that releases a nominal 20 µg of buprenorphine per hour over 7 days.

Transcription

1 SCHEDULING STATUS S6 PROPRIETARY NAME AND DOSAGE FORM SOVENOR 5 Patch (Transdermal patch) SOVENOR 10 Patch (Transdermal patch) SOVENOR 20 Patch (Transdermal patch) COMPOSITION Each SOVENOR 5 Patch contains 5 mg buprenorphine in a medicine-containing matri that releases a nominal 5 µg of buprenorphine per hour over 7 days. Each SOVENOR 10 Patch contains 10 mg buprenorphine in a medicine-containing matri that releases a nominal 10 µg of buprenorphine per hour over 7 days. Each SOVENOR 20 Patch contains 20 mg buprenorphine in a medicine-containing matri that releases a nominal 20 µg of buprenorphine per hour over 7 days. Inactive ingredients: Levulinic acid, oleyl oleate, polyacrylate (dry solids), polyethylene terephthalate (PET) and povidone (PVP). PHARMACOLOGICAL CLASSIFICATION A 2.7 Narcotic analgesics PHARMACOLOGICAL ACTION Pharmacodynamic properties: Buprenorphine is a µ-opioid partial agonist. It also has antagonistic activity at the kappaopioid receptor. In a positive controlled study of effects of buprenorphine base transdermal patch on the QT interval in normal volunteers, 40 µg/hr was associated with a mean prolongation of the QTc interval of 5.9 msec compared to placebo. Ten mcg per hour was not different than placebo. Pharmacokinetic properties: Each buprenorphine base transdermal patch provides a steady delivery of buprenorphine for up to 7 days. Steady state is achieved during the first application. After removal of buprenorphine base transdermal patch, buprenorphine concentrations decline; decreasing approimately 50 % in 12 hours (range h). 1

2 The absorption does not vary significantly across the specified application sites. Mean eposure (AUC) at each of the application sites is within approimately ± 11 % of the mean eposure for the four sites. Following buprenorphine base transdermal patch application, buprenorphine diffuses from the patch through the skin. Buprenorphine is approimately 96 % bound to plasma proteins. Buprenorphine metabolism in the skin following buprenorphine base transdermal patch application is negligible. Norbuprenorphine, is the only known active metabolite of buprenorphine. INDICATIONS SOVENOR Patch is indicated for the treatment of chronic musculoskeletal pain of the joints and the lower back, when that pain is of moderate to severe intensity sufficient to require an opioid to obtain adequate analgesia. CONTRAINDICATIONS SOVENOR Patch is contraindicated in: o patients with known hypersensitivity to buprenorphine or to any of the ecipients (refer to COMPOSITION); o patients suffering from delirium tremens; o patients with severe hepatic impairment; o patients suffering from myasthenia gravis. SOVENOR Patch should not be used in patients with head injury, intracranial lesions or increased intracranial pressure, shock or a reduced level of consciousness of uncertain origin. WARNINGS and SPECIAL PRECAUTIONS SOVENOR Patch should be used with caution in patients with impaired respiratory function and in patients concurrently receiving monoamine oidase inhibitors (MAOIs) or who have received MAOIs within the previous two weeks (see INTERACTIONS). Severe febrile illness may increase the rate of buprenorphine absorption from SOVENOR Patch. Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route. A number of deaths have occurred when addicts have intravenously abused buprenorphine, usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines in combination with buprenorphine have been reported (see INTERACTIONS). 2

3 Caution should be eercised when prescribing SOVENOR Patch to patients known to have, or suspected to having, problems with drug or alcohol abuse or serious mental illness. SOVENOR Patch is not recommended for analgesia in the immediate post-operative period or in other situations characterized by rapidly varying analgesic requirement. Buprenorphine as in SOVENOR Patch produces morphine-like effects, including euphoria and physical dependence. Administration of buprenorphine to persons who are physically dependant on full µ-opioid agonists may precipitate an abstinence syndrome. Effects on the ability to drive and use machines: SOVENOR Patch may impair the ability to drive and operate machinery. INTERACTIONS Caution in the use of any opioid including SOVENOR Patch in patients taking MAOIs or who have received MAOIs within the previous two weeks is appropriate. SOVENOR Patch should be used with caution in patients who are concurrently taking other CNS depressants or other medicines that may cause respiratory depression, hypotension, profound sedation or potentially result in coma. Such agents include sedatives or hypnotics, general anaesthetics, other opioid analgesics, phenothiazines, centrally acting anti-emetics, benzodiazepines and alcohol. Reductions in hepatic blood flow induced by some general anaesthetics (eg. halothane) and other medicines may result in a decreased rate of hepatic elimination of the medicine buprenorphine. Buprenorphine as in SOVENOR Patch is primarily metabolised by glucoronidation and to a lesser etent (about 30 %) by CYP3A4. Concomitant treatment with CYP3A4 inhibitors may lead to elevated plasma concentrations with intensified efficacy of buprenorphine. A medicine interaction study with the CYP3A4 inhibitor ketoconazole did not produce clinically relevant increases in mean maimum (C ma ) or total (AUC) buprenorphine eposure following SOVENOR Patch with ketoconazole as compared to SOVENOR Patch alone. The interaction between buprenorphine and CYP3A4 enzyme inducers has not been studied. Co-administration of buprenorphine and enzyme inducers (e.g. phenobarbital, carbamazapine, phenytoin and rifampin) could lead to increased clearance which might result in reduced efficacy. The potential eist for INR elevation in patients who are concomitantly taking warfarin. PREGNANCY AND LACTATION SOVENOR Patch should not be used during pregnancy or lactation. Buprenorphine has been shown to cross the placenta in humans. 3

4 Buprenorphine has been detected in new born blood, urine and meconium and also in mother s milk at low concentrations. DOSAGE AND DIRECTIONS FOR USE SOVENOR Patch should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. SOVENOR Patch should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Application sites should be rotated whenever a transdermal patch is replaced or added. Application sites should be re-used at no less than 3 week intervals. If the application site must be cleaned, it should be done with clear water only. Soaps, alcohol, oils, lotions, or abrasive devices should not be used. The skin must be dry before the transdermal patch is applied. SOVENOR Patch should be worn continuously for 7 days. SOVENOR Patch should be pressed firmly in place at the application site, making sure contact is complete, especially around the edges. If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape. If a transdermal patch falls off, a new one should be applied. Bathing, showering, or swimming should not affect the system. While wearing SOVENOR Patch, patients should be advised to avoid eposing the SOVENOR Patch site to direct eternal heat sources such as heating pads, electric blankets, heat lamps, etc., as an increase in absorption of buprenorphine may occur. The effects of the use of SOVENOR Patch in hot tubs and saunas have not been studied. Application directions: Open the pouch just before applying the patch. Take off the thin cover sheet. Attach the patch to the upper arm, upper chest, upper back, or sides of the chest. Press the patch with the hand for approimately 30 seconds and check that it is properly attached. The patch should not be used if the seal is broken. Dosage and Titration: The lowest SOVENOR Patch dose available, SOVENOR 5 Patch (5 µg/h) should be used as the initial dose in all patients. 4

5 During initiation, titration, and treatment with SOVENOR Patch, patients may continue their eisting NSAID or paracetamol regimen as needed. The dose of SOVENOR Patch should not be increased at less than 3-day intervals when steady state levels are attained. Changes in SOVENOR Patch dosage may be individually titrated based on the need for supplemental analgesia and the patient s analgesic response to SOVENOR Patch. To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches be applied at the same time, regardless of patch strength. Titration should continue every 3-7 days until adequate analgesia is achieved. If adequate pain control cannot be achieved with SOVENOR Patch, therapy with SOVENOR Patch should be discontinued and the patient converted to an appropriate analgesic regimen as determined by a physician. Discontinuation: After removal of SOVENOR Patch, plasma concentrations decrease gradually. This should be considered when therapy with SOVENOR Patch is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of SOVENOR Patch. Children: The safety and efficacy of SOVENOR Patch in patients under 18 years of age has not been established. Renal impairment: No special dose adjustment of SOVENOR impairment. Patch is necessary in patients with renal Hepatic impairment: There is no need for dosage adjustment when using SOVENOR Patch in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment may accumulate buprenorphine during SOVENOR Patch treatment. SOVENOR Patch should not be used in such patients. 5

6 SIDE EFFECTS The following side effects have been reported during the use of SOVENOR Patch: The table lists adverse reactions reported from 9 completed studies with SOVENOR Patch. The reactions are listed as MeDRA preferred term by system organ class and absolute frequency. Body System/ Adverse Reaction Terms Events Immune system disorders: hypersensitivity reaction (including oropharyngeal swelling and swollen tongue) Metabolism and nutrition disorders: anoreia dehydration* Psychiatric disorders: confusion, depression*, insomnia, nervousness affect lability, agitation, aniety, depersonalisation, euphoric mood, hallucination, libido decreased, nightmares psychotic disorder Nervous system disorders: dizziness, headache*, somnolence* paraesthesia concentration impairment, coordination abnormal, dysarthria, dysgeusia, hypoaesthesia, memory impairment, migraine, syncope*, tremor Eye disorders: dry eye, vision blurred miosis Very common > 10 % 6 Frequency of Occurrence Common Uncommon Rare > 1 % and > 0.1 % and > 0.01 % < 10 % < 1 % and < 0.1 %

7 Ear and labyrinth disorders: tinnitus, vertigo Cardiac disorders: angina pectoris, palpitations, tachycardia Vascular disorders: vasodilatation flushing, hypertension*, orthostatic hypotension Respiratory, thoracic and mediastenal disorders: dyspnoea* asthma aggravated*, cough, hiccups, hyperventilation, hypoia, rhinitis, wheezing respiratory failure Gastrointestinal disorders constipation*, dry mouth, nausea*, vomiting* abdominal pain*, diarrhoea*, dyspepsia* flatulence diverticulitis*, dysphagia, ileus Hepatobiliary disorders: biliary colic* Skin and subcutaneous tissue disorders: pruritus* rash*, sweating* dry skin, face oedema, urticaria Musculoskeletal and connective tissue disorders: muscle cramp, muscle spasm, myalgia Renal and urinary disorders: urinary incontinence, urinary retention urinary hesitation 7

8 Reproductive system and breast disorders: seual dysfunction General disorders and administration site conditions: application site reaction (including application site erythema, application site oedema, application site pruritus, application site rash) asthenia* (including muscle weakness), chest pain*, pain, peripheral oedema influenza like illness, malaise, oedema, pyreia*, rigors*, withdrawal syndrome * At least one serious case KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Respiratory depression and apnoea may occur, also sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis. Remove any SOVENOR Patch in contact with the patient and dispose of it properly. Establish and maintain a patent airway, assist and control respiration as indicated, and maintain adequate body temperature and fluid balance. Oygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. A specific antagonist such as naloone may reverse the effects of buprenorphine. Treatment with naloone should begin with the usual doses but may require up to 5 to 12 mg intravenously. The onset of the naloone effect may be delayed by 30 minutes or more. Maintenance of adequate ventilation is essential when managing a SOVENOR Patch overdose and more important than specific antidote treatment with a narcotic antagonist such as naloone. IDENTIFICATION SOVENOR 5 Patch: A square, transdermal patch with rounded corners on rigid aluminium removable protective layer with a beige coloured backing layer. In the centre is posted a buprenorphine-containing adhesive matri, printed with SOVENOR 5 mg, 5 mcg/h. SOVENOR 10 Patch: A rectangular, transdermal patch with rounded corners on rigid aluminium removable protective layer with a beige coloured backing layer. In the centre is 8

9 posted a buprenorphine-containing adhesive matri, printed with SOVENOR 10 mg, 10 mcg/h. SOVENOR 20 Patch: A square, transdermal patch with rounded corners on rigid aluminium removable protective layer with a beige coloured backing layer. In the centre is posted a buprenorphine-containing adhesive matri, printed with SOVENOR 20 mg, 20 mcg/h. PRESENTATION One transdermal patch packed into a heat sealed protective pouch composed of composite material, paper, LDPE film, aluminium and ethylene copolymer. Two or four individually sealed pouches are packed into one outer carton. STORAGE INSTRUCTIONS Store at or below 25 C. Store in original package. Store this medicine out of the reach of children. REGISTRATION NUMBERS South Africa: S6 SOVENOR 5 Patch: 41/2.7/0589 SOVENOR 10 Patch: 41/2.7/0590 SOVENOR 20 Patch: 41/2.7/0591 Namibia: NS4 SOVENOR 5 Patch: 12/2.7/0253 SOVENOR 10 Patch: 12/2.7/0254 SOVENOR 20 Patch: 12/2.7/0255 Botswana: S1B SOVENOR 5 Patch: SOVENOR 10 Patch: SOVENOR 20 Patch: BOT B BOT B BOT B NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION Mundipharma (Pty) Ltd 2 nd Floor, Mariendahl House Newlands on Main Claremont

10 South Africa SOVENOR Patch DATE OF PUBLICATION OF THE PACKAGE INSERT 17 April 2009 = SOVENOR is a Trademark 10

11 SKEDULERINGSTATUS SOVENOR Patch S6 EIENDOMSNAAM EN DOSEERVORM SOVENOR 5 Patch (Transdermale pleister) SOVENOR 10 Patch (Transdermale pleister) SOVENOR 20 Patch (Transdermale pleister) SAMESTELLING Elke SOVENOR 5 Patch bevat 5 mg buprenorfien in 'n medisyne-bevattende matriks wat 'n nominale 5 µg buprenorfien per uur oor 7 dae vrystel. Elke SOVENOR 10 Patch bevat 10 mg buprenorfien in 'n medisyne-bevattende matriks wat 'n nominale 10 µg buprenorfien per uur oor 7 dae vrystel. Elke SOVENOR 20 Patch bevat 20 mg buprenorfien in 'n medisyne-bevattende matriks wat 'n nominale 20 µg buprenorfien per uur oor 7 dae vrystel. Onaktiewe bestanddele: Levuliniese suur, oleyl oleaat, poli-akrilaat (droë soliede) poliëtileen tereftalaat (PET) en povidoon (PVP). FARMAKOLOGIESE KLASSIFIKASIE A 2.7 Narkotiese analgetika FARMAKOLOGIESE WERKING Farmakodinamiese eienskappe: Buprenorfien is 'n gedeeltelike µ-opioïed agonis. Dit besit ook antagonistiese werking by die kappa-opioïed reseptor. In 'n positiewe, gekontroleerde studie wat die effekte van buprenorfien transdermale pleister op die QT interval bestudeer het, is daar by normale vrywilligers wat 40 µg/uur toegedien was, 'n gemiddelde QTc interval verlenging van 5.9 msek waargeneem in vergelyking met plasebo. Die effek van tien mikrogram per uur was soortgelyk aan die plasebo. Farmakokinetiese eienskappe: Elke buprenorfien transdermale pleister voorsien n konstante eenvormige dosis buprenorfien oor n periode van 7 dae. n Konstante bloedvlak word tydens die eerste toediening bereik. Na die transdermale pleister verwyder word, verminder die buprenorfien konsentrasies met ongeveer 50 % binne 12 ure na dit verwyder is (speling uur). 11

12 Die absorpsie van buprenorfien vanuit die transdermale pleister is soortgelyk by al die moontlike voorgestelde aanwendingsareas. Gemiddelde absorbsie (AOK) by elk van die aanwendingsareas is ongeveer ± 11 % van die gemiddelde absorbsie vir die vier aanwendingsareas. Buprenorfien versprei vanaf die pleister deur die vel, nadat die transdermale pleister aangewend is. Buprenorfien is ongeveer 96 % gebonde aan plasmaproteïene. Die metabolisme van buprenorfien na transdermale aanwending, is gering. Norbuprenorfien is die enigste bekende metaboliet van buprenorfien. INDIKASIES SOVENOR Patch is aangedui vir die behandeling van matige tot ernstige, kroniese muskuloskeletale pyn van die gewrigte en die lae rug, wanneer behandeling met n opioied regverdig is, ten einde voldoende pynverligting te kry. KONTRA-INDIKASIES SOVENOR Patch is teenaangedui by: o pasiënte wat hipersensitief is vir buprenorfien of enige van die bestanddele (sien SAMESTELLING); o pasiënte wat aan delirium tremens lei; o pasiënte met ernstige hepatiese inkorting; o pasiënte wat aan Myastenia Gravis lei. SOVENOR Patch behoort nie deur pasiënte wat lei aan enige hoofbesering, intrakraniale letsels of verhoogde intrakraniale druk, skok of 'n verlaagde vlak van bewussyn (van onsekere oorsaak), gebruik te word nie. WAARSKUWINGS en SPESIALE VOORSORGMAATREëLS SOVENOR Patch behoort met sorg gebruik te word deur pasiënte wat ingekorte respiratoriese funksie het, wat monoamienoksidase inhibeerders (MAOIs) gebruik of wat MAOIs in die laaste twee weke ontvang het (sien INTERAKSIES). Ernstige koors kan die absorpsie van buprenorfien vanuit SOVENOR Patch versnel. Buprenorfien kan die asemhaling beduidend onderdruk, veral wanneer dit intraveneus toegedien word. 'n Aantal gevalle, waar verslaafdes buprenorfien intraveneus misbruik het, gewoonlik gelyktydig met bensodiasepiene, het gelei tot hul dood. Daarmee saam is daar ook n aantal gevalle gerapporteer waar die gesamentlike gebruik van etanol, bensodiasepiene en buprenorfien tot die dood gelei het (sien INTERAKSIES). 12

13 Sorg behoort uitgeoefen te word wanneer SOVENOR Patch aan pasiënte, wat verdink word van, of wat voorheen, dwelms of alkohol misbruik het, of pasiënte wat aan ernstige geestessiekte toestande ly, voorgeskryf word. SOVENOR Patch word nie vir die behandeling van onmiddelike post-operatiewe pyn of in situasies wat deur vinnige variërende vlakke van pyn, gekarakteriseer word, aanbeveel nie. Buprenorfien, soos in SOVENOR Patch, mag morfienagtige effekte veroorsaak, wat euforie en fisiese afhanklikheid insluit. Toediening van buprenorfien in persone wie fisies afhanklik is aan volle µ-opioïed agoniste, kan onttrekkingsimptome veroorsaak. Effek op die vermoë om te bestuur of masjienerie te hanteer: SOVENOR Patch kan die vermoë om te bestuur en met masjienerie te werk, belemmer. INTERAKSIES Versigtigheid moet toegepas word by pasiënte wat MAOIs neem of wat MAOIs tydens die laaste twee weke geneem het, wanneer die gebruik van enige opioïed, insluitend SOVENOR Patch, oorweeg word. SOVENOR Patch moet versigtig gebruik word deur pasiënte wat gelyktydig ander SSS onderdrukkers of ander medisyne neem wat respiratoriese depressie, hipotensie, sedasie of potensieel 'n koma tot gevolg kan hê. Sulke middels sluit in sedeermiddels of hipnotika, algemene anestetika, ander opioïed analgetika, fenotiasiene, sentraalwerkende anti-emetika, bensodiasepiene en alkohol. Middels wat die hepatiese bloedvloei verlaag bv. sekere algemene anestetika (bv. halotaan), kan die hepatiese eliminasie van buprenorfien vertraag. Buprenorfien, soos in SOVENOR Patch, word primêr gemetaboliseer deur glukoronidasie en tot 'n mindere mate (omtrent 30 %) deur CYP3A4. Middels wat die CYP3A4 ensiem sisteem inhibeer kan tot verhoogde plasmakonsentrasies van buprenorfien lei. 'n Medisyne-interaksie studie met die CYP3A4 inhibeerder, ketokonasool, het nie kliniese relevante verhogings in gemiddelde maksimum (C maks ) of totale (AOK) van buprenorfien gelewer nie. Die interaksie tussen buprenorfien en CYP3A4 ensiem induseerders is nog nie bestudeer nie. Gelyktydige toediening van buprenorfien en ensiem induseerders (bv. fenobarbital, karbamasepien, fenitoïen en rifampisien) kan die metabolisme van burprenorfien verhoog en die doeltreffendheid van behandeling verlaag. Die potensiaal vir INR verhoging bestaan by pasiënte wat gelyktydig warfarien neem. SWANGERSKAP EN LAKTASIE SOVENOR Patch moet nie tydens swangerskap of laktasie gebruik word nie. Buprenorfien kruis die plasenta in mense. 13

14 Buprenorfien is al opgemerk in die bloed, uriene en mekonium van die pasgeborene, asook in lae konsentrasies in die moedersmelk. DOSIS EN GEBRUIKSAANWYSINGS SOVENOR Patch moet aangewend word aan nie-geirriteerde, intakte vel op die buitenste deel van die bo-arm, boonste gedeelte van die borskas, boonste gedeelte van die rug of die kant van die borskas. SOVENOR Patch moet aan 'n relatiewe haarlose of bykans haarlose area aangewend word. Indien die area nie haarloos is nie, moet die hare gesny word en nie geskeer word nie. Aanwendingsareas moet roteer word wanneer 'n transdermale pleister vervang of bygevoeg word. Aanwendingsareas moet nie weer gebruik word in minder as 3 week intervalle nie. Indien die aanwendingsarea skoongemaak moet word, moet dit met skoon water alleenlik gedoen word. Sepe, alkohol, olies, velreinigers of growwe voorwerpe moet nie gebruik word om die area skoon te maak nie. Die vel moet droog wees voordat die transdermale pleister aangewend word. SOVENOR Patch moet aaneenlopend vir 7 dae gedra word. SOVENOR Patch moet ferm in plek by die aanwendingsarea gedruk word om seker te maak dat kontak volledig is, veral rondom die kante. Indien die kante los raak, kan dit met geskikte vel-kleefband in plek gehou word. Indien 'n transdermale pleister afval moet 'n nuwe een aangewend word. Bad, stort of swem behoort nie die sisteem te beïnvloed nie. Terwyl SOVENOR Patch gedra word, moet pasiënte ingelig word om die aanwendingsarea nie bloot te stel aan direkte, eksterne hitte bronne, soos warmsakke, elektriese komberse, verhittingslampe ens. nie, siende dit kan lei tot 'n verhoging in die absorpsie van buprenorfien. Die effek van die gebruik van SOVENOR Patch in warm baddens en saunas is nog nie bestudeer nie. Aanwendingsaanwysings: Maak die sakkie oop net voordat die pleister aangewend word. Verwyder die dun deklagie. Heg die pleister of aan die bo-arm, boonste gedeelte van die borskas, die boonste gedeelte van die rug of die kante van die borskas vas. Druk die pleister met die hand vir ongeveer 30 sekondes en maak seker dat dit ordentlik vasheg. Die pleister moet nie gebruik word indien die seël gebreek is nie. 14

15 Dosis en Titrasie: Die laagste SOVENOR Patch dosis beskikbaar, SOVENOR 5 Patch (5 µg/uur) moet as die aanvangsdosis by alle pasiënte gebruik word. Tydens aanvang, titrasie en behandeling met SOVENOR Patch, kan pasiënte voortgaan met hul bestaande NSAIM of parasetamol behandeling soos nodig. Die dosis van SOVENOR Patch moet nie vermeerder word in minder as 3-dag intervalle wanneer konstante bloedvlakke bereik is nie. n Verandering in die dosis van SOVENOR Patch kan individueel getitreer word, gebaseer op die behoefte vir aanvullende analgetika en die pasiënt se analgetiese respons met SOVENOR Patch. Om die dosis te verhoog, moet 'n groter pleister die huidige pleister wat gedra word vervang of 'n kombinasie van pleisters moet op verskillende plekke aangewend word om die gewenste dosis te behaal. Daar word aanbeveel dat nie meer as twee pleisters op dieselfde tyd aangewend word nie, ongeag die sterkte van die pleister. Titrasie behoort voort te gaan elke 3-7 dae totdat voldoende pynstillende effek bereik is. Indien voldoende pynkontrole nie bereik kan word met SOVENOR Patch nie, moet die behandeling met SOVENOR Patch gestaak word en die pasiënt oorgeskakel word na 'n geskikte analgetiese behandeling, soos deur die geneesheer bepaal. Staking: Na die verwydering van SOVENOR Patch, verlaag plasma konsentrasies geleidelik. Dit moet in ag geneem word wanneer behandeling met SOVENOR Patch gevolg word deur ander opioïede. As 'n algemene reël moet 'n daaropvolgende opioïed nie binne 24 uur na die verwydering van SOVENOR Patch, toegedien word nie. Kinders: Die veiligheid en doeltreffendheid van SOVENOR Patch by pasiënte jonger as 18 jaar is nog nie vasgestel nie. Renale inkorting: Geen spesiale dosis aanpassing van SOVENOR Patch is nodig by pasiënte met renale inkorting nie. Hepatiese inkorting: Die dosis van SOVENOR Patch hoef nie aangepas te word vir pasiënte met ligte tot matige hepatiese inkorting nie. 15

16 Buprenorfien kan akkumuleer in die liggaam van pasiënte wat aan ernstige hepatiese inkorting ly gedurende die behandeling met SOVENOR Patch. SOVENOR Patch moet nie by sulke pasiënte gebruik word nie. NEWE-EFFEKTE Die volgende newe-effekte is aangemeld tydens die gebruik van SOVENOR Patch: Die tabel lys nadelige reaksies wat aangemeld is vir 9 voltooide studies met SOVENOR Patch. Die reaksies is gelys as MeDRA voorkeurterme deur sisteem-orgaanklas en absolute frekwensie. Liggaamsisteem/ Frekwensie van Voorkoms Nadelige Reaksie Terme Gebeure Baie Algemeen Ongewone Skaars algemeen > 1 % > 0.1 % > 0.01 % > 10 % en en en < 10 % < 1 % < 0.1 % Imuunsisteemversteurings: hipersensitiwiteitsreaksie (insluitend orofaringeale swelling en geswelde tong) Metabolisme- en voedingversteurings: anoreksie dehidrasie* Psigiatriese versteurings: verwarring, depressie*, slapeloosheid, senuweeagtigheid affekteer labiliteit, agitasie, angs, ontpersoonliking, euforiese gemoed, hallusinasies, verlaagde libido, nagmerries psigotiese afwykings Senusisteemversteurings: duiseligheid, hoofpyn*, slaperigheid* parastesie konsentrasie inkorting, abnormale koördinasie, disartrie, disgeusie, hipo-estesie, geheue inkorting, migraine, sinkopie*, tremor 16

17 Oogversteurings: droë oë, dowwe visie miose Oor- en labarintversteurings: tinnitus, vertigo Kardiale versteurings: angina pectoris, palpitasies, tagikardie Vaskulêre versteurings: vasodilatasie gloede, hipertensie*, ortostatiese hipotensie Respiratoriese, torakale en mediastenale versteurings: dispnee* verergerde asma*, hoes, hik, hiperventilasie, hipoksie, rinitis, gehyg respiratoriese versaking Gastroïntestinale versteurings: konstipasie*, droë mond, naarheid*, braking* abdominale pyn*, diarree*, dispepsie* winderigheid divertikulitis*, disfagie, ileus Hepatobiliêre versteurings: biliêre koliek* Vel en onderhuidseweefselversteurings: pruritus* uitslag*, sweet* droë vel, gesigedeem, urtikarie Muskuloskeletale en bindweefselversteurings: spierkramp, spierspasma, mialgie Renale en urinêre versteurings: urinêre inkontinensie, urinêre terughouding urinêre aarseling Voorplantingsisteem- en borsversteurings: seksuele disfunksie 17

18 Algemene versteurings en aanwendingsarea toestande: aanwendingsarea reaksie (insluitend aanwendingsarea eriteem, aanwendingsarea edeem, aanwendingsarea gejeuk, aanwendingsarea uitslag) astenie* (insluitend spierswakheid), borspyn*, pyn, perifere edeem griepagtige siekte, ongesteldheid, edeem, pireksie*, koue rillings*, onttrekkingssindroom * Ten minste een ernstige geval BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN Respiratoriese depressie en apnee kan voorkom, asook sedasie, lomerigheid, naarheid, braking, kardiovaskulêre ineenstorting en duidelike miose. Verwyder enige SOVENOR Patch in kontak met die pasiënt en doen weg daarmee op die geskikte manier. 'n Oop lugweg moet bewerkstellig en behou word. Daarna moet die asemhaling ondersteun en gekontroleer word en daarmee saam moet die geskikte liggaamstemperatuur en vloeistofbalans gehandhaaf word. Suurstof, intraveneuse vloeistowwe, vasopressors en ander ondersteunende maatreëls behoort soos nodig, toegepas te word. 'n Spesifieke antagonis, soos naloksoon, kan die effekte van buprenorfien omkeer. Behandeling met naloksoon moet met die gewone voorgeskrewe aanvangsdosis toegedien word, maar intraveneuse behandeling, van 5 tot 12 mg mag benodig word. Die aanvangs effek van naloksoon kan met tot 30 minute of meer vertraag word. Dit is essensieel en belangriker om voldoende ventilasie te bewerkstellig en te handhaaf as om n spesifieke teenmiddel soos naloksoon te gebruik gedurende die behandeling van n oordosering. IDENTIFIKASIE SOVENOR 5 Patch: 'n Vierkantige transdermale pleister met geronde hoeke en n roomkleurige agterlaag op n rigiede aluminium verwyderbare beskermende laag. In die middel is 'n buprenorfien bevattende klewerige matriks, gedruk met SOVENOR 5, 5 mcg/h. SOVENOR 10 Patch: 'n Reghoekige transdermale pleister met geronde hoeke en n roomkleurige agterlaag op n rigiede aluminium verwyderbare beskermende laag. In die 18

19 middel is 'n buprenorfien bevattende klewerige matriks, gedruk met SOVENOR 10, 10 mcg/h. SOVENOR 20 Patch: 'n Vierkantige transdermale pleister met geronde hoeke en n roomkleurige agterlaag op n rigiede aluminium verwyderbare beskermende laag. In die middel is 'n buprenorfien bevattende klewerige matriks, gedruk met SOVENOR 20, 20 mcg/h. AANBIEDING Een transdermale pleister verpak in 'n hitte verseëlde beskermende sakkie wat n samestelling is van papier, LDPE film, aluminium en etileen ko-polimeer. Twee of vier individuele geseëlde sakkies verpak in 'n karton. BERGINGSINSTRUKSIES Bewaar by of benede 25 C. Bewaar in die oorspronklike verpakking. Bewaar hierdie medisyne buite die bereik van kinders. REGISTRASIENOMMERS Suid Afrika: S6 SOVENOR 5 Patch: 41/2.7/0589 SOVENOR 10 Patch: 41/2.7/0590 SOVENOR 20 Patch: 41/2.7/0591 Namibië: NS4 SOVENOR 5 Patch: 12/2.7/0253 SOVENOR 10 Patch: 12/2.7/0254 SOVENOR 20 Patch: 12/2.7/0255 Botswana: S1B SOVENOR 5 Patch: SOVENOR 10 Patch: SOVENOR 20 Patch: BOT B BOT B BOT B NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT Mundipharma (Edms) Bpk 2 de Vloer, Mariendahl House Newlands on Main Claremont

20 Suid Afrika SOVENOR Patch DATUM VAN PUBLIKASIE VAN DIE VOUBILJET 17 April 2009 = SOVENOR is 'n Handelsmerk 20