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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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ARPEFLU (Umifenovir) 100 mg, 20/30 caps
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Description
The instruction for medical use
of Nemozol Torgovoye medicine a name
Nemozol
Mezhdunarodnoye the unlicensed
name Albendazol Lekarstvennaya a form
Suspension for intake, 100 mg / 5 ml, 20 ml
Structure
of 5 ml of suspension contain
active agent – albendazol 100 mg,
excipients: microcrystalline cellulose, sodium carboxymethylcellulose, glycerin, benzoic acid, potassium hydroxide, sorbic acid, polysorbate-80, sorbitol solution of 70% not crystallized, sodium of a karmelloz dried up, potassium of hydroxide of 5% solution for correction of value rn from 4.5 to 5.5, fragrance essence the fruit mixed ID25676, fragrance essence with taste of frozen excellent FB2867, the water purified.
Description
Uniform suspension of white or almost white color.
Pharmacotherapeutic group
Anthelminthic drugs. Benzimidazole derivatives. Albendazol
the ATX P02CA03 Code
the Pharmacological
Pharmacokinetics Later properties of oral administration albendazole is badly adsorbed from a gastro intestinal path (less than 5%), in not changed look the bioavailability – low is not defined in plasma.
Systemic pharmacological action increases if the dose is accepted with greasy food which increases absorption and the maximum concentration in plasma (Cmax) by 5 times. Linking with proteins of plasma of-70%, gets in significant amounts into bile, a liver, cerebrospinal fluid, urine, a wall and liquids of cysts of helminths. It is metabolized in a liver with formation of primary metabolite of albendazole of the sulphoxide having anthelminthic activity. Time of achievement of Cmax of albendazole of sulphoxide is 2-5 h. Albendazole sulphoxide is metabolized in albendazole sulphone (secondary metabolite) and other oxidized products.
After reception of a single dose of 400 mg (20 ml of suspension) pharmacological an active metabolite – sulphoxide of albendazole reaches plasma concentration from 1.6 to 6.0 µmol/l. Elimination half-life of albendazole makes 8.5 h. It is removed with bile through intestines in the form of albendazole of a sulfoksid and only an insignificant part of its quantity is removed with urine.
At damage of a liver the bioavailability increases, at this Cmax of albendazole of sulphoxide increases twice, and elimination half-life is extended. Induces P450 1A2 cytochrome in cells of a liver of the person.
A pharmacodynamics
Nemozol – antiprotozoan and anthelminthic drug of a broad spectrum of activity, derivative carbamate benzimidazole.
Nemozol breaks processes of transport of glucose, suppresses polymerization beta tubulina, causes disorder of function of the microtubular device in a helminth organism that leads to his death and removal from a human body.
Drug is active against the intestinal parasites causing a skin syndrome of Larva Migrans (syndrome of the wandering larvae)
– Nematodae (roundworms): Ascaris lumbricoides (ascarid), Trichocephalus trichiuris (threadworm), Enterobius vermicularis (pinworm), Ancylostoma duodenale (hookworm), Necator americanus, Strongyloides stercoralis, Trichinella spiralis,
– Cestoidea (tape-worms): Hymenolepsis nana (dwarfish tapeworm), Taenia solium (pork tapeworm), Taenia saginata (bull tapeworm),
– Trematodae (flukes): Opisthorchius viverrini, Clonorchis sinensis,
– Pretosae (elementary): Giardia lamblia (intestinal or duodenal).
Nemozol is active against tissue parasites, Echinococcus granulosus and Echinococcus multilocularis defiant cystous and alveolar echinococcosis Nemozol is effective at treatment of the neurotsistitsirkoz caused by a larval invasion of Taenia solium, the gepatikolez caused by Capilaria philippinensis and a gnatostomoza, caused by Gnathostoma spinigerum invasion. The majority of the drugs used for treatment of an ascaridosis is effective only concerning an intestinal stage of this helminthosis. Nemozol is effective concerning all stages of development of an ascarid, a trichinella. The efficiency is 95100%.
Indications
– intestinal nematodoses: an ascaridosis, an enterobiosis, a trichuriasis, ankilostomidoz, a strongyloidosis
– fabric nematodoses: a trichinosis, toksokaroz
– fabric tsestodoza: the teniosis, cysticercosis (including neurotsistitsirkoz), a hymenolepiasis, echinococcosis (cystous, an alveococcosis)
– an opisthorchosis, a clonorchosis
– a giardiasis
the Route of administration and doses
accept Suspension inside, in time or after meal, it is possible to wash down with water. Use of laxative drugs and a special diet are not required. It is recommended to carry out simultaneous treatment of all family members. The dose is established individually, depending on a type of helminth and body weight of the patient.
The Ascaridosis, a trichuriasis (threadworm)
Nemozol appoint treatment of intestinal nematodoses to adults and children 12 years in a dose of 400 mg (20 ml of suspension) in day once or in 2 receptions after a meal are more senior, to children of 6 – 12 years of 200 mg (10 ml of suspension) once, if necessary repeat in 3 weeks. Special preparation and a diet is not required.
The enterobiosis (pinworms)
is Enough prescribing of drug in a dose of 400 mg (20 ml of suspension) to adults and children 12 years are more senior, to children 6 years up to 12 years of 5 mg/kg of body weight once are more senior. Neither preparation, nor a diet is required. In 14 days it is necessary to repeat a course of treatment in the same dose and in the same mode.
The strongyloidosis (intestinal ugritsa)
Drug is appointed to adults and children 12 years of 400 mg (20 ml of suspension) are more senior, to children 6 years up to 12 years in a dose of 10 mg/kg of body weight once within 3 days are more senior. In a week it is recommended to carry out a treatment recycle in the same doses.
Ankilostomidoz (krivogolovka)
of a drug Dose the same, as at treatment of a strongyloidosis. At one-day treatment the efficiency is 85%, and when lengthening a course up to 23 days it increases.
Treatment of fabric nematodoses
the Trichinosis
of Standard schemes of treatment of a trichinosis does not exist. Treatment is carried out individually taking into account terms of an invasion, its clinical manifestations and also weight of a condition of the patient. Nemozol appoint to children 6 years up to 12 years in a dose of 10 mg/kg of body weight a day are more senior, to adults and children 12 years (weighing more than 60 kg) an average dosage of 800 mg (40 ml of suspension) in day in 2 receptions after a meal within 7 10 days are more senior. At a heavy invasion and organ defeats (myocarditis, a pneumonitis, an encephalomeningitis) also glucocorticosteroids and symptomatic means are appointed. The efficiency
of treatment is estimated on clinical, laboratory and tool indicators (normalization of temperature, the termination of muscular pains, disappearance of hypostases, normalization of the electrocardiogram, disappearance of physical and radiological signs of damage of lungs, regression of neurologic symptomatology, decrease in an eosinophilia of blood, etc.).
Toksokaroz
Nemozol appoint to children 6 years up to 12 years in a dose of 10 mg/kg of body weight a day are more senior, to adults and children 12 years (weighing more than 60 kg) an average dosage of 800 mg (40 ml of suspension) in day in 2 receptions after a meal within 10 days are more senior. As a rule, carrying out repeated courses of treatment at an interval of 2 weeks month is required. Side reactions are rare, are shown by slight dispetichesky disorders. Increase in level of aminotransferases is extremely seldom observed.
Treatment of fabric tsestodoz
Cystous echinococcosis
Treatment of echinococcosis usually operational. The chemotherapy is carried out in cases of a rupture of cysts and planting of an organism, in the postoperative period when there is a danger of planting at disturbance of integrity of a cyst during operation and also in cases of multiple defeats by cysts of the small sizes (no more than 35 cm). Antirecurrent treatment is recommended after operation when it is impossible to exclude existence of other localizations of a parasite of the small sizes. Large cysts it is inexpedient to treat because of inefficiency and a possibility of receiving complications due to disturbance of integrity of a cyst under the influence of drug.
Before prescribing of drug the complete blood count test, biochemical blood test (hepatonephric complex) is necessary. Treatment is carried out at normal laboratory indicators.
Nemozol appoint in a dose to adults and children 12 years (weighing more than 60 kg) on 400 mg (20 ml of suspension) 2 times a day are more senior, to children there are 6 12 years 10 mg/kg/days of body weight in 2 3 receptions after a meal. Duration of a course of treatment is 4 weeks.
In the course of treatment each 57 days the test of blood and aminotransferases is conducted. At decrease in leukocytes below than the 3.0Õ109/l and 56 multiple increase in level of aminotransferases it is necessary to suspend treatment before normalization or considerable improvement of indicators. In cases of the progressing leukopenia and a giperfermentemiya the drug withdrawal is required. Purpose of gepatoprotektor during treatment and in cases of toxic manifestations is ineffective, drug withdrawal is necessary. Treatment of echinococcosis multicourse. Nemozol appoint courses at an interval of 2 nedeli1 month. Duration of treatment of clinically apparent forms of an invasion (presence of cysts) of 12-18 months.
The efficiency of treatment is estimated at tool control and control of dynamics of a caption of specific antibodies. At correctly certain indications to prescribing of drug and observance of a dosage and mode of course treatment recovery is observed.
Alveolar echinococcosis
Treatment of alveolar echinococcosis operational. The chemotherapy is an additional tool. Nemozol’s doses and the mode of its appointment same, as well as in cystous echinococcosis. Duration of course treatment is defined by a condition of the patient and tolerance of drug. Full treatment at use only Nemozola does not come.
Cysticercosis
Nemozol is appointed to adults and children 12 years (weighing more than 60 kg) on 400 mg (20 ml of suspension) 3 times a day are more senior, to children there are 6 12 years in a dose 15 mg/kg of body weight in 3 receptions after a meal. Duration of a course is 2830 days. In 2 days prior to administration of drug and in the first week (sometimes according to indications it is more long) administration of drug appoint glucocorticosteroids (4050 mg of Prednisolonum). Before treatment, in the course of administration of drug and upon termination of carry out the same control, as at treatment of echinococcosis. Control of efficiency of treatment of cysticercosis of a brain is exercised in clinical parameters and results of a x-ray computer tomography of a brain and a nuclear magnetic resonance. At effective treatment the disappearance and/or calcification of the centers is observed. Quite often carrying out repeated courses of treatment is required. It is necessary to remember what even in cases of good effect of treatment of full regress of clinical symptomatology can not come because of the created permanent structural changes of brain fabric.
The giardiasis, an opisthorchosis
to Adults and children are more senior than 12 years weighing more than 60 kg on 400 mg (20 ml of suspension) of 1 times a day within 3 days, or weighing less than 60 kg, including children from 6 to 12 years, at the rate of 10-15 mg/kg of 1 times/days within 5-7 days.
The maximum daily dose of 800 mg (40 ml of suspension) the patient with the body weight of 60 kg and more, less than 60 kg 15 mg/kg.
Side effects
– allergic reactions: rash, an itching, urticaria, an erythema, including Stephens’s syndrome – Johnson
– a headache, dizziness
– nausea, vomiting, an abdominal pain, diarrhea, a constipation
– increase in level of hepatic enzymes, hepatitis
– a leukopenia, a pancytopenia, an agranulocytosis, a thrombopenia
– fever
– increase in arterial blood pressure
– a renal failure
– aplastic anemia, suppression of marrow,
the Contraindication neutropenia
– hypersensitivity to an albendazol and other components of medicine
– eye retina pathology
– pregnancy and the period of a lactation
– children’s age up to 6 years
Medicinal interactions
Cimetidinum, a praziquantel and dexamethasone increase plasma levels of an albendazol.
Special instructions
to avoid Nemozol’s reception during early pregnancy, women of childbearing age have to carry out treatment in the first week after periods or after the negative test for pregnancy. It is necessary to take contraception measures during treatment and within one month after completion of administration of drug in system helminthosis.
Perhaps weak or moderate increase in level of hepatic enzymes which are normalized after the termination of reception of Nemozol. Definition of indicators of function of a liver has to is carried out before each cycle of treatment and each two weeks during treatment. If indicators of transaminases increase twice and more, Nemozol it is necessary to cancel. Treatment is repeated when indicators of function of a liver are normalized.
Nemozol can cause reversible moderate lowering of total number of leukocytes. Blood tests have to be made at the beginning and each two weeks during each 28-day cycle. At development of a leukopenia, drug should be cancelled. In the course of short courses of treatment the control of peripheral blood (once in 57 days) and aminotransferases in the same terms is necessary.
If necessary patients with neurotsistitsirkozy, have to receive the complex therapy including steroids and antikonvulsant. In diseases of eyes before an initiation of treatment the eye retina research is necessary. In eye cysticercosis the antiparasitic treatment is contraindicated because of a possibility of heavy complications (amotio of a retina) and development of a blindness.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose does not influence
Cases are not described.
The form of release and packing
On 20 ml of drug place in the plastic bottles capacity with a screw mouth corked by the screwed aluminum cover with laying. Put on the dosing polyvinylchloride cap a cover.
On 1 bottle together with the instruction for use in the state and Russian languages place in a cardboard box.
To Store storage conditions in the dry, protected from light place at
a temperature not higher than 250 S. Hranit out of children’s reach!
3 years
not to apply a period of storage after expiry date.
Prescription status
According to the prescription
Ipca laboratories Limited Producer, India
48, Kandivili Ind. Estate, Mumbai 400067, India
the Owner of the registration certificate
of Ipca Laboratories Limited, India
the Address of the organization accepting claims for territories of the Republic of Kazakhstan from consumers on quality of products
Almaty, Kurmangaza St., 48 and, office 10
ph.: 261-51-41
fax: 261-44-66
regulatory@kazeuropharm.com
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