FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Maltese: Pankreatite (anki kronika)*, Ematemesi, Nefħa taxxufftejn*, Ostruzzjoni gastrointestinali (inkluż imblukkar talmusrana ż-żgħira, ileus)*, Dwejjaq addominali, Ulċerazzjoni orali*, Enterite*, Gastrite*, Emorraġija ġinġivali, Mard ta' rifluss gastroesofaġeali*, Kolite (li tinkludi clostridium difficile)*, Kolite iskemika#,Infjammazzjoni gastrointestinali*, Disfaġija, Sindrome ta' imsaren irritabbli, Disturb gastrointestinali
English: In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Maltese: F'pazjenti b'ALL taċ-ċelluli B li rkadew fi żmien 18-il xahar mid-dijanjosi (n = 27) ir-rata ta' CR kienet 67% (95% CI: 46, 84); ir-rata ta' sopravivenza ta' 4 xhur mingħajr avvenimenti kienet 44% (95% CI: 26, 62).
English: Bortezomib is a cytotoxic agent.
Maltese: Bortezomib hu sustanza ċitotossika.
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Maltese: Tneħħijiet totali medji mill-ġisem kienu 102 u 112 l/siegħa wara lewwel doża għad-dożi ta' 1.0 mg/m2 u 1.3 mg/m2, rispettivament, u fuq medda minn 15 sa 32 l/siegħa u 18 sa 32 l/siegħa għad-dożi sussegwenti ta' 1.0 mg/m2 u 1.3 mg/m2, rispettivament.
English: Patients in the BzmbDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m2 administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
Maltese: Pazjenti fil-grupp ta' BzmbDx irċivew 4 ċikli ta' 21 jum, kull wieħed minnhom jikkonsisti minn bortezomib (1.3 mg/m2 mogħti ġol-vini darbtejn kuljum f'jiem 1, 4. 8 u 11) u dexamethasone orali (40 mg/jum f'jiem 1 sa 4 u f'jiem 9 sa 12, f'Ċikli 1 u 2, u f'jiem 1 sa 4 f'Ċikli 3 u 4).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX32.
Maltese: Sustanzi antineoplastiċi, sustanzi antineoplastiċi oħra, Kodiċi ATC:
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Maltese: Thalidomide huwa sustanza teratoġenika attiva umana magħrufa li jikkaġuna difetti severi li jistgħu jkunu ta' theddida għall-ħajja.
English: Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Maltese: Wara li ngħataw dożi f'daqqa ġol-vini ta' 1.0 mg/m2 u 1.3 mg/m2 lil 11-il pazjent b'majeloma multipla u b'valuri ta' tneħħija tal-kreatinina ikbar minn 50 ml/min, il-medja ta' konċentrazzjonijiet massimi ta' bortezomib fil-plażma wara l-ewwel doża kienu ta' 57 u 112 ng/ml, rispettivament.
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Maltese: Informazzjoni ristretta disponibbli dwar it-trattament mill-ġdid b'bortezomib f'majeloma multipla li rkadiet.
English: Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Maltese: 4% talpazjenti esposti għal bortezomib kienu fil-medda ta' età bejn 65-74 sena u ≥ 75 sena, rispettivament.
English: Pulmonary disorders
Maltese: Disturbi fil-pulmun
English: 10 ml Type 1 tubular colourless glass vial with a grey bromobutyl rubber stopper, sealed with a light green flip off aluminium seal containing 3.5 mg bortezomib.
Maltese: Kunjett tal-ħġieġ ta' 10 ml ta' Tip 1, tubulari u bla kulur, b'tapp tal-lastku griż tal-bromobutyl, issiġillat b'siġill flip off tal-aluminju ta' lewn aħdar ċar, li fih 3.5 mg ta' bortezomib.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Maltese: Newropatija periferali ta' Grad ≥ 3 seħħ f'6% tal-pazjenti fil-grupp li ngħata t-trattament taħt il-ġilda meta mqabbel ma' 16% fil-grupp li ngħata t-trattament ġol-vini (p=0.0264).
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Maltese: Il-kinetika talinibizzjoni tal-proteasome ġiet evalwata in vitro, u bortezomib intwera li jiddissoċja mill-proteasome b't1/2 ta' 20 minuta, u b'hekk wera li l-inibizzjoni tal-proteasome minn bortezomib hija riversibbli.
English: The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Maltese: Għandha tingħata kunsiderazzjoni tal-proporzjon tal-benefiċċju/riskju qabel ma titkompla t-terapija b'bortezomib.
English: Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Sun Pharmaceutical Industries Europe B.V.
English: The concentration of the resulting solution will be 1 mg/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni li tinkiseb se tkun ta' 1 mg/ml.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)#, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Maltese: Koagulazzjoni intravaskulari mifruxa, Tromboċitożi*, Sindrome ta' Iperviskożità, Disturb fil-plejtlits NOS, Mikroanġiopatija trombotika (inkl purpura tromboċitopenika)#, Disturb tad-demm NOS, Dijatesi emorraġika, Infiltrazzjoni limfoċitika
English: Overall response (CR+CRu+PR)h n(%)
Maltese: Rispons totali (CR+CRu+PR)h n(%) 211 (92.1%)
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Maltese: Inċidenza ta' newropatija periferali fl-istudju LYM-3002 skont it-tossiċità u l-waqfien tattrattament minħabba newropatija periferali
English: Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
Maltese: Fibrillazzjoni kardijaka (inkluż tal-atriju), Arritmija*, Insuffiċjenza kardijaka (inkluż ventrikulari tax-xellug u tal-lemin)*, Iskemija mijokardijaka, Funzjoni ħażina talventrikulu*
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Maltese: It-trattament b'bortezomib b'mod komuni ħafna jiġi assoċjat ma' tossiċitajiet ematoloġiċi (tromboċitopenija, newtropenija u anemija).
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Maltese: Emboliżmu periferali, Limfoedema, Sfurija, Eritromelalġija, Twessigħ tal-vini/arterji tad-demm, Tibdil fil-kulur tal-vini, Insuffiċjenza fil-vini
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP).
Maltese: Infezzjoni b'HBV b'riżultati fatali seħħet f'0.8% (n=2) tal-pazjenti fil-grupp li ma kienx ittrattat b'bortezomib (rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone;
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Maltese: III, open-label, fejn il-pazjenti ntgħażlu b'mod każwali, li qabbel l-effikaċja u s-sigurtà tal-kombinazzjoni ta' bortezomib, rituximab, cyclophosphamide, doxorubicin, u prednisone (BzmbR-CAP; n=243) ma' dik ta' rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone (R-CHOP; n=244) f'pazjenti adulti b'MCL (Stadju II, III jew IV) li qatt ma kienu ttrattati qabel.
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Maltese: Insuffiċjenza epatika, Epatomegalija, Sindrome ta' BuddChiari, Epatite minħabba citomegalovirus, Emorraġija epatika, Kolelitijasi
English: Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Maltese: Sintomi ta' nawsja u rimettar*, Dijarea*, Stomatite*, Stitikezza
English: Other medicines and Bortezomib SUN
Maltese: Mediċini oħra u Bortezomib SUN
English: Complete response (CR) was evaluated at the end of Block 1.
Maltese: Rispons sħiħ (CR) ġie vvalutat fl-aħħar ta' Blokk 1.
English: - If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib SUN dosing day (other than day 1)
Maltese: - Jekk l-għadd tal-plejtlits ikun ≤ 30 109/l jew l-ANC ikun ≤ 0.75 x 109/l fil-jum meta jkun jmiss doża ta' Bortezomib SUN (sakemm ma jkunx l-1 jum)
English: When Bortezomib SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Maltese: Meta Bortezomib SUN jingħata flimkien ma' thalidomide, trid issegwi l-programm ta' prevenzjoni għal thalidomide (ara l-fuljett ta' tagħrif talprodotti għal thalidomide).
English: Phase III
Maltese: ANNESS III
English: The safety and efficacy of bortezomib in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' bortezomib fit-tfal li għadhom m'għalqux 18-il sena għadhom ma ġewx determinati s'issa (ara sezzjonijiet 5.1 u 5.2).
English: Discontinue Bortezomib SUN
Maltese: trattament b'Bortezomib SUN.
English: Dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib SUN 21-day treatment cycle.
Maltese: Dexamethasone jingħata millħalq f'doża ta' 20 mg f'jiem 1, 2, 4, 5, 8, 9, 11, u 12 taċ-ċiklu ta' trattament ta' Bortezomib SUN ta' 21 jum.
English: Common Renal impairment*
Maltese: Indeboliment tal-kliewi*
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Maltese: III li fih il-parteċipanti b'mod każwali, fi gruppi paralelli, open-label, u multiċentriku sar fuq 646 pazjent li qabbel is-sigurtà u l-effikaċja ta' bortezomib ma' pegylated liposomal doxorubicin kontra monoterapija b'bortezomib f'pazjenti b'majeloma multipla li kienu rċivew talanqas terapija waħda qabel u li ma' progressawx waqt li kienu qed jieħdu terapija bbażata fuq anthracycline.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio;
Maltese: PR=Rispons Parzjali (Partial Response); CI=Intervall ta' Kunfidenza (Confidence Interval), HR=Proporzjon ta' Periklu
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors.
Maltese: Għalhekk il-pazjenti għandhom jiġu mmonitorjati mill-qrib meta jingħataw bortezomib flimkien ma' inibituri potenti ta' CYP3A4
English: Antiviral prophylaxis is recommended in patients being treated with bortezomib.
Maltese: Profilassi antivirali hija rakkomandata f'pazjenti li qed jiġu ttrattati b'bortezomib.
English: The following medicinal products are given on day 1 of each Bortezomib SUN 21-day treatment cycle as intravenous infusions:
Maltese: Il-prodotti mediċinali li ġejjin jingħataw f'jum 1 ta' kull wieħed miċ-ċiklu ta' trattament ta' 21 jum ta' Bortezomib SUN bħala infużjonijiet ġol-vini:
English: Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/
Maltese: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
English: Rare side effects (may affect up to 1 in 1,000 people) - blood clot in small blood vessels (thrombotic microangiopathy)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) - tagħqid tad-demm fil-kanali żgħar tad-demm (mikroanġjopatija trombotika).
English: For dose adjustments, see Table 5 below.
Maltese: Għal aġġustamenti fid-doża, ara Tabella 5 hawn taħt.
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Maltese: Dawn ir-reazzjonijiet avversi huma bbażati fuq sett ta' dejta integrata ta' 5,476 pazjent li minnhom 3,996 pazjent kienu ttrattati b'bortezomib b'1.3 mg/m2 u inklużi f'Tabella 7.
English: - If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl, Bortezomib SUN may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).
Maltese: - Jekk it-tossiċità tgħaddi i.e. il-pazjent ikollu ANC ta' ≥ 750 ċellula/μL u għadd tal-plejtlits ta' ≥ 25,000 ċellula/μL, Bortezomib SUN jista' jerġa' jinbeda f'doża mnaqqsa b'livell wieħed ta' doża (minn 1.3 mg/m2 għal 1 mg/m2, jew minn 1 mg/m2 għal 0.7 mg/m2).
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib SUN at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment moderat jew sever tal-fwied għandhom jinbdew fuq Bortezomib SUN f'doża mnaqqsa ta' 0.7 mg/m2 f'kull injezzjoni waqt l-ewwel ċiklu ta' trattament, u sussegwentement tista' tiġi kkunsidrata żieda sa doża ta' 1.0 mg/m2 jew aktar tnaqqis sa doża ta' 0.5 mg/m2 skont it-tollerabiltà tal-pazjent (ara Tabella 6 u sezzjonijiet 4.4 u 5.2).
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial
Maltese: Mantle ittrattati b'BzmbR-CAP fi prova klinika
English: Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzmbDx group and 52/242 [21%] in VDDx group).
Maltese: BzmbDx u 52/242 [21%] fil-grupp ta' VDDx).
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide).
Maltese: • istruzzjonijiet dwar il-preskrizzjoni u l-għoti li jinkludu t-tul taċ-ċikli u l-għadd ta' ċikli, sabiex jiġi minimizzat ir-riskju ta' medikazzjoni u erruri ta' għoti indotti potenzjalment bl-eżistenza ta' żewġ programmi ta' trattament differenti b'bortezomib fil-kumbinazzjoni fl-Ambjent ta'Trapjant Indott (Transplant Inductive Setting) (Bortezomib SUN flimkien ma' dexamethasone, u Bortezomib SUN flimkien ma' dexamethasone u thalidomide);
English: Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Newropatija periferali tas-sensi, Disastesija*, Nevralġija*
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Maltese: Fl-istudju LYM-3002 fejn bortezomib ingħata flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (R-CAP), l-inċidenza ta' newropatija periferali fil-korsijiet ta' għoti kombinat ta' mediċini, hija ppreżentata fit-tabella hawn taħt:
English: Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
Maltese: Emorraġija ċerebrali*, Emorraġija intrakranjali (li jinkludi s-sottoaraknojdi)*, Edema tal-moħħ, Attakk iskemiku temporanju, Koma, Żbilanċ fis-sistema awtonomika nervuża, Newropatija awtonomika, Puplesija kranjali*, Paralisi*, Paresi*, Presinkope, Sindrome tal-istemma tal-moħħ, Disturb ċerebrovaskulari, Ġerħa fl-għerq tan-nerv, Iperattività psikomotorili, Kompressjoni fis-sinsla, Disturb flgħarfien NOS, Disfunzjoni motorili, Disturb fis-sistema nervuża
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Maltese: Meta jintuża thalidomide attenzjoni partikulari għal testijiet ta' tqala u rekwiżiti ta' prevenzjoni hija meħtieġa (ara sezzjoni 4.6).
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BzmbR-CAP) Bortezomib SUN is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11, followed by a 10-day rest period on days 12-21.
Maltese: Terapja kombinata b'rituximab, cyclophosphamide, doxorubicin u prednisone (BzmbR-CAP) Bortezomib SUN jingħata permezz ta' injezzjoni ġol-vinijew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m2 ta' erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimgħatejn f'jiem 1, 4, 8, u 11, segwit minn perjodu ta' mistrieħ ta' 10 ijiem f'jiem 12-21.
English: Skin reaction, Jessner's lymphocytic infiltration, Palmarplantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Maltese: Reazzjoni tal-ġilda, Infiltrazzjoni limfoċitika ta' Jessner, Sindrome ta' eritrodisestesija Palmar-Plantar, Emorraġija taħt il-ġilda, Livedo reticularis, Ebusija tal-ġilda, Papule, Reazzjoni ta' fotosensittività, Seborrea, Għaraq kiesaħ, Disturb tal-ġilda NOS, Eritrożi, Ulċera tal-ġilda, Disturbi tad-dwiefer
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: 1.1 Preparazzjoni tal-kunjett ta' 3.5 mg: b'attenzjoni żid 3.5 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib SUN billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia *, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Maltese: Ipermagnesemija*,Aċidożi, Żbilanċ fl-elettroliti*, Ammont eċċessiv ta' fluwidu, Ipokloremija*, Ipovolemija, Iperkloremija*, Iperfosfatemija*, Disturb metaboliku, Nuqqas fil-kumpless tal-vitamina B, Nuqqas ta' vitamina B12, Gotta, Żieda fl-aptit, Intolleranza għallalkoħol
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Maltese: Tossiċità gastrointestinali, li tinkludi nawsja, dijarea, rimettar u stitikezza huma komuni ħafna waqt trattament b'bortezomib.
English: Refer to the Summary of Product Characteristics of rituximab for more information.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' rituximab għal aktar informazzjoni.
English: When toxicity resolves re-initiate Bortezomib SUN treatment and reduce dose to 0.7 mg/m2 once per week.
Maltese: Meta t-tossiċità tgħaddi erġa' ibda t-trattament b'Bortezomib SUN u naqqas id-doża għal 0.7 mg/m2 darba filġimgħa.
English: Time to progression Events n (%) Mediana (95% CI)
Maltese: Żmien għall-progressjoni Każijiet n (%) Medjana (95% CI)
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Maltese: Wara injezzjoni bolus ġol-vini taħt il-ġilda b'doża ta' 1.3 mg/m2 lill-pazjenti b'majeloma multipla (n=14 fil-grupp ta' ġol-vini, n=17 fil-grupp ta' taħt il-ġilda), l-esponiment sistemiku totali wara lgħoti ta' doża ripetuta (AUClast) kienet ekwivalenti għall-għotjiet ta' taħt il-ġilda u ta' ġol-vini.
English: Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Maltese: Riżultati tal-effikaċja mill-istudju LYM-3002 Punt aħħari tal-effikaċja
English: You might receive up to 6 cycles (24 weeks).
Maltese: Inti tista' tirċievi sa 6 ċikli (24 ġimgħa).
English: Table 4: Posology for Bortezomib SUN combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Maltese: Tabella 4: Pożoloġija għal terapija kombinata b'Bortezomib SUN għal pazjenti b'majeloma multipla li ma kienux ġew ittrattati qabel eliġibbli għal trapjant b'ċelluli staminali ematopojetiċi
English: After reconstitution, each ml solution contains 2.5 mg bortezomib.
Maltese: Wara r-rikostituzzjoni, kull ml ta' soluzzjoni jkun fih 2.5 mg bortezomib.
English: d Based on Log rank test stratified with IPI risk and stage of disease.
Maltese: d Abbażi tat-test Log rank stratifikat bir-riskju IPI u l-istadju tal-marda.
English: Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Maltese: Insuffiċjenza akuta tal-kliewi, Insuffiċjenza kronika talkliewi*, Infezzjoni fil-passaġġ urinarju*, Sinjali u sintomi tal-passaġġ urinarju*, Ematurija*, Żamma urinarja, Disturb ta' kif tagħmel l-awrina*, Proteinurija, Azotemija, Oligurija*, Pollakijurija
English: - In cycles 5 to 9, Bortezomib SUN is administered once weekly on days 1, 8, 22 and 29.
Maltese: F'Ċikli 5-9, Bortezomib SUN jingħata darba fil-ġimgħa f'jiem 1, 8, 22 u 29.
English: (95% CI) Hazard ratio (95% CI)c p-valued
Maltese: Proporzjon ta' periklu (95% CI)c valur-pd