FrancophonIA/ELRC3.0 huggingface dataset:
English: • infection of the hair roots; influenza; skin infection due to virus; upper respiratory tract infection(such as inflammation of the nasal cavity or sinuses located around the nose; common cold); infection in the lymph node (gland in the neck, armpit, or groin)
Maltese: • infezzjoni tal-għeruq tax-xagħar; influwenza; infezzjoni tal-ġilda minħabba l-virus; infezzjoni fl-apparat respiratorju ta' fuq (bħal infjammazzjoni tal-kavità nażali jew issinusijiet li jinsabu madwar l-imnieħer; riħ komuni); infezzjoni fil-glandoli limfatiċi (glandola fl-għonq, l-abt, jew l-irqiq ta' bejn il-koxxa u ż-żaqq)
English: Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir, in mice, rats, dogs and rabbits.
Maltese: Saru studji tossikoloġiċi li mhumiex kliniċi inkluż studji konvenzjonali tal-farmakoloġija tas-sigurtà, tossiċità fuq l-iżvilupp u ta' doża ripetuta, ġenotossiċità u tossiċità fuq l-iżvilupp u tossiċità ġuvenili b'raltegravir fuq ġrieden, firien, klieb u fniek.
English: Raltegravir is also available in a chewable tablet formulation for children weighing at least 11 kg and in granules for oral suspension formulation for infants and toddlers from 4 weeks of age and weighing at least 3 kg to less than 20 kg.
Maltese: Raltegravir huwa disponibbli wkoll f'formulazzjoni ta' pillola li tomgħodha għal tfal li jiżnu tal-inqas 11 kg u fi granuli għal formulazzjoni ta' suspensjoni orali għat-trabi u t-tfal żgħar li għandhom 4 ġimgħat jew aktar u li jiżnu tal-inqas 3 kg sa inqas minn 20 kg. Ara l-SmPCs tal-pillola li tomgħodha u l-granuli għal suspensjoni orali għal informazzjoni addizzjonali dwar id-dożaġġ.
English: Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues, showed activity in an in vitro cytogenetic assay and the mouse lymphoma assay.
Maltese: Lamivudine ma nstabx li hu mutaġeniku f'testijiet batterjali imma, bħal ħafna analogi nuklejosidi, wera attività f'analiżi ċitoġenetika in vitro u fl-analiżi ta' linfoma fil-ġrieden.
English: • muscle pain and discomfort, joint pain
Maltese: • uġigħ u skumdità fil-muskoli, uġigħ fil-ġogi
English: If co-administration with rifampicin is unavoidable, DUTREBIS may be switched to a regimen of the individual components (lamivudine and raltegravir).
Maltese: L-interazzjoni ma ġietx studjata evitat, DUTREBIS jista' jinqaleb għal reġim talkomponenti individwali (lamivudine u raltegravir).
English: CART has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Maltese: CART ġiet assoċjata mar-ridistribuzzjoni ta' xaħam fid-demm (lipodistrofija) f'pazjenti b'HIV.
English: Week 48 and Week 240 outcomes for patients on the recommended dose of raltegravir 400 mg twice daily from STARTMRK are shown in Table 3.
Maltese: L-eżiti tal-Ġimgħa 48 u l-Ġimgħa 240 għall-pazjenti fuq id-doża rakkomandata ta' raltegravir 400 mg darbtejn kuljum minn STARTMRK huma murija fitTabella 3.
English: Patients received either the 400 mg tablet formulation (6 to 18 years of age) or the chewable tablet formulation (2 to less than 12 years of age).
Maltese: Il-pazjenti rċevew il-formulazzjoni ta' pillola ta' 400 mg (minn 6 sa 18il sena) jew formulazzjoni ta' pillola li tomgħodha (minn sentejn sa 11-il sena).
English: 6 hours after raltegravir raltegravir AUC  11 % raltegravir C12 hr  49 % raltegravir Cmax  10 %
Maltese: raltegravir AUC ↑ 44 % raltegravir C12 hr ↑ 6 % raltegravir Cmax ↑ 60 %
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 50 and 400 copies/ml.
Maltese: Għal analiżijiet minn fatturi pronjostiċi, insuffiċjenzi viroloġiċi ġew ittrasferiti għal perċentwal < 50 u 400 kopja/ml.
English: The raltegravir component in DUTREBIS (300 mg raltegravir) fixed-dose combination tablet was not bioequivalent with respect to C12, however, based on PK/PD modelling, no clinically meaningful differences in raltegravir exposure are expected.
Maltese: Il-komponent ta' raltegravir fil-pillola b'kombinazzjoni ta' doża fissa ta' DUTREBIS (300 mg raltegravir) ma kienx bijoekwivalenti fir-rigward ta' C12, madankollu, abbażi tal-immudellar PK/PD, mhuma mistennija ebda differenzi klinikament sinifikanti f'espożizzjoni għal raltegravir.
English: This leaflet was last revised in {MM/YYYY}
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: 126 treatment experienced children and adolescents 2 to 18 years of age.
Maltese: Dan listudju kellu rreġistrati fih 126 tifel/tifla u adolexxenti li esperjenzaw il-kura li għandhom bejn sentejn u 18-il sena.
English: Based on these data, raltegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or P-glycoprotein.
Maltese: Abbażi ta' din id-dejta, raltegravir mhuwiex mistenni li jaffettwa l-farmakokinetika ta' prodotti mediċinali li huma sottostrati ta' dawn lenzimi jew glikoproteina-P.
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Maltese: +370 5 278 02 47 msd_lietuva@merck.com
English: Co-administration of raltegravir with a calcium carbonate antacid decreased raltegravir plasma levels; however, this interaction is not considered clinically meaningful.
Maltese: L-għoti flimkien ta' raltegravir ma' antaċidu talkarbunat tal-kalċju naqqas il-livelli fil-plażma ta' raltegravir; madankollu, din l-interazzjoni mhijiex ikkunsidrata klinikament sinifikanti.
English: Developmental toxicity
Maltese: TAL-PRODOTT MEDIĊINALI
English: DK
Maltese: D.
English: In intravenous studies with lamivudine, the mean volume of distribution is 1.3 l/kg.
Maltese: Fi studji dwar it-teħid minn ġol-vina b'lamivudine, il-volum medju tad-distribuzzjoni huwa 1.3 l/kg.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Maltese: Għalkemm l-etjoloġija hija kkunsidrata bħala multifattorjali (inkluż użu ta' kortikosterojdi, il-konsum ta' alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem ogħla), ġew irrapportati każijiet ta' osteonekrożi b'mod partikolari f'pazjenti b'marda HIV avvanzata u/jew espożizzjoni fit-tul għal CART.
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 400 and 50 copies/ml.
Maltese: Għal analiżijiet minn fatturi pronjostiċi, insuffiċjenzi viroloġiċi ġew ittrasferiti għal perċentwal < 400 u 50 kopja/ml.
English: There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside reverse transcriptase inhibitors (see section 4.4).
Maltese: Kien hemm rapporti ta' disfunzjoni mitokondrijali fi trabi esposti in utero u/jew wara t-twelid għal inibituri ta' nucleoside reverse transcriptase (ara
English: Co-administration of DUTREBIS with medicinal products that are known to be potent UGT1A1 inhibitors (e.g., atazanavir) may increase plasma levels of raltegravir.
Maltese: L-għoti flimkien ta' DUTREBIS ma' prodotti mediċinali oħrajn, magħrufin li huma inibituri qawwija ta' UGT1A1 (eż., atazanavir) jistgħu jżidu l-livelli fil-plażma ta' raltegravir.
English: • rash (more often when used in combination with darunavir)
Maltese: • raxx (aktar ta' spiss meta jintuża flimkien ma' darunavir)
English: Based on in vitro and in vivo studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway.
Maltese: Abbażi ta' studji in vitro u in vivo, raltegravir jitneħħa prinċipalment permezz ta' metaboliżmu minn ġo mogħdija ta' glukuronidazzjoni mwettqa minn UGT1A1.
English: Lamivudine is eliminated mainly by active renal secretion via the organic cationic transport system.
Maltese: Lamivudine jitneħħa prinċipalment mis-sekrezzjoni attiva mill-kliewi permezz tas-sistema tat-trasport organika u ketajonika.
English: The likelihood of metabolic interactions of lamivudine with other medicinal products is low due to the small extent of hepatic metabolism (5-10 %) and low plasma protein binding.
Maltese: Ilprobabbiltà ta' interazzjonijiet metaboliċi ta' lamivudine ma' prodotti mediċinali oħrajn hija żgħira minħabba li l-ammont ta' metaboliżmu fil-fwied huwa żgħir (5-10%) u minħabba li l-għaqid mal
English: • trimethoprim - used to treat infections.
Maltese: • trimethoprim - użat biex jikkura l-infezzjonijiet.
English: Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32 % of the dose was excreted in faeces and urine, respectively.
Maltese: Wara l-għoti ta' doża orali ta' raltegravir radjutikkettat, madwar 51 u 32 % tad-doża tneħħiet fl-ippurgar u l-awrina, rispettivament.
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni tal-HIV avvanzata u bi storja ta' infezzjoni opportunistika, jistgħu jseħħu sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet preċedenti ftit wara li tinbeda lkura kontra l-HIV.
English: If rifampicin administration cannot be avoided, DUTREBIS may be switched to a regimen of the individual components (lamivudine and raltegravir).
Maltese: Jekk l-għoti ta' rifampicin ma jistax jiġi evitat, DUTREBIS jista' jinqaleb għal reġim ta' komponenti individwali (lamivudine u raltegravir).
English: However, if co-administration with rifampicin is unavoidable, DUTREBIS may be switched to a regimen of the individual components (lamivudine and raltegravir).
Maltese: Madankollu, jekk lgħoti flimkien ma' rifampicin ma jistax jiġi evitat, DUTREBIS jista' jinqaleb għal reġim ta' komponenti individwali (lamivudine u raltegravir).
English: Lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of nucleoside reverse transcriptase inhibitors (NRTIs), such as lamivudine.
Maltese: Aċidożi lattika, ġeneralment assoċjata ma' tkabbir tal-fwied u xaħam fil-fwied, ġiet irrapportata meta ntużaw l-inibituri nucleoside reverse transcriptase (NRTIs), bħal lamivudine.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Maltese: Il-possibbiltà ta' nuqqas ta' interazzjonijiet ma' prodotti mediċinali oħra li jingħataw fl-istess ħin għandha tiġi kkunsidrata, b'mod partikolari meta r-rotta ewlenija taleliminazzjoni tkun is-sekrezzjoni attiva mill-kliewi permezz tas-sistema tat-trasport organika u ketajonika ta' trasport eż. trimethoprim.
English: Taking an aluminium and magnesium antacid within 6 hours of raltegravir administration significantly decreased raltegravir plasma levels.
Maltese: Aluminju u manjeżju li fihom antaċidi jnaqqsu l-livelli filplażma ta' raltegravir.
English: Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Maltese: Ġew irrapportati mijopatija u rabdomijoliżi.
English: The major circulating entity was raltegravir and represented approximately 70 % of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide.
Maltese: L-entità maġġuri li kienet qed tiċċirkola kienet raltegravir u rrappreżentat madwar 70 % tar-radjuattività totali; ir-radjuattività li baqgħet fil-plażma kienet irrappreżentata minn raltegravir-glucuronide.
English: Tel: +39 06 361911 medicalinformation.it@merck.com
Maltese: (0) 1992 467272 medicalinformationuk@merck.com
English: uncommon gastritis, abdominal discomfort, abdominal pain upper, abdominal tenderness, anorectal discomfort, constipation, dry mouth, epigastric discomfort, erosive duodenitis, eructation, gastrooesophageal reflux disease, gingivitis, glossitis, odynophagia, pancreatitis, peptic ulcer,
Maltese: insuffiċjenza renali, nefrite, nefrolitijasi, nokturja, ċesta tal-kliewi, indeboliment renali, nefrite tubulointerstizjali disfunzjoni erettili, ġinekomastija, sintomi tal-menopawsa
English: Tmax was not significantly affected by renal function.
Maltese: Tmax ma kienx affettwat b'mod sinifikanti mill-funzjoni renali.
English: Co-administration of DUTREBIS with high doses of co-trimoxazole for the treatment of Pneumocystis carinii pneumonia (PCP) and toxoplasmosis should be avoided.
Maltese: L-għoti flimkien ta' DUTREBIS ma' dożi qawwija ta' co-trimoxazole għall-kura talpnewmonjaPneumocystis carinii (PCP) u tossoplażmożi għandu jiġi evitat.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Maltese: Ir-reżistenza ta' HIV-1 għal lamivudine tinvolvi l-iżvilupp ta' bidla fl-aċidu amminiku M184V qrib issit attiv tar-reverse transcriptase (RT) virali.
English: One pack size is
Maltese: Mhux magħruf ir
English: Further information on Xerava 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: Xerava contains the active substance eravacycline.
Maltese: Xerava fih is-sustanza attiva eravacycline.
English: Xerava (eravacycline) EMA/521584/2018
Maltese: EMA/521584/2018
English: The most common side effects with Xerava (which may affect up to 1 in 10 people) are thrombophlebitis (inflammation of veins caused by a blood clot), phlebitis (inflammation of a vein), nausea (feeling sick), vomiting and reactions at the site of the infusion including reddening of skin, reduced sense of touch and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Xerava (li jistgħu jaffettwaw sa persuna 1 minn kull 10 ) huma tromboflebite (infjammazzjoni tal-vini kkawżata minn embolu tad-demm), flebite (infjammazzjoni ta' vina), nawsja (tħossok ma tiflaħx), remettar u reazzjonijiet fil-post tal-infużjoni inkluż ħmura tal-ġilda, tnaqqis fis-sens tal-mess u tal-uġigħ.
English: The medicine is given once every 12 hours for at least 4 days and up to 14 days.
Maltese: Il-mediċina tingħata darba kull 12-il siegħa għal mill-anqas 4 ijiem u sa 14-il jum.
English: In the second study involving 499 patients, Xerava was compared with meropenem (another antibiotic).
Maltese: Fit-tieni studju li involva 499 pazjent, Xerava tqabbel ma' meropenem (antibijotiku ieħor).
English: Other information about Xerava
Maltese: Informazzjoni oħra dwar Xerava
English: The active substance in Xerava, eravacycline, belongs to a group of antibiotics called tetracyclines.
Maltese: Is-sustanza attiva f'Xerava, l-eravacycline, tagħmel parti minn grupp ta' antibijotiċi msejjaħ “tetraċiklini”.
English: Xerava was shown to be as effective as alternative antibiotics in 2 main studies of adults with cIAIs.
Maltese: Xerava ntwera li huwa effettiv daqs antibijotiċi alternattivi f'żewġ studji ewlenin ta' adulti b'cIAIs.
English: After around a month, 87% of patients treated with Xerava were cured of their infection, compared to 89% of patients treated with ertapenem.
Maltese: Wara madwar xahar, 87 % tal-pazjenti kkurati b'Xerava tfejqu mill-infezzjoni tagħhom, meta mqabbla ma' 89 % tal-pazjenti kkurati b'ertapenem.
English: In the first study involving 538 patients, Xerava was compared with ertapenem (another antibiotic).
Maltese: Fl-ewwel studju li involva 538 pazjent, Xerava tqabbel ma' ertapenem (antibijotiku ieħor).
English: After around a month, 92% of patients treated with Xerava and 92% of patients treated with meropenem were cured of their infection.
Maltese: Wara madwar xahar, 92 % tal-pazjenti kkurati b'Xerava u 92 % tal-pazjenti kkurati b'meropenem tfejqu mill-infezzjoni tagħhom.
English: Xerava's safety profile was considered acceptable.
Maltese: Il-profil tas-sigurtà ta' Xerava tqies aċċettabbli.
English: As for all medicines, data on the use of Xerava are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Xerava hija ssorveljata kontinwament.
English: What are the risks associated with Xerava?
Maltese: X'inhuma r-riskji assoċjati ma' Xerava?
English: How does Xerava work?
Maltese: Kif jintuża Xerava?
English: Xerava is as effective as alternative antibiotics in treating infections caused by various types of bacteria and produced high cure rates.
Maltese: Xerava huwa effettiv daqs antibijotiċi alternattivi fil-kura ta' infezzjonijiet ikkawżati minn varji tipi ta' batterji, u pproduċa rati ta' fejqan għoljin.
English: Tetracyclines work by binding to and blocking part of the cell machinery in bacterial cells that is involved in making proteins.
Maltese: It-tetraċiklini jaħdmu billi jintrabtu ma' u jimblukkaw parti mill-makkinarju taċ-ċellola f'ċelloli batterjali li huwa involut fil-produzzjoni ta' proteini.
English: The dose depends on the patient's bodyweight, and may be increased if the patient is also taking a type of medicine called a ‘strong CYP3A4 inducer'.
Maltese: Id-doża tiddependi mill-piż tal-ġisem tal-pazjent, u tista' tiżdied jekk il-pazjent ikun qiegħed jieħu wkoll tip ta' mediċina msejħa “induttur CYP3A4 b'saħħtu”.
English: Xerava is an antibiotic used to treat complicated intra-abdominal (belly) infections (cIAI) in adults.
Maltese: Xerava huwa antibijotiku li jintuża għall-kura ta' infezzjonijiet intra-addominali (żaqq) kkumplikati (cIAI) fl-adulti. “Ikkumplikati” tfisser li l-infezzjoni hija diffiċli biex tiġi kkurata minħabba li tkun infirxet fl-ispazju addominali.
English: Xerava must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other tetracycline antibiotics.
Maltese: Xerava m'għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għal kwalunkwe wieħed millingredjenti tal-mediċina jew għal antibijotiċi tetraċiklini oħra.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xerava have been included in the summary of product characteristics and the package leaflet.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi r-rakkomandazzjonijiet u lprekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' Xerava.
English: Content Package size
Maltese: Kontenut Daqs tal-pakkett
English: The full EPAR for Cuprymina 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: This summary was last updated in 08-2012.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi 08-2012.
English: Other information about Cuprymina
Maltese: Informazzjoni oħra dwar Cuprymina
English: This is a summary of the European public assessment report (EPAR) for Cuprymina.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Cuprymina.
English: The active substance in Cuprymina, copper (64Cu) chloride, is a radioactive compound that emits a type of radiation known as beta radiation.
Maltese: Is-sustanza attiva f'Cuprymina, copper (64Cu) chloride, hija kompost radjuattiv li jemetti tip ta' radjazzjoni magħrufa bħala radjazzjoni beta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cuprymina on 23 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cuprymina fil-23 ta' Awwissu 2012.
English: The company presented information from the scientific literature on the potential uses of Cuprymina.
Maltese: Il-kumpanija ppreżentat informazzjoni mil-litteratura xjentifika dwar l-użu potenzjali ta' Cuprymina.
English: The information supplied by the company showed that Cuprymina can be used to radiolabel medicines with 64Cu, with potential utility for detecting of the sites and spread of tumours.
Maltese: L-informazzjoni pprovduta mill-kumpanija uriet li Cuprymina jista' jintuża għal radjutikkettar ta' mediċini b'64Cu, b'utilità potenzjali għall-kxif tal-post fejn jinsabu t-tumuri u l-firxa ta' tumuri.
English: What is Cuprymina?
Maltese: X'inhu Cuprymina?
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's summary of product characteristics (SmPC).
Maltese: Il-mediċina radjotikkettata mbagħad tingħata lill-pazjent skont l-istruzzjonijiet fissommarju tal-karatteristiċi tal-prodott tal-mediċina (SmPC).
English: Cuprymina is used to radiolabel medicines that have been specially developed for use with copper (64Cu) chloride.
Maltese: Cuprymina jintuża biex isir radjitikkettar ta' mediċini li ġew żviluppati apposta għall-użu b'copper (64Cu) chloride.
English: What is the risk associated with Cuprymina?
Maltese: X'inhu r-riskju assoċjat ma' Cuprymina?
English: Some of the scientific literature presented showed how radiolabelling with radioactive forms of Copper, including 64Cu, were used together with imaging techniques to detect the site and spread of tumours and how it could potentially be used to treat various types of cancer.
Maltese: Parti mil-litteratura xjentifika ppreżentata uriet kif ir-radjutikkettar b'forom radjuattivi ta' Ram, inkluż 64Cu, intużaw flimkien ma' tekniki ta' 'imaging' sabiex jikxfu l-post fejn jinsab u l-firxa tat-tumuri u kif dan jista' jintuża potenzjalment biex jikkura tipi varji ta' kanċer.
English: Why has Cuprymina been approved?
Maltese: Għaliex ġie approvat Cuprymina?
English: Cuprymina itself is radioactive and so its use in radiolabelling may carry a risk of cancer and hereditary defects.
Maltese: Cuprymina nfisha hija radjuattiva u għalhekk, l-użu tagħha fir-radjutikkettar jista' jġorr miegħu riskju ta' kanċer u difetti ereditarji.
English: How has Cuprymina been studied?
Maltese: Kif ġie studjat Cuprymina?
English: EPAR summary for the public copper (64Cu) chloride
Maltese: Cuprymina hija soluzzjoni li fiha s-sustanza radjuattiva copper (64Cu) chloride. 64Cu hija forma radjuattiva ta' ram.
English: Given the well-known risks of exposure to radiation through radiolabeling, the Committee decided that Cuprymina is only to be used if justified by the likely medical benefit.
Maltese: Minħabba r-riskji magħrufin sew tal-espożizzjoni għal radjazzjoni permezz ta' radjutikkettar, il-Kumitat iddeċieda li Cuprymina għandu jitnuża biss jekk dan ikun iġġustifikat mill-benefiċċju mediku probabbli.
English: Cuprymina is not used on its own but is used for radiolabelling other medicines.
Maltese: Cuprymina ma jintużax waħdu iżda jintuża għar-radjutikkettar ta' mediċini oħrajn.
English: The CHMP considered that there are no major safety concerns with regard to potential copper toxicity, since Cuprymina is used at very low doses.
Maltese: L-effett intenzjonat tar-radjazzjoni jiddependi fuq in-natura tal-mediċina li tkun ġiet radjutikkettata.
English: The side effects with Cuprymina depend largely on the medicine it has been used to radiolabel and will be described in that medicine's package leaflet.
Maltese: L-effetti sekondarji b'Cuprymina jiddependu fil-parti l-kbira tagħhom fuq il-mediċina li Cuprymina jkun intuża għar-radjutikkettar tagħha u sejrin jiġu deskritti fil-fuljett ta' tagħrif ta' dik il-mediċina.
English: Therefore, the CHMP decided that Cuprymina's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant, is-CHMP iddeċieda li lbenefiċċji ta' Cuprymina huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għattqegħid fis-suq.
English: Radiolabelling is a technique where a substance is labelled with a radioactive compound.
Maltese: Ir-radjutikkettar huwa teknika li permezz tagħha, sustanza tiġi radjutikkettata b'kompost radjuattiv.
English: 3.0 point worsening
Maltese: Aggravament ta' 3.0 punti
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Madankollu, l-effett ta' Zinbryta fuq tilqim ieħor (tilqim ħaj) mhuwiex magħruf.