FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm GmbH had been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li Pioglitazone ratiopharm GmbH għandu kwalità komparabbli u huwa bijoekwivalenti għal Actos.
English: Pioglitazone ratiopharm GmbH was developed as a ‘generic medicine'.
Maltese: Pioglitazone ratiopharm GmbH ġie żviluppat bħala ‘mediċina ġenerika'.
English: The active substance in Pioglitazone ratiopharm GmbH, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone ratiopharm GmbH, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u talfwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm GmbH, for the treatment of type 2 diabetes.
Maltese: Fit-3 ta' Frar 2012, ratiopharm GmbH uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Pioglitazone ratiopharm GMbH, għat-trattament tad-dijabete tat-tip 2.
English: Pioglitazone ratiopharm GmbH is a medicine that contains the active substance pioglitazone.
Maltese: Pioglitazone ratiopharm GmbH huwa mediċina li fiha s-sustanza attiva pijoglitażonu.
English: This means that Pioglitazone ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone ratiopharm GmbH huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: Because Pioglitazone ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone ratiopharm GmbH huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Actos.
English: 19 November 2014
Maltese: 19 ta' Novembru 2014
English: On 5 September 2014, the marketing authorisation holder for the advanced therapy medicine MACI (matrix applied characterised autologous cultured chondrocytes) closed the EU manufacturing site for the medicine, which is located in Denmark.
Maltese: Fil-5 ta' Settembru 2014, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għall-mediċina ta' terapija avvanzata MACI (matrix applied characterised autologous cultured chondrocytes) għalaq is-sit ta' manifattura tal-UE għall-mediċina, li jinsab fid-Danimarka.
English: MACI is an advanced therapy medicinal product called a ‘tissue engineered product'.
Maltese: MACI huwa prodott mediċinali ta' terapija avvanzata msejjaħ ”prodott maħdum b'tessut”.
English: Article 118 of Directive 2001/83/EC, which specifies that a marketing authorisation must be suspended in case any one of the requirements laid down in Article 41 (such as the need for a manufacturing site) is no longer met.
Maltese: 1 Artikolu 118 tad-Direttiva 2001/83/KE, li jispeċifika li awtorizzazzjoni għat-tqegħid fis-suq għandha tiġi sospiża filkaż li kwalunkwe wieħed mir-rekwiżiti stabbiliti fl-Artikolu 41 (bħall-ħtieġa għal sit ta' manifattura) ma jibqax sodisfatt.
English: Since 2013 MACI has been marketed in Denmark, Greece and the UK.
Maltese: Minn 2013 l'hawn MACI tqiegħed fis-suq fid-Danimarka, fil-Greċja u fir-Renju Unit.
English: Because MACI is an advanced therapy medicine, the review was carried out by the Committee on Advanced Therapies (CAT), and was subsequently endorsed by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicines for human use.
Maltese: Minħabba li MACI huwa mediċna għal terapija avvanzata, ir-reviżjoni saret mill-Kumitat għat-Terapiji Avvanzati (CAT - Committee on Advanced Therapies), u sussegwentament ġiet aċċettata mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), li huwa responsabbli għal affarijiet relatati ma' mediċini għall-użu mill-bniedem.
English: Information to healthcare professionals
Maltese: Informazzjoni għall-pazjent
English: Based on the draft opinion adopted by the CAT, the CHMP adopted a final opinion on 25 September 2014, recommending the suspension of the marketing authorisation for MACI until a new manufacturing site is registered in the EU.
Maltese: Abbażi tal-abbozz ta' opinjoni adottat mis-CAT, is-CHMP adotta opinjoni finali fil-25 ta' Settembru 2014, u rrakkomanda s-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq għal MACI sakemm sit ta' manifattura ġdid jiġi rreġistrat fl-UE.
English: Following the closure of the manufacturing site and because EU legislation1 requires authorised medicines to have a registered manufacturing site, a review was initiated at the request of the European Commission on 10 September 2014 (under Article 20 of Regulation (EC) No 726/2004) to determine whether the marketing authorisation for MACI should be suspended or revoked.
Maltese: Wara l-għeluq tas-sit ta' manifattura u minħabba li l-leġiżlazzjoni tal-UE1 titlob li mediċini awtorizzati jkollhom sit ta' manifattura rreġistrat, fl-10 ta' Settembru 2014 inbdiet reviżjoni fuq talba talKummissjoni Ewropea (skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004) biex tiddetermina jekk l-awtorizzazzjoni għat-tqegħid fis-suq għal MACI għandhiex tiġi sospiża jew revokata.
English: It was subsequently evaluated through the European Medicines Agency to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the Agency in order to obtain an EU-wide marketing authorisation; this was obtained in 2013.
Maltese: Sussegwentament ġie evalwat mill-Aġenzija Ewropea għall-Mediċini biex ikun konformi marregolamenti tal-UE dwar terapiji avvanzati, li jeħtieġu li t-terapiji avvanzati kollha fl-Istati Membri talUE jgħaddu minn evalwazzjoni mill-Aġenzija sabiex jiksbu awtorizzazzjoni għat-tqegħid fis-suq madwar l-UE kollha; din inkisbet fl-2013.
English: • Surgeons and hospitals that have been using MACI were informed in June 2014 of the planned closure of the EU manufacturing site for MACI.
Maltese: • Kirurgi u sptarijiet li kienu qegħdin jużaw MACI ġew infurmati f'Ġunju 2014 bl-għeluq ippjanat tassit ta' manifattura tal-UE għal MACI.
English: The final opinion was sent to the European Commission, which issued a legally binding decision on 19 November 2014.
Maltese: L-opinjoni finali ntbagħtet lillKummissjoni Ewropea, li ħarġet deċiżjoni finali li torbot legalment fid-19 ta' Novembru 2014.
English: • Patients who have already started treatment (i.e. those who have had their biopsies taken) should have been informed about the closure and should have discussed arrangements for completion of treatment with their treating surgeon.
Maltese: • Pazjenti li diġà bdew il-kura (jiġifieri dawk li diġà tteħditilhom il-bijopsija) għandhom jiġu infurmati dwar l-għeluq u għandhom ikunu ddiskutew arranġamenti għat-tlestija tal-kura mal-kirurgu li jkun qiegħed jagħtihom il-kura.
English: Consequently, the licence of the manufacturing site was withdrawn.
Maltese: B'konsegwenza ta' dan, il-liċenzja tas-sit ta' manifattura ġiet irtirata.
English: MACI was on the market since 1998 in individual EU countries according to national procedures.
Maltese: MACI ilu fis-suq mill-1998 f'pajjiżi tal-UE individwali permezz ta' proċeduri nazzjonali.
English: Following the closure of the site, the marketing authorisation holder has been requested to store any remaining biopsies that have not yet been used to allow for potential later treatment with MACI, unless patients and their treating surgeons have explicitly indicated that they do not wish to complete
Maltese: Wara l-għeluq tas-sit, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq intalab jaħżen kwalunkwe bijopsija li kien fadal li kienet għadha ma ntużatx biex tkun tista' ssir kura potenzjali aktar tard b'MACI, sakemm il-pazjenti u l-kirurgi li jkunu qegħdin jikkurawhom ma jindikawx b'mod espliċitu li ma jixtiqux itemmu l-kura b'MACI.
English: • For patients who have already started treatment (i.e. those who have had their biopsies taken) company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons have explicitly indicated that they no longer wish to complete treatment with MACI.
Maltese: • Għal pazjenti li diġà bdew il-kura (jiġifieri dawk li diġà tteħditilhom il-bijopsija) il-kumpanija għamlet arranġamenti biex taħżen kwalunkwe bijopsija eżistenti sabiex il-kura tkun tista' titlesta sakemm il-pazjenti u l-kirurgi li jkunu qegħdin jikkurawhom ma jkunux indikaw b'mod espliċitu li ma jixtiqux itemmu l-kura b'MACI.
English: In addition, surgeons were asked not to start new patients on MACI.
Maltese: Barra minn hekk, il-kirurgi ntalbu ma jibdewx pazjenti ġodda fuq MACI.
English: MACI is unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Maltese: MACI mhuwiex disponibbli għal pazjenti ġodda fl-UE sakemm jiġi reġistrat sit ta' manifattura ġdid fl-UE.
English: Date of first authorisation: 9 March 2000 Date of latest renewal: 9 March 2010
Maltese: Data tal-aħħar tiġdid: 9 ta' Marzu 2010
English: 1,200 mg)
Maltese: 1,200 mg)d
English: Laboratory Tests
Maltese: Testijiet tal-Laboratorju
English: *AUC12 (ng.hr/mL) for ribavirin; AUC0-24 (IU.hr/mL) for IntronA
Maltese: *AUC12 (ng.hr/mL) għal ribavirin; AUC0-24 (IU.hr/mL) għal IntronA
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Maltese: Tmax (hr) Cmax (ng/mL) AUC* Tneħħija apparenti L/siegħa/kg
English: Authorized Representative: BD, Laagstraat 57, B-9140 Temse, Belgium
Maltese: BD, Laagstraat 57, B-9140
English: Be sure the solution is at room temperature up to 25°C.
Maltese: Kun ċert li s-soluzzjoni tkun fit-temperatura tal-kamra ta' mhux aktar minn 25°C.
English: Diagram A
Maltese: Dijagramma A
English: IntronA (3 MIU TIW) + ribavirin
Maltese: (3 MIU TIW) + ribavirin
English: Severity was generally mild to moderate.
Maltese: Is-severità kienet ġeneralment minn ħafifa sa moderata.
English: Headache, dizziness
Maltese: Dijabete, dijabete aggravata
English: This leaflet was last revised in.
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Palpitation, tachycardia
Maltese: Palpitazzjoni, takikardija
English: IntronA with food and drink and alcohol
Maltese: IntronA ma' ikel, xorb u alkoħol
English: IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Maltese: I/R IntronA (3 MIU 3 darbiet fil-ġimgħa) + ribavirin (1,000/1,200 mg/jum)
English: Ocular adverse events
Maltese: Avvenimenti avversi okulari
English: IntronA (3 MIU TIW) + ribavirin (800 mg)
Maltese: (3 MIU TIW) + ribavirin (800 mg)
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1,64 %  12 years of age.
Maltese: Total ta' 118-il pazjent ġew irreġistrati: 57 % irġiel, 80 % Kawkasi, u 78 % b'ġenotip 1, 64 % li kellhom ≤ 12-il sena.
English: Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection
Maltese: Farinġite*, infezzjoni virali* Bronkite, sinusite, herpes simplex (reżistenza), rinite Infezzjoni batterjali
English: The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
Maltese: L-interferoni huma familja ta' molekuli żgħar ta' proteina b'piżijiet molekulari ta' madwar 15,000 sa 21,000 dalton.
English: Effect on fertility Interferon may impair fertility (see section 4.6 and section 5.3).
Maltese: Interferon jista' jindebbolixxi l-fertilità (ara sezzjoni 4.6 u sezzjoni 5.3).
English: Diagram C
Maltese: Dijagramma C
English: 25 million IU/2.5 mL
Maltese: 25 miljun IU/2.5 mL
English: Serum levels were below the detection limit 16 and 24 hours, respectively, post-injection.
Maltese: Il-livelli fis-serum kienu inqas mil-limitu li jistgħu jitkejlu 16 u 24 siegħa, rispettivament, wara l-injezzjoni.
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Maltese: Interferon alfa-2b rikombinanti jinibixxi wkoll ir-replikazzjoni virali in vitro u in vivo.
English: The activity of IntronA is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l0
Maltese: L-attività ta' IntronA hija espressa f'termini ta' IU, b'1 mg ta' proteina ta' interferon alfa-2b rikombinanti li tikkorrispondi għal 2.6 x l08 IU.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/week pegylated interferon alfa-2b.
Maltese: b: valur p ibbażat fuq it-test chi-square. ċ: individwi < 75 kg irċivew 100 µg/ġimgħa ta' interferon alfa-2b pegilat u individwi ≥ 75 kg irċivew 150 µg/ġimgħa ta'
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy.
Maltese: Arritmiji kardijaċi (primarjament sopraventrikulari) normalment jirrispondu għal terapija konvenzjonali iżda jistgħu jkunu jeħtieġu t-twaqqif tat-terapija ta' IntronA.
English: Included are hairy cell leukaemia, chronic myelogenous leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour, and malignant melanoma.
Maltese: Inklużi hemm illewkimja tal-hairy cell, lewkimja tal-mudullun kronika, majeloma multipla, limfoma follikulari, tumur karċinojde u melanoma malinna.
English: The pharmacokinetics of IntronA and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Maltese: Il-farmakokinetika ta' IntronA u ribavirin (normalizzat għad-doża) huma simili fl-adulti u tfal jew adolexxenti.
English: Pharmacotherapeutic group: interferon alfa-2b, ATC code: L03A B05
Maltese: Kategorija farmakoterapewtika: interferon alfa-2b, Kodiċi ATC:
English: p value pegylated interferon alfa-2b (100 or c µg/week) + ribavirin
Maltese: Valur pa interferon alfa-2b pegilat (100 jew 150ċ µg/ġimgħa) + ribavirin
English: Male: testicular pain
Maltese: Rġiel: uġigħ fit-testikoli
English: Excipients: disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Maltese: Sustanzi mhux attivi: disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 u ilma għall-injezzjonijiet.
English: 18 million IU/3 mL
Maltese: 18-il miljun IU/3 mL
English: Chronic Hepatitis C - Combination therapy with ribavirin In clinical trials of 118 children and adolescents (3 to 16 years of age), 6 % discontinued therapy due to adverse reactions.
Maltese: Epatite Ċ Kronika - Terapija kombinata b'ribavirin Fi provi kliniċi b'118-il tifel u tifla u adolexxenti (3 sa 16-il sena), 6 % waqqfu t-terapija minħabba reazzjonijiet avversi.
English: Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome
Maltese: Frekwenza urinarja Kollass renali, insuffiċjenza renali, sindrome nefrotiku
English: Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm 3), severe neutropaenia (< 750/mm or severe thrombocytopaenia (< 70,000/mm
Maltese: Il-kura għandha titwaqqaf f'każ ta' lewkopenija severa (< 1,200/mm3), newtropenija severa (< 750/mm3) jew tromboċitopenija severa (< 70,000/mm3).
English: In clinical trials using IntronA therapy, 2.8 % patients overall developed thyroid abnormalities.
Maltese: Fi provi kliniċi bl-użu tat-terapija b'IntronA, 2.8 % talpazjenti kollha żviluppaw anormalitajiet tat-tirojde.
English: If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Maltese: Jekk ikun hemm suspett li hemm is-sindrome VKH, il-kura antivirali għandha titwaqqaf u tiġi diskussa terapija b'kortikosterojdi (ara sezzjoni 4.8).
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rarely (≥1/10,000 to <1/1,000); very rarely (<1/10,000); not known.
Maltese: Fost ilklassijiet tas-sistemi tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf.
English: Pack of 2 vials
Maltese: Pakkett ta' 2 kunjetti
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Maltese: Ribavirin 15 mg/kg/jum bħala 2 dożi diviżi
English: Genotype 2/3/4 (n=26)
Maltese: Rispons Globali a (n=118) Ġenotip 1 (n=92) Ġenotip 2/3/4 (n=26)
English: Diagram D
Maltese: Dijagramma D
English: Flushing, pallor
Maltese: Fwawar, pallidità
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Maltese: Total ta' 107 pazjent irċivew kura li minnhom 52 % kienu nisa, 89 % Kawkasi, 67 % b'HCV Ġenotip 1 u 63 % li kellhom < 12il sena.
English: HCV Genotype
Maltese: HCV
English: Other medicines and IntronA
Maltese: Mediċini oħra u IntronA
English: The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white blood cells < 1,500/mm 3, granulocytes < 1,000/mm 3, thrombocytes < 100,000/mm 3).
Maltese: Id-doża mogħtija għanda titnaqqas b'50 % f'każ li jseħħu problemi ematoloġiċi (ċelluli bojod taddemm < 1,500/mm3, granuloċiti < 1,000/mm3, tromboċiti < 100,000/mm3).
English: IntronA is available in four different pack sizes:
Maltese: IntronA jiġi f'erba' daqsijiet ta' pakketti differenti:
English: Table 7 Mean (% CV) multiple-dose pharmacokinetic parameters for IntronA and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
Maltese: Tabella 7 Medja ( % CV) tal-parametri farmakokinetiċi ta' dożi multipli għal IntronA u kapsuli ta' ribavirin meta jingħataw lil tfal jew adolexxenti b'epatite Ċ kronika
English: Diagram B
Maltese: Dijagramma B
English: Hypertriglyceridemia
Maltese: Ipertrigliċeridemija
English: 5 million IU/0.5 mL
Maltese: 5 miljun IU/0.5 mL
English: Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
Maltese: Reazzjonijiet ta' sensittività eċċessiva akuta (eż. urtikarja, anġjoedima, bronkokostrizzjoni, anafilassi) għal interferon alfa-2b ġew osservati b'mod rari waqt it-terapija b'IntronA.
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Maltese: Aplasija pura taċ-ċelluli ħomor, purpura tromboċitopenika idjopatika, purpura trombotika tromboċitopenika
English: CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Maltese: Korsijiet li jixbhu lil dak ta'CHOP huma rakkomandati, iżda hemm disponibbli biss esperjenza klinika bis-CHVP (kombinazzjoni ta' cyclophosphamide, doxorubicin, teniposide u prednisolone).
English: The clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9 % and in chronic hepatitis patients is 6.2 %.
Maltese: L-inċidenza klinika ta' fatturi newtralizzanti li jiżviluppaw fil-pazjenti bil-kanċer ikkurati sistemikament hi ta' 2.9 % u ta' 6.2 % filpazjenti b'epatite kronika.
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SPC).
Maltese: Il-mekkaniżmu wara dawn l-avvenimenti mhux magħruf (ara sezzjonijiet 4.3, 4.4 u 4.5 tal-SPC ta' telbivudine).
English: Malignant melanoma, induction therapy: 20 million IU/m 2, intravenously, given daily for 5 days a week for a 4 week period.
Maltese: Melanoma malinna, terapija ta' induzzjoni: 20 miljun IU/m², ġol-vini, mogħtija kuljum għal 5 ijiem fil-ġimgħa għal perjodu ta' 4 ġimgħat.
English: Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2).
Maltese: L-abort kien osservat fil-kategoriji kollha tad-dożi (7.5 miljun, 15-il miljun u 30 miljun IU/kg), u kien statistikament sinifikanti meta mqabbel mal-kontroll fil-gruppi tad-doża medja u ta' dik għolja (li tikkkorrispondi għal 90 u 180 darba tad-doża rakkomandata ta' 2 miljun IU/m² ġol-muskoli jew taħt ilġilda).
English: Immune system disorders Very rarely:
Maltese: Effetti sekondarji rrappurtati b'mod rari:
English: Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia
Maltese: Tromboċitopenija, limfadenopatija, limfopenija Anemija aplastika
English: d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Maltese: interferon alfa-2b pegilat. d: dożi ta' ribavirin kien 800 mg għal pazjenti < 60 kg, 1,000 mg għal pazjenti li jiżnu 60-75 kg, u 1,200 mg għal pazjenti li jiżnu > 75 kg.
English: In these patients, the addition of ribavirin to IntronA increased by as much as 10-fold the efficacy of IntronA used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %).
Maltese: F'dawn il-pazjenti, iż-żieda ta' ribavirin ma' IntronA żiedet b'sa 10 darbiet l-effettività ta' IntronA użat waħdu fil-kura ta' epatite Ċ kronika (48.6 % vs. 4.7 %).
English: A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is  34 %, but < 90 % Ph+ cells in the marrow.
Maltese: Rispons ċitoġeniku maġġuri huwa definit bħala < 34 % ċelluli Ph+ lewkimiċi fil-mudullun, filwaqt li rispons minuri huwa ≥ 34 %, iżda < 90 % ċelluli Ph+ fil-mudullun.
English: p value
Maltese: Valur pb
English: Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons.
Maltese: Interferon alfa-2b rikombinanti huwa proteina li tinħall flilma u għandu piż molekulari ta' madwar 19,300 dalton.
English: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Maltese: Il-kura ta' pazjenti adulti li għandhom l-epatite B kronika assoċjata ma' evidenza ta' replikazzjoni virali tal-epatite B (preżenza ta' DNA tal-virus tal-epatite B (HBV-DNA) u antiġen tal-epatite B (HBeAg), alanine aminotransferase (ALT) għoli u infjammazzjoni u/jew fibrożi attiva fil-fwied li tkun ikkonfermata b'mod istoloġiku.
English: Genotype 1  2 million copies/mL Genotype 1 > 2 million copies/mL
Maltese: ≤ 2 miljun kopja/mL Ġenotip 1
English: 3 million IU/0.5 mL
Maltese: 3 miljun IU/0.5 mL
English: If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Maltese: Jekk l-X-ray turi infiltrati pulmonarji jew ikun hemm evidenza ta' indeboliment fil-funzjoni tal-pulmun, il-pazjent għandu jkun immonitorjat mill-qrib, u, jekk meħtieġ, jitwaqqaf interferon alpha.