veNTIlATIoN - Green Cross Publishing
veNTIlATIoN - Green Cross Publishing
veNTIlATIoN - Green Cross Publishing
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Butrans ® patches contain an opioid analgesic<br />
PRESCRIBING INFORMATION<br />
BuTrans ® 5µg/h, 10µg/h and 20µg/h Transdermal Patch<br />
Presentation: BuTrans 5µg/h, 10µg/h, 20µg/h. Transdermal beige patches<br />
containing buprenorphine. Indications: Treatment of non-malignant pain of<br />
moderate intensity when an opioid is necessary for obtaining adequate<br />
analgesia. BuTrans is not suitable for the treatment of acute pain. Dosage and<br />
Administration: BuTrans should be administered every 7 days. Elderly and<br />
adults over 18 years only: Use the 5 µg/h patch for at least the first 3 days of<br />
treatment, before increasing the dose if necessary. Do not use more than two<br />
patches at a time. Contra-indications: Known buprenorphine or excipient<br />
hypersensitivity, opioid dependent patients, narcotic withdrawal treatment,<br />
respiratory depression, us e of MAO inhibitors within the past 2 weeks,<br />
myasthenia gravis, delirium tremens, pregnancy and lactation. Precautions<br />
and Warnings: Convulsive disorders, head injury, shock, reduced<br />
consciousness of uncertain origin, intracranial lesions or increased intracranial<br />
pressure, severe hepatic impairment, history of drug abuse. Not<br />
recommended immediately postoperatively or for situations characterised by<br />
a narrow therapeutic index or for rapidly varying analgesic requirements. May<br />
® Butrans is a Registered Trademark. © 2009 Napp Pharmaceuticals Limited. CODE 0924BTN. Date of item: April 2009<br />
days<br />
pain relief in<br />
one BuTrans patch<br />
BuTrans® matrix patches are Ireland’s first patches designed to provide 7 days’<br />
continuous relief from moderate osteoarthritis pain. Good news for doctors,<br />
good news for patients, good news for joints.<br />
affect ability to drive or use machinery. Interactions: Monoamine oxidase<br />
inhibitors (MAOIs), CNS depressants (e.g. benzodiazepines, opioid<br />
derivatives, antidepressants, sedatives, alcohol, anxiolytics, neuroleptics,<br />
clonidine). CYP 3A4 inhibitors and inducers, products reducing hepatic blood<br />
flow (e.g. halothane). Side Effects: Common: anorexia, confusion,<br />
depression, insomnia, nervousness, headache, dizziness, somnolence,<br />
paraesthesia, vasodilation, dyspnoea, constipation, dry mouth, nausea,<br />
vomiting, abdominal pain, diarrhoea, dyspepsia, sweating, tiredness, pain,<br />
peripheral oedema, application site reaction, chest pain, pruritus, erythema,<br />
rash, exanthema, asthenia. Potentially serious side effects also include: allergic<br />
reactions, psychotic disorder, hallucinations, nightmares, drug dependence,<br />
mood swings, dysarthria, migraine, syncope, visual disturbance, angina<br />
pectoris, palpitations, tachycardia, hypotension, hypertension, aggravated<br />
asthma, respiratory failure, diverticulitis, dysphagia, ileus, biliary colic,<br />
myalgia, depersonalisation, memory impairment, respiratory depression,<br />
urinary retention, decreased libido, pyrexia, rigors, alanine aminotransferase<br />
increased, drug withdrawal syndrome, abnormal coordination, circulatory<br />
collapse, wheezing. Please consult the SPC for details of other side-effects.<br />
Legal Category: CD (Sch2) POM. Package Quantities: 5 µg/h transdermal<br />
patch: 2 individually sealed patches. 10 µg/h transdermal patch: 4 individually<br />
sealed patches. 20 µg/h transdermal patch: 4 individually se aled patches.<br />
Marketing Authorisation Numbers: PA 913/24/1-3. Marketing<br />
7 7 Days’ Days’<br />
continuous continuous<br />
relief relief from from<br />
MODERATE MODERATE<br />
OSTEOARTHRITIS<br />
OSTEOARTHRITIS<br />
PAIN<br />
PAIN<br />
Not suitable for the treatment of acute pain.<br />
Authorisation Holder: Napp Pharmaceuticals Limited, Cambridge Science Park,<br />
Milton Road, Cambridge CB4 0GW, UK. Further information is available<br />
from: Mundipharma Pharmaceuticals Ltd, Millbank House, Arkle Road,<br />
Sandyford, Dublin 18. Tel: +353 (0)1 2063800. Member of the<br />
Mundipharma/Napp independent associated companies. Date of Preparation:<br />
February 2009.<br />
Adverse events should be reported to<br />
Mundipharma Pharmaceuticals Limited on (01) 206 3800<br />
When non-opioid analgesics aren’t enough