FrancophonIA/ELRC3.0 huggingface dataset:
English: Lamivudine Teva Pharma B.V. contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola miksija b'rita, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets EU/1/09/596/001 20 tablets (blister) EU/1/09/596/002 30 tablets (blister) EU/1/09/596/003 60 tablets (blister) EU/1/09/596/004 90 tablets (blister) EU/1/09/596/005 100 tablets (blister) EU/1/09/596/006 500 tablets (blister) EU/1/09/596/007 60 tablets (bottle) EU/1/09/596/015 80 tablets (blister)
Maltese: Lamivudine Teva Pharma B.V. 150 mg pilloli miksija b'rita EU/1/09/596/001 20 pillola (folji) EU/1/09/596/002 30 pillola (folji)
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Maltese: Fi studju farmakokinetiku (PENTA 15), erba' individwi kkontrollati viroloġikament li kellhom inqas minn 12-il xahar qalbu minn reġimen ta' soluzzjoni orali darbtejn kuljum għal darba kuljum ta' abacavir flimkien ma' lamivudine.
English: White opaque PVC/PVdC - Aluminium blisters Pack sizes of 20, 30, 60, 80, 90, 100 or 500 film-coated tablets
Maltese: Daqsijiet ta' pakketti li fihom 20, 30, 60, 80, 90, 100 jew 500 pillola miksija b'rita
English: However, the extent (based on the AUC) of lamivudine absorbed is not influenced.
Maltese: Madankollu, l-ammont (bażata fuq l-AUC) ta' lamivudine assorbit ma ġietx influwenzata.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (<4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Maltese: Abbażi ta' aktar minn 200 par ta' omm/wild ikkurati għall-HIV, ilkonċentrazzjonijiet ta' lamivudine fis-serum fi trabi mreddgħin ta' ommijiet ikkurati għall-HIV huma baxxi ħafna (<4% tal-konċentrazzjonijiet fis-serum tal-omm) u progressivament jonqsu għal livelli mhux traċċabbli meta trabi mreddgħin jaslu fl-età ta' 24 ġimgħa.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Pazjenti li kienu diġa' jbatu b'disfunzjoni tal-fwied, inkluża l-epatite kronika attiva, ikollhom żieda filfrekwenza ta' anormalitajiet fil-funzjoni tal-fwied waqt it-terapija kombinata antiretrovirali, u għandhom ikunu mmonitorjati skont il-prattika standard.
English: Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V mutations.
Maltese: Terapija antiretrovirali b'diversi mediċini li fiha lamivudine intweriet li hija effettiva f'pazjenti inkonsapevoli li qed jieħdu mediċina antiretrovirali kif ukoll f'pazjenti b'virusus li fihom ilmutazzjonijiet ta' M184V.
English: Three subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48.
Maltese: Tliet individwi kellhom tagħbija virali li ma setgħetx titkejjel u wieħed kellu HIV-RNA plażmatika ta' 900 kopja/mL wara Ġimgħa 48.
English: Not applicable.
Maltese: Rabdomajoliżi.
English: The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to lamivudine-containing therapy remains under investigation.
Maltese: Ir-relazzjoni bejn suxxetibilità in vitro ta' HIV għal lamivudine u r-rispons kliniku għal terapija li fiha lamivudine tibqa' tiġi mistħarrġa.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Light grey, diamond shaped, biconvex film-coated tablet with approx. 14.5 mm length and 7.0 mm width - engraved with “L 150” and breakline on one side and breakline on the other.
Maltese: Pillola griża ċara, f'għamla ta' djamant, imżaqqa fuq żewġ naħat u miksija b'rita, twila madwar 14.5 mm u wiesgħa madwar 7.0 mm, li fuqha hemm imnaqqax “L 150” u ferq fuq naħa waħda u ferq fuq in-naħa l-oħra.
English: Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase in peak plasma levels.
Maltese: L-għoti wkoll ta' zidovudine rriżulta f'żieda ta' 13% fl-espożizzjoni ta' zidovudine u żieda ta' 28% fl-ogħla livelli fil-plażma.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 December 2009
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Diċembru 2009
English: Hepatobiliary disorders
Maltese: Disfunzjoni tal-mitokondrija:
English: How to take Lamivudine Teva Pharma B.V.
Maltese: Tiħux Lamivudine Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Lamivudine Teva Pharma B.V. 300 mg film-coated tablets
Maltese: Lamivudine Teva Pharma B.V. 150 mg pilloli miksija b'rita Lamivudine Teva Pharma B.V.
English: maltitol).
Maltese: Cl)
English: These medicines should not be used with Lamivudine Teva Pharma B.V.:
Maltese: Jekk inti jkollok xi sintomi ta' infezzjoni waqt li tkun qed tieħu Lamivudine Teva Pharma B.V. :
English: Drug Interactions: Lamivudine Teva Pharma B.V. should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Maltese: Lamivudine Teva Pharma B.V. m'għandux jittieħed ma' prodotti mediċinali oħra li fihom lamivudine jew prodotti mediċinali li fihom emtricitabine (ara sezzjoni 4.5).
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets lamivudine
Maltese: Lamivudine Teva Pharma B.V. 300 mg pilloli miksija b'rita. lamivudine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/596/014
Maltese: EU/1/09/596/014
English: Excipient(s)
Maltese: NUMRU(I)
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets lamivudine
Maltese: Lamivudine Teva Pharma B.V. 150 mg pilloli miksija b'rita lamivudine
English: Paediatric population: In a study performed in paediatric patients (see section 5.1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving an oral solution of lamivudine as compared to those receiving the tablet formulation.
Maltese: Fi studju mwettaq f'pazjenti pedjatriċi (ara sezzjoni 5.1 studju ARROW), rati aktar baxxi ta' soppressjoni viroloġika u reżistenza virali aktar frekwenti ġew irrappurtati fi tfal li rċevew is-soluzzjoni orali ta' lamivudine meta mqabbla ma' dawk li rċevew il-formulazzjoni tal pillola.
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogueDNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Maltese: L-istudju wera li feti esposti in utero għat-taħlita spiċċaw b'livell ogħla ta' analogi nukleosidi inkorporati ma' DNA f'organi multipli tal-feti, u wera sinjali ta' telomere iqsar minn dawk esposti biss għal zidovudine.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Maltese: Apparti infezzjonijiet opportunistiċi, jistgħu jseħħu wkoll disturbi awtoimmuni (kundizzjoni li sseħħ meta s-sistema immunitarja tattakka tessut tal-ġisem b'saħħtu) wara li tibda tieħu mediċini għallkura tal-infezzjoni tal-HIV tiegħek.
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Maltese: Bħala regola ġenerali, meta tabib jiddeċiedi li jagħti sustanzi antiretrovirali għall-kura ta' infezzjoni tal-HIV f'nisa tqal u konsegwentament għat-tnaqqis tar-riskju ta' trasmissjoni vertikali tal-HIV lit tarbija li tkun għadha kif twieldet, id-dejta mill-annimali kif ukoll l-esperjenza klinika f'nisa tqal għandhom jiġu kkunsidrati.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati b'HIV li għandhom defiċjenza immunitarja severa fil-ħin tal-bidu tat-terapija antiretrovirali kkombinata (TARK), jista' jkun hemm reazzjoni infjammatorja għall-infezzjonijiet opportunistiċi asintomatiċi jew residwali.
English: In any case, initiation of susceptible NRTI's should always be preferred to maintenance of lamivudine therapy.
Maltese: F'kull ċirkostanza, huwa dejjem preferibbli li jinbdew NRTI suxxettibli għal terapija mantenuta b'lamivudine.
English: Opportunistic infections: Patients receiving Lamivudine Teva Pharma B.V. or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Maltese: Pazjenti li jkunu qed jieħdu Lamivudine Teva Pharma B.V. jew xi terapija antiretrovirali oħra jistgħu jaqbduhom infezzjonijiet opportunistiċi u kumplikazzjonijiet oħra tal-infezzjoni tal-HIV.
English: Other medicines and Lamivudine Teva Pharma B.V.
Maltese: Mediċini oħra u Lamivudine Teva Pharma B.V.
English: The abacavir + lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of <80 c/mL at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested (<200 c/mL, <400 c/mL, <1000 c/mL), which all fell well within this non-inferiority margin.
Maltese: Il-grupp ta' dożaġġ ta' darba kuljum ta' abacavir + lamivudine ntwera li mhuwiex inferjuri għal grupp ta' dożaġġ ta' darbtejn kuljum skont il-marġni ta' nuqqas ta' inferjorità speċifikat minn qabel ta' -12%, għall-punt ta' tmiem primarju ta' <80 c/mL f'Ġimgħa 48 kif ukoll f'Ġimgħa 96 (punt ta'
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART).
Maltese: Ġew rapportati wkoll każijiet ta' osteonekrosi, partikolarment f'pazjenti li għandhom fatturi ta' riskju rikonoxxuti, mard tal-HIV avvanzat jew espożizzjoni fuq tul ta' żmien għal terapija antiretrovirali kkombinata (CART).
English: CLINICAL PARTICULARS
Maltese: IL- PRODOTT MEDIĊINALI
English: Treatment with Lamivudine Teva Pharma B.V. should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Maltese: Ittrattament b'Lamivudine Teva Pharma B.V. għandu jitwaqqaf minnufih jekk ikun hemm sinjali jew sintomi kliniċi jew anormalitajiet tal-laboratoju li jissuġerixxu pankreatite.
English: These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Maltese: Dawn irriżultati kienu miksuba f'popolazzjoni inkonsapevoli li qed tieħu mediċina antiretrovirali, u li prinċipalment tikkonsisti minn pazjenti asintomatiċi infettati b'HIV (CDC stadju A).
English: Administration of lamivudine tablets is bioequivalent to lamivudine oral solution with respect to AUC∞ and Cmax in adults.
Maltese: L-għoti tal-pilloli ta' lamivudine huwa bijoekwivalenti għas-soluzzjoni orali ta' lamivudine fir-rigward tal-AUC∞ u s-Cmax fl-adulti.
English: Adults, adolescents and children who weigh at least 25 kg The usual dose of Lamivudine Teva Pharma B.V. is 300 mg a day.
Maltese: Adulti, adolexxenti u tfal li jiżnu tal-inqas 25 kg
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hawn rapporti ta' każi ta' disfunzjoni tal-mitokondrija fi trabi li taw riżultat negattiv għall-HIV u li ġew esposti għal analogi nukleosidi fl-utru u/jew wara t-twelid; dawn kienu predominantament jikkonċernaw kura b'korsijiet li fihom zidovudine.
English: Children receiving lamivudine oral tablets according to the recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet formulation has higher bioavailability (see section 4.2).
Maltese: Madankollu, sakemm il-pazjent ma jkollux indeboliment tal-kliewi, ma jkunx hemm bżonn ta' bdil fid-dożaġġ ta' lamivudine (ara sezzjoni 4.2).
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Maltese: Prodotti mediċinali oħra (eż. ranitidine, cimetidine) ma jiġux eliminati b'mod sħiħ b'dan il-mekkaniżmu u nstab li ma jiġux affettwati b'lamivudine.
English: If you take more Lamivudine Teva Pharma B.V. than you should Accidentally taking too much Lamivudine Teva Pharma B.V. is unlikely to cause any serious problems.
Maltese: Jekk bi żball tieħu aktar Lamivudine Teva Pharma B.V. aktar milli għandek bżonn mhux probabbli li se joħloqlok xi problemi serji.
English: Older people: No specific data are available; however, special care is advised in this age group due to age-associated changes such as the decrease in renal function and alteration of haematological parameters.
Maltese: Ebda dejta speċifika disponibbli; madankollu, huwa rrakkomandat li tingħata kura speċjali f'dan il-grupp ta' età minħabba tibdiliet assoċjati mal-età bħat-tnaqqis fil-funzjoni tal-kliewi u tibdil fil-parametri ematoloġiċi.
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Maltese: Huwa importanti li taqra l-informazzjoni aktar l-isfel f'din is-sezzjoni taħt ‘Effetti sekondarji oħra li jista' jkun hemm terapija b'taħlita ta' mediċini għall-HIV.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Maltese: Il-possibilità ta' interazzjonijiet ma' prodotti mediċinali oħra li jingħataw fl-istess ħin għandu jiġi kkonsidrat, b'mod partikolari meta l-passaġġ ewlieni ta' eliminazzjoni jikkonsisti minn tnixxija attiva mill-kliewi permezz ta' sistema ta' trasport katajonika organika eż. trimethoprim.
English: The frequency of which is unknown (see section 4.4).
Maltese: Il-frekwenza ta' din mhix magħrufa (ara sezzjoni 4.4).
English: Each film-coated tablet contains 300 mg. - The other ingredients are:
Maltese: Doża ta' darba kuljum (300 mg darba kuljum):
English: Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of adult patients with chronic HBV infection (for details of clinical studies, see the prescribing information for lamivudine 100 mg).
Maltese: Lamivudine f'doża ta' 100 mg kuljum intwera wkoll li hu effettiv fil-kura ta' pazjenti adulti li jbatu minn infezzjoni kronika ta' HBV (għad-dettalji tal-istudji kliniċi, ara t-tagħrif għall-preskrizzjoni għal lamivudine 100 mg).
English: Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues, showed activity in an in vitro cytogenetic assay and the mouse lymphoma assay.
Maltese: Lamivudine ma kienx mutaġeniku f'testijiet ta' batterji, biss bħal ħafna analogi nukleosidi wera attività f'assaġġ ċitoġenetiku in vitro u f'analiżi ta' limfoma fil-ġurdien.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg of lamivudine.
Maltese: Id-doża rakkomandata ta' lamivudine hija 300 mg kuljum.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Maltese: Fi tfal li ommijiethom kienu ħadu NRTIs waqt it-tqala, il-benefiċċju mill protezzjoni kontra l-HIV kien akbar mir-riskju tal-effetti sekondarji.
English: • headache
Maltese: Epatite.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Maltese: Disturbi awtoimmuni (bħall-marda ta' Graves u epatite awtoimmuni) ġew irrapportati wkoll li jseħħu fl-ambjent ta' riattivazzjoni immuni; madankollu, ilħin irrapportat għall-bidu huwa aktar varjabbli u dawn l-avvenimenti jistgħu jseħħu bosta xhur wara l-bidu tal-kura (ara sezzjoni 4.4).
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Each film-coated tablet contains 150 mg lamivudine.
Maltese: Lamivudine Teva Pharma B.V. 150 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 150 mg lamivudine.
English: Children weighing ≥20 kg to <25 kg: The recommended dose is 225 mg daily.
Maltese: Tfal li jiżnu minn ≥20 kg sa <25:
English: Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Maltese: Tagħrif limitat juri li lamivudine jidħol fis-sistema ċentrali nervuża u jilħaq il-fluwidu ċerebrospinali (CSF).
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Each film-coated tablet contains 300 mg lamivudine.
Maltese: Lamivudine Teva Pharma B.V. 300 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 300 mg lamivudine.
English: You need to know about important signs and symptoms to look out for while you are taking Lamivudine Teva Pharma B.V..
Maltese: Inti għandek bżonn tkun taf dwar sinjali u sintomi importanti li għandek toqgħod attent għalihom waqt li tkun qed tieħu Lamivudine Teva Pharma B.V.
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Maltese: Evidenza minn studji kliniċi turi li meta lamivudine u zinovudine jittieħdu flimkien, idumu aktar biex jitfaċċaw iżolati reżistenti għal zidovudine f'dawk li qabel ma kinux ħadu terapija antiretrovirali.
English: NAME OF THE MEDICINAL PRODUCT Lamivudine Teva Pharma B.V. 150 mg film-coated tablets lamivudine
Maltese: KARTUNA - LAMIVUDINE TEVA PHARMA B.V. PHARMA 150 MG PILLOLI MIKSIJA B'RITA
English: Blood and lymphatic systems disorders
Maltese: Microcrystilline cellulose
English: The therapy should be initiated by a physician experienced in the management of HIV infection.
Maltese: It-terapija trid tinbeda minn tabib ta' esperjenza fil-ġestjoni tal-infezzjonijiet tal-HIV.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Maltese: Ir-reżistenza ta' HIV-1 għal lamivudine tinvolvi l-iżvilupp ta' bidla fl-aċidu amminiku M184V qrib is-sit attiv tar-reverse transcriptase (RT) tal-virus.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor about the risks and benefits to you and your baby of taking Lamivudine Teva Pharma B.V.. Lamivudine Teva Pharma B.V. and similar medicines may cause side effects in unborn babies.
Maltese: Meta tkun qed tiġi kkurat għall-HIV, huwa diffiċili tgħid jekk sintomu huwiex effett sekondarju ta' Lamivudine Teva Pharma jew ta' mediċini oħra li tkun qed tieħu, jew effett tal-marda ta' HIV nnifisha.
English: Each infusion lasts 10 or 30 minutes, according to the dose.
Maltese: Kull infużjoni ddum 10 minuti sa 30 minuta, skont id-doża.
English: It is given in four-week treatment cycles, on days 1, 2, 8, 9, 15 and 16 of each cycle.
Maltese: Dan jingħata f'ċikli ta' kura ta' erba' ġimgħat, fil-jiem 1, 2, 8, 9, 15 u 16 ta' kull ċiklu.
English: Kyprolis received a marketing authorisation valid throughout the EU on 19 November 2015.
Maltese: Kyprolis irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fid-19 ta' Novembru 2015.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: Kyprolis contains the active substance carfilzomib.
Maltese: Kyprolis fih is-sustanza attiva carfilzomib.
English: The active substance in Kyprolis, carfilzomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva f'Kyprolis, carfilzomib, hija inibitur ta' proteasome.
English: Other information about Kyprolis
Maltese: Informazzjoni oħra dwar Kyprolis
English: What are the risks associated with Kyprolis?
Maltese: X'inhuma r-riskji assoċjati ma' Kyprolis?
English: Other serious side effects are dyspnoea, acute kidney injury, tumour lysis syndrome (a complication due to the breakdown of cancer cells), infusion-related reactions, thrombocytopenia, internal bleeding, posterior reversible encephalopathy syndrome (a brain disorder that can cause headache, confusion, fits and loss of vision, and which may improve over time) as well as thrombotic microangiopathy and TTP/HUS (diseases involving problems with the blood clotting system).
Maltese: Effetti sekondarji serji oħra huma dispnea, korriment akut tal-kliewi, sindrome ta' lisi tat-tumur (kumplikazzjoni minħabba t-tkissir taċ-ċelloli talkanċer), reazzjonijiet relatati mal-infużjoni, tromboċitopenja, fsada interna, sindrome ta' enċefalopatija riversibbli posterjuri (disturb tal-moħħ li jista' jikkawża wġigħ ta' ras, konfużjoni, aċċessjonijiet u telf tal-vista, u li jista' jitjieb maż-żmien) kif ukoll mikroanġjopatija trombotika u TTP/HUS (mard li jinvolvi problemi bis-sistema tal-koagulazzjoni).
English: Multiple myeloma is rare, and Kyprolis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 June 2008.
Maltese: Il-majeloma multipla hija rari, u Kyprolis ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-3 ta' Ġunju 2008.
English: Kyprolis is a cancer medicine used together with the medicines lenalidomide and dexamethasone or with dexamethasone alone, to treat multiple myeloma (a cancer of the bone marrow).
Maltese: Kyprolis huwa mediċina kontra l-kanċer li tintuża flimkien mal-mediċini lenalidomide u dexamethasone jew ma' dexamethasone waħdu, biex tikkura majeloma multipla (kanċer tal-mudullun).
English: From cycle 13 onwards, the doses on day 8 and 9 are omitted if Kyprolis is used with lenalidomide and dexamethasone.
Maltese: Mit-13-il ċiklu 'l quddiem, id-dożi fil-jiem 8 u 9 ma jingħatawx jekk Kyprolis jintuża ma' lenalidomide u dexamethasone.
English: The most common side effects with Kyprolis (which may affect more than 1 in 5 people) are anaemia (low red blood cell counts), tiredness, nausea, diarrhoea, thrombocytopenia (low blood platelet counts), fever, dyspnoea (difficulty breathing), respiratory tract (airways) infection, cough and neutropenia (low levels of neutrophils, a type of white blood cell).
Maltese: L-effetti sekondarji l-aktar komuni b'Kyprolis (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma anemija (għadd baxx ta' ċelloli ħomor tad-demm), għeja, nawżja, dijarea, tromboċitopenija (għadd baxx ta' pjastrini tad-demm), deni, dispnea (diffikultà biex tieħu nifs), infezzjoni fil-passaġġ respiratorju (passaġġi tan-nifs), sogħla u newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm).
English: As for all medicines, data on the use of Kyprolis is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Kyprolis hija ssorveljata kontinwament.