Properties
What is it?
Composition Active substance: Silver sulfadiazine. 1 ml contains 10 mg of silver sulfadiazine. Excipients: Isopropyl myristate, colloidal silicon dioxide, lavender essence, absolute ethanol, and norflurane (HFA-134a). Use The preparation contains silver sulfadiazine, which is an antimicrobial (anti-infective) agent of the sulfonamide group. The preparation is indicated for the treatment and prevention of infections in second and third-degree burns, as well as for the treatment of varicose ulcers and bedsores. Contraindication - Hypersensitivity to silver sulfadiazine, sulfonamides, or any other ingredient of this preparation. -- Large-area lesions; - Newborns, premature infants, the last days of pregnancy, lactation. Warnings and Precautions Before using Silvederma, inform your doctor or pharmacist. Special attention is required in the following cases: - Liver or kidney diseases, avoid using the preparation on large-area lesions, open wounds, and especially ulcers. - In case of a decrease in white blood cells, a control analysis is recommended. - In case of glucose-6-phosphate dehydrogenase enzyme deficiency. - Keep the area treated with the preparation away from direct sunlight to avoid changes in skin pigmentation and the appearance of gray discoloration on the skin. Use of Silvederma with other medicines Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. Pregnancy and lactation Before using this preparation, consult your doctor or pharmacist for advice. Silvederma is not used in the last days of pregnancy and during lactation. Driving and operating machinery It is unlikely that Silvaderm will cause any side effects when driving or operating machinery. Silvederma contains alcohol This product contains 29.84% ethanol by volume, equivalent to 235.76 mg/ml, which may cause a burning sensation on damaged skin. How to use Always use the preparation as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The preparation is absorbed superficially through the skin. Instructions for use: - Shake the container before each use. - Spray the preparation onto the wound area once, twice, or several times a day, as directed by your doctor. Overdose In case of overdose or accidental ingestion, contact your doctor and specify the preparation, the amount of medicine taken or used. Missed dose Do not use a double dose to compensate for a missed dose. If you have any further questions about the use of this medicine, consult your doctor or pharmacist. Side effects Like all medicines, this medicine may cause side effects, although not everyone gets them. Very rare side effects: (may affect up to 1 in 10,000 patients): - Life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) may develop. Side effects of unknown frequency (cannot be estimated from available data). If you experience any of the following reactions, seek medical attention immediately: - Allergic reactions; - Skin reactions such as burning sensation or pain; - Change in skin color/graying at the application site due to sun exposure; - Decrease in white blood cells (leukopenia); - Increased serum osmolality. The highest risk period for the development of serious skin reactions is the first few weeks of treatment. If Stevens-Johnson syndrome or toxic epidermal necrolysis develops during the use of the preparation, its use should be discontinued. If a rash or skin symptoms develop, the use of the preparation should be discontinued, and your doctor should be informed immediately about the use of the preparation. Reporting of side effects If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in these instructions for use. Storage conditions Keep out of reach of children; do not use the preparation after the expiry date indicated on the container. The expiry date is the last day of the specified month. Store at a temperature not exceeding 30 0 C. Store in the original packaging to protect from light and excessive heat. Do not freeze. The preparation cannot be used near open flames, lit cigarettes, and certain devices (e.g., hair dryers) because it contains alcohol. Do not puncture or incinerate the container, even if it is completely empty. It is flammable. Do not dispose of medicines in wastewater or household waste. Dosage form and description Aluminum container sealed with a valve, containing 50 ml of suspended medicinal substance. Holder and responsible for manufacturing LLC Laboratory Aldo Union (Laboratorio ALDO UNION S.L.) Baronesa de Maldà Street 73 08950 Esplugues de Llobregat Barcelona, Spain.