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Zentel 1’s 400 mg coated tablets

$17.20

8df9549cd97d

Description

The instruction for medical use

of Zentel Torgovoye medicine a name
Zentel

Mezhdunarodnoye the unlicensed

name Albendazol Lekarstvennaya a form
of the Tablet, 400 mg

Structure
One tablet contains
active agent – albendazol 400 mg,
excipients: lactose, cellulose microcrystalline, starch corn, sodium lauryl sulfate, dye yellow sunset, povidone, sodium saccharin, magnesium stearate, sodium of a kroskarmelloz, fragrances vanilla, orange and intensively fruit.

The description
of the Tablet of light orange color with impregnations, rounded off, oblong with a biconvex surface, with risky on the one hand and stamping of ALB400 on the other hand, with a characteristic fruit smell.

Pharmacotherapeutic group
Drugs for treatment of a nematodosis. Benzimidazole derivatives.
Albendazol.
The ATX P02CA03 code

the Pharmacological

Pharmacokinetics Later properties of oral administration albendazol is badly adsorbed from a GIT
(less than 5%), in not changed look the bioavailability – low is not defined in blood 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. Time of achievement of Cmax of an albendazol of sulphoxide is 2-5 h. 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 the albendazole sulphoxide having anthelminthic activity. Albendazola sulphoxide is metabolized in an albendazol sulphone (secondary metabolite) and other oxidized products.
After reception of a single dose of 400 mg pharmacological the active metabolite, sulphoxide of an albendazol, reaches plasma concentration from 1.6 to 6.0 mikromol/l at administration of drug with food. Elimination half-life of an albendazol of sulphoxide makes 8.5 h. It is removed with bile through intestines in the form of an albendazol of sulphoxide, and only its insignificant part 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 IA cytochrome in cells of a liver of the person.
A pharmacodynamics
Zentel – antiprotozoan and anthelminthic drug of a broad spectrum of activity, derivative carbamate benzimidazole.
Zentel breaks processes of transport of glucose, 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 parasites causing intestinal infections and a skin syndrome including:
Nematodes

of Ascaris lumbricoides (roundworm)

of Trichuris trichiura (threadworm)

of Enterobius vermicularis (pinworm)

of Ancylostoma duodenale (hookworm)

of Necator americanus (nematode)

of Strongyloides stercoralis Larva Migrans (syndrome of the wandering larvae)

of Hymenolepsis nana Cestode (dwarfish soliter)

Taenia saginata (bull soliter)
of the Trematode

of Opisthorchis viverrini Clonorchis sinensis
of Protozoa
of Giardia lamblia (intestinal or duodenal)
Zentel is active Taenia solium (pork soliter) against tissue parasites, including the cystous and alveolar echinococcosis caused by an invasion of Echinococcus granulosus and Echinococcus multilocularis. Zentel is effective for treatment of the neurotsistitsirkoz caused by a larval invasion of Taenia solium, the gepatikolez caused by Capilaria philippinensis and a gnatostomoza, caused by an invasion of Gnathostoma spinigerum, Echinococcus granulosus, Echinococcus multilocularis.

Indications
– an enterobiosis
– ankilostomidoz and a necatoriasis
– a hymenolepiasis
– a teniosis
– a strongyloidosis
– an ascaridosis
– a trichuriasis
– a clonorchosis
– an opisthorchosis
– a skin syndrome of Larva Migrans
– cystous echinococcosis (hepatic, alveolar, peritoneal)
– neurotsistitsirkoz
– an intestines nematodosis
– gnatostomoz
– a trichinosis
– toksokaroz

the Route of administration and doses
take the Drug inside together with meal. Reception at the same time is preferable day.
Some patients can have difficulties with ingestion of a tablet, in such cases the tablet can be chewed and washed down with a small amount of water or to pound.
If there does not occur recovery in three weeks, the second year of treatment registers.
Intestinal infections and a skin syndrome of Larva Migrans

the Infection

reception Duration

the Enterobiosis, ankilostomidoz, nekatorioz,
an ascaridosis, pinworms,
a trichuriasis

of 400 mg of 1 times/days (1 tablet) once

the Strongyloidosis, a teniosis, a hymenolepiasis

of 400 mg (1 tablet) of 1 times/days within 3 days.
At confirmation of a hymenolepiasis carrying out a repeated course of treatment lasting from 10 days up to 21 days is recommended.

A clonorchosis, an opisthorchosis

of 400 mg (1 tablet) 2 times a day within 3 days.

A skin syndrome of Larva Migrans

of 400 mg (1 tablet) of 1 times a day. Duration of reception is from 1 day to 3 days.

A giardiasis

of 400 mg (1 tablet) of 1 times a day within 5 days.
Elderly patients
Experience of use for patients are more senior than 65 years is limited. Correction of a dose is not required, however patients should be careful when assigning with abnormal liver functions.
A renal failure
As removal of an albendazod and its primary metabolite, albendazol sulphoxide, slightly, influence of renal pathology on renal clearance is improbable. However, at patients with a renal failure it is necessary to carry out monitoring of function of kidneys at Zentel’s appointment.
The liver failure
Because albendazol it is quickly metabolized by means of hepatic metabolism to primary metabolite albendazol sulphoxide, an abnormal liver function has considerable impact on pharmacokinetics albendazol sulphoxide. Patients with disturbance of indicators of hepatic tests (transamins) owe baht are carefully examined until prescribing of the drug Zentel.
System gelmintny infections
(long treatment by higher doses).
The mode of dosing is set individually depending on age, body weight and also from severity of an infection.
The dose for patients at body weight more than 60 kg makes 400 mg 2 times a day. Weighing less than 60 kg drug is appointed at the rate of 15 mg/kg / in day. This dose has to be divided into 2 receptions. The maximum daily dose makes 800 mg.

The infection

reception Duration

Cystous echinococcosis

Zentel is appointed in case of inoperable pathology, before surgery, in the post-operational period when the course of preoperative therapy was too short or viable cysts, after chrezkozhny drainage of cysts are found in the diagnostic or therapeutic purposes.
The course of treatment makes 28 days.
At an inoperable form of peritoneal cysts, cysts in lungs and a liver three 28-day cycles of treatment divided by a 14-day break in administration of drug are recommended. In the presence of cysts in a brain and bones longer course of therapy can be required.
Before operation two 28-day cycles divided by a 14-day break in administration of drug are recommended. If surgical intervention is necessary until the termination of a two-cyclic course, Zentel has to be accepted until surgery.
If the presurgical course was less than 14 days or viable cysts are found, then after operation carry out two cycles for 28 days divided by a 14-day break in administration of drug.

Alveolar
echinococcosis

of 28 days. The second 28-dnevny year is repeated after a two-week break in administration of drug. Treatment can be continued within several months or years.

Neurotsistitsirkoz *

Duration of reception from 7 to 30 days, in dependence of the response of the patient to the carried-out therapy. The second year can be repeated after a two-week break in administration of drug.

Parynchemal cysts and grunulema

Duration of reception from 7 to 28 days, in dependence of the response of the patient to the carried-out therapy.

Arachnoidal and ventrikulyarny cysts

Duration of reception is 28 days.

Uviform cysts

reception Duration of 28 days, in dependence of the response of the patient to the carried-out therapy.

* Patients also have to receive therapy by steroids and anticonvulsant drugs. Oral or intravenous corticosteroids are recommended for use at the beginning of the first week of therapy for prevention of episodes of intracranial hypertensia.

An infection

reception Duration

the Nematodosis

of 400 mg of 1 times a day within 10 days. Is more often than one course of therapy happens enough, but treatment can be continued in case of positive clinical symptoms or parasitological tests.

Gnatostomoz

of 400 mg of 1 times a day within 10-20 days. Is more often than one course of therapy happens enough, but treatment can be continued in case of positive clinical symptoms or parasitological tests.

A trichinosis
Toksokaroz

of 400 mg 2 times a day a course of 5-10 days. Is more often than one course of therapy happens enough, but treatment can be continued in case of positive clinical symptoms or parasitological tests.

Side effects
According to manifestation frequency side reactions are defined as very frequent (& gt, 1/10), frequent (& gt, 1/100, & lt, 1/10), sometimes (& gt, 1/1000, & lt, 1/100), rare (≥1/10, 000 and & lt, 1/1000), very rare (& lt, 1/10, 000).
Short-term therapy by low doses
Sometimes
– a headache and dizziness
– pain in the field of epigastrium or a stomach, nausea, vomiting and diarrhea
Seldom
– reactions of hypersensitivity, including rash, an itching and urticaria
– increase in level of liver enzymes
is Very rare
– a multiformny erythema, Stephenson-Johnson’s syndrome
Long-term therapy by high doses
Very often
– a headache
– slight or average increase of level of hepatic enzymes
Is frequent
– dizziness
– an abdominal pain, nausea, vomiting and diarrhea (at treatment of echinococcosis)
– a reversible alopecia (poredeniye and moderate loss of hair)
– fever
Sometimes
– reactions of hypersensitivity, including rash, an itching and urticaria
– a leukopenia
– hepatitis
Very seldom
– the pancytopenia, aplastic anemia, an agranulocytosis
Patients with liver pathology, including hepatic echinococcosis, are more predisposed to suppression of a funtskiya of marrow.
– the multiformny erythema, Stephenson-Johnson’s syndrome

of the Contraindication
– hypersensitivity to an albendazol and other components
of medicine
– the existing or planned pregnancy, the lactation period
– children’s and teenage age do18 years

Medicinal interactions
Tsimetedin, a praziquantel and dexamethasone increase plasma levels of a metabolite of an albendazol responsible for system efficiency of a product.
Ritonavir, Phenytoinum, carbamazepine and phenobarbital can potentially reduce plasma concentration of an active metabolite of an albendazol – an albendazol of sulphoxide. The clinical value of this fact is unknown, however can affect Zentel’s efficiency, especially at treatment of system helminthoses. Patients have to be under observation of the doctor regarding efficiency of treatment that can demand purpose of the alternative mode of dosing or revision of the carried-out therapy.

Special instructions
to avoid Zentel’s reception during early pregnancy, women of childbearing age have to carry out treatment within the first week of periods or after the negative test for pregnancy. The test for pregnancy has to be repeated at least once before the following cycle. It is necessary to take precautionary measures against conception in time and within one month after completion of administration of drug in a system infection.
In the course of treatment of patients the drug Zentel can existence at them the existing neurotsistitsirkoz will come to light, especially patients in a zone with high degree have a spread of tenozny infections.At the patients who are treated for a neurotsistitsirkoz and system gelmintny infections the neurologic symptoms against the background of Zentel’s reception connected with death of parasites can be shown. Attacks, increase in intracranial pressure and focal symptoms belong to these symptoms. Symptoms can be shown right after the beginning of therapy and demand immediate treatment by steroids and antikolvulsant. Oral or intravenous corticosteroids are recommended for use at the beginning of the first week of therapy for prevention of episodes of intracranial hypertensia.
Perhaps weak or moderate increase in level of hepatic enzymes which it is normalized after the termination of reception of Zentel.
In the course of therapy, cases of development of hepatitis were revealed. Definition of indicators of function of a liver has to be carried out before each cycle of treatment and each two weeks during treatment. If indicators of transaminases increase twice and more, Zentel it is necessary to cancel. Treatment is resumed when indicators of function of a liver return to norm, but patients have to be under observation of the attending physician.
Zentel can cause suppression of function of marrow in this connection blood tests have to be made at the beginning and each two weeks during each 28-day cycle. Patients with liver diseases, including hepatic echinococcosis, have more expressed tendency to suppression of marrow conducting to a pancytopenia, aplastic anemia, an agranulocytosis and a leukopenia that demands careful monitoring of a picture of blood. At clinically significant decrease in level of uniform elements of blood, Zentel it is necessary to cancel.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Side effects affecting ability of driving of vehicles and service of the mechanical equipment in the movement were not observed.

Overdose
Symptoms are not described.

Form of release and packing
of the Tablet, 400 mg.
On 1 tablet place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
Each blister strip packaging together with the instruction for use in the state and Russian languages is placed in a pack from cardboard.

To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!

Not to use a period of storage of 5 years after an expiration date

Prescription status
According to the prescription

the Producer GlaksoSmitKlyayn Yu.A. Ltd (technical training College), Republic of South Africa
(39 Hawkins Avenue, Epping Industria 1, 7460 Care Town, Republic of South Africa)

Owner of the registration certificate
Yu.A. GlaksoSmitKlyayn. Ltd (technical training College), the Republic of South Africa
(39 Hawkins Avenue, Epping Industria 1, 7460 Care Town, Republic of South Africa)
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Predstavitelstvo GlaksoSmitKlyayn Export Ltd in Kazakhstane050059, Almaty, Furmanov St., 273 Phone number: +7 727 258 28 92, +7 727 259 09 96 Fax number: + 7 727 258 28 90 E-mail address:
To Develop kaz.med@gsk.com

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