FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious allergic skin reaction (Stevens-Johnson syndrome or Lyell syndrome).
Maltese: Reazzjonijiet allerġiċi serji tal-ġilda (sindrome ta' Stevens-Johnson u sindrome ta' Lyell).
English: Cladribine is a purine nucleoside analogue acting as an antimetabolite.
Maltese: Cladribine, hu analogu nukleòside tal-purina li jaġixxi bħala anti-metabolu.
English: Very common: immunosuppression * Rare: graft-versus-host disease *
Maltese: Komuni ħafna: immunosuppressjoni * Rari: graft-versus-host-disease *
English: Rare: Cardiac failure, atrial fibrillation, cardiac decompensation
Maltese: Insuffiċjenza kardijaka, fibrillazzjoni atrijali, dikumpensazzjoni kardijaka
English: The cumulative frequencies of second malignancy are 5%, 10-12% and 13-14% following 5, 10 and 15 years respectively after diagnosis of hairy cell leukaemia.
Maltese: Ilfrekwenzi kumulattivi ta' malinni sekondarji huma ta' 5%, 10-12% u 13-14% wara 5, 10 u 15-il sena rispettivament mid-dijanjożi tal-lewkimja taċ-ċelluli ċiljati.
English: Progressive multifocal leukoencephalopathy (PML) Cases of PML, including fatal cases, have been reported with cladribine.
Maltese: Lewkoenċefalopatija multifokali progressiva (PML) Każijiet ta' PML, inklużi każijiet fatali, ġew irrappurtati bi cladribine.
English: Reduced ossification was observed at 1.0 mg/kg/day.
Maltese: Tnaqqis fl-ossifikazzjoni kien osservat b'1.0 mg/kg/kuljum.
English: Their frequency varies widely, ranging from 2% to 21%.
Maltese: Il-frekwenza tagħhom tvarja ħafna, minn 2% sa 21%.
English: Gastrointestinal adverse reactions like nausea (5-28%), vomiting (1-13%), and diarrhoea (3-12%) as well as fatigue (2-48%), headache (1-23%), and decreased appetite (1-22%) have been reported during treatment with cladribine.
Maltese: Reazzjonijiet avversi gastrointestinali bħal nawżeja (5-28%), rimettar (1-13%), u dijarrea (3-12%) kif ukoll għejja (2-48%), uġigħ ta' ras (1-23%) u nuqqas ta' aptit (1-22%) kienu irrappurtati waqt it-trattament bi cladribine.
English: The effect on human fertility is unknown.
Maltese: L-effett fuq il-fertilità umana mhuwiex magħruf.
English: Pack size of 1 or 5 vials.
Maltese: Daqs tal-pakkett ta' 1 jew 5 kunjetti.
English: In 7- to 14-day continuous intravenous infusion studies in cynomolgus monkeys, the target organs were the immune system ( 0.3 mg/kg/day), bone marrow, skin, mucous membranes, nervous system and testes ( 0.6 mg/kg/day) and kidneys ( 1 mg/kg/day).
Maltese: Fi studji ta' infużjoni kontinwa fil-vini minn 7 sa 14-il jum f'xadini tar-razza cynomolgus, l-organi targit kienu s-sistema immunoloġika ( 0.3 mg/kg/kuljum), il-mudullun, il-ġilda, il-membrani mukużi, is-sistema nervuża, it-testikoli ( 0.6 mg/kg/kuljum) u l-kliewi ( 1 mg/kg/kuljum).
English: An influence of cladribine on the activity of other antineoplastic agents has not been observed in vitro (e.g. doxorubicin, vincristine, cytarabine, cyclophosphamide) and in vivo.
Maltese: Influwenza ta' cladribine in vitro fuq l-attività ta' sustanzi anti-neoplastiċi oħra (eż. doxorubicin, vincristine, cytarabine, cyclophosphamide) u in vivo ma kinitx osservata.
English: The frequencies are defined as follows: 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), not known (cannot be estimated from the available data).
Maltese: 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), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Reduced function of your body's immune system.
Maltese: Tnaqqis fil-funzjoni tas-sistema immuni ta' ġismek.
English: Pharmacokinetic studies in humans showed that the plasma concentration curve of cladribine fits a 2or 3-compartment model with - and β-half-lives of on average 35 minutes and 6.7 hours, respectively.
Maltese: Studji farmakokinetiċi fil-bniedem urew li l-kurva tal-konċentrazzjoni ta' cladribine fil-plażma taqbel ma' mudell ta' 2 jew 3 kompartamenti b'- u β-half-lives b'medja ta' 35 minuta u 6.7 sigħat rispettivament.
English: Rare serious adverse reactions
Maltese: Reazzjonijiet avversi rari serji
English: 10 mg cladribine in 5 ml solution.
Maltese: 10 mg ta' cladribine f'soluzzjoni ta' 5 ml.
English: Very common: rash, localised exanthema, diaphoresis Common: pruritus, skin pain, erythema, urticaria Rare: Stevens-Johnson syndrome/Lyell syndrome
Maltese: Komuni ħafa: raxx; exanthema lokalizzata, dijaforesi Komuni: ħakk, uġigħ fil-ġilda, eritema, urtikarja Rari: is-sindrome ta' Stevens-Johnson/is-sindrome ta' Lyell
English: Each ml of solution contains 2 mg of cladribine (2-CdA).
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih 2 mg ta' cladribine (2-CdA).
English: Uncommon: somnolence, paraesthesia, lethargy, polyneuropathy, confusion, ataxia
Maltese: Mhux komuni: ħedla tan-ngħas, parestiżja, letarġija, polinewropatija, konfużjoni, atassja
English: LITAK contains the active substance cladribine.
Maltese: X'fih LITAK - Is-sustanza attiva hi cladribine.
English: Fatal outcome
Maltese: Riżultat fatali
English: The mean volume of distribution of cladribine is 9.2 l/kg.
Maltese: Il-volum medju tad-distribuzzjoni ta' cladribine hu ta' 9.2 l/kg.
English: Moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or moderate to severe hepatic impairment (Child-Pugh score > 6) (see also section 4.4).
Maltese: Indeboliment renali minn moderat sa serju (clearance tal-kreatitina ≤ 50 ml/min) jew indeboliment talfwied minn moderat sa serju (punteġġ ta' Child-Pugh > 6) (ara wkoll sezzjoni 4.4).
English: Frequently observed symptoms of overdose are nausea, vomiting, diarrhoea, severe bone marrow depression (including anaemia, thrombocytopenia, leukopenia, and agranulocytosis), acute renal insufficiency, as well as irreversible neurologic toxicity (paraparesis/quadriparesis), Guillain-Barré syndrome, and Brown-Séquard syndrome.
Maltese: Sintomi ta' doża eċċessiva osservati b'mod frekwenti huma nawżeja, rimettar, dijarrea, dipressjoni severa tal-mudullun (inkluż l-anemija, tromboċitopenja, lewkopenja u agranuloċitosi), insuffiċjenza akuta tal-kliewi kif ukoll tossiċità newroloġika irriversibbli (parapareżi/kwadripareżi), is-sindrome ta' Guillain-Barré u s-sindrome ta' Brown-Séquard.
English: Uncommon: conjunctivitis Very rare: blepharitis
Maltese: Mhux komuni: konġuntivite Rari ħafna: blefarite
English: At least 10 cases with acute autoimmune haemolytic anaemia have been reported.
Maltese: Ta' l-inqas 10 każijiet ta' anemija emolitika awtoimmunitarja akuta kienu rrappurtati.
English: Serious adverse reactions like ileus, severe hepatic failure, renal failure, cardiac failure, atrial fibrillation, cardiac decompensation, apoplexy, neurological disturbances in speech and swallowing, tumour lysis syndrome with acute renal failure, transfusion-related graft-versus-host disease, Stevens-Johnson syndrome/Lyell syndrome (toxic epidermal necrolysis), haemolytic anaemia, hypereosinophilia (with erythematous skin rash, pruritus, and facial oedema) are rare.
Maltese: Reazzjonijiet avversi serji bħal ileus, insuffiċjenza severa tal-fwied, insuffiċjenza renali, insuffiċjenza kardijaka, fibrillazzjoni atrijali, dikompensazzjoni kardijaka, apoplexy, disturbi newroloġiċi li jifettwaw il-ħila biex titkellem u tibla', sindrome tal-lisi tat-tumur b'insuffiċjenza akuta tal-kliewi, mard relatat mat-trasfużjoni tal-graft-versus-host, is-sindrome ta' Stevens-Johnson/is-sindrome ta' Lyell (nekroliżi tossika epidermika), anemija emolitika, ipereosinofilja (b'raxx eritematuż tal-ġilda, prurite u edima tal-wiċċ) huma rari.
English: Rare: renal failure
Maltese: Rari: insuffiċjenza renali
English: The overall response rate was 97% with long-lasting remission, with 73% of patients staying in complete remission after four years follow-up time.
Maltese: Irrata ta' rispons total kienet ta' 97% bi tnaqqis fil-mard li jdum għal żmien twil, bi 73% tal-pazjenti li baqgħu b'assenza totali ta' mard wara erba' snin ta' follow-up.
English: 9/l) are observed in about 20% to 30% of all patients.
Maltese: 9/l) huma osservati f'madwar 20% sa 30% tal-pazjenti kollha.
English: Cladribine is a cytotoxic medicinal product, which is mutagenic to cultured mammalian cells.
Maltese: Clabridine huwa prodott mediċinali ċitotossiku, li hu mutaġeniku fuq ċelluli mammiferi kultivati.
English: Adverse reactions that have been reported are listed in the table below by frequency category and system organ class.
Maltese: Reazzjonijiet avversi li ġew irraportati huma elenkati fit-tabella t'hawn isfel skont il-kategorija ta' frekwenza u l-klassi tal-organi tas-sistema.
English: Very rare side effects (may affect up to 1 in 10.000 people) Depression, epileptic attack.
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000 persuna) Dipressjoni, attakk epilettiku.
English: Cladribine is a prodrug which is taken up rapidly in cells after parenteral administration, and is phosphorylated intracellularly to the active nucleotide 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by deoxycytidine kinase (dCK).
Maltese: Clabridine hija mediċina magħrufa bħala ‘prodrug' li tidħol malajr fiċ-ċelluli wara li tingħata b'injezzjoni, u tkun fosforilata fiċ-ċelluli għan-nukleòtide attiv 2-chlorodeoxyadenosine-5'triphosphate (CdATP) b'deoxycytidine kinase (dCK).
English: Cladribine is contraindicated in pregnancy.
Maltese: Clabridine huwa kontraindikat waqt it-tqala.
English: The prodrug cladribine is metabolised intracellularly, predominantly by deoxycytidine kinase, to 2-chlorodeoxyadenosine-5'-monophosphate, that is further phosphorylated to the diphosphate by nucleoside monophosphate kinase and to the active metabolite 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by nucleoside diphosphate kinase.
Maltese: Il-prodroga clabridine hi metabolizzata b'mod intraċellulari, l-aktar bl-enżima deoxycytidine kinase għal 2-chlorodeoxyadenosine-5'-monophosphate, li jkun imbagħad fosforilat aktar għad-diphosphate bl-enżima nucleoside monophosphate kinase u għall-metabolu 2-chlorodeoxyadenosine-5'triphosphate (CdATP) bin-nukleòside diphosphate kinase.
English: LITAK is indicated for the treatment of hairy cell leukaemia.
Maltese: LITAK huwa indikat għat-trattament ta' lewkimja tac-ċelluli ċiljati (‘hairy cell leukaemia').
English: Common: myalgia, arthralgia, arthritis, bone pain
Maltese: Komuni: mijalġja, artralġja, artrite, uġigħ fil-għadam
English: Cladribine is teratogenic in mice (at doses of 1.5-3.0 mg/kg/day, given on gestation days 6-15).
Maltese: Clabridine huwa teratoġeniku fil-ġrieden (f'dożi ta' 1.5-3.0 mg/kg/kuljum, mogħti fil-jiem tat-tqala 615).
English: Paediatric use The use of LITAK in children has not been investigated (see section 4.2).
Maltese: Użu pedjatriku L-użu ta' LITAK fit-tfal ma kienx investigat (ara sezzjoni 4.2).
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: In another study using a dose of 0.10 mg/kg body weight/day, the maximum plasma concentration Cmax after continuous intravenous infusion was 5.1 ng/ml (tmax: 12 hours) compared to 51 ng/ml after subcutaneous bolus injection (tmax: 25 minutes).
Maltese: Fi studju ieħor li juża doża ta' 0.10 mg/kg piż talġisem/kuljum, il-konċentrazzjoni massima tal-plażma Cmax wara infużjoni kontinwa fil-vini kienet ta' 5.1 ng/ ml (tmax: 12-il siegħa) meta mqabbla ma' 51 ng/ ml wara l-injezzjoni bolus taħt il-ġilda (tmax: 25 minuta).
English: Plasma protein binding of cladribine is 25% on average, with a wide interindividual variation (5-50%).
Maltese: It-twaħħil mal-proteina tal-plażma ta' cladribine hija ta' 25% fuq il-medja b'varjazzjoni interindividwali wiesa' (5-50%).
English: Effects on sternal ossification were seen at 1.5 and 3.0 mg/kg/day.
Maltese: L-effetti fuq l-ossifikazzjoni ta' l-isternu dehru b'1.5 u 3.0 mg/kg/kuljum.
English: Pharmacotherapeutic group: Purine analogues, ATC code: L01BB04
Maltese: Analogi tal-purina, Kodiċi ATC:
English: LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or with moderate to severe hepatic impairment (Child-Pugh score > 6) (see sections 4.3, 4.4 and 5.2).
Maltese: LITAK huwa kontra-indikat f'pazjenti li għandhom indeboliment moderat jew serju renali (clearance tal-kreatitina ≤ 50 ml/min) jew li għandhom indeboliment moderat jew serju tal-fwied (punteġġ ta' Child-Pugh > 6) (ara sezzjonijiet 4.3, 4.4 u 5.2)
English: The frequency of second malignancy following treatment with LITAK was 3.4% in all 232 hairy cell leukaemia patients treated, during a 10-year period.
Maltese: Ilfrekwenza tat-tieni malinn wara t-trattament b'LITAK kienet ta' 3.4% fil-232 pazjenti kollha li kellhom il-lewkimja taċ-ċelluli ċiljati matul kura f'perijodu ta' 10 snin.
English: The mean plasma clearance amounts to 794 ml/min after intravenous infusion and to 814 ml/min after subcutaneous bolus injection at a dose of 0.10 mg/kg body weight/day.
Maltese: It-tneħħija tal-plażma medja tammonta għal 794 ml/min wara infużjoni fil-vini u għal 814 ml/min wara l-għoti ta' injezzjoni bolus taħt il-ġilda b'doża ta' 0.10 mg/kg tal-piż korporju/kuljum.
English: What LITAK contains - The active substance is cladribine.
Maltese: LITAK fih is-sustanza attiva cladribine. Cladribine hi sustanza ċitostatika.
English: Sleepiness, numbness and tingling of the skin, feebleness, inactivity, disorder of peripheral nerves, confusion, impaired ability to coordinate movements.
Maltese: Ngħas, tmewwit u tnemnim fil-ġilda, debbulizza, inattività, disturb fin-nervaturi periferali, konfużjoni, indebolimet fil-ħila biex tikkoordina l-movimenti.
English: Pancytopenia is normally reversible and the intensity of bone marrow aplasia is dose-dependent.
Maltese: Il-panċitopenja hija ġeneralment riversibbli u l-intensità ta' l-aplażja tal-mudullun tiddependi mid-doża.
English: The single substitution of hydrogen for chlorine at position 2 distinguishes cladribine from its natural counterpart 2'-deoxyadenosine and renders the molecule resistant to deamination by adenosine deaminase.
Maltese: Sostituzzjoni waħda talhydrogen mal-chlorine f'pożizzjoni 2 tiddistingwi cladribine mill-kontroparti naturali tiegħu 2'deoxyadenosine, u jagħmel il-molekula reżistenti għad-deamination mill- adenosine deaminase.
English: LITAK 2 mg/ml solution for injection cladribine
Maltese: IL-PRODOTT MEDIĊINALI LITAK 2 mg/ ml soluzzjoni għall-injezzjoni cladribine
English: Culture-negative fever following treatment with cladribine occurs in 10-40% of patients with hairy cell leukaemia and is rarely observed in patients with other neoplastic disorders.
Maltese: Deni li huwa negattiv għall-koltura (‘culture-negative fever') wara t-trattament bi cladribine iseħħ f'10-40% tal-pazjenti b'lewkimja taċ-ċelluli ċiljati u rarament kien osservat f'pazjenti b'mard neoplastiku ieħor.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium chloride (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid
English: After subcutaneous bolus injection of a 0.14 mg/kg cladribine dose, a Cmax of 91 ng/ml is reached on average after 20 minutes only.
Maltese: Wara l-injezzjoni bolus taħt il-ġilda ta' doża ta' 0.14 mg/kg ta' cladribine, Cmax ta' 91 ng/ ml hija mkejla wara medja ta' 20 minuta biss.
English: Paediatric population LITAK is contraindicated in patients less than 18 years of age (see section 4.3).
Maltese: Popolazzjoni pedjatrika LITAK huwa kontraindikat f'pazjenti li għandhom inqas minn 18-il sena (ara sezzjoni 4.3).
English: Inflammation of the gallbladder.
Maltese: Mhux applikabbli.
English: Common side effects (may affect up to 1 in 10 people) Repeated occurrence of malignant (cancerous) disease.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni) Ripetizzjoni ta' okkorrenza ta' marda malinna (kanċeruża).
English: Very rare: lung embolism
Maltese: Rari ħafna: emboliżmu fil-pulmun
English: LITAK 2 mg/ml solution for injection
Maltese: IL-PRODOTT MEDIĊINALI LITAK 2 mg/ml soluzzjoni għall-injezzjoni
English: Rare side effects (may affect up to 1 in 1.000 people) Reduced liver function.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000 persuna) Tnaqqis fil-funzjoni tal-fwied.
English: Before and during treatment with LITAK, you will have regular blood tests to check whether it is safe for you to continue with your treatment.
Maltese: Qabel u waqt it-trattament b'LITAK, int ser ikollok testijiet regolari tad-demm sabiex jiġi verifikat li ma jkunx ta' periklu għalik li tkompli bit-trattament.
English: Very common severe complications, in some cases with fatal outcome, are opportunistic infections (e.g. Pneumocystis carinii, Toxoplasma gondii, listeria, candida, herpes viruses, cytomegalovirus and atypical mycobacteria).
Maltese: Pneumocystis carinii, Toxoplasma gondii, listerja, kandida, vajrusis ta' l-erpete, cytomegalovirus u mycobacteria mhux tipika).
English: Due to the similar intracellular metabolism, cross-resistance with other nucleoside analogues, such as fludarabine or 2'-deoxycoformycin may occur.
Maltese: Minħabba x-xebħ fil-metaboliżmu intraċellulari, il-cross-resistance ma' nukleòsidi analogi oħra, bħal fludarabine jew 2'-deoxycoformycin, tista' sseħħ.
English: Intracellular concentration of cladribine exceeds its plasma concentration by 128 to 375 times.
Maltese: Il-konċentrazzjoni intraċellulari ta' cladribine tgħaddi l-konċentrazzjoni tagħha fil-plażma b'128 sa 375 darba.
English: In rabbits, cladribine is teratogenic at doses of 3.0 mg/kg/day (given on gestation days 7-19).
Maltese: Filfniek, cladribine huwa teratoġeniku f'dożi ta' 3.0 mg/kg/kuljum (mogħtija bejn is-7 u d-19-il jum tattqala).
English: Skin rashes (2-31%) are mainly described in patients with other concomitantly administered medicinal products known to cause rash (antibiotics and/or allopurinol).
Maltese: Il-ħruġ ta' raxx tal-ġilda (2-31%) kien osservat l-aktar ma' prodotti mediċinali li jingħataw fl-istess ħin li hu magħruf li jikkawżaw ir-raxx (antibijotiċi u/jew allopurinol).
English: However, an in vitro study revealed cross-resistance between cladribine and nitrogen mustard (chlormethine); for cytarabine, one author has described an in vivo cross-reaction without loss of activity.
Maltese: Madankollu, studju in vitro kixef il-cross-resistance bejn cladribine u l-mustarda tan-nitroġenu (chlormethine); għal cytarabine, awtur iddeskriva l-cross reaction in vivo mingħajr telf fl-attività.
English: Severe long-term lymphocytopenias have been reported rarely which, however, could not be associated with late infectious complications.
Maltese: Kienu rrappurtati limfoċitopenji serji fit-tul b'mod rari li, madankollu, ma setgħux ikunu assoċjati ma' komplikazzjonijiet ta' infezzjonijiet li seħħew aktar tard.
English: Fever.
Maltese: Infezzjonijiet.
English: Each ml solution contains 2 mg cladribine.
Maltese: Kull millilitru ta' soluzzjoni fih 2 mg ta' cladribine.
English: Rare: hepatic failure
Maltese: Rari: insuffiċjenza epatika
English: How to store LITAK
Maltese: Jekk tinsa tuża LITAK
English: Very rare: amyloidosis
Maltese: Rari: ileus
English: Very common: pancytopenia/myelosuppression *, neutropenia, thrombocytopenia, anemia, lymphopenia Uncommon: haemolytic anaemia * Rare: hypereosinophilia
Maltese: Mhux komuni: anemija emolitika * Rari: ipereosinofilija
English: Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse reactions, such as myelo- and immunosuppression, long-lasting lymphocytopenia, and opportunistic infections.
Maltese: Cladribine hija sustanza anti-neoplastika u immunosoppressiva li tista' twassal biex ikun hemm numru konsiderevoli ta' reazzjonijiet avversi tossiċi, bħalma huma t-trażżin tal-attività tal-mudullun u limmunosoppressjoni, limfoċitopenija fit-tul u infezzjonijet opportunistiċi.
English: The highest incidence of second malignancy with LITAK was 6.5% after a median follow-up of 8.4 years.
Maltese: L-ogħla inċidenza tat-tieni tumur malinn wara li ngħata LITAK kienet ta' 6.5% f'medja ta' 8.4 snin li tkomplew l-osservazzjonijiet medjani.
English: EU/1/04/275/001 EU/1/04/275/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/275/002
English: Very common: purpura Common: petechiae, haemorrhages * Uncommon: phlebitis
Maltese: Komuni ħafna: purpura Komuni: tbengil, emorraġiji * Mhux komuni: flebite
English: In case of an accumulation of the serum uric acid above the normal range, the dose of allopurinol may be increased to 300 mg/day.
Maltese: F'każ ta' akkumulazzjoni ta' l-uric acid fis-serum fuq il-livell normali, id-doża ta' l-allopurinol tista' tiżdied għal 300 mg/kuljum.
English: Tiredness, chills, decreased appetite.
Maltese: Għeja, tertir ta' bard, nuqqas t'aptit.
English: Cytotoxic.
Maltese: Dgħjufija.
English: Common: tachycardia, heart murmur, hypotension, epistaxis, myocardial ischemia *
Maltese: Komuni: takikardja, tħaxwix tal-qalb, pressjoni tad-demm baxxa, epistassi, iskemija mijokardjali * Rari:
English: Contains sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections
Maltese: Fih sodium chloride, sodium hydroxide (għall-aġġustament tal-pH) u hydrochloric acid (għallaġġustament tal-pH) u ilma għall-injezzjonijiet
English: Very common: nausea, vomiting, constipation, diarrhoea Common: gastrointestinal pain, flatulence Rare: ileus
Maltese: Komuni ħafa: nawseja, rimettar, stitikezza, dijarea Komuni: uġigħ gastro-intestinali, gass
English: Reduced kidney function.
Maltese: Effetti sekondarji possibbli 5.
English: Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected to have adverse effects on human gametogenesis (see section 5.3).
Maltese: Sustanzi neoplastiċi, bħal cladribine, li jinterferixxu mad-DNA, RNA u s-sintesi tal-proteini, jistgħu jkunu mistennija li jkollhom effetti avversi fuq il-gametoġenesi tal-bniedem (ara sezzjoni 5.3).
English: Experience with patients older than 65 years is limited.
Maltese: Esperjenza fuq pazjenti li għandhom aktar minn 65 sena hija limitata.
English: The intracellular retention time of cladribine nucleotides in vivo is clearly prolonged as compared to the retention time in the plasma: Half-lives t1/2 of initially 15 hours and subsequently more than 30 hours were measured in leukaemic cells.
Maltese: Iż-żmien tarritenzjoni tan-nukleòtidi ta' cladribine in vivo huwa mtawwal b'mod ċar meta mqabbel maż-żmien tażżamma fil-plażma. ‘Half-lives' t1/2 inizjalment ta' 15-il siegħa u sussegwentement ta' aktar minn 30 siegħa ġew imkejla f'ċelluli lewkemiċi.
English: Like other nucleoside analogues, treatment with cladribine is associated with myelosuppression and profound and prolonged immunosuppression.
Maltese: Bħal nukleosidi analogi oħra, it-trattament bi cladribine huwa assoċjat ma' trażżin tal-attività talmudullun u immunosoppressjoni profonda u fit-tul.
English: The biexponential decline of the serum concentration of cladribine after subcutaneous bolus injection is comparable to elimination parameters after 2-hour intravenous infusion with an initial and terminal half-life of approximately 2 hours and 11 hours, respectively.
Maltese: It-tnaqqis biesponenzjali tal-konċentrazzjoni tas-serum ta' cladribine wara l-injezzjoni bolus taħt il-ġilda huwa komparabbli għall-parametri ta' l-eliminazzjoni wara sagħtejn ta' infużjoni filvini b'‘half life' inizjali u terminali ta' madwar sagħtejn u 11-il siegħa rispettivament.
English: Inflammation of a vein.
Maltese: Infjammazzjoni ta' xi vina.