FrancophonIA/ELRC3.0 huggingface dataset:
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Maltese: Rapporti ta' konsegwenzi sinifikani assoċjati ma' tromboċitopenja inkluż fatalitajiet minħabba fsada tat-tumuri ma kienux frekwenti.
English: A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m2 for five days every three weeks.
Maltese: Numru żgħir ta' pazjenti b'indeboliment tal-fwied (bilirubin fis-serum bejn 1.5 u 10 mg/dl) ingħataw topotecan ġol-vina b'doża ta' 1.5 mg/m2 għal ħamest ijiem kull tlett ġimgħat.
English: - fever - sudden decline of your general health - sore throat or burning sensation when passing water - severe stomach pain, fever and possibly diarrhoea (rarely with blood in it) - these can be signs of bowel inflammation (neutropenic colitis).
Maltese: - deni - deterjorament f'daqqa tas-saħħa ġenerali tiegħek - uġigħ fil-griżmejn jew sensazzjoni ta' ħruq meta tgħaddi l-ilma - uġigħ sever fl-istonku, deni u possibbilment dijarea (rarament bid-demm fiha) - dawn jistgħu jkunu sinjali ta' infjammazzjoni tal-musrana (kolite newtropenika).
English: Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively.
Maltese: Inċidenza ta' għeja u astenja serja (skala 3 jew 4) kienet ta' 3 % u 3 % rispettivament.
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 14 days at 20°C - 25°C.
Maltese: Minn perspettiva mikrobijoloġika, ladarba jkun infetaħ, il-prodott jista' jinħażen għal massimu ta' 14il ġurnata f'temperatura ta' 20°C - 25°C.
English: Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Maltese: Serja (numru ta' newtrofili < 0.5 x 109/l) wara l-ewwel kors instabet f'55 % tal-pazjenti li damet  sebat ijiem f'20 % u b'kollox f'77 % tal-pazjenti (39 % tal-korsijiet).
English: It is important that Topotecan Eagle is further diluted before use (see section 6.6).
Maltese: Huwa importanti li Topotecan Eagle jiġi dilwit ulterjorment qabel l-użu (ara sezzjoni 6.6).
English: In an intravenous population study, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Maltese: Fi studju li sar fuq pazjenti li rċievew il-mediċina ġol-vina, il-ko-amministrazzjoni ta' granisetron, ondansetron, morphine jew kortikosterojdi ma jidhirx li kellhom effetti sinifikant fuq il-farmakokinetika ta' topotecan totali (filforma attiva jew inattiva).
English: Cervical Carcinoma
Maltese: Karċinoma ċervikali
English: Multidose vial: once opened, store for a maximum of 14 days at 20°C-25°C.
Maltese: Fjala b'bosta dożi: ladarba tkun infetħet, aħżen għal massimu ta' 14-il ġurnata f'temperatura ta' bejn 20°C-25°C.
English: The concentration of topotecan is higher (3 mg/ml) than with other topotecan products.
Maltese: Il-konċentrazzjoni ta' topotecan hija ogħla (3 mg/ml) milli bi prodotti oħra ta' topotecan.
English: For reduced dose '1.25 mg/m2'
Maltese: Għal doża mnaqqsa '1.25 mg/m2'
English: Log rank p-value
Maltese: GĦALL-ĦRUĠ TAL-LOTT
English: Volume of solution required (ml)
Maltese: Volum ta' soluzzjoni meħtieġ (ml)
English: 11.1, 18.6) for patients receiving BSC alone (p = 0.0104).
Maltese: (Log-rank p=0.0104).
English: - The other ingredients are: hydrochloric acid (E507) (for pH adjustment) and water for injections.
Maltese: • Is-sustanzi l-oħra huma: hydrochloric acid (E507) (għall-aġġustament tal-pH) u ilma għall injezzjonijiet.
English: Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
Maltese: Topotecan Eagle 3 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni topotecan
English: The experience in children is limited, therefore no recommendation for treatment of paediatric patients with topotecan can be given (see sections 5.1 and 5.2).
Maltese: L-esperjenza fit-tfal hija limitata u għalhekk ma tista' tingħata l-ebda rakkommandazzjoni għattrattment ta' pazjenti pedjatriċi b'topotecan (ara sezzjonijiet 5.1 u 5.2).
English: This is because you are more likely to get severe lung problems (interstitial lung disease) when using Topotecan Eagle;
Maltese: Dan għaliex hemm mil-probabbiltà li jkollok problemi serji fil-pulmun (mard interstizjali tal-pulmun) meta tuża Topotecan Eagle;
English: Rare - severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness) - sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema) - itchy rash (or hives).
Maltese: - reazzjonijiet allerġiċi severi (anafilattiċi) li jikkawżaw nefħa tax-xuftejn, tal-wiċċ jew talgħonq li jwasslu għal diffikulta serja biex tieħu n-nifs, raxx jew urtikarja tal-ġilda, xokk anafilattiku (tnaqqis sever fil-pressjoni tad-demm, issir pallidu, aġitazzjoni, polz dgħajjef,
English: Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
Maltese: U MNEJN JINGĦATA Topotecan Eagle 15 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni Topotecan
English: Topotecan Eagle 3 mg/1 ml is for single use only.
Maltese: Topotecan Eagle 3 mg/1 ml huwa għall-użu ta' darba biss.
English: Common - mild allergic reactions (including rash) - yellow skin (jaundice) caused by liver problems - itching (pruritus)
Maltese: Komuni - reazzjonijiet allerġiċi ħfief (inkluż raxx) - ġilda safra (suffejra) ikkawżata minn problemi fil-fwied - ħakk (prurite) - infezzjoni severa (sepsis) - tħossok ma tiflaħx (telqa).
English: How Topotecan Eagle is prepared
Maltese: X'fih Topotecan Eagle
English: Very common: febrile neutropenia, neutropenia (see Gastrointestinal disorders),
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni ħafna: newtropenja bid-deni, newtropenja (ara Disturbi gastro-intestinali),
English: What Topotecan Eagle contains - The active substance is topotecan.
Maltese: • Is-sustanza attiva hija topotecan.
English: - Topotecan Eagle is supplied in cartons containing 1 vial.
Maltese: • Topotecan Eagle jiġi fornut f'pakketti li fihom fjala waħda.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Maltese: Il-volum ta' distribuzzjoni naqas ftit u b'hekk il-half-life żdiedet biss b'14 %.
English: In this leaflet:
Maltese: Manifattur:
English: EXP Read the leaflet for the shelf life of the diluted product.
Maltese: JIS Aqra l-fuljett għall-perjodu ta' shelf life tal-prodott dilwit.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients whilst receiving topotecan.
Maltese: Għeja kienet irrappurtata bejn wieħed u ieħor f'25 % tal-pazjenti u astenja f'bejn wieħed u ieħor 16 % tal-pazjenti waqt li kienu qed jieħdu topotecan.
English: For storage conditions of once-opened and diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali li jkun infetaħ u ġie dilwit, ara sezzjoni 6.3.
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
Maltese: IL-PRODOTT MEDIĊINALI Topotecan Eagle 15 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Maltese: Studji pre-klinikali juru li r-rabta ta' topotecan ma' proteini tal-plażma huwa baxx (35 %) u distribuzjoni bejn ċelluli tad-demm u plażma kienet pjuttost omoġeni.
English: 18.3, 31.6) compared to 13.9 weeks (95 % C.I.
Maltese: 9 ġimgħa (95 % C.I. 18.3, 31.6) meta mqabbla ma'13.9 ġimgħa (95 % C.I. 11.1,18.6) għall-pazjenti li rċievew BSC waħdu (p=0.0104).
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Maltese: Topotecan m'għandux jerġa' jiġi amministrat ħlief jekk l-għadd tan-newtrofili jkun  1.5 x 109/l, lgħadd ta' plejtlits ikun  100 x 109/l, u l-livell tal-emoglobina jkun  9 g/dl (wara trasfużjoni, jekk ikun hemm bżonn).
English: Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT United Kingdom Tel: +1 (201) 326-5324 Fax: +1 (201) 391-2430
Maltese: Fax: +1 (201) 391-2430
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Maltese: Flimkien ma' newtropenja qawwija, kien hemm inċidenza ta' deni jew infezzjoni f'16% tal-pazjenti waqt l-ewwel kors u b'kollox f'23 % tal-pazjenti (6 % tal-korsijiet).
English: BATCH NUMBER Batch
Maltese: AKTAR TAGĦRIF
English: One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
Maltese: U KWANTITATTIVA ml wieħed ta' konċentrat għal soluzzjoni għall-infużjoni fih 3 mg topotecan (bħala hydrochloride).
English: Patients with prior Cisplatin chemoradiotherapy
Maltese: KUNDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI
English: Among all patients treated in clinical trials (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Maltese: Fost il-pazjenti kollha li kienu kkurati fi studji kliniċi (inklużi kemm dawk b'newtropenja qawwija kif ukoll dawk li ma żviluppawx newtropenja qawwija), 11 % (4 % tal-korsijiet) kellhom d-deni u 26 % (9 % tal-korsijiet) qabdithom infezzjoni.
English: For reduced dose '1.0 mg/m2'
Maltese: Għal doża mnaqqsa '1.0 mg/m
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Maltese: Jekk it-tnaqqis fid-doża jiġi magħżul għal pazjenti li jġarrbu newtropenja qawwija (l-għadd tannewtrofils < 0.5 x 109/l) għal sebat ijiem jew aktar, jew newtropenja qawwija assoċċjata ma' deni jew infezzjoni jew li t-trattament kien ittardjat minħabba newtropenja, id-doża għandha titnaqqsilhom b'20 % għal 0.60 mg/m2 /ġurnata għall-korsijiet sussegwenti (jew sussegwement titnaqqas għal 0.45mg/m2/jum jekk ikun hemm bżonn).
English: - One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
Maltese: • ml wieħed ta' konċentrat għal soluzzjoni għall-infużjoni fih 3 mg topotecan (bħala hydrochloride).
English: Infections and infestations Very common: infection Common: sepsis2
Maltese: tromboċitopenja, anemija, lewkopenja Komuni: panċitopenija
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Maltese: Topotecan m'għandux jerġa' jiġi amministrat ħlief jekk l-għadd tan-newtrofili jkun  1 x 109/l, lgħadd ta' plejtlits ikun  100 x 109/l, u l-livell tal-emoglobina jkun  9 g/dl (wara trasfużjoni, jekk ikun hemm bżonn).
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Maltese: Pazjenti li qabel kellhom esponiment għal cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament biż-żewġ mediċini flimkien (ara sezzjoni 5.1).
English: In an open-label trial involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m2 given as a
Maltese: Fi prova open-label li kienet tinvolvi t-tfal (n=108, varjazzoni fl-età: trabi sa 16-il sena) b'tumuri li reġgħu feġġew jew kienu solidi progressivi, topotecan inbeda f'doża ta' 2.0 mg/m2 mogħtija bħala infużjoni ta' 30 minuta għal ħamest ijiem ripetuta kull tliet ġimgħat sa sena skont ir-rispons għatterapija.
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Maltese: Newtropenja qawwija damet iktar minn sebat ijiem fi 11 % tat-total tal-korsijiet.
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
Maltese: IL-PRODOTT MEDIĊINALI Topotecan Eagle 3 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni.
English: As expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Maltese: Kif inhu mistenni, pazjenti li għandhom stat ta' saħħa ħażina (PS > 1) għandhom rata ta' rispons aktar baxxa u inċidenza ogħla ta' kumplikazzjonijiet bħal-deni, infezzjoni u sepsis (ara sezzjoni 4.8).
English: The recommended monotherapy dose of topotecan in patients with small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Maltese: Id-doża ta' topotecan rakkomandata f' monoterapija f'pazjenti b'karċinoma tal-ovarji jew taċ-ċelluli ż-żgħar tal-pulmun u li għandhom tneħħija tal-krejatinina ta' bejn l-20 u d-39 ml/min hija ta' 0.75 mg/m2 /ġurnata għal ħamest ijiem konsekuttivi.
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Maltese: Sustanza iffurmata mill-metaboliżmu ta' N-desmethyl, li ntweriet li kellha attività tixtiebaħ jew anqas minn dik tas-sustanza oriġinali f'assay ibbażat fiċ-ċellula, instabet fl-awrina, fil-plasma u fil-ħmieġ.
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Maltese: Topotecan jinibixxi topoisomerase-I billi jistabiliżża lill-kumpless kovalenti talenżima u lid- DNA maqsum bl-istrand li huwa l-proċess intermedjarju tal-mekaniżmu katalitiku.
English: Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.
Maltese: Aktar ġrajjiet avversi intwerew meta topotecan ingħata flimkien ma' cisplatin, madanakollu, dawn ilġrajjiet intwerew b'monoterapija b'cisplatin u mhumiex attribwiti għal topotecan.
English: For reduced dose '0.60 mg/m
Maltese: Għal doża mnaqqsa '0.60 mg/m
English: The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Maltese: Ir-rata ta' rispons għal topotecan fil-programm ikkombinat tal-kanċer taċ-ċelluli ż-żgħar tal-pulmun (n=480) għall-pazjenti fejn reġgħet feġġet il-marda li kienet sensittiva għat-terapija ewlenija, kien ta' 20.2 %.
English: In this case, it is used with another medicine called cisplatin.
Maltese: F'dan il-każ, jintuża ma' mediċina oħra jisimha cisplatin.
English: - Do not breast-feed while using Topotecan Eagle.
Maltese: • Treddax waqt li qiegħda tuża Topotecan Eagle.
English: Read the leaflet for the shelf life of the diluted product.
Maltese: Aqra l-fuljett għall-perjodu ta' shelf life tal-prodott dilwit.
English: 5 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with yellow polypropylene flip-off cap, and with yellow vial ring collar.
Maltese: Konċentrat ta' 5 ml li jiġi ġo fjal tal-ħġieg ċar tat-tip 1, flimkien ma' tapp griż tal-gomma butyl u siġill tal-aluminium b'tapp tal-plastik tal-polypropylene li jinfetaħ b'daqqa ta saba', u b'kullar cirkolari talfjal ta' kulur isfar.
English: The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
Maltese: Il-profil tal-effetti avversi għal topotecan meta jingħata flimkien ma' cisplatin fi provi kliniċi talkanċer taċ-ċerviċi huwa konsistenti ma' dak li ntwera b'monoterapija ta' topotecan.
English: 2 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4)
Maltese: 2 Mwiet minħabba sepsis kienu rrappurtati f'pazjenti kkurati b'topotecan (ara sezzjoni 4
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m2/day to 1.25 mg/m2/day (or subsequently down to 1.0 mg/m2/day if necessary).
Maltese: Jekk it-tnaqqis fid-doża jiġi magħżul għal pazjenti li jġarrbu newtropenja qawwija (l-għadd ta' newtrofili < 0.5 x 109/l) għal sebat ijiem jew iktar, jew newtropenja qawwija bid-deni jew infezzjoni, jew li kellhom il-kura sospiża minħabba newtropenja, id-doża għandha titnaqqas b'0.25 mg/m2/jum għal 1.25 mg/m2/ġurnata (jew sussegwentement imnaqqsa għal 1.0 mg/m2/ġurnata jekk ikun hemm bżonn).
English: Diluted solution
Maltese: Tqala u treddigħ
English: The experience of using Topotecan Eagle in children is limited.
Maltese: L-esperjenza tal-użu ta' Topotecan Eagle fit-tfal hija limitata.
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Maltese: Suppressjoni tal-mudullun tal-għadam li twassal għal-sepsis u mewt minħabba sepsis ġew irrappurtati f'pazjenti trattati b'topotecan (ara sezzjoni 4.8).
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Maltese: Id-doża rakkommandata ta' topotecan hija ta' 0.75 mg/m2/ġurnata amministrata bħala infużjoni ġolvina għal 30 minuta kuljum fil-ġranet 1, 2 u 3. Cisplatin huwa amministrat bħala infużjoni ġol-vina filġurnata 1 f'doża ta' 50 mg/m2/ġurnata u wara tingħata d-doża ta' topotecan.
English: In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
Maltese: Fl-istudji kliniċi li saru, topotecan ma baqax jingħata jekk d-doża tnaqqset għal 1.0 mg/m2 u kien hemm il-bżonn ta' aktar tnaqqis fid-doża biex jiġu ikkontrollati l-effetti avversi.
English: For cervical cancer Topotecan Eagle will be used with another medicine called cisplatin.
Maltese: Fil-każ ta' kanċer taċ-ċerviċi Topotecan Eagle sejjer jintuża ma' mediċina oħra msejħa cisplatin.
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Maltese: F'dawn listudji, ma' kienu jidhru l-ebda differenzi fil-farmakokinetika ta' topotecan fost il-pazjenti tfal, adoloxxenti u adulti ż-żgħar b'tumuri solidi jew lewkimja, iżda t-tagħrif huwa limitat wisq biex tasal għall-konklużjonijiet definiti.
English: Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients.
Maltese: Tneħħija fil-plażma ta' topotecan kollu (fil forma attiva u inattiva) f'pazjenti li għandhom indeboliment tal-fwied biss naqset b'xi 10 % meta ġiet imqabbla ma' dik fil-pazjenti li kienu fi grupp ta' kontroll.
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Maltese: It-tneħħija ta' topotecan sseħħet l-aktar permezz tal-idroliżi tal-lactone ring biex jifforma r-ring-opened carboxylate.
English: Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
Maltese: Fi prova klinika randomised u kumparattiva tal-fażi
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to dose reduce to maintain neutrophil counts.
Maltese: Għandhom jiġu adottati l-proċeduri normali għal maniġġar u rimi ta' prodotti mediċinali ta' kontra ttumuri: o Il-ħaddiema jridu jiġu mħarrġa kif jippreparaw il-prodott mediċinali.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jwettaq l-attivitajiet ta' farmakoviġilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deċiż fis=Sistema talImmaniġġar tar-Riskju(RMP) inkluż f' Modulu 1.8.2 tal- awtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti tas-Sistema tal-Immaniġġar tar-Riskju kif deċiż mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
English: Cervical cancer - The usual dose is 0.75 mg of the medicine for each square meter of your body.
Maltese: Kanċer taċ-ċerviċi - Id-doża tas-soltu hija ta' 0.75 mg tal-mediċina għal kull metru kwadru tal-ġisem tiegħek.
English: • The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Maltese: • Ir-riskju ta' infezzjonijiet, li jinkludu infezzjonijiet opportuniċtiċi, u l-kontraindikazzjoni għal użu f'pazjenti li huma kompromessi immunoloġikament.
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Repso with a physician educational pack containing the following:
Maltese: L-Istati Membri għandhom jiżguraw li d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jipprovdi t-tobba li mistennija jippreskrivu/jużaw Repso bil-pakkett edukazzjonali għat-tobba li jkun fih dan li ġej:
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Maltese: It-tobba u l-pazjenti għandhom ikunu konxji li hemm servizz tal-pariri ad hoc li jipprovdi tagħrif dwar it-testijiet tal-laboratorju fuq il-livell ta' leflunomide
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Maltese: L-informazzjoni pprovduta fil-Fuljett tat-Tabib għandu jipprovdi tagħrif dwar tnaqqis fid-doża, waqfien u proċeduri ta' tneħħija f'każ ta' ALT mgħolli..
English: • inactivated polioviruses;
Maltese: • poljovirusijiet inattivati;
English: The full EPAR for Infanrix hexa 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: Other information about Infanrix hexa:
Maltese: Informazzjoni oħra dwar Infanrix hexa:
English: • parts of the hepatitis B virus;
Maltese: • partijiet mill-virus tal-epatite B;
English: • polysaccharides (sugars) from Haemophilus influenzae type b.
Maltese: • polisakkaridi (zokkor) mill-Haemophilus influenzae tip b.
English: Infanrix hexa diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Maltese: Infanrix hexa difterite (D), tetnu (T), pertussis (aċellolari, komponent) (PA), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV) u Haemophilus influenzae tip b (Hib) vaċċin konjugat (assorbit)
English: Subsequent injections should be given in different areas.
Maltese: Injezzjonijiet sussegwenti għandhom jingħataw f'postijiet differenti.