FrancophonIA/ELRC3.0 huggingface dataset:
English: Fluciclovine (18F) is preferentially taken up into prostate cancer cells compared with surrounding normal tissues.
Croatian: Fluciklovin (18F) se preferencijalno nakuplja u tumorskim stanicama prostate u usporedbi s okolnim normalnim tkivima.
English: Axumin is supplied in a 10 mL or 15 mL type 1 glass vial sealed with a fluoro-coated chlorobutyl, chlorobutyl or bromobutyl rubber closure and aluminium overseal.
Croatian: I od 10 ml ili 15 ml zatvorenoj fluoro-premazani klorobutilnim, klorobutilnim ili bromobutilnim gumenim zatvaračem i aluminijskim prstenom.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Croatian: U svakom slučaju, dijagnostički rezultati trebaju biti postignuti što je moguće manjom primijenjenom aktivnosti.
English: Diagnostic performance of fluciclovine (18F) to detect recurrences has not been investigated in patients with a suspected recurrence based on elevated blood PSA levels after primary radical treatment with a recent positive whole-body bone scintigraphy.
Croatian: Dijagnostičke performanse fluciklovina (18F) u otkrivanju ponovne pojave bolesti nisu ispitane u bolesnika sa sumnjom na ponovnu pojavu bolesti na temelju povišenih razina PSA u krvi nakon primarnog radikalnog liječenja s nedavnom pozitivnom scintigrafijom kostiju cijelog tijela.
English: Interpretation of fluciclovine (18F) images and limitations of use Fluciclovine (18F) images should be interpreted by appropriately trained personnel.
Croatian: Tumačenje snimaka dobivenih s fluciklovinom (18F) i ograničenje primjene Snimke dobivene s fluciklovinom (18F) smije tumačiti samo osoblje koje je za to prikladno educirano.
English: - The active substance is fluciclovine (18F).
Croatian: - Djelatna tvar je fluciklovin (18F).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL:
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA ZAŠTITNOM SPREMNIKU:
English: Elderly No dose adjustment required.
Croatian: Nije potrebno prilagođavati dozu.
English: In in vitro studies, fluciclovine (18F) was not taken up by common drug transporters indicating a negligible potential for drug interactions.
Croatian: U in vitro ispitivanjima, fluciklovin (18F) se nije unosio uobičajenim prijenosnicima lijeka što ukazuje na zanemarivu mogućnost interakcija s drugim lijekovima.
English: 88.6% for all three readers while specificity ranged from 17.2-53.6%.
Croatian: Osjetljivost fluciklovina (18F) na temelju bolesnika bila je viša od 88,6% za sve tri osobe koje su očitale rezultate, a specifičnost se kretala između 17,2% i 53,6%.
English: The PSA value may affect the diagnostic performance of fluciclovine (18F) PET. (see section 5.1, Pharmacodynamic properties).
Croatian: Vrijednost PSA može utjecati na dijagnostičke performanse fluciklovina (18F) u PET snimanju (vidjeti dio 5.1 Farmakodinamička svojstva).
English: Images should only be interpreted by readers trained in the interpretation of PET images with fluciclovine (18F).
Croatian: Snimke smiju tumačiti samo specijalisti educirani za tumačenje PET snimki s fluciklovinom (18F).
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Croatian: Postupke primjene treba izvršiti na način koji u najvećoj mogućoj mjeri smanjuje mogućnost kontaminacije lijeka i ozračivanja osoba koje njime rukuju.
English: Any unused material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Via Piero Maroncelli 40
Croatian: Advanced Accelerator Applications (Italy) s.r.l. Via Piero Maroncelli 40
English: Total body
Croatian: Maternica Cijelo tijelo
English: For sodium, see leaflet for further information.
Croatian: Za dodatne informacije o natriju vidjeti uputu o lijeku.
English: After administration of Axumin you should:
Croatian: Nakon primjene lijeka Axumin:
English: Adrenal glands Brain
Croatian: Nadbubrežne žlijezde Mozak
English: Effect of blood PSA level on the patient-based diagnostic performance of fluciclovine (18F) PET-CT at BED-001 Emory
Croatian: Tablica 2. Utjecaj razine PSA u krvi na dijagnostičke performanse PET-CT snimki s fluciklovinom (18F) na temelju bolesnika u ispitivanju BED-001 u Emoryju
English: Renal/Hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Croatian: Oštećenje funkcije bubrega/jetre Farmakokinetika u bolesnika s oštećenjem funkcije bubrega ili jetre nije okarakterizirana.
English: How Axumin is used
Croatian: Kako se primjenjuje Axumin
English: Patient and region based diagnostic performance of fluciclovine 18F PET vs histopathology
Croatian: Tablica 1. Dijagnostičke performanse PET snimki s fluciklovinom 18F bazirane na bolesniku i regiji u usporedbi s histopatologijom
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Croatian: Radiofarmaceutike treba čuvati u skladu s nacionalnim propisima koji reguliraju radioaktivne materijale.
English: Method of administration Axumin is for intravenous use.
Croatian: Axumin je namijenjen za intravensku primjenu.
English: Axumin 1600 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at calibration time.
Croatian: Axumin 1600 MBq/ml otopina za injekciju Jedna bočica sadrži od 1 do 10 ml otopine, što odgovara 1600 do 16 000 MBq u vrijeme umjeravanja.
English: The Patient-based diagnostic performance of fluciclovine (18F) PET-CT by blood PSA level is shown in Table 2.
Croatian: Dijagnostičke performanse PET-CT snimanja s fluciklovinom (18F) na temelju bolesnika prema razini PSA u krvi prikazane su u Tablici 2.
English: The medicinal product may be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection by up to a factor of 8.
Croatian: Metoda pripreme Lijek se može razrijediti otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju do 8 puta većeg volumena konačne otopine.
English: Axumin 3200 MBq/mL solution for injection 10 hours from the time of calibration (ToC)
Croatian: Axumin 3200 MBq/ml otopina za injekciju 10 sati nakon vremena umjeravanja (ToC)
English: Axumin may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection by a factor of 8.
Croatian: Axumin se može razrijediti otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju do 8 puta većeg volumena konačne otopine.
English: Axumin 3200 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at calibration time.
Croatian: Axumin 3200 MBq/ml otopina za injekciju Jedna bočica sadrži od 1 do 10 ml otopine, što odgovara 3200 do 32 000 MBq u vrijeme umjeravanja.
English: Axumin 3200 MBq/mL solution for injection fluciclovine (18F)
Croatian: Axumin 3200 MBq/ml otopina za injekciju fluciklovin (18F)
English: Axumin 1600 MBq/mL solution for injection 8 hours from the time of calibration (ToC)
Croatian: Axumin 1600 MBq/ml otopina za injekciju 8 sati nakon vremena umjeravanja (ToC)
English: Activity: {YYYY} MBq in {xx.x} mL at {hh:mm}{Time Zone} {DD/MM/YYYY}
Croatian: Volumen: {xx,x} ml Aktivnost: {YYYY} MBq u {xx,x} ml u {hh:mm}{vremenska zona} {DD/MM/GGGG}
English: Activity: {YYYY} MBq in {xx.x}mL at {hh:mm}{Time Zone} {DD/MM/YYYY}
Croatian: Volumen: {xx,x} ml Aktivnost: {YYYY} MBq u {xx,x}ml u {hh:mm}{vremenska zona} {DD/MM/GGGG}
English: Axumin 1600 MBq/mL solution for injection Axumin 3200 MBq/mL solution for injection
Croatian: Axumin 1600 MBq/ml otopina za injekciju Axumin 3200 MBq/ml otopina za injekciju
English: Package leaflet: Information for the patient Axumin 1600 MBq/mL solution for injection Axumin 3200 MBq/mL solution for injection fluciclovine (18F) This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Axumin 1600 MBq/ml otopina za injekciju Axumin 3200 MBq/ml otopina za injekciju fluciklovin (18F)
English: Axumin is for multidose use.
Croatian: Axumin je namijenjen za višekratnu primjenu.
English: Axumin 1600 MBq/mL solution for injection fluciclovine (18F)
Croatian: Axumin 1600 MBq/ml otopina za injekciju fluciklovin (18F)
English: Image interpretation errors can occur with PET with fluciclovine (18F) (see section 5.1).
Croatian: Kod PET snimanja s fluciklovinom (18F) moguće su pogreške u tumačenju snimki (vidjeti dio 5.1).
English: Urinary bladder wall Uterus
Croatian: Štitnjača Stijenka mokraćnog mjehura
English: Gallbladder wall Lower large intestine wall Small intestine wall Stomach wall Upper large intestine wall Heart wall
Croatian: Stijenka tankog crijeva Stijenka želuca
English: How Axumin is stored
Croatian: Kako se čuva Axumin
English: Each multidose vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at the date and time of calibration (ToC).
Croatian: Jedna višedozna bočica sadrži između 1 i 10 ml otopine, što odgovara između 3200 to 32 000 MBq na dan i sat umjeravanja (ToC).
English: The detection of prostate cancer recurrence in prostate/prostate bed, regional lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported.
Croatian: Kod PET snimanja s fluciklovinom (18F) prijavljeno je otkrivanje ponovne pojave karcinoma prostate u prostati/ležištu prostate, regionalnim limfnim čvorovima, kostima, mekom tkivu i neregionalnim limfnim čvorovima.
English: The activity per vial ranges from 1600 MBq to 16000 MBq at the date and time of calibration.
Croatian: Aktivnost po bočici kreće se između 1600 MBq i 16000 MBq na dan i sat umjeravanja.
English: Image acquisition
Croatian: Način primjene
English: An additional study BED002 conducted a blinded read of fluciclovine (18F) PET-CT images from the
Croatian: Dodatno ispitivanje BED-002 provelo je slijepo očitavanje PET-CT snimki s fluciklovinom (18F) iz podataka podskupine iz Emoryja u ispitivanju BED-001, a tri osobe su očitale rezultate.
English: Location
Croatian: Mjesto
English: The diagnostic performance of fluciclovine (18F) PET-CT for the detection of recurrence overall (at any location), and in 3 different locations (prostate/bed, pelvic lymph nodes, and distant metastases) is shown in Table 1.
Croatian: (na bilo kojem mjestu) i na 3 različita mjesta (prostata/ležište prostate, zdjelični limfni čvorovi i udaljene metastaze) prikazane su u Tablici 1.
English: - If you get any side effects, talk to your nuclear medicine doctor.
Croatian: Ako imate bilo kakvih pitanja, obratite se svom liječniku specijalisti nuklearne medicine.
English: The activities of LAT-1 and ASCT2 are known to be upregulated in prostate cancer, providing a mechanism for the enhanced accumulation of fluciclovine (18F) in prostate cancer.
Croatian: povećana kod karcinoma prostate, pružajući mehanizam za povećano nakupljanje fluciklovina (18F) u karcinomu prostate.
English: Axumin has not been studied in patients with renal or hepatic impairment.
Croatian: Oštećenje funkcije bubrega i jetre Axumin nije ispitan u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Kidneys
Croatian: Nuspojave
English: Please refer to the SmPC [SmPC should be included in the box]
Croatian: Pogledajte sažetak opisa svojstava lijeka [Sažetak opisa svojstava lijeka treba se nalaziti u kutiji].
English: Axumin 3200 MBq/mL solution for injection
Croatian: Axumin 3200 MBq/ml otopina za injekciju
English: Before administration of Axumin you should
Croatian: Prije primjene lijeka Axumin trebate
English: Axumin 1600 MBq/mL solution for injection
Croatian: Axumin 1600 MBq/ml otopina za injekciju
English: The activity of fluciclovine (18F) has to be measured with an activimeter immediately prior to injection.
Croatian: Distribucija Fluciklovin (18F) se distribuira neposredno nakon primjene u jetru (14% od primijenjene aktivnosti),
English: Each mL of solution for injection contains 3200 MBq of fluciclovine (18F) at date and time of calibration (ToC).
Croatian: Jedan ml otopine za injekciju sadrži 3200 MBq fluciklovina (18F) na dan i sat umjeravanja (ToC).
English: Parosmia
Croatian: OBLIK
English: Each mL of solution for injection contains 1600 MBq of fluciclovine (18F) at date and time of calibration (ToC).
Croatian: Jedan ml otopine za injekciju sadrži 1600 MBq fluciklovina (18F) na dan i sat umjeravanja (ToC).
English: Breasts
Croatian: Parozmija
English: The activity per vial ranges from 3200 MBq to 32000 MBq at the date and time of calibration (ToC).
Croatian: Aktivnost po bočici kreće se između 3200 MBq i 32000 MBq na dan i sat umjeravanja.
English: Lungs
Croatian: Pluća Mišići
English: Each mL of solution contains 1600 MBq fluciclovine (18F) at date and time of calibration (ToC).
Croatian: Jedan ml otopine sadrži 1600 MBq fluciklovina (18F) na dan i sat umjeravanja (engl. time of calibration, ToC).
English: Each mL of solution contains 3200 MBq of fluciclovine (18F) at the date and time of calibration (ToC).
Croatian: Jedan ml otopine sadrži 3200 MBq fluciklovina (18F) na dan i sat umjeravanja (ToC).
English: True positive (%) False positive (%) True negative (%) False negative (%) Sensitivity [95% CI] Specificity [95% CI]
Croatian: Osjetljivost [95% CI]
English: Possible side effects
Croatian: Mehanizam djelovanja
English: In use
Croatian: U primjeni
English: The full EPAR for Clopidogrel Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Krka nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The standard dose is one 75-mg tablet once a day.
Croatian: Standardna je doza jedna tableta od 75 mg jednom na dan.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Croatian: Nakon toga se daje standardna doza od 75 mg jednom na dan u trajanju od najmanje četiri tjedna (kod infarkta miokarda s „elevacijom ST-segmenta”) ili u trajanju od najviše 12 mjeseci (kod nestabilne angine ili „non-Q” infarkta miokarda).
English: This means that Clopidogrel Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Croatian: To znači da je Clopidogrel Krka sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Plavix.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Croatian: Kod akutnog koronarnog sindroma liječenje obično počinje s početnom dozom od četiri tablete.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Croatian: • imaju bolest perifernih arterija (problemi s protokom krvi u arterijama);
English: Clopidogrel Krka clopidogrel
Croatian: Clopidogrel Krka klopidogrel
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Clopidogrel Krka.
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Croatian: Akutni koronarni sindrom skupina je srčanih problema koji uključuju srčane udare i nestabilnu anginu (težak oblik boli u prsima).
English: What measures are being taken to ensure the safe and effective use of Clopidogrel Krka?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Clopidogrel Krka?
English: Clopidogrel Krka can be started between seven days and six months after the stroke;
Croatian: Terapija lijekom Clopidogrel Krka može započeti od sedam dana do šest mjeseci nakon udara;
English: What are the benefits and risks of Clopidogrel Krka?
Croatian: Koje su koristi i rizici od lijeka Clopidogrel Krka?
English: What is Clopidogrel Krka and what is it used for?
Croatian: Što je Clopidogrel Krka i za što se koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel Krka have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Clopidogrel Krka nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Clopidogrel Krka can be started between a few days and 35 days after the attack;
Croatian: Terapija lijekom Clopidogrel Krka može započeti od nekoliko dana do 35 dana nakon infarkta;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Krka on 23 September 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Clopidogrel Krka u promet koje vrijedi na prostoru Europske unije od 23. rujna 2009.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel Krka has been shown to have comparable quality and to be bioequivalent to Plavix.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da lijek Clopidogrel Krka posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Plavix.
English: It is not intended to provide practical advice on how to use Clopidogrel Krka.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Clopidogrel Krka.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Croatian: Primjenjuje se u onih bolesnika kod kojih je prisutan barem jedan čimbenik rizika od vaskularnih problema, kao što su srčani udar ili moždani udar, koji ne mogu uzimati antagoniste vitamina K (lijekovi koji sprečavaju stvaranje krvnih ugrušaka) i kod kojih postoji mali rizik od krvarenja.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Croatian: • boluju od stanja poznatog pod nazivom „akutni koronarni sindrom”, pri čemu se ovaj lijek treba davati zajedno s aspirinom (još jedan lijek koji sprečava stvaranje krvnih ugrušaka).
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Croatian: • su nedavno pretrpjele ishemijski moždani udar (udar uzrokovan prestankom dotoka krvi u određeni dio mozga).
English: For more information about treatment with Clopidogrel Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Clopidogrel Krka pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Clopidogrel Krka is used to prevent problems caused by blood clots in adults who have:
Croatian: Krka koristi se za sprečavanje problema uzrokovanih stvaranjem krvnih ugrušaka u odraslih osoba koje:
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Croatian: To sprečava „lijepljenje” trombocita, čime se smanjuje rizik od nastanka krvnih ugrušaka i pomaže pri sprečavanju infarkta miokarda ili moždanog udara.
English: Clopidogrel Krka is available as tablets containing 75 mg clopidogrel.
Croatian: Krka dostupan je u obliku tableta koje sadrže 75 mg klopidogrela.
English: Clopidogrel Krka is a ‘generic medicine'.
Croatian: Krka je „generički lijek”.
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Croatian: Klopidogrel sprečava nakupljanje trombocita tako što inhibira vezanje tvari naziva ADP na posebni receptor na površini trombocita.
English: Other information about Clopidogrel Krka
Croatian: Ostale informacije o lijeku Clopidogrel Krka
English: Because Clopidogrel Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Krka generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: For practical information about using Clopidogrel Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Clopidogrel Krka bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Because Clopidogrel Krka is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Croatian: Budući da je Clopidogrel Krka generički lijek, ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Plavix.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Krka is used together with aspirin, the dose of which should not be higher than 100 mg.
Croatian: Krka koristi se zajedno s aspirinom, čija doza ne smije biti veća od 100 mg.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Croatian: Do nastanka krvnih ugrušaka dolazi kada se posebne stanice u krvi koje se nazivaju trombociti nakupljaju (sljepljuju).
English: The Agency recommended that Clopidogrel Krka be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Clopidogrel Krka u promet.
English: The active substance in Clopidogrel Krka, clopidogrel, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar lijeka Clopidogrel Krka, klopidogrel, jest inhibitor nakupljanja trombocita.
English: Why is Clopidogrel Krka approved?
Croatian: Zašto je lijek Clopidogrel Krka odobren?
English: How has Clopidogrel Krka been studied?
Croatian: Kako je Clopidogrel Krka ispitivan?
English: How does Clopidogrel Krka work?
Croatian: Kako djeluje Clopidogrel Krka?
English: Clopidogrel Krka contains the active substance clopidogrel.
Croatian: Krka sadržava djelatnu tvar klopidogrel.
English: Clopidogrel Krka can only be obtained with a prescription.
Croatian: Krka izdaje se samo na liječnički recept.
English: The joint PASS final study report submitted by the MAHs complies with their obligation to perform a PASS to evaluate the effectiveness of the risk minimisation activities as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Croatian: Završno izvješće zajedničkog PASS ispitivanja koje su podnijeli nositelji odobrenja za stavljanje lijeka u promet u skladu je s njihovom obvezom provođenja PASS ispitivanje kako bi se procijenila učinkovitost aktivnosti za minimizaciju rizika kako je zadano tijekom postupka EMA/H/A-107i/1357 po članku 107i za lijekove koji sadrže ciproteron/etinilestradiol.
English: The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Croatian: Nositelj odobrenja treba podnijeti protokol za PASS u skopu podnošenja plana upravljanja rizikom kako bi se procijenila učinkovitost aktivnosti za minimizaciju rizika.
English: Therefore, in view of available data regarding the joint PASS final study report, the PRAC Rapporteur considered that changes to the conditions of the marketing authorisation were warranted.
Croatian: Stoga, s obzirom na dostupne podatke o završnom izvješću o zajedničkom PASS ispitivanju, PRAC-ov izvjestitelj smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.