FrancophonIA/ELRC3.0 huggingface dataset:
English: Manufacturer RIEMSER Pharma GmbH Bahnhofstr.
Maltese: Suomi/Finland RIEMSER Pharma GmbH Puh/Tel:
English: Therefore, pharmacological effects related to systemic exposure should be minimal.
Maltese: Għalhekk, l-effetti farmakoloġiċi relatati ma' l-espożizzjoni sistemika għandhom ikunu minimi.
English: Solution for infusion.
Maltese: Soluzzjoni għall-infużjoni
English: Ear and labyrinth disorders vertigo, tinnitus
Maltese: Disturbi fil-widnejn u fis-sistema labirintika sturdament, żanżin filwidnejn
English: _ _1 Neisseria meningitidis serogroup A polysaccharide* 5 micrograms Neisseria meningitidis serogroup C polysaccharide* 5 micrograms Neisseria meningitidis serogroup W-135 polysaccharide* 5 micrograms Neisseria meningitidis serogroup Y polysaccharide* 5 micrograms *conjugated to tetanus toxoid carrier protein 44 micrograms
Maltese: _ _1 Polysaccharide tas-serogrupp A ta' Neisseria meningitidis* 5 mikrogrammi Polysaccharide tas-serogrupp C ta' Neisseria meningitidis* 5 mikrogrammi Polysaccharide tas-serogrupp W-135 ta' Neisseria meningitidis* 5 mikrogrammi Polysaccharide tas-serogrupp Y ta' Neisseria meningitidis* 5 mikrogrammi *konjugat ma' proteina ġarriera tat-toxoid tat-tetnu 44 mikrogramma
English: 10 vials + 10 pre-filled syringes + 20 needles
Maltese: 10 kunjetti + 10 siringi mimlijin għal-lest + 20 labra
English: 10 vials + 10 pre-filled syringes
Maltese: 10 kunjetti + 10 ampulli
English: 1 vial + 1 prefilled syringe + 2 needles
Maltese: Daqs tal-pakkett kunjett 1 + siringa 1 mimlija għal-lest
English: MA (EU) number (Invented) name
Maltese: Numru tal-EMA Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: 90 (3 x 30) tablets (multipack)
Maltese: Daqs tal-pakkett flixkun (HDPE) 30 pillola flixkun (HDPE) 90 (3 x 30) pillola (pakkett multiplu)
English: Ref.: EMEA/619504/2009 EMEA/H/C/1071
Maltese: EMEA/619518/2009 EMEA/H/C/1071
English: The active substance in Topotecan Teva, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva ta' Topotecan Teva, topotecan, hija mediċina kontra l-kanċer li tappartjeni għallgrupp tal-‘inibituri tat-topojsomerażi' (topoisomerase).
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Teva to Teva Pharma B.V. on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Topotecan Teva lil Teva Pharma B.V. fit-21 ta' Settembru 2009.
English: Topotecan Teva topotecan EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku
English: It is used after at least one other treatment has failed;
Maltese: Jintuża wara li tal-inqas trattament ieħor ikun falla;
English: Topotecan Teva is given as an infusion lasting 30 minutes every day for five days with a three-week interval between the start of each course.
Maltese: Topotecan Teva jingħata bħala infużjoni li ddum 30 minuta kuljum għal ħamest ijiem b'intervall ta' tliet ġimgħat bejn il-bidu ta' kull kors.
English: What are the benefit and risk of Topotecan Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Topotecan Teva?
English: Other information about Topotecan Teva:
Maltese: Aktar tagħrif dwar Topotecan Teva:
English: This means that Topotecan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Maltese: Topotecan Teva huwa ‘mediċina ġenerika' Dan ifisser li Topotecan Teva huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Hycamtin.
English: What is Topotecan Teva?
Maltese: Kif jintuża Topotecan Teva?
English: Because Topotecan Teva is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Topotecan Teva huwa mediċina ġenerika, il-benefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: Why has Topotecan Teva been approved?
Maltese: Għaliex ġie approvat Topotecan Teva?
English: Because Topotecan Teva is a generic medicine, the company has provided data from the published literature on topotecan.
Maltese: Billi Topotecan Teva huwa mediċina ġenerika, il-kumpanija pprovdiet tagħrif mil-letteratura ppubblikata dwar topotecan.
English: No additional studies were needed as Topotecan Teva is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali billi Topotecan Teva huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Hycamtin.
English: When used with cisplatin in cervical cancer, Topotecan Teva is given on days 1, 2 and 3 (with cisplatin given on day 1).
Maltese: Topotecan Teva, meta użat maċ-ċisplatinu fil-kanċer tal-għonq tal-utru, jingħata bħala infużjoni filjiem numru 1, 2 u 3 (biċ-ċisplatinu jingħata fil-jum 1).
English: How has Topotecan Teva been studied?
Maltese: Kif ġie studjat Topotecan Teva?
English: How does Topotecan Teva work?
Maltese: Topotecan Teva topotecan
English: Topotecan Teva is a concentrate that is made up into a solution for infusion (drip into a vein).
Maltese: Topotecan Teva huwa konċentrat li jitħallat biex isir soluzzjoni għall-infużjoni (dripp fil-vina).
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park,
Maltese: Edificio 10 Sintra Business Park,
English: 00-380 Warsawa, Poland
Maltese: Kruczkowskiego 8 st., 00-380 Warszawa, Poland
English: Luxembourg Baxter SA, Bd René Branquart
Maltese: Lussemburgu Baxter S.A. Bd René Branquart 80
English: Baxter SPA piazzale dell' industria 2000144-Roma Italy
Maltese: Piazzale dell'Industria 20 00144
English: Belgium Baxter SA Bld R Branquart 80 7860 Lessines Belgium
Maltese: Boulevard R. Branquart 80 7680 Lessines Belgium
English: Halandri, 152 33 Greece
Maltese: Diophar SA Kifissias 368 Halandri 15233 Greece
English: Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A1020 Wien, Austria
Maltese: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020
English: Annex I
Maltese: N/A
English: Denmark Baxter A/S, Gydevang 43, DK3450 Allerød,
Maltese: Danimarka Baxter A/S Gydevang 43
English: Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands
Maltese: 3542 CE Utrecht The Netherlands
English: Baxter Hungary Kft. Népfürdő u. 22.
Maltese: Baxter Hungary Kft.
English: Unterschleißheim
Maltese: Għamla
English: Ljubljana,Slovenia
Maltese: Oslo, Norway
English: 0.0051 % w/v
Maltese: 0,0184% w/v 0,0051% w/v
English: BAXTER
Maltese: Belġju
English: Dianeal PD4 med Glucos 13,6 mg/ml
Maltese: Dianeal PD4 Glucose 13,6 mg/ml
English: Norway
Maltese: Norfolk,
English: Norfolk IP24 3SE United Kingdom
Maltese: Thetford IP24
English: Caxton Way, Thetford, Norfolk,
Maltese: Thetford, Norfolk, IP24
English: Dianeal PD4 med Glucos 38,6 mg/ml
Maltese: Dianeal PD4 Glucose 38,6 mg/ml
English: 1,36%/2,27%/3,86% dextrose anydre
Maltese: Dianeal PD4 Glucose 1,36%/2,27%/3,86% dextrose anhydrous
English: HEALTHCARE S.A. Moneen Road, Castelbar, County Mayo, Ireland
Maltese: Moneen Road Castlebar, County Mayo lreland
English: Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland
Maltese: Finlandja Baxter Healthcare S.A. Moneen Road Castlebar, CO.
English: 5.4 g / l 4.5 g / l 0.184 g / l
Maltese: 0.184 g/l
English: Clopidogrel Acino Pharma clopidogrel EPAR summary for the public
Maltese: Clopidogrel Acino Pharma clopidogrel Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino Pharma to Acino Pharma GmbH on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Clopidogrel Acino Pharma lil Acino Pharma GmbH fil 21 ta' Settembru 2009.
English: The active substance in Clopidogrel Acino Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel Acino Pharma, clopidogrel, hu inibitur ta' l-aggregazzjoni tal-platelets.
English: Other information about Clopidogrel Acino Pharma:
Maltese: Informazzjoni oħra dwar Clopidogrel Acino Pharma:
English: Clopidogrel Acino Pharma is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Acino Pharma huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: This means that Clopidogrel Acino Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Clopidogrel Acino Pharma huwa ‘mediċina ġenerika' li jfisser li Clopidogrel Acino Pharma huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Clopidogrel Acino Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Acino Pharma jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: What are the benefit and risk of Clopidogrel Acino Pharma?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Clopidogrel Acino Pharma?
English: Because Clopidogrel Acino Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel Acino Pharma huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: What is Clopidogrel Acino Pharma?
Maltese: X'inhu Clopidogrel Acino Pharma?
English: Clopidogrel Acino Pharma can be given to the following groups of patients:
Maltese: Clopidogrel Acino Pharma jista' jingħata lillgruppi ta' pazjenti li ġejjin:
English: The standard dose of Clopidogrel Acino Pharma is one 75 mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Clopidogrel Acino Pharma hija ta' pillola waħda ta' 75 mg darba kuljum, malikel jew fuq stonku vojt.
English: Because Clopidogrel Acino Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Clopidogrel Acino Pharma huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel Acino Pharma wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: How has Clopidogrel Acino Pharma been studied?
Maltese: Kif ġie studjat Clopidogrel Acino Pharma?
English: Why has Clopidogrel Acino Pharma been approved?
Maltese: Għaliex ġie approvat Clopidogrel Acino Pharma?
English: Fipronil kills adult parasites.
Maltese: Il-fipronil toqtol lill-parassiti adulti.
English: Other information about Broadline
Maltese: Informazzjoni oħra dwar Broadline
English: Further information on Broadline can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/broadline.
Maltese: Aktar informazzjoni dwar Broadline tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/veterinary/EPAR/broadline.
English: This summary was last updated in July 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Lulju 2019.
English: Broadline received a marketing authorisation valid throughout the EU on 4 December 2013.
Maltese: Broadline rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-4 ta' Diċembru 2013.
English: Broadline was 100% effective against the L4 larval stage of heartworm.
Maltese: Broadline kien 100 % effettiv kontra l-istadju tal-larvi L4 tad-dud fil-qalb.
English: What are the risks associated with Broadline?
Maltese: X'inhuma r-riskji assoċjati ma' Broadline?
English: The study showed effectiveness of 86 to 87% against adult fleas for Broadline throughout the 30 day post-treatment period compared with between 76 and 82% for cats treated with another medicine containing just fipronil and (S)-methoprene.
Maltese: L-istudju wera effikaċja ta' 86 sa 87 % kontra l-briegħed adulti għal Broadline matul il-perjodu ta' 30 jum ta' wara l-kura meta mqabbel ma' bejn 76 u 82 % għall-qtates ikkurati b'mediċina oħra li fiha biss fipronil u (S)-metopren.
English: Broadline (fipronil/(S)methoprene/eprinomectin/praziquantel)
Maltese: Broadline (fipronil/(S)
English: For ticks, effectiveness was between 85 and 93% for Broadline-treated cats compared with 92 and 98% for cats treated with the comparator product.
Maltese: Għall-qurdien, l-effikaċja kienet bejn 85 u 93 % għall-qtates ikkurati bi Broadline meta mqabbel ma' 92 u 98 % għall-qtates ikkurati bil-prodott komparatur.
English: Broadline contains four active substances: fipronil, (S)-methoprene, eprinomectin and praziquantel.
Maltese: Broadline fih erba' sustanzi attivi: fipronil, (S)-metopren, eprinomektin u prażikwantel.
English: Broadline was more than 90% effective in reducing lungworm larvae at 28 days after treatment and all treated cats showing respiratory signs (such as wheezing, persistent coughing and a runny nose) were clinically cured.
Maltese: Broadline kien aktar minn 90 % effettiv fit-tnaqqis tal-larvi tad-dud fil-pulmun fit-28 jum wara l-kura u l-qtates ikkurati kollha li wrew sinjali respiratorji (bħal tħarħir, sogħla persistenti u flissjoni) ġew ikkurati b'mod kliniku.
English: Broadline is a veterinary medicine used to treat cats with, or at risk of, mixed infestations by tapeworms, roundworms and external parasites (fleas, ticks, and a burrowing mite called Notoedres cati which is a cause of mange).
Maltese: Broadline huwa mediċina veterinarja li tintuża fil-kura tal-qtates bi, jew f'riskju ta', infestazzjonijiet imħallta minn dud, roundworms u parassiti esterni (briegħed, qurdien u dudu li jħaffer li jissejjaħ Notoedres cati li jikkawża skabbja).
English: Twenty cats naturally infested with lungworm were treated with Broadline.
Maltese: Għoxrin qattus infestat bid-dud fil-pulmun ġew ikkurati bi Broadline.
English: The effectiveness of Broadline against cat mange was examined in a laboratory study with 18 naturally infested cats.
Maltese: L-effikaċja ta' Broadline kontra l-iskabbja tal-qtates ġiet eżaminata fi studju ġo laboratorju bi 18-il qattus infestat b'mod naturali.
English: The study showed almost 100% effectiveness against tapeworms, roundworms and hookworms for both Broadline and the comparator product.
Maltese: L-istudju wera kważi 100 % effikaċja kontra d-dud, roundworms u hookworms kemm għal Broadline kif ukoll għall-prodott komparatur.
English: The study showed over 98% effectiveness of the medicine against the mite, with a clinical cure in all animals.
Maltese: L-istudju wera li l-effikaċja talmediċina kontra d-dud kienet aktar minn 98 %, b'kura klinika għall-annimali kollha.
English: The effectiveness of Broadline against feline lungworm was investigated in a field study in Italy.
Maltese: L-effikaċja ta' Broadline kontra d-dud fil-pulmun tal-qtates kienet investigata fi studju fuq il-post flItalja.
English: Effectiveness was measured by identifying adult worm segments (tapeworms) or counting worm eggs (roundworms) in faeces at day 14 after treatment.
Maltese: L-effikaċja tkejlet bl-identifikazzjoni tas-segmenti tad-dud adulti (dud) jew bl-għadd tal-bajd tad-dud (roundworms) fl-ippurgar fl-14-il jum wara l-kura.
English: It may also be used as part of a treatment strategy for flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: Jista' jintuża wkoll bħala parti minn strateġija ta' kura għal dermatite allerġika għall-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: If the cat licks the application site, temporary excessive salivation may occur.
Maltese: Jekk il-qattus jilgħaq is-sit tal-applikazzjoni, jista' jkun hemm bżieq eċċessiv temporanju.
English: Praziquantel acts on the cell membranes of tapeworms, leading to the death of the parasite.
Maltese: Il-prażikwantel taġixxi fuq il-membrani taċ-ċelloli tad-dud, li twassal għall-mewt tal-parassiti.
English: The other two active substances in Broadline, eprinomectin and praziquantel, act as ‘endoparasiticides'.
Maltese: Is-sustanzi attivi l-oħra fi Broadline, l-eprinomektin u l-prażikwantel, jaġixxu bħala “endoparassitiċidi”.
English: Two of the active substances in Broadline, fipronil and (S)-methoprene, act as ‘ectoparasiticides'.
Maltese: Tnejn mis-sustanzi attivi fi Broadline, il-fipronil u l-(S)-metopren, jaġixxu bħala “ektoparassitiċidi”.
English: If a cat swallows the medicine, it may result in vomiting (being sick) and/or short-lived effects on the nervous system, shown by signs such as lack of muscular coordination, disorientation, lack of interest in surroundings and pupil dilation.
Maltese: Jekk qattus jibla' l-mediċina, dan jista' jirriżulta f'remettar (iħossu ma jiflaħx) u/jew effetti li ma jdumux fuq issistema nervuża, li jidhru b'sinjali bħal nuqqas ta' koordinazzjoni muskolari, diżorjentazzjoni, nuqqas ta' interess fil-madwar u dilazzjoni tal-ħabba tal-għajn.
English: The effectiveness of Broadline against intestinal worms was investigated in one EU field study involving cats with tapeworm, roundworm or hookworm infections or mixed infections.
Maltese: L-effikaċja ta' Broadline kontra d-dud fl-intestini ġiet investigata fi studju wieħed tal-UE fuq il-post li kien jinvolvi qtates b'infezzjonijiet ta' dud, roundworm jew hookworm jew infezzjonijiet imħallta.
English: For external parasites, Broadline treats flea infestations and prevents new infestations for at least one month; it also prevents environmental flea contamination for over a month.
Maltese: Għal parassiti esterni, Broadline jikkura infestazzjonijiet bil-briegħed u jipprevjeni infestazzjonijiet ġodda mill-inqas għal xahar; jipprevjeni wkoll kontaminazzjoni ambjentali bil-briegħed għal aktar minn xahar.
English: All these signs resolve spontaneously within 24 hours.
Maltese: Dawn is-sinjali kollha jitilqu spontanjament fi żmien 24 siegħa.
English: It blocks channels in their nerve cells that allow charged chloride particles (ions) to pass, interfering with the transmission of nerve signals and leading to overstimulation and death.
Maltese: Timblokka l-kanali fiċ-ċelloli tan-nervituri tagħhom li jippermettu lill-partikoli ċċarġjati tal-klorur (joni) jgħaddu, filwaqt li tinterferixxi mat-trażmissjoni ta' sinjali tannervituri u twassal għal stimulazzjoni żejda u mewt.
English: For worms, Broadline is used to treat tapeworms, roundworms and hookworms in the gut as well as a type of worm that infects the bladder and two types of feline lungworm.
Maltese: Għad-dud, Broadline jintuża fil-kura kontra d-dud, ir-roundworms u l-hookworms fl-imsaren kif ukoll tip ta' dud li jinfesta l-bużżieqa tal-awrina u żewġ tipi ta' dud li jinfestaw il-pulmun tal-qtates.
English: The effectiveness of Broadline to prevent heartworm disease was shown in three laboratory studies, using artificially infected cats.
Maltese: L-effikaċja ta' Broadline għall-prevenzjoni tal-marda tad-dud fil-qalb intweriet fi tliet studji fillaboratorju, bl-użu ta' qtates infettati b'mod artifiċjali.
English: Eprinomectin interferes with channels in the nerve and muscle cells of roundworms that allow charged chloride particles (ions) to pass, leading to their paralysis and death.
Maltese: L-eprinomektin tinterferixxi mal-kanali fiċ-ċelloli tan-nervituri u tal-muskoli tal-ħniex li jippermettu lillpartikoli ċċarġjati tal-klorur (joni) jgħaddu, u dan iwassal għall-paraliżi u l-mewt tagħhom.
English: What benefits of Broadline have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Broadline li ħarġu mill-istudji?
English: How is Broadline used?
Maltese: Kif jaħdem Broadline?
English: The effectiveness of Broadline against fleas and ticks was investigated in an EU field study involving cats infested with fleas, ticks, or both.
Maltese: L-effikaċja ta' Broadline kontra l-briegħed u l-qurdien kienet investigata fi studju tal-UE fuq il-post li kien jinvolvi qtates infestati bil-briegħed, bil-qurdien, jew bit-tnejn li huma.
English: Broadline is available as a spot-on solution in applicators of two different volume sizes for use in cats of various bodyweights and can only be obtained with a prescription.
Maltese: Broadline jiġi bħala soluzzjoni għall-użu lokalizzat f'applikaturi ta' żewġ daqsijiet ta' volum differenti għall-użu fil-qtates b'diversi piżijiet tal-ġisem u jista' jinkiseb biss b'riċetta ta' tabib.
English: The main measure of effectiveness was reduction of numbers of worm larvae in faeces at 28 days after single treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tnaqqis fin-numru ta' larvi tad-dud fl-ippurgar fit-28 jum wara kura waħda.
English: Docefrez is a ‘generic medicine'.
Maltese: Docefrez huwa ‘mediċina ġenerika'.
English: Other information about Docefrez:
Maltese: Informazzjoni oħra dwar Docefrez:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docefrez to Sun Pharmaceutical Industries Europe B.V. on 15 May 2010.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Docefrez lil Sun Pharmaceutical Industries Europe B.V. fl-15 ta' mejju 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Docefrez.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Evalwazzjoni Pubbliku Ewropew (EPAR) għal Docefrez.
English: Docefrez is used with cisplatin and 5-fluorouracil.
Maltese: Docefrez jintuża ma' cisplatin u ma' 5-fluorouracil.
English: Docefrez is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: Docefrez jintuża ma' prednisone jew ma' prednisolone (mediċini kontra l-infjammazzjoni);
English: Docefrez is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Maltese: Docefrez jintuża ma' cisplatin u 5-fluoroouracil (mediċini oħrajn kontra l-kanċer);
English: What are the benefit and risk of Docefrez?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Docefrez?
English: It contains the active substance docetaxel.
Maltese: Huwa fih is-sustanza attiva docetexel.
English: The active substance in Docefrez, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docefrez, docetaxel, tagħmel parti minn grupp ta' mediċini kontra l-kanċer magħrufin bħala taxanes.
English: Docefrez is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Maltese: Docefrez jintuża biss meta n-numru ta' neutrophil (tip ta' ċelloli bojod fid-demm) ikun normali (minn tal-inqas 1,500 ċellola/mm3).
English: The CHMP concluded that, in accordance with EU requirements, Docefrez has been shown to be comparable to Taxotere.
Maltese: Is-CHMP ikkonkluda li, skont il-ħtiġijiet tal-UE, Docefrez intwera li huwa komparabbli ma' Taxotere.
English: This means that Docefrez is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Maltese: Dan ifisser li Docefrez huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) u msejħa Taxotere.
English: Why has Docefrez been approved?
Maltese: Għaliex ġie approvat Docefrez?
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Maltese: Docetaxel iwaqqaf il-kapaċità taċ-ċelloli li jeqirdu l-‘iskeletru' intern li jippermettilhom li jinqasmu u li jimmultiplikaw.
English: Because Docefrez is a generic medicine, the company provided data on docetaxel from the published literature.
Maltese: Minħabba li Docefrez huwa mediċina ġenerika, il-kumpanija pprovdiet dejta dwar docetaxel minn litteratura ippubblikata.
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Maltese: • kanċer tal-prostata, meta l-kanċer ma jirrispondix għal kura ormonali.