The instruction for medical use of FEBROFID medicine the Trade name Febrofid Mezhdunarodnoye the unlicensed name Ketoprofen Dosage Form Gel for external use of 2.5% Structure of 100 g of gel contain active agent – ketoprofen lizinovy salt of 2.5 g excipients: polyethyleneglycol 200, methylparahydroxybenzoate, propilparagidroksibenzoat, carbomer, trietanolamine, water purified. The description Gel transparent or slightly opalescent from colourless till light-yellowish color. Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs for topical administration. Ketoprofen. The ATX M02AA10 code the Pharmacological Pharmacokinetics Levels properties of concentration of ketoprofen were measured in fabrics and plasma at 24 patients who transferred surgical intervention on a knee joint. After repeated transdermal use of gel of ketoprofen the levels of concentration of ketoprofen in plasma were 60 times less (9-39 ng/g) than that, reached after reception of a single oral dose (490-3300 ketoprofen ng/g). Levels of fabric concentration of ketoprofen in a zone applications of medicine were found within the concentration range identical both for gel, and for an oral form of medicine in spite of the fact that concentration levels when using gel were connected with much higher degree of variability between patients. On the basis of assessment of data of uric excretion it is established that the bioavailability of ketoprofen after topical administration is, about, 5% of the level received after oral administration of medicinal substance. Linking of drug with proteins of plasma reaches about 99%. Ketoprofen is emitted with urine mainly in the form of a glyukuronidny conjugate. The pharmacodynamics Ketoprofen represents the non-steroidal anti-inflammatory drug possessing the anti-inflammatory and anesthetizing action. Indications Febrofid gel is shown for decrease in intensity of a pain syndrome at the morbid conditions of the musculoskeletal system which arose owing to the suffered injuries such as damages of sports character, dislocations, stretchings, bruises. Febrofid gel reduces pain at easy degree of arthritis. A route of administration and doses For external use. Adults to Apply a small amount (3-5 cm) of gel to skin of the painful or inflamed parts of the body. To apply daily, 2-4 times a day during the period up to 7 days long. It is necessary to put carefully, however at the same time it is necessary to mass well the problem site for ensuring penetration of the medicinal substance which is contained in gel in glubzhelezhashchy fabrics. The usual recommended dose makes 15 grams a day (the strip of the squeezed-out gel 14 cm long approximately corresponds to 7.5 g). Patients of advanced age of Modification of a dose it is not required. Children Use of drug is not recommended as safety of use of drug for children is not established. Side effects Infrequently (≥1/1000 to & lt, 1/100) – local skin reactions, such as erythema, eczema, skin itching and burning sensation It is rare (≥1/10,000 to & lt, 1/1000) – a photosensitization and urtikarny rash (urticaria) – bullous or fliktenulyarny eczema with a tendency to distribution or generalization Is very rare (& lt, 1/10,000) – Does not know aggravation of already available symptoms of a renal failure (degree of frequency of emergence cannot be estimated on the basis of the available data) – an acute anaphylaxis, a Quincke’s disease (Quincke), reactions of hypersensitivity. Contraindications – reactions of a photosensitization in the anamnesis, – reactions of hypersensitivity, such as symptoms of bronchial asthma, allergic rhinitis on influence of ketoprofen, the fenofibrat, thiapro-foehn acid, acetylsalicylic acid or other medicines relating to non-steroidal anti-inflammatory drugs (NPVP) in the anamnesis, – skin allergic reactions to ketoprofen, thiapro-foehn acid, fenofibrat, blockers of ultraviolet radiation or cosmetics in the anamnesis, – stay under direct sunshine during treatment and within 2 weeks after drug phase-out, including impact of scattered sunlight and radiation of a sunbed (see also section Special Instructions), – reactions of hypersensitivity to any excipients which are a part of drug – the third trimester of pregnancy, – pathological changes of integuments (eczema or eels), infectious inflammation of the skin, in the presence of open wounds. Febrofid gel should not be applied on mucous membranes, to apply in a crotch zone, it is necessary to avoid hit of gel in eyes and also it is not necessary to use gel with occlusive bandages. Medicinal interactions of Interaction are improbable owing to low serumal concentration of drug after its topical administration. Considerable extent of interaction is noted in the course of use of high doses of drug a methotrexate together with non-steroidal anti-inflammatory drugs, including ketoprofen, at a system method of administration. Special instructions After each use of gel it is necessary to wash up hands carefully. It is necessary to stop immediately drug treatment in case of any reaction from skin, including skin reactions after combined use of the sun-protection means containing oktokrilen. In order to avoid risk of emergence of a photosensitization the sites of skin to which gel is applied should be preserved against impact of sunlight by wearing free clothes throughout the entire period of use of drug and within two weeks after the treatment termination. It is necessary not to allow contact of gel with mucous membranes or its hit in eyes. It is not necessary to exceed the recommended treatment period (see the section Route of Administration and Doses) in connection with risk of developing contact dermatitis and reactions of a photosensitization which manifestations amplify eventually. The patients having bronchial asthma in combination with chronic rhinitis, chronic sinusitis and/or polipozy mucous a nose are subject to bigger risk of developing of an allergy to acetylsalicylic acid and/or other non-steroidal anti-inflammatory drugs (NPVP) in comparison with other population. Safety and efficiency of use of drug for children is not established. Despite minimality of system effects, it is necessary to apply gel at patients with reduced function of cardiovascular, gepatobiliarny and urinary systems with extra care: there are messages about separate cases of emergence of the system undesirable reactions consisting in damage of kidneys. If after use of gel there was skin rash, treatment has to be stopped. You do not apply Febrofid gel on the sites of skin which are located under occlusive dressings. Sites of an integument on which Febrofid gel was applied should not be subjected to influence of direct sunshine or ultra-violet light in sunbeds both in the course of treatment, and within two weeks after its end in order to avoid development of phototoxic reactions and a photoallergy. Drug contains methylparahydroxybenzoate and ethylparahydroxybenzoate which can cause the allergic reactions which are (perhaps delayed). Use during pregnancy and a lactation Pregnancy It is necessary to refrain from use of the medicines containing ketoprofen in the first and second trimesters of pregnancy. During the third trimester of pregnancy all inhibitors of a prostaglandinsintetaza, including ketoprofen, can induce emergence of the toxic effect directed to a cardiopulmonary system and kidneys of a fruit. At the end of pregnancy there can occur increase in a blood clotting time both at mother, and at a fruit. Non-steroidal anti-inflammatory drugs can also become one of the reasons of a delay of childbirth. Therefore, use of ketoprofen is contraindicated in the last trimester of pregnancy. A lactation Trace concentration of ketoprofen are distinguished with breast milk therefore Febrofid gel should not be applied during breastfeeding. Influence on ability of driving of automobiles and service of the mechanical equipment Is not present data Overdose At topical administration of drug the development of symptoms of overdose is improbable. At accidental ingestion, gel can become the reason of emergence of system adverse effects which expressiveness will be proportional to amount of the drug which got inside. However at emergence of incident of this sort the treatment has to have the supporting and symptomatic character. The form of release and packing On 30 or 50 g of drug place in the aluminum tubas with a membrane corked by a cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions in the place protected from light at a temperature from 15 °C to 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after the expiry date specified on packing. Prescription status According to the prescription the Name and the country of the manufacturing organization of Medan of Pharm of the joint-stock company, Poland the Name and the country of the owner of the registration certificate of JSC Khimfarm, the Republic of Kazakhstan the Name and the country of the organization packer of Medan of Pharm of the joint-stock company, Poland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products 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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