FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user Karvea 300 mg tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Karvea 300 mg tablete irbesartan
English: Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: Karvea 150 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
English: Package leaflet: Information for the user Karvea 150 mg tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Karvea 150 mg tablete irbesartan
English: Hepatic impairment:
Croatian: Klinička djelotvornost:
English: What Karvea looks like and contents of the pack Karvea 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Croatian: Karvea 75 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2871 na drugoj strani.
English: Package leaflet: Information for the user Karvea 150 mg film-coated tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Karvea 150 mg filmom obložene tablete irbesartan
English: orthostatic hypotension* Uncommon: flushing
Croatian: ortostatska hipotenzija*
English: What Karvea looks like and contents of the pack Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Croatian: Karvea 75 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
English: What Karvea looks like and contents of the pack Karvea 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Croatian: Karvea 300 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2873 na drugoj strani.
English: Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Croatian: Karvea 150 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
English: In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Croatian: U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (dvije tablete na dan) jedanput na dan.
English: In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Croatian: U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (četiri tablete na dan) jedanput na dan.
English: Package leaflet: Information for the user Karvea 300 mg film-coated tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Karvea 300 mg filmom obložene tablete irbesartan
English: EU/1/97/049/011 - 14 tablets EU/1/97/049/004 - 28 tablets EU/1/97/049/005 - 56 tablets EU/1/97/049/014 - 56 x 1 tablets EU/1/97/049/006 - 98 tablets
Croatian: EU/1/97/049/011 - 14 tableta EU/1/97/049/004 - 28 tableta EU/1/97/049/005 - 56 tableta EU/1/97/049/014 - 56 x 1 tableta EU/1/97/049/006 - 98 tableta
English: Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Croatian: Karvea 300 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
English: EU/1/97/049/021 - 14 tablets EU/1/97/049/022 - 28 tablets EU/1/97/049/035 - 30 tablets EU/1/97/049/023 - 56 tablets EU/1/97/049/024 - 56 x 1 tablets EU/1/97/049/032 - 84 tablets EU/1/97/049/038 - 90 tablets EU/1/97/049/025 - 98 tablets
Croatian: EU/1/97/049/021 - 14 tableta EU/1/97/049/022 - 28 tableta EU/1/97/049/035 - 30 tableta EU/1/97/049/023 - 56 tableta EU/1/97/049/024 - 56 x 1 tableta EU/1/97/049/032 - 84 tableta EU/1/97/049/038 - 90 tableta EU/1/97/049/025 - 98 tableta
English: EU/1/97/049/016 - 14 tablets EU/1/97/049/017 - 28 tablets EU/1/97/049/034 - 30 tablets EU/1/97/049/018 - 56 tablets EU/1/97/049/019 - 56 x 1 tablets EU/1/97/049/031 - 84 tablets EU/1/97/049/037 - 90 tablets EU/1/97/049/020 - 98 tablets
Croatian: EU/1/97/049/016 - 14 tableta EU/1/97/049/017 - 28 tableta EU/1/97/049/034 - 30 tableta EU/1/97/049/018 - 56 tableta EU/1/97/049/019 - 56 x 1 tableta EU/1/97/049/031 - 84 tableta EU/1/97/049/037 - 90 tableta EU/1/97/049/020 - 98 tableta
English: What Karvea looks like and contents of the pack Karvea 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Croatian: Karvea 150 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2872 na drugoj strani.
English: What Karvea contains  The active substance is irbesartan.
Croatian: Djelatna tvar je irbesartan.
English: 300 mg (four tablets a day) once daily depending on blood pressure response.
Croatian: Doza se kasnije može povećati na 300 mg (četiri tablete na dan) jedanput na dan, ovisno o vrijednostima krvnog tlaka.
English: EU/1/97/049/012 - 14 tablets EU/1/97/049/007 - 28 tablets EU/1/97/049/008 - 56 tablets EU/1/97/049/015 - 56 x 1 tablets EU/1/97/049/009 - 98 tablets
Croatian: EU/1/97/049/012 - 14 tableta EU/1/97/049/007 - 28 tableta EU/1/97/049/008 - 56 tableta EU/1/97/049/015 - 56 x 1 tableta EU/1/97/049/009 - 98 tableta
English: EU/1/97/049/010 - 14 tablets EU/1/97/049/001 - 28 tablets EU/1/97/049/002 - 56 tablets EU/1/97/049/013 - 56 x 1 tablets EU/1/97/049/003 - 98 tablets
Croatian: EU/1/97/049/010 - 14 tableta EU/1/97/049/001 - 28 tableta EU/1/97/049/002 - 56 tableta EU/1/97/049/013 - 56 x 1 tableta EU/1/97/049/003 - 98 tableta
English: EU/1/97/049/026 - 14 tablets EU/1/97/049/027 - 28 tablets EU/1/97/049/036 - 30 tablets EU/1/97/049/028 - 56 tablets EU/1/97/049/029 - 56 x 1 tablets EU/1/97/049/033 - 84 tablets EU/1/97/049/039 - 90 tablets EU/1/97/049/030 - 98 tablets
Croatian: EU/1/97/049/026 - 14 tableta EU/1/97/049/027 - 28 tableta EU/1/97/049/036 - 30 tableta EU/1/97/049/028 - 56 tableta EU/1/97/049/029 - 56 x 1 tableta EU/1/97/049/033 - 84 tableta EU/1/97/049/039 - 90 tableta EU/1/97/049/030 - 98 tableta
English: What Karvea looks like and contents of the pack Karvea 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Croatian: Karvea 150 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
English: What Karvea looks like and contents of the pack Karvea 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Croatian: Karvea 300 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg film-coated tablets.
Croatian: Karvea 75 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets.
Croatian: Karvea 75 mg tablete
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie
Croatian: 54, rue La Boétie
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: NAZIV LIJEKA Karvea 75 mg tablete irbesartan NAZIV NOSITELJA
English: Energy (keV)*
Croatian: Energija (keV)*
English: This should be taken into consideration when using the following information:
Croatian: Ovo treba uzeti u obzir prilikom korištenja navedenih podataka:
English: After thawing, do not freeze again.
Croatian: Nakon odmrzavanja ne ponovno zamrzavati.
English: He will decide at which time you will be authorised to leave the nuclear medicine department.
Croatian: On će odlučiti u koje će Vam vrijeme biti dopušteno napustiti odjel nuklearne medicine.
English: (12 h CET)
Croatian: (12 h SEV)
English: Cases of bleeding have been reported, some of which have been serious.
Croatian: Opisani su slučajevi krvarenja, od kojih su neka bila ozbiljna.
English: This effect is moderate and brief and will disappear after some hours.
Croatian: Ova pojava je blaga i kratkotrajna i nestat će nakon nekoliko sati.
English: Date of latest renewal: 12 December 2007
Croatian: Datum zadnje obnove odobrenja: 12. prosinca 2007.
English: Such reactions are usually responsive to analgesics.
Croatian: Ove reakcije obično dobro reagiraju na analgetike.
English: You should not be alarmed at this; in such case, your pain medicine will be slightly increased.
Croatian: Zbog toga se ne trebate uzbuñivati; u tom slučaju Vaša doza analgetika bit će malo povećana.
English: Relief of pain may persist for 4 weeks up to 4 months.
Croatian: Potom učinak smanjenja boli može trajati 4 tjedna do 4 mjeseca.
English: ATC Code: V10BX02
Croatian: ATC oznaka: V10BX02
English: The possibility of pregnancy must strictly be ruled out.
Croatian: Mogućnost trudnoće mora biti sa sigurnošću isključena.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Croatian: PODACI NA BRAILLEOVOM PISMU <Prihvaćeno obrazloženje za nenavoñenje Brailleovog pisma>
English: Urinary excretion occurred predominantly during the first 4 hours (30.3 ± 13.5 %).
Croatian: Izlučivanje urinom većinom se odvija tijekom prva 4 sata (30,3 ± 13,5 %).
English: During 6 hours following the injection of Quadramet, your physician will encourage you to drink and void as often as possible.
Croatian: Tijekom 6 sati nakon injekcije Quadrameta Vaš će Vas liječnik poticati na pijenje i mokrenje što je češće moguće.
English: Quadramet is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Croatian: Ne preporučuje se primjena Quadrameta kod djece mlañe od 18 godina zbog nedostatka podataka o sigurnosti i djelotvornosti.
English: You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection).
Croatian: Bit će Vam dopušteno napustiti odjel nuklearne medicine nakon obavljene dozimetrijske kontrole (općenito unutar 6 sati nakon injekcije Quadrameta).
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 nepovoljnog djelovanja zračenja budu niži nego li od same bolesti.
English: • in pregnant women (See section 4.6).
Croatian: • trudnice (vidjeti dio 4.6).
English: Manufacturer: CIS bio international.
Croatian: Proizvoñač: CIS bio international.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA ml
English: These effects were deemed to be related to the progression of the disease.
Croatian: Smatra se da su one povezane s napredovanjem bolesti.
English: What Quadramet is and what it is used for
Croatian: Što je Quadramet i za što se koristi
English: This radiopharmaceutical is used for the treatment of bone pain due to your disease.
Croatian: Ovaj se radiofarmaceutik koristi za liječenje koštane boli uzrokovane Vašom bolešću.
English: In the absence of compatibility studies, this medicinal product must not be mixed with the other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj se lijek ne smije miješati s drugim lijekovima.
English: TABLE 2 : RADIATION ABSORBED DOSES
Croatian: TABLICA 2: DOZE APSORBIRANOG ZRAČENJA
English: It should be clear without particles.
Croatian: Mora biti bistra i bez vidljivih čestica.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: If you have the impression that the effect of Quadramet is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Imate li dojam da je učinak Quadrameta prejak ili preslab, recite to svom liječniku ili ljekarniku.
English: This is usually mild and self-limiting and occurs within 72 hours of injection.
Croatian: Ova je reakcija obično blaga i prolazi sama od sebe, a dogaña se unutar 72 sata od injekcije.
English: What you need to know before you take Quadramet
Croatian: Što trebate znati prije nego primite Quadramet
English: This medicinal product is not intended to be injected on a regular or continuous basis.
Croatian: Ovaj lijek nije namijenjen za redovitu i trajnu primjenu.
English: Quadramet must not be administered to pregnant women.
Croatian: Quadramet se ne smije primijeniti u trudnica.
English: At 4 and 24 hours, plasma radioactivity had decreased from 1.3 ± 0.7 % to 0.05 ± 0.03 %.
Croatian: Nakon 4 i 24 sata od aplikacije, radioaktivnost u plazmi smanjena je s 1,3 ± 0,7 % na 0,05 ± 0,03 %.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1 odobrenja za stavljanje gotovog lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: The risks to be expected are associated with the inadvertent administration of excess radioactivity.
Croatian: Mogući očekivani rizici povezani su s neopreznom primjenom prevelike radioaktivnosti.
English: MARKETING AUTHORISATION NUMBER EU/1/97/057/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/97/057/001
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.
Croatian: Način njihovog prijema, čuvanja, korištenja, transporta i odlaganja mora biti u skladu s odredbama i dozvolama nadležnih lokalnih službenih tijela.
English: For this product the effective dose resulting from an injected activity of 2 590 MBq is 796 mSv.
Croatian: Za ovaj lijek efektivna doza kao posljedica primjene aktivnosti od 2590 MBq iznosi 796 mSv.
English: Use of Quadramet in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefit of the treatment outweighs its risks.
Croatian: Primjena Quadrameta u bolesnika s dokazano kompromitiranom rezervom koštane srži uslijed prethodnog liječenja ili proširenosti bolesti se ne preporučuje, osim ako potencijalna dobit od liječenja ne prevladava njegove rizike.
English: The data on the safety of repeated dosing are limited and based on compassionate use of the product.
Croatian: Podaci o sigurnosti primjene ponovljenih doza su ograničeni i temelje se na milosrdnoj primjeni ovog lijeka.
English: Quadramet is contra-indicated (see 4.3) in pregnancy.
Croatian: Quadramet je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: In patients, Quadramet is rapidly cleared from the blood.
Croatian: Quadramet se brzo uklanja iz krvi.
English: The same results were observed for Sm-EDTMP enriched with radiolysis degradants.
Croatian: Isti rezultati primijećeni su i u ispitivanjima provedenim s Sm-EDTMPom obogaćenim razgradnim produktima radiolize.
English: Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.
Croatian: Bolesnici u kojih se bolovi smanje mogu se savjetovati da pokušaju smanjiti primjenu opioidnih analgetika.
English: The activity should be measured by a dose calibrator immediately before administration.
Croatian: Aktivnost je potrebno izmjeriti pomoću kalibratora doze neposredno prije primjene lijeka.
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Croatian: Potrebno je poštivati pravila asepse u skladu sa zahtjevima dobre proizvoñačke prakse za lijekove.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING METALLIC BOX / LEADPOT
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU METALNA KUTIJA / OLOVNA POSUDA
English: The following information is intended for medical or healthcare professionals only: The complete SmPC of Quadramet is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Croatian: Sljedeći podaci namijenjeni su samo liječnicima i zdravstvenim djelatnicima: Cjeloviti Sažetak opisa svojstava lijeka Quadramet priložen je kao zaseban dokument unutar pakovanja, s ciljem da zdravstvenim djelatnicima pruži dodatne znanstvene i praktične podatke o primjeni i uporabi ovog radiofarmaceutika.
English: GBq/vial,
Croatian: GBq/bočica,
English: In contrast, skeletal uptake was inversely proportional to plasma radioactivity at 30 minutes.
Croatian: Nasuprot tome, apsorpcija u kostima bila je obrnuto proporcionalna radioaktivnosti u plazmi nakon 30 minuta.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc.
Croatian: Pri primjeni radiofarmaceutika nastaje rizik od vanjskog zračenja za druge ljude, ili kontaminacije prolijevanjem urina, povraćanjem itd.
English: Because Quadramet is excreted in the urine, radiation exposure was based on a urinary voiding interval of 4.8 hours.
Croatian: Budući da se Quadramet izlučuje urinom, izloženost zračenju temeljena je na intervalu mokrenja od 4,8 sati.
English: Radiopharmaceuticals may be received, used and administered only by authorised persons in designated clinical settings.
Croatian: Radiofarmaceutike smiju preuzimati, koristiti i primjenjivati samo ovlaštene osobe u specijaliziranim kliničkim ustanovama.
English: Repeat administration of Quadramet should be based on an individual patient's response to prior treatment and on clinical symptoms.
Croatian: Ponovna primjena Quadrameta ovisi o individualnom odgovoru bolesnika na prethodnu primjenu i kliničkim simptomima.
English: The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level of 2.5 mg/kg.
Croatian: Produkti radiolize Sm-EDTMP pokazali su se toksičnim za bubrege kod štakora i pasa, kod kojih je koncentracija pri kojoj nije bilo neželjenih učinaka iznosila 2,5 mg/kg.
English: The administration can however be repeated after 8 weeks following injection, subject to the evolution of your disease.
Croatian: Primjena se ipak može ponoviti 8 tjedana nakon prve injekcije, nakon obavljene procjene stanja Vaše bolesti.
English: If you experience back pain or sensory abnormalities, please inform your physician as soon as possible.
Croatian: Osjetite li bol u leñima ili poremećaje osjeta, molimo obavijestite svog liječnika što je prije moguće.
English: (Corresponding to 20 to 80 µg/ml of samarium)
Croatian: (što odgovara 20 do 80 µg/ml samarija)
English: For an administered activity of 2 590 MBq, the typical radiation dose to the target organ, skeletal metastases, is 86.5 Gy and the typical radiation doses to the critical organs are: normal bone surfaces 17.5 Gy, red marrow 4.0 Gy, urinary bladder wall 2.5 Gy, kidneys 0.047 Gy and ovaries 0.021 Gy.
Croatian: Za primijenjenu aktivnost od 2590 MBq, standardna doza zračenja u ciljnom organu, koštanim metastazama, iznosi 86,5 Gy, a standardne doze zračenja u kritičnim organima su: površina zdravih kostiju 17,5 Gy, crvena koštana srž 4,0 Gy, stijenka mokraćnog mjehura 2,5 Gy, bubrezi 0,047 Gy i jajnici 0,021 Gy.
English: What Quadramet contains
Croatian: Što Quadramet sadrži
English: Quadramet should only be administered by physicians experienced in the use of radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians.
Croatian: Quadramet smiju primjenjivati samo liječnici s iskustvom u primjeni radiofarmaceutika i nakon sveukupne onkološke evaluacije bolesnika od strane kvalificiranog liječnika.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 05 February 1998
Croatian: Datum prvog odobrenja: 05. veljače 1998.
English: Posology The recommended dose of Quadramet is 37 MBq per kg body weight.
Croatian: Doziranje Preporučena doza Quadrameta iznosi 37 MBq po kilogramu tjelesne težine.
English: For the other patients the urine should be collected for at least six (6) hours.
Croatian: Kod ostalih bolesnika urin je potrebno sakupljati najmanje šest (6) sati.
English: Excipient with known effect: sodium 8.1 mg/mL.
Croatian: Pomoćna tvar poznatog učinka: natrij 8,1 mg/ml.
English: What Quadramet is and what it is used for What you need to know before you take Quadramet How to take Quadramet
Croatian: Što je Quadramet i za što se koristi Što trebate znati prije nego primite Quadramet Kako primjenjivati Quadramet Moguće nuspojave
English: A small number of patients have reported a transient increase in bone pain shortly after injection (flare reaction).
Croatian: Mali broj bolesnika prijavio je prolazno pojačanje koštane boli nedugo nakon injekcije (reakcija razbuktavanja boli).
English: Non-radioactive Sm-EDTMP showed no mutagenic potential in a battery of in vivo and in vitro tests.
Croatian: Neradioaktivni Sm-EDTMP nije pokazao mutageni potencijal u nizu in vivo i in vitro provedenih ispitivanja.
English: There are no available clinical data relating to the excretion of Quadramet in human milk.
Croatian: Nema dostupnih kliničkih podataka o izlučivanju Quadrameta u majčino mlijeko kod ljudi.
English: Radiation dose to specific organs, which may not be the target organ of therapy, may be influenced significantly by pathophysiological changes induced by the disease process.
Croatian: Doza zračenja za pojedine organe, koji ne moraju biti ciljni organi pri liječenju, može biti pod značajnim utjecajem patofizioloških promjena uzrokovanih samom bolešću.
English: Radioactive Sm-EDTMP has not been tested for mutagenicity/carcinogenicity but due to the radiation dose resulting from therapeutic exposure it should be regarded as presenting a genotoxic/carcinogenic risk.
Croatian: Radioaktivni Sm-EDTMP nije ispitivan u smislu mutagenosti/kancerogenosti, ali na temelju doza zračenja nakon terapijske izloženosti ovom lijeku, smatra se potencijalno genotoksičnim/kancerogenim.
English: Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days).
Croatian: Samarij-153 emitira beta čestice srednje energije i gama foton koji omogućuje scintigrafiju, i ima vrijeme poluraspada od 46,3 sata (1,93 dana).
English: If your renal function is decreased, the amount of product will be adapted.
Croatian: Ako imate oslabljenu funkciju bubrega, količina lijeka bit će prilagoñena tome.
English: Women of childbearing potential have to use effective contraception during the treatment and the whole period of follow-up.
Croatian: Za vrijeme liječenja, žene generativne dobi moraju primjenjivati učinkovitu kontracepciju, kao i čitavo vrijeme praćenja nakon završetka liječenja.
English: For instructions on preparation of the medicinal product before administration, see section 12.
Croatian: Za upute o pripremi lijeka prije primjene vidjeti dio 12.
English: Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium (
Croatian: Quadramet je indiciran za ublažavanje boli u bolesnika s multiplim i bolnim osteoblastičnim koštanim metastazama koje, prilikom scintigrafije, na sebe vežu bifosfonate obilježene tehnecijem (