FrancophonIA/ELRC3.0 huggingface dataset:
English: Gingival hyperplasia
Maltese: Disturbi psikjatriċi Dipressjoni
English: EU/1/06/370/009 EU/1/06/370/010 EU/1/06/370/011 EU/1/06/370/012 EU/1/06/370/013 EU/1/06/370/014 EU/1/06/370/015 EU/1/06/370/016 EU/1/06/370/028 EU/1/06/370/029 EU/1/06/370/030 EU/1/06/370/035 EU/1/06/370/038
Maltese: EU/1/06/370/011 EU/1/06/370/012 EU/1/06/370/013 EU/1/06/370/014
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Exforge, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli bi pressjoni għolja (ara sezzjoni 4.1) li għandhom indeboliment epatiku jinqalbu għal amlodipine jew Exforge, għandha tintuża l-inqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m basis).
Maltese: Ma kien hemm ebda effett fuq il-fertilità tal-firien ikkurati b'amlodipine (irġiel għal 64 ġurnata u n-nisa 14-il ġurnata qabel it-tgħammir) b'dożi sa 10 mg/kg/ġurnata (8 darbiet*id-doża massima rakkomandata għall-bniedem ta' 10 mg fuq bażi ta' mg/m2).
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Exforge containing the same component doses.
Maltese: Għall-konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/kapsuli separati jistgħu jinqalbu għal Exforge li fihom l-istess dożi tal-komponenti.
English: In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans.
Maltese: Fi studji imodinamiċi, amlodipine ma kienx assoċjat ma' effett inotropiku negattiv meta ingħata fil-medda ta' dożi terapewtiċi lill-annimali u bnedmin b'saħħithom, anki meta ingħata ma' beta blockers fil-bnedmin.
English: Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Maltese: Exforge jikkombina żewġ sustanzi kontra l-pressjoni għolja ma' mekkaniżmi kumplimentari sabiex tkun kontrollata l-pressjoni tad-demm f'pazjenti b'pressjoni għolja naturali: amlodipine huwa membru ta' klassi li huma antagonisti ta' calcium u valsartan ta' klassi ta' mediċini li huma antagonisti ta angiotensin II. Il-kombinazzjoni ta' dawn iż-żewġ sustanzi twassal għal effett kontra l-pressjoni għolja adittiv, b'mod li l-pressjoni titbaxxa aktar milli kieku jingħataw il-mediċini waħidhom.
English: Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Maltese: Sustanzi oħrajn li jbaxxu l-pressjoni li jintużaw ta' spiss eż imblokkaturi tar-riċetturi alpha dijuretiċi) u prodotti mediċinali oħrajn li jista' jkollhom effetti avversi li jbaxxu l-pressjoni (eż mediċini triċikliċi kontra d-depressjoni, imblokkaturi tar-riċetturi alpha għall-kura ta' iperplażja beninna tal-prostata) jistgħu jżidu l-effett kontra l-pressjoni għolja tal-kombinazzjoni.
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge” and “Warnings and precautions”); diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce); lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Maltese: “Twissijiet u prekawzjonijiet”); - dijuretiċi (tip ta' mediċina magħrufa bħala ukoll bħala “tal-pipì” li żżid l-ammont ta' awrina li tagħmel; - lithium (mediċina li tintuża biex tikkura d-dipressjoni); - dijuretiċi li jfaddlu potassju, supplimenti ta' potassju, melħ tal-ikel għal min ibati bil-pressjoni li jkun fih potassju u sustanzi oħra li jistgħu iżidu l-livelli ta' potassju; - ċertu tipi ta' mediċini kontra l-uġigħ msejħa mediċini anti-infjammatorji mhux sterojdi
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Exforge, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli anzjani bi pressjoni għolja (ara sezzjoni 4.1) jinqalbu għal amlodipine jew Exforge, għandha tintuża linqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: EMA/123618/2012 EMEA/H/C/001166
Maltese: EMEA/33055/2016 EMA/H/C/001166
English: This summary was last updated in 02-2012.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 01-2016.
English: Clopidogrel Acino is a ‘generic medicine'.
Maltese: Clopidogrel Acino huwa "mediċina ġenerika".
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Maltese: • ikollhom mard fl-arterji periferali (problemi fil-fluss tad-demm fl-arterji);
English: Other information about Clopidogrel Acino
Maltese: Informazzjoni oħra dwar Clopidogrel Acino
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Acino.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Clopidogrel Acino.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino on 28 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Clopidogrel Acino fit-28 ta' Lulju 2009.
English: The active substance in Clopidogrel Acino, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Clopidogrel Acino, il-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: • patients who have recently had a myocardial infarction (heart attack).
Maltese: • reċentement kellhom infart mijokardijaku (attakk tal-qalb).
English: The standard dose of Clopidogrel Acino is one 75 mg tablet once a day.
Maltese: Id-doża standard ta' Clopidogrel Acino hija pillola waħda ta' 75 mg darba kuljum.
English: This means that Clopidogrel Acino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel Acino huwa simili għall"mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Because Clopidogrel Acino is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Peress li Clopidogrel Acino huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Maltese: Imbagħad titkompla bid-doża standard ta' 75-mg darba kuljum għal tal-inqas erba' ġimgħat (fil-każi ta' infart mijokardiku b' 'elevazzjoni tas-segment ST') jew sa 12-il xahar (fil-każi ta' anġina instabbli jew infart mijokardiku ‘mhux tal-mewġa Q').
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Acino has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel Acino wera li għandu kwalità komparabbli ma' Plavix u li huwa bijoekwivalenti għalih.
English: Clopidogrel Acino is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Acino huwa mediċina li fiha s-sustanza attiva klopidogrel.
English: EPAR summary for the public clopidogrel
Maltese: Sommarju tal-EPAR għall-pubbliku
English: What is Clopidogrel Acino?
Maltese: X'inhu Clopidogrel Acino?
English: Because Clopidogrel Acino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.
Maltese: Peress li Clopidogrel Acino huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċini ta' referenza.
English: What are the benefits and risks of Clopidogrel Acino?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Clopidogrel Acino?
English: In acute coronary syndrome, Clopidogrel Acino is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Clopidogrel Acino jintuża flimkien ma' aspirina, fejn id-doża m'għandhiex taqbeż il-100 mg.
English: The full EPAR for Clopidogrel Acino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar informazzjoni rigward ilkura bi Clopidogrel Acino, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Clopidogrel Acino can be started between a few days and 35 days after the attack;
Maltese: Clopidogrel Acino jista' jinbeda fl-ewwel ftit jiem wara l-attakk u sa 35 jum wara;
English: Clopidogrel Acino can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Maltese: Is-sindromu koronarju akut huwa grupp ta' problemi fil-qalb li jinkludu l-attakki tal-qalb u l-anġina instabbli (tip sever ta' uġigħ fis-sider).
English: Clopidogrel Acino is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Acino jintuża biex jipprevjeni problemi kkawżati minn emboli tad-demm f'adulti li:
English: Why has Clopidogrel Acino been approved?
Maltese: Għaliex ġie approvat Clopidogrel Acino?
English: • patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Maltese: • ikollhom kundizzjoni li tissejjaħ ‘sindromu koronarju akut', meta għandu jittieħed ma' aspirina (mediċina oħra li tipprevjeni l-emboli tad-demm).
English: The full EPAR for Cholib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Fenofibrate is a ‘PPARα agonist'.
Maltese: Fenofibrate huwa ‘agonist ta' PPARα'.
English: The second active substance, simvastatin, belongs to the group called ‘statins'.
Maltese: It-tieni sustanza attiva, simvastatin, tagħmel parti mill-grupp magħruf bħala ‘statins'.
English: This is a summary of the European public assessment report (EPAR) for Cholib.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Cholib.
English: It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Maltese: Wera li Cholib wassal għal tnaqqis akbar fil-livelli tattrigliċeridi (33% kontra 7%) u għal livelli ogħla tal-kolesterol tajjeb (żieda ta' 6% kontra tnaqqis ta' 1%).
English: Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone.
Maltese: Studju ieħor qabbel Cholib 145/40 mg ma' simvastatin 40 mg f'450 pazjent li ma kinux qed jirċievu kura adegwata b'40 mg simvastatin waħdu.
English: Other information about Cholib
Maltese: Informazzjoni oħra dwar Cholib
English: This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
Maltese: Dan ifisser li jattiva tip ta' riċettur magħruf bħala l-‘peroxisome proliferator-activated receptor alpha' (PPARα), li huwa involut fit-tkissir ta' xaħmijiet mid-dieta, speċjalment it-trigliċeridi.
English: Why is Cholib approved?
Maltese: Għal xiex ġiet approvat Cholib?
English: In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin.
Maltese: Fi studju ewlieni li qabbel Cholib 145/20 mg ma' 40 mg f'1,050 pazjent li ma kinux qed jirċievu kura adegwata b'20 mg simvastatin waħdu, il-livelli tat-trigliċeridi naqsu b'madwar 36% b'Cholib wara 12-il ġimgħa meta mqabbla ma' 12% b'simvastatin.
English: Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
Maltese: Cholib jista' jinkiseb biss b'riċetta ta' tabib u huwa disponibbli bħala pilloli (145/20 mg u 145/40 mg).
English: This summary was last updated in 08-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi 08-2013.
English: The most common side effects with Cholib are raised blood creatinine levels, upper respiratory tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme).
Maltese: L-effetti sekondarji l-aktar komuni b'Cholib huma żieda fil-livelli ta' krejatinina fid-demm, infezzjoni filparti ta' fuq tal-apparat respiratorju (irjiħat), żieda fl-għadd tal-plejtlits fid-demm, gastroenterite (dijarea u rimettar) u żieda fil-livelli ta' alanine aminotransferase (enzima tal-fwied).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cholib fis-26 ta' Awwissu 2013.
English: It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Maltese: Inaqqas ilkolesterol totali fid-demm billi jimblokka l-azzjoni ta' HMG-CoA reductase, enzima fil-fwied involuta filproduzzjoni ta' kolesterol.
English: It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Maltese: M'għandux jintuża wkoll fuq nisa tqal jew li qed ireddgħu, fuq persuni magħrufa li għandhom reazzjonijiet għall-fibrati jew ketoprofen minħabba ddawl, jew dawk li għandhom mard tal-fwied jew tal-marrara, pankreatite, jew tnaqqis moderat jew sever tal-funzjoni tal-kliewi, jew li preċedentement kellhom problemi fil-muskoli waqt li kienu qed jieħdu statins jew fibrati.
English: What are the risks associated with Cholib?
Maltese: X'inhuma r-riskji assoċjati ma' Cholib?
English: What measures are being taken to ensure the safe and effective use of Cholib?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Cholib??
English: A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Cholib jintuża bl-aktar mod sigur possibbli.
English: The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Maltese: Is-sustanzi attivi f'Cholib, fenofibrate u simvastatin, jaħdmu b'modi differenti u l-azzjonijiet tagħhom għandhom effett kumplimentari.
English: In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Maltese: Barra minn hekk, il-livelli tal-kolesterol tajjeb żdiedu b'madwar 7% b'Cholib meta mqabbla ma' madwar 2% b'simvastatin.
English: Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
Maltese: Cholib intwera li huwa aktar effettiv minn statins weħedhom biex inaqqas il-livelli tat-trigliċeridi u jżid il-livelli tal-kolesterol tajjeb.
English: How is Cholib used?
Maltese: Kif jintuża Cholib?
English: The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Maltese: Il-kolesterol li jinġibed mid-demm b'dan ilmod huwa l-kolesterol ‘ħażin'.
English: Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine.
Maltese: Cholib ma għandux jintuża fuq persuni li jbatu minn sensittività eċċessiva (allerġiċi) għall-karawett, soya lecithin jew għal xi sustanza tal-mediċina.
English: The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
Maltese: Il-Kumitat innota wkoll li l-kombinazzjoni ta' fenofibrate u simvastatin diġà qed tintuża fil-prattika klinika.
English: It contains two active substances, fenofibrate and simvastatin, and is used together with a low fat diet and exercise with the aim of reducing patients' levels of triglycerides (a type of fat) and increasing their levels of ‘good' cholesterol (HDL cholesterol).
Maltese: Fih żewġ sustanzi attivi, fenofibrate u simvastatin, u jintuża flimkien ma' dieta b'kontenut baxx ta' xaħam u eżerċizzju bil-għan li jnaqqas illivelli tat-trigliċeridi (tip ta' xaħam) tal-pazjenti u jżid il-livelli tal-kolesterol ‘tajjeb' (kolesterol HDL) tagħhom. Cholib għandu jintuża fuq adulti f'riskju għoli ta' mard tal-qalb li l-livelli tal-kolesterol ‘ħażin' (kolesterol LDL) tagħhom diġà qegħdin jiġu kkontrollati bid-doża korrispondenti ta' simvastatin waħdu.
English: 10 ampoules
Maltese: 10 ampulli
English: Intravenous use ampoule (glass) 10 ml
Maltese: Ampulla (ħġieġ) 10 ml
English: 6 ml
Maltese: Kunjett (ħġieġ) 6 ml
English: Inactivated Mycoplasma hyopneumoniae strain P-5722-3 (inactivated)
Maltese: RP* Mycoplasma hyopneumoniae, strejn P-5722-3 inattivat (inattivat)
English: --1 Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Maltese: --1 Rikombinant kimeriku tal-porcine circovirus tip 1 inattivat li fih il-proteina ORF2 tal-porcine circovirus tip 2 2.3 - 12.4
English: * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Maltese: 1.5 - 3.8 RP* * Unità ta' qawwa relattiva determinata mill-ammont ta' antiġeni bl-ELISA (test ta' qawwa in vitro) imqabbel ma' tilqima ta' referenza.
English: Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
Maltese: 3 ml (3.5 mg/ml) skartoċċ 1
English: The full EPAR for Topotecan Eagle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Topotecan Eagle jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The company provided data from the published literature on topotecan.
Maltese: Il-kumpannija pprovdiet dejta minn letteratura ppubblikata dwar it-topotecan.
English: EPAR summary for the public topotecan
Maltese: Sommarju tal-EPAR għall-pubbliku topotecan
English: The active substance in Topotecan Eagle, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva f'Topotecan Eagle, it-topotecan, hija mediċina kontra l-kanċer li tappartjeni għallgrupp tal-‘inibituri tat-topoisomerażi'.
English: Topotecan Eagle is a medicine that contains the active substance topotecan.
Maltese: Topotecan Eagle huwa mediċina li fiha s-sustanza attiva topotecan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Topotecan Eagle on 22 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Topotecan Eagle fil-22 ta' Diċembru 2011.
English: The CHMP concluded that, in accordance with EU requirements, Topotecan Eagle has been shown to have comparable quality and to be bioequivalent to Hycamtin.
Maltese: Is-CHMP ikkonkluda li, b'konformità mar-rekwiżiti tal-UE, Topotecan Eagle wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Hycamtin.
English: This is a summary of the European public assessment report (EPAR) for Topotecan Eagle.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Topotecan Eagle.
English: Topotecan Eagle also has a different (higher) strength from Hycamtin.
Maltese: Topotecan Eagle għandu wkoll konċentrazzjoni differenti (għolja) minn Hycamtin.
English: Because Topotecan Eagle is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Topotecan Eagle huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Why has Topotecan Eagle been approved?
Maltese: Għaliex ġie approvat Topotecan Eagle?
English: What is Topotecan Eagle?
Maltese: X'inhu Topotecan Eagle?
English: When used with cisplatin in cervical cancer, Topotecan Eagle is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Maltese: Meta użat maċ-ċisplatinu fil-kanċer tal-għonq tal-utru, Topotecan Eagle jingħata bħala infużjoni fil-jiem nru 1, 2 u 3 (biċ-ċisplatinu jingħata fil-jum 1).
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Maltese: Din timblokka enzima li tissejjaħ topojsomerażi I, li hija involuta fid-duplikazzjoni tad-DNA.
English: What are the benefits and risks of Topotecan Eagle?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Topotecan Eagle?
English: While the reference medicine, Hycamtin, is available as a powder to be made up into a concentrate, Topotecan Eagle is available as a ready-made concentrate.
Maltese: Filwaqt li l-mediċina ta' referenza, Hycamtin, tiġi bħala trab biex titħallat f'konċentrat, Topotecan Eagle tiġi bħala konċentrat diġà lest.
English: How has Topotecan Eagle been studied?
Maltese: Kif ġie studjat Topotecan Eagle?
English: No additional studies in patients were needed as Topotecan Eagle is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali fil-pazjenti peress li Topotecan Eagle jingħata permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Hycamtin.
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Maltese: Jintuża wkoll flimkien ma' ċisplatinu (cisplatin - mediċina oħra kontra l-kanċer) fit-trattament ta' nisa bil-kanċer tal-għonq tal-utru (ċerviċi), f'każ ta' kanċer reċidiv wara r-radjoterapija jew fil-każ meta lmarda tkun fi stadju avvanzat (stadju IVB: il-kanċer ikun infirex lil hinn miċ-ċerviċi).
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Hycamtin, il-benefiċċju huwa akbar mir-riskju identifikat.
English: Other information about Topotecan Eagle
Maltese: Aktar tagħrif dwar Topotecan Eagle