FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common serious side effects with Iclusig (which may affect more than 2 in 100 people) are pneumonia (infection of the lungs), pancreatitis (inflammation of the pancreas), pyrexia (fever), abdominal pain (stomach ache), myocardial infarction (heart attack), atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), peripheral arterial occlusive disease (problem with blood flow in the arteries), anaemia (low red blood cell counts), angina pectoris (pains to the chest, jaw and back due to problems with blood flow to the heart), decreased blood levels of platelets (components that help the blood to clot), febrile neutropenia (low white blood cell counts with fever), hypertension (high blood pressure), coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), cardiac failure (when the heart does not work as well as it should), cerebrovascular accident (stroke), sepsis (blood poisoning), cellulitis (inflammation of the deep skin tissue), acute kidney injury (kidney damage), urinary tract infection (infection of the structures that carry urine) and increased levels of lipase (an enzyme).
Slovenian: Najpogostejši resni neželeni učinki zdravila Iclusig (ki se lahko pojavijo pri več kot 2 od 100 bolnikov) so pljučnica (vnetje pljuč), pankreatitis (vnetje trebušne slinavke), zvišana telesna temperatura, bolečine v trebuhu, miokardni infarkt (srčni napad), atrijska fibrilacija (nepravilno in hitro krčenje preddvorov srca), periferna arterijska okluzivna bolezen (težave s pretokom krvi po arterijah), anemija (nizko število rdečih krvnih celic), angina pektoris (bolečine v prsih, čeljusti in hrbtu zaradi težav s pretokom krvi do srca), zmanjšano število trombocitov (sestavine krvi, ki je pomembna za strjevanje krvi), febrilna nevtropenija (nizko število belih krvnih celic z zvišano telesno temperaturo), hipertenzija (visok krvni tlak), bolezen koronarnih arterij (srčna bolezen, ki jo povzroči zapora krvnih žil, ki oskrbujejo srčno mišico), srčno popuščanje (stanje, pri katerem srce ne deluje tako dobro, kot bi moralo), cerebrovaskularni dogodek (možganska kap), sepsa (zastrupitev krvi), celulitis (vnetje globokega podkožnega tkiva), akutna poškodba ledvic (okvara ledvic), okužba sečil (okužba struktur, po katerih se prenaša urin) in zvišane ravni lipaze (encima).
English: Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome that leads to the development of leukaemia.
Slovenian: Ph+ pomeni, da so se nekateri bolnikovi geni prerazporedili tako, da tvorijo poseben kromosom, imenovan kromosom Philadelphia, ki povzroča razvoj levkemije.
English: This enzyme is found on the surface of leukaemia cells where it is involved in stimulating the cells to divide uncontrollably.
Slovenian: Ta encim na površini levkemičnih celic sodeluje pri spodbujanju celic k nenadzorovani delitvi.
English: What are the risks associated with Iclusig?
Slovenian: Kakšna tveganja so povezana z zdravilom Iclusig?
English: Also, the company will conduct a study in order to determine the best starting dose of Iclusig and to assess the safety and effectiveness of Iclusig following dose reduction in patients with chronic phase CML who achieve major cytogenetic response.
Slovenian: Podjetje bo tudi izvedlo študijo za določitev najustreznejšega začetnega odmerka zdravila Iclusig in ocenitev varnosti in učinkovitosti tega zdravila po zmanjšanju odmerka pri bolnikih s KML v kronični fazi, pri katerih je bil dosežen bistven citogenetski odziv.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Iclusig 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 Iclusig upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Slovenian: Zdravilo Iclusig z zaviranjem Bcr-Abl pomaga nadzorovati rast in širjenje levkemičnih celic.
English: The response to treatment was assessed by measuring the proportion of patients who had a ‘major haematological response' (when the number of white blood cells returns to normal or there is no evidence of leukaemia) or a ‘major cytogenetic response' (when the proportion of white blood cells containing the Philadelphia chromosome falls to below 35%).
Slovenian: Odziv na zdravljenje so ocenili z merjenjem deleža bolnikov, ki so dosegli bistven hematološki odziv (število belih krvnih celic se je povrnilo na normalno raven ali ni bilo več sledi levkemije) ali bistven citogenetski odziv (delež belih krvnih celic s kromosomom Philadelphia je padel pod 35 %).
English: If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Slovenian: Če se pri bolniku pojavijo določeni resni neželeni učinki, se lahko zdravnik odloči za zmanjšanje nadaljnjih odmerkov ali za odložitev ali ukinitev zdravljenja.
English: Side effects reported with Iclusig are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Iclusig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The company that markets Iclusig will provide educational material for all doctors who are expected to prescribe this medicine highlighting important risks for which monitoring and dose adjustments are recommended.
Slovenian: Podjetje, ki trži zdravilo Iclusig, bo pripravilo izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali zdravilo, in v njem poudarilo pomembna tveganja, v zvezi s katerimi se priporoča spremljanje bolnikov in prilagoditev odmerkov.
English: What benefits of Iclusig have been shown in studies?
Slovenian: Kakšne koristi zdravila Iclusig so se pokazale v študijah?
English: • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
Slovenian: • akutno limfoblastno levkemijo (ALL) pri bolnikih s prisotnim kromosomom Philadelphia (Ph+).
English: For more information about using Iclusig, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Iclusig glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Slovenian: Kromosom Philadelphia je prisoten pri nekaterih bolnikih z ALL in pri večini bolnikov s KML.
English: Regarding its safety, the side effects with Iclusig were largely similar to those of other tyrosine kinase inhibitors and mostly manageable with dose reduction or dose delay.
Slovenian: Kar zadeva varnost zdravila, so neželeni učinki zdravila Iclusig v veliki meri podobni kot pri drugih zaviralcih tirozin-kinaze in jih je večinoma mogoče obvladati z zmanjšanjem ali odložitvijo odmerka.
English: It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Slovenian: Uporablja se tudi pri bolnikih z gensko mutacijo, znano kot „mutacija T315I‟, zaradi katere so bolniki odporni proti zdravljenju z imatinibom, dasatinibom ali nilotinibom.
English: Venous thromboembolic reactions (problems due to blood clots in the veins) occurred in 6% of patients.
Slovenian: Venske trombembolične reakcije (težave zaradi krvnih strdkov v venah) so se pojavile pri 6 % bolnikov.
English: The recommended starting dose is 45 mg once per day.
Slovenian: Priporočeni začetni odmerek je 45 mg enkrat na dan. Zdravljenje se nadaljuje, dokler je za bolnika koristno.
English: The risk of problems (including heart attacks and strokes) resulting from blood clots or blockages in arteries or veins could be reduced by checking for and treating contributory conditions such as high blood pressure and raised cholesterol both before and during treatment.
Slovenian: Tveganje za težave (tudi za srčne napade in možganske kapi), ki so posledica nastajanja krvnih strdkov ali zapor v arterijah in venah, se lahko zmanjša s pregledi za odkrivanje stanj, ki prispevajo k njihovemu nastanku, kot sta visok krvni tlak in zvišana raven holesterola, tako pred zdravljenjem kot med njim, in zdravljenjem teh stanj.
English: Arterial occlusive adverse events (clots or blockages in the arteries) occurred in 25% of patients, with serious adverse events occurring in 20% of patients.
Slovenian: Arterijski okluzivni neželeni dogodki (strdki ali zapore v arterijah) so se pojavili pri 25 % bolnikov, od tega so se resni neželeni dogodki pojavili pri 20 % bolnikov.
English: Iclusig is a cancer medicine that contains the active substance ponatinib.
Slovenian: Iclusig je zdravilo proti raku, ki vsebuje učinkovino ponatinib.
English: Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate.
Slovenian: Zdravilo Iclusig se uporablja pri bolnikih, ki ne prenašajo oziroma se ne odzivajo na dasatinib (za bolnike s KML ali ALL) ali nilotinib (za bolnike s KML), tj. drugi zdravili proti raku istega razreda, ter pri bolnikih, pri katerih nadaljnje zdravljenje z imatinibom (še enim takim zdravilom) ni primerno.
English: Iclusig can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of leukaemia.
Slovenian: Predpisovanje in izdaja zdravila Iclusig je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem levkemije.
English: Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Slovenian: Zdravilo Iclusig se je izkazalo kot učinkovito za bolnike s KML ali Ph+ ALL z omejenimi možnostmi zdravljenja.
English: Why is Iclusig authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Iclusig odobreno v EU?
English: Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation.
Slovenian: Zdravilo Iclusig so proučevali v eni glavni študiji s 449 bolniki s KML ali Ph+ ALL, ki niso prenašali zdravljenja z dasatinibom ali nilotinibom oziroma so bili proti njima odporni ali pa so imeli mutacijo T315I.
English: These compounds act by blocking enzymes known as tyrosine kinases.
Slovenian: Te spojine delujejo tako, da zavirajo encime, znane pod imenom tirozin-kinaze.
English: Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl.
Slovenian: Ponatinib deluje tako, da zavira tirozin-kinazo, imenovano Bcr-Abl.
English: Serious venous occlusive adverse events (clots or blockages in the veins) occurred in 5% of patients.
Slovenian: Resni venski okluzivni neželeni dogodki (strdki ali zapore v venah) so se pojavili pri 5 % bolnikov.
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors'.
Slovenian: Učinkovina zdravila Iclusig, ponatinib, spada v skupino zdravil, imenovanih zaviralci tirozin-kinaze.
English: For the full list of side effects and restrictions with Iclusig, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Iclusig glejte navodilo za uporabo.
English: Iclusig can lead to clots or blockages in arteries and veins and patients should have the condition of their heart and circulation considered before starting and during treatment, and be treated appropriately for any problems.
Slovenian: Zdravilo Iclusig lahko povzroči nastanek strdkov ali zapor v arterijah in venah, zato je treba pred zdravljenjem in med njim oceniti stanje bolnikovega srca in ožilja ter morebitne težave ustrezno rešiti.
English: • among the patients with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
Slovenian: • med bolniki s Ph+ ALL je bistven hematološki odziv doseglo približno 41 % (13 od 32) bolnikov.
English: • among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
Slovenian: • med bolniki s KML v kronični fazi je bistven citogenetski odziv doseglo približno 54 % (144 od 267)
English: • among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
Slovenian: • med bolniki s KML v pospešeni fazi je bistven hematološki odziv doseglo približno 58 % (48 od 83)
English: • among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
Slovenian: • med bolniki s KML v blastni fazi je bistven hematološki odziv doseglo približno 31 % (19 od 62)
English: How is Iclusig used?
Slovenian: Kako se zdravilo Iclusig uporablja?
English: How does Iclusig work?
Slovenian: Kako zdravilo Iclusig deluje?
English: The dose may need to be reduced or interrupted if the patient experiences certain side effects; it should be interrupted immediately if a blockage develops in an artery or vein.
Slovenian: Če se pri bolniku pojavijo določeni neželeni učinki, bo morda treba zmanjšati odmerek ali prekiniti zdravljenje.
English: The CVMP, therefore, recommended a variation of the Marketing Authorisation.
Slovenian: CVMP zato priporoča spremembo dovoljenja za promet z zdravilom.
English: In addition, a more robust test for potency should be applied to the product in the future.
Slovenian: Poleg tega bi bilo treba v prihodnje za izdelek uporabljati odpornejšo obliko testa učinkovitosti.
English: However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Slovenian: Kljub temu je pomembno zagotoviti, da se meje sprejemljivosti pri testu učinkovitosti ne oddaljijo od prvotnih meja.
English: The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) meni, da na osnovi razpoložljivih podatkov ni zadržkov glede varnosti ali učinkovitosti izdelka.
English: The Marketing Authorisation(s) should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Slovenian: Dovoljenje(a) za promet bi morali spremeniti, tako da bi se odstopanja pri testu serološke učinkovitosti pri miših zmanjšala z ustreznimi ukrepi, kakršen je zamenjava uporabe referenčnega cepiva v testih serološke učinkovitosti pri miših z uporabo referenčnega seruma.
English: The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Slovenian: Med ocenjevanjem variacije tipa II za spremembo testa farmakološke učinkovitosti pri miših, da bi ta ustrezal popravljeni monografiji Evropske farmakopeje (Ph.Eur) za cepiva proti erizipelu, je bila kot referenčno cepivo sprejeta serija cepiva 8500, zaradi česar je treba to serijo in tiste pred njo sprejeti kot skladne s pogoji dovoljenja za promet z zdravilom za oba izdelka.
English: London, June 2008 EMEA/532233/2007- Rev.1
Slovenian: Tel: +34 91 5981343 Fax: +34 91 5972434 Email: rodrigv2@fdah.com
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Slovenian: Fort Dodge Animal Health SpA
English: OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN ERY
Slovenian: Email: lastrag@fdah.com
English: European Medicines Agency Veterinary Medicines and Inspections
Slovenian: Farmacevtska oblika
English: Suvaxyn Ery is indicated for the active immunisation of pigs (gilts and sows) to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Slovenian: Rua Dr. António Loureiro Borges, nº2, ArquiparqueMiraflores, 1495-131 Algés
English: France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Ery.
Slovenian: Spremembe referenčnega cepiva v tem zaključku se nanašajo na zamenjavo serije cepiva 8500 s serijo 9097 in naknadno zamenjavo serije 9097 s serijo 9861.
English: The usual dose is one infusion of 4 mg over at least 15 minutes.
Slovenian: Običajni odmerek je ena 4-miligramska infuzija v trajanju najmanj 15 minut.
English: Further information on Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Slovenian: Nadaljnje informacije o zdravilu Zoledronska kislina Accord so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
English: This reduces bone loss.
Slovenian: S tem se zmanjša izguba kostne mase.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Zometa, zato jih ni treba ponoviti za zdravilo Zoledronska kislina Accord.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Zoledronska kislina Accord primerljivo raven kakovosti kot zdravilo Zometa in mu je tudi drugače primerljivo.
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderately reduced kidney function.
Slovenian: Pri uporabi za preprečevanje z okostjem povezanih zapletov se infundiranje lahko ponovi vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D. Nižji odmerek zdravila je priporočljiv pri bolnikih s kostnimi metastazami (rakom, ki se je razširil na kosti), če imajo blago do zmerno okvarjeno delovanje ledvic.
English: As for every medicine, the company provided studies on the quality of Zoledronic Acid Accord.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Zoledronska kislina Accord.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Slovenian: Ti zapleti so zlomi kosti, spinalna kompresija (ko hrbtenjačo stisne kost), kostna obolenja, ki zahtevajo radioterapijo (zdravljenje z obsevanjem) ali kirurški poseg, ter hiperkalciemija (visoke ravni kalcija v krvi).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zoledronic Acid Accord 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 Zoledronska kislina Accord upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Slovenian: Osteonekroza čeljusti je bolezen, ki poškoduje čeljustnico, kar lahko povzroči bolečine, oteklost v ustih ali majanje zob.
English: Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Slovenian: Ker je zdravilo Zoledronska kislina Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: For more information about using Zoledronic Acid Accord, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Zoledronska kislina Accord glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoledronska kislina Accord?
English: This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Slovenian: To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Zometa.
English: Side effects reported with Zoledronic Acid Accord are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Zoledronska kislina Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Zoledronic Acid Accord received a marketing authorisation valid throughout the EU on 16 January
Slovenian: Za zdravilo Zoledronska kislina Accord je bilo 16. januarja 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: An overview of Zoledronic Acid Accord and why it is authorised in the EU
Slovenian: Pregled zdravila Zoledronska kislina Accord in zakaj je odobreno v EU
English: As for all medicines, data on the use of Zoledronic Acid Accord are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zoledronska kislina Accord stalno spremljajo.
English: Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein.
Slovenian: Predpisovanje in izdaja zdravila Zoledronska kislina Accord je le na recept, predpiše in daje pa ga lahko le zdravstveni delavec, ki ima izkušnje z uporabo tovrstnih zdravil, ki se dajejo v veno.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Slovenian: Zmanjšanje izgubljanja kostne mase vpliva na manjšo lomljivost kosti, kar je koristno pri preprečevanju zlomov pri bolnikih z rakom, ki imajo metastaze v kosteh.
English: Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Slovenian: Zoledronska kislina Accord je zdravilo, ki se uporablja za preprečevanje zapletov, povezanih z okostjem, pri odraslih z napredovalim rakom, ki vpliva na kosti.
English: What are the benefits and risks of Zoledronic Acid Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina Accord?
English: Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.
Slovenian: Zdravilo Zoledronska kislina Accord se lahko uporablja tudi za zdravljenje hiperkalcemije, ki jo povzročajo tumorji.