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Description
The instruction
for medical use
of TERAFLYU LAHR THERAFLU LAR medicine
the Trade name
TeraFlya LAHR
the International unlicensed name
Is not present
the Dosage form
Spray for topical administration
Structure
100 ml of spray contain
active agents: benzoxonium chloride of 0.2 g,
lidocaine hydrochloride of 0.15 g
excipients: glycerin, ethanol of 96% (about/about), 0.1 M acid chlorohydrogen, oil mint, left menthol, water purified.
The description
Transparent colourless solution with a mint smell.
Pharmacotherapeutic group
Drugs for treatment of diseases of a throat. Antiseptic agents. The other
drugs ATX R02AA20 Code Pharmacological Properties
of Pharmako
Benzoksoniya’s kinetics chloride is practically not absorbed.
It is found in the person about 1% of the entered dose in urine, concentration of substance in blood is not found. Accumulation of substance in body tissues is not revealed. Lidocaine is absorbed at oral administration and through a mucous membrane of an oral cavity. It is metabolized at the first passing through a liver, at oral introduction its bioavailability is about 35%.
Metabolites are removed together with urine, less than 10% of substance are removed in
an invariable look.
Benzoksoniya’s pharmacodynamics chloride – salt of quarternary ammonium (N-dodecyl N, M-di N-Benzylium (2 hydroxyethyl) of ammonium chloride), thanks to the cationic structure has membranotropny activity and has the significant bacteriostatic and bactericidal action against gram-positive (Staphylococcus aureus, Staphylococcus epidermis) and gram-negative microorganisms (Citrobacter freundli, Klebsiella pneumoniae, Proteus rettgeri, Pseudomonas aeruginosa, Salmonella wien, Serratia marcescens).
Benzoxonium has also antifungal and antiviral activity in relation to membrane viruses (including influenza viruses, a parainfluenza and herpes).
Lidocaine is local anesthetic of an amide row. Changing permeability of a cellular membrane for sodium ions, lidocaine blocks carrying out nervous impulses, than the anesthetizing effect which at inflammatory processes reduces painful feelings in a throat when swallowing is reached it.
Indications
– infections of a mouth and throat (pharyngitis, laryngitis, stomatitis, aphthous ulcers, an ulocace)
– as supportive application (adenoid disease).
Route of administration and doses
Locally. Holding vertically a barrel, spray in an oral cavity.
Adults and teenagers are more senior than 12 years: when holding each procedure carry out 2 – 4 squirts on the struck area of an oral cavity or a back wall of an oral cavity of 3-6 times a day with time interval of not less than 2-3 hours.
Children from 4 to 11 years: when holding each procedure carry out 2 squirts on the struck area of an oral cavity or a back wall of an oral cavity of 3-6 times a day with time interval of not less than 2-3 hours.
Duration of treatment should not exceed 5 days.
If relief of symptoms of a disease within 5 days after the beginning of administration of drug is not observed it is necessary to stop administration of drug.
Side effects
Often (from & gt, 1/100 to & lt, 1/10):
– discomfort in an oral cavity, in the form of local irritation which is temporary
Very seldom (from & lt, 1/10000):
– the hypersensitivity (including edema of face, lips, language, a throat)
– dispnoe
– paresthesia, rash, an itching
– at prolonged use of drug can be observed reversible brown coloring of language or teeth
of the Contraindication to use
– hypersensitivity to lidocaine or other local anastetika, benzoxonium to chloride or other ammoniac connections and also to any other component of drug
– children’s age up to 4 years
– pregnancy and the period of a lactation.
Medicinal interactions
of Medicinal interactions it was not observed owing to small dosages of active agents.
Lidocaine can theoretically interact with other drugs applied at the same time, for example, with other arrhythmia medicines.
Special instructions
At children spray has to be applied only under observation of adults as can cause development reflex laringo- and a bronchospasm. Drug should not be used at the children incapable to hold the breath during spraying.
If relief of symptoms of a disease within 5 days after the beginning of administration of drug is not observed it is necessary to stop administration of drug. To avoid hit of drug in eyes. Not to inhale drug at dispersion.
It is not recommended to take the drug in time or just before food or drink in connection with the anesthetizing effect of lidocaine that can lead to swallowing difficulty. Bioavailability of lidocaine at oral use low, but at drug ingestion it can render toxic effects on central nervous system, such as spasms and death (at children and adults after intake of viscous solutions of lidocaine and also rinsing of 4% lidocaine solution). Lidocaine overdose treatment symptomatic, also consists in control of cardiovascular and respiratory functions and also spasms.
With care drug should be used in the presence of injuries of a mucous membrane of a mouth and throat.
Drug contains small amounts of ethanol (alcohol), less than 100 mg on one dose, the maximum single dose 4 squirts. Drug should not be used in case of damage of a nozzle – the spray.
Features of influence of drug on ability to run the vehicle or potentially dangerous mechanisms.
Contains ethanol. Drug has insignificant impact on ability to run the vehicle or potentially dangerous mechanisms.
Overdose
lidocaine Content in Teraflya Lahr is insignificant and cannot cause serious symptoms of overdose.
Symptoms: at accidental reception of high doses – nausea or vomiting.
Treatment: it is recommended to drink milk or to eat the ovalbumin beaten in water or activated carbon. If it is necessary, it is necessary to give soothing, but it is necessary to avoid vomiting and washing. To avoid alcohol as it promotes absorption.
All patients, accidentally or intentionally large amounts of the drugs which took inside with lidocaine, have to ask for medical care immediately.
A form of release and packing
On 30 ml of drug in bottles from polyethylene of high density.
On 1 bottle together with the dosing device, a plastic protective cover, a polypropylene nozzle and 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 higher than 30 S. Hranit out of children’s reach!
Not to use a period of storage of 5 years after expiry date.
Prescription status
Without prescription
of Proizvoditel Novartis Konsyyumer Hels SA, Switzerland
the Owner of the registration certificate
of Novartis Konsyyumer Hels SA, Switzerland
the Address of the organization accepting in the territory of the Republic of Kazakhstan
claims from the consumer on quality of a product
of Filial Novartis Pharm Services AG in RK
Almaty, Luganskogo St., 96
ph. (727) 258-12-91 8-800-080-0650 (it is free from all stationary phones across the Republic of Kazakhstan)
Fax: +7 (727) 244-26-51
e-mail: drugsafety.cis@novartis.com
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