FrancophonIA/ELRC3.0 huggingface dataset:
English: In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Maltese: Fi studju dwar l-iżvilupp tal-embriju-fetu tal-far, kien hemm numru akbar ta' uretri mwessa', sternebre malformati, u l-falanġi tas-sieq bid-dwiefer ta' quddiem mingħajr għadam kienu nnutati b'esponimenti ta' madwar 12-il darba (valsartan) u 10 darbiet (amlodipine) id-dożi kliniċi ta' 160 mg valsartan u 10 mg amlodipine.
English: EU/1/06/372/036 280 film-coated tablets (4x70) EU/1/06/372/039 280 film-coated tablets (20x14)
Maltese: EU/1/06/372/039 280 pillola miksija b'rita (20x14)
English: The safety and efficacy of Copalia in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Copalia fit-tfal ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: EU/1/06/372/035 280 film-coated tablets (4x70) EU/1/06/372/038 280 film-coated tablets (20x14)
Maltese: EU/1/06/372/038 280 pillola miksija b'rita (20x14)
English: How to store Copalia
Maltese: X'fih Copalia
English: Copalia 10 mg/160 mg film-coated tablets
Maltese: Copalia 10 mg/160 mg pilloli miksija b'rita
English: Copalia 5 mg/160 mg film-coated tablets
Maltese: Copalia 5 mg/160 mg pilloli miksija b'rita
English: No drug-drug interaction studies have been performed with Copalia and other medicinal products.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni ma' Copalia u prodotti mediċinali oħrajn.
English: EU/1/06/372/009 EU/1/06/372/010 EU/1/06/372/011 EU/1/06/372/012 EU/1/06/372/013 EU/1/06/372/014 EU/1/06/372/015 EU/1/06/372/016 EU/1/06/372/028 EU/1/06/372/029 EU/1/06/372/030 EU/1/06/372/035 EU/1/06/372/038
Maltese: EU/1/06/372/016 EU/1/06/372/028 EU/1/06/372/029 EU/1/06/372/030
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli bi pressjoni għolja (ara sezzjoni 4.1) li għandhom indeboliment epatiku jinqalbu għal amlodipine jew Copalia, għandha tintuża l-inqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Copalia in placebo-controlled studies.
Maltese: Pressjoni baxxa eċċessiva dehret f'0.4% tal-pazjenti b'pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b'Copalia fi studji kontrollati bi plaċebo.
English: There are no clinical studies on fertility with Copalia.
Maltese: Ma saru l-ebda studji kliniċi fuq il-fertilità b'Copalia.
English: What Copalia looks like and contents of the pack Copalia 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Maltese: Copalia 5 mg/80 mg pilloli huma tondi u sofor skuri b' “NVR” fuq naħa u “NV” fuq in-naħa l-oħra.
English: Hyperglycaemia
Maltese: Kif taħżen Copalia
English: Copalia combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Maltese: Copalia jikkombina żewġ sustanzi kontra l-pressjoni għolja ma' mekkaniżmi kumplimentari sabiex tkun kontrollata l-pressjoni tad-demm f'pazjenti b'pressjoni għolja naturali: amlodipine huwa membru ta' klassi li huma antagonisti ta' calcium u valsartan ta' klassi ta' mediċini li huma antagonisti ta angiotensin II. Il-kombinazzjoni ta' dawn iż-żewġ sustanzi twassal għal effett kontra l-pressjoni għolja adittiv, b'mod li l-pressjoni titbaxxa aktar milli kieku jingħataw il-mediċini waħidhom.
English: Copalia 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Maltese: Copalia 5 mg/80 mg jista' jingħata lill-pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b'amlodipine 5 mg jew valsartan 80 mg waħidhom.
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli anzjani bi pressjoni għolja (ara sezzjoni 4.1) jinqalbu għal amlodipine jew Copalia, għandha tintuża linqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: Lifmior etanercept
Maltese: Lifmior etanersept
English: The full EPAR for Lifmior 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: It contains the active substance etanercept.
Maltese: Fih is-sustanza attiva etanersept.
English: Other information about Lifmior
Maltese: Informazzjoni oħra dwar Lifmior
English: In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Maltese: Fl-adulti, id-doża rakkomandata normali hija 25 mg darbtejn fil-ġimgħa jew 50 mg darba fil-ġimgħa.
English: Further studies have been carried out in over 2,300 patients with other inflammatory diseases (juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and axial spondyloarthritis).
Maltese: Saru iktar studji f'iktar minn 2,300 pazjent b'mard infjammatorju ieħor (artrijte idjopatika ġuvenili, artrite psorjatika, spondilite ankilosanti , psorjasi tal-plakka u spondiloartrite assjali).
English: This is a summary of the European public assessment report (EPAR) for Lifmior.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lifmior.
English: In rheumatoid arthritis, five studies have been carried out involving around 2,200 patients.
Maltese: Fl-artrite rewmatojde, saru ħames studji li involvew madwar 2,200 pazjent.
English: Three of these studies in patients who had taken arthritis medicines in the past showed about two-thirds of the patients who received Lifmior had a reduction in symptoms of 20% or more after three months based on a standard rating score (ACR 20).
Maltese: Tlieta minn dawn l-istudji f'pazjenti li ħadu l-mediċini għall-artrite fil-passat urew li madwar żewġ terzi tal-pazjenti li rċevew Lifmior kellhom tnaqqis fis-sintomi ta' 20% jew iktar wara tliet xhur skont punteġġ ta' klassifikazzjoni standard (ACR 20).
English: The most common side effects with Lifmior (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Maltese: L-effetti sekondarji l-aktar komuni b'Lifmior (li dehru f'iktar minn pazjent 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (inkluż dmija, tbenġil, ħmura, ħakk, uġigħ u nefħa), u infezzjonijiet (inkluż irjiħat, u infezzjonijiet fil-pulmun, fil-bużżieqa tal-awrina u fil-ġilda).
English: What is the risk associated with Lifmior?
Maltese: X'inhu r-riskju assoċjat ma' Lifmior?
English: The active substance in Lifmior, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Lifmior, etanersept, hija proteina li tfasslet biex timblokka l-attività ta' sustanza magħrufa bħala fattur tan-nekrożi tumorali (TNF).
English: • psoriatic arthritis (psoriasis with inflammation of the joints) in adults
Maltese: • artrite psorjatika (psorjasi b'infjammazzjoni tal-ġogi) fl-adulti
English: Why is Lifmior approved?
Maltese: Għaliex ġie approvat Lifmior?
English: In a fourth study of rheumatoid arthritis patients who had not taken methotrexate before, those receiving 25 mg Lifmior twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months.
Maltese: F'raba' studju ta' pazjenti b'artrite rewmatojde li qatt qabel ma kienu ħadu methotrexate, dawk li kienu qed jieħdu 25 mg Lifmior darbtejn fil-ġimgħa kellhom inqas ħsara fil-ġogi minn dawk li kienu qed jieħdu methotrexate waħidha wara 12 u 24 xahar.
English: • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.
Maltese: • spondiloartrite assjali (marda infjammatorja kronika tas-sinsla tad-dahar fl-adulti meta ma jkunx hemm anomaliji nnotati fuq ir-raġġi X.
English: The company that markets Lifmior will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.
Maltese: Il-kumpanija li tikkummerċjalizza Lifmior se tipprovdi materjal edukattiv għat-tobba li mistennija jippreskrivu l-prodott biex jgħallmu lill-pazjenti kif jużaw il-pinna mimlija għal-lest b'mod korrett u kard ta' twissija speċjali għall-pazjenti sabiex ikunu jistgħu jagħrfu effetti sekondarji serji, u jkunu jafu meta għandhom ifittxu attenzjoni urġenti mit-tabib tagħhom.
English: Several studies have shown that Lifmior is more effective at reducing symptoms of inflammatory conditions than placebo (a dummy treatment) or a comparator medicine.
Maltese: Diversi studji wrew li Lifmior hu iktar effettiv biex jitnaqqsu sintomi ta' kundizzjonijiet infjammatorji minn plaċebo (kura finta) jew mediċina komparatur.
English: • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults
Maltese: • spondilite ankilotika (marda li tikkawża infjammazzjoni fil-ġogi tas-sinsla tad-dahar) fl-adulti
English: Lifmior is an anti-inflammatory medicine for treating the following diseases:
Maltese: Lifmior hu mediċina antiinfjammatorja għall-kura tal-mard li ġej:
English: The CHMP therefore concluded that Lifmior's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP għalhekk ikkonkluda li l-benefiċċji ta' Lifmior huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Lifmior is identical to Enbrel, which has been authorised in the EU since 3 February 2000.
Maltese: Lifmior hu identiku għal Enbrel, li ġie awtorizzat fl-UE mit-3 ta' Frar 2000.
English: Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Lifmior is used for.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Lifmior.
English: These studies also showed that Lifmior produced a greater improvement in symptoms than placebo after three to four months using various standard rating scores such as ACR, ASAS and PASI.
Maltese: Dawn l-istudji wrew ukoll li Lifmior ipproduċa iktar titjib fis-sintomi minn plaċebo wara tlieta sa erba' xhur bl-użu ta' punteġġi ta' klassifikazzjoni standard bħal pereżempju ACR, ASAS u PASI.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Maltese: Billi jimblokka t-TNF, etanersept inaqqas l-infjammazzjoni u sintomi oħrajn tal-mard.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children
Maltese: • psorjasi tal-plakka (marda li tikkawża rqajja' ħomor, bil-qoxra fuq il-ġilda) fl-adulti u t-tfal
English: A fifth study showed that Lifmior on its own or in combination with methotrexate was more effective than methotrexate alone.
Maltese: Ħames studju, wera li Lifmior waħdu jew meħud flimkien ma' methotrexate kien iktar effikaċi minn methotrexate waħdu.
English: • certain forms of juvenile idiopathic arthritis (inflammation of joints in children and adolescents)
Maltese: • ċerti forom ta' artrite idjopatika ġuvenili (infjammazzjoni tal-ġogi fit-tfal u l-adolexxenti)
English: How does Lifmior work?
Maltese: Kif jintuża Lifmior?
English: • Instanyl nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Maltese: • L-isprej għall-imnieħer Instanyl huwa indikat biss għall-ġestjoni ta' uġigħ qawwi f'daqqa f'adulti li diġà qed jirċievi terapija ta' manteniment b'opijodi għal uġigħ kroniku tal-kanċer.
English: The Member States should ensure that, the MAH provides all physicians, pharmacists and patients expected to prescribe/dispense/use Instanyl with educational material regarding the correct and safe use of the product.
Maltese: Sejjer jitħejja materjal edukattiv għall-pazjenti, għat-tobba u għall-ispiżjara li jipprovdi informazzjoni rigward l-użu korrett u mingħajr periklu tal-prodott permezz ta' materjal edukattiv:
English: • The pharmacist must be familiar with the educational material of Instanyl nasal spray before using it in his/her organisation.
Maltese: • L-ispiżjar għandu jkun familjari mal-materjal edukattiv tal-isprej għall-imnieħer li fih fentanyl qabel ma jużah fl-organizzazzjoni tiegħu.
English: • The Instanyl nasal spray dose strengths cannot be compared with other Fentanyl products.
Maltese: • Il-qawwiet tad-dożi tal-isprej għall-imnieħer Instanyl ma jistgħux jitqabblu ma' prodotti oħra b'fentanyl.
English: • The prescribers of Instanyl nasal spray must critically select the patients and counsel them on:
Maltese: Materjal edukattiv għall-pazjenti għandu jinkludi dan li ġej:
English: • Instructions for opening and closing of the child-resistant box (for the multidose nasal spray) or blister (for the single-dose nasal spray)
Maltese: L-Istati Membri għandhom jiżguraw li l -kundizzjonijiet u r-restrizzjonijiet kollha fir-rigward tal-użu mingħajr periklu u effettiv tal-prodott mediċinali deskritti hawn taħt jiġu implimentati:
English: • For the multi-dose nasal spray: information about the dose counting scheme
Maltese: • Għall-isprej għall-imnieħer ta' ħafna dożi informazzjoni dwar l-indikazzjoni korretta
English: • Information about dose counting scheme included in the labelling and the educational material for the multi-dose nasal spray
Maltese: • L-informazzjoni dwar l-iskema tal-għadd tad-dożi nkluża fit-tikketta u fil-materjal edukattiv lura b'mod sistematiku skont ir-regolamenti lokali.
English: • Instanyl nasal spray should be used only by physicians experienced in the management of opioid therapy in cancer patients.
Maltese: • Uża biss l-isprej għall-imnieħer Instanyl jekk ikunu qed jesperjenzaw episodji ta' uġigħ tal-kanċer li jiżdied f'daqqa.
English: Educational material for the pharmacists should highlight the following:
Maltese: Materjal edukattiv għall-ispiżjara għandu jenfasizza dan li ġej:
English: • For the single-dose nasal spray all unused devices should be returned systematically according to the local regulation.
Maltese: lura b'mod sistematiku skont ir-regolamenti lokali.
English: Kivexa abacavir and lamivudine
Maltese: Kivexa abacavir u lamivudina
English: The full EPAR for Kivexa 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: In the first study, 66% (253 out of 384) of the patients taking abacavir once a day had viral loads below 50 copies/ml after 48 weeks of treatment, compared with 68% (261 out of 386) of the patients taking it twice a day.
Maltese: Fl-ewwel studju, 66% (253 minn 384) tal-pazjenti li ħadu labakavir darba kuljum kellhom tagħbijiet virali inqas minn 50 kopja/ml wara 48 ġimgħa ta' kura, meta mqabbla ma' 68% (261 minn 386) tal-pazjenti li ħaduh darbtejn kuljum.
English: Kivexa has been studied in three main studies involving a total of 1,230 patients.
Maltese: Kivexa ġie studjat fi tliet studji ewlenin, li fihom ħadu sehem 1,230 pazjent.
English: Other information about Kivexa
Maltese: Aktar informazzjoni dwar Kivexa
English: The most common side effects with Kivexa (seen in between 1 and 10 patients in 100) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal pain (stomach ache), headache, arthralgia (joint pain), muscle disorders, cough, nasal symptoms (nose problems, such as irritation and runny nose), fever, lethargy (lack of energy), tiredness, insomnia (difficulty sleeping), malaise (feeling unwell), loss of appetite and alopecia (hair loss).
Maltese: L-effetti sekondarji l-aktar komuni b'Kivexa (li dehru f'bejn pazjent 1 u 10 minn 100) huma ipersensittività (reazzjonijiet allerġiċi), raxx, nawżja (dardir), remettar, dijarea, uġigħ addominali (uġigħ ta' stonku), uġigħ ta' ras, artralġija (uġigħ fil-ġogi), disturbi fil-muskoli, sogħla, sintomi nażali (problemi fl-imnieħer bħal irritazzjoni jew imnieħer inixxi), deni, letarġija (nuqqas ta' enerġija), eżawriment (għeja), insomnija (diffikultà biex torqod), telqa (ma tħossokx f'sikktek), telf ta' aptit u alopeċja (telf ta' xagħar).
English: Kivexa is a medicine that contains two active substances, abacavir (600 mg) and lamivudine (300 mg).
Maltese: Kivexa huwa mediċina li fiha żewġ sustanzi attivi, l-abakavir (600 mg) u l-lamivudina (300 mg).
English: This document is a summary of the European public assessment report (EPAR) for Kivexa.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kivexa.
English: The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene.
Maltese: Ir-riskju ta' ipersensittività huwa ogħla filpazjenti li għandhom il-ġene HLA-B (tip 5701).
English: Both active substances in Kivexa, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: Iż-żewġ sustanzi attivi f'Kivexa, l-abakavir u l-lamivudina, huma inibituri nukleosidiċi tat-transkrittażi inversa (NRTIs).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kivexa on 17 December 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Kivexa valida fl-Unjoni Ewropea kollha fis-17 ta' Diċembru 2004.
English: The combination tablet taken once a day was also as effective as the medicines taken separately twice a day in reducing viral loads over 24 weeks of treatment.
Maltese: Il-pillola li fiha lkombinazzjoni meħuda darba kuljum kellha wkoll l-istess effikaċja daqs dik tal-mediċini meħudin separatament darbtejn kuljum fit-tnaqqis tat-tagħbijiet virali matul 24 ġimgħa ta' kura.
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, dyspnoea (difficulty breathing), cough, lethargy, malaise, headache, signs of liver damage in the blood and myalgia (muscle pain).
Maltese: Fost is-sintomi kważi dejjem hemm deni jew raxx, iżda huma wkoll komuni ħafna nawżja, remettar, dijarea, uġigħ addominali, dispnea (diffikultà biex tieħu nnifs), sogħla, letarġija, telqa (ma tħossokx f'sikktek), uġigħ ta' ras, sinjali ta' ħsara tal-fwied fid-demm u mijalġija (uġigħ fil-muskoli).
English: What is the risk associated with Kivexa?
Maltese: X'inhu r-riskju assoċjat ma' Kivexa?
English: Therefore, the studies compared abacavir taken at a dose of 600 mg once a day and at a dose of 300 mg twice a day, in combination with lamivudine and one or two other antiviral medicines.
Maltese: Għaldaqstant, l-istudji qabblu l-abakavir meħud f'doża ta' 600 mg darba kuljum u f'doża ta' 300 mg darbtejn kuljum, flimkien mal-lamivudina u mediċina antivirali waħda oħra jew tnejn oħra.
English: Kivexa is used in combination with at least one other antiviral medicine to treat adults and children weighing at least 25 kg who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Jintuża flimkien ma' tal-anqas mediċina antivirali oħra għall-kura ta' adulti u tfal li jiżnu mill-inqas 25 kg li huma infettati bil-vajrus tal-immunodefiċjenza umana (HIV), il-vajrus li jikkawża s-sindromu millimmunodefiċjenza akkwiżita (AIDS).
English: What is Kivexa?
Maltese: Kif jintuża Kivexa?
English: How has Kivexa been studied?
Maltese: Kif ġie studjat Kivexa?
English: Both active substances have been available in the European Union (EU) since the late 1990s: abacavir has been authorised as Ziagen since 1999, and lamivudine has been authorised as Epivir since 1996.
Maltese: Iż-żewġ sustanzi attivi ilhom disponibbli fl-Unjoni Ewropea (UE) mill-aħħar tad-disgħinijiet: l-abakavir ilu awtorizzat bħala Ziagen mill-1999, u l-lamivudina ilha awtorizzata bħala Epivir mill-1996.
English: Why has Kivexa been approved?
Maltese: Għaliex ġie approvat Kivexa?
English: Patients who need to adjust the dose of abacavir or lamivudine should take the medicines separately.
Maltese: Il-mediċina tista' tinkiseb biss bi preskrizzjoni medika.
English: Kivexa does not cure HIV infection or AIDS, but can delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Kivexa ma jfejjaqx infezzjoni mill-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara prodotta lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Kivexa, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Kivexa, meħud flimkien ma' tal-anqas mediċina oħra tal-HIV, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: The CHMP decided that Kivexa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Kivexa huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Maltese: It-tnejn li huma jaħdmu b'mod simili billi jimblukkaw l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV li tippermetti l-vajrus jinfetta ċ-ċelloli u jiġġenera aktar virusis.
English: A risk management plan has been developed to ensure that Kivexa is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Kivexa jintuża bl-aktar mod sigur possibbli.
English: At the time of Kivexa's authorisation, abacavir was authorised at a dose of 300 mg twice a day.
Maltese: Fiż-żmien meta Kivexa ġie awtorizzat, l-abakavir kiseb awtorizzazzjoni f'doża ta' 300 mg darbtejn kuljum.
English: What is Kivexa used for?
Maltese: Kif jaħdem Kivexa?
English: For more information and the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: Two studies used the active substances taken as separate medicines, while the third used a combination tablet for the once-daily dose.
Maltese: Żewġ studji użaw is-sustanzi attivi meħuda bħala mediċini separati, filwaqt li t-tielet wieħed uża pillola li fiha kombinazzjoni tad-doża darba kuljum.
English: 8.8 µg/0.1 ml 22 µg/0.25 ml
Maltese: 8.8 µg/0.1 mL 22 µg/0.
English: Initiation pack: 2 cartridges
Maltese: 2 skrataċ
English: Initiation pack: 6 pre-filled syringes of 8.8 µg + 6 pre-filled syringes of 22 µg
Maltese: 6 pinen mimlijin għallest ta' Rebif 8.8 mikrogrammi u 6 pinen mimlijin għallest ta' Rebif 22 mikrogrammi
English: International non-proprietary name (INN): altrenogest
Maltese: Isem mhux proprjetarju internazzjonali (INN): altrenogest
English: The Committee appointed Dr C. Ibrahim as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Maltese: Holzhauser-Alberti bħala ko-rapporteur.
English: This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Maltese: Din hija applikazzjoni ġenerika skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza, is-soluzzjoni żejtnija ta' 4 mg/ml ta' Regumate.