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Ketoprofen 2.5g of 50% gel for topical application




The instruction for medical use of medicine Ketoprofen the Trade name Ketoprofen the International unlicensed name Ketoprofen Dosage Form Gel for external use of 2.5%, 50 g Structure of 100 g of gel contain active agent – ketoprofen of 2.5 g, excipients – karbopol, ethanol of 96% (ethanol), trolamin, parahydroxybenzoate, water purified marked. The description Transparent or slightly opalescent, uniform, colourless or with a yellowish shade gel Pharmacotherapeutic group Drugs for topical treatment of diseases of the musculoskeletal system. Non-steroidal anti-inflammatory drugs for topical administration. Ketoprofen. The ATX M02AA10 code the Pharmacological Pharmacokinetics Later properties of oral introduction of a single dose of ketoprofen the maximum concentration it in blood is reached within 2 hours. Elimination half-life of ketoprofen from plasma fluctuates from 1 to 3 hours. Linking with proteins of plasma makes 60 – 90%. Removal happens generally to urine, in the look connected with glucuronic acid, about 90% of the entered dose are removed within 24 hours. Absorption of the drug administered through skin happens, on the contrary, very slowly. Even at introduction from 50 to 150 mg of ketoprofen through skin the value of concentration of active ingredient in blood plasma in 5 – 8 hours is 0.08 – 0.15 mkg/ml. The pharmacodynamics the Ketoprofen which is in the corresponding filler through skin reaches the inflamed zone, providing, thus, a possibility of local treatment of damages of the joints, sinews, ligaments and muscles which are followed by a pain syndrome. Indications – topical treatment in muscle, bones pains or joints of rheumatic or traumatic origin (bruises, sprains, a muscle strain, muscle tensions of a neck, a lumbago). The route of administration and doses Adults and children are more senior than 15 years. Gel should be applied locally. It is applied on the struck area one – three times a day. At one applique the strip of gel 5-10 cm long is put. For the best absorption, putting gel should be accompanied with easy rubbing in. More than five days should not exceed duration of treatment, except those cases when there are corresponding instructions of the doctor. Side effects It was reported about local skin reactions which could go out of the site of putting drug subsequently. Cases of more significant reactions, such as bullous or fliktenulezny eczema capable to extend and gain generalized character belong to unusual occurrences. Other side effects of anti-inflammatory drugs (hypersensitivity, disturbances from digestive tract and kidneys) depend on penetration of the operating component through skin and, therefore, on amount of the applied gel, the area of the processed surface, integrity of integuments, duration of treatment and use of occlusive bandages. During the post-marketing period it was reported about the following side effects. They are specified on bodies and the systems of bodies and classified according to emergence frequency: very often (from 10% and above), it is frequent (from 1% to 10%), sometimes (from 0.1% to 1%), is rare (from 0.01% to 0.1%), is very rare (less than 0.01%), including separate cases. Sometimes (from 0.1% to 1%) – an erythema, an itching, eczema, burning sensation It is rare (from 0.01% to 0.1%) – reactions of a photosensitization, bullous dermatitis, a small tortoiseshell Very seldom (less than 0.01%) – anaphylactic reactions, reactions of hypersensitivity – a round ulcer, gastrointestinal bleeding, diarrhea – contact dermatitis, a Quincke’s disease – aggravation of renal dysfunction or renal failure Elderly patients are more subject to emergence of side reactions on non-steroidal anti-inflammatory drugs. Contraindications – any reactions of a photosensitization in the anamnesis – the known reactions of hypersensitivity, for example, asthma symptoms, allergic rhinitis or a small tortoiseshell which arose at use of ketoprofen, the fenofibrat, thiapro-foehn acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NPVS) – existence in the anamnesis of skin manifestations of an allergy at use of ketoprofen, thiapro-foehn acid, the fenofibrat, UF-blockers or perfumery products – influence of sunshine (even diffused light) or UF-radiation in a sunbed during treatment by gel and within 2 weeks after its termination – hypersensitivity – gel should not be applied to any of drug excipients on sites of skin where there are signs of defeat, for example, eczema, an acne, infectious process or open wounds – the third trimester of pregnancy – children’s age up to 15 years. Medicinal interactions of Messages about interaction of Ketoprofen with other medicines did not arrive. Similar interactions are improbable in connection with low concentration of drug in plasma after topical administration. Nevertheless, it is recommended to perform regular inspection of the patients taking the coumarinic drugs. The special instructions Gel should be applied with care at patients with a heart, liver or renal failure. It was reported about isolated cases of the systemic side effects connected with damage of kidneys. The hypersensitivity or asthma can result topical administration of large amounts of drug in such system effects as, for example. When developing rash the therapy should be stopped. During treatment and 2 weeks after it it is necessary to avoid direct impact of sunlight and also visit of a sunbed. It is not necessary to exceed the recommended treatment duration as eventually risk of developing contact dermatitis and reactions of a photosensitization grows. Besides, it is necessary to observe the following precautionary measures: – After each use of drug it is necessary to wash hands carefully. – At development of any skin reactions including connected with the accompanying use of the products containing oktokrilen the treatment by gel should be stopped immediately. – In order to avoid development of a photosensitization of skin it is recommended to protect clothes those areas on which drug is applied — during treatment and within two weeks after its termination. – Use of gel should not be combined with carrying an occlusive bandage. – It is necessary to avoid hit of gel on mucous membranes or in eyes. – At the patients having asthma in combination with chronic rhinitis, chronic sinusitis, and/or nose polyps higher risk of developing an allergy to aspirin and/or NPVS, than at other people takes place. Pregnancy and the period of a lactation As researches of safety of use of ketoprofen for pregnant women were not conducted, in the first and second trimester of pregnancy of its use it is necessary to avoid. Use at a lactation the Data on transition of ketoprofen to milk of mother are absent. Ketoprofen is not recommended to be applied at nursing mothers. The feature of influence on ability to run the vehicle and especially dangerous mechanisms About influence on ability to run motor transport and to serve mechanisms was not reported. The overdose At topical administration overdose is improbable. At accidental ingestion of gel, systemic side effects which expressiveness depends on amount of the swallowed drug can develop. Nevertheless, at development of the phenomena of overdose it is necessary to carry out the symptomatic and supporting treatment corresponding to treatment at overdose of anti-inflammatory drugs. The form of release and packing On 50 g of drug place in an aluminum tuba. The tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard. Storage conditions In the place protected from light at a temperature from 15 °C to 25 °C. To store out of children’s reach! 2 years not to apply a period of storage after the expiration date specified on packing. Prescription status According to the prescription ABP VetProm Producer, Bulgaria 2400 Radomir, Father Paisius St., 26 the Owner of the registration certificate the VetPryy ABP, Bulgaria 2400 Radomir, Father Paisius St., 26 the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) the Name of the organization: MFS Company LLP Address: Republic of Kazakhstan, Almaty, Emtsov St., 26 office building of “THORN”, et. 2, office 6 phone number: +7 727 317 20 30 fax: +7 727 317 20 30 mobile phone number: +7 701 718 25 92 e-mail: 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 the Name of the organization: MFS Company LLP Address: Republic of Kazakhstan, Almaty, Emtsov St., 26 office building of “THORN”, et. 2, office 6 phone number: +7 727 317 20 30 fax: +7 727 317 20 30 mobile phone number: +7 701 718 25 92 e-mail:
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