Valusal gel for external use 25mg/g 50g №1

Name:
Valusal gel for nar.prim.25mg/g in a tube.50g in pack No. 1
Description:
Transparent or slightly turbid, colorless or slightly yellowish gel, with a specific odor. The main active substance Ketoprofen Release form 30 g or 50 g in an aluminum tube with a varnished inner surface, with a protective aluminum membrane on the neck and a cone-shaped device for piercing the membrane in a white plastic screw-on bush. 1 aluminum tube in a carton pack along with instructions for use. Dosage 25mg/g in tubes.50g in pack No. 1 Pharmacodynamics Ketoprofen is a non-steroidal anti-inflammatory and analgesic substance (phenylpropionic acid derivative), which, by inhibiting the activity of cyclooxygenase and lipoxygenase, prevents the synthesis of prostaglandins, thromboxanes and leukotrienes. Reduces pain and swelling caused by inflammation. Pharmacokinetics With repeated external use of ketoprofen (for example, 375 mg of ketoprofen), its plasma concentration is approximately 100 times lower than with a single oral application of 150 mg of ketoprofen. Ketoprofen is metabolized to acylglucuronides and excreted mainly in the urine. The half-life of ketoprofen after repeated application of the gel is on average 17 hours, and the bioavailability is approximately 5%. Indications for use Painful and inflammatory conditions of soft tissues. Dosage and administrationAdults The gel is applied, slightly rubbing, in a thin layer on the damaged areas of the body 1-2 times a day. The skin on the painful area should be free of lesions. The amount of gel applied depends on the size of the damaged area of the body. The daily dose should not exceed 15 g (7.5 g corresponds to 14 cm of gel). On first use, to open the tube, pierce the neck membrane of the tube with the protrusion on the back of the bush. An occlusive dressing must not be applied to the gel-treated surface. Clothing in contact with the damaged surface should not cause inconvenience to the patient. Apply the gel for short periods of treatment. The treatment period is individual (1-10 days) and depends on the nature of the disease and severity. Caution: Do not exceed the recommended dose without consulting your doctor. If you are unsure about anything, consult your doctor. If you feel that the effect of the drug is too strong or weak, tell your doctor about it. If signs of illness persist during the use of the drug, consult your doctor. Elderly Patients: There is no evidence that the elderly need a different dosage. If you miss another dose of the drug, take it immediately. Do not use a double dose to replace a missed one. Continue use as directed by your doctor. Application during pregnancy and lactation With the external use of ketoprofen during pregnancy, there are no clinical data. Animal studies do not reveal direct or indirect effects on pregnancy, fetal development, childbirth or postnatal development. The use of the drug in the first and second trimester of pregnancy is possible only after a careful weighing of the benefits and risks. In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis, including ketoprofen, can have cardiopulmonary and renal toxic effects on the fetus, and can also increase the bleeding time in the mother and child. Therefore, the use of the drug during the last trimester of pregnancy is contraindicated. Breast-feeding Despite the low bioavailability of ketoprofen and the unlikely effect on the child when applied topically, the drug is not recommended for use during this period. Precautions Avoid getting the gel on mucous membranes, eyes or affected skin; if a skin rash occurs, the drug should be discontinued. Be sure to wash your hands after using the gel. To prevent the development of photosensitivity reactions: wash hands thoroughly after applying the gel; do not expose the gel application area to sunlight (including in cloudy weather), as well as UV radiation throughout the entire period of treatment and two weeks after stopping the use of the drug (including solarium); protect the place where the gel is applied with clothing from exposure to sunlight; do not apply gel under occlusive dressings; immediately stop applying the gel at the first signs of a skin reaction. When using the gel in large quantities, systemic side effects may occur, including hypersensitivity and asthma. Use with caution in patients with kidney damage. Do not use in children and adolescents (under 18 years of age). Avoid using the gel near an open flame (the preparation contains alcohol). Interaction with other drugs When applied externally, the bioavailability of ketoprofen is negligible, so the possibility of interaction with other drugs is unlikely. With simultaneous use with other drugs containing ketoprofen and octocrylene, hypersensitivity reactions are possible (see side effects). Contraindications Hypersensitivity to ketoprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (ibuprofen, diclofenac, metamizole or analgin, butadione, etc.), gel excipients, thiaprofenic acid, fenofibrate, UV blockers or perfumes. The manifestation of a skin reaction, including when used simultaneously with products containing ketoprofen and octocrylene (octocrylene is an auxiliary substance that is used to slow down the destruction of cosmetic and hygiene products under the influence of light, such as shampoos, products that are used after shaving, shower gels and baths, skin creams, lipsticks, anti-aging creams, makeup removers, hairsprays). Photoallergic reactions in history. Affected or inflamed skin (eg, eczema, acne, open wounds); the gel should not be applied to the eyes, the skin around the eyes, the anus, genitals and mucous membranes. Children and adolescents (under 18 years of age), as there is insufficient information on the use of the drug in this age group of patients. Last trimester of pregnancy. Carefully! Avoid getting the gel in your eyes or accidentally swallowing the gel. Composition 1 g of gel contains: active substance – 25 mg of ketoprofen; excipients: ethanol 96%, carbomer, diethanolamine, lavender oil, methyl parahydroxybenzoate, orange oil, propyl parahydroxybenzoate, purified water. Overdose Since the absorption of ketoprofen into the systemic circulation is negligible, drug poisoning when applied externally is unlikely. In case of incorrect use of the gel or accidental overdose, side effects may occur throughout the body (see Side Effects). If the gel caused poisoning, the treatment is symptomatic, there is no antidote. If there are signs of overdose, suspected overdose or accidental ingestion of the gel, contact your doctor immediately. Take the package of the drug with you to the doctor. Side effects Like all medicines, this medicine may cause side effects in some patients. Local reactions Local skin reactions may occur, which may extend beyond the injured surface; in isolated cases, they can turn into severe reactions and spread throughout the body. From time to time, redness of the skin, peeling, rash may occur. Rarely, blisters and hives may occur. Very rarely, local swelling of the skin may occur. In isolated cases, hypersensitivity reactions (bronchospasm, attacks of shortness of breath) occurred. Rarely, the gel may increase sensitivity to UV radiation (natural and artificial sunlight). To avoid this, contact of the damaged surface with direct sunlight should also be avoided for two weeks after the use of the drug (including solarium). For advice on preventing the development of photosensitivity reactions, see the Precautions section. Systemic reactions In case of improper use (long-term and / or in large quantities) or accidental overdose, general side effects may occur. From the digestive tract: pain in the upper abdomen, nausea, bloating, lack of appetite. From the nervous system: headache, dizziness, drowsiness. There may also be deviations in the activity of the kidneys, asthma. Contains ethanol, so frequent use of the gel may cause dryness and irritation of the skin. If side effects occur, stop using this drug, rinse the skin surface thoroughly with running water. If the listed adverse reactions occur, as well as if an adverse reaction occurs that is not mentioned in the instructions, you should consult a doctor. Storage conditionsStore at a temperature not exceeding 25 °C. Do not freeze. Keep out of the reach of children. Shelf life – 2 years. Do not use after the expiration date indicated on the package. 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