FrancophonIA/ELRC3.0 huggingface dataset:
English: ViraferonPeg, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Maltese: ViraferonPeg, bi jew mingħajr ribavirin, tqabbel ma' interferon alfa-2b f'ħames studji ewlenin li b'kollox involvew aktar minn 6,000 adult b'epatite C li ma kinux ġew ikkurati qabel, inkluż 328 pazjent b'ċirrożi u 507 pazjenti li kienu nfettati wkoll bl-HIV.
English: The combination of ViraferonPeg and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Maltese: Il-kombinazzjoni ta' ViraferonPeg ma' ribavirin ġiet studjata wkoll fi studju wieħed li kien jinvolvi 1,354 pazjent li l-kura preċedenti tagħhom ma kinitx irnexxiet u fi studju wieħed li kien jinvolvi 107 tfal u adoloxxenti ta' bejn tlieta u 17-il sena li ma kinux ġew ikkurati qabel.
English: ViraferonPeg is a medicine that contains the active substance peginterferon alfa-2b.
Maltese: ViraferonPeg huwa mediċina li fih is-sustanza attiva peginterferon alfa-2b.
English: In adults (aged 18 years and older), ViraferonPeg can be used in patients who have not been treated before or whose previous treatment failed.
Maltese: Fl-adulti (minn 18-il sena 'l fuq), ViraferonPeg jista' jintuża f'pazjenti li ma jkunux ġew ittrattati qabel jew li t-trattament preċedenti tagħhom ma jkunx irnexxa.
English: The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'ViraferonPeg, peginterferon alfa-2b, tagħmel parti mill-grupp magħruf bħala ‘interferons'.
English: Peginterferon alfa-2b is similar to interferon alfa-2b, which has been available in the European Union (EU) for a number of years.
Maltese: Peginterferon alfa-2b jixbah lill-interferon alfa-2b, li ilu disponibbli fl-Unjoni Ewropea (UE) għal numru ta' snin.
English: What is ViraferonPeg?
Maltese: X'inhu ViraferonPeg?
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ViraferonPeg in a triple therapy combination with ribavirin and boceprevir compared with ViraferonPeg and ribavirin alone.
Maltese: Żewġ studji ewlenin li jinvolvu 1,503 pazjent bl-epatite Ċ tat-tip 1 u mard tal-fwied ikkumpensat investigaw l-effett ta' ViraferonPeg f'taħlita ta' terapija trippla ma' ribavirin u boceprevir meta mqabbel ma' ViraferonPeg u ribavirin waħedhom.
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), ViraferonPeg is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Maltese: F'adulti oħrajn bil-vajrus tal-epatite C fid-demm tagħhom, inklużi pazjenti infettati wkoll bil-vajrus uman tal-immunodefiċjenza (HIV), ViraferonPeg jingħata jew ma' ribavirin (terapija doppja) jew waħdu jekk ma jkunux jistgħu jieħdu ribavirin.
English: ViraferonPeg can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Maltese: ViraferonPeg jista' jingħata f'taħlita ta' terapija trippla ma' ribavirin u boceprevir lil adulti bl-epatite Ċ tat-tip 1 li l-fwied tagħhom ikun ġarrab ħsara iżda li xorta jkun għadu jaħdem normali (mard tal-fwied ikkumpensat).
English: In adults, ViraferonPeg was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to ViraferonPeg alone and around a half responding to the combination of ViraferonPeg and ribavirin.
Maltese: Fl-adulti, ViraferonPeg kien iktar effikaċi minn interferon alfa-2b, f'pazjenti li ma kinux ġew ikkurati qabel, b'madwar kwart tal-pazjenti jwieġbu għal ViraferonPeg waħdu u madwar nofs iwieġbu għallkombinazzjoni ta' ViraferonPeg u ribavirin.
English: The replacement acts in the same way as naturally produced interferon alpha.
Maltese: Is-sostituzzjoni taħdem bl-istess mod bħal interferon alpha prodott b'mod naturali.
English: Dual therapy with ribavirin is also used in previously untreated children and adolescents (aged between three and 17 years) as long as their liver is still working normally.
Maltese: It-terapija doppja ma' ribavirin tintuża wkoll fi tfal u adoloxxenti (ta' bejn 3 u 17-il sena) li ma ġewx ittrattati qabel, dejjem jekk il-fwied tagħhom ikun għadu jaħdem normali.
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Maltese: Hemm ukoll żieda sinifikanti fir-rati ta' kura f'pazjenti bl-epatite Ċ tat-tip 1 fit-tul meta jingħataw terapija trippla ta' PegIntron flimkien ma' ribavirin u boceprevir.
English: The CHMP decided that ViraferonPeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li ViraferonPeg għandu iktar benefiċċji milli riskji u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has ViraferonPeg been studied?
Maltese: Kif ġie studjat ViraferonPeg?
English: Why has ViraferonPeg been approved?
Maltese: Għaliex ġie approvat ViraferonPeg?
English: Other information about ViraferonPeg:
Maltese: Tagħrif ieħor dwar ViraferonPeg:
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ViraferonPeg in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of ViraferonPeg with ribavirin alone.
Maltese: Fl-istudji dwar terapija trippla f'pazjenti bl-epatite Ċ tat-tip 1 u l-mard tal-fwied ikkumpensat, intwera li ViraferonPeg flimkien ma' ribavirin u boceprevir huwa aktar effettiv milli t-taħlita doppja ta' ViraferonPeg ma' ribavirin waħedhom.
English: ViraferonPeg must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Maltese: ViraferonPeg ma għandux jintuża f'pazjenti b'kundizzjoni medika severa, bi problemi severi tal-fwied, b'mard tat-tirojde sakemm dan ma jkunx ikkontrollat, blepilessija jew bi problemi oħrajn tas-sistema nervuża ċentrali.
English: In children and adolescents, the dose is 60 micrograms per square metre body surface area (calculated using the patient's height and weight).
Maltese: Fi tfal u adoloxxenti, id-doża hija 60 mikrogrammi għal kull metru kwadru tal-erja tal-wiċċ tal-ġisem (ikkalkolata permezz tat-tul u l-piż tal-pazjent).
English: The combination of ViraferonPeg with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Maltese: Il-kombinazzjoni ta' ViraferonPeg u ribavirin kienet iktar effikaċi f'pazjenti b'ċirrożi u f'pazjenti infettati bl-HIV.
English: What is the risk associated with ViraferonPeg?
Maltese: X'inhu r-riskju assoċjat ma' ViraferonPeg?
English: Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with ViraferonPeg and ribavirin.
Maltese: Madwar kwart tal-adulti li l-kura preċedenti tagħhom ma kinitx irnexxiet u madwar żewġ terzi tat-tfal u adoloxxenti rrispondew għat-trattament b'ViraferonPeg u ribavarin.
English: In children and adolescents receiving ViraferonPeg in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Maltese: Fi tfal u adoloxxenti li jkunu qiegħdin jirċievu ViraferonPeg ma' ribavirin, l-effetti sekondarji kienu simili għal dawk tal-adulti, għalkemm it-tkabbir imnaqqas deher ukoll f'aktar minn pazjent wieħed minn kull 10.
English: International non-proprietary name (INN): beclomethasone dipropionate
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): beclomethasone dipropionate
English: What is orBec?
Maltese: Kif kien mistenni li jintuża orBec?
English: Ref. EMEA/266786/2008
Maltese: Londra, 30 ta' Mejju 2008 Ref tad-Dok. EMEA/304448/2008
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment idum 210t'ijiem biex jevalwa applikazzjoni ġdida.
English: The applicant presented data on experimental models for beclomethasone dipropionate from the scientific literature.
Maltese: L-applikant ippreżenta dejta fuq mudelli sperimentali għal beclomethasone dipropionate milletteratura xjentifika.
English: On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease.
Maltese: Fit-22 ta' Mejju 2008, DOR BIOPHARMA UK Ltd orBec innotifikat uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li hija tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għat-trattament ta' mard gastrointestinali graft-versus-host disease. orBec ġie kklassifikat bħala prodott mediċinali orfni fit-13 ta' Marzu 2002.
English: orBec is a medicine containing the active substance beclomethasone dipropionate.
Maltese: X'inhu orBec? orBec huwa mediċina li fiha s-sustanza attiva beclomethasone dipropionate.
English: The active substance of orBec, beclomethasone dipropionate, is a corticosteroid that has been used in inhaled, nasal and skin medicines since the 1970s.
Maltese: Is-sustanza attiva ta' orBec, beclomethasone dipropionate, huwa kortikosterojde li ilu jintuża f'mediċini li jittieħdu man-nifs, nażali u tal-ġilda sa mis-sebgħinijiet.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Skond ir-reviżjoni taddokumentazzjoni inizjali, is-CHMP jħejji lista ta' mistoqsijiet f'jum 120, u din tintbagħat lillkumpanija.
English: The effectiveness of orBec was studied in one main study, in which orBec was compared with placebo (a dummy treatment) in 129 patients with gastrointestinal graft-versus-host disease.
Maltese: L-effikaċja ta' orBec ġiet studjata fi studju ewlieni wieħed, li fih, orBec tqabbel mal-plaċebo (trattament finta) f'129 pazjent b'mard gastrointestiali graft-versus-host.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun forniet it-tweġibiet għall-mistoqsijiet, is-CHMP janalizzahom u jista', qabel ma jagħti opinjoni, jistaqsi xi mistoqsijiet oħra fil-jum 180.
English: It was to be available as two separate tablets, to be taken together: one immediate-release tablet (immediate-release means that the tablet has been made to allow the active substance to be released immediately) and one gastro-resistant tablet (gastro-resistant means that the tablet's content passes through the stomach without being broken down until it reaches the intestine).
Maltese: Kellu jiġi bħala żewġ pilloli separati, biex jittieħdu flimkien: pillola b'rilaxx immedjat (rilaxx immedjat ifisser li l-pillola saret b'mod li tħalli lis-sustanza attiva tiġi rilaxxata immedjatament) u pillola gastro-reżistenti (gastroreżistenti tfisser li l-kontenut tal-pillola jgħaddi mill-istonku mingħajr ma jitkisser sa ma jilħaq limsaren).
English: orBec was expected to be used for the treatment of gastrointestinal graft-versus-host disease.
Maltese: Għalxiex kien mistenni li jintuża orBec? orBec kien mistenni li jintuża fit-trattament ta' mardiet gastrointestinali graft-versus-host.
English: It works by dampening down the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cell.
Maltese: Jaħdem billi jnaqqas l-attività tas-sistema immuni (id-difiżi naturali tal-ġisem) billi jeħel ma' riċetturi f'diversi tipi ta' ċelloli immuni.
English: Based on the review of the data and the company's response to the CHMP list of question at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that orBec could not have been approved for the treatment of gastrointestinal graft-versus-host disease.
Maltese: Abbażi tar-reviżjoni tad-dejta u tat-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fi żmien l-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma proviżorja li orBec ma setax jiġi approvat għat-trattament ta' mard gastrointestinali graft-versus-host.
English: Patients with gastrointestinal graft-versus-host disease have damage to the stomach and the intestine, which causes severe inflammation of these organs.
Maltese: Pazjenti b'mard gastrointestinali graft-versus-host ikollhom ħsara fl-istonku u l-imsaren, li tikkawża infjammazzjoni severa ta' dawn l-organi.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with orBec.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kienx hemm konsegwenzi għall-pazjenti li fil-preżent huma inklużi fi provi kliniċi jew fi programmi ta' użu b'kumpassjoni b'orBec.
English: 50018 Scandicci (Firenze), Italy
Maltese: 50018 Scandicci (Firenze), L-Italja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1369/001
Maltese: EU/1/19/1369/001
English: • 100×100 mm sterile gauze
Maltese: • garża sterili 100×100 mm
English: Respiratory and central nervous system (CNS) depression
Maltese: Depressjoni respiratorja u tas-sistema nervuża ċentrali (CNS - central nervous system)
English: • The active substance is buprenorphine.
Maltese: • Is-sustanza attiva hi buprenorphine.
English: Acute alcoholism or delirium tremens
Maltese: Alkoħoliżmu akut jew delirium tremens.
English: Ethylene vinyl acetate copolymer
Maltese: Ethylene vinyl acetate kopolimer
English: Scandicci ITALY
Maltese: Scandicci L-ITALJA
English: Heroin
Maltese: Eroina
English: • 5 mL syringe with 25G×1.5" needle (0.5×38 mm)
Maltese: • siringa ta' 5 mL b'labra b'daqs ta' 25G×1.5" (0.5×38 mm)
English: Weeks 1 to 16
Maltese: Ġimgħat 1 sa 16
English: Buprenorphine is approximately 96% protein bound, primarily to alpha and beta globulin.
Maltese: Buprenorphine huwa bejn wieħed u ieħor 96% marbut mal-proteini, primarjament ma' alpha u beta globulin.
English: L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A. Strada Statale 67
Maltese: Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A.
English: • antiseptic solution, such as chlorhexidine
Maltese: • soluzzjoni antisettika, bħal chlorhexidine
English: • depression, euphoria
Maltese: • depressjoni, ewforja
English: • local anaesthetic, such as 1% lidocaine with adrenaline 1:100,000
Maltese: • anestetiku lokali, bħal 1% lidocaine b'adrenaline 1:100,000
English: Percentage of negative results
Maltese: Persentaġġ ta' riżultati negattivi
English: • sleeplessness, anxiety, hostility, nervousness
Maltese: • nuqqas ta' rqad, ansjetà, ostilità, nervi
English: Study PRO-805 (ITT)
Maltese: Studju PRO-806 (ITT)
English: • two X-plant clamps (vasectomy fixation clamps with 2.5 mm ring diameter)
Maltese: • żewġ X-plant clamps (vasectomy fixation clamps b'ċirku b'dijametru ta' 2.5 mm)
English: CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error
Maltese: CI=interval ta' kunfidenza, ITT=intenzjoni li jiġu ttrattati, N=numru ta' individwi, SE=żball standard
English: Placebo N=55
Maltese: Plaċebo N=55
English: Placebo N=54
Maltese: Plaċebo N=54
English: • nefazodone: a medicine to treat depression
Maltese: • nefazodone: mediċina għat-trattament tad-depressjoni
English: Frequency categories are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • sterile ruler
Maltese: • riga sterili
English: Treatment with Sixmo
Maltese: Trattament b'Sixmo
English: Number (%) of patients with broken implant(s) N=number of patients with data available.
Maltese: Numru (%) ta' impjanti miksura Numru (%) ta' pazjenti b'impjant(i) miksura N=numru ta' pazjenti b'data disponibbli.
English: This endpoint was considered to be of clinical relevance in the targeted indication.
Maltese: Dan il-punt finali kien ikkunsidrat klinikament rilevanti fl-indikazzjoni mmirata.
English: • phenobarbital, carbamazepine, phenytoin: medicines to treat epilepsy and other illnesses
Maltese: • phenobarbital, carbamazepine, phenytoin: mediċini għat-trattament tal-epilessija u mard ieħor
English: • thin adhesive strip around 6 mm wide (butterfly strip)
Maltese: • strixxa rqiqa li teħel wiesa' madwar 6 mm (butterfly strip)
English: TEVA Czech Industries s.r.o.
Maltese: Isem u indirizz tal-manifattur tas-sustanza attiva TEVA Czech Industries s.r.o.
English: In Studies PRO-805 and PRO-806, 62.0% and 39.5% of Sixmo-treated subjects required supplemental SL buprenorphine.
Maltese: Fi Studji PRO-805 u PRO-806, 62.0% u 39.5% tal-individwi ttrattati b'Sixmo kellhom bżonn SL buprenorphine addizzjonali.
English: Patients who have contraindications for MRI.
Maltese: Pazjenti li għandhom kontraindikazzjonijiet għal MRI.
English: L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A, Strada Statale 67,
Maltese: Molteni & C. dei F.lli Alitti Soc.Es.S.
English: Study PRO-806
Maltese: Studju PRO-806
English: Prior to entry into acute studies PRO-805, PRO-806, PRO-810 and TTP-400-02-01, patients were treatment naïve adults, with moderate to severe opioid dependency.
Maltese: PRO-805, PRO-806, PRO-810 u TTP-400-02-01, il-pazjenti kienu adulti li qatt ma ħadu trattament qabel, b'dipendenza fuq l-opjojdi moderata sa severa.
English: Severe respiratory insufficiency
Maltese: Insuffiċjenza respiratorja severa.
English: Implant kit: 4 Sixmo implants with 1 applicator
Maltese: Kit tal-impjant: 4 impjanti ta' Sixmo b'applikatur wieħed
English: NAME OF THE MARKETING AUTHORISATION HOLDER L. Molteni & C. dei F.lli Alitti
Maltese: Molteni & C. dei F.lli Alitti
English: • mosquito forceps
Maltese: • forċipi tat-tip mosquito
English: Clinical efficacy and safety with Sixmo
Maltese: Effikaċja klinika u sigurtà b'Sixmo
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ (mu) and κ (kappa)
Maltese: Buprenorphine huwa agonist parzjali/antagonist tal-opjojdi li jeħel mar-riċetturi μ (mu) u κ (kappa)
English: Patients treated with CYP inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, amiodarone, amprenavir, fosamprenavir, aprepitant, fluconazole, erythromycin and grapefruit juice) should be monitored for signs and symptoms of toxicity or overdose (miosis, lip cyanosis, sedation, bradycardia, hypotension, respiratory depression).
Maltese: Pazjenti ttrattati b'inibituri ta' CYP (eż. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, amiodarone, amprenavir, fosamprenavir, aprepitant, fluconazole, erythromycin u meraq tal-grejpfrut) għandhom jiġu mmonitorjati għal sinjali u sintomi ta' tossiċità jew ta' doża eċċessiva (mijożi, ċjanosi tax-xufftejn, sedazzjoni, bradikardija, pressjoni baxxa, depressjoni respiratorja).
English: • the patient experiences severe or intolerable side effects (including severe precipitated withdrawal);
Maltese: • il-pazjent ikollu effetti sekondarji severi jew intollerabbli (inkluż irtirar sever preċipitat);
English: Study PRO-806 included an open-label comparator arm with sublingual buprenorphine (12 to 16 mg/day).
Maltese: Studju PRO-806 inkluda grupp ta' paragun openlabel b'buprenorphine taħt l-ilsien (12 sa 16-il mg/jum).
English: During clinical pharmacologic studies in opioid-dependent patients, buprenorphine shows ceiling effects on a number of PD and safety parameters.
Maltese: Waqt studji farmakoloġiċi kliniċi f'pazjenti dipendenti fuq l-opojdi, buprenorphine juri effetti ta' limitu massimu fuq numru ta' parametri PD u ta' sigurtà.
English: Grasp the centre of the implant with the X-plant clamp(s) (Figure 17) and apply gentle traction.
Maltese: Aqbad l-impjant min-nofs bl-X-plant clamp (Figura 17) u iġbed bil-mod.
English: In the analysis of the CDF (weeks 1 to 16), a statistically significant difference between treatments (p=0.0361) was seen, which was in favour of Sixmo.
Maltese: Fl-analiżi tas-CDF (ġimgħat 1 sa 16), kienet osservata differenza statistikament sinifikanti bejn ittrattamenti (p=0.0361), li kienet favur Sixmo.
English: Because buprenorphine levels cannot be adjusted during Sixmo treatment, Sixmo is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (sections 4.3, 4.4 and 5.2).
Maltese: Minħabba li l-livelli ta' buprenorphine ma jistgħux jiġu aġġustati waqt trattament b'Sixmo, Sixmo huwa kontraindikat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) (sezzjonijiet 4.3, 4.4 u 5.2).
English: • 4 Sixmo implants
Maltese: • 4 impjanti ta' Sixmo
English: • a history of connective tissue disease such as scleroderma • a history of recurrent methicillin-resistant Staphylococcus aureus infections (MRSA)
Maltese: • storja ta' infezzjonijiet rikorrenti kkawżati minn Staphylococcus aureus reżistenti għal methicillin (MRSA - methicillin-resistant Staphylococcus aureus)
English: Primary opioid of abuse, n (%)
Maltese: Età medjana (firxa), snin Opjojd primarju ta' abbuż, n (%)
English: • surgical marker
Maltese: • markatur kirurġiku
English: Table 2: Patient characteristics in the studies PRO-805 and PRO-806 Study PRO-805
Maltese: Tabella 2: Karatteristiċi tal-pazjent fl-istudji PRO-805 u PRO-806 Studju PRO-805
English: Avoid grapefruit juice to prevent possible side effects.
Maltese: Evita l-meraq tal-grejpfrut biex tevita effetti sekondarji possibbli.
English: This study enrolled 84 patients in the Sixmo group and 89 patients in the sublingual buprenorphine group, with a median age (range) of 36 (21 to 63) years and 37 (22 to 64) years in the Sixmo and sublingual buprenorphine groups, respectively.
Maltese: Dan l-istudju rreġistra 84 pazjent fil-grupp ta' Sixmo u 89 pazjent fil-grupp ta' buprenorphine taħt l-ilsien, b'età medjana (firxa) ta' 36 (21 sa 63) sena u 37 (22 sa 64) sena fil-gruppi ta' Sixmo u buprenorphine taħt l-ilsien, rispettivament.
English: • Opioid antagonists: naltrexone and nalmefene can block the pharmacological effects of buprenorphine.
Maltese: • Antagonisti tal-opjojdi: naltrexone u nalmefene jistgħu jimblukkaw l-effetti farmakoloġiċi ta' buprenorphine.
English: A mass balance study of buprenorphine showed complete recovery of radiolabel in urine (30%) and faeces (69%) collected up to 11 days after dosing.
Maltese: Studju tal-bilanċ tal-massa ta' buprenorphine wera rkupru komplut tar-radjutikketta fl-awrina (30%) u fl-ippurgar (69%) miġbura sa 11-il ġurnata wara d-dożaġġ.
English: MOLTeNI-2019-01 - A prospective, observational (non-interventional), postauthorisation safety cohort study to evaluate the incidence of the breakages and insertion/removal complications of buprenorphine implants (Sixmo) in the routine clinical care
Maltese: MOLTeNI-2019-01 - Studju prospettiv, ta' osservazzjoni (mhux ta' intervent), wara lawtorizzazzjoni dwar is-sigurtà ta' koorti biex jevalwa l-inċidenza ta' ksur u kumplikazzjonijiet waqt it-tqegħid/tneħħija tal-impjanti ta' buprenorphine (Sixmo) waqt kura klinika ta' rutina
English: Sixmo is provided in a carton.
Maltese: Sixmo huwa pprovdut f'kartuna.
English: Sixmo is formulated as a diversion and abuse deterrent formulation.
Maltese: Sixmo huwa fformulat bħala formulazzjoni li tiskoraġixxi devjazzjoni u abbuż.
English: Sixmo 74.2 mg implant buprenorphine
Maltese: Sixmo 74.2 mg impjant buprenorphine