FrancophonIA/ELRC3.0 huggingface dataset:
English: Apply liquid adhesive to the skin margins and allow to dry before closing the incision with the thin adhesive strip around 6 mm wide (butterfly strip).
Maltese: Applika kolla likwida mal-marġini tal-ġilda u ħalliha tinxef qabel ma tagħlaq l-inċiżjoni bi strixxa rqiqa li teħel wiesa' madwar 6 mm (butterfly strip).
English: Apply a pressure bandage with sterile gauze to minimize bruising.
Maltese: Applika pressure bandage b'garża sterili biex timminimizza t-tbenġil.
English: Mean steady-state plasma buprenorphine concentrations were consistent across all clinical studies, at approximately 0.5 to 1 ng/mL (with the 4-implant dose), and were maintained for approximately 20 weeks (week 4 through week 24) in a 24-week treatment period.
Maltese: Ilkonċentrazzjonijiet medji fi stat fiss ta' buprenorphine fil-plażma kienu konsistenti fl-istudji kliniċi kollha, f'bejn wieħed u ieħor 0.5 sa 1 ng/mL (bid-doża ta' 4 impjanti), u nżammu għal madwar 20 ġimgħa (ġimgħa 4 sa ġimgħat 24) f'perjodu ta' trattament ta' 24 ġimgħa.
English: Cardiac disorders common palpitations** uncommon atrial flutter, bradycardia
Maltese: mhux komuni tferfir mgħaġġel tal-atriju, bradikardija
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.4 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 4.4 u 5.2)
English: The mortality index was significantly increased in the buprenorphine groups.
Maltese: L-indiċi tal-mortalità żdied b'mod sinifikanti fil-gruppi ta' buprenorphine.
English: These adverse reactions are presented by MedDRA system organ class, preferred term, and frequency.
Maltese: Dawn ir-reazzjonijiet avversi huma ppreżentati skont il-klassi tas-sistemi u tal-organi ta' MedDRA, itterminu ppreferut, u l-frekwenza.
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant (buprenorphine)
Maltese: Sixmo 74.2 mg impjant (buprenorphine)
English: The implant time was 24 weeks.
Maltese: Iż żmien bl-impjant kien ta' 24 ġimgħa.
English: Apply the sterile fenestrated drape to the patient's arm (Figure 4).
Maltese: Applika d-drapp sterili ffenestrat fuq id-driegħ tal-pazjent (Figura 4).
English: In each of the two studies, the proportion of subjects requiring supplemental SL BPN was significantly higher in the placebo group than in the Sixmo group (90.9% and 66.7% of subjects, with mean days of use per week of 2.17 and 1.27, in PRO-805 and PRO-806, respectively).
Maltese: (90.9% u 66.7% ta' individwi, b'medja ta' ġranet ta' użu kull ġimgħa ta' 2.17 u 1.27, fi PRO-805 u
English: Musculoskeletal and connective disorders common bone pain**, myalgia** uncommon muscle spasms, limb discomfort, musculoskeletal pain, neck pain, pain in extremity, temporomandibular joint syndrome, arthralgia*** Renal and urinary disorders uncommon urinary hesitation, micturition urgency, pollakisuria
Maltese: mhux komuni spażmi fil-muskoli, skumdità fir-riġlejn, uġigħ muskolu-skeletriku, uġigħ fl-għonq, uġigħ fl estremitajiet, sindrome tal-ġogi temporomandibulari, artralġja***
English: Buprenorphine may reduce the ability to drive and use machines; especially during the first 24 to 48 hours up to one week following implant insertion.
Maltese: Buprenorphine jista' jnaqqas il-ħila biex issuq u tħaddem magni; speċjalment matul l-ewwel 24 sa 48 siegħa u sa ġimgħa wara t-tqegħid tal-impjant.
English: Clean the removal site with an antiseptic solution, such as chlorhexidine.
Maltese: Naddaf is-sit mnejn se jitneħħa b'soluzzjoni antisettika, bħal chlorhexidine.
English: Pharmacotherapeutic group: Other nervous system drugs, Drugs used in opioid dependence, ATC code: N07BC01
Maltese: Mediċini oħra li jaħdmu fuq is-sistema nervuża, Mediċini użati f'każ ta' dipendenza fuq l-opjojdi, Kodiċi ATC:
English: Patients with mild to moderate hepatic impairment should be monitored for signs and symptoms of toxicity, or overdose caused by increased levels of buprenorphine (see section 4.2).
Maltese: Pazjenti b'indeboliment ħafif sa moderat tal-fwied għandhom jiġu mmonitorjati għal sinjali u sintomi ta' tossiċità, jew doża eċċessiva kkawżati minn livelli miżjuda ta' buprenorphine (ara sezzjoni 4.2).
English: Each Sixmo implant is packaged individually into a PET/LDPE/Alu/LDPE-peelable foil laminate sachet.
Maltese: Kull impjant ta' Sixmo huwa ppakkjat individwalment f'qartas tal-fojl laminat li jista' jitqaxxar talPET/LDPE/Alu/LDPE.
English: • fainting
Maltese: • treddigħ
English: Of these 309 patients, 107 patients were treated for an additional 6 months in extension studies (i.e. for 2 implant cycles).
Maltese: Minn dawn it-309 pazjenti, 107 pazjent kienu ttrattati għal 6 xhur oħra fi studji ta' estensjoni (jiġifieri għal 2 ċikli ta' impjant).
English: Retention in treatment was high, with 96.4% of Sixmo patients and 94.4% of sublingual buprenorphine patients completing the study.
Maltese: Iż-żamma fuq it-trattament kienet għolja, b'96.4% tal pazjenti fuq Sixmo u 94.4% tal-pazjenti fuq buprenorphine taħt l-ilsien li lestew l-istudju.
English: A standard battery of genotoxicity tests conducted on extracts of Sixmo and ethylene vinyl acetate (EVA) placebo implants was negative.
Maltese: Sensiela standard ta' testijiet dwar l-effett tossiku fuq il-ġeni mwettqa fuq estratti ta' Sixmo u impjanti plaċebo ta' ethylene vinyl acetate (EVA) kienu negattivi.
English: Sixmo is contraindicated in patients with severe hepatic impairment.
Maltese: Sixmo huwa kontraindikat f'pazjenti b'indeboliment sever tal-fwied.
English: • cellulitis, skin infection, boil
Maltese: • ċellulite, infezzjoni tal-ġilda, musmar
English: • abnormal function of the bile duct
Maltese: • funzjoni mhux normali tal-kanal tal-bili
English: The efficacy and safety of buprenorphine in elderly patients > 65 years has not been established.
Maltese: L-effikaċja u s-sigurtà ta' buprenorphine f'pazjenti anzjani ta' > 65 sena ma ġewx determinati.
English: Healthcare professionals should consider the potential role and contribution of buprenorphine when given in conjunction with other CNS depressant medicinal products, CYP3A4 inhibitors, other opioids and in cases of hepatic impairment when determining whether the implants should be removed (see sections 4.4 and 4.5).
Maltese: buprenorphine meta jingħata flimkien ma' prodotti mediċinali oħra b'effett depressiv fuq is-CNS, inibituri ta' CYP3A4, opjojdi oħra u f'każijiet ta' indeboliment tal-fwied meta wieħed ikun qed jiddetermina jekk l-impjanti għandhomx jitneħħew (ara sezzjonijiet 4.4 u 4.5).
English: • painful period, erectile dysfunction
Maltese: • menstrwazzjoni bl-uġigħ, disfunzjoni erettili
English: • 1 implant applicator
Maltese: • applikatur tal-impjant wieħed
English: Please note: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
Maltese: Buprenorphine jista' jikkawża depressjoni respiratorja severa, possibilment fatali fit-tfal li huma esposti għalih b'mod aċċidentali.
English: • participation in a structured activity/job
Maltese: • parteċipazzjoni f'attività/xogħol strutturat
English: Both buprenorphine and norbuprenorphine can further undergo glucuronidation by UDPglucuronosyltransferases.
Maltese: UDP-glucuronosyltransferases.
English: • breathing depression, yawning
Maltese: mhux komuni depressjoni respiratorja, titwib
English: Mean (SE)
Maltese: sinkope**
English: • decreased sexual desire, decreased orgasmic sensation
Maltese: • xewqa sesswali mnaqqsa, sensazzjoni orgażmika mnaqqsa
English: • pregnancy
Maltese: • tqala
English: It has a relatively wide therapeutic window as a consequence of its partial agonist/antagonist properties, which attenuates suppression of cardiovascular and respiratory function.
Maltese: Huwa għandu tieqa terapewtika relattivament wiesgħa bħala konsegwenza tal-kwalitajiet tiegħu ta' parzjali/antagonist, li jtaffi s soppressjoni tal-funzjoni kardjovaskulari u respiratorja.
English: EXP
Maltese: SL BPN
English: After Sixmo implant insertion, an initial buprenorphine peak was observed and the median Tmax occurred at 12 hours after insertion.
Maltese: Wara t-tqegħid tal-impjant Sixmo, ġie osservat l-ogħla livell inizjali ta' buprenorphine u Tmax medjan seħħ 12-il siegħa wara t-tqegħid.
English: After determining that anaesthesia is adequate and effective, make a shallow incision 2.5 to 3 mm in length at incision site marking.
Maltese: Wara li jiġi determinat li l-anestesija hija adegwata u effettiva, għamel inċiżjoni mhux fonda twila 2.5 sa 3 mm fuq il-marki tas-sit tal-inċiżjoni.
English: General disorders and administration site conditions common fatigue, chills, asthenia, pain, implant site haematoma*, implant site pain*, implant site pruritus*, implant site haemorrhage*, implant site erythema*, implant site scar*, chest pain**, malaise***, drug withdrawal syndrome*** uncommon oedema peripheral, discomfort, face oedema, feeling cold, pyrexia, swelling, implant site oedema*, implant site reaction*, device expulsion*, impaired healing*, implant site
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata komuni għeja, sirdat, astenja, uġigħ, ematoma fis-sit tal impjant*, uġigħ fis-sit tal-impjant*, ħakk fis-sit tal-impjant *, emorraġija fis-sit tal-impjant*, eritema fis-sit tal-impjant*, ċikatriċi fis-sit talimpjant*, uġigħ fis-sider**, telqa***, sindrome ta' rtirar tal-mediċina***
English: vomiting, tachycardia, hypertension, piloerection, dilated pupils;
Maltese: sedazzjoni, bradikardija, pressjoni baxxa, depressjoni respiratorja);
English: Treatment of acute pain during Sixmo therapy
Maltese: Trattament ta' uġigħ akut waqt terapija b'Sixmo
English: The safety and efficacy of Sixmo in children under 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Sixmo fit-tfal b'età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Suitable methods for location include ultrasound with a high frequency linear array transducer (10 MHz or greater) or, in case ultrasound is not successful, magnetic resonance imaging (MRI).
Maltese: Metodi xierqa biex jiġu lokalizzati jinkludu ultrasound b'linear array transducer ta' frekwenza għolja (10
English: • infection, such as viral infection (e.g. flu)
Maltese: • infezzjoni, bħal infezzjoni kkawżata minn virus (eż. influwenza)
English: Figure 2: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-24 (co-primary endpoint 1), Study PRO-806 (ITT Population)
Maltese: (punt finali ko-primarju 1), Studju PRO-806 (Popolazzjoni ITT)
English: The healthcare professional should review the patient's treatment history for concomitant use of CYP3A4 inhibitors prior to initiating Sixmo treatment to determine suitability (see section 4.5).
Maltese: Il-professjonist tal-kura tas-saħħa għandu janalizza l-istorja tat-trattament talpazjent għall-użu fl-istess waqt ta' inibituri ta' CYP3A4 qabel ma jibda t-trattament b'Sixmo biex jiġi determinat kemm huwiex adattat (ara sezzjoni 4.5).
English: Step 14: Put on sterile gloves.
Maltese: Kull doża tikkonsisti f'4 impjanti.
English: • breast-feeding
Maltese: Indeboliment tal-fwied
English: • the patient experiences lack of efficacy, as evidenced by lasting withdrawal symptoms that require repeated management with sublingual buprenorphine
Maltese: • il-pazjent ikollu nuqqas ta' effikaċja, kif muri minn sintomi ta' rtirar li jdumu li jeħtieġu immaniġġjar ripetut bi buprenorphine taħt l-ilsien Twaqqif
English: • cough, breathlessness
Maltese: • kolla likwida
English: In this double-blind and double-dummy study, patients maintained on doses of sublingual buprenorphine of 8 mg/day or less were transferred to 4 Sixmo implants (and daily sublingual placebo), or sublingual buprenorphine 8 mg/day or less (and 4 placebo implants).
Maltese: 8 mg/jum jew inqas ġew trasferiti għal 4 impjanti ta' Sixmo (u plaċebo taħt l-ilsien kuljum), jew buprenorphine taħt l-ilsien 8 mg/jum jew inqas (u 4 impjanti plaċebo).
English: See section 4.8 for how to report adverse reactions
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rrappurtati reazzjonijiet avversi.
English: The implants will be positioned in a close fan-shaped distribution 4 to 6 mm apart, with the fan opening towards the shoulder (Figure 3).
Maltese: L-impjanti se jitqiegħdu f'distribuzzjoni qrib xulxin forma ta' mrewħa 4 sa 6 mm 'il bogħod minn xulxin, blimrewħa tiftaħ lejn l-ispalla (Figura 3).
English: • pain, such as abdominal pain, bone pain, muscle pain, chest pain, headache
Maltese: • sindrome ta' rtirar tal-mediċina, bħal għaraq, tħossok sħun u kiesaħ
English: • mental condition, chracterised by delusions and irrationality
Maltese: • kundizzjoni mentali, ikkaratterizzata minn delużjonijiet u nuqqas ta' raġuni
English: • have severly reduced liver function
Maltese: • funzjoni tal-kliewi mnaqqsa
English: Patients previously treated with sublingual buprenorphine or sublingual buprenorphine + naloxone, must be on stable doses between 2 to 8 mg/day for at least 30 days and deemed clinically stable by the treating healthcare professional.
Maltese: Pazjenti li qabel kienu ttrattati b'buprenorphine taħt l-ilsien jew b'buprenorphine taħt l-ilsien + naloxone, għandhom ikunu fuq dożi stabbli bejn 2 sa 8 mg/jum għal mill-inqas 30 ġurnata u meqjusa klinikament stabbli mill-professjonist tal-kura tas-saħħa li jkun qed jikkura.
English: Generally, concentrations were comparable to the trough buprenorphine concentration of 8 mg per day sublingual buprenorphine.
Maltese: Ġeneralment, il-konċentrazzjonijiet kienu komparabbli mal-anqas konċentrazzjoni ta' buprenorphine ta' 8 mg kuljum ta' buprenorphine taħt l-ilsien.
English: Metabolism and nutrition disorders common decreased appetite uncommon abnormal weight gain, dehydration, increased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni tnaqqis fl-aptit mhux komuni żieda mhux normali fil-piż, deidratazzjoni, żieda fl-aptit
English: • signs of intoxication or overdose appear (miosis, lip cyanosis, sedation, bradycardia,
Maltese: buprenorphine (mijożi, ċjanosi tax-xufftejn, sedazzjoni, bradikardija, pressjoni baxxa, depressjoni respiratorja).
English: Renal elimination plays a relatively small role (approximately 30%) in the overall clearance of buprenorphine and buprenorphine plasma concentrations were not increased in patients with renal impairment.
Maltese: Eliminazzjoni mill-kliewi għandha rwol relattivament żgħir (madwar 30%) fit-tneħħija totali ta' buprenorphine u l-konċentrazzjonijiet ta' buprenorphine fil-plażma ma żdidux f'pazjenti b'indeboliment tal-kliewi.
English: Plasma concentrations of buprenorphine after insertion of Sixmo are highest during the first 24 to 48 hours.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' buprenorphine wara t-tqegħid ta' Sixmo huma l-ogħla matul lewwel 24 sa 48 siegħa.
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 fuq l-annimali, kif ukoll esperjenza klinika, urew li buprenorphine jista' jipproduċi dipendenza, iżda f'livell aktar baxx minn agonist sħiħ, eż. morfina.
English: Instructions for removal of Sixmo
Maltese: Mediċini oħra u Sixmo
English: Breakage rates decreased in studies using the current technique and training.
Maltese: Ir-rati ta' ksur naqsu fi studji fejn intużat teknika kurrenti u taħriġ.
English: Buprenorphine is extensively metabolized in the liver.
Maltese: Buprenorphine huwa metabolizzat b'mod estensiv fil-fwied.
English: • The other ingredient is ethylene vinyl acetate copolymer.
Maltese: • Is-sustanza mhux attiva l-oħra hija ethylene vinyl acetate kopolimer.
English: Respiratory, thoracic and mediastinal disorders common cough**, dyspnoea** uncommon respiratory depression, yawning Gastrointestinal disorders common constipation, nausea, vomiting, diarrhoea, abdominal pain, gastrointestinal disorder**, tooth disorder** uncommon dry mouth, dyspepsia, flatulence, haematochezia
Maltese: Disturbi gastro-intestinali komuni stitikezza, dardir, rimettar, dijarea, uġigħ addominali, disturb gastrointestinali**, disturb fis-snien**
English: • latex, talc-free sterile gloves
Maltese: • infezzjoni fl-apparat tal-awrina
English: Do not blot or wipe away.
Maltese: bejn it-tieni u t-tielet impjant.
English: Severe hepatic impairment
Maltese: Indeboliment epatiku sever.
English: After determining the anaesthesia is adequate and effective, make a 7 to 10 mm incision with a scalpel, parallel to the axis of the arm, between the second and third implants.
Maltese: Wara li tiddetermina li l-anestesija hija adegwata u effettiva, għamel inċiżjoni ta' 7 sa 10 mm bi skarpell, parallel mal-assi tad-driegħ,
English: Table 5: Implant breakage in Sixmo double-blind Phase 3 studies Current technique and training PRO-806
Maltese: Ksur tal-implant fi studji double-blind ta' Fażi 3 ta' Sixmo
English: • pinpoint pupils
Maltese: • Benzodiazepines:
English: Step 5: Lower the applicator to a horizontal position; lift the skin up with the tip of the applicator, but keep the cannula in the subcutaneous connective tissue (Figure 6).
Maltese: Baxxi l-applikatur għal pożizzjoni orizzontali; erfa' l-ġilda 'l fuq bil-ponta talapplikatur, iżda żomm il-kannula fit-tessut konnettiv ta' taħt il-ġilda (Figura 6).
English: Step 15: Pick up the skin edge with Adson single toothed tissue forceps and separate the tissues above and below the visible implant, using an iris scissors or a curved mosquito forceps (Figure 16).
Maltese: Kun ċert li tinjetta l-anestetiku lokali fil-fond lejn iċ-ċentru tal-impjanti; dan effettivament jimbotta l-impjanti lejn il-ġilda, u jiffaċilita t-tneħħija tal-impjanti.
English: The concomitant use of monoamine oxidase inhibitors (MAOI) might produce an exaggeration of the effects of opioids, based on experience with morphine (see section 4.5).
Maltese: jipproduċi esaġerazzjoni tal-effetti tal-opjojdi, ibbażat fuq esperjenza bil-morfina (ara sezzjoni 4.5). Ġilda
English: • sterile fenestrated drape
Maltese: • ngħas eċċessiv
English: Furthermore, after establishment of non-inferiority, superiority of Sixmo over sublingual buprenorphine was tested and established (p=0.034).
Maltese: Barra dan, wara li ġie stabbilit in-nuqqas ta' inferjorità, is-superjorità ta' Sixmo fuq buprenorphine taħt lilsien ġiet ittestjata u stabbilita (p=0.034).
English: Although some patients may require occasional supplemental dosing with buprenorphine, patients should not be provided with prescriptions for sublingual buprenorphine-containing products for asneeded use.
Maltese: Jekk ikun hemm suspett ta' problemi fil-fwied, it-tabib tiegħek se jagħmel testijiet biex jiddeċiedi jekk it-trattament għandux jitwaqqaf.
English: The dissociation of buprenorphine from the µ-opioid receptors is expected to take up to several days after discontinuation of Sixmo treatment, which will prevent withdrawal symptoms immediately after removal of Sixmo.
Maltese: Tużax dawn il-mediċini waqt it-trattament b'Sixmo peress li jistgħu jikkawżaw bidu f'daqqa ta' sintomi ta' rtirar fit-tul u intensi.
English: The primary efficacy endpoint in both studies was the cumulative distribution function (CDF) of the percentage of urine samples that were negative for illicit opioids (as evaluated through thrice weekly urine toxicology and patient self-reported opioid use).
Maltese: - cumulative distribution function) tal-persentaġġ ta' kampjuni tal-awrina li kienu negattivi għallopjojdi illeċiti (kif evalwat permezz ta' tossikoloġija tal-awrina tliet darbiet fil-ġimgħa u l-użu ta'
English: Risk of serious complications of insertion and removal of implants Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants (see section 4.4).
Maltese: Riskju ta' kumplikazzjonijiet serji kkawżati mit-tqegħid u t-tneħħija tal-impjanti Kumplikazzjonijiet rari iżda serji inklużi ħsara fin-nervituri u migrazzjoni li wasslet għal emboliżmu u mewt jistgħu jseħħu kawża ta' tqegħid ħażin ta' impjanti mediċinali (ara sezzjoni 4.4).
English: Using aseptic technique, place the sterile equipment on the sterile field of the instrument stand.
Maltese: Permezz ta' teknika asettika, poġġi l-apparat sterili fuq ilparti sterili tal-istand għall-apparat.
English: • the patient experiences withdrawal symptoms, e.g. sweating, lacrimation, yawning, nausea,
Maltese: • il-pazjent ikollu sintomi ta' rtirar, eż. għaraq, dmugħ, titwib, dardir, rimettar, takikardija,
English: • alcohol pad
Maltese: • imselħa bl-alkoħol
English: • dilated pupils
Maltese: • tnaqqis fl-aptit
English: Literature data indicated no genotoxic properties of buprenorphine.
Maltese: Data mil-letteratura ma tindika l-ebda kwalitajiet ġenotossiċi ta' buprenorphine.
English: • have severe breathing problems
Maltese: Disturbi respiratorji,
English: Sixmo is not recommended during pregnancy and in women of childbearing potential not using contraception.
Maltese: Sixmo mhux rakkomandat waqt it-tqala, u lanqas f'nisa ta' età li jistgħu joħorġu tqal li ma jkunux qed jużaw kontraċezzjoni.
English: • muscle spasms, limb discomfort
Maltese: • diffikultajiet biex tieħu nifs, nifs bil-mod
English: Having the patient flex the biceps muscle may facilitate identification of the site (Figure 2).
Maltese: Jekk il-pazjent jgħawweġ ilmuskolu tal-biceps jista' jiffaċilita l-identifikazzjoni tas-sit (Figura 2).
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Maltese: L-ispektrum ta' anormalitajiet ivarja minn żidiet temporanji mingħajr sintomi fit-transaminases tal-fwied għal rapporti ta' każijiet ta' falliment talfwied, nekrosi tal-fwied, sindrome epatorenali, enċefalopatija tal-fwied u mewt.
English: Identify the insertion site, which is at the inner side of the upper arm, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle.
Maltese: 'il fuq mill-epikondil medjali, fis-sulkus bejn il-muskoli biceps u triceps.
English: Adverse drug reactions were categorized as implant or non-implant adverse reactions.
Maltese: Reazzjonijiet avversi tal-mediċina ġew ikklassifikati bħala reazzjonijiet avversi tal-impjant jew dawk mhux tal-impjant.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence
Maltese: Għoti fl-istess waqt ta' antagonisti ta' opjojdi (naltrexone, nalmefene) għat-trattament ta' dipendenza fuq l-alkoħol jew l-opjojdi.
English: • pressure bandage around 8 cm wide • 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) Istruzzjonijiet għat-tneħħija ta' Sixmo
English: • have had an increased formation of scare tissue
Maltese: • tirojde mhux attiva biżżejjed
English: Sixmo implants are intended to be in place for 6 months of treatment and provide a sustained delivery of buprenorphine.
Maltese: Impjanti ta' Sixmo huma maħsuba biex jibqgħu f'posthom għal 6 xhur ta' trattament u jipprovdu twassil sostnut ta' buprenorphine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (kit)
Maltese: Kartuna ta' barra (kit)
English: In both studies adult patients with opioid dependence who were new entrants to buprenorphine treatment were treated over 24 weeks with 4 Sixmo or 4 placebo implants.
Maltese: Fiż-żewġ studji pazjenti adulti b'dipendenza fuq l-opjojdi li kienu ġodda għal trattament ta' buprenorphine kienu trattati għal perjodu ta' 24 ġimgħa b'4 impjant ta' Sixmo jew 4 tal-plaċebo.