natgillin/translations-raw huggingface dataset:
Marbocyl Solo 10% Solution for Injection for cattle
Marbocyl Solo 10% Solution for Injection marbofloksacin 10 % m/v govedo intramuskular no
MARBOCYL 2% solução injectável para suínos e bovinos
Marbocyl 2% Solution for Injection marbofloksacin 2 % m/v govedo prašiči intramuskular no
VETAFLUMINA 50% Flumequine
VETAFLUMINA 50% flumekvin
Special warning(s) “Official and local antimicrobial policies should be taken into account when the product is used.” “Whenever possible, quinolones 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 quinolones and may decrease the effectiveness of treatment with other (fluoro)quinolones due to the potential for cross resistance.”
Posebno(a) opozorilo(a) „Pri uporabi zdravila morate upoštevati uradne in lokalne doktrine protimikrobnega zdravljenja.“ „Kadar je mogoče, uporabite kinolone na podlagi testa občutljivosti.“ „Uporaba zdravila, ki ne sledi navodilom v povzetku glavnih značilnosti zdravila, lahko zviša pogostnost proti kinolonom odpornih bakterij ter lahko zmanjša učinkovitost zdravljenja z drugimi (fluoro)kinoloni zaradi možnosti navzkrižne odpornosti.“
Flumequine 10% Flumequine
Flumequine 10% flumekvin
Cattle Goats Horses Rabbits Sheep Fish Pigs Poultry
30 mg prašek za peroralno raztopino govedo koze konji kunci ovce ribe prašiči perutnina
Germany Bayer Animal Health GmbH 51368 Leverkusen
Norveška Bayer Animal Health GmbH 51368 Leverkusen
Subcutaneous, intramuscular
teleta prašiči subkutano, intramuskular no
Baytril 2,5% Solucion Oral
Baytril 2,5% Solucion Oral peroralna raztopina govedo
• 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;
• v povzetkih glavnih značilnosti 83 zdravil, ki bili so zajeti v to napotitev, ni bilo previdnostnih stavkov v zvezi z uporabo (fluoro)kinolonov pri živalih za proizvodnjo živil;
Marbocyl 10 % Injektionslösung für Rinder und Schweine
Marbocyl 10% Solution for Injection marbofloksacin 10 % m/v govedo prašiči subkutano
Cattle Goats Horses Sheep
150 mg tableta govedo koze konji ovce
Kariflox 10 % Solution Buvable Pour Poules et Dindes
Kariflox 10 % oral solution peroralna raztopina piščanci purani
Enrocare 10% Solution for Injection for Cattle, Pigs
Enrocare 10% Solution for Injection for Cattle, Pigs govedo prašiči subkutano, intramuskular no
ENROXIL MAX 100 mg/ml, injekcinis tirpalas galvijams
ENROXIL MAX 100 mg/ml, injekcinis tirpalas galvijams govedo subkutano
Enroxil 5%, enrofloksacyna 100mg/ml solution for injection for cattle,pig and dog
Enroxil 5%, enrofloksacyna 100mg/ml solution for injection for cattle,pig and dog enrofloksacin 5 g/100 ml govedo prašiči psi intramuskular no, subkutano
Cattle Buffalos Calves Foals Lambs Kids Pigs Piglets Rabbits Fowl
flumekvin peroralna raztopina ptice prašiči jagnjeta kozlički govedo
Poultry Pigs Sheep Cattle Fish
500 mg/g peroralni prašek govedo ovce koze prašiči perutnina kunci ribe
Marbocyl 2 % injection Marbofloxacin 20 mg/ml
Marbocyl 2 % injection marbofloksacin 20 mg/ml govedo prašiči subkutano, intramuskular no
Oily suspension
peroralna suspenzija ptice
Calves Poultry
peroralna raztopina piščanci
Amendment to the summary of product characteristics and package leaflet
Dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
Enroxil 10% oral , enrofloksacyna 100mg/ml solution for use in drinking water for chicken
Enroxil 10% oral , enrofloksacyna 100mg/ml solution for use in drinking water for chicken enrofloksacin 10 g/100 ml peroralna raztopina piščanci
Enrofloxarom Forte Enrofloxacin 50 mg/tablet
Enrofloxarom Forte enrofloksacin 50 mg/tableto tablete perutnina prašiči psi mačke
Enroxil 10% solution Enrofloxacin 100 mg/ml
Enroxil 10% solution enrofloksacin 100 mg/ml peroralna raztopina perutnina
Marbofloxacin 50 mg/tablet
MARBOCYL bolus marbofloksacin 50 mg/tableto tablete govedo
Solution for injection Pigs Dogs
teleta prašiči psi intramuskular no
Alsir 5% Solucion Inyectable
ALSIR 5% solução injectável govedo prašiči subkutano, intramuskular no
Subcutaneous intramuscular
prašiči teleta intramuskular no
Baytril One 100 mg/ml Injektionslösung für Rinder
Baytril One 100 mg/ml Injektionslösung für Rinder govedo subkutano, intravensko
MARBOCYL S 10% Marbofloxacin 100 mg/ml
MARBOCYL S 10% marbofloksacin 100 mg/ml govedo intramuskular no
Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats
Powerflox 50 mg/ml Solution for injection govedo prašiči psi mačke intramuskular no, subkutano
Enrofloxacin 100 g/1000 ml
Kin-O-Flox enrofloksacin 100 g/1000 ml peroralna raztopina perutnina
Baytril RSI 100 mg/ml - Injektionslösung für Rinder und Schweine
Baytril RSI 100 mg/ml - Injektionslösung für Rinder und Schweine govedo prašiči subkutano ali intravensko ali intramuskular no
ENROCIN 10 %, geriamasis tirpalas
ENROCIN 10 %, geriamasis tirpalas peroralna raztopina piščanci purani
Flumesyva 10% powder
Flumesyva 10% powder flumekvin
Germany Vétoquinol S. A. Magny Vernois
Portugalska Vétoquinol S. A. Magny Vernois
Exotic Animals (small mammals, reptiles, avian species)
Baytril 2.5% Oral Solution peroralna raztopina teleta eksotične živali (majhni sesalci, plazilci, ptice)
Flumequine Durden Flumequine
Doxaquin flumekvin
Advocine 180, 180 mg/ml, Solution Injectable Pour Bovins
Advocine 180, 180 mg/ml, Solution Injectable Pour Bovins danofloksacin 180 mg govedo subkutano, intravensko
Enrocare 5% Solution for Injection for cattle, pigs, dogs and cats
Enrocare 5% Solution for Injection for Cattle, Pigs, Dogs and Cats govedo prašiči psi mačke subkutano, intramuskular no
Poultry Turkeys
peroralna raztopina perutnina
Syvaquinol 25 injectable
Syvaquinol 25 injectable govedo pujski psi subkutano, intramuskular no
Syvaquinol 10 % oral solution
Syvaquinol 10 % oral solution peroralna raztopina piščanci
Enro-Quinol Plus 10 % oral solution
Enro-Quinol Plus 10 % oral solution peroralna raztopina piščanci purani
Marbocyl 10, 100 mg/ml solution for injection for cattle and pig
Marbocyl 10, 100 mg/ml solution for injection for cattle and pig marbofloksacin 100 mg/ml govedo prašiči intramuskular no, subkutano
Enrofloxacin 10% WDT, Solution for injection
Enrofloxacin 10% WDT, Solution for injection govedo prašiči intravensko, intramuskular no, subkutano
FLUMAX 50% Flumequine
FLUMAX 50% flumekvin
Enroxil 5 % premix for medicated feeding stuff
Enroxil 5 % premix for medicated feeding stuff enrofloksacin 5 g/100 g predmešanica za izdelavo zdravilne krmne mešanice prašiči piščanci
Enrofloxacina Premix Enrofloxacin 50 mg/g
Enrofloxacina Premix enrofloksacin 50 mg/g predmešanica za pripravo zdravilne krmne mešanice prašiči perutnina
Baytril 100 mg/ml Injektionslösung für Rinder und Schweine
Baytril 100mg/ml Injektionslösung govedo prašiči intravensko, intramuskular no, subkutano
Injektionslösung 50 mg/ml für Kälber, Schweine und Hunde
Injektionslösung 50 mg/ml für Kälber, Schweine und Hunde teleta prašiči psi subkutano, intramuskular no
MARBOCYL 10%, solução injectável para suínos e bovinos
MARBOCYL 10%, solução injectável para suínos e bovinos marbofloksacin 100 mg govedo svinje subkutano, intramuskular no
Intramuscular, subcutaneous, intravenous
neprežvekovalna teleta prežvekovalna teleta prašiči intramuskular no, subkutano, intravensko
Baytril 0,5% Solucion Oral
Baytril 0,5% Solucion Oral peroralna raztopina pujski
Baytril 5% Solucion Inyectable
Baytril 5% Solution for Injection enrofloksacin 5 %
Cattle Sheep Goats Pigs
govedo koze ovce prašiči subkutano intravensko
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.
Posebno(a) opozorilo(a) „Pri uporabi zdravila morate upoštevati uradne in lokalne doktrine protimikrobnega zdravljenja.“ „Fluorokinolone je treba prihraniti za zdravljenje kliničnih stanj, ki so se odzvala slabo, oz. tistih, pri katerih se pričakuje slab odziv na druge skupine protimikrobnih snovi.“ „Kadar je mogoče, uporabite fluorokinolone na podlagi testa občutljivosti.“ „Uporaba zdravila, ki ne sledi navodilom v povzetku glavnih značilnosti zdravila, lahko zviša pogostnost proti fluorokinolonom odpornih bakterij ter lahko zmanjša učinkovitost zdravljenja z drugimi kinoloni zaradi možnosti navzkrižne odpornosti.“
Piglets
Miraflores
Marbofloxacin 100 mg/ml
Marbokem marbofloksacin 100 mg/ml govedo intramuskular no
Enrofloxacin 2.5%
enrofloksacin 2,5 % peroralna raztopina govedo
ADVOCIN 2,5% Danofloxacin 25 mg/ml
ADVOCIN 2,5% danofloksacin 25 mg/ml govedo prašiči intramuskular no, subkutano, intravensko
Syvaquinol 100 Inyectable
Syvaquinol 100 Inyectable govedo prašiči subkutano, intramuskular no
20g/100g
20g/100g prašek perutnina prašiči
ENROBIOFLOX 10 %, geriamasis tirpalas
ENROBIOFLOX 10 %, geriamasis tirpalas peroralna raztopina perutnina govedo prašiči golobi
Intramuscular, intravenous, subcutaneous
govedo prašiči intramuskular no, intravensko, subkutano
Intramuscular, subcutaneous
govedo prašiči intramuskular no, subkutano
Enrofloxarom 10% Enrofloxacin 100 mg/ml
Enrofloxarom 10% enrofloksacin 100 mg/ml peroralna raztopina perutnina
Gandexil Enrofloxacina Enrofloxacin 100 mg/ml
Gandexil Enrofloxacina enrofloksacin 100 mg/ml peroralna raztopina pitovni piščanci kunci
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
4.5 Posebni previdnostni ukrepi i) Posebni previdnostni ukrepi za uporabo pri živalih Priporočila za preudarno rabo „Pri uporabi zdravila morate upoštevati uradne in lokalne doktrine protimikrobnega zdravljenja.“ „Fluorokinolone je treba prihraniti za zdravljenje kliničnih stanj, ki so se odzvala slabo, oz. tistih, pri katerih se pričakuje slab odziv na druge skupine protimikrobnih snovi.“ „Kadar je mogoče, uporabite fluorokinolone na podlagi testa občutljivosti.“ „Uporaba zdravila, ki ne sledi navodilom v povzetku glavnih značilnosti zdravila, lahko zviša pogostnost proti fluorokinolonom odpornih bakterij ter lahko zmanjša učinkovitost zdravljenja z drugimi kinoloni zaradi možnosti navzkrižne odpornosti.“
Cattle Sheep Chickens Pigs
100 mg/g prašek govedo prašiči kokoši
Enroxyl Max
Enroxyl Max govedo subkutano
Cattle Goats Rabbits Sheep Fish Pigs Poultry
500 mg prašek za peroralno raztopino govedo koze kunci ovce ribe prašiči perutnina
Pigs Lambs Cattle Hens Turkeys
Enrogal peroralna raztopina prašiči govedo jagnjeta koze jagnjeta perutnina
Belgium Dopharma Research BV Zalmweg 24
Nizozemska Dopharma Research BV Zalmweg 24
Enroxil 10% , enrofloksacyna 100mg/ml solution for injection for cattle and pig
Enroxil 10% , enrofloksacyna 100mg/ml solution for injection for cattle and pig enrofloksacin 10 g/100 ml govedo prašiči intramuskular no, subkutano
Belgium Bayer N.V. Louizalaan 143
Islandija Bayer A/S Nørgaardsvej 32
ADVOCIN 180, 180 mg/ml, solução injectável para bovinos
ADVOCIN 180, 180 mg/ml, solução injectável para bovinos danofloksacin 180 mg/ml govedo subkutano, intravensko
Enrofloxacin 10 g/100 ml
Enrofloxacino Universal enrofloksacin 10 g/100 ml peroralna raztopina perutnina kunci
Enrofloxacin 10%
Baytril enrofloksacin 10 %
Inoxyl Bolus
Inoxyl Bolus oksolinska kislina
Enroxil solution for injection 50 mg/ml for calves, pigs and dogs
Enroxil solution for injection 50 mg/ml for calves, pigs and dogs govedo prašiči psi subkutano, intramuskular no
Enrofloxacin 0.5%
enrofloksacin 0,5 % peroralna raztopina pujski
Baytril Injection 5% Enrofloxacin 5 g/100 ml
BAYTRIL 0,5% Sol. Orale enrofloksacin 0,5 g/100 ml peroralna raztopina pujski
Calves Lambs Poultry
Quimiocoli peroralna raztopina pitovni piščanci
Enroxil 5% premix pro medikaci krmiva
Enroxil 5% premix enrofloksacin 50 mg/g predmešanica za pripravo zdravilne krmne mešanice perutnina prašiči
Baytril 0,5 % Oral Solution
Baytril 0,5 % Oral Solution peroralna raztopina prašiči
Calves Pigs Poultry
peroralna raztopina piščanci purani
Marbofloxacin 100 mg
Marboken marbofloksacin 100 mg govedo intramuskular no
Syvaquinol 100 injectable
Syvaquinol 100 injectable govedo prašiči subkutano, intramuskular no
1MUI/g Colistin sulphate 200mg/g oxolinic acid
1 Mi.e./g kolistin sulfata 200 mg/g oksolinske kisline prašek za peroralno raztopino teleta pujski pitovni piščanci
Cattle Sheep Chickens Hens
peroralna raztopina pitovni piščanci plemenske kokoši purani
Powerflox 100 mg/ml Solution for Injection for Cattle and Pigs
Powerflox 100 mg/ml Solution for injection govedo prašiči intravensko, intramuskular no, subkutano
Marbofloxacin 20 mg/ml
marbofloksacin 20 mg/ml govedo prašiči intravensko
Advocin 180, 180 mg/ml, Solution for Injection for Cattle
ADVOCIN 180, 180 mg/ml, Solution for Injection for Cattle danofloksacin 180 mg/ml govedo subkutano, intravensko
ADVOCIN 180, 180 mg/ml, Solution for Injection for Cattle
Advocin 180, 180 mg/ml, Solution for Injection for Cattle danofloksacin 180 mg/ml govedo subkutano, intravensko
Flumiquil 50 % Flumequine
Flumiquil 50% flumekvin
Flumiquil 50% Flumequine
Flumiquil 50 % flumekvin
Quinoflox 100 mg/ml oral solution
Quinoflox 100 mg/ml oral solution peroralna raztopina piščanci purani
Syvaquinol 25 Inyectable
Syvaquinol 25 Inyectable govedo prašiči psi subkutano, intramuskular no
Enrofloksacyna 10% enrofloksacyna 100 mg/ml oral solution for chicken, turkey and pogeons
Enrofloksacyna 10% enrofloksacyna 100 mg/ml oral solution for chicken, turkey and pogeons enrofloksacin 10 g/100 ml peroralna raztopina piščanci purani golobi
Cattle Lambs Pigs
govedo prašiči intramuskular no
Cat
Kent
Intraruminal device Cattle
govedo intramuskular no
Flumesyva Liquido
Flubactin flumekvin
Medicated premix Pigs Poultry
50 g predmešanica za pripravo zdravilne krmne mešanice govedo prašiči perutnina kunci
Baytril 10 % injection Enrofloxacin 100 mg/ml
Baytril 10 % injection enrofloksacin 100 mg/ml govedo prašiči subkutano, intramuskular no
Marbokem 100 mg/ml solution for injection
MARBOKEM 100 mg/ml solution for injection marbofloksacin 100 mg/ml govedo intramuskular no
BAYTRIL 5% solução injectável
BAYTRIL 5% solução injectável govedo prašiči subkutano
Cattle (non ruminating) Hens (non laying)
500 mg/g prašek govedo (neprežvekovalci) kokoši (nenesnice)
Danofloxacin 25 mg/ml
25 mg/ml danofloksacina)
Enrobioflox 5% injection, 50mg/ml solution for injection for pig, cattle and dog
Enrobioflox 5% injection, 50mg/ml solution for injection for pig, cattle and dog enrofloksacin 10 g/100 ml govedo prašiči psi intramuskular no, subkutano
Injektionslösung 100 mg/ml für Rinder und Schweine
Injektionslösung 100 mg/ml für Rinder und Schweine govedo prašiči subkutano, intramuskular no
Lithuania Laboratorios Hipra, S.A. Avda.
Bolgarija Laboratorios Hipra, S.A. Avda.
Enrofloxacin 5% WDT, Solution for injection
Enrofloxacin 5% WDT, Solution for injection govedo prašiči psi intramuskular no, subkutano
500 mg/g
500 mg/g prašek prašiči
Baytril 10% Solucion Inyectable
Baytril 10% Solucion Inyectable govedo prašiči subkutano, intramuskular no
BAYTRIL 0,5% solução oral
BAYTRIL 0,5% solução oral peroralna raztopina prašiči
Colistine sulphate 12 g Oxolinic acid 100g
kolistin sulfat oksolinska kislina kolistin sulfat 12 g oksolinska kislina 100 g predmešanica za pripravo zdravilne krmne mešanice prašiči ovce ptice
Chickens Pigeons Turkeys
Roxacin peroralna raztopina perutnina
Advocin 2.5% Solution for Injection
Advocin 2.5% Solution for Injection danofloksacin 2,5 % raztopina za injiciranje govedo prašiči subkutano, intramuskular no
Intramuscular, subcutaneous, intramuscular
govedo svinje subkutano, intramuskular no
Baytril 5 % injection Enrofloxacin 50 mg/ml
Baytril Bolus enrofloksacin 500 mg bolus teleta
Ref. EMEA/690893/2008
EMEA/86067/2009
The Committee also had concerns over what happens to the medicine in the body, how it should be given and how safe it is.
Nadalje je Odbor je izrazil zaskrbljenost glede tega, kaj se z zdravilom zgodi v telesu, kako bi ga bilo treba dajati in kako varno je.
International non-proprietary name (INN): contusugene ladenovec
Mednarodno nelastniško ime (INN): contusugene ladenovec
People who have this mutation are more likely to develop cancer.
Pri ljudeh s to mutacijo je razvoj raka verjetnejši.
Li-Fraumeni cancer can occur in many areas of the body but usually affects the breast, brain, bone or soft tissue (tissue that connects, surrounds and supports other structures in the body).
Li-Fraumeni rak se lahko razvije skoraj kjer koli v telesu, vendar navadno prizadene prsi, možgane, kosti ali mehko tkivo (tkivo, ki povezuje, obdaja ali podpira druge strukture v telesu).
Advexin was designated as an orphan medicinal product on 23 October 2006.
Zdravilo Advexin je bilo 23. oktobra 2006 določeno kot zdravilo sirota.
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.
Družba je predstavila tudi rezultate številnih manjših študij, ki so proučevale učinke različnih odmerkov zdravila Advexin na različne vrste raka.
This is a type of virus that has been altered genetically so that it can carry a gene into the cells of the body.
To je vrsta virusa, ki je bila gensko spremenjena tako, da lahko nese gen v celice telesa.
Questions and answers on the withdrawal of the marketing application for Advexin
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Advexin
The effects of Advexin were first tested in experimental models before being studied in humans.
Učinki zdravila Advexin so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The patient received 12 Advexin injections into some of the tumours over a five-month period.
Bolnik je v obdobju petih mesecev prejel 12 injekcij zdravila Advexin v nekatere tumorje.
Advexin was expected to be used to treat Li-Fraumeni cancer in patients from the age of 18 years.
Zdravilo Advexin naj bi se uporabljalo za zdravljenje Li-Fraumeni raka pri bolnikih, starejših od 18 let.
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.
Družba Gendux Molecular Limited je dne 17. decembra 2008 obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Advexin, namenjenim za zdravljenje Li-Fraumeni raka.
The application was at day 179 when the company withdrew.
Družba je vlogo umaknila na 179. dan postopka.
The company presented information from a study on one patient with Li-Fraumeni cancer in the lower abdomen, the bones and the brain.
Družba je predstavila podatke iz študije na enem bolniku z Li-Fraumeni rakom v spodnjem delu trebuha, kosteh in možganih.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Advexin?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Advexin?
The effectiveness of the medicine was assessed by using scans to look at how the tumours responded to treatment.
Za ocenjevanje učinkovitosti zdravila so uporabili slikanje, ki je pokazalo, kako so se tumorji odzvali na zdravljenje.
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.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP , je imel Odbor zadržke in je začasno menil, da zdravila Advexin ni mogoče odobriti za zdravljenje Li-Fraumeni raka.
What is Advexin?
Kaj je zdravilo Advexin?
The CHMP was concerned that there was not enough evidence to show that the injection of Advexin into Li-Fraumeni tumours led to benefits for patients.
CHMP je skrbelo, da ni dovolj dokazov, ki bi potrjevali, da je injiciranje zdravila Advexin v tumorje Li-Fraumeni za bolnike koristno.
London, 22 January 2009 Doc.
London, 22.01.09 Sklic na dok.
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.
Virus, uporabljen pri zdravilu Advexin, je „adenovirus“, ki je bil gensko spremenjen tako, da se ne more podvajati in posledično pri ljudeh ne more povzročiti okužbe.
What was Advexin expected to be used for?
Za kaj naj bi se zdravilo Advexin uporabljalo?
In addition, the company had not supplied enough evidence to demonstrate that Advexin could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Družba tudi ni predložila dovolj dokazil o zanesljivi izdelavi zdravila Advexin ali o njegovi neškodljivosti za okolje ali ljudi, ki bi z njim rokovali.
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.
Li-Fraumeni rak je vrsta raka, ki se pojavi pri bolnikih s Li-Fraumeni sindromom, stanjem, pri katerem je gen, imenovan p53, poškodovan zaradi mutacije.
Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Ker rakave celice vsebujejo poškodovano DNK, protein p53 pomaga pri popravilu DNK ali pa povzroči odmrtje celice.
Advexin was expected to be injected directly into the tumours, thus allowing the cancer cells to produce normal p53 protein again.
Zdravilo Advexin naj bi se injiciralo neposredno v tumor in tako omogočilo rakavim celim, da ponovno proizvedejo normalen protein p53.
The gene carried by the virus in Advexin is the normal (non-defective) p53 gene.
Gen, ki ga nosi virus v zdravilu Advexin, je normalen (nepoškodovan) gen p53.
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.
Protein p53, ki ga proizvaja v telesu prisoten nepoškodovani gen p53, običajno pomaga pri obnovi poškodovane DNK in povzroči smrt celic, če DNK ne more biti popravljena.
The active substance in Advexin, contusugene ladenovec, is a ‘viral vector'.
Zdravilna učinkovina v zdravilu Advexin, contusugene ladenovec, je virusni vektor.
The company did not inform the CHMP whether there were any consequences of the withdrawal for patients in clinical trials or compassionate use programmes with Advexin.
Družba odbora CHMP ni obvestila, ali ima umik kakršne koli posledice za bolnike v kliničnih preskušanjih ali programih sočutne uporabe zdravila Advexin.