Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Indivior UK Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300; GTIN: 5054792000330
CUSTOMER INFO: Minimum Point Size = 10.00pt N/A N/A N/A N/A N/A N/A N/A N/A BARCODE INFO Barcode Type: Barcode Number: Magnification: Truncated By: Full Height: Bar Height (Smallest Bar) : BWR: Encoded Data: Trident Reference No: ZEN Ref: Action: Brand: Category: Segment Group: Segment: Pack Size: Market/Country: Date: Component Code (2D if applicable) : Parent Technical Packaging Specification: Supplier Code: Supply Point: Pharmacode No/NE: Edgemark Position: CAD Cam Ref: Printer: Substrate: N/A Not Required N/A 0000000 Buprenorphine Treatment Subutex 0.4mg, 2mg & 8mg N/A- TRIND426870 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only. STUDIO USE ONLY v1.0 Sm•Art check results: Cutter Guides Technical & Non Printing Items Cutter 2 (if applicable) Guides 2 (if applicable) Essentra Packaging (Bradford, UK) Sub-Lflt-D0081679-340x298mm TR1909767 Paper White UK 24/08/20 C SM01105 G=1; O=4; R=0; - JG - 24/08/20 10:11:05 Indivior Artwork and Print Specification Approved by Sonoco Trident on behalf of Indivior Signed: Date: NOT APPROVED FOR COLOUR ARTWORK APPROVAL D0081679 Artwork Type: Submission 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 1 LT H Process Black Colours RBH Contact: Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 10mm 10mm 8 mm 80mm 10mm 75mm 75mm 10mm 80mm 5mm 5mm 5mm 5mm 80mm 10mm 75mm 75mm 10mm 80mm 5mm 5mm 5mm 5mm SM01105 0000000 PACKAGE LEAFLET: INFORMATION FORTHE USER SUBUTEX®0.4 MG, 2 MG AND 8 MG SUBLINGUAL TABLETS buprenorphine 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. • Thi Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Subutex 0.4 mg sublingual tablets Subutex 2 mg sublingual tablets Subutex 8 mg sublingual tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Subutex 0.4 mg sublingual tablets Each tablet contains 0.4 mg buprenorphine (as buprenorphine hydrochloride). Excipient(s) with known effect: lactose For the full list of excipients, see section 6.1 Subutex 2 mg sublingual tablets Each tablet contains 2 mg buprenorphine (as buprenorphine hydrochloride). Excipient(s) with known effect: lactose For the full list of excipients, see section 6.1 Subutex 8 mg sublingual tablets Each tablet contains 8 mg buprenorphine (as buprenorphine hydrochloride). Excipient(s) with known effect: lactose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Sublingual tablet Subutex 0.4 mg sublingual tablets Uncoated oval white flat bevelled edged tablet, nominal dimensions 8 mm x 4 mm, debossed with “04” on one side. Subutex 2 mg sublingual tablets Uncoated oval white flat bevelled edged tablet, nominal dimensions 10 mm x 5 mm, debossed with “B2” on one side. Subutex 8 mg sublingual tablets Uncoated oval white flat bevelled edged tablet, nominal dimensions 14 mm x 7 mm, debossed with “B8” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). The decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between the clinician and patient with review at regular intervals (usually at least three-monthly, depending on clinical progress). Posology Treatment with Subutex sublingual tablets is intended for use Citiți documentul complet