The instruction for medical use of Nebolitoks Torgovoye medicine a name of Nebolitoks the International unlicensed name Is not present the Dosage form Gel for external use of 50 g Structure 1 g of gel contains: active agents: Nimesulide of 10 mg, methyl salicylate of 100 mg, menthol of BP of 50 mg excipients: carbomer 940 (Karbopol 940), dinatrium edetat, anhydrous citric acid, was polioksit the hydrogenated castor oil, by propylene glycol, 2 propyl alcohol, benzyl alcohol, trietanolamine, water purified. Description Uniform gel of yellow color Pharmacotherapeutic Musculoskeletal system group. Drugs for topical administration in articulate and muscular pain. Other drugs. The ATX M02AX10 code the Pharmacological Pharmacokinetics Distribution properties in fabrics in the field of putting gel – 70%, bioavailability – 30%. Time necessary for achievement of the maximum concentration (TCmax) is 1.5 - 2.5 hours, the maximum concentration (Cmax) makes 3.5 - 6.5 mg/ml. communication with proteins of plasma – 95%, with erythrocytes – 2%, with lipoproteids – 1%. Change of a dose does not influence extent of binding. The share of free fraction in blood makes 1%. Distribution volume – 0.19 - 0.35 l/kg. Well gets into acidic environment of the center of inflammation (40%), synovial fluid (43%). Easily gets through gistogematichesky barriers. The pharmacodynamics Nimesulide – non-steroidal anti-inflammatory drug (NPVS) from a class of sulfonanilid, possesses anti-inflammatory, analgeziruyushchy and antiagregantny action. Nimesulide – selection inhibitor of cyclooxygenase 2, the mechanism of effect of Nimesulide is connected with protein kinase inhibition With, IV phosphodiesterase and proteinases, with inhibition of a histamine and release (TNF-α), with synthesizing of the factor of activation of thrombocytes (FAT). Nebolitoks the gel containing methyl salicylate, menthol is effective as analgeziruyushchy means. Methyl salicylate is derivative salicylic acid and possesses irritant action that leads to release of substance P of neurons. Reduction of accumulation of substance P in nerve terminations leads to reduction of pain. Methyl salicylate when drawing on skin causes analgetic effect and decrease in muscular tension at the expense of the receptors which are in muscle tissue irrespective of influence of efferent nerve terminations. Methyl salicylate slows down synthesis of prostaglandins as a result of oppression of cyclooxygenases that reduces hypostasis and infiltration of the inflamed fabrics. Menthol possesses the cooling action, at the expense of irritation of cold receptors. At external use, Nimesulide, methyl salicylate, menthol are quickly absorbed and get into hypodermic cellulose, muscle tissue, the articulate capsule and directly into a joint cavity. The clinical effect at topical administration occurs in 4 weeks. Indications - topical symptomatic treatment of the musculoskeletal system of various origin, for reduction of pain and inflammation: - at traumatic damages (bruises, stretching of a ligaments, muscles and sinews) - arthritises of various etiology - in complex treatment of a pain syndrome in rheumatism the Route of administration and doses Is appointed locally. Nebolitoks gel is evenly applied, without rubbing, on the struck area a column of gel 3 cm long 3 – 4 times a day. Gel is applied on the clean and dry surface of skin. The amount of gel and frequency of use can vary depending on the size of the processed site and reaction of the patient, no more than 4 times a day. The maximum daily dose makes 5 mg/kg (1 tuba a day). Duration of use of drug is 10 days. Side effects Side effects are defined with the following frequency: Very often ≥ 1/10 it is frequent ≥ 1/100 - & lt, 1/10 Infrequently ≥ 1/1.000 - & lt, 1/100 is rare ≥ 1/10.000 - & lt, 1/1.000 Is very rare also lt, 1/10.000 It should frequency from the available data Disturbance can be estimated from skin and hypodermic cellulose Not often local reactions - the irritation of skin, skin rash, peeling, a skin itching, tranzitorny discoloration of skin, an erythema, peeling of skin, contact dermatitis is not known system reactions - heartburn, nausea, vomiting, diarrhea, a gastralgia, an ulceration of a mucous membrane of digestive tract - a liquid delay - thrombocytopenia, a leukopenia, an agranulocytosis, anemia - increase in activity of hepatic transaminases - lengthening of a bleeding time - a hamaturia - an acute anaphylaxis - disturbance of breath in the presence of bronchial asthma of the Message about expected side reactions Providing data on expected side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction and also through the national system of collection of information. Contraindications - hypersensitivity to Nimesulide and other components of drug, acetylsalicylic acid and other NPVS - a dermatosis, injuries of epidermis, a skin infection in a scope (for gel) - pregnancy and the period of a lactation - children's age up to 18 years Medicinal interactions Interaction with other medicines is practically not observed because of extremely low concentration of active agent. Pharmacokinetic interaction happens at the level of linking with proteins of plasma: gel increases concentration of the medicines competing for communication with proteins of plasma – digoxin, Phenytoinum, lithium drugs, diuretics, hypotensive drugs, other NPVS, anticoagulants, cyclosporine, a methotrexate, oral hypoglycemic drugs. Miyelotoksichny medicines cause strengthening of a gematoksichnost. Special instructions At emergence of local irritation the use of gel has to be symptomatic therapy is stopped and is appointed. Not to apply gel around eyes, on a mucous surface, on other open parts of the body, on wound surfaces, in dermatitis. It is impossible to touch by hands with gel of sensitive areas of a surface of skin. It is necessary to avoid use of gel with air-tight bandages. After putting gel it is necessary to wash up hands with soap. The tuba should be closed densely after gel use. Burns can be after full rubbing in of drug. Burns usually pass in several days after drug withdrawal. It is necessary to apply with care Nimesulide gel at patients with the increased risk of development of the side effects connected with intake of salicylates. At prolonged use the systematic control of functions of kidneys is necessary. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Topical administration of drug in the form of gel does not influence ability to driving of motor transport and to control of mechanisms. Overdose Symptoms: strengthening of side effects. Treatment: drug withdrawal, symptomatic therapy. A release form On 50 g place in the tuba aluminum laminated the sealed membrane and the cover closed by the screwing plastic. On 1 tuba together with the instruction for medical use in the Kazakh and Russian languages place in a pack from cardboard. Storage conditions In the place protected from light, at a temperature not above 25 °C to Store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Producer/packer Oxford Laboratories Pvt. Ltd., B 306, Christal Plaza, New Link Road, Andheri (Vest), Mumbai 400,053, India the Holder of the registration certificate Oxford Laboratories Pvt. Ltd, India the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: ConsultAsia Almaty LLP, Shevchenko St. of 165 B ph./fax: +77051708825/+727-379-42-58 e-mail: pv@consultingasia.kz
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