FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Cimzia, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Cimzia pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Certolizumab pegol has been designed to attach to a messenger protein in the body called tumour necrosis factor alpha (TNF-alpha).
Croatian: Certolizumabpegol namijenjen je vezivanju na posrednički protein u tijelu pod nazivom faktor nekroze tumora alfa (TNF-alfa).
English: A third study compared Cimzia with placebo as well as another medicine called etanercept.
Croatian: U trećem ispitivanju lijek Cimzia uspoređen je s placebom te još jednim lijekom pod nazivom etanercept.
English: Cimzia received a marketing authorisation valid throughout the EU on 1 October 2009.
Croatian: Lijek Cimzia dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 1. listopada
English: • In the treatment of moderate to severe plaque psoriasis, Cimzia was compared with placebo in two main studies.
Croatian: • U liječenju umjerene do teške plak psorijaze, lijek Cimzia uspoređen je s placebom u dvama glavnim ispitivanjima.
English: Cimzia contains the active substance certolizumab pegol.
Croatian: Cimzia sadrži djelatnu tvar certolizumabpegol.
English: In a study in 879 patients who had never received DMARDs, treatment with Cimzia and methotrexate led to remission in almost 29% of patients (189 out of 655), compared with 15% (32 out of 213) of patients receiving placebo with methotrexate.
Croatian: U ispitivanju koje je uključilo 879 bolesnika koji nikada nisu primali lijekove DMARD, terapija lijekom Cimzia i metotreksatom dovela je do remisije u gotovo 29 % bolesnika (189 od 655), u usporedbi s 15 % (32 od 213) bolesnika koji su primali placebo i metotreksat.
English: • For active rheumatoid arthritis that had not improved adequately with disease-modifying antirheumatic drug (DMARD) treatment, two main studies found Cimzia effective when used with methotrexate when compared with placebo (dummy treatment).
Croatian: • U slučaju aktivnog reumatoidnog artritisa koji se uz primjenu antireumatskih lijekova koji mijenjaju tijek bolesti (DMARD) nije odgovarajuće poboljšao, dva glavna ispitivanja pokazala su da je lijek Cimzia učinkovit kada se primjenjuje s metotreksatom u usporedbi s placebom (prividno liječenje).
English: How does Cimzia work?
Croatian: Kako djeluje Cimzia?
English: • active rheumatoid arthritis (a disease causing inflammation of the joints) when it is used in combination with another medicine, methotrexate, or given alone when treatment with
Croatian: • aktivnog reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova) kada se primjenjuje u kombinaciji s drugim lijekom, metotreksatom ili samostalno ako liječenje metotreksatom nije prikladno,
English: In the first study, symptoms were reduced by at least 20% in 57% of patients who received Cimzia (141 out of 246) compared with 9% of patients who received placebo (11 out of 127).
Croatian: U prvom ispitivanju simptomi su se smanjili za najmanje 20 % u 57 % bolesnika koji su primali lijek Cimzia (141 od 246) u usporedbi s 9 % bolesnika koji su primali placebo (11 od 127).
English: The company that markets Cimzia will provide educational packs for doctors who will prescribe Cimzia.
Croatian: Tvrtka koja stavlja lijek Cimzia u promet mora dostaviti komplete za obuku liječnika koji će propisivati taj lijek.
English: Cimzia (certolizumab pegol)
Croatian: Cimzia (certolizumabpegol)
English: What benefits of Cimzia have been shown in studies?
Croatian: Koje su koristi od lijeka Cimzia utvrđene u ispitivanjima?
English: After 12 weeks of treatment, Cimzia 200 mg every two weeks led to 61% of patients responding and 67% responding with Cimzia 400 mg every two weeks compared with 53% of patients receiving etanercept and 5% of patients receiving placebo.
Croatian: Nakon 12 tjedana liječenja, uz terapiju lijekom Cimzia u dozi od 200 mg svaka dva tjedna, postignut je odgovor u 61 % bolesnika i u 67 % bolesnika koji su primali lijek Cimzia u dozi od 400 mg svaka dva tjedna, u usporedbi s 53 % bolesnika koji su primali etanercept i 5 % onih koji su primali placebo.
English: In the other main study, symptoms were reduced by at least 20% in 59% of patients who received Cimzia (228 out of 388) compared with 14% of patients who received placebo (27 out of 198).
Croatian: U drugom glavnom ispitivanju simptomi su se smanjili za najmanje 20 % u 59 % bolesnika koji su primali lijek Cimzia (228 od 388) u usporedbi s 14 % bolesnika koji su primali placebo (27 od 198).
English: Treatment with Cimzia 200 mg every two weeks in the two studies led to 66.5% and 52.6% of patients responding compared with 6.5% and 4.5% of patients receiving placebo.
Croatian: U dvama ispitivanjima uz terapiju lijekom Cimzia u dozi od 200 mg svaka dva tjedna postignut je odgovor u 66,5 % i 52,6 % bolesnika u usporedbi sa 6,5 % i 4,5 % bolesnika koji su primali placebo.
English: Cimzia is available as pre-filled syringes, prefilled pens and dose-dispenser cartridge.
Croatian: Lijek Cimzia dostupan je u napunjenim štrcaljkama, napunjenim brizgalicama i ulošcima za dozator.
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Cimzia is used for.
Croatian: Taj posrednik uključen je u nastanak upale te se u visokim razinama nalazi u bolesnika oboljelih od bolesti koje se liječe lijekom Cimzia.
English: For detailed information on the use of Cimzia in all conditions, see the summary of product characteristics.
Croatian: Detaljne informacije o primjeni lijeka Cimzia kod svih bolesti pogledajte u sažetku opisa svojstava lijeka.
English: Patients on Cimzia 400 mg every two weeks led to 75.8% and 55.4% of patients responding.
Croatian: U bolesnika koji su primali lijek Cimzia u dozi od 400 mg svaka dva tjedna, odgovor je postignut u 75,8 % i 55,4 % bolesnika.
English: For patients receiving Cimzia 400 mg every four weeks 52% saw an improvement.
Croatian: Među bolesnicima koji su primali lijek Cimzia u dozi od 400 mg svaka četiri tjedna, poboljšanje je zabilježeno u 52 % bolesnika.
English: • For psoriatic arthritis, symptoms improved by at least 20% in 58% of patients treated with Cimzia 200 mg every two weeks compared with 24% of patients receiving placebo.
Croatian: • U slučaju psorijatičnog artritisa, simptomi su se poboljšali za najmanje 20 % u 58 % bolesnika koji su primali lijek Cimzia u dozi od 200 mg svaka dva tjedna u usporedbi s 24 % bolesnika koji su primali placebo.
English: including ankylosing spondylitis and when the X-ray does not show disease but there are clear signs of inflammation.
Croatian: • aksijalnog spondiloartritisa (bolesti koja uzrokuje upalu i bol u kralježnici), uključujući ankilozantni spondilitis te kad na rendgenskoj snimci nema dokaza bolesti, ali postoje jasni znakovi upale,
English: After training, patients may inject Cimzia themselves if their doctor agrees.
Croatian: Ako ih se u tome uvježba i liječnik je suglasan, bolesnici mogu sami sebi ubrizgavati lijek Cimzia.
English: • A study in patients with axial spondyloarthritis showed that symptoms improved by at least 20% after 12 weeks in around 60% of patients treated with Cimzia compared with around 40% of patients receiving placebo.
Croatian: • Ispitivanje provedeno u bolesnika s aksijalnim spondiloartritisom pokazalo je da su se u otprilike 60 % bolesnika koji su primali terapiju lijekom Cimzia simptomi poboljšali za najmanje 20 % nakon 12 tjedana, u usporedbi s otprilike 40 % bolesnika koji su primali placebo.
English: How is Cimzia used?
Croatian: Kako se Cimzia primjenjuje?
English: For the full list of side effects of Cimzia, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Cimzia potražite u uputi o lijeku.
English: 7 days from the date/hour of manufacture.
Croatian: 7 dana od datuma/sata izrade.
English: Timepoints for measurements were 5 minutes, 1 hour, 6 hours, 1 day, 4 days and 15 days.
Croatian: Vremenske točke mjerenja bile su: 5 minuta, 1 sat, 6 sati, 1 dan, 4 dana i 15 dana.
English: • OTHER CONDITIONS
Croatian: • DRUGI UVJETI
English: Intravenous administration should not be protracted over more than 2 hours.
Croatian: Intravenska primjena ne bi trebala trajati duže od 2 sata.
English: 4.5 Interactions with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Organ Adult male 70 kg
Croatian: Odrasli muškarac 70 kg
English: You will be asked to stop breast-feeding.
Croatian: Od Vas će se zatražiti da prekinete dojenje.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Yttrium (
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI itrijev (
English: It is important to tell your doctor if there is any possibility that you are pregnant.
Croatian: Morate obavijestiti svog liječnika ako postoji ikakva mogućnost da ste trudni.
English: The vial should never be opened and must be kept inside its lead shielding.
Croatian: Bočica se nikada ne smije otvoriti i mora se držati unutar svog olovnog štitnika.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Croatian: U svim slučajevima, potrebno je osigurati da rizici od zračenja budu niži nego li od same bolesti.
English: This leaflet was last revised in ().
Croatian: Uputa je zadnji puta revidirana u
English: YTRACIS.
Croatian: YTRACIS-a.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Molimo recite svome liječniku ili ljekarniku ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Y) chloride 1.850 GBq/ml
Croatian: Y) klorid 1,850 GBq/ml
English: These complexes are rapidly eliminated by the kidneys.
Croatian: Ovi se kompleksi brzo eliminiraju bubrezima.
English: Faecal and urinary elimination is slow: about 13 % of the administered activity is eliminated in 15 days.
Croatian: Eliminacija stolicom i urinom je spora: oko 13% primjenjene radioaktivnosti eliminira se za 15 dana.
English: Before use, packaging and radioactivity should be checked.
Croatian: Prije upotrebe potrebno je provjeriti pakovanje i radioaktivnost.
English: When the target is reached, Ytracis gives tiny radiation doses to these specific sites.
Croatian: Kada se cilj dosegne, YTRACIS daje male doze zračenja na ta specifična mjesta.
English: Usual precautions regarding sterility and radioactivity should be respected.
Croatian: Treba poštivati uobičajene mjere opreza glede sterilnosti i radioaktivnosti.
English: Like all medicines, YTRACIS can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, YTRACIS može uzrokovati nuspojave, iako ne kod svakoga.
English: In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.
Croatian: U svakom slučaju treba pratiti krvne parametre u pacijenta i odmah poduzeti odgovarajuće mjere ako postoje znakovi oštećenja koštane srži.
English: YTRACIS is only to be used by specialists with the appropriate experience.
Croatian: Ytracis smiju primjenjivati samo specijalisti s odgovarajućim iskustvom.
English: Date of the last renewal: 24/03/2008
Croatian: Datum zadnje obnove odobrenja: 24.03.2008.
English: However, should this occur, you will receive appropriate treatment from your doctor.
Croatian: Ako se to dogodi, Vaš će liječnik poduzeti odgovarajuće korake.
English: - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Croatian: - Potvrñena trudnoća ili sumnja na trudnoću ili kada trudnoća nije isključena (vidjeti dio 4.6).
English: Read all of this leaflet carefully before you start taking this medicine.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati lijek.
English: Dosage Your physician will decide on the amount of YTRACIS to be used in your case.
Croatian: Doziranje Vaš će liječnik odrediti količinu YTRACISa koja će se primijeniti u Vašem slučaju.
English: Particular care should be taken when administering radioactive medicinal products to children and adolescents.
Croatian: Potrebna je posebna pažnja kad se radioaktivni lijek primjenjuje kod djece i adolescenata.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Croatian: Za svaku ženu kojoj je izostala mjesečnica treba pretpostaviti da je trudna dok se ne dokaže suprotno.
English: 90Y-yttrium has a half-life of 2.67 days (64.1 hours).
Croatian: Poluvrijeme života itrija (90Y) je 2,67 dana (64,1 sat).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
Croatian: POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN DOHVATA I POGLEDA DJECE Čuvati izvan dohvata i pogleda djece.
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.
Croatian: Za svakog pacijenta izlaganje ionizirajućem zračenju mora biti opravdano na temelju kliničke koristi.
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.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Primjenom radioaktivnog lijeka nastaje rizik za druge ljude od vanjskog zračenja ili kontaminacije prolijevanjem urina, povraćanjem itd.
English: Adult female 57 kg 15 years 10 years 5 years
Croatian: Odrasla žena 57 kg 15 godina 10 godina 5 godina 1 godina Novoroñenče
English: At 1 and 24 hours, blood radioactivity decreases from 11 % to 0.14 % of the administered activity.
Croatian: Nakon 1 i 24 sata radioaktivnost u krvi pada s 11% na 0,14% primjenjene radioaktivnosti.
English: 4.7 Effects on ability to drive or use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima ili rada na strojevima
English: The MAH must ensure that the system of pharmacovigilance, as described in version 7 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav, kako je opisano u verziji 7, prikazanoj u Modulu 1.8.1. obrasca prijave nositelja odobrenja, ustrojen i funkcionalan prije promet i za vrijeme dok je lijek na tržištu.
English: It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium (90Zr).
Croatian: On se raspada uz emisiju beta zračenja maksimalne energije od 2,281 MeV (99,98 %) na stabilni cirkonij (90Zr).
English: Activity measurements using an ionisation chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated.
Croatian: Mjerenje radioaktivnosti pomoću ionizacijske komore vrlo je osjetljivo na geometrijske faktore, stoga se mora obaviti pod geometrijskim uvjetima koji su odgovarajuće validirani.
English: The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Croatian: Kelirajući agensi su najučinkovitiji ako se primijene odmah ili unutar jednog sata od ekspozicije, kada je radionuklid u cirkulaciji ili dostupan tkivnim tekućinama i plazmi.
English: Radioactive medicinal products should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Korisnik treba pripremati radioaktivne lijekove na način koji zadovoljava uvjete sigurnosti od zračenja i zahtjeve farmaceutske kakvoće.
English: Do not use after the expiry date and time stated on the label.
Croatian: Ne smije se upotrijebiti nakon isteka datuma i vremena roka valjanosti navedenog na pakovanju.
English: Radioactive medicinal products should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.
Croatian: Radioaktivni lijek mora primiti, koristiti i primijeniti samo ovlašteno osoblje u odgovarajućem kliničkom okruženju, a primitak, čuvanje, korištenje, transport i uklanjanje takvog lijeka mora se obavljati u skladu s pravilnicima i odgovarajućim dozvolama kompetentnih vlasti.
English: If the administration cannot be delayed, a lactating mother should be advised to stop breastfeeding.
Croatian: Ako se primjena ne može odgoditi, majci se mora savjetovati da prekine dojenje.
English: Cal: {DD/MM/YYYY} (12 h CET) METHOD AND ROUTE(S) OF ADMINISTRATION NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS.
Croatian: Kal. : {DD/MM/GGGG} (12 h SEV) NAČIN I PUT(EVI) PRIMJENE LIJEKA NIJE NAMIJENJENO ZA IZRAVNU PRIMJENU BOLESNICIMA.
English: Radiopharmaceutical precursor - Not intended for direct application to patients.
Croatian: Radiofarmaceutski prekursor - Nije namijenjen za izravnu primjenu u bolesnika.
English: There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.
Croatian: Nema dostupnih podataka o toksičnosti itrijevog (90Y) klorida, niti o njegovom utjecaju na reprodukciju životinja odnosno o mutagenom ili kancerogenom potencijalu.
English: NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS
Croatian: NIJE NAMIJENJENO ZA IZRAVNU PRIMJENU BOLESNICIMA
English: For this product, the effective dose resulting from an intravenously injected activity of 1 GBq is 700 mSv for a 57-kg female adult and 650 mSv for a 70-kg male adult.
Croatian: Za ovaj lijek, efektivna doza nakon intravenski injicirane radioaktivnosti od 1 GBq iznosi 700 mSv za odraslu ženu tešku 57 kg i 650 mSv za odraslog muškarca teškog 70 kg.
English: The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended therapeutic result.
Croatian: Primijenjena radioaktivnost mora biti takva da posljedična doza zračenja bude što niža, imajući pri tom na umu postizanje željenog terapijskog učinka.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING METALLIC BOX / LEAD POT
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU ILI, AKO NEMA VANJSKOG PAKOVANJA, NA UNUTARNJEM PAKOVANJU METALNA KUTIJA / OLOVNA POSUDA
English: To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Croatian: Samo za radioaktivno obilježavanje molekula nosača, koje su specifično razvijene i odobrene za radioaktivno obilježavanje ovim radionuklidom.
English: What YTRACIS contains
Croatian: Što YTRACIS sadrži
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti u skladu s lokalnim propisima.
English: No interaction studies have been performed.
Croatian: Ispitivanja interakcija ovog lijeka nisu provedena.
English: Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the administration could be reasonably delayed until the mother has ceased breastfeeding.
Croatian: Prije primjene radioaktivnog lijeka kod majke koja doji potrebno je razmotriti je li razumno primjenu odgoditi dok majka ne prestane s dojenjem.
English: Activity may be measured using an ionisation chamber.
Croatian: Radioaktivnost se može izmjeriti pomoću ionizacijske komore.
English: YTRACIS is contraindicated in the following cases: - Hypersensitivity to the active substance or to any of the excipients.
Croatian: YTRACIS je kontraindiciran u sljedećim slučajevima: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari.
English: It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities.
Croatian: Važno je da sav stakleni pribor, injekcijske igle itd., koji se koriste u pripremi radioaktivno označenog lijeka, budu potpuno čiste kako bi se osiguralo da nema tragova takvih metalnih nečistoća.
English: Yttrium (90Y) is a beta pure emitter.
Croatian: Itrij (90Y) emitira samo beta zračenje.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION
Croatian: DODATAK II A. PROIZVOðAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ODOBRENJA
English: In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time.
Croatian: U kostima, postotak injicirane radioaktivnosti naraste od 3,1% 5 minuta nakon injekcije do 18% nakon 6 sati, a zatim postepeno opada.
English: WHAT YTRACIS IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE YTRACIS I ZA ŠTO SE KORISTI
English: It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Croatian: Njime će rukovati i njega će primjenjivati samo osoblje koje je školovano i osposobljeno za sigurno rukovanje radioaktivnim materijalom.
English: (GBq : GigaBecquerel, Becquerel is the unit in which radioactivity is measured).
Croatian: gigabekerel, bekerel je jedinica za mjerenje radioaktivnosti).
English: - The other ingredients are hydrochloric acid and water for injections.
Croatian: - Ostali sastojci su kloridna kiselina i voda za injekcije.
English: 1 g of the chelating agents should be administered by slow intravenous injection over 3-4 minutes or by infusion (1 g in 100-250 ml of dextrose, or normal saline).
Croatian: 1 g kelirajućeg agensa treba primijeniti u obliku spore intravenske injekcije kroz 3-4 minute ili infuzijom (1 g u 100-250 ml dekstroze ili fiziološke otopine).
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)
Croatian: ROK VALJANOSTI EXP {DD/MM/GGGG} (12h SEV) BROJ SERIJE Serija: {XXXXX} SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA Vol.: {Z} ml Akt.: {Y}________GBq/bočica Kal.
English: The following information is intended for medical or healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of YTRACIS.
Croatian: Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim djelatnicima: Za detaljne informacije pogledajte Sažetak opisa svojstava lijeka za YTRACIS.
English: What YTRACIS looks like and contents of the pack
Croatian: Kako YTRACIS izgleda i sadržaj pakovanja
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Potrebno je poduzeti mjere zaštite od zračenja prema odredbama nacionalnih propisa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/250/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/03/250/001
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Croatian: • UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU LIJEKA ZADANI NOSITELJU ODOBRENJA
English: The dosimetry estimates were based on a rat biodistribution study and the calculations were effected in accordance with MIRD/ICRP 60 recommendations.
Croatian: Procjena primljenih doza temeljena je na ispitivanju biodistribucije u štakora, a izračuni su učinjeni u skladu s preporukama MIRD/ICRP 60.