FrancophonIA/ELRC3.0 huggingface dataset:
English: Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.
Maltese: Evita li tuża f'annimali deidrati b'mod sever, ipovolaemiċi jew ipotensivi,peress li jista' jkun hemm riskju potenzjali ta' tossiċità tal-kliewi.
English: Muscle Liver Kidney
Maltese: Muskolu Fwied Kliewi
English: Florfenicol is considered to be a bacteriostatic agent, but in vitro studies demonstrate its bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: Florfenicol hu kkonsidrat li hu sustanza batterjostatika, imma studjiin vitro wrew l-attività batteriċidali kontra Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days.
Maltese: Dawn l-effetti kienu transitorji u ġeneralment irriżolvew mingħajr ebda trattament fi żmien 5 ijiem sa 15-il jum, imma jistgħu jippersistu sa 49 jum.
English: Pack size: 1 vial per cardboard box
Maltese: Kunjett 1 f'kaxxa tal-kartun
English: A single subcutaneous injection at a dosage of 40 mg florfenicol/kg bodyweight and 0.5 mg meloxicam/ kg bodyweight (i.e. 1 ml/10 kg bodyweight).
Maltese: Injezzjoni waħda taħt il-ġilda ta' dożaġġ ta' 40 mg florfenicol/kg/piż tal-ġisem u 0.5 mg meloxicam/kg/piż tal-ġisem (i.e. 1 ml/10 kg piż tal-ġisem).
English: Antiinfectious agents/Antibi otics
Maltese: Sustanzi ta' kontra linfezzjoni / Antibijotiċi
English: Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq responsabbli għall-ħrug tal-lott: Ceva Santé Animale
English: Florfenicol is mainly excreted via the urine and to a small extent via the faeces with a half-life of about 60 h. Meloxicam excretion is equally divided between urine and faeces, with a half-life of about 23 h.
Maltese: L-eliminazzjoni ta' meloxicam huwa maqsum b'mod ugwali bejn urina u lippurgar, b'half-life ta' madwar 23 h.
English: Repeated weekly administration of overdoses (3x and 5x the recommended dose) in calves was associated with decreased milk consumption, decreased weight gain, loose faeces or diarrhoea.
Maltese: Għoti ripetut kull ġimgħa ta' dożi eċċessivi (3x u 5x id-doża rakkomandata) f'għoġġiela kien assoċjat ma' konsum inqas ta' ħalib, żieda mnaqqsa fil-piż, ippurgar maħlul jew dijarea.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Pharmacokinetic particulars
Maltese: Karatteristiċi farmakodinamiċi
English: Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: It-testijiet tal-laboratorju wrew li florfenicol huwa attiv kontra l-patoġeni batteriċi iżolati l-aktar komuni involuti fil-mard respiratorju tal-ifrat li jinkludu Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: 400 mg/ml florfenicol 5 mg/ml meloxicam
Maltese: 5 mg/ml meloxicam
English: Meloxicam also has anti-endotoxic properties, because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin after administration in calves, lactating cows and pigs.
Maltese: Meloxicam għandu wkoll proprjetajiet antiendotossiċi, peress li ntwera li jimpedixxi l-produzzjoni ta' thromboxane B2 indott mll-endotossina E.coli wara l-għoti f'għoġġiela, baqar ireddgħu u ħnieżer.
English: Repeated weekly administration of a 5x dose was fatal in 7 out of 8 calves after the third administration.
Maltese: L-għoti ripetut ta' 5x id-doża kien fatali f'7 mit-8 għoġol wara t-tielet għotja.
English: Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle florfenicol / meloxicam
Maltese: VETERINARJU Zeleris 400 mg/ml + 5 mg/ml soluzzjoni għal injezzjoni għall-ifrat florfenicol / meloxicam
English: Meat and offal: 56 days.
Maltese: Laħam u ġewwieni tal-annimali: 56 jum
English: Sum of florfenicol and its metabolites measured as florfenicolamine
Maltese: Is-somma ta' florfenicol u l-metaboliti tiegħu mkejla bħala amin ta' florfenicol
English: Each ml contains:
Maltese: Daqs tal-pakkett:
English: INDICATION
Maltese: TAMMINISTRA
English: Muscle Liver Kidney Milk
Maltese: Muskolu Fwied Kliewi Ħalib
English: Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle
Maltese: VETERINARJU Zeleris 400 mg/ml +5 mg/ml soluzzjoni għal injezzjoni għall-ifrat
English: Fertility Do not use in adult bulls intended for breeding (see section “Contraindications”).
Maltese: Fertilità Tużax f'barrin adulti maħsuba għat-tgħammir (ara sezzjoni 4.3 "Kontraindikazzjonijiet").
English: Excipients:
Maltese: Żmiem ta' tiżmim:
English: Resistance to florfenicol is mainly mediated by an efflux system due to a specific (Flo-R) or multidrug transporter (AcrAB-TolC).
Maltese: Ir-reżistenza għal florfenicol issir prinċipalment permezz ta' sistema ta' efluss minħabba trasportatur speċifiku (Flo-R) jew ta' diversi mediċini (AcrAB-ToIC).
English: After subcutaneous administration of the product at recommended dose of 1 ml/10 kg bodyweight maximum mean plasma concentration (Cmax) of 4.6 mg/l and 2.0 mg/l occurred 10 hours (h) and 7 h after dosing for florfenicol and meloxicam, respectively.
Maltese: Wara l-għoti taħt il-ġilda tal-prodott fid-doża rakkomandata ta' 1 ml/10 kg piż tal-ġisem ilkonċentrazzjoni massima medja fil-plażma (Cmax) ta' 4.6 mg/l u 2.0 mg/l seħħew 10 sigħat (h) u 7 h wara l-għoti tad-doża ta' florfenicol u meloxicam, rispettivament. Livelli effikaċi ta' florfenicol filplażma jibqgħu jinżammu 'l fuq mill-MIC90 ta' 1 µg/ml, 0.5 µg/ml u 0.2 µg/ml għal 72 h, 120 h u 160 h, rispettivament.
English: Fertility Do not use in adult bulls intended for breeding (see section 4.3).
Maltese: Fertilità Tużax f'barrin adulti maħsuba għal tgħammir (ara sezzjoni 4.3).
English: EXP Once broached, use within 28 days, by __/__/__.
Maltese: Ġaladarba jinfetaħ, uża fi żmien 28 jum, sa __/__/__
English: For the full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa tal-ingredjenti ara s-sezzjoni 6.1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 50 ml, 100 ml and 250 ml vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun ta' kunjetti ta' 50 ml, 100 ml u 250 ml
English: Repeated weekly administration of a 3x dose was fatal in 1 out of 8 calves after the third administration.
Maltese: Għoti ripetut kull ġimgħa ta' 3x id-doża kien fatali f'1 mit-8 għoġġiela wara t-tielet għotja.
English: SC
Maltese: UŻU
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lil kirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Milk: Not authorised for use in lactating animals producing milk for human consumption.
Maltese: Mhux awtorizzat għal użu f'annmali li jreddgħu li jipproduċu ħalib għal konsum uman.
English: Surveillance data of the susceptibility of target field isolates from cattle, collected between 2004 and 2012 across Europe, show consistent efficacy of florfenicol with no finding of resistant isolates.
Maltese: Tagħrif ta' sorvelljanza tas-suxxettibilità ta' iżolati fil-kamp tal-mira minn ifrat, miġbura bejn l-2004 u 2012 minn madwar l-Ewropa, juru effikaċja konsistenti għal florfenicol mingħajr ebda riżultati għal iżolati reżistenti.
English: The genes corresponding to these mechanisms are coded on mobile genetic elements such as plasmids, transposon or genes cassettes.
Maltese: Il-ġeni li jikkorispondu ma' dawn ilmekkaniżmi huma kkodifikati f'elementi ġenetiċi mobbli bħal plasmids, transposon jew kasetti ta' ġeni.
English: Species
Maltese: IEĦOR
English: 1 ml contains 400 mg of florfenicol and 5 mg of meloxicam.
Maltese: OĦRA 1 ml fih 400 mg ta' florfenicol u 5 mg ta' meloxicam Soluzzjoni safra u ċara
English: People with known hypersensitivity to florfenicol, meloxicam or to any of the excipients should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma magħrufin li huma sensittivi għal florfenicol, meloxicam jew għal xi wieħed milleċċipjenti għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: Dose dependent maternotoxic and foetotoxic effects have been observed after oral administration of meloxicam to pregnant rats.
Maltese: Effetti maternotossiċi u fetotossiċi dipendenti fuq id-doża ġew osservati wara l-għoti mill-ħalq ta' meloxicam lil firien tqal.
English: Not for animals from which milk is produced for human consumption
Maltese: Ħalib Mhux awtorizzat għal użu f'annmali li jreddgħu li jipproduċu ħalib għal konsum uman.
English: Otherwise, the use of a multiple-dose syringe is recommended.
Maltese: Inkella, l-użu ta' siringa ta' dożi multipli hi rakkomandata.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MOD TA' AMMINISTRAZZJONI Taħt il-ġilda
English: The in vitro Minimum Inhibitory Concentration (MIC) distribution values for these field isolates are presented in the table below.
Maltese: Il-valuri ta' firxa tal-Konċentrazzjoni Minima ta' Impediment (MIC - Minimum Inhibitory Concentartion) in vitro għal dawn l-iżolati tal-kamp huma ppreżentati fit-tabella t'hawn isfel.
English: Interactions with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Maltese: Interazzjonijiet ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni M'għandekx tamministra flimkien ma' glukokortikojdi, mediċini antinfjammatorji mhux steojdali jew sustanzi antikoagulanti.
English: It reduces leukocyte infiltration into the inflamed tissue.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni.
English: Further information on Adcetris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Adcetris.
Maltese: ema.europa.eu/medicines/human/EPAR/Adcetris.
English: Adcetris (brentuximab vedotin)
Maltese: Adcetris (brentussimab vedotin)
English: Hodgkin's lymphoma
Maltese: Linfoma ta' Hodgkin
English: Adcetris has been given ‘conditional approval'.
Maltese: Adcetris ingħata ‘approvazzjoni kondizzjonali'.
English: This overview was last updated in 01-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'01-2019.
English: The most common side effects of Adcetris given alone (which may affect more than 1 in 10 people) are infections (including infections of the nose and throat), peripheral sensory or motor neuropathy (nerve damage that affects feeling or muscle control and co-ordination), tiredness, nausea (feeling sick), diarrhoea, fever, neutropenia, rash, cough, vomiting, joint pain, infusion-related reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain.
Maltese: L-effetti sekondarji l-aktar komuni (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet (inkluż infezzjonijiet tal-imnieħer u l-gerżuma) newropatija periferali sensorjali jew newropatija periferali tal-movimenti (ħsara fin-nervituri li taffettwa l-ħass jew il-kontroll tal-muskoli u l-koordinazzjoni), għeja, nawżja (tħossok ma tiflaħx), dijarea, deni, newtropenja, raxx, sogħla, rimettar, uġigħ fil-ġogi, reazzjonijiet relatati mal-infużjoni, ħakk, stitikezza, dispnea (diffikultà fit-teħid tan-nifs), telf fil-piż, uġigħ fil-muskoli u wġigħ addominali (fiż-żaqq).
English: Other information about Adcetris
Maltese: Informazzjoni oħra dwar Adcetris
English: After 2 years, 82% of patients given Adcetris survived without their disease getting worse, compared with 77% of patients given bleomycin.
Maltese: Wara sentejn, 82 % tal-pazjenti li ngħataw Adcetris għexu mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbel ma' 77 % tal-pazjenti li ngħataw bleomycin.
English: The active substance in Adcetris, brentuximab vedotin, is made up of a CD30 monoclonal antibody (a type of protein that attaches to CD30).
Maltese: Is-sustanza attiva f'Adcetris, il-brentussimab vedotin, hija magħmula minn antikorp monoklonali CD30 (tip ta' proteina li teħel ma' CD30).
English: A complete response was observed in 33% of patients (34 out of 102).
Maltese: Rispons komplet kien osservat fuq 33% tal-pazjenti (34 minn 102).
English: Cutaneous T-cell lymphoma
Maltese: Linfoma taċ-ċellola T fil-ġilda
English: The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).
Maltese: Ilproporzjon ta' pazjenti li l-marda tagħhom irrispondiet għall-kura għal tal-inqas erba' xhur kien 56% ta' dawk li ngħataw Adcetris (36 minn 64 pazjent) u 13% ta' dawk li ngħataw kuri alternattivi (8 minn 64 pazjent).
English: In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% (34 out of 58).
Maltese: F'dan l-istudju, 86% tal-pazjenti (50 minn 58) irrispondew parzjalment jew kompletament għall-kura u dan ir-rispons kien komplet għal 59% (34 minn 58).
English: • together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in HL patients who have stage IV disease (advanced cancer that has spread to other parts of the body) that has not been treated before;
Maltese: • flimkien ma' doxorubicin, vinblastine u dacarbazine (mediċini oħra kontra l-kanċer) f'pazjenti HL li għandhom mard ta' stadju IV (kanċer avvanzat li nfirex għal partijiet oħra tal-ġisem) li ma jkunx ġie kkurat qabel;
English: The benefit was sustained during 3 years of follow-up.
Maltese: Il-benefiċċju kien sostnut wara segwitu ta' 3 snin.
English: For 23% of these patients (9 out of 40) a complete response was observed.
Maltese: Għal 23% ta' dawn ilpazjenti (9 minn 40) kien osservat rispons komplet.
English: What are the risks associated with Adcetris?
Maltese: X'inhuma r-riskji assoċjati ma' Adcetris?
English: What information is still awaited for Adcetris?
Maltese: Liema informazzjoni għadha mistennija għal Adcetris?
English: Systemic anaplastic large cell lymphoma
Maltese: Linfoma sistemika anaplastika taċ-ċelloli l-kbar
English: The monoclonal antibody is attached to monomethyl auristatin E, a cytotoxic (cell-killing) molecule.
Maltese: L-antikorp monoklonali jeħel ma' monomethyl auristatin E, molekula ċitotossika (li toqtol iċ-ċelloli).
English: Adcetris is a cancer medicine used to treat adults with Hodgkin's lymphoma (HL, a type of cancer that originates from blood cells in the lymphatic system, a part of the immune system).
Maltese: Adcetris huwa mediċina kontra l-kanċer li tintuża fil-kura ta' adulti b'linfoma ta' Hodgkin (HL, tip ta' kanċer li joriġina minn ċelloli tad-demm fis-sistema linfatika, parti mis-sistema immunitarja).
English: In this study, 75% of patients (76 out of 102) responded partially or completely to treatment.
Maltese: F'dan l-istudju, 75% tal-pazjenti (76 minn 102) irrispondew parzjalment jew kompletament għall-kura.
English: In a main study of 1334 patients with CD30-positive HL who had not received previous treatment, Adcetris was compared with bleomycin (another HL medicine) when each was given with other cancer medicines (doxorubicin, vinblastine and dacarbazine).
Maltese: Fi studju ewlieni ta' 1334 pazjent b'HL pożittiv għal CD30 li ma kinux irċevew kura preċedenti, Adcetris tqabbel mal-bleomycin (mediċina HL oħra) meta kull wieħed ingħata mediċini oħra kontra l-kanċer (doxorubicin, vinblastine u dacarbazine).
English: For the full list of all side effects with Adcetris, including side effects when used with doxorubicin, vinblastine and dacarbazine, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha b'Adcertis inklużi l-effetti sekondarji meta jintuża ma' doxorubicin, vinblastine and dacarbazine, ara l-fuljett ta tagħrif.
English: • CD30-positive cutaneous T-cell lymphoma (CTCL), a lymphoma of T lymphocytes that initially affects the skin, in patients who have received at least one previous treatment.
Maltese: • linfoma pożittiva għal CD 30 taċ-ċellula T fil-ġilda (CTCL), linfoma tal-linfoċiti T li fil-bidu taffettwa l-ġilda, f'pazjenti li kienu rċevew għall-inqas kura waħda preċedenti.
English: Further information on the orphan designations can be found on the European Medicines Agency's website (Hodgkin's lymphoma: 15 January 2009; Anaplastic large cell lymphoma: 15 January 2009; Cutaneous T-cell lymphoma: 11 January 2012).
Maltese: Aktar informazzjoni dwar id-denominazzjonijiet orfni tista' tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (linfoma ta Hodgkin: 15 ta' Jannar 2009;
English: As for all medicines, data on the use of Adcetris are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Adcetris hija ssorveljata kontinwament.
English: • systemic anaplastic large cell lymphoma (sALCL, a CD30-positive cancer of white blood cells called T lymphocytes), when the cancer has come back or has not responded to other treatments;
Maltese: • linfoma sistemika anaplastika taċ-ċelloli l-kbar (sALCL, kanċer taċ-ċelloli tad-demm bojod pożittiv għal CD30 imsejħa linfoċiti T), meta l-kanċer ikun reġa' tfaċċa jew ma jkunx irrisponda għal kuri oħra;
English: Adcetris contains the active substance brentuximab vedotin.
Maltese: Adcetris fih is-sustanza attiva brentussimab vedotin.
English: Adcetris has been shown to be of benefit in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment.
Maltese: Adcetris intwera li kien ta' benefiċċju fil-linfoma pożittiva għal CD 30 taċ-ċellula T fil-ġilda fi studju ewlieni f'128 pazjent b'CTCL pożittiva għal CD30 li mill-inqas kien kellhom kura preċedenti.
English: In patients with CTCL, a clinically significant benefit was seen over treatment with bexarotene or methotrexate.
Maltese: F'pazjenti b'CTCL intwera benefiċċju klinikament sinifikanti bil-kura b'bexarotene jew methotrexate.
English: The medicine is given by a 30 minute infusion (drip) into a vein every 2 or 3 weeks.
Maltese: Il-mediċina tingħata b'infużjoni (dripp) ta' 30 minuta fil-vina kull ġimagħtejn jew tliet ġimgħat.
English: These diseases are rare, and Adcetris was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Maltese: Dan il-mard huwa rari, u Adcetris ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) f'diversi dati.
English: The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, and the cancer cells eventually die.
Maltese: L-antikorp monoklonali jwassal lil monomethyl auristatin E saċ-ċelloli tal-kanċer pożittivi għal CD30, u ladarba jkun fiċ-ċelloli tal-kanċer, iwaqqafhom milli jinqasmu, li eventwalment joqtol liċ-ċelloli tal-kanċer.
English: The European Medicines Agency noted that, despite limited data and studies that did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy.
Maltese: L-Aġenzija Ewropea għall-Mediċini nnotat li, minkejja data limitata u studji li ma kinux qabblu lil Adcetris ma' kura ta' kontroll, Adcetris kien ikkunsidrat ta' benefiċċju għall-pazjenti b'HL u sALCL li lkanċer tagħhom kien reġa' tfaċċa jew li ma kinux irrispondew għat-terapija.
English: The company that markets the medicine will carry out a study on the benefits of the medicine in sALCL patients and a safety study in a larger population of HL and sALCL patients.
Maltese: Il-kumpanija li tqiegħed il-mediċina fis-suq se twettaq studju dwar il-benefiċċji tal-mediċina fuq pazjenti b'sALCL u studju tas-sigurtà fuq popolazzjoni akbar ta' pazjenti b'HL u sALCL.
English: What measures are being taken to ensure the safe and effective use of Adcetris?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Adcetris?
English: Adcetris was studied in 58 sALCL patients whose cancer had come back or had not responded to treatment.
Maltese: Adcetris ġie studjat fi 58 pazjent b'sALCL li l-kanċer tagħhom kien reġa' tfaċċa jew li ma kienx irrisponda għall-kura.
English: In another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back.
Maltese: Fi studju ewlieni ieħor, Adcetris tqabbel ma' plaċebo (kura finta) fi 329 pazjent b'HL pożittiv għal CD30 li kienu rċevew trapjant awtologu taċ-ċelloli staminali u li kienu f'riskju akbar li l-kanċer tagħhom javvanza jew li jerġa' jitfaċċa.
English: Adcetris is used when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface) and is given:
Maltese: Adcetris jintuża meta ċ-ċelloli tat-tumur ikunu pożittivi għal CD30 (meta jkollhom proteina msejħa CD30 fuq ilwiċċ tagħhom) u jingħataw:
English: How is Adcetris used?
Maltese: Kif jaħdem Adcetris?
English: The data on these patients showed that 55% of patients (22 out of 40) responded to treatment.
Maltese: Id-data dwar dawn il-pazjenti wriet li 55% tal-pazjenti (22 minn 40) irrispondew għall-kura.
English: Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs.
Maltese: Adcetris ma għandux jintuża flimkien ma bleomycin (mediċina oħra kontra l-kanċer) peress li din ilkombinazzjoni hija ta' ħsara għall-pulmuni.
English: Adcetris is also used to treat adults with two other lymphomas:
Maltese: Adcetris jintuża wkoll biex jikkura adulti b'żewġ linfomi oħra:
English: The full EPAR for Pandemrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Side effects are similar in children.
Maltese: Fit-tfal kien hemm effetti sekondarji simili.
English: This summary was last updated in 05-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 05-2016.
English: Pandemrix contains a flu strain called A/California/7/2009 (H1N1)v-like strain (X-179A).
Maltese: Pandemrix fih razza ta' influwenza msejħa A/California/7/2009 (H1N1) tip li jixbah lil v (X-179A.
English: Other information about Pandemrix
Maltese: Informazzjoni oħra dwar Pandemrix
English: Pandemrix influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Maltese: Pandemrix vaċċin għall-influwenza (H1N1)v (virjon maqsum, diżattivat, aġġuvant)
English: This document is a summary of the European Public Assessment Report (EPAR) for Pandemrix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pandemrix.
English: • healthy adults aged between 18 and 60 years (180 subjects in two studies);
Maltese: • adulti f'saħħithom ta' bejn it-18 u s-60 sena (180 individwu fiż-żewġ studji);
English: Pandemrix is a vaccine.
Maltese: Pandemrix huwa vaċċin.
English: Pandemrix must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Maltese: Pandemrix m'għandux jingħata lil nies li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi (baxxi ħafna) fil-vaċċin, bħal bajd jew proteina tat-tiġieġ, ovalbumin (proteina fl-abjad tal-bajd), formaldejde, sulfat ġentamiċin (antibijotiku) u deossikolat tas-sodju.