The instruction for medical use of COMBI HALAZOLINUM medicine of 0.05% COMBI HALAZOLINUM of 0.1% the Trade name Combi Halazolinum of 0.05% Combi Halazolinum of 0.1% the International unlicensed name Is not present the Dosage form nasal spray Structure 1 ml of solution contains Combi Halazolinum of 0.05% Active agents: 0.5 mg of xylomethazolinum of a hydrochloride and 50.0 mg of a dekspantenol. Combi Halazolinum of 0.1% Active agents: 1.0 mg of xylomethazolinum of a hydrochloride and 50.0 mg of a dekspantenol. Excipients: phosphate dinatrium dodecahydrate, potassium dihydrophosphate, a chloride benzalkoniya solution, water purified. Description Transparent solution. Pharmacotherapeutic group Drugs for treatment of a respiratory system. Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Sympathomimetics in a combination with other drugs (excepting corticosteroids). Xylomethazolinum in a combination with other drugs. ATH R01AB06 code the Pharmacological Xylomethazolinum Pharmacokinetics properties a hydrochloride in case of intranasal use of xylomethazolinum of a hydrochloride, quantity which is absorbed can be sufficient for manifestation of systemic action, for example, from the central unequal system and (or) a cardiovascular system. There are no data a pharmacokinetics research at the person. Dekspantenol Dekspantenol is absorbed by skin and is oxidized in an organism in the enzymatic way to pantothenic acid. In plasma vitamin is transported in the form connected with proteins. Pantothenic acid is the making element of coenzyme A which participates in many biochemical processes. There are no exact researches concerning metabolism of a dekspantenol in skin and in mucous membranes. After intake about 60-70% of a dose 30-40% with a stake are removed with urine, and. A pharmacodynamics Combi Halazolinum – the combined medicine in the form of nasal spray which part the alpha sympathomimetic (xylomethazolinum) and B5 provitamin are (dekspantenol). Xylomethazolinum has vasoconstrictive effect owing to what eliminates hypostasis of a mucous membrane. Dekspantenol is derivative pantothenic acid (B5 vitamin), promotes healing of wounds and protects mucous membranes. Xylomethazolinum Xylomethazolinum hydrochloride the hydrochloride is derivative an imidazole with sympathomimetic action, generally on alpha and adrenergic receptors. Causes narrowing of blood vessels of a mucous membrane of a nose therefore hypostasis and hyperaemia of a mucous membrane of a nasal cavity decrease. Reduction of hyperaemia of a mucous membrane of a nose facilitates nasal breath of patients at whom symptoms of disturbance of passability of the nasal courses in the period of catarrhal diseases and after the undergone operation on a nose are noted. Action comes within several minutes (usually 5-10 minutes) after use. Dekspantenol Dekspantenol is to alcohol derivatives of pantothenic acid and belongs to group of vitamins B. After transformation in an organism to the main making coenzyme A, participates in processes of metabolism of carbohydrates, fats and proteins. Is necessary for the normal growth, function of nervous system, regeneration of skin and mucous membranes. Takes part in synthesis of acetylcholine and corticosteroids. Influences growth of hair and nails and also accelerates healing of wounds. Indications Symptomatic treatment of impassability of the nasal courses during catarrhal diseases and after surgical intervention in a nasal cavity – for the purpose of stimulation of processes of healing of a mucous membrane and improvement of passability of the nasal courses. The route of administration and doses the Drug Combi Halazolinum is intended only for intranasal use. For hygienic reasons only one patient has to use packing of drug. It is not necessary to use drug more than 7 days. If after 7 days there does not occur improvement or the patient will feel worse, it is necessary to see a doctor. It is always necessary to consult with the doctor concerning duration of use of drug for children. It is necessary to take a break for several days before beginning to use drug again. It is not necessary to apply doses above recommended. Combi Halazolinum of 0.05% 1 dose of nasal spray (0.1 ml of solution) contains 0.05 mg of xylomethazolinum of a hydrochloride and 5.0 mg of a dekspantenol. Children aged from 2 up to 6 years On one dose of spray in each nasal course 1 or 2 times a day (each 8–10 hours). It is not necessary to apply more than 3 doses of drug in each nasal course in day. To the child only adults have to administer the drug Combi Halazolinum of 0.05%. Combi Halazolinum of 0.1% 1 dose of nasal spray (0.1 ml of solution) contains 0.1 mg of xylomethazolinum of a hydrochloride and 5.0 mg of a dekspantenol. Adults and children are more senior than 6 years On one dose of spray in each nasal course 1 or 2 times a day (each 8–10 hours). It is not necessary to apply more than 3 doses of drug in each nasal course in day. Route of administration 1. Before each use of drug it is necessary to remove a protective nozzle. 2. Before the first use of a new bottle, after removal of a nozzle, it is necessary to press the doser of 3-5 times, before emergence of a cloudlet of spray. Before the subsequent use it is not obligatory to press the doser several times. 3. The tip of the doser should be entered into the nasal course. 4. Holding a bottle in vertical position, it is necessary to press the doser that leads to dispersion of a dose of drug in a nasal cavity. 5. To repeat the procedure at administration of drug in other nasal course. 6. After use it is necessary to put on a protective nozzle. Side effects Infrequently (arise less than at 1 on 100 patients): – reactions of hypersensitivity (for example, a Quincke’s disease, a small tortoiseshell, an itching) it is rare (arise less than at 1 on 1,000 patients): – the strengthened heartbeat – tachycardia – the increased arterial blood pressure is Very rare (arise less than at 1 on 10,000 patients): – excitement, insomnia, fatigue (for example, drowsiness, a sedation), a headache, hallucinations (mainly at children) – arrhythmia – strengthening of hypostasis mucous at decrease in effect of drug, nasal bleeding – spasms (especially at children) Frequency is unknown (there is no opportunity to estimate frequency on the basis of available data): – burning sensation and dryness in a nose, sneezing of the Contraindication – Hypersensitivity to xylomethazolinum to a hydrochloride, a dekspantenol or any of drug excipients. – Dry rhinitis (rhinitis sicca). – After the surgical interventions which are carried out by an endonasal method and after the operations proceeding with opening of a firm meninx. – Children’s age up to 2 years (for Combi Halazolinum of 0.05%). – Children’s age up to 6 years (for Combi Halazolinum of 0.1%). – Period of pregnancy and lactation. Medicinal interactions At simultaneous use of xylomethazolinum and monoamine oxidase inhibitors (MAO) of type of Tranylcyprominum or tricyclic antidepressants and also the medicines increasing arterial blood pressure there can step increase in arterial blood pressure, as a result of effect of these drugs on a cardiovascular system. It is necessary to avoid simultaneous use of the drug Combi Halazolinum with other sympathomimetics (for example, ephedrine, pseudoephedrine which are a part of drugs for treatment of catarrhal diseases) because of summation of their action. Special instructions It is necessary to observe extra care, using the drug Combi Halazolinum in a case: – uses of monoamine oxidase inhibitors (MAO) and other drugs which can lead to increase in arterial blood pressure, – the increased intraocular pressure, especially in case of closed-angle glaucoma, – diseases of a cardiovascular system (for example, coronary heart disease, arterial hypertension), – pheochromocytomas, – metabolic diseases (for example, a hyperthyroidism, diabetes), – hypersensitivity to sympathomimetics. If during use of the drug Combi Halazolinum there are such symptoms as insomnia, dizziness, a tremor, spasmodic heartbeat, the increased arterial blood pressure, it is necessary to stop drug use, – porphyrias, – a prostate hyperplasia. It is not necessary to apply doses above recommended. Because of danger of a mucosal atrophy of a nose, in chronic rhinitis drug has to be used only under observation of the doctor. It is not necessary to use the drug Combi Halazolinum more than 7 days as more long use can lead to the changes of a mucous membrane of a nose which are difficult responding to treatment. Prolonged use of sympathomimetics or their use in doses more can cause than recommended a reactive hyperemia of mucous membranes of a nose and as a result, to lead to narrowing of airways. “The effect of a ricochet” leads to narrowing of the nasal courses that forces the patient to use repeatedly drug and to pass to its constant use. Subsequently secondary medicamentous rhinitis (rhinitis medicamentosa) and even an atrophy a mucous membrane of a nose develops. In more mild cases of a reactive hyperemia of a mucous membrane of a nose can be enough to stop use of sympathomimetic means at first in one nasal course (to maintain passability of a nose), and then after symptoms to disappear, in the second. Considering risk of transmission of infection, packing of drug has to be used only by one patient. In connection with the contents the chloride benzalkoniya, drug can cause irritation of a mucous membrane of a nose. If during use of drug for children there is an excitement or difficulties with backfilling, it is necessary to stop drug use. The drug Combi Halazolinum of 0.05% should not be used at children 2 years are younger. The drug Combi Halazolinum of 0.1% should not be used at children 6 years are younger. Pregnancy and the period of a lactation Influence of drug during pregnancy and the period of a lactation was not studied. It is not necessary to use the drug Combi Halazolinum during pregnancy and in the period of a lactation. Features of influence of drug on ability to run the vehicle or potentially dangerous mechanisms In the dosages exceeding recommended drug can affect ability to run the vehicle or potentially dangerous mechanisms. The overdose Overdose is possible when exceeding the recommended doses or at administration of drug inside. In case of administration of drug inside it is necessary to see a doctor immediately. Overdose symptoms. The clinical picture of intoxication derivatives of an imidazole can be various as phases of stimulation can alternate with the periods of suppression of the central nervous system and a cardiovascular system. The overdose, especially at children, can lead to considerable influence on central nervous system, including spasms, a coma, bradycardia, an apnoea, hypertensia or hypotension, the increased muscular tension. Uneasiness, excitement, hallucinations and spasms belong to symptoms of stimulation of central nervous system. Symptoms of oppression of central nervous system are shown in the form of decrease in body temperature, slackness, drowsiness and a coma. There can be also such symptoms as: miosis, mydriasis, perspiration, fever, cyanosis, pallor of integuments, nausea, tachycardia, bradycardia, arrhythmia, cardiac arrest, hypertensia, shocklike hypotension, fluid lungs, respiratory depression and apnoea. Treatment: in cases of heavy overdose the hospital treatment is shown. Prescribing of activated carbon (adsorbent), sodium sulfate (laxative) or gastric lavage (in case of large numbers) should be carried out immediately as xylomethazolinum the hydrochloride is quickly soaked up. For a lowering of arterial pressure it is possible to appoint the non-selective antagonist of α-adrenoceptors. Vasoconstrictors are contraindicated. If necessary – decrease in body temperature, anticonvulsant therapy and oxygen inhalation. Form of release and packing On 10 ml of solution in the polyethylene bottles with a capacity of 15 ml corked by an aluminum cap with the pump, the doser and the applicator with a protective nozzle. On a bottle the label is pasted. On 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 above 25 °C. To store the opened bottle at a temperature not over 25 ºС. To store out of children’s reach! The period of storage the Opened bottle needs to be used 3 years within 12 weeks. Not to apply after an expiration date. Prescription status Without prescription the Producer/packer of Medana AO Farma Polskoy Organizatsii Voyskovoy 57, 98-200 St. Seradz, Poland the Name and the country of the owner of the registration certificate of JSC Varshavsky the pharmaceutical plant Polfa, Poland the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of JSC Khimfarm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 Phone number +7 7252 (610151) the E-mail address of email@example.com the Address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number +7 7252 (610150)
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