The instruction for medical use of Flavamed® medicine solution for cough for children the Trade name of Flavamed® solution for cough for children the International unlicensed name Ambroxol Dosage Form Solution for intake 15mg/5ml Structure of 5 ml of drug contains active agent – Ambroxol of a hydrochloride of 15 mg, excipients: benzoic acid, glycerin of 85%, sorbitol of 70% (uncrystallizable), hydroxyethylcellulose (molar extent of substitution 2.5, average viscosity 6000 mpa*s), a fragrance concentrate with a smell of raspberry (No. 516028), the water purified the Description Transparent colourless or slightly brownish color liquid with a fruit smell (raspberry smell). The pharmacotherapeutic group Mucolytic means the Code of automatic telephone exchange R05CB06 the Pharmacological Pharmacokinetics Later properties of intake Ambroxol is soaked up almost completely. Tmax at intake makes 1-3 hours. The absolute bioavailability of Ambroxol at intake decreases approximately by one third owing to effect of the first passing through a liver. As a result of it the Ambroxol metabolites (e.g., dibromoantranilovy acid, glucuronides) which are removed through kidneys are formed. Ambroxol contacts proteins of plasma on average for 85% (from 80% to 90%). Elimination half-life of drug makes about 7-12 h of plasma. The general elimination half-life of Ambroxol and its metabolites makes about 22 h. Ambroxol breaks a placental barrier, gets to cerebrospinal fluid and to breast milk. About 90% of Ambroxol are removed through kidneys in the form of the metabolites which are formed in a liver. Less than 10% of Ambroxol are removed through kidneys in not changed look. In view of high extent of linking of Ambroxol with proteins and its considerable volume of distribution and also in view of its slow redistribution from fabrics in blood, removal of a little considerable part of drug by means of dialysis or an artificial diuresis it is improbable. In a serious illness of a liver the clearance of Ambroxol decreases by 20-40%. In a heavy renal failure it is necessary to be afraid of accumulation of metabolites of Ambroxol in an organism. The pharmacodynamics Ambroxol represents the substituted benzylamine and is a Bromhexine metabolite. Its difference from Bromhexine consists in absence of methyl group and available hydroxyl group in a para-trance the provision of a tsiklohexilny ring. Though the mechanism of effect of Ambroxol is completely not studied, it is known that it has sekretolitichesky and sekretomotorny effect. Effects of drug are shown in 30 minutes after reception and remain within 6-12 hours depending on a dose. In preclinical trials it is shown that Ambroxol increases a share of a serous component in a bronchial secret. It facilitates phlegm transport due to reduction of its viscosity and strengthening of work of a ciliary epithelium. Ambroxol activates the system of surfactant due to immediate effect on pnevmotsita 2 types in alveoluses and the cells Klara which are in small airways. It strengthens education and removal of surface-active material in alveoluses and a bronchial tree of a fruit and adult organism. Besides, in a number of preclinical trials it was shown that Ambroxol has antioxidant effect. Today the clinical importance of this effect is not established. Against the background of use of Ambroxol the increase in concentration of antibiotics of amoxicillin, a tsefuroksim, erythromycin and doxycycline in a phlegm and a bronchial secret is noted. Today the clinical importance of this effect is not established. Indications – acute and chronic diseases of the bronchial tubes and lungs which are followed by disturbance of education and removal of slime the Route of administration and doses in the absence of the additional instructions Flavamed® for cough accept solution in the following doses: Children under 2 years of ½ measured spoons (2.5 ml) Flavameda® of solution for cough 2 times a day (15 mg of Ambroxol of a hydrochloride a day are equivalent) should be applied only under observation of the doctor. Children from 2 to 5 years of ½ measured spoons (2.5 ml) of Flavameda® of solution for cough 3 times a day (22.5 mg of Ambroxol of a hydrochloride a day are equivalent). Children from 6 to 12 years 1 measured spoon (5 ml) of Flavameda® of solution for cough 2-3 times a day (30-45 mg of Ambroxol of a hydrochloride a day are equivalent). Adults and teenagers are more senior than 12 years 2 measured spoons (on 5 ml) Flavameda® of solution for cough 3 times a day (90 mg of Ambroxol of a hydrochloride a day) in the first 2-3 days are equivalent, then on 2 measured spoons (on 5 ml) Flavameda® of solution for cough 2 times a day (60 mg of Ambroxol of a hydrochloride a day are equivalent). Note: If necessary adults can accept 60 mg of Ambroxol of a hydrochloride 2 times a day (120 mg of Ambroxol of a hydrochloride a day are equivalent). The way and duration of use of Flavamed® solution for cough is recommended to be accepted after a meal, using a measured spoon for exact dosing. Флавамед® for cough it is possible to accept solution independently no more than 4-5 days then it is necessary to see a doctor. Side effects Sometimes (³ 1/1000 – & lt, 1/100) – reactions of hypersensitivity (skin rash, a face edema, difficulty of breath, an itching), temperature increase – nausea, an abdominal pain, vomiting Very seldom (& lt, 1/10000) – anaphylactic reactions, up ment of shock – heavy skin reactions, such as Stephens-Johnson’s syndrome and epidermal necrolysis of the Contraindication – hypersensitivity – the I trimester of pregnancy Medicinal interactions In a combination with Flavamed® antibechics solution for cough it is necessary to apply to Ambroxol or one of drug components with care and only in the presence of weighty indications as antibechics suppress a tussive reflex and can break evacuation of a phlegm from airways. At Ambroxol use concentration in a phlegm and a bronchial secret of such antibiotics as amoxicillin, tsefuroksy, erythromycin and doxycycline raises. The clinical value of this phenomenon is not found out today. Special instructions Very seldom against the background of treatment by Ambroxol developed heavy skin reactions, such as Stephens-Johnson’s syndrome and Lyell’s disease. At emergence of any changes from skin or mucous it is necessary to stop immediately intake of Ambroxol and to see a doctor. As Flavamed® solution for cough can strengthen slime secretion, it should be applied with care at disturbances of bronchial motility and the strengthened slime secretion (e.g., at seldom found syndrome of motionless cilia). Also Flavamed® for cough should appoint solution with extra care (for example, with longer intervals or in a reduced dose) in a renal failure and in a serious illness of a liver. In a renal failure of heavy degree the accumulation of the metabolites of Ambroxol which are formed in a liver is probable. Флавамед® solution for cough contains sorbite. In this regard it is contraindicated at hereditary intolerance of fructose which, however, meets quite seldom. One measured spoon (5 ml) of solution for intake contains 1.75 g of sorbite (= 0.15 grain units). Caloric content of sorbite is 2.6 kcal/g. Patients should appoint drug with care with intolerance of a histamine. At this category of patients it is necessary to avoid Ambroxol use for a long time as it influences metabolism of a histamine and can lead to emergence of symptoms of intolerance (for example, a headache, cold and an itching). At children 2 years are younger than Flavamed® solution for cough should be applied only under observation of the doctor. Pregnancy and the period of a lactation Pregnancy is available insufficient amount of data on use of Ambroxol during pregnancy, especially within the first 28 weeks Today. In preclinical trials Ambroxol had no teratogenic effect. Флавамед® for cough pregnant women can appoint solution only after careful assessment of a ratio of advantage and risk. The lactation period In preclinical trials it is revealed that Ambroxol gets into breast milk. As experience of use of drug in the period of a lactation at the person is limited, solution for cough can appoint Flavamed® the feeding women only after careful assessment of a ratio of advantage and risk. The feature of influence of drug on ability to driving and service of cars of Proofs of influence of drug on ability to driving and service of cars is not available, the corresponding researches were not conducted. Overdose Symptoms: The overdose of Ambroxol is not followed by symptoms of serious intoxication. Perhaps some concern and diarrhea. As well as in preclinical trials, the significant overdose of Ambroxol at the person can be followed by the strengthened salivation, desires on vomiting, vomiting and a lowering of arterial pressure. Treatment: Such emergency measures as calling of vomiting and gastric lavage, are not recommended, it is necessary to apply them only in case of the significant overdose. Also symptomatic treatment is recommended. The form of release and packing of 100 ml of a ready-made product place in the bottle from brown glass supplied with the screwing-up cover. 1 bottle with a spoon for dosing and the instruction for use in the state and Russian languages is packed into a cardboard box. To Store storage conditions at a temperature not above 25oc. To store out of children’s reach! 3 years not to apply a period of storage after the expiration date specified on packing. Use of drug after opening of a bottle within 6 months Prescription status Without prescription the Owner of the registration certificate and AG BERLIN-HEMI producer (MENARINI GROUP) Gliniker Weg 125 12489 Berlin, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan is recommended to a claim from consumers on quality of products (goods): Representative office of JSC Berlin-Hemi AG in RK Phone number: +77272446183, 2446184, 2446185 fax number: +7 727 2446180 the e-mail address: Kazakhstan@berlin-chemie.com Director of the Pharmacological center Kuzdenbayeva R.S. Scientific secretary Mirmanova R.K. Expert / / Director of representation Iskakova
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