国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine
Qdem Pharmaceuticals Ltd
N02AE01
Buprenorphine
5microgram/1hour
Transdermal patch
Transdermal
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04070200; GTIN: 05060307920246
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _BUTEC_ _®_ _ _5 MICROGRAM/HOUR TRANSDERMAL PATCHES _BUTEC_ _®_ _ _10 MICROGRAM/HOUR TRANSDERMAL PATCHES _BUTEC_ _®_ _ _20 MICROGRAM/HOUR TRANSDERMAL PATCHES Buprenorphine THESE PATCHES CONTAIN A STRONG PAIN KILLER ENSURE THAT OLD PATCHES ARE REMOVED BEFORE APPLYING A NEW ONE PATCHES MUST NOT BE CUT DO NOT EXPOSE THE PATCHES TO A HEAT SOURCE (SUCH AS A HOT WATER BOTTLE) DO NOT SOAK IN A HOT BATH OR TAKE A HOT SHOWER WHILST WEARING A PATCH IF YOU DEVELOP A FEVER TELL YOUR DOCTOR IMMEDIATELY FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY AND ONLY CHANGE YOUR PATCH ON THE SAME DAY AND AT THE SAME TIME 7 DAYS LATER IF YOUR BREATHING BECOMES SHALLOW AND WEAK TAKE THE PATCH OFF AND SEEK MEDICAL HELP 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 or nurse. 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, pharmacist or nurse. This includes any possible effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What _BUTEC_ patches are and what they are used for 2. What you need to know before you use _BUTEC_ patches 3. How to use _BUTEC_ patches 4. Possible side effects 5. How to store _BUTEC_ patches 6. Content of the pack and other information 1. WHAT _BUTEC_ PATCHES ARE AND WHAT THEY ARE USED FOR _BUTEC_ patches contain the active ingredient buprenorphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. They have been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller. _BUTEC_ patches should not be used to relieve acute pain. _BUTEC_ patches act through the skin. After appli 完全なドキュメントを読む
OBJECT 1 BUTEC 5, 10 AND 20 MICROGRAM/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 18-Oct-2016 | Qdem Pharmaceuticals Limited 1. Name of the medicinal product _BUTEC _5, 10 and 20 microgram/hour transdermal patch 2. Qualitative and quantitative composition 5 microgram/hour transdermal patch contains: 5 mg of buprenorphine in a 6.25 cm 2 area releasing a nominal 5 micrograms of buprenorphine per hour over a period of 7 days. 10 microgram/hour transdermal patch contains: 10 mg of buprenorphine in a 12.5 cm 2 area releasing a nominal 10 micrograms of buprenorphine per hour over a period of 7 days. 20 microgram/hour transdermal patch contains: Each transdermal patch contains 20 mg of buprenorphine in a 25 cm 2 area releasing a nominal 20 micrograms of buprenorphine per hour over a period of 7 days. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch. 5 microgram/hour patch Beige coloured patch with rounded corners. Square patch marked: _BUTEC_ 5 μg/h 10 microgram/hour patch Beige coloured patch with rounded corners. Rectangular patch marked: _BUTEC_ 10 μg/h 20 microgram/hour patch Beige coloured patch with rounded corners. Square patch marked: _BUTEC_ 20 μg/h 4. Clinical particulars 4.1 Therapeutic indications Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia _BUTEC _is not suitable for the treatment of acute pain. _BUTEC _is indicated in adults. 4.2 Posology and method of administration Posology _BUTEC _should be administered every 7th day. _Patients aged 18 years and over_: The lowest _BUTEC_ dose (_BUTEC_ 5 microgram/hour transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient. _Titration_: During initiation of treatment with _BUTEC_, short-acting supplemental analgesics may be required (see section 4.5) as needed until 完全なドキュメントを読む