FrancophonIA/ELRC3.0 huggingface dataset:
English: Imipenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
Maltese: Imipenem jagħmel użu mill-attività batteriċidjali tiegħu billi jimpedixxi s-sintesi tas-superfiċje taċ-ċellula tal-batterju f'batterji Gram-pożittivi u Gram-negattivi permezz ta' rbit mal-proteini li jintrabtu malpenicillin (PBPs).
English: Rare pseudomembranous colitis, candidiasis
Maltese: Infezzjonijiet u infestazzjonijiet Rari kolite psewdomembranuża, kandidjasi
English: Very rare haemolytic anaemia, bone marrow depression
Maltese: Rari ħafna anemija emolitika, depressjoni tal-mudullun talgħadam
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship Similar to other beta-lactam antibacterial agents, the time that imipenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy.
Maltese: Relazzjoni Farmakokinetika/Farmakodinamika (PK/PD) B'xebh ma' sustanzi antibatteriċi beta-lactam oħra, il-ħin li l-konċentrazzjonijiet ta' imipenem jaqbżu lMIC (T>MIC) intwerew li jaqblu l-aħjar mal-effikaċja.
English: Event
Maltese: Epatika
English: Poland: TIENAM
Maltese: Tienam Il-Polonja: TIENAM
English: • Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)
Maltese: • Marda rari assoċjata ma' dgħufija fil-muskoli tmur għall-agħar (aggravament ta' myasthenia gravis)
English: Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see Incompatibility and After reconstitution): 0.9% sodium chloride.
Maltese: Il-kontenuti ta' kull kunjett għandhom jiġu ttrasferiti ġo 100 ml ta' soluzzjoni adattata għall-infużjoni (ara Inkompatibbiltà u Wara r-rikostituzzjoni): 0.9% sodium chloride.
English: Each vial contains imipenem monohydrate equivalent to 500 mg imipenem and cilastatin sodium equivalent to 500 mg cilastatin.
Maltese: Kull kunjett fih imipenem monohydrate ekwivalenti għal 500 mg ta' imipenem u cilastatin sodium ekwivalenti għal 500 mg ta' cilastatin.
English: In healthy elderly volunteers (65 to 75 years of age with normal renal function for their age), the pharmacokinetics of a single dose of TIENAM 500 mg/500 mg administered intravenously over 20 minutes were consistent with those expected in subjects with slight renal impairment for which no dose alteration is considered necessary.
Maltese: F'voluntiera anzjani f'saħħithom (età ta' 65 sa 75 sena b'funzjoni normali tal-kliewi għall-età tagħhom), il-farmakokinetika ta' doża waħda ta' 500 mg/500 mg ta' PRIMAXIN
English: Ureoplasma urealyticum * All methicillin-resistant staphylococci are resistant to imipenem/cilastatin.
Maltese: Ureoplasma urealyticum * L-istaphylococci kollha reżistenti għal methicillin huma reżistenti għal imipenem/cilastatin. ** Intużat il-breakpoint EUCAST li mhix relatata mal-ispeċi.
English: In normal volunteers, intravenous infusion of TIENAM over 20 minutes resulted in peak plasma levels of imipenem ranging from 12 to 20 μg/ml for the 250 mg/250 mg dose, from 21 to 58 μg/ml for the 500 mg/500 mg dose, and from 41 to 83 μg/ml for the 1000 mg/1000 mg dose.
Maltese: IV fuq perjodu ta' 20 minuta ġol-vina wassal għall-ogħla livelli ta' imipenem fil-plażma fuq medda ta' 12 sa 20 μg/ml għad-doża ta' 250 mg/250 mg, minn 21 sa 58 μg/ml għad-doża ta' 500 mg/500 mg, u minn 41 sa 83 μg/ml għad-doża ta' 1000 mg/1000 mg. Logħla livelli medji ta' imipenem fil-plażma wara d-dożi ta' 250 mg/250 mg, 500 mg/500 mg, u 1000 mg /1000 mg kienu 17, 39, u 66 μg/ml, rispettivament.
English: It is devoid of intrinsic antibacterial activity and does not affect the antibacterial activity of imipenem.
Maltese: Huwa m'għandu l-ebda attività antibatterika intrinsika u ma jaffettwax l-attività antibatterika ta' imipenem.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (anafilattiċi) serji u xi kultant fatali ġew irrappurtati f'pazjenti li kienu qed jirċievu terapija bil-beta-lactams.
English: Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents.
Maltese: Tnaqqis fil-livelli ta' valproic acid li jistgħu jitbaxxew aktar mill-medda terapewtika ġew irrappurtati meta valproic acid ingħata flimkien ma' sustanzi carbapenem.
English: CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.
Maltese: IT-TAĦLITA MHIX QEGĦDA GĦAL INFUŻJONI DIRETTA.
English: • Inflammation of stomach or intestine (gastro-enteritis)
Maltese: • Infjammazzjoni fl-istonku jew fl-imsaren (gastroenterite)
English: • Inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)
Maltese: • Infjammazzjoni fil-musrana b'dijareja bid-demm (kolite emorraġika)
English: Very rare polyarthralgia, thoracic spine pain
Maltese: Rari ħafna poliartralġja, uġigħ fis-sinsla toraċika
English: This medicinal product contains approximately 1.6 mEq (approximately 37.6 mg) of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Dan il-prodott mediċinali fih madwar 1.6 mEk (madwar 37.6 mg) ta' sodium f'kull doża ta' 500 mg li għandu jitqies minn pazjenti fuq dieta b'ammont ikkontrollat ta' sodium.
English: Therefore it is unlikely that the suckling infant will be exposed to significant quantities.
Maltese: Għalhekk mhuwiex probabbli li t-tarbija li qed titredda' tiġi esposta għal kwantitajiet sinifikanti.
English: Tell your doctor about any medical condition you have or have had including: allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment) colitis or any other gastrointestinal disease any central nervous system disorders such as localized tremors or epileptic seizures liver, kidney or urinary problems
Maltese: Għid lit-tabib tiegħek dwar xi kundizzjoni medika li għandek jew li qatt kellek fil-passat inkluż: allerġiji għal kwalunkwe mediċini inkluż antibijotiċi (reazzjonijiet allerġiċi li jseħħu f'daqqa waħda u jkunu ta' periklu għall-ħajja jeħtieġu kura medika immedjata) kolite jew kwalunkwe mard gastrointestinali ieħor kwalunkwe disturb fis-sistema ċentrali nervuża bħal tregħid lokalizzat jew aċċessjonijiet talepilessija problemi fil-fwied, fil-kliewi jew tal-awrina
English: Serious anaphylactic reactions require immediate emergency treatment.
Maltese: Reazzjonijiet anafilattiċi serji jeħtieġu kura ta' emerġenza immedjata.
English: Elderly population No dose adjustment is required for the elderly patients with normal renal function (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' pazjenti anzjani b'funzjoni normali tal-kliewi (ara sezzjoni 5.2).
English: 20 ml Type I glass vials.
Maltese: Tagħmilx is-soluzzjoni rrikostitwita fil-friża.
English: When treating patients with creatinine clearances of 5 ml/min/1.73 m2 who are undergoing dialysis use the dose recommendation for patients with creatinine clearances of 6 to 20 ml/min/1.73 m2 (see table 1).
Maltese: Meta tkun qed tikkura pazjenti bi tneħħija tal-kreatinina ta' 5 ml/min/1.73 m2 li qegħdin jagħmlu ddijalisi uża r-rakkomandazzjonijiet tad-doża għal pazjenti bi tneħħija tal-kreatinina ta' bejn is-6 u l-20 ml/min/1.73 m2 (ara tabella 1).
English: Cilastatin is a specific inhibitor of dehydropeptidase-I enzyme and effectively inhibits metabolism of imipenem so that concomitant administration of imipenem and cilastatin allows therapeutic antibacterial levels of imipenem to be attained in both urine and plasma.
Maltese: Cilastatin huwa impeditur speċifiku tal-enzima dehydropeptidase-I u jimpedixxi b'mod effettiv ilmetaboliżmu ta' imipenem sabiex għoti ta' imipenem flimkien ma' cilastatin jħalli jintlaħqu livelli terapewtiċi ta' imipenem kontra l-batterji kemm fl-awrina kif ukoll fil-plażma.
English: If you have kidney problems or weigh less than 70 kg, your doctor may lower your dose.
Maltese: Jekk inti għandek problemi fil-kliewi jew tiżen anqas minn 70 kg, it-tabib tiegħek jista' jbaxxilek id-doża.
English: Hepatic impairment No dose adjustment is recommended in patients with impaired hepatic function (see section 5.2).
Maltese: Ma huwa rrakkomandat l-ebda aġġustament fid-doża ta' pazjenti b'indeboliment fil-funzjoni tal-fwied (ara sezzjoni 5.2).
English: • A spinning sensation (vertigo), headache
Maltese: • Tħoss kollox idur bik (vertiġini), uġigħ ta' ras
English: • Hives
Maltese: Zienam
English: • Stomach pain
Maltese: • Infjammazzjoni tal-fwied
English: • complicated skin and soft-tissue infections
Maltese: • Infezzjonijiet ikkumplikati fil-ġilda u fit-tessuti rotob
English: • complicated intra-abdominal infections
Maltese: • Infezzjonijiet ikkumplikati fl-apparat tal-awrina
English: A positive direct Coombs' test, prolonged prothrombin time, decreased haemoglobin, increases in serum bilirubin, elevations in serum creatinine, elevations in blood urea nitrogen
Maltese: Mhux komuni riżultat pożitiv tat-test dirett ta' Coombs', titwil tal-ħin tal-protrombin, tnaqqis fl-emoglobina, żidiet fil-bilirubin tas-serum, jogħla l-livell talkreatinina fis-serum, jogħla l-livell tannitroġenu mill-urea fid-demm
English: The urinary recovery of active (non-metabolized) imipenem decreased to approximately 60% of the dose when TIENAM was administered with probenecid.
Maltese: L-irkuprar ta' imipenem attiv (mhux metabolizzat) mill-awrina naqas għal madwar 60% tad-doża meta PRIMAXIN
English: • Psychic disturbances (such as mood swings and impaired judgment)
Maltese: • Disturbi psikiki (bħal bidla kbira fil-burdata u ġudizzju indebolit)
English: Co-administration of cilastatin with imipenem in a 1:1 ratio prevented the nephrotoxic effects of imipenem in rabbits and monkeys.
Maltese: Għoti ta' cilastatin flimkien ma' imipenem fi proporzjon ta' 1:1 laqa' kontra l-effetti nefrotossiċi ta' imipenem fil-fniek u fix-xadini.
English: Multiple dosing has no effect on the pharmacokinetics of either imipenem or cilastatin, and no accumulation of imipenem/cilastatin was observed (see section 4.2).
Maltese: Ħafna dożi m'għandhom l-ebda effett fuq il-farmakokinetika kemm ta' imipenem kif ukoll ta' cilastatin, u ma kienet osservata l-ebda akkumulazzjoni ta' imipenem/cilastatin (ara sezzjoni 4.2).
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 25/25 mg/kg administered every 6 hours.
Maltese: Huwa rrakkomandat li infezzjonijiet issusspettati jew ippruvati li huma kkawżati minn speċi batteriċi anqas suxxettibbli (bħal Pseudomonas aeruginosa) u infezzjonijiet qawwijin ħafna (eż. f'pazjenti newtropeniċi bid-deni) għandhom jiġu kkurati b'25/25 mg/kg mogħtija kull 6 sigħat.
English: Rare anaphylactic reactions
Maltese: Rari reazzjonijiet anafilattiċi
English: Each dose >500 mg/500 mg should be infused over 40 to 60 minutes.
Maltese: Kull doża >500 mg/500 mg għandha tingħata permezz ta' infużjoni fuq perjodu ta' bejn 40 u 60 minuta.
English: Table 1: Reduced dose in adults with impaired renal function and body weight 70 kg*
Maltese: Tabella 1: Tnaqqis fid-doża f'adulti b'indeboliment fil-funzjoni tal-kliewi u piż tal-ġisem 70 kg* Tneħħija tal-kreatinina (ml/min/1.73 m2)
English: • uncommon: affects 1 to 10 users in 1,000
Maltese: • mhux komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 1,000 li jużawh
English: It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
Maltese: Huwa rrakkomandat li l-INR għandu jiġi mmonitorjat b'mod frekwenti waqt u ftit wara l-għoti ta' antibijotiċi flimkien ma' sustanza antikoagulanti orali.
English: • Inability of the kidney to perform normal function
Maltese: • Funzjoni tal-fwied mhux normali nnutata minn testijiet tad-demm
English: CNS adverse reactions such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended doses based on renal function and body weight were exceeded.
Maltese: Ġew irrappurtati reazzjonijiet avversi fis-CNS bħal attività monoklonika, stati ta' konfużjoni, jew aċċessjonijiet speċjalment meta nqabżu d-dożi rrakkomandati bbażati fuq il-funzjoni tal-kliewi u l-piż talġisem.
English: • Itching of the vulva in women
Maltese: • infezzjonijiet waqt u wara l-ħlas
English: Concomitant administration of TIENAM and probenecid resulted in minimal increases in the plasma levels and plasma half-life of imipenem.
Maltese: IV flimkien ma' probenecid wassal għal żidiet minimi fil-livelli u l-half-life ta' imipenem fil-plażma.
English: Uncommon urticaria, pruritus
Maltese: Bħal kull mediċina oħra, PRIMAXIN
English: Uncommon fever, local pain and induration at the injection site, erythema at the injection site
Maltese: Mhux komuni deni, uġigħ lokali u ebusija fis-sit tal-injezzjoni, ħmura fis-sit tal-injezzjoni
English: Discontinuation of therapy with imipenem/cilastatin and the administration of specific treatment for Clostridium difficile should be considered.
Maltese: Għandu jiġi kkunsidrat twaqqif tat-terapija b'imipenem/cilastatin u l-għoti ta' kura speċifika għal Clostridium difficile.
English: 5 Non-species related breakpoint have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Maltese: Breakpoint mhux relatata mal-ispeċi kienu l-biċċa l-kbira stabbiliti fuq il-bażi ta' dejta PK/PD u huma indipendenti mid-distribuzzjonijiet tal-MIC ta' speċi speċifiċi.
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with imipenem/cilastatin and with nearly all other anti-bacterial agents and may range from mild to life-threatening in severity.
Maltese: Il-kumplament tad-doża mogħtija kien irkuprat mill-awrina bħala metaboliti mhux atttivi kontra l-batterji, u essenzjalment ma kien hemm lebda tneħħija ta' imipenem mal-ippurgar.
English: Haematology A positive direct or indirect Coombs test may develop during treatment with imipenem/cilastatin.
Maltese: Ematoloġija Riżultat pożittiv dirett jew indirett għat-test ta' Coombs jista' jiżviluppa waqt kura b'imipenem/cilastatin.
English: Mechanism of resistance Resistance to imipenem may be due to the following:
Maltese: Speċi reżistenti b'mod inerenti:
English: Uncommon seizures, myoclonic activity, dizziness, somnolence
Maltese: Mhux komuni aċċessjonijiet, attività monoklonika, sturdament, ħedla tan-ngħas
English: Approximately 70-80% of the dose of cilastatin was recovered unchanged in the urine as cilastatin within 10 hours of administration of TIENAM.
Maltese: Madwar 70-80% mid-doża ta' cilastatin kienet irkuprata mhux mibdula mill-awrina bħala cilastatin fi żmien 10 sigħat minn meta ngħata PRIMAXIN
English: • very rare: affects less than 1 user in 10,000
Maltese: • rari ħafna: jaffettwaw anqas minn persuna waħda minn kull 10,000 li jużawh
English: For patients on haemodialysis, TIENAM is recommended only when the benefit outweighs the potential risk of seizures (see section 4.2).
Maltese: IV huwa rrakkomandat biss meta l-benefiċċju jkun akbar mir-riskju ta' aċċessjonijiet li jista' jkun hemm (ara sezzjoni 4.2).
English: TIENAM and associated names (see Annex I) 500 mg/500 mg powder for solution for infusion [See Annex I - To be completed nationally]
Maltese: IV u ismijiet assoċjati (ara Anness I) 500 mg/500 mg trab għal soluzzjoni għall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Stage IIIc/M1A/M1B
Maltese: Stadju IIIc/M1A/M1B
English: Interrupt treatment until grade 0 - 1.
Maltese: Interrompi t-trattament sa grad 0 - 1.
English: ● The active substance is vemurafenib.
Maltese: • Is-sustanza attiva hi vemurafenib.
English: INFORMATION IN BRAILLE zelboraf
Maltese: INFORMAZZJONI BIL-BRAILLE zelboraf
English: Stage MIC
Maltese: Stadju MIC
English: LDH: Lactate Dehydrogenase, ECOG PS: Eastern Cooperative Oncology Group Performance Status
Maltese: LDH: Lactate Dehydrogenase, ECOG PS: Stat ta' Prestazzjoni tal-Eastern Cooperative Oncology Group
English: Pancreatitis(2)
Maltese: Pankreatite(2)
English: • Common: ALT, alkaline phosphatase, bilirubin
Maltese: • Komuni: ALT, alkaline phosphatase, bilirubin
English: Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Maltese: Titanium dioxide (E171) Macrogol 3350
English: • Uncommon: AST
Maltese: • Mhux komuni: AST
English: Vemurafenib moderately inhibited CYP2C8 in vitro.
Maltese: Vemurafenib inibixxa b'mod moderat CYP2C8 in vitro.
English: Dermatologic reactions (f)
Maltese: Reazzjonijiet dermatoloġiċi (f)
English: V600D
Maltese: V600A
English: (neuropathy peripheral)
Maltese: (newropatija periferali)
English: BRAFV600E BRAFV600K BRAFV600R
Maltese: BRAFV600E BRAFV600K
English: BRAFV600G BRAFV600M BRAFV600A
Maltese: BRAFV600D BRAFV600G BRAFV600M
English: Grenzach-Wyhlen Germany
Maltese: Grenzach-Wyhlen
English: LDH >ULN
Maltese: LDH normali LDH >ULN
English: • Very common: GGT
Maltese: • Komuni ħafna: GGT
English: Grade (CTC-AE) (a)
Maltese: Grad (CTC-AE)
English: BORR extracranial n (%)a
Maltese: BORR barra millkranju n (%)a
English: ● Film-coating: iron oxide red, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide.
Maltese: • Kisja b'rita: iron oxide aħmar, macrogol 3350, polyvinyl alcohol, talc u titanium dioxide.
English: Median overall survival was 15.9 months (95% CI: 11.6, 18.3).
Maltese: 9 xhur (CI ta' 95%: 11.6, 18.3).
English: Rash papular, panniculitis (including erythema nodosum), keratosis pilaris
Maltese: Raxx papulari, pannikulite (inkluż eritema nodosum), keratosi pilaris
English: In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µg⋅h/mL and 4.1 ± 2.3 µg/mL.
Maltese: II, AUC0-8h u Cmax f'ġurnata 1 kienu ta' 22.1 ± 12.7 µg⋅h/mL u 4.1 ± 2.3 µg/mL.
English: Summary of the safety profile
Maltese: Sommarju tal- profil ta' sigurtà
English: ● Skin problems including warts
Maltese: • Problemi tal-ġilda inkluż felul
English: Cohort 2 Previously treated n = 56
Maltese: Koorti 2 Ittrattati qabel n = 56
English: CYP3A4 is the primary enzyme responsible for the metabolism of vemurafenib in vitro.
Maltese: CYP3A4 hija l-enzima primarja responsabbli għall-metaboliżmu ta' vemurafenib in vitro.
English: Sarcoidosis (1)(2)(j)
Maltese: Sarkojdożi (1)(2)(j)
English: Determination of BRAF mutation status
Maltese: Determinazzjoni tal-istat ta' mutazzjoni BRAF
English: QTc>500 ms at baseline
Maltese: QTc>500 ms fil-linja bażi
English: Sarcoidosis (j)
Maltese: Sarkojdożi (j)
English: Date of latest renewal: 22 September 2016
Maltese: Data tal-aħħar tiġdid: 22 ta' Settembru 2016
English: ● The recommended dose is 4 tablets twice a day (a total of 8 tablets).
Maltese: • Id-doża rakkomandata hija 4 pilloli darbtejn kuljum (total ta' 8 pilloli).
English: Table 6: Kinase inhibitory activity of vemurafenib against different BRAF kinases Kinase
Maltese: Tabella 6: Attività inibitorja ta' kinase ta' vemurafenib kontra BRAF kinases differenti
English: • To grade 4
Maltese: Grad 4
English: ● medicines for depression (e.g. amitriptyline, imipramine)
Maltese: • mediċini għad-depressjoni (eż. amitriptyline, imipramine)
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639
Maltese: Il-Manifattur Roche Pharma AG Emil-Barell-Strasse 1 D-79639
English: Do not take Zelboraf:
Maltese: Tiħux Zelboraf:
English: Taking too much Zelboraf may increase the likelihood and severity of side effects.
Maltese: Teħid ta' Zelboraf aktar milli suppost jista' jżid il-probabbiltà u s-severità ta' effetti sekondarji.
English: A total of 675 patients were randomised to vemurafenib (n=337) or dacarbazine (n=338).
Maltese: Total ta' 675 pazjent kienu randomised għal vemurafenib (n=337) jew dacarbazine (n=338).
English: Hazard Ratio 95% Confidence Interval
Maltese: Intervall ta' Kunfidenza ta' 95%
English: ● Tablet core: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate
Maltese: • Qalba tal-pillola: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl cellulose u magnesium stearate
English: Hypersensitivity reactions (e)
Maltese: Reazzjonijiet ta' sensittività eċċessiva (e)
English: Plantar fascial fibromatosis(1)(2)
Maltese: Fibromatosi talfaxxa plantari(1)(2)
English: At the pre-specified interim analysis with a December 30, 2010 data cut-off, significant improvements in the co-primary endpoints of OS (p<0.0001) and PFS (p<0.0001) (unstratified log-rank test) were observed.
Maltese: Fl-analiżi interim speċifikata minn qabel b'waqfien tad-data fit-30 ta' Diċembru 2010, kien osservat titjib sinifikanti fil-miri koprimarji ta' OS (p<0.0001) u PFS (p<0.0001) (test log-rank mhux stratifikat).
English: The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE).
Maltese: (a) L-intensità tal-avvenimenti avversi kliniċi ggradati skont Kriteriji ta' Terminoloġija Komuni għallAvvenimenti Avversi v4.0
English: Retinal vein occlusion, iridocyclitis
Maltese: Okklużjoni tal-vini tar-retina, iridoċiklite
English: Number of events (%) Median PFS (months) (95% CI)
Maltese: Numru ta' avvenimenti (%) PFS medjana (xhur) (CI ta' 95%)
English: Acute interstitial nephritis(1)(2) (h),
Maltese: Nefrite akuta tal interstizju(1)(2) (h),
English: The overall survival rate at 6 months was 77% (95% CI: 70%, 85%) and at 12 months was 58% (95% CI: 49%,
Maltese: Ir-rata ta' sopravivenza globali wara 6 xhur kienet ta' 77% (CI ta' 95%: 70%, 85%) u wara 12-il xahar kienet ta' 58% (CI ta' 95%: 49%, 67%).
English: Cohort 1 No previous treatment n = 90
Maltese: Koorti 1 L-ebda trattament qabel n = 90
English: ● Bell's palsy (a form of facial paralysis that is often reversible)
Maltese: • Bell's palsy (forma ta' paraliżi fil-wiċċ li ġeneralment tkun riversibbli)
English: However, the parent compound was the predominant component (95%) in plasma.
Maltese: Madankollu, is-sustanza oriġinali kienet il-komponent predominanti (95%) fil-plażma.
English: Responders n (%) (95% CI)b
Maltese: Persuni li rrispondew n (%) (CI ta' 95%)b
English: ● Swelling usually in the legs (peripheral oedema)
Maltese: • Nefħa ġeneralment fir-riġlejn (edima periferali)
English: Toxic epidermal necrolysis (e), StevensJohnson syndrome (f)
Maltese: Sindrome ta' Stevens-Johnson (f)
English: The most common (≥ 5%) Grade 3 ADRs were cuSCC, keratoacanthoma, rash, arthralgia and gamma-glutamyltransferase (GGT) increased.
Maltese: L-ADRs ta' Grad 3 l-aktar komuni (≥ 5%) kienu cuSCC, keratoakantoma, raxx, artralġija u żieda f'gamma glutamyltransferase (GGT).
English: The efficacy of vemurafenib has been evaluated in 336 patients from a phase III clinical trial (NO25026) and 278 patients from two phase II clinical trials (NP22657 and MO25743).
Maltese: L-effikaċja ta' vemurafenib kienet evalwata fi 336 pazjent mill-prova klinika ta' fażi III (NO25026) u f'278 pazjent minn żewġ provi kliniċi ta' fażi II (NP22657 u MO25743).
English: Figure 1: Kaplan-Meier curves of overall survival - previously untreated patients (December 20, 2012 cut-off)
Maltese: Kaplan-Meier tas-sopravivenza globali - pazjenti li ma kinux ittrattati qabel (waqfien fl-20 ta' Diċembru 2012)
English: (2) (i)
Maltese: NUMRU(I)
English: Musculoskeletal/Connective Tissue disorder
Maltese: Disturb Muskoluskeletriku/tat-Tessut Konnettiv
English: In cellular anti-proliferation assays the inhibitory concentration 50 (IC50) against V600 mutated cell lines (V600E, V600R, V600D and V600K mutated cell lines) ranged from 0.016 to 1.131 µM whereas the IC50 against BRAF wild type cell lines were 12.06 and 14.32 µM, respectively.
Maltese: (IC50 - inhibitory concentration 50) kontra razez ta' ċelluli V600 mutati (razez ta' ċelluli V600E, V600R, V600D u V600K mutati) varjat minn 0.016 sa 1.131 µM filwaqt li l-IC 50 kontra razez ta' ċelluli b'BRAF tat-tip selvaġġ kienet ta' 12.06 u 14.
English: Results from the phase I study (NO25390) in paediatric patients
Maltese: Riżultati minn studju ta' fażi I (NO25390) f'pazjenti pedjatriċi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/751/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/751/001