FrancophonIA/ELRC3.0 huggingface dataset:
English: A multi-centre, randomised, open-label, Phase-3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population N = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT N = 863) in overall survival (adjusted hazard ratio (HR) 0.94; 95% CI= 0.84-1.05).
Maltese: Studju każwali u multiċentriku ta' Fażi 3, bit-tikketta tingħaraf, bi pemetrexed flimkien ma' cisplatin kontra gemcitabine flimkien ma' cisplatin f'pazjenti b'kanċer tal-pulmun mhux b'ċelluli żgħar (NSCLC) lokalment avvanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li pemetrexed flimkien ma' cisplatin (popolazzjoni bl-Intenzjoni Li Tittratta (ITT) n = 862) laħaq il-punt aħħari primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma' cisplatin (ITT NN=863) fis-sopravivenza totali (proporzjon aġġustat ta' riskju 0.94; 95% CI = 0.841.05).
English: Pemetrexed Hospira 500 mg contains approximately 54 mg sodium per vial.
Maltese: Pemetrexed Hospira 500 mg fih madwar 54 mg sodium f'kull kunjett.
English: You will also receive an injection of vitamin B12 (1,000 micrograms) in the week before administration of Pemetrexed Hospira and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Hospira treatment).
Maltese: B12 (1,000 mikrogramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Hospira u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura bi Pemetrexed Hospira).
English: 75% of previous dose (both Pemetrexed
Maltese: 75% tad-doża ta' qabel (kemm Pemetrexed Hospira u cisplatin)
English: Mesothelioma
Maltese: Mesoteljoma:
English: Dose modification table for Pemetrexed Hospira (as single agent or in combination) and cisplatin - Non-haematologic toxicities a, b
Maltese: Tabella għall-modifikazzjoni ta' Pemetrexed Hospira (bħala terapija b'sustanza unika jew ikkombinata) u cisplatin - Tossiċitajiet mhux ematoloġiċi a, b
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Hospira 100 mg trab għal konċentrat għall-infużjoni Pemetrexed Hospira 500 mg trab għal konċentrat għall-infużjoni Pemetrexed Hospira 1,000 mg trab għal konċentrat għall-infużjoni
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Hospira.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed Hospira.
English: Type I glass vial with rubber stopper containing 100 mg, 500 mg or 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull pakkett fih kunjett wieħed ta' 100 mg, 500 mg jew 1,000 mg pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Patients should be regularly monitored for acute tubular necrosis, decreased renal function and signs and symptoms of nephrogenic diabetes insipidus (e.g. hypernatraemia).
Maltese: Il-pazjenti għandhom jiġu mmonitorati regolarment għal nekrożi tubulari akuta, funzjoni renali indebolita u sinjali u sintomi ta' insipidus tad-dijabete nefroġenika (eż. ipernatremja).
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Maltese: Effikaċja ta' pemetrexed flimkien ma' cisplastin kontra cisplatin f'mesoteljoma plewratika malinna
English: Neutrophils/Granulocyt es decreased
Maltese: Tnaqqis finnewtrofili/granuloċiti
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg
Maltese: Tikketta tal-kunjett tal-1,000 mg
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna 1f'1,000)
English: However, patients with hepatic impairment, such as bilirubin > 1.5-times the upper limit of normal and/or aminotransferase > 3.0-times the upper limit of normal (hepatic metastases absent) or > 5.0-times the upper limit of normal (hepatic metastases present), have not been specifically studied.
Maltese: Madankollu, ma ġewx studjati speċifikament pazjenti b'indeboliment tal-fwied bħal każijiet ta' bilirubina > 1.5 darbiet il-limitu massimu tan-normal u/jew aminotransferase > 3.0 darbiet il-limitu massimu tan-normal (mingħajr metastażi fil-fwied) jew > 5.0 darbiet il-limitu massimu tan-normal (b'metastażi fil-fwied).
English: When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2°C to 8°C).
Maltese: Meta ppreparati kif suppost, l-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed, ġiet ippruvata għal 24 siegħa f'temperatura ta' friġġ (2°C sa 8°C).
English: Other medicines and Pemetrexed Hospira
Maltese: Mediċini oħra u Pemetrexed Hospira
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Maltese: Każijiet li dehru b'mod rari jinkludu s-sindromu ta' Stevens-Johnson u nrkroliżi epidermali tossika.
English: Pemetrexed Hospira 1,000 mg vials contain approximately 108 mg sodium per vial.
Maltese: Kull kunjett ta' 1,000 mg fih madwar 108 mg sodium
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups
Maltese: L-effikaċja ta' pemetrexed + cisplatin vs gencitabine + cisplatin bħala kura tal-ewwel preferenza f'kanċer mhux b'ċelluli żgħar - Popolazzjoni ITT u sottogruppi istoloġiċi
English: The recommended dose of Pemetrexed Hospira is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: Pemetrexed Hospira flimkien ma' cisplatin Id-doża rakkomandata ta' Pemetrexed Hospira hi ta' 500 mg/m2 tal-erja tas-superfiċje tal-ġisem (body surface area, BSA) mogħtija bħala infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Pemetrexed / Cisplatin (N = 226)
Maltese: Parametru ta' effikaċja Pemetrexed / Cisplatin (N = 226)
English: The resulting solution contains 25 mg/ml pemetrexed.
Maltese: Wara r-rikostituzzjoni kull kunjett fih 25 mg/ml ta' pemetrexed.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 839 patients with NSCLC who were randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine.
Maltese: It-tabella hawn taħt tagħti l-frekwenza u s-severità ta' l-effetti mhux mixtieqa li huma kkunsidrati possibbilment relatati mal-mediċina taħt studju u li ġew irrapportati f'>5% ta' 839 pazjent b'NSCLC li b'mod każwali ntgħażlu biex jirċievu cisplatin u pemetrexed u 830 pazjent b'NSCLC li b'mod każwali ntgħażlu biex jirċievu cisplatin u gemcitabine.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Maltese: Tikketta tal-kunjett tal-500 mg
English: When using Pemetrexed Hospira in combination with cisplatin:
Maltese: Meta tuża Pemetrexed Hospira flimkien ma' cisplatin:
English: The median OS for the overall population (N = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p = 0.01192).
Maltese: Il-medjan tal-OS tal-popolazzjoni in ġenerali (N= 663) kien ta' 13.4 xhur għall-fergħa ta' pemetrexed u ta' 10.6 xhur għall-fergħa tal-plaċebo, hazard ratio= 0.79 (95 %CI = 0.65 - 0.95; p =
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Maltese: Irrikostitwixxi kunjetti ta' 100mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9mg/ml (0.9%) sodium chloride, mingħajr preżervattiv.
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Maltese: Irrikostitwixxi kunjetti ta' 500 mg b' 20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride mingħajr preżervattiv.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (N = 399, 9.3 versus 8.0 months, adjusted hazard ratio (HR) = 0.78; 95% CI = 0.61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (N =172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95% CI = 1.08-2.26, p = 0.018).
Maltese: Analiżi ta' l-impatt tal-istoloġija ta' NSCLC fuq issopravivenza totali wriet id-differenzi ta' pemetrexed kontra docetaxel għal kull tip ta' istoloġija minbarra l-istoloġiji li fil-biċċa l-kbira tagħhom kienu tat-tip skwamużi (N=399, 9.3 kontra 8.0 xhur, HR aġġustat = 0.78; 95% CI =0 .61-1.00, p = 0.
English: 20 November 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2015
English: Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Hospira treatment.
Maltese: Kortikosterojdi: it-tabib tiegħek jordnalek pilloli tal-isterojdi (ekwivalenti għal 4 milligrammi ta' dexamethasone darbtejn kuljum) li jkollok bżonn tieħu l-ġurnata ta' qabel, dakinhar u l-ġurnata ta' wara l-kura bi Pemetrexed Hospira.
English: Infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue have been reported with an unknown frequency (e.g. acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis).
Maltese: Bi frekwenza mhix magħrufa ġew rapportati disturbi infettivi u mhux infettivi tad-dermis, l-ipoderma u/jew it-tessut ta' taħt il-ġilda (eż. dermo-ipodermite batterjali akuta, psewdoċellulite, dermatite).
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion
Maltese: Pemetrexed Hospira 100 mg trab għal konċentrat għall-infużjoni
English: Pemetrexed Hospira contains sodium
Maltese: Pemetrexed Hospira fih is-sodju
English: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Maltese: Il-pazjenti fiż-żewġ fergħat tal-istudju ġew mogħtija l-folic acid u l-vitamina B12.
English: Fast heart rate
Maltese: Superjo rità
English: Each 500 mg vial contains approximately 54 mg sodium.
Maltese: Kull kunjett ta' 500 mg fih madwar 54 mg sodium
English: Limited clinical data from a separate randomised, Phase-3, controlled trial, suggest that efficacy data (overall survival, progression-free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (N = 41) and patients who did not receive previous docetaxel treatment (N = 540).
Maltese: Informazzjoni klinika limitata, minn prova separata b'kontrolli u każwali ta' Fażi 3, tissuġġerixxi li linformazzjoni dwar l-effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed hija simili bejn il-pazjenti li kienu ġew ikkurati qabel b'docetaxel (N=41) u pazjenti li ma rċevewx kura b'docetaxel qabel (NN=540).
English: After reconstitution, each vial contains 25 mg/ml of pemetrexed
Maltese: Is-soluzzjoni li tirriżulta jkun fiha 25 mg/ml pemetrexed.
English: Dose modification table for Pemetrexed Hospira (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: Tabella 3. Tabella għall-modifikazzjoni tad-doża għal Pemetrexed Hospira (bħala terapija b'sustanza unika jew ikkombinata) u cisplatin - Newrotossiċità
English: PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan-Meier ta' sopravivenza mingħajr progressjoni (PFS) u sopravivenza totali ta' pemetrexed kontra plaċebo f'pazjenti b' NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamużi:
English: Hyperpigmentation has been commonly reported.
Maltese: B'mod komuni ġiet rapportatata l-iperpigmentazzjoni.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Hospira has finished.
Maltese: Cisplatin ukoll jingħata b'infużjoni f'waħda mill-vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l-infużjoni ta' Pemetrexed Hospira.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Maltese: Il-volum xieraq tas-soluzzjoni rikostitwita ta' pemetrexed irid jerġa' jiġi dilwit sa 100 ml b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: Dose modification table for Pemetrexed Hospira (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500/mm3 and nadir platelets ≥ 50,000/mm3
Maltese: L-għadd l-iktar baxx t'ANC < 500/mm 3 u l-għadd l iktar baxx ta' plejtlits ≥ 50,000/mm
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Hospira is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' Pemetrexed Hospira hi ta' 500 mg/m2 BSA mogħti b'infużjoni minn ġol-vina fuq perjodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull kunjett fih 100 milligramma ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤5% tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl-AST, żieda fl-ALT, infezzjoni, newtropenja bid-deni, insuffiċjenza renali, deni, diżidratazzjoni, Konġunktivite u tnaqqis fit-tneħħija ta' kreatinina.
English: • Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have fewer white blood cells than normal which is very common).
Maltese: • Deni jew infezzjoni (komuni): jekk għandek temperatura ta' 38ºC jew aktar, għarqan jew għandek sinjali oħra ta' infezzjoni (peress li jista' jkollok ċelluli bojod tad-demm inqas min-normal, li huwa komuni ħafna).
English: Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull kunjett fih 1,000 mg ta' pemetrexed (bħala pemetrexed sodium hemipentahydrate).
English: Creatinine elevation 10.7 Creatinine clearance decreased**
Maltese: Tnaqqis fit-tneħħija ta' kreatinina**
English: Pemetrexed Hospira is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Maltese: Pemetrexed Hospira tingħata flimkien ma' cisplatin, mediċina oħra ta' kontra l-kanċer, bħala kura għal mesoteljoma plewrali malinna, tip ta' kanċer li jaffettwa r-rita tal-pulmun, lil pazjenti li jkunu għadhom ma ngħatawx kimoterapija.
English: Each 100 mg vial contains approximately 11 mg sodium.
Maltese: Eċċipjent b'effett magħruf Kull kunjett ta' 100 mg fih madwar 11 mg sodium.
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Maltese: Meta tinkludi lfażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċċelluli huma l-iżjed tat-tip skwamużi kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Maltese: Irrikostitwixxi kunjetti ta' 100 mg b' 40 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride mingħajr preżervattiv.
English: Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull kunjett fih 500 milligramma ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Reconstitute each 1,000 mg vial with 40 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 1,000 mg b'40 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preżervattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Hospira powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Maltese: Qabel ma jingħatalek, it-trab ta' Pemetrexed Hospira jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9 %) sodium chloride, mill-ispiżjar ta' l-isptar, infermier jew tabib.
English: Concomitant administration of nephrotoxic drugs (e.g., aminoglycoside, loop diuretics, platinum compounds, ciclosporin) could potentially result in delayed clearance of pemetrexed.
Maltese: Jekk jingħataw mediċini nefrotossiċi (eż. aminoglikosidi, dijuretiċi li jaħdmu fuq il-liwja tubulari, komposti tal-platinu, cyclosporin) fl-istess żmien, dawn jistgħu jwasslu għal dewmien fit-tneħħija ta' pemetrexed.
English: Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull kunjett fih 500 mg pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95% CI=0.64-0.96, p=0.0195).
Maltese: Wara li bdiet il-kura bi pemetrexed flimkien ma' cisplatin (4 ċikli), il-kura bi pemetrexed kienet statistikament superjuri għal plaċebo għall-OS (medjan 13.9 xhur kontra 11.0 xhur, hazard ratio = 0.78, 95%CI=0.
English: Pemetrexed Hospira must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Maltese: Pemetrexed Hospira għandu jingħata biss bis-superviżjoni ta' tabib ikkwalifikat fl-użu tal-kimoterapija kontra l-kanċer.
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preżervattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Pemetrexed Hospira in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: Pemetrexed Hospira hija mediċina li tintuża fil-kura tal-kanċer.
English: Oedema
Maltese: Dardir
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 100 mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preżervattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull kunjett fih 100 mg ta' pemetrexed (bħala pemetrexed sodium hemipentahydrate).
English: Common Vomiting Mucositis/
Maltese: Dgħufija fil-muskoli
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Hospira 1,000 mg trab għal konċentrat għall-infużjoni
English: Erythematous oedema mainly of the lower limbs has been reported with an unknown frequency.
Maltese: Edema eritematosi l-iżjed fir-riġlejn ġiet irrapportata bi frekwenza mhux magħrufa.
English: London, 14 August 2008 EMEA/CHMP/524284/2008
Maltese: Londra, 14 ta' Awwissu 2008 EMEA/CHMP/524293/2008
English: Octegra was initially approved in June 1999.
Maltese: Octegra ġie approvat inizjalment f'Ġunju 1999.
English: Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Maltese: Octegra pilloli miksijin b'rita fihom 400 mg moxifloxacin bħala hydrochloride.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Octegra and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
Maltese: (CHMP) WARA RIFERIMENT SKOND L-ARTIKOLU 6 (12) Octegra u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): moxifloxacin INFORMAZZJONI TA' SFOND *
English: In terms of safety the longer treatment duration, the risk of effects on cartilage in young patients and the risk of QT-prolongation were of concern.
Maltese: F'termini ta' sigurtà fir-rigward ta' kura fit-tul, ir-riskju tal-effetti fuq ilkartilaġni (qarquċa tal-għadam) f'żgħażagħ u r-riskju tal-prolongament-QT kienu ta' tħassib.
English: 1 September 2014 EMA/465179/2014
Maltese: EMA/465179/2014
English: The injectable form of domperidone was withdrawn in 1985 because of such side effects.
Maltese: Il-forma injettabli ta' domperidone ġiet irtirata fl-1985 minħabba tali effetti sekondarji.
English: The review of domperidone was initiated on 1 March 2013 at the request of the Belgian medicines authority, the Federal Agency for Medicines and Health Products (FAGG-AFMPS), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' domperidone nbdiet fl-1 ta' Marzu 2013 fuq it-talba tal-awtorità tal-mediċini Belġjana, lAġenzija Federali għal Mediċini u Prodotti tas-Saħħa (FAGG-AFMPS), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: • The new recommended dose in adults (and adolescents ≥ 35 kg where licensed) is 10 mg orally up to three times daily (maximum dose of 30 mg daily).
Maltese: • Id-doża ġdida rrakkomandata fl-adulti (u adolexxenti ≥ 35 kg fejn liċenzjati) hija 10 mg mill-ħalq sa tliet darbiet kuljum (doża massima ta' 30 mg kuljum).
English: On 23 April 2014, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed recommendations to restrict the use of domperidone-containing medicines.
Maltese: Fit-23 ta' April 2014, il-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri DeċentralizzatiUman (CMDh) approva rakkomandazzjonijiet biex jiġi limitat l-użu ta' mediċini li fihom domperidone.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta lill-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards ta' sigurtà armonizzati għal mediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.