FrancophonIA/ELRC3.0 huggingface dataset:
English: Epoprostenol: Limited data obtained from a study (AC-052-356 [BREATHE-3]) in which 10 paediatric patients received the combination of bosentan and epoprostenol indicate that after both single- and multiple-dose administration, the Cmax and AUC values of bosentan were similar in patients with or without continuous infusion of epoprostenol (see section 5.1).
Maltese: [BREATHE-3]) fejn 10 pazjenti pedjatriċi ngħataw il-kombinazzjoni ta' bosentan u epoprostenol jindika li wara l-għoti kemm ta' doża waħda u kemm ta' dożi multipli, il-valuri tas-Cmax kif ukoll tal-AUC ta' bosentan kienu simili kemm fil-pazjenti li ngħataw infużjoni kontinwa ta' epoprostenol kif ukoll f'dawk li ma ngħatawx infużjoni kontinwa (ara sezzjoni 5.1).
English: Based on the findings in studies BREATHE-3, FUTURE 1, and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients.
Maltese: Ibbażat fuq is-sejbiet fl-istudji BREATHE-3, FUTURE 1, u FUTURE-3, jidher li l-esponiment għal bosentan jilħaq stat fiss b'dożi aktar baxxi f'pazjenti pedjatriċi minn fl-adulti, u jidher li dożi ogħla minn 2 mg/kg darbtejn kuljum (4 mg/kg darbtejn kuljum jew 2 mg/kg tliet darbiet kuljum) ma jwasslux għall-esponiment akbar għal bosentan f'pazjenti pedjatriċi.
English: Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Maltese: Il-pazjenti kienu kkurati bi 62.5 mg ta' bosentan mogħtija darbtejn kuljum għal 4 ġimgħat, segwiti minn 125 mg mogħtija darbtejn kuljum għal 12-il ġimgħa addizzjonali.
English: The results did not indicate an additional benefit of bosentan in this population:
Maltese: Ir-riżultat ma indikax xi benefiċċju addizzjonali ta' bosentan f'din il-popolazzjoni:
English: In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with PAH WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
Maltese: Il-kura fl-adulti ġeneralmant tinbeda b'62.5 mg darbtejn kuljum (filgħodu u filgħaxija) għall-ewwel 4 ġimgħat, u wara t-tabib tiegħek normalment se jagħtik parir biex tieħu pillola ta' 125 mg darbtejn kuljum, skond kif tirreaġixxi għal STAYVEER.
English: Patients should be advised not to swallow the desiccant found in the white high-density polyethylene bottles.
Maltese: Fi tfal maskili ma jistax jiġi eskluż impatt fit-tul fuq il-fertilità wara kura b'bosentan.
English: Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Maltese: Bosentan wera effetti teratoġeniċi fil-firien fejn intlaħqu livelli fil-plażma ogħla minn 1.5 darbiet iktar mill-konċentrazzjonijiet fil-plażma li ntlaħqu fid-doża terapewtika fil-bniedem.
English: Due to limited data in children below 2 years of age, pharmacokinetics remain not well characterised in this age category.
Maltese: Minħabba dejta limitata fi tfal b'età ta' inqas minn sentejn, il-farmakokinetika baqgħet mhux ikkaratterizzata tajjeb f'din il-kategorija ta' età.
English: In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
Maltese: Fi studju randomised u kkontrollat bil-plaċebo, li sar f'pazjenti b'PPHN (FUTURE-4), total ta' 13-il tarbija tat-twelid kienu kkurati bil-formulazzjoni tal-pillola li tinxtered ta' bosentan b'doża ta'
English: The full EPAR for Pemetrexed Fresenius Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Pemetrexed Fresenius Kabi is a ‘generic medicine'.
Maltese: Pemetrexed Fresenius Kabi huwa ‘mediċina ġenerika'.
English: The company provided data from the published literature on pemetrexed.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar il-pemetrexed.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Maltese: • mesoteljoma plewrika malinna (kanċer tar-rita tal-pulmun, normalment ikkawżat minn esponiment għall-asbestos), meta jintuża flimkien ma' ċisplatin f'pazjenti li ma ngħatawx kimoterapija qabel u li l-kanċer li għandhom ma jistax jitneħħa b'intervent kirurġiku;
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Fil-ġisem, il-pemetrexed tinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti fil-produzzjoni ta' ‘nukleotidi' (nukleotidi - li fuqhom jinbnew id-DNA u l-RNA, il-materjal ġenetiku taċ-ċelloli).
English: Other information about Pemetrexed Fresenius Kabi
Maltese: Informazzjoni oħra dwar Pemetrexed Fresenius Kabi
English: Pemetrexed Fresenius Kabi is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Fresenius Kabi huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers tal-pulmun:
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Fresenius Kabi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pemetrexed Fresenius Kabi.
English: The active substance in Pemetrexed Fresenius Kabi, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Fresenius Kabi, il-pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jiddividu ruħhom, bħaċ-ċelloli tal-kanċer) li tagħmel parti mill-grupp tal‘antimetaboliti'.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Maltese: Il-konverżjoni talpemetrexed għall-forma attiva tagħha ssir iktar malajr fiċ-ċelloli tal-kanċer milli f'ċelloli normali, u dan iwassal għal livelli ogħla tal-forma attiva tal-mediċina u l-azzjoni ddum iktar fiċ-ċelloli tal-kanċer.
English: This means that Pemetrexed Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Pemetrexed Fresenius Kabi huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Alimta.
English: Pemetrexed Fresenius Kabi pemetrexed
Maltese: Kif jintuża Pemetrexed Fresenius Kabi?
English: When Pemetrexed Fresenius Kabi is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Pemetrexed Fresenius Kabi jingħata ma' ċisplatin, mediċina ‘antiemetika' (biex tipprevjeni r-remettar) u fluwidi (biex jipprevjenu d-diżidratazzjoni) jenħtieġ li jingħataw ukoll qabel jew wara d-doża ta' ċisplatin.
English: Why is Pemetrexed Fresenius Kabi approved?
Maltese: Għaliex ġie approvat Pemetrexed Fresenius Kabi?
English: No additional studies were needed as Pemetrexed Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: Ma kien meħtieġ l-ebda studju addizzjonali peress li Pemetrexed Fresenius Kabi huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Alimta.
English: What are the benefits and risks of Pemetrexed Fresenius Kabi?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pemetrexed Fresenius Kabi?
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Fresenius Kabi.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti jenħtieġ li jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u jirċievu injezzjonijiet ta' vitamina
English: How has Pemetrexed Fresenius Kabi been studied?
Maltese: Kif ġie studjat Pemetrexed Fresenius Kabi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Fresenius Kabi has been shown to be comparable to Alimta.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Pemetrexed Fresenius Kabi wera li huwa komparabbli ma' Alimta.
English: How is Pemetrexed Fresenius Kabi used?
Maltese: Kif jaħdem Pemetrexed Fresenius Kabi?
English: Ebilfumin is available as capsules (30 mg, 45 mg, and 75 mg).
Maltese: Ebilfumin jiġi bħala kapsuli (30 mg, 45 mg u 75 mg).
English: Further information on Ebilfumin can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ebilfumin.
Maltese: Aktar informazzjoni dwar Ebilfumin tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/ebilfumin.
English: This overview was last updated in 04-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 04-2019.
English: Ebilfumin received a marketing authorisation valid throughout the EU on 22 May 2014.
Maltese: Ebilfumin irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fit22 ta' Mejju 2014.
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given once a day for 10 days after contact with an infected person.
Maltese: Id-doża tas-soltu għall-adulti u għat-tfal li jiżnu iktar minn 40 kg hija ta' 75 mg li tingħata darba kuljum għal 10 ijiem wara kuntatt ma' persuna infettata.
English: Other information about Ebilfumin
Maltese: Informazzjoni oħra dwar Ebilfumin
English: What are the benefits and risks of Ebilfumin?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ebilfumin?
English: Ebilfumin can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu).
Maltese: Ebilfumin jista' jintuża wkoll bħala kura preventiva f'każijiet ta' eċċezzjoni, pereżempju meta l-vaċċin tal-influwenza staġjonali jista' ma jipprovdix protezzjoni suffiċjenti u meta tfaqqa' pandemija (epidemija globali tal-influwenza).
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given twice a day for 5 days.
Maltese: Id-doża tassoltu għall-adulti u għat-tfal li jiżnu iktar minn 40 kg hija ta' 75 mg li tingħata darbtejn kuljum għal 5 ijiem.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Tamiflu, and do not need to be repeated for Ebilfumin.
Maltese: Studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat diġà twettqu bil-mediċina ta' referenza, Tamiflu, u m'għandhomx għalfejn jiġu ripetuti għal Ebilfumin.
English: Because Ebilfumin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ebilfumin huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: • To treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community;
Maltese: • Għall-kura tal-influwenza, jista' jintuża f'adulti u fit-tfal (inklużi trabi tat-twelid wara terminu sħiħ) li jkollhom is-sintomi tal-influwenza, meta l-virus tal-influwenza jkun qed jiċċirkola fil-komunità;
English: For adults with a weakened immune system (the body's natural defences), it is given for 10 days.
Maltese: Għall-adulti b'sistema immuni dgħajfa (id-difiżi naturali tal-ġisem), dan jingħata għal 10 ijiem.
English: Oseltamivir works on the neuraminidases of both influenza-A (the most common type) and influenza-B viruses.
Maltese: Oseltamivir jaħdem fuq in-newramidażi kemm tal-virus tal-influwenza A (it-tip l-aktar komuni) kif ukoll il-virus tal-influwenza B.
English: • To prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community.
Maltese: • Għall-prevenzjoni tal-influwenza, jista' jintuża f'adulti u fit-tfal li jkollhom aktar minn sena li kellhom kuntatt ma' xi ħadd li kellu l-influwenza u l-influwenza tkun qed tiċċirkola fil-komunità.
English: How is Ebilfumin used?
Maltese: Ebilfumin?
English: The active substance in Ebilfumin, oseltamivir, acts on the flu virus, blocking some of the enzymes on its surface known as neuraminidases.
Maltese: Is-sustanza attiva f'Ebilfumin, l-oseltamivir, taġixxi fuq il-virus tal-influwenza, billi timblokka xi wħud mill-enzimi fuq il-wiċċ tiegħu magħrufa bħala newramidażi.
English: Ebilfumin contains the active substance oseltamivir.
Maltese: Ebilfumin fih is-sustanza attiva oseltamivir.
English: How has Ebilfumin been studied?
Maltese: Kif ġie studjat Ebilfumin?
English: Ebilfumin is an antiviral medicine used to treat or prevent influenza (flu).
Maltese: Ebilfumin huwa mediċina antivirali li tintuża għall-kura jew għall-prevenzjoni tal-influwenza (flu).
English: In the treatment of flu, Ebilfumin must be started within two days of the onset of symptoms.
Maltese: Fil-kura tal-influwenza, Ebilfumin għandu jinbeda fi żmien jumejn mill-bidu tas-sintomi.
English: How does Ebilfumin work?
Maltese: Kif jaħdem Ebilfumin?
English: As for all medicines, data on the use of Ebilfumin are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ebilfumin hija ssorveljata kontinwament.
English: For children who weigh less than 40 kg, the dose is calculated according to the child's weight.
Maltese: Għal tfal li jiżnu inqas minn 40 kg, id-doża tiġi kkalkulata skont il-piż tat-tifel/tifla.
English: This means that Ebilfumin contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Tamiflu.
Maltese: Dan ifisser li Ebilfumin fih listess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Tamiflu.
English: Side effects reported with Ebilfumin are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ebilfumin huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: As for every medicine, the company provided studies on the quality of Ebilfumin.
Maltese: Bħal kull mediċina, il-kumpanija pprovdiet studji dwar il-kwalità ta Ebilfumin.
English: Therefore, the Agency's view was that, as for Tamiflu, the benefit of Ebilfumin outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-opinjoni talAġenzija kienet li, bħal fil-każ ta' Tamiflu, il-benefiċċju ta' Ebilfumin huwa akbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu fl-UE.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ebilfumin has been shown to have comparable quality and to be bioequivalent to Tamiflu.
Maltese: L-Aġenzija Ewropea għall-mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Ebilfumin wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Tamiflu.
English: The full EPAR and risk management plan summary for Portrazza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 800 mg on days 1 and 8 of each 3-week cycle.
Maltese: Id-doża rakkomandata hija ta' 800 mg filjiem 1 u 8 ta' kull ċiklu ta' 3 ġimgħat.
English: Other information about Portrazza
Maltese: Informazzjoni oħra dwar Portrazza
English: Portrazza contains the active substance necitumumab.
Maltese: Portrazza fih is-sustanza attiva necitumumab.
English: The most common side effects with Portrazza (which may affect more than 1 in 10 people) are skin reactions, vomiting, stomatitis (inflammation of the lining of the mouth), fever, weight loss and low blood measurements of various minerals (magnesium, calcium, phosphate and potassium).
Maltese: L-effetti sekondarji l-aktar komuni b'Portrazza (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma reazzjonijiet fil-ġilda, rimettar, stomatite (infjammazzjoni tal-kisja tal-ħalq), deni, tnaqqis fil-piż u kejl tad-demm baxx ta' diversi minerali (manjeżju, kalċju, fosfat u potassju).
English: This is a summary of the European public assessment report (EPAR) for Portrazza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Portrazza.
English: In this study, patients treated with Portrazza in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months versus 9.9 months).
Maltese: F'dan l-istudju, il-pazjenti kkurati b'Portrazza flimkien mal-kimoterapija għexu bħala medja 1.6 xhur aktar minn dawk ikkurati bil-kimoterapija biss (11.5 xhur meta mqabbel ma' 9.9 xhur).
English: Why is Portrazza approved?
Maltese: Għaliex ġie approvat Portrazza?
English: Most of the patients (95%) had cancer cells with EGFR.
Maltese: Ħafna mill-pazjenti (95%) kellhom ċelloli tal-kanċer b'EGFR.
English: What are the risks associated with Portrazza?
Maltese: X'inhuma r-riskji assoċjati ma' Portrazza?
English: The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to EGFR on the surface of the cancer cells.
Maltese: Is-sustanza attiva f'Portrazza, necitumumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex tagħraf u teħel ma' EGFR fuq il-wiċċ taċ-ċelloli tal-kanċer.
English: Portrazza necitumumab
Maltese: Kif jintuża Portrazza?
English: The most common serious side effects are severe skin reactions (6% of patients) and blood clots (4% of patients).
Maltese: L-effetti sekondarji serji laktar komuni huma reazzjonijiet severi fil-ġilda (6% tal-pazjenti) u koagulazzjoni tad-demm (4% talpazjenti).
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku necitumumab
English: A main study of 1,093 patients with advanced squamous non-small cell lung cancer showed that adding Portrazza to gemcitabine and cisplatin chemotherapy can lead to a modest improvement in survival.
Maltese: Studju globali ta' 1,093 pazjent b'kanċer tal-pulmun taċ-ċelloli mhux żgħar skwamużi avvanzat wera li meta Portrazza jiżdied ma' kimoterapija li tikkonsisti minn gemcitabine u cisplatin jista' jwassal għal titjib modest fis-sopravivenza.
English: How is Portrazza used?
Maltese: Kif jaħdem Portrazza?
English: In addition, the company that markets the medicine will provide doctors with educational material with information on risk of blood clots and on the small number of cardiac arrest cases seen in studies.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed il-mediċina fis-suq sejra tipprovdi lit-tobba b'materjal edukattiv b'informazzjoni dwar ir-riskju ta' koagulazzjoni tad-demm u dwar in-numru żgħir ta' każijiet ta' arrest kardijaku li ġew osservati fl-istudji.
English: For the first 6 cycles, Portrazza is given together with gemcitabine and cisplatin chemotherapy, after which it is given on its own for as long the disease remains stable and the patient can tolerate it.
Maltese: Għall-ewwel 6 ċikli, Portrazza jingħata flimkien ma' kimoterapija li tikkonsisti minn gemcitabine u cisplatin, u warajhom dan jingħata waħdu sakemm il-marda tibqa' stabbli u l-pazjent jista' jittolleraha.
English: EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing them to divide uncontrollably.
Maltese: EGFR normalment jikkontrolla t-tkabbir u ddiviżjoni taċ-ċelloli, iżda fiċ-ċelloli tal-kanċer EGFR huwa spiss attiv iżżejjed, u dan iwassal biex jinqasmu mingħajr kontroll.
English: Portrazza is given as a one hour infusion (drip) into a vein.
Maltese: Portrazza jingħata bħala infużjoni (dripp) ta' siegħa ġol-vina.
English: Portrazza is only used in adults whose cancer cells have a specific protein (EGFR) on their surface and it is used together with gemcitabine and cisplatin chemotherapy.
Maltese: Portrazza jintuża biss f'adulti li ċ-ċelloli tal-kanċer tagħhom għandhom proteina speċifika (EGFR) fuq issuperfiċje tagħhom u jintuża flimkien ma' kimoterapija li tikkonsisti minn gemcitabine u cisplatin.
English: For the full list of all side effects reported with Portrazza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Portrazza, ara l-fuljett ta' tagħrif.
English: A risk management plan has been developed to ensure that Portrazza is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Portrazza jintuża bl-aktar mod sigur possibbli.
English: Source; Brennan et al., Addiction 2005; 100 : 777-86
Maltese: Sors; Brennan et al., Addiction 2005; 100 : 777-86
English: Clinical aspects
Maltese: 3. Aspetti kliniċi
English: Benefit-Risk assessment
Maltese: Valutazzjoni benefiċċju-riskju
English: Whereas
Maltese: Men
English: Both problem drinkers and non-problem drinkers were included.
Maltese: Nonproblem Drinkers
English: Ethypharm submitted an application for the renewal, under the mutual recognition procedure, of Ethirfin and associated names, 20mg, 60 mg, 120 mg and 200 mg.
Maltese: Ethypharm issottomettiet applikazzjoni għat-tiġdid, taħt proċedura ta' rikonoxximent reċiproku, ta' Ethirfin u ismijiet assoċjati, 20 mg, 60 mg, 120 mg u 200 mg.
English: Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
Maltese: Dipressjoni u uġigħ fl-istess ħin għandhom impatt akbar minn disturb wieħed jew l-ieħor waħedhom u, f'pazjenti bl-uġigħ, id-depressjoni hija assoċjata ma' aktar siti ta' uġigħ, aktar intensità ta' uġigħ, aktar dewmien tal-uġigħ, u probabbilità akbar ta' rispons baxx għall-kura (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
English: Dissolution profiles have been performed using the 200 mg capsule strength only.
Maltese: Saru profili ta' dissoluzzjoni bl-użu biss ta' kapsula ta' qawwa ta' 200 mg.
English: The dissolution medium was water, loaded with 5, 10 and 20% ethanol in line with the EMA QWP Q&A document Need for in vitro Dissolution Studies with Alcohol for Modified Release Oral Products Including Opioid Drug Products.
Maltese: Il-mezz ta' dissoluzzjoni kien ilma, mgħobbi b'5, 10 u 20% etanol skont iddokument tal-EMA QWP Q&A Need for in vitro Dissolution Studies with Alcohol for Modified
English: About 20% of the responders reported chronic pain (>6 months).
Maltese: Madwar 20% ta' min irrisponda irrapporta uġigħ kroniku (>6 xhur).
English: The dissolution test method used was the routine test, i.e. paddle apparatus at 100 rpm with 1000 ml of medium.
Maltese: Il-metodu tat-test ta' dissoluzzjoni użat kien it-test ta' rutina, jiġifieri, apparat bil-paletta (paddle apparatus) b'100 rpm b'1000 ml ta' mezz.