Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Pimecrolimus 10 mg/g;
Viatris Limited
Pimecrolimus 10 mg/g
1 %
Topical cream
Active: Pimecrolimus 10 mg/g Excipient: Benzyl alcohol Cetyl alcohol Citric acid Glyceryl monostearate Medium-chain triglycerides Oleyl alcohol Propylene glycol Purified water Sodium cetostearyl sulfate Sodium hydroxide Stearyl alcohol
Tube, aluminium, physician sample pack, 2 g
Prescription
Prescription
Lek Pharmaceuticals d.d.
Patients 3 months of age and older with atopic dermatitis (eczema) for the: · short-term treatment of signs and symptoms; and · intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where topical corticosteroids are ineffective, intolerable or inappropriate.
Package - Contents - Shelf Life: Tube, aluminium, physician sample pack - 2 g - 12 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 5 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 10 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 15 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 100 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C
2001-06-25
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION ELIDEL ® _PIMECROLIMUS 1% W/W CREAM_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using ELIDEL. This leaflet answers some common questions about ELIDEL cream. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks to you or your child of using ELIDEL cream against the benefits they expect it will provide. This leaflet has mostly been written for patients who are using ELIDEL on themselves, but, as ELIDEL can be used in children as young as 3 months, the same advice and precautions need to be exercised when parents and carers are using ELIDEL on children who have been prescribed the product. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ELIDEL CREAM IS USED FOR ELIDEL cream is used to treat the early signs and symptoms of eczema (also called atopic dermatitis), such as itching, redness and tiny bumps or thickening of the skin. It is suitable for infants of 3 months or older, children, teenagers and adults. ELIDEL can be used to treat repeated episodes of eczema. Treatment is started as soon as the first symptoms of eczema appear, to prevent these from progressing to more severe symptoms that may require the use of a steroid cream. However, if a steroid cream is required to treat an episode of eczema, ELIDEL cream should be stopped and restarted to treat any remaining symptoms after the steroid cream has been stopped. ELIDEL cream is a steroid-free medicine that treats inflammation of the skin. It works in specific cells in the skin that cause inflammation and the characteristic redness and itching of eczema. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED. Your doctor may have prescribed it for another purpose. This medicine is only available with a Olvassa el a teljes dokumentumot
Page 1 of 11 NEW ZEALAND DATA SHEET ELIDEL ® 1. PRODUCT NAME Elidel 1% w/w (10 mg/g) topical cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains 10 mg of pimecrolimus. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream for cutaneous use. The cream is whitish, odourless, non-staining, and easily spreadable. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Treatment of patients 3 months of age and older with atopic dermatitis (eczema) for the: • short-term treatment of signs and symptoms; and • intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis, where topical corticosteroids are ineffective, intolerable or inappropriate. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE Apply a thin layer of Elidel cream to the affected skin twice daily and rub in gently and completely. Emollients are considered maintenance therapy for patients with atopic dermatitis (eczema). In the intermittent long-term management of atopic dermatitis (eczema), Elidel cream treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease. Elidel cream should be used twice daily until signs and symptoms resolve. In general, the duration of treatment with Elidel cream for each eczema episode should not exceed 6 weeks (also see ‘Use in paediatric patients’). If signs and symptoms persist beyond 6 weeks, or the condition worsens, Elidel cream should be stopped and patients should be re-examined to confirm the diagnosis of atopic dermatitis, Treatment should be discontinued when there is no longer evidence of the disease apart from dry skin. Treatment can be resumed upon first recurrence of signs and symptoms to prevent flares of the disease. If the patient is not well controlled on Elidel cream and emollients alone, a short course of a topical mid-potency corticosteroid can be used. Once the flare is under control, the patient can resume using Elidel cream and emollients as outlined below. Page 2 of Olvassa el a teljes dokumentumot