FrancophonIA/ELRC3.0 huggingface dataset:
English: The study involved 300 patients and lasted six weeks.
Slovenian: Študija je trajala šest tednov in vključevala 300 bolnikov.
English: Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Invega
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za spremembo dovoljenja za promet z zdravilom Invega
English: There are no consequences on the use of Invega in its authorised indication, for which the balance of benefits and risks remains unchanged.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Invega za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
English: The application was at day 85 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 85. dan postopka.
English: It is available as prolonged-release tablets (tablets that release paliperidone slowly from the tablet over a few hours).
Slovenian: Na voljo je v obliki tablet s podaljšanim sproščanjem (tablet, pri katerih se paliperidon več ur počasi sprošča iz tablete).
English: In all three studies, the main measure of effectiveness was the change in the severity of acute manic episodes, as measured using a standard symptom scale.
Slovenian: V vseh treh študijah je bilo glavno merilo učinkovitosti sprememba stopnje resnosti akutnih maničnih epizod, kar so merili na podlagi standardne lestvice simptomov.
English: The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.
Slovenian: CHMP je bil v postopku ocenjevanja začetne dokumentacije, ki jo je posredovala družba, in še ni podal nikakršnih priporočil.
English: In the brain, paliperidone attaches to several different receptors on the surface of nerve cells.
Slovenian: Paliperidon se v možganih veže na različne receptorje na površini živčnih celic.
English: The company presented the results of three main studies involving a total of 1,262 adults with bipolar I disorder who were having an acute manic episode.
Slovenian: Družba je predstavila rezultate treh glavnih študij, ki so vključevale skupno 1 262 odraslih z bipolarno motnjo I, pri katerih so se pojavljale akutne manične epizode.
English: On 15 December 2008, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Invega, to add the treatment of acute manic episodes associated with bipolar I disorder.
Slovenian: Dne 15. decembra 2008 je družba Janssen-Cilag International NV uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za spremembo dovoljenja za promet z zdravilom Invega, v kateri je zaprosila, da se doda zdravljenje akutnih maničnih epizod, povezanih z bipolarno motnjo I.
English: Invega was expected to be used to treat acute (sudden) manic episodes.
Slovenian: Zdravilo Invega bi se naj uporabljalo za zdravljenje akutnih (nenadnih) maničnih epizod.
English: The CHMP was evaluating the initial documentation provided by the company.
Slovenian: CHMP je takrat ocenjeval začetno dokumentacijo, ki jo je predložila družba.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: S tem se prekine prenos signalov med možganskimi celicami preko živčnih prenašalcev - kemičnih snovi, ki omogočajo komunikacijo med celicami.
English: What is Invega?
Slovenian: Kaj je zdravilo Invega?
English: The 12-week study also included a group of patients treated with quetiapine taken alone (another treatment for bipolar I disorder).
Slovenian: Dvanajsttedenska študija je vključevala tudi skupino bolnikov, ki so bili zdravljeni samo s kvetiapinom (drugim zdravilom za bipolarno motnjo I).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Invega for bipolar I disorder or any other disease.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Invega pri zdravljenju bipolarne motnje I ali katere koli druge bolezni.
English: Invega is already used to treat schizophrenia, a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Slovenian: Zdravilo Invega se že uporablja za zdravljenje shizofrenije, ki je duševna bolezen s številnimi simptomi, kot so nepovezano razmišljanje in govor, halucinacije (prisluhi ali prividi), sumničavost in zmotna prepričanja.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Invega?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Invega?
English: What is happening with Invega used for the treatment of schizophrenia?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravila Invega, ki se uporablja za zdravljenje shizofrenije?
English: Invega was also expected to be used in adults with bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal or depressed mood.
Slovenian: Zdravilo Invega bi se naj uporabljalo pri odraslih z bipolarno motnjo I, duševno boleznijo, pri kateri bolniki doživljajo manične epizode (obdobja nenormalno privzdignjenega razpoloženja), ki se izmenjujejo z obdobji normalnega ali depresivnega razpoloženja.
English: Ref. EMEA/2672/2009
Slovenian: EMEA/92138/2009 Error!
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s and in the treatment of bipolar I disorder since the early 2000s.
Slovenian: Paliperidon je aktivni presnovek risperidona, drugega antipsihotika, ki se od devetdesetih let dvajsetega stoletja uporablja za zdravljenje shizofrenije in od začetka enaindvajsetega stoletja za zdravljenje bipolarne motnje I.
English: Two of the studies compared Invega taken alone with placebo (a dummy treatment), one in 469 patients over three weeks and another in 493 patients over 12 weeks.
Slovenian: V dveh teh študijah so zdravilo Invega, uporabljeno kot samostojno zdravilo, primerjali s placebom (zdravilom brez zdravilne učinkovine), pri čemer je prva študija trajala tri tedne in vključevala 469 bolnikov, druga študija pa je trajala 12 tednov in vključevala 493 bolnikov.
English: What was Invega expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Invega uporabljalo?
English: The third study compared the effects of Invega and placebo when they were taken together with either lithium or sodium valproate (other treatments for bipolar I disorder).
Slovenian: V tretji študiji so učinke zdravila Invega primerjali z učinki placeba, ki so ju bolniki jemali sočasno bodisi z litijem ali z natrijevim valproatom (drugima zdraviloma za zdravljenje bipolarne motnje I).
English: Invega is a medicine containing the active substance paliperidone.
Slovenian: Invega je zdravilo, ki vsebuje zdravilno učinkovino paliperidon.
English: How is Invega expected to work?
Slovenian: Kako naj bi zdravilo Invega delovalo?
English: The active substance in Invega, paliperidone, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Invega je paliperidon, ki je antipsihotično zdravilo.
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in bipolar I disorder.
Slovenian: Paliperidon deluje v glavnem tako, da blokira receptorje za nevrotransmitorja dopamin in 5-hidroksitriptamin (imenovan tudi serotonin), ki sta udeležena pri razvoju bipolarne motnje I. Z blokiranjem teh receptorjev naj bi paliperidon pomagal normalizirati dejavnost možganov in zmanjšal simptome akutnih maničnih epizod.
English: Your doctor will advise you what to do.
Slovenian: Zdravnik vam bo svetoval, kaj storiti.
English: • your kidneys do not work properly
Slovenian: • vaše ledvice ne delujejo ustrezno,
English: frequency cannot be estimated from the available data.
Slovenian: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
English: Your doctor will be mindful of other signs as well.
Slovenian: Zdravnik bo pozoren tudi na druge znake.
English: In addition, an updated RMP should be submitted:
Slovenian: Dodatno je treba predložiti posodobljen RMP:
English: Caution should also be exercised in the following cases:
Slovenian: Previdni morate biti tudi v naslednjih primerih:
English: Tell your doctor if:
Slovenian: Obvestite zdravnika, če:
English: The following information is intended for medical or healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravnikom ali zdravstvenemu osebju:
English: It is for use in adults only.
Slovenian: Namenjeno je samo za odrasle.
English: The expiry date refers to the last day of the month.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Use is not recommended in neonates, infants, children and adolescents.
Slovenian: Uporaba ni priporočena pri novorojenčkih, dojenčkih, otrocih in mladostnikih.
English: No carcinogenicity studies were performed.
Slovenian: Študij kancerogenosti niso opravili.
English: Driving and using machines
Slovenian: Vožnja in uporaba strojev
English: Based on clinical trial experience in more than 1,800 patients, the following adverse reactions have been observed.
Slovenian: Glede na izkušnje v kliničnih preskušanjih pri več kot 1.800 bolnikih, so poročali o naslednjih neželenih učinkih.
English: • you had any reactions to previous injections of contrast media
Slovenian: • ste v preteklosti imeli kakršnekoli reakcije pri injiciranju kontrastnih sredstev,
English: Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use this medicine, especially if you are 65 years of age or older.
Slovenian: Morda se bo zdravnik odločil za krvne preiskave, s katerimi bo ugotovil, ali ledvice dobro delujejo, preden se odloči za uporabo tega zdravila, zlasti če ste stari 65 let ali več.
English: It is used to help detect changes in the blood vessels which are known or suspected to be abnormal.
Slovenian: Uporablja se za odkrivanje sprememb v krvnih žilah, za katere vemo ali sumimo, da so nenormalne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 October 2005
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 03.10.2005
English: If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Slovenian: Če karkoli od naštetega velja za vas, se bo zdravnik odločil, ali bo nameravano preiskavo opravil.
English: Do not use Ablavar
Slovenian: Ne uporabljajte Ablavar
English: Ninety-four percent (94%) of the urinary excretion occurred in the first 72 hours.
Slovenian: Štiriindevetdeset odstotkov (94 %) izločanja v urinu se pojavi v prvih 72 urah.
English: In clinical trials, imaging was completed up to approximately one hour following injection.
Slovenian: V kliničnih preskušanjih je bilo slikanje končano v približno eni uri po injiciranju.
English: Gadofosveset binds reversibly to human serum albumin.
Slovenian: Gadofosveset se reverzibilno veže na človeški serumski albumin.
English: Bayer Schering Pharma AG D - 13342 Berlin Germany
Slovenian: Bayer Schering Pharma AG D - 13342 Berlin Nemčija
English: You must tell your doctor if you think you are or might become pregnant.
Slovenian: Svojemu zdravniku povejte, če mislite, da ste noseči ali boste morda zanosili.
English: Experience with other contrast media shows that the risk of hypersensitivity reactions is higher in those patients.
Slovenian: Izkušnje z drugimi kontrastnimi sredstvi kažejo, da je tveganje za preobčutljivostne reakcije pri teh bolnikih večje.
English: The usual injection site is the back of your hand or just in front of your elbow.
Slovenian: Običajno mesto injiciranja je zgornja stran dlani ali tik pred komolcem.
English: Tell your doctor immediately if you notice itching, a feeling of mild swelling in your throat or tongue, which might be a first sign of some allergy-like reaction.
Slovenian: Takoj obvestite zdravnika, če opazite srbenje ali občutek zatekanja v grlu ali na jeziku, ki sta lahko prva znaka alergijske reakcije.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o tem izdelku najdete na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: Below are listed the reported/experienced side effects by frequency): Very common:
Slovenian: Spodaj našteti neželeni učinki so navedeni po pogostnosti; Zelo pogosti:
English: The safety and effectiveness of Ablavar in patients under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost uporabe Ablavar pri bolnikih pod 18 let nista dokazana.
English: Laboratory test interactions
Slovenian: Interakcije pri laboratorijskih preiskavah
English: Ask your doctor for advice before taking any medicine.
Slovenian: Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
English: At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.
Slovenian: Pri kliničnih odmerkih se učinek na dojenčka ne pričakuje zaradi majhne količine, ki se izloča v mleko, in slabe absorpcije iz črevesja.
English: Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of potential severe reactions to the contrast agent itself.
Slovenian: Na razpolago mora biti ustrezna oprema za ukrepanje ob kakršnemkoli zapletu med postopkom ter za nujno zdravljenje morebitnih hudih reakcij na samo kontrastno sredstvo.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernico CHMP za sistem za obvladovanje tveganja (CHMP Guideline on Risk Management Systems) za zdravila za uporabo v humani medicini je treba predložiti posodobljen RMP istočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
English: Electrocardiographic changes
Slovenian: Spremembe elektrokardiograma
English: However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Slovenian: Vendar pa ni dokazov, da je hemodializa primerna za preprečevanje nefrogene sistemske fibroze (NSF).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij inkompatibilnosti tega zdravilo ne smete mešati z drugimi zdravili.
English: However if use is required you should only receive one dose of this medicine during a scan and you should not receive a second injection for at least 7 days.
Slovenian: Če je uporaba potrebna, morate med slikanjem prejeti le en odmerek zdravila, do druge injekcije pa mora preteči vsaj 7 dni.
English: • you have a cardiac pacemaker or any ferromagnetic implant or a metallic stent in your body
Slovenian: • imate srčni spodbujevalnik ali kakršen koli feromagnetni vsadek ali železno opornico v telesu,
English: The doctor will decide how much medicine is needed for your examination.
Slovenian: Zdravnik se bo odločil, koliko Ablavar potrebujete za pregled.
English: Effects were of higher severity in rats than in monkeys, probably because of the higher renal clearance in rats.
Slovenian: Pri podganah so bili učinki hujši kot pri opicah, verjetno zaradi večjega ledvičnega očistka pri podganah.
English: This medicine is used together with an imaging technique called magnetic resonance imaging (MRI).
Slovenian: To zdravilo se uporablja pri metodi slikanja, imenovani magnetnoresonančno slikanje (MRI).
English: The diagnosis can be made with greater accuracy than without using this medicine.
Slovenian: Diagnozo lahko z uporabo kontrastnega sredstva postavimo natančneje kot brez njega.
English: Because gadofosveset is bound to albumin, an interaction with other plasma protein bound active substances (e.g., ibuprofen and warfarin) is generally possible, i.e., a competition for the protein binding site can occur.
Slovenian: Ker se gadofosveset veže na albumin, so interakcije z drugimi zdravilnimi učinkovinami, ki se vežejo na plazemske beljakovine (npr. ibuprofen in varfarin), na splošno možne, tj. lahko pride do kompeticije na mestu vezave na plazemske beljakovine.
English: Ablavar is for diagnostic use only.
Slovenian: Ablavar se uporablja samo v diagnostične namene.
English: In clinical trials using Ablavar, no specific trends were observed that would signify a potential interaction of the medicinal product with laboratory test methods.
Slovenian: Pri kliničnih preskušanjih s Ablavar niso opazili trendov, ki bi pomenili potencialne interakcije zdravila z laboratorijskimi testnimi metodami.
English: Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri ponavljajočih se visokih odmerkih (glejte poglavje 5.3).
English: Pharmacotherapeutic group: Contrast media, paramagnetic contrast media, ATC code: V08CA.
Slovenian: Farmakoterapevtska skupina: kontrastno sredstvo, paramagnetno kontrastno sredstvo, oznaka ATC: V08CA.
English: Children or adolescents under 18 years This medicine should not be used in children or adolescents under 18 year of age.
Slovenian: Otroci ali mladostniki, mlajši od 18 let Zdravila ni dovoljeno uporabljati pri osebah, mlajših od 18 let, niso izvedli.
English: This medicine, a contrast agent with magnetic properties, helps to visualise the passage of blood through the vessels by brightening the blood for an extended period.
Slovenian: To zdravilo, pri katerem gre za kontrastno sredstvo z magnetnimi lastnostmi, pomaga vizualizirati pretok krvi skozi žile tako, da kri za dlje časa razsvetli.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Načrt za obvladovanje tveganja (RMP - Risk Management Plan) Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 2.0 načrta za obvladovanje tveganja (RMP), predstavljeno v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah RMP, s katerim soglaša Odbor za zdravila za uporabo v humani medicini CHMP.
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Slovenian: Pri bolnikih, pri katerih opravljajo presaditev jeter, je tveganje še posebej visoko, saj je v tej skupini incidenca akutne ledvične odpovedi visoka.
English: In patients with moderate to severe renal impairment the half-life is markedly prolonged and the AUC increased by 2-3fold.
Slovenian: Pri bolnikih z zmerno do hudo ledvično okvaro je razpolovni čas opazno podaljšan, vrednost AUC pa povečana za dva- do trikrat.
English: Dynamic imaging begins immediately upon injection.
Slovenian: Dinamično slikanje se začne takoj po injiciranju.
English: There are no data from the use of Ablavar in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi Ablavar pri nosečnicah.
English: It has been shown in published studies that MRA in the presence of metallic stents causes artefacts.
Slovenian: Objavljene študije so pokazale, da MRA v prisotnosti kovinskih opornic povzroča artefakte.
English: Medicinal product subject to restricted medicinal prescription (See Annex 1: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P 450 enzyme system.
Slovenian: In vitro študije, pri katerih so uporabili človeške jetrne mikrosome, niso pokazale potenciala za zaviranje encimskega sistema citokrom P450.
English: The anticoagulant activity of warfarin was not altered and the efficacy of the medicinal product was not influenced.
Slovenian: Antikoagulantno delovanje varfarina je ostalo nespremenjeno pa tudi vpliva na učinkovitost zdravila ni bilo.
English: Steady state imaging can begin after the dynamic scan has been completed.
Slovenian: Slikanje v stanju dinamičnega ravnovesja se lahko začne po tem, ko je dinamično slikanje končano.
English: However, in a series of in vitro drug interaction studies (in 4.5 % human serum albumin and human plasma), gadofosveset demonstrated no adverse interaction with digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac and piroxicam at clinically relevant concentrations.
Slovenian: Vendar v nizu in vitro študij medsebojnega delovanja zdravil (pri katerih so uporabili 4,5 odstotni človeški serumski albumin in človeško plazmo) pri klinično relevantnih koncentracijah gadofosveset ni imel neželenega medsebojnega delovanja z digitoksinom, propranololom, verapamilom, varfarinom, fenprokumonom, ibuprofenom, diazepamom, ketoprofenom, naproksenom, diklofenakom in piroksikamom.
English: If use of Ablavar cannot be avoided, the dose should not exceed 0.03 mmol/kg body weight.
Slovenian: Če uporaba Ablavar ni mogoče izogniti, odmerek ne sme preseči 0,03 mmol/kg telesne mase.
English: The plasma concentration-time profile of intravenously administered gadofosveset conforms to a twocompartment open model.
Slovenian: Profil koncentracija - čas v plazmi intravensko uporabljenega gadofosveseta ustreza dvodelnemu odprtemu modelu.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Slovenian: • v 60 dneh po dosegu pomembnega mejnika (farmakovigilančni ali za zmanjševanje tveganja); • na zahtevo Evropske agencije za zdravila.
English: Plasma protein binding was in a range 80% to 87% for up to the first 4 hours after injection.
Slovenian: Stopnja vezave na plazemske beljakovine je v prvih 4 urah po injiciranju v intervalu od 80 % do 87 %.
English: Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3).
Slovenian: Gadolinij vsebuje kontrastno sredstvo, ki se v mleko izloča v zelo majhnih količinah (glejte poglavje 5.3).
English: Hypersensitivity to the active substance or to any of the excipients.
Slovenian: Preobčutljivost za učinkovino ali katerokoli pomožno snov.
English: Delayed reactions may occur (after hours to days).
Slovenian: Lahko pride do poznih reakcij (po nekaj urah ali dneh).
English: The reliability of lumen visualisation in a stented vessel with Ablavar has not been evaluated.
Slovenian: Zanesljivost prikaza svetline s Ablavar v žilah z nameščeno opornico ni bila ocenjena.
English: Repeated-dose toxicity studies revealed vacuolation of the tubular cells of the kidneys, with strong evidence for reversibility of the effect.
Slovenian: Študije toksičnosti pri večkratnem odmerjanju so pokazale vakuolizacijo ledvičnih tubularnih celic z močnimi dokazi, da je učinek reverzibilen.