The instruction for medical use
of Gervetin Torgovoye medicine a name
Mezhdunarodnoye the unlicensed
name Benzydamine Dosage Form Spray for topical administration, 0.15%, 30 ml
the 100th milliliter of spray contains
active agent of benzydamine a hydrochloride of 0.150 g,
excipients: methylparahydroxybenzoate, glitserol, 96% ethanol, sodium saccharin, Natrii hydrocarbonas, polysorbate 60, a liquid peppermint 27198/14, water
the Pharmacotherapeutic group cleaned the Description Transparent, colourless solution with a mint smell
Dental drugs. Other drugs for treatment of diseases of an oral cavity. Benzydamine.
The ATX A01AD02 code
Pharmacokinetics At properties topical administration is well soaked up through mucous membranes and quickly gets into the inflamed fabrics. It is removed by kidneys in the form of metabolites.
Benzidamin belongs to group of indazol and is non-steroidal anti-inflammatory drug. Renders the anti-inflammatory, analgeziruyushchy, locally anesthetizing and antibacterial action against a wide range of microorganisms. Reduces permeability of capillaries, stabilizes cellular membranes and slows down production of ATP and other makroergichesky connections in processes of oxidizing phosphorylation.
Anti-inflammatory and a membrane the stabilizing effect of drug is caused by slowing down of synthesis and an inactivation of prostaglandins, a histamine, bradykinin, cytokines, factors of a complement and other nonspecific disturbing factors.
Analgeziruyushchy and locally anesthetic effect is caused by indirect decrease in concentration of the biogenous amines having algogenny properties, and increase in a threshold of painful sensitivity of the receptor device, benzydamine also blocks interaction of bradykinin with fabric receptors, restores microcirculation and reduces painful sensitivity in the inflammation center.
Topical symptomatic treatment (as a part of complex therapy):
– inflammatory diseases of an oral cavity and throat (ulitis, stomatitis, pharyngitis)
– as addition to conservative dental care and after odontectomy
the Route of administration and doses
– the adult and the patient of advanced age appoint: on 4-8 doses each 1.5-3 h,
– to children at the age of 6-12 years: on 4 doses each 1.5-3 h,
– to children at the age of 3-6 years: on 1 dose on 4 kg of body weight, at most 4 doses, each 1.5-3
Parts 1. Put a bottle in vertical position, turn a cap nozzle to the left or to the right at an angle 90 0C to a bottle.
2. Enter a nozzle into an oral cavity and press a cap (in the drawing it is noted by an arrow) several times according to the recommended dose. The period between pressing has to be not less than 5 seconds.
3. Return a nozzle to initial situation.
Attention: before the first use press several times the spray in air.
Follow all iinstruktion of the doctor, do not stop therapy and do not change a dosage without consultation with the doctor. If you missed administration of drug, accept the passed dose as soon as possible. If already time of the following reception came, then do not use the passed dose, and just continue according to the usual scheme.
The double dose cannot be accepted! Duration of treatment should not exceed 7 days. It is not necessary to exceed the recommended dose. More prolonged use only according to the recommendation and under observation of the doctor.
– dryness in a mouth, feeling of numbness, burning in an oral cavity (usually passing, are completely reversible and seldom demands additional treatment), change of taste, paresthesia in oral cavities, discoloration of language
– allergic reactions (skin rash), drowsiness
– nausea, vomiting
– a photosensitization
– a laryngospasm, a bronchospasm
– anaphylactic reactions
After topical administration benzydamine can get in small amounts to a blood stream and, therefore, rare system undesirable effects are possible.
– hypersensitivity to active agent or to one of ingredients
– children’s age up to 3 years
are not established
instructions Therapy Gervetinom should not exceed 7 days except for cases according to the recommendation of the doctor.
In infectious and inflammatory diseases the use as a part of combination therapy is necessary.
It is necessary to avoid hit of spray in eyes.
Drug can cause in patients with bronchial asthma and bronchial asthma in the anamnesis a bronchospasm. Such patients have to be warned about it surely.
Drug contains methylparahydroxybenzoate which can cause allergic reactions (as well the remote reactions).
At a small number of patients, inflammation and a mucous oral cavity ulcers and drinks can be symptoms of serious diseases. Patients at whom symptoms of inflammation accrue or improvement within 3 days of treatment is not noted, have to see behind consultation the attending physician or the stomatologist.
Long-term treatment by benzydamine can cause reaction of hypersensitivity. In this case treatment it is necessary to stop and hold the corresponding treatment.
If improvement did not occur after 7 days of therapy, it is necessary to see a doctor. Drug contains ethanol of 96% therefore it is not recommended for use by the alcoholic, epilepsy.
Pregnancy and the period of a lactation
Clinical trials on use of drug for pregnant women and in the period of a lactation were not carried out therefore it is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug contains alcohol, it needs to be considered at control of motor transport and carrying out the works requiring special attention.
So far about overdose cases by the drug Gervetin it was not reported.
Symptoms: vomiting, abdominal pain, concern, fear, hallucinations, spasms, ataxy, fever, tachycardia and paralysis of breath.
Treatment: termination of administration of drug, gastric lavage, symptomatic treatment.
The form of release and packing
On 30 ml of drug place in a plastic bottle with the portioning device. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not higher than 25 C. To store out of children’s reach!
A period of storage
not to use drug after an expiration date.
REPLEK FARM Ltd Producer. Skopje, Skopje, the Republic of Macedonia
the Name and the country of the owner of the registration certificate
of Spey Medical Ltd., London, Great Britain
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Cepheus Medical LLP (Tsefey Medikal),
050000, RK, Almaty, Panfilov St. 98,
BC OLD SQUARE, office 807