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Diclofenac-ratiopharm 1% 40g gel tube 5’s




Instruction for medical use of Diklofenak-ratiopharm medicine of 1% gel Trade name of Diklofenak-ratiopharm of 1% gel International unlicensed name Diclofenac Dosage Form Gel of 1% 40 G Structure of 100 G of Gel soderzhataktivny substance: diclofenac of sodium of 1.0 g, excipients: diisopropyl adipate, hydroxypropyl cellulose, lactic acid of 90%, sodium disulphite, isopropyl alcohol, water for injections the Description Transparent colourless gel with a characteristic smell of isopropanol Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs for topical administration. Diclofenac the Code of automatic telephone exchange of M 02AA 15 Pharmacological Pharmacokinetics At properties drawing on skin gel is soaked up not completely and slowly gets into the subject fabrics (in hypodermic cellulose, muscle tissue, the articulate capsule and in a joint cavity). In comparison with administration of drug inside only 0.5-6% of active agent reach system blood circulation. The maximum levels in plasma are reached in 1-2 hours. The average period of stay in blood plasma up to 9 h. Linking with proteins of blood plasma makes 99%. After fast metabolism in a liver by hydroxylation and linking with glucuronic acid 2/3 of substance are removed through kidneys and 1/3 – through bile. The pharmacodynamics of Diklofenak-ratiopharm of 1% gel renders expressed the anti-inflammatory, anesthetizing and moderate febrifugal action. The mechanism of action Diklofenak-ratiopharm of 1% gel is caused by suppression of activity of enzyme of cyclooxygenase therefore reactions of an arachidonic cascade are blocked and synthesis of PGE2 prostaglandins, PGF2b, A2 thromboxane, prostacyclin, leukotrienes and emission of lizosomalny enzymes which play a major role in pathogenesis of inflammation, pain and fever is broken. Diklofenak-ratiopharm 1% gel suppresses aggregation of thrombocytes. Indications – for the local, supporting and symptomatic treatment of a pain syndrome in acute strain of muscle and ligaments, dislocations or bruises tied with injuries (sports, production, household, etc.) without disturbance of integrity of integuments and soft tissues the Route of administration and doses of Diklofenak-ratiopharm of 1% gel is applied to skin in a painful part of the body on 9-10 cm of gel (3 g) 3 times a day and easily rubbed. In case of need imposings of a bandage, the bandage is applied in a few minutes after gel to the dried-up surface. Gel cannot be applied under air-tight bandages. The maximum daily dose of gel makes 9 g (or 90 mg of diclofenac of sodium). Duration of therapy is 1-2 weeks. Side effects Often (≥1% – & lt, 10%) – local skin irritations (reddening, an itching, burning, rash) Infrequently (≥0.1% – & lt, 1%) – contact dermatitis Very seldom (& lt, 0.01%, including isolated cases) – gastrointestinal disorders – generalized skin rash – reactions of hypersensitivity in the form of angionevrotichensky hypostasis and dispnoe Contraindications – hypersensitivity to diclofenac, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, isopropyl alcohol, propylene glycol or to other substances of medicine open wounds, the inflamed or infected skin, mucous membranes, eczema – the III trimester of pregnancy (when drawing on big surfaces or for a long time). – children’s and teenage age up to 18 years the Medicinal interactions were not observed Special instructions It is necessary to be careful when assigning Diklofenak-ratiopharm of 1% gel the patient having in the anamnesis asthma attacks, skin reactions or acute rhinitis on non-steroidal anti-inflammatory drugs or analgetics. Patients with asthma, obstructive respiratory diseases, a pollinosis and polyps in a nose more often than others, can react to use of nonsteroid protiv of ospalitelny means in the form of attacks of asthma, local cutaneous dropsies and mucous (including, a Quincke’s edema) or small tortoiseshells. Diklofenak-ratiopharm gel is applied only as external means! It is necessary to avoid hit of drug on eyes, mucous membranes, open wounds or damages. Propylene glycol can cause irritation of skin. Pregnancy and the period of a lactation of Diklofenak-ratiopharm of 1% gel can be applied in the I and II trimesters of pregnancy only after thorough examination of a ratio advantage/risk. During the III trimester of pregnancy putting gel on the big site of skin the long time is contraindicated. Diclofenac can suppress labor pains, cause premature closing of ductus arteriosus, the increased tendency to bleeding in mother and a fruit, to hypostasis at mother. In the period of a lactation of Diklofenak-ratiopharm of 1% it is preferable not to apply gel as the minimum quantity of diclofenac is distinguished in breast milk. Features of influence of medicine on ability of driving or potentially dangerous mechanisms the Overdose does not influence If the recommended dose is exceeded during skin use, gel has to be removed, and the site of skin is washed with water. A form of release and packing On 40 g of gel in aluminum tubas with a cover from polyethylene of high density. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 25C. To store out of children’s reach! 4 years not to apply a period of storage after expiry date! Prescription status Without prescription the Producer/packer of Merkle GmbH, Germany the Owner of the registration certificate ‘ratiopharm GmbH’, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of ratiopharm Kazakhstan LLP 050000 Republic of Kazakhstan Almaty, Al-Farabi Avenue 19 Business center of Nurla Tau, body 1B, office 603 the Name and the address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of ratiopharm Kazakhstan LLP 050000 Republic of Kazakhstan Almaty, Al-Farabi Avenue 19 Business center of Nurla Tau, body 1B, office 603

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