FrancophonIA/ELRC3.0 huggingface dataset:
English: - Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Topotecan Actavis may reduce your ability to fight infections.
Maltese: - Infezzjonijiet (komuni ħafna, jistgħu jaffettwaw iktar minn persuna 1 waħda minn kull 10 għaxra ), b'sinjali bħal: - deni - il-kundizzjoni ġenerali tiegħek tmur lura sew - sintomi lokali bħal ġriżmejk jaħarquk jew ħruq meta tgħaddi l-awrina - uġigħ ta' żaqq qawwi, deni u possibilment dijareja (rarament bid-demm) jistgħu jkunu sinjali ta' infjammazzjoni tal-musrana (kolite newtropenika).
English: In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of Packed Red Blood Cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %) respectively.
Maltese: F'dan l-istudju, sitta u erbgħin (43 %) pazjent irċevew G-CSF fuq medda ta' 192 (42.1 %) kors; ħamsa u sittin (60 %) rċievew transfużjonijiet ta' Celluli Ħomor tad-Demm Ippakkjati u ħamsin (46 %) irċevew plejtlits fuq medda ta' 139 u 159 kors (30.5 % u 34.9 %) rispettivament.
English: In an intravenous population study, the coadministration 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 intravenuż li sar fuq pazjenti, il-ko-amministrazzjoni ta' granisetron, ondansetron, morfina jew kortikosterojdi ma jidhirx li kellha effett sinifikanti fuq il-farmakokinetika ta' topotecan totali (fil-forma attiva jew inattiva).
English: Tel: +43 (0)662 435 235 00
Maltese: Actavis GmbH Tel: +43 (0)662 435 235 00
English: The median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Maltese: Is-soppravivenza medjana kienet ta' 30.3 ġimgħat (95 % CI: 26.
English: The mean metabolite:parent AUC ratio was less than 10 % for both total topotecan and topotecan lactone.
Maltese: Il-proporzjoni AUC metabolit medjan: sustanza oriġinali kien ta' anqas minn 10 % kemm għal topotecan kif ukoll għal topotecan lactone.
English: In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Maltese: Fi provi kliniċi, ġie irrapurtat raxx f'4 % tal-pazjenti u ħakk f'1.5 % tal-pazjenti.
English: - Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Topotecan Actavis 4 mg with 4 ml water for injections
Maltese: - Topotecan Actavis 1 mg b'1.1 ml ilma għall-injezzjonijiet billi għandu 10% żejjed - Topotecan Actavis 4 mg b'4 ml ilma għall-injezzjonijiet
English: Packs:
Maltese: Pakketti:
English: Each vial contains 0.52 mg (0.0225 mmol) sodium.
Maltese: Kull fjala fiha 0.52 mg (0.
English: Metabolism accounts for < 10 % of the elimination of topotecan.
Maltese: Il-metaboliżmu jgħodd għal < 10 % tal-eliminazzjoni ta' topotecan.
English: A phase III trial (study 478) compared oral topotecan plus Best Supportive Care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan + BSC, 90 days for BSC) and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Maltese: III (studju 478) qabblet topotecan orali flimkien ma' l-Aħjar Kura ta' Appoġġ (BSC - Best Supportive Care) (n = 71) ma' BSC waħdu (n = 70) f'pazjenti li l-kanċer tagħhom reġa' feġġ wara t-terapija ewlenija (żmien medjan għall-progressjoni [TTP] mit-terapija ewlenija: 84 jum għal-terapija b'topotecan orali + BSC, 90 jum għall-BSC) u li għalihom trattament ieħor b'kimoterapija li tingħata fil-vina ma kienx ikkunsidrat xieraq.
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Maltese: Pazjenti li qabel kienu ħadu Kimoradjuterapija b'Cisplatin qabel Cisplatin
English: 5.2 mg/m in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Maltese: It-tieni studju inkluda limiti tad-doża bejn 2.0 mg/m2 u 5.2 mg/m2 fi tfal (n = 18), adoloxxenti (n = 3) u adulti żgħażagħ (n = 3) b'lewċemija.
English: Hazard ratio (95 % C.I.)
Maltese: .I) Proporzjon ta' periklu (95 % C.I.)
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Maltese: - L-ingredjenti l-oħra huma: mannitol (E421), aċdu tartariku (E334), aċdu idrokloriku (E507) u idrossidu tas-sodju.
English: - Itching (pruritus).
Maltese: Soppravivenza (xhur)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 July 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' Lulju 2009
English: A doctor or nurse will give you the reconstituted and diluted Topotecan Actavis solution as an infusion (drip), usually into your arm, over about 30 minutes.
Maltese: Tabib jew infermier itik id-doża rikostitwita u dilwita tas-soluzzjoni ta' Topotecan Actavis bħala infużjoni (dripp), isoltu ġod-driegħ, fuq medda ta' madwar 30 minuta.
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Maltese: Topotecan ġie assoċjat ma' rapporti ta' mard interstizjali tal-pulmun (ILD), li uħud minnhom kienu fatali (ara sezzjoni 4.8).
English: - Severe allergic (anaphylactic) reactions (rare; may affect up to 1 in 1,000 people), with signs such as: - swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.
Maltese: - Reazzjonijiet allerġiċi severa (Anafilattiċi) (rari; jistgħu jaffettwaw sa persuna 1 minn kull 1,000 ruħ), b'sinjali bħal: - nefħa tal-wiċċ, xofftejn, ilsien jew griżmejn, diffikultà biex tieħu nifs, pressjoni tad-demm baxxa, sturdament u raxx bil-ħakk.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 mg topotecan (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVI Kull fjala fiha 4 mg topotecan (bħala idrokloridu).
English: malaise
Maltese: Tqala
English: anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari:
English: Tfno.
Maltese: għeja
English: oC ± 2
Maltese: estravażazzjoni3
English: Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Maltese: u 24.7 ġimgħat rispettivament.
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: Metabolit N-desmethyl, li wera attività tixtiebah jew anqas minn dik tas-sustanza oriġinali fi prova bbażata fiċ-ċellula, instabet flawrina, fil-plasma u fil-ħmieġ.
English: After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Maltese: Wara r-rikostituzzjoni, 1 ml konċentrat fih 1 mg topotecan.
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67 % when compared with a control group of patients.
Maltese: It-tneħħija mill-plażma f'pazjenti li għandhom indeboliment tal-fwied (bilirubin fis-serum bejn 1.5 u 10 mg/dl) naqset għal bejn wieħed u ieħor 67 % meta ġiet imqabbla ma' dik f'pazjenti li kienu fi grupp ta' kontroll.
English: The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Maltese: L-attività ta' topotecan kontra t-tumuri tikkonsisti fl-inibizzjoni ta' topoisomerase-I, li hija enżima partikolarment involuta fir-replikazzjoni ta' DNA minħabba li tliġġem l-istrejn tat-tidwir introdott qabel il-moving replication fork.
English: In another randomised phase III trial which compared IV topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Maltese: III li qabblet topotecan li jingħata fil-vina ma' ċiklofosfamid, doxorubicin u vincristine (CAV) f'pazjenti b'SCLC sensittiv li reġa' feġġ, ir-rata totali ta' rispons kienet ta' 24.3 % għal topotecan meta mqabbla ma'18.3 % għall-grupp CAV.
English: As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Maltese: Bħal prodotti mediċinali ċitotossiċi oħra, topotecan jista' jikkawża mjelosoppressjoni severa.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Maltese: Tqabbil ta' parametri farmakokinetiċi ma ssuġġerew l-ebda tibdil fil-farmakokinetika f'perjodu ta' 5 ijiem ta' dożaġġ.
English: When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Maltese: Meta jintuża flimkien ma' cisplatin, l-informazzjoni kompleta ta' kif jiġi preskritt cisplatin għandha tiġi kkonsultata.
English: Dosage in renally impaired patients
Maltese: Pazjenti b'indeboliment renali
English: Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively.
Maltese: Inċidenza ta' għeja u astenija severa (skala 3 jew 4) kienet ta' 3 u 3 % rispettivament.
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Maltese: M'hemmx biżżejjed esperjenza dwar l-użu ta' topotecan f'pazjenti li għandhom indeboliment serju talkliewi (tneħħija tal-krejatinina < 20 ml/min) jew li jbatu minn indeboliment serju tal-fwied (bilirubin fis-serum ≥ 10 mg/dl) minħabba ċirrożi.
English: Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Maltese: L-irkupru totali ta' materjali li għandhom x'jaqsmu mal-prodott mediċinali wara l-ħames dożi ta' topotecan li ngħataw darba kuljum kien ta' 71-76 % tad-doża amministrata fil-vina.
English: Marketing Authorisation Holder Actavis Group PTC ehf.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Actavis Group PTC ehf.
English: Österreich Actavis GmbH
Maltese: България Актавис ЕАД
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Maltese: Ilmjelosoppressjoni twassal għas-sepsis u mwiet dovuti għas-sepsis ġew irrappurtati f'pazjenti trattati b'topotecan (ara sezzjoni 4.8).
English: - Feeling sick (nausea), vomiting; diarrhoea; stomach pain; constipation.
Maltese: • Tħoss dardir (nawsja); rimettar; dijarea; uġigħ fl-istonku; stitikezza
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mg topotecan (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull fjala fiha 1 mg topotecan (bħala idrokloridu)
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Maltese: Rapporti ta' konsegwenzi sinifikanti assoċjati ma' tromboċitopenja inkluż fatalitajiet minħabba fsada tat-tumuri ma kienux frekwenti.
English: sepsis Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) Blood and lymphatic system disorders Very common:
Maltese: 1Fatalitajiet dovuti għal sepsis ġew irrapportati f'pazjenti kkurati b'topotecan (ara sezzjoni 4.4) Disturbi tad-demm u tas-sistema limfatika Komuni ħafna:
English: Common side effects (may affect up to 1 in 10 people) - Allergic (hypersensitivity) reactions (including rash).
Maltese: • Reazzjonijiet allerġiċi (sensittività eċċessiva) (inkluż raxx)
English: 11 Ion Mihalache Blvd Bucharest
Maltese: Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd 011171 Bucharest Ir-Rumanija
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 ttrattati fi studji kliniċi (inklużi kemm dawk b'newtropenija severa kif ukoll dawk li ma żviluppawx newtropenija severa), 11 % (4 % tal-korsijiet) kellhom d-deni u 26 % (9 % tal-korsijiet) qabdithom infezzjoni.
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/m 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-vini fl-ammont ta' 1.5 mg/m2 għal ħamest ijiem kull tliet ġimgħat.
English: 1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
Maltese: 1 ml of 1 mg/ml soluzzjoni topotecan
English: Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fjala Tip I tal-ħġieġ bla kulur (5 ml), tapp brombutiliku griż u siġill tal-aluminju b'għatu tal-plastik li jitfaqqa' li fiha 1 mg topotecan.
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated cisplatin use.
Maltese: L-informazzjoni ta' kif għandu jiġi preskritt cisplatin għandha tiġi kkonsultata għall-lista kompleta ta' reazzjonijiet avversi assoċjati mal-użu ta' cisplatin.
English: Other side effects with Topotecan Actavis include:
Maltese: Effetti sekondarji oħra b'Topotecan Actavis jinkludu:
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħin tal-prodott mediċinali rikostitwit u dilwit, ara s-sezzjoni 6.3. 6.5
English: Topotecan Actavis 1 mg powder for concentrate for solution for infusion Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Maltese: Topotecan Actavis 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Topotecan Actavis 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan
English: Each vial contains 1 mg or 4 mg topotecan (as hydrochloride).
Maltese: Kull fjala fiha 1 mg jew 4 mg ta' topotecan (bħala idrokloridu).
English: Metabolism and nutrition disorders Very common:
Maltese: Disturbi tal-metaboliżmu u n-nutrizzjoni Komuni ħafna:
English: One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Maltese: Prova waħda tal-Fażi II (studju 065) u studju wieħed tal-Fażi III (studju 396) tmexxew sabiex tiġi evalwata l-effikaċja ta' topotecan orali kontra topotecan li jittiehed ġol-vina f'pazjenti li kienu rkadew ≥ 90 jum wara li lestew kors ta' kimoterapija (ara Tabella 1).
English: Platelet transfusions were given in 4 % of courses.
Maltese: Trasfużjonijiet ta' plejtlits ingħataw f'4 % tal-korsijiet.
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Maltese: Dożi eċċessivi ġew irrappurtati f'pazjenti li qegħdin jiġu kkurati b'topotecan ġol-vina (sa 10 darbiet tad-doża rakkomandata) u kapsuli topotecan (sa 5 darbiet tad-doża rakkomandata).
English: The physico-chemical stability of the drug product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25
Maltese: L-istabbiltà fiżiko-kimiċi tas-soluzzjoni tal-prodott mediċinali miksuba wara d-dilwizzjoni filsoluzzjonijiet għall-infużjoni (NaCl 0.9% u Glucose 5%) intweriet għall-4 sigħat f'temperatura ambjentali, f'kundizzjonijiet ta' dawl normali, fuq kampjuni rikostitwit u maħżuna għal 12-il siegħa u rispettivament 24 siegħa f'temperatura ta '25oC ± 2oC u wara dilwit.
English: The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
Maltese: Ilkonċentrati ttestjati nħażnu f'temperatura ta' 25 ± 2°C għal 12-il siegħa and 24 siegħa rispettivament wara r-rikostituzzjoni, u mbagħad dilwiti.
English: Subsequent doses
Maltese: Dożi sussegwenti
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Maltese: Wara li topotecan ingħata ġol-vina f'dożi ta' 0.5 sa 1.5 mg/m2 bħala infużjoni ta' 30 minuta kuljum għal ħamest ijiem, topotecan wera tneħħija għolja fil-plażma ta' 62 l/h (SD 22), li tikkorrispondi għal bejn wieħed u ieħor 2/3 taċ-ċirkolazjoni tad-demm fil-fwied.
English: How to store Topotecan Actavis Contents of the pack and other information
Maltese: Kif taħżen Topotecan Actavis Kontenut tal-pakkett u informazzjoni oħra
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 astenija f'bejn wieħed u ieħor 16 % tal-pazjenti waqt li kienu qed jieħdu topotecan.
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Maltese: L-istabilità kimika u fiżika tas-soluzzjoni miksuba wara d-dilwizzjoni tal-konċentrat f' soluzzjoni ta' klorur tas-sodju 9 mg/ml (0.9 %) għall-injezzjoni jew 50 mg/ml (5 %) soluzzjoni ta' glukożju għallinfużjoni ntweriet għal 4 sigħat b'temperatura ta' 25 ± 2°C, f'kundizzjonijiet ta' dawl normali.
English: How to store Topotecan Actavis
Maltese: X'fih Topotecan Actavis
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/536/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/536/002
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Maltese: newtropenija bid-deni newtropenija (ara disturbi gastrointestinali taħt)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
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: Il-prassi onkoloġika standard għall-ġestjoni tan-newtropenija hija li jew jiġi amministrat topotecan flimkien ma' prodotti mediċinali oħra (eż. G-CSF) jew inkella titnaqqas id-doża sabiex jinżamm lgħadd tan-newtrofili.
English: Excipient with known effect:
Maltese: Effetti sekondarji serji:
English: If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Maltese: Jekk jingħataw cisplatin jew carboplatin lill-pazjent fil-jum 1 tad-dożaġġ ta' topotecan, trid tingħata doża iktar baxxa ta' kull aġent, biex tkun tista' titjieb it-tollerabilità mqabbla mad-doża ta' kull aġent jekk laġent tal-platinu jingħata fil-jum 5 tad-dożaġġ tat-topotecan.
English: What Topotecan Actavis contains - The active substance is topotecan.
Maltese: - Is-sustanza attiva hija topotecan.
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 taċ-ċelluli ż-żgħar tal-pulmun u li għandhom tneħħija talkrejatinina ta' bejn l-20 u d-39 ml/min hija ta' 0.75 mg/m2/jum għal ħamest ijiem konsekuttivi.
English: pancytopenia
Maltese: • Infezzjonijiet
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: Reazzjonijiet avversi huma elenkati hawn taħt, ikklassifikati skond is-sistema tal-ġisem u l-frekwenza assoluta (l-effetti kollha rappuratati).
English: - Infections.
Maltese: Anemija:
English: 18.3, 31.6) compared to 13.9 weeks (95 % C.I.
Maltese: 9 ġimgħat (95 % C.I. 18.3, 31.6) meta mqabbel ma'13.9 ġimgħat (95 % C.I. 11.1, 18.6) għall-pazjenti li rċevew BSC waħdu (p = 0.0104).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull fjala, jiġifieri essenzjalment 'ħieles mis-sodju'.
English: Hepatobiliary disorders Common:
Maltese: Tromboċitopenija:
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Maltese: Newtropenija severa damet iktar minn sebat ijiem fi 11 % tat-total tal-korsijiet.
English: After reconstitution 1 ml concentrate contains 1 mg topotecan.
Maltese: Wara r-rikostituzzjoni kull 1 ml konċentrat fih 1 mg topotecan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/536/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/536/001
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 jeħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament biż-żewġ mediċini flimkien (ara sezzjoni 5.1).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-ħinijiet tal-ħażna u l-kondizzjonijiet qabel l-użu huma r-responsabbiltà tal-utent u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C sa 8° C, sakemm ir-rikostituzzjoni/dilwizzjoni ma tkunx saret f'kondizzjonijiet asettiċi ikkontrollati u validati.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħrajn ta' interazzjoni
English: The observed signs and symptoms for overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Maltese: Is-sinjali osservati u sintomi għal doża eċċessiva kienu konsistenti mal-avvenimenti mhux mixtieqa magħrufa assoċjati ma topotecan (ara sezzjoni 4.8).
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Maltese: Il-volum approprjat tat-taħlita rikostitwita jrid jerġa' jiġi dilwit ma' soluzzjoni ta' 9 mg/ml (0.9 %) klorur tas-sodju għallinjezzjoni jew inkella ma' 50 mg/ml (5 %) glukożju għall-infużjoni ġol-vina, sabiex ikun hemm konċentrazzjoni finali ta' bejn 25 u 50 mikrogramma/ml.
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Maltese: Bejn wieħed u ieħor 51 % tneħħa bħala topotecan totali u 3 % tneħħa bħala N-desmethyl topotecan fl-awrina. Leliminazzjoni mal-ħmieġ ta' topotecan totali kienet ta' 18 % filwaqt li l-eliminazzjoni mal-ħmieġ ta' N-desmethyl topotecan kienet ta' 1.7 %.