FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients aged 2 to 5 years and ≥ 14 kg Day 1: lumacaftor 300 mg + ivacaftor 376 mg Day 2: lumacaftor 150 mg + ivacaftor 188 mg
Maltese: Għal pazjenti li għandhom minn sentejn sa 5 snin u jiżnu 14-il kg jew iktar Jum 1: lumacaftor 300 mg + ivacaftor 376 mg
English: For patients aged 2 to 5 years and ≥ 14 kg lumacaftor 300 mg + ivacaftor 376 mg
Maltese: Għal pazjenti li għandhom minn sentejn sa 5 snin u jiżnu 14-il kg jew iktar lumacaftor 300 mg + ivacaftor 376 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR SACHET
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Orkambi
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lumacaftor/ivacaftor in pregnant women.
Maltese: Għal lumacaftor/ivacaftor m'hemmx dejta jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu fin-nisa tqal.
English: Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface.
Maltese: Ivacaftor hu potenzjatur ta' CFTR li jiffaċilita żieda fit-trasport ta' chloride billi jsaħħaħ il-probabbiltà ta' kanal miftuħ (jew gating) tal-proteina CFTR fil-wiċċ taċ-ċellula.
English: Co-administration with sensitive CYP3A substrates or CYP3A substrates with a narrow therapeutic index is not recommended (see section 4.5).
Maltese: L-għoti flimkien ma' substrati sensittivi ta' CYP3A jew substrati ta' CYP3A b'indiċi terapewtiku dejjaq, mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Post-Authorisation Efficacy Study (PAES) Based on an agreed protocol, the Applicant should conduct a long-term effectiveness study to compare disease progression among children with CF homozygous for F508del-CFTR and are aged 2 through 5 years at the time of Orkambi treatment initiation versus disease progression among concurrent matched cohort of children with CF who have never received Orkambi treatment, in addition to a longitudinal historical cohort.
Maltese: Abbażi ta' protokoll li kien hemm qbil fuqu, l-Applikant għandu jwettaq studju tal-effettività fit-tul biex jiġu mqabbla l-progressjoni tal-marda fi tfal b'CF homozygous għal F508del-CFTR u li jkollhom bejn sentejn sa ħames snin meta inbeda t-trattament ta' Orkambi kontra l-progressjoni tal-marda fost koorti akkoppjata konkorrenti ta' tfal b'CF li qatt ma ġew ittrattati b'Orkambi, flimkien ma' koorti storika lonġitudinali.
English: ** For patients rolled over from Trials 1 and 2 (placebo-to-lumacaftor/ivacaftor group) total exposure was up to 96 weeks.
Maltese: Ilmaġġoranza tal-pazjenti ma komplewx għal raġunijiet li ma kinux is-sigurtà. **Għal pazjenti li komplew minn Provi 1 u 2 (il-grupp tal- plaċebo għal lumacaftor/il-grupp ta' ivacaftor), l-esponiment totali kien sa 96 Ġimgħa.
English: Lumacaftor/ivacaftor may decrease the exposures of these antidepressants, which may reduce their efficacy.
Maltese: Lumacaftor/ivacaftor jista' jnaqqas l-esponimenti ta' dawn l-antidepressanti, li jista' jnaqqas l-effikaċja tagħhom.
English: It is a medicine used for long-term treatment of cystic fibrosis (CF) in children aged 2 years and older who have a specific change (called F508del mutation) affecting the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR), which plays an important role in regulating the flow of mucus in the lungs.
Maltese: Hu mediċina li tintuża għall-kura fit-tul ta' fibrożi ċistika (CF) fi tfal li jkollhom sentejn u aktar, li jkollhom bidla speċifika (magħrufa bħala mutazzjoni F508del) li taffettwa l-ġene għal proteina msejħa cystic fibrosis transmembrane conductance regulator (CFTR), li għandha rwol importanti biex tirregola l-imxija tal-mukus filpulmun.
English: For patients aged 6 to 11 years 300 mg lumacaftor + 375 mg ivacaftor
Maltese: 300 mg lumacaftor + 375 mg ivacaftor
English: Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Maltese: Kull qartas fih 100 mg ta' lumacaftor u 125 mg ta' ivacaftor.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Orkambi 150 mg/188 mg granules lumacaftor/ivacaftor
Maltese: U MNEJN GĦANDU JINGĦATA Orkambi 150 mg/188 mg granijiet lumacaftor/ivacaftor
English: It is a medicine used for long-term treatment of cystic fibrosis (CF) in patients aged 6 years and older who have a specific change (called F508del mutation) affecting the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR), which plays an important role in regulating the flow of mucus in the lungs.
Maltese: Hu mediċina li tintuża għall-kura fit-tul ta' fibrożi ċistika (CF) f'pazjenti li jkollhom 6 snin u aktar, li jkollhom bidla speċifika (magħrufa bħala mutazzjoni F508del) li taffettwa l-ġene għal proteina msejħa cystic fibrosis transmembrane conductance regulator (CFTR), li għandha rwol importanti biex tirregola l-imxija tal-mukus filpulmun.
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day for the first week of treatment re-initiation.
Maltese: Jekk Orkambi jitwaqqaf għal aktar minn ġimgħa u mbagħad jerġa' jinbeda waqt li jkunu qed jittieħdu inibituri qawwija ta' CYP3A, id-doża ta' Orkambi għandha titnaqqas għal qartas wieħed (lumacaftor 100 mg/ivacaftor 125 mg għal pazjenti li jkollhom minn sentejn sa 5 snin u jiżnu inqas minn 14-il kg; lumacaftor 150 mg/ivacaftor 188 mg għal pazjenti li jkollhom bejn sentejn u 5 snin u jiżnu 14-il kg jew iktar) darba iva u darba le għall-ewwel ġimgħa tal-bidu mill-ġdid tal-kura.
English: Lumacaftor had no effects on fertility and reproductive performance indices in male and female rats.
Maltese: Lumacaftor ma kellu l-ebda effetti fuq indiċijiet ta' prestazzjoni tal-fertilità u dawk riproduttivi f'firien irġiel u nisa.
English: The majority of events were mild or moderate in severity, non-serious and did not result in treatment discontinuation (see section 4.4).
Maltese: Il-maġġoranza tal-avvenimenti kienu ħfief jew moderati fis-severità, mhux serji, u ma rriżultawx fit-twaqqif tal-kura (ara sezzjoni 4.4).
English: The primary efficacy analysis of this extension study included data up to Week 72 of Trial 3 with a sensitivity analysis that included data up to Week 96 of Trial 3.
Maltese: L-analiżi primarja tal-effikaċja ta' dan l-istudju ta' estensjoni kien jinkludi dejta sa Ġimgħa 72 ta' Prova 3 b'analiżi tas-sensittività li kienet tinkludi dejta sa Ġimgħa 96 ta' Prova 3.
English: Transaminase elevations have been observed more frequently in paediatric patients than in adult patients (see section 4.8).
Maltese: Żidiet fit-transaminases ġew osservati b'mod aktar aktar frekwenti f'pazjenti pedjatriċi milli f'pazjenti adulti (ara sezzjoni 4.8).
English: Uncommon may affect up to 1 in 100 people:
Maltese: Mhux komuni jistgħu jaffettwaw 1 minn kull 100 persuna:
English: Trial 2 evaluated 559 patients aged 12 years and older (mean age 25.0 years) with ppFEV1 at screening between 40-90 (mean ppFEV1 60.5 at baseline [range: 31.3 to 99.8]).
Maltese: 0 sena) b'ppFEV1 waqt l-iscreening ta' bejn 40-90 (medja ta' ppFEV1 ta' 60.5 fil-linja bażi [medda: 31.3 sa 99.8]).
English: Orkambi 100 mg/125 mg film-coated tablets:
Maltese: Orkambi 100 mg/125 mg pilloli miksija b'rita:
English: Lumacaftor is a CFTR corrector that acts directly on F508del-CFTR to improve its cellular processing and trafficking, thereby increasing the quantity of functional CFTR at the cell surface.
Maltese: Lumacaftor hu korrettur ta' CFTR li jaġixxi direttament fuq F508del-CFTR biex ittejjeb l-ipproċessar ċellulari u t-traffikar tagħha, u b'hekk iżid il-kwantità ta' CFTR funzjonali fuq ilwiċċ taċ-ċellula.
English: Ivacaftor is not an inhibitor of OAT1 and OAT3.
Maltese: Ivacaftor mhuwiex inibitur ta' OAT1 u OAT3.
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with lumacaftor/ivacaftor.
Maltese: Kontraċettivi ormonali, li jinkludu dawk orali, li jistgħu jiġu injettati, użu minn fuq il-ġilda, u dawk li jistgħu jiġu impjantati, m'għandhomx jiġu afdati bħala li huma metodu effettiv ta' kontraċezzjoni meta jingħataw flimkien ma' lumacaftor/ivacaftor.
English: During a 24-week, open label, Phase 3b clinical study (Trial 5) in 46 patients aged 12 years and older with advanced lung disease (ppFEV1 < 40) [mean ppFEV1 29.1 at baseline (range: 18.3 to 42.0)], the incidence of respiratory events was 65.2%.
Maltese: Matul studju kliniku ta' Fażi 3b, open-label, li dam 24 ġimgħa (Prova 5), li sar fuq 46 pazjent li kellhom 12-il sena u aktar, b'mard avvanzat tal-pulmun (ppFEV1 <40)
English: Lumacaftor/ivacaftor may alter the exposure of warfarin.
Maltese: Lumacaftor/ivacaftor jista' jibdel lesponiment ta' warfarin.
English: ↔ LUM, IVA ↑ or ↓ fexofenadine
Maltese: Iċċekkja mattabib jekk ikollok xi dubju.
English: Following multiple oral dose administration of ivacaftor in combination with lumacaftor, the exposure of ivacaftor generally increased with dose from 150 mg every 12 hours to 250 mg every 12 hours.
Maltese: Wara l-għoti ta' dożi multipli orali ta' ivacaftor flimkien ma' lumacaftor, l-esponiment ta' ivacaftor ġeneralment żdied mad-doża minn 150 mg kull 12-il siegħa għal 250 mg kull 12-il siegħa.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet lumacaftor/ivacaftor
Maltese: Orkambi 100 mg/125 mg granijiet f'qartas lumacaftor/ivacaftor
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 100 mg + ivacaftor 125 mg For patients aged 2 to5 years and ≥ 14 kg lumacaftor 150 mg + ivacaftor 188 mg
Maltese: Għal pazjenti li għandhom minn sentejn sa 5 snin u jiżnu 14-il kg jew iktar lumacaftor 150 mg + ivacaftor 188 mg
English: Vascular disorders uncommon Hypertension
Maltese: Disturbi vaskulari mhux komuni
English: Lumacaftor/ivacaftor may decrease the exposures of these proton pump inhibitors, which may reduce their efficacy.
Maltese: Lumacaftor/ivacaftor jista' jnaqqas lesponimenti ta' dawn l-inibituri tal-pompa tal-protons, li jista' jnaqqas l-effikaċja tagħhom.
English: Changes in ppFEV1 in response to lumacaftor alone or in combination with ivacaftor were also evaluated in the double-blind, placebo-controlled, Phase 2 trial in patients with CF age 18 years and older.
Maltese: Bidliet fil-ppFEV1 bi tweġiba għal lumacaftor waħdu jew flimkien ma' ivacaftor, ġew evalwati wkoll fil-prova ta' Fażi 2, double-blind, ikkontrollata bi plaċebo, f'pazjenti b'CF li kellhom 18-il sena u aktar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1059/007
English: Pregnancy
Maltese: dabigatran
English: Table 1: Recommended dose of Orkambi in patients aged 6 years and older Age
Maltese: Tabella 1: Doża rakkomandata ta' Orkambi f'pazjenti li jkollhom 6 snin u aktar
English: The exact mechanisms by which lumacaftor improves cellular processing and trafficking of F508del-CFTR and ivacaftor potentiates F508del-CFTR are not known.
Maltese: Il-mekkaniżmi preċiżi li permezz tagħhom lumacaftor itejjeb l-ipproċessar ċellulari u t-traffikar ta' F508del-CFTR u ivacaftor isaħħaħ F508del-CFTR mhumiex magħrufa.
English: Contents of the pack and other information What Orkambi contains
Maltese: Informazzjoni importanti dwar il-kontenut ta' Orkambi
English: Clinical comment fluconazole
Maltese: Fluconazole
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1059/005
English: Common may affect up to 1 in 10 people:
Maltese: Komuni jistgħu jaffettwaw sa 1 minn kull 10 persuni:
English: Among different age paediatric cohorts, in the 2 to 5 years old patients, transaminase elevations have been observed more frequently than in the 6 to 11 years old (see section 4.8).
Maltese: Fost koorti pedjatriċi ta' etajiet differenti, ġew osservati żidiet fit-transaminases b'mod aktar frekwenti fil-pazjenti li kellhom bejn sentejn u 5 snin milli f'dawk li kellhom bejn 6 u 11il sena (ara sezzjoni 4.8).
English: No specific antidote is available for overdose with lumacaftor/ivacaftor.
Maltese: M'hemm l-ebda antidot speċifiku għal doża eċċessiva b'lumacaftor/ivacaftor.
English: Orkambi 200 mg/125 mg is available in the following pack sizes:
Maltese: Orkambi 200 mg/125 mg hu disponibbli fid-daqsijiet tal-pakketti li ġejjin:
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with lumacaftor/ivacaftor and ivacaftor monotherapy.
Maltese: Każijiet ta' opaċitajiet mhux konġenitali tal-lenti mingħajr impatt fuq il-vista, ġew irrappurtati f'pazjenti pedjatriċi kkurati b'lumacaftor/ivacaftor umonoterapija ta' ivacaftor.
English: Immediate packaging
Maltese: Kontenut Daqs talpakkett
English: For the mutual recognition procedure (MRP), Belgium acted as a reference Member State and Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom were concerned Member States.
Maltese: Għall-proċedura ta' rikonoxximent reċiproku (MRP), il-Belġju aġixxa bħala Stat Membru ta' referenza u l-Bulgarija, il-Kroazja, Franza, il-Ġermanja, l-Irlanda, l-Italja, in-Netherlands, il-Polonja, il-Portugall, ir-Rumanija, is-Slovenja, Spanja u r-Renju Unit kienu l-Istati Membri kkonċernati.
English: Animal species Route of administration
Maltese: Mod ta' amministrazzjoni
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium
Maltese: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Il-Belġju
English: − Clinically validate the upper limit for total protein content.
Maltese: − Jivvalida b'mod kliniku l-ogħla limitu għall-kontenut tal-proteini totali.
English: With Commission Decisions 5694 of 10/08/2010 and 7077 of 07/10/2010 the marketing authorisations for PregSure BVD were suspended.
Maltese: Bid-Deċiżjonijiet tal-Kummissjoni 5694 tal-10/08/2010 u 7077 tas-07/10/2010 l-awtorizzazzjonijiet għat-tqegħid fis-suq għal PregSure BVD ġew sospiżi.
English: The limit should be equal to or below the quantity of total protein of the CattleMarker IBR vaccine used in hyperimmunisation study 9134R-08-11-457.
Maltese: Il-limitu għandu jkun ugwali għal jew inqas mill-kwantità tal-proteina totali tal-vaċċin CattleMarker IBR użat fi studju ta' iperimmunizzazzjoni 9134R-08-11-457.
English: Applicant/marketing authorisation holder
Maltese: Applikant/Detentur talawtorizzazzjoni għattqegħid fis-suq
English: The frequency of this condition had been dramatically exacerbated by PregSure BVD vaccination in the 2000's leading to the characterisation of a strong association between the occurrence of BNP and the use of Pregsure BVD; however the frequency of BNP disease caused by PregSure BVD vaccination has not been solidly determined, varying from 5% to 0.004% according to the source; the CVMP approximated this frequency to be around 0.01% during the Article 78 procedure.
Maltese: Il-frekwenza ta' din il-kundizzjoni ggravat b'mod drammatiku mit-tilqim PregSure BVD fl-2000's li wassal għall-karatterizzazzjoni ta' assoċjazzjoni qawwija bejn l-okkorrenza tal-BNP u l-użu ta' Pregsure BVD; madankollu, il-frekwenza tal-marda BNP ikkawżata mit-tilqim PregSure BVD ma ġietx determinata b'mod sod, li tvarja minn 5% sa 0.004% skont is-sors; is-CVMP apporissimizza li din il-frekwenza kienet madwar 0.01% matul il-proċedura talArtikolu 78.
English: If dead, bone marrow histopathology shows trilineage hypoplasia.
Maltese: Jekk mejta, l-istopatoloġija tal-mudullun turi iperplażja trilineage.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, l-isspeċi tal-annimal, mod ta' amministrazzjoni, l-applikant/id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated) is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Maltese: L-emulsjoni ta' CattleMarker IBR Inactivated għall-injezzjoni għall-frat (minn hawn 'il quddiem imsejħa CattleMarker IBR Inactivated) huwa vaċċin ta' rinotrakeite tal-bovini li tittieħed (IBR) inattivata li fiha lvirus tal-ħerpes tal-bovini negattiv għal glikoproteina E (gE) (BoHV-1), razza Difivac.
English: Annex I
Maltese: Anness 1
English: • to reduce the clinical signs (pyrexia and duration of dyspnoea) of infectious bovine rhinotracheitis (IBR) and virus shedding caused by BoHV-1 infection;
Maltese: • biex jitnaqqsu s-sinjali kliniċi (piressija u t-tul tad-dispnea) tar-rinotrakeite bovina li tittieħed (IBR) u t-tixrid tal-virus ikkawżat mill-infezzjoni BoHV-1;
English: Overall summary of the scientific evaluation of CattleMarker IBR Inactivated (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' CattleMarker IBR Inactivated (ara Anness I)
English: If alive, profound thrombocytopenia (with or without neutropenia, lymphopenia and nonregenerative anaemia).
Maltese: Jekk ħajja, tromboċitopenja profonda (bi jew mingħajr newtropenja, limfopenija u anemija mhux riġenerattiva).
English: Should proposals for alternative immunisation schemes, indications, or contraindications be necessary, these regulatory measures should also be handled consistently with the normal operating practices for adverse event reports and variations associated with veterinary medicinal products.
Maltese: Jekk il-proposti għal skemi ta' immunizzazzjoni, indikazzjonijiet, jew kontraindikazzjonijiet alternattivi jkunu neċessarji, dawn il-miżuri regolatorji għandhom jiġu trattati wkoll b'mod konsistenti mal-prattiki operattivi normali għal rapporti ta' avvenimenti avversi u varjazzjonijiet assoċjati mal-prodotti mediċinali veterinarji.
English: Since the issues raised by Germany remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation CattleMarker IBR Inactivated and consequently the matter was referred to the CVMP on 29 September 2015 under Article 33(4) of Directive 2001/82/EC.
Maltese: Peress li l-kwistjonijiet imqajmin mill-Ġermanja baqgħu ma ssolvewx, l-Istati Membri kkonċernati naqsu milli jilħqu qbil fir-rigward tal-awtorizzazzjoni għat-tqegħid fis-suq għall-CattleMarket IBR Inactivated u konsegwentement il-kwistjoni ġiet riferuta lis-CVMP fid-29 ta' Settembru 2015 skont lArtikolu 33(4) tad-Direttiva 2001/82/KE.
English: − PSURs shall be provided every 6 months for the first 5 years of commercialisation.
Maltese: − Il-PSURs għandhom jiġu pprovduti kull 6 xhur għall-ewwel 5 snin tal-kummerċjalizzazzjoni.
English: − Send out a letter to all customers receiving the CattleMarker IBR Inactivated for the first time with additional information to raise awareness for possible BNP cases.
Maltese: − Tintbagħat ittra lill-klijenti kollha li jirċievu CattleMarket IBR Inactivated għall-ewwel darba f'informazzjoni addizzjonali biex titqajjem sensibilizzazzjoni lejn każijiet possibbli ta' BNP.
English: Nonetheless in the assessment in the frame of this procedure under Article 78 of Directive 2001/82/EC the frequency of the BNP caused by PregSure BVD was approximated to be around 0.01% by the CVMP.
Maltese: Madankollu fil-valutazzjoni fil-qafas ta' din il-proċedura skont l-Artikolu 78 tad-Direttiva 2001/82/KE ilfrekwenza tal-BNP ikkawżata minn PregSure BVD kienet approssimata li hija madwar 0.01% misCVMP.
English: Later the marketing authorisations for PregSure BVD were withdrawn by the MAH Pfizer (now Zoetis) from all EU and in 2011 even from non-EU countries after reports about BNP cases in PregSure BVD-vaccinated herds in New Zealand became public.
Maltese: Wara, l-awtorizzazzjonijiet għal PregSure BVD ġew irtirati mill-MAH Pfizer (issa Zoetis) mill-UE kollha u fl-2011 anki minn pajjiżi mhux tal-UE wara li rapporti dwar każijiet ta' merħliet imlaqqma bi PregSure BVD fi New Zealand saru pubbliċi.
English: Onset of protection for female cattle is 2 weeks or 19 days prior to breeding or insemination and duration is 12 months post primary vaccination.
Maltese: Il-bidu tal-protezzjoni għal frat femminili huwa ta' ġimagħtejn u 19-il jum qabel it-tnissil jew linseminazzjoni u t-tul huwa ta' 12-il xahar wara t-tilqima primarja.
English: gE deleted IBR vaccines such as CattleMarker IBR Inactivated are “DIVA vaccines”, differentiating infected from vaccinated animals.
Maltese: Vaċċini tal-IBR bil-gE imħassar bħal CattleMarket IBR Inactivated huma "vaċċini DIVA" (DIVA vaccines), li jagħmlu distinzjoni bejn annimali infettati u annimali mlaqqmin.
English: Active immunisation of female cattle from 6 months of age is also indicated:
Maltese: Huwa indikat ukoll tilqim attiv tal-frat femminili mill-età ta' 6 xhur:
English: • The MAH has provided data demonstrating that the risk that repeated injections with the vaccine
Maltese: • L-MAH ipprovda data li turi li r-riskju li l-injezzjonijiet ripetuti bil-vaċċin CattleMarket IBR
English: Germany Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Is-Slovenja Zoetis Belgium SA Rue Laid Burniat 1
English: Poland
Maltese: Billi
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1
Maltese: L-Ispanja Zoetis Belgium SA Rue Laid Burniat 1
English: Romania Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Ir-Rumanija Zoetis Belgium SA Rue Laid Burniat 1
English: The marketing authorisation holder (MAH), Zoetis Belgium SA, submitted an application for mutual recognition of the marketing authorisation granted by Belgium in accordance with Article 32 of Directive 2001/82/EC.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fuq is-suq (MAH), Zoetis Belgium SA, ippreżenta applikazzjoni għar-rikonoxximent reċiproku tal-awtorizzazzjoni għat-tqegħid fis-suq mogħtija millBelġju skont l-Artikolu 32 tad-Direttiva 2001/82/KE.
English: The MAH proposed a post-marketing pharmacovigilance surveillance program utilising its usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated.
Maltese: L-MAH ippropona programm ta' sorveljanza tal-farmakoviġilanza ta' wara t-tqegħid fis-suq bl-użu tassistema ta' farmakoviġilanza normali tiegħu għall-monitoraġġ tal-annimali mlaqqma b'CattleMarker IBR Inactivated.
English: Data has been provided to demonstrate that CattleMarker IBR Inactivated, unlike PregSure BVD, has a reduced amount of immunologically significant amount of ANAS remaining from its manufacturing process on the bovine derived kidney cell line in the final product.
Maltese: Id-data ġiet ipprovduta biex turi li CattleMarket IBR Inactivated, b'differenza għal PregSure BVD, għandu ammont imnaqqas ta' ammont immunoloġikament sinifikanti ta' ANAS li jifdal mill-proċess ta' manifattura tiegħu fuq il-linja ta' ċelloli tal-kliewi derivata mill-bovini fil-prodott finali.
English: Any confirmed BNP calves will also be assessed for MHC-I alloantibodies.
Maltese: Kwalunkwe għoġol b'BNP ikkonfermata se jiġi vvalutat ukoll għall-alloantikopri talMHC-I.
English: CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant, Procision-A, as PregSure BVD.
Maltese: CattleMarker IBR Inactivated huwa prodott fuq l-istess linja ta' ċelloli tal-bovini u huwa ssupplimentat mill-istess aġġuvant qawwi ħafna, Procision-A, bħal PregSure BVD.
English: A filtration step using three filtration membranes has been integrated into the production process for clarification of the antigen preparations.
Maltese: Stadju ta' filtrazzjoni bl-użu ta' tliet membrani ta' filtrazzjoni ġie integrat fil-proċess ta' produzzjoni għall-kjarifika tal-preparazzjonijiet tal-antiġen.