FrancophonIA/ELRC3.0 huggingface dataset:
English: Multi-drug resistant Mycobacterium tuberculosis (MDRH&R-TB): isolate resistant to at least isoniazid and rifampicin, but susceptible to fluoroquinolones and second line injectable agents.
Maltese: Mycobacterium tuberculosis (MDRH&R-TB) reżistenti għal diversi mediċini: iżolati reżistenti għal tal-anqas isoniazid u rifampicin, imma suxxetibbli għal fluoroquinolones u sustanzi injetabbli bħala t-tieni linja ta' preferenza.
English: However, in patients with severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease requiring haemodialysis or peritoneal dialysis, bedaquiline concentrations may be increased due to alteration of active substance absorption, distribution, and metabolism secondary to renal dysfunction.
Maltese: Madanakollu, f'pazjenti b'indeboliment tal-kliewi sever (tneħħija ta' kreatinina < 30 ml/min) jew mard tal-kliewi talaħħar stadju li jeħtieġ emodijalisi jew dijalisi peritoneali, il-konċentrazzjonijiet ta' bedaquiline jistgħu jiżdiedu minħabba l-alterazzjoni ta' sustanzi attivi assorbiti, distribuzzjoni, u metaboliżmu sekondarju għal funzjonament abnormali tal-kliewi.
English: Headache, dizziness
Maltese: DATA TA' SKADENZA
English: • Take 200 mg (2 tablets of 100 mg) once a day for 3 days of each week only.
Maltese: • Ħu 200 mg (2 pilloli ta' 100 mg) darba kuljum għal 3 ijiem fil-ġimgħa biss.
English: The other nine deaths among those treated with SIRTURO occurred after completion of treatment with this agent (range 86 911 days post SIRTURO; median 344 days).
Maltese: Id-disa' mwiet l-oħra fost dawk ittrattati b'SIRTURO seħħew wara t-tlestija ta' trattament b'din is-sustanza (firxa ta' 86-911-il jum wara SIRTURO; medjan 344 jum).
English: An additive or synergistic effect on QT prolongation of bedaquiline when co-administered with other medicinal products that prolong the QT interval cannot be excluded and frequent monitoring is recommended (see section 4.4).
Maltese: Effett addittiv jew sinerġistiku fuq it-titwil ta' QT ta' bedaquiline meta jingħata flimkien ma' prodotti mediċinali oħra li jtawwlu l-intervall ta' QT ma jistax jiġi eskluż u monitoraġġ frekwenti hu rakkomandat (ara sezzjoni 4.4).
English: Normal spermatogenesis and a normal amount of spermatozoa in the epidydimides were noted in these animals.
Maltese: Spermatoġenesi normali u ammont normali ta' spermatożoa fl-epididimide ġew innotati f'dawn l-annimali.
English: In a study in 44 healthy subjects receiving a single 800 mg dose of SIRTURO, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8).
Maltese: Fi studju b'44 individwu b'saħħtu li kienu qed jirċievu doża waħda ta' 800 mg ta' SIRTURO, ir-reazzjonijiet avversi kienu konsistenti ma' dawk osservati fi studji kliniċi fid-doża rakkomandata (ara sezzjoni 4.8).
English: Published data on patients treated with bedaquiline as part of therapy for drugresistant TB and lopinavir/ritonavir-based ART have shown that bedaquiline exposure (AUC) over 48 hours was increased approximately 2 fold.
Maltese: Dejta ppublikata dwar pazjenti ttrattati b'bedaquiline bħala parti minn terapija għal TB reżistenti għall-mediċini u ART ibbażat fuq lopinavir/ritonavir urew li l-esponiment għal bedaquiline (AUC) fuq 48 siegħa żdied madwar darbtejn aktar.
English: In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO no clinically relevant difference in exposure between men and women were observed.
Maltese: F'analiżi farmakokinetika ta' popolazzjoni ta' pazjenti b'tuberkolosi kurati b'SIRTURO ma ġiet osservata l-ebda differenza klinikament rilevanti fl-esponiment bejn irġiel u nisa.
English: Extent of resistance based on central laboratory drug susceptibility testing results was not available for 32 subjects in the mITT population.
Maltese: Il-firxa ta' reżistenza fuq riżultati ta' testijiet dwar issuxxetibilità ta' mediċina li saru f'laboratorju ċentrali ma kinux disponibbli għal 32 individwu filpopolazzjoni mITT.
English: In the Phase IIb, open label study (C209), 6.9% (16/233) patients died.
Maltese: IIb, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża, mietu 6.9% (16/233) tal-pazjenti.
English: QT interval and concomitant clofazimine use
Maltese: Intervall ta' QT u użu fl-istess waqt bi clofazimine
English: In the 120-week C208 trial where SIRTURO was administered for 24 weeks in combination with a background regimen, more deaths occurred in the SIRTURO treatment group than in the placebo group (see section 5.1).
Maltese: Fil-prova C208 ta' 120 ġimgħa meta SIRTURO kien amministrat għal 24 ġimgħa flimkien ma' programm ta' kura fl-isfond, kien hemm aktar imwiet fil-grupp ta' kura b'SIRTURO milli fil-grupp tal-plaċebo (ara sezzjoni 5.1).
English: Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial)
Maltese: Skop tal-mediċina rifampicin, rifapentine, rifabutin sabiex jikkuraw xi infezzjonijiet bħal tuberkolosi
English: As bedaquiline is highly bound to plasma proteins, it is unlikely that it will be significantly removed from plasma by haemodialysis or peritoneal dialysis.
Maltese: Peress li bedaquiline jintrabat tajjeb ma' proteini fil-plażma, huwa improbabbli li ser jitneħħa b'mod sinifikanti mill-plażma b'emodijalisi jew dijalisi peritoneali.
English: A more pronounced effect on bedaquiline may be observed during prolonged co-administration of ketoconazole or other inhibitors of CYP3A4.
Maltese: Effett aktar notevoli fuq bedaquiline jista' jiġi osservat waqt l-għoti prolongat ta' ketoconazole jew impedituri oħra ta' CYP3A4.
English: • you have liver disease or you drink alcohol on a regular basis;
Maltese: • għandek mard tal-fwied jew tixrob alkoħol fuq bażi regolari;
English: Elderly population (≥ 65 years of age) There is limited clinical data (n = 2) on the use of SIRTURO in elderly patients.
Maltese: Popolazzjoni anzjana (≥ 65 sena) Hemm tagħrif kliniku ristrett (n = 2) dwar l-użu ta' SIRTURO f'pazjenti anzjani.
English: After the end of SIRTURO treatment (i.e. after week 24), QTcF increases in the SIRTURO group gradually became less pronounced.
Maltese: Wara t-tmiem ta' kura b'SIRTURO (i.e. wara ġimgħa 24), iż-żieda ta' QTcF fil-grupp ta' SIRTURO gradwalment ġie inqas notevoli.
English: d.o.o.
Maltese: U L-UŻU
English: Co-administration of bedaquiline and medicinal products that induce CYP3A4 may decrease bedaquiline plasma concentrations and reduce its therapeutic effect.
Maltese: L-għoti fl-istess waqt ta' bedaquiline u prodotti mediċinali li jinduċu CYP3A4 jista' jnaqqas il-konċentrazzjonijiet ta' bedaquiline fil-plażma u jnaqqas l-effett terapewtiku tiegħu.
English: QT interval prolonging medicinal products
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra
English: an herbal product to relieve anxiety ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials)
Maltese: prodott magħmul minn ħxejjex li jtaffi l-ansjetà ciprofloxacin, erythromycin, clarithromycin
English: Pre-extensively drug resistant tuberculosis (pre-XDR-TB): isolate resistant to isoniazid, rifampicin, and either any fluoroquinolone or at least one second line injectable agent (but not to both a fluoroquinolone and a second line injectable agent).
Maltese: Tuberkulosi reżistenti b'mod estensiv minn qabel għal mediċini (pre-XDR-TB): iżolati reżistenti għal isoniazid, rifampicin, u jew xi fluoroquinolone jew tal-anqas sustanza injetabbli bħala t-tieni linja ta' preferenza (imma mhux kemm fluoroquinolone u t-tieni linja ta' preferenza).
English: • Swallow the tablets whole with water.
Maltese: • Ibla' l-pilloli sħaħ mal-ilma.
English: Those patients studied all had CD4+ cell counts greater than 250 x 10
Maltese: Dawk il-pazjenti studjati lkoll kellhom l-għadd ta' ċelluli ta' CD4+ akbar minn 250 x 10
English: ketoconazole, fluconazole to treat fungal infections (antifungals)
Maltese: Sabiex jiġu kkurati infezzjonijiet batteriċi (antibatteriċi)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with SIRTURO in one or more subsets of the paediatric population in the treatment of multi-drug resistant Mycobacterium tuberculosis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'SIRTURO f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' Mycobacterium tuberculosis reżistenti għal diversi mediċini (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The following definitions applies for resistance categories used:
Maltese: Id-definizzjonijiet li ġejjin japplikaw għal kategoriji ta' reżistenzi użati:
English: Clinical data on co-administration of bedaquiline and antiretroviral agents in patients co-infected with human immunodeficiency virus and multi-drug resistant Mycobacterium tuberculosis are not available (see section 4.4).
Maltese: L-esponiment għal bedaquiline kien inqas f'individwi b'pazjenti infettati bit-tuberkolosi reżistenti għal diversi mediċini milli għal individwi b'saħħithom.
English: General measures to support basic vital functions including monitoring of vital signs and electrocardiogram (QT interval) monitoring should be taken in case of deliberate or accidental overdose.
Maltese: Miżuri ġenerali t'appoġġ tal-funzjonijiet vitali jinkludu monitoraġġ tal-organi vitali u monitoraġġ b'elettrokardjogramma (intervall QT) għandhom jittieħdu f'każ ta' doża eċċessiva apposta jew aċċidentali.
English: Arthralgia
Maltese: Mjalġja
English: Bedaquiline exposure may be increased during co-administration with inhibitors of CYP3A4.
Maltese: L-esponiment ta' bedaquiline jista' jiżdied waqt l-għoti konġunt b'impedituri ta' CYP3A4.
English: The causes of death in the remaining SIRTURO subjects were alcohol poisoning, hepatitis/hepatic cirrhosis, septic shock/peritonitis, cerebrovascular accident and motor vehicle accident.
Maltese: Il-kawżi tal-mewt fl-individwi l-oħra li kienu fuq SIRTURO kienu avvalenament alkoħoliku, epatite/ċirrożi epatika, xokk settiku/peritonite, aċċident ċerebrovaskulari u aċċident b'vettura li fiha mutur.
English: The plasma protein binding of bedaquiline is > 99.9% in all species tested, including human.
Maltese: Ir-rabta mal-proteini fil-plażma ta' bedaquiline hi > 99.9% fl-ispeċi kollha ttestjati, li jinkludi lbniedem.
English: Tablets are packaged in aluminium/aluminium foil blisters.
Maltese: Il-pilloli huma ppakkjati f'folji tal-aluminju/fojl tal-aluminju.
English: Acquired resistance mechanisms that affect bedaquiline MICs include mutations in the atpE gene, which codes for the ATP synthase target, and in the Rv0678 gene, which regulates the expression of the MmpS5-MmpL5 efflux pump.
Maltese: L-ewwel punt ta' riferiment aħħari ta' effikaċja kien iż-żmien ta' konverżjoni ta' kultura tal-isputum waqt il-kura b'SIRTURO (medjan ta' 57 jum, għal 205 pazjenti b'tagħrif suffiċjenti).
English: This is called multi-drug resistant pulmonary tuberculosis.
Maltese: Dan jissejjaħ tuberkolosi pulmonari reżistenti għal diversi mediċini.
English: * Patients who died during the trial or discontinued the trial were considered as non-responders.
Maltese: * Pazjenti li mietu waqt il-prova jew waqqfu waqt il-prova kienu kkonsidrati bħala persuni li ma rrispondewx.
English: Carton containing 4 push-through blister strips (containing 6 tablets per strip).
Maltese: Kartuna li fiha 4 folji li tista' timbotta' minnhom (li fihom 6 pilloli f'kull folja).
English: Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their respective adverse reactions.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott tal-prodotti mediċinali użati f'kombinazzjoni ma' SIRTURO għar-reazzjonijiet avversi rispettivi tagħhom.
English: Therefore, the combination of bedaquiline and moderate or strong CYP3A4 inhibitors used systemically for more than 14 consecutive days should be avoided.
Maltese: Għalhekk, il-kombinazzjoni ta' bedaquiline u impedituri moderati u qawwija ta' CYP3A4 użati sistemikament għal aktar minn 14-il jum għandha tiġi evitata.
English: After the 24-week investigational period, the background regimen was continued to complete 18 to 24 months of total multi-drug resistant Mycobacterium tuberculosis treatment.
Maltese: Wara l-perjodu ta' stħarriġ ta' 24 ġimgħa, il-programm ta' kura flisfond kien issoktat biex jitlestaw 18 sa 24 xahar ta' kura għal Mycobacterium tuberculosis reżistenti għal diversi mediċini.
English: In the rat, no adverse effects were observed in a pre- and post-natal development study at maternal plasma exposure (AUC) similar to humans and exposure in the offspring 3-fold higher than in adult humans.
Maltese: Fil-far, ma' kien osservat l-ebda effett avvers fi studju tal-iżvilupp qabel u wara t-twelid fl-esponiment tal-plażma maternali ( AUC ) simili għall-bnedmin u l-esponiment filfrieħ 3 darbiet ogħla milli fil-bniedem adult.
English: Other medicines may affect SIRTURO.
Maltese: Mediċini oħra jistgħu jaffettwaw SIRTURO.
English: BLISTER
Maltese: Kardjovaskulari
English: Adverse drug reactions for SIRTURO were identified from pooled Phase IIb clinical trial data (both controlled and uncontrolled) containing 335 patients who received SIRTURO in combination with a background regimen of tuberculosis medicinal products.
Maltese: IIb (kemm b'kontrolli u mingħajr kontrolli) li fiha ħadu sehem 335 pazjent li rċevew SIRTURO flimkien ma' programm ta' kura fl-isfond ta' prodotti mediċinali għat tuberkolosi.
English: Bedaquiline exposure may be reduced during co-administration with inducers of CYP3A4.
Maltese: L-esponiment ta' bedaquiline jista' jonqos waqt l-għoti konġunt b'indutturi ta' CYP3A4.
English: The short-term co-administration of bedaquiline with isoniazid/pyrazinamide in healthy subjects did not result in clinically relevant changes in the exposure (AUC) to bedaquiline, isoniazid or pyrazinamide.
Maltese: L-għoti konġunt ta' bedaquiline ma' isoniazid/pyrazinamide għal żmien qasir f'individwi b'saħħithom ma rriżultatx f'bidliet klinikament rilevanti fl-esponiment (AUC) ta' bedaquiline, isoniazid jew pyrazinamide.
English: Compared to the exposures (AUC) observed in subjects with MDR-TB in the bedaquiline phase II trials, the exposures (AUC) in rats at high doses were similar in males and 2-fold higher in females for bedaquiline, and 3-fold higher in males and 2-fold higher in females for M2.
Maltese: II, l-esponimenti (AUC) fil-firien f'dożi għoljin kienu simili fl-irġiel u darbtejn aktar fin-nisa għal bedaquiline, u 3 darbiet ogħla fl-irġiel u darbtejn aktar fin-nisa għal M2.
English: Increases in plasma exposure to bedaquiline would be expected when it is coadministered with other ritonavir-boosted HIV protease inhibitors.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: See section 4.5, QT interval and concomitant clofazimine use, for further information regarding patients using clofazimine concomitantly.
Maltese: Ara sezzjoni 4.5, intervall ta' QT u l-użu fl-istess waqt ta' clofazimine, għal aktar tagħrif dwar pazjenti li jużaw clofazimine fl-istess waqt.
English: One death in the SIRTURO group and one death in the placebo group were reported after the week 120 window.
Maltese: Mewta waħda fil-grupp ta' SIRTURO u mewta waħda fil-grupp ta' plaċebo ġew irrappurtati wara li għaddew 120 ġimgħa.
English: B. PACKAGE LEAFLET
Maltese: Punti ta' Riferiment
English: The full EPAR and risk management plan summary for Cosentyx 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 secukinumab.
Maltese: Fih is-sustanza attiva s-sekukinumab.
English: Other information about Cosentyx
Maltese: Informazzjoni oħra dwar Cosentyx
English: This is a summary of the European public assessment report (EPAR) for Cosentyx.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cosentyx.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cosentyx on 15 January 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cosentyx fil-15 ta' Jannar 2015.
English: Cosentyx is an anti-inflammatory medicine used to treat adult patients with:
Maltese: Cosentyx huwa mediċina antiinfjammatorja li tintuża fil-kura ta' pazjenti adulti bi:
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku sekukinumab
English: The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed to recognise and attach to a messenger molecule in the immune system called interleukin 17A.
Maltese: Is-sustanza attiva f'Cosentyx, is-sekukinumab, hija antikorp monoklonali, tip ta' proteina, li tkun tfasslet biex tagħraf u teħel ma' molekula messaġġiera fis-sistema immunitarja msejħa interleukin 17A.
English: In a study of 397 patients with psoriatic arthritis, between 51% and 54% of patients on the approved doses of Cosentyx achieved a 20% reduction in ACR scores (painful, swollen joints and other symptoms) after 24 weeks.
Maltese: Fi studju ta' 397 pazjent b'artrite psorjatika, bejn 51% u 54% tal-pazjenti li kienu fuq id-dożi approvati ta' Cosentyx kisbu tnaqqis ta' 20% fil-punteġġi ACR (uġigħ, nefħa fil-ġogi u sintomi oħra) wara 24 ġimgħa.
English: This compares with 44% of those on a comparator medicine etanercept and 4% of those on placebo.
Maltese: Dan jitqabbel ma' 44% ta' dawk fuq mediċina komparatur etanercept u 4% ta' dawk fuq plaċebo.
English: Why is Cosentyx approved?
Maltese: Għaliex ġie approvat Cosentyx?
English: • psoriatic arthritis (inflammation of the joints associated with psoriasis) when disease-modifying anti-rheumatic drugs (DMARDs) do not work well enough;
Maltese: • artrite psorjatika (infjammazzjoni tal-ġogi assoċjata ma' psorjażi) meta mediċini antirewmatiċi li jimmodifikaw il-marda (DMARDs) ma jaħdmux tajjeb biżżejjed;
English: In 4 psoriasis studies involving 2,403 patients, 79% of those on Cosentyx achieved a 75% reduction in their PASI scores (a measure of disease severity and area of skin affected) after 12 weeks of treatment.
Maltese: F'4 studji ta' psorjażi li fihom ħadu sehem 2,403 pazjenti, 79% ta' dawk li kienu fuq Cosentyx kisbu tnaqqis ta' 75% fil-punteġġ PASI (kejl tas-severità tal-marda u tal-erja ta' ġilda affettwata) wara 12-il ġimgħa ta' kura.
English: This compares with 15% of patients on placebo.
Maltese: Dan jitqabbel ma' 15% tal-pazjenti li kienu qed jieħdu plaċebo.
English: This molecule is involved in the inflammation and other immune system processes that cause psoriasis and are involved in psoriatic arthritis and ankylosing spondylitis.
Maltese: Din il-molekula hija involuta fl-infjammazzjoni u fi proċessi oħra tas-sistema immunitarja li jikkawżaw psorjażi u li huma involuti f'artrite psorjatika u f'ankilosing spondilite.
English: Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and ankylosing spondylitis, with patients showing greater improvements with Cosentyx than with placebo (a dummy treatment) or with a comparator medicine, etanercept.
Maltese: L-istudji wrew li Cosentyx huwa effettiv fil-kura ta' psorjażi, artrite psorjatika u ankilosing spondilite, fejn il-pazjenti wrew iżjed titjib b'Cosentyx milli bi plaċebo (kura finta) jew b'mediċina komparatur, etanercept.
English: By attaching to and blocking the action of interleukin 17A, secukinumab reduces the activity of the immune system and the symptoms of the disease.
Maltese: Billi teħel ma' u timblokka l-azzjoni ta' interleukin 17A, is-sekukinumab tnaqqas l-attività tas-sistema immunitarja u ssintomi tal-marda.
English: Finally, in a study of 219 patients with ankylosing spondylitis, 61% of patients given the approved dose of Cosentyx achieved a 20% reduction in ASAS scores (back pain, morning stiffness and other symptoms) after 16 weeks, compared with 28% of patients on with placebo.
Maltese: Fl-aħħar nett, fi studju ta' 219-il pazjent b'ankilosing spondilite, 61% tal-pazjenti li kienu ngħataw iddożi approvati ta' Cosentyx kisbu tnaqqis ta' 20% fil-punteġġi ASAS (uġigħ fid-dahar, ebusija filgħodu u sintomi oħra) wara 16-il ġimgħa, meta mqabbla ma' 28% tal-pazjenti fuq plaċebo.
English: Cosentyx secukinumab
Maltese: Kif jintuża Cosentyx?
English: What are the risks associated with Cosentyx?
Maltese: X'inhuma r-riskji assoċjati ma' Cosentyx?
English: For the full list of all side effects and restrictions with Cosentyx, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Cosentyx, ara l-fuljett ta' tagħrif.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) when conventional treatments do not work well enough.
Maltese: • ankilosing spondilite (marda li tikkawża infjammazzjoni u uġigħ fil-ġogi tas-sinsla) meta kura konvenzjonali ma taħdimx tajjeb biżżejjed.
English: • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) when the patient needs systemic (whole body) treatment;
Maltese: • psorjażi moderata sa severa tal-plakka (marda li tikkawża rqajja' ħomor bil-qxur fuq il-ġilda) meta l-pazjent ikun jeħtieġ kura sistemika (li taffettwa lill-ġisem kollu);
English: The medicine has been shown to be of substantial clinical benefit in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis.
Maltese: Il-mediċina ntweriet li hija ta' benefiċċju kliniku sostanzjali f'pazjenti bi psorjażi, b'artrite psorjatika u b'ankilosing spondilite.
English: A risk management plan has been developed to ensure that Cosentyx is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Cosentyx jintuża bl-aktar mod sigur possibbli.
English: Because Cosentyx may increase the risk of infection, it must not be given to patients with serious active infections such as tuberculosis.
Maltese: Minħabba li Cosentyx jista' jżid ir-riskju ta' infezzjoni, m'għandux jingħata lil pazjenti b'infezzjonijiet attivi serji bħal tuberkolożi.
English: In addition, 65% of patients given Cosentyx had clear or nearly clear skin, compared with 27% of patients given etanercept and 2% of those given placebo.
Maltese: Barra minn hekk, 65% tal-pazjenti li ngħataw Cosentyx kellhom ġilda nadifa jew kważi nadifa, meta mqabbla ma' 27% tal-pazjenti li ngħataw etanercept u 2% ta' dawk li ngħataw plaċebo.
English: The most common side effects with Cosentyx (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds) with inflammation of the nose and throat (nasopharyngitis) and blocked or runny nose (rhinitis).
Maltese: L-effetti sekondarji l-aktar komuni b'Cosentyx (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju (irjiħat) b'infjammazzjoni tal-imnieħer u lgriżmejn (nażofarinġite) u mnieħer imblukkat jew imnieħer iqattar (rinite).
English: Limited data are available.
Maltese: Dejta limitata hi disponibbli.
English: Adolescents and adults 12-65 years
Maltese: Adolexxenti u adulti 12-65 sena
English: Bayer HealthCare LLC 800 Dwight Way, Berkeley, CA 94710 United States
Maltese: Bayer HealthCare LLC 800 Dwight Way, Berkeley, CA 94710
English: Novimed Ltd. Teл.
Maltese: Novimed Ltd.
English: FVIII inhibition uncommon (PTPs)*
Maltese: mhux komuni (PTPs)*
English: Dose/prophylaxis injection, IU/kg BW median (min, max)
Maltese: Doża/injezzjoni ta' profilassi, IU/kg BW medjan (min, max)
English: 2 http://www.bloodjournal.org/content/109/11/4648.full.pdf 3 Gouw SC et al. PedNet and RODIN Study Group.
Maltese: 2 http://www.bloodjournal.org/content/109/11/4648.full.pdf Gouw SC et al.
English: Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids.
Maltese: Octocog alfa (fattur VIII tal-koagulazzjoni rikombinanti umana b'tul sħiħ (rDNA)) hi proteina ppurifikata li għandha 2,332 amino acids.