FREE Shippingto US, AU, UK and EU on all orders over $149

Description

The instruction for medical use

of Zentel Torgovoye medicine a name
Zentel

Mezhdunarodnoye the unlicensed

name Albendazol Lekarstvennaya a form
Suspension for intake of 4%, 10 ml

Structure
of 100 ml of drug contain
active agent – albendazol 4.0 g,
excipients: magnesium aluminosilicate, sodium carboxymethylcellulose, glycerin, polysorbate 80, sorbitan mono-laurate, potassium sorbate, benzoic acid, sorbic acid, anti-foam silicone 1510, sodium saccharin, fragrance orange, fragrance vanilla, fragrance intensively fruit, the water purified.

The description
Suspension from white till cream color with a smell of orange and vanilla

Pharmacotherapeutic group
Anthelminthic drugs. 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
Intestinal infections and a skin syndrome of Larva Migrans
– an enterobiosis
– ankilostomidoz and a necatoriasis
– a hymenolepiasis
– a teniosis
– a strongyloidosis
– an ascaridosis
– a trichuriasis
– the clonorchosis and an opisthorchosis caused by Opisthorchic viverrini and/or
Clonorchis sinensis
– a skin syndrome of Larva Migrans
– a giardiasis at children
System gelmintny infections
– the cystous echinococcosis caused by Echinococcus granulosus (in case of inoperable pathology, before surgery, in the post-operational period when the course of preoperative therapy was too short or viable cysts or in case of planting of adjacent areas are found during operation, after chrezkozhny drainage of cysts in the diagnostic or therapeutic purposes)
– the alveolar echinococcosis caused by Echinococcus multilocularis granulosus (in case of inoperable pathology, in particular in cases of local and widespread metastases, after palliative surgical intervention, after radical surgery or transplantation of a liver)
– neurotsistitsirkoz, the caused Taenia solium (in case of existence single or multiple cysts or granulematozny defeat of parenchymatous tissue of brain, arachnoidal or intra ventricular cysts, uviform cysts)
– the intestines nematodosis caused by Capillaria philippinensis
– gnatostomoz, the caused Gnathostoma spinigerum and other similar subspecies
– the trichinosis caused by Trichinella spiralis and T. pseudospiralis
– toksokaroz, the caused Toxocara canis and other similar subspecies

the Route of administration and doses
take the Drug inside together with meal. Reception at the same time is preferable day. Before the use the bottle with suspension needs to be shaken up carefully.
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

Prodolzhitelnost’s Age of reception

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

Adults and children are more senior than 2 years

of 400 mg of 1 times/days (10 ml of suspension) once

Children from 1 to 2 years

of 200 mg of 1 times/days (5 ml of suspension) once

the Strongyloidosis, a teniosis, a hymenolepiasis

Adults and children are more senior than 2 years

of 400 mg (10 ml) of suspension 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.

The clonorchosis, an opisthorchosis

Adults and children are more senior than 2 years

of 400 mg (10 ml) of suspension 2 times a day within 3 days.

The skin syndrome of Larva Migrans

Adults and children is more senior than 2 years

of 400 mg (10 ml) of suspension of 1 times a day. Prodolzhitelnost of reception makes from 1 day to 3 days.

A giardiasis

Only children from 2 to 12 years

of 400 mg (10 ml) of suspension of 1 times a day within 5 days.

System gelmintny infections
(long treatment by higher doses).
Prescribing of drug is not recommended to children up to 6 years by high doses in connection with limited experience of use of drug for this age category.
The mode of dosing is set individually depending on age, body weight and also from severity of an infection.
Doz for patients at body weight more than 60 kg 400 mg make 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

the Body weight

of the patient Doz Prodolzhitelnost of reception

Cystous echinococcosis

& gt, 60

kg 800 mg the day divided into 2 receptions on 400 mg

the Course of treatment makes 28 days.
Perhaps repeated prescribing of drug in the form of 3 cycles for 28 days with a 14-day break in administration of drug after each cycle.

& lt, 60

kg 15 mg/kg the day divided into two identical a dose, appointed in two steps (the maximum daily dose – 800 mg/days)

Inoperable and multiple cysts

At an inoperable form of peritoneal cysts, cysts in lungs and a liver is recommended three 28-day cycles of treatment divided by a 14-day break in administration of drug. In the presence of cysts in a brain and bones longer course of therapy can be required.

Preoperative therapy

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.

Postoperative therapy / chrezkozhny drainage of cysts in the diagnostic or therapeutic purposes

If the presurgical course was less than 14 days or viable cysts or in case of planting of adjacent areas are found during operation, after operation carry out two cycles for 28 days divided by a 14-day break in administration of drug.

Alveolar
echinococcosis

& gt, 60

kg 800 mg the day divided into 2 receptions on 400 mg

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.

& lt, 60

kg 15 mg/kg the day divided into two identical a dose, appointed in two steps (the maximum daily dose – 800 mg/days)

Neurotsistitsirkoz *

& gt, 60

kg 800 mg the day divided into 2 receptions on 400 mg

Duration of reception from 7 to 30 days depending on 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.

& lt, 60

kg 15 mg/kg the day divided into two identical a dose, appointed in two steps (the maximum daily dose – 800 mg/days)

Parynchemal cysts and grunulema

& gt, 60

kg 800 mg the day divided into 2 receptions on 400 mg

Duration of reception from 7 to 28 days depending on the response of the patient to the carried-out therapy.

& lt, 60

kg 15 mg/kg the day divided into two identical a dose, appointed in two steps (the maximum daily dose – 800 mg/days)

Arachnoidal and ventrikulyarny cysts

& gt, 60

kg 800 mg the day divided into 2 receptions on 400 mg

Duration of reception make 28 days.

& lt, 60

kg 15 mg/kg the day divided into two identical a dose, appointed in two steps (the maximum daily dose – 800 mg/days)

Uviform cysts

& gt, 60

kg 800 mg the day divided into 2 receptions on 400 mg

reception Duration of 28 days depending on the answer of the patient to carried out therapy.

& lt, 60

kg 15 mg/kg a day, divided into two identical a dose, appointed in two steps (the maximum daily dose – 800 mg/days)
* 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.

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, and in case of substantial increase of indicators of activity of a liver or the significant decrease in uniform elements of blood Zentel’s use has to be cancelled.

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 function of marrow.
– the multiformny erythema, Stephenson-Johnson’s syndrome

of the Contraindication
– hypersensitivity to an albendazol and other components of medicine
the pregnancy – existing, assumed or planned,
the lactation period
– eye retina pathology
– children’s age till 1 year

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
At the patients who are treated for a neurotsistitsirkoz can be shown the neurologic symptoms against the background of Zentel’s reception connected with death
of parasites. 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.
Suspension contains benzoic acid which is a weak irritant for skin, eyes and a mucous membrane. It can increase risk of developing jaundice at newborn babies.
Perhaps weak or moderate increase in level of hepatic enzymes which are normalized after the termination of reception of Zentel.
In the course of therapy, cases of development of hepatitis against the background of Zentel’s reception 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. At clinically significant decrease in level of uniform elements of blood, Zentel it is necessary to cancel.
Use in pediatric practice
Drug is not shown to children aged till 1 year.
Pregnancy and the period of a lactation
the Drug Zentel is contraindicated in the presence of the existing, assumed or planned pregnancy. In order to avoid Zentel’s appointment during early pregnancy, the woman of childbearing age have to begin therapy only after the negative test for pregnancy which has to be repeated at least once prior to the beginning of the following cycle. Observance of reliable measures of contraception throughout all cycle of treatment and in addition for a month after its termination is necessary.
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.

A form of release and packing
On 10 ml in plastic bottles with metal covers.
On 1 plastic bottle together with the instruction for use in the state and Russian languages I place in a pack from cardboard.

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

A period of storage
3 years
not to use after an expiration date

Prescription status
According to the prescription

Farmaclair Producer, 440, Avenue du General de Gaulle, 14200 Herouville-Saint-Clair, France

the Packer
of Farmaclair, 440, Avenue du General de Gaulle, 14200 Herouville-Saint-Clair, France
the Owner of the registatsionny certificate
of Laboratoire GlaxoSmithKline, 100, route de Versailles 78163 Marly-le-Roi Cedex, France

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

Additional information

Ingredient

Reviews

There are no reviews yet.

Be the first to review “Zentel 4% 10 ml oral suspension”

Your email address will not be published. Required fields are marked *

Wishlist 0
Open wishlist page Continue shopping