The instruction for medical use of FLUIMUCIL medicine the Trade name Fluimucil the International unlicensed name Acetylcysteinum Dosage Form Solution for injections and inhalations, 100 mg/ml, 3 ml Structure One ampoule contains active agent – Acetylcysteinum of 300 mg, excipients: dinatrium edetat, sodium hydroxide, water for injections. The description Transparent colourless solution with a slight sulfuric smell Pharmacotherapeutic group Expectorant drugs. Mucolytics. Acetylcysteinum. The code of automatic telephone exchange R05CB01 the Pharmacological Pharmacokinetics At properties intravenous administration of 600 mg of Acetylcysteinum the maximum concentration in plasma makes 300 mmol/l, plasma elimination half-life – 2 hours. The general clearance is equal to 0.21 l/h/kg, and distribution volume at the plateau is equal to 0.34 l/kg. In a liver it is deacetylated to cysteine. In blood the mobile balance of the free and connected with proteins of plasma Acetylcysteinum and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Acetylcysteinum gets into intercellular space, is mainly distributed in a liver, kidneys, lungs, a bronchial secret. It is removed by kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), an insignificant part is allocated in not changed look through intestines. Gets through a placental barrier. The pharmacodynamics Mucolytic means, dilutes a phlegm, increases its volume, facilitates department of a phlegm. Action is connected with ability of free sulfhydryl groups of Acetylcysteinum to break off inside – and intermolecular disulfide bridges of acid mucopolysaccharides of a phlegm that leads to a depolymerization of mucoproteins and reduction of viscosity of a phlegm. Keeps activity at a purulent phlegm. Increases secretion of less viscous sialomutsin scyphoid cells, reduces adhesion of bacteria on epithelial cells of a mucous membrane of bronchial tubes. Stimulates mucous cells of bronchial tubes which secret lyses fibrin. Has similar effect on the secret which is formed in inflammatory diseases of ENT organs. Has the antioxidant effect caused by existence of the SH group capable to neutralize electrophilic oxidizing toxins. Acetylcysteinum easily gets in a cell, is deacetylated to L-cysteine from which intracellular glutathione is synthesized. Glutathione – high-reactive tripeptide, powerful antioxidant, the cytoprotector catching endogenous and exogenous free radicals and toxins. Acetylcysteinum warns exhaustion and promotes increase in synthesis of the intracellular glutathione participating in oxidation-reduction processes of cells thus promoting a detoxication of hazardous substances. Effect of Acetylcysteinum as antidote in poisoning with paracetamol is explained by it. Protects alfa1-antitrypsin (elastase inhibitor) from the inactivating influence of HOCl – the oxidizer produced by myeloperoxidase of active phagocytes. Possesses also anti-inflammatory action (due to suppression of education of the free radicals and active oxygen-containing agents responsible for development of inflammation in pulmonary fabric). Indications – the acute and chronic respiratory disorders which are characterized by hypersecretion dense it is difficult for the separated slime. – paracetamol overdose the Route of administration and doses It is inhalation. To adults and children: on 300 mg (3 ml) 1-2 times a day within 5-10 days. Frequency of use and a relative dosage can change the doctor in acceptance limits, depending on clinical implication and therapeutic effect, without the need for differentiation of a dosage for adults and children. Endobronchial instillation. To adults and children: on 300 mg (3 ml) 1-2 times a day or as required, according to the chosen way of reception (a constant catheter, the bronchoscope, etc.). Intranasal or endoauricular instillation or washing. To adults and children: for instillations – on 2-3 drops 2-3 times a day, for washing of cavities – on ½ – 1 ampoule on the procedure Intravenously at overdose of paracetamol (acetaminophen). Initial dose: on 150 mg/kg of body weight it is entered intravenously in the corresponding volume of 5% of solution of glucose within 15 minutes. Subsequent doses: on 50 mg/kg it is entered by intravenously drop infusion within 4 hours, then on 100 mg/kg – intravenous perfusion during sleduyushchikh16 hours, in both cases into 5% glucose solution. Side effects At topical administration: – hypersensitivity – a bronchospasm, a rhinorrhea, bronchial obstruction – stomatitis, nausea, vomiting – urticaria, skin rash, an itching At parenteral use: – an acute anaphylaxis, anaphylactic and anaphylactoid reactions, hypersensitivity – tachycardia – a bronchospasm, breath disturbance – nausea, vomiting – a Quincke’s disease, a small tortoiseshell, fever, skin rash, an itching – a face edema – the lowering of arterial pressure, lengthening of a prothrombin time is Seldom or never possible development of heavy skin reactions, such as Stephens-Johnson’s syndrome, Lyell’s disease. In case of development of such undesirable reactions, drug should be cancelled immediately. At intake of Acetylcysteinum, cases of decrease in aggregation of thrombocytes are described. Contraindications – hypersensitivity to Acetylcysteinum and auxiliary components of drug – pregnancy and the period of a lactation – children up to 2 years, except for paracetamol overdose therapy cases. Medicinal interactions Fluimucil can be applied together with bronchodilators of systemic effect, vasoconstrictors, etc. The combined use of Acetylcysteinum with antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex. At simultaneous use with such antibiotics as tetracyclines (excepting doxycycline), ampicillin, Amphotericinum B, their interaction with thiol group of Acetylcysteinum is possible that leads to decrease of the activity of both drugs. Therefore the interval between intake of these drugs has to make not less than 2 hours. The concomitant use of Acetylcysteinum and nitroglycerine can lead to strengthening of vasodilating action of the last. Acetylcysteinum eliminates toxic effects of paracetamol. Special instructions It is necessary to be careful at use of drug as antidote at patients with body weight less than 40 kg as risk of development of a delay of liquid in an organism with the subsequent hyponatremia, spasms and death is possible. Intake of Acetylcysteinum, in particular, in the form of the inhaled aerosol, can bring in an initiation of treatment to fluidifying and, at the same time, increase in volume of a bronchial secret. If patients are not capable to expectorate properly, it is necessary to release airways, using a postural drainage, or sucking away liquid from bronchial tubes, in order to avoid stagnation of a secret. The patients having bronchial asthma have to be under strict observation during treatment: at emergence of an attack of a bronchial spasm the treatment has to be immediately stopped. With care to apply at patients with a round ulcer of a stomach, including in the anamnesis, especially in cases of combined use with other medicines rendering irritant action on mucous a stomach. Intravenous administration of drug has to be carried out under stringent medical control. Acetylcysteinum at use as antidote can extend a prothrombin time [to reduce the prothrombin ratio, to raise an indicator of the international normalized relation (INR)]. When opening an ampoule the sulphurous smell which is a specific smell of active agent and does not affect quality of drug is felt. Acetylcysteinum solution at storage in an open ampoule or transfer in the device for dispersion can accept in exceptional cases pink color, but it does not affect efficiency and tolerance of drug. The ampoule of Fluimucil is opened before the use. The opened ampoule can be stored in the fridge within 24 hours, during this time drug can be used only for inhalations. Solution of Fluimucil should not adjoin to rubber and metal surfaces. The feature of influence on ability to run the vehicle and potentially dangerous mechanisms does not influence. Overdose Symptoms: at intravenous administration the symptoms of overdose are similar to side effects of drug, but are more expressed. Local use of the raised doses can lead to extensive fluidifying of a secret in bronchial tubes. Treatment: the immediate termination of administration of drug both the further symptomatic and supporting treatment. Specific antidote is unknown. Acetylcysteinum is dialyzed. In case of the complicated expectoration at formation of large volume of slime, as necessary, it is necessary to carry out mechanical suction for maintenance of airways abroach. A form of release and packing On 3 ml of drug in ampoules of dark glass with the color line of a break. On 5 ampoules are placed in plastic blister strip packaging. On 1 blister strip packaging together with the instruction for use in the state and Russian languages place in a cardboard box. Storage conditions At a temperature not higher than 25 of 0C. To store out of children’s reach! Not to use a period of storage of 5 years after the expiration date specified on packing. Prescription status According to the prescription the Producer Zambon S.P.A., Via della Chimica, 9 – 36100 Vicenza, Italy the Owner of the registration certificate S.P.A. Zambon, Italy 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: TOO « VIVA PHARM” 2nd Ostroumova St., 33, Almaty, Republic of Kazakhstan
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