FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 3 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 125 mg/m2/ġurnata (3.38 mg/kg/ġurnata) sa 250 mg/m2/ġurnata (6.76 mg/kg/ġurnata) maqsuma f'infużjoni waħda jew tnejn kuljum, mogħtija minn 3 sa 4 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra,
English: You should tell your doctor if you have: - liver or kidney problems, - heart or lung problems, - seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
Maltese: - problemi fil-fwied jew fil-kliewi, - problemi fil-qalb jew fil-pulmuni, - aċċessjonijiet/attakki tal-qamar (epilessija) jew batejt minnhom fil-passat (jekk ġejt ittrattat b'phenytoin jew fosphenytoin).
English: The recommended dose ranges from 250 mg/m2/day (10 mg/kg/day) to 350 mg/m2/day (14 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 250 mg/m2/ġurnata (10 mg/kg/ġurnata) sa 350 mg/m2/ġurnata (14 mg/kg/ġurnata) bħala infużjoni waħda kuljum, mogħtija għal 3 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 1050 mg/m2 (42 mg/kg), matul il-perjodu tat-trattament sħiħ ta'
English: After intravenous administration, plasma concentrations of the active substance fit a two compartment model with a rapid distribution phase.
Maltese: Wara l-amministrazzjoni ġol-vini, il-konċentrazzjonijiet filplażma tas-sustanza attiva joqogħdu f'mudell ta' żewġ kompartimenti b'fażi ta' distribuzzjoni rapida.
English: Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being 60% or lower, which was considered by the physicians as the threshold to prove efficacy.
Maltese: Fil-kuri kollha ta' kondizzjonament li fihom thiotepa, ir-rati ta' rikaduta wara aktar minn sena ġew irrappurtati li huma ta' 60% jew inqas, li kien meqjus mit-tobba bħala l-limitu li jagħti prova tal-effikaċja.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Sorsi oħra ta' informazzjoni Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu.
English: The total volume of reconstituted vials to be administered should be further diluted in 500 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration (1000 ml if the dose is higher than 500 mg).
Maltese: Ilvolum totali ta' kunjetti rikostitwiti li jridu jingħataw għandhom jiġu dilwiti aktar b'500 ml ta' 9 mg/ml (0.9) soluzzjoni ta' sodium chloride għal injezzjoni qabel jingħata (1000 ml kemm-il darba ddoża hi ogħla minn 500 mg).
English: Concomitant use with live attenuated vaccines (except yellow fever vaccines), phenytoin and fosphenytoin is not recommended (see section 4.5).
Maltese: L-użu konkomitanti ma' vaċċini ħajjin attenwati (minbarra vaċċini tad-deni l-isfar), phenytoin u fosphenytoin mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Renal and urinary disorders
Maltese: Disturbi renali u fis-sistema awrinarja
English: The metabolites are active alkylating agents but the role they play in the antitumor activity of thiotepa remains to be elucidated.
Maltese: Il-metaboliti huma sustanzi alkilanti attivi iżda r-rwol li jaqdu flattività ta' thiotepa kontra t-tumuri għadu jrid jiġi ċċarat.
English: GERM CELL TUMOURS
Maltese: FULJETT TA' TAGĦRIF
English: Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Qabel u wara kull infużjoni, il-linja ta' ġol-kateter għandha titlaħlaħ b'madwar 5 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għal injezzjoni.
English: Hearing impaired Ototoxicity Tinnitus
Maltese: Azoospermia Amenorreja
English: The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata hija 250 mg/m2/ġurnata (10 mg/kg/ġurnata) maqsuma f'żewġ infużjonijiet kuljum, mogħtija qabel HPCT alloġeneiku, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 250 mg/m2 (10 mg/kg), matul il-perjodu tat-trattament sħiħ ta' kundizzjonament.
English: TEPADINA can impair male and female fertility.
Maltese: TEPADINA jista' jindebolixxi l-fertilità tal-irġiel u tan-nisa.
English: It was teratogenic in mice and in rats, and foeto-lethal in rabbits.
Maltese: Kien teratoġeniku fil-ġrieden u fil-firien, u letali għall-fetu fil-fniek.
English: • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Maltese: • meta jkunu meħtieġa dożi għoljin ta' kemoterapija b'appoġġ ta' HPCT għall-kura ta' tumuri solidi f'pazjenti adulti u pedjatriċi.
English: TEPADINA is administered by a qualified healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial.
Maltese: TEPADINA jingħata minn professjonist mediku kkwalifikat, bħala infużjoni għal ġol-vini (dripp ġo vina) wara d-diluzzjoni tal-kunjett individwali.
English: What is Clenil?
Maltese: X'inhu Clenil?
English: It is also available under the trade names of Becloneb, Beclospin and Sanasthmax.
Maltese: Huwa disponibbli wkoll taħt l-ismijiet kummerċjali ta' Becloneb, Beclospin u Sanasthmax.
English: The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 5.1 (pharmacodynamics).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħrajn tal-SmPC inklużi s-sezzjonijiet 4.6 (fertilità, tqala u treddigħ), 4.8 (effetti sekondarji), u 5.1 (farmakodinamiċi).
English: The maximum daily dose is 3,200 micrograms in adults and adolescents (up to 1,600 micrograms taken twice a day) and 1,600 micrograms in children below 12 years (up to 800 micrograms taken twice a day).
Maltese: Id-doża massima ta' kuljum hija ta' 3,200 mikrogramma fladulti u fl-adolexxenti (sa 1,600 mikrogramma meħuda darbtejn kuljum) u 1,600 mikrogramma fi tfal taħt it-12-il sena (sa 800 mikrogramma meħudin darbtejn kuljum).
English: On 15 September 2016, the European Medicines Agency completed a review of Clenil.
Maltese: Fil-15 ta' Settembru 2016, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Clenil.
English: Clenil is marketed in the following EU Member States: France, Germany, Greece, Ireland and Italy.
Maltese: Clenil jitqiegħed fis-suq fl-Istati Membri tal-UE li ġejjin: Franza, il-Ġermanja, il-Greċja, l-Irlanda u lItalja.
English: The areas harmonised include:
Maltese: Il-partijiet armonizzati jinkludu:
English: Clenil contains the active substance beclometasone dipropionate (which belongs to a group of antiinflammatory medicines commonly known as ‘corticosteroids').
Maltese: Clenil fih is-sustanza attiva beclometasone dipropionate (li tifforma parti minn grupp ta' mediċini antinfjammatorji magħrufin b'mod komuni bħala 'kortikosterojdi').
English: The European Commission issued a decision on this opinion on 11/11/2016.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fi 11/11/2016.
English: Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)
Maltese: Mistoqsijiet u tweġibiet dwar Clenil u ismijiet assoċjati (beclometasone dipropionate, 400 u 800 mikrogramma sospensjoni għal nebulizzatur)
English: Why was Clenil reviewed?
Maltese: Għaliex ġie rieżaminat Clenil?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Clenil in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Clenil fl-Unjoni Ewropea (UE).
English: The CHMP also agreed that Clenil should no longer be used to treat allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites) because the available data do not support this use and other medicines available as nasal sprays may be better tolerated.
Maltese: Is-CHMP qabel ukoll li Clenil m'għandux jintuża aktar għall-kura ta' rinite allerġika (infjammazzjoni talpassaġġi fl-imnieħer ikkawżata minn allerġija, pereżempju hay fever jew allerġija għad-dust mites) minħabba li d-dejta disponibbli ma tappoġġjax dan l-użu u mediċini oħrajn disponibbli bħala sprejs talimnieħer jistgħu jiġu ttollerati aħjar.
English: Clenil is a medicine used for the maintenance treatment of asthma in adults and children.
Maltese: Clenil huwa mediċina użata għall-kura ta' manteniment tal-ażma fl-adulti u fit-tfal.
English: On 19 June 2015, the Italian medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Clenil and associated names in the EU.
Maltese: Fit-19 ta' Ġunju 2015, l-aġenzija regolatorja tal-mediċina Taljana rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Clenil u ismijiet assoċjati fl-UE.
English: In children up to 5 years of age, the decision to start Clenil for the treatment of recurrent wheezing should be determined by the severity and frequency of the wheezing episodes.
Maltese: Fi tfal sal-età ta' 5 snin, id-deċiżjoni sabiex jinbeda Clenil għall-kura ta' tħarħir rikorrenti għandha tiġi ddeterminata mis-severità u l-frekwenza tal-episodji ta' tħarħir.
English: Clenil has been authorised in the EU via national procedures.
Maltese: Clenil ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The Committee agreed that Clenil should no longer be used to treat common bronchostenotic conditions (narrowing of the airways in the lungs) because of the lack of rigorous evidence from adequately designed clinical studies.
Maltese: Il-Kumitat qabel li Clenil m'għandux jintuża aktar għall-kura ta' kundizzjonijiet bronkostenotiċi komuni (tidjiq tal-passaġġi tal-arja fil-pulmun) minħabba n-nuqqas ta' evidenza rigoruża minn studji kliniċi imfassla b'mod adegwat.
English: Having harmonised the indication, the CHMP also harmonised recommendations on the doses.
Maltese: Wara li armonizza l-indikazzjoni, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar id-dożi.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Fid-dawl tad-data sottomessa u d-diskussjoni xjentifika fil-Kumitat, is-CHMP kien tal-fehma li l-SmPCs, it-tikkettar u l-fuljetti ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: The starting dose of Clenil depends on the frequency and severity of symptoms and it can be adjusted until symptoms are under control.
Maltese: Iddoża tal-bidu ta' Clenil tiddependi fuq il-frekwenza u s-severità tas-sintomi u tista' tkun aġġustata sakemm is-sintomi jkunu taħt kontroll.
English: 4.4 Special warnings and precautions for use
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Date of latest renewal: 10/07/2011
Maltese: Data ta' l-aħħar tiġdid: 10/07/2011
English: System organ class
Maltese: Klassi tal-organi tassistema
English: Rai Stage III/IV Disease
Maltese: Stadju Rai III/IV
English: Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands
Maltese: Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, l-Olanda
English: United Kingdom/Ireland Genzyme Therapeutics Ltd. (United
Maltese: United Kingdom/Ireland Genzyme Therapeutics Ltd.
English: *Pearson chi-square test or Exact test *** log-rank test stratified by Rai group (Stage I-II vs III-IV)
Maltese: *Test Pearson chi-square jew test Exact ** It-Tul ta' l-aħjar rispons *** Test log-rank stratifikat skond il-grupp Rai (Stadju I-II vs III-IV) **** b'influss ta' 4-kuluri
English: Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
Maltese: Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Il-Ġermanja.
English: 33.1% Not Applicable
Maltese: 33.1% Ma Japplikax
English: Fatal Transfusion Associated Graft Versus Host Disease (TAGVHD) has also been reported.
Maltese: Fatal Transfusion Associated Graft Versus Host Disease (TAGVHD) kienet irrapportata wkoll.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/07/2001
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 06/07/2001
English: The frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala: 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).
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
Maltese: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ir-Renju Unit Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, il-Ġermanja.
English: Pneumocystis jiroveci infection
Maltese: Infezzjoni Pneumocystis jiroveci
English: Protein total decreased
Maltese: Total tal-proteina mnaqqas Anoreksja
English: MabCampath is contraindicated during pregnancy.
Maltese: MabCampath huwa kontra-indikat waqt it-tqala.
English: Disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate, water for injections.
Maltese: Disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate, ilma għall-injezzjonijiet.
English: 53.4% Not Applicable N=82
Maltese: 53.4% Ma Japplikax
English: In addition, an oral antihistamine, e.g. diphenhydramine 50 mg, and an analgesic, e.g. paracetamol 500 mg, may be given.
Maltese: Barra dan, jistgħu jingħataw ukoll antistamina orali e.ż. diphenhydramine 50 mg, u analġeżiku e.ż. paracetamol 500.
English: Dose modification* ANC < 250/μl and/or platelet count ≤25,000/μl
Maltese: ANC < 250/μl u/jew għadd ta' plejtlits ta' ≤25,000/μl
English: It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice.
Maltese: Mhux qed jiġi propost li sorveljanza sistematika u regolari ta' l-espressjoni ta' CD52 għandha titwettaq bħala prattika klinika regolari.
English: Patients have received repeated unit doses of up to 240 mg of MabCampath.
Maltese: Pazjenti rċevew dożi waħdiena ripetuti sa 240 mg ta' MabCampath.
English: • are over 65 years of age as you may be more intolerant to the medicine than other patients.
Maltese: • għandek aktar minn 65 sena, peress li tista' tkun aktar intolleranti għal mediċina minn pazjenti
English: • antibiotics and antivirals may be given to provide you with extra protection.
Maltese: • jistgħu jingħatawlek anti-bijotiċi u antivirali sabiex jipprovdulek aktar protezzjoni.
English: Because MabCampath is a recombinant humanized protein, a P450 mediated drug-drug interaction would not be expected.
Maltese: Peress li Mabcampath huwa proteina rikombinanti umanizzat, interazzjoni ta' mediċina ma' mediċina permezz ta' P450 mhix mistennija.
English: ORR was superior in patients with any 11q deletion (87% v 29%; p<0.0001) or sole deletion 13q (91% v 62%; p=0.0087) treated with MabCampath compared to chlorambucil.
Maltese: ORR kien superjuri f'pazjenti b'kull tneħħija ta' 11q (87% v 29%; p<0.0001) jew tneħħija ta' 13q waħedha (91% v 62%; p=0.0087) kkurati b'MabCampath meta mqabbel ma' chlorambucil.
English: Pneumonia Herpes simplex
Maltese: Herpes simplex Pnewmonite
English: Profound lymphocyte depletion, an expected pharmacological effect of MabCampath, inevitably occurs and may be prolonged.
Maltese: Tnaqqis sostanzjali tal-limfoċiti, effett farmakologiku mistenni ta' MabCampath, jiġri inevitabbilment u jista' jdum.
English: Body tinea
Maltese: Truxija Tinnitus
English: Gradual escalation from 10 to 30 mg 30 mg iv 3 x weekly 30 mg iv 3 x weekly 30 mg iv 3 x weekly
Maltese: 30 mg iv 3 x filġimgħa
English: In the MabCampath arm 36/77 (46.8%) of patients with asymptomatic PCR positive CMV received antiviral therapy and 47/77 (61%) of these patients had MabCampath therapy interrupted.
Maltese: Fil-grupp ta' MabCampath 36/77 (46.8) pazjent b'CMV mhux sintomatiku pożittiv bil-PCR irċevew terapija antivirali u 47/77 (61%) minn dawn il-pazjenti kellhom it-terapija ta' MabCampath interrota.
English: MabCampath Fab binding was observed in lymphoid tissues and the mononuclear phagocyte system.
Maltese: Irbit ta' MabCampath ma' Fab kien osservat f'tessuti limfatiċi u fis-sistema fagoċita mononukleari.
English: Store in a refrigerator (2C-8C).
Maltese: Aħżen fi friġġ (2 C-8 C).
English: In first line patients, treated with either MabCampath or chlorambucil, there were 21 patients with the 17p deletion, 54 patients with 11q deletion, 34 patients with trisomy 12, 51 patients with normal karyotype and 67 patients with sole 13q deletion.
Maltese: F'pazjenti kkurati għall-ewwel darba, b'MabCampath jew b'chlorambucil, kien hemm 21 pazjent bi tneħħija ta' bis-17 p, 54 pazjent bi tneħħija ta' 11 q, 34 pazjent b'trisomy 12, 51 pazjent b'karjotip normali u 67 pazjent bi tneħħija ta' 13 q waħedha.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: Immune system disorders: Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain Barré syndrome and its chronic form, chronic inflammatory demyelinating polyradiculoneuropathy have been reported.
Maltese: Disturbi fis-sistema immuni: Kienu rrappurtati fenomeni awtoimmuni serji u xi kultant fatali inkluż anemija emolitika awtoimmuni, tromboċitopenija autoimmuni, anemija aplastika, is-sindrome ta' Guillain Barré u l-forma kronika tiegħu, u demyelinating polyradiculoneuropathy infjammatorja kronika.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
Maltese: Boehringer Ingelheim Pharma GmbH & Co.
English: Cytomegalovirus infection
Maltese: Cytomegalovirus
English: Median Age (Years)
Maltese: Età Medjana (Snin)
English: In this study, asymptomatic positive PCR only for CMV was reported in 77/147 (52.4%) of MabCampath-treated patients; symptomatic CMV infection was reported less commonly in 23/147 MabCampath treated patients (16%).
Maltese: F'dan l-istudju, CMV mhux sintomatiku pożittiv biss permezz ta' PCR kien irrapportat f'77/147 (52.4%) pazjent ikkurat b'MabCampath; infezzjoni sintomatika ta' CMV kienet irrapportata b'mod inqas komuni f'23/147 pazjent (16%) ikkurat b'MabCampath.
English: MabCampath pharmacokinetics followed a 2-compartment model and displayed non-linear elimination kinetics.
Maltese: Ilfarmakokinetika ta' MabCampath segwiet mudell b'2 kompartamenti u wriet kinetiċi ta' eliminazzjoni li mhumiex lineari.
English: Median PFS was superior in patients with sole 13q deletion treated with MabCampath (24.4 v 13.0 months; p=0.0170 stratified by Rai Stage).
Maltese: PFS medjan kien superjuri f'pazjenti bi tneħħija ta' 13 q waħedha kkurati b'MabCampath (24.4 v 13.0 xhur; p=0.0170 stratifikati skond Stadju Rai).
English: Peripheral ischaemia
Maltese: Edima periferali
English: België/Belgique/Belgien/ Luxemburg/ Luxembourg
Maltese: Danmark/Norge/Sverige/Suomi/Finland/ Ísland
English: Infections and infestations: Serious and sometimes fatal viral (e.g. adenovirus, parainfluenza, hepatitis B, progressive multifocal leukoencephalopathy (PML)), bacterial (including tuberculosis and atypical mycobacterioses, nocardiosis), protozoan (e.g. toxoplasma gondii), and fungal (e.g. rhinocerebral mucormycosis) infections, including those due to reactivation of latent infections have occurred during post-marketing surveillance.
Maltese: Infezzjonijiet serji u xi daqqiet anki fatali kkawżati minn viri (e.ż. adenovirus, parainfluwenza, epatite B, lewkoenċefalopatija multifokali mifruxa (PML)), batterja (inkluż tuberkulożi u mikobatterjosi atipika, nokardjosi), protożoa (e.ż. toxoplasma gondii) u infezzjonijiet ikkawżati minn fungu (e.ż. mukomikosi rinoċerebrali), inkluż dawk dovuti għarriattivazzjoni ta' infezzjonijiet rieqda, seħħew waqt sorvelljanza ta' wara t-tqegħid fis-suq.
English: There are no known incompatibilities with other medicinal products.
Maltese: Mhux magħruf li jeżistu inkompatibilitajiet ma' prodotti mediċinali oħrajn.
English: • The risk of opportunistic infections, in particular CMV viraemia
Maltese: • Ir-riskju ta' infezzjonijiet opportunistiċi, b'mod partikolari viremija CMV
English: Staphylococcal bacteraemia Tuberculosis Bronchopneumonia Herpes ophthalmicus Beta haemolytic streptococcal infection Candidiasis Genital candidiasis Urinary tract infection Cystitis
Maltese: Bronkopnewmonja Herpes ophthalmicus Infezzjoni emolitika beta kkawżata minn streptococcus Kandidajasi
English: HOW TO STORE MABCAMPATH
Maltese: X'fih MabCampath
English: With repeated administration and consequent plasma concentration accumulation, the rate of elimination approached zero-order kinetics.
Maltese: B'għoti ripetut u konsegwentement akkumulazzjoni fil-konċentrazzjoni tal-plażma, ir-rata ta' eliminazzjoni resqet lejn kinetika zero-order.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC04.
Maltese: Aġenti antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Gradual escalation from 10 to 30 mg
Maltese: Żjieda gradwali minn 10 sa 30 mg
English: Chlorambucil n=148
Maltese: Analiżi indipendenti tar-rata u t-tul tar-rispons Chlorambucil n=148
English: A trend toward improved ORR was observed in patients with 17p deletion treated with MabCampath (64% v 20%; p=0.0805).
Maltese: Xejra lejn ORR imtejjeb kienet osservata f'pazjenti bi tneħħija ta' 17p ikkurati b'MabCampath (64% v 20%; p0.0805).
English: (Poola/Polija/Lenkija), Tel: + 48 22 246 0900
Maltese: Polska/Eesti/Latvija/Lietuva Genzyme Polska Sp. z o.o. (Poola/Polija/Lenkija), Tel: + 48 22 246 0900
English: Cardiac arrest Myocardial infarction Angina pectoris Atrial fibrillation Arrhythmia supraventricular Sinus bradycardia Supraventricular extrasystoles
Maltese: Infart mijokardijaku Fibrillazzjoni atrijali Takikardja supraventrikulari Arritimija
English: Significant Fab binding was also observed in the male reproductive tract (epididymis, sperm, seminal
Maltese: Irbit sinifikanti ma' Fab kien osservat ukoll fl-apparat riproduttiv maskili (epididimis, sperma, bużżieqa seminali) u l-ġilda.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ir-Renju Unit
English: Resume MabCampath at 30 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl.
Maltese: Kompli MabCampath b'30 mg meta l-ANC huwa ≥ 500/μl u l-għadd ta' plejtlits huwa ≥ 50,000/μl.