FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xgeva have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xgeva upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: In the second study which involved 507 patients treatment with Xgeva prevented surgery in about half (109 of 225) of the group in whom surgery would have resulted in complications.
Slovenian: V drugi študiji, v katero je bilo vključenih 507 bolnikov, je zdravljenje z zdravilom Xgeva preprečilo kirurški poseg pri približno polovici (109 od 225) oseb v skupini, pri kateri bi kirurški poseg lahko povzročil zaplete.
English: An overview of Xgeva and why it is authorised in the EU
Slovenian: Pregled zdravila Xgeva in zakaj je odobreno v EU
English: The first study involved 2,046 patients with breast cancer and the second study involved 1,901 men with prostate cancer which did not respond to hormonal treatment.
Slovenian: V prvo študijo je bilo vključenih 2 046 bolnic z rakom dojke, v drugo pa 1 901 moški z rakom prostate, ki se niso odzvali na hormonsko zdravljenje.
English: The Agency noted that there is a need for an effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
Slovenian: Ugotovila je, da obstaja potreba po učinkovitem zdravilu za zdravljenje bolezni kosti pri napredovalem raku, zlasti pri bolnikih z ledvičnimi težavami, saj so trenutno razpoložljiva zdravljenja lahko toksična za ledvice.
English: This reduces the loss of bone, making fractures and other serious bone complications less likely.
Slovenian: Zaradi tega je izguba kostne mase manjša, zlomi in drugi hudi zapleti z okostjem pa manj verjetni.
English: What benefits of Xgeva have been shown in studies?
Slovenian: Kakšne koristi zdravila Xgeva so se pokazale v študijah?
English: Why is Xgeva authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Xgeva odobreno v EU?
English: In patients with giant cell tumour of bone, 120 mg is injected under the skin once a week for 3 weeks, and then once every 4 weeks.
Slovenian: Pri bolnikih z gigantocelularnim kostnim tumorjem se odmerek 120 mg injicira v podkožje enkrat tedensko prve tri tedne, nato pa enkrat vsake štiri tedne.
English: Side effects reported with Xgeva are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Xgeva, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Xgeva and what is it used for?
Slovenian: Kaj je zdravilo Xgeva in za kaj se uporablja?
English: In patients with giant cell tumour of bone, Xgeva was effective in controlling the disease.
Slovenian: Pri bolnikih z gigantocelularnim kostnim tumorjem je bilo zdravilo Xgeva učinkovito pri obvladovanju bolezni.
English: Treatment of giant cell tumour of bone
Slovenian: Zdravljenje gigantocelularnega kostnega tumorja
English: It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.
Slovenian: Daje se bolnikom, pri katerih zdravljenje s kirurškim posegom ni mogoče oziroma bi verjetno povzročilo zaplete.
English: Xgeva must not be used in patients with wounds from dental or mouth surgery have not yet healed, or in people with severe, untreated hypocalcaemia.
Slovenian: Zdravila Xgeva ne smejo uporabljati bolniki, pri katerih se rane v ustih zaradi zobozdravstvenih ali oralnih posegov še niso zacelile, ali bolniki s hudo, nezdravljeno hipokalciemijo.
English: What are the risks associated with Xgeva?
Slovenian: Kakšna tveganja so povezana z zdravilom Xgeva?
English: For patients with giant cell tumour of bone the possibility of complete surgical removal of the tumour after treatment and the reduction in extent of the surgery in some patients were considered clinically important.
Slovenian: Pri bolnikih z gigantocelularnim kostnim tumorjem so kot klinično pomembno ocenili možnost popolne kirurške odstranitve tumorja po zdravljenju in zmanjšanje obsega kirurškega posega pri nekaterih bolnikih.
English: All the studies looked at the risk of patients having a first ‘skeletal-related event' (such as a fracture, pressure on the spinal cord or the need for radiotherapy or surgery to the bone) during the study period by measuring how long it took for this event to happen.
Slovenian: V vseh študijah so pri bolnikih med zdravljenjem proučevali tveganje za pojav prvega „z okostjem povezanega dogodka“ (kot je zlom, pritisk na hrbtenjačo ali potreba po radioterapiji ali kirurškem posegu na kosti), tako da so opazovali, kako dolgo traja, da pride do tovrstnega dogodka.
English: Xgeva was compared with zoledronic acid (another medicine used to prevent bone complications) in four main studies in patients with different types of cancer which had spread to the bone.
Slovenian: Zdravilo Xgeva so primerjali z zoledronsko kislino (drugim zdravilom, ki se uporablja za preprečevanje z okostjem povezanih zapletov) v štirih glavnih študijah, v katerih so sodelovali bolniki z različnimi vrstami raka, ki se je razširil na kosti.
English: These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.
Slovenian: Zapleti vključujejo zlome kosti, spinalno kompresijo (pritisk na hrbtenjačo, ki je posledica poškodbe okoliške kosti) ali težave s kostmi, pri katerih je potrebna radioterapija (zdravljenje z obsevanjem) ali kirurški poseg.
English: Two main studies looked at the effect of Xgeva in adults or full-grown adolescents with giant cell tumour of bone that was unsuitable for surgery or in whom surgery would have resulted in severe complications like amputation of a limb.
Slovenian: V dveh glavnih študijah so proučevali učinek tega zdravila pri odraslih ali popolnoma razvitih mladostnikih z gigantocelularnim kostnim tumorjem, pri katerih kirurški poseg ni bil primeren ali bi povzročil hude zaplete, na primer amputacijo uda.
English: The company that markets Xgeva will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they have symptoms.
Slovenian: Družba, ki trži zdravilo Xgeva, bo pripravila kartico, s katero bo bolnike seznanila s tveganjem pojava osteonekroze čeljustnice in jih pozvala, naj v primeru, da se pojavijo simptomi, poiščejo zdravniško pomoč.
English: The third study involved 1,776 patients with advanced solid tumours in various parts of the body or with multiple myeloma (a cancer of the bone marrow).
Slovenian: V tretjo študijo je bilo vključenih 1 776 bolnikov z napredovalim solidnim tumorjem na različnih delih telesa ali oseb z diseminiranim plazmacitomom (rakom kostnega mozga).
English: The active substance in Xgeva, denosumab, is a monoclonal antibody which has been designed to recognise and attach to a protein called RANKL.
Slovenian: Učinkovina v zdravilu Xgeva, denosumab, je monoklonsko protitelo, ki je bila zasnovana tako, da prepozna beljakovino, imenovano RANKL, in se veže nanjo.
English: The most common side effects with Xgeva (seen in more than 1 patient in 10) are hypocalcaemia (low levels of calcium in the blood), pain in the muscles and bones, dyspnoea (difficulty breathing) and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Xgeva (ki so se pojavili pri več kot 1 bolniku od 10) so hipokalciemija (nizka raven kalcija v krvi), bolečine v mišicah in kosteh, dispneja (težave z dihanjem) in driska.
English: The cells in giant cell tumour of bone are also activated via RANKL, and treatment with denosumab prevents them from growing and breaking down bone, allowing normal bone to replace the tumour.
Slovenian: Beljakovina RANKL aktivira tudi celice gigantocelularnega kostnega tumorja, zdravljenje z denosumabom pa preprečuje njihovo rast in razgradnjo kosti, s čimer normalnim kostnim celicam omogoča, da nadomestijo tumorske.
English: The European Medicines Agency decided that Xgeva's benefits are greater than its risks for patients with cancers that has spread to the bone, and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Xgeva večje od z njim povezanih tveganj za bolnike z rakom, ki se je razširil na kosti, in da se lahko odobri za uporabo v EU.
English: To prevent bone complications in cancer that has spread to the bone, 120 mg is given once every 4 weeks as a single injection under the skin in the thigh, abdomen (belly) or upper arm.
Slovenian: Za preprečevanje z okostjem povezanih zapletov pri raku, ki se je razširil na kosti, se odmerek 120 mg daje enkrat na štiri tedne z eno injekcijo v podkožje, in sicer v stegno, trebuh ali nadlaket.
English: Xgeva is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone.
Slovenian: Xgeva je zdravilo, ki se uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih z napredovalim rakom, ki se je razširil na kosti.
English: The Agency considered that the benefits of Xgeva in giant cell tumour of bone were greater than the risks, and recommended that it be authorised for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Xgeva pri gigantocelularnem kostnem tumorju večje od z njim povezanih tveganj, in priporočila, da se lahko odobri za uporabo v EU.
English: Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Slovenian: Zdravilo Xgeva se uporablja tudi za zdravljenje vrste kostnega raka, ki se imenuje gigantocelularni kostni tumor, pri odraslih in mladostnikih s popolnoma razvitim okostjem.
English: In another study involving 1,718 patients with newly diagnosed multiple myeloma, Xgeva was as effective as zoledronic acid in delaying the patients' first skeletal-related event.
Slovenian: V naslednji študiji, v katero je bilo vključenih 1 718 bolnikov z novoodkritim diseminiranim plazmacitomom, je bilo zdravilo Xgeva pri odložitvi prvega z okostjem povezanega dogodka enako učinkovito kot zoledronska kislina.
English: The Agency considered that Xgeva was effective in preventing bone-related events and was less toxic to the kidneys and easier to use than existing treatments.
Slovenian: Zato je menila, da se je zdravilo Xgeva izkazalo za učinkovito pri preprečevanju z okostjem povezanih dogodkov in da je bilo v primerjavi z obstoječimi oblikami zdravljenja manj toksično za ledvice ter preprostejše za uporabo.
English: Xgeva contains the active substance denosumab.
Slovenian: Zdravilo Xgeva vsebuje učinkovino denosumab.
English: For the full list of side effects and restrictions with Xgeva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Xgeva glejte navodilo za uporabo.
English: By attaching to RANKL and blocking it, denosumab reduces the formation and activity of the osteoclasts.
Slovenian: Denosumab z vezavo na beljakovino RANKL in njenim zaviranjem zmanjšuje nastajanje in delovanje osteoklastov.
English: How is Xgeva used?
Slovenian: Kako se zdravilo Xgeva uporablja?
English: Xgeva can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Xgeva je le na recept.
English: In these studies, Xgeva reduced the risk of developing a first skeletal-related event by 18% compared with zoledronic acid.
Slovenian: V teh študijah je zdravilo Xgeva v primerjavi z zoledronsko kislino zmanjšalo tveganje za pojav prvega z okostjem povezanega dogodka za 18 %.
English: In this study, Xgeva reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid.
Slovenian: V tej študiji je zdravilo Xgeva v primerjavi z zoledronsko kislino zmanjšalo tveganje za pojav prvega z okostjem povezanega dogodka za 16 %.
English: For more information about using Xgeva, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Med zdravljenjem z zdravilom Xgeva morajo bolniki jemati dodatke kalcija in vitamina D. Za več informacij glede uporabe zdravila Xgeva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Other common side effects (seen in up to 1 patient in 10) are development of another form of cancer in patients with advanced cancer, hypophosphataemia (low levels of phosphate in the blood), excessive sweating, tooth loss and osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth).
Slovenian: prekomerno potenje, izguba zob in osteonekroza čeljustnice (odmiranje kostnega tkiva čeljustnice, kar lahko povzroči bolečine, oteklost v ustih ali majanje zob).
English: The company presented results of one main study involving 463 patients undergoing different types of
Slovenian: Družba je predstavila rezultate ene glavne študije, ki je vključevala 463 bolnikov, pri katerih so bili opravljeni različni operativni posegi.
English: The Committee also noted that because the sponge and spray worked differently and should have been studied separately, there was not enough to determine the effects of the spray.
Slovenian: Odbor je tudi ugotovil, da zaradi različnega delovanja gobice in pršila in ker bi ju bilo treba proučevati ločeno, ni bilo dovolj dokazov za opredelitev učinkov pršila.
English: According to EU requirements, Recothrom should have been compared with a standard treatment that did not contain thrombin.
Slovenian: V skladu z zahtevami EU bi zdravilo Recothrom morali primerjati s standardnim zdravilom, ki ne vsebuje trombina.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na vprašanja, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Slovenian: Dopis, s katerim družba odbor CHMP obvešča o umiku vloge, je na voljo tukaj.
English: The effects of Recothrom were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Recothrom so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: It contains the active substance thrombin alfa.
Slovenian: Vsebuje zdravilno učinkovino trombin alfa.
English: Thrombin converts another protein called fibrinogen into smaller units called fibrin.
Slovenian: Trombin pretvarja drugo beljakovino, imenovano fibrinogen, v manjše enote, imenovane fibrin.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Recothrom?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Recothrom?
English: The CHMP was concerned that the company provided evidence from specialised surgeries, whereas Recothrom was intended for more general use.
Slovenian: CHMP je izrazil zaskrbljenost, da je družba predložila dokaze iz specializiranih operativnih posegov, medtem ko je zdravilo Recothrom namenjeno za splošnejšo uporabo.
English: The fibrin particles then stick together, forming clots which help to stop the bleeding.
Slovenian: Delci fibrina se nato zlepijo in tvorijo strdke, ki pomagajo zaustaviti krvavitev.
English: The active substance in Recothrom, thrombin alfa, is a copy of thrombin, a protein that is found naturally in the blood.
Slovenian: Zdravilna učinkovina zdravila Recothrom, trombin alfa, je kopija beljakovine trombin, ki je naravno prisotna v krvi.
English: The company informed the CHMP that at this time there are no ongoing clinical trials or compassionate use programmes with Recothrom in Europe.
Slovenian: Družba je obvestila CHMP, da trenutno ni nobenih kliničnih preskušanj ali programov sočutne uporabe zdravila Recothrom v Evropi.
English: In addition, not enough evidence was presented to show that Recothrom used with a gelatin sponge was more effective than a sponge alone.
Slovenian: Poleg tega ni bilo predstavljenih dovolj dokazov, ki bi pokazali, da je zdravilo Recothrom skupaj z želatinasto gobico učinkovitejše od samostojne uporabe gobice.
English: On 11 December 2009, Bayer Schering Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Recothrom, for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Slovenian: Družba Bayer Schering Pharma AG je dne 11. decembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Recothrom, namenjenim zaustavitvi krvavitve med operativnim posegom, kjer standardne operativne tehnike ne zadoščajo.
English: The study compared Recothrom with another medicine containing thrombin and the main measure of effectiveness was the number of patients whose bleeding stopped within 10 minutes.
Slovenian: ki vsebuje trombin, glavno merilo učinkovitosti pa je bilo število bolnikov, pri katerih se je krvavitev zaustavila v 10 minutah.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Recothrom could not have been approved for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Recothrom ni mogoče odobriti za uporabo pri zaustavitvi krvavitve med operativnim posegom, kjer standardne operativne tehnike ne zadoščajo.
English: Thrombin also helps to make specialised cells in the blood called platelets to stick together, forming clots which also reduce the bleeding.
Slovenian: Trombin pomaga tudi pri zlepljanju specializiranih celic v krvi, imenovanih trombociti, ki tvorijo strdke, ki prav tako zmanjšajo krvavitev.
English: Recothrom was expected to be used to stop bleeding during an operation when standard surgical techniques are insufficient.
Slovenian: Zdravilo Recothrom naj bi se uporabljalo za zaustavitev krvavitve med operativnim posegom, kadar standardne operativne tehnike ne zadoščajo.
English: Finally, there were concerns about the medicine that Recothrom was compared with (the comparator) in the main study.
Slovenian: Nenazadnje pa so obstajali tudi zadržki glede zdravila (primerjalnega zdravila), s katerim so primerjali zdravilo Recothrom v glavni študiji.
English: What is Recothrom?
Slovenian: Kaj je zdravilo Recothrom?
English: What was Recothrom expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Recothrom uporabljalo?
English: Recothrom was expected to be applied to the surgical wounds either using a gelatin sponge soaked with the solution, or by spraying the solution directly into the surgical wound.
Slovenian: Zdravilo Recothrom naj bi se apliciralo na operativne rane z želatinasto gobico, prepojeno z raztopino, ali s pršenjem raztopine neposredno na operativno rano.
English: How was Recothrom expected to work?
Slovenian: Kako naj bi zdravilo Recothrom delovalo?
English: Recothrom is a powder and solvent for solution to be applied to a surgical wound.
Slovenian: Zdravilo Recothrom sestavljata prašek in topilo, iz katerih pripravimo raztopino za apliciranje na operativni rani.
English: After reconstitution: 4 weeks.
Slovenian: Po pripravi: 4 tedne.
English: Cut at line -------------------------------------------------------------------------------------------------------
Slovenian: Prerežite po črti -----------------------------------------------------------------------------------------------
English: frequency can not be estimated from the available data
Slovenian: pogostnosti se iz razpoložljivih podatkov ne da oceniti
English: Stabilisation of the cardiovascular system should be given priority.
Slovenian: Prednost je treba dati stabilizaciji kardiovaskularnega sistema.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov} <{tel}> <{fax}> <{e-naslov}>
English: The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State for evaluation:
Slovenian: Predlagatelj se zavezuje, da bo pristojnemu nacionalnemu organu referenčne države članice v ocenitev predložil naslednje informacije:
English: See 4.2 for information on paediatric use.
Slovenian: Glejte 4.2 za informacije glede pediatrične uporabe.
English: This medicinal product is authorized in the Member States of the EEA under the following names:
Slovenian: To zdravilo je v državah članicah EGP odobreno pod naslednjimi imeni:
English: • The follow-up measures as set out in the CHMP Assessment Report
Slovenian: • nadaljnje ukrepe, kot so določeni v poročilu CHMP o oceni zdravila.
English: Therefore, the use of losartan is not recommended.
Slovenian: Zato uporabe losartana ne priporočamo.
English: Sector 1, Bucureşti, România
Slovenian: Sector 1, Bukarešta, Romunija
English: • PSUR should be submitted every 6 months for a year.
Slovenian: • redno letno poročilo o varnosti zdravila (PSUR) je treba predložiti vsakih šest mesecev za posamezno leto.
English: Losartan has been evaluated in clinical studies as follows:
Slovenian: Losartan so ocenjevali v naslednjih kliničnih študijah:
English: The mean length of follow-up was 4.8 years.
Slovenian: Spremljanje je povprečno trajalo 4,8 let.
English: After that year the safety data will be evaluated and it will be decided whether a longer PSUR period is permitted.
Slovenian: Po tem letu bodo podatki o varnosti ocenjeni, sprejeta pa bo odločitev, ali bo dovoljeno daljše obdobje za predložitev letnega poročila o varnosti zdravila.
English: Exposure in infants/ toddlers was comparatively high.
Slovenian: Izpostavljenost pri dojenčkih/malčkih je bila sorazmerno visoka.
English: Shake the suspension prior to each use and return promptly to the refrigerator.
Slovenian: Pred vsako uporabo suspenzijo pretresite in jo potem takoj vrnite v hladilnik.
English: This also applies to children 6 to 16 years of age.
Slovenian: To velja tudi za otroke, stare 6 do 16 let.
English: 11415 Tallinn, Estonia
Slovenian: 11415 Talin, Estonija
English: 28027 MADRID, Spain
Slovenian: 28027 MADRID, Španija
English: The doctor may increase the dose if blood pressure is not controlled.
Slovenian: Zdravnik lahko odmerek poveča, če tlak ni pod nadzorom.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Slovenian: Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
English: HOW TO MEASURE AND GIVE A DOSE OF ORAL SUSPENSION
Slovenian: KAKO ODMERITI IN DATI ODMEREK PERORALNE SUSPENZIJE
English: Losartan is not recommended:- for use in children below 6 years old due to insufficient data on safety and/or efficacy in these patient groups.
Slovenian: Uporabe losartana ne priporočamo: - pri otrocih, mlajših od 6 let, zaradi pomanjkljivih podatkov glede varnosti in/ali učinkovitosti za to starostno skupino.
English: • if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
Slovenian: • če ste alergični (preobčutljivi) na losartan ali katerokoli sestavino zdravila,