Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
SULPHADIAZINE SILVER
TEVA ISRAEL LTD
D06BA01
CREAM
SULPHADIAZINE SILVER 1 %
DERMAL
Required
TEVA ISRAEL LTD, ISRAEL
SILVER SULFADIAZINE
SILVER SULFADIAZINE
Treatment of infected burn wounds, leg ulcers and pressure sores.
2021-10-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Silverol ® Cream Skin cream Composition Silver Sulfadiazine 1% in a water-soluble base. For information regarding inactive ingredients and allergens in the medicine, see “Important information about some of the ingredients of the medicine” in section 2 and “Additional information” in section 6. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? A topical antimicrobial preparation for treatment of burns, infected pressure ulcers and infected leg ulcers. Therapeutic class: antibacterial of the sulfonamides group. 2. BEFORE USING THE MEDICINE Do not use this medicine: • If you are sensitive (allergic) to the active ingredient, silver sulfadiazine, or to any of the other ingredients this medicine contains, such as cetostearyl alcohol or propylene glycol (see section 6 “Additional information”) • If you are sensitive to medicines that contain sulfonamides • If you are pregnant or breastfeeding • In premature or newborn infants during the first few months of their lives Special warnings regarding the use of the medicine Before treatment with Silverol Cream, inform the doctor, pharmacist or nurse if: - You are suffering from kidney or liver problems - You have glucose-6-phosphate dehydrogenase (G6PD) deficiency - You are taking medicines prescribed by your doctor for treatment of epilepsy or diabetes - You are using a biological medicine for the removal of dead tissue from a leg ulcer or a sore Upon using sulfadiazine, rashes that may be life- threatening have been reported (Stevens-Johnson syndrome, toxic ep Aqra d-dokument sħiħ
Silverol Cream SPC Notification 11-2023 Summary of Product Characteristics Silverol Cream Dermal cream 1. NAME OF THE MEDICINAL PRODUCT Silverol Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition _Active Ingredient _ Silver Sulfadiazine 1% Excipients with known effect: Propylene glycol, cetostearyl alcohol. For a full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Dermal cream. White to slightly grey-white or pinkish-white. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Antimicrobial preparation for local treatment of burns, infected pressure sores and leg ulcers. 4.2 Posology and method of administration Silverol should be applied in a layer approximately 3-5 mm thick with a sterile, gloved hand or spatula, to completely cover the burn area. Ordinarily, blisters are not opened, but loose tissue is generally removed prior to application. After application of Silverol, the wound should either be left exposed or covered with a fine mesh gauze and an elastic mesh bandage. The exposure method is preferable in some patients (such as children) and for certain parts of the body (face, genitalia, etc.). When the wound is exposed, Silverol should be reapplied at about 12-hour intervals, or more frequently if the medication is rubbed off on the bedding. When dressings are used, they should be changed daily or on alternate days. Use of dressings serves to press the medication firmly against the wound, helps keep the area moist, reduces evaporative water loss and prevents drying/caking of the medication. Silverol dressings can usually be left in place for about 48 hours during the first 2 weeks post burn. Subsequently, necrotic tissue undergoes proteolytic decomposition, producing considerable exudate which dilutes the drug and necessitates more frequent dressing changes. When feasible, patients should be bathed daily as an aid in debridement. A whirlpool bath is particularly helpful, but patients may be bathed in bed or in a shower. Silverol Cream SPC Notification 11-2023 With Silverol treat Aqra d-dokument sħiħ