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The active substance in Protopic, tacrolimus, is an immunomodulator. This means that it works on the immune system (the body’s natural defences). Tacrolimus has been used since the mid-1990s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ). In atopic dermatitis, an over-reaction of the ...
The active substance is tacrolimus monohydrate. One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate). The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac-α-tocopherol.
Protopic should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis. The ointment should be applied as a thin layer to the skin. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu.
How To Use Protopic 0.1% Ointment 10g. This medicine is for external use only. It should be applied to clean, dry and intact skin. Always wash your hands before and after using the lotion. Take an appropriate amount and massage gently the affected areas to facilitate the absorption. Replace cap tightly after each use.
RMP. I. The medicine and what it is used for. Protopic is authorised for the treatment of moderate to severe AD (see SmPC for the full indication). It contains tacrolimus as the active substance and it is given by topical administration. II. Risks associated with the medicine and activities to minimise or further characterise the risks.
Protopic is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration. Protopic 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopic 0.03% is indicated ...
2006年3月27日 · Finalising its safety review of Protopic/Protopy (tacrolimus) and Elidel (pimecrolimus), the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefit associated with the use of these dermatological medicinal products outweigh the risks, but that they should be used with greater caution in order to reduce potential risks of skin cancer and ...
assess the long-term safety of tacrolimus ointment for the treatment of atopic dermatitis, category 3). The Package Leaflet is updated accordingly. The RMP is updated to version 16.0. In addition, the marketing authorisation holder (MAH) took the opportunity to
Chronic AD is characterised by thickened skin with accentuated markings (lichenification) and fibrotic papules. During infancy, AD primarily involves the face, scalp and extensor surfaces of the extremities. In older patients, the flexural folds of the extremities are the predominant location for lesions.
A substância ativa é o tacrolímus mono-hidratado. Um grama de Protopic 0,1% pomada contém 1,0 mg de tacrolímus (sob a forma mono-hidratada). Os outros componentes são vaselina branca, parafina líquida, carbonato de propileno, cera branca de abelhas, parafina sólida, butil-hidroxitolueno (E321) e todo-rac-alfatocoferol.
