FrancophonIA/ELRC3.0 huggingface dataset:
English: Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window.
Slovenian: Slike morajo biti posnete z gama kamero, na kateri je nameščen kolimator visoke ločljivosti in ki je umerjena s 159 keV.
English: Clinical categorisation into the respective dementia group was based on a standardised and comprehensive clinical and neuropsychiatric evaluation.
Slovenian: Na osnovi standardizirane in poglobljenega kliničnega in neuropsihiatričnega pregleda je bila opravljena klinična kategorizacija v omenjene kategorije demenc.
English: What DaTSCAN looks like and contents of the pack DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Slovenian: Zdravilo DaTSCAN je 2,5 ali 5 ml brezbarvna raztopina za injiciranje v enoodmerni, brezbarvni, stekleni 10 mililiterski viali, zaprti z gumijastim zapiralom in kovinskim tesnilom.
English: Medicinal products shown in animal studies not to interfere with DaTSCAN imaging include pergolide.
Slovenian: Raziskave na živalih so pokazale, da pergolid ne vpliva na slikanje z zdravilom DaTSCAN.
English: Experimental studies with a striatal phantom, suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5-4.5 mm for those systems currently in use.
Slovenian: Poskusi na striatnem fantomu kažejo, da pridobimo najboljše slike s takšno nastavitvijo velikosti matrike in povečave, da je pri sistemih v trenutni rabi velikost slikovne pike med 3,5 in 4,5 mm. Za optimalne slike mora biti število rezultatov najmanj 500 k. Za običajne slike sta značilni dve simetrični srpasti področji enake intenzivnosti.
English: I) (specific activity range 2.5 to
Slovenian: I) (obseg specifičnega delovanja
English: No interaction studies have been performed in humans.
Slovenian: Pri ljudeh študije interakcij z drugimi zdravili niso bile opravljene.
English: Acetic acid Sodium acetate Ethanol
Slovenian: 6.1 Seznam pomožnih snovi ocetna kislina natrijev acetat etanol voda za injiciranje
English: Gastrointestinal disorders Uncommon: Nausea, dry mouth Not known: Vomiting
Slovenian: Bolezni prebavil Občasno: navzea, suha usta Ni znano: bruhanje
English: I) at 2300 CET on DD/MM/YYYY.
Slovenian: I) ob 2300 CET dne DD/MM/LLLL
English: Ioflupane (
Slovenian: Ioflupan (
English: The values for the sensitivity of DaTSCAN in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%.
Slovenian: Senzitivnost zdravila DaTSCAN pri ločevanju verjetne DLB od ne-DLB je bila med 75,0% in 80,2%, specifičènost pa med 88,6% in 91,4%.
English: Alternative techniques which do not involve radioactivity should be considered.
Slovenian: Pretehtajte druge možnosti zdravljenja, pri katerih se ne uporablja radioaktivnost.
English: Muscles
Slovenian: Mišice
English: EXP: 7 h post-ref. Ref.: 185 MBq/2.5 ml at 1200 CET on DD/MM/YYYY
Slovenian: Uporabno do: 7 h po ref. Ref.: 185 MBq/2,5 ml ob 1200 CET dne DD/MM/LLLL
English: • Instead use formula feed for your child. Express your breast milk regularly and throw away any breast milk you have expressed.
Slovenian: Mleko si v tem času redno izbrizgavajte in vse iztisnjeno mleko zavrzite.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN
English: Alternative techniques which do not involve ionising radiation should be considered.
Slovenian: Pretehtajte možnost uporabe drugih metod, ki ne vključujejo ionizirajočih sevanj.
English: How DaTSCAN is used
Slovenian: Kako uporabljati zdravilo DaTSCAN
English: - Hypersensitivity (allergic) - Shortness of breath - Redness of the skin - Itching - Rash - Hives (urticaria) - Excessive sweating - Vomiting - Low blood pressure - Feeling hot
Slovenian: - preobčutljivost (alergija) - kratka sapa - pordela koža - srbenje - izpuščaj - koprivnica (urtikarija)
English: EXP: 20 h post-ref. Ref.: 370 MBq/5 ml at 2300 CET on DD/MM/YYYY
Slovenian: Uporabno do: 20 h po ref. Ref.: 370 MBq/5 ml ob 2300 CET dne DD/MM/LLLL
English: Where it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Slovenian: Ob vsaki nujni uporabi radiofarmacevtskih izdelkov pri ženskah v rodni dobi morate preveriti, ali je oseba noseča.
English: EXP: 7 h post-ref. Ref.: 185 MBq/2.5 ml ioflupane (
Slovenian: Uporabno do: 7 h po ref. Ref.: 185 MBq/2,5 ml ioflupana (
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains ioflupane (
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter raztopine vsebuje ioflupan (
English: Formal studies have not been carried out in patients with significant renal or hepatic impairment.
Slovenian: Pri bolnikih s težjo obliko okvare ledvic ali jeter niso opravili formalnih raziskav.
English: Metabolism and nutrition disorders Uncommon: Appetite increased
Slovenian: Presnovne in prehranske motnje Občasno: povečan tek
English: It is not known whether ioflupane (
Slovenian: Ni znano, ali se ioflupan (
English: EXP: 20 h post-ref. Ref.: 370 MBq/5 ml ioflupane (
Slovenian: Uporabno do: 20 h po ref. Ref.: 370 MBq/5 ml ioflupana (
English: What you need to know before DaTSCAN is used DaTSCAN must not be used
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo DaTSCAN
English: Administration of 185 MBq of ioflupane (
Slovenian: Pri uporabi 185 MBq ioflupana (
English: Brain
Slovenian: Možgani
English: NAME OF THE MEDICINAL PRODUCT DaTSCAN 74 MBq/ml solution for injection
Slovenian: DaTSCAN 74 MBq/ml raztopina za injiciranje
English: These stop the radioactivity building-up in your thyroid gland.
Slovenian: To bo preprečilo kopičenje radioaktivnosti v ščitnici.
English: This leaflet was last revised in <{MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency web site; http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: • Parkinsonism (including Parkinson's disease) and
Slovenian: Do sprememb v tem delu možganov pride pri: parkinsonizmu (vključno s Parkisonovo boleznijo) in demenci, povezani z Lewyjevimi telesci
English: Liver
Slovenian: Jetra
English: Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk.
Slovenian: Preden uporabite radiofarmacevtski izdelek pri doječi materi, morate pretehtati možnost zamika raziskave, dokler mati ne preneha dojiti.
English: Each 2.5 ml single dose vial contains 185 MBq ioflupane (
Slovenian: Ena 2,5-mililitrska enoodmerna viala vsebuje 185 MBq ioflupana (
English: GE Healthcare B.V. De Rondom 8
Slovenian: GE Healthcare B.V.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 27. julij 2000
English: DaTSCAN should be used without dilution.
Slovenian: Zdravilo DaTSCAN uporabljamo nerazredčeno.
English: DaTSCAN contains the active substance ioflupane (
Slovenian: Zdravilo DaTSCAN vsebuje učinkovino ioflupan (
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo DaTSCAN nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Each ml of solution contains ioflupane (
Slovenian: En mililiter raztopine vsebuje ioflupan (
English: Breastfeeding It is not known whether ioflupane (
Slovenian: Dojenje Ni znano, ali se ioflupan (
English: Small intestine wall
Slovenian: Stena sečnega mehurja Maternica
English: How DaTSCAN is stored
Slovenian: Shranjevanje zdravila DaTSCAN
English: Each 5 ml single dose vial contains 370 MBq ioflupane (
Slovenian: Ena 5-mililitrska enoodmerna viala vsebuje 370 MBq ioflupana (
English: • amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); also a drug of abuse)
Slovenian: Mednje sodijo: buproprion (za zdravljenje depresije (žalosti)) benzatropin (za zdravljenje Parkinsonove bolezni) mazindol (za zmanjševanje apetita pri zdravljenju debelosti) sertralin (za zdravljenje depresije (žalosti)) metilfenidat (za zdravljenje hiperaktivnosti pri otrocih in narkolepsije (pretiranespečnosti) fentermin (za zmanjševanje apetita pri zdravljenju debelosti) amfetamin (za zdravljenje hiperaktivnosti pri otrocih in narkolepsije (pretirane spečnosti); uporablja se tudi za zlorabo drog) kokain (včasih se uporablja kot anestetik za operacijo nosu; uporablja se tudi za zlorabo drog)
English: • You should not breast-feed your child for 3 days after DaTSCAN is given.
Slovenian: Tri dni po prejetju zdravila DaTSCAN ne smete dojiti.
English: B. CONDITIONS OR RESTRICTIONS REARDING SUPPLY AND USE
Slovenian: (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: • A picture, known as a scan, can be taken.
Slovenian: Posnamemo lahko sliko.
English: Kidneys
Slovenian: Vranica
English: Any ioflupane (
Slovenian: Preostanek ioflupana (
English: Ovaries
Slovenian: Ledvici
English: GE Healthcare B.V. Tel: +31 (0) 40 299 10 00
Slovenian: Tel: +31 (0) 40 299 10 00
English: Ear and labyrinth disorders Uncommon: Vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Občasno: vrtoglavica
English: 5 ml presentation
Slovenian: pakiranje po 5 ml
English: GE Healthcare Buchler GmbH & Co. KG Tel: +49 (0) 5 307 93 00
Slovenian: KG Tel: +49 (0) 5 307 93 00
English: Breast
Slovenian: Dojki
English: Contents of the pack and other information What DaTSCAN contains
Slovenian: Izgled zdravila DaTSCAN in vsebina pakiranja
English: The studies included data from 970 patients.
Slovenian: Študije so vključevale podatke 970 bolnikov.
English: edotreotide
Slovenian: edotreotid
English: The PET scan images are then taken 40 to 90 minutes later.
Slovenian: Slikanje s PET se izvede od 40 do 90 minut po tem.
English: This makes it possible to see where the tumours are and whether they have spread.
Slovenian: Tako se lahko vidi, kje so tumorji in ali so se razširili.
English: The tumours can then spread elsewhere in the body (metastasis).
Slovenian: Ti tumorji se lahko razširijo drugod po telesu (metastaze).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the technical and diagnostic performance of the medicine had been demonstrated.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je presodil, da je bila tehnična in diagnostična učinkovitost tega zdravila dokazana.
English: A comparison using data from several of these studies (a meta-analysis) was also presented.
Slovenian: Predstavljena je bila tudi primerjava, ki je uporabila podatke iz več od teh študij (metaanaliz).
English: The medicine is not used directly, but must be ‘radiolabelled' before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation.
Slovenian: Zdravilo se ne uporablja neposredno, ampak ga je pred injiciranjem treba radioaktivno označiti, kar pomeni, da je označen z ločeno snovjo, ki oddaja majhne količine radioaktivnosti.
English: This is a summary of the European public assessment report (EPAR) for SomaKit TOC.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo SomaKit TOC.
English: Taken together, the studies were sufficient to show the effectiveness of SomaKit TOC for detection, although the exact results varied.
Slovenian: Gledano skupaj so študije zadoščale za dokaz učinkovitosti zdravila SomaKit TOC pri odkrivanju, čeprav so se natančni rezultati razlikovali.
English: The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection.
Slovenian: Družba je zato zagotovila informacije iz več večinoma majhnih študij v objavljeni literaturi, da bi pokazala učinkovitost zdravila SomaKit TOC pri odkrivanju.
English: What measures are being taken to ensure the safe and effective use of SomaKit TOC?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila SomaKit TOC?
English: The risks of side effects seemed to be low and the CHMP therefore decided that SomaKit TOC's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Tveganja za neželene učinke so bila majhna in Odbor za zdravila za uporabo v humani medicini (CHMP) je zato zaključil, da so koristi zdravila SomaKit TOC večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.
Slovenian: V štirih drugih primerjalnih študijah so opazili, da je zdravilna učinkovina v zdravilu SomaKit TOC odkrila več tumorjev, kot jih je [111In]indij-pentetreotid pri istih bolnikih.
English: It is given as a single injection into a vein immediately after being radiolabelled.
Slovenian: Daje se kot eno injiciranje v veno neposredno po radioaktivnem označevanju.
English: Not all cells have these receptors but most welldifferentiated GEP-NET cells have high amounts on their surface.
Slovenian: Vse celice nimajo teh receptorjev, vendar ima večina celic dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev velike količine receptorjev na svoji površini.
English: Some studies looked at the sensitivity of the PET scans (how well the scans identified patients who had GEP-NETs or their metastases), some analysed specificity (how reliable scans were at identifying subjects who had no GEP-NETs) and some looked at lesion detection rate (how good scans were at identifying the tumours).
Slovenian: Nekatere študije so se osredotočile na občutljivost slikanja s PET (kako dobro so slikanja identificirala bolnike z dobro diferenciranimi gastroenteropankreatičnimi nevroendokrinimi tumorji in njihove metastaze), nekatere so analizirale specifičnost (kako zanesljiva so bila slikanja pri identificiranju oseb, ki niso imela dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev), druge pa so se osredotočile na stopnjo odkrivanja lezij (kako učinkovita so bila slikanja pri identificiranju tumorjev).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu SomaKit TOC je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: GEP-NETs are cancers which start in types of cells in the gut or pancreas that normally release hormones.
Slovenian: Gastroenteropankreatični nevroendokrini tumorji so vrste raka, ki se začnejo v tipih celic v črevesju ali trebušni slinavki, ki običajno sproščajo hormone.
English: For localising the primary GEP-NET, one study showed that the medicine had a sensitivity of 45% compared with 10% in patients given another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study that showed that the former had better sensitivity.
Slovenian: Za lokaliziranje primarnih dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev je ena študija pokazala, da je bila občutljivost zdravila 45 % v primerjavi z 10 % pri bolnikih, ki so prejemali drugo odobreno zdravilo za diagnostične namene, [111In]indij-pentetreotid, kar je bilo potrjeno z drugo študijo, ki je pokazala, da je bila občutljivost pri prejšnjem zdravilu boljša.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SomaKit TOC have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila SomaKit TOC upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Because the number of patients with GEP-NETs is low, the disease is considered ‘rare', and SomaKit TOC was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 March 2015.
Slovenian: Ker je bolnikov z gastroenteropankreatičnimi nevroendokrinimi tumorji malo, velja ta bolezen za redko, zato je bilo zdravilo SomaKit TOC 19. marca 2015 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: For more information about treatment with SomaKit TOC, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom SomaKit TOC preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The resulting build-up of radiation can be detected by the special camera of the PET scan.
Slovenian: Posledično kopičenje radioaktivnosti se lahko zazna s posebno kamero pri slikanju s PET.
English: SomaKit TOC can only be obtained with a prescription and the injection must only be prepared and given in a suitable facility by experts in handling radioactive medicines.
Slovenian: Predpisovanje in izdaja zdravila SomaKit TOC je le na recept, injekcijo pa mora pripraviti in dati v primernem objektu le strokovnjak za ravnanje z radioaktivnimi zdravili.
English: After SomaKit TOC is radiolabelled it emits a small amount of radiation which poses a low risk of cancer or hereditary abnormalities.
Slovenian: Po tem, ko je zdravilo SomaKit TOC radiološko označeno, oddaja majhno količino radioaktivnosti, kar predstavlja majhno tveganje za nastanek raka ali razvoj dednih okvar.
English: For the full list of side effects or restrictions with SomaKit TOC, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov ali omejitev z zdravilom SomaKit TOC glejte navodilo za uporabo.
English: The full EPAR for SomaKit TOC 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 SomaKit TOC je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in SomaKit TOC, edotreotide, attaches specifically to receptors called somatostatin receptors on the surface of cells.
Slovenian: Zdravilna učinkovina v zdravilu SomaKit TOC, edotreotid, se veže zlasti na receptorje, imenovane somatostatinski receptorji, na površini celic.
English: Other information about SomaKit TOC
Slovenian: Druge informacije o zdravilu SomaKit TOC
English: SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called welldifferentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Slovenian: SomaKit TOC je zdravilo, ki se uporablja za diagnostične namene pri odraslih bolnikih, pri katerih se domneva, da imajo tako imenovano dobro diferencirane gastroenteropankreatične nevroendokrine tumorje (GEP-NET).
English: What is SomaKit TOC and what is it used for?
Slovenian: Kaj je zdravilo SomaKit TOC in za kaj se uporablja?
English: For practical information about using SomaKit TOC, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila SomaKit TOC naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: SomaKit TOC is available as a kit for preparing a solution for injection.
Slovenian: Zdravilo SomaKit TOC je na voljo kot komplet za pripravo raztopine za injiciranje.
English: What are the risks associated with SomaKit TOC?
Slovenian: Kakšna tveganja so povezana z zdravilom SomaKit TOC?
English: SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers.
Slovenian: Zdravilo SomaKit TOC se uporablja s tehniko, imenovano pozitronska emisijska tomografija (slikanje s PET), da se pridobijo slike za lokalizacijo raka.
English: What benefits of SomaKit TOC have been shown in studies?
Slovenian: Kakšne koristi je zdravilo SomaKit TOC izkazalo v študijah?
English: SomaKit TOC contains the active substance edotreotide.
Slovenian: Zdravilo SomaKit TOC vsebuje zdravilno učinkovino edotreotid.
English: Why is SomaKit TOC approved?
Slovenian: Zakaj je bilo zdravilo SomaKit TOC odobreno?
English: It is not intended to provide practical advice on how to use SomaKit TOC.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The prepared medicine, radiolabelled with gallium (68Ga) chloride, attaches to these receptors on the GEP-NET cells.
Slovenian: Pripravljeno zdravilo, radioaktivno označeno z (68Ga)galijevim kloridom, se veže na te receptorje na celicah dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev.
English: Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%.
Slovenian: Rezultati nadaljnjih študij so pokazali, da ima edotreotid, označen z (68Ga)galijevim kloridom, občutljivost 100 % in specifičnost 89 %, stopnjo odkrivanja lezij pa 75 %.
English: The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs.
Slovenian: Uporaba zdravilne učinkovine zdravila SomaKit TOC, edotreotida, radioaktivno označene z (68Ga)galijevim kloridom, je dobro uveljavljena pri odkrivanju dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev.
English: How is SomaKit TOC used?
Slovenian: Kako se zdravilo SomaKit TOC uporablja?
English: How does SomaKit TOC work?
Slovenian: Kako zdravilo SomaKit TOC deluje?
English: Adopted at the 9-12 March 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 9. in 12. marcem 2015
English: Having considered the available evidence in the literature and from individual case safety reports, the PRAC has agreed that the MAH(s) of aripiprazole-containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Slovenian: Po proučitvi razpoložljivih dokazov iz literature in posameznih poročil o varnosti se je odbor PRAC strinjal, da mora(jo) imetnik(i) dovoljenj za promet z zdravili, ki vsebujejo aripiprazol, v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
English: Aripiprazole - Aggression and related events (EPITT no
Slovenian: Aripiprazol - nasilno vedenje in povezani dogodki (EPITT št.
English: The PRAC has further agreed that the MAH for Abilify and Abilify Maintena should submit in the next PSUR (data lock point 16/07/2015), a cumulative review of aripiprazole overdose and the risk of aggression and related events.
Slovenian: Odbor PRAC se je nadalje strinjal, da mora imetnik dovoljenj za zdravili Abilify in Abilify Maintena v naslednje redno posodobljeno poročilo o varnosti (PSUR) (presečni datum obdobja zbiranja podatkov je 16. 7. 2015) vključiti skupne podatke o prevelikih odmerjanjih aripiprazola ter tveganju za nasilno vedenje in povezane dogodke.
English: Summary of Product Characteristics:
Slovenian: Povzetek glavnih značilnosti zdravila
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: Aggression
Slovenian: Po sprostitvi peroralnega aripiprazola na trg so poročali o naslednjih neželenih učinkih, vendar njihova pogostost ni znana: nasilno vedenje
English: Frequency ‘not known': aggression
Slovenian: Pogostost ni znana: nasilno vedenje
English: Psychiatric disorders
Slovenian: Preglednica z neželenimi učinki: psihiatrične motnje
English: EU/1/04/295/001
Slovenian: EU/1/04/295/001 Xagrid