FrancophonIA/ELRC3.0 huggingface dataset:
English: On 18 December 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 confirmed by majority that medicines containing acipimox should have their marketing authorisations amended to ensure that they are used across the European Union only as an additional or alternative treatment in type IIb and type IV hyperlipoproteinaemia.
Maltese: Fit-18 ta' Diċembru 2013, il-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Bniedem (CMDh)1 ikkonferma b'maġġoranza li l-mediċini li fihom acipimox għandu jkollhom l-awtorizzazzjonijiet għat-tqegħid fis-suq tagħhom emendati biex jiġi żgurat li jintużaw flUnjoni Ewropea kollha biss bħala kura addizzjonali jew alternattiva fl-iperlipoproteinemija tat-tip IIIb u t-tip IV.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: L-ewwel, din id-dejta ġiet irriveduta mill-Kumitat Konsultattiv dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC).
English: • Based on the available data, the PRAC noted a number of clinical differences between acipimox and nicotinic acid, with acipimox having a longer duration of action and non-clinical studies showing that acipimox is consistently less potent than nicotinic acid as an agonist of the HCA2 receptor.
Maltese: • Abbażi tad-dejta disponibbli, il-PRAC innota numru ta' differenzi kliniċi bejn acipimox u l-aċidu nikotiniku, b'acipmox ikollu perjodu ta' azzjoni itwal u studji mhux kliniċi juru li acipomox huwa konsistentement inqas qawwi minn aċidu nikotiniku bħala agonista tar-riċettur HCA2.
English: Acipimox is a substance closely related to nicotinic acid that has been available since 1984 as Olbetam and other trade names for the treatment of lipid disorders.
Maltese: Acipimox hija sustanza relatata mill-qrib mal-aċidu nikotiniku li ilha disponibbli sa mill-1984 bħala Olbetam u marki kummerċjali oħra għall-kura ta' disturbi fil-lipidi.
English: • However, based on the results from HPS2-THRIVE and the chemical similarity of acipimox and nicotinic acid, prescribers should be aware of the potential increased risk of myopathy when acipimox is used in combination with a statin.
Maltese: li l-effetti tiegħu ma ġewx stabbiliti, u ġew identifikati wkoll id-differenzi possibbli bejn l-aċidu nikotiniku u acipimox.
English: The original reason for the review of acipimox was HPS2-THRIVE, a large study which looked at the long-term effect of the combination of nicotinic acid (a substance related to acipimox) and another medicine, laropiprant, in treating lipid disorders.
Maltese: Ir-raġuni oriġinali għar-reviżjoni ta' acipimox kienet HPS2-THRIVE, studju kbir li ta ħarsa lejn l-effett fit-tul tal-kombinazzjoni tal-aċidu nikotiniku (sustanza relatata ma' acipimox) u mediċina oħra, laropiprant, fil-kura ta' disturbi fil-lipidi.
English: • Having reviewed the available safety data, including data on nicotinic acid obtained from HPS2THRIVE, the PRAC considered the safety profile of acipimox to be well characterised.
Maltese: • Wara li rriveda d-dejta disponibbli dwar is-sigurtà, inkluż id-dejta dwar l-aċidu nikotiniku miksuba minn HPS2-THRIVE, il-PRAC ikkunsidra l-profil ta' sigurtà ta' acipimox bħala kkaratterizzat b'mod tajjeb.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Bniedem (CMDh), li adotta pożizzjoni finali.
English: • The main role of acipimox is to prevent the non-cardiovascular complications of hypertriglyceridaemia and acipimox should not be used for the prevention of cardiovascular disease in the absence of convincing LDL-C or outcome data.
Maltese: • Ir-rwol ewlieni ta' acipimox huwa li jipprevjeni l-kumplikazzjonijiet mhux kardjovaskulari ta' ipertrigliċeridimja u acipimox ma għandux jintuża għall-prevenzjoni ta' mard kardjovaskulari finnuqqas ta' dejta li tirriżulta jew LDL-C konvinċenti.
English: The PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity associated with the concomitant use of acipimox with statins, which was addressed by adding a warning to the product information.
Maltese: Il-PRAC ikkunsidra li d-dejta disponibbli ma identifikat l-ebda informazzjoni ġdida dwar is-sigurtà li għandha impatt fuq bejn il-benefiċċju u r-riskju ta' acipimox, bl-eċċezzjoni ta' riskju potenzjali ta' tossiċità fil-muskoli, assoċjata mal-użu konkomitanti ta' acipimox ma' statini, li kien indirizzat permezz ta' żieda fl-informazzjoni dwar il-prodott.
English: • The review has shown that acipimox can be useful as an additional or alternative treatment to lower high levels of triglycerides (a particular type of fat) in the blood of patients with high levels of these fats (with or without high cholesterol), who cannot be treated by means such as diet, exercise, or other medicines.
Maltese: • Ir-reviżjoni wriet li acipmox jista' jkun utli bħala kura addizzjonali jew alternattiva biex jitnaqqsu livelli għoljin ta' trigliċeridi (tip partikolari ta' xaħam) fid-demm ta' pazjenti b'livelli għoljin ta' dawn ix-xaħmijiet (b'kolesterol għoli jew le), li ma jistgħux jiġu kkurati b'dieta, eżerċizzju fiżiku, jew mediċini oħra.
English: Nicotinic acid was also authorised in combination with laropiprant.
Maltese: L-aċidu nikotiniku kien awtorizzat ukoll flimkien ma' laropiprant.
English: Laropiprant has no effect on cholesterol but it reduces flushing, which is a known side effect of nicotinic acid.
Maltese: Laropiprant ma għandu ebda effett fuq il-kolesterol, iżda jnaqqas il-fwawar, li huma effett sekondarju magħruf tal-aċidu nikotiniku.
English: At least 92% developed protective levels of
Maltese: Għallinqas 92% żviluppaw livelli ta' protezzjoni ta'
English: The marketing authorisation was renewed on 19 July 2001 and on 19 July 2006.
Maltese: Lawtorizzazzjoni għat-tqegħid fis suq ġiet imġedda fid-19 ta' Lulju 2001 u fid-19 ta' Lulju 2006.
English: The most common side effects with Tritanrix HepB (seen in more than 1 in 10 doses of the vaccine) are drowsiness, feeding problems, fever, redness, swelling, pain, unusual crying and irritability.
Maltese: L-aktar effetti sekondarji komuni bi Tritanrix HepB (jidhru f'aktar minn doża 1 minn kull 10 talvaċċin) huma sturdament, problemi bit-tmigħ, deni, ħmura, nefħa, uġigħ, biki mhux normali u irritabbiltà.
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: l-epatite B huma prodotti permezz ta' metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': huma magħmulin minn ħmira li rċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-proteini.
English: Tritanrix HepB has been studied in six studies involving a total of 872 infants aged between seven and 20 weeks, all of whom received the vaccine.
Maltese: Tritanrix HepB ġie studjat f'sitt studji li b'kollox involvew 872 tarbija ta' bejn seba' u 20 ġimgħa, li kollha kemm huma rċevew it-tilqima.
English: Tritanrix HepB is a vaccine.
Maltese: Tritanrix HepB huwa vaċċin.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRITANRIX HEPB EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) TRITANRIX HEPB
English: It contains toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough) and parts of the hepatitis B virus as active substances.
Maltese: Fih tossojdi (tossini kimikament imdgħajjfin) minn difterite u tetnu, Bordetella pertussis inattivat (maqtul) (batterju li jikkaġuna sogħla konvulżiva) u partijiet mill-virus ta' l-epatite B bħala sustanzi attivi.
English: The studies showed that the production of protective levels of antibodies against diphtheria, tetanus and hepatitis B occurred in at least 98% of the infants.
Maltese: L-istudji wrew li l-produzzjoni ta' livelli ta' protezzjoni ta' antikorpi kontra d-difterite, it-tetnu u lepatite B seħħet f'għallinqas 98% tat-trabi.
English: How has Tritanrix HepB been studied?
Maltese: Kif ġie studjat Tritanrix HepB?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Tritanrix HepB's benefits are greater than its risks for active immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards.
Maltese: Tritanrix HepB jintuża għat-tilqim ta' trabi li għandhom minn sitt ġimgħat sa sena kontra difterite, tetnu, pertussi (sogħla konvulżiva) u epatite B.
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Tritanrix HepB on 19 July 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq valida madwar l-Unjoni Ewropea, għal Tritanrix HepB lil GlaxoSmithKline Biologicals s.a fid-19 ta' Lulju 1996.
English: What is the risk associated with Tritanrix HepB?
Maltese: X'inhu r-riskju assoċjat ma' Tritanrix HepB?
English: • killed whole B. pertussis, the bacterium that causes pertussis;
Maltese: • B. pertussis sħiħ maqtul, il-batterju li jikkawża pertussi;
English: Tritanrix HepB is a vaccine, which is available as a suspension for injection.
Maltese: Tritanrix HepB huwa vaċċin, li huwa disponibbli bħala sospensjoni għal injezzjoni.
English: Tritanrix HepB is given by deep injection into a muscle, preferably the thigh.
Maltese: Tritanrix HepB jingħata b'injezzjoni fil-fond ġo muskolu, preferibbilment fil-koxxa.
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses contained in the vaccine as ‘foreign' and makes antibodies against them.
Maltese: Meta tarbija tingħata t-tilqima, is-sistema immunitarja tagħraf il-partijiet tal-batterji u virusijiet li jkunu fit-tilqima bħala ‘barranin' u tagħmel antikorpi kontra tagħhom.
English: For the full list of all side effects reported with Tritanrix HepB, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati ma' Tritanrix HepB, ara l-Fuljett ta'
English: The active substances in Tritanrix HepB have been available in the European Union (EU) for a number of years in other vaccines.
Maltese: Is-sustanzi attivi fi Tritanrix HepB ilhom disponibbli fl-Unjoni Ewropea (UE) għal bosta snin f'vaċċini oħrajn.
English: The effects of Tritanrix HepB were first tested in experimental modes before being studied in humans.
Maltese: L-effetti ta' Tritanrix HepB ġew l-ewwel ittestjati f'modi sperimentali qabel ma ġew studjati fuq ilbniedem.
English: The main measure of effectiveness was the production of protective antibodies in the infants after the first set of vaccinations.
Maltese: Il-miżura ewlenija ta' l-effettività kienet il-produzzjoni ta' antikorpi ta' protezzjoni fit-trabi wara l-ewwel sett ta' tilqim.
English: In areas where hepatitis B is common, vaccination against hepatitis B at birth should be continued as normal, with Tritanrix HepB started at six weeks of age.
Maltese: F'żoni fejn l-epatite B hija komuni, ittilqima kontra l-epatite B mat-twelid għandha titkompla b'mod normali, bi Tritanrix HepB jinbeda fl
English: Further studies looked at the effects of the vaccine in younger infants and at the persistence of antibody levels after vaccination.
Maltese: Studji oħrajn studjaw l-effetti tat-tilqima fi trabi iżgħar u l-persistenza tal-livelli ta' antikorpi wara t
English: As for all vaccines, if Tritanrix HepB is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Maltese: Bħal fil-każ tal-vaċċini kollha, jekk Tritanrix HepB jintuża fi trabi prematuri ħafna, hemm ir-riskju li t-trabi jesperjenzaw apneja (waqfiet qosra fit-teħid tan-nifs).
English: The Committee recommended that Tritanrix HepB be
Maltese: Il-Kumitat irrakkomanda li Tritanrix HepB jingħata
English: EMA/708487/2015 EMEA/H/C/002771
Maltese: EMEA/H/C/002771
English: The full EPAR and risk management plan summary for Imlygic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Imlygic, talimogene laherparepvec, is a type of gene therapy called ‘oncolytic virus'.
Maltese: Is-sustanza attiva Imlygic, talimogene laherparepvec, hija tip ta' terapija tal-ġeni msejħa "oncolytic virus".
English: It contains the active substance talimogene laherparepvec.
Maltese: Fih is-sustanza attiva talimogene laherparepvec.
English: Why is Imlygic approved?
Maltese: Għal xiex ġiet approvat Imlygic?
English: This is a summary of the European public assessment report (EPAR) for Imlygic.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Imlygic.
English: Other information about Imlygic
Maltese: Informazzjoni oħra dwar Imlygic
English: Response to treatment was defined as reduction by at least 50% in the signs of melanoma.
Maltese: Ir-rispons għall-kura kien definit bħala tnaqqis b'mill-inqas 50% fis-sinjali tal-melanoma.
English: When looking at the subset of patients in the study (249 patients) whose disease had not spread to the lung or other internal organs, 25% (41 out of 163) of patients treated with Imlygic had a sustained response to treatment, compared with around 1% (1 out of 86) of patients treated with GM-CSF.
Maltese: Meta tħares lejn is-sottogrupp ta' pazjenti fl-istudju (249 pazjent) li l-marda tagħhom ma kinitx infirxet għall-pulmun jew organi interni oħra, 25% (41 minn 163) tal-pazjenti kkurati b'Imlygic kellhom rispons sostnut għall-kura, meta mqabbla ma' madwar 1% (1 minn 86) tal-pazjenti kkurati b'GM-CSF.
English: It is derived from a weakened herpes simplex virus 1 (the cold sore virus).
Maltese: Hija derivata minn virus tal-herpes simplex imdgħajef 1 (il-virus tal-ħżiża).
English: In addition, Imlygic makes the infected melanoma cells produce a protein called GM-CSF.
Maltese: Barra minn hekk, Imlygic iġiegħel iċ-ċelloli melanoma infettati jipproduċu proteina msejħa GM-CSF.
English: Regarding safety, Imlygic was relatively well tolerated and most side effects were mild or moderate in severity.
Maltese: Rigward is-sigurtà, Imlygic ġie ttollerat relattivament sew u ħafna mill-effetti sekondarji kienu ħfief jew moderati fis-severità.
English: Thus, CHMP decided that Imlygic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: għaldaqstant ikkonkluda li l-benefiċċji ta' Imlygic huma akbar mir-riskji tiegħu u rrakkomanda li jiġi approvat għall-użu fl-UE.
English: Imlygic is a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Imlygic huwa tip ta' mediċina ta' terapija avvanzata msejħa ‘prodott ta' terapija tal-ġeni'.
English: The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea (feeling sick), flu-like illness and pain at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Imlygic (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 4 ) huma għeja, tertir, deni, nawżea (dardir), mard bħall-influwenza u uġigħ fil-post tal-injezzjoni.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju tal-karatteristiċi talprodott (parti wkoll mill-EPAR).
English: What are the risks associated with Imlygic?
Maltese: X'inhuma r-riskji assoċjati ma' Imlygic?
English: Imlygic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that cannot be surgically removed and that has spread to other parts of the body (but not to bone, lung, brain and other internal organs).
Maltese: Imlygic huwa mediċina tal-kanċer li tintuża biex tikkura adulti b'melanoma (tip ta' kanċer tal-ġilda) li ma tistax titneħħa b'mod kirurġiku u li tkun infirxet għal partijiet oħra tal-ġisem (iżda mhux fl-għadam, fil-pulmun, fil-moħħ u f'organi interni oħra).
English: The company has put in place a controlled distribution programme to qualified centres to ensure that the cold storage and handling requirements are observed and to control the distribution to the patients.
Maltese: Il-kumpanija waqqfet programm ta' distribuzzjoni kkontrollata għal ċentri kkwalifikati sabiex tiżgura li r-rekwiżiti ta' ħażna kiesħa u ta' mmaniġġjar jiġu osservati u sabiex tikkontrolla d-distribuzzjoni lillpazjenti.
English: It is given as an injection into melanoma tumours.
Maltese: Jingħata bħala injezzjoni fittumuri tal-melanoma.
English: Because Imlygic contains a herpes virus, it may reactivate at a later time causing herpes infections such as cold sores.
Maltese: Minħabba li Imlygic fih il-virus tal-herpes, jista' jerġa' jattiva aktar tard u jikkawża infezzjonijiet tal-herpes bħal ħżiża.
English: Patients with inoperable melanoma which had spread to other parts of the body (but not to bone, brain or lung) showed a prolonged reduction in their melanoma tumours when treated with Imlygic, although it is still not known whether this will translate into longer survival.
Maltese: Pazjenti b'melanoma inoperabbli li kienet infirxet għal partijiet oħra tal-ġisem (iżda mhux fl-għadam, fil-moħħ jew fil-pulmun) urew tnaqqis fit-tul fit-tumuri tal-melanoma tagħhom meta kienu kkurati b'Imlygic, għalkemm għadu mhux magħruf jekk dan huwiex se jsarraf f'sopravivenza itwal.
English: Imlygic has been studied in one main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (but not to bone and brain).
Maltese: Imlygic ġie studjat fi studju ewlieni wieħed li jinvolvi 436 pazjent b'melanoma inoperabbli li kienet infirxet għal partijiet oħra tal-ġisem (iżda mhux għall-għadam u l-moħħ).
English: Patients will also be provided with educational materials and a patient alert card informing on the risks with the medicine and how to avoid accidental exposure to Imlygic.
Maltese: Il-pazjenti se jkunu pprovduti wkoll b'materjal edukattiv u kartuna ta' allerta għall-pazjenti li jinfurmawhom dwar ir-riskji tal-mediċina u kif jevitaw esponiment aċċidentali għal Imlygic.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Imlygic is a therapy with a novel mechanism of action which can be a valuable addition to existing therapies for advanced inoperable melanoma, an area of unmet medical need.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota li Imlygic huwa terapija b'mekkaniżmu ġdid ta' azzjoni li tista' tkun żieda siewja għat-terapiji eżistenti għal melanoma inoperabbli avvanzata, qasam ta' ħtieġa medika li ma ntlaħaqx.
English: This protein stimulates the patient's immune system (the body's natural defences) to recognise and destroy melanoma cells.
Maltese: Din il-proteina tistimula s-sistema immunitarja tal-pazjent (id-difiżi naturali tal-ġisem) sabiex jagħrfu u jeqirdu ċ-ċelloli tal-melanoma.
English: In patients whose immune system is weak (e.g. patients with HIV), Imlygic may cause more widespread disease.
Maltese: F'pazjenti fejn is-sistema immunitarja hija dgħajfa (eż. pazjenti bl-HIV), Imlygic jista' jikkawża mard aktar mifrux.
English: As part of this programme, the medicine will only be supplied to doctors who have received appropriate educational materials on the risk of herpes infection, particularly in patients with an impaired immune system, on the risk of transmission of the virus to healthcare professionals or other close contacts of the patient (accidental exposure), and on the necessary precautions to be taken when administering and disposing of the product.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Imlygic jintuża bl-aktar mod sigur possibbli.
English: The most common serious side effect (affecting around 2 in 100 people) was cellulitis (infection of the upper layers of the skin).
Maltese: L-effett sekondarju serju l-aktar komuni (jaffettwa madwar żewġ persuni minn kull 100) kien iċ-ċellulite (infezzjoni tassaffi ta' fuq tal-ġilda).
English: For the full list of all side effects and restrictions reported with Imlygic, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet kollha rrappurtati b'Imlygic, ara l-fuljett ta' tagħrif.
English: How does Imlygic work?
Maltese: Kif jaħdem Imlygic?
English: Most of these side effects were mild or moderate in severity.
Maltese: Ħafna minn dawn l-effetti sekondarji kienu ħfief jew moderati fis-severità tagħhom.
English: ≤ Grade 1;
Maltese: ≤ Grad 1;
English: 06 May 2019
Maltese: 6 ta 'Mejju 2019
English: Pliva Ljubljana d.o.o.
Maltese: Pliva Hrvatska d.o.o
English: Over 99% of patients had an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Maltese: Iktar minn 99% tal-pazjenti kellhom stat ta' prestazzjoni ta' ECOG (Eastern Cooperative Oncology Group) ta' 0 jew 1.
English: There were no differences in terminal half-lives.
Maltese: Ma kien hemm l-ebda differenzi fil-half-lives terminali.
English: The active substance is paclitaxel.
Maltese: Is-sustanza attiva hi paclitaxel.
English: Overall Response Rate (independent review)
Maltese: Rata ta' Rispons Globali (evalwazzjoni indipendenti)
English: Albumin (human) Sodium caprylate N-acetyl-DL-tryptophan Sodium chloride Hydrochloric acid Sodium hydroxide
Maltese: Albumina (umana) Sodium caprylate N-acetyl-DL-tryptophan Sodium chloride Hydrochloric acid Sodium hydroxide
English: *This data is based on Clinical Study Report: CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
Maltese: CA012-0 Addendum bid-data finali (23 ta' Marzu, 2005) a Test chi-squared b Test Log-rank
English: • Depression, sleep problems
Maltese: • Depressjoni, problemi ta' rqad
English: Pazenir contains sodium
Maltese: Pazenir fih sodium
English: Reconstitution of 100 mg:
Maltese: Rikostituzzjoni ta' 100 mg:
English: Grades 1-4
Maltese: Gradi 1-4
English: 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Maltese: 30 minuta f'Jiem 1, 8 u 15 ta' kull ċiklu ta' 21 jum.
English: Grade 3-4
Maltese: Gradi 3-4
English: The reconstituted dispersion has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Maltese: Id-dispersjoni rikostitwita għandha pH ta' 6-7.5 u osmolalità ta' 300-360 mOsm/kg.
English: The median time to disease progression was 5.3 months (175 mg/m2; 95% CI: 4.6-6.2 months) and 6.1 months (300 mg/m2; 95% CI: 4.2-9.8 months).
Maltese: Iż-żmien medjan sa progressjoni tal-marda kien ta' 5.3 xhur (175 mg/m2; CI ta' 95%: 4.6-6.2 xhur) u 6.1 xhur (300 mg/m2; CI ta' 95%: 4.2-9.8 xhur).
English: Figure 1: Kaplan-Meier curve of overall survival (intent-to-treat population)
Maltese: Stampa 1: Kurva ta' Kaplan-Meier ta' sopravivenza globali (popolazzjoni b'intenzjoni li tiġi ttrattata)
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000).
English: • A disorder of the electrical conduction system of the heart (atrioventricular block)
Maltese: • Disturb tas-sistema tal-konduzzjoni elettrika tal-qalb (imblokk atrijoventrikulari)
English: 95% CI pA+G/pG(95% Cl) P-value (chi-square test)
Maltese: Proporzjon ta' Sopravivenza pA+G/pG(95% Cl) valur-P (chi-square test)
English: Teva Nederland B.V. (additional entity) Swensweg 5
Maltese: Nederland B.V. (entità addizzjonali) Swensweg 5
English: Very rare: Stevens-Johnson syndrome2, toxic epidermal necrolysis2
Maltese: Rari ħafna: Sindrome ta' Stevens-Johnson2, nekrolisi tossika talepidermide2
English: Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Maltese: Kull ml ta' konċentrat fih 0.183 mmol ta' sodium, li hu 4.2 mg ta' sodium.
English: • if you have poor kidney function;
Maltese: • jekk għandek funzjoni tal-kliewi batuta;
English: The generation of foam must be avoided.
Maltese: ragħwa għandha tkun evitata.