FrancophonIA/ELRC3.0 huggingface dataset:
English: On 15 February 2007 the CVMP adopted a “Public Statement on the use of (fluoro)quinolones in foodproducing animals in the European Union: Development of Resistance and Impact on Human Health” (EMEA/SAGAM/184651/2005) concluding that the use of (fluoro)quinolones in animals has selected for resistance in animal pathogens and food borne zoonotic pathogens and that there was a need for risk management interventions.
Maltese: Żvilupp ta' Reżistenza u l-Impatt fuq is-Saħħa tal-Bniedem” (EMEA/SAGAM/184651/2005) li tikkonkludi li l-użu tal-(fluworo)kwinoloni fl-annimali għażel għal reżistenza f'patoġeni tal-annimali u patoġeni żoonotiċi li jinġarru mill-ikel u li kien hemm ħtieġa għal interventi ta' ġestjoni tar-riskju.
English: Vétoquinol S. A. Magny Vernois B.P.
Maltese: Magny Vernois B.P. 189
English: Flumechina 20% Liquida
Maltese: Flumechina 20% Liquida Flumequine
English: Laboratorios Syva, S.A. Parroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN
Maltese: Laboratorios Syva, S.A. Parroco Pablo Diez, 49-57 24010
English: Hungary Laboratorios Karizoo, S.A. Polg.
Maltese: L-Ungerija Laboratorios Karizoo, S.A. Polg.
English: Hungary Abo-Mix Co. Ltd. Simai u. 6
Maltese: L-Ungerija Abo-Mix Co.
English: Via Augusta, 302
Maltese: Laboratorio Maymo, S.A. Via Augusta, 302
English: Romania Laboratorios Karizoo, S.A. Polg.
Maltese: Ir-Rumanija Laboratorios Karizoo, S.A. Polg.
English: Vétoquinol Biowet Sp. z o.o.
Maltese: Vétoquinol Biowet Sp. z o.o. ul.
English: Denmark Ceva Santé Animale Zone Industrielle La Ballastiere
Maltese: Id-Danimarka Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126
English: Pigs Lambs Cattle Hens Turkeys
Maltese: Frat Majjali Tjur Fniek
English: Enrocare 5% Solution for Injection for Cattle, Pigs, Dogs and Cats
Maltese: Enrocare 5% Solution for Injection for cattle, pigs, dogs and qtates
English: Enrocare 5% Solution for Injection for cattle, pigs, dogs and cats
Maltese: Enrocare 5% Solution for Injection for Cattle, Pigs, Dogs and Qtates
English: Baytril RSI 100 mg/ml - Injektionslösung für Rinder und Schweine
Maltese: Baytril RSI 100 mg/mlInjektionslösung für Rinder und Schweine
English: Enrofloxacino Solucion Oral
Maltese: Ganadexil Enrofloxacino Solucion Oral
English: Cattle (suckling calves)
Maltese: Tjur (Brojlers u dundjani)
English: Intravenous, subcutaneous
Maltese: Ġol-muskoli, Ġolvini
English: Box 17020
Maltese: Postboks 2090
English: Cattle Buffalos Calves Foals Lambs Kids Pigs Piglets Rabbits Fowl
Maltese: Buffli Żwiemel Nagħaġ Mogħoż Majjali Fniek Klieb Qtates Tiġieġ
English: Poulrty
Maltese: Puławy
English: Lithuania Laboratorios Hipra, S.A. Avda.
Maltese: Il-Litwanja Laboratorios Hipra, S.A. Avda.
English: Romania Dopharma Research BV Zalmweg 24
Maltese: Ir-Rumanija Dopharma Research BV Zalmweg 24
English: Recommendations for prudent use “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.” B. For products listed in Annex I containing quinolones (flumequine, oxolinic acid): 4.5 Special precautions for use i) Special precautions for use in animals
Maltese: Għall-prodotti elenkati fl-Anness I li fihom kwinoloni (flumequine, oxolinic acid): 4.5 Prekawzjonijiet speċjali għall-użu i) Prekawzjonijiet speċjali għall-użu fl-annimali Rakkomandazzjonijiet għal użu prudenti “Għandhom jiġu kkunsidrati l-politiki antimikrobjali uffiċjali u lokali meta jintuża l-prodott.” “Kull fejn hu possibbli, il-kwinoloni għandhom jintużaw biss abbażi ta' ttestjar ta' suxxettibbiltà.” “L-użu tal-prodott li jiddevja mill-istruzzjonijiet mogħtija fl-SPC jista' jżid il-prevalenza ta' batterji reżistenti għall-kwinoloni u jista' jnaqqas l-effikaċja tat-trattament bi (fluworo) kwinoloni oħrajn minħabba l-potenzjal ta' trans-reżistenza.
English: Calves Piglets Broilers
Maltese: Frat Majjali Tiġieġ Brojlers
English: Denmark Bayer Animal Health GmbH 51368 Leverkusen
Maltese: Id-Danimarka Bayer Animal Health GmbH 51368 Leverkusen
English: Cattle Sheep Goats Sows
Maltese: Frat Ovini Majjali Klieb
English: Romania Bayer HealthCare AG Animal Health Division 51368 Leverkusen
Maltese: Ir-Rumanija Bayer HealthCare AG Animal Health Division 51368 Leverkusen
English: Rodents (rabbit, guinea pigs, mice, hamsters) Hunting birds Exotic birds Dogs
Maltese: Rodenti (fniek, fniek tal-indi, ġrieden żgħar, ħamsters)
English: Loughrea
Maltese: Horia
English: 7 44153 Ancenis Cedex FRANCE
Maltese: Coophavet S.A.S Saint Herblion, B.P. 7 44153 Ancenis Cedex FRANCE
English: B.P.
Maltese: B.
English: Subcutaneous intramuscular
Maltese: Soluzzjoni injettabbli
English: Broilers Turkeys
Maltese: Brojlers Majjali
English: Vetpartners OOD Ivan Asen || Str. 4270 Parvomaj BULGARIA
Maltese: 4270 Parvomaj
English: No.
Maltese: Av.
English: Chickens Broilers
Maltese: Tiġieġ Brojlers
English: • adequate precautionary phrases related to the use of (fluoro)quinolones intended for foodproducing species have been included in Summary of the Product Characteristics for 318 products concerned by this referral;
Maltese: • frażijiet ta' prekawzjoni relatati mal-użu tal-(fluworo)kwinoloni maħsuba għall-ispeċijiet li jipproduċu l-ikel ġew inklużi fis-Sommarju tal-Karatteristiċi tal-Prodott għal 318-il prodott ikkonċernat minn din ir-referenza;
English: Lithuania Dopharma Research BV Zalmweg 24
Maltese: Il-Litwanja Dopharma Research BV Zalmweg 24
English: Intraruminal device Cattle
Maltese: Bovini Razza tal-majjali
English: Intramuscular, subcutaneous, intramuscular
Maltese: Ġol-muskoli, Ġolvini, ġol-muskoli
English: Romania Vétoquinol Biowet Sp. z o.o.
Maltese: Ir-Rumanija Vétoquinol Biowet Sp. z o.o. ul.
English: Marbocyl 10% Marbofloxacin per ml: marbofloxacin
Maltese: Marbocyl 10% Marbofloxacin għal kull ml: marbofloxacin 100 mg
English: Since then additional fluoroquinolone molecules have been authorised and a number of different veterinary medicines are now available on the market.
Maltese: Minn dakinhar molekoli oħrajn tal-fluworokwinoloni ġew awtorizzati u għadd ta' mediċini veterinarji differenti issa huma disponibbli fis-suq.
English: Lithuania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Maltese: Esmeralda, 19 - 4º
English: Romania Laboratorios Hipra, S.A. Avda.
Maltese: Ir-Rumanija Laboratorios Hipra, S.A. Avda.
English: Lavet Gyógyszergyártó Kft. Ottó u. 14
Maltese: Ottó u. 14
English: Colistine sulphate 12 g Oxolinic acid 100g
Maltese: Colistine sulphate 12 g
English: With regard to 132 products no information was submitted by the Applicants/Marketing Authorisation Holders or competent national authorities and therefore an assessment of the concerned Summary of the Product Characteristics could not be made.
Maltese: Fir-rigward ta' 132 prodott, ma ġiet sottomessa l-ebda informazzjoni mill-Applikanti/Detenturi talAwtorizzazzjoni għat-Tqegħid fis-Suq jew awtoritajiet nazzjonali kompetenti u għaldaqstant ma setgħetx issir evalwazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott ikkonċernat.
English: Subcutaneous, intramuscular, intravenosous
Maltese: Taħt il-ġilda, ġolmuskoli, intravenosous
English: Broilers, Turkeys, Cattle
Maltese: Brojlers, Dundjani, Frat
English: Chickens Dogs Cats
Maltese: Majjali Dog
English: Subsequently, the European Commission invoked Community interest and referred all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species to the Agency in order to ensure that the warnings on prudent use included in the Summary of the Product Characteristics for these classes of products were harmonised in line with those recommended in the CVMP Reflection paper.
Maltese: Sussegwentement, ilKummissjoni Ewropea invokat l-interess tal-Komunità u rreferiet il-prodotti mediċinali veterinarji kollha li fihom kwinoloni inklużi fluworokwinoloni maħsuba għall-użu fl-ispeċijiet li jipproduċu l-ikel lillAġenzija sabiex tiżgura li t-twissijiet dwar l-użu prudenti inkluż fis-Sommarju tal-Karatteristiċi talProdott għal dawn il-klassijiet ta' prodotti jkunu armonizzati f'konformità ma' dawk rakkomandati fidDokumenti ta' Riflessjoni tas-CVMP.
English: Poultry (broilers and turkeys)
Maltese: Tjur (tiġieġ and dundjani)
English: Veterinary medicinal products that do not contain prudent use warnings in section 4 of the SPC
Maltese: Prodotti mediċinali veterinarji li fihom it-twissijiet kollha tajbin ta' użu prudenti fis-sezzjoni
English: Broilers Pigs
Maltese: Brojlers Fniek
English: Gastroenteral solution
Maltese: Soluzzjoni gastroenterali
English: Birds
Maltese: Arques
English: Calves Pigs
Maltese: Porc Franvet
English: Hungary Laboratorios Hipra, S.A. Avda.
Maltese: L-Ungerija Laboratorios Hipra, S.A. Avda.
English: Lithuania Krka, d. d., Novo mesto Šmarješka cesta 6
Maltese: Il-Litwanja Krka, d. d., Novo mesto Šmarješka cesta 6
English: Special warning(s) “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.” B. For products listed in Annex I containing quinolones (flumequine, oxolinic acid): 12.
Maltese: Twissija (twissijiet) speċjali “Għandhom jiġu kkunsidrati l-politiki antimikrobjali uffiċjali u lokali meta jintuża l-prodott.” “Kull fejn hu possibbli, il-kwinoloni għandhom jintużaw biss abbażi ta' ttestjar ta' suxxettibbiltà.” “L-użu tal-prodott li jiddevja mill-istruzzjonijiet mogħtija fl-SPC jista' jżid il-prevalenza ta' batterji reżistenti għall-fluworokwinoloni u jista' jnaqqas l-effikaċja tat-trattament bi (fluworo)kwinoloni oħrajn minħabba l-potenzjal ta' trans-reżistenza.
English: They are well distributed in the body after administration and are active against a wide range of microorganisms.
Maltese: Dawn jitqassmu sew fil-ġisem wara li jingħataw u huma attivi kontra firxa wiesgħa ta' mikrorganiżmi.
English: Rabbits Poultry
Maltese: Tjur Fniek
English: Lithuania Vétoquinol Biowet Sp. z o.o.
Maltese: Il-Litwanja Vétoquinol Biowet Sp. z o.o. ul.
English: Bayer A/S Nørgaardsvej 32 Postboks 2090 2800 KGS Lyngby DENMARK
Maltese: L-Iżlanda Bayer A/S Nørgaardsvej 32
English: 40% Enrofloxacin 400 mg/g
Maltese: Enroflox pulv. 40% Enrofloxacin 400 mg/g
English: Germany Bayer Animal Health GmbH 51368 Leverkusen
Maltese: Il-Greċja Bayer Animal Health GmbH 51368 Leverkusen
English: • no precautionary phrases related to the use of (fluoro)quinolones intended for food-producing species have been included in Summary of the Product Characteristics of 83 products concerned by this referral;
Maltese: • l-ebda frażi ta' prekawzjoni relatata mal-użu tal-(fluworo)kwinoloni maħsuba għall-ispeċijiet li jipproduċu l-ikel ma ġiet inkluża fis-Sommarju tal-Karatteristiċi tal-Prodott ta' 83 prodott ikkonċernat minn din ir-referenza;
English: Broiler chickens Breeding hens Turkeys
Maltese: Brojlers Dundjani Fniek
English: Bayer HealthCare AG Animal Health Division 51368 Leverkusen GERMANY
Maltese: Il-Polonja Bayer HealthCare AG Animal Health Division 51368 Leverkusen
English: Quinolones represent a class of antimicrobials that is most important in the treatment of severe and invasive infections in humans and animals and are therefore of special interest for public and animal health.
Maltese: Il-kwinoloni jirrappreżentaw klassi ta' antimikrobjali li hija l-aktar importanti fit-trattament ta' infezzjonijiet severi u invażivi fil-bnedmin u l-annimali u għaldaqstant huma ta' interess speċjali għassaħħa pubblika u dik tal-annimali.
English: Romania Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
Maltese: Ir-Rumanija Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49-57 24010
English: Germany Krka, d. d., Novo mesto Šmarješka cesta 6
Maltese: L-Irlanda Krka, d. d., Novo mesto Šmarješka cesta 6
English: Romania Krka, d. d., Novo mesto Šmarješka cesta 6
Maltese: Ir-Rumanija Krka, d. d., Novo mesto Šmarješka cesta 6
English: Veterinary medicinal products containing all the correct prudent use warnings in section 4 of the SPC (Special precautions for use), exactly as the CVMP recommendation and veterinary medicinal products containing all the prudent use warnings in section 4 of the SPC, which is however not exactly the text recommended by the CVMP, but conveys the same key messages; Group 2.
Maltese: 4 tal-SPC (Prekawzjonijiet speċjali għall-użu), eżatt bħar-rakkomandazzjoni tas-CVMP u prodotti mediċinali veterinarji li fihom it-twissijiet kollha ta' użu prudenti fis-sezzjoni 4 tal
English: Pfizer Animal Health Walton Oaks Dorking Road Tadworth, Surrey FT20 7NS
Maltese: L-Irlanda Pfizer Animal Health Walton Oaks
English: Drwalewskie Zakłady Przemysłu
Maltese: Il-Litwanja Lavet Gyógyszergyártó
English: de Reus a Vignols km
Maltese: Tiġieġ Majjali Ħamiem
English: Mink Coypu Rabbits
Maltese: Majjali Frat Klieb
English: Romania Ascor Chimici S.r.l.
Maltese: Ir-Rumanija Ascor Chimici S.r.l. Via Piana 265
English: List of the names, strengths of the veterinary medicinal products, animal species, route of administration, recommended dose and applicants/marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, mnejn jingħata, doża rakkomandata u awtorizzazzjoni tal-applikanti/tat-tqegħid fis-suq fl-Istati Membri
English: Calves Chickens
Maltese: Klieb Qtates
English: Rabbit
Maltese: Frat
English: Rabbits
Maltese: Tjur
English: Denmark Krka, d. d., Novo mesto Šmarješka cesta 6
Maltese: L-Olanda Krka, d. d., Novo mesto Šmarješka cesta 6
English: Bioweterynaryjnego S.A. ul.
Maltese: Il-Polonja Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A. ul.
English: Biowet Puławy Sp. z o.o.
Maltese: Il-Polonja Biowet Puławy Sp. z o.o. ul. Arciucha 2
English: Cattle Lambs Pigs
Maltese: Tjur Frat Majjali
English: Hungary Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
Maltese: L-Ungerija Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49-57 24010
English: Germany Krka, d.d., Novo mesto Šmarješka cesta 6
Maltese: L-Irlanda Krka, d.d., Novo mesto Šmarješka cesta 6
English: Exotic Animals (small mammals, reptiles, avian species)
Maltese: Għoġġiela Annimali eżotiċi (mammali żgħar, rettili, speċi talgħasafar)
English: Chickens (broilers) Turkeys
Maltese: Tiġieġ (Brojlers) Dundjani
English: 62-200 Gniezno POLAND
Maltese: 2800 KGS Lyngby DENMARK
English: Calves Lambs Poultry Fish
Maltese: Klieb Qtates Frat Majjali
English: Broilers Rabbits
Maltese: Majjali Frat
English: Hens Turkeys Cattle Lambs Kids Pigs
Maltese: Taħlita lesta medikata Majjali Tjur
English: Belgium Dopharma Research BV Zalmweg 24
Maltese: Il-Belġju Dopharma Research BV Zalmweg 24
English: Romania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Maltese: Ir-Rumanija Industrial Veterinaria S.A.
English: Belgium Krka, d. d., Novo mesto Šmarješka cesta 6
Maltese: Il-Belġju Krka, d. d., Novo mesto Šmarješka cesta 6
English: Pigs Broilers Turkeys
Maltese: Tjur Frat Fniek
English: Poultry Turkeys
Maltese: Fniek Tjur
English: Romania Vétoquinol S. A. Magny Vernois
Maltese: Ir-Rumanija Vétoquinol S.
English: Hungary Vétoquinol Biowet Sp. z o.o.
Maltese: L-Ungerija Vétoquinol Biowet Sp. z o.o. ul.
English: Subcutaneous intravenous
Maltese: Apparat intraruminali
English: Flumesyva 10% powder
Maltese: Flumesyva 10% powder Flumequine
English: Krka, d.d., Novo mesto Šmarješka cesta 6
Maltese: Il-Ġermanja Krka, d.d., Novo mesto Šmarješka cesta 6
English: Hungary S.P. Veterinaria S.A. Ctra.
Maltese: L-Estonja Industrial Veterinaria S.A.
English: Intramuscular (cattle and pig), intravenous (cattle)
Maltese: Ġol-muskoli (frat u majjali), Ġol-vini (frat)
English: 2540 Nicosia
Maltese: 25125 Brescia
English: Fluquick Poudre A 50
Maltese: Fluquick Poudre A 50 % Flumequine
English: • Fluoroquinolone products “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.”
Maltese: • Prodotti li fihom fluworokwinoloni “Għandhom jiġu kkunsidrati l-politiki antimikrobjali uffiċjali u lokali meta jintuża l-prodott.” “Il-fluworokwinoloni għandhom ikunu riservati għat-trattament ta' kondizzjonijiet kliniċi li kellhom rispons dgħajjef, jew huma mistennija li jkollhom rispons dgħajjef, għal klassijiet oħrajn ta' antimikrobjali.” “Kull fejn hu possibbli, il-fluworokwinoloni għandhom jintużaw biss abbażi ta' ttestjar ta' suxxettibbiltà.” “L-użu tal-prodott li jiddevja mill-istruzzjonijiet mogħtija fl-SPC jista' jżid il-prevalenza ta' batterji reżistenti għall-fluworokwinoloni u jista' jnaqqas l-effikaċja tat-trattament bi kwinoloni oħrajn minħabba l-potenzjal ta' trans-reżistenza.
English: Cattle (non ruminating) Hens (non laying)
Maltese: Tjur żgħir (tiġieġ u dundjani)
English: Wirtz Farma B.V.
Maltese: L-Olanda Wirtz Farma B.V. Leijsendwarsstraat 26
English: Belgium Vétoquinol N.V. Kontichsesteenweg 42
Maltese: Kontichsesteenweg 42
English: Hungary Krka, d. d., Novo mesto Šmarješka cesta 6
Maltese: Il-Ġermanja Krka, d. d., Novo mesto Šmarješka cesta 6
English: Goats
Maltese: Qtates
English: Laboratorios Syva, S.A. arroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN
Maltese: Laboratorios Syva, S.A. arroco Pablo Diez, 49-57
English: Ref. EMEA/690893/2008
Maltese: EMEA/86061/2009
English: London, 22 January 2009 Doc.
Maltese: Londra, 22 ta' Jannar 2009 Dok. ta' Ref.
English: International non-proprietary name (INN): contusugene ladenovec
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): contusugene ladenovec
English: What is Advexin?
Maltese: X'inhu Advexin?
English: Advexin was designated as an orphan medicinal product on 23 October 2006.
Maltese: Advexin ġie kklassifikat bħala prodott mediċinali orfni fit-23 ta' Ottubru 2006.
English: The active substance in Advexin, contusugene ladenovec, is a ‘viral vector'.
Maltese: Is-sustanza attiva f'Advexin, contusugene ladenovec, huwa ‘vettur virali'.
English: Advexin was expected to be injected directly into the tumours, thus allowing the cancer cells to produce normal p53 protein again.
Maltese: Advexin kien mistenni li jiġi injettat direttament fit-tumuri, b'hekk jippermetti li ċelloli tal-kanċer jipproduċu mill-ġdid il-proteina normali p53.
English: Advexin is a suspension for injection that contains contusugene ladenovec, a genetically modified virus which carries the p53 gene.
Maltese: Advexin huwa sospensjoni għal injezzjoni li fiha l-contusugene ladenovec, vajrus li huwa ġenetikament modifikat li jġorr il-ġene p53.
English: On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer.
Maltese: Fis-17 ta' Diċembru 2008 Gendux Molecular Limited uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Advexin, għat-trattament ta' kanċer Li-Fraumeni.
English: Advexin was expected to be used to treat Li-Fraumeni cancer in patients from the age of 18 years.
Maltese: Advexin kien mistenni li jintuża għat-trattament ta' kanċer Li-Fraumeni f'pazjenti mill-età ta' 18-il sena.
English: Li-Fraumeni cancer is a type of cancer that occurs in patients with Li-Fraumeni syndrome, a condition where a gene called p53 is defective because of a mutation.
Maltese: Il-kanċer Li-Fraumeni huwa tip ta' kanċer li jseħħ f'pazjenti bis-sindromu Li-Fraumeni, kondizzjoni fejn il-ġene msejjaħ p53 huwa difettuż minħabba mutazzjoni.
English: The gene carried by the virus in Advexin is the normal (non-defective) p53 gene.
Maltese: Il-ġene li jġorr il-vajrus f'Advexin huwa l-ġene p53 normali (mhux difettuż).
English: The virus in Advexin is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Maltese: Il-virus f'Advexin hu ‘adenovirus' li jkun ġie manipulat biex ma jkunx jista' jagħmel kopji tiegħu nnifsu u għalhekk ma jikkawżax infezzjonijiet fil-bniedem.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun ippreżentat it-tweġibiet tagħha għall-mistoqsijiet imressqa, isCHMP jirrevedihom u jista', qabel ma jagħti opinjoni, iressaq xi mistoqsijiet oħra fil-180 jum.
English: Advexin was expected to cure or slow down the disease by restoring the normal protective function of the cells.
Maltese: Advexin kien mistenni li jikkura jew inaqqas it-tkabbir tal-marda billi jġib lura l-funzjoni protettiva normali taċ-ċelloli.
English: How is Advexin expected to work?
Maltese: Għal xiex kien mistenni li jintuża Advexin?
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Abbażi tar-reviżjoni taddokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-120 jum, li mbagħad tintbagħat lillkumpanija.
English: The p53 protein, which is produced from the non-defective p53 gene present in the human body, normally contributes to the repair of damaged DNA and causes cell death when the DNA cannot be repaired.
Maltese: Il-proteina p53, prodotta mill-ġene p53 li mhuwiex difettuż preżenti fil-ġisem uman, normalment tikkontribwixxi għat-tiswija ta' DNA li saritilha l-ħsara u jikkawża l-mewt taċ-ċelloli meta d-DNA ma tistax tiġi msewwija.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP kien ivvaluta ttweġibiet mill-kumpanija għal lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet pendenti li baqgħu ma ġewx solvuti.
English: The company also presented the results of a number of small studies looking at the effects of a range of doses of Advexin on different types of cancer.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' numru ta' studji żgħar li jeżaminaw l-effetti ta' firxa ta' dożi ta' Advexin fuq tipi differenti ta' kanċer.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Advexin could not have been approved for the treatment of Li-Fraumeni cancer.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Advexin ma setax jiġi approvat għattrattament tal-kanċer Li-Fraumeni.
English: The effects of Advexin were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Advexin għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati filbniedem.