FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of buprenorphine/naloxone in elderly patients over 65 years of age have not been established.
Maltese: Is-sigurtà u effikaċja ta' buprenorphine/naloxone f'pazjenti anzjani li jkollhom iktar minn 65 sena ma ġewx determinati.
English: No synergistic enhancement of toxicity has been observed.
Maltese: L-ebda żieda sinerġistika fit-tossiċità ma ġiet osservata.
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
Maltese: Fi studju double-blind, double-dummy, tat-tip grupp parallel, li qabbel soluzzjoni etanolika ta' buprenorphine ma' kontroll attiv ta' agonist sħiħ, 162 persuna ntgħażlu b'mod każwali biex jirċievu ssoluzzjoni etanolika ta' buprenorphine taħt l-ilsien f'doża ta' 8 mg/kuljum (doża li hi bejn wieħed u ieħor paragunabbli ma' doża ta' 12-il mg/kuljum ta' buprenorphine/naloxone), jew żewġ dożi relattivament baxxi ta' kontroll attiv, li wieħed minnhom kien baxx biżżejjed biex iservi bħala alternattiva għall-plaċebo, waqt il-fażi ta' induzzjoni ta' minn 3 sa 10 ijiem, fażi ta' manteniment ta' 16-il ġimgħa u fażi ta' detossifikazzjoni ta' 7 ġimgħat.
English: - The active substances are buprenorphine and naloxone.
Maltese: - Is-sustanzi attivi huma buprenorphine u naloxone.
English: 6.2 Incompatibilities Not applicable.
Maltese: Togħma naturali ta' lumi u lime 6.2 Inkompatibilitajiet
English: Suboxone 8 mg/2 mg sublingual tablets are white hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Maltese: Il-pilloli ta' taħt l-ilsien ta' Suboxone 8 mg/2 mg huma bojod, bikonvessi eżagonali, ta' 11 mm u imnaqqxa bil-“N8” fuq naħa waħda.
English: Suboxone sublingual tablets should be used with caution in patients with moderate hepatic impairment (See section 4.3 and 5.2).
Maltese: Il-pilloli taħt l-ilsien ta' Suboxone għandhom jintużaw b'kawtela f'pazjenti b'indeboliment epatiku moderat (ara sezzjoni 4.3 u 5.2).
English: EU/1/06/359/004 8 mg sublingual tablets 28
Maltese: EU/1/06/359/004 8 mg pilloli għal taħt l-ilsien 28
English: Suboxone may cause drowsiness.
Maltese: Suboxone jista' jikkawża n-ngħas.
English: EU/1/06/359/002 2 mg sublingual tablets 28
Maltese: EU/1/06/359/002 2 mg pilloli għal taħt l-ilsien 28
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindrome bħal meta tieqaf tieħu d-drogi fi trabi tat-twelid (ara sezzjoni 4.6)
English: Erectile dysfunction
Maltese: Burdata ewforika
English: EU/1/06/359/006 16 mg sublingual tablets 28
Maltese: EU/1/06/359/006 16 mg pilloli għal taħt l-ilsien 28
English: Peak plasma concentrations are achieved 90 minutes after sublingual administration.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma jintlaħqu 90 minuta wara l-għoti taħt l-ilsien.
English: Amnesia Hyperkinesia Sezuire
Maltese: Amnesija aċċessjonijiet Iperkinesija
English: • asthma or other breathing problems
Maltese: • jekk għandek problemi respiratorji serji
English: o CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.
Maltese: Użu fl-istess ħin ta' indutturi ta' CYP3A4 ma' buprenorphine jista' jnaqqas il-konċentrazzjonijiet ta' buprenorphine fil-plasma, u dan jista' jirriżulta f'kura subottimali għal dipendenza fuq opjojdi b'buprenorphine.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Leukocytosis Leukopenia Lymphadenopathy Thrombocytopenia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Important things to be aware of:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).
Maltese: Dawn jinkludu mediċini użati biex tiġi ttrattata l-epilessija (bħal carbamazepine u phenytoin), u mediċini użati biex tiġi ttrattata t-tuberkulożi
English: The combination of buprenorphine and naloxone has been investigated in acute and repeated dose (up to 90 days in rats) toxicity studies in animals.
Maltese: L-użu flimkien ta' buprenorphine u naloxone ġiet investigata fi studji dwar it-tossiċità fl-annimali b'dożi akuti u ripetuti (sa 90 jum fil-firien).
English: Reproduction studies by oral administration of buprenorphine: naloxone (ratio 1:1) indicated that embryolethality occurred in rats in the presence of maternal toxicity at all doses.
Maltese: naloxone (proporzjon ta' 1:1) indikaw li l-embrijoletalità seħħet fil-firien fil-preżenza ta' tossiċità materna bid-dożi kollha.
English: • some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, certain antibiotics, may extend the effects of this medicine.
Maltese: • xi mediċini kontra l-fungus (użati biex jiġu ttrattati l-infezzjonijiet fungali) bħal ketoconazole, itraconazole, ċerti antibijotiċi, jistgħu jtawwlu l-effetti ta' din il-mediċina.
English: Dansom Lane
Maltese: ANNESS III
English: Ear and labyrinth disorders
Maltese: Disturbi fil- widna u labrynth
English: Dosage adjustment and maintenance therapy
Maltese: • Monitoraġġ addizzjonali
English: Each 2 mg/0.5 mg sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' Suboxone 2 mg/0.5 mg fiha 2 mg ta' buprenorphine (bħala hydrochloride) u 0.5 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Sublingual tablet White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Maltese: Abjad pilloli bikonvessi eżagonali ta ' 11 mm bil" N8 " imnaqqxa fuq in-naħa waħda.
English: • naltrexone and nalmefene (drugs used to treat addictive disorders) may prevent the therapeutic effects of Suboxone.
Maltese: • naltrexone u nalmefene (mediċini użati biex jittrattaw disturbi vizzju) jista' jimpedixxi l-effetti terapewtiċi ta' Suboxone.
English: The safety and efficacy of buprenorphine/naloxone in children below the age of 15 years have not been established.
Maltese: Is-sigurtà u effikaċja ta' buprenorphine/naloxone fi tfal ta' inqas minn 15-il sena ma ġewx determinati.
English: Name and address of the manufacturer responsible for batch release Reckitt Benckiser Healthcare (UK) Ltd
Maltese: Reckitt Benckiser Healthcare (UK) Ltd Dansom Lane
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħrufa (il-frekwenza ma tistax tisġi stmata mid-dejta disponibbli):
English: Naloxone is an antagonist at -opioid receptors.
Maltese: Naloxone hu antagonist f'riċetturi µ tal-oppjojd.
English: The recommended starting dose in adults and adolescents over 15 years of age is one to two Suboxone 2 mg/0.5 mg. An additional one to two Suboxone 2 mg/0.5 mg may be administered on day one depending on the individual patient's requirement.
Maltese: Id-doża tal-bidu rakkomandata f'persuni adulti u adolexxenti li għandhom iżjed minn 15-il sena hi ta' pillola waħda sa żewġ pilloli Suboxone ta' 2 mg/0.5 mg. Pillola waħda sa żewġ pilloli ta' Suboxone ta' 2 mg/0.5 mg addizzjonali jistgħu jingħataw fl-ewwel ġurnata skont il-ħtieġa tal-pazjent individwali.
English: Common side effects (may effect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1minn kull 10):
English: Regular monitoring of liver function is recommended (see section 4.4).
Maltese: Monitoraġġ regolari tal-funzjoni tal-fwied hu rakkomandat (ara sezzjoni 4.4).
English: Posology
Maltese: Email:
English: If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Suboxone therapy.
Maltese: Jekk tkun qed tieħu l-methadone jew opjojde li jaġixxi fit-tul, idealment, id-doża tal-methadone għandha titnaqqas għal inqas minn 30 mg/kuljum qabel ma tibda t-terapija b'Suboxone.
English: Urine Abnormality
Maltese: Anormalità fl
English: The medicinal product is metabolized in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Maltese: Il-prodott mediċinali jiġi metabolizzat fil-fwied, primarjament permezz ta' konjugazzjoni ta' glucuronide, u jiġi eliminat fl-awrina.
English: They may also cause central nervous system depression, which is very serious.
Maltese: Jistgħu anki jikkawżaw dipressjoni tas-sistema nervuża ċentrali, li hija serja ħafna.
English: HU8 7DS
Maltese: AUC0-48
English: Each 8 mg/2 mg tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola taħt l-ilsien fiha 8 mg ta' buprenorphine (bħala hydrochloride) u 2 mg ta' naloxone (bħala hydrochloride dihydrate).
English: The most commonly reported treatment related adverse reactions reported during the pivotal clinical trials were constipation and symptoms commonly associated with drug withdrawal (i.e. insomnia, headache, nausea, hyperhidrosis and pain).
Maltese: Ir-reazzjonijiet avversi assoċjati mal-kura li l-aktar ġew irrappurtati b'mod komuni waqt il-provi kliniċi importanti ħafna kienu stitikezza u sintomi assoċjati komunement ma' meta wieħed jieqaf jieħu d-drogi (i.e. nuqqas ta' rqad, uġigħ ta' ras, dardir, iperidrosi u uġigħ).
English: Hepatic encepalopathy Syncope
Maltese: Enċefalopatija
English: o the concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.
Maltese: o l-użu konkomitanti ma' inibituri ta' monoamine oxidase (MAOI) jista' jikkawża tħarrix taleffetti tal-oppjojdi, ibbażat fuq l-esperjenza bil-morfina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7 and 28 TABLETS 2 mg STRENGTH
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PAKKETT TA' 7 u 28 PILLOLA B'QAWWA TA' 2 mg
English: The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both buprenorphine/naloxone versus placebo (p < 0.0001) and buprenorphine versus placebo (p < 0.0001).
Maltese: Ilperċentwal tal-kampjuni tal-awrina li ttieħdu tliet darbiet fil-ġimgħa li kienu negattivi għal oppjojdi mhux tal-istudju kienet statistikament ogħla kemm għal buprenorphine/naloxone kontra l-plaċebo (p <0.
English: In cases of intravenous drug misuse, some adverse experiences are attributed to the act of misuse rather than the medicinal product and include local reactions, sometimes septic (abscess, cellulitis), and potentially serious acute hepatitis, and other acute infections such as pneumonia, endocarditis have been reported (see section 4.4).
Maltese: • F'każijiet ta' użu ħażin tad-droga minn ġol-vina xi esperjenzi avversi huma attribwiti pjuttost għall-att ta 'użu ħażin milli ghall-prodott mediċinali u jinkludu, reazzjonijiet lokali, kultant settiċi (axxessi, ċellulite), u epatite akuta potenzjalment serja, u ġew irrappurtati infezzjonijiet akuti bħal pulmonite u endokardite (ara sezzjoni 4.4).
English: Sublingual tablet White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Maltese: Abjad pilloli bikonvessi eżagonali ta ' 6.5 mm bil" N2 " imnaqqxa fuq in-naħa waħda.
English: Hypotension
Maltese: Impotenza
English: How to take Suboxone
Maltese: X'fih Suboxone
English: Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Maltese: Effetti mhux mixtieqa kienu bbażati fuq l-attività farmakoloġika magħrufa ta' sustanzi oppjojdi agonisti u/jew antagonistiċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sublingual tablet contains 8 mg buprenorphine as buprenorphine hydrochloride and 2 mg naloxone as naloxone hydrochloride dihydrate.
Maltese: DIKJARAZZJONI TAS-SUSTANZA (I) ATTIVA Kull pillola għal taħt l-ilsien fiha 8 mg ta' buprenorphine bħala buprenorphine hydrochloride u 2 mg ta' naloxone bħala naloxone hydrochloride dihydrate.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA (I) ATTIVA Kull pillola għal taħt l-ilsien fiha 16 mg ta' buprenorphine (bħala hydrochloride) u 4 mg ta' naloxone (bħala hydrochloride dihydrate).
English: The frequency of possible side effects listed below is defined using the following convention: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100), Not known (cannot be estimated from available data).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), Mhux komuni (≥1/1,000 sa <1/100), Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli.
English: Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist e.g. morphine.
Maltese: Studji fl-annimali, kif ukoll l-esperjenza klinika, urew li buprenorphine jista' jipproduċi dipendenza, iżda f'livell aktar baxx minn agonist sħiħ, eż. morfina.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and nondependent persons in case of accidental or deliberate ingestion.
Maltese: Buprenorphine/naloxone jista' jikkawża indeboliment respiratorju sever u li possibilment jista' jkun fatali fi tfal u fuq persuni mhux dipendenti fil-każ ta' inġestjoni aċċidentali jew deliberata.
English: The primary study comparison was to assess the efficacy of buprenorphine and buprenorphine/naloxone individually against placebo.
Maltese: Il-paragun tal-istudju ewlieni kien li jevalwa l-effikaċja ta' buprenorphine u buprenorphine/naloxone individwalment kontra l-plaċebo.
English: This product should be used with care in patients with asthma or respiratory insufficiency (e.g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (curvature of spine leading to potential shortness of breath)).
Maltese: Dan il-prodott għandu jintuża b'kawtela f'pazjenti bl-ażma jew insuffiċjenza respiratorja (eż. mard pulmonari ostruttiv kroniku, allarm pulmonari, tnaqqis fir-riserva respiratorja, ipoksija, iperkapnija, indeboliment respiratorju li kien jeżisti qabel jew kifoskoljożi (kurvatura tal-ispina li twassal għal qtugħ ta' nifs potenzjali)).
English: Severe hepatic impairment
Maltese: Influwenza Infezzjoni Farinġite
English: Hepatic encephalopathy Syncope
Maltese: Epatika Sinkope
English: Elderly No pharmacokinetic data in elderly patients are available.
Maltese: Anzjani L-ebda dejta farmakokinetika mhi disponibbli dwar pazjenti anzjani.
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.
Maltese: Din il-mediċina tista 'tikkawża depressjoni respiratorja ( kapaċità mnaqqsa li jieħdu nifs )severa, possibbilment fatali , fit-tfal u nies mhux dipendenti li jeduha aċċidentalment jew apposta .
English: Both active substances of Suboxone, buprenorphine and naloxone, are extensively metabolized in the liver, and the plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment.
Maltese: L ż-żewġ sustanzi attivi ta 'Suboxone, buprenorphine u naloxone, huma metabolizzat b'mod estensiv fil-fwied, u il-livelli fil-plażma nstabu li jkunu ogħla kemm għall buprenorphine u naloxone f'pazjenti b'indeboliment epatiku moderat u sever.
English: • naltrexone and nalmefene (drugs used to treat addiction disorders) may prevent the therapeutic effects of Suboxone.
Maltese: • naltrexone u nalmefene (mediċini użati biex jittrattaw disturbi ta'vizzji) jista' jimpedixxi leffetti terapewtiċi ta' Suboxone.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA (I) ATTIVA Kull pillola għal taħt l-ilsien fiha 2 mg ta' buprenorphine (bħala hydrochloride) u 0.5 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Maltese: Suboxone jintuża biex jikkura d-dipendenza fuq mediċini oppjojdi (narkotiċi) bħal eroina jew morfina f'persuni dipendenti fuq id-droga li jkunu qablu li jiġu kkurati għall-vizzju tagħhom.
English: NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets buprenorphine / naloxone
Maltese: Informazzjoni għall-utent Suboxone 16 mg/4 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets buprenorphine/naloxone
Maltese: Informazzjoni għall-utent Suboxone 8 mg/2 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: Buprenorphine/naloxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Maltese: Buprenorphine/naloxone jistgħu jikkawżaw ngħas, partikularment meta jittieħdu flimkien mal-alkoħol jew ma' depressanti tas-sistema nervuża ċentrali (bħal kalmanti, sedattivi jew mediċini ipnotiċi) (ara sezzjoni 4.5).
English: • if you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence.
Maltese: • jekk qed tieħu naltrexone jew nalmefene għat -trattament ta ' dipendenza fuq l-alkoħol jew opjojdi.
English: • Naltrexone and nalmefene (drugs used to treat addictive disorders) may prevent the therapeutic effects of Suboxone.
Maltese: • naltrexone u nalmefene (mediċini użati biex jittrattaw disturbi tal-vizzji) jista' jimpedixxi leffetti terapewtiċi ta' Suboxone.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Maltese: Mediċini oħrajn tas-sistema nervuża, mediċini użati f'disturbi ta' vizzji ta' dipendenza fuq id-droga, Kodiċi ATC:
English: • Dependence This product can cause dependence.
Maltese: Dan il-prodott jista' jikkawża dipendenza.
English: A dietary dose of 100 ppm (estimated exposure approximately 2.4x for buprenorphine at a human dose of 24 mg buprenorphine/naloxone based on AUC, plasma levels of naloxone were below the limit of detection in rats) had no adverse effect on fertility in females.
Maltese: Doża mad-dieta ta' 100 ppm (esponiment stmat li hu madwar 2.4x għal buprenorphine b'doża fil-bniedem ta' 24 mg ta' buprenorphine/naloxone fuq bażi tal-AUC, il-livelli ta' naloxone fil-plażma kienu taħt il-limitu ta'
English: Maize starch
Maltese: Pressjoni baxxa
English: NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets buprenorphine / naloxone
Maltese: Informazzjoni għall-utent Suboxone 2 mg/0.5 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Maltese: Numru ta' każijiet ta' mewt minħabba depressjoni respiratorja ġew irrappurtati, partikularment meta buprenorphine ntuża flimkien ma' benzodiazepines (ara sezzjoni 4.5) jew meta buprenorphine ma ntużax skont l-informazzjoni fuq ir-riċetta.
English: Buprenorphine is a partial agonist at the µ (mu)-opiate receptor and chronic administration produces dependence of the opioid type.
Maltese: Buprenorphine hu agonist parzjali fir-riċettur μ (mu) tal-oppjojd u l-għoti fit-tul jikkawża dipendenza tat-tip tal-oppjojdi.
English: Abdominal Pain Diarrhoea Dyspepsia Flatulence
Maltese: Uġigħ Addominali Dijarea
English: 28 sublingual tablets
Maltese: 28 pillola għal taħt l-ilsien
English: In this trial, 326 heroin-addicted subjects were randomly assigned to either buprenorphine/naloxone 16 mg per day, 16 mg buprenorphine per day or placebo.
Maltese: F'din il-prova, 326 persuna li kienu dipendenti fuq l-eroina ġew assenjati b'mod każwali jew 16-il mg buprenorphine/naloxone kuljum, jew 16-il mg ta' buprenorphine kuljum jew plaċebo.
English: Dose titration in steps of 2-8 mg buprenorphine is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 24 mg buprenorphine.
Maltese: Titrazzjoni tad-doża pass pass ta' 2-8 mg buprenorphine hi ggwidata minn evalwazzjoni mill-ġdid tal-istat kliniku u psikoloġiku tal-pazjent, u m'għandhiex taqbeż doża massima waħda ta' kuljum ta' 24 mg buprenorphine.
English: INFORMATION IN BRAILLE Suboxone 8 mg/2 mg sublingual tablets
Maltese: Suboxone 8 mg/2 mg pilloli taħt l-ilsien
English: Symptomatic treatment of respiratory depression, and standard intensive care measures, should be implemented.
Maltese: Kura sintomatika għal depressjoni respiratorja, u miżuri ta' kura intensiva standard, għandhom jiġu implimentati.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the  and  (kappa) opioid receptors of the brain.
Maltese: Buprenorphine huwa agonist/antagonist parzjali tal-oppjojdi li jeħel mar-riċetturi µ u κ (kappa) taloppjojdi tal-moħħ.
English: On Day 3, those randomized to receive buprenorphine/naloxone were switched to the combination tablet.
Maltese: F'Jum 3, dawk li ntgħażlu b'mod każwali biex jirċievu buprenorphine/naloxone, inqalbu għall-pillola kombinata.
English: Vomiting
Maltese: Epatorenali
English: Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Maltese: Suboxone jintuża f'persuni adulti u adolexxenti li għandhom iktar minn 15-il sena, li jkunu qed jirċievu wkoll appoġġ mediku, soċjali u psikoloġiku.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/001 2 mg sublingual tablets 7
Maltese: FIS-SUQ EU/1/06/359/001 2 mg pilloli għal taħt l-ilsien 7
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/005 16 mg sublingual tablets 7
Maltese: FIS-SUQ EU/1/06/359/005 16 mg pilloli għal taħt l-ilsien 7
English: Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicinal product is not safeguarded against theft.
Maltese: Skont ir-riżultati, il-prodott mediċinali jista' jitwaqqaf b'kawtela biex jiġu evitati sintomi bħal meta wieħed jieqaf jieħu d-drogi u biex jiġi evitat li l-persuna terġa' tibda tuża drogi illegali.
English: NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets buprenorphine / naloxone
Maltese: Suboxone 8 mg/2 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone (see sections 4.2 and
Maltese: • F'pazjenti li jkollhom dipendenza notevoli fuq id-drogi, l-għoti inizjali ta' buprenorphine jista' jipproduċi sindrome ta' meta wieħed jieqaf jieħu d-drogi bħal dak assoċjat ma' naloxone (ara sezzjonijiet 4.2 u 4.4).
English: Diarrhoea Dyspepsia Flatulence Vomiting
Maltese: Infezzjoni fl-apparat tal-awrina Infezzjoni vaġinali
English: Abdominal Pain Diarrhoea Dyspepsia Flatulence Vomiting
Maltese: Uġigħ fid-Dahar Artralġja Spażmi muskolari