be carried out gradually within, at least, one or two weeks.

Suicide / suicide thoughts or clinical deterioration

The depression is connected with the increased risk of emergence of suicide thoughts, drawings to itself damages and a suicide at children, teenagers and young people (24 years are younger). This risk remains until approach of the expressed remission. In view of the fact that before improvement of a condition of the patient from an initiation of treatment there can pass several weeks or more, patients have to be under fixed medical observation before improvement. According to the standard clinical experience, the risk of a suicide can increase at early stages of approach of remission.

Other mental disorders for which therapy it is appointed кветиапин are also connected with the increased risk of the events connected with a suicide. Besides, such states can be komorbidny with a depressive episode. Thus, the precautionary measures applied at therapy of patients with a depressive episode have to be accepted also at treatment of patients with other mental disorders. Patients with suicide events in the anamnesis, and also the patients clearly introducing the suicide ideas before therapy treat group of the increased risk of suicide intentions and suicide attempts and have to be observed carefully in the course of treatment. Patients with a liver failure

Kvetiapin is intensively metabolized in a liver. Therefore it is necessary to be careful at use of a kvetiapin for patients with a liver failure, especially at the beginning of therapy.

Interaction with other medicines

Also see the section "Interaction with Other Medicines". Use of a kvetiapin in a combination with strong inductors of fermental system of a liver, such as carbamazepine and Phenytoinum, promotes decrease in concentration of a kvetiapin in plasma and can reduce efficiency of therapy kvetiapiny. Purpose of a kvetiapin to the patients receiving inductors of fermental system of a liver is possible only if the expected advantage of therapy kvetiapiny surpasses the risk connected with cancellation of drug inductor of liver enzymes. Change of a dose of drugs inductors of microsomal enzymes has to be gradual. If necessary, their substitution by the drugs which are not inducing microsomal enzymes is possible (for example, valproic acid drugs).

In view of influence of a kvetiapin on the central nervous system, кветиапин it is necessary to take with caution in a combination with other drugs possessing the oppressing action on the central nervous system or alcohol.

Influence on ability of control of vehicles and mechanisms

Kvetiapin can cause drowsiness therefore during treatment the control of vehicles is not recommended to patients, and also it is not recommended to work with the mechanisms constituting danger.


Side effects:

The most often found side effects at reception of a kvetiapin: drowsiness, dizziness, dryness in a mouth, slightly expressed adynamy, a lock, tachycardia, orthostatic hypotension and dyspepsia.

Reception of a kvetiapin, as well as other antipsychotic drugs, can be followed by increase in body weight, faints, development of a malignant antipsychotic syndrome, leukopenia, neutropenia and peripheral hypostases.

Frequency of side reactions is specified in a type of the following gradation: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); seldom (≥ 1/10000, <1/1000); very seldom (<1/10000), including cases which frequency is not known.

From the central nervous system: very often - drowsiness, dizziness, a headache; often - a dysarthtia, unusual and dreadful dreams, a syncope, extrapyramidal symptoms; infrequently - spasms, a syndrome of uneasy legs; very seldom - late dyskinesia.

From cardiovascular system: often - orthostatic hypotension, tachycardia.

From digestive tract: very often - dryness in a mouth; often - a lock, dyspepsia; infrequently - a dysphagy; seldom - jaundice; very seldom - hepatitis.

From respiratory system: often - rhinitis.

From system of blood: often - a leukopenia; infrequently - an eosinophilia; frequency is not known - a neutropenia.

From immune system: infrequently - hypersensitivity reaction; very seldom - anaphylactic reactions.

From integuments: very seldom - a Quincke's disease, Stephens's syndrome - Dzhonsona6.

Metabolic disturbances: very seldom - a diabetes mellitus.

Changes of laboratory and tool indicators: very often - increase in concentration of triglycerides, the general cholesterol (mainly, cholesterol of lipoproteids of low density); often - increase in body weight, increase in activity hepatic тралсаминаз (aspartate aminotransferases (ACT) and alaninaminotranspherase (ALT)), decrease in quantity of neutrophils, a hyperglycemia; infrequently - the increase in activity of a kreatinfosfokinaza which is not connected with a malignant antipsychotic syndrome, thrombocytopenia.

Others: very often - a syndrome of "cancellation"; often - an adynamy, peripheral hypostases, a sight illegibility; seldom - a priapism, a malignant antipsychotic syndrome.

1. Watch the section "Special Instructions".

2. Drowsiness usually arises within the first 2 weeks after the beginning of therapy and is, as a rule, allowed against the background of the continuing reception of a kvetiapin.

3. Perhaps asymptomatic increase in activity of ACT, ALT and a gammaglyutamiltranspeptidaza (GGT) in blood serum, as a rule, reversible against the background of the continuing reception of a kvetiapin.

4. As well as other antipsychotic drugs кветиапин often causes orthostatic hypotension which is followed by dizziness, tachycardia and in certain cases - a faint, especially at the beginning of therapy.

5. Very exceptional cases of a decompensation of a diabetes mellitus are celebrated.

6. Assessment of frequency of this side effect was made on the basis of results of post-marketing observation.

7. Increase in concentration of glucose in blood on an empty stomach ≥ 126 mg/dl (≥ 7,0 mmol/l) or blood glucose after meal ≥ 200 mg/dl (≥ 11,1 mmol/l) at least at single use.

Lengthening of an interval of QT, ventricular arrhythmia, sudden death, cardiac standstill and bidirectional ventricular tachycardia are considered as the side effects inherent in neuroleptics.

Therapy kvetiapiny is connected with small dozozavisimy decrease in concentration of hormones of a thyroid gland, in particular, of the general thyroxine (T4) and free T4. The maximum decrease in the general and free T4 is registered on the 2nd and 4th week of therapy kvetiapiny without further decrease in concentration of hormones at prolonged treatment. Further there were no signs of clinically significant changes in concentration of thyritropic hormone. Practically in all cases concentration of the general and free T4 was returned to initial after the therapy termination kvetiapiny irrespective of treatment duration. Insignificant decrease in the general triiodothyronine (Тз) and return Tz was noted only when using high doses. Level of tiroksinsvyazyvayushchy globulin (TSG) remained invariable, increase in level of thyritropic hormone (TTG) was not noted.


Interaction with other medicines:

At co-administration of the drugs possessing a strong inhibiting effect on CYP3A4 isoenzyme (such as antifungal means of group of azoles and makrolidny antibiotics), concentration of a kvetiapin in plasma can increase. In a research of pharmacokinetics of a kvetiapin in various dosage at purpose of a kvetiapin to or along with ketokonazoly led to increase in the maximum concentration (Cmax) and the area under a curve "concentration time" (AUC) of a kvetiapin by 5-8 times, and also to reduction of clearance of a kvetiapin. The elimination half-life of a kvetiapin increased, but the average time of achievement of the maximum concentration of Tmax did not change. In such cases it is necessary to apply lower doses of a kvetiapin. Special attention should be paid to the elderly and weakened patients. It is necessary to estimate individually a ratio of risk and advantage for each patient. Therefore joint purpose of a kvetiapin and inhibitors of CYP3A4 cytochrome contraindicated. Also it is not recommended to accept кветиапин together with grapefruit juice. Co-administration of a kvetiapin with the drugs inducing fermental system of a liver such as carbamazepine, is possible decrease in concentration of drug in plasma that can demand increase in a dose of a kvetiapin, depending on clinical effect. In a research of pharmacokinetics of a kvetiapin in various dosage, at appointment to or along with carbamazepine (the inductor of liver enzymes) led it to significant increase in clearance of a kvetiapin. Such increase in clearance of a kvetiapin reduced AUC on average by 13% in comparison with use of a kvetiapin without carbamazepine.

Co-administration of a kvetiapin with other inductor of microsomal enzymes of a liver - Phenytoinum, also led to increase in clearance of a kvetiapin. At co-administration of a kvetiapin and Phenytoinum (or other inductors of liver enzymes, such as barbiturates, rifampicin) increase in a dose of a kvetiapin can be required. Also the dose decline of a kvetiapin at cancellation of Phenytoinum or carbamazepine or other inductor of fermental system of a liver or replacement by the drug which is not inducing microsomal enzymes of a liver can be required (for example, valproic acid).

The pharmacokinetics of drugs of lithium does not change at co-administration of a kvetiapin.

Clinically significant changes of a farkakokinstika of valproic acid and kvetiapin at joint purpose of Valproatum of seven-sodium and a kvetiapin are noted. Kvetiapin did not cause induction of the hepatic fermental systems participating in phenazone metabolism.

The pharmacokinetics of a kvetiapin significantly does not change at co-administration with antipsychotic drugs - risperidony or a haloperidol. However, the concomitant use of a kvetiapin and thioridazine led to increase in clearance of a kvetiapin.

The pharmacokinetics of a kvetiapin significantly does not change at simultaneous use of Cimetidinum which is P450 cytochrome inhibitor. The pharmacokinetics of a kvetiapin significantly did not change at Imipraminum antidepressant co-administration (CYP2D6 isoenzyme inhibitor) or fluoxetine (inhibitor of isoenzymes of CYP3A4 and CYP2D6).

Pharmacokinetic researches on studying of interaction of a kvetiapin with the drugs used at cardiovascular diseases were not conducted. It is necessary to be careful at the combined use of a kvetiapin and the drugs capable to cause disturbance of electrolytic balance and lengthening of an interval of QTc,

It is necessary to be careful at the combined use of a kvetiapin with other drugs influencing the central nervous system and also with alcohol as it can increase risk of development of side effects of a kvetiapin.


Contraindications:

— hypersensitivity to any of drug components;
— combined use with P450 cytochrome inhibitors (antifungal drugs of group of azoles, erythromycin, кларитромицин, нефазодон, inhibitors of proteases);
— deficit of lactase, glyukozo-galaktozny malabsorption, lactose intolerance;
— psychoses at elderly patients with dementia;
— children's age up to 18 years;
— lactation period;
— pregnancy.

With care
At patients with the cardiovascular and cerebrovascular diseases or other states contributing to arterial hypotension; advanced age; liver failure; convulsive attacks in the anamnesis.

Use of the drug SERVITEL® at pregnancy and feeding by a breast
Safety and efficiency of drug at pregnancy is not established therefore drug is appointed only in case the advantage for mother exceeds risk for a fruit. If use of drug in the period of a lactation is necessary, then breastfeeding needs to be stopped.

Use at abnormal liver functions
With care at a liver failure.

Use for elderly patients
Contraindicated at psychoses at elderly patients with dementia. With care at elderly patients.

Use for children
Contraindicated to children up to 18 years.


Overdose:

Data on overdose of a kvetiapin are limited. Cases of reception of a kvetiapin in the dose exceeding 20 g without fatal effects and with a complete recovery are described. It was extremely seldom reported about overdose cases kvetiapiny, leading to death or a coma.

At patients with a serious cardiovascular illness in the anamnesis the risk of development of side effects at overdose can increase.

Symptoms: the symptoms noted at overdose, generally were a consequence of strengthening of the known pharmacological effects of drug, such as drowsiness and excessive sedation, tachycardia and lowering of arterial pressure.

Treatment: there are no specific antidotes to a kvetiapin. In cases of serious intoxication it is necessary to consider the possibility of symptomatic therapy, and it is recommended to hold the events directed to maintenance of function of breath, cardiovascular system, ensuring adequate oxygenation and ventilation of the lungs. A gastric lavage (after an intubation if the unconscious patient) and purpose of absorbent carbon and purgatives can promote removal of not absorbed kvetiapin, however efficiency of these measures is not studied. Fixed medical observation has to continue before improvement of a condition of the patient.


Storage conditions:

At a temperature not above 25 °C.
To store in the place, unavailable to children.


Issue conditions:

According to the recipe


Packaging:

Tablets, film coated, 25, 100, 200 mg.

Tablets are film coated, 25 mg. According to 30 tab. in PVC / the aluminum blister. 2 blisters place in a cardboard pack.

Tablets, film coated, 100 mg and 200 mg. According to 15 tab. in PVC / the aluminum blister. 4 blisters place in a cardboard pack.



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