Cold and Flu / Cough

Mucosolvan 15 mg / 2 ml 100 ml oral solution

Brands: ISTITUTO de ANGELI (Italy)

$16.50

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Mucosolvan 15 mg / 2 ml 100 ml oral solution quantity

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c965401ce5ba

Brands:: ISTITUTO de ANGELI (Italy)

Description

The instruction for medical use of LAZOLVAN® medicine the Trade name of LAZOLVAN the International unlicensed name Ambroxol Dosage Form Solution for intake and inhalations of 15 mg / 2 ml, 100 ml Structure of 2 ml of solution contain active agent – Ambroxol a hydrochloride of 15 mg, excipients: citric acid monohydrate, dinatrium hydrophosphate a dihydrate, sodium chloride, a benzalkoniya chloride, water purified. Description Transparent, colourless or slightly brownish solution. Pharmacotherapeutic group Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol. ATX R05CB06 code Pharmacological Pharmacokinetics Absorption properties. Absorption high and full, a lineynozavisima from a therapeutic dose. The maximum plasma concentration is reached within 1 – 2.5 hours. Distribution. Distribution in fabrics fast and extensive, with the maximum concentration of active agent in lungs. The volume of distribution is about 552 l. Communication with proteins of blood plasma makes about 90%. Metabolism and removal. About 30% of the dose accepted inside are exposed to presistemny metabolism. Ambroxol the hydrochloride under the influence of the main CYP3A4 enzyme is metabolized mainly in a liver by a glyukuronization and partially breaks up to dibromantranilovy acid (about 10% of a dose). After intake, in 3 days, 26% of a dose also about 6% in a free form were found in urine in connected. Elimination half-life makes about 10 hours. The general clearance – within 660 ml/min., renal clearance is about 8% of the general clearance. It is removed by kidneys: about 83% of the general dose are allocated in 5 days after reception. Removal decreases in an abnormal liver function that leads to increase in level in blood plasma by 1.3-2 times. Gender and age do not influence pharmacokinetics of Ambroxol and do not demand dose adjustment. Meal does not influence bioavailability of Ambroxol of a hydrochloride. The Ambroxol pharmacodynamics a hydrochloride – active ingredient of drug LAZOLVAN. Preclinical trials showed that Ambroxol increases secretion of slime in airways, increases production of pulmonary surfactant, stimulates physical activity of cilia of a ciliary epithelium, leading to improvement of mukotsiliarny transport of a phlegm. Kliniko-pharmakologichesky researches confirmed increase in mukotsiliarny clearance that promotes decrease in viscosity of a phlegm and facilitates cough. Mestnoanesteziruyushchy effect of Ambroxol is caused by dose-dependent reversible blockade of the cloned neural natrium channels. Under the influence of hydrochloride Ambroxol the release of cytokines from blood and also from fabric mononuclear and polimorfnuklearny cells considerably decreases. Clinical trials on patients with a sore throat showed considerable reduction of pain and reddening in a throat. Indications Sekretolitichesky therapy of the acute and chronic bronchopulmonary diseases which are characterized by disturbance of secretion and the complicated phlegm otkhozhdeniye. Route of administration and doses Intake of 1 ml = 25 drops. To adults and children 12 years are more senior: the first 2-3 days on 4 ml of solution 3 times a day (90 mg of Ambroxol of a hydrochloride a day are equivalent), further on 2 ml 3 times a day (45 mg of Ambroxol of a hydrochloride a day are equivalent). At serious conditions the scheme of reception of 4 ml of solution x 3 times a day can be continued, after consultation with the doctor. Children are from 6 to 12 years old: on 2 ml of solution 2-3 times a day (30-45 mg of Ambroxol of a hydrochloride a day are equivalent). Children are from 2 to 5 years old: 1 ml of solution 3 times a day (22.5 mg of Ambroxol of a hydrochloride a day are equivalent). To children up to 2 years: 1 ml of solution 2 times a day (15 mg of Ambroxol of a hydrochloride a day are equivalent). To children under 2 years drug can be appointed only according to the recommendation of the doctor. Dosage in a renal and/or liver failure the use of LAZOLVAN solution is shown to Patients with a dekompensirovanny renal failure and heavy degree of a liver failure only after consultation with the doctor. In case of need, the maintenance dose has to be respectively the interval between administrations of drug is reduced or is increased. Duration of reception is not limited, but it is not necessary to take the drug more than 4-5 days without consultation of the doctor. The drug can be taken irrespective of meal, washing down with enough liquid (for example, waters, tea or fruit juice), by means of the enclosed measured glass. For improvement of sekretolitichesky effect of drug it is necessary to drink enough liquid. It is inhalation to Adults and children 6 years are more senior: 1-2 inhalations on 2-3 ml of solution daily. To children up to 6 years: 1-2 inhalations on 1-2 ml of solution daily. If only one inhalation a day is possible, it is necessary to take in addition the drug orally. During inhalation it is necessary to keep normal respiration. LAZOLVAN solution for inhalations can be used in various devices for inhalation. It can be mixed with normal saline solution in equal parts (a ratio 1:1) to receive optimum moistening of the air delivered from an inhaler. LAZOLVAN solution for inhalations should not be mixed with kromoglitsiyevy acid and also with other solutions where rn the level of the turning-out mix can be more than 6.3, such as alkaline solutions for the nebulizer (for example, Emser salt). The level increased rn can cause sedimentation of a free basis of Ambroxol of a hydrochloride or turbidity of solution. Solution should be warmed to body temperature before its inhalation. Patients with bronchial asthma should give usual bronkhospazmolitichesky medicine before inhalation. Side effects the Undesirable phenomena are given below on system and organ classes and frequency on the following classification: very often ≥ 1/10 it is frequent ≥ 1/100 to & lt, 1/10 infrequently ≥1/1000 to & lt, 1/100 is rare ≥1/10.000 to & lt, 1/1000 is very rare also lt, 1/10.000 frequency are unknown undesirable reactions which frequency is unknown as it cannot be estimated on the basis of the available Narusheniya’s data from the immune system Seldom: – reaction of hypersensitivity Frequency is unknown: – anaphylactic reactions, including an acute anaphylaxis, a Quincke’s disease and naggers Narusheniya from skin and hypodermic fabrics Seldom: – rash, urticaria Frequency is unknown: – heavy skin reactions (including a multiformny erythema, Stephens-Johnsona/syndrome a toxic epidermal necrolysis and sharp generalized exanthematous pustulez) Narusheniya from nervous system Often: – a dysgeusia (disturbances a vkusovospriyatiya) Narusheniya from a respiratory system Often: – decrease in sensitivity in a drink (pharyngeal giposteziya) of Narusheniya from a GIT Often: – nausea, decrease in sensitivity in an oral cavity (oral giposteziya) Infrequently: – vomiting, diarrhea, dyspepsia, an abdominal pain, dryness in a mouth it is rare: – dryness in a throat * for detection of new information on safety of drug, we ask medical experts to report about any expected undesirable reactions. The contraindication – hypersensitivity to active agent or to any of auxiliary components of drug – heavy degree of a liver and renal failure – rare hereditary diseases, Medicinal interactions, incompatible with drug components, was not reported about clinically significant adverse interactions with other drugs. Intake of Ambroxol and antibiotics (amoxicillin, tsefuroksy, erythromycin) can result in the increased concentration of the last in a bronchopulmonary secret and a phlegm. Special instructions Are registered very exceptional cases of severe damages of skin such as Stephens-Johnson’s syndrome and toxic epidermal necrolysis at hydrochloride Ambroxol use. Mainly they are caused by weight of a basic disease and/or the accompanying treatment. At patients signs of the beginning of a nonspecific disease with the following symptoms can be shown: fervescence, all body pain, rhinitis, cough and sore throat. In case of skin defeats it is necessary to see a doctor and to stop intake of Ambroxol of a hydrochloride. Use of LAZOLVAN solution is shown to patients with a dekompensirovanny renal failure and heavy degree of a liver failure only after consultation with the doctor. Ambroxol as any active agent which is metabolized in a liver and emitted by kidneys can cause accumulation of metabolites in a liver in patients with a heavy renal failure of LAZOLVAN solution the benzalkoniya contains chloride. With presence of hyperactivity of airways this preservative can cause a spasm of bronchial tubes in patients during inhalation. LAZOLVAN solution contains 42.8 mg of sodium on the recommended daily dose, it should be considered to the patients who are on a diet with restriction of content of sodium. Fertility, pregnancy and period of a lactation Pregnancy. Ambroxol the hydrochloride gets through a placental barrier. Preclinical trials did not show direct or indirect negative impact on pregnancy, fetation, childbirth and post-natal development. Extensive clinical experience of use of drug after the 28th week of pregnancy did not show signs of an adverse effect on a fruit. Nevertheless, it is not recommended to apply LAZOLVAN solution in the period of the I trimester of pregnancy. Lactation. LAZOLVAN solution is allocated with breast milk therefore it is not recommended to take the drug during breastfeeding. Fertility. Preclinical trials did not show direct or indirect negative impact on fertility. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Researches were not conducted. There are no messages about cases of influence of drug on ability to drive the car or mechanisms during the post-marketing period. Overdose Symptoms: signs are comparable to the known side effects: nausea, vomiting, diarrhea, dyspepsia. Treatment: symptomatic therapy. The form of release and packing On 100 ml of drug spill in the bottles of brown glass corked by the screw-on covers with control of the first opening. On 1 bottle together with a measured glass and the instruction for medical use in the state and Russian languages put in a pack cardboard. To Store storage conditions at a temperature not higher than 25 wasps, in the place protected from light, not to freeze. To store out of children’s reach! 3 years to Use a period of storage during 1 year after opening. Not to use after the expiration date specified on packing. Prescription status Without prescription of Proizvoditel Institut de Angueli S.R. L., Locke. Prulli, 103/C, 50066 of Reggello (Fl), Italy the Name and the country of the owner of the registration certificate of Sanofi-Aventis Doychland GmbH, Frankfurt, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187 of “B” phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: quality.info@sanofi.com the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. of 187 B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail:
To Develop Kazakhstan.Pharmacovigilance@sanofi.com

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