FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that MACI is more effective than microfracture surgery at relieving pain and improving knee function: two years after surgery, patients treated with MACI had an average score of 82 for pain and 61 for knee function, compared with 71 and 49 respectively for patients treated with microfracture surgery.
Maltese: L-istudju wera li MACI huwa aktar effikaċi mill-kirurġija b'mikrofrattura biex itaffi l-uġigħ u jtejjeb il-funzjoni tal-irkoppa: sentejn wara l-operazzjoni, il-pazjenti kkurati b'MACI kellhom punteġġ medju ta' 82 għall-uġigħ u 61 għallfunzjoni tal-irkoppa, meta mqabbel ma' 71 u 49 rispettivament għall-pazjenti kkurati bil-kirurġija b'mikrofrattura.
English: A standard scale, known as the ‘knee injury and osteoarthritis outcome score' (KOOS), was used to measure pain and knee function, where 0 reflects extreme problems and 100 reflects an absence of problems.
Maltese: Skala standard, magħrufa bħala l-‘punteġġ tal-korriment fl-irkoppa u r-riżultat tal-osteoartrite' (KOOS), intużat biex tkejjel l-uġigħ u l-funzjoni tal-irkoppa, fejn 0 kien jindika problemi estremi u 100 kien jirrappreżenta nuqqas ta' problemi.
English: The study involved 144 adults with defects ranging between 3 and 20 cm2 in area.
Maltese: L-istudju kien jinvolvi 144 adult b'difetti li l-wisa' tagħhom tvarja minn 3 sa 20 cm2 .
English: As MACI is an advanced therapy product, it was initially assessed by the Committee for Advanced Therapies (CAT).
Maltese: Peress li MACI huwa prodott ta' terapija avvanzata, għall-ewwel ġie vvalutat mill-Kumitat għat-Terapiji Avvanzati (CAT).
English: The other important risks are those related to the surgical procedure itself, including infection, inflammation, haemoarthrosis (blood in the joints), arthrofibrosis (scar tissue in the joints), and thromboembolic events (blood clots).
Maltese: Ir-riskji l-oħrajn importanti huma dawk marbuta mal-proċedura kirurġika nnifisha, inklużi infezzjoni, infjammazzjoni, emorartrożi (demm fil-ġogi), artrofibrożi (tessut taċċikatriċi fil-ġogi), u avvenimenti tromboemboliċi (demm magħqud).
English: MACI is used to repair full-thickness defects with a surface area of between 3 to 20 cm2 in adults who are experiencing symptoms (such as pain and problems moving the knee).
Maltese: MACI jintuża għat-tiswija ta' difetti ta' ħxuna sħiħa b'superfiċje ta' bejn 3 sa 20 cm2 f'adulti li jkollhom is-sintomi (bħal uġigħ u diffikultà biex iċaqalqu l-irkoppa).
English: MACI was compared with microfracture surgery (a surgical procedure commonly used to treat cartilage defects) in a main study which looked at pain relief and improvements in knee function in patients with full thickness cartilage defects in the knee.
Maltese: MACI tqabbel mal-kirurġija b'mikrofrattura (proċedura kirurġika li normalment tintuża fil-kura taddifetti fil-qarquċa) fi studju ewlieni li qies is-solliev mill-uġigħ u t-titjib fil-funzjoni tal-irkoppa f'pazjenti b'difetti fil-ħxuna kollha tal-qarquċa fl-irkoppa.
English: How does MACI work?
Maltese: MACI
English: A risk management plan has been developed to ensure that MACI is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li MACI jintuża bl-aktar mod sigur possibbli.
English: MACI was evaluated to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the EMA in order to obtain an EU-wide marketing authorisation.
Maltese: MACI ġie vvalutat li jikkonforma mar-regolament tal-UE dwar it-terapiji avvanzati, li jeżiġi li t-terapiji avvanzati kollha fl-Istati Membri tal-UE jiġu vvalutati mill-EMA biex jiksbu awtorizzazzjoni għat-tqegħid fis-suq l-UE kollha.
English: It consists of the patient's own cartilage cells on 14.5 cm2 collagen membranes, which are used by a surgeon to fill in the spaces where cartilage is damaged.
Maltese: Jikkonsisti fiċ-ċelloli tal-qarquċa tal-pazjent innifsu fuq membrani tal-kollaġen ta' 14.5 cm2, li jintużaw minn kirurgu biex jimla l-ispazji fejn il-qarquċa tkun difettuża.
English: MACI is an advanced therapy product called a ‘tissue engineered product'.
Maltese: MACI huwa prodott terapewtiku avvanzat imsejjaħ ‘prodott ta' inġinerija tat-tessuti'.
English: The active substance in MACI consists of the patient's own cartilage cells, which are implanted into the cartilage defect in the knee.
Maltese: Is-sustanza attiva f'MACI tikkonsisti fiċ-ċelloli tal-qarquċa tal-pazjent innifsu, li jiġu impjantati filqarquċa difettuża fl-irkoppa.
English: It is not intended to provide practical advice on how to use MACI.
Maltese: Għal xiex ġiet approvat MACI?
English: MACI must not be used in patients with severe osteoarthritis (swelling and pain) of the knee, inflammatory joint disease, or uncorrected inborn blood clotting disorders.
Maltese: Il-Kumitat innota li kuri bħal MACI huma diġà stabbiliti fil-prattika klinika u li rriżultati mill-istudju ewlieni kienu konsistenti mar-riżultati tad-dokumentazzjoni xjentifika.
English: The CHMP therefore concluded that MACI's benefits are greater than its risks and recommended that it
Maltese: Is-CHMP għaldaqstant ikkonkluda li l-benefiċċji ta' MACI huma akbar mir-riskji tiegħu u rrakkomanda li jiġi approvat għall-użu fl-UE.
English: For both pain and function, improvements of around 45 points were seen in MACI patients compared with around 35 points in patients that
Maltese: Kemm għall-uġigħ kif ukoll għall-funzjoni, deher titjib ta' madwar 45 punt fil-pazjenti ta' MACI meta mqabbla ma' madwar 35 punt fil-pazjenti li saritilhom operazzjoni bil-mikrofrattura.
English: Excess cartilage growth and detachment of the implant may occur in between 1 and 10 patients in 1,000 treated with MACI.
Maltese: Jistgħu jiżviluppaw tkabbir żejjed fil-qarquċa u distakk tal-impjant f'persuna waħda sa għaxra f'kull 1,000 li jiġu kkurati b'MACI.
English: The CHMP's recommendation is based on an initial assessment by the CAT.
Maltese: Ir-rakkomandazzjoni tas-CHMP hija bbażata fuq valutazzjoni inizjali mill-CAT.
English: In addition, patients treated with MACI had fewer side effects compared with microfracture
Maltese: Barra dan, il-pazjenti kkurati b'MACI kellhom inqas effetti sekondarji meta mqabbla malpazjenti kkurati bil-mikrofrattura.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the main study had shown that MACI was superior to microfracture surgery in treating patients with cartilage defects of the knee.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni fl-UE u l-kondizzjonijiet ta' użu.
English: In addition, surgeons and healthcare professionals who will be involved in treating patients with MACI will receive educational materials providing detailed guidance on how to use MACI as well as information on its risks and the need to follow-up patients treated with MACI.
Maltese: Barra minn hekk, il-kirurgi u l-professjonisti tal-kura tas-saħħa li jkunu involuti fil-kura ta' pazjenti b'MACI sejrin jirċievu materjal edukattiv ieħor li jipprovdi gwida dettaljata dwar kif għandu jintuża MACI kif ukoll tagħrif dwar ir-riskji tiegħu u l-ħtieġa li l-pazjenti kkurati b'MACI jibqgħu jiġu mmonitorjati.
English: Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg).
Maltese: Duloxetine Mylan huwa disponibbli bħala kapsuli gastroreżistenti (30 u 60 mg).
English: The full EPAR and risk management plan summary for Duloxetine Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Duloxetine Mylan jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Duloxetine Mylan contains the active substance duloxetine and is a ‘generic medicine'.
Maltese: Duloxetine Mylan fih is-sustanza attiva d-duloksetina u huwa ‘mediċina ġenerika'.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturb ta' ansjetà ġeneralizzata (ansjetà u nervi fit-tul dwar ħwejjeġ ta' kuljum).
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Maltese: Għad-disturb tal-ansjetà ġeneralizzata, id-doża inizjali rakkomandata hija 30 mg darba kuljum, iżda huwa possibbli li d-doża tiżdied sa 60, 90 jew 120 mg skont ir-rispons tal-pazjent.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Mylan.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Duloxetine Mylan.
English: Other information about Duloxetine Mylan
Maltese: Informazzjoni oħra dwar Duloxetine Mylan
English: It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Din taħdem billi tipprevjeni lin-newrotrażmettituri tas-serotonina (5-hydroxytryptamine) u n-noradrenalina milli jerġgħu jiġu assorbiti fiċ-ċelloli nervużi fil-moħħ u fis-sinsla tad-dahar.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Maltese: • uġigħ minħabba newropatija periferika dijabetika (ħsara lin-nervituri fl-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Mylan on 19 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Duloxetine Mylan fid-19 ta' Ġunju 2015.
English: Because Duloxetine Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cymbalta.
Maltese: Billi Duloxetine Mylan huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Cymbalta.
English: Duloxetine Mylan duloxetine
Maltese: Kif jintuża Duloxetine Mylan?
English: For major depression, the recommended dose of Duloxetine Mylan is 60 mg once a day.
Maltese: Għal dipressjoni qawwija, id-doża rakkomandata ta' Duloxetine Mylan hija 60 mg kuljum.
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva f'din il-mediċina, id-duloksetina, hija inibitur tal-assorbiment mill-ġdid ta' serotoninanoradrenalina.
English: Why is Duloxetine Mylan approved?
Maltese: Għaliex ġie approvat Duloxetine Mylan?
English: What are the benefits and risks of Duloxetine Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Duloxetine Mylan?
English: Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Cymbalta, il-benefiċċji huma akbar mir-riskju identifikat.
English: A risk management plan has been developed to ensure that Duloxetine Mylan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Duloxetine Mylan jintuża bl-aktar mod sigur possibbli.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Mylan has been shown to have comparable quality and to be bioequivalent to Cymbalta.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Duloxetine Mylan għandu kwalità komparabbli u huwa bijoekwivalenti għal Cymbalta.
English: This means that Duloxetine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Maltese: Dan ifisser li Duloxetine Mylan jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Cymbalta.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: In-newtrotrażmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw bejniethom.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Maltese: "Gastroreżistenti" tfisser li l-kontenut tal-kapsuli jgħaddi mill-istonku u jibqa' intatt sa meta jilħaq l-intestini.
English: The Committee recommended that Duloxetine Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Duloxetine Mylan ikun approvat għall-użu fl-UE.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Maltese: Għall-uġigħ newropatiku dijabetiku, id-doża rakkomandata hija ta' 60 mg darba kuljum, iżda xi pazjenti aktarx jeħtieġu doża aktar qawwija ta' 120 mg kuljum.
English: Further information on Kigabeq 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: Other common side effects include psychiatric disorders such as agitation, excitedness, aggression, nervousness, depression and paranoid reactions, as well as reduced consciousness and confusion.
Maltese: Effetti sekondarji komuni oħrajn jinkludu disturbi psikjatriċi bħal aġitazzjoni, eċitament, aggressjoni, nervożiżmu, dipressjoni, reazzjonijiet paranojdi, kif ukoll tnaqqis fis-sensi u konfużjoni.
English: The reference medicine for Kigabeq is Sabril (500 mg granules).
Maltese: Il-mediċina ta' referenza għal Kigabeq hija Sabril (granuli ta' 500 mg).
English: The active substance in Kigabeq, vigabatrin, blocks the action of an enzyme called GABA transaminase, which breaks down a substance in the brain called GABA (gamma aminobutyric acid).
Maltese: Is-sustanza attiva f'Kigabeq, il-vigabatrin, timblokka l-azzjoni ta' enzima msejħa GABA transminase, li tkisser sustanza fil-moħħ imsejħa GABA (aċidu gamma-aminobutirriku).
English: Kigabeq contains the active substance vigabatrin and is a ‘hybrid medicine'.
Maltese: Kigabeq fih is-sustanza attiva vigabatrin u huwa "mediċina ibrida".
English: • on its own to treat infantile spasms (West syndrome), a rare epilepsy disorder that starts at a very young age, usually in the first few months of life;
Maltese: • Waħdu għall-kura ta' spażmi infantili (Sindrome ta' West), disturb tal-epilessija rari li jibda minn età żgħira ħafna, normalment fl-ewwel xhur tal-ħajja;
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Kigabeq is available in a different form and strengths.
Maltese: Dan ifisser li huwa simili għal "mediċina ta' referenza" li fiha l-istess sustanza attiva, iżda Kigabeq huwa disponibbli f'forma u f'qawwiet differenti.
English: Other information about Kigabeq
Maltese: Informazzjoni oħra dwar Kigabeq
English: The medicine is available as soluble tablets of 100 or 500 mg, with a score-line so they can be halved.
Maltese: Il-mediċina tiġi bħala pilloli li jinħallu ta' 100 mg jew ta' 500 mg, b'linja minn fejn il-pilloli jistgħu jinqasmu min-nofs.
English: The company provided information from the published literature on the benefits and risks of vigabatrin in the approved uses.
Maltese: Il-kumpanija pprovdiet informazzjoni mil-letteratura ppubblikata dwar il-benefiċċji u r-riskji talvigabatrin fl-użijiet approvati.
English: The most common side effects with vigabatrin (which may affect more than 1 in 10 people) are visual field defects (effects on vision), tiredness, sleepiness and joint pains.
Maltese: L-effetti sekondarji l-aktar komuni bil-vigabatrin (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma difetti fil-kamp viżiv (effetti fuq il-vista), għeja, ngħas u wġigħ fil-goġi.
English: GABA reduces the electrical activity of the brain.
Maltese: GABA tirriduċi l-attività elettrika tal-moħħ.
English: What are the risks associated with Kigabeq?
Maltese: Kif jintuża Kigabeq?
English: It also carried out a study that showed that Kigabeq is bioequivalent to the reference medicine, Sabril.
Maltese: Il-kumpanija wettqet ukoll studju li wera li Kigabeq huwa bijoekwivalenti għall-mediċina ta referenza, Sabril.
English: For the full list of side effects and restrictions with Kigabeq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Kigabeq, ara l-fuljett ta' tagħrif.
English: Vigabatrin should not be used in patients who already have visual field defects.
Maltese: Il-vigabatrin ma għandux jintuża f'pazjenti li diġà għandhom indeboliment sinifikanti difetti fil-kamp viżiv.
English: Rarely there may be effects on the retina (the light-sensing layer at the back of the eye), encephalopathy (brain damage) or attempts at suicide.
Maltese: Rarament jista' jkun hemm effetti fuq ir-retina (is-saff li jipperċepixxi d-dawl fuq wara tal-għajn), enċefalopatija (ħsara fil-moħħ) jew tentattivi ta' suwiċidju.
English: This helps suppress the abnormal electrical activity that leads to infantile spasms and partial epilepsy, and so controls the symptoms of these conditions.
Maltese: Dan jgħin biex irażżan l-attività elettrika anormali li twassal għal spażmi infantili u epilessija parzjali, u b'hekk jikkontrolla s-sintomi ta' dawn il-kondizzjonijiet.
English: As for all medicines, data on the use of Kigabeq are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Kigabeq hija ssorveljata kontinwament.
English: Kigabeq is a medicine for treating epilepsy in children between 1 month and 7 years of age.
Maltese: Kigabeq huwa mediċina għall-kura tal-epilessija fi tfal ta' bejn xahar u 7 snin.
English: How is Kigabeq used?
Maltese: Kif jaħdem Kigabeq?
English: The European Medicines Agency decided that in accordance with EU requirements, Kigabeq has been shown to have comparable quality and to be bioequivalent to Sabril.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE, Kigabeq ntwera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Sabril.
English: Therefore, the Agency's view was that, as for Sabril, Kigabeq's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-opinjoni tal-Aġenzija kienet li, bħal għal Sabril, il-benefiċċji ta' Kigabeq huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: West Nile recombinant canarypox virus (vCP2017 virus)
Maltese: West Nile virus rikombinanti tal-canarypox (virus vCP2017)
English: Other information about Proteq West Nile:
Maltese: Informazzjoni oħra dwar Proteq West Nile:
English: This summary was last updated on 05/08/2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 05/08/2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Proteq West Nile to MERIAL on 05/08/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Proteq West Nile lil MERIAL fi 05/08/2011.
English: Horses vaccinated with Proteq West Nile may have a slightly raised body temperature (up to 1.5°C) lasting up to two days.
Maltese: Żwiemel imlaqqmin bi Proteq West Nile jista' jkollhom temperatura tal-ġisem xi ftit elevata (sa 1.5°C) li ddum sa jumejn.
English: It is available as a suspension for injection.
Maltese: Huwa disponibbli f'sospensjoni għal injezzjoni.
English: Proteq West Nile is a vaccine that contains West Nile recombinant canarypox virus (vCP2017 virus).
Maltese: Proteq West Nile huwa vaċċin li fih il-virus tal-canarypox rikombinanti tal-West Nile (virus vCP2017).
English: Proteq West Nile is a vaccine.
Maltese: Proteq West Nile huwa vaċċin.
English: The vaccine strain vCP2017 in Proteq West Nile is a ‘carrier' canarypox virus that has been given a gene that makes it able to produce part of the West Nile virus, the proteins PreM and E. The canarypox viruses do not spread or multiply in the vaccinated horses.
Maltese: Ir-razza tal-vaċċin vCP2017 fi Proteq West Nile hija virus tal-canarypox ‘ġarrier' li ngħata ġeni li jagħmluh kapaċi jipproduċi parti mill-virus tal-West Nile, il-proteini PreM u E.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is Proteq West Nile?
Maltese: X'inhu Proteq West Nile?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that Proteq West Nile is generally well tolerated and useful in reducing clinical outbreaks of West Nile disease.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkunsidra li Proteq West Nile huwa ġeneralment ittollerat tajjeb u li huwa ta' siwi fit-tnaqqis ta' tifqigħat kliniċi tal-marda tal-West Nile.
English: Why has Proteq West Nile been approved?
Maltese: Għalfejn ġie approvat Proteq West Nile?
English: West Nile disease is a mosquito-borne viral disease that can cause encephalitis (inflammation of the brain) and meningitis (inflammation of the lining of the brain and spinal cord).The vaccine is used to reduce the number of horses with the West Nile virus in their blood (viraemia) or with clinical signs of the disease.
Maltese: Il-marda tal-West Nile hija marda virali li tinġarr min-nemus u li tista' tikkawża enċefalite (infjammazzjoni tal-moħħ) u meninġite (infjammazzjoni tal-inforra tal-moħħ u tal-korda spinali).
English: For a full list of the side-effects reported with Proteq West Nile, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati bi Proteq West Nile, ara lfuljett ta' tagħrif.
English: The withdrawal period is zero days.
Maltese: Il-perjodu ta' tiżmim huwa 0 ġranet.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: L-informazzjoni dwar l-istat tal-preskrizzjoni ta' dan ilprodott tista' tiġi kkonsultata fuq it-tikketta/l-pakkett ta' barra.
English: What is the risk associated with Proteq West Nile?
Maltese: Għal xiex jintuża Proteq West Nile?
English: How has Proteq West Nile been studied?
Maltese: Kif ġie studjat Proteq West Nile?
English: Respiratory events
Maltese: Avvenimenti respiratorji
English: Final CSR December 2021
Maltese: CSR finali Diċembru 2021
English: Oral hypoglycemics: repaglinide
Maltese: Ipogliċemiċi orali: repaglinide
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Maltese: Titanium dioxide (E171) Macrogol 3350
English: Antibiotics: clarithromycin, telithromycin
Maltese: Antibijotiċi: clarithromycin, telithromycin
English: (See the end of section 2 - Important information about the contents of Orkambi.)
Maltese: (Ara t-tmiem ta' sezzjoni 2 - Informazzjoni importanti dwar il-kontenut ta' Orkambi.)
English: Clinical comment erythromycin
Maltese: Kumment kliniku erythromycin
English: Antifungals: itraconazole*, ketoconazole, posaconazole, voriconazole
Maltese: Antifungali: itraconazole*, ketoconazole, posaconazole, voriconazole
English: † From Trials 1, 2 and 3.
Maltese: Minn Provi 1, 2 u 3.
English: 6 to 11 years
Maltese: 6 sa 11-il sena
English: There are different strengths of Orkambi tablet for different age groups.
Maltese: Hemm qawwiet differenti tal-pillola Orkambi għal gruppi differenti ta' età.
English: Blister consisting of PolyChloroTriFluoroEthylene (PCTFE)/PolyVinyl Chloride (PVC) with a paper-backed aluminium foil lidding.
Maltese: Folja li tikkonsisti minn PolyChloroTriFluoroEthylene (PCTFE)/PolyVinyl Chloride (PVC) b'paper-backed foil lidding tal-aluminju.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:19 ta' Novembru, 2015
English: See section 4.5 for interactions with immunosuppressants.
Maltese: Ara sezzjoni 4.5 għal interazzjonijiet ma' immunosoppressanti.
English: LS Means (95% CI)
Maltese: (Least Squares) (95% CI)