FrancophonIA/ELRC3.0 huggingface dataset:
English: After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).
Maltese: Wara tliet minuti, il-fsada twaqqfet f'75% tal-pazjenti kkurati b'TachoSil (44 minn 59), meta mqabbla ma' 33% ta' dawk ikkurati b'tekniki standard (20 minn 60).
English: The active substances in TachoSil, fibrinogen and thrombin, are proteins extracted from blood, which are involved in the natural clotting process.
Maltese: Is-sustanzi attivi f'TachoSil, il-fibrinoġen u t-trombina, huma proteini li estratti mid-demm, li huma involuti fil-proċess naturali ta' koagulazzjoni.
English: Why has TachoSil been approved?
Maltese: Għaliex ġie approvat TachoSil?
English: • Another study in 726 patients compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery.
Maltese: • Studju ieħor f'726 pazjent qabbel TachoSil ma' tekniki attwali li jintużaw fil-prattika ta' kuljum filprevenzjoni ta' tnixxija ta' FĊS waqt intervent kirurġiku newroloġiku.
English: The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery.
Maltese: L-istudji qabblu TachoSil u tekniki kirurġiċi standard bħal sutura u stapling f'total ta' 490 pazjent li kellhom intervent kirurġiku pulmonari.
English: What is TachoSil?
Maltese: X'inhu TachoSil?
English: TachoSil is used when standard techniques are not sufficient.
Maltese: TachoSil jintuża meta tekniki standard ma jkunux biżżejjed.
English: However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.
Maltese: Madankollu, fit-tieni studju, li kien jinvolvi 301 pazjent, kienu meħtieġa medja ta' 15.3 sigħat biex jieqaf il-ħruġ permezz ta' TachoSil meta mqabbla ma' 20.5 sigħat b'tekniki standard.
English: A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.
Maltese: It-tielet studju qabbel TachoSil ma' sutura standard f'185 pazjent li kellhom intervent kirurġiku tal-kliewi.
English: Like other sealants, TachoSil may cause an allergic reaction.
Maltese: Bħal siġillanti oħrajn, TachoSil jista' jikkawża reazzjoni allerġika.
English: Thromboembolic complications (blood clots in vessels) may occur if TachoSil is applied inside a blood vessel.
Maltese: Jista' jkun hemm kumplikazzjonijiet tromboemboliċi (emboli tad-demm fil-vażijiet) jekk TachoSil ikun applikat f'xi vażu.
English: The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery.
Maltese: L-istudji qabblu l-effetti ta' TachoSil u argon beamer (apparat li jaħraq il-wiċċ maqtugħ u jnaqqas il-fsada) f'total ta' 240 adult li kellhom intervent kirurġiku fuq il-fwied.
English: What is the risk associated with TachoSil?
Maltese: X'inhu r-riskju assoċjat ma' TachoSil?
English: When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot.
Maltese: Meta TachoSil jiġi applikat fil-parti tal-fsada matul l-intervent kirurġiku, l-indewwa tikkawża lis-sustanzi attivi biex jirreaġixxu flimkien, u dan iwassal għall-formazzjoni rapida ta' koagulazzjoni.
English: TachoSil was more effective than stitching in the kidney surgery patients.
Maltese: TachoSil kien aktar effettiv mis-sutura fil-pazjenti tal-interventi kirurġiċi fuq il-kliewi.
English: How has TachoSil been studied?
Maltese: Kif ġie studjat TachoSil?
English: TachoSil must not be applied inside a blood vessel.
Maltese: TachoSil ma għandux jiġi applikat ġewwa vażu.
English: • during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
Maltese: • bħala sostenn għas-sutura waqt intervent kirurġiku fuq il-vażijiet;
English: TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery.
Maltese: TachoSil kien aktar effettiv mill-argon beamer fit-twaqqif tal-fsada waqt l-interventi kirurġiċi fuq ilfwied.
English: TachoSil should only be applied directly onto the treatment site so that it covers 1 to 2 cm beyond the edge of the wound.
Maltese: TachoSil għandu jiġi applikat biss fuq is-sit tal-kura sabiex jgħatti minn 1 sa 2 cm 'l barra mit-tarf talferita.
English: For the full list of all side effects and restrictions with TachoSil, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'TachoSil, ara l-fuljett ta' tagħrif.
English: A risk management plan has been developed to ensure that TachoSil is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li TachoSil jintuża bl-aktar mod sigur possibbli.
English: This summary was last updated in 04-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 04-2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUINTANRIX EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) QUINTANRIX Sommarju ta' l-EPAR għall-pubbliku
English: The vaccine is ‘adsorbed'.
Maltese: Il-vaċċin huwa ‘adsorbit'.
English: • ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Maltese: • ‘antiġen tal-wiċċ' (proteini mill-wiċċ) tal-virus ta' l-epatite B.
English: Other information about Quintanrix:
Maltese: Informazzjoni oħra dwar Quintanrix:
English: Quintarix was as effective as the two separate vaccines at producing protective levels of antibodies.
Maltese: Quintarix kien effettiv daqs iż-żewġ vaċċini separati fil-produzzjoni ta' livelli ta' protezzjoni ta' antikorpi.
English: In three studies, the effects of Quintarix were compared with those of the combination of Tritanrix HepB and a vaccine containing Hib: two of these studies involved a total of 1,208 infants who were vaccinated at two, four and six months of age and one involved 294 infants vaccinated at three, four and five months of age.
Maltese: Fi tliet studji, l-effetti ta' Quintarix tqabblu ma' dawk tal-kumbinazzjoni ta' Tritanrix HepB u vaċċin li fih Hib: tnejn minn dawn l-istudji involvew total ta' 1,208 trabi li kienu mlaqqmin fl-età ta' xahrejn, erba' u sitt xhur u wieħed li involva 294 tarbija imlaqqmin fl-età ta' tliet, erba' u ħames xhur.
English: Quintanrix is a vaccine.
Maltese: Quintanrix huwa vaċċin.
English: It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and polysaccharides (sugars) from the bacterium Haemophilus influenzae type b (‘Hib', a bacterium that causes meningitis).
Maltese: Fih issustanzi attivi li ġejjin: tossojdi (tossini kimikament imdgħajjfin) minn difterite u tetnu, Bordetella pertussis inattivat (maqtul) (batterju li jikkaġuna sogħla konvulżiva), partijiet mill-virus ta' l-epatite B u polisakkaridi (zokkrijiet) mill-batterju Haemophilus influenzae tip b (‘Hib', batterju li jikkaġuna meninġite).
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: L-antiġeni tal-wiċċ tal-virus ta' l-epatite B huma magħmulin permezz ta' metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': huma magħmulin minn ħmira li rċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-proteini.
English: The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
Maltese: L-effetti ta' Quintanrix ġew studjati f'ħames studji ewlenin li nvolvew aktar minn 2,000 tarbija.
English: The fourth study compared the effects of Quintarix given at six, 10 and 14 weeks of age in 318 infants who either had or had not received a hepatitis B vaccine at birth.
Maltese: Ir-raba' studju qabbel l-effetti ta' Quintarix mogħti fl-età ta' 6, 10 u 14-il ġimgħa fi 318-il tarbija li jew kienu rċievew jew ma kinux irċievew vaċċin kontra l-epatite B mat-twelid.
English: The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after the booster vaccination.
Maltese: L-istudju ta' tilqima buster wera wkoll li Quintanrix kien effettiv daqs żewġ vaċċini separati, b'bejn 92 u 100% tat-trabi ikollhom livelli ta' protezzjoni ta' antikorpi 42 jum wara t-tilqima buster.
English: The active substances in Quintanrix have been available in the European Union (EU) for a number of years in other vaccines: diphtheria, tetanus, pertussis and hepatitis B, has been available in Tritanrix HepB since 1996.
Maltese: Is-sustanzi attivi fi Quintanrix ilhom disponibbli fl-Unjoni Ewropea (UE) għal bosta snin f'vaċċini oħrajn: difterite, tetnu, pertussi u epatite B, ilhom disponibbli fi Tritanrix HepB sa mill-1996.
English: Quintanrix is used to vaccinate infants under one year of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and ‘invasive' diseases caused by Hib (such as bacterial meningitis).
Maltese: Quintanrix jintuża għat-tilqim ta' trabi li għandhom inqas minn sena kontra difterite, tetnu, pertussi (sogħla konvulżiva), epatite B u mard ‘invażiv' ikkaġunat minn Hib (bħalma hija meninġite batterika).
English: What is Quintanrix?
Maltese: X'inhu Quintanrix?
English: Overall, between 95 and 100% of the infants had protective levels of antibodies to diphtheria, tetanus, pertussis, hepatitis B and Hib, one month after the first vaccination course.
Maltese: B'mod ġenerali, bejn 95 u 100% tat-trabi kellhom livelli ta' protezzjoni ta' antikorpi għal difterite, tetnu, pertussi, epatite B u Hib, xahar wara l-ewwel kors ta' tilqim.
English: Quintanrix is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
Maltese: Quintanrix huwa vaċċin, li jiġi bħala trab u sospensjoni li jitħallat f'sospensjoni għal injezzjoni.
English: For the full list of side effects reported with Quintanrix, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati ma' Quintanrix, ara l-Fuljett ta' Tagħrif.
English: There was no impact of prior hepatitis B vaccination on the effectiveness of Quintanrix.
Maltese: Ma kien hemm l-ebda impatt ta' tilqim preċedenti kontra l-epatite B ta' qabel fuq l-effettività ta' Quintanrix.
English: The vaccine is given by deep injection into a muscle, preferably the thigh.
Maltese: Ilvaċċin jingħata b'injezzjoni fil-fond ġo muskolu, preferibbilment fil-koxxa.
English: • polysaccharides extracted from the ‘capsules' that surround the bacterium Hib - the polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine;
Maltese: • polisakkaridi estratti mill-‘kapsuli' li jiċċirkndaw il-batterju Hib - il-polisakkaridi huma kimikament imwaħħlin (ikkonġugati) ma' tossojde tat-tetnu bħala proteina ġarriera għaliex dan itejjeb ir-reazzjoni għall-vaċċin;
English: The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s.a. on 21 October 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq valida madwar l-Unjoni Ewropea, għal Quintanrix lil GlaxoSmithKline Biologicals s.a fil-21 ta' Ottubru 2004.
English: Why has Quintanrix been approved?
Maltese: Għaliex ġie approvat Quintanrix?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix's benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster immunisation of young children during the second year of life.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Quintanrix huma ikbar mir-riskji tiegħu għal tilqim primarju ta' trabi (matul l-ewwel sena ta' ħajja) kontra difterite, tetnu, pertussi, epatite B u mard invażiv ikkaġunat minn Hib u għal tilqim buster ta' tfal żgħar waqt it-tieni sena ta' ħajja.
English: The Hib component has also been available in other vaccines.
Maltese: Il-komponent Hib kien ukoll disponibbli f'vaċċini oħrajn.
English: What is the risk associated with Quintanrix?
Maltese: X'inhu r-riskju assoċjat ma' Quintanrix?
English: • toxoids from the bacteria that cause diphtheria and tetanus;
Maltese: • tossojdi minn batterji li jikkaġunaw difterite u tetnu;
English: The fifth study looked at the effects of a fourth, booster dose of Quintanrix in the second year of life in 357 infants.
Maltese: Il-ħames studju ħares lejn l-effetti ta' raba', doża buster ta' Quintanrix fit-tieni sena ta' ħajja fi 357 tarbija.
English: Quintanrix contains small amounts of:
Maltese: Quintanrix fih ammonti żgħar ta':
English: The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
Maltese: L-aktar effetti sekondarji komuni bi Quintanrix (jidhru f'aktar minn doża 1 minn kull 10 tal-vaċċin) huma l-irritabbiltà, ħedla, telf ta' aptit, uġigħ, ħmura u nefħa, u deni.
English: Quintanrix can be given to children who received a hepatitis B vaccine at birth.
Maltese: Quintanrix jista' jingħata lil tfal li rċievew vaċċin kontra l-epatite B mat-twelid.
English: After the first vaccination course, a booster should be given, preferably before the end of the second year of life.
Maltese: Wara l-ewwel kors ta' tilqim, għandu jingħata buster, preferibbilment qabel it-tieni sena tal-ħajja.
English: How has Quintanrix been studied?
Maltese: Kif ġie studjat Quintanrix?
English: How does Quintanrix work?
Maltese: Għalxiex jintuża Quintanrix?
English: Further information on Deferiprone Lipomed 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: Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects.
Maltese: Dożi ta' aktar minn 100 mg/kg kuljum mhumiex rakkomandati minħabba riskju ta' żieda potenzjali tal-effetti sekondarji.
English: The usual dose of Deferiprone Lipomed is 75 mg per kilogram body weight each day, divided into three separate doses.
Maltese: Id-doża normali ta' Deferiprone Lipomed hija 75 mg għal kull kilogramm tal-piż tal-ġisem kuljum, maqsuma fi tliet dożi separati.
English: Deferiprone Lipomed contains the active substance deferiprone and is a ‘generic medicine'.
Maltese: Deferiprone Lipomed fih is-sustanza attiva deferiprone u huwa "mediċina ġenerika".
English: What are the benefits and risks of Deferiprone Lipomed?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Deferiprone Lipomed?
English: Other information about Deferiprone Lipomed
Maltese: Informazzjoni oħra dwar Deferiprone Lipomed
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ferriprox, and do not need to be repeated for Deferiprone Lipomed.
Maltese: Studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użi approvati diġà twettqu bil-mediċina ta' referenza, Ferriprox, u ma għandhomx għalfejn jiġu ripetuti għal Deferiprone Lipomed.
English: As for all medicines, data on the use of Deferiprone Lipomed are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Deferiprone Lipomed hija ssorveljata kontinwament.
English: Because Deferiprone Lipomed is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Deferiprone Lipomed huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The active substance in Deferiprone Lipomed, deferiprone, is an iron chelator.
Maltese: Is-sustanza attiva f'Deferiprone Lipomed, id-deferiprone, hija kelatur tal-ħadid.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar mediċini ġeneriċi, ara ddokument ta' mistoqsijiet u tweġibiet hawn.
English: How is Deferiprone Lipomed used?
Maltese: Deferiprone Lipomed?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Deferiprone Lipomed has been shown to have comparable quality and to be bioequivalent to Ferriprox.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Deferiprone Lipomed ntwera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Ferriprox.
English: • in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions requires rapid or intensive correction of iron levels.
Maltese: • flimkien ma' kelatur tal-ħadid ieħor, meta l-kura b'kelatur tal-ħadid waħdu ma tkunx effettiva jew meta l-prevenzjoni jew il-kura ta' kondizzjonijiet ta' periklu għall-ħajja tkun teħtieġ korrezzjoni rapida jew intensiva tal-livelli tal-ħadid.
English: Deferiprone Lipomed is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Maltese: Deferiprone Lipomed huwa "kelatur tal-ħadid" (sustanza li teħel mal-ħadid) li jintuża fil-kura ta' eċċess ta' ħadid (eċċess ta' ħadid fil-ġisem) f'pazjenti b'talassemija maġġuri.
English: This means that Deferiprone Lipomed contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Ferriprox.
Maltese: Dan ifisser li Deferiprone Lipomed fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-UE msejħa Ferriprox.
English: Side effects reported with Deferiprone Lipomed are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Deferiprone Lipomed huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija wettqet ukoll studju li wera li huwa ‘bijoekwivalenti' għall-mediċina ta' referenza.
English: How has Deferiprone Lipomed been studied?
Maltese: Kif ġie studjat Deferiprone Lipomed?
English: Deferiprone Lipomed is used:
Maltese: Deferiprone Lipomed jintuża:
English: Therefore, the Agency's view was that, as for Ferriprox, the benefit of Deferiprone Lipomed outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-opinjoni tal-Aġenzija kienet li, bħal fil-każ ta' Ferriprox, il-benefiċċju ta' Deferiprone Lipomed huwa akbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu fl-UE.
English: Patients with thalassaemia major need frequent blood transfusions.
Maltese: Pazjenti li jbatu minn talassemija maġġuri jeħtieġu trasfużjonijiet tad-demm frekwenti.
English: Deferiprone Lipomed is available as 500 mg tablets to be taken by mouth.
Maltese: Deferiprone Lipomed jiġi bħala kapsuli ta' 500 mg li għandhom jittieħdu mill-ħalq.
English: * Withdrawal period (milk): - Zero hours after calving (when the dry period length is 32 days or more) - 4 days (8 milkings) after calving (when the dry period length is less than 32 days)
Maltese: * Perjodu ta' tiżmin (ħalib): - Żero sigħat wara t-twelid (meta t-tul tal-perjodu xott ikun 32 jum jew aktar) - 4 ijiem (8 ħalbiet) wara t-twelid (meta t-tul tal-perjodu xott ikun inqas minn 32 jum)
English: Route of administration
Maltese: Mod ta' Amministrazzjoni
English: Annex A EU (MA) Number Invented name
Maltese: Numru tal-UE (MA)
English: Packaging Content Package size
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: Strength Pharmaceutical form
Maltese: Qawwa Għamla Farmaċewtika
English: Cattle (dairy cows)
Maltese: Ifrat (baqar talħalib)
English: EU/2/15/192/001 Velactis 1.12 mg/ml
Maltese: Speċi li fuqhom għandu jintuża l-prodott
English: Solution for injection
Maltese: Soluzzjoni għall-injezzjoni.
English: 5 vials Meat and offal: 23 days
Maltese: 5 kunjetti Laħam u ġewwieni tal-annimali:
English: Target species
Maltese: Perjodu ta' Tiżmim
English: 1 April 2016
Maltese: 1 ta' April 2016
English: More information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Dropcys?
Maltese: X'inhu Dropcys?
English: Dropcys is a medicine that contains the active substance mercaptamine hydrochloride (also known as cysteamine hydrochloride).
Maltese: Dropcys huwa mediċina li fiha s-sustanza attiva mercaptamine hydrochloride (magħrufa wkoll bħala cysteamine hydrochloride).
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 1 April 2016.
Maltese: Wara li kkunsidra r-raġunijet għal din ittalba, is-CHMP reġa' eżamina l-opinjoni inizjali u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fl-1 ta' April 2016.
English: On 17 December 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dropcys, intended to prevent and treat the build-up of the amino acid cystine in the cornea (the transparent layer in front of the eye).The company that applied for authorisation in the EU is Lucane Pharma.
Maltese: Fis-17 ta' Diċembru 2015, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq tal-prodott mediċinali Dropcys, intiż sabiex jipprevjeni u jikkura l-akkumulazzjoni tal-aċidu amminiku cystine filkornea (is-saff trasparenti quddiem l-għajn).
English: The active substance in Dropcys, mercaptamine hydrochloride, was expected to react with cystine to dissolve it and to form substances that could be removed from the cells.
Maltese: Is-sustanza attiva fi Dropcys, mercaptamine hydrochloride, kienet mistennija li tirreaġixxi ma' cystine sabiex iddewwibha u sabiex tifforma sustanzi li jistgħu jitneħħew miċ-ċelluli.
English: Dropcys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 October 2014 for the treatment of cystinosis.
Maltese: Dropcys kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-15 ta' Ottubru 2014, għall-kura taċ-ċistinożi.
English: Although the role of mercaptamine eye drops in the treatment of corneal deposits appears sufficiently supported by the literature, current clinical recommendations and its routine use in hospital preparations, there were few data supporting the effectiveness of the concentration of mercaptamine used in Dropcys (0.1% solution).
Maltese: Għalkemm ir-rwol tal-qtar fl-għajnejn mercaptamine fil-kura tad-depożiti fil-kornea jidher li huwa appoġġjat biżżejjed mil-letteratura, ir-rakkomandazzjonijiet kliniċi attwali u l-użu ta' rutina tiegħu fil-preparazzjonijiet tal-isptar, ftit kien hemm dejta li tappoġġja l-effettività talkonċentrazzjoni ta' mercaptamine użat fi Dropcys (0.1% soluzzjoni).
English: Refusal of the marketing authorisation for Dropcys (mercaptamine hydrochloride)
Maltese: (mercaptamine hydrochloride)
English: What was Dropcys expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Dropcys?
English: During the re-examination, the CHMP looked again at the data from the company.
Maltese: Waqt l-eżaminazzjoni mill-ġdid, is-CHMP reġa' ta titwila lejn id-dejta mill-kumpanija.