FrancophonIA/ELRC3.0 huggingface dataset:
English: International Non-Proprietary Name (INN): Perindopril
Slovenian: Mednarodno nelastniško ime (INN): Perindopril
English: The arbitration procedure was discussed and initiated by the CHMP at its plenary meeting in April 2005, and a Rapporteur (Dr Gonzalo Calvo Rojas) and Co-Rapporteur (Dr. Gottfried Kreutz) were appointed.
Slovenian: Arbitražni postopek je CHMP obravnaval in začel na svojem plenarnem zasedanju aprila 2005, ko sta bila imenovana poročevalec (dr. Gonzalo Calvo Rojas) in soporočevalec (dr. Gottfried Kreutz).
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE NA PODLAGI NAPOTITVE IZ ČLENA 6(12)
English: It is licensed in the EU through the Mutual Recognition Procedure (MRP) and was first marketed in France in 1988 as Coversyl 2 and 4 mg.
Slovenian: V Evropi je odobren po postopku medsebojnega priznavanja in je bil najprej v prodaji v Franciji leta 1988 kot Coversyl 2 in 4 mg.
English: Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 27 July
Slovenian: Opombe: Informacije, podane v tem dokumentu in v Dodatkih odražajo samo mnenje CHMP z dne 27. julija
English: This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the “reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
Slovenian: Ta napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi z variacijo tipa II za novo indikacijo pri “zmanjšanju tveganj kardiovaskularnih dogodkov pri bolnikih s stabilno koronarno arterijsko boleznijo”.
English: Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), currently indicated for the treatment of hypertension and symptomatic heart failure.
Slovenian: Coversyl in povezana imena vsebujejo perindopril, zelo znan, močan inhibitor angiotenzinske konvertaze (ACE-I), ki je trenutno indiciran za zdravljenje hipertenzije in simptomatske odpovedi srca.
English: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
Slovenian: Zmanjšanje tveganj kardioloških zapletov pri bolnikih, ki so doživeli miokardni infarkt in/ali revaskularizacijo.
English: Based on the evaluation of the currently available data and the (Co-)Rapporteurs' assessment reports, the CHMP adopted an opinion on 27 July 2005 recommending the variation of the Marketing Authorisations for the addition of the following new indication:
Slovenian: Na podlagi vrednotenja trenutno dosegljivih podatkov ter poročevalčevega in soporočevalčevega poročila o oceni, je CHMP dne 27. julija 2005 sprejel mnenje, s katerim je priporočil dopolnitev dovoljenja za promet z zdravilom za vključitev nove indikacije:
English: The questions identified pertained to the inclusion of a specific group of revascularised patients in the proposed indication, the justification of the beneficial effect of perindopril beyond a mere reduction of myocardial infarction, and an overall justification of the claimed indication based on the results of relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy.
Slovenian: Obravnavana vprašanja so se nanašala na vključitev posebne skupine revaskulariziranih bolnikov v predlagano indikacijo, utemeljitev, da korist uporabe perindoprila presega zgolj zmanjšanje miokardnega infarkta, ter na splošno utemeljitev zahtevane indikacije na podlagi rezultatov iz ustrezne objavljene literature o drugih inhibitorjih ACE, kar se tiče bolnikov, ki bi jih vključili v zdravljenje ter ciljev terapije.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II and the amended Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, in dopolnjen Povzetek glavnih značilnosti zdravila v Dodatku III.
English: At the end of the MRP procedure there was a discrepancy between different MS regarding the wording of the indication that adequately reflects the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by the Netherlands to the CHMP on 17.03.2005.
Slovenian: O uradni napotitvi na arbitražo v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003, kot je bila spremenjena, je Nizozemska obvestila CHMP dne 17.3.2005.
English: Date of first authorisation: 22 May 2017
Slovenian: Datum prve odobritve: 22. maj 2017
English: Activity in the brain is low.
Slovenian: Aktivnost v možganih je majhna.
English: It will be the smallest quantity necessary to get the desired information.
Slovenian: To bo najmanjša količina, ki je potrebna za pridobitev želenih podatkov.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in sections 6.6 and 12.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavjih 6.6 in 12.
English: It might be helpful to estimate the effective dose that was applied.
Slovenian: Morda bi bilo koristno oceniti uporabljeni efektivni odmerek.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Slovenian: Vendar boste v primeru prevelikega odmerjanja prejeli ustrezno zdravljenje.
English: One injection is usually sufficient to conduct the test that your doctor needs.
Slovenian: Ena injekcija običajno zadostuje za izvedbo preiskave, ki jo potrebuje zdravnik.
English: Individual benefit/risk justification
Slovenian: Utemeljitev koristi/tveganja pri posamezniku
English: Histopathology standard of truth data was available for 99 of the 115 subjects.
Slovenian: Histopatološki podatki, določeni kot standard resnice, so bili na voljo za 99 od 115 preiskovancev.
English: Appropriate aseptic precautions should be taken.
Slovenian: Sprejeti je treba ustrezne aseptične previdnostne ukrepe.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Slovenian: To osebje bo posebej pazilo na varno uporabo tega zdravila in vas obveščalo o svojih ukrepih.
English: Axumin is not intended for use in children and adolescents aged under 18 years.
Slovenian: Zdravilo Axumin ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Slovenian: Zdravilo se shranjuje na odgovornost specialista v ustreznih prostorih.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Slovenian: Aplicirana aktivnost mora biti v vsakem primeru tako nizka, kot jo je razumno mogoče doseči za pridobitev zahtevanih diagnostičnih podatkov.
English: Axumin will only be used in specially controlled areas.
Slovenian: Zdravilo Axumin se uporablja samo na posebej nadzorovanih območjih.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se ne uporabi takoj, je za čas in pogoje shranjevanja med uporabo odgovoren uporabnik.
English: The major route of elimination is via the renal pathway.
Slovenian: Glavna pot izločanja je skozi ledvice.
English: Typical total scan time is between 20-30 minutes.
Slovenian: Običajni skupni čas slikanja je 20-30 minut.
English: The Healthcare professionals self-training material shall contain the following key elements:
Slovenian: Gradivo za samostojno usposabljanje zdravstvenih delavcev mora vsebovati ključne elemente:
English: radioactive
Slovenian: radioaktivno
English: Washout of activity from most organs and tissues (with the exception of the pancreas) is slow.
Slovenian: Izpiranje aktivnosti iz večine organov in tkiv (razen trebušne slinavke) je počasno.
English: From a microbiological point of view, unless the method of opening/ dose withdrawal/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča, če način odprtja/odvzema odmerka/razredčitve ne izključi nevarnosti mikrobiološke kontaminacije, je treba zdravilo uporabiti takoj.
English: Withdrawals should be performed under aseptic conditions.
Slovenian: Odvzem odmerkov je treba opraviti v aseptičnih pogojih.
English: The solution should be inspected visually prior to use.
Slovenian: Raztopino je treba pred uporabo vizualno pregledati.
English: In clinical studies side effects were reported by less than 1 in 100 patients given the medicine.
Slovenian: V kliničnih študijah so poročali o pojavu neželenih učinkov pri manj kot 1 od 100 bolnikov, ki so prejeli zdravilo.
English: - Pain or rash at the site of injection, altered taste in the mouth, altered sense of smell.
Slovenian: - Bolečina ali izpuščaj na mestu injiciranja, spremenjen okus v ustih, spremenjen čut za vonj.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Slovenian: Specialist nuklearne medicine vas bo obvestil o običajnem trajanju postopka.
English: Urinary excretion is slow, reaching approximately 3% of administered radioactivity within 4 hours and 5% within 24 hours.
Slovenian: Izločanje z urinom je počasno; v 4 urah doseže približno 3 % aplicirane radioaktivnosti in v 24 urah 5 %.
English: Paediatric population For information on use in the paediatric population, see section 4.2.
Slovenian: Pediatrična populacija Za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: Effective dose
Slovenian: Efektivni odmerek
English: Increasing the duration of acquisition over the pelvis may increase the sensitivity of detection of disease.
Slovenian: Podaljšanje časa slikanja nad predelom medenice lahko poveča občutljivost za odkrivanje bolezni.
English: Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
Slovenian: Vrednosti so bile izračunane iz podatkov biološke porazdelitve pri ljudeh ob uporabi programske opreme OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling).
English: The patient should be positioned supine with arms above the head.
Slovenian: Bolnik mora ležati na hrbtu z rokami nad glavo.
English: This medicinal product is not intended for regular or continuous administration.
Slovenian: To zdravilo ni namenjeno za redno ali neprekinjeno uporabo.
English: This medicine is not indicated for use in women.
Slovenian: To zdravilo ni namenjeno za uporabo pri ženskah.
English: Histological assessment of extraprostatic sites (either regional lymph nodes or distant sites) was only conducted for sites with positive image findings.
Slovenian: Histološko oceno lokacij zunaj prostate (bodisi regionalnih bezgavk ali oddaljenih lokacij) so izvedli samo na lokacijah s pozitivnimi ugotovitvami na slikah.
English: Long-term carcinogenicity studies have not been carried out.
Slovenian: Dolgotrajne študije karcinogenosti zdravila niso bile opravljene.
English: If the injection volume is between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used.
Slovenian: Če je volumen injiciranja med 0,5 in 1 ml, se smejo uporabiti samo brizge ustrezne velikosti (1 ml).
English: - not eat or drink for at least 4 hours before the scan (you can take your usual medicines with small amounts of water).
Slovenian: - jesti ali piti vsaj 4 ure pred slikanjem (vendar lahko vzamete običajna zdravila z majhno količino vode).
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of Axumin to be used in your case.
Slovenian: Specialist nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila Axumin, ki bo uporabljena v vašem primeru.
English: Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Slovenian: Vaš zdravnik in specialist nuklearne medicine sta presodila, da korist tega postopka z radiofarmakom odtehta tveganje zaradi izpostavljenosti sevanju.
English: For the limitations in the interpretation of a positive scan, see section 4.4 and 5.1.
Slovenian: Za omejitve pri razlaganju pozitivnega rezultata slikanja glejte poglavji 4.4 in 5.1.
English: For instructions on dilution of the medicinal product before administration, see section 12.
Slovenian: Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 12.
English: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud France
Slovenian: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud Francija
English: Table 3: Estimated radiation absorbed doses for adults receiving Axumin Organ/Tissue
Slovenian: Preglednica 3: Ocenjeni absorbirani odmerki sevanja pri odraslih, ki so prejeli zdravilo Axumin Organ/tkivo
English: The patient should be encouraged to drink sufficient amounts and void as often as possible during the first hours after the scan in order to reduce radiation exposure of the bladder.
Slovenian: Bolnika je treba spodbujati k pitju zadostnih količin tekočine in čim pogostejšem odvajanju v prvih urah po slikanju, da se zmanjša izpostavljenost sečnega mehurja sevanju.
English: Prior to administration of fluciclovine (18F), patients should not eat or drink for at least 4 hours (other than small amounts of water for taking medicinal products).
Slovenian: Pred aplikacijo [18F]fluciklovina bolniki ne smejo jesti ali piti vsaj 4 ure (razen majhne količine vode ob jemanju zdravil).
English: Blinded reads were compared with the histopathological standard of truth.
Slovenian: Slepe razlage so primerjali s histopatološkimi izvidi, določenimi kot standard resnice.
English: The nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine.
Slovenian: Specialist nuklearne medicine vas bo obvestil, če boste morali po prejemu tega zdravila uporabiti kakršne koli druge posebne previdnostne ukrepe.
English: You should discuss the results of the test with the doctor that requested the scan.
Slovenian: O rezultatih preiskave se morate pogovoriti z zdravnikom, ki je zahteval pregled.
English: This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: Z njim bodo ravnali in vam ga dajali samo strokovnjaki, ki so usposobljeni za njegovo varno uporabo.
English: Uptake by tumours is rapid, with the highest tumour-to-normal tissue contrast between 4 and 10 minutes after injection and continuing for around 30 minutes, with a 61% reduction in mean tumour uptake at 90 minutes after injection.
Slovenian: Privzem v tumorje je hiter, z največjim kontrastom med tumorskim in normalnim tkivom od 4 do 10 minut po injiciranju, in se nadaljuje približno 30 minut, z 61-odstotnim zmanjšanjem povprečnega privzema v tumor 90 minut po injiciranju.
English: The use of Axumin does involve exposure to small amounts of radioactivity.
Slovenian: Uporaba zdravila Axumin vključuje izpostavljenost majhni količini radioaktivnosti.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images.
Slovenian: Obvestite specialista za nuklearno medicino, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, saj lahko vpliva na razlago slik.
English: Quality control
Slovenian: Preverjanje kakovosti
English: The recommended maximum volume of injection of undiluted Axumin is 5 mL.
Slovenian: Največja priporočena količina nerazredčenega zdravila Axumin v injekciji je 5 ml.
English: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL UK
Slovenian: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL Velika Britanija
English: Mean absorbed dose per unit administered activity (µGy/MBq)
Slovenian: Povprečni absorbirani odmerek na enoto aplicirane aktivnosti (µGy/MBq)
English: The following side effects of Axumin are common (may affect up to 1 in 100 people).
Slovenian: Naslednji neželeni učinki zdravila Axumin so pogosti (pojavijo se lahko pri največ 1 od 100
English: Only clear solutions, free of visible particles should be used.
Slovenian: Uporabiti se smejo samo bistre raztopine brez vidnih delcev.
English: If at any time in the preparation of this medicinal product the integrity of the vial is compromised it should not be used.
Slovenian: Če je kadar koli med pripravo tega zdravila celovitost viale ogrožena, se viala ne sme uporabiti.
English: Fluciclovine is not incorporated into proteins.
Slovenian: Fluciklovin se ne vgradi v proteine.
English: Exp{hh:mm}{Time Zone}{DD/MM/YYYY}
Slovenian: Exp{hh:mm}{časovni pas}{DD/MM/LLLL}
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Axumin in one or more subsets of the paediatric population in diagnosis of amino acid metabolism in solid tumours (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Axumin za eno ali več podskupin pediatrične populacije pri diagnosticiranju presnove aminokislin pri solidnih tumorjih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Washout of 18F activity from the blood is such that about half of the maximum 18F concentration in blood is reached by about 1 hour after administration.
Slovenian: Izpiranje aktivnosti 18F iz krvi je takšno, da je približno polovica največje koncentracije 18F v krvi dosežena približno 1 uro po dajanju.
English: A CT scan should be obtained for attenuation correction and anatomic correlation.
Slovenian: Izdelati je treba sliko CT za popravek oslabitve in anatomsko korelacijo.
English: Axumin must not be used after the expiry date which is stated on the shield label after Exp.
Slovenian: Zdravila Axumin ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ščitniku poleg oznake »Exp«.
English: - if you are allergic to fluciclovine (18F) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na [18F]fluciklovin ali katero koli sestavino tega zdravila (navedeno v poglavju
English: The scan will usually start approximately 5 minutes after the Axumin injection is given.
Slovenian: Slikanje se navadno opravi približno 5 minut po injiciranju zdravila Axumin.
English: Any unused material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljen material je treba odstraniti skladno z lokalnimi predpisi.
English: As a result of the manufacturing process some vials are distributed with punctured rubber stoppers.
Slovenian: Zaradi postopka izdelave imajo nekatere viale na trgu predrte gumijaste zamaške.
English: In addition, fluciclovine uptake may be increased by an inflammatory reaction to recent radiotherapy or cryotherapy.
Slovenian: Poleg tega se lahko privzem fluciklovina poveča zaradi vnetne reakcije na nedavno obsevanje ali krioterapijo.
English: Toxicological studies with rats and dogs have demonstrated that with a single intravenous injection no deaths were observed.
Slovenian: V toksikoloških študijah pri podganah in psih ni bilo po posamezni intravenski injekciji nobenega smrtnega primera.
English: Axumin is a clear, colourless solution stored in a glass vial.
Slovenian: Zdravilo Axumin je bistra, brezbarvna raztopina, shranjena v stekleni viali.
English: The complete SmPC of Axumin is provided as a separate document in the package of the medicinal product, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Slovenian: Celoten povzetek glavnih značilnosti zdravila Axumin, ki je na voljo kot ločen dokument v pakiranju izdelka, zagotavlja zdravstvenim delavcem dodatne znanstvene in praktične informacije o dajanju in uporabi tega radiofarmaka.
English: The quantity to be administered usually recommended for an adult is 370 MBq (megabecquerel, the unit used to express radioactivity).
Slovenian: Količina, ki se običajno priporoča za odrasle, je 370 MBq (megabekerel je enota, ki se uporablja za izražanje radioaktivnosti).
English: A quantitative correlation between fluciclovine uptake and enhanced fluciclovine influx into cells was not assessed in vivo in healthy volunteers or prostate cancer patients.
Slovenian: Kvantitativna korelacija med privzemom fluciklovina in povečanim dotokom fluciklovina v celice ni bila ocenjena in vivo pri zdravih prostovoljcih ali bolnikih z rakom prostate.
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmake je treba pripraviti na način, ki zadošča zaščiti pred sevanjem in zahtevam za farmacevtsko kakovost.
English: As the effective dose is 8.2 mSv when the maximal recommended activity of 370 MBq is administered these adverse reactions are expected to occur with a low probability.
Slovenian: Ker je efektivni odmerek 8,2 mSv pri uporabi največje priporočene aktivnosti 370 MBq, je pojavnost neželenih učinkov malo verjetna.
English: For detection of extraprostatic recurrences (regional lymph node and/or distal metastases) sensitivity was 84.2% (32/38) (95%CI: 68.7-94%) and specificity was 89.7% (78/87) (95%CI: 81.3-95.2%), respectively.
Slovenian: Pri odkrivanju ponovitev zunaj prostate (regionalne bezgavke in/ali oddaljene metastaze) je bila občutljivost 84,2 % (32/38) (95 % IZ: 68,7-94 %) in specifičnost 89,7 % (78/87) (95 % IZ: 81,3-95,2 %).
English: The pivotal efficacy data derives from 115 patients recruited into the BED-001 study at Emory
Slovenian: Ključni podatki o učinkovitosti temeljijo na 115 bolnikih, ki so sodelovali v študiji BED-001 na Univerzi Emory.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Slovenian: prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja pristojnega urada.
English: This medicine contains up to 39 mg sodium per dose.
Slovenian: To zdravilo vsebuje do 39 mg natrija na odmerek.
English: If you have previously had treatment for prostate cancer and information from other tests (e.g. prostate specific antigen, PSA) indicates that the cancer may have returned, an Axumin PET scan can help your doctor find the locations where the cancer has come back.
Slovenian: Če ste se v preteklosti že zdravili zaradi raka na prostati in podatki iz drugih preiskav (npr. prostatičnega specifičnega antigena, PSA) kažejo, da se je rak morda vrnil, lahko pozitronska emisijska tomografija z zdravilom Axumin pomaga zdravniku najti mesta, kjer se je rak ponovil.
English: An overdose is unlikely because you will only receive a single dose of Axumin precisely controlled by the nuclear medicine doctor supervising the procedure.
Slovenian: Prevelik odmerek ni verjeten, saj boste prejeli samo en odmerek zdravila Axumin, ki ga bo odgovorni specialist nuklearne medicine natančno nadzoroval.
English: With increasing time post injection, distributed uptake is apparent and is mostly associated with skeletal muscle.
Slovenian: Po injekciji sčasoma postane očiten porazdeljen privzem, večinoma v skeletne mišice.
English: They are listed below by MedDRA body system organ class.
Slovenian: Ti so navedeni spodaj, razvrščeni po organskih sistemih skladno z MedDRA.
English: Each mL of solution contains 7.7 mg of sodium.
Slovenian: En ml raztopine vsebuje 7,7 mg natrija.
English: No. subjects in analysis
Slovenian: Št. preiskovancev v analizi
English: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIA
Slovenian: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG Forschungszentrum 2444 Seibersdorf AVSTRIJA