FrancophonIA/ELRC3.0 huggingface dataset:
English: In a GCP-compliant randomised blinded controlled clinical field study Florgane 300 mg/ml proved to be non-inferior in the treatment of swine respiratory disease associated with A. pleuropneumoniae and P. multocida at both single IM doses of 22.5 mg/kg and 30 mg/kg bw when compared to a control product containing 300 mg florfenicol/ml administered at a dose of 15 mg/kg bw IM twice 48 hours apart.
Slovenian: V randomizirani slepi kontrolirani klinični terenski študiji, skladni z DLP, se je zdravilo Florgane 300 mg/ml izkazalo kot neinferiorno pri zdravljenju bolezni dihal pri prašičih, povezanimi s patogenoma A. pleuropneumoniae in P. multocida, pri obeh enkratnih intramuskularnih odmerkih 22,5 mg/kg in 30 mg/kg telesne mase v primerjavi s kontrolnim zdravilom s 300 mg florfenikola/ml, ki je bilo injicirano intramuskularno v odmerku 15 mg/kg dvakrat v razmiku 48 ur.
English: Resistance to florfenicol remains very low among porcine respiratory pathogens whereas the active substance has been used for more than one decade in pigs in swine respiratory disease.
Slovenian: Odpornost prašičjih respiratornih patogenov na florfenikol ostaja zelo nizka, čeprav se zdravilna učinkovina že več kot eno desetletje uporablja za zdravljenje bolezni dihal pri prašičih.
English: For the claimed bacteria species good susceptibility against florfenicol with MIC90 valules for P. multocida and A. pleuropneumoniae of 0.5 µg/ml was determined.
Slovenian: Pri zadevnih vrstah bakterij so zabeležili dobro občutljivost za florfenikol z vrednostmi MIK90 0,5 µg/ml za patogena P. multocida in A. pleuropneumoniae.
English: Overall, the data package submitted by the applicant is considered sufficient taking into account the nature of this application for an extension of the marketing authorisation (hybrid application).
Slovenian: Upoštevajoč naravo predložene vloge, sveženj podatkov, ki ga je predložil predlagatelj, v splošnem zadostuje za razširitev dovoljenja za promet z zdravilom (hibridna vloga).
English: The benefit of Florgane 300 mg/ml suspension for injection is that swine respiratory disease associated with susceptible Actinobacillus pleuropneumoniae and Pasteurella multocida can be treated.
Slovenian: Korist zdravila Florgane 300 mg/ml raztopina za injiciranje je, da je mogoče bolezni dihal pri prašičih, povezane z občutljivima patogenoma Actinobacillus pleuropneumoniae in Pasteurella multocida, zdraviti.
English: This application is an extension to add pigs as a target species to the existing 300 mg florfenicol/ml suspension for injection product authorised for use in cattle.
Slovenian: Ta vloga je razširitev, s katero bi prašiče dodali kot novo ciljno vrsto k obstoječemu zdravilu 300 mg florfenikol/ml raztopina za injiciranje, ki je odobreno za uporabo pri govedu.
English: This extension application was submitted as a decentralised procedure under Article 13(3) of Directive 2001/82/EC, as amended, to the above-mentioned Member States as for the initial application for cattle.
Slovenian: Ta vloga za razširitev je bila, tako kot začetna vloga za govedo, zgoraj omenjenim državam članicam predložena kot decentralizirani postopek v skladu s členom 13(3) Direktive 2001/82/ES, kot je bila spremenjena.
English: • the CVMP reviewed all available data submitted by the applicant to support the use of the product in the target species pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection;
Slovenian: • odbor CVMP je ponovno proučil vse razpoložljive podatke, ki jih je predložil predlagatelj v podporo uporabi zdravila pri ciljni vrsti prašičev za zdravljenje okužb dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, ki so občutljive za florfenikol pri odmerku 22,5 mg florfenikola/kg telesne mase, ki se ga daje intramuskularno z enkratnim injiciranjem;
English: The overall conclusion is that that the efficacy dataset as a whole is adequate to support the efficacy of the product in target species pigs at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Slovenian: Splošni zaključek Odbora je, da je podatkovni niz kot celota primeren za podporo učinkovitosti zdravila pri ciljni vrsti prašičev pri odmerku 22,5 mg florfenikola/kg telesne mase, ki se daje intramuskularno z enkratnim injiciranjem za zdravljenje okužb dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, ki so občutljive za florfenikol.
English: Belgium Emdoka bvba John Lijsenstraat 16
Slovenian: Madžarska Emdoka bvba John Lijsenstraat 16
English: Florgane 300 mg/ml suspension for injection contains florfenicol as active ingredient.
Slovenian: Florgane 300 mg/ml raztopina za injiciranje vsebuje zdravilno učinkovino florfenikol.
English: Luxembourg Emdoka bvba John Lijsenstraat 16
Slovenian: Luksemburg Emdoka bvba John Lijsenstraat 16
English: Plasmid mediated resistance has only been scarcely identified among porcine respiratory pathogens without indication of spreading.
Slovenian: Med prašičjimi respiratornimi patogeni so le redko poročali o odpornosti, pridobljeni s plazmidi, brez sledu širjenja.
English: The intended use in pigs is for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Slovenian: Zdravilo je namenjeno zdravljenju prašičev z okužbami dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, ki so občutljive za florfenikol.
English: Greece
Slovenian: Grčiji
English: The applicant submitted an application for a decentralised procedure for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Slovenian: Predlagatelj je predložil vlogo za decentralizirani postopek za zdravilo Florgane 300 mg/ml raztopina za injiciranje za govedo in prašiče, in povezana imena.
English: Spain1
Slovenian: Španija1
English: Czech Republic Emdoka bvba John Lijsenstraat 16
Slovenian: Nizozemska Emdoka bvba John Lijsenstraat 16
English: Portugal
Slovenian: Portugalski
English: Considering the MIC data from most recent isolates, obtained from pigs suffering from respiratory disease in the last 5 years florfenicol exhibited consistent MICs with MIC90 ranges of 0.25-1 µg/ml for
Slovenian: Glede na podatke o MIK, pridobljenih iz najnovejših izoliranih patogenov prašičev z boleznimi dihal v zadnjih 5 letih, so za florfenikol veljale enakomerne MIK z razponom MIK90 od 0,25 do 1 µg/ml za patogen P. A. pleuropneumoniae ter 0,5 µg/ml za patogen P. multocida.
English: Scientific conclusions and grounds for the granting of the extension of the marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle to the target species pigs
Slovenian: Znanstveni zaključki in razlogi za odobritev razširitve dovoljenja za promet z zdravilom Florgane 300 mg/ml raztopina za injiciranje za govedo na ciljno vrsto prašičev
English: Bulgaria
Slovenian: Bolgariji
English: Slovakia
Slovenian: Slovaška republika
English: The reference veterinary medicinal product is Nuflor Swine Injectable Solution 300 mg/ml.
Slovenian: Referenčno zdravilo za uporabo v veterinarski medicini je Nuflor Swine 300 mg/ml raztopina za injiciranje.
English: Thus, the impact on development of florfenicol resistance when used in the proposed dose of 22.5 mg/kg bw IM once compared to authorised dosing regimens can hardly be estimated.
Slovenian: Zato je skoraj nemogoče oceniti, kako predlagani enkratni intramuskularni odmerki 22,5 mg/kg telesne mase vplivajo na razvoj odpornosti na florfenikol v primerjavi z odobrenimi načini odmerjanja.
English: In conclusion, the benefit-risk ratio is considered positive for Florgane300 mg/ml suspension for injection for cattle and pigs.
Slovenian: V zaključku je Odbor presodil, da je razmerje med koristmi in tveganji zdravila Florgane 300 mg/ml raztopina za injiciranje za govedo in prašiče pozitivno.
English: Overall summary of the scientific evaluation of Florgane 300 mg/ml suspension for injection for cattle and pigs
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Florgane 300 mg/ml raztopina za injiciranje za govedo in prašiče
English: Grounds for the granting of the extension of the marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle to the target species pigs
Slovenian: Razlogi za odobritev razširitve dovoljenja za promet z zdravilom Florgane 300 mg/ml raztopina za injiciranje za govedo na ciljno vrsto prašičev
English: The reference product was Nuflor Swine Injectable Solution 300 mg/ml.
Slovenian: Referenčno zdravilo je bilo zdravilo Nuflor Swine 300 mg/ml raztopina za injiciranje.
English: Florgane 300 mg/ml will not differ from the previous florfenicol formulations as far as the plasma elimination phase and sub-therapeutic periods are concerned.
Slovenian: Kar zadeva fazo plazemske eliminacije in koncentracije pod terapevtsko ravnijo, se zdravilo Florgane 300 mg/ml ne bo razlikovalo od prejšnjih pripravkov s florfenikolom.
English: Melanoma
Slovenian: Melanom
English: Further information on Opdivo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/opdivo.
Slovenian: Nadaljnje informacije o zdravilu Opdivo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/opdivo.
English: What measures are being taken to ensure the safe and effective use of Opdivo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Opdivo?
English: • melanoma, a type of skin cancer.
Slovenian: • melanoma, tj. vrste kožnega raka.
English: Opdivo received a marketing authorisation valid throughout the EU on 19 June 2015.
Slovenian: Za zdravilo Opdivo je bilo 19. junija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: Classical Hodgkin lymphoma
Slovenian: Klasični Hodgkinov limfom
English: An overview of Opdivo and why it is authorised in the EU
Slovenian: Pregled zdravila Opdivo in zakaj je odobreno v EU
English: Other information about Opdivo
Slovenian: Druge informacije o zdravilu Opdivo
English: As for all medicines, data on the use of Opdivo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Opdivo stalno spremljajo.
English: Studies of classical Hodgkin lymphoma involved only a small number of patients.
Slovenian: V študije klasičnega Hodgkinovega limfoma je bilo vključeno le manjše število bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opdivo have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Opdivo, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The Agency therefore decided that Opdivo's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Opdivo večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: What benefits of Opdivo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Opdivo izkazalo v študijah?
English: After treatment, cancer cells were partially or completely cleared in around 66% of patients (63 out of 95).
Slovenian: Po zdravljenju so bile rakave celice delno ali v celoti odstranjene pri okoli 66 % (63 od 95) bolnikov.
English: Treatment with Opdivo must be started and supervised by a doctor experienced treating cancer.
Slovenian: Zdravljenje z zdravilom Opdivo mora začeti in nadzorovati zdravnik z izkušnjami z zdravljenjem raka.
English: What is Opdivo and what is it used for?
Slovenian: Kaj je zdravilo Opdivo in za kaj se uporablja?
English: Opdivo was used on its own and not compared with any other medicine.
Slovenian: Zdravilo Opdivo se je uporabljalo samostojno in ga niso primerjali z nobenim drugim zdravilom.
English: The company will also provide further data on the long-term benefits of Opdivo and carry out studies to try to identify which patients are most likely to benefit from treatment with the medicine.
Slovenian: Predložilo bo tudi dodatne podatke o dolgotrajnih koristih jemanja zdravila Opdivo in izvedlo študije, s katerimi bo poskušalo ugotoviti, katerim bolnikom bo zdravljenje s tem zdravilom najverjetneje koristilo.
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Slovenian: Priskrbelo bo tudi opozorilno kartico za bolnike, ki bo vsebovala informacije o tveganjih tega zdravila in navodila, kdaj se posvetovati z zdravnikom, če se pojavijo simptomi.
English: What are the risks associated with Opdivo?
Slovenian: Kakšna tveganja so povezana z zdravilom Opdivo?
English: The dose and frequency to be given depends on the condition and whether it is used alone or in combination with ipilimumab.
Slovenian: Odmerek in pogostnost infundiranja sta odvisna od tega, ali se zdravilo uporablja samostojno ali v kombinaciji z ipilimumabom.
English: As it is not clear how much ipilimumab contributes to the benefits when given in combination with Opdivo in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of ipilimumab and if the risks associated with ipilimumab can be further minimised.
Slovenian: Ker ni jasno, v kolikšni meri ipilimumab doprinese h koristim zdravljenja, kadar se uporablja v kombinaciji z zdravilom Opdivo pri bolnikih z napredovalim karcinomom ledvičnih celic, mora podjetje izvesti študijo za določitev natančnega doprinosa ipilimumaba in raziskati, ali je mogoče tveganja, povezana s to učinkovino, še dodatno zmanjšati.
English: Why is Opdivo authorised?
Slovenian: Zakaj je bilo zdravilo Opdivo odobreno?
English: The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Slovenian: Zdravnik bo morda moral počakati z naslednjimi odmerki, če se pojavijo določeni neželeni učinki, ali popolnoma prekiniti zdravljenje, če so neželeni učinki resni.
English: Most will go away with appropriate treatment or on stopping Opdivo.
Slovenian: Večina učinkov izzveni z ustreznim zdravljenjem ali prekinitvijo uporabe zdravila Opdivo.
English: For more information about using Opdivo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Opdivo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Opdivo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Opdivo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: In the study, 20% of patients (54 out of 270) responded to treatment and had a tumour size reduction.
Slovenian: V študiji se je 20 % (54 od 270) bolnikov odzvalo na zdravljenje in so se njihovi tumorji zmanjšali.
English: In studies of urothelial cancer where other treatments had failed, patients responded to treatment with Opdivo.
Slovenian: V študijah urotelnega raka, pri katerem druga zdravljenja niso bila uspešna, so se bolniki odzvali na zdravljenje z zdravilom Opdivo.
English: However, high response rates were seen in these patients, in whom other treatments had failed and who had few other treatment options.
Slovenian: Kljub temu so opazili visoke stopnje odziva na zdravljenje pri bolnikih, pri katerih druge oblike zdravljenja niso bile uspešne ali ki so imeli manj možnosti zdravljenja.
English: Patients given only ipilimumab lived for 2.9 months without their disease getting worse.
Slovenian: Bolniki, ki so prejemali samo ipilimumab, so živeli 2,9 meseca brez poslabšanja bolezni.
English: • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient's own stem cells to form new bone marrow that produces healthy blood cells).
Slovenian: • klasičnega Hodgkinovega limfoma, tj. raka limfocitov (vrste belih krvnih celic), ki se ni odzval na zdravljenje ali se je ponovil po avtologni presaditvi matičnih celic (postopku, pri katerem bolnikov kostni mozeg nadomestijo z njegovimi lastnimi matičnimi celicami, da začnejo tvoriti nov kostni mozeg, ki proizvaja zdrave krvne celice).
English: Opdivo is also commonly associated with side effects related to the activity of the immune system on body organs.
Slovenian: Zdravilo Opdivo je pogosto povezano tudi z neželenimi učinki, ki se pojavijo zaradi delovanja imunskega sistema na telesne organe.
English: In this study, where patients were followed up for at least 6 months, around 32% (38 out of 120) of patients given Opdivo responded to treatment and had a reduction in their tumours compared with about 11% (5 out of 47) of patients given investigator's choice of treatment (dacarbazine or a combination of carboplatin and paclitaxel).
Slovenian: V tej študiji, v kateri so bolnike spremljali vsaj šest mesecev, se je približno 32 % (38 od 120) bolnikov, ki so prejemali zdravilo Opdivo, odzvalo na zdravljenje, saj so se njihovi tumorji zmanjšali, v primerjavi s približno 11 % (5 od 47) bolnikov, ki so prejemali zdravljenje, ki ga je izbral raziskovalec (dakarbazin ali kombinacijo karboplatina in paklitaksela).
English: Urothelial cancer
Slovenian: Urotelni rak
English: The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Slovenian: Rezultati so pokazali, da so v skupini bolnikov z zmernim ali visokim tveganjem za poslabšanje raka, na splošno dlje časa živeli tisti, ki so prejemali omenjeno kombinacijo, kot tisti, ki so prejemali sunitinib.
English: The company that markets Opdivo will provide educational packs for doctors who are expected to prescribe Opdivo containing information on how the medicine should be used, how to manage side effects, particularly those related to the activity of the immune system, and possible risks for classical Hodgkin lymphoma patients if they go on to have an allogeneic stem cell transplant (a transplant of stem cells from a donor).
Slovenian: Podjetje, ki trži zdravilo Opdivo, bo pripravilo izobraževalno gradivo za zdravnike, ki naj bi predpisovali to zdravilo, v katerem bodo informacije o načinu njegove uporabe, obvladovanju neželenih učinkov, zlasti tistih, povezanih z delovanjem imunskega sistema, ter o možnih tveganjih pri bolnikih s klasičnim Hodgkinovim limfomom, pri katerih bo izvedena alogenska presaditev krvotvornih matičnih celic (presaditev matičnih celic darovalca).
English: More patients were alive after 2 years with Opdivo and ipilimumab treatment (64%) than with Opdivo alone (59%) or ipilimumab alone (45%).
Slovenian: Po dveh letih je živelo več bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom Opdivo in ipilimumabom (64 %), kot tistih, ki so prejemali samo zdravilo Opdivo (59 %) ali samo ipilimumab (45 %).
English: For the full list of side effects and restrictions with Opdivo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Opdivo glejte navodilo za uporabo.
English: The European Medicines Agency considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC, renal cell carcinoma or SCCHN) by either increasing patients' survival or the time they could live without their disease getting worse.
Slovenian: Evropska agencija za zdravila je menila, da so pri zdravilu Opdivo prepričljivo dokazane koristi za bolnike z nekaterimi napredovalimi oblikami raka (melanomom, nedrobnoceličnim pljučnim rakom, karcinomom ledvičnih celic ali ploščatoceličnim karcinomom glave in vratu), saj je podaljšalo čas njihovega preživetja ali čas, ko so lahko živeli brez poslabšanja bolezni.
English: Opdivo is a cancer medicine used to treat the following:
Slovenian: Opdivo je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih bolezni:
English: The first study, involving 418 previously untreated advanced melanoma patients, found that patients treated with Opdivo survived longer than patients who received the cancer medicine dacarbazine: 73% of patients treated with Opdivo were alive at 12 months compared with 42% of patients given dacarbazine.
Slovenian: V prvi študiji, ki je vključevala 418 predhodno nezdravljenih bolnikov z napredovalim melanomom, so ugotovili, da so bolniki, ki so se zdravili z zdravilom Opdivo, živeli dlje kot tisti, ki so jemali zdravilo za zdravljenje raka dakarbazin: 73 % bolnikov, zdravljenih z zdravilom Opdivo, je bilo po dvanajstih mesecih še živih v primerjavi z 42 % tistih, ki so prejemali dakarbazin.
English: Patients treated with Opdivo lived on average 31 months before the cancer came back or before a new melanoma occurred or they died, compared with 24 months for patients treated with ipilimumab.
Slovenian: Bolniki, ki so prejemali zdravilo Opdivo, so v povprečju živeli 31 mesecev, preden se je bodisi rak ponovil bodisi pojavil nov melanom bodisi so umrli, v primerjavi s 24 meseci pri bolnikih, ki so se zdravili z ipilimumabom.
English: The most common side effects with Opdivo (which may affect more than 1 in 10 people) include tiredness, diarrhoea, nausea (feeling sick), rash and itching, pain in joints, muscles and bones, and hypothyroidism (an underactive thyroid gland), most of which are mild to moderate in severity.
Slovenian: Najpogostejši neželeni učinki zdravila Opdivo (ki lahko prizadenejo več kot 1 osebo od 10) so utrujenost, driska, navzeja (slabost), izpuščaj in srbenje, bolečine v sklepih, mišicah in kosteh ter hipotiroidizem (nezadostno delovanje ščitnice), njihova resnost pa je večinoma blaga do zmerna.
English: Side effects from Opdivo were considered manageable with appropriate measures and were outweighed by the benefits.
Slovenian: Neželeni učinki zdravila Opdivo veljajo ob ustreznih ukrepih za obvladljive in jih odtehtajo njegove koristi.
English: • advanced renal cell carcinoma, a kidney cancer.
Slovenian: • napredovalega karcinoma ledvičnih celic, tj. raka ledvic.
English: Other common side effects with Opdivo in combination with ipilimumab, which are also mostly mild or moderate, include pyrexia (fever), thyroid issues, decreased appetite, vomiting, colitis (inflammation of the gut), abdominal (belly) pain, headache and breathing difficulty.
Slovenian: Drugi pogosti neželeni učinki zdravila Opdivo v kombinaciji z ipilimumabom, ki so tudi večinoma blagi ali zmerni, so pireksija (povišana telesna temperatura), težave s ščitnico, zmanjšan tek, bruhanje, kolitis (vnetje prebavil), bolečine v trebuhu, glavobol in težave z dihanjem.
English: The active substance in Opdivo, nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Slovenian: Učinkovina v zdravilu Opdivo, nivolumab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna receptor (prijemališče), imenovano PD-1, ki se nahaja na določenih celicah imunskega sistema, imenovanih celice T, in se veže nanjo.
English: The average survival with Opdivo was 12.2 months, compared with 9.4 months with docetaxel.
Slovenian: Povprečni čas preživetja pri zdravilu Opdivo je bil 12,2 meseca, pri docetakselu pa 9,4 meseca.