FrancophonIA/ELRC3.0 huggingface dataset:
English: In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Maltese: F'individwi mhux dijabetiċi (gliċemija normali), vildagliptin ma jistimulax is-sekrezzjoni ta'l-insulina jew inaqqas livelli tal-glucose.
English: Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see section 5.3).
Maltese: Studji fuq bhejjem li saru b'vildagliptin u metformin ma wrewx evidenza ta' teratoġeniċità, iżda effetti tossiċi fuq il-fetu b'dożi tossiċi għall-omm (ara sezzjoni 5.3).
English: - Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Maltese: - Eucreas huwa indikat għal terapija ta' kombinazzjoni tripla mal-insulina bħala aġġunt għad-dieta u l-eżerċizzju sabiex jitjieb il-kontroll gliċemiku f'pazjenti adulti meta l-insulina f'doża stabbli u metformin waħedhom ma jipprovdix kontroll gliċemiku xieraq.
English: Eucreas is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Maltese: Eucreas jiġi f'pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b'rita u f'pakketti b'ħafna li jkun fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pillola miksija b'rita.
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Informazzjoni għall-utent Eucreas 50 mg/850 mg pilloli miksija b'rita Eucreas 50 mg/1000 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP.
Maltese: L-għotja ta' vildagliptin twassal għall-impediment mgħaġġel u komplet ta' l-attività tad-DPP-4 li twassal għal żieda fil-livelli endoġeni ta' waqt is-sawm u wara l-ikel ta' l-ormoni inkretin GLP-1 u GIP.
English: Eucreas 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Maltese: Eucreas 50 mg/1000 mg pilloli miksija b'rita huma pilloli sofor skuri, ovali b'“NVR” fuq naħa waħda u “FLO” fuq l-oħra.
English: If no adequate strength of Eucreas is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Eucreas, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Maltese: Pazjenti b'indeboliment epatik, inklużi pazjenti li jkollhom ALT jew AST qabel il-kura > 3 darbiet ULN, m'għandhomx jiġu kkurati b'Eucreas (ara sezzjonijiet 4.2, 4.3 u 4.8).
English: Your doctor will tell you exactly the dose of Eucreas to take.
Maltese: M'hemmx dejta dwar doża eċċessiva b'Eucreas.
English: Avoid excessive alcohol intake while taking Eucreas since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol meta tkun qed tieħu Eucreas peress li dan jista' jżid ir-riskju ta' aċidożi lattika (jekk jogħġbok ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: The potential risk for humans is unknown.
Maltese: Ir-riskju li jista' jkun hemm fuq il-bniedem, mhux magħruf.
English: - Each Eucreas 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Maltese: - Kull pillola miksija b'rita ta' Eucreas fiha 50 mg vildagliptin u 1000 mg metformin hydrochloride (jikkorrispondu għal 780 mg metformin).
English: The dose of Eucreas should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Maltese: Id-doża ta' Eucreas għandha tipprovdi doża ta' 50 mg vildagliptin darbtejn kuljum (100 mg doża totali ta' kuljum) u doża ta' metformin simili għad-doża li qed tittieħed diġà.
English: Do not take Eucreas - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Eucreas - jekk inti allerġiku għal vildagliptin, metformin jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: What Eucreas looks like and contents of the pack Eucreas 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Maltese: Eucreas 50 mg/850 mg pilloli miksija b'rita huma pilloli sofor, ovali b'“NVR” fuq naħa waħda u “SEH” fuq l-oħra.
English: Eucreas 50 mg/850 mg film-coated tablets
Maltese: Eucreas 50 mg/850 mg pilloli miksija b'rita
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Maltese: It-titjib fil-proporzjon ta' l-insulina/glucagon waqt l-ipergliċemija minħabba ż-żieda fil-livelli ta' lormoni inkretin tirriżulta f'tnaqqis fil-produzzjoni ta' glucose waqt is-sawm u wara l-ikel, li twassal għal tnaqqis fil-gliċemija.
English: • Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.
Maltese: • Frekwenza mhux magħrufa (ma tistax tiġi stabbilita mid-dejta disponibbli): raxx bil-ħakk,
English: Eucreas is used to treat adult patients with type 2 diabetes.
Maltese: Eucreas jintuża għall-kura ta' pazjenti adulti bid-dijabete tat-tip 2.
English: Eucreas 50 mg/1000 mg film-coated tablets
Maltese: Eucreas 50 mg/1000 mg pilloli miksija b'rita
English: Some patients have had the following side effects while taking Eucreas and insulin:
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Eucreas u l-insulina:
English: In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
Maltese: Fi provikliniċi, l-inċidenza ta' l-ipogliċemija kienet komuni f'pazjenti li kienu qed jirċievu vildagliptin flimkien ma' metformin (1%) u mhux komuni f'pazjenti li kienu qed jirċievu plaċebo flimkien ma' metformin (0.4%).
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Eucreas may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: • Aċidożi lattika (rari ħafna: tista' taffettwa sa persuna 1 minn kull 10,000 li qed jużawh):
English: The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the longterm benefit of intensive blood glucose control in type 2 diabetes.
Maltese: L-istudju prospettiv randomised UKPDS (Studju Prospettiv tad-Dijabete UK) stabilixxa l-benefiċċju fuq żmien twil tal-kontroll tal-glucose fid-demm fid-dijabete tat-tip 2.
English: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Maltese: Kull pillola miksija b'rita fiha 50 mg vildagliptin u 850 mg metformin hydrochloride (li jissarraf f'660 mg ta' metformin).
English: Eucreas is not recommended for use in children and adolescents (< 18 years).
Maltese: Eucreas mhux irrakkomandat għall-użu fit-tfal u adolexxenti (< 18-il sena).
English: The safety and efficacy of vildagliptin and metformin as triple oral therapy in combination with a thiazolidinedione have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' vildagliptin u metformin bħala terapija orali tripla flimkien ma' thiazolidinedione għadhom mhumiex stabbiliti.
English: By increasing the endogenous levels of these incretin hormones, vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion.
Maltese: Meta jżid il-livelli endoġeni ta' dawn l-ormoni inkretin, vildagliptin itejjeb is-sensittività taċ-ċelluli beta għall-glucose, li jwassal għal titjib fis-sekrezzjoni ta' l-insulina li tiddependi mill-glucose.
English: A slow increase in the dose may also improve gastrointestinal tolerability.
Maltese: It-tnaqqis bil-mod tad-doża jista' wkoll itejjeb ittolerabilità gastrointestinali.
English: Skin reactions such as erythema, pruritus and urticaria *A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin.
Maltese: B12 flimkien ma' tnaqqis fil-livelli fis-serum kien osservat b'mod rari ħafna f'pazjenti li kienu ttrattati għal żmien twil b'metformin.
English: The marketing authorisation was renewed on 13 March 2002 and on 13 March 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet mġedda fit-13 ta' Marzu 2002.
English: This summary was last updated in 04-2009.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 04-2009.
English: During the study period, 9% of the patients died (11 out of 125), 6% had amputations (7 out of 125) and 10% had new thromboembolic complications (12 out of 125).
Maltese: Matul il-perjodu ta' studju, 9% tal-pazjenti mietu (11 minn 125), 6% kellhom jagħmlu amputazzjoni (7 minn 125) u 10% kellhom komplikazzjonijiet tromboemboliċi ġodda (12 minn 125).
English: It contains the active substance lepirudin.
Maltese: Huwa fih is-sustanza attiva lepirudin.
English: The marketing authorisation holder is Celgene Europe Ltd.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Celgene Europa Ltd.
English: The active substance in Refludan, lepirudin, is nearly identical to hirudin, the anti-clotting substance produced by leeches.
Maltese: Lepirudin, issustanza attiva f'Refludan, huwa kważi identiku għal hirudin, is-sustanza antikoagulanti prodotta missangisugi.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REFLUDAN EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) REFLUDAN
English: The studies looked at the numbers of patients who died, had an amputation, and had new thromboembolic (clotting) complications.
Maltese: pazjenti li mietu, kellhom amputazzjoni, u kellhom komplikazzjonijiet ġodda tromboemboliċi (tagħqid).
English: Lepirudin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce lepirudin.
Maltese: Lepirudin huwa magħmul b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': huwa magħmul minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha possibbli tipproduċih.
English: What is Refludan?
Maltese: X'inhu Refludan?
English: See the Package Leaflet for the full list of restrictions.
Maltese: Ara l-Fuljett ta' Tagħrif għal-lista sħiħa ta' restrizzjonijiet.
English: What is the risk associated with Refludan?
Maltese: X'inhu r-riskju assoċjat ma' Refludan?
English: The diagnosis must be confirmed using specific tests, such as the heparin-induced platelet aggregation assay (HIPAA) test.
Maltese: Id-dijanjosi trid tiġi kkonfermata bl-użu ta' testijiet speċifiċi, bħat-test tal-aggregazzjoni tal-analiżi tal-pjastrina indotta mill-eparina (HIPAA - heparin-induced platelet aggregation assay).
English: Refludan has been studied in two main studies involving 198 patients, 125 of whom had HIT and thromboembolic disease.
Maltese: Refludan ġie studjat f'żewġ studji ewlenin li involvew 198 pazjent, li minnhom 125 kienu morda bittromboċitopenija indotta mill-eparina (HIT) u t-tromboemboliżi.
English: Refludan is an antithrombotic medicine (a medicine that prevents the blood from clotting).
Maltese: Refludan huwa mediċina antitrombotika (mediċina li tipprevjeni d-demm milli jagħqad).
English: The recommended dose is 0.4 mg per kilogram body weight as a single injection into a vein, followed by a continuous infusion at a dose of 0.15 mg/kg per hour for two to 10 days, or longer if needed.
Maltese: Id-doża rakkomandata hija 0.4 mg għal kull kilogram ta' piż korporju bħala injuezzjoni unika fil-vina, segwita b'infużjoni kontinwa ta' doża ta' 0.15mg/kg fis-siegħa għal bejn jumejn u għaxart ijiem, jew izjed fit-tul jekk ikun hemm bżonn.
English: Other information about Refludan:
Maltese: Aktar tagħrif dwar Refludan:
English: It is used in adults with heparin-induced thrombocytopenia (HIT, a type of allergy to heparin that causes a lack of platelets in the blood or clots in the blood vessels) and who have thromboembolic disease (abnormal development of blood clots) that needs injected anti-clotting treatment, usually heparin.
Maltese: Refludan jintuża sabiex jimpedixxi t-tagħqid tad-demm f'pazjenti adulti bi tromboċitopenija indotta mill-eparina (HIT, ċertu tip ta' allerġija għalleparina li tikkawża nuqqas ta' pjastrini (platelets) fid-demm jew emboli fil-vini u l-arterji) u li għandhom mard tromboemboliku (żvilupp anormali ta' emboli) li jeħtieġ trattament antitrombotiku injettat, ġeneralment eparina.
English: By blocking thrombin, Refludan greatly reduces the risk of blood clots forming, preventing subsequent damage.
Maltese: Billi jimblokkka t-trombina, Refludan inaqqas ħafna r-riskju li jiffurmaw emboli, u b'hekk jevita ħsara suċċessiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Refludan on 13 March 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Refludan fit-13 ta' Marzu 1997.
English: For the full list of all side effects reported with Refludan, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Refludan, ara l-Fuljett ta' Tagħrif.
English: The doses need to be reduced in patients with kidney problems.
Maltese: Id-dożi jeħtieġ li jitnaqqsu f'pazjenti bi problemi fil-kliewi.
English: Lepirudin specifically blocks a substance called thrombin, which is central for the complete process of blood clotting.
Maltese: Lepirudin jimblokka speċifikament sustanza msejħa trombina, li hija l-qofol tal-proċess sħiħ tat-taqgħqid tad-demm.
English: Why has Refludan been approved?
Maltese: Għaliex ġie approvat Refludan?
English: How has Refludan been studied?
Maltese: Kif ġie studjat Refludan?
English: Refludan should not be used in people who may be hypersensitive (allergic) to lepirudin, any other hirudin derivative, or any of the other ingredients.
Maltese: Refludan ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għal lepirudin, kull derivattiv ta' hirudin, jew għal kwalunkwe sustanza oħra tiegħu.
English: The studies did not compare Refludan with any other treatments, so the results were judged against historical controls (the results expected in untreated patients, based on past studies).
Maltese: L-istudji ma qabblux Refludan ma' trattamenti oħra, għaldaqstant ir-riżultati ġew iġġudikati fuq il-kontrolli storiċi (ir-riżultat mistenni f'pazjenti li ma kinux ġew trattati, skont studji fil-passat).
English: How is Refludan used?
Maltese: Għalxiex jintuża Refludan?
English: Its use is not advisable in patients who are bleeding or are at risk of bleeding because of a recent biopsy, stroke or major surgery, or because they are over the age of 65 years, among other reasons.
Maltese: L-użu tiegħu mhux irrakkomandat f'pazjenti li għandhom fsada jew għandhom riskju ta' fsada minħabba bijopsija riċenti, puplesija jew operazzjoni serja, jew minħabba li għandhom 'il fuq minn 65 sena, fost raġunijiet oħra.
English: In the comparison with historical controls, the two trials taken together showed a significant benefit of Refludan on the rate of new thromboembolic complications and a trend towards increased survival.
Maltese: Fit-tqabbil mal-kontrolli li saru maż-żmien, iż-żewġ provi meħudin flimkien urew benefiċċju sinifikanti ta' Refludan fuq ir-rata ta' kumplikazzjonijiet tromboemboliċi ġodda u tendenza favur sopravivenza akbar.
English: Refludan is a powder that is dissolved to make up a solution for injection or infusion (drip into a vein).
Maltese: Refludan huwa trab li jinħall biex jifforma soluzzjoni għall-injezzjoni jew l-infużjoni (dripp fil-vina).
English: What benefit has Refludan shown during the studies?
Maltese: X'benefiċċju wera Refludan matul l-istudji?
English: EU/1/99/097/001 Beromun
Maltese: EU/1/99/097/001
English: Isolated limb perfusion (intra-arterial use)
Maltese: Perfużjoni iżolata ta' driegħ/riġel (użu għal ġo larterja)
English: Powder for solution for infusion
Maltese: Trab għal soluzzjoni għallinfużjoni
English: MA (EU) number Invented name Strength Pharmaceutical form
Maltese: Isem ivvintat Qawwa Għamla farmaċewtika
English: vial (glass)
Maltese: kunjett (ħġieġ) 1 mg
English: Primula veris L. and/or Primula elatior (L.) Hill, flos
Maltese: Primula veris L. u/jew Primula elatior (L.) Hill, flos
English: Primula flower EMA/423706/2016EMA/423706/2016
Maltese: 20 ta' Settembru 2016 EMA/423706/2016
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/423706/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Primula flower
Maltese: Fjura tal-primula
English: What are the risks associated with primula flower medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-fjura tal-primula?
English: Primula flower is the common name for the flowers of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Maltese: Fjura tal-primula huwa l-isem komuni għall-fjuri tal-pjanta Primula veris L. u/jew Primula elatior (L.) Hill.
English: Primula flower medicines should only be used in adults and adolescents over the age of 12 years.
Maltese: Il-mediċini li fihom il-fjura tal-primula għandhom jintużaw biss fl-adulti u fl-adolexxenti li għandhom 'il fuq minn 12-il sena.
English: What is primula flower?
Maltese: X'inhi l-fjura tal-primula?
English: Further information on the HMPC assessment of primula flower medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions only cover primula flower preparations which are obtained by comminuting (reducing into tiny pieces) the flowers or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss il-preparazzjonijiet tal-fjura tal-primula li huma maħduma billi jindaħnu (f'biċċiet żgħar) il-fjuri jew bl-użu ta' teknika għall-estrazzjoni ta' komponenti billi tpoġġi lmaterjali tal-pjanta f'solvent (bħall-etanol) biex jinħallu l-komponenti u jiffurmaw estratt likwidu.
English: Other information about primula flower medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom il-fjura tal-primula
English: Further information on the risks associated with these primula flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom il-fjura tal-primula, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (‘All Documents') fil-websajt tal-Aġenzija:
English: In its assessment, the HMPC considered laboratory studies which showed primula flower increased production of airway secretions, making phlegm less thick and easier to expel.
Maltese: Ir-riproduzzjoni hija awtorizzata kemm-il darba jissemma' s-sors oriġinali.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula flower.
Maltese: Ma twettaq l-ebda studju kliniku bil-fjura tal-primula.
English: Herbal medicines containing these primula flower preparations are usually available as herbal tea to be drunk and in liquid forms to be taken by mouth.
Maltese: għandu jiġi kkonsultat tabib jew prattikant tal-kura tas-saħħa kwalifikat.
English: MA (EU) number
Maltese: Numru talproċedura ta' l-EU
English: EMA/237735/2019 EMEA/H/C/004951
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 ta' April 2019 EMA/237735/2019 EMEA/H/C/004951
English: Cabazitaxel Teva was developed as a ‘hybrid medicine'.
Maltese: Cabazitaxel Teva ġie żviluppat bħala “mediċina ibrida”.
English: On 26 April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cabazitaxel Teva, intended for the treatment of prostate cancer.
Maltese: Fis-26 ta' April 2019, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Cabazitaxel Teva, maħsub għall-kura ta' kanċer tal-prostata.
English: What is Cabazitaxel Teva?
Maltese: X'inhu Cabazitaxel Teva?
English: Cabazitaxel Teva was to be used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Maltese: Cabazitaxel Teva kellu jintuża flimkien ma' prednisone jew ma' prednisolone (mediċini antiinfjammatorji) f'pazjenti li fil-passat kienu ġew ikkurati b'docetaxel (mediċina oħra kontra l-kanċer).
English: Although cabazitaxel is a derivative of docetaxel, laboratory studies have shown that cabazitaxel and docetaxel have different properties, for example cabazitaxel can cross the blood-brain barrier while docetaxel cannot.
Maltese: Għalkemm cabazitaxel huwa derivattiv ta' docetaxel, studji fil-laboratorju wrew li cabazitaxel u docetaxel għandhom karatteristiċi differenti, pereżempju cabazitaxel jista' jaqsam il-barriera ematoenċefalika filwaqt li docetaxel ma jistax.
English: Cabazitaxel Teva is a cancer medicine that contains the active substance cabazitaxel.
Maltese: Cabazitaxel Teva huwa mediċina kontra l-kanċer li fih is-sustanza attiva cabazitaxel.
English: The applicant also made reference to another medicine, Taxotere, which contains docetaxel.
Maltese: L-applikant għamel referenza wkoll għal mediċina oħra, Taxotere, li fiha docetaxel.
English: Cabazitaxel Teva is expected to work in the same way as the reference medicine, Jevtana.
Maltese: Cabazitaxel Teva huwa mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Jevtana.
English: How does Cabazitaxel Teva work?
Maltese: Kif jaħdem Cabazitaxel Teva?
English: Because Cabazitaxel Teva was developed as a hybrid medicine, the company presented data from the published literature to demonstrate that it is similar to Jevtana.
Maltese: Minħabba li Cabazitaxel Teva ġie żviluppat bħala mediċina ibrida, il-kumpanija ppreżentat data milletteratura ppubblikata biex turi li huwa simili għal Jevtana.
English: What was Cabazitaxel Teva expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Cabazitaxel Teva?
English: The company made reference to two medicines, Jevtana (containing cabazitaxel) and Taxotere (containing docetaxel, see below for more details).
Maltese: Il-kumpanija għamlet referenza għal żewġ mediċini, Jevtana (li fiha cabazitaxel) u Taxotere (li fiha docetaxel, ara hawn taħt għal aktar dettalji).
English: For more information on hybrid medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ibridi, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk.
English: What did the company present to support its application?
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Teva