FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of NeuroBloc (see section 4.3).
Maltese: Pazjenti b'disturbi newromuskolari jistgħu jkollhom żieda fir-riskju ta' effetti klinikament sinifikanti li jinkludu problemi severi biex tibla' u kompromess respiratorju minn dożi tipiċi ta' NeuroBloc (ara sezzjoni 4.3).
English: 0.5 ml, 1 ml or 2 ml solution in a 3.5 ml Type I glass vial, with siliconised butyl rubber stoppers oversealed by aluminium crimped caps.
Maltese: Soluzzjoni ta' 0.5 ml, 1 ml jew 2 ml f'kunjetti tal-ħġieġ tat-Tip I ta' 3.5 ml, b'tappijiet tal-lastiku butyl issiġġilati b'għotjien ta' l-aluminju magħfusin bil-pressa.
English: NeuroBloc should not be used during pregnancy unless the clinical condition of the woman requires treatment with Botulinum Toxin Type B (see section 5.3).
Maltese: NeuroBloc m'għandux jingħata waqt it-tqala ħlief meta jkun hemm bżonn speċifiku tat-trattament b'Tossina Botulinum ta' Tip B (ara sezzjoni 5.3).
English: And
Maltese: U
English: Store in a refrigerator at 2oC-8oC.
Maltese: Aħżen fi friġġ (2oC - 8oC).
English: The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/kg.
Maltese: Il-Livell tadDoża bl-Ebda Effett Osservat (NOEL) sistemiku ġie muri li hu madwar 960 U/kg.
English: Nervous system disorders dry mouth, headache torticollis (worsening from baseline), taste perversion
Maltese: Disturbi fis-sistema nervuża ħalq xott, uġigħ ta' ras tortikollis (tirkadi mil-linja bażi), perverżjoni tat-togħma
English: if you are allergic to Botulinum Toxin Type B or any of the other ingredients of NeuroBloc (listed in section 6) if you have other problems with your nerves or muscles, such as amyotrophic lateral sclerosis (Lou Gehrig's disease), peripheral neuropathy, myasthenia gravis or Lambert-Eaton syndrome (muscle weakness or numbness or pain) if you have been experiencing shortness of breath or difficulty swallowing
Maltese: - jekk inti allerġiku għal Tossina Botulinum ta' Tip B jew għal xi ingredjenti oħra ta' din ilmediċina (imniżżla fis-sezzjoni 6). - jekk għandek problemi oħrajn fin-nervaturi jew fil-muskoli tiegħek, bħal sklerosi amitrofika laterali (il-marda ta' Lou Gehrig), newropatija periferali, mijastenja gravis jew is-sindrome ta' Lambert-Eaton (dgħufija fil-muskoli jew tmewwit jew uġigħ) - jekk ikun qed ikollok qtugħ ta' nifs jew diffikultà biex tibla'
English: The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' NeuroBloc fit-tfal tal-età ta' anqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2).
Maltese: Biex tippermetti d-diviżjoni tad-doża totali bejn diversi injezzjonijiet, NeuroBloc jista' jiġi dilwit b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride (ara sezzjoni 4.2).
English: Common (may affect up to 1 in 10 people) blurred vision or drooping of your upper eyelid indigestion or being sick (vomiting) constipation neck pain feeling weak, pain or stiff muscles around your body loss of strength or energy changes in the taste of your food and drink changes in the sound of your voice flu-like symptoms
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - vista mċajpra jew id-dendil ta' tebqet il-għajn tan-naħa ta' fuq - indiġestjoni u/jew tirremetti - stitikezza - uġigħ fl-għonq - tħossok dgħajjef, ikollok uġigħ jew ebusija fil-muskoli madwar ġismek - nuqqas jew ta' saħħa jew enerġija - tibdil kif ittiegħem l-ikel u x-xorb - tibdil fil-vuċi tiegħek - sintomi bħal tal-influwenza
English: The following effects have also been reported during post marketing use: abnormal accommodation, ptosis, vomiting, constipation, flu-like symptoms, asthenia, angioedema, rash, urticaria and pruritus.
Maltese: L-effetti li ġejjin kienu rrappurati wkoll waqt l-użu ta' wara t-tqegħid fis-suq: akkomodazzjoni mhux normali, ptosi, rimettar, stitikezza, sintomi bħal ta' l-influwenza, astenja, anġjoedema, raxx, urtikarja u ħakk.
English: Adverse reactions related to spread of toxin distant from the site of administration have been reported: exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases (see section 4.4).
Maltese: Reazzjonijiet avversi relatati mal-firxa ta' tossina li tkun imbiegħda mis-sit tal-għoti kienu rrappurtati: dgħufija eċċessiva fil-muskoli, problemi biex tibla', dispnea, pnewmonite tal-aspirazzjoni b'riżultat fatali f'xi każijiet (ara sezzjoni 4.4).
English: The primary efficacy assessment was the TWSTRS Total score, and secondary efficacy assessments included VAS assessment of change evaluated by patient and investigator, conducted at 4, 8 and 12 weeks after treatment.
Maltese: Il-punteġġ totali, u l-evalwazzjonijiet tal-effikaċja sekondarja kienu jinkludu l-evalwazzjoni VAS tal-bidla evalwata mill-pazjent u l-investigatur, imwettqa wara 4, 8 u 12-il ġimgħa wara l-kura.
English: To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2 of Summary of Product Characteristics).
Maltese: Biex tippermetti d-diviżjoni tad-doża totali bejn diversi injezzjonijiet, NeuroBloc jista' jiġi dilwit b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni (ara sezzjoni 4.2 tas-Sommarju talKaratteristiċi tal-Prodott).
English: The potency of Neurobloc is 5000 U/ml.
Maltese: NeuroBloc 5000
English: Other medicines and NeuroBloc
Maltese: Mediċini oħra u NeuroBloc
English: The potential risk for humans is unknown.
Maltese: Ir-riskju li jista' jkun hemm fuq in-nies, mhux magħruf.
English: Musculoskeletal connective tissue and bone disorders myasthenia
Maltese: Disturbi muskolu-skeltriċi u tat-tessuti konnettivi mijastenja
English: Skin allergies such as rash with or without paleness, redness, patches, severe itching; and skin eruptions such as welts or hives have also been reported after receiving NeuroBloc.
Maltese: Allerġiji tal-ġilda bħal raxx bi jew mingħajr sfura, ħmura, irqajja', ħakk sever; u eruzzjonijiet tal-ġilda bħal welts jew urtikarja kienu rrappurtati wkoll wara li pazjent ikun ingħata NeuroBloc.
English: EU/1/00/166/001 - 2500 U EU/1/00/166/002 - 5000 U EU/1/00/166/003 - 10,000 U
Maltese: U EU/1/00/166/002 - 5000
English: You may need urgent medical treatment.
Maltese: Jista' jkollok bżonn ta' kura medika urġenti.
English: Single dose pharmacology studies in cynomolgus monkeys have shown no effects other than the anticipated dose-dependent paralysis of injected muscles, together with some diffusion of toxin at high doses producing similar effects in neighbouring non-injected muscles.
Maltese: Studji farmakoloġiċi ta' doża waħda fix-xadini cynomolgus ma wrew l-ebda effetti għajr il-paraliżi mistennija dipendenti fuq id-doża tal-muskoli injettati, flimkien ma' xi firxa ta' tossina f'dożi għoljin li jipproduċu effetti simili fil-muskoli tal-madwar mhux injettati.
English: However, in clinical studies, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.
Maltese: Madankollu, fi studji kliniċi, NeuroBloc ġie mogħti 16-il ġimgħa wara l-injezzjoni ta' Tossina Botulinum ta' Tip A.
English: In addition to improved function as demonstrated by a reduction in TWSTRS-total score, treatment with NeuroBloc was associated with a significant reduction in TWSTRS-Pain and pain VAS scores at each treatment session at weeks 4, 8 and 12 relative to baseline.
Maltese: Flimkien ma' funzjoni mtejba, kif muri mit-tnaqqis fil-punteġġ ta' TWSTRS totali, il-kura b'NeuroBloc kienet assoċjata ma' tnaqqis sinifikanti f'Uġigħ TWSTRS u punteġġi VAS tal-uġigħ f'kull sessjoni ta' kura f'ġimgħat 4, 8 u 12, meta mqabbel mal-linja bażi.
English: As with many biological/biotechnology proteins used as therapeutic agents, repeated administration of NeuroBloc may be associated with development of antibodies to Botulinum Toxin Type B in some patients.
Maltese: Bħal fil-każ ta' ħafna proteini bijoloġiċi użati bħala mediċini terapewtiċi, l-amministrazzjoni ripetuta ta' NeuroBloc tista' tkun assoċjata mal-iżvilupp ta' antikorpi għal Tossina Botulinum ta' Tip B f'xi pazjenti.
English: Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4).
Maltese: Effetti sekondarji relatati mal-firxa tat-tossina l-bogħod mis-sit ta' l-għotja kienu rrappurtati (indebboliment esaġerat fil-muskoli, disfaġja, dispnea, pnewmonja ta' aspirazzjoni b'riżultat fatali f'xi każijiet) (ara sezzjoni 4.4).
English: Single dose intramuscular toxicology studies have been performed in cynomolgus monkeys.
Maltese: Ġew imwettqa studji tossikoloġiċi intramuskolari ta' doża waħda fix-xadini cynomolgus.
English: Specifically, these studies showed approximately 19-25% seroconverted within 18 months of initiation of treatment, increasing to approximately 33-44% with up to 45 months of treatment.
Maltese: Speċifikament, dawn l-istudji wrew madwar 19-25% seroconvertiti fi żmien 18-il xahar mill-bidu tal-kura, u dawn żdiedu għal madwar 33-44% b'sa 45 xahar ta' kura.
English: NeuroBloc is a neuromuscular blocking agent.
Maltese: NeuroBloc huwa sustanza li timblokka n-newromuskoli.
English: In patients with neuromuscular disorders or history of dysphagia and aspiration, botulinum toxins should only be used in an experimental setting under strict medical supervision.
Maltese: F'pazjenti b'disturbi newromuskolari jew storja medika ta' problemi biex tibla' u aspirazzjoni, tossini botulinum għandhom jintużaw biss fi sfond sperimentali taħt superviżjoni medika stretta.
English: These dose units are specific to NeuroBloc only and are not relevant to preparations of Botulinum Toxin Type A. The unit dose recommendations for Botulinum Toxin Type A are significantly lower than those for NeuroBloc and administration of Botulinum Toxin Type A at the unit dose recommended for NeuroBloc may result in systemic toxicity and life-threatening clinical sequelae.
Maltese: Ir-rakkommandazzjonijiet għall-unità ta' doża għal Tossina Botulinum ta' Tip A huma ferm inqas minn dawk għal NeuroBloc u l-għoti ta' Tossina Botulinum ta' Tip A f'unità ta' doża rakkommandata għal NeuroBloc tista' tirriżulta f'tossiċità sistemika u riżultati li jheddu l-ħajja.
English: The potency of this medicinal product is expressed in NeuroBloc 5000 U/ml.
Maltese: Il-qawwa ta' dan il-prodott mediċinali hija espressa f'NeuroBloc 5000
English: Analysis of the TWSTRS sub scales revealed significant effects on the severity of cervical dystonia and its associated pain and disability.
Maltese: Analiżi tas-sub skali tat-TWSTRS wrew effetti sinnifikanti fuq il-gravità ta' distonja ċervikali u l-uġigħ u d-diżabilità assoċjati magħha.
English: The safety of NeuroBloc outside the approved indication has not been established.
Maltese: Is-sigurtà ta' NeuroBloc 'il barra mill-indikazzjoni approvata ma ġietx stabbilita.
English: For instructions on dilution of the product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: The presence of antibodies in these studies was assessed using the mouse protection assay (also known as the Mouse Neutralization Assay, MNA).
Maltese: Il-preżenza ta' antikorpi f'dawn l-istudji ġiet evalwata bl-użu ta' assaġġ tal-protezzjoni talġrieden (magħruf ukoll bħala Mouse Neutralization Assay, MNA).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 0.5 ml vial
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT kunjett ta' 0.5 ml
English: Special populations
Maltese: TA' EĊĊIPJENTI
English: Standard tests to investigate the mutagenicity of NeuroBloc have not been performed.
Maltese: Ma saru l-ebda testijiet stàndard sabiex tiġi investigata l-mutaġeniċità ta' NeuroBloc.
English: How to store NeuroBloc
Maltese: Kif gћandek tuża NeuroBloc
English: In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.
Maltese: B'mod komuni ma' Tossina Botulinum ta' Tip A, rogħda elettrofiżjoloġiku, li mhuwiex assoċjat ma' dgħufija klinika jew ma' anormalitajiet elettrofiżjoloġiċi oħra, jista' jseħħ f'xi muskoli distanti.
English: On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Maltese: Fuq dawn iż-żewġ skali, punteġġi ta' 50 ma jindikaw ebda bidla, 0 ħafna agħar, u 100 ħafna aħjar.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1.0 ml vial
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT kunjett ta' 1.0 ml
English: Aspiration pneumonia caused by food particles or vomit entering into the lungs, and respiratory disease, have been reported after treatment with botulinum toxins (Type A and Type B).
Maltese: Pnewmonja tal-aspirazzjoni kkawżata minn biċċiet tal-ikel jew rimettar li jidħlu fil-pulmun, u mard respiratorju, kienu rrappurtati wara l-kura b'tossini botulinum (Tip A u Tip B).
English: This can be due to the high dosages usually used in this population.
Maltese: L-irkuprar normalment iseħħ fuq perjodu ta' żmien.
English: Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.
Maltese: Informazzjoni minn studji kliniċi tissuġġerixxi li l-effikaċja hija dipendenti fuq id-doża iżda dawn il-provi, minħabba li ma kienux iddisinjati għal tqabbil, ma jurux differenza sinifikanti bejn 5000
English: Change from Baseline -2.0 P-Value*
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: STUDY 2 (A-Responsive Patients)
Maltese: STUDJU 2 (Pazjenti li Jirrispondu għal A)
English: In non clinical experiments, NeuroBloc solution has been diluted up to 6-fold without any resulting change in potency.
Maltese: F'esperimenti mhux kliniċi, soluzzjoni ta' NeuroBloc ġiet dilwita sa 6 darbiet mingħajr ma rriżultat l-ebda bidla fil-potenza.
English: What you need to know before you use NeuroBloc Do not use NeuroBloc:
Maltese: X'għandek tkun taf qabel ma tuża NeuroBloc Tużax NeuroBloc:
English: In the fertility studies the NOAEL was 300 U/kg/day for general toxicity in both males and females and 1000 U/kg/day for fertility and reproductive performance.
Maltese: U/kg/ġurnata għal fertilità u rendiment riproduttiv.
English: Each ml contains 5000 U Botulinum Toxin Type B.
Maltese: U ta' Tossina Botulinum ta' Tip B.
English: Renal and hepatic impairment
Maltese: Tqala, treddigħ u fertilità
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> Other sources of information
Maltese: Dan il-fuljett kien rivedut l-aħħar f' <{XX/SSSS}> <{xahar SSSS}> Sorsi oħra ta' informazzjoni
English: Solution for injection.
Maltese: Soluzzjoni għall-injezzjoni.
English: To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and the solution used immediately.
Maltese: Biex tippermetti d-diviżjoni tad-doża totali bejn diversi injezzjonijiet, NeuroBloc jista' jiġi dilwit b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride u s-soluzzjoni għandha tintuża immedjatament.
English: Both studies enrolled adult patients (³ 18 years) who had a history of receiving Botulinum Toxin Type A. The first study enrolled patients who were clinically resistant to type A toxin (A-non responders), confirmed by a Frontalis Type A test.
Maltese: L-ewwel studju rreġistra pazjenti li kienu klinikament reżistenti għat-tossina tat-tip A (pazjenti li ma jirrispondux għal A), ikkonfermati b'test Frontalis tat-tip A.
English: There were 77 subjects enrolled into the first study and 109 subjects into the second.
Maltese: Kien hemm 77 pazjent irreġistrat fl-ewwel studju u 109 pazjenti fit-tieni.
English: Spread of toxin effect
Maltese: .8 Effetti mhux mixtieqa
English: NeuroBloc 5000 U/ml solution for injection Botulinum Toxin Type B
Maltese: U/ml soluzzjoni għall-injezzjoni Tossina Botulinum ta' Tip B
English: The available reports indicate that the product has been used in the paediatric population.
Maltese: Ir-rapporti disponibbli jindikaw li l-prodott intuża fil-popolazzjoni pedjatrika.
English: Do not shake.
Maltese: Mekkaniżmu ta' azzjoni
English: From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination the product should be used immediately.
Maltese: Mill-aspett mikrobijoloġiku, sakemm il-metodu ta' ftuħ/dilwizzjoni ma teskludix r-riskju ta' kontaminazzjoni b'mikrobi, il-prodott għandu jintuża minnufiħ.
English: Immunogenicity data from three long term clinical studies indicate that approximately one third of patients develop antibodies, as determined by the mouse neutralisation/mouse protection assay dependent on duration of exposure (see section 5.1).
Maltese: Dejta dwar l-immunoġeniċità minn tliet studji fit-tul jindikaw li madwar terz tal-pazjenti jiżviluppaw antikorpi, kif stabbilit mill-assaġġ tan-newtralizzazzjoni tal-ġrieden/assaġġ tal-protezzjoni tal-ġrieden li jiddependu mit-tul ta' żmien ta' espożizzjoni (ara sezzjoni 5.1).
English: INSTRUCTIONS ON USE
Maltese: Twissijiet u prekawzjonijiet
English: A serious condition called “botulism” which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body.
Maltese: Kundizzjoni serja msejħa “botuliżmu” li tikkawża paralisi tal-muskoli u waqfien tan-nifs, tista' sseħħ jekk tiġi injettata wisq mis-sustanza attiva (tossina botulinum) f'ġismek.
English: The application was withdrawn after ‘day 181'.
Maltese: L-applikazzjoni ġiet irtirata wara ‘jum 181'.
English: It contains the active substance doxorubicin (2 mg/ml).
Maltese: Fih is-sustanza attiva doksorubiċina (2 mg/ml).
English: What is Doxorubicin SUN?
Maltese: X'inhu Doxorubicin SUN?
English: Doxorubicin SUN was assessed as a ‘hybrid generic medicine'.
Maltese: Doxorubicin SUN ġie vvalutat bħala ‘mediċina ġenerika ibrida'.
English: On 20 Jul 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Doxorubicin SUN, intended for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma.
Maltese: Fl-20 ta' Lulju 2011, Sun Pharmaceutical Industries Europe B.V. innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Doxorubicin SUN, maħsub għall-kura ta' kanċer metastatiku tas-sider, għall-kanċer avvanzat tal-ovarji u għall-majeloma multipla progressiva.
English: Doxorubicin SUN was expected to work in the same way as the reference medicine, Caelyx.
Maltese: Doxorubicin SUN kien mistenni jaħdem bl-istess mod tal-mediċina ta' referenza, Caelyx.
English: Doxorubicin SUN was to be used in combination with bortezomib (another anticancer medicine).
Maltese: Doxorubicin SUN kellu jintuża flimkien mal-bortezomib (mediċina oħra kontra l-kanċer).
English: The active substance in Doxorubicin SUN and Caelyx, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Maltese: Is-sustanza attiva f'Doxorubicin SUN u Caelyx, id-doksorubiċina, hija mediċina ċitotossika li tappartieni lill-grupp ‘antraċiklini'.
English: In Caelyx and Doxorubicin SUN, doxorubicin is contained (encapsulated) in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Maltese: F'Caelyx u f'Doxorubicin SUN, id-doksorubiċina tinżamm (enkapsulata) f'‘liposomi pegilati' (sferi żgħar grassi miksijin b'kimika msejħa polijetelina glikola.
English: • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working;
Maltese: • kanċer avvanzat tal-ovarji (kanċer tal-ovarji) f'nisa li l-kura preċedenti tagħhom, inkluż b'mediċina kontra l-kanċer ibbażata fuq il-platinu, ma baqgħetx taħdem;
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP kien ivvaluta d-dokumentazzjoni pprovduta mill-kumpanija u ħejja lista ta' mistoqsijiet.
English: This included the total amount of doxorubicin and the amounts of liposome-encapsulated doxorubicin, free doxorubicin and doxorubicinol (the main metabolite of doxorubicin).
Maltese: Dan inkluda l-ammont totali tad-doksorubiċina u l-ammonti tal-doksorubiċina inkapsulati f'liposomi, iddoksorubiċina libera u d-doksorubiċinolu (il-metabolit prinċipali tad-doksorubiċina).
English: It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects.
Maltese: Inaqqas ukoll l-effetti tiegħu fuq tessuti u ċelloli mhux tal-kanċer, u għaldaqstant huwa inqas probabbli li jikkawża xi effett sekondarju.
English: Doxorubicin SUN is concentrate to be made up into a solution for infusion (drip into a vein).
Maltese: Doxorubicin SUN huwa konċentrat magħmul f'soluzzjoni għal infużjoni (dripp f'vina).
English: • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant.
Maltese: • majeloma multipla (kanċer taċ-ċelloli fil-mudullun), f'pazjenti b'marda progressiva li kienu ngħataw mill-inqas kura oħra fl-imgħoddi u li diġà jkun sarilhom minn trapjant tal-mudullun jew li ma jkunx jista' jsirilhom dan it-trapjant.
English: • metastatic breast cancer in patients at risk of heart problems.
Maltese: • kanċer metastatiku tas-sider f'pazjenti b'riskju ta' problemi fil-qalb. ‘Metastatiku' tfisser li kanċer ikun inxtered għal partijiet oħra tal-ġisem.
English: How was Doxorubicin SUN expected to work?
Maltese: Għal xiex kien mistenni jintuża Doxorubicin SUN?
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union containing the same active substance, called Caelyx.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea li fiha l-istess sustanza attiva, imsejħa Caelyx.
English: Doxorubicin SUN was originally also expected to be used to treat AIDS-related Kaposi's sarcoma (a cancer of the blood vessels) but this indication was withdrawn during the evaluation process.
Maltese: Oriġinarjament, Doxorubicin SUN kien mistenni wkoll jintuża biex jittratta sarkoma ta' Kaposi relatata mal-AIDS (kanċer tal-vażi tad-demm) iżda din l-indikazzjoni ġiet irtirata matul il-proċess ta' valutazzjoni.
English: Based on the data submitted, the CHMP was of the opinion that the studies did not provide enough evidence to show that Doxorubicin SUN was similar to the reference medicine.
Maltese: Fuq il-bażi tad-dejta sottomessa, is-CHMP kien tal-opinjoni li l-istudji ma pproduċewx evidenza biżżejjed li turi li Doxorubicin SUN kien simili għall-mediċina ta' referenza.
English: Doxorubicin SUN was expected to be used to treat the following types of cancer in adults:
Maltese: Doxorubicin SUN kien mistenni jintuża biex jittratta dawn it-tipi ta' kanċer fl-adulti:
English: These included studies in patients with ovarian cancer and multiple myeloma to investigate the concentrations of doxorubicin in the blood produced by Doxorubicin SUN compared with Caelyx.
Maltese: Dawn inkludew studji f'pazjenti b'kanċer tal-ovarji u b'majeloma multipla sabiex jinvestigaw ilkonċentrazzjonijiet tad-doksorubiċina fid-demm prodotti b'Doxorubicin SUN apparagun ma' Caelyx.
English: Pazenir (paclitaxel)
Maltese: Pazenir (paklitaksel)