국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
alitretinoin
Eisai GmbH
L01XX22
alitretinoin
Antineoplastic agents
Sarcoma, Kaposi
Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:lesions are not ulcerated or lymphoedematous, and;treatment of visceral KS is not required, and;lesions are not responding to systemic antiretroviral therapy, and;radiotherapy or chemotherapy are not appropriate.
Revision: 17
Withdrawn
2000-10-11
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: IINFORMATION FOR THE USER Panretin 0.1% gel Alitretinoin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. 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 Panretin is and what it is used for 2. What you need to know before you use Panretin 3. How to use Panretin 4. Possible side effects 5. How to store Panretin 6. Contents of the pack and other information 1. WHAT PANRETIN IS AND WHAT IT IS USED FOR Panretin belongs to a group of medicines that are related to vitamin A and known as retinoids. Panretin is used in patients with AIDS-related Kaposi’s sarcoma (KS) and is for the treatment of the KS lesions: - that are on the skin only - which have not responded to your HIV treatment - where the skin or lesion is not broken - where the surrounding skin is not swollen - if your doctor thinks that other treatments are not suitable for you. Panretin does not treat KS that is inside the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PANRETIN DO NOT USE PANRETIN: - if you are allergic to alitretinoin or to similar medicines containing retinoids - if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant - if you are planning a pregnancy - if you are breast-feeding - on KS lesions close to any other skin complaint TAKE SPECIAL CARE WITH PANRETIN - Panretin is not approved for use in children and adolescents under 18 years of age. - Do not apply the gel on or near sensitive parts of your body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum, o 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Panretin 0.1 % gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains 1 mg alitretinoin (0.1%). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. Clear yellow gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDS- related Kaposi’s sarcoma (KS) when: - lesions are not ulcerated or lymphoedematous - treatment of visceral KS is not required - lesions are not responding to systemic antiretroviral therapy - radiotherapy or chemotherapy are not appropriate 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Panretin therapy should only be initiated and maintained by specialist physicians experienced in the treatment of patients with KS. _Men_ Patients should apply Panretin to cutaneous KS lesions using sufficient gel so as to cover each lesion with a generous coating. _Frequency of application_ Patients should initially apply Panretin twice a day to cutaneous KS lesions. The application frequency can be increased stepwise to three or four times a day according to individual lesion tolerance, allowing no less than two weeks between dose increases. The frequency of application should be adjusted for each lesion independently. If application site toxicity occurs, the application frequency can be reduced as described below. There are no data on the efficacy of Panretin applied less frequently than twice daily. Local dermal irritation may be graded according to the five-point scale shown in Table 1. Guidelines for treatment adjustments necessitated by local dermal treatment-related toxicity are specified in Table 2. 3 TABLE 1 GRADING OF LOCAL DERMAL IRRITATION GRADE DEFINING CLINICAL SIGNS 0 = No reaction None 1 = Mild Definite pink to red coloration 2 = Moderate Increased redness, possible oedema 3 = Severe Very red, with oedema, with or without vesiculation 4 = Very severe Deep red, swelling and oedema wit 전체 문서 읽기