FrancophonIA/ELRC3.0 huggingface dataset:
English: For systemically administered levofloxacin containing products the listing of risk factors within the first above mentioned sentence should additionally include “in patients receiving daily doses of 1000 mg levofloxacin”.
Maltese: Għall-prodotti li fihom levofloxacin mogħtija b'mod sistemiku l-lista ta' fatturi ta' riskju fl-ewwel sentenza msemmija hawn fuq għandha tinkludi wkoll “f'pazjenti li rċivew dożi ta' kuljum ta' 1000 mg levofloxacin”.
English: Ciprofloxacin Current indications in product information of ciprofloxacin containing products
Maltese: Ciprofloxacin Indikazzjonijiet attwali flinformazzjoni dwar il-prodott ta' prodotti li fihom ciprofloxacin
English: • Severe skin and soft-tissue infections (last line)
Maltese: • Infezzjonijiet severi fil-ġilda u fit-tessut artab (laħħar linja)
English: Current category 1 indications in product information of levofloxacin
Maltese: Indikazzjonijiet attwali ta' kategorija 1 fl-informazzjoni dwar il-prodott ta' levofloxacin
English: • Acute exacerbations of chronic bronchitis
Maltese: • Aggravar akut ta' bronkite kronika
English: • Severe/Serious gastro-intestinal bacterial infections
Maltese: • Infezzjonijiet gastrointestinali severi/serji kkawżati minn batterja
English: • Gonorrhoea o gonorrhoea o uncomplicated gonorrhea o Gonococcal urethritis, pharyngitis, proctitis or cervicitis from Neisseria gonorrhoeae irrespective of the production of penicillinase.
Maltese: • Gonorrea o Gonorrea o Uretrite u ċerviċite kkawżati minn gonokokki u mhux kkawżati minn gonokokki (ikkumplikati jew mhux ikkumplikati) o Gonorrea uretrali u ċervikali mhux ikkumplikata.
English: Should medicinal products no longer have any authorised indications with a positive benefit-risk balance then the national competent authorities should take the appropriate action in line with the conclusions on this procedure under Article 31 of Directive 2001/83/EC.
Maltese: Jekk il-prodotti mediċinali ma jibqgħalhomx indikazzjonijiet awtorizzati b'bilanċ pożittiv tal-benefiċċji u r-riskji, l-awtoritajiet kompetenti nazzjonali għandhom jieħdu azzjoni xierqa f'konformità malkonklużjonijiet dwar din il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: • Acute and chronic prostatitis, including severe forms
Maltese: • Infjammazzjoni tal-prostata akuta u kronika, inklużi forom severi
English: Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease
Maltese: Aggravar akut ta' bronkite kronika u ta' marda kronika ostruttiva tal-pulmun
English: • Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
Maltese: • Infezzjonijiet bronkopulmonari kkawżati minn Pseudomonas aeruginosa f'pazjenti b'fibrożi ċistika
English: An asterisk should be added to the title of selected SOCs as follows: Musculoskeletal and connective tissue disorders* Nervous system disorders*
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi* Disturbi fis-sistema nervuża*
English: Community-acquired pneumonia.
Maltese: Pulmonite li tkun ittieħdet millkomunità.
English: At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered.
Maltese: Mal-ewwel sinjal ta' tendinite (eż. nefħa li tweġġa', infjammazzjoni) it-trattament b'[INN] għandu jitwaqqaf u għandu jiġi kkunsidrat trattament alternattiv.
English: • Acute pyelonephritis
Maltese: • Pajlonefrite akuta
English: • Gonorrhoea • Gonococcal urethritis in humans
Maltese: • Infezzjonijiet fl-għadam u lġogi
English: • Respiratory infections o Acute, chronic or recurrent respiratory tract infections; superior - acute otitis media, otitis externa, sinusitis, pharyngitis and laryngitis o Acute, chronic or recurrent respiratory tract infections caused by Haemophilus influenzae or other Gram-negative or multi-resistant pathogens, as well as by Staphylococcus aureus o Respiratory tract infections (with the exception, if infection is of pneumococcal origin or is suspected) o Severe respiratory infections caused by gram-negative bacilli and susceptible staphylococci o Lower respiratory tract infections
Maltese: • Infezzjonijiet respiratorji o Infezzjonijiet fil-passaġġ respiratorju akuti, kroniċi jew ripetuti; otite medja, otite esterna, sinożite, farinġite u larinġite superjuri - akuti o Infezzjonijiet fil-passaġġ respiratorju akuti, kroniċi jew ripetuti kkawżati minn Haemophilus influenzae jew patoġeni oħra Gram-negattivi jew b'reżistenzi multipli, kif ukoll minn Staphylococcus aureus o Infezzjonijiet fil-passaġġ respiratorju (bleċċezzjoni, jekk l-infezzjoni hija ta' oriġini pnewmokokkali jew hu ssuspettat li hi) o Infezzjonijiet respiratorji severi kkawżati minn baċilli gram-negattivi u staphylococci suxxettibbli o Infezzjonijiet fl-apparat respiratorju t'isfel
English: Urinary tract infections
Maltese: Infezzjonijiet fl-apparat urinarju
English: • Urinary tract infections
Maltese: • Infezzjonijiet fl-apparat urinarju
English: • Acute exacerbations of chronic obstructive
Maltese: • Otite medja suppurattiva kronika
English: • Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis.
Maltese: • Aggravar akut ta' marda kronika ostruttiva tal-pulmun inkluża bronkite kronika.
English: General disorders and administrative site conditions* Psychiatric disorders*
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata* Disturbi psikjatriċi*
English: Rufloxacin Current category indications included in product information for rufloxacin containing products
Maltese: Rufloxacin Indikazzjonijiet ta' kategorija attwali inklużi fl-informazzjoni dwar il-prodott ta' prodotti li fihom rufloxacin
English: • Urethritis and cervicitis due to bacteria susceptible to fluoroquinolones
Maltese: • Uretrite u ċerviċite kkawżati minn batterja suxxettibbli għall-fluoroquinolones
English: • Bacterial gastroenteritis o Bacterial gastroenteritis o Bacterial enteritis o Intestinal infections o bacterial diarrhoea, which needs antibacterial treatment
Maltese: • Gastroenterite kkawżata minn batterja o Gastroenterite kkawżata minn batterja o Enterite kkawżata minn batterja o Infezzjonijiet intestinali o dijarea kkawżata minn batterja, li teħtieġ trattament antibatteriku
English: Lomefloxacin Current indications in product information for lomefloxacin containing products
Maltese: Indikazzjonijiet attwali fl-informazzjoni dwar il-prodott ta' prodotti li fihom lomefloxacin
English: • Superinfection of chronic otitis (whatever its nature) and cavities after mastodectomy
Maltese: • Superinfezzjoni ta' otite kronika (tkun xi tkun innatura tagħha) u kavitajiet wara mastodektomija
English: Very rare cases of long lasting ( up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Maltese: Każijiet rari ħafna ta' reazzjonijiet avversi għall-mediċina li jdumu ħafna (sa xhur jew snin) jew permanenti, bħal infjammazzjonijiet ta' tendon, tiċrit ta' tendon, uġigħ fil-ġogi, uġigħ fid-dirgħajn u r-riġlejn, diffikultà biex timxi, sensazzjonijiet anormali bħal tingiż, tnemnim, tgħarrix, ħruq, nuqqas ta' sensazzjoni jew uġigħ (newropatija), depressjoni, għeja, disturbi fl-irqad, indeboliment fil-memorja, kif ukoll indeboliment fis-smigħ, fil-vista, u fit-togħma u x-xamm ġew assoċjati mal-għoti ta' antibijotiċi li fihom quinolone u fluoroquinolone, f'xi każijiet irrispettivament minn fatturi ta' riskju li jeżistu minn qabel.
English: (complicated or uncomplicated) o Infections of bones (osteitis, osteomyelitis) o Bone and joint infections o Gram negative infection of bones and joints o Bone infections (such as osteomyelitis and orthopaedic material/implant infection, especially when used in association with other antibiotics like rifampicin o Alternative form of treatment for bones and joints infections
Maltese: (ikkumplikati jew mhux ikkumplikati) o Infezzjonijiet fl-għadam (osteite, osteomijelite) o Infezzjonijiet fl-għadam u l-ġogi o Infezzjoni gram negattiva fl-għadam u lġogi o Infezzjonijiet fl-għadam (bħal osteomijelite u infezzjoni kkawżata minn materjal/impjant ortopediku, speċjalment meta jintuża flimkien ma' antibijotiċi oħra bħal rifampicin) o Forma alternattiva ta' trattament għal infezzjonijiet fl-għadam u l-ġogi
English: • Simple uncomplicated acute cystitis
Maltese: • Ċistite akuta sempliċi mhux ikkumplikata
English: • Chronic bacterial sinusitis • Chronic suppurative otitis media otorhinolaryngological infections Genital tract infections o Infections of genital organs o Infections of genitals o Severe genital tract infections caused by gram-negative bacilli and susceptible staphylococci
Maltese: • Infezzjonijiet fl-apparat ġenitali o Infezzjonijiet fl-organi ġenitali o Infezzjonijiet fil-ġenitali o Infezzjonijiet severi fl-apparat ġenitali kkawżati minn baċilli gram-negattivi u staphylococci suxxettibbli
English: Chronic ear, nose and throat infections o Severe chronic ENT infections caused by gram-negative bacilli and susceptible staphylococci o Chronic and recurrent infections of the nose, throat and ear, only when caused by Gram-negative pathogens, including Pseudomonas, or by Staphylococci o Chronic and recurrent infections of ears, nose and throat, above all if they are caused by gram-negative bacteria including Pseudomonas, or if they are caused by Staphylococcus o Ear, nose and throat (ENT) infections (such as: chronic sinusitis, superinfection in chronic otitis, prophylaxis of infections following inner ear surgery)
Maltese: • Otite medja suppurattiva kronika il-gerżuma u l-widna, meta kkawżati minn patoġeni Gram-negattivi biss, inkluż Pseudomonas, jew minn Staphylococci o Infezzjonijie kroniċi u ripetuti fil-widnejn, l-imnieħer u l-gerżuma, speċjalment jekk huma kkawżati minn batterja gramnegattiva inkluż Pseudomonas, jew jekk huma kkawżati minn Staphylococcus o Infezzjonijiet fil-widnejn, l-imnieħer u lgerżuma (ENT - ear, nose and throat) (bħal: sinożite kronika, superinfezzjoni f'otite kronika, profilassi ta' infezzjonijiet wara operazzjoni fil-widna ta' ġewwa) o Infezzjonijiet otorinolaringoloġiċi kroniċi u ripetuti
English: • Salmonella infections (carrier) • Germ carrying of salmonellosis
Maltese: • Infezzjonijiet ikkawżati minn salmonella
English: • Cystitis o Cystitis o Acute and chronic cystitis in women
Maltese: • Ċistite o Ċistite o Ċistite akuta u kronika fin-nisa
English: These infections include: cystitis, pyelitis, chronic prostatitis and infections related to urological surgical procedures, neurogenic bladder or nephrolithiasis (except acute and chronic complicated pyelonephritis) caused by bacteria sensitive to norfloxacin o Upper and lower, complicated and uncomplicated, acute and chronic urinary tract infections.
Maltese: proċeduri kirurġiċi uroloġiċi, bużżieqa talawrina newroġenika jew nefrolitjasi (minbarra pajlonefrite akuta u kronika kkumplikata) ikkawżati minn batterja sensittiva għal norfloxacin o Infezzjonijiet akuti u kroniċi fil-passaġġ talawrina ta' fuq u t'isfel ikkumplikati u mhux ikkumplikati.
English: • Urinary infections o Urinary tract infections o Urinary infection - severe infections caused by gramnegative bacilli and susceptible staphylococci o Urinary tract infections (including prostatitis) o Infections of urinary tract (inclusive of prostatitis)
Maltese: • Infezzjonijiet urinarji o Infezzjonijiet fl-apparat urinarju o Infezzjoni urinarja - infezzjonijiet severi kkawżati minn baċilli gramnegattivi u staphylococci suxxettibbli o Infezzjonijiet fil-passaġġ talawrina (inkluż infjammazzjoni talprostata) o Infezzjonijiet fil-passaġġ talawrina (li jinkludu infjammazzjoni tal-prostata) o Infezzjonijiet fil-passaġġ talawrina (ċistite akuta jew ripetuta, pajlonefrite akuta mhux ikkumplikata)
English: The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids.
Maltese: Ir-riskju ta' tendinite u tiċrit ta' tendon) jiżdied f'pazjenti anzjani, pazjenti b'indeboliment tal-kliewi, pazjenti bi trapjanti ta' organi solidi, u dawk li ngħataw trattament b'kortikosterojdi fl-istess waqt.
English: • Prostatitis o prostatitis o chronic bacterial prostatitis o Acute prostatitis caused by Escherichia coli
Maltese: • Infjammazzjoni tal-prostata o infjammazzjoni tal-prostata o infjammazzjoni kronika tal-prostata kkawżata minn batterja o Infjammazzjoni akuta tal-prostata kkawżata minn Escherichia coli
English: Pefloxacin Current indications included in product information for pefloxacin containing products
Maltese: Pefloxacin Indikazzjonijiet attwali inklużi flinformazzjoni dwar il-prodott ta' prodotti li fihom pefloxacin
English: The indications in the table below should be deleted for all quinolones/ fluoroquinolones containing products Pharyngitis-Tonsillitis
Maltese: L-indikazzjonijiet fit-tabella t'hawn taħt għandhom jitħassru għall-prodotti kollha li fihom quinolones/ fluoroquinolones Farinġite-Tonsillite
English: • Gonococcal urethritis and cervicitis including cases due to susceptible Neisseria gonorrhoeae
Maltese: • Uretrite u ċerviċite gonokokkali inklużi każijiet ikkawżati minn Neisseria gonorrhoeae suxxettibbli
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott sussegwentement tista' tiġi aġġornata mill-awtoritajiet kompetenti talIstat Membru, flimkien mal-Istat Membru ta' referenza, kif xieraq, skont il-proċeduri stabbiliti filKapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: In chronic bronchitis during recurrent exacerbations
Maltese: Fi bronkite kronika waqt aggravar ripetut
English: • Acute exacerbation of chronic obstructive pulmonary disease including bronchitis
Maltese: • Aggravar akut ta' marda kronika ostruttiva tal-pulmun inkluża bronkite
English: • Simple uncomplicated acute cystitis in the premenopausal adult women
Maltese: • Ċistite akuta sempliċi mhux ikkumplikata f'nisa adulti qabel il-menopawsa
English: • Bacterial prostatitis, epididymoorchitis
Maltese: • Infjammazzjoni tal-prostata kkawżata minn batterja, orkite talepididimu
English: • Exacerbation of chronic obstructive pulmonary disease
Maltese: • Aggravar ta' marda kronika ostruttiva tal-pulmun
English: Ear and labyrinth disorders*
Maltese: Disturbi fil-widnejn u fis-sistema labirintika*
English: • Urethritis including cases due to susceptible Neisseria gonorrhoeae
Maltese: • Uretrite u ċerviċite inklużi każijiet ikkawżati minn Neisseria gonorrhoeae suxxettibbli
English: • Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
Maltese: • Aggravar akut ta' marda kronika ostruttiva tal-pulmun inkluża bronkite kronika
English: • Urinary tract infections o Urinary tract infection o Upper and lower urinary tract infections o Upper and lower urinary tract infections, complicated or not o Infections of the upper and lower urinary tract o Upper and lower, acute and chronic urinary tract infections o Complicated and uncomplicated urinary tract infections (cystitis and pyelonephritis) o Upper and lower urinary tract infections coming from bacteria such as E. coli, K. pneumoniae, Proteus, P. aeruginosa
Maltese: • Infezzjonijiet fl-apparat urinarju o Infezzjoni fil-passaġġ tal-awrina o Infezzjonijiet fil-passaġġ tal-awrina ta' fuq u t'isfel o Infezzjonijiet fil-passaġġ tal-awrina ta' fuq u t'isfel, ikkumplikati jew le o Infezzjonijiet fil-passaġġ tal-awrina ta' fuq u t'isfel o Infezzjonijiet akuti u kroniċi fil-passaġġ tal-awrina ta' fuq u t'isfel o Infezzjonijiet ikkumplikati u mhux ikkumplikati fil-passaġġ tal-awrina (ċistite u pajlonefrite) o Infezzjonijiet fil-passaġġ tal-awrina ta' fuq u t'isfel li ġejjin minn batterja bħal E. coli, K. pneumoniae, Proteus, P. aeruginosa
English: • Epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
Maltese: • Orkite tal-epididimu inklużi każijiet ikkawżati minn Neisseria
English: o Uncomplicated acute gonococcal urethritis and cervicitis o Gonococcal urethritis due to susceptible strains of Neisseria gonorrhoeae and non-gonococcal urethritis
Maltese: • Infjammazzjoni tal-prostata kkawżata minn batterja, orkite talepididimu inklużi każijiet ikkawżati minn Neisseria gonorrhoeae suxxettibbli
English: You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Maltese: Int u ttabib tiegħek se tiddeċiedu jekk għandux jitkompla t-trattament wara li jiġi kkunsidrat ukoll antibijotiku minn klassi oħra.
English: • Skin and soft tissue infections o Skin infections o Skin infection - severe infections caused by gram-negative bacilli and susceptible staphylococci o Skin and soft tissue infections by penicillin resistant Staphylococcus o Infections of skin and soft tissue caused by staphylococcus resistant to penicillin
Maltese: • Infezzjoni fil-passaġġ respiratorju o Infezzjonijiet respiratorji o Infezzjoni respiratorjainfezzjonijiet severi kkawżati minn baċilli gram-negattivi u staphylococci suxxettibbli o Infezzjoni tal-passaġġ respiratorju (aggravar akut ta' bronkite kronika, aggravar ta' fibrożi ċistika, pulmonite nożokomjali)
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
Maltese: Dawn jinkludu wġigħ f'tendon, fil-muskoli jew fil-ġogi tar-riġlejn u d-dirgħajn, diffikultà biex timxi, sensazzjonijiet anormali bħal tingiż, tnemnim, tgħarrix, nuqqas ta' sensazzjoni jew ħruq (parastesija), disturbi fis-sensi inkluż indeboliment fil-vista, fit-togħma u x-xamm, u ssmigħ, depressjoni, indeboliment fil-memorja, għeja kbira, u disturbi severi fl-irqad.
English: • Gonoccocal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae
Maltese: • Uretrite u ċerviċite gonokokkali kkawżati minn Neisseria gonorrhoea suxxettibbli
English: • Prevention of infections due to ofloxacin susceptible pathogens (prophylaxis of infections, in patients with a significant reduction in resistance to infections (e.g., in neutropenic states)
Maltese: • Prevenzjoni ta' infezzjonijiet ikkawżati minn patoġeni suxxettibbli għal ofloxacin (profilassi ta' infezzjonijiet, f'pazjenti bi tnaqqis sinifikanti firreżistenza għall-infezzjonijiet (eż. fi stati newtropeniċi))
English: • Complicated skin and soft-tissue infections
Maltese: • infezzjonijiet fil-ġilda u fit-tessut artab
English: In addition of the amendments recommended below, the following sentence should be included in all quinolones and fluoroquinolones containing medicinal products at the end of section 4.1:
Maltese: Minbarra l-emendi rakkomandati hawn taħt, is-sentenza li ġejja għandha tiġi inkluża fil-prodotti mediċinali kollha li fihom quinolones u fluoroquinolones fi tmiem is-sezzjoni 4.1:
English: • Acute exacerbation of chronic sinusitis
Maltese: • Aggravar akut ta' sinożite kronika
English: Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
Maltese: Evita kull eżerċizzju li mhux neċessarju għax dan jista' jżid ir-riskju ta' tiċrit ta' tendon.
English: • Bone and joint infections (last line) o Bone and joint infections: such as osteomyelitis or septic arthritis.
Maltese: • Infezzjonijiet fl-għadam u l-ġogi (l-aħħar linja) o Infezzjonijiet fl-għadam u l-ġogi: bħal osteomijelite jew artrite settika.
English: • Acute uncomplicated cystitis.
Maltese: • Ċistite akuta mhux ikkumplikata.
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of <product name> therapy.
Maltese: Infjammazzjoni u tiċrit ta' tendons jistgħu jseħħu fi żmien l-ewwel 48 siegħa ta' trattament u anki sa diversi xhur wara li titwaqqaf it-terapija b'<isem ilprodott>.
English: • Genital tract infections o Genital infections (chronic prostatitis) o Genital tract infection - severe infections caused by gramnegative bacilli and susceptible staphylococci
Maltese: • Infezzjonijiet fil-passaġġ ġenitali o Infezzjonijiet fil-ġenitali (infjammazzjoni kronika talprostata) o Infezzjoni fil-passaġġ ġenitaliinfezzjonijiet severi kkawżati minn baċilli gram-negattivi u staphylococci suxxettibbli
English: This summary was last updated in 08-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2017.
English: The most common side effects with Gazyvaro (which may affect more than 1 in 10 people) are upper respiratory infections (such as throat and nose infections), pneumonia (lung infection), urinary tract infections, cold sores, coughs, diarrhoea, constipation, joint and back pain, headache, insomnia, hair loss, itching, fever, weakness, neutropenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), lymph node pain and reactions related to the infusion (which may include vomiting, dizziness, breathing difficulties, flushing, changes in blood pressure and rapid heart rate).
Maltese: L-effetti sekondarji l-aktar komuni b'Gazyvaro (li jistgħu jaffettwaw aktar minn persuna 1 minn 10) huma infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (bħal infezzjonijiet tal-griżmejn u talimnieħer), pulmonite (infezzjoni fil-pulmun), infezzjonijiet fl-apparat tal-awrina, selħiet tax-xufftejn, sogħla, dijarea, stitikezza, uġiegħ fid-dahar u fil-ġogi, uġigħ ta' ras, insomnja, telf ta' xagħar, ħakk, deni, dgħufija, newtropenija u lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), tromboċitopenija (għadd baxx ta' pjastrini tad-demm), anemija (għadd baxx ta' ċelloli ħomor tad-demm), uġigħ fin-nodi linfotiċi u reazzjonijiet relatati mal-infużjoni (li jistgħu jinkludu remettar, sturdamet, diffikultajiet fitteħid tan-nifs, fwawar, bidliet fil-pressjoni tad-demm u rata mgħaġġla tal-qalb).
English: The full EPAR for Gazyvaro 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: The summaries of the opinion of the Committee for Orphan Medicinal Products for Gazyvaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CLL and FL).
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Gazyvaro jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CLL and FL).
English: This is a summary of the European public assessment report (EPAR) for Gazyvaro.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Gazyvaro.
English: Gazyvaro contains the active substance obinutuzumab.
Maltese: Gazyvaro fih is-sustanza attiva obinutuzumab.
English: The study compared Gazyvaro plus other chemotherapy medicines with rituximab plus other chemotherapy medicines, and over a follow-up period of about three years on average, 17% (101 of 601 patients) given Gazyvaro died or their disease got worse, whereas 24% (144 of 601 patients) given rituximab died or their disease got worse.
Maltese: L-istudju qabbel Gazyvaro flimkien ma' mediċini oħra ta' kimoterapija ma' rituximab flimkien ma' mediċini oħra ta' kimoterapija, u tul perjodu ta' segwitu ta' medja ta' madwar tliet snin, 17% (101 minn 601 pazjenti) li ngħataw Gazyvaro mietu jew il-marda tagħhom iggravat, filwaqt li 24% (144 minn 601 pazjenti) li ngħataw rituximab mietu jew il-marda tagħhom iggravat.
English: For CLL, 28-day cycles are used.
Maltese: Għal CLL, jintużaw ċikli ta' 28 jum.