natgillin/translations-raw huggingface dataset:
Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Karvea se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu ako je uzimate u tom razdoblju.
Because no information is available regarding the use of Karvea during breast-feeding, Karvea is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
Budući da nema dostupnih podataka o upotrebi lijeka Karvea tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s ustanovljenim boljim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
The blood pressure lowering effect of Karvea is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy. 
Učinak lijeka Karvea na snižavanje krvnog tlaka vidljiv je unutar 1-2 tjedna, s maksimalnim učinkom nakon 4-6 tjedana od početka terapije.
How to take Karvea 
Kako uzimati Karvea
Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. 
Karvea sprječava vezanje angiotenzina II na te receptore uzrokujući opuštanje krvnih žila i sniženje krvnog tlaka.
Lithium: the combination of lithium and Karvea is not recommended (see section 4.5). 
Litij: ne preporučuje se kombinacija litija i lijeka Karvea (vidjeti dio 4.5).
In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). 
U bolesnika u kojih se bolest ne može dostatno kontrolirati dozom od 150 mg jedanput na dan, doza lijeka Karvea može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists. 
Iako to još nije potvrđeno za lijek Karvea, sličan učinak može se očekivati s antagonistima receptora angiotenzina II.
Karvea is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 
Karvea se primjenjuje u odraslih bolesnika za liječenje visokog krvnog tlaka (esencijalne hipertenzije) zaštitu bubrega u bolesnika sa šećernom bolešću tipa 2 koji imaju povišeni krvni tlak i laboratorijski dokazanu oslabljenu bubrežnu funkciju.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Karvea on the progression of renal disease and all-cause mortality were examined. 
U 1715 hipertenzivnih bolesnika sa šećernom bolešću tipa 2, proteinurijom ≥ 900 mg/dan i serumskim kreatininom u rasponu od 1,0 do 3,0 mg/dl ispitivan je dugotrajan učinak lijeka Karvea (prosječno 2,6 godina) na progresiju bubrežne bolesti i svih uzroka mortaliteta.
hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock 
reakcije preosjetljivosti kao što su angioedem, osip, urtikarija, anafilaktička reakcija, anafilaktički šok Poremećaji metabolizma i prehrane Nepoznato:
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Karvea, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. 
Hiperkalijemija: kao i kod ostalih lijekova koji djeluju na renin-angiotenzin-aldosteronski sustav, tijekom liječenja lijekom Karvea može se pojaviti hiperkalijemija, posebice ako je prisutna oštećena bubrežna funkcija, izražena proteinurija zbog dijabetičke bubrežne bolesti i/ili zatajenje srca.
The study examined the long-term effects (2 years) of Karvea on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline). 
U ispitivanju su ispitivani dugotrajni učinci (2 godine) lijeka Karvea na progresiju klinički izražene proteinurije (brzina izlučivanja albumina u mokraću > 300 mg/dan i porast u vrijednostima brzine izlučivanja albumina u mokraću od najmanje 30% u odnosu na početne vrijednosti).
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. 
U tom će Vam slučaju Vaš liječnik možda raditi redovite pretrage krvi, posebno određivanje koncentracije kalija u krvi u slučaju oslabljene funkcije bubrega ako trebate ići na bilo kakav kirurški zahvat ili trebate primiti anestetike ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću. aliskiren Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi u redovitim intervalima.
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2). 
Tijekom sljedeća dva tjedna kada su bolesnici ponovo randomizirani ili na lijek ili na placebo, bolesnici na placebu imali su porast od 2,4 i 2,0 mmHg za SjSKT i SjDKT,u usporedbi s promjenom od +0,1 i -0,3 mmHg u bolesnika na svim dozama irbesartana (vidjeti dio 4.2).
NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe 
Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. 
Karvea usporava slabljenje bubrežne funkcije u bolesnika koji imaju povišen krvni tlak i boluju od šećerne bolesti tipa 2.
The concomitant use of Karvea with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1). 
Istodobna primjena lijeka Karvea s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). 
Dokaz koristi lijeka Karvea na bubrežnu funkciju u hipertenzivnih bolesnika sa šećernom bolešću tipa 2 zasniva se na ispitivanjima u kojima se irbesartan prema potrebi uzimao kao dopuna ostaloj antihipertenzivnoj terapiji za postizanje ciljnog krvnog tlaka (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
Karvea is for oral use. 
Karvea je namijenjena za primjenu kroz usta.
Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). 
Ne smijete je uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu ako je uzimate u tom stadiju (vidjeti dio o trudnoći).
Each tablet of Karvea 75 mg contains 75 mg irbesartan. 
Jedna Karvea 75 mg tableta sadrži 75 mg irbesartana.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”). 
“Nemojte uzimati lijek Karvea” i “Upozorenja i mjere opreza”).
Warning and precautions Talk to your doctor before taking Karvea and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Karvea for diabetic kidney disease. 
Obratite se svom liječniku prije nego uzmete lijek Karvea ako se nešto od dolje navedenog odnosi na Vas: ako Vas muči prekomjerno povraćanje ili proljev ako imate problema s bubrezima ako imate srčanih problema ako uzimate lijek Karvea zbog dijabetičke bolesti bubrega.
Each tablet of Karvea 150 mg contains 150 mg irbesartan. 
Jedna Karvea 150 mg tableta sadrži 150 mg irbesartana.
The efficacy of Karvea is not influenced by age or gender. 
Dob i spol ne utječu na djelotvornost lijeka Karvea.
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. 
U kliničkim ispitivanjima s bolesnicima liječenima lijekom Karvea prijavljene su sljedeće nuspojave: Vrlo često (mogu se javiti u više od 1 na 10 osoba): ako imate povišen krvni tlak i šećernu bolest tipa 2 te bolest bubrega, krvne pretrage mogu pokazati povišene vrijednosti kalija.
Each tablet of Karvea 300 mg contains 300 mg irbesartan. 
Jedna Karvea 300 mg tableta sadrži 300 mg irbesartana.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Karvea has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. 
Karvea se, međutim, pokazala sigurnom za primjenu s ostalim antihipertenzivnim lijekovima poput beta blokatora, dugodjelujućih blokatora kalcijevih kanala i tiazida.
Karvea 75 mg film-coated tablets irbesartan 
Karvea 75 mg filmom obložene tablete irbesartan
Karvea 300 mg tablets irbesartan 
Karvea 300 mg tablete
 The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. 
Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, laktoza hidrat, magnezijev stearat, koloidni hidratizirani silicijev dioksid, prethodno geliran kukuruzni škrob i poloksamer 188. Vidjeti dio 2., „Karvea sadrži laktozu“
How to store Karvea 
Kako čuvati lijek Karvea
NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Karvea 75 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 75 mg irbesartana POPIS POMOĆNIH TVARI
Do not take Karvea  if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant. 
Nemojte uzimati lijek Karvea ako ste alergični na irbesartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako ste trudni više od 3 mjeseca (također se preporučuje izbjegavati Karvea i u ranoj trudnoćividjeti dio o trudnoći) ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren
Karvea 150 mg film-coated tablets irbesartan 
Karvea 150 mg filmom obložene tablete irbesartan
Package leaflet: Information for the user Karvea 75 mg tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Karvea 75 mg tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Karvea 300 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Karvea 300 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 300 mg irbesartana POPIS POMOĆNIH TVARI
NAME OF THE MEDICINAL PRODUCT Karvea 150 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Karvea 150 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 150 mg irbesartana POPIS POMOĆNIH TVARI
Karvea 300 mg film-coated tablets irbesartan 
Karvea 300 mg filmom obložene tablete irbesartan
Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Karvea 75 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Karvea 75 mg film-coated tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Karvea 75 mg filmom obložene tablete irbesartan
Karvea 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Karvea 75 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
Karvea 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Karvea 300 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Karvea 300 mg tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Karvea 300 mg tablete irbesartan
Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Karvea 150 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Karvea 150 mg tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Karvea 150 mg tablete irbesartan
Hepatic impairment: 
Klinička djelotvornost:
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. 
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.
Package leaflet: Information for the user Karvea 150 mg film-coated tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Karvea 150 mg filmom obložene tablete irbesartan
orthostatic hypotension* Uncommon: flushing 
ortostatska hipotenzija*
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. 
Karvea 75 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
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. 
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.
Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Karvea 150 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
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. 
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.
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. 
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.
Package leaflet: Information for the user Karvea 300 mg film-coated tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Karvea 300 mg filmom obložene tablete irbesartan
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 
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
Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Karvea 300 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
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 
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
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 
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
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. 
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.
What Karvea contains  The active substance is irbesartan. 
Djelatna tvar je irbesartan.
300 mg (four tablets a day) once daily depending on blood pressure response. 
Doza se kasnije može povećati na 300 mg (četiri tablete na dan) jedanput na dan, ovisno o vrijednostima krvnog tlaka.
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 
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
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 
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
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 
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
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. 
Karvea 150 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
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. 
Karvea 300 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
NAME OF THE MEDICINAL PRODUCT Karvea 75 mg film-coated tablets. 
Karvea 75 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets. 
Karvea 75 mg tablete
Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie 
54, rue La Boétie
NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE 
NAZIV LIJEKA Karvea 75 mg tablete irbesartan NAZIV NOSITELJA
Energy (keV)* 
Energija (keV)*
This should be taken into consideration when using the following information: 
Ovo treba uzeti u obzir prilikom korištenja navedenih podataka:
After thawing, do not freeze again. 
Nakon odmrzavanja ne ponovno zamrzavati.
He will decide at which time you will be authorised to leave the nuclear medicine department. 
On će odlučiti u koje će Vam vrijeme biti dopušteno napustiti odjel nuklearne medicine.
(12 h CET) 
(12 h SEV)
Cases of bleeding have been reported, some of which have been serious. 
Opisani su slučajevi krvarenja, od kojih su neka bila ozbiljna.
This effect is moderate and brief and will disappear after some hours. 
Ova pojava je blaga i kratkotrajna i nestat će nakon nekoliko sati.
Date of latest renewal: 12 December 2007 
Datum zadnje obnove odobrenja: 12. prosinca 2007.
Such reactions are usually responsive to analgesics. 
Ove reakcije obično dobro reagiraju na analgetike.
You should not be alarmed at this; in such case, your pain medicine will be slightly increased. 
Zbog toga se ne trebate uzbuñivati; u tom slučaju Vaša doza analgetika bit će malo povećana.
Relief of pain may persist for 4 weeks up to 4 months. 
Potom učinak smanjenja boli može trajati 4 tjedna do 4 mjeseca.
ATC Code: V10BX02 
ATC oznaka: V10BX02
The possibility of pregnancy must strictly be ruled out. 
Mogućnost trudnoće mora biti sa sigurnošću isključena.
INFORMATION IN BRAILLE <Justification for not including Braille accepted> 
PODACI NA BRAILLEOVOM PISMU <Prihvaćeno obrazloženje za nenavoñenje Brailleovog pisma>
Urinary excretion occurred predominantly during the first 4 hours (30.3 ± 13.5 %). 
Izlučivanje urinom većinom se odvija tijekom prva 4 sata (30,3 ± 13,5 %).
During 6 hours following the injection of Quadramet, your physician will encourage you to drink and void as often as possible. 
Tijekom 6 sati nakon injekcije Quadrameta Vaš će Vas liječnik poticati na pijenje i mokrenje što je češće moguće.
Quadramet is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy. 
Ne preporučuje se primjena Quadrameta kod djece mlañe od 18 godina zbog nedostatka podataka o sigurnosti i djelotvornosti.
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection). 
Bit će Vam dopušteno napustiti odjel nuklearne medicine nakon obavljene dozimetrijske kontrole (općenito unutar 6 sati nakon injekcije Quadrameta).
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself. 
U svim slučajevima potrebno je osigurati da rizici od nepovoljnog djelovanja zračenja budu niži nego li od same bolesti.
• in pregnant women (See section 4.6). 
• trudnice (vidjeti dio 4.6).
Manufacturer: CIS bio international. 
Proizvoñač: CIS bio international.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA ml
These effects were deemed to be related to the progression of the disease. 
Smatra se da su one povezane s napredovanjem bolesti.
What Quadramet is and what it is used for 
Što je Quadramet i za što se koristi
This radiopharmaceutical is used for the treatment of bone pain due to your disease. 
Ovaj se radiofarmaceutik koristi za liječenje koštane boli uzrokovane Vašom bolešću.