Expiration date: 12/2027
Composition
Composition (per 1 tablet) Active ingredients: Antibodies to the brain-specific protein S-100, affinity purified - 0.003 g*
Excipients: lactose monohydrate 0.267 g, microcrystalline cellulose 0.03 g, magnesium stearate 0.003 g. * applied to lactose monohydrate in the form of an aqueous alcohol mixture containing no more than 10-16 ng / g of the active form of the active substance.
The dosage form
of the tablet for resorption
Description
Tablets are flat-cylindrical in shape, with a risk and a chamfer, from white to almost white in color. The inscription MATERIA MEDICA is printed on the flat side with the risk, and the inscription TENOTEN KID is printed on the other flat side.
Pharmacodynamics
The drug has a soothing, anti-anxiety (anxiolytic) effect, without causing undesirable hypnogenic and muscle relaxant effects. Improves the tolerance of psychoemotional stress. It has stress-protective, nootropic, antiamnestic, antihypoxic, neuroprotective, antiasthenic, and antidepressant effects.
In conditions of intoxication, hypoxia, and conditions after acute cerebrovascular accident, it has a neuroprotective effect, limits the area of damage, and normalizes learning and memory processes in the central nervous system (CNS).
It inhibits the processes of lipid peroxidation.
It modifies the functional activity of the S-100 protein, which interacts synaptic (informational) and metabolic processes in the brain. By exerting GABA-mimetic and neurotrophic effects, it increases the activity of stress-limiting systems and promotes the restoration of neuronal plasticity processes.
Indications for use
Neurotic and neurosis-like disorders accompanied by increased excitability, irritability, anxiety, impaired behavior and attention, and vegetative disorders.
Attention deficit hyperactivity disorder.
Contraindications
No cases of overdose have been identified so far.
Use during pregnancy and lactation
The safety of using Tenoten for children in pregnant women and during lactation has not been studied. If necessary, the risk / benefit ratio should be taken into account.
Side effects
When used according to the indicated indications and in the indicated dosages, no side effects were detected. Reactions of increased individual sensitivity to the components of the drug are possible.
Interaction
To date, no cases of incompatibility with other medicines have been reported.
Method of administration and dosage
Inside. 1-2 tablets per dose (keep in mouth until completely dissolved - not during meals). If necessary, the tablets can be dissolved in a small amount of boiled water at room temperature.
Neurotic and neurosis-like disorders.
Take 1 tablet 1 to 3 times a day, the course of treatment is 1-3 months.
If necessary, the course of treatment can be extended to 6 months or repeated after 1-2 months.
Attention deficit hyperactivity disorder.
Take 2 tablets each
2 times a day, the course of treatment is 1-3 months. If there is no permanent improvement in the condition within 3-4 weeks after the start of treatment, it is necessary to consult a doctor.
Overdose
No cases of overdose have been identified so far.
Special instructions
The drug contains lactose monohydrate, and therefore it is not recommended to prescribe it to patients with congenital galactosemia, glucose or galactose malabsorption syndrome, or with congenital lactase deficiency.
Due to the activating properties of the drug Tenoten for children, the last dose should be taken no later than 2 hours before bedtime.
Form of release
Tablets for resorption.
Conditions of release from pharmacies
Without a prescription
Storage conditions
At a temperature not exceeding 25 C. Keep out of reach of children.
During the period of use of the drug, store the contour cell packaging in a cardboard pack provided by the manufacturer.
Expiration date
Do not use for 3 years after the expiration date.
Composition
Composition per 1 ml
Active substance: affinity-purified antibodies to the brain-specific protein S-100 - 10,000 EMD* Excipients: maltitol, glycerol, potassium sorbate, anhydrous citric acid, purified water.
* EMD - units of modifying action.
Packaging and release form
Drops for oral administration of 25 ml in vials with dropper. Each vial, along with the instructions for medical use, is placed in a cardboard pack.
Dosage form
A colorless or almost colorless transparent liquid.
Pharmacotherapeutic group
anxiolytic agent sedative
Pharmacodynamics
The drug has a soothing, anti-anxiety (anxiolytic) effect, without causing undesirable hypnogenic and muscle relaxant effects. Improves the tolerance of psychoemotional stress. It has stress-protective, nootropic, antiamnestic, antihypoxic, neuroprotective, antiasthenic, and antidepressant effects.
In conditions of intoxication, hypoxia, and conditions after acute cerebrovascular accident, it has a neuroprotective effect, limits the area of damage, and normalizes learning and memory processes in the central nervous system (CNS). It inhibits the processes of lipid peroxidation. It modifies the functional activity of the S-100 protein, which interacts synaptic (informational) and metabolic processes in the brain. By exerting GABA-mimetic and neurotrophic effects, it increases the activity of stress-limiting systems and promotes the restoration of neuronal plasticity processes.
Pharmacokinetics
The sensitivity of modern physico-chemical analysis methods (gas-liquid chromatography, high-performance liquid chromatography, chromatography-mass spectrometry) does not allow us to assess the content of the active substance of the drug Tenoten® for children in biological fluids, organs and tissues due to the specific composition of the drug (see the section "Composition per 1 ml of drops for oral administration"), which technically makes it is impossible to study pharmacokinetics.
Indications
Tenoten® for children is indicated for use in children aged 1 month to 1 year.
Consequences of perinatal damage to the central nervous system (grade I-II cerebral ischemia, grade I-II intracranial hemorrhage, combined damage to the central nervous system) in children of the first year of life.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Children under 1 month of age.
Children from the age of 1 year.
Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Use during pregnancy and lactation
The safety of using Tenoten® for children in pregnant women and during breastfeeding has not been studied. The drug is intended for use in children under 1 year of age.
Method of administration and dosage
Inside. Take 10 drops (0.5 ml) once a day 15 minutes before morning feeding of the baby at about the same time. Before use, the drops can be diluted in a small amount (1-5 ml) of boiled water at room temperature. The duration of therapy is 12 weeks.
Special instructions
The drug contains maltitol, and therefore it is not recommended to prescribe it to patients with rare congenital fructose intolerance. Due to the activating properties of the drug Tenoten® for children, the last dose should be taken no later than 2 hours before bedtime.
Impact on the ability to drive vehicles, mechanisms
The drug is intended for use in children under 1 year of age.
Side effects
Reactions of increased individual sensitivity to the components of the drug, mild diarrhea are possible.
Drug interaction
To date, no cases of incompatibility with other medicines have been reported.
Overdose
In case of overdose, dyspeptic phenomena are possible due to the excipients included in the preparation. Treatment: symptomatic.
Storage temperature
from 2℃ to 25℃
Special storage conditions
After opening, the bottle should be stored at a temperature of no more than 25 ° C for 35 days.
Do not freeze.