Gelmintoks 125 mg / 2.5 ml 15 ml of oral suspension

The instruction for medical use

of GELMINTOKS medicine

the Trade name
of Gelmintoks

the International unlicensed



name Pyrantelum Dosage Form Suspension for intake of 125 mg / 2.5 ml, 15 ml

Structure
of 100 ml of suspension contain
active agent - Pyrantelum embonat 14.42 g (in terms of Pyrantelum of 5.0 g),
excipients: the sorbitol crystallizing liquid, glycerin, polysorbate 80, lecithin soy, povidone, anhydrous citric acid, Natrium benzoicum (E 211), an emulsion silicone, fragrance of blackcurrant/caramel (solution of vanillin, diacetyl, benzoic aldehyde, lactones, ionones, essential oil of a lemon, extract from buds of blackcurrant and the alkolyat of blackcurrant in propylene glycol), aluminum and magnesium silicate, water


the Homogeneous suspension of light yellow color purified the Description with a characteristic smell of blackcurrant and caramel. Loss of a deposit can be observed. At manual agitation of a particle easily again pass into suspension.

Pharmacotherapeutic group
Anthelminthic drugs. Drugs for treatment of a nematodosis. Tetragidropirimidina derivatives. Pyrantelum.
The ATX P02CC01 code

the Pharmacological

Pharmacokinetics Practically properties is not absorbed from digestive tract. After reception of a single dose of 12.5 mg/kg of body weight the concentration of Pyrantelum in blood plasma during 1-3 h makes 0.05-0.13 mkg/ml. It is partially metabolized in a liver up to N-methyl-1.3-propanediamina. It is removed through intestines (about 93%) in not changed look, kidneys (7%) - in not changed look or in the form of a metabolite.
The pharmacodynamics
Protivogelmintny drug, causes neuromuscular blockade of helminths, sensitive to it, and provides their exile without excitement and stimulation of migration of the struck worms. In a gleam of intestines it is effective against mature and unripe sensitive helminths of both sexes.
It is highly effective against the invasions caused by pinworms (Enterobius vermicularis), ascarids (Ascaris lumbricoides), hookworms (Ankylostoma duodenale and Necator americanus).

Indications
- an ascaridosis
- an enterobiosis (infection with pinworms)
- a dochmiasis

the Route of administration and doses
Inside. Suspension is recommended to children from the birth and the adult. To shake up suspension before the use.
1 ml of suspension contains 50 mg of Pyrantelum, 1 measured spoon contains 2.5 ml contains 125 mg of Pyrantelum.
gelmintoks it is possible to accept at any time, without preliminary intake of laxatives, not necessarily on an empty stomach.
An enterobiosis and an ascaridosis (also at the mixed invasions these parasites): drug is appointed once in the recommended dose, at the rate of 10 mg/kg of body weight, once.
Depending on age and the body weight of the patient the following doses are applied:

to children from 6 months to 2 years: 1 measured spoon of suspension once (125 mg),
to children is from 2 to 6 years: 2 measured spoons of suspension once (250 mg),
to children are from 6 to 12 years: 4 measured spoons of suspension once (500 mg),
to children are more senior than 12 years and the adult
weighing less than 75 kg: 6 measured spoons once (750 mg),
weighing more than 75 kg: 8 measured spoons of suspension once (1000 mg).
For prevention of repeated infection it is recommended to repeat administration of drug in 3 weeks.
Ankilostomidoza: In endemia zones, in case of infection of Necator americanus or in case of heavy infection Ankylostoma duodenale, a dosage makes 20 mg/kg / in day (for one or two receptions) within 3 days, that is:
- to children from 6 months to 12 years: on 2 measured spoons of suspension (250 mg) on each 10 kg of weight a day within 3 days,
- to children 12 years and the adult are more senior:
weighing less than 75 kg: on 12 measured spoons of suspension (1.5 g) a day within 3 days,
weighing more than 75 kg: on 16 measured spoons of suspension (2.0 g) a day within 3 days.
In case of Ankylostoma duodenale infection out of endemia zones (proceeds more easily) appoint in a dose in 10 mg/kg at one time.

Side effects
Sometimes - nausea, vomiting, an abdominal pain, tenesmus, spasms, diarrhea and loss of appetite (most often these symptoms are explained by death of helminths), - skin rash, fervescence
It is rare - a headache, dizziness, drowsiness, insomnia, weakness, feeling of fatigue,
- slight short-term increase of activity of hepatic transaminases
- congestion of a nose
In isolated cases
- a hearing disorder, hallucinations, confusion of consciousness,

Contraindication paresthesia
- hypersensitivity to Pyrantelum and other components of drug
- a myasthenia (treatment period)
- a liver failure
- simultaneous use of piperazin
- children's age up to 6 months.

Medicinal interactions
co-administration of levamisole, piperazin is not recommended. Increases concentration of theophylline in plasma.

Special
instructions C care children's age up to 2 years. In case of the available diseases of a liver it is necessary to warn the doctor. In order to avoid repeated infection it is necessary to follow rules of hygiene strictly: to wash hands, to cut and clean nails, not to allow combing of area of a crotch, to change daily bed and underwear. There is no need of use of depletive.
In an enterobiosis all family is exposed to treatment. Infection can often not be shown by any symptoms.
After completion of treatment in 14 days it is necessary to conduct control parasitological a research.
This drug contains sorbitol. Use of this drug is not recommended to the patients suffering from intolerance of fructose (rare hereditary disease).

To apply pregnancy and the period of a lactation At pregnancy only in urgent cases, according to strict indications after careful assessment of a ratio of advantage / risk for a fruit by which the doctor defines, and strictly to adhere recommended dosed If during treatment you find out that you are pregnant, see a doctor since only he will be able to make the decision on need to continue treatment. Due to the insufficiency of researches, drug should not be used during feeding by a breast, behind an exception, cases when it is strictly necessary.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
dizziness In some cases can be observed therefore it is necessary to be careful during driving of vehicles and service of the mechanical equipment.
Overdose
Thanks to the small speed of absorption, concentration in plasma remain low.
Symptoms: anorexia, nausea, vomiting, diarrhea, asthenia, dizziness, headache. Sometimes, the overdose leads to increase in hepatic transaminases (aspartate aminotransferase).
Treatment: there is no specific antidote. Immediate gastric lavage and also monitoring of respiratory and cardiovascular functions is recommended.

A form of release and packing
Suspension in bottles of brown glass on 15 ml. One bottle and a measured spoon with a capacity of 2.5 ml place together with the instruction for medical use in the state and Russian languages in a cardboard pack.


To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C.
To store out of children's reach!


3 years
not to use a period of storage after the expiration date specified on packing.

Prescription status
According to the prescription


the Producer Innotera Shuzi, Rue Rene Shantero L'Isl Ver, 41150, Shuzi-Sur-Cis, France.

The owner of the registration certificate
Laboratory Innotek Internasional, Arkey, France
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Representation Innotek Internasional Laboratory of S.A.S. in RK 050059, Republic of Kazakhstan, Almaty, Al-Farabi Ave., 17, business center of Nurla Tau, the block of 4 B, office 606, ph./fax: +7-727-311-09-71, +7-727-311-09-72, e-mail: innotech@innotech.kz