국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tretinoin
Alliance Healthcare (Distribution) Ltd
L01XF01
Tretinoin
10mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500
PACKAGE LEAFLET: INFORMATION FOR THE USER TRETINOIN 10 MG SOFT CAPSULES TRETINOIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDI- CINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have 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 Tretinoin is and what it is used for 2. What you need to know before you take Tretinoin 3. How to take Tretinoin 4. Possible side effects 5. How to store Tretinoin 6. Contents of the pack and other information 1. WHAT TRETINOIN IS AND WHAT IT IS USED FOR Tretinoin 10 mg soft capsules contains a medicine called tretinoin. This belongs to a group of medicines called ‘retinoids’. These medicines are similar to vitamin A. Tretinoin is used to treat a type of blood problem called ‘acute pro- myelocytic leukaemia’. It works by slowing the growth of certain types of diseased blood cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRETINOIN DO NOT TAKE TRETINOIN IF YOU ARE ALLERGIC TO: • tretinoin or any of the other ingredients of this medicine (listed in section 6) • other ‘retinoid’ medicines. These include isotretinoin, acitretin and tazarotene • peanuts or soya. This is because Tretinoin contains soya-bean oil. DO NOT TAKE TRETINOIN IF: • you are pregnant, planning to become pregnant or breast- feeding (see section 2, Pregnancy, breast-feeding and fertility) • you are taking vitamin A, tetracyclines or retinoids. DO NOT TAKE THIS MEDICINE IF ANY OF THE ABOVE APPLY TO YOU. IF YOU ARE NOT SURE, TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING TRETINOIN. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tretinoin if: • you 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vesanoid 10 mg soft capsules Tretinoin 10mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 1 soft capsule contains 10 mg of tretinoin (all-trans retinoic acid, ATRA) Excipients with known effect: 1 soft capsule contains 107.92 mg of soya-bean oil. The capsule-shell contains between 1.93 – 2.94 mg of sorbitol. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, soft Oval, bi-coloured orange-yellow/reddish-brown capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vesanoid/Tretinoin is indicated in combination with arsenic trioxide or chemotherapy for the treatment of patients with acute promyelocytic leukaemia (APL) which is newly diagnosed, relapsed or refractory to chemotherapy (see sections 4.2 and 5.1). Treatment regimens Combination of tretinoin with chemotherapy or arsenic trioxide is known to be effective and to induce very high rates of haematologic remission in patients with genetically confirmed APL, i.e. patients whose blasts harbor the t(15;17) by karyotyping or FISH or the PML-RARa fusion as detected by PCR. Thus, genetic confirmation of diagnosis is mandatory. Combination treatment with arsenic trioxide has been shown an effective treatment option in patients with newly diagnosed low- to-intermediate risk APL. However, because APL is characterized by high risk of early haemorrhagic death, current recommendations dictate that early treatment with tretinoin is started as soon as possible upon morphologic suspicion only. For the selection of treatment strategy the relapse risk - indicated by pre-therapeutic white blood cell count (WBC) and platelet count (Sanz score) with high-risk (WBC >10x10 9 /L), intermediate risk (WBC ≤ 10x10 9 /L, platelet count ≤ 40x10 9 /L), and low risk (WBC ≤ 10x10 9 /L, platelet count > 40x10 9 /L) - should be taken into consideration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For all therapy phases a total daily dose of 45 mg/m 2 전체 문서 읽기