FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina 30-49 ml/min) id-doża għandha tkun ta' 10 mg (1 ml ta' soluzzjoni, ekwivalenti għal żewġ għafsiet lisfel).
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5 - 1 µmol) with large interindividual variations.
Maltese: Dożi ta' 20 mg kuljum jwasslu għal konċentrazzjonijiet ta' memantine fil-plażma fi stat fiss f'medda ta' bejn 70 sa 150 ng/ml (0.5-1µmol) b'varjazzjonijiet kbar bejn individwu.u ieħor.
English: BATCH NUMBER
Maltese: LOTT B.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropea dwar il-Mediċini (EMA) http://www.ema.europa.eu/.
English: Package leaflet: Information for the user
Maltese: Kontenuttal-pakkett u informazzjoni oħra
English: Memantine Merz 20 mg film-coated tablets Memantine hydrochloride
Maltese: Memantine Merz 20 mg pilloli miksijin b'rita Memantine hydrochloride
English: One pump actuation contains 5mg memantine hydrochloride.
Maltese: Għafsa waħda fiha 5 mg ta' Memantine hydrochloride.
English: Memantine Merz acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Maltese: Memantine Merz jaħdem fuq dawn ir riċetturi-NMDA u it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment renali moderat (rata ta' tneħħija tal kreatinina 30-49 ml/min) id-doża għandha tkun 10 mg kuljum.
English: Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Maltese: Dożi eċċessivi relattivament għoljin (200 mg u 105 mg/jum għal 3 ijiem, rispettivament) kienu assoċjati ma' sintomi ta' għeja biss, dgħjufija u/jew dijarea jew ma ebda sintomu.
English: Memantine Merz 5mg Memantine Merz 10 mg Memantine Merz 15 mg Memantine Merz 20 mg film-coated tablets
Maltese: Memantine Merz 5 mg Memantine Merz 10 mg Memantine Merz 15 mg Memantine Merz 20 mg Pilloli miksija b'rita
English: - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Memantine Merz tablets (see section 6).
Maltese: - jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal memantine hydrochloride jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: Memantine Merz film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or in multipacks of 840 (20 x 42) tablets.
Maltese: Il-pilloli miksijin b'rita ta' Memantine Merz jiġu f'pakketti ta' folji bi 14-il pillola, 28 pillola, 42 pillola, 56 pillola, 98 pillola.
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Memantine Merz and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Memantine Merz did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Maltese: Fi provi kliniċi f'pazjenti b'dimenzja severa għal moderata, b'1,784 pazjent ikkurat b'Memantine Merz u 1,595 pazjent ikkurat bi plaċebo, ir-rata globali ta' reazzjonijiet avversi li seħħew b'Memantine Merz ma kinitx differenti min dik tal-plaċebo; ir-reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil-qawwa.
English: Memantine Merz 5 mg/pump actuation, oral solution memantine hydrochloride
Maltese: Memantine Merz 5 mg/għafsa soluzzjoni orali memantine hydrochloride
English: Breast-Feeding
Maltese: TAL-PRODOTT
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
Maltese: F'pazjenti b'indeboliment epatiku ħafif għal moderat (Child-Pugh A u Child-Pugh B) m'hemmx bżonn ta' tibdil fid-doża.
English: Memantine Merz 10 mg film-coated tablets Memantine hydrochloride
Maltese: Memantine Merz 10 mg pilloli miksijin b'rita Memantine hydrochloride
English: One pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Maltese: Kull attivazzjoni tal-pompa (għafsa waħda l-isfel) tagħti 0.5 ml ta' soluzzjoni li fiha 5 mg ta' memantine hydrochloride ekwivalenti għal 4.16 mg ta' memantine.
English: No genotoxicity has been observed following testing of memantine in standard assays.
Maltese: Ma ġiet osservata l-ebda tossiċità għal ġeni wara testijiet b'memantine f'assaġġi standard.
English: Memantine Merz oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Maltese: Is-soluzzjoni orali Memantine Merz, tiġi fi fliexken ta' 50 ml, 100 ml jew 10 x 50 ml.
English: Treatment of patients with moderate to severe Alzheimer's disease.
Maltese: Kura ta' pazjenti bil-marda ta' Alzheimer moderata għal severa.
English: Pack sizes of 14, 28, 30, 42, 50, 56, 98, 100, 112, and multipacks containing 840 (20 x 42), 980 (10 x 98) or 1000 (20 x 50) tablets are presented.
Maltese: Pakketti multipli ta' 840 (10 x 42), 980 (10 x 98) jew 1000 (20 x 50) pillola.
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Maltese: Minbarra hekk, il-pH ta' l-awrina tista' titla minħabba każijiet ta' aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal-passaġġ awrinarju b'Proteus bacteria.
English: Pancreatitis2
Maltese: Tittrazzjoni tad-doża
English: Magnesium stearate
Maltese: Titrazzjoni tad-doża
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very rare (may affect up to 1 in 10,000 users):
Maltese: • Uġigħ ta' ras, ngħas, stitkezza, testijiet tal-funzjoni tal-fwied għoljin, sturdament, disturbi tal bilanċ, qtugħ ta' nifs, pressjoni għolja tad-demm u sensittivita' eċċessiva għal-mediċini Mhux komuni (jistgħu jaffettwaw sa persuna minn kull 100 utent):
English: INSTRUCTIONS ON USE
Maltese: Informazzjoni għall utent
English: Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride li hi ekwivalenti għal 8.31 mg memantine.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Maltese: Skala ta' assessjar tal-marda Alzheimer ADAS-cog (p=0.003) u CIBIC-plus (p=0.004) f'Ġimgħa 24
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhoea).
Maltese: Il-pazjent kellu sintomi fuq is-sistema nervuża ċentrali fosthom, ma setgħax joqod bi kwietu, psikożi, alluċinazzjonijiet tal-vista, pro-aċċessjonijiet, ngħas, sturdament u telf mis-sensi.
English: Memantine Merz 20 mg
Maltese: Memantine Merz pilloli ta' 20 mg
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: 1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Maltese: 1 Alluċinazzjonijiet dehru l-aktar f'pazjenti bil-marda ta' Alzheimer severa.
English: half a 10 mg tablet week 2
Maltese: nofs pillola ta' 10 mg ġimgħa 2
English: B. PACKAGE LEAFLET
Maltese: PAKKETT INTERMEDJU /
English: PHARMACEUTICAL FORM
Maltese: PROPRJETAJIET FARMAKOLOĠIĊ
English: The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Maltese: L-użu ta' prodotti mediċinali msejjħa amantadine (għat-trattament tal-marda ta' Parkinson), ketamine (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment użata għas-sogħla) u antagonisti oħra ta' NMDA fl-istess ħin għandu jkun evitat.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Maltese: Fl-aktar każ estrem ta' doża eċċessiva, il-pazjent irnexxielu jibqa ħaj meta ħa b'mod orali 2000 mg memantine b'effetti fuq is-sistema nervuża ċentrali (koma għal 10 t'ijiem, u wara kellu diplopja u aġitazzjoni).
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p<0.0001).
Maltese: Meta pazjenti deher li marru għall-agħar fit-tlett oqsma, ir-riżultati wrew effett statistikament sinifikanti ta' memantine biex jevita li jmorru għall-agħar, darbtejn aktar mill-pazjenti ikkurati bi plaċebo hekk kif pazjenti kkurati b'memantine marru għall-agħar fit-tlett oqsma (21% vs. 11%, p<0.0001).
English: Memantine Merz belongs to a group of medicines known as anti-dementia medicines.
Maltese: Memantine Merz jagħmel parti minn grupp ta' mediċini magħrufa bħala mediċini kontra d-dimenzja.
English: Memantine Merz 20 mg tablets
Maltese: Memantine Merz 20 mg pilloli miksijin b'rita
English: Memantine Merz 5 mg film-coated tablets Memantine Merz 10 mg film-coated tablets Memantine Merz 15 mg film-coated tablets Memantine Merz 20 mg film-coated tablets Memantine hydrochloride
Maltese: Memantine Merz 5 mg pilloli miksijin b'rita Memantine Merz 10 mg pilloli miksijin b'rita Memantine Merz 15 mg pilloli miksijin b'rita Memantine Merz 20 mg pilloli miksijin b'rita Memantine hydrochloride
English: Memantine Merz is not recommended for children and adolescents under the age of 18 years.
Maltese: Memantine Merz mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: Pack sizes of 14, 28, 42, 56, 98 or multipacks containing 840 (20 x 42) film-coated tablets are presented.
Maltese: Daqsijiet tal-pakkett ta' 14, 28, 42, 56, 98 pillola miksija b'rita huma disponibbli.
English: three pump actuations week 4 and beyond four pump actuations
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Package leaflet: Information for the user Memantine Merz 20 mg film-coated tablets
Maltese: Informazzjoni għall utent Memantine Merz 20 mg pilloli miksijin b'rita
English: Drug hypersensitivity
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Merz Pharma GmbH & Co. KGaA Eckenheimer Landstr.
Maltese: Merz Pharma GmbH & Co.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: Relazzjoni farmaokinetika/farmakodinamika
English: Component of a multipack, can't be sold separately.
Maltese: Jagħmel parti minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta'
English: Memantine Merz contains sorbitol
Maltese: Kif jidher Memantine Merz u l-kontenuti tal-pakkett
English: EU/1/12/799/013 EU/1/12/799/014 EU/1/12/799/015 EU/1/12/799/016 EU/1/12/799/017 EU/1/12/799/018 EU/1/12/799/019 EU/1/12/799/020 EU/1/12/799/021 EU/1/12/799/022 EU/1/12/799/023 EU/1/12/799/024
Maltese: EU/1/12/799/017 EU/1/12/799/018 EU/1/12/799/019 EU/1/12/799/020
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Maltese: Fi studju ieħor b'terapija waħda għal marda ta' Alzheimer ħafifa għal moderata, total ta' 470 pazjent (punteġġi totali MMSE mal-linja bażi ta' 11-23) kienu randomizzati.
English: Memantine Merz should be administered orally once a day.
Maltese: Memantine Merz għandha tingħata b'mod orali darba kuljum.
English: In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Maltese: F'pazjenti b'indeboliment sever renali (tneħħija tal-kreatinina 5-29 ml/min) id-doża għandha tkun 10 mg (1 ml ta' soluzzjoni,
English: See package leaflet for further information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Memantine Merz 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped filmcoated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Maltese: Il-pilloli miksijin b'rita ta' 10 mg huma sofor ċari għal sofor, miksijin b'rita u b'forma ovali, b'xaqq minn fejn tista' taqsam il-pillola u mnaqqxin b' “1-0” fuq naħa waħda u b' “M M” fuq in-naħa l-oħra.
English: Concomitant use of N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Maltese: L-użu fl-istess ħin ta' antagonisti-N-methyl-D-aspartate (NMDA) oħra bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) -and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Maltese: Skala ta' assessjar tal-marda ta' Alzheimer (ADAS-cog) (p=0.003) u CIBIC-plus (p=0.004)
English: No special requirements.
Maltese: Ilma purifikat
English: The recommended daily dose is 20 mg once a day.
Maltese: Id-doża ta' manteniment rakkomandata hi ta' 20 mg kuljum.
English: Dosage
Maltese: Anzjani
English: Dyspnoea
Maltese: Sturdament
English: Colloidal anhydrous silica
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Package leaflet: Information for the user Memantine Merz 5 mg/pump actuation, oral solution
Maltese: IL-PRODOTT MEDIĊINALI Memantine Merz 5 mg/għafsa soluzzjoni orali
English: Tablet cores for 5/10/15/20 mg film-coated tablets Microcrystalline cellulose Croscarmellose sodium
Maltese: Meta ngħataw dożi ta' 5 sa 30 mg kuljum, il-proporzjon tal-medja ta' fluwidu ċerebrospinali CSF/serum kien kalkolat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (10 x 50 ml) WRAPPED IN FOIL (INCLUDING BLUE BOX)
Maltese: TIKKETTA TAT-TGEŻWIR TA' BARRA FUQ IL-MULTIPAKKS (10 x 50 ml) MGEŻWRA FIL-FOJL (LI JINKLUDI L-KAXXA BLU)
English: The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Maltese: Il-pilloli miksijin b'rita ta' 15 mg huma oranġjo għal oranġjo griżi, pilloli miksijin b'rita li huma ovalioblong b'intaljar ta' ‘15' fuq naħa u ‘MEM' fuq naħa oħra.
English: • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Maltese: • Infjammazzjoni tal-frixa, infjammazzjoni tal-fwied (epatite) u reazzjonijiet psikotiċi
English: Lundbeck B.V. Tel: +31 20 697 1901
Maltese: Tel: +31 20 697 1901
English: Memantine Merz 5 mg film-coated tablets Memantine Merz 10 mg film-coated tablets Memantine Merz 15 mg film-coated tablets Memantine Merz 20 mg film-coated tablets
Maltese: Memantine Merz 5 mg pilloli miksijin b'rita Memantine Merz 10 mg pilloli miksijin b'rita Memantine Merz 15 mg pilloli miksijin b'rita Memantine Merz 20 mg pilloli miksijin b'rita
English: Elevated liver function test
Maltese: Test tal-funzjoni tal-fwied għoli
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Maltese: F'każ ta' sinjali u sintomi ta' simulazzjoni eċċessiva tas-Sistema Nervuża Ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas-sintomi bir-reqqa.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta'
English: At a dose of memantine of 20 mg per day the (CSF) levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
Maltese: B'doża ta' 20 mg memantine kuljum il-livelli ta' CSF qablu mal-valur-ki (ki = kostanti ta' l-impediment) ta' memantine, li hija 0.5µmol fil-kortiċi ta' quddiem tal-bniedem.
English: • The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Maltese: • Il-mod kif jaħdem jindika li l-effeti ta' L-Dopa, agonisti dopaminerġiċi, u antikolinerġiċi jistgħu jkunu aktar qawwija meta jingħataw flimkien ma' antaginisti ta' NMDA bħal memantine.
English: The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Maltese: psikożi, alluċinazzjonijiet tal-vista, pro-aċċessjonijiet, ngħas, sturdament u telf mis-sensi.
English: Lundbeck Italia S.p.A. Tel: +39 02 677 4171
Maltese: Merz Pharma España S.L. Tel: +34 91 657 47 84
English: It contains the active substance enfuvirtide (90 mg/ml).
Maltese: Fih is-sustanza attiva enfuvirtide (90 mg/ml).
English: Fuzeon is an antiviral medicine.
Maltese: Fuzeon hu mediċina antivirali.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FUZEON EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) FUZEON Sommarju ta' l-EPAR għall-pubbliku
English: Other information about Fuzeon:
Maltese: Informazzjoni oħra dwar Fuzeon:
English: The active substance in Fuzeon, enfuvirtide, is a fusion inhibitor.
Maltese: Is-sustanza attiva f'Fuzeon, enfuvirtide, hija inibitur tal-fużjoni.
English: The values in the second study were 96 and 78%, respectively.
Maltese: Il-valuri fit-tieni studju kienu 96 u 78% rispettivament.
English: The marketing authorisation was renewed on 27 May 2008.
Maltese: L-awtorizzazzjoni għattqegħid fis-suq ġiet imġedda fis-27 ta' Mejju 2008.
English: It is used in combination with other antiviral medicines for the treatment of patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Jintuża flimkien ma' mediċini antivirali oħra fit-trattament ta' pazjenti infettati bil-virus ta' l-immunodefiċjenza umana tat-tip 1 (HIV 1), virus li jikkawża l-acquired immune deficiency syndrome (AIDS).
English: In the first study, viral loads fell by an average of 98% in the patients taking Fuzeon, compared with 83% in the patients not taking Fuzeon.
Maltese: Fl-ewwel studju, il-viral loads naqsu b'medja ta' 98% fil-pazjenti li kienu qed jieħdu Fuzeon, meta imqabbla ma' 83% fil-pazjenti li ma kinux qed jieħdu Fuzeon.
English: This summary was last updated in 07-2008.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 07-2008.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The approved dose of Fuzeon in children brings about similar levels of the active substance in the blood to the approved dose in adults.
Maltese: Id-doża approvata ta' Fuzeon fit-tfal twassal għal livelli ta' sustanza attiva fid-demm simili għad-doża approvata fl-adulti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fuzeon to Roche Registration Limited on 27 May 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Fuzeon lil Roche Registration Limited fis-27 ta' Mejju 2003.
English: What is Fuzeon?
Maltese: X'inhu Fuzeon?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Fuzeon's benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Fuzeon jisbqu r-riskji tiegħu f'kombinazzjoni ma' prodotti mediċinali antiretrovirali oħra għattrattament ta' pazjenti infettati bl-HIV-1 li jkunu ngħataw trattament jew li ma jkunux marru għallaħjar bi programmi ta' trattament li jkunu jikkonsistu minn ta' l-inqas prodott mediċinali wieħed millklassijiet li ġejjin, protease inhibitors, non-nucleoside reverse transcriptase inhibitors u nucleoside reverse transcriptase inhibitors, jew li jkollhom intolleranza għal programmi ta' trattament bilmediċini antiretrovirali ta' qabel.
English: These must include at least one medicine from each of the following classes of medicine used to treat HIV infection: protease inhibitors; non-nucleoside reverse transcriptase inhibitors; and nucleoside reverse transcriptase inhibitors.
Maltese: Dawn ikunu jridu jinkludu ta' l-inqas mediċina waħda minn kull waħda mill-klassijiet segwenti ta' mediċini wżati fit-trattament ta' l-infezzjoni ta' l-HIV: protease inhibitors, non-nucleoside reverse transcriptase inhibitors u nucleoside reverse transcriptase inhibitors.
English: Fuzeon has also been studied in 39 children aged between three and 16 years.
Maltese: Fuzeon ġie studjat ukoll f'39 tifel u tifla ta' bejn tlieta u 16-il sena.
English: Why has Fuzeon been approved?
Maltese: Għaliex ġie approvat Fuzeon?
English: The medicine can only be obtained with a prescription.
Maltese: Reproduction is authorised provided the source is acknowledged
English: The two main studies of Fuzeon included 1,013 patients aged 16 years or over who were infected with HIV and had taken, or were not responding to, other antiviral medicines.
Maltese: Iż-żewġ studji ewlenin ta' Fuzeon inkludew 1,013-il pazjent minn 16-il sena 'l fuq li kienu infettati blHIV u li kienu ħadu, jew li ma kinux qed jirrispondu għal, mediċini antivirali oħra.
English: Taking Fuzeon with optimised background therapy was more effective at reducing viral loads than optimised background therapy alone.
Maltese: It-teħid ta' Fuzeon ma' terapija ta' sfond ottimizzata kien iktar effettiv mit-terapija l-oħra waħidha fittnaqqis tal-viral loads.
English: What is the risk associated with Fuzeon?
Maltese: X'riskji huma assoċjati ma' Fuzeon?
English: As with all other anti-HIV medicines, patients taking Fuzeon may be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Maltese: Bħal fil-każijiet kollha l-oħra ta' mediċini kontra l-HIV, il-pazjenti li jkunu qed jieħdu Fuzeon ikollhom riskju ta' osteonekrożi (mewt tat-tessut tal-għadam) jew għas-sindromu tar-riattivazzjoni immunoloġika (sintomi ta' infezzjoni kkawżati mis-sistema immunoloġika li tkun qed tirkupra).
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) after 48 weeks of treatment.
Maltese: Il-kejl ewlieni ta' l-effikaċja kien it-tibdil fil-livelli ta' l-HIV fid-demm (viral load) wara 48 siegħa ta' trattament.