FrancophonIA/ELRC3.0 huggingface dataset:
English: GROUNDS FOR OPINION
Maltese: RAĠUNIJIET GĦALL-OPINJONI
English: The CHMP considered that insertion, migration and removal related events (collectively known as IRREs) occur at a low and decreasing frequency.
Maltese: Is-CHMP ikkunsidra li episodji relatati mal-inklużjoni, il-migrazzjoni u t-tneħħija (kolletivament magħrufin bħala IRREs) iseħħu fi frekwenza baxxa u li qed tonqos.
English: The implant is a single rod of 4 cm length and 2 mm in diameter and contains 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) co-polymer.
Maltese: L-impjant huwa virga waħdanija twila 4 ċm u b'dijametru ta' 2 mm u fiha 68 mg etonogestrel (ENG) mifrux f'matriċi talkopolimer ethylene vinyl acetate (EVA).
English: • The MAH will continue with the 6-monthly reports of all unintended pregnancy and insertion/removal related problems (IRRE) during the next 5 year renewal period.
Maltese: • L-MAH se jkompli b'rapporti ta' kull 6 xhur ta' kull tqala mhux intenzjonata u problemi relatati mal-inklużjoni/tneħħija (IRRE) waqt il-perijodu ta' tiġdid tal-5 snin li ġejjin.
English: • The MAH will submit a type II variation in 2009 to introduce the new Implanon (Implanon NXT).
Maltese: • L-MAH se jissottometti varjazzjoni tip II fl-2009 biex jintroduċi Implanon il-ġdid (Implanon NXT).
English: Organon Ireland Ltd. Drynam Road Swords
Maltese: Organon Ireland Ltd.
English: A RMP proposal for Implanon NXT will be part of this variation.
Maltese: Proposta tal-RMP għal Implanon NXT se tkun parti minn din il-varjazzjoni.
English: Of some relevance is the interim analysis data from the ongoing case-control study of the progestogen releasing contraceptive IUD (Mirena) (ICPE meeting report, 2008).
Maltese: Hija ta' relevanza d-dejta tal-analiżi interim mill-istudju tal-kontroll tal-każ dejjem għaddej tal-kontraċettiv IUD (Mirena) li jerħi proġestoġen (rapport tal-laqgħa tal-ICPE, 2008).
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jassiguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: The indicated period of use is 3 years.
Maltese: Il-perijodu indikat għall-użu huwa ta' 3 snin.
English: The big advantage of implants is the absence of problems with compliance or gastro-intestinal disturbances that negatively affect contraceptive efficacy versus the disadvantages of irregular bleeding being there with all continuous progestogen-only methods that inhibit ovulation.
Maltese: Il-vantaġġ kbir tal-impjanti huwa n-nuqqas ta' problemi mal-konformità jew disturbi gastrointestinali li jaffettwaw b'mod negattiv l-effikaċja kontraċettiva kontra l-iżvantaġġi ta' fsada irregolari li jkun hemm bil-metodi kollha ta' proġestoġen biss kontinwu li jimpedixxu l-ovulazzjoni.
English: The difference between the observed and the expected numbers of cases is substantial and is unlikely to be explained by underreporting alone.
Maltese: Id-differenza bejn in-numru ta' każijiet osservati u n-numru ta' każijiet mistennija hija sostanzjali u dan mhuwiex mistenni li jkun spjegat binnuqqas ta' rapportar biss.
English: The CHMP concluded that the contraceptive efficacy of Implanon is superior to that of other hormonal contraceptives and that the Pearl Indices obtained for Implanon are significantly lower than those obtained with other systemic hormonal contraceptives, and certainly lower than those obtained with combined oral contraceptives, especially as these are prone to non-compliance, and gastrointestinal disturbances.
Maltese: Is-CHMP ikkonkluda li l-effikaċja kontraċettiva ta' Implanon hija superjuri għal dik ta' kontraċettivi ormonali oħrajn u l-Indiċijiet Pearl miksubin għal Implanon huma ferm iktar baxxi milli dawk miksubin b'kontraċettivi ormonali sistemika oħrajn, u ċertament inqas minn dawk miksubin b'kontraċettivi orali kkombinati, b'mod speċjali peress li dawn huma suxxettibbli għal nuqqas ta' konformità u disturbi gastrointestinali.
English: Slovak Republic N.V. Organon Kloosterstraat 6 PO Box 20
Maltese: Il-Finlandja N.V. Organon Kloosterstraat 6 PO Box 20
English: Czech Republic N.V. Organon Kloosterstraat 6 PO Box 20
Maltese: N.V. Organon Kloosterstraat 6 PO Box 20
English: Similarly, the removal of Implanon due to irregular bleeding should not be regarded as a serious consequence since the “surgical intervention” to remove Implanon must be considered minimal, requiring a 0,5-1cm superficial skin incision, after which the implant can be easily extracted.
Maltese: Bl-istess mod, it-tneħħija ta' Implanon minħabba fsada irregolari m'għandhiex titqies bħala konsegwenza serja minħabba li l-“intervent kirurġiku” biex jitneħħa Implanon huwa meqjus minimu, li jeħtieġ inċiżjoni superfiċjali tal-ġilda ta' 0.5-1ċm, wara liema, l-impjant ikun jista' jitneħħa faċilment.
English: This is because Mirena represents a continuous and long-term systemic progestogen exposure in young women.
Maltese: Dan minħabba li Mirena tirrappreżenta esponiment kontinwu u sistemiku fit-tul f'nisa żgħar fl-età.
English: The CHMP, having considered the data submitted in the application is of the opinion that further risk minimisation activities are necessary for the safe and effective use of the medicinal product.
Maltese: Wara li kkunsidra d-dejta ppreżentata fl-applikazzjoni, is-CHMP huwa tal-opinjoni li iktar attivitajiet ta' minimizzazzjoni tar-riskju huma neċessarji għall-użu sigur u effettiv ta' dan il-prodott mediċinali.
English: • The marketing authorisation holder (MAH) will continue with the 12 monthly PSURs.
Maltese: • Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) se jkompli bil-PSURs ta' kull 12il xahar.
English: The Mirena study and reports from the US AMP should be included in the updated RMP.
Maltese: L-istudju Mirena u rapporti mill-US AMP għandhom jiġu inklużi fl-RMP aġġornat.
English: • An update on bleeding in section 4.8 in the SPC and leaflet as proposed in the draft MAH labelling.
Maltese: • Aġġornament fuq il-fsada f'sezzjoni 4.8 fl-SPC u l-fuljett kif propost fl-abbozz tat-tikketta talMAH.
English: The MAH has compiled data of available relevant studies and overall, the epidemiological data on the association between progestogen-only contraception (POC) and breast cancer risk are sparse and reflect mostly the use of injectable DMPA.
Maltese: Il-MAH ġabar dejta ta' studji relevanti disponibbli u kollox ma' kollox, id-dejta epidemjoloġika fuq lassoċjazzjoni bejn kontraċettiv ibbażat fuq proġestoġen biss (POC) u r-riskju ta' kanċer tas-sider huma skarsi u jirriflettu prinċipalment l-użu ta' DMPA injettabbli.
English: • The marketing authorisation holder (MAH) will continue with the 12 monthly Periodic Safety Update Reports (PSURs).
Maltese: • Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) se jkompli bir-Rapporti Perjodiċi ta' Aġġornament dwar is-Sigurtà (PSURs) ta' kull 12-il xahar.
English: The contraceptive action of Implanon is primarily achieved by inhibition of ovulation.
Maltese: L-azzjoni kontraċettiva ta' Implanon tinkiseb primarjament permezz ta' impediment tal-ovulazzjoni.
English: In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and is therefore of the opinion that the benefit-risk profile of Implanon is positive.
Maltese: Bħala konklużjoni, is-CHMP jikkunsidra li Implanon huwa metodu effikaċi ta' kontraċezzjoni mingħajr ebda tħassib ta' sigurtà apparenti u għaldaqstant huwa tal-opinjoni li l-profil benefiċċju/riskju ta' Implanon huwa wieħed pożittiv.
English: • With the 6 monthly IRRE report, the MAH will submit the latest results of the ongoing active monitoring program (AMP) in the USA.
Maltese: • Mar-rapport IRRE ta' kull 6 xhur, l-MAH se jissottometti l-aħħar riżultati tal-programm ta' sorveljanza attiva (AMP) għaddej il-ħin kollu fl-Istati Uniti.
English: In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and that the benefit-risk balance of Implanon is positive.
Maltese: Bħala konklużjoni, is-CHMP qies li Implanon huwa metodu effikaċi ta' kontraċezzjoni mingħajr l-ebda thassib fir-rigward tas-sigurtà apparenti u li l-bilanċ benefiċċju/riskju għal Implanon huwa wieħed pożittiv.
English: Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Maltese: Il-proċedura ġiet irreferuta lis-CHMP, peress li ma ntlaħaq lebda qbil sa Jum 60.
English: This is well known and sometimes a reason for method discontinuation.
Maltese: Dan huwa magħruf sew u xi kultant huwa rraġuni għat-twaqqif tal-metodu.
English: The CHMP considers that correct insertion is a simple procedure and that the IRRE problems can be prevented or reduced by compliance with updated instructions and training materials.
Maltese: Is-CHMP ikkunsidra li l-inklużjoni korretta hija proċedura sempliċi u li l-problemi tal-IRRE jistgħu jkunu impeduti jew imnaqqsin b'konformità mal-istruzzjonijiet aġġornati u mal-materjali ta' taħriġ.
English: The CHMP was of the view that written informed consent in the EU is associated with products where there are established serious risks and that the introduction of a request for informed consent for Implanon, one of several widely used methods of contraception, is unjustified and would strongly signal a risk that is certainly not present.
Maltese: Is-CHMP kien tal-opinjoni li kunsens infurmat bil-miktub fl-UE huwa assoċjat ma' prodotti fejn hemm riskji serji stabbiliti u li l-introduzzjoni ta' talba għal kunsens infurmat għal Implanon, wieħed minn diversi metodi ta' kontraċezzjoni użati b'mod komuni, mhuwiex iġġustifikat u jimplika bilqawwa sinjal ta' riskju li ċertament mhuwiex qiegħed hemm.
English: The CHMP considered that bleeding irregularities are expected with all progestogen-only methods, in particular those that inhibit ovulation.
Maltese: Is-CHMP ikkunsidra li huma mistennija irregolaritajiet fil-fsada bil-metodi proġestoġen biss kollha, b'mod partikolari dawk li jimpedixxu l-ovulazzjoni.
English: It is acknowledged that the available studies have limitations, e.g. the lack of data on the associations with POPs, limited power to examine risk relationships in subgroups, and further no meaningful data to examine the effects of implants.
Maltese: Huwa rikonoxxut li l-istudji disponibbli għandhom il-limitazzjonijiet, ngħidu aħna, innuqqas ta' dejta fuq l-assoċjazzjonijiet mal-POPs, l-abbiltà limitata biex jiġu eżaminati relazzjonijiet ta' riskju fis-sottogruppi, u ebda dejta sinifikanti oħra biex jiġu eżaminati l-effetti tal-impjanti.
English: However, although the bleeding pattern often is unpredictable, many women report reduction in episode frequency and total number of bleeding days compared to their normal menstrual pattern.
Maltese: Madankollu, għalkemm il-metodu tal-fsada ta' spiss huwa imprevedibbli, ħafna nisa jirrapportaw tnaqqis fil-frekwenza tal-episodji u tan-numru totali ta' jiem ta' fsada meta mqabbla mal-mod mestrwali tagħhom.
English: The issue was referred to the CMD (h) and an assessment was carried out by the RMS.
Maltese: Il-kwistjoni ġiet riferuta lisCMD(h) u saret valutazzjoni mill-RMS.
English: ANNEX IV CONDITIONS FOR THE RENEWAL OF THE MARKETING AUTHORISATION
Maltese: ANNESS IV KUNDIZZJONIJIET GĦAT-TIĠDID TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FISSUQ
English: Furthermore, the reports on Implanon removals in breast cancer patients from the US AMP program are likely to yield valuable information from case series that are expected to be relatively complete.
Maltese: Barra minn hekk, ir-rapporti fuq tneħħijiet ta' Implanon f'pazjenti b'kanċer tassider mill-programm US AMP x'aktarx li jipprovdu informazzjoni siewja minn serje ta' każijiet li huma mistennijin li jkunu relattivament lesti.
English: Furthermore, the degree of underreporting is assumed to be lower for Implanon compared to spontaneous ADR reporting in general, therefore the CHMP does not consider that spontaneous reports on breast cancer in users of Implanon give rise to a new signal of an adverse effect.
Maltese: Barra dan, il-grad ta' nuqqas ta' rapportar sħiħ huwa mistenni li jkun iktar baxx għal Implanon meta mqabbel ma' rapportar spontanju tal-ADR b'mod ġenerali, għaldaqstant isCHMP ma jikkunsidrax li rapporti spontanji fuq kanċer tas-sider f'dawk li jużaw Implanon jagħtu lok għal sinjal ġdid ta' effett avvers.
English: 20 November 2018
Maltese: Novembru 2018
English: Treatment difference (%)a (95% CI)
Maltese: (%)a (95% CI)
English: LS mean (%) (SE) 35.1 (2.48) 28.4 (2.47) 6.7
Maltese: Medja LS (%) (SE) 35.1 (2.48) 28.4
English: Statistic Buvidal
Maltese: Statistika Buvidal
English: Medical dependence
Maltese: Dipendenza medika
English: Acute alcoholism or delirium tremens
Maltese: Alkoħoliżmu akut jew delirium tremens
English: - Dependence: This medicine can cause dependence.
Maltese: Dan il-mediċina tista' tikkawża dipendenza.
English: CDF = cumulative distribution function, CI = confidence interval, LS = least squares; SE = standard error, SL BPN/NX = sublingual buprenorphine/naloxone a Difference = Buvidal - SL BPN/NX.
Maltese: CDF = funzjoni ta' distribuzzjoni kumulattiva, CI = intervall ta' kunfidenza, LS (least squares) = linqas kwadri; SE = żball standard, SL BPN/NX = buprenorphine/naloxone għal taħt l-ilsien a Differenza = Buvidal - SL BPN/NX.
English: Table 3 presents adverse reactions reported for buprenorphine, including Buvidal.
Maltese: Tabella 3 tippreżenta reazzjonijiet avversi rrappurtati għal buprenorphine, inkluż Buvidal.
English: • monoamine oxidase inhibitors (MAOI): Possible exacerbation of the opioids effects, based on experience with morphine.
Maltese: • inibituri ta' monoamine oxidase (MAOI): Il-possibbilità ta' aggravament tal-effetti bl-opjojdi, abbażi ta' esperjenza bil-morfina.
English: • antidepressants (used to treat depression)
Maltese: • antidepressanti (jintużaw għat-trattament tad-depressjoni)
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden Phone: +800 2577 2577
Maltese: Ideon Science Park SE-223 70 Lund, l-Iżvezja Telefon: +800 2577 2577
English: System Organ Class Very common Common
Maltese: Sistema talKlassifika talOrgani
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in opioid dependence, ATC code: N07BC01
Maltese: Mediċini oħrajn tas-sistema nervuża, mediċini użati għal dipendenza fuq l-opjojdi, Kodiċi ATC: N07BC01
English: Buprenorphine is also metabolised to buprenorphine-3βglucuronide by UGT1A1.
Maltese: Buprenophine huwa wkoll metabolizzat għal buprenorphine-3β-glucuronide permezz ta' UGT1A1.
English: Buvidal has complete absolute bioavailability.
Maltese: Buvidal għandu bijodisponibilità kompluta u assoluta.
English: • Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4.
Maltese: • Buprenorphine jiġi metabolizzat għal norbuprenorphine primarjament permezz ta' CYP3A4.
English: Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzymes increased
Maltese: Żieda fl-aspartat aminotransferażi Żieda fl-enzimi epatiċi
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden
Maltese: Ideon Science Park SE-223 70 Lund, l-Iżvezja
English: Safety syringe parts:
Maltese: Siringa tas-Sigurtà:
English: The apparent volume of distribution for buprenorphine is approximately 1900 L. Buprenorphine is approximately 96% protein-bound, primarily to alpha and beta globulin.
Maltese: Il-volum apparenti għad-distribuzzjoni għal buprenorphine huwa bejn wieħed u ieħor 1900 L. Buprenorphine huwa bejn wieħed u ieħor 96% marbut mal-proteina, primarjament mal-alfa u beta globulin.
English: - gabapentinoids (gabapentin or pregabalin) (used to treat epilepsy or neuropathic pain).
Maltese: - gabapentinoids (gabapentin jew pregabalin) (jintużaw biex jittrattaw epilessija jew uġigħ newropatiku).
English: The most common adverse reactions were injection site pain (8.9%), injection site pruritus (6.1%) and injection site erythema (4.7%).
Maltese: L-iktar reazzjonijiet avversi komuni kienu wġigħ fis-sit tal-injezzjoni (8.9 %), prurite fis-sit tal-injezzjoni (6.1%) u eritema fis-sit tal-injezzjoni (4.7%).
English: Excipients: Soybean phosphatidylcholine, glycerol dioleate, ethanol anhydrous
Maltese: Soybean phosphatidylcholine, glycerol dioleate, ethanol anhydrous
English: Buprenorphine is oxidatively metabolised by 14-N-dealkylation to N-desalkyl-buprenorphine (also known as norbuprenorphine) via cytochrome P450 CYP3A4 and by glucuroconjungation of the parent molecule and the dealkylated metabolite.
Maltese: Buprenorphine jiġi metabolizzat b'mod ossidattiv minn 14-N-dealkylation għal N-desalkylbuprenorphine (magħrufa wkoll bħala norbuprenorphine) permezz taċ-ċitokromu P450 CYP3A4 u permezz tal-konjugazzjoni glucuronide tal-molekula oriġinali u l-metabolit dealkylated.
English: Figure 8:
Maltese: Figura 8:
English: Name and address of the manufacturer(s) responsible for batch release Rechon Life Science AB
Maltese: Manifattur Rechon Life Science AB
English: The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and frequency not known (cannot be estimated from available data).
Maltese: It-termini u l-frekwenzi li ġejjin japplikaw: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100) u frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Due to limited data in adolescents (aged 16 or 17 years), patients in this age group should be monitored closely during treatment.
Maltese: Minħabba n-nuqqas ta' dejta fl-adolexxenti (età 16 jew 17il sena), il-pazjenti f'dan il-grupp ta'età għandhom jiġu mmonitorjati aktar mill-qrib matul ittrattament.
English: Of the 428 randomised patients, 69.0% (147/213) of the patients in the Buvidal treatment group and 72.6% (156/215) of the patients in the sublingual buprenorphine/naloxone treatment group completed the 24-week treatment period.
Maltese: Mill-428 pazjent magħżula b'mod każwali, 69.0% (147/213) tal-pazjenti fil-grupp tat-trattament b'Buvidal u 72.6% (156/215) tal-pazjenti fil-grupp tat-trattament ta' buprenorphine/naloxone għal taħt l-ilsien lestew il-perjodu ta' trattament li dam 24 ġimgħa.
English: Elderly No pharmacokinetic data in elderly patients (> 65 years) are available.
Maltese: M'hemm l-ebda dejta farmakokinetika f'pazjenti anzjani (> 65 sena) disponibbli.
English: For pharmacokinetic properties, see section 5.2 and for treatment termination, see section 4.2.
Maltese: Għal tagħrif farmakokinetiku, ara sezzjoni 5.2 u għall-waqfien tat-trattament, ara sezzjoni 4.2.
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons.
Maltese: L-effetti ceiling tal-agonisti tal-opjojdi ġew osservati matul studji farmakoloġiċi kliniċi fuq persuni dipendenti fuq l-opjojdi.
English: Overall, 156 patients (68.7%) completed the 48-week treatment period.
Maltese: B'mod globali, 156 pazjent (68.7%) lestew il-perjodu tat-trattament li dam 48 ġimgħa.
English: P-value
Maltese: Valur-P
English: • other central nervous system depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances.
Maltese: Derivattivi oħrajn ta' opjojdi (eż. methadone, mediċini analġeżiċi u kontra s-sogħla), ċertu antidepressanti, antagonisti sedattivi ta' riċettur H1, barbiturati, mediċini kontra l-ansjetà minbarra benzodiazepines, antipsikotiċi, clonidine u sustanzi relatati.
English: Figure 5:
Maltese: Figura 5:
English: Hepatitis and hepatic events
Maltese: Epatite u avvenimenti epatiċi
English: • Intravascular, intramuscular and intradermal administration must be avoided.
Maltese: • Għandu jkun evitat għoti intravaskulari, intramuskolari u intradermali.
English: Elimination of buprenorphine from Buvidal is release-rate limited with a terminal half-life ranging from 19 to 25 days.
Maltese: L-eliminazzjoni ta' buprenorphine minn Buvidal hija limitata mir-rata ta' tneħħija b'half-life terminali li tvarja minn 19 sa 25 jum.
English: Buvidal 64 mg, 96 mg and 128 mg are given monthly.
Maltese: Buvidal 64 mg, 96 mg, 128 mg
English: CDF of percentage of urine samples negative for illicit opioids over weeks 4-24
Maltese: CDF tal-perċentwali talkampjuni tal-awrina negattivi għal opjojdi illegali matul il-ġimgħat 4 sa 24
English: Agitation
Maltese: Nervożità
English: moderate hepatic impairment (Child-Pugh Class B) (n=8)
Maltese: (Child-Pugh Klassi B)
English: This is normal.
Maltese: Dan hu normali.
English: Excipients: Soybean phosphatidylcholine, glycerol dioleate, N-methylpyrrolidone
Maltese: TA' EĊĊIPJENTI Sustanzi mhux attivi: Soybean phosphatidylcholine, glycerol dioleate, N-methylpyrrolidone
English: Hepatic function should be monitored regularly whilst on treatment.
Maltese: Il-funzjoni tal-fwied għandha tkun immonitorjata regolarment waqt li jkun għaddej it-trattament.
English: No pharmacokinetic data in paediatrics (less than 18 years) are available.
Maltese: Ma hemm disponibbli l-ebda data farmakokinetika fil-pedjatrija (inqas minn 18-il sena).
English: Buvidal 8 mg, 16 mg, 24 mg and 32 mg are given weekly.
Maltese: Buvidal 8 mg, 16 mg, 24 mg, 32 mg
English: This is unlikely to be a safety concern.
Maltese: Dan mhuwiex probabbli li huwa ta' tħassib għas-sikurezza.
English: - alcohol or medicines containing alcohol.
Maltese: - alkoħol jew mediċini li fihom l-alkoħol.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji fuq annimali ma jindikawx tossiċità riproduttiva (ara s-sezzjoni 5.3).
English: Figure 3:
Maltese: Figura 3:
English: Figure 7:
Maltese: Figura 7:
English: Treatment is intended for use in adults and adolescents aged 16 years or over.
Maltese: Ittrattament huwa intenzjonat għall-użu f'adulti u adolexxenti li għandhom 16-il sena u aktar.
English: Buprenorphine may cause drowsiness particularly when taken together with alcohol or central nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids or hypnotics (see sections 4.5 and 4.7).
Maltese: Buprenorphine jista' jikkawża n-ngħas, l-aktar jekk jittieħed flimkien mal-alkoħol jew sustanzi li jikkawżaw tnaqqis tas-sistema nervuża ċentrali bħal benzodiazepines, kalmanti, sedattivi, gabapentinoids jew ipnotiċi (ara sezzjoni 4.5 u 4.7).
English: Figure 6:
Maltese: Figura 6:
English: Percentage of urine samples negative for illicit opioids
Maltese: Perċentwali ta' kampjuni tal-awrina negattivi għallopjojdi illegali
English: A 1 mL pre-filled syringe (glass, Type I) with plunger stopper (fluoropolymer-coated bromobutyl rubber) with needle (½-inch, 23 gauge, 12 mm) and needle shield (styrene butadiene rubber).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Siringa mimlija għal-lest (ħġieġ, Tip I) ta' 1 mL b'tapp bi planġer (b'tapp tal-lastku tal-bromobutyl miksi bil-fluoropolymer) b'labra (½ pulzier, daqs ta' 23, 12 mm) u protezzjoni tal-labra (lastku tat-tip styrene butadiene).
English: Other medicines and Buvidal
Maltese: Mediċini oħra u Buvidal
English: In the double-blind, phase 3 efficacy trial, injection site-related adverse reactions were observed in 36 (16.9%) of the 213 patients (5% of the administered injections) in the Buvidal treatment group.
Maltese: Fil-prova tal-effikaċja ta' fażi 3 double-blind, reazzjonijiet avversi relatati mas-sit tal-injezzjoni kienu osservati f'36 (16.9%) tal-213-il pazjent (5% tal-injezzjonijiet li ngħataw) fil-grupp ta' trattament ta' Buvidal.
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 li jirriżulta f'żieda tas-Cmax u l-AUC ta' buprenorphine u norbuprenorphine.