Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
BUPRENORPHINE
RAFA LABORATORIES LTD
N02AE
PATCHES MATRIX
BUPRENORPHINE 20 MG
TRANSDERMAL
Required
LTS LOHMANN THERAPIE SYSTEME AG, GERMANY
ORIPAVINE DERIVATIVES
Treatment of moderate to severe opioid responsive chronic pain conditions which are not adequately responding to non-opioid analgesics.
2021-12-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only BUTRANS 5, BUTRANS 10, BUTRANS 15, BUTRANS 20 MATRIX TYPE TRANSDERMAL PATCHES ACTIVE INGREDIENT: Each patch of Butrans 5 contains Buprenorphine 5 mg and releases 5 mcg/hr. Each patch of Butrans 10 contains Buprenorphine 10 mg and releases 10 mcg/hr. Each patch of Butrans 15 contains Buprenorphine 15 mg and releases 15 mcg/hr. Each patch of Butrans 20 contains Buprenorphine 20 mg and releases 20 mcg/hr. For the list of the additional ingredients, see section 6. • THE PATCHES CONTAIN A STRONG PAINKILLER (OPIOID). • ENSURE THAT THE OLD PATCH IS REMOVED BEFORE APPLYING A NEW PATCH. • DO NOT CUT THE PATCHES. • DO NOT EXPOSE THE PATCHES TO A HEAT SOURCE (SUCH AS HOT WATER BOTTLES). • AVOID HOT BATHS AND/OR HOT SHOWERS WHILST WEARING THE PATCH. • IF YOU DEVELOP A FEVER INFORM YOUR DOCTOR IMMEDIATELY. • FOLLOW THE DOSAGE AND MANNER OF USAGE INSTRUCTIONS CAREFULLY AND CHANGE YOUR PATCH ON THE SAME DAY AND AT THE SAME TIME 7 DAYS LATER. • IF YOUR BREATHING BECOMES SHALLOW AND WEAK REMOVE THE PATCH AND SEEK MEDICAL ATTENTION. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. Keep this leaflet in case you need to read it again. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your condition. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. This medicine is intended for use in adults. Medicines of the opioids group may cause addiction, especially with prolonged use, and they have a potential for misuse and overdose. A reaction to an overdose may be manifested by slow breathing and may even cause death. Make sure you know the name of the medicine, the dosage that you take, how often you take it, the duration of treatment, potential side effects and risks. Additional infor Perskaitykite visą dokumentą
BuTrans-DL-30-April 2023- 07 1 DOCTOR LEAFLET BUTRANS 5, 10, 15, 20 Transdermal patch 1. NAME OF THE MEDICINAL PRODUCT _BUTRANS 5_ transdermal patch _BUTRANS 10_ transdermal patch _BUTRANS 15_ transdermal patch _BUTRANS 20_ transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each _BUTRANS 5_ transdermal patch contains 5 mg buprenorphine. Area containing active substance: 6.25 cm 2 . Nominal release rate: 5 micrograms of buprenorphine per hour (over a period of 7 days). Each _BUTRANS 10_ transdermal patch contains 10 mg buprenorphine. Area containing active substance: 12.5 cm 2 . Nominal release rate: 10 micrograms of buprenorphine per hour (over a period of 7 days). Each _BUTRANS 15_ transdermal patch contains 15 mg buprenorphine. Area containing active substance: 18.75 cm 2 . Nominal release rate: 15 micrograms of buprenorphine per hour (over a period of 7 days). Each _BUTRANS 20_ transdermal patch contains 20 mg buprenorphine. Area containing active substance: 25 cm 2 . Nominal release rate: 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. Beige coloured patch with rounded corners. _BUTRANS 5_ : Square patch marked: _BUTRANS 5_ μg/h, _BUTRANS 10_ : Rectangular patch marked: _BUTRANS 10_ μg/h. _BUTRANS 15_ : Rectangular patch marked: _BUTRANS 15_ μg/h. _BUTRANS 20_ : Square patch marked: _BUTRANS 20_ μg/h. 4. CLINICAL PARTICULARS WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see section 4.4 & 4.5]. • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. 2 4 Perskaitykite visą dokumentą