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Description
The instruction for medical use of Ketotop® medicine the Trade name of Ketotop® the International unlicensed name Ketoprofen Dosage Form the Transdermalny plaster Structure 1 plaster contains active agent – ketoprofen of 30.0 mg excipients: diethylene glycol the monoethyl ether, mineral oil hydrogenated stiren/metilstiren/inden a kopolimer, acrylic glue solution 1, acrylic glue solution 2, polyisobutylene high-molecular, polyisobutylene low-molecular, n-hexane, isopropyl alcohol, a tape fabric. The description the Plaster on a fabric basis of light-beige color, a rectangular shape with the rounded-off corners placed by the sticky party on a protective insert with marking. Pharmacotherapeutic group Musculoskeletal system. Drugs for topical administration in muscular and articulate pain. Non-steroidal anti-inflammatory drugs for topical administration. Ketoprofen the ATX M02AA10 Code the Pharmacological Pharmacokinetics Bioavailability properties of ketoprofen in the form of a plaster makes 5% therefore action has local character and has no system effects. Effect of drug begins to be shown 2-3 hours later after drawing a plaster on skin. Time of achievement of peak plasma concentration is 5-6 hours, level in blood plasma is 0.08-0.15 mkg/ml. Duration of effect reaches 3-4 hours. Linking with proteins of plasma makes 60-90%. 12 hours later after drawing a plaster on area of a joint – concentration of ketoprofen in synovial fluid reaches 1.31 mkg/ml +0.89. Drug is exposed to metabolism in a liver where it conjugates with glucuronic acid with formation of conjugates which are removed mainly with urine. Elimination half-life of ketoprofen from plasma fluctuates from 1 to 3 hours. The pharmacodynamics of Ketotop® a plaster possesses local anesthetic and anti-inflammatory (including antiedematous) action. The mechanism of effect of the ketoprofen which is a part of Ketotopa® of a plaster is connected with inhibition of biosynthesis of prostaglandins and leukotrienes due to suppression of activity of enzyme of cyclooxygenase. Ketoprofen influences the first (alteration) and the second (exudation) of a phase of inflammatory process. Besides, ketoprofen is bradykinin inhibitor (chemical mediator of pain and inflammation), it stabilizes membranes of lysosomes against osmotic damage and interferes with release of lizosomalny enzymes which mediate destruction of fabric at inflammatory reactions. At an articulate syndrome causes easing of joint pains at rest and at the movement, reduction of morning constraint. Indications – (in uncomplicated injuries, including, sports) – in stretchings or ruptures of sheaves, tendinites, bruises of muscles and ligaments and also in dorsodynias – pains local, connected with chronic inflammatory diseases (including, rheumatologic) Apply the Route of administration and doses to topical treatment of pain and reduction of inflammation and hypostasis of fabrics outwardly. To adults and children 15 years are more senior Ketotop® plaster on painful parts of the body, 2 times a day. It is not necessary to apply a plaster on the damaged surface of skin. Duration of therapy depends on weight and the nature of damage, but no more than 6 days. It is impossible to apply several plasters at the same time. Plasters of Ketotop® can be used together with oral non-steroidal anti-inflammatory drugs as auxiliary treatment. Side effects Often (≥ 1/100 to & lt, 1/10) – dyspepsia, nausea, an abdominal pain – local reactions in the form of an erythema, a skin itching, burning (contact dermatitis) Infrequently (≥ 1/1, 000 to & lt, 1/100) – dizziness, a headache Seldom (≥ 1/10,000 to & lt, 1/1, 000) – a Quincke’s disease – paresthesia – deterioration in sight, a ring in ears – a small tortoiseshell, reaction of a photosensitization – an asthenia, sleep disorders Is very rare (& lt, 1/10,000) – an agranulocytosis, thrombocytopenia, a leukopenia, anemia – change of taste – a depression, confusion of consciousness – increase in arterial blood pressure, hypostases – a bronchospasm (especially at patients with the known hypersensitivity to acetylsalicylic acid and other NPVP), short wind, rhinitis, reactions of hypersensitivity, an acute anaphylaxis, exfoliative dermatitis, bullous or fliktenulezny eczema – an abnormal liver function, increase in level of hepatic enzymes – a hamaturia, a renal failure, a nephrotic syndrome, interstitial nephrite of the Contraindication – hypersensitivity to ketoprofen or other components of drug – reactions of hypersensitivity to a fenofibrat, thiapro-foehn acid, blockers of UV rays or perfumery, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (instructions in the anamnesis on the bronchial asthma, a small tortoiseshell or rhinitis connected with intake of acetylsalicylic acid) – reaction of a photosensitization in the anamnesis – eczema, the becoming wet dermatitis, an open or contaminated wound in the place of expected imposing of a plaster (the plaster should not be applied to the injured skin) – solar insolation, even in cloudy weather, influence of UV rays in a sunbed during treatment and in 2 weeks after its termination – a heavy renal and liver failure – ulcer colitis, exacerbation of a peptic ulcer of a stomach and duodenum – children’s age up to 15 years – pregnancy and the period of a lactation Medicinal interactions Interaction with other medicines at topical administration of Ketotopa® of a plaster is improbable. The concomitant use of acetylsalicylic acid reduces extent of linking of ketoprofen with proteins of plasma. Кетотоп® increases concentration in methotrexate blood (strengthens its side effects). Special instructions should not be applied a plaster on the damaged surface of skin, open wounds. After drawing a plaster it is necessary to wash up hands carefully. At emergence of irritation of skin, it is necessary to stop therapy temporarily. Treatment has to be immediately suspended at emergence of any skin reactions, including skin reactions after use of oktokrilensoderzhashchy cosmetics. During therapy and within 2 weeks after the termination of therapy it is necessary to avoid direct sunlight and ultra-violet radiation. The plaster of Ketotop® should be applied with care in a heavy renal failure. The plaster has no smell, does not contain dyes, does not leave spots on clothes. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms does not influence. Overdose Symptoms: at overdose of drug strengthening of side effects, such as irritation of skin, itching, erythema is possible. Treatment: to stop use of a plaster, to carefully wash skin with water. A form of release and packing the Plaster is supplied with a protective insert from the combined material consisting of polyethyleneterephthalate, paper and polyethyleneterephthalate with a silicone covering. On 7 transdermalny plasters with a protective insert place in a heat-sealable package from the combined material consisting of polyethyleneterephthalate, aluminum foil and linear polyethylene of the lowered density (LLDPE). On 20 heat-sealable packages, together with the approved instruction for medical use in the state and Russian languages place in a pack from cardboard. It is allowed packings on 7 transdermalny plasters with a protective insert, in a heat-sealable package from the combined material consisting of polyethyleneterephthalate, aluminum foil and linear polyethylene of the lowered density (LLDPE) (without investment in a pack from cardboard) together with the approved iinstruktion on medical use in the state and Russian languages to place in a box of cardboard. The number of instructions invests on number of heat-sealable packages Storage conditions to Store in the place protected from light at a temperature not above 25 °C. To store out of children’s reach! A period of storage 3 years not to apply after an expiration date Prescription status According to the prescription the Name and the country of the organization producer/packer Handok Inc., the Republic of Korea the Name and the country of the owner of the registration certificate of JSC Khimpharm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 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 of JSC Khimpharm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number +7 7252 (610151) Number of the +7 7252 (561342 answering machine) the E-mail address of complaints@santo.kz 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 JSC Khimpharm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number +7 7252 (610150)
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