FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing iodocasein/thiamine.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, għal prodotti mediċinali li fihom iodocasein/thiamine.
English: The product information lists hyperthyroidism as a contra-indication and advises on the need for a regular control of the thyroid function during treatment with recommendation for discontinuation of the treatment in case of abnormal tests results of thyroid function, with symptoms of hyperthyroidism, tachycardia and arrhythmia.
Maltese: L-informazzjoni dwar il-prodott telenka l-ipertirojdiżmu bħala kontroindikazzjoni u tagħti parir dwar il-ħtieġa li jsir kontroll regolari tal-funzjoni tat-tirojde waqt il-kura b'rakkomandazzjoni li titwaqqaf ilkura f'każ ta' riżultati mhux normali ta' testijiet tal-funzjoni tat-tirojde, b'sintomi ta' ipertirojdiżmu, takikardija u arritmija.
English: On 16 September 2009, the Italian Competent Authority (AIFA) issued a Rapid Alert informing the Members States, the EMEA and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended, of the suspension of the Marketing Authorisation of iodocasein/thiamine containing medicinal product (Antiadiposo) in its Member State, due to serious cases of hyperthyroidism and thyrotoxicosis.
Maltese: Fis-16 ta' Settembru 2009, l-Awtorità Kompetenti Taljana (AIFA) ħarġet Twissija Rapida li tinforma lill-Istati Membri, lill-EMEA u lill-Kummissjoni Ewropea (KE) skont l-Artikolu 107 tadDirettiva 2001/83/KE, kif emendata, dwar is-sospensjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq tal-prodott mediċinali li fih iodocasein/thiamine (Antiadiposo) fl-Istat Membru tiegħu, minħabba każijiet serji ta' ipertirojdiżmu u tijrotossikożi.
English: Cases of hyperthyroidism and thyrotoxicosis, 12 and 3, respectively were reported in subjects being treated with iodocasein/thiamine.
Maltese: Każijiet ta' ipertirojdiżmu u tijrotossikożi, 12 u 3, rispettivament ġew irrapportati f'suġġetti li kienu qegħdin jiġu kkurati b'iodocasein/thiamine.
English: • The Committee noted that iodocasein/thiamine is approved for a condition for which alternative treatments are available.
Maltese: • Il-Kumitat innota li iodocasein/thiamine huwa approvat għal kundizzjoni li għaliha hemm kuri alternattivi disponibbli.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATION
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: Serious cases of hyperthyroidism and thyrotoxicosis, related with iodocasein/thiamine treatment have been reported.
Maltese: Ġew irrapportati każijiet serji ta' ipertirojdiżmu u ta' tijrotossikożi, relatati mal-kura b'iodocasein/thiamine.
English: All reported cases were related with iodocasein/thiamine and 6 cases considered serious.
Maltese: Il-każijiet irrapportati kollha kienu relatati ma' iodocasein/thiamine u 6 każijiet kienu kkunsidrati serji.
English: • The Committee concluded, after having reviewed the available data, that iodocasein/thiamine is associated with serious cases of hyperthyroidism and thyrotoxicosis.
Maltese: • Il-Kumitat ikkonkluda, wara li rreveda d-dejta disponibbli, li iodocasein/thiamine huwa assoċjat ma' każijiet serji ta' ipertirojdiżmu u tijrotossikożi.
English: Taking all the above elements in consideration and the fact that there are other therapeutic alternatives available for the treatment of obesity, the CHMP concluded that the benefit/risk balance for iodocasein/thiamine is not considered favourable and recommended the revocation of the Marketing Authorisation for the medicinal product referred to in Annex I.
Maltese: Meta wieħed jikkunsidra l-elementi kollha ta' hawn fuq u l-fatt li hemm alternattivi terapewtiċi oħrajn disponibbli għall-kura tal-obeżità, is-CHMP ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju għal iodocasein/thiamine mhuwiex ikkunsidrat favorevoli u rrakkomanda r-revoka tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għall-prodott mediċinali msemmi fl-Anness I.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCT(S) CONTAINING IODOCASEIN/THIAMINE (see Annex I)
Maltese: IODOCASEIN/THIAMINE (ara Anness I)
English: However, this daily dose represents an iodine dose intake which is 120 times higher than the recommended daily dose.
Maltese: Madankollu, din id-doża ta' kuljum tirrappreżenta konsum ta' doża ta' jodju li hija 120 darba ogħla mid-doża rakkomandata ta' kuljum.
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an opinion on 22 October 2009 recommending the revocation of the Marketing Authorisation for iodocasein/thiamine containing medicinal product referred to in Annex I.
Maltese: B'mod konformi mad-dispożizzjonijiet skont l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendat, il-Kumitat tal-Aġenzija dwar Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ħejja opinjoni fit-22 ta' Ottubru 2009 fejn irrakkomanda r-revoka tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għall-prodotti mediċinali kollha li fihom iodocasein/thiamine imsemmija fl-Anness I
English: Available data are insufficient to enable the demonstration of the benefits of thyroid hormone therapy in inducing weight loss in obese subjects during caloric deprivation or on morbidity and mortality in patients with non thyroidal illnesses.
Maltese: Id-dejta disponibbli m'hijiex biżżejjed biex tippermetti l-wiri tal-benefiċċji tal-kura bl-ormoni tattirojde fl-ikkawżar ta' telf fil-piż f'suġġetti obeżi waqt il-privazzjoni tal-kaloriji jew fuq il-morbidità u l-mortalità f'pazjenti b'mard li mhuwiex tirojdali.
English: Grade 3 Grade 4 Grade 3 Grade 4
Maltese: Grad 3 Grad 4 Grad 3
English: Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence Italy
Maltese: Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence L-Italja
English: Sections 4.5, 4.6, 4.7, 4.8 and 4.9 were also harmonised.
Maltese: Sezzjonijiet 4.5, 4.6, 4.7, 4.8 u 4.9 ġew ukoll armonizzati.
English: Formation of dFdU from parent compound: 91%-98%.
Maltese: Formazzjoni ta' dFdU mis-sustanza oriġinali: 91%-98%.
English: Lilly, S.A., Avenida de la Industria, 30 28108 Alcobendas Madrid Spain
Maltese: Lilly, S.A., Avenida de la Industria, 30 28108 Alcobendas Madrid Spanja
English: The active substance is gemcitabine.
Maltese: - Is-sustanza attiva hi gemcitabine.
English: PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Cyprus
Maltese: PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Ċipru
English: Germany Lilly Deutschland GmbH Teichweg 3
Maltese: Il-Ġermanja Lilly Deutschland GmbH Teichweg 3
English: Eli Lilly Sweden AB Box 721
Maltese: L-Isvezja Eli Lilly Sweden AB Box 721
English: Oy Eli Lilly Finland,Ab Rajatorpantie 41 C, PL 16, 01641 Vantaa Finland
Maltese: Il-Finlandja Oy Eli Lilly Finland,Ab Rajatorpantie 41 C, PL 16, 01641 Vantaa
English: Half-life of terminal elimination: 0.7-12 hours.
Maltese: Half-life ta' eliminazzjoni terminali: 0.7-12-il siegħa.
English: LILLY France SAS 13, rue Pagès 92158 Suresnes Cedex France
Maltese: LILLY France SAS 13, rue Pagès 92158 Suresnes Cedex Franza
English: Percentage of standard dose of Gemzar (%)
Maltese: Persentaġġ tad-doża normali ta' Gemzar (%)
English: • Elevation of liver transaminases (AST and ALT) and alkaline phosphatase
Maltese: • Livelli għoljin tat-transaminases talfwied (AST and ALT) u alkaline phosphatase
English: • Leucopaenia (Neutropaenia Grade 3 = 19.3 %; Grade 4 = 6 %).
Maltese: • Lewkopenja (Newtropenja Grad 3 = 19.3 %;
English: Number (%) of Patients MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) arm (N=196)
Maltese: Numru (%) ta' Pazjenti Fergħa ta' MVAC (methotrexate, vinblastine, doxorubicin u cisplatin) (N=196)
English: 3991 RA Houten The Netherlands
Maltese: 3991 RA Houten
English: Pulmonary
Maltese: Pulmonarju
English: Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), Mhux komuni (≥1/1000 sa <1/100), Rari (≥1/10,000 sa <1/1000), Rari ħafna (<1/10,000).
English: FARMASERVE LILLY S.A.Cl 15 Km National Road Athens-Lamia Kifissia, 14564 Greece
Maltese: FARMASERVE LILLY S.A.Cl 15 Km National Road Athens-Lamia
English: Mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
Maltese: Mannitol (E421), sodium acetate, hydrochloric acid u sodium hydroxide.
English: Platelet count (x 106/l)
Maltese: Għadd tal-plejtlits (x 106/l)
English: Hungary Eli Lilly Nederland BV PO Box 379
Maltese: L-Ungerija Eli Lilly Nederland BV PO Box 379
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby Denmark
Maltese: Id-Danimarka Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby Id-Danimarka
English: Eli Lilly Denmark, Nybrovej 110, 2800 Lyngby
Maltese: L-Islanda Eli Lilly Denmark, Nybrovej 110, 2800 Lyngby
English: Renal
Maltese: Renali
English: • Insomnia
Maltese: • Insomnja
English: • Ulceration
Maltese: • Ulċerazzjoni
English: Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke,
Maltese: Ir-Renju Unit Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke,
English: Peak plasma concentrations (3-15 minutes after end of 30-minute infusion, 1000 mg/m2): 28-52 µg/ml.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma (3-15-il minuta wara t-tmiem ta' 30 minuta ta' infużjoni, 1000 mg/m2): 28-52 µg/ml.
English: Hampshire RG24 9NL United Kingdom
Maltese: Hampshire RG24 9NL
English: Adult respiratory distress syndrome (see section 4.4)
Maltese: Sindromu ta' diffikultà respiratorja fl-adulti (ara sezzjoni 4.4)
English: Gemcitabine plus carboplatin arm (N=175) Grade 3 Grade 4 Grade 3 Grade 4
Maltese: Fergħa ta' Gemcitabine flimkien ma' carboplatin (N=175) Grad 3 Grad 4 Grad 3
English: Grade 3 and 4 Adverse Events Carboplatin versus Gemcitabine plus carboplatin Number (%) of Patients Carboplatin arm (N=174)
Maltese: Grad 3 u 4 Carboplatin kontra Gemcitabine flimkien ma' carboplatin Numru (%) ta' Pazjenti Fergħa ta' Carboplatin (N=174)
English: The primary metabolite, 2'-deoxy-2', 2'-difluorouridine (dFdU), is not active and is found in plasma and urine.
Maltese: Il-metabolita primarja, 2'-deoxy-2', 2'-difluorouridine (dFdU), m'hijiex attiva u ssibha fil-plażma u fl-awrina.
English: Tissue distribution: Extensive.
Maltese: Distribuzzjoni fit-tessuti:
English: Rare • Myocardial infarct
Maltese: • Infart mijokardiku
English: Eli Lilly farmacevtska družba, d.o.o.
Maltese: L-Islovenja Eli Lilly farmacevtska družba, d.o.o. Dunajska 156
English: The 121 women and 232 men ranged in age from 29 to 79 years.
Maltese: Il-121 mara u 232 raġel kellhom etá li tvarja minn 29 sa 79 sena.
English: The CHMP adopted the proposed revised wording:
Maltese: Il-CHMP adotta l-kitba rreveduta proposta:
English: Renal clearance was 2 to 7 l/hr/m2.
Maltese: Tneħħija renali kienet minn 2 sa 7 l/siegħa/m
English: dFdCTP kinetics
Maltese: Il-kinetika ta' dFdCTP
English: Gemcitabine plus cisplatin arm (N=200)
Maltese: Fergħa ta' Gemcitabine flimkien ma' cisplatin (N=200)
English: • Thrombocytopaenia
Maltese: • Tromboċitożi
English: Eli Lilly Ges.m.b.H Kölblgasse 8-10 1030 Wien Austria
Maltese: L-Awstrija Eli Lilly Ges.m.b.H Kölblgasse 8-10
English: Lithuania Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA United Kingdom
Maltese: Il-Litwanja Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA Ir-Renju Unit
English: Lilly France S.A. 2 rue du colonel Lilly 67642 Fegersheim France
Maltese: Il-Polonja Lilly France S.A. 2 rue du colonel Lilly 67642 Fegersheim Franza
English: Luxembourg Eli Lilly Benelux s.a. 52, rue de l'Etuve
Maltese: Eli Lilly Benelux s.a. 52, rue de l'Etuve B-1000 Bruxelles Il-Belġju
English: Renal and urinary disorders Renal failure (see section 4.4) Haemolytic uraemic syndrome (see section 4.4)
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Insuffiċjenza renali (ara sezzjoni 4.4) Sindromu uremiku emolitiku (ara sezzjoni 4.4)
English: Eli Lilly Norge AS, Postboks 6090 Etterstad, N-0601 Oslo Norway
Maltese: In-Norveġja Eli Lilly Norge AS, Postboks 6090
English: Gemcitabine plus Paclitaxel arm (N=262) Grade 3 Grade 4 Grade 3 Grade 4
Maltese: Fergħa ta' Gemcitabine flimkien ma' Paclitaxel (N=262) Grad 3 Grad 4 Grad 3
English: Lilly France S.A.S., rue du Colonel Lilly, F-67640, Fegersheim, France This leaflet was last approved in
Maltese: Lilly France S.A.S., rue du Colonel Lilly, F-67640, Fegersheim, Franza Dan il-fuljett kien approvat l-aħħar f'
English: Elderly population(> 65 years)
Maltese: Popolazzjoni anzjana (> 65 sena)
English: Mild to moderate renal insufficiency (GFR from 30 ml/min to 80 ml/min) has no consistent, significant effect on gemcitabine pharmacokinetics.
Maltese: Insuffiċjenza renali ħafifa sa moderata (GFR minn 30 ml/min sa 80 ml/min) m'għandha ebda effett konsistenti sinifikanti fuq il-farmakokinetika ta' gemcitabine
English: Pharmacotherapeutic group: pyrimidine analogues ATC code: L01BC05
Maltese: Kategorija farmakoterapewtika: analogi ta' pyramidine, Kodiċi ATC:
English: • Alopecia
Maltese: • Alopeċja Komuni
English: Severe skin reactions, including desquamation and bullous skin eruptions, Lyell's Syndrome, StevenJohnson Syndrome
Maltese: Reazzjoni severi fil-ġilda li jinkludi d-deskwamazzjoni u eruzzjonijiet bullożi fuq il-ġilda, Sindromu ta' Lyell, Sindromu Steven-Johnson
English: Intracellular metabolism of gemcitabine produces the gemcitabine mono, di and triphosphates (dFdCMP, dFdCDP and dFdCTP) of which dFdCDP and dFdCTP are considered active.
Maltese: Il-metaboliżmu intraċellulari ta' gemcitabine jipproduċi il-mono, id-di u t-trifosfati ta' gemcitabine (dFdCMP, dFdCDP and dFdCTP) li minnhom dFdCDP u dFdCTP huma kkunsidrati attivi.
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment)
Maltese: Hydrochloric acid (E507) (għall-aġġustament tal-pH) Sodium hydroxide (E524) (għall-aġġustament tal-pH) 6.2 Inkompatibilitajiet
English: Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim France
Maltese: Ir-Rumanija Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim
English: Very Rare • Anaphylactoid reaction
Maltese: Rari ħafna • Reazzjoni anafilattika
English: Unopened vial: Store below 30°C.
Maltese: Aħżen f'tempaeratura inqas minn 30°C.
English: The infusion will last approximately 30 minutes.
Maltese: L-infużjoni ser iddum madwar 30 minuta.
English: Vascular disorders Clinical signs of peripheral vasculitis and gangrene
Maltese: Disturbi vaskulari Sinjali kliniċi ta' vaskulite periferali u kankrena
English: Nervous system disorders Cerebrovascular accident
Maltese: Disturbi fis-sistema nervuża Inċident ċerebrovaskulari
English: Cellular metabolism and mechanism of action: Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
Maltese: Metaboliżmu ċellulari u mod ta' kif jaħdem: Gemcitabine (dFdC), li huwa antimetabolita ta' pyrimidine, jiġi metabolizzat ġewwa ċ-ċelluli permezz ta' nucleoside kinase, f'nucleosides diphosphate (dFdCDP) u triphosphate (dFdCTP) attivi.
English: One vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine.
Maltese: Kunjett fih gemcitabine hydrochloride ekwivalenti għal 1000 mg gemcitabine.
English: • Oedema/peripheral oedemaincluding facial oedema.
Maltese: • Edima/edima periferali-li tinkludi edima fil-wiċċ.
English: Frequency grouping
Maltese: Grupp ta' frekwenza
English: • Myalgia
Maltese: • Mijalġja
English: A randomised phase III study of 405 patients with advanced or metastatic urothelial transitional cell carcinoma showed no difference between the two treatment arms, gemcitabine/cisplatin versus methotrexate/vinblastine/adriamycin/cisplatin (MVAC), in terms of median survival (12.8 and 14.8 months respectively, p=0.547), time to disease progression (7.4 and 7.6 months respectively, p=0.842) and response rate (49.4% and 45.7% respectively, p=0.512).
Maltese: III b'405 pazjenti b'karċinoma ta' ċellula tranżitorja uroteljali avvanzat jew metastatiku , fiż-żewġ fergħat ta' kura gemcitabine/cisplatin kontra methotrexate/vinblastine/adriamycin/cisplatin (MVAC), f'termini ta' sopravivenza medjana (12.8 u 14.8 xhur rispettivament, p=0.547 ) żmien għall-progressjoni tal-marda (7.4 u 7.6 xhur rispettivament, p=0.842) u rata ta' rispons (49.4% u 45.7% rispettivament, p=0.512). Madankollu l-profil ta' tossiċità tal-kombinazzjoni gemcitabine u cisplatin kien aħjar minn MVAC.
English: The following pharmacokinetic parameters were obtained for doses ranging from 500 to 2,592 mg/m2 that were infused from 0.4 to 1.2 hours.
Maltese: Il-parametri farmakokinetiċi li ġejjin ġew miksuba minn dożi li jvarjaw minn 500 sa 2,592 mg/m2 u kellhom ħin ta' infużjoni li jvarja minn 0.4 sa 1.2 sigħat.
English: Triphasic plasma concentration versus time curve, mean half-life of terminal phase - 65 hours (range 33-84 hr).
Maltese: Kurva ta' konċentrazzjoni fil-plażma trifażiku kontra l-ħin, il-medja tal-half-life tal-fażi terminali - 65 siegħa (marġni ta' 33-84 siegħa).
English: Half-life: This ranged from 42 to 94 minutes depending on age and gender.
Maltese: Din kienet tvarja minn 42 sa 94 minuta skond l-età u s-sess.
English: • not known: frequency can't be estimated from the available data
Maltese: • mhux magħruf: il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli
English: Anaphylactic reaction (severe hypersensitivity/ allergic reaction) Sloughing of skin and severe skin blistering
Maltese: Reazzjoni anafilattika ( reazzjoni ta' sensittività eċċessiva / allerġika severa )
English: Gemcitabine has been well tolerated in patients over the age of 65.
Maltese: Gemcitabine huwa tollerat tajjeb minn pazjenti li għandhom iżjed minn 65 sena.
English: The pharmacokinetics of gemcitabine have been examined in 353 patients in seven studies.
Maltese: Il-farmakokinetika ta' gemcitabine ġiet eżaminata fi 353 pazjent f'seba' studji.
English: Grade 3 and 4 Adverse Events MVAC versus Gemcitabine plus cisplatin
Maltese: Avvenimenti Avversi ta' Grad 3 u 4 MVAC kontra Gemcitabine flimkien ma' cisplatin
English: For instructions on reconstitution, see section 6.6
Maltese: Għall-istruzzjonijiet dwar ir-rikostituzzjoni, ara sezzjoni 6.6
English: Eli Lilly Netherlands BV Grootslag 1-5
Maltese: L-Olanda Eli Lilly Netherlands BV Grootslag 1-5
English: Common • Anorexia
Maltese: • Anoressija
English: Gemcitabine can suppress bone marrow function as manifested by leucopaenia, thrombocytopaenia and anaemia.
Maltese: Gemcitabine jista' jrażżan il-funzjoni tal-mudullun li jirriżulta f'lewkopenja,tromboċitopenja u anemija.
English: Laboratory Anaemia Thrombocytopaenia Neutropaenia Non-laboratory Febrile neutropaenia Fatigue Diarrhoea Motor neuropathy Sensory neuropathy *Grade 4 neutropaenia lasting for more than 7 days occurred in 12.6% of patients in the combination arm and 5.0% of patients in the paclitaxel arm.
Maltese: Laboratorju Anemija Tromboċitopenja Newtropenja Mhux ta' laboratorj Newtropenja bid-deni Għeja Dijarea Newropatija motorja Newropatija sensorjali *Newropenja ta' Grad 4 li damet iżjed minn 7 tijiem seħħet f'12.6% tal-pazjenti fil-fergħa kkombinata u f'5.0% tal-pazjenti fil-fergħa ta' paclitaxel.
English: ELI LILLY ITALIA S.P.A..
Maltese: ELI LILLY Benelux s.a.
English: Eli Lilly Nederland BV Grootslag 1-5
Maltese: L-Olanda Eli Lilly Nederland BV Grootslag 1-5
English: Second, dFdCTP competes with dCTP for incorporation into DNA (self-potentiation).
Maltese: Bħala t-tieni ħaġa, dFdCTP jikkompeti ma' dCTP biex jiġi inkorporat fid-DNA (isaħħaħ lilu nnifsu)
English: • Absolute granulocyte count < 100 x 106/l for more than 3 days
Maltese: • Għadd assolut tal-granuloċiti < 100 x 10 6/l għal iżjed minn 3 ġranet
English: In another randomised phase III study of 135 patients with stage IIIB or IV NSCLC, a combination of gemcitabine and cisplatin showed a statistically significant higher response rate than a combination of cisplatin and etoposide (40.6% and 21.2%, respectively, p=0.025).
Maltese: III b'135 pazjent b'NSCLC fi stadju IIIB jew IV kombinazzjoni ta' gemcitabine u cisplatin urew rata ta' rispons statistikament ogħla b'mod sinfikanti meta mqabbla ma' kombinazzjoni ta'cisplatin u etopside (40.6% u 21.2%, rispettivament, p=0.025).
English: A statistically significant prolongation of the time to progression of disease, from 5.8 to 8.6 months (log-rank p= 0.0038) was observed in the patients treated with GCb compared to patients treated with Cb.
Maltese: Ġiet osservata żieda statistikament sinifikanti fiżżmien għall-progressjoni tal-marda minn 5.8 sa 8.6 xhur (log-rank p= 0.0038) f'pazjenti kkurati b'GCb meta mqabbla ma' pazjenti kkurati b'Cb.
English: Gemcitabine should be discontinued at the first signs of any evidence of microangiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopaenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH.
Maltese: Gemcitabine għandu jitwaqqaf ma' l-ewwel sinjali ta' evidenza ta' anemija emolitika mikroanġjopatika, bħal livell ta' emoglobina li jibda jinżel b'mod mgħaġġel flimkien mat-tromboċitopenja, livelli għoljin tal- bilirubin fis-serum, tal-krejatinina fis-serum, tal-urea nitrogen fid demm jew LDH.
English: In a randomised phase III study, 356 patients with advanced epithelial ovarian carcinoma who had relapsed at least 6 months after completing platinum based therapy were randomised to therapy with gemcitabine and carboplatin (GCb), or carboplatin (Cb).
Maltese: III, 356 pazjent, b'karċinoma ta' l-ovarji epitiljali avvanzat u li rkadew wara għallinqas 6 xhur minn meta kienu spiċċaw terapija bbażata fuq il-platinum, ġew mogħtija b'mod arbitrarju jew gemcitabine u carboplatin (GCb), jew carboplatin (Cb).
English: Gemzar 1g powder for injection 1g
Maltese: Gemzar 1g trab għall-injezzjoni 1g
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways (wheeze) Abnormal chest X ray/scan (scarring of the lungs)
Maltese: Pulmonite interstizjali ( il-boroż żgħar ta' l-arja fil-pulmun irabbu qoxra) Spażmu fil-passaġġi ta' l-arja (tħarħir) X ray/ritratt tas-sider mhux normali (il-pulmuni jrabbu qoxra)
English: • ovarian cancer, together with carboplatin.
Maltese: • kanċer ta' l-ovarji, flimkien ma' carboplatin.
English: In general, the CHMP considered the proposed wording to be adequate, but implemented a number of revisions, including sections on impaired bone-marrow function, combination with carboplatin and cisplatin, live attenuated vaccines and Pharmacovigilance reports on cardiovascular events and viral hepatitis reactivation.
Maltese: B'mod ġenerali, il-CHMP ikkunsidra li l-kitba proposta hija adegwata, iżda implimenta numru ta' reviżjonijiet, inklużi sezzjonijiet fuq funzjoni indebolita tal-mudullun, kombinazzjoni ma' carboplatin u cisplatin, vaċċini ħajjin attenwati u rapporti ta' Farmakoviġilanza fuq episodji kardjovaskulari u attivazzjoni mill-ġdid ta' epatite virali.
English: The volume of distribution of the central compartment was 12.4 l/m2 for women and 17.5 l/m2 for men (inter-individual variability was 91.9%).
Maltese: Distribuzzjoni Il-volum ta' distribuzzjoni fil-kompartiment ċentrali kien ta' 12.4 l/m għan-nisa u ta' 17.5 l/m għallirġiel (il-varjabbilità bejn indivdwu u ieħor kienet ta' 91.9%).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Maltese: U KWANTITATTIVA Kunjett fih gemcitabine hydrochloride ekwivalenti għal 200 mg gemcitabine.