FrancophonIA/ELRC3.0 huggingface dataset:
English: In two three-month controlled clinical studies in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily in the morning was 7 to 9 mmHg.
Maltese: F'żewġ studji kliniċi kkontrollati ta' tliet xhur f'pazjenti bi glawkoma open angle jew pressjoni għolja ta' l-għajnejn u linja bażi medja ta' IOP ta' 23 sa 26 mmHg, l-effett medju ta' tnaqqis fl-IOP ta' DuoTrav mogħti darba kuljum filgħodu kien ta' 7 sa 9 mmHg.
English: Ophthalmic beta blockers may induce dryness of eyes.
Maltese: Sustanzi oħra imblokkaturi tar-riċetturi beta
English: - The active substances are travoprost and timolol.
Maltese: - Is-sustanzi attivi huma travoprost u timolol.
English: In pregnant rats, systemic administration of travoprost at doses more than 200 times the clinical dose during the period of organogenesis resulted in an increased incidence of malformations.
Maltese: F'firien tqal, lgħoti sistemiku ta' travoprost f'dożi aktar minn 200 darba d-doża klinika, waqt il-perijodu talorganoġenesi rriżulta f'żjieda fl-inċidenza ta' malformazzjonijiet.
English: Prostatic specific antigen increased
Maltese: Żieda fl-antiġen speċifiku għall-prostata
English: DuoTrav eye drop solution is a combination of two active substances (travoprost and timolol).
Maltese: DuoTrav soluzzjoni ta' qtar għall-għajnejn huwa taħlita ta' żewġ sustanzi attivi (travoprost u timolol).
English: Following once-daily administration of DuoTrav PQ in healthy subjects (N=22) for 5 days, travoprost free acid was not quantifiable in plasma samples from the majority of subjects (94.4%) and generally was not detectable one hour after dosing.
Maltese: Wara l-għoti ta' DuoTrav PQ darba kuljum f'individwi b'saħħithom (N=22) għal 5 ijiem, l-aċidu ħieles ta' travoprost ma setax jiġi ikwantifikat fil-kampjuni tal-plażma fil-maġġoranza ta' l-individwi (94.4%) u ġeneralment ma kienx osservat siegħa wara d-dożaġġ.
English: How to store DuoTrav
Maltese: X'fih DuoTrav
English: Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no adverse effects on postnatal development (7000 times the clinical dose) and increased foetal resorptions in rabbits (14000 times the clinical dose).
Maltese: Studji dwar it-tossiċità fuq is-sistema riproduttiva b'timolol urew ossifikazzjoni ttardjata tal-fetu fil-firien bl-ebda effett avvers fuq l-iżvilupp ta' wara t-twelid (7000 darba id-doża klinika) u żjieda fl-assorbiment mill-ġdid tal-fetu fil-fniek (14000 darba id-doża klinika).
English: Prostaglandins and prostaglandin analogues are biologically active substances that may be absorbed through the skin.
Maltese: Prostaglandins u analogi ta' prostaglandin huma sustanzi attivi bijoloġikament li jistgħu jiġu assorbiti mill-ġilda.
English: Peptic ulcer reactivated, gastrointestinal disorder, diarrhoea, constipation, dry mouth, abdominal pain, nausea, vomiting
Maltese: Attivazzjoni mill-ġdid ta' ulċera peptika, disturb gastrointestinali, dijarea, stitikezza, ħalq xott, uġigħ addominali, dardir, rimettar
English: This may cause undesirable effects similar to those seen with systemic beta-blocking agents.
Maltese: Dan jista' jikkawża effetti mhux mixtieqa simili għal dawk osservati b'sustanzi sistemiċi li jimblokkaw ir-riċetturi beta.
English: Skin exfoliation, hair texture abnormal, dermatitis allergic, hair colour changes, madarosis, pruritus, hair growth abnormal, erythema
Maltese: Tqaxxir tal-ġilda, ix-xagħar jinħass mhux normali, dermatite allerġika, bidliet fil-kulur taxxagħar, madarosi, ħakk, tkabbir ta' xagħar mhux normali, eritema
English: Unilateral treatment can result in permanent heterochromia.
Maltese: Kura f'għajn waħda jista' jirriżulta f'eterokromja permanenti.
English: In case of accidental ingestion, symptoms of overdose from systemic beta blockade may include bradycardia, hypotension, bronchospasm and heart failure.
Maltese: F'każ ta' teħid aċċidentali mill-ħalq, sintomi ta' doża eċċessiva minn imblukkar sistemiku beta jistgħu jinkludu bradikardija, pressjoni baxxa, bronkospażmu u insuffiċjenza tal-qalb.
English: The full EPAR for Epoetin Alfa Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar informazzjoni dwar Epoetin Alfa Hexal tinsab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 04-2016.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'08-2018.
English: For patients with kidney failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Maltese: Għal pazjenti b'insuffiċjenza tal-kliewi, b'sindromi majelodisplastiċi jew li jkunu qed jirċievu kimoterapija, il-livelli tal-emoglobina għandhom jibqgħu fil-medda rakkomandata (bejn 10 grammi u 12-il gramma għal kull deċilitru fl-adulti u bejn 9.5 u 11 g/dl fit-tfal).
English: The reference medicine for Epoetin Alfa Hexal is Eprex/Erypo.
Maltese: Il-mediċina ta' referenza għal Epoetin Alfa Hexal hija Eprex/Erypo.
English: Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Maltese: Epoetin Alfa Hexal, injettat f'vina, tqabbel mal-mediċina ta' referenza fi studju ewlieni li fih ħadu sehem 479 pazjent b'anemija kkawżata minn problemi fil-kliewi.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Maltese: • għall-kura tal-anemija (għadd baxx ta' ċelloli ħomor tad-demm) li tkun qed tikkawża sintomi f'pazjenti b'‘insuffiċjenza kronika tal-kliewi' (tnaqqis progressiv u fit-tul fil-kapaċità tal-kliewi li jaħdmu sew) jew bi problemi oħra fil-kliewi;
English: Epoetin Alfa Hexal is a ‘biosimilar' medicine.
Maltese: Epoetin Alfa Hexal fih is-sustanza attiva epoetina alfa u huwa ‘mediċina bijosimili'.
English: The most common side effects with Epoetin Alfa Hexal (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Epoetin Alfa Hexal (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma dardir (tħossok ma tiflaħx), dijarea, rimettar, deni u uġigħ ta' ras.
English: It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Maltese: Jintuża wkoll f'pazjenti b'livelli normali ta' ħadid fid-demm li jistgħu jesperjenzaw kumplikazzjonijiet minn trasfużjoni tad-demm, jekk ma jagħtux id-demm tagħhom stess qabel lintervent kirurġiku u huma mistennija jitilfu bejn 900 u 1,800 ml ta' demm;
English: Epoetin Alfa Hexal epoetin alfa
Maltese: Epoetin Alfa Hexal (epoetina alfa)
English: The active substance in Epoetin Alfa Hexal, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells from the bone marrow.
Maltese: Is-sustanza attiva f'Epotein Alfa Hexal, l-epoetina alfa, hija kopja ta' ormon imsejjaħ eritropojetina, u taħdem eżattament bl-istess mod bħall-ormon naturali biex tistimula l-produzzjoni taċ-ċelloli ħomor tad-demm mill-mudullun.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epoetin Alfa Hexal on 28 August 2007.
Maltese: Epoetin Alfa Hexal irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fit28 ta' Awwissu 2007.
English: What is Epoetin Alfa Hexal?
Maltese: Epoetin Alfa Hexal.
English: Other information about Epoetin Alfa Hexal
Maltese: Informazzjoni oħra dwar Epoetin Alfa Hexal
English: • patients undergoing surgery who cannot receive medicines for the prevention of blood clots.
Maltese: • pazjenti għaddejjin minn intervent kirurġiku li ma jistgħux jingħataw mediċini għall-prevenzjoni ta'
English: What is the risk associated with Epoetin Alfa Hexal?
Maltese: X'inhuma r-riskji assoċjati ma' Epoetin Alfa Hexal?
English: It must not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Maltese: • pazjenti li se jsirilhom intervent kirurġiku ortopediku maġġuri li għandhom problemi kardjovaskulari serji (fil-qalb u fl-arterji u l-vini) inkluż attakk tal-qalb reċenti jew puplesija.
English: In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo.
Maltese: Studju ieħor fuq 114-il pazjent bil-kanċer li kienu qed jirċievu kimoterapija wera li Epoetin Alfa Hexal injettat taħt il-ġilda kien effettiv daqs Eprex/Erypo biex iżomm il-livelli ta' emoglobina f'livelli rakkomandati.
English: Epoetin Alfa Hexal was studied to show that it is comparable to the reference medicine, Eprex/Erypo.
Maltese: Dan ifisser li Epoetin Alfa Hexal huwa simili ħafna għal mediċina bijoloġika oħra (il-‘mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: For the full list of all side effects reported with Epoetin Alfa Hexal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Epoetin Alfa Hexal, ara l-fuljett ta' tagħrif.
English: The medicine can only be obtained with a prescription.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara hawn.
English: Dr Calvo-Rojas (Spain)
Maltese: Dr Calvo-Rojas (Spanja)
English: What is Protium?
Maltese: X'inhu Protium?
English: EMA/CHMP/565104/2009 rev EMEA/H/A-30/1002
Maltese: EMA/CHMP/565104/2009 rev.
English: 15 April 2010
Maltese: 15 ta' April 2010
English: Dr Enzmann (Germany)
Maltese: Dr Enzmann (il-Ġermanja)
English: The active substance in Protium, pantoprazole, is a proton pump inhibitor (PPI).
Maltese: Is-sustanza attiva fi Protium, il-pantoprażol, hija inibitur tal-pompa protonika (PPI).
English: 6 April 2009, 24 August 2009 and 19 October
Maltese: 6 ta' April 2009, 24 ta' Awwissu 2009 u 19 ta' Ottubru
English: Pantoloc, PantoLomberg, Pantopan, Pantoprazol 20 mg Byk, Pantoprazol NYC, Pantoprazol Nycomed, Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale and Zurcazol.
Maltese: Protium jinstab ukoll fl-UE u fiż-ŻEE b'ismijiet kummerċjali oħrajn: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantoprazol 20 mg Byk, Pantoprazol NYC, Pantoprazol Nycomed, Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale u Zurcazol.
English: Protium has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Il-ħtieġa tal-armonizzazzjoni ta' Protium ġiet identifikata mill-Grupp ta' Koordinazzjoni għal Proċeduri Reċiproċi u Deċentralizzati - Umani (CMD(h)).
English: • stomach or duodenal ulcer,
Maltese: • ulċera fl-istonku jew fid-duwodenu,
English: 1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: 1 Artikolu 30 ta' Direttiva 2001/83/KE kif emendat, referenza fuq bażi ta' deċiżjonijiet diverġenti addottati minn Stati membri jippompjaw l-aċidu fl-istonku.
English: • reflux oesophagitis (inflammation of the gullet, due to acid),
Maltese: • esofagite ta' rifluss (infjammazzjoni fil-gerżuma, minħabba aċidu),
English: The 40 mg gastroresistant tablets can also be used to eradicate Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
Maltese: Il-pilloli 40 mg gastroreżistenti jistgħu jintużaw ukoll biex jeqirdu l-batteru Helicobacter pylori (H. pylori) flimkien ma' terapija antibijotika xierqa f'pazjenti li jkollhom ulċeri assoċjati mal-batteru H. pylori.
English: Why was Protium reviewed?
Maltese: Għaliex ġie rivedut Protium?
English: Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions are treated with a daily dose of 80 mg of pantoprazole, either as two 40 mg tablets or an injection.
Maltese: Is-Sindromu ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn jiġu ttrattati b'doża ta' 80 mg pantoprażol kuljum, jew b'żewġ pilloli ta'
English: Protium is authorised in the EU via national procedures.
Maltese: Protium huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Questions and answers on the referral for Protium and associated names pantoprazole, 20 or 40 mg gastro-resistant tablets and 40 mg powder for solution for injection
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Protium u ismijiet assoċjati pantoprażol, 20 jew 40 mg pilloli gastro-reżistenti u 40 mg trab għal soluzzjoni għal injezzjoni
English: The main areas harmonised include:
Maltese: L-oqsma prinċipali armonizzati jinkludu:
English: The Committee recommended that the 40 mg gastro-resistant tablets and the 40 mg powder for solution for injection should be used to treat reflux oesophagitis, gastric and duodenal ulcer, and Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Maltese: Il-Kumitat irrakkomanda li l-pilloli 40 mg gastro-reżistenti u 40 mg trab għal soluzzjoni għal injezzjoni għandhom jintużaw għat-trattament tal-esofaġite ta' rifluss, ulċera gastrika u duwodenali, u sSindromu ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn.
English: The recommended dosage for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management of reflux oesophagitis and the prevention of gastroduodenal ulcers in patients taking NSAIDs, the recommended dose is one 20 mg tablet once daily.
Maltese: Id-doża rrakkomandata għat-trattament tal-marda gastro-esofagite sintomatika, il-ġestjoni fit-tul ta' esofagite ta' rifluss u l-prevenzjoni ta' ulċeri gastroduwodenali f'pazjenti li jkunu qegħdin jieħdu NSAIDs hija pillola waħda ta' 20 mg darba kuljum.
English: The Committee recommended that the 20 mg gastro-resistant tablets should be used for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management and prevention of relapse in reflux oesophagitis and the prevention of gastroduodenal ulcers induced by non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
Maltese: Il-Kumitat irrakkomanda li l-pilloli 20 mg gastro-reżistenti għandhom jintużaw għall-kura tal-marda tar-rifluss gastro-esofegali sintomatika, għall-ġestjoni u l-prevenzjoni fit-tul ta' rikaduta fl-esofaġite ta' rifluss u lprevenzjoni ta' ulċeri gastroduwodenali kkaġunati minn mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs) mhux selettivi f'pazjenti f'riskju li jeħtieġu kura kontinwa bl-NSAID.
English: The CHMP agreed on a harmonised indication (the disease for which the medicine may be used).
Maltese: Is-CHMP qabel dwar indikazzjoni armonizzata (il-mard li għalih tista' tintuża din il-mediċina).
English: However, if the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended while high doses of PPI should be avoided.
Maltese: Madankollu jekk l-użu konkomittanti tas-sustanza atażanavir ma' PPI jitqies inevitabbli, huwa rrakkomandat li jsir monitoraġġ kliniku mill-qrib (eż. ammont ta' vajrusijiet) filwaqt li jiġu evitati dożi għoljin ta' PPI.
English: The recommended dose for reflux oesophagitis and gastric or duodenal ulcers is one 40 mg tablet or one 40 mg injection daily.
Maltese: Id-doża rakkomandata għall-esofagite ta' rifluss u għall-ulċeri gastriċi jew duwodenali hija pillola waħda ta' 40 mg jew injezzjoni ta' 40 mg kuljum.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Maltese: Din taħdem billi timblokka l-‘pompi protoniki', li huma proteini li jinstabu f'ċelloli speċjalizzati fil-kisja tal-istonku li
English: Co-administration of atazanavir with PPIs is not recommended.
Maltese: It-tweġibiet tal-kumpanija ngħataw nhar:
English: The company that markets these medicines is Nycomed.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Nycomed.
English: Protium can also be used for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment, and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcers.
Maltese: Protium jista' jintuża wkoll għall-prevenzjoni ta' ulċeri fl-istonku li jistgħu jiġu kkawżati minn xi mediċini użati għall-kura ta' uġigħ u infjammazzjonijiet msejħa mediċini mhux sterojdi kontra linfjammazzjonijiet (NSAIDs) mhux selettivi, fejn il-pazjent ikun jeħtieġ trattament kontinwu bl-NSAID, u biex jgħin l-istonku jeħles minn batterju msejjaħ Helicobacter pylori, li huwa magħruf li jikkawża ulċeri fl-istonku.
English: The active substance is docetaxel.
Maltese: Is-sustanza attiva hi docetaxel.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor a
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide FAC = 5-fluorouracil, doxorubicin u cyclophospamide CI = confidence interval - intervall ta' kunfidenza; ER = estrogen receptor - riċettatur tal-estroġen PR = progesterone receptor - riċettatur tal-progesterone a
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 January 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Jannar 2012
English: 117 allée des Parcs F-69 800 Saint Priest France
Maltese: 117 allée des Parcs F-69 800 Saint Priest Franza
English: Citric acid (pH adjustment)
Maltese: Citric Acid (għal aġġustament ta' pH)
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Maltese: Minoranza ta' pazjenti kienu ittestjati bl-użu ta' fluorescence insitu hybridization (FISH).
English: 117 allée des parcs 69800 Saint Priest France
Maltese: 117 allée des parcs 69800 Saint Priest Franza
English: With primary G-CSF prophylaxis (n = 421) n (%)
Maltese: Bi profilassi primarja b'GCSF (n = 421) n (%)
English: Congestive heart failure (CHF)
Maltese: Insuffiċjenza konġestiva tal-qalb (CHF - Congestive Heart Failure)
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Maltese: Riskju proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-Trattament: 5.4% [95% CI: -1.1; 12.0] Differenza fit-Trattament: 6.2% [95% CI: 0.2; 12.3]
English: Overall response rate (CR+PR) (%) p-value
Maltese: Ir-rata globali ta' rispons (CR+PR) (%) valur p
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: ER/PR-negative or Grade 3 or tumor size >5 cm
Maltese: ER/PR-negattiv jew Grade 3 jew daqs tat-tumur >5 cm
English: Ethanol anhydrous Polysorbate 80
Maltese: Polysorbate 80
English: The ORR was 59.3% (95% CI: 52.8-65.9) in AT arm versus 46.5% (95% CI: 39.8-53.2) in AC arm.
Maltese: Ir-RTTR kienet 59.3% (95% CI: 52.8-65.9) fil-fergħa AT versu 46.5% (95% CI: 39.853.2) fil-fergħa AC.
English: Cases of persisting alopecia have been reported.
Maltese: Ġew irrapportati każijiet ta' alopeċija persistenti.
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Maltese: Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + 5-FU *Cox model (aġġustament għas-sit tat-tumur Primarju, T and N stadji kliniċi u PSWHO) **Logrank test ***Chi-square test
English: Progressive Disease as Best Overall Response (%) *Unstratified logrank test
Maltese: Mard progressiv bħala l-aħjar rispons globali (%) *Unstratified logrank test
English: Docetaxel Mylan contains ethanol
Maltese: Docetaxel Mylan fih l-ethanol
English: LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous and citric acid.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: polysorbate 80, ethanol anidru u citric acid.
English: Number of
Maltese: NUMRU(I)
English: Other medicines and Docetaxel Mylan
Maltese: Mediċini oħra u Docetaxel Mylan
English: • Mitoxantrone 12 mg/m² every 3 weeks for 10 cycles.
Maltese: • Mitoxantrone 12 mg/m² mogħti kull 3 ġimghat għal 10 ċikli.
English: Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Maltese: Kategorija farmako-terapewtika: sustanzi antineoplastiċi, taksanes, Kodiċi ATC:
English: The recommended dose of docetaxel is 75 mg/m².
Maltese: Id-doża rakkomandata ta' docetaxel hija 75 mg/m².
English: Age category 2 <35 years ≥35 years
Maltese: Kategorija tal-età 1 <50 sena ≥50 sena Kategorija tal-età 2 <35 sena ≥35 sena Stat ta' riċettatur ormonali
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Maltese: Għalkemm il-possibbiltà t'interazzjoni in vivo ta' docetaxel ma' prodott mediċinali ieħor li ngħata konkomittantement ma kienx investigat formalment, linterazzjonijiet in-vitro b'sustanzi li huma marbuta sew mal-proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole u sodium valproate, m'effetwawx ir-rabta ta' docetaxel mal-proteina.
English: Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Maltese: Issopravivenza totali kienet ukoll b'mod sinifikattiv itwal (p = 0.0201) favur il-fergħa TCF b'riskju mnaqqas ta' mortalità ta' 22.7%.
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Maltese: Differenza fit-trattament: 7.1% [95% CI: 0.7; 13.5] *Ikkoreġġuti għal paraguni multipli u aġġustati għall-fatturi stratifikanti (stadju tal-marda u l-post tattrattament), ibbażati fuq il-popolazzjoni ta' pazjenti evalwati.
English: • Docetaxel 75 mg/m² every 3 weeks for 10 cycles.
Maltese: • Docetaxel 75 mg/m² kull 3 ġimgħat għal 10 ċikli.
English: Diarrhoea grade 4
Maltese: Dijarea ta' grad 4
English: Grade 3
Maltese: Dijarea ta' grad 3
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Maltese: Dawn ir-reazzjonijiet kienu deskritti bl-użu ta' Kriterji ta' Tossiċità Komuni ta' NCI (grad 3 = G3; grad 3-4 = G3/4; grad 4 = G4), it-terminoloġija COSTART u l-MedDRA.
English: 5 vials of 4 ml
Maltese: 5 kunjetti ta' 4 ml
English: Hypotension; Hypertension; Haemorrhage
Maltese: Infjammazzjoni tal-mukoża; Uġigħ;
English: EU/1/11/748/006 - 5 vials
Maltese: EU/1/11/748/006 - 5 kunjetti
English: In combination with cisplatin and 5-fluorouracil
Maltese: f'kombinazzjoni ma' cisplatin u 5-fluorouracil
English: Summary of the safety profile for all indications
Maltese: Sommarju tal-profil ta' sigurtà għall-indikazzjonjiet kollha