Name:
Aertal cream for external. approx. 1.5% in tubes 60g in pack No. 1
Description:
White cream Main active ingredient Aceclofenac Release formCream Dosage0.0150 g In experimental models, it inhibits the development of edema and hyperemia, regardless of the nature of the inflammation. Studies of the mechanisms of action of this drug, both in animals and in humans, have shown that aceclofenac, in all likelihood, inhibits the secretion of prostaglandins and leukotrienes through reversible inhibition of cyclooxygenase. Clinical efficacy and safety In a four-day study of skin tolerance (irritation) of Airtal cream, in a comparative analysis with placebo cream and double-distilled water, a less pronounced irritant effect of Airtal cream was found compared to other test substances. In another study on twelve volunteers, the size of the area of hyperemia under the influence of ultraviolet radiation was assessed before and after the application of Aertal cream. It was found that after applying the cream, the size of the area of hyperemia after 7 hours was less in the areas treated with aceclofenac, compared with areas treated with placebo and control areas (untreated). It has been proven that Aertal cream has anti-inflammatory and analgesic effects when applied topically to treat injuries of the musculoskeletal system. In comparative clinical studies, it has been confirmed that the efficacy of aceclofenac is at least comparable to that of other topical anti-inflammatory drugs. This clinical efficacy is combined with satisfactory local and systemic tolerance. Therefore, Aertal cream is an effective drug for use in injuries or inflammatory diseases of the musculoskeletal system. Pharmacokinetics The pharmacokinetics of Aertal cream when applied topically has been studied in various experimental animal and human models. Absorption Cream Aertal is absorbed from the application area, quickly reaching saturation. It accumulates in the absorption zone, which contributes to an increase in anti-inflammatory activity, and gradually enters the systemic circulation in small concentrations, and therefore the risk of side effects, including on the gastrointestinal tract, is minimized. Distribution Aceclofenac is distributed throughout the body. Withdrawal Aceclofenac is metabolized in the liver and excreted slowly, partly unchanged, in the urine and feces. Indications for use Treatment of all types of local pain and inflammation due to any damage to the musculoskeletal system, including sports injuries. The drug can be used to reduce inflammation of the tendons, ligaments, muscles and joints in cases of strain, overexertion or bruises, as well as to treat lumbago, torticollis and periarthritis. Method of application and doses Dosage regimen Aertal cream should be applied three times a day with light massaging movements on the affected area. The applied dose depends on the size of the affected area: 1.5-2 g of Aertal cream approximately corresponds to a strip of cream 5-7 cm long. It is necessary to draw the patient’s attention to the fact that when using the drug without prescription by the attending physician for the treatment of muscle or joint injuries (sprains, distortions, bruises) or inflammation of the ligaments, the duration of use should not exceed 2 weeks. The duration of use of the drug without prescription by the attending physician for the treatment of arthritis should not exceed 3 weeks. If symptoms worsen or do not improve after 7 days of use, the patient should consult a physician for further evaluation. Children No data available. The use of Aertal cream in children is not recommended. Elderly patients (over 65 years old) For the treatment of elderly patients, the dose used in adult patients can be used. Use during pregnancy and lactation Pregnancy No adverse effects on pregnancy, embryonic/fetal development, childbirth or postnatal development have been found in animal studies. Clinical data on the safety of the use of the drug during pregnancy in humans are not available; in this regard, Aertal cream should not be used during pregnancy. Breastfeeding Data on whether aceclofenac is secreted into breast milk are not available. Therefore, the use of the drug during breastfeeding is not recommended. Precautions If there is local irritation at the site of application of Aertal cream, it is necessary to stop using it and treat the symptoms of local irritation accordingly. The cream should not be used to treat open wounds, mucous membranes, as well as eczematous skin irritation, or in cases where there is any other pathological process on the skin at the site of application of the cream. Data on the safety and efficacy of aceclofenac cream in children under 18 years of age are not available. To prevent photosensitivity reactions, protect the area to which the cream is applied from sunlight. Hypersensitivity and skin reactions. Just like other NSAIDs, Aertal cream may cause allergic reactions at the beginning of use, including anaphylactic / anaphylactoid reactions. There are reports of the occurrence in rare cases of serious skin reactions, including fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of NSAIDs (see section “Side Effects”). Patients are most at risk of these reactions early in the course of treatment, with most skin reactions occurring within the first month of treatment. If a skin rash, mucosal lesions or other manifestations of hypersensitivity occur, treatment with Aertal cream should be discontinued. In rare cases, the varicella-zoster virus can cause serious complications in the form of skin and soft tissue infections. At present, the negative impact of NSAIDs on the course of these infections cannot be completely excluded. In this regard, it is not recommended to use aceclofenac in infections caused by the varicella-zoster virus. Cream Aertal contains 0.002 g of methyl parahydroxybenzoate (E218) and 0.0005 g of propyl parahydroxybenzoate (E216), which can cause allergic reactions (including delayed ones). As part of the auxiliary component of the wax emulsion cream, Aertal also contains cetylstearyl alcohol. It may cause local skin reactions (eg contact dermatitis). Interaction with other drugs Despite the lack of data on possible interactions of the drug Aertal with other drugs, care must be taken when prescribing it to patients taking other drugs, especially those that include lithium, digoxin. Caution should also be exercised with concomitant therapy with oral anticoagulants, diuretics, or pain medications. Contraindications Hypersensitivity to the active ingredient of the drug or any of the excipients listed in the “Composition” section. The drug should not be administered to patients with a history of hypersensitivity to other non-steroidal anti-inflammatory drugs (NSAIDs). Although a possible cross-hypersensitivity with diclofenac has not been confirmed, this drug is not recommended for patients with a history of hypersensitivity to diclofenac. Aceclofenac, by analogy with other non-steroidal anti-inflammatory drugs, is contraindicated in patients in whom acetylsalicylic acid or NSAIDs cause asthmatic attacks, urticaria or acute rhinitis. Composition 1.0 g of cream contains: Active ingredient: micronized aceclofenac – 0.0150 g; Excipients: emulsion wax, liquid paraffin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water. Overdose The occurrence of an overdose of aceclofenac is unlikely. In case of overdose, symptomatic treatment should be carried out. Side effects Cream Aertal demonstrated satisfactory local tolerance. In some cases, mild or moderate local irritation is described, accompanied by skin flushing and itching, which disappear when treatment is stopped. In rare cases, the varicella-zoster virus in combination with NSAID treatment can cause serious complications in the form of skin and soft tissue infections. In addition, there are anecdotal reports of photosensitivity reactions (from ? 1/1000 to < 1/100) of skin areas to which the cream was applied, exposed to intense sunlight without adequate UV protection. Below is a table of adverse reactions, according to data from clinical studies and post-registration use of aceclofenac, grouped according to the classes of organ systems and frequency: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from ? 1/1,000 to < 1/100); rarely (from ? 1/10,000 to 1/1,000), very rarely (< 1/10,000). Organ system class Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to 1/1,000) Very rare (< 1/10,000) Systemic disorders and injection site complications Photosensitivity reaction; Hyperemia; Skin itching. Skin irritation Bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) There have been reports of rare cases of serious skin reactions, including death, in connection with the use of NSAIDs (among them, exfoliative dermatitis, Stevens- Johnson and toxic epidermal necrolysis). Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. Buy Airtal cream 1.5% 60g №1 Price for Airtal cream 1.5% 60g №1 Instructions for use for Airtal cream 1.5% 60g №1
INN | Aceclofenac |
---|---|
The code | 75 034 |
Barcode | 5 997 001 362 907 |
Active substance | Aceclofenac |
Manufacturer | Gideon Richter Pls. under license from Almirall AG, Switzerland, Hungary |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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