FrancophonIA/ELRC3.0 huggingface dataset:
English: Care should be taken when treating cats or dogs with known heart or kidney problems, animals that are dehydrated and cats with liver problems.
Slovenian: Pri zdravljenju mačk in psov z znanimi težavami s srcem ali ledvicami, dehidriranih živali ter mačk s težavami z jetri je potrebna pazljivost.
English: Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs.
Slovenian: Tablete zdravila Onsior, ki so jih živali prejele enkrat dnevno, so zmanjšale bolečino in izboljšale gibljivost pri mačkah in psih.
English: Onsior is an anti-inflammatory veterinary medicine for use in cats and dogs to treat pain and inflammation.
Slovenian: Onsior je protivnetno zdravilo za uporabo v veterinarski medicini za zdravljenje bolečin in vnetij pri mačkah in psih.
English: In cats, Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo.
Slovenian: Pri mačkah so tablete zdravila Onsior zmanjšale zmerne bolečine in vnetje zaradi ortopedskega operativnega posega do dva dneva po posegu v primerjavi z živalmi, ki so prejemale placebo.
English: Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems.
Slovenian: Tablete zdravila Onsior se ne smejo uporabljati pri psih in mačkah, ki že imajo težave z želodcem in črevesjem, kot so razjede ali krvavitve v želodcu, ali pri psih s težavami z jetri.
English: How does Onsior work?
Slovenian: Kako zdravilo Onsior deluje?
English: In cats, Onsior tablets are used to treat pain and inflammation associated with acute (short term) and chronic (long term) musculoskeletal disorders (problems with the muscles and bones) and to reduce moderate pain and inflammation associated with orthopaedic (bone) surgery.
Slovenian: Pri mačkah se tablete zdravila Onsior uporabljajo za zdravljenje bolečin in vnetij, povezanih z akutnimi (kratkotrajnimi) in kroničnimi (dolgotrajnimi) kostno-mišičnimi obolenji (težavami z mišicami in kostmi), ter za zmanjšanje zmernih bolečin in vnetij, povezanih z ortopedskimi operativnimi posegi (operativnimi posegi na kosteh).
English: After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days.
Slovenian: Po operativnem posegu se pri mačkah lahko zdravljenje z dajanjem enakega odmerka dnevno ob istem času nadaljuje do največ dva dneva.
English: By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.
Slovenian: Robenakoksib z zaviranjem tvorjenja prostaglandinov zmanjšuje bolečino in vnetje, ki ju povzročajo kostno-mišična obolenja, operativni poseg ali osteoartritis.
English: The solution for injection caused a gradual decrease in pain scores in cats and dogs after surgery.
Slovenian: Raztopina za injiciranje je postopno zmanjšala bolečino pri mačkah in psih po operativnem posegu.
English: The side effects of Onsior are similar to those seen with other NSAIDs.
Slovenian: Neželeni učinki zdravila Onsior so podobni tistim, ki so jih opazili pri drugih nesteroidnih protivnetnih zdravilih.
English: For a full list of side effects of Onsior, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Onsior glejte navodilo za uporabo.
English: Treatment in cats is limited to six days for acute musculoskeletal disorders and longer term for chronic musculoskeletal disorders, with monitoring by the veterinarian.
Slovenian: Pri mačkah je zdravljenje akutnih kostno-mišičnih obolenj omejeno na šest dni, kronična kostno-mišična obolenja pa se lahko zdravijo daljše obdobje, pod nadzorom veterinarja.
English: Hands should be washed after giving the medicine to a dog or cat.
Slovenian: Po dajanju zdravila psu ali mački si je treba umiti roke.
English: The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea.
Slovenian: Najpogostejši neželeni učinki tablet in raztopine za injiciranje so blagi in prehodni učinki v želodcu in črevesju, opaženi kot bruhanje, mehko blato in driska.
English: It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients.
Slovenian: Zdravilo Onsior se ne sme uporabljati pri brejih živalih, psičkih ali muckih, ki se dojijo, ali živalih, ki so namenjene za razplod ali so preobčutljive za (alergične na) robenakoksib ali katero koli drugo sestavino zdravila.
English: For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or selfinjection of Onsior might be dangerous for the unborn child.
Slovenian: Nenamerno zaužitje ali samoinjiciranje zdravila Onsior je lahko pri nosečnicah, še posebno v poznejši nosečnosti, nevarno za nerojenega otroka.
English: Onsior contains the active substance robenacoxib.
Slovenian: Zdravilo Onsior vsebuje zdravilno učinkovino robenakoksib.
English: In dogs, Onsior tablets are used to treat pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain and inflammation in the joints).
Slovenian: Pri psih se tablete zdravila Onsior uporabljajo za zdravljenje bolečin in vnetij pri kroničnem osteoartritisu (dolgotrajni bolezni, ki povzroča bolečine in vnetja v sklepih).
English: Onsior was as effective as the comparator NSAIDs.
Slovenian: Zdravilo Onsior je bilo enako učinkovito kot primerjalna nesteroidna protivnetna zdravila.
English: After surgery in cats, a daily dose may be given for up to two further days.
Slovenian: Po operativnem posegu se pri mačkah lahko zdravljenje nadaljuje do največ dva dneva z dajanjem enega odmerka dnevno.
English: How is Onsior used?
Slovenian: Kako se zdravilo Onsior uporablja?
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering.
Slovenian: Raztopina za injiciranje se uporablja za zdravljenje bolečin in vnetij po operativnih posegih na kosteh ali mehkih tkivih, kot je sterilizacija.
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery.
Slovenian: Raztopina za injiciranje se uporablja za zdravljenje bolečin in vnetij po operativnih posegih na kosteh ali mehkih tkivih.
English: In cats, the 6-mg tablet and the solution for injection can be used interchangeably when used to reduce pain and inflammation associated with orthopaedic surgery.
Slovenian: Za zmanjšanje bolečin in vnetij po ortopedskih operativnih posegih pri mačkah se lahko 6-miligramska tableta in raztopina za injiciranje uporabljata izmenično.
English: Arzerra has been authorised since April 2010.
Slovenian: Zdravilo Arzerra je bilo odobreno aprila 2010.
English: The full European Public Assessment Report for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Arzerra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was based on the number of patients who showed a partial or complete response to treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se deloma ali popolnoma odzvali na zdravljenje.
English: On 10 November 2016, the CHMP adopted a positive opinion recommending an extension to this indication: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
Slovenian: 1 Odbor CHMP je dne 10. novembra 2016 sprejel pozitivno mnenje, v katerem je priporočil razširitev te indikacije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: Potem ko je odbor CHMP ocenil odgovore družbe na vprašanja, so nekatera vprašanja še vedno ostala nerešena.
English: Additionally, although some patients (39 out of 53) responded to the combination Arzerra plus bendamustine, only a few patients (6 out of 53) had a complete response, and these data were not supported by further study results.
Slovenian: Poleg tega so se sicer nekateri bolniki (39 bolnikov od 53) odzvali na kombinacijo zdravila Arzerra in bendamustina, vendar se je nanjo popolnoma odzvalo samo nekaj bolnikov (6 bolnikov od 53), teh podatkov pa nadaljnji rezultati študije niso podprli.
English: It can also be used in patients whose disease has not responded to previous treatment with fludarabine and a medicine called alemtuzumab1.
Slovenian: Prav tako se lahko uporablja pri bolnikih, ki se niso odzvali na predhodna zdravljenja s fludarabinom in zdravilom, imenovanim alemtuzumab1.
English: What is happening with Arzerra for the treatment of other diseases?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravila Arzerra za zdravljenje drugih bolezni?
English: The company presented the results from a study involving 53 patients with relapsed CLL.
Slovenian: Družba je predložila rezultate študije, ki je vključevala 53 bolnikov s ponovljeno KLL.
English: There are no consequences on the use of Arzerra in its authorised indications.
Slovenian: Umik vloge nima nobenih posledic za uporabo zdravila Arzerra pri odobrenih indikacijah.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Slovenian: Vlogo so umaknili po tem, ko je odbor CHMP že ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: On 8 November 2016, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Arzerra to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia (CLL).
Slovenian: Družba Novartis Europharm Ltd je dne 8. novembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Arzerra, ki naj bi se uporabljalo v novi kombinaciji z bendamustinom, namenjenim zdravljenju ponovljene kronične limfocitne levkemije (KLL).
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the objections raised by the CHMP with regard to the design of the study and its patient population.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da njena odločitev temelji na ugovorih odbora CHMP v zvezi z zasnovo študije in vključeno populacijo bolnikov.
English: It contains the active substance ofatumumab and is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Slovenian: Vsebuje zdravilno učinkovino ofatumumab in je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The company informed the CHMP that there are no consequences for patients currently included in or who may be joining clinical trials using Arzerra.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo ali bodo morda sodelovali v kliničnih preskušanjih zdravila Arzerra.
English: Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Slovenian: Arzerra je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih s kronično limfocitno levkemijo (KLL), rakom vrste belih krvnih celic, imenovanih limfociti.
English: It is used together with the cancer medicines chlorambucil or bendamustine in previously untreated patients who cannot be given treatment based on another medicine, fludarabine.
Slovenian: Uporablja se skupaj z drugim zdravilom za zdravljenje raka, klorambucilom ali bendamustinom, pri predhodno nezdravljenih bolnikih, ki ne morejo prejemati zdravljenja na osnovi drugega zdravila, fludarabina.
English: Arzerra was also expected to be used in combination with bendamustine to treat adults with relapsed CLL (CLL that came back after previous treatment).
Slovenian: Zdravilo Arzerra naj bi se uporabljajo v kombinaciji z bendamustinom za zdravljenje odraslih s ponovljeno KLL (KLL, ki se je po predhodnem zdravljenju vrnila).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not considered to be robust and the CHMP concluded that the medicine could not have been approved based on the data presented by the company.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da rezultati študije niso robustni, in sklenil, da zdravila Arzerra na podlagi podatkov, ki jih je predložila družba, ni mogoče odobriti.
English: Arzerra was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 7 November 2008 for CLL.
Slovenian: Zdravilo Arzerra je bilo dne 7. novembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje KLL.
English: The CHMP was concerned that the study did not compare Arzerra with any other medicine and only included 53 patients with relapsed CLL.
Slovenian: Odbor CHMP je izrazil zadržke, ker v študiji zdravila Arzerra niso primerjali z nobenim drugim zdravilom in ker je študija vključevala samo 53 bolnikov s ponovljeno KLL.
English: What is Arzerra?
Slovenian: Kaj je zdravilo Arzerra?
English: The active substance in Arzerra, ofatumumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called CD20 on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Slovenian: Zdravilna učinkovina v zdravilu Arzerra, ofatumumab, je monoklonsko protitelo, beljakovina, zasnovana za prepoznavo in vezavo na drugo beljakovino, imenovano CD20 na površini limfocitov, tudi na rakavih limfocitih, ki se pojavijo pri KLL.
English: What was Arzerra expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Arzerra uporabljalo?
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Arzerra could not have been approved for the treatment of relapsed CLL in combination with bendamustine.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Arzerra ni mogoče odobriti za zdravljenje ponovljene KLL v kombinaciji z bendamustinom.
English: All patients received Arzerra plus bendamustine; Arzerra was not compared with any other treatment in this study.
Slovenian: Zdravila Arzerra v tej študiji niso primerjali z nobenim drugim zdravilom.
English: • have cancer.
Slovenian: • imate raka.
English: Date of latest renewal: 15 January 2015
Slovenian: Datum zadnjega podaljšanja: 15. januar 2015
English: Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Slovenian: Ελλάδα Amgen Ελλάς Φαρμακευτικά ΕΠΕ.
English: It must be used within this 30 days period.
Slovenian: Uporabiti ga morate v 30 dneh.
English: Specific radiographic findings characterise these events.
Slovenian: Za te dogodke so značilni specifični radiografski izvidi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2010
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26. maj 2010
English: The study was not powered to show a difference in fractures.
Slovenian: Študija ni bila zasnovana tako, da bi pokazala razliko v zlomih.
English: Long-term antiresorptive treatment
Slovenian: Dolgoročno antiresorpcijsko zdravljenje
English: Oestrogen helps keep bones healthy.
Slovenian: Estrogen pomaga ohranjati zdrave kosti.
English: • are a smoker (as this may increase the risk of dental problems).
Slovenian: • ste kadilec (to lahko poveča tveganje za zobozdravstvene težave),
English: These events have also occurred without antiresorptive therapy.
Slovenian: Ti dogodki so se pojavili tudi brez antiresorpcijskega zdravljenja.
English: These cases were predominantly cellulitis.
Slovenian: V teh primerih je šlo v glavnem za celulitis.
English: The bones become weaker and break more easily.
Slovenian: Kosti postanejo šibkejše in se lažje zlomijo.
English: • hair loss (alopecia).
Slovenian: • izguba las in dlak (alopecija).
English: Bone is a living tissue and is renewed all the time.
Slovenian: Kost je živo tkivo in se ves čas obnavlja.
English: Amgen Singapore Manufacturing 1 Tuas View Drive Singapore 637026
Slovenian: Amgen Singapore Manufacturing 1 Tuas View Drive Singapur 637026
English: DO NOT use it if the date has passed the last day of the month shown.
Slovenian: NE uporabite je, če je že pretekel zadnji dan navedenega meseca.
English: 0-2 years
Slovenian: 0-2 leti
English: Use the peel-off stickers to mark the next injection date on your personal calendar and/or the reminder card to keep a record of the next injection date.
Slovenian: Uporabite odlepne nalepke, da boste na svojem osebnem koledarju označili datum naslednje injekcije, in/ali opomnilno kartico za evidenco o datumu naslednje injekcije.
English: If any of these apply to you, tell your doctor immediately.
Slovenian: Če kaj od naštetega velja za vas, to takoj povejte zdravniku.
English: To avoid bending the needle, gently pull the cover from the needle straight off without twisting, as shown in pictures 1 and 2.
Slovenian: Da ne boste zvili igle, previdno snemite pokrovček igle naravnost z nje, ne da bi ga upogibali, tako kot prikazujeta sliki 1 in 2.
English: • painful urination, frequent urination, blood in the urine, inability to hold your urine,
Slovenian: • boleče uriniranje, pogosto uriniranje, kri v urinu, nezmožnost zadrževanja urina,
English: Concomitant glucocorticoid treatment is an additional risk factor for hypocalcaemia.
Slovenian: Sočasno glukokortikoidno zdravljenje je dodaten dejavnik tveganja za hipokalciemijo.
English: • if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na denosumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Before receiving treatment, tell your doctor or nurse (health care professional) if you:
Slovenian: Preden dobite zdravilo, morate zdravniku ali medicinski sestri (zdravstvenemu delavcu) povedati, če:
English: It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Slovenian: Pomembno je, da zdravniku poveste, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
English: 0-3 years *p < 0.0001, **p < 0.0001 - exploratory analysis
Slovenian: 0-3 leta *p < 0,0001, **p < 0,0001 - eksploratorna analiza
English: Thereafter, injections should be scheduled every 6 months from the date of the last injection.
Slovenian: Nato morate injekcije dobivati na 6 mesecev od datuma zadnje injekcije.
English: • don't receive routine dental care or have not had a dental check-up for a long time.
Slovenian: • niste deležni redne zobozdravstvene oskrbe ali dlje časa niste opravili zobozdravniškega pregleda,
English: Hypocalcaemia (see section 4.4).
Slovenian: Hipokalciemija (glejte poglavje 4.4).
English: It allows continued monitoring of the benefit-risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
English: Prolia is not recommended for children and adolescents under 18 years of age.
Slovenian: Zdravilo Prolia ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
English: Always wash your hands before every injection.
Slovenian: Vedno si umijte roke pred injiciranjem.
English: How do you give the injection?
Slovenian: Kako dati injekcijo?
English: The carcinogenic potential of denosumab has not been evaluated in long-term animal studies.
Slovenian: Kancerogenega potenciala denosumaba v dolgoročnih študijah na živalih niso ocenili.
English: Patients who did not complete the study for any reason had higher on-treatment fracture rates.
Slovenian: Bolnice, ki študije zaradi katerega koli razloga niso zaključile, so imele večjo pogostnost zlomov med zdravljenjem.
English: Although this imbalance was identified via a pooled analysis, it was not identified via a stratified analysis.
Slovenian: Čeprav so to razliko ugotovili s kumulativno analizo, pa se ni pokazala pri stratificirani analizi.
English: Temporary interruption of treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Razmisliti je treba o začasnem prenehanju zdravljenja, dokler se to stanje ne razreši in se sovpleteni dejavniki tveganja ublažijo, če je mogoče.
English: Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG).
Slovenian: Nizek kalcij v krvi lahko povzroči tudi motnjo srčnega ritma, imenovano podaljšanje QT, ki je vidna na elektrokardiogramu (EKG).
English: This can eventually lead to a condition called osteoporosis.
Slovenian: Končna posledica je lahko bolezen, ki jo imenujemo osteoporoza.
English: It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.
Slovenian: Posebej pomembno je, da zdravniku poveste, če se zdravite z drugim zdravilom, ki vsebuje denosumab.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4).
Slovenian: Priporočljivo je, da se potreba po nadaljevalnem zdravljenju občasno ponovno oceni na podlagi koristi in možnih tveganj denosumaba pri individualnem bolniku, posebno po 5 ali več letih uporabe (glejte poglavje 4.4).
English: The instructions for use, handling and disposal are given in section 6.6.
Slovenian: Za navodila glede uporabe, ravnanja z zdravilom in odstranjevanja glejte poglavje 6.6.
English: Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
Slovenian: Osteoporoza se lahko pojavi tudi pri moških, in sicer iz številnih razlogov, med katerimi sta staranje in/ali nizka koncentracija moškega hormona testosterona.
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Slovenian: Standardni testi za preučevanje genotoksičnega potenciala denosumaba niso bili opravljeni, ker takšni testi za to molekulo niso pomembni.
English: • The used syringe should be disposed of in accordance with local requirements.
Slovenian: • Uporabljeno brizgo je treba zavreči v skladu z lokalnimi predpisi.
English: Prolia n = 3,902
Slovenian: Zdravilo Prolia n = 3.902
English: Sodium hydroxide (for pH adjustment)* Sorbitol (E420)
Slovenian: Natrijev hidroksid (za prilagoditev pH)* Sorbitol (E420)
English: Administration should be performed by an individual who has been adequately trained in injection techniques.
Slovenian: Zdravilo mora aplicirati oseba, ki se je za injiciranje ustrezno usposobila.
English: MedDRA system organ class Frequency category
Slovenian: Organski sistem po MedDRA Kategorija pogostnosti
English: Prolia is not recommended in paediatric patients (age < 18) as the safety and efficacy of Prolia in these patients have not been established.
Slovenian: Uporaba zdravila Prolia ni priporočljiva za pediatrične bolnike (stare < 18 let), ker njegovi učinkovitost in varnost pri teh bolnikih nista dokazani.
English: It is important to identify patients at risk for hypocalcaemia.
Slovenian: Pomembno je, da identificirate bolnike s tveganjem za hipokalciemijo.