FrancophonIA/ELRC3.0 huggingface dataset:
English: A vial contains 0.5 ml (0.925 GBq at calibration) to 2 ml (3.700 GBq at calibration).
Slovenian: Ena viala vsebuje 0,5 (0,925 GBq ob kalibraciji) do 2 ml (3,700 GBq ob kalibraciji).
English: Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Slovenian: Bolnišnično osebje mora zagotoviti pravilno shranjevanje zdravila in uporabo pred datumom izteka roka uporabnosti.
English: The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Ytracis will lead to increase bone marrow toxicity and haematopoetic stem cell damage.
Slovenian: Prisotnost prostega itrijevega (90Y) klorida v telesu po naključni aplikaciji Ytracisa poveča toksičnost za kostni mozeg in okvare krvotvornih matičnih celic.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Slovenian: Izpostavljenost radioaktivnemu sevanju je povezana z nastankom raka in nagnjenostjo k razvoju dednih genetskih okvar.
English: Y) chloride 1.850 GBq/ml
Slovenian: Itrijev (90Y) klorid 1,850 GBq/ml
English: OTHER
Slovenian: Francija
English: If you use more YTRACIS than you should
Slovenian: Če ste uporabili večji odmerek zdravila YTRACIS, kot bi smeli:
English: Yttrium (90Y) is a beta pure emitter.
Slovenian: Itrij (90Y) je čisti sevalec beta.
English: Like all medicines, YTRACIS can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo YTRACIS neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: For in vitro radiolabelling.
Slovenian: Za in vitro radioaktivno označevanje.
English: Colourless Type I glass 2-ml vial, closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.
Slovenian: Brezbarvna 2-ml viala iz stekla tipa I, zaprta s teflonsko prevlečenim klorobutilnim zamaškom iz gume in aluminijasto zaščitno zaporko.
English: 5 How to store YTRACIS Further information
Slovenian: 5 Shranjevanje zdravila YTRACIS Dodatne informacije
English: In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood.
Slovenian: Pri podganah se po intravenski aplikaciji itrijev (90Y) klorid hitro izloči iz krvi.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: 6.6 Special precautions for disposal and other handling The administration of radioactive medicinal products creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Aplikacija radiofarmakov predstavlja tveganje izpostavljenosti drugih oseb zunanjemu sevanju ali kontaminaciji zaradi razlitja urina, bruhanja ipd. Zaradi tega moramo upoštevati nacionalne predpise glede previdnostnih ukrepov za zaščito pred ionizirajočimi sevanji.
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of YTRACIS.
Slovenian: Spodnja preglednica o dozimetriji omogoča oceno doze sevanja, ki jo prispeva nekonjugirani itrij (90Y) po aplikaciji zdravila, označenega z itrijem (90Y), ali po naključni intravenski injekciji zdravila
English: Adult female 57 kg 15 years 10 years 5 years
Slovenian: Odrasla ženska 15 let
English: In the liver, 18 % of the injected activity is taken up 5 min after injection.
Slovenian: Pet minut po aplikaciji se v jetrih nakopiči 15 % injicirane aktivnosti.
English: Cal : {DD/MM/YYYY} (12 h CET)
Slovenian: : {DD/MM/LLLL} (12h po srednjeevropskem času) Akt.
English: Alternative techniques which do not involve ionising radiation should always be considered.
Slovenian: Vedno je treba upoštevati možnost uporabe alternativnih metod, ki niso povezane z radioaktivnim sevanjem.
English: CIS bio international BP 32
Slovenian: BP 32
English: Particular care should be taken when administering radioactive medicinal products to children and adolescents.
Slovenian: Uporaba radioaktivnih zdravil pri otrocih in mladostnikih zahteva posebno previdnost.
English: When the target is reached, Ytracis gives tiny radiation doses to these specific sites.
Slovenian: Ko dosežeta ciljne celice, zdravilo YTRACIS minimalno obseva ta specifična mesta.
English: YTRACIS is a radiopharmaceutical precursor.
Slovenian: YTRACIS je radiofarmacevtski predhodnik.
English: Batch N°: {XXXXX}
Slovenian: Vol.: {Z} ml
English: GENERAL CLASSIFICATION FOR SUPPLY Medical product subject to medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: For further information regarding the treatment and possible effects caused by the medicinal product to be radiolabelled please refer to the package leaflet of the medicinal product to be radiolabelled.
Slovenian: Za nadaljnje informacije glede zdravljenja in možnih učinkov zdravila, ki naj bi ga označili z radioaktivnim izotopom, upoštevajte navodilo za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: Activity may be measured using an ionisation chamber.
Slovenian: Aktivnost lahko izmerimo s pomočjo radionuklidnega kalibratorja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of sterile solution contains 1.850 GBq Yttrium (90Y) chloride, at the date of calibration, corresponding to 92 ng of Yttrium.
Slovenian: 1 ml sterilne raztopine vsebuje 1,850 GBq itrijevega (90Y) klorida na dan kalibracije, kar odgovarja 92 ng itrija.
English: Liver uptake decreases then to 8.4 % 24 hours after injection.
Slovenian: 24 ur po aplikaciji pa stopnja akumulacije v jetrih upade na 8,4%.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJE
English: Radionuclide procedures carried out in pregnant women also involve radiation doses to the foetus.
Slovenian: Uporaba postopkov z radioaktivnimi izotopi pri nosečnicah pomeni hkrati izpostavljenost ploda določenim dozam sevanja.
English: The quantity of YTRACIS required for radiolabelling and the quantity of Yttrium (90Y)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use.
Slovenian: Količina YTRACISa potrebna za označevanje z radioaktivnim izotopom kot tudi količina z itrijem (90Y) označenega zdravila, ki ga kasneje apliciramo, je odvisna od samega zdravila, ki ga označujemo, in od namena njegove uporabe.
English: PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution.
Slovenian: FARMACEVTSKA OBLIKA Radiofarmacevtski predhodnik, raztopina.
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Pharmaceutical Manufacturing Practice, in order to maintain the sterility of YTRACIS and to maintain sterility throughout the labelling procedures.
Slovenian: Da bi zagotovili sterilnost YTRACISa in celotnega postopka označevanja, moramo upoštevati ustrezne previdnostne ukrepe za zagotavljanje asepse, ki so v skladu z Dobro farmacevtsko proizvodno prakso.
English: See section 12, for detailed instructions of product preparation.
Slovenian: Podrobna navodila za pripravo zdravila so v poglavju 12.
English: B.PACKAGE LEAFLET
Slovenian: B.NAVODILO ZA UPORABO
English: EXPIRY DATE EXP {DD/MM/YYYY} (12h CET) BATCH NUMBER Batch: {XXXXX} CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vol.: {Z} ml Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET)
Slovenian: NI NAMENJENO ZA NEPOSREDNO UPORABO PRI BOLNIKIH DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP:{DD/MM/LLLL} (12h po srednjeevropskem času) ŠTEVILKA SERIJE Batch:{XXXXX} VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Vol.: {Z} ml Akt.
English: EXP {DD/MM/YYYY} (12h CET)
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP:{DD/MM/LLLL} (12h po srednjeevropskem času)
English: Each millilitre of solution contains 1.850 GBq of Yttrium (90Y) chloride at the date of calibration.
Slovenian: 1 ml sterilne raztopine vsebuje 1.850 GBq itrijevega (90Y) klorida na dan kalibracije (GBq:
English: - The active substance is Yttrium (90Y) chloride.
Slovenian: - Zdravilna učinkovina je itrijev (90Y) klorid.
English: YTRACIS is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by approved route.
Slovenian: YTRACIS je namenjen za in vitro označevanje zdravil z radioaktivnim izotopom, ki se nato aplicirajo po ustaljenem postopku.
English: Possible side effects following the intravenous administration of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, will be dependent on the specific medicinal product being used.
Slovenian: Možni neželeni učinki po intravenski aplikaciji z itrijem (90Y) označenih zdravil, ki so pripravljena z uporabo YTRACISa, so odvisni od vrste uporabljenega zdravila.
English: Vol.: {Z} ml Act.: {Y} GBq/vial
Slovenian: : {Y}________GBq/vialo Kal.
English: The radiation dose received by the various organs following administration of a Yttrium (90Y)
Slovenian: Absorbirana doza sevanja za maternico po aplikaciji z itrijem (90Y)
English: HOW TO USE YTRACIS
Slovenian: KAKO UPORABLJATI ZDRAVILO YTRACIS
English: Method of Administration
Slovenian: Način aplikacije
English: 91192 GIF-SUR-YVETTE Cedex France
Slovenian: 91192 GIF-SUR-YVETTE Cedex Francija
English: The two main organs where Yttrium (90Y) chloride distributes are the liver and bones.
Slovenian: Pretežno se itrijev (90Y) klorid razporedi v jetra in kosti.
English: NAME OF THE MEDICINAL PRODUCT YTRACIS Radiopharmaceutical precursor, solution.
Slovenian: IME ZDRAVILA YTRACIS radiofarmacevtski predhodnik, raztopina
English: YTRACIS is not to be administered directly to the patient.
Slovenian: YTRACIS se ne daje bolnikom neposredno.
English: Radiopharmaceutical precursor, solution.
Slovenian: Radiofarmacevtski predhodnik, raztopina.
English: Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Informacije o prejetih dozah sevanja za vsako posamezno zdravilo po aplikaciji tega radioaktivno označenega zdravila najdete v Povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: F-91192 Gif-sur-Yvette Cedex FRANCE
Slovenian: F-91192 GIF-SUR-YVETTE CEDEX FRANCIJA
English: Hydrochloric acid 30 %
Slovenian: 30 % klorovodikova kislina voda za injekcije
English: What YTRACIS is and what it is used for Before you use YTRACIS How to use YTRACIS Possible side effects
Slovenian: Kaj je zdravilo YTRACIS in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo YTRACIS Kako uporabljati zdravilo YTRACIS Možni neželeni učinki
English: The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Slovenian: Farmakokinetične lastnosti z itrijem (90Y) označenih zdravil, ki so pripravljeni z uporabo YTRACISa pred aplikacijo, so odvisne od vrste zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Informacije o tem najdete v Povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: What YTRACIS contains
Slovenian: Kaj vsebuje zdravilo YTRACIS
English: For information concerning special warnings and precautions for use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Informacije o posebnih opozorilih in previdnostnih ukrepih glede uporabe z itrijem (90Y) označenih zdravil najdete v Povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Za informacije o kontraindikacijah za določena z itrijem (90Y) označena zdravila, ki so pripravljena z uporabo YTRACISa, upoštevajte Povzetek glavnih značilnosti zdravila/navodilo za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: The product should be aseptically withdrawn through the stopper using sterilised single use needle and syringe after disinfection of the stopper.
Slovenian: S pomočjo sterilne injekcijske igle in brizge za enkratno uporabo moramo izdelek aseptično izvleči skozi zamašek, ki smo ga predhodno razkužili.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION YTRACIS Yttrium (90Y) chloride
Slovenian: IME ZDRAVILA IN POT(I) UPORABE YTRACIS itrijev (90Y) klorid POSTOPEK UPORABE Za in vitro radioaktivno označevanje.
English: For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Več informacij o tem najdete v navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Informacije o interakcijah povezanih z uporabo z itrijem (90Y) označenih zdravil najdete v Povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CIS bio international
English: Yttrium (90Y) chloride
Slovenian: YTRACIS radiofarmacevtski predhodnik, raztopina Itrijev (90Y) klorid
English: This summary was last updated in 10-2015.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2015.
English: Sycrest asenapine
Slovenian: Sycrest asenapin
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom prejšnjega stoletja dalje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sycrest on 1 September 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sycrest, veljavno po vsej Evropski uniji, izdala 1. septembra 2010.
English: This dose can be increased to 10 mg twice a day depending on how the patient responds.
Slovenian: Ta odmerek se lahko poveča na 10 mg dvakrat na dan, odvisno od bolnikovega odziva.
English: Other information about Sycrest:
Slovenian: Druge informacije o zdravilu Sycrest:
English: It is available as sublingual tablets (5 and 10 mg).
Slovenian: Na voljo je v obliki podjezičnih tablet (5 in 10 mg).
English: Sycrest tablets should not be chewed or swallowed.
Slovenian: Tablete zdravila Sycrest se ne smejo žvečiti ali pogoltniti.
English: The recommended starting dose of Sycrest is 5 mg twice a day, one dose in the morning and one in the evening.
Slovenian: Priporočeni začetni odmerek zdravila Sycrest je 5 mg dvakrat na dan, en odmerek zjutraj in drugi zvečer.
English: What measures are being taken to ensure the safe and effective use of Sycrest?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sycrest?
English: Sublingual tablets are tablets that are placed under the tongue, where they dissolve.
Slovenian: Podjezične tablete so tablete, ki se položijo pod jezik, kjer se nato raztopijo.
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Slovenian: Natančen mehanizem njegovega delovanja ni znan, znano pa je, da se veže na več različnih receptorjev na površini živčnih celic v možganih.
English: The patient should avoid eating or drinking for 10 minutes after taking the medicine.
Slovenian: Bolnik 10 minut po zaužitju zdravila ne sme jesti ali piti.
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Slovenian: Spada med netipična antipsihotična zdravila, ker se razlikuje od starejših antipsihotikov, ki so na voljo od petdesetih let
English: This is a summary of the European public assessment report (EPAR) for Sycrest.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sycrest.
English: Since these neurotransmitters are involved in bipolar disorder, Sycrest helps to normalise the activity of the brain, reducing the symptoms of the disease.
Slovenian: Ker ta živčna prenašalca sodelujeta pri bipolarni motnji, zdravilo Sycrest pomaga normalizirati dejavnost možganov in oslabi simptome bolezni.
English: The full EPAR for Sycrest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sycrest je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Sycrest is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Sycrest je bil pripravljen načrt obvladovanja tveganj.
English: What benefit has Sycrest shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sycrest izkazalo med študijami?
English: For more information about treatment with Sycrest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sycrest preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Sycrest is used to treat moderate to severe manic episodes (extremely high mood) in adults (aged 18 years or over) with bipolar disorder, a mental illness in which patients have periods of abnormally high mood alternating with periods of normal or depressed mood.
Slovenian: Zdravilo Sycrest se uporablja za zdravljenje zmernih do hudih maničnih epizod (izjemno privzdignjenega razpoloženja) pri odraslih (starejših od 18 let) z bipolarno motnjo, tj. duševno boleznijo, pri kateri imajo bolniki obdobja nenormalno privzdignjenega razpoloženja, ki se izmenjujejo z obdobji normalnega ali depresivnega razpoloženja.
English: The most common side effects with Sycrest (seen in more than 1 patient in 10) are anxiety and somnolence (sleepiness).
Slovenian: Najpogostejša neželena učinka zdravila Sycrest (opažena pri več kot 1 bolniku od 10) sta tesnobnost in zaspanost.
English: The main measure of effectiveness was the change in the patients' ‘Young mania rating scale' (Y-MRS) score.
Slovenian: Glavno merilo učinkovitosti je bila sprememba bolnikovih simptomov po ocenjevalni lestvici za manijo (Y-MRS).
English: The Y-MRS rates the severity of symptoms of manic episodes on a scale from 0 to 60.
Slovenian: Z njo se ocenjuje resnost simptomov maničnih epizod na lestvici od 0 do 60.
English: Sycrest is a medicine that contains the active substance asenapine.
Slovenian: Sycrest je zdravilo, ki vsebuje zdravilno učinkovino asenapin.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sycrest.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It is thought that Sycrest works by blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Slovenian: Domneva se, da zdravilo Sycrest deluje tako, da zavira receptorje za živčna prenašalca 5-hidroksitriptamin (imenovanega tudi serotonin) in dopamin.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: S tem prekine signale, ki jih med možganskimi celicami prenašajo živčni prenašalci, tj. kemične snovi, ki omogočajo sporazumevanje med živčnimi celicami.
English: The studies on schizophrenia were not considered to have shown sufficient evidence of the effectiveness in treating this disease.
Slovenian: V študijah zdravljenja shizofrenije niso zbrali dovolj dokazov o učinkovitosti tega zdravila pri tej bolezni.
English: The active substance in Sycrest, asenapine, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Sycrest, asenapin, je antipsihotično zdravilo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sycrest, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What is the risk associated with Sycrest?
Slovenian: Kakšna tveganja so povezana z zdravilom Sycrest?
English: When taken in combination with other medicines, Sycrest should be taken last.
Slovenian: Če se zdravilo Sycrest uporablja sočasno z drugimi zdravili, ga je treba vzeti nazadnje.
English: Sycrest was also studied in patients with schizophrenia.
Slovenian: Zdravilo Sycrest so proučevali tudi pri bolnikih s shizofrenijo.
English: The CHMP decided that Sycrest's benefits are greater than its risks and recommended that it be given marketing authorisation for the treatment of moderate to severe manic episodes in patients with bipolar disorder.
Slovenian: CHMP je zaključil, da so koristi zdravila Sycrest večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet za zdravljenje zmernih do hudih maničnih epizod pri bolnikih z bipolarno motnjo.
English: The studies included short- and long-term studies in patients receiving Sycrest, other medicines for schizophrenia (olanzapine, risperidone or haloperidol) or placebo.
Slovenian: Te študije so zajemale kratko- in dolgotrajne študije pri bolnikih, ki so prejemali zdravilo Sycrest, druga zdravila za shizofrenijo (olanzapin, risperidon ali haloperidol) ali placebo.
English: Why has Sycrest been approved?
Slovenian: Zakaj je bilo zdravilo Sycrest odobreno?