Ultrafastin gel 2.5% 30g №1

NameUltrafastin. Release formGel. INNKetoprofen. FTGNpvp. Brief characteristics Colorless to light yellowish gel, transparent or slightly opalescent. Composition 1 g of gel contains active substance: ketoprofen lysine salt 25.0 mg excipients: polyethylene glycol 200, methylhydroxybenzoate, propylhydroxybenzoate, carbomer, triethanolamine, purified water. Pharmacotherapeutic groupNon-steroidal anti-inflammatory drugs for external use ATX code: M02AA10. Pharmacological properties The drug is intended for external use. The active substance contained in the drug – ketoprofen in the form of a lysine salt, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory and analgesic effects. The use of the lysine salt of ketoprofen makes it possible to achieve a higher concentration, faster and deeper penetration of the active substance to the site of inflammation. Ketoprofen lysine salt in the form of a gel when applied topically diffuses rapidly through the skin. Clinical studies confirm the high degree of absorption of ketoprofen lysine salt and good distribution in the tissues at the site of application. The use of iontophoresis and ultrasonic treatment increases the transdermal transport of ketoprofen lysine salt and its local concentration in tissues. The drug is biotransformed in the liver and excreted in the urine as inactive metabolites. Indications for use Topical treatment for pain in muscles, bones or joints of rheumatic or traumatic origin: for example, bruises, sprains, muscle strains, neck stiffness, lumbago. Contraindications Hypersensitivity to ketoprofen and / or other components of the drug. Hypersensitivity reactions such as: symptoms of bronchial asthma, allergic rhinitis after the use of ketoprofen, thiaprofenic acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, as well as a history of fenofibrate. Weeping dermatoses, eczema, infected abrasions, wounds, burns. Hypersensitivity to sunlight in history. History of skin allergic reactions to ketoprofen, thiaprofenic acid, fenofibrate, UV blockers, or perfumes. Sunlight exposure, even when the sky is cloudy, as well as UV rays in a solarium, during treatment and for 2 weeks after discontinuation of the drug. Do not use in the III trimester of pregnancy. Do not use in children under 18 years of age. Interactions with other medicinal products Ketoprofen used externally is absorbed to a small extent, so the occurrence of drug interactions with other medicinal products is unlikely. Precautions Avoid getting the gel on the mucous membranes and in the eyes. Do not use the drug under an occlusive dressing. Do not apply on damaged areas of the skin. Ketoprofen should be used with caution in patients with circulatory failure, impaired renal or hepatic function, since isolated cases of systemic adverse effects, manifested by impaired renal function, have been described. It is necessary to protect from the sun (including UV rays in a solarium) areas of the skin treated with gel during treatment and for 2 weeks after treatment. During treatment and for 2 weeks after its completion, exposure to UV rays (including solariums) should be avoided. After each application of the gel, wash your hands thoroughly, unless the hands are the area requiring treatment. When rubbing into the skin for a long time, it is recommended to wear protective gloves. Treatment should be stopped immediately if any skin reactions occur, including skin reactions after simultaneous use with products containing octocrylene (certain cosmetic and hygiene products). Do not exceed the recommended period of use due to the increased risk of developing contact dermatitis and hypersensitivity reactions with prolonged use. Caution should be exercised in patients with chronic bronchial asthma in combination with chronic rhinitis, sinusitis and / or polyposis rhinitis. Patients in this group have a higher risk of developing allergic reactions to acetylsalicylic acid and / or NSAIDs than the rest of the population. Do not use the drug on large areas of the skin. The drug contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which can cause hypersensitivity reactions (possibly delayed). Pregnancy and lactation If the patient is pregnant, breastfeeding, suspects that she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before using the drug. In the I and II trimester of pregnancy, the drug can be used only when the potential benefit to the mother outweighs the risk of negative effects on the fetus. In the III trimester of pregnancy, the use of the drug is contraindicated. Not recommended for use during breastfeeding. Influence on the ability to drive vehicles and maintain mechanical equipment No effect. Route of administration and doses The drug should be used in accordance with the leaflet or according to the doctor’s recommendations. In case of any doubt, you should consult your doctor or pharmacist. For outdoor use. 2-3 times a day, apply a small amount (3-5 cm) of the gel on the skin in a painful place and rub it in easily. Wash your hands thoroughly after each application of the gel. There is no need to apply a dry dressing, as the gel is well absorbed through the skin, has no smell, does not contain dyes, does not leave greasy stains, and does not stain clothes. It is not recommended to wear tight clothing (see section “Contraindications”). Elderly Patients There are no specific dosage recommendations for elderly patients. In those most prone to adverse reactions, the lowest dose should be combined with adequate clinical safety monitoring. Children Not recommended as safety in children has not been established. Overdose In case of overdose, you should immediately consult a doctor. Data on overdose of the drug when applied topically to the skin are not available. In case of accidental oral use, drowsiness, nausea and vomiting may occur. Ingestion of high doses can cause respiratory depression, coma, convulsions, bleeding from the gastrointestinal tract, an increase or decrease in blood pressure, and acute renal failure. Treatment for inadvertent oral ingestion: Life-sustaining measures should be applied and symptomatic treatment normally used in case of poisoning with non-steroidal anti-inflammatory drugs should be initiated. When taking the drug inside, if more than an hour has not passed since the ingestion, gastric lavage should be carried out and symptomatic treatment should be applied. Side effects Like all medicines, Ultrafastin can cause side effects, although not everybody gets them. Reported local skin reactions, which subsequently could go beyond the site of application of the drug. Rare events include cases of more pronounced reactions, such as bullous or phlyctenular eczema, which can spread and become generalized. Other side effects of anti-inflammatory drugs (hypersensitivity, disorders of the gastrointestinal tract and kidneys) depend on the penetration of the active ingredient through the skin and, therefore, on the amount of gel applied, the surface area treated, the integrity of the skin, the duration of treatment and the use of occlusive dressings. Since entering the market, the following side effects have been reported. They are listed by organs and organ systems and classified according to the frequency of occurrence: very often (from 10% and above), often (from 1% to 10%), sometimes (from 0.1% to 1%), rarely (from 0.01% to 0.1%), very rare (less than 0.01%), including isolated cases. Organ system Sometimes Rare Very rare Immune system disorders Anaphylactic reactions, hypersensitivity reactions Gastrointestinal disorders Peptic ulcer, gastrointestinal bleeding, diarrhea Skin and subcutaneous tissue disorders Erythema, pruritus, eczema, burning sensation Reactions photosensitivity, bullous dermatitis, urticaria Contact dermatitis, angioedema Renal and urinary tract disorders Worsening of renal dysfunction or renal insufficiency Elderly patients are more susceptible to adverse reactions to non-steroidal anti-inflammatory drugs. The appearance of all side (unusual) effects, including those not listed in the leaflet, must be reported to the attending physician. Shelf life 3 years. The medicinal product should not be used after the expiration date indicated on the package. Expiration date means the last day of the specified month. PackagingGel 2.5%, 30 g or 50 g in aluminum tubes. The end of the tube is closed with an aluminum membrane and a screw cap with a punch. Each tube is placed together with the leaflet in individual cardboard boxes. Storage conditionsKeep in a place protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children. Conditions of release By prescription. Buy Ultrafastin gel 2.5% 30g No. 1 Price for Ultrafastin gel 2.5% 30g No. 1 Instructions for use for Ultrafastin gel 2.5% 30 g No. 1