Kraj: Holandia
Język: niderlandzki
Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CALCIPOTRIOL
Sandoz B.V.
D05AX02
CALCIPOTRIOL
Zalf
DINATRIUMEDETAAT 2-WATER ; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339) ; MACROGOLSTEARYLETHER ; PARAFFINE, DUNVLOEIBAAR ; PARAFFINE, ZACHT (E 905) ; PROPYLEENGLYCOL (E 1520) ; TOCOFEROL, DL-ALFA ACETAAT ; WATER, GEZUIVERD,
Cutaan gebruik
Calcipotriol
Hulpstoffen: DINATRIUMEDETAAT 2-WATER; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339); MACROGOLSTEARYLETHER; PARAFFINE, DUNVLOEIBAAR; PARAFFINE, ZACHT (E 905); PROPYLEENGLYCOL (E 1520); TOCOFEROL, DL-ALFA ACETAAT; WATER, GEZUIVERD;
2007-05-01
Sandoz B.V. Page 1/7 Calcipotriol zalf 0,05 mg/g, zalf RVG 33408 1313-V6 1.3.1.3 Package Leaflet juli 2018 PACKAGE LEAFLET: INFORMATION FOR THE USER CALCIPOTRIOL ZALF 0,05 MG/G, ZALF Calcipotriol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What [NATIONALLY COMPLETED NAME] is and what it is used for 2. What you need to know before you use [NATIONALLY COMPLETED NAME] 3. How to use [NATIONALLY COMPLETED NAME] 4. Possible side effects 5. How to store [NATIONALLY COMPLETED NAME] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [NATIONALLY COMPLETED NAME] is used on the skin for local treatment of mild to moderately severe psoriasis (psoriasis vulgaris). Psoriasis is when your skin cells are being produced too quickly. This causes scaling and redness. This ointment helps bring the rate at which your skin cells are produced back to normal. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME] DO NOT USE [NATIONALLY COMPLETED NAME]: if you are allergic to calcipotriol or to any of the other ingredients of this medicine (listed in Section 6). if you have severe liver or kidney impairment if you have a problem with your calcium metabolism or if the level of calcium in your body is too high. This ointment can increase calcium levels in the blood. Sandoz B.V. Page 2/7 Calcipotriol zalf 0,05 mg/g, zalf RVG 33408 1313-V6 1.3.1.3 Package Leaflet juli 2018 if you concomitantly use treatment with other medicinal prod Przeczytaj cały dokument
Sandoz B.V. Page 1/8 Calcipotriol zalf 0,05 mg/g, zalf RVG 33408 1311-v5 1.3.1.1 Summary of the Product Characteristics juli 2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Calcipotriol zalf 0,05 mg/g, zalf 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 0.05 mg (is equal to 50 micrograms) of calcipotriol. Excipient with known effect: Propylene glycol _10mg/g_ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment White to off-white ointment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] is indicated for the topical treatment of mild to moderately severe psoriasis (psoriasis vulgaris). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _ As monotherapy [ Nationally completed name] should be applied to the affected skin on limbs or trunk once or twice daily. At the beginning of treatment, twice daily (morning and evening) application is recommended. For maintenance therapy, the frequency of application may be decreased to once daily, depending on the response. Ointment has to be applied as a thin layer to affected skin with gentle rubbing to cover the affected area until most of the ointment disappears. Sandoz B.V. Page 2/8 Calcipotriol zalf 0,05 mg/g, zalf RVG 33408 1311-v5 1.3.1.1 Summary of the Product Characteristics juli 2018 The maximum amount of ointment applied should not exceed 100 grams per week. If it is used together with cream or solution containing calcipotriol, the total weekly dose of calcipotriol should not exceed 5 mg (for example 40 ml scalp solution plus 60 g of cream or ointment). The duration of therapy depends on the clinical appearance. A pronounced therapeutic effect is generally seen after a maximum of 4-8 weeks. Therapy can be repeated. As combination therapy Once daily application in combination with topical corticosteroids (e.g. administration of [ Nationally completed name] in the morning and steroid in the evening) is effective and well tolerated. _ _ _Renal/hepati Przeczytaj cały dokument