FrancophonIA/ELRC3.0 huggingface dataset:
English: Warning and precautions Talk to your doctor before taking Aprovel 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 Aprovel for diabetic kidney disease.
Croatian: ako Vas muči prekomjerno povraćanje ili proljev ako imate problema s bubrezima ako imate srčanih problema ako uzimate Aprovel zbog dijabetičke bolesti bubrega.
English: Cartons of 56 x 1 film-coated tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Croatian: Kutija s 56 x 1 filmom obloženom tabletom u PVC/PVDC/aluminij perforiranim blisterima djeljivim na jedinične doze.
English: CHINOIN PRIVATE CO. LTD. Lévai u.5.
Croatian: Lévai u.5.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Croatian: Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena hipromeloza silicijev dioksid magnezijev stearat
English: Tablet core:
Croatian: Mehanizam djelovanja:
English: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Croatian: Za učinak liječenja ocjenjivane su podskupine prema spolu, rasi, dobi, trajanju šećerne bolesti, početnom krvnom tlaku, serumskom kreatininu i brzini izlučivanja albumina.U podskupinama žena i pripadnika crne rase, koji su činili 32% odnosno 26% ukupne populacije u ispitivanju, nisu bili vidljivi povoljni učinci na bubrege, premda to intervali pouzdanosti nisu isključivali.
English: Excipient with known effect: 30.75 mg of lactose monohydrate per tablet.
Croatian: Pomoćna tvar s poznatim učinkom: 30,75 mg laktoze hidrata po tableti.
English: Excipient with known effect: 61.50 mg of lactose monohydrate per tablet.
Croatian: Pomoćna tvar s poznatim učinkom: 61,50 mg laktoze hidrata po tableti.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Croatian: Općenito: u bolesnika u kojih vaskularni tonus i funkcija bubrega ovise najviše o aktivnosti reninangiotenzin-aldosteronskog sustava (npr. bolesnici s teškim kongestivnim zatajenjem srca ili postojećom bolešću bubrega, uključujući stenozu bubrežne arterije) liječenje inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, koji utječu na taj sustav, povezano je s pojavom akutne hipotenzije, azotemije, oligurije i rijetko, akutnim zatajenjem bubrega(vidjeti dio 4.5).
English: Excipient with known effect: 25.50 mg of lactose monohydrate per film-coated tablet.
Croatian: Pomoćna tvar s poznatim učinkom: 25,50 mg laktoze hidrata po filmom obloženoj tableti.
English: Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.
Croatian: Pomoćna tvar s poznatim učinkom: 15,37 mg laktoze hidrata po tableti.
English: Excipient with known effect: 102.00 mg of lactose monohydrate per film-coated tablet.
Croatian: Pomoćna tvar s poznatim učinkom: 102,00 mg laktoze hidrata po filmom obloženoj tableti.
English: Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Aprovel 75 mg tablete irbesartan
English: Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Croatian: Aprovel 75 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
English: Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: Aprovel 75 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
English: Package leaflet: Information for the user Aprovel 75 mg film-coated tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Aprovel 75 mg filmom obložene tablete irbesartan
English: Excipient with known effect: 51.00 mg of lactose monohydrate per film-coated tablet.
Croatian: Pomoćna tvar s poznatim učinkom: 51,00 mg laktoze hidrata po filmom obloženoj tableti.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
Croatian: 6.1 Popis pomoćnih tvari celuloza, mikrokristalična karmelozanatrij, umrežena laktoza hidrat magnezijev stearat silicijev dioksid, koloidni, hidratizirani kukuruzni škrob, prethodno geliran poloksamer 188
English: Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: Aprovel 300 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
English: Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: Aprovel 150 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
English: Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Aprovel 150 mg tablete irbesartan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 150 mg tablete irbesartan NAZIV NOSITELJA
English: Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Aprovel 300 mg tablete irbesartan
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 75 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
English: Thu
Croatian: ČET
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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 Aprovel 150 mg film-coated tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Aprovel 150 mg filmom obložene tablete irbesartan
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji bubrega i mokraćnog sustava
English: Drug substance*
Croatian: ortostatska hipotenzija*
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan.
Croatian: Jedna filmom obložena tableta sadrži 75 mg irbesartana.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe ROK VALJANOSTI
English: Patients with high blood pressure and type 2 diabetes with kidney disease 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: Patients with high blood pressure and type 2 diabetes with kidney disease 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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
Croatian: Jedna filmom obložena tableta sadrži 150 mg irbesartana.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 75 mg tablete irbesartan NAZIV NOSITELJA
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutijas 98 tableta u PVC/PVDC/aluminij blisterima.
English: fatigue Uncommon: chest pain
Croatian: umor Manje često: bol u prsištu Pretrage
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Aprovel 75 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 75 mg irbesartana POPIS POMOĆNIH TVARI
English: Package leaflet: Information for the user Aprovel 300 mg film-coated tablets irbesartan
Croatian: Uputa o lijeku: Informacija za korisnika Aprovel 300 mg filmom obložene tablete irbesartan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 300 mg tablete irbesartan NAZIV NOSITELJA
English: Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Croatian: Aprovel 150 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg film-coated tablets.
Croatian: Aprovel 75 mg filmom obložene tablete
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg 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 jedanput na dan.
English: EU/1/97/046/011 - 14 tablets EU/1/97/046/004 - 28 tablets EU/1/97/046/005 - 56 tablets EU/1/97/046/014 - 56 x 1 tablets EU/1/97/046/006 - 98 tablets
Croatian: EU/1/97/046/011 - 14 tableta EU/1/97/046/004 - 28 tableta EU/1/97/046/005 - 56 tableta EU/1/97/046/014 - 56 x 1 tableta EU/1/97/046/006 - 98 tableta
English: Each tablet contains: irbesartan 75 mg
Croatian: Jedna tableta sadrži 75 mg irbesartana
English: Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Croatian: Aprovel 300 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
Croatian: Jedna filmom obložena tableta sadrži 300 mg irbesartana.
English: 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: Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
English: Hepatobiliary disorders: Uncommon: jaundice Not known:
Croatian: Poremećaji jetre i žuči Manje često: žutica Nepoznato:
English: EU/1/97/046/021 - 14 tablets EU/1/97/046/022 - 28 tablets EU/1/97/046/035 - 30 tablets EU/1/97/046/023 - 56 tablets EU/1/97/046/024 - 56 x 1 tablets EU/1/97/046/032 - 84 tablets EU/1/97/046/038 - 90 tablets EU/1/97/046/025 - 98 tablets
Croatian: EU/1/97/046/021 - 14 tableta EU/1/97/046/022 - 28 tableta EU/1/97/046/035 - 30 tableta EU/1/97/046/023 - 56 tableta EU/1/97/046/024 - 56 x 1 tableta EU/1/97/046/032 - 84 tableta EU/1/97/046/038 - 90 tableta EU/1/97/046/025 - 98 tableta
English: EU/1/97/046/016 - 14 tablets EU/1/97/046/017 - 28 tablets EU/1/97/046/034 - 30 tablets EU/1/97/046/018 - 56 tablets EU/1/97/046/019 - 56 x 1 tablets EU/1/97/046/031 - 84 tablets EU/1/97/046/037 - 90 tablets EU/1/97/046/020 - 98 tablets
Croatian: EU/1/97/046/016 - 14 tableta EU/1/97/046/017 - 28 tableta EU/1/97/046/034 - 30 tableta EU/1/97/046/018 - 56 tableta EU/1/97/046/019 - 56 x 1 tableta EU/1/97/046/031 - 84 tableta EU/1/97/046/037 - 90 tableta EU/1/97/046/020 - 98 tableta
English: Blood and lymphatic system disorders Not known:
Croatian: Poremećaji krvi i limfnog sustava
English: Each tablet contains: irbesartan 150 mg
Croatian: Jedna tableta sadrži 150 mg irbesartana
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 300 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
English: 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: Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
English: EU/1/97/046/012 - 14 tablets EU/1/97/046/007 - 28 tablets EU/1/97/046/008 - 56 tablets EU/1/97/046/015 - 56 x 1 tablets EU/1/97/046/009 - 98 tablets
Croatian: EU/1/97/046/012 - 14 tableta EU/1/97/046/007 - 28 tableta EU/1/97/046/008 - 56 tableta EU/1/97/046/015 - 56 x 1 tableta EU/1/97/046/009 - 98 tableta
English: EU/1/97/046/010 - 14 tablets EU/1/97/046/001 - 28 tablets EU/1/97/046/002 - 56 tablets EU/1/97/046/013 - 56 x 1 tablets EU/1/97/046/003 - 98 tablets
Croatian: EU/1/97/046/010 - 14 tableta EU/1/97/046/001 - 28 tableta EU/1/97/046/002 - 56 tableta EU/1/97/046/013 - 56 x 1 tableta EU/1/97/046/003 - 98 tableta
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 150 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
English: EU/1/97/046/026 - 14 tablets EU/1/97/046/027 - 28 tablets EU/1/97/046/036 - 30 tablets EU/1/97/046/028 - 56 tablets EU/1/97/046/029 - 56 x 1 tablets EU/1/97/046/033 - 84 tablets EU/1/97/046/039 - 90 tablets EU/1/97/046/030 - 98 tablets
Croatian: EU/1/97/046/026 - 14 tableta EU/1/97/046/027 - 28 tableta EU/1/97/046/036 - 30 tableta EU/1/97/046/028 - 56 tableta EU/1/97/046/029 - 56 x 1 tableta EU/1/97/046/033 - 84 tableta EU/1/97/046/039 - 90 tableta EU/1/97/046/030 - 98 tableta
English: leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često:
English: 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: Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
English: 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: Bijela do gotovo bijela, bikonveksna, ovalna filmom obložena tableta, s utisnutom oznakom srca na jednoj i brojem 2873 na drugoj strani.
English: If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Croatian: Diuretici i drugi antihipertenzivni lijekovi: drugi antihipertenzivi mogu pojačati hipotenzivni učinak irbesartana.
English: 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: Bijela do gotovo bijela, bikonveksna, ovalna filmom obložena tableta, s utisnutom oznakom srca na jednoj i brojem 2871 na drugoj strani.
English:  If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets.
Croatian: Aprovel 75 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets.
Croatian: Aprovel 150 mg tablete
English: 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: Bijela do gotovo bijela, bikonveksna, ovalna filmom obložena tableta, s oznakom srca na jednoj i brojem 2872 na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg film-coated tablets.
Croatian: Aprovel 150 mg filmom obložene tablete
English: Gastrointestinal disorders Common:
Croatian: Poremećaji probavnog sustava Često:
English: orthostatic hypotension* Uncommon: flushing Respiratory, thoracic and mediastinal disorders Uncommon: cough
Croatian: Manje često: crvenilo praćeno osjećajem vrućine Poremećaji dišnog sustava, prsišta i sredoprsja Manje često: kašalj
English: Hepatic impairment
Croatian: Oštećena funkcija bubrega
English: Nederland sanofi-aventis Netherlands B.V. Tel: +31 (0)182 557 755
Croatian: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 48 00
English: (included in section 1 text)
Croatian: (Uključeno u tekst u dijelu 1)
English: This process is called remodelling.
Croatian: Taj proces naziva se preoblikovanje.
English: This will help to prevent dehydration.
Croatian: To će pomoći u sprječavanju dehidracije.
English: Some side effects could be serious
Croatian: Neke nuspojave mogu biti ozbiljne
English: You should therefore be careful when driving, using machines or performing other tasks that need full attention.
Croatian: Stoga morate biti oprezni dok upravljate vozilima, radite sa strojevima ili obavljate druge zadatke koji zahtijevaju Vašu punu pozornost.
English: The infusion must be conducted according to standard medical practice.
Croatian: Infuzija se mora provoditi u skladu sa standardnom liječničkom praksom.
English: The response rate in these patients was about 52%.
Croatian: Stopa odgovora u tih bolesnika bila je približno 52%.
English: Check with your doctor or nurse if you are not sure.
Croatian: Provjerite s liječnikom ili medicinskom sestrom ako niste sigurni.
English: Local reactions
Croatian: Lokalne reakcije
English: Withdraw an appropriate volume of the concentrate needed, as follows:
Croatian: Izvucite odgovarajući volumen potrebnog koncentrata na sljedeći način:
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: Median time to normocalcaemia was 4 days.
Croatian: Medijan vremena do normokalcemije bio je 4 dana.
English: Date of first authorisation: 19 November 2012 Date of latest renewal: 24 August 2017
Croatian: Datum prvog odobrenja: 19. studeni 2012 Datum posljednje obnove odobrenja: 24. kolovoza 2017
English: (to appear in roundel)
Croatian: (pojavljuje se u krugu)
English: Unopened bag: 2 years
Croatian: Neotvorena vrećica: 2 godine
English: Time on study (weeks)
Croatian: Vrijeme u ispitivanju (tjedni)
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: Frequency cannot be estimated from available data.
Croatian: Učestalost se ne može procijeniti iz dostupnih podataka.
English: The clinical relevance of these findings is unknown.
Croatian: Klinički značaj tih nalaza je nepoznat.
English: Each pack contains one bag.
Croatian: Svako pakiranje sadrži jednu vrećicu.
English: Patients who have received doses higher than those recommended should be carefully monitored.
Croatian: Bolesnike koji su primili više doze od preporučenih treba pažljivo pratiti.
English: No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Croatian: Nije potrebna prilagodba doze s obzirom da je biološka dostupnost, distribucija i eliminacija slična u starijih bolesnika i mlađih ispitanika.
English: After opening: 24 hours at 2
Croatian: Nakon otvaranja: 24 sata na 2
English: After opening: 24 hours at 2°C - 8°C
Croatian: Nakon otvaranja: 24 sata na 2°C-8°C.
English: The following information is intended for medical or health care professionals only.
Croatian: Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim radnicima.
English: Adults and elderly
Croatian: Odrasli i starije osobe
English: It is normal that old bone is removed and is replaced with new bone material.
Croatian: Normalno je da se stara kost razgrađuje i da se nadomješta novim koštanim materijalom.
English: No symptomatic cases of hypocalcaemia were observed.
Croatian: Nisu opaženi simptomatski slučajevi hipokalcemije.
English: It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat.
Croatian: Važno je pokušati spriječiti razvoj ONČ, jer je to bolno stanje koje može biti problem liječiti.
English: Special populations (see section 4.2)
Croatian: Posebne populacije (vidjeti dio 4.2)
English: Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Croatian: Liječnik će Vas obavijestiti o simptomima koji su povezani s hipokalcemijom.
English: It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Croatian: Važno je da se pažljivo pridržavate tog savjeta kako razina kalcija u krvi ne bi postala preniska u razdoblju nakon infuzije.
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Croatian: Dostupni su ograničeni podaci o ponovnom liječenju Pagetove bolesti (vidjeti dio 5.1).
English: NR Not Reached
Croatian: ND nije dosegnuto
English: If the disease is not treated, bones may become deformed and painful, and may break.
Croatian: Ako se bolest ne liječi, kosti mogu postati deformirane i bolne te se mogu slomiti.
English: Physicians should consider clinical monitoring for these patients.
Croatian: Liječnik treba razmotriti kliničko praćenje tih bolesnika.
English: * Common in Paget's disease only.
Croatian: * Često samo u Pagetovoj bolesti.
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Croatian: Kako bi se smanjio rizik od razvoja osteonekroze čeljusti, postoje neke mjere opreza koje treba poduzeti.
English: Mutagenicity and carcinogenic potential
Croatian: Mutagenost i kancerogeni potencijal