FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean doses per week in Sixmo subjects in PRO-805 and PRO-806 studies were 5.16 mg and 3.16 mg, with relatively low mean days of use per week of 0.45 and 0.31, respectively.
Maltese: PRO-806 kienu 5.16 mg u 3.16 mg, b'medja ta' ġranet ta' użu kull ġimgħa relattivament baxx ta' 0.45 u 0.31, rispettivament.
English: Sixmo with food, drink and alcohol
Maltese: Sixmo ma' ikel, xorb u alkoħol
English: Study PRO-806 had two co-primary endpoints, which were the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups (coprimary 1), and the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups, with imputation based on illicit drug self-report data (co-primary 2).
Maltese: Studju PRO-806 kellu żewġ punti finali ko-primarji, li kienu s-CDF tal-persentaġġ ta' kampjuni tal awrina li kienu negattivi għall-opjojdi illeċiti għal Ġimgħat 1 sa 24 fil-gruppi ta' Sixmo u plaċebo (koprimarju 1), u s-CDF tal-persentaġġ ta' kampjuni tal-awrina li kienu negattivi għall-opjojdi illeċiti għal Ġimgħat 1 sa 24 fil-gruppi ta' Sixmo u tal-plaċebo, b'inputazzjoni bbażata fuq data ta' droga illeċita rrappurtata mill-pazjent innifsu (ko-primarju 2).
English: • verapamil, diltiazem, amiodarone: medicines to treat high blood pressure and heart disorders
Maltese: • verapamil, diltiazem, amiodarone: mediċini għat-trattament ta' pressjoni għolja u disturbi tal qalb
English: CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error In the analysis of the CDF (co-primary endpoint 1), a statistically significant difference between treatments (p<0.0001) was seen, which was in favour of Sixmo.
Maltese: Fl-analiżi tas-CDF (punt finali ko-primarju 1), kienet osservata differenza statistikament sinifikanti bejn it-trattamenti (p < 0.0001), li kienet favur Sixmo.
English: sublingual buprenorphine N=119
Maltese: Buprenorphine taħt l-ilsien N=119
English: Sixmo contains the active substance buprenorphine, which is a type of opioid medicine.
Maltese: Sixmo fih is-sustanza attiva buprenorphine, li hija tip ta' mediċina opjojda.
English: The Sixmo PK was assessed in opioid-dependent patients treated with Sixmo in studies TTP-400-0201, PRO-810, PRO-805, PRO-806, PRO-807 and PRO-811.
Maltese: TTP-400-02-01, PRO-810, PRO-805, PRO-806, PRO-807 u PRO-811.
English: • certain medicines to treat depression or Parkinson's disease, called monoamine oxidase inhibitors, such as phenelzine, isocarboxazid, iproniazid and tranylcypromine
Maltese: monoamine oxidase, bħal phenelzine, isocarboxazid, iproniazid u tranylcypromine
English: In faeces, almost all of the buprenorphine and norbuprenorphine were free (buprenorphine: 33% free and 5% conjugated; norbuprenorphine: 21% free and 2% conjugated).
Maltese: 33% ħieles u 5% konjugat; norbuprenorphine: 21% ħieles u 2% konjugat).
English: Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Maltese: Kull impjant fih buprenorphine hydrochloride ekwivalenti għal 74.2 mg ta' buprenorphine.
English: • Keep this leaflet.
Maltese: opjojdi oħra.
English: • reduced adrenal gland function, such as Addison's disease
Maltese: • funzjoni tal-glandola adrenali mnaqqsa, bħall-marda ta' Addison
English: Buprenorphine has a mean elimination half-life from plasma ranging from 24 to 48 hours.
Maltese: Buprenorphine għandu half-life medja tal-eliminazzjoni mill-plażma li tvarja minn 24 sa 48 siegħa.
English: Figure 17
Maltese: Figura 17
English: White/Off-white to pale yellow, rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Maltese: Impjant Impjant abjad/abjad jagħti fil-griż sa isfar ċar, forma ta' virga, twil 26.5 mm u b'dijametru ta' 2.4 mm.
English: A key secondary endpoint in Study PRO-806 was the difference in proportions of urine samples that were negative for opioids over 24 weeks for Sixmo versus sublingual buprenorphine.
Maltese: Punt finali sekondarju ewlieni fl-Istudju PRO-806 kien id-differenza fil-proporzjonijiet tal-kampjuni tal-awrina li kienu negattivi għall-opjojdi matul 24 ġimgħa għal Sixmo kontra buprenorphine taħt l ilsien.
English: • restlessness, excitement, excitability, abnormal thoughts
Maltese: • nuqqas ta' kwiet, eċitament, eċċitabilità, ħsibijiet mhux normali
English: Renal elimination may be prolonged since 30% of the administered dose is eliminated by the renal route.
Maltese: L-eliminazzjoni mill-kliewi tista' tkun imtawwla peress li 30% tad-doża mogħtija hija eliminata permezz tal-kliewi.
English: Figure 14
Maltese: Figura 14
English: The formation of norbuprenorphine was initially found to be performed by CYP3A4; subsequent studies also demonstrated the involvement of CYP2C8.
Maltese: Il-formazzjoni ta' norbuprenorphine fil-bidu nstabet li kienet qed issir minn CYP3A4; studji sussegwenti wrew ukoll l-involviment ta' CYP2C8.
English: • naltrexone, nalmefene, used to treat addiction They can block the effects of buprenorphine.
Maltese: • naltrexone, nalmefene, użati għat-trattament ta' dipendenza Jistgħu jimblukkaw l-effetti ta' buprenorphine.
English: Overdose symptoms include:
Maltese: Sintomi ta' doża eċċessiva jinkludu:
English: The safety and efficacy of Sixmo was investigated in 3 double-blind Phase 3 clinical studies in which a total of 309 patients were treated with Sixmo for up to 6 months (1 implant cycle).
Maltese: Is-sigurtà u l-effikaċja ta' Sixmo kienu investigati fi 3 studji kliniċi double-blind ta' Fażi 3 li fihom total ta' 309 pazjenti kienu ttrattati b'Sixmo għal perjodu sa 6 xhur (ċiklu ta' impjant wieħed).
English: When a hepatic event is suspected, liver function evaluation is required, including consideration whether to discontinue treatment with Sixmo.
Maltese: Meta jkun hemm suspett ta' avveniment epatiku, hija meħtieġa evalwazzjoni tal-funzjoni tal-fwied, inkluża konsiderazzjoni jekk għandux jitwaqqaf it-trattament b'Sixmo.
English: ITT=intent-to-treat, SL BPN = sublingual buprenorphine Buprenorphine was not included in urine toxicology assessments.
Maltese: ITT= intenzjoni li jiġu ttrattati, SL BPN = buprenorphine taħt l-ilsien Buprenorphine ma kienx inkluż fil-valutazzjonijiet tat-tossikoloġija tal-awrina.
English: 747 70 Opava, Komarov CZECH REPUBLIC
Maltese: Opava, Komarov
English: Note: Do not push the obturator.
Maltese: Nota: Timbuttax l-obturator.
English: Sixmo is a white/off-white to pale yellow rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Maltese: Sixmo huwa impjant abjad/abjad jagħti fil-griż sa isfar ċar, forma ta' virga, twil 26.5 mm u b'dijametru ta' 2.4 mm.
English: • reduced consciousness
Maltese: • koxjenza mnaqqsa
English: Nevertheless, it is possible to extract the buprenorphine from the Sixmo implant.
Maltese: Madankollu, huwa possibbli li buprenorphine jiġi estratt mill-impjant Sixmo.
English: Sixmo was shown to be noninferior to sublingual buprenorphine, the proportion of responders being 87.6% in the sublingual buprenorphine and 96.4% in the Sixmo group.
Maltese: Sixmo intwera li mhux inferjuri għal buprenorphine taħt l-ilsien, il-proporzjon ta' pazjenti li rrispondew kien ta' 87.6% fil-grupp ta' buprenorphine taħt l-ilsien u 96.4% fil-grupp ta' Sixmo.
English: • pressure bandage around 8 cm wide
Maltese: • pressure bandage wiesa' madwar 8 ċm
English: If the implants cannot be located, the doctor may use ultrasound or a type of scan called magnetic resonance imaging (MRI).
Maltese: reżonanza manjetika (MRI - magnetic resonance imaging).
English: • latex, talc-free, sterile gloves
Maltese: • ingwanti sterili tal-latex, mingħajr talkum
English: CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.
Maltese: Inibituri ta' CYP3A4 jistgħu jinibixxu l-metaboliżmu ta' buprenorphine u jwasslu għal żieda tas-Cmax u l-AUC ta' buprenorphine u norbuprenorphine.
English: Co-administration during buprenorphine treatment is contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3).
Maltese: Għoti waqt trattament b'buprenorphine huwa kontraindikat minħabba l interazzjoni potenzjalment perikoluża li tista' tippreċipita bidu f'daqqa ta' sintomi ta' rtirar tal opjojdi mtawla u intensi (ara sezzjoni 4.3).
English: The CDF results for co-primary endpoint 2 were fundamentally the same as for endpoint 1 (p < 0.0001).
Maltese: Ir-riżultati tas-CDF għall-punt finali ko-primarju 2 kienu fundamentalment l-istess bħal dawk għallpunt finali 1 (p < 0.0001).
English: Figure 3: Plasma buprenorphine concentrations after insertion of Sixmo (concentrations up to day 28 are based on study PRO-810, while concentrations after day 28 are based on studies PRO-805, PRO-806, PRO-807 and PRO-811)
Maltese: Figura 3: Konċentrazzjonijiet ta' buprenorphine fil-plażma wara t-tqegħid ta' Sixmo (konċentrazzjonijiet sa jum 28 huma bbażati fuq studju PRO-810, filwaqt li konċentrazzjonijiet wara jum 28 huma bbażati fuq studji PRO-805, PRO-806,
English: • increased level of a liver enzyme, alanine aminotransferase, in blood tests
Maltese: • livell miżjud ta' enzima tal-fwied, alanine aminotransferase, fit-testijiet tad-demm
English: Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Maltese: Sixmo huwa indikat għal trattament ta' sostituzzjoni għal dipendenza fuq opjojdi f'pazjenti adulti klinikament stabbli li jeħtieġu mhux aktar minn 8 mg/jum ta' buprenorphine taħt l-ilsien, f'qafas ta' trattament mediku, soċjali u psikoloġiku.
English: • reactions at the implant site infection, including wound infection rash, scaring reduced healing swollen area containing pus
Maltese: • reazzjonijiet fis-sit tal-impjant infezzjoni, inkluża infezzjoni tal-ferita raxx, ċikatriċi fejqan imnaqqas żona minfuħa li fiha l-materja
English: Two additional randomised, double-blind, placebo-controlled Phase 3 studies provide supportive data on efficacy and PK (Studies PRO-805 and PRO-806).
Maltese: Żewġ studji addizzjonali randomised, double blind, ikkontrollati bil-plaċebo ta' Fażi 3 jipprovdu data ta' appoġġ dwar l-effikaċja u l-PK (Studji PRO-805 u PRO-806).
English: • Monoamine oxidase inhibitors (MAOI): Possible exacerbation of the effects of opioids, based on experience with morphine.
Maltese: • Inibituri ta' monoamine oxidase (MAOI - monoamine oxidase inhibitors):
English: • Adson single tooth tissue forceps
Maltese: • forċipi Adson tat-tessut b'sinna waħda
English: • Other CNS depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase CNS depression.
Maltese: Derivattivi ta' opjojdi oħrajn (eż. methadone, analġeżiċi u sustanzi għas-sogħla), ċerti antidepressanti, antagonisti sedattivi tar-riċettur H1, barbiturati, ansjolitiċi minbarra benzodiazepines, newrolettiċi, clonidine u sustanzi relatati: dawn il-kombinazzjonijiet iżidu d-depressjoni tas-CNS.
English: Reproductive system and breast disorders uncommon dysmenorrhoea, erectile dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider mhux komuni menstrwazzjoni bl-uġigħ, disfunzjoni erettili
English: • sutures, such as 4-0 Prolene™ with an FS-2 cutting needle (may be absorbable)
Maltese: • suturi, eżempju 4-0 Prolene™ b'labra FS-2 biex taqta' (jistgħu jkun tat-tip li jiġu assorbiti)
English: • rash, rash pustular, skin lesion
Maltese: • raxx, raxx bil-ponot, leżjoni fil-ġilda
English: • dizziness, drowsiness
Maltese: • deidratazzjoni, żieda fl-aptit
English: Implant site related adverse reactions with the current (and commercially used) insertion and removal techniques were reported in 25.9% and 14.1% of patients in the double-blind and extension studies, respectively.
Maltese: Reazzjonijiet avversi relatati mas-sit tal-impjant bit-tekniki ta' tqegħid u tneħħija attwali (u użati b'mod kummerċjali) kienu rrappurtati f'25.9% u 14.
English: Anaesthetise the insertion area at the incision site and just under the skin, along the planned insertion channels, by injecting 5 mL lidocaine 1% with adrenaline 1:100,000.
Maltese: Anestetizza l-erja fejn se jitqiegħed fis-sit tal-inċiżjoni, eżatt taħt il-ġilda, tul il-kanali ppjanati fejn se jitqiegħed, billi tinjetta 5 mL lidocaine 1% b'adrenaline 1:100,000.
English: Generally, other buprenorphine treatments/formulations are considered more appropriate in this situation.
Maltese: Ġeneralment, trattamenti/formulazzjonijiet oħra ta' buprenorphine huma kkunsidrati aktar xierqa f'din is sitwazzjoni.
English: Almost all of the dose was accounted for in terms of buprenorphine, norbuprenorphine, and two unidentified buprenorphine metabolites.
Maltese: buprenorphine, norbuprenorphine, u żewġ metaboliti ta' buprenorphine mhux identifikati.
English: The safety of Sixmo was evaluated in five Phase 3 studies (3 double-blind and placebo and/or activecontrolled studies, and two open-label extension studies).
Maltese: Is-sigurtà ta' Sixmo kienet evalwata f'ħames studji ta' Fażi 3 (3 studji double-blind u kkontrollati bilplaċebo u/jew b'sustanza attiva, u żewġ studji ta' estensjoni open-label).
English: • fatigue, chills, weakness, increased muscle tone
Maltese: • għeja, sirdat, dgħjufija, żieda fit-ton tal-muskoli
English: Figure 1: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-16, Study PRO-805 (ITT)
Maltese: Negattivi għall-Opjojdi f'Ġimgħat 1-16, Studju PRO-805 (ITT)
English: Psychiatric disorders common insomnia, anxiety, hostility**, nervousness**, paranoia** uncommon depression, libido decreased, sleep disorder, apathy, euphoric mood, orgasmic sensation decreased, restlessness, irritability, drug dependence***, agitation***, thinking abnormal***
Maltese: mhux komuni depressjoni, tnaqqis fil-libido, disturb fl-irqad, apatija, burdata ewforika, tnaqqis tas-sensazzjoni orgażmika, nuqqas ta' kwiet, irritabilità, dipendenza fuq id-droga***, aġitazzjoni***, ħsiebijiet mhux normali***
English: Precipitation of opioid withdrawal syndrome
Maltese: Preċipitazzjoni tas-sindrome ta' irtirar tal-opjojdi
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.2 and 5.2).
Maltese: Kawtela hija rakkomandata meta tingħata doża lill-pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-krejatinina < 30 mL/min) (ara sezzjonijiet 4.2 u 5.2).
English: Retention in treatment was high in the Sixmo groups, with 65.7% and 64.0% of patients completing studies PRO-805 and PRO-806, respectively.
Maltese: Iż-żamma fuq it-trattament kienet għolja fil-gruppi ta' Sixmo, b'65.7% u 64.0% tal-pazjenti li temmew l-istudji PRO-805 u PRO-806, rispettivament.
English: Buprenorphine undergoes N-dealkylation to its major pharmacologically active metabolite norbuprenorphine and subsequent glucuronidation.
Maltese: Buprenorphine jgħaddi minn N-dealkylation għall-metabolit farmakoloġikament attiv ewlieni tiegħu norbuprenorphine u glucuronidation sussegwenti.
English: Table 1: Adverse reactions reported in clinical studies and from post-marketing data with Sixmo and/or reported with other buprenorphine product System organ class
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati fi studji kliniċi u minn data ta' wara t-tqegħid fis suq b'Sixmo u/jew irrappurtati bi prodott ieħor li fih buprenorphine Klassi tas-sistemi u talorgani
English: • consistency in participation in recommended behavioural therapy/peer support programme
Maltese: • konsistenza fil-parteċipazzjoni fil-programm rakkomandat ta' terapija ta' mġiba/appoġġ ta'
English: The MAH shall ensure that in each MS where SIXMO is marketed, all physicians expected to insert / remove SIXMO subcutaneous (SC) implant are provided with an educational programme, aiming at preventing / minimising the important identified risk of implant protrusion / (spontaneous) expulsion, the important potential risks of damage to nerves or blood vessels during insertion / removal procedure, (dislocation and) migration / missing (partial) implant.
Maltese: L-MAH għandu jiżgura li f'kull MS fejn jinbiegħ SIXMO, it-tobba kollha li mistennija jqiegħdu/jneħħu l-impjant ta' SIXMO taħt il-ġilda (SC - subcutaneous) jiġu pprovduti bi programm edukattiv, bil-għan li jiġu evitati/minimizzati ir-riskju importanti identifikat ta' tqabbiż 'il barra/ ħruġ (spontanju) tal-impjant, ir-riskji potenzjali importanti ta' ħsara fin-nervituri jew fil-kanali tad-demm waqt il-proċedura tat-tqegħid/ tneħħija, (qlugħ minn postu u) migrazzjoni tal-impjant/ impjant nieqes (parzjalment nieqes).
English: • consistency in compliance with clinic visit requirements
Maltese: • konsistenza fil-konformità mar-rekwiżiti ta' żjara fil-klinika
English: • Similarly, inducers of CYP3A4 (e.g. phenobarbital, carbamazepine, phenytoin, rifampin) may have the potential to reduce buprenorphine plasma concentrations because of increased metabolism of buprenorphine to norbuprenorphine.
Maltese: (eż. phenobarbital, carbamazepine, phenytoin, rifampin) jista' jkollhom il-potenzjal li jnaqqsu l-konċentrazzjonijiet ta' buprenorphine fil-plażma minħabba żieda fil-metaboliżmu ta' buprenorphine għal norbuprenorphine.
English: • CYP3A4 inhibitors and inducers: Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when Sixmo is given concurrently with medicinal products that affect CYP3A4 activity.
Maltese: Buprenorphine huwa metabolizzat għal norbuprenorphine primarjament permezz ta' CYP3A4; għalhekk, jistgħu jseħħu interazzjonijiet potenzjali meta Sixmo jingħata flimkien ma' prodotti mediċinali li jaffettwaw l-attività ta' CYP3A4.
English: • iris scissors
Maltese: • imqass tat-tip iris
English: Follow steps 6 through 9 for the insertion of the three remaining implants through the same incision.
Maltese: Segwi passi 6 sa 9 biex jitiegħdu t-tliet impjanti li fadal mill-istess inċiżjoni.
English: There are no or limited data on effects of buprenorphine on human fertility (see section 5.3).
Maltese: M'hemmx data jew hemm data limitata dwar l-effetti ta' buprenorphine fuq il-fertilità tal-bniedem (ara sezzjoni 5.3).
English: In urine, most of the buprenorphine and norbuprenorphine was conjugated (buprenorphine: 1% free and 9.4% conjugated; norbuprenorphine: 2.7% free and 11% conjugated).
Maltese: il-biċċa l-kbira ta' buprenorphine u norbuprenorphine kienu konjugati (buprenorphine: 1% ħieles u 9.4% konjugat; norbuprenorphine:
English: • changes in blood levels increased enzyme levels: aspartate aminotransferase, gamma-glutamyltransferase, blood lactate dehydrogenase, lipase, amylase decreased enzyme levels: alkaline phosphatase increased bicarbonate level increased bilirubin level - a yellow breakdown substance of the blood pigment increased glucose level decreased cholesterol level decreased haematocrit - the percentage of blood cells on the blood volume decreased haemoglobin - the red blood cell pigment, increased mean cell haemoglobin increase in certain white blood cell count: monocyte, neutrophils decreased cell count: platelets, red blood cells, lymphocytes
Maltese: • tibdil fil-livelli tad-demm żieda fil-livelli ta' enzimi: aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase fid-demm, lipase, amylase tnaqqis fil-livell ta' enzima: alkaline phosphatase żieda fil-livell ta' bicarbonate żieda fil-livell tal-bilirubina - sustanza safra tat-tifrik tal-pigment tad-demm żieda fil-livell tal-glucose tnaqqis fil-livell tal-kolesterol tnaqqis fl-ematokrit - il-persentaġġ ta' ċelluli tad-demm fil-volum tad-demm tnaqqis fl-emoglobina - il-pigment taċ-ċelluli ħomor tad-demm, żieda fl-emoglobina medja taċ-ċelluli żieda fl-għadd ta' ċerti ċelluli bojod tad-demm: monoċiti, newtrofili
English: • medicines to treat HIV infections with active substance names ending in “navir”, such as ritonavir, nelfinavir, amprenavir, fosamprenavir
Maltese: • mediċini għat-trattament ta' infezzjonijiet bl-HIV bl-ismijiet tas-sustanzi attivi jispiċċaw b'“navir”, bħal ritonavir, nelfinavir, amprenavir, fosamprenavir
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant
Maltese: Sixmo 74.2 mg impjant
English: Vascular disorders common hot flush, vasodilatation**, hypertension**
Maltese: Disturbi vaskulari komuni fwawar, vażodilatazzjoni**, pressjoni għolja**
English: • If it is not possible to palpate the remaining implant, an ultrasound or MRI should be performed per techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Maltese: • Jekk ma jkunx possibbli li l-impjant li jifdal jinħass, għandu jitwettaq ultrasound jew MRI skont it-tekniki deskritti fis-sezzjoni 4.2 taħt “Istruzzjonijiet għat-tneħħija ta' Sixmo”.
English: Patients receiving Sixmo should be closely monitored for signs of toxicity if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole and itraconazole, or macrolide antibiotics).
Maltese: (eż. inibituri ta' protease bħal ritonavir, nelfinavir jew indinavir, jew antifungali azole bħal ketoconazole u itraconazole, jew antibijotiċi macrolide).
English: In clinical studies and from post-marketing data 7 cases of clinically relevant implant breakage (breakage associated with an adverse reaction) were observed.
Maltese: Fi studji kliniċi u minn data ta' wara t-tqegħid fis-suq ġew osservati 7 każijiet ta' ksur klinikament rilevanti tal-impjant (ksur assoċjat ma' reazzjoni avversa).
English: Investigations common alanine aminotransferase increased uncommon aspartate aminotransferase increased, weight decreased, blood lactate dehydrogenase increased, gamma-glutamyl-transferase increased, weight increased, blood alkaline phosphatase decreased, amylase increased, blood bicarbonate increased, blood bilirubin increased, blood cholesterol decreased, blood glucose increased, haematocrit decreased, haemoglobin decreased, lipase increased, lymphocyte count decreased, mean cell haemoglobin increased, mean cell volume abnormal, monocyte count increased, neutrophil count increased, platelet count decreased, red blood cell count decreased
Maltese: Investigazzjonijiet komuni żieda ta' alanine aminotransferase mhux komuni żieda ta' aspartate aminotransferase, tnaqqis filpiż, żieda ta' lactate dehydrogenase fid-demm, żieda ta' gamma-glutamyl-transferase, żieda filpiż, tnaqqis ta' alkaline phosphatase fid-demm, żieda ta' amylase, żieda ta' bicarbonate fiddemm, żieda ta' bilirubina fid-demm, tnaqqis ta' kolesterol fid-demm, żieda ta' glucose fid-demm, tnaqqis ta' ematokrit, tnaqqis fl-emoglobina,
English: In this analysis, the percentage of opioid negative urines in the sublingual buprenorphine group was very similar to the results in the Sixmo group (33% versus 31%), and non-inferiority of Sixmo to sublingual buprenorphine was shown.
Maltese: F'din l-analiżi, il-persentaġġ ta' awrina negattiva għall-opjojdi fil-grupp ta' buprenorphine taħt l-ilsien kien simili ħafna għar-riżultati fil-grupp ta' Sixmo (33% kontra 31%), u ntwera li ma kienx hemm inferjorità ta' Sixmo għal buprenorphine taħt l ilsien.
English: In study PRO-805, the primary endpoint was the CDF of the percentage of urine samples that were negative for illicit opioids over weeks 1 to 16, while the CDF over weeks 17 to 24 was evaluated as secondary endpoint.
Maltese: Fi studju PRO-805, il-punt finali primarju kien is-CDF tal-persentaġġ ta' kampjuni tal-awrina li kienu negattivi għall-opjojdi illeċiti matul ġimgħat waħda sa 16, filwaqt li s-CDF matul ġimgħat 17 sa 24 kienet evalwata bħala punt finali sekondarju.
English: Mark the channel tracks where each implant will be inserted by drawing 4 lines - with each line 40 mm long.
Maltese: Immarka l-linji tal-kanali fejn se jiddaħħal kull impjant billi tpinġi 4 linji - b'kull linja twila 40 mm.
English: PC:
Maltese: Eċċipjent: