FrancophonIA/ELRC3.0 huggingface dataset:
English: Hungary Eurovet Animal Health B.V., P.O. 179,
Slovenian: Madžarska Eurovet Animal Health B.V., P.O. 179,
English: • Chickens (broiler, pullet, breeder): 10 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by P. multocida and 20 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by
Slovenian: • Piščanci (brojlerji, za vzrejo nesnic, vzrejni): 10 mg doksiciklinijevega hiklata na kg telesne mase na dan 3-4 dni za zdravljenje okužb, ki jih povzroča P. multocida, in 20 mg doksiciklinijevega hiklata na kg telesne mase na dan 3-4 dni za zdravljenje okužb, ki jih povzroča O. rhinotracheale.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for pigs and chickens Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only)
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Soludox 500 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Soludox 433 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci (FR)
English: Doxycycline is primarily excreted with the faeces.
Slovenian: Doksiciklin se v glavnem izloča z blatom.
English: Pigs and chicken
Slovenian: Prašiči piščanci
English: The chicken meat residue depletion data for both dosing regimens (10 mg doxycycline hyclate per kg body weight per day for 4 days and 20 mg doxycycline hyclate per kg body weight per day for 4 days) were submitted.
Slovenian: Za oba režima odmerjanja so bili predloženi podatki o izločanju ostankov v piščančjem mesu (10 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni in 20 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni).
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET) Izpolni država članica
English: Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae susceptible to doxycycline.
Slovenian: Prašiči: Za zdravljenje kliničnih znakov, povezanih z obolenjem dihal pri prašičih, ki ga povzročajo Actinobacillus pleuropneumoniae, Pasteurella multocida, in Mycoplasma hyopneumoniae, občutljivi na doksiciklin.
English: Use during pregnancy or lactation
Slovenian: Uporaba v obdobju brejosti in laktacije
English: 10 mg doxycycline hyclate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by P. multocida and
Slovenian: 10 mg Doksiciklinijev hiklata (20 mg izdelka) na kg teže na dan 3-4 zaporedne dni, če gre za infekcije, ki jih je povzročila P. multocida, in
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON 10 X 100 GRAM only
Slovenian: PODATKI NA ZUNANJI OVOJNINI samo ŠKATLA 10 X 100 GRAMOV
English: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4 consecutive days.
Slovenian: 12,5 mg Doksiciklinijev hiklata (25 mg izdelka) na kg teže na dan, 4 zaporedne dnei.
English: - Meat and offal: 12 days, following a dose rate of 20 mg/kg body weight for 4 days.
Slovenian: - Meso in organi: 12 dni, po odmerku 20 mg / kg telesne teže za 4 dni.
English: 500 mg/g, suukaudse lahuse pulber sigadele
Slovenian: 500 mg/g, suukaudse lahuse pulber sigadele doksiciklinijev hiklat
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP recommends the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxyfar 50 % and associated names (see Annex I).
Slovenian: CVMP priporoča spremembo dovoljenj za promet z zdravilom Doxyfar 50 % in z njim povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
English: OTHER INFORMATION Pack sizes: 100g, 10x100g, 250g, 500g and 1 kg Not all pack sizes may be marketed.
Slovenian: DRUGE INFORMACIJE Velikosti ovojnine: 100g, 10x100g, 250g, 500g in 1 kg Ni nujno, da so v prometu vsa navedena pakiranja
English: 20 mg doxycycline hyclate (40 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by O. rhinotracheale
Slovenian: 20 mg Doksiciklinijev hiklata (40 mg izdelka) na kg teže na dan 3-4 zaporedne dneve dolgo, če gre za infekcije, ki jih je povzročila O. rhinotracheale
English: Chickens: - Meat and offal: 3 days, following a dose rate of 10 mg/kg body weight for 4 days.
Slovenian: Piščanci: - Meso in organi: 3 dni, po odmerku 10 mg/kg telesne teže za 4 dni.
English: • Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropeumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae susceptible to doxycycline.
Slovenian: • Prašiči: za zdravljenje kliničnih znakov, povezanih s prašičjo boleznijo dihal, kadar jo povzročajo bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida in Mycoplasma hyopneumoniae, ki so občutljive na doksiciklin.
English: OTHER INFORMATION Pack sizes: 100g, 10x 100g, 250g, 500g and 1 kg Not all pack sizes may be marketed.
Slovenian: DRUGE INFORMACIJE Velikosti ovojnine: 100g, 10x 100g, 250g, 500g in 1 kg Ni nujno, da so v prometu vsa navedena pakiranja
English: Special precautions for use
Slovenian: NAVODILO ZA UPORABO
English: • Chickens (broiler, pullet, breeder): Where clinical disease is present in the flock, to reduce mortality, morbidity and clinical signs and to reduce lesions due to Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by O. rhinotracheale.
Slovenian: • Piščanci (brojlerji, za vzrejo nesnic, vzrejni): Kadar je v jati prisotna klinična bolezen, za zniževanje umrljivosti, obolevnosti in kliničnih znakov ter za zmanjševanje lezij zaradi
English: Chickens
Slovenian: KARENCE
English: Denmark Eurovet Animal Health B.V., P.O. 179,
Slovenian: Eurovet Animal Health B.V., P.O. 179,
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Pred uporabo preberite navodilo za uporabo.
English: The following indications for Doxyfar 50% and associate names were agreed:
Slovenian: Potrjene so bile naslednje indikacije za zdravilo Doxyfar 50 % in povezana imena:
English: The following recommended dose for Doxyfar 50% and associate names was agreed:
Slovenian: Dogovorjeni so bili naslednji priporočeni odmerki zdravila Doxyfar 50 % in povezanih imen:
English: DOXY ORT 50% Poeder voor toediening aan het drinkwater van varkens en kippen
Slovenian: DOXY ORT 50% Poeder voor toediening aan het drinkwater van varkens en kippen doksiciklinijev hiklat
English: (1997), Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens, Veterinary Record, July 12, 141(2), p. 37-40
Slovenian: (1997): Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens.
English: A chicken meat withdrawal period of 3 days when chickens are treated with 10 mg doxycycline hyclate/kg bw/day for 4 days; and a meat withdrawal period of 12 days when the chicken are treated with 20 mg doxycycline hyclate/kg bw/day for 4 days can be accepted.
Slovenian: Potrjena je lahko karenca za meso piščancev 3 dni, kadar piščance 4 dni zdravijo z 10 mg doksiciklinijevega hiklata na kg telesne mase na dan; in karenca 12 dni, kadar piščance 4 dni zdravijo z 20 mg doksiciklinijevega hiklata na kg telesne mase na dan.
English: Finland Eurovet Animal Health B.V., Handelsweg 25,
Slovenian: Nizozemska Eurovet Animal Health B.V., Handelsweg 25,
English: Summary of product characteristics, labelling and package leaflet
Slovenian: Povzetek glavnih značilnosti zdravila, besedilo za oznake, navodilo za uporabo
English: SOLUDOX 50%, poeder voor toediening via het drinkwater aan varkens en kippen
Slovenian: SOLUDOX 50%, poeder voor toediening via het drinkwater aan varkens en kippen doksiciklinijev hiklat
English: Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179, 5530 AD Bladel The Netherlands
Slovenian: Handelsveg 25 - PO Box 179, 5530 AD Bladel The Netherlands
English: This veterinary medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje tega zdravila ni posebnih navodil.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
English: Residue depletion data in pigs support a meat withdrawal period of 4 days when pigs are administered at 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days.
Slovenian: Podatki o izločanju ostankov pri prašičih podpirajo karenco za meso 4 dni, kadar prašiči do 8 dni prejemajo 12,5 mg doksiciklinijevega hiklata na kg telesne mase na dan.
English: DOXYFAR 50% Poeder voor toediening aan het drinkwater van varkens en kippen
Slovenian: DOXYFAR 50% Poeder voor toediening aan het drinkwater van varkens en kippen doksiciklinijev hiklat
English: LEAFLET
Slovenian: Jakost
English: Tartaric acid
Slovenian: doksiciklinijev hiklat
English: Residue depletion data in chickens support a meat withdrawal period of 3 days when chickens are administered at 10 mg doxycycline hyclate/kg body weight/day for 4 days.
Slovenian: Podatki o izločanju ostankov pri piščancih podpirajo karenco za meso 3 dni, kadar piščanci 4 dni prejemajo 10 mg doksiciklinijevega hiklata na kg telesne mase na dan.
English: 500 mg/g, suukaudse lahuse pulber kanadele
Slovenian: 500 mg/g, suukaudse lahuse pulber kanadele doksiciklinijev hiklat
English: Doxycycline hyclate France: Doxycycline Excipients
Slovenian: Doksiciklinijev hiklat FR: Doksiciklin Pomožne snovi Vinska kislina
English: Lithuania Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179, 5530 AD Bladel
Slovenian: Handelsveg 25 - PO Box 179, 5530 AD Bladel
English: F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Antimicrobial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 51: 374 - 379
Slovenian: 4 F. J. Angulo et al.: Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Anti-microbial
English: Residue depletion data in chickens support a meat withdrawal period of 12 days when chickens are administered at 20 mg doxycycline hyclate/kg body weight/day for 4 days.
Slovenian: Podatki o izločanju ostankov pri piščancih podpirajo karenco za meso 12 dni, kadar piščanci 4 dni prejemajo 20 mg doksiciklinijevega hiklata na kg telesne mase na dan.
English: A chicken meat withdrawal period of 3 days following a dose rate of 10 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable.
Slovenian: Za piščančje meso je bila za odmerek 10 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni sprejemljiva tridnevna karenca.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Slovenian: NAVEDBA ZDRAVILNE UCINKOVINE IN DRUGIH SNOVI
English: Soludox 50% Doxycycline hyclate 500 mg/g
Slovenian: Soludox 50% doksiciklinijev hiklat
English: MARKETING AUTHORISATION HOLDER To be completed nationally
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Izpolni država članica
English: The pig meat residue depletion data was made available and supported a meat withdrawal period of 4 days when pigs are administered 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days.
Slovenian: Predloženi so bili podatki o izločanju ostankov v prašičjem mesu, ki so potrdili karenco za meso 4 dni, kadar prašiči 8 dni prejemajo 12,5 mg doksiciklinijevega hiklata na kg telesne mase na dan.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Treba izpolniti
English: Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille
Slovenian: Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille doksiciklinijev hiklat
English: Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille
Slovenian: Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille doksiciklinijev hiklat
English: Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata
Slovenian: Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata doksiciklinijev hiklat
English: Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām
Slovenian: Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām doksiciklinijev hiklat
English: INN & Strength
Slovenian: Vet.Res.
English: Special precautions for use in animals
Slovenian: 4.2 Indikacije za uporabo pri tarčnih živalskih vrstah
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens Doxycycline hyclate.
Slovenian: Soludox 500 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Doksiciklinijev hiklat.
English: Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner
Slovenian: Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner doksiciklinijev hiklat
English: France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline.
Slovenian: FR: Soludox 433 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Doksiciklin.
English: Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané
Slovenian: Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané doksiciklinijev hiklat
English: In addition a chicken meat withdrawal period of 12 days following a dose rate of 20 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable.
Slovenian: Za odmerek 20 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni pa je bila za piščančje meso sprejemljiva 12-dnevna karenca.
English: Soludox, 500 mg/g, Water Soluble Powder for Pigs
Slovenian: Soludox, 500 mg/g, Water Soluble Powder for Pigs doksiciklinijev hiklat
English: • Amounts to be administered;
Slovenian: • odmerjanje;
English: Doxycycline (as hyclate) 433 mg/g
Slovenian: doksiciklin (kot hiklat) 433 mg/g prašek za uporabo v pitni vodi
English: France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline
Slovenian: FR: Soludox 433 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Doksiciklin
English: Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām
Slovenian: Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām doksiciklinijev hiklat
English: There have been no reports of adverse events, including suspected lack of expected efficacy of the product in pigs in the Periodic Safety Update Report data covering the period of the last 5 years.
Slovenian: Dopolnjeno redno poročilo o varnosti zdravila (PSUR), ki je zajemalo obdobje zadnjih petih let, ni vključevalo nobenih poročil o neželenih učinkih pri prašičih, vključno z domnevno manjšo učinkovitostjo od pričakovane.
English: Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine
Slovenian: Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine doksiciklinijev hiklat
English: Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour poulets
Slovenian: Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour poulets doksiciklin (kot hiklat) 433 mg/g prašek za uporabo v pitni vodi
English: Soludox 500 mg/g powder for use in drinking water for chickens
Slovenian: Soludox 500 mg/g powder for use in drinking water for chickens doksiciklinijev hiklat
English: Soludox 500 mg per gram voor gebruik in drinkwater voor kippen
Slovenian: Soludox 500 mg per gram voor gebruik in drinkwater voor kippen doksiciklinijev hiklat
English: Soludox 500 mg/g polvo para administración en agua de bebida para porcino
Slovenian: Soludox 500 mg/g polvo para administración en agua de bebida para porcino doksiciklinijev hiklat
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens Doxycycline hyclate
Slovenian: Soludox 500 mg/g prašek za uporabo v pitni vodi za prašiče in piščanci Doksiciklinijev hiklat
English: 6.3 Shelf life
Slovenian: 4.11 Karence
English: Powder for use in drinking water
Slovenian: = .... mg zdravila na l pitne vode
English: Ref.: EMEA/748861/2009 EMEA/H/C/558/II/29
Slovenian: : EMEA/748861/2009 EMEA/H/C/558/II/29
English: It is already used to treat the following types of cancer:
Slovenian: Uporablja se že za zdravljenje naslednjih vrst raka:
English: Erbitux has been authorised since June 2004.
Slovenian: Zdravilo Erbitux je odobreno od junija 2004.
English: As a result, the tumour cells can no longer receive the messages needed for growth, progression and spread.
Slovenian: Posledica te vezave je, da tumorske celice ne morejo več prejemati sporočil, potrebnih za svojo rast, napredovanje in širjenje.
English: These ‘subgroup analyses' attempted to identify a group of patients that would benefit from treatment.
Slovenian: Z„analizami podskupin“ so skušali določiti skupino bolnikov, ki bi ji zdravljenje koristilo.
English: The CHMP was also concerned over discrepancies in the studies' findings between the two main measures of effectiveness.
Slovenian: CHMP je izrazil pomisleke tudi glede neujemanja izsledkov študij med dvema glavnima meriloma učinkovitosti.
English: The full European Public Assessment Report for Erbitux is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Erbitux je na voljo tukaj.
English: The company presented the results of two main studies involving a total of 1,801 adults with advanced, metastatic or recurrent non-small cell lung cancer who had not been treated before.
Slovenian: Družba je predstavila rezultate dveh glavnih študij, ki so vključevale skupno 1 801 odraslo osebo z napredovalim, metastatskim ali ponavljajočim se nedrobnoceličnim pljučnim rakom, ki predhodno še ni bil zdravljen.
English: ‘Metastatic' means that the cancer has spread to other parts of the body;
Slovenian: „Metastatski“ pomeni, da se je rakavo obolenje razširilo na druge dele telesa;
English: In November 2009, following the re-examination, the CHMP added a further concern over the ways in which the studies' results were analysed after they can been completed.
Slovenian: CHMP je novembra 2009 po ponovni proučitvi izrazil dodatni zadržek glede načina analize rezultatov študij po njihovem zaključku.
English: There are no consequences on the use of Erbitux in its authorised indications, for which the balance of benefits and risks remains unchanged.
Slovenian: Zavrnitev nima nobenih posledic za uporabo zdravila Erbitux za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
English: Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Erbitux cetuximab
Slovenian: Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Erbitux cetuksimab
English: The change concerned an extension of indication to add the treatment of non-small cell lung cancer.
Slovenian: Sprememba se je nanašala na razširitev indikacije z vključitvijo zdravljenja nedrobnoceličnega pljučnega raka.
English: Erbitux can be used when the cancer is locally advanced (when the tumour has grown but has not spread), recurrent (when it has come back after previous treatment) or metastatic.
Slovenian: Zdravilo Erbitux se lahko uporablja, ko je rak lokalno napredoval (tumor je zrasel, a se ni razširil), je ponavljajoč (se je po prejšnjem zdravljenju ponovil) ali metastatski.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Erbitux.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. julija 2009 priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Erbitux.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Slovenian: Gre za protitelo (vrsto beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen) v telesu in se veže nanjo.
English: It was to be used in patients who had not been treated before, when the tumour cells had a protein on their surface called epidermal growth factor receptor (EGFR).
Slovenian: Uporabljalo naj bi se pri predhodno še nezdravljenih bolnikih, pri katerih so tumorske celice imele na površini beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR).
English: The main measures of effectiveness were how long the patientssurvived and how long they lived without their cancer getting worse.
Slovenian: Glavno merilo učinkovitosti je bil čas preživetja in čas do poslabšanja bolezni.
English: What are the consequences of the refusal for patients in clinical trials using Erbitux?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Erbitux?
English: In July 2009, the CHMP was concerned that the benefits of adding Erbitux to standard platinum-based chemotherapy were modest in terms of survival times, and that the medicine did not have a convincing effect on how long patients lived without their cancer getting worse.
Slovenian: Julija 2009 je CHMP menil, da so bile koristi dodajanja zdravila Erbitux k standardnemu zdravljenju s kemoterapijo na osnovi platine skromne z vidika časa preživetja in da zdravilo ni imelo prepričljivega učinka na čas do poslabšanja bolezni.
English: Erbitux was to be used in combination with platinum-based chemotherapy (a combination of anticancer medicines that includes a medicine such as cisplatin or carboplatin).
Slovenian: Zdravilo Erbitux naj bi se uporabljalo v kombinaciji s kemoterapijo na osnovi platine (kombinacijo zdravil proti raku, ki vključuje zdravila, kot sta cisplatin ali karboplatin).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Erbitux.
Slovenian: Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Erbitux.
English: • ‘squamous cell' cancers of the head and neck.
Slovenian: • ploščatoceličnega raka glave in vratu.
English: Therefore, the CHMP was of the opinion that the benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks.
Slovenian: CHMP je zato menil, da koristi zdravila Erbitux pri zdravljenju nedrobnoceličnega pljučnega raka ne odtehtajo z njim povezanih tveganj.
English: What is happening with Erbitux for the treatment of cancer of the colon or rectum and cancers of the head and neck?
Slovenian: Kakšne so posledice za zdravilo Erbitux, indicirano za zdravljenje raka debelega črevesa ali danke oziroma raka glave in vratu?
English: In both studies, the combination of Erbitux with platinum-based chemotherapy was compared with platinum based chemotherapy without Erbitux.
Slovenian: V obeh študijah so kombinacijo zdravila Erbitux s kemoterapijo na osnovi platine primerjali s kombinacijo kemoterapije na osnovi platine brez dodanega zdravila Erbitux.
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Slovenian: Zato je priporočil zavrnitev spremembe dovoljenja za promet.
English: What was Erbitux expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Erbitux uporabljalo?
English: Severe side effects were seen in some lung cancer patients who received Erbitux - these were similar to the side effects seen in patients treated with Erbitux for other types of cancer.
Slovenian: Pri nekaterih bolnikih s pljučnim rakom, ki so prejemali zdravilo Erbitux, so se pojavili resni neželeni učinki, ki so bili podobni neželenim učinkom, opaženim pri bolnikih, zdravljenih z zdravilom Erbitux zaradi drugih vrst raka.
English: How is Erbitux expected to work?
Slovenian: Kako naj bi zdravilo Erbitux delovalo?