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Description
The instruction for medical use of Septolete® medicine totat the Trade name of Septolete® totat the International unlicensed name there Is no Dosage form Spray for topical administration Structure 1 ml of drug contains active agents: benzydamine a hydrochloride of 1.5 mg, cetylpyridinium chloride of 5 mg (in a look monohydrate chloride cetylpyridinium), excipients: alcohol of 96%, glycerin, a makrogolglitserina hydroksistearat, sodium saccharin, peppermint oil, water purified the Description Transparent from colourless till yellowish color liquid Pharmacotherapeutic group Drugs for treatment of diseases of a throat. Antiseptic agents. Other drugs. The ATX R02AA20 code the Pharmacological Pharmacokinetics From properties of two active ingredients – cetylpyridinium chloride and benzydamine – is soaked up only benzydamine. Therefore cetylpyridinium chloride does not enter pharmacokinetic interaction with benzydamine at the system level. Absorption of benzydamine through mucous membranes of a mouth and throat was shown by means of identification of active ingredient in blood serum which number, nevertheless, was insufficiently for rendering systemic action. However, at system use, benzydamine is soaked up. Thus, the level of absorption of benzydamine is higher at use of dosage forms which are dissolved in an oral cavity, in comparison with dosage forms for topical administration (for example spray for an oral cavity). In usually recommended doses the absorption of benzydamine at use of spray is insignificant. RaspredelenieObem of distribution of all dosage forms is identical. VyvedeniePreparat is brought generally with urine, more, in the form of inactive metabolites. Elimination half-life and the general clearance are similar for all dosage forms. The pharmacodynamics the Mechanism of effect of Benzydamine a hydrochloride represents a molecule with nonsteroid chemical structure with the anti-inflammatory and anesthetizing properties. The action mechanism, is connected with inhibition of synthesis of prostaglandins and, thereby, with decrease in local signs of inflammation (such as pain, reddening, a swelling, burning). Benzydamine the hydrochloride also possesses moderate local anestetichesky action. Clinical performance and safety Benzydamine, is generally applied at treatment of diseases of a stomatopharynx. Cetylpyridinium chloride – an antiseptic agent from group of quarternary ammonium connections, has antimicrobial, antifungal and virulitsidny effect. Cetylpyridinium chloride is active concerning gram-positive bacteria and is less active concerning gram-negative bacteria, and, therefore, has optimal antiseptic and bactericidal effect. Totat indications of Septolete®, spray is shown to adults and children 6 years for the anti-inflammatory, anesthetizing and antiseptic treatment of irritations in a throat, an oral cavity and gums are more senior, in an ulitis, pharyngitis, laryngitis and tonsillitis and also before exodontia. The route of administration and doses to Adults and children are more senior than 12 years: for use of a single dose, the raspylitelny head has to be pressed one – two times. It is possible to repeat the procedure every 2 hour, 3-5 times a day. For achievement of optimum effect, it is not recommended to use drug directly to or after toothbrushing. It is not necessary to exceed the recommended dose. Септолете® totat, spray for topical administration, it is possible to use within 7 days. To patients of advanced age: the recommended dose same, as well as for adult patients. Children are from 6 to 12 years old: for use of a single dose, the raspylitelny head has to be pressed once. It is possible to repeat the procedure every 2 hour, 3-5 times a day. When using spray children have to be under supervision of adults. To children up to 6 years: contraindicated (See the section Contraindications). The route of administration Before the first use needs to be pressed several times on a raspylitelny head, small drops will not appear yet. If the spray is not used during the long span (for example, at least, within one week), press a raspylitelny head once that small drops appeared. Before use remove a plastic cover Open widely a mouth, direct a nozzle to a throat and press a raspylitelny head 1-2 times. Hold the breath during dispersion. After each use, close a plastic cover a raspylitelny head. By single pressing 0.1 mg of spray which contains 0.15 mg of benzydamine of a hydrochloride and 0.5 mg chloride cetylpyridinium are taken. Side effects Seldom (³1/10,000 to & lt, 1/1,000): hypersensitivity reactions bronchospasm small tortoiseshell, photosensitivity Very seldom (& lt, 1/10,000): the irritation of a mucous membrane of an oral cavity, burning sensation in an oral cavity Is unknown (it cannot be estimated on the basis of the available data): burning and/or numbness of a mucous membrane of an oral cavity of the Contraindication hypersensitivity to active agents or to any excipient the children’s age up to 6 years totat Medicinal interactions of Septolete®, spray for topical administration, it is not necessary to apply along with other drugs from group of antiseptic agents. Totat the special instructions Septolete®, spray for topical administration, it is not necessary to apply more than 7 days. In the absence of noticeable signs of improvement of a state, after 3 days of treatment it is necessary to consult the doctor. Use of local drugs, especially during the long span, can lead to reactions of a sensitization. In this case treatment has to be the corresponding therapy is suspended and is carried out. Септолете® totat, spray for topical administration, it is impossible to apply along with anion connections which are present at toothpastes therefore, it is not recommended to take the drug directly to or after toothbrushing. Patients should not eat, drink, chew right after drug use. Drug cannot be used for inhalations. This medicine contains a small amount of ethanol (alcohol, less than 100 mg on 1 dose). Totat use in pediatrics of Septolete®, spray for topical administration, it is not recommended to children up to 6 years. Pregnancy and the period of a lactation safety of use of benzydamine of a hydrochloride Given relatively and cetylpyridinium of chloride during pregnancy are absent or are limited. Септолете® totat, spray for topical administration, are not recommended for use during pregnancy. It is unknown whether the hydrochloride and its metabolites get into maternal milk of benzydamine. The risk for newborns/babies cannot be excluded. It is necessary to make the decision on the breastfeeding termination, or to refuse/refrain from therapy by the drug Septolete® totat, spray for topical administration, taking into account advantage of breastfeeding for the child and advantage of therapy for mother. Totat features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms About influence of Septolete®, spray for topical administration, on ability of control of vehicles and other mechanisms it was not reported. Overdose Symptoms: toxic manifestations of overdose of benzydamine include: excitement, spasms, the increased sweating, an ataxy, a fever and vomiting. In view of lack of specific antidote, treatment of acute intoxication benzydamine exclusively symptomatic. Signs and symptoms of intoxication at intake of significant amounts cetylpyridinium of chloride include: nausea, vomiting, short wind, cyanosis, asphyxia with the subsequent paralysis of respiratory muscles, oppression of central nervous system, arterial hypotension and a coma. Treatment: in view of lack of specific antidote, treatment of acute overdose exclusively symptomatic. Overdose treatment chloride cetylpyridinium also symptomatic. In case of overdose it is necessary to see a doctor Forma of release and packing On 30 ml of drug place in plastic bottles with the raspylitelny valve and a protective cap 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 at a temperature not over 25 ºС. To store out of children’s reach! A period of storage 2 years the use Period after opening of a bottle – 6 months. Not to apply after an expiration date Prescription status Without prescription the Producer of KRK, of. The place is new, Slovenia Shmaryeshka 6, 8501 the place, Slovenia the Owner of the registration certificate of KRK, of Is new. The place is new, Slovenia Shmaryeshka 6, 8501 the place Is new, Slovenia
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine of KRKA Kazakhstan LLP, RK, 050059, Almaty, Al-Farabi Ave. 19, body 1, the 2nd floor, the 207th office
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