FrancophonIA/ELRC3.0 huggingface dataset:
English: Busulfan is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Maltese: Busulfan għandu jittieħed qabel it-trapjant taċ-ċelluli ematopojetiċi proġenitriċi (haematopoietic progenitor cell transplantation, HPCT).
English: Busulfan in combination with fludarabine (FB) In adults The recommended dose and schedule of administration is: - fludarabine administered as a single daily one-hour infusion at 30 mg/m² for 5 consecutive days or 40 mg/m² for 4 consecutive days.
Maltese: Id-doża rakkomandata u l-iskeda tal-għoti hi: - fludarabine mogħti bħala infużjoni ta' siegħa, darba kuljum f'doża ta' 30 mg/m² għal 5 ijiem konsekuttivi jew 40 mg/m² għal 4 ijiem konsekuttivi.
English: In paediatric population, absolute neutrophil counts < 0.5x109/l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Maltese: 9/1 f'medjan ta' 3 ġranet ta' wara t-trapjant ġie irreġistrat f'100% tal-pazjenti u dam 5 u 18.5 ġranet fi trapjant awtologuż u alloġenejiku rispettivament.
English: Haematemesis Ileus
Maltese: U L-UŻU.
English: IV after dilution
Maltese: IV wara d-dilwazzjoni
English: (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%).
Maltese: 9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni tal-glukows ta' 5% għall-injezzjoni.
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the busulfan studies.
Maltese: Pazjent bata minn każ fatali ta' sindrom akut ta' periklu respiratorju b'difett sussegwenti respiratorju assoċjat ma' fibrożi pulmonari interstitjali fl-istudji ta' busulfan.
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Maltese: Gastrointestinali: infjammazzjoni tal- mukoża tal-esofagu, paraliżi tal-imsaren, rammettar tad-demm.
English: Pregnancy
Maltese: Ematurija
English: Femoral artery thrombosis Capillary leak
Maltese: Trombożi talarterja femorali Sindrom ta' nixxija kapillari
English: DMA is teratogenic in rats.
Maltese: DMA hu teratoġeniku fil-firien.
English: Documentation on the safety and efficacy of busulfan in combination with fludarabine (FB) prior to allogeneic HPCT derives from the literature review of 7 published studies involving 731 patients with myeloid and lymphoid malignancies reporting the use of intravenous busulfan infused once daily instead of four doses per day.
Maltese: Id-dokumentazzjoni dwar is-sigurtà u l-effikaċja tal- Busulfan flimimkien ma' fludarabine (FB) qabel HPCT alloġeniku toħroġ mir-reviżjoni tal-letteratura ta' 7 studji ppubblikati li kienu jinvolvu 731 pazjent b'tumuri malinni majelojdi u limfojdi li rrappurtaw l-użu ta' busulfan ġol-vini mogħti bħala infużjoni darba kuljum minflok erba' dożi kuljum.
English: Pancytopenia
Maltese: Ċitotossiku
English: In adult and paediatric studies, patients received either phenytoin or benzodiazepines as seizure prophylaxis treatment (see sections 4.4 and 4.5).
Maltese: Fl-istudji li saru f'adulti u studji pedjatriċi, il-pazjenti ngħataw phenytoin jew benżodjażepini bħala kura għall-profilasi tal-puplesija (ara sezzjonijiet 4.4 u 4.5).
English: Pharmacokinetics in adults
Maltese: Farmak okinetika f'adulti
English: In pregnant rats, busulfan produced sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries.
Maltese: Fil-każ ta' firien tqal, busulfan ikkaġuna sterilità kemm fil-frieħ maskili u dawk feminili minħabba n-nuqqas ta' ċelluli ġerminali fit-testes u l-ovarji.
English: • Quantity of diluent: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent
Maltese: Kabi) x (10) = B ml tad-dilwent Biex tipprepara s-soluzzjoni finali għall-infużjoni, żid (A) ml ta' Busulfan Fresenius Kabi ma' (B) ml tad-diluwent (soluzzjoni ta' klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew is-soluzzjoni tal-glukows għall-injezzjoni ta' 5%)
English: This medicine contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Maltese: Din il-mediċina fiha s-sustanza attiva busulfan, li tappartjeni għall-grupp ta' mediċini msejħa aġenti alkilatini.
English: A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimen-related toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Maltese: Inċidenza mnaqqsa tal-Marda Okklussiva fil-Vini tal-Fwied (Hepatic Vein Occlusive Disease, HVOD) u ta' regimen relattat mat-tossiċità kien nnotat f'pazjenti meta l-perijodu ta' żmien bejn l-aħħar doża talbusulfan mill-ħalq u l-ewwel doża ta' cyclosphosphamide hu > 24 siegħa.
English: However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900 - 1500 µmol/L.minute).
Maltese: Madankollu varjabilità ogħla kienet osservata fi tfal <9 kg li wasslet għal 60% tat-tfal li kisbu t-tieqa terpewtika (900-1500 μmol/L.kull minuta).
English: Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Maltese: Respiratorji: qtugħ ta' nifs, tnixxija mill- imnieħer (rinite), mard tal-gerżuma, sogħla, sulluzzu, ħruġ ta' demm mill-imnieħer, ħsejjes annormali tan-nifs.
English: Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Maltese: Madwar 30% tad-doża mogħtija hi eliminata fl-awrina fuq firxa ta' 48 sigħat b'1% bħala busulfan mhux mibdul.
English: PK/PD relationship was observed between stomatitis and AUCs in autologous patients and between bilirubin increase and AUCs in a combined autologous and allogeneic patient analysis.
Maltese: Ir-relazzjoni PK/PD kien osservat bejn l-istomatite u l-AUCs f'pazjenti awtologużi u bejn żjieda fil-bilirubin u l-AUCs f'analiżi magħdud ta' pazjenti li għamlu trapjant awtologuż u alloġenejiku.
English: Busulfan is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and haematopoietic progenitor cell transplantation (HPCT).
Maltese: Busulfan jingħata bħala infużjoni ta' sagħtejn kull 6 sigħat fuq medda ta' 4 ġranet konsekuttivi għal total ta' 16-il doża qabel cyclosphosphamide jew melphalan u t-trapjant taċ-ċelluli ematopojetiċi proġenitriċi (HPCT).
English: - The other ingredients are dimethylacetamide and macrogol 400.
Maltese: Is-sustanzi l-oħra huma dimethylacetamide u macrogol 400.
English: - Busulfan will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days.
Maltese: - Busulfan se jingħata f'doża ta' 3.2 mg/kg bħala infużjoni ta' tliet sigħat, darba kuljum immedjatament wara fludarabine għal 2 jew 3 ijiem konsekuttivi.
English: Cardiac-disorders Tachycardia
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Adverse reactions information is derived from two clinical trials (n=103) of busulfan.
Maltese: Tagħrif dwar reazzjonijiet avversi inkisbu minn żewġ studji kliniċi (n=103) ta' busulfan.
English: In that case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual busulfan infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Maltese: F'dan il-każ infużjoni issettjata bi spazju minimali pprajmjat għandha tintuża (i.e.0.3 - 0.6 ml), ippramjat b'soluzzjoni ta' droga qabel il-bidu tal-infużjoni attwali ta' busulfan u mbagħad tkun ifflaxxjata b'soluzzjoni tal-klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni tal-glukows (5%) għall-injezzjoni.
English: Overall mortality and non-relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Maltese: Kollox ma' kollox, il-mortalità u l-mortalità fejn ma kienx hemm rikaduta ta' aktar minn 100 ġurnata wara t- trapjant kien (8/61) 13% u (6/61) 10% f'pazjenti allotrapjantati, rispettivament.
English: Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion busulfan
Maltese: Busulfan Fresenius Kabi 6 mg/ml konċentrat sterili busulfan
English: Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Each vial is sleeved with shrinkable plastic film.
Maltese: Kull kunjett għandu kmiem b'film tal-plastik li jista 'jinxtorob.
English: 5 How to store Busulfan Fresenius Kabi Contents of the pack and other information
Maltese: Kif taħżen Busulfan Fresenius Kabi Kontenut tal-pakkett u informazzjoni oħra
English: Store in a refrigerator (2°C-8°C).
Maltese: maħżuna f'25°C  2°C
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
Maltese: 9/1 kien 21-il ġurnata (minn 12 sa 47-il ġurnata) f'pazjenti alloġenejiċi, u 11-il ġurnata (minn 10 sa 15-il ġurnata) f'pazjenti awtologużi.
English: How to store Busulfan Fresenius Kabi
Maltese: Kif taħżen Busulfan Fresenius Kabi
English: Hyponatraemia
Maltese: Ipogonadiżmu
English: Thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Maltese: 9/l jew li għandhom bżonn transfużjoni tal-pjastrini) seħħet fil-medjan ta' bejn 5-6 ġurnata f'98% tal-pazjenti.
English: Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Maltese: Stabbilità kimika u fiżika wara d-dilwizzjoni f'soluzzjoni għall-injezzjoni ta' glukosju 5% jew klorid tas-sodju 9 mg/ml (0.9%) ġiet murija għal 8 sigħat (inkluż il-ħin tal-infużjoni)
English: It is recommended to administer anticonvulsants 12 h prior to busulfan to 24 h after the last dose of busulfan.
Maltese: Hu rrakkomandat li għandhom jingħataw antikonvulżivi 12-il siegħa qabel busulfan sa 24 siegħa wara l-aħħar doża ta' busulfan.
English: Therefore, men treated with busulfan are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with busulfan.
Maltese: Mela, irġiel li jkunu kkurati b'busulfan jingħataw parir li ma jnisslu l-ebda tarbija matul u sa 6 xhur wara t-trattament u jiksbu pariri fuq iċ-ċrijo-konservazzjoni tal- isperma qabel il-kura minħabba l-possibilità ta' infertilità irreversibbli kaġun tat-terapija b'busulfan.
English: Elimination in faeces is negligible.
Maltese: L-eliminazzjoni fl-ippurgar hi negliġibbli.
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with busulfan due to a possible decrease in the metabolism of busulfan (See section 4.5).
Maltese: Wieħed għandu joqgħod attent meta jieħu l-paracetamol qabel (inqas minn 72 siegħa) jew fl-istess ħin mal-busulfan minħabba l-possibilità ta' tnaqqis fil-metaboliżmu tal-busulfan (ara sezzjoni 4.5).
English: The most serious side effects of busulfan therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Maltese: L-aktar effetti oħra serji tat-terapija busulfan jew tal-proċedura tat-trapjant għandhom mnejn jinkludu tnaqqis fil-għadd taċ-ċelluli tad-demm li jkunu qed jiċċirkulaw (l-effett intiż tal-mediċina biex jippreparak għall-infużjoni tiegħek tat-trapjant), infezzjoni, mard tal-fwied inkluż l-imblokkar tal-vina tal-fwied, marda tat-trapjant kontra r-riċevitur (it-trapjant jattakka l-ġismek) u komplikazzjonijiet pulmonari.
English: Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Maltese: It-trattament bil-Busulfan f'tifla preadolexxenti fixkel il-bidu tal-pubertà minħabba l-falliment ovarjan.
English: Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Maltese: Kabi għandu jiġi dilwit qabel ma jintuża jew b'soluzzjoni tal-klorid tas-sodju ta'9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni tal-glukows ta' 5% għall-injezzjoni.
English: Chest pain Oedema Oedema general Pain
Maltese: UŻATI JEW SKART MINN DAWN
English: • Quantity of diluent:
Maltese: Soluzzjoni dilwita:
English: Paracetamol is described to decrease glutathione levels in blood and tissues, and may therefore decrease busulfan clearance when used in combination (see section 4.4).
Maltese: Il-paracetamol hu deskritt li kapaċi jnaqqas il-livelli tal-glutathione fid-demm u fit-tessuti, u għalhekk għandu mnejn inaqqas it-tneħħija ta' busulfan meta jintużaw flimkien (ara sezzjoni 4.4).
English: Cataract Corneal thinning
Maltese: Katarretta Traqqiq talkornea
English: Dyspnoea Epistaxis Cough Hiccup
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Maltese: 1 ml ta' konċentrat fih 6 mg ta' busulfan u jipprovdi 0.5 mg/ml ta' busulfan wara d-dilwazzjoni
English: Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Maltese: Gastrointestinali: dardir, infjammazzjoni tal-mukoża tal-ħalq, rammettar, uġigħ abdominali, dijarea, xedda, ħruq ta' stonku, uġigħ fit-toqba tas-sorm, likwidu fiż-żaqq.
English: Hyperventilation Respiratory failure
Maltese: Iperventilazzjoni Difett respiratorju Emorraġiji Alveolari
English: Busulfan in combination with cyclophosphamide or melphalan Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Maltese: Busulfan flimkien ma' ċiklofosfamid jew melphalan Reazzjonijiet avversi li kienu rrappurtati kemm fl-adulti kif ukoll f'pazjenti pedjatriċi bħala aktar minn każ iżolat huma elenkati hawn taħt u kienu kklassifikati skont is-sistema tal-klassifika tal-organi u skont il-frekwenza.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: A MANIFATTUR(I) RESPONSABBLI
English: • Quantity of Busulfan Fresenius Kabi: Y (kg) x D (mg/kg)
Maltese: • Kwantità ta' dilwent: (A ml ta' Busulfan Fresenius
English: Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Maltese: Busulfan Fresenius Kabi m'għandux jitpoġġa ġo borza li tintuża għal ġol-vini li ma fihiex soluzzjoni ta' klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni ta' glukows ta' 5% għall-injezzjoni.
English: Busulfan Fresenius Kabi must always be added to the diluent, not the diluent to the Busulfan Fresenius Kabi.
Maltese: Il-Busulfan Fresenius Kabi għandu dejjem jiżdied mad-dilwent, mhux id-dilwent ma' Busulfan Fresenius Kabi.
English: Busulfan Fresenius Kabi can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Maltese: Kabi jista 'wkoll jipproduċi sintomi ta' menopawża u f'tfajliet pre-adolexxenti jista' jipprevjenji l-bidu tal-pubertà.
English: Paediatric population (0 to 17 years) The recommended dose of busulfan is as follows:
Maltese: popolazzjoni pedjatrika (minn 0 sa 17-il sena)
English: In paediatric population, for the BuMel regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.
Maltese: Fil-popolazzjoni pedjatrika, għar-regimen BuMel, kien innutat li l-għoti tal-melphalan inqas minn 24 siegħa wara l-aħħar għotja mill-ħalq tal-busulfan għandu mnejn influwenza l-iżvilupp tat-tossiċitajiet.
English: To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Maltese: 30.6 ml), ippramjat b'soluzzjoni tal-prodott mediċinali qabel il-bidu tal-infużjoni attwali ta' busulfan u mbagħad tkun ifflaxxjata b'soluzzjoni tal-klorid tas-sodju ta' 9 mg/ml (0.9%) għallinjezzjoni jew soluzzjoni tal-glukows (5%) għall-injezzjoni.
English: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent
Maltese: X'inhu Busulfan Fresenius Kabi u għalxiex jintuża
English: Busulfan Fresenius Kabi in combination with fludarabine The recommended dose of busulfan is 3.2 mg/kg Each infusion will last 3 hours
Maltese: − Id-doża rakkomandata ta' Busulfan Fresenius Kabi hi ta' 3.2 mg/kg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busulfan Fresenius Kabi 6 mg/ml sterile concentrate busulfan
Maltese: Informazzjoni għall-utent Busulfan Fresenius Kabi 6 mg/ml konċentrat għal soluzzjoni għall-infużjoni. busulfan
English: Patients older than 50 years of age (n=23) have been successfully treated with busulfan without dose-adjustment.
Maltese: Pazjenti li għandhom aktar minn 50 sena (n=23) ġew ikkurati b'suċċess b' Busulfan mingħajr aġġustament tad-doża.
English: Women must stop breast-feeding before starting their treatment with Busulfan Fresenius Kabi.
Maltese: In-nisa għandhom jieqfu jreddgħu qabel ma jibdew it-trattament b' Busulfan Fresenius Kabi.
English: What Busulfan Fresenius Kabi is and what it is used for What you need to know before you use Busulfan Fresenius Kabi How to use Busulfan Fresenius Kabi Possible side effects
Maltese: Aqra din il-gwida qabel ma tipprepara u tagħti l-Busulfan Fresenius Kabi.
English: Medicines before you receive Busulfan Fresenius Kabi:
Maltese: Mediċini oħra u Busulfan Fresenius Kabi
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany 12.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: The patients received the dosing mentioned in section 4.2.
Maltese: Il-pazjenti rċevew id-doża msemmija fis-sezzjoni 4.2.
English: Before receiving Busulfan Fresenius Kabi, you will be medicated with - anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and - antiemetic medicines to prevent vomiting.
Maltese: Il-pazjenti kollha għandhom ikunu premedikati permezz ta' prodotti mediċinali antikonvulżivi biex jiġu evitati attakki ta' puplesija liema attakki kienu rrapurtati meta tingħata doża għolja ta' busulfan.
English: Haematuria Moderate renal insufficiency
Maltese: Insuffiċjenza moderata tal-kliewi
English: It is unknown whether busulfan and DMA are excreted in human milk.
Maltese: Mhux magħruf jekk busulfan u DMA jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: For storage conditions after dilution of the medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali wara li jkun dilwit, ara sezzjoni 6.3. 6.5
English: What Busulfan Fresenius Kabi contains - The active substance is busulfan.
Maltese: − Is-sustanza attiva hi busulfan.
English: The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Maltese: L-okkorrenza ta' episodji infettivi jew attivazzjoni mill-ġdid ta' aġenti infettivi opportunistiċi jirrifletti prinċipalment l-istat immuni tal-pazjent li jkun jirċievi r-regimen kondizzjonarju.
English: The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis.
Maltese: Ma sar l-ebda esperiment speċifiku kliniku biex jassessja l-interazzjoni bejn mediċina u oħra bejn busulfan mogħti ġol-vini u jew metronidazole.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Maltese: L-użu profilaktiku jew empiriku tal-antinfettivi (batterjali, fungali, virali) għandhom jiġu meqjusa għall-fini tal-prevenzjoni u l-immaniġġjar tal-infezzjonijiet matul il-perijodu newtropeniku.
English: This will help protect them against infectious bronchitis.
Maltese: Dan se jgħin jipproteġihom kontra l-bronkite infettiva.
English: Avian infectious bronchitis vaccine (live attenuated)
Maltese: Vaċċin tal-bronkite infettiva tat-tjur (ħaj attenwat)
English: Nobilis IB 4-91 is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus.
Maltese: Nobilis IB 4-91 huwa vaċċin veterinarju li fih il-virus ħaj attenwat (imdgħajjef) tal-bronkite infettiva tat-tjur .
English: Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens.
Maltese: Nobilis IB 4-91 jintuża sabiex it-tiġieġ jiġu immunizzati sabiex jitnaqqsu s-sinjali respiratorji ta' bronkite infettiva kkawżata mir-razza varjant IB 4-91, li tikkawża bronkite infettiva fit-tiġieġ.
English: Nobilis IB 4-91 is available as a lyophilisate (freeze-dried powder) which is to be made up into a suspension.
Maltese: Nobilis IB 4-91 jiġi bħala lyophilisate (lijofilizzat) li jifforma f'sospensjoni.
English: In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls.
Maltese: Fi prova waħda, wara tliet ġimgħat, 100% tattiġieġ kienu żviluppaw antikorpi għall-virus IB 4-91 meta mqabbla ma' 17% tal-kontrolli.
English: Nobilis IB 4-91 is a vaccine.
Maltese: Nobilis IB 4-91 huwa vaċċin.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 exceed the risks for the approved indication and recommended that Nobilis IB 4-91 should be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Nobilis IB 4-91 huma akbar mir-riskji tiegħu għall-indikazzjoni approvata, u għaldaqstant irrakkomanda li Nobilis IB 4-91 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The avian infectious bronchitis virus in Nobilis IB 4-91 has been attenuated (weakened) so that it does not cause disease.
Maltese: Il-virus tal-bronkite infettiva tat-tjur f'Nobilis IB 4-91 ġie attenwat (imdgħajjef) sabiex ma jikkawżax mard.
English: The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials.
Maltese: Il-vaċċin Nobilis IB 4-91 ġie studjat f'diversi skedi ta' vaċċinazzjoni f'numru ta' provi.
English: There was a clear immune response to Nobilis IB 4-91.
Maltese: Kien hemm reazzjoni immuni ċara għal Nobilis IB 4-91.
English: What is Nobilis IB 4-91?
Maltese: X'hinu Nobilis IB 4-91?
English: What is the withdrawal period?
Maltese: Kemm hu twil il-perjodu ta' tiżmim?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 on 9 June 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nobilis IB 4-91 fid-9 ta' Ġunju 1998.
English: What is the risk associated with Nobilis IB 4-91?
Maltese: X'inhu r-riskju assoċjat ma' Nobilis IB 4-91?