FrancophonIA/ELRC3.0 huggingface dataset:
English: Subgroup survival analysis showed a consistent survival benefit for treatment with Xofigo, independent of use of bisphosphonates at baseline and prior use of docetaxel.
Maltese: L-analiżi tas-sopravivenza tas-sottogrupp uriet benefiċċju ta' sopravivenza konsistenti għall-kura b'Xofigo, indipendenti mill-użu ta' bisphosphonates fil-linja bażi u użu preċedenti ta' docetaxel.
English: A higher rate of non-prostate cancer related deaths was observed in the placebo group (26/541, 4.8% in the Xofigo arm compared to 23/268, 8.6% in the placebo arm).
Maltese: Kienet osservata rata ogħla ta' mwiet mhux relatati ma' kanċer tal-prostata fil-grupp tal-plaċebo (26/541, 4.8% fil-grupp ta' Xofigo meta mqabbel ma' 23/268, 8.6% fil-grupp tal-plaċebo).
English: Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy.
Maltese: Effetti addizzjonali fuq il-mikro-ambjent tat-tumur inklużi osteoblasts u osteoklasts ukoll jikkontribwixxu għall-effikaċja in vivo.
English: Each mL of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.
Maltese: Kull mL ta' soluzzjoni fih 1100 kBq ta' radium-223 dichloride, li jikkorrispondu għal 0.58 ng ta' radium-223 fid-data ta' referenza.
English: Neutropenia (all grades) was reported in 5% of patients treated with Xofigo and in 1% of patients receiving placebo.
Maltese: Newtropenija (il-gradi kollha) ġiet irrappurtata f'5% tal-pazjenti kkurati b'Xofigo u f'1% tal-pazjenti li rċivew plaċebo.
English: No overall differences in safety or efficacy were observed between elderly (aged ≥ 65 years) and younger patients (aged < 65 years) in the phase III study.
Maltese: L-ebda differenzi ġenerali fis-sigurtà u l-effikaċja ma ġew osservati bejn pazjenti anzjani (b'età ≥ 65 sena) u pazjenti iżgħar (b'età < 65 sena) fl-istudju ta' fażi
English: Overall, the frequency of grade 3 and 4 neutropenia was lower in patients that did not previously receive docetaxel (0.8% in patients treated with Xofigo versus 0.8% in patients receiving placebo) compared to patients that previously received docetaxel (3.2% in patients treated with Xofigo versus 0.6% in patients receiving placebo).
Maltese: B'mod ġenerali, il-frekwenza ta' newtropenija ta' grad 3 u 4 kienet iktar baxxa f'pazjenti li fil-passat ma ħadux docetaxel (0.8% f'pazjenti kkurati b'Xofigo kontra 0.8% f'pazjenti li rċivew plaċebo) meta mqabbla ma' pazjenti li fil-passat irċivew docetaxel (3.2% f'pazjenti kkurati b'Xofigo kontra 0.6% f'pazjenti li rċivew plaċebo).
English: The absorbed radiation dose calculation was performed based on clinical biodistribution data.
Maltese: Il-kalkolu tad-doża ta' radjazzjoni assorbita twettaq skont id-dejta tal-bijodistribuzzjoni klinika.
English: The gamma radiation associated with the decay of radium-223 and its daughters allows for the radioactivity measurement of Xofigo and the detection of contaminations with standard instruments.
Maltese: Ir-radjazzjoni gamma assoċjata mat-tnaqqis fil-potenza (decay) ta' radium-223 u l-emissjonijiet tiegħu tippermetti li jsir kejl tar-radjuattività ta' Xofigo u l-iskoperta ta' kontaminazzjonijiet bi strumenti standard.
English: The most serious adverse reactions were thrombocytopenia and neutropenia (see section 4.4 and ‘Description of selected adverse reactions' below).
Maltese: Ir-reazzjonijiet avversi l-aktar serji kienu tromboċitopenija u newtropenija (ara sezzjoni 4.4 u ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula' hawn taħt).
English: Single Xofigo doses containing an activity of up to 276 kBq per kg body weight were evaluated in a phase I clinical trial and no dose-limiting toxicities were observed.
Maltese: Dożi waħidhom ta' Xofigo b'attività sa 276 kBq għal kull kg ta' piż tal-ġisem ġew evalwati fi prova klinika ta' fażi I u ma ġew osservati l-ebda tossiċitajiet li jillimitaw id-doża.
English: Xofigo 1100 kBq/mL solution for injection radium Ra 223 dichloride For intravenous use.
Maltese: Xofigo 1100 kBq/mL soluzzjoni għall-injezzjoni radium Ra 223 dichloride Użu għal ġol-vina.
English: Thrombocytopenia and neutropenia
Maltese: Tromboċitopenija u newtropenija
English: Thrombocytopenia (all grades) occurred in 11.5% of patients treated with Xofigo and 5.6% of patients receiving placebo.
Maltese: Tromboċitopenija (il-gradi kollha) seħħet fi 11.5% tal-pazjenti kkurati b'Xofigo u f'5.6% tal-pazjenti li rċivew plaċebo.
English: Since radium-223 distributes mainly to bone, the potential risk for adverse effects in the male gonads in cancer patients with castration-resistant prostate cancer is very low, but cannot be excluded (see section 4.6).
Maltese: Peress li fil-biċċa l-kbira radium-223 jiġi distribwit fl-għadam, ir-riskju potenzjali ta' effetti avversi filgonadi maskili f'pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni hu baxx ħafna, iżda ma jistax jiġi eskluż (ara sezzjoni 4.6).
English: Xofigo increases the risk of bone fractures (see section 5.1).
Maltese: Xofigo iżid ir-riskju ta' ksur fl-għadam (ara sezzjoni 5.1).
English: Depending on the volume administered, this medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose, equivalent to 2.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Skont il-volum mogħti, dan il-prodott mediċinali jista' jkun fih sa 2.35 mmol (54 mg) ta' sodium f'kull doża, ekwivalenti għal 2.7% tal-ammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult..
English: Pharmacokinetic data were obtained in 25 patients at activities ranging from 51 to 276 kBq/kg.
Maltese: Inkisbet dejta farmakokinetika u dwar il-bijodistribuzzjoni u d-dożimetrija minn 3 studji ta' fażi I. Dejta farmakokinetika nkisbet minn 25 pazjent f'attivitajiet li varjaw minn 51 sa 276 kBq/kg.
English: The MAH shall conduct and submit the results of a phase IV biodistribution study according to an agreed protocol in order to further characterize correlation between the extent of the disease, the dose and the distribution of radium-223 in bone metastases versus sites of impaired bone health (e.g. osteoporosis) versus normal bone structure.
Maltese: IV skont protokoll miftiehem sabiex jikkaratterizza aktar il-korrelazzjoni bejn il-firxa tal-marda, id-doża u d-distribuzzjoni ta' radium-223 f'metastasi fl-għadam kontra siti ta' saħħa indebolita fl-għadam (eż. osteoporożi) kontra struttura normali tal-għadam.
English: There is a potential risk that radiation from Xofigo could affect your fertility.
Maltese: Hemm riskju potenzjali li radjazzjoni minn Xofigo jista' jkollha effett fuq il-fertilità tiegħek.
English: The rate of elimination of radium-223 dichloride from the gastrointestinal tract is influenced by the high variability in intestinal transit rates across the population, with the normal range from once daily to once weekly bowel evacuation.
Maltese: Ir-rata ta' eliminazzjoni ta' radium-223 dichloride mill-apparat gastrointestinali hija influwenzata mill-varjabilità għolja fir-rati ta' transitu intestinali filpopolazzjoni kollha, b'firxa normali ta' ppurgar minn darba kuljum sa darba fil-ġimgħa.
English: An increased risk of death and fractures was observed in a clinical study, where Xofigo was added to abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration resistant prostate cancer.
Maltese: Żieda fir-riskju ta' mewt u fratturi kienet osservata fi studju kliniku, fejn Xofigo ġie miżjud ma' abiraterone acetate u prednisone/prednisolone f'pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni mhux sintomatiku jew kemmxejn sintomatiku.
English: Duration of the procedure - Xofigo is given once every 4 weeks for a total of 6 injections.
Maltese: Tul tal-proċedura - Xofigo jingħata darba kull 4 ġimgħat għal total ta' 6 injezzjonijiet.
English: For radium-223, as primarily an alpha emitter, additional assumptions were made for the intestine, red marrow and bone/osteogenic cells, to provide the best possible absorbed dose calculations for Xofigo, considering its observed biodistribution and specific characteristics (see Table 4).
Maltese: Għal radium-223, li primarjament jerħi partiċelli alpha, saru suppożizzjonijiet addizzjonali għallimsaren, il-mudullun l-aħmar u ċ-ċelluli tal-għadam/osteoġeniċi, biex jipprovdu l-aħjar kalkolu possibbli ta' doża assorbita għal Xofigo, b'konsiderazzjoni tal-bijodistribuzzjoni osservata u l-karatteristiċi speċifiċi tiegħu (ara Tabella 4).
English: Pain relief
Maltese: Bijotrasformazzjoni
English: Small intestine wall Stomach wall ULI3 wall
Maltese: Kisja tal-istonku Kisja tal-ULI3
English: Fifteen minutes post injection, about 20% of the injected activity remained in the blood.
Maltese: Ħmistax-il minuta wara l-injezzjoni, madwar 20% tal-attività injettata baqgħet fid-demm.
English: Bone marrow suppression
Maltese: Mhux applikabbli.
English: These findings were related to radiation-induced impairment of haematopoiesis and a reduction of osteogenesis and started at the lowest activity of 22 kBq per kg body weight (0.4 times the clinically recommended dose).
Maltese: Dawn is-sejbiet kienu relatati ma' indeboliment indott mir-radjazzjoni ta' ematopoesi u tnaqqis ta' osteoġenesi u bdew bl-inqas attività ta' 22 kBq għal kull kg ta' piż tal-ġisem (0.4 darbiet id-doża rrakkomandata klinikament).
English: Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects.
Maltese: Esponiment globali kumulattiv fit-tul għar-radjazzjoni jista' jkun assoċjat ma' riskju miżjud ta' kanċer u difetti ereditarji.
English: 4Absorbed dose data to the lung are based on model-derived calculation using pooled blood time-activity data from all subjects
Maltese: 4Id-data tad-doża assorbita fil-pulmun hija bbażata fuq kalkolu derivat mill-mudell bl-użu ta' data miġbura f'daqqa talattività fid-demm mal-ħin mill-individwi kollha
English: In particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased.
Maltese: B'mod partikolari, ir-riskju ta' osteosarkoma, sindrome majelodisplastika u lewkimja jista' jiżdied.
English: The fraction of energy emitted from radium-223 and its daughters as alpha-particles is 95.3% (energy range of 5.0 - 7.5 MeV).
Maltese: 3% (firxa ta' enerġija ta' 5.0 - 7.5
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xofigo in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) and in the treatment of multiple myeloma (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat l-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Xofigo f'kull sett tal-popolazzjoni pedjatrika fit-trattament tal-kondizzjonijiet kollha inklużi fil-kategorija ta' neoplażmi malinni (minbarra tumuri tas-sistema nervuża ċentrali, neoplasmi tat-tessuti ematopoetiċi u limfojdi) u fit-trattament ta' majeloma multipla (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku)
English: No case of osteosarcoma has been reported in clinical studies with Xofigo.
Maltese: Ma ġewx osservati osteosarkomi fi studji fuq il-klieb.
English: However, in keeping with the ALARA (“As Low As Reasonably Achievable”) principle, for minimisation of radiation exposure, it is recommended to minimise the time spent in radiation areas, to maximise the distance to radiation sources, and to use adequate shielding.
Maltese: Madankollu, b'konformità mal-prinċipju ALARA (“As Low As Reasonably Achievable”), għall-minimizzazzjoni ta' esponiment għar-radjazzjoni, hu rrakkomandat li jiġi minimizzat il-ħin li persuna tkun f'żoni ta' radjazzjoni, li tiġi massimizzata d-distanza bejn sorsi ta' radjazzjoni, u li tintuża protezzjoni adegwata.
English: Radium is present in the solution as a free ion.
Maltese: Radium hu preżenti fis-soluzzjoni bħala jone ħielsa.
English: Gallbladder wall LLI2 Wall
Maltese: Kisja tal-LLI2
English: INSTRUCTION FOR PREPARATION OF RADIOPHARMACEUTICALS This medicinal product should be visually inspected before use.
Maltese: ISTRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI RADJUFARMAĊEWTIĊI
English: No significant QTc prolonging effects were observed after intravenous injection of Xofigo in comparison with placebo in a subgroup of 29 patients in the phase III study (ALSYMPCA).
Maltese: Ma ġew osservati l-ebda effetti sinifikanti ta' titwil ta' QTc wara injezzjoni fil-vini ta' Xofigo meta mqabbel ma' plaċebo f'sottgrupp ta' 29 pazjent fl-istudju ta' fażi III (ALSYMPCA).
English: A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP < 220 U/L.
Maltese: Analiżi ta' sottogrupp speċifikata minn qabel uriet ukoll li s-sopravivenza globali ma tjibitx b'mod sinifikanti f'pazjenti b'ALP totali ta' < 220 U/L.
English: 28 days.
Maltese: 2,2 min
English: - If you plan to take Xofigo following treatment with abiraterone and prednisone/prednisolone, you must wait 5 days before starting treatment with Xofigo.
Maltese: - Jekk qed tippjana li tieħu Xofigo wara trattament b'abiraterone u prednisone/prednisolone, għandek tistenna 5 ijiem qabel tibda t-trattament b'Xofigo.
English: Table 2: Survival results from the phase III ALSYMPCA study
Maltese: Tabella 3: Punti aħħarin sekondarji tal-effikaċja mill-istudju ta' fażi
English: However, since excretion in urine is minimal and the major route of elimination is via the faeces, renal impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
Maltese: Madankollu, peress li t-tneħħija fl-awrina hi minima u r-rotta maġġuri tat-tneħħija hi fl-ippurgar, indeboliment tal-kliewi mhux mistenni li jaffettwa l-farmakokinetika ta' radium-223 dichloride.
English: B. PACKAGE LEAFLET
Maltese: Tabella ta' fatturi
English: Spinal cord compression
Maltese: Kompressjoni tassinsla
English: Secondary malignant neoplasms
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Data on a safe period after which Xofigo can be administered following treatment with abiraterone acetate in combination with prednisone/prednisolone and vice versa is limited.
Maltese: Data dwar perjodu ta' sigurtà li warajh Xofigo jista' jingħata wara trattament b'abiraterone acetate flimkien ma' prednisone/prednisolone u viċe versa hija limitata.
English: In EOD4 (“superscan”) patients, thrombocytopenia (all grades) was reported in 19.6% of patients treated with Xofigo and in 6.7% of patients receiving placebo.
Maltese: 6% tal-pazjenti kkurati b'Xofigo u f'6.7% talpazjenti li rċivew plaċebo.
English: Xofigo is used to treat adults with advanced castration-resistant prostate cancer in progression after at least two other cancer treatments apart from treatments to maintain reduced levels of male hormone (hormone therapy), or who cannot take any other cancer treatment.
Maltese: Xofigo jintuża biex jikkura adulti b'kanċer avanzat tal-prostata reżistenti għall-kastrazzjoni fi progressjoni wara mill-inqas żewġ trattamenti oħra għall-kanċer minbarra trattamenti biex iżommu livelli mnaqqsa talormon maskili (terapija ta' ormoni), jew li ma jistgħux jieħdu trattament ieħor għall-kanċer.
English: Xofigo is administered as an intravenous injection and is thus 100% bioavailable.
Maltese: Xofigo jingħata bħala injezzjoni fil-vini u għalhekk hu 100% bijodisponibbli.
English: No histological changes were observed in organs involved in the excretion of radium-223 dichloride.
Maltese: Ma ġie osservati l-ebda tibdil istoloġiku f'organi involuti fit-tneħħija ta' radium-223 dichloride.
English: Radium-223 is an isotope which decays and is not metabolised.
Maltese: Radium-223 huwa isotop li jonqos fil-potenza (decay) u ma jiġix immetabolizzat.
English: Xofigo increases the incidence of diarrhoea, nausea, and vomiting (see section 4.8) which may result in dehydration.
Maltese: Xofigo iżid l-inċidenza ta' dijarea, dardir u rimettar (ara sezzjoni 4.8) li tista' twassal għal deidratazzjoni.
English: The alpha particle range from radium-223 is less than 100 µm (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.
Maltese: Il-firxa ta' partiċelli alpha minn radium-223 hi inqas minn 100 µm (inqas minn 10 dijametri ta' ċelluli) u dan jimminimizza l-ħsara lil tessut normali fil-madwar.
English: After repeated administration of the clinically recommended activity of 55 kBq per kg body weight once every 4 weeks for 6 months, two dogs developed non-displaced pelvic fractures.
Maltese: Wara għoti ripetut tal-attività rrakkomandata klinikament ta' 55 kBq għal kull kg ta' piż tal-ġisem darba kull 4 ġimgħat għal 6 xhur, żewġt iklieb żviluppaw ksur mhux spostat fil-pelvi.
English: The dose regimen of Xofigo is an activity of 55 kBq per kg body weight, given at 4 week intervals for 6 injections.
Maltese: Il-kors tad-doża ta' Xofigo hu attività ta' 55 kBq għal kull kg ta' piż tal-ġisem, mogħti f'intervalli ta' 4 ġimgħat għal 6 injezzjonijiet.
English: Grade 1 and 2 injection site reactions, such as erythema, pain and swelling, were reported in 1.2% of patients treated with Xofigo and in 0% of patients receiving placebo.
Maltese: Reazzjonijiet ta' grad 1 u 2 fis-sit tal-injezzjoni, bħal eritema, uġigħ u nefħa, ġew irrappurtati f'1.2% talpazjenti kkurati b'Xofigo u f'0% tal-pazjenti li rċivew plaċebo.
English: Studies on the mutagenic and carcinogenic potential of Xofigo have not been performed.
Maltese: Ma sarux studji dwar il-potenzjal mutaġeniku u karċinoġeniku ta' Xofigo.
English: Hepatic impairment
Maltese: Kompressjoni tas-sinsla
English: There is no relevant use of Xofigo in the paediatric population in the indication of prostate cancer.
Maltese: M'hemm l-ebda użu rilevanti ta' Xofigo fil-popolazzjoni pedjatrika, fl-indikazzjoni ta' kanċer tal-prostata.
English: The whole body measurements at 7 days after injection (after correcting for decay) indicate that a median of 76% of administered activity was excreted from the body.
Maltese: Il-kejl mill-ġisem kollu sebat ijiem wara l-injezzjoni (wara korrezzjoni għat-tnaqqis fil-potenza) jindika li medjan ta' 76% tal-attività mogħtija tneħħiet mill-ġisem.
English: The vial contains 6 mL of solution.
Maltese: Il-kunjett fih 6 mL ta' soluzzjoni.
English: What Xofigo looks like and contents of the pack
Maltese: Kif jidher Xofigo u l-kontenut tal-pakkett
English: A risk of osteonecrosis of the jaw (dead tissue in the jaw bone which is mainly seen in patients who have been treated with bisphosphonates) cannot be excluded (see section 4).
Maltese: Riskju ta' osteonekrosi tax-xedaq (tessut mejjet fl-għadam tax-xedaq li fil-biċċa l-kbira jidher f'pazjenti li jkunu ġew ikkurati b'bisphosphonates) ma jistax jiġi eskluż (ara sezzjoni 4).
English: The clinical efficacy and safety of concurrent initiation of Xofigo, abiraterone acetate and prednisone/prednisolone treatment was assessed in a randomized, placebo-controlled multicenter phase III study (ERA-223 trial) in 806 chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases.
Maltese: Ir-reazzjonijiet avversi ematoloġiċi osservati fl-istudji kliniċi b'Xofigo huma ħafna aktar baxxi fil-frekwenza u s-severità minn dawk li jistgħu jiġu mistennija mid-dożi assorbiti kkalkulati għall-mudullun l-aħmar.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Ottubru 2015
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
Maltese: Din hija proċedura fejn Stat Membru partikolari (l'Istat Membru ta' referenza', f'dan il-każ ir-Renju Unit) jivvaluta mediċina veterinarja bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-'Istati Membri kkonċernati', f'dan il-każ l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, idDanimarka, l-Estonja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja u Spanja).
English: The active substance of Gutal is zinc oxide.
Maltese: Is-sustanza attiva ta' Gutal hija l-ossidu taż-żingu.
English: Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Maltese: Gutal huwa prodott mediċinali veterinarju ġeneriku bbażat fuq prodott ta' referenza, ZincoTec Ossidu taż-Żingu 100% Taħlita Lesta għal Għalf Medikat, li huwa awtorizzat firRenju Unit.
English: On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
Maltese: Fis-6 ta' Mejju 2015, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni talprodott mediċinali Gutal 1000 g/kg taħlita mediċinali lesta għal għalf medikat għall-qżieqeż.
English: Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
Maltese: Huvepharma NV issottomettiet applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Gutal lirRenju Unit permezz ta' proċedura deċentralizzata.
English: Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Maltese: Għaliex Gutal 1000 g/kg taħlita lesta għal għalf medikat għall-qżieqeż ġie rivedut?
English: The CVMP also recommended that the product information for Gutal be amended.
Maltese: Is-CVMP irrakkomanda wkoll li tiġi emendata l-informazzjoni talprodott għal Glutal.
English: What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Maltese: X'inhu Gutal 1000 g/kg taħlita lesta għal għalf medikat għall-qżieqeż?
English: The European Commission issued a decision on 22 October 2015.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fit-22 ta' Ottubru 2015.
English: The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Maltese: mitigazzjoni tar-riskji proposti biex jiġi kkontrollat ir-riskju huma inadegwati biex jikkontrollaw jew jipprevjenu l-akkumulazzjoni kontinwa taż-żingu u, barra minn hekk, mhumiex fattibbli biex jiġu implimentati fl-irziezet tal-ħnieżer kollha.
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Maltese: Madankollu, l-Istati Membri ma kinux kapaċi jaslu għal ftehim u d-Direttorat tal-Mediċini Veterinarji tar-Renju Unit irrefera l-kwistjoni lis-CVMP għal arbitraġġ fit-30 ta' Settembru 2014.