FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Croatian: I u indikaciji kontracepcije ostaje povoljan, što je predmetom usuglašenih uvjeta, ograničenja, upozorenja, drugih izmjena u informacijama o lijeku i dodatnih mjera minimiziranja rizika.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Croatian: I u indikaciji kontracepcije ostaje povoljan, no predmetom je uključivanja usuglašenih ograničenja, upozorenja i drugih izmjena u informacijama o proizvodu.
English: Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/10/654/001 Leflunomide ratiopharm 10 mg Film-coated tablet
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja EU/1/10/654/001 Leflunomid ratiopharm 10 mg Filmom obložena tableta Kroz usta
English: Other medicines and Januvia
Croatian: Drugi lijekovi i Januvia
English: What Januvia is and what it is used for
Croatian: Što je Januvia i za što se koristi
English: STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: PRESTANITE uzimati lijek Januvia i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: What Januvia contains
Croatian: Što Januvia sadrži
English: What Januvia looks like and contents of the pack
Croatian: Kako Januvia izgleda i sadržaj pakiranja
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Croatian: Datum posljednje obnove odobrenja: 23. veljače 2012.
English: Do not take Januvia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Januvia - ako ste alergični na sitagliptin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Your doctor may ask you to stop Januvia.
Croatian: Vaš liječnik može zatražiti da prestanete s uzimanjem lijeka Januvia.
English: Due to lack of human data, Januvia should not be used during pregnancy.
Croatian: Zbog nedostatka podataka o primjeni u ljudi, Januvia se ne smije uzimati tijekom trudnoće.
English: If you have kidney problems, your doctor may prescribe lower doses(such as 25mg or 50mg).
Croatian: Ako imate tegobe s bubrezima, liječnik Vam može propisati niže doze (kao što su 25 mg ili 50 mg).
English: If you take more Januvia than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Croatian: Ako uzmete više lijeka Januvia nego što ste trebali Uzmete li veću dozu ovog lijeka od propisane, odmah se javite svom liječniku.
English: The level of digoxin in your blood may need to be checked if taking with Januvia.
Croatian: Možda će biti potrebno provjeravati razinu digoksina u Vašoj krvi ukoliko se uzima s lijekom Januvia.
English: There is no experience with doses above 800 mg in clinical studies.
Croatian: Nema iskustva s dozama većim od 800 mg u kliničkim ispitivanjima.
English: The usual recommended dose is: one 100 mg film-coated tablet once a day by mouth
Croatian: Uobičajena preporučena doza je: jedna filmom obložena tableta od 100mg jedanput na dan kroz usta
English: - an allergic reaction to Januvia (see section 4).
Croatian: - Alergijsku reakciju na lijek Januvia (pogledajte dio 4).
English: Method of administration Januvia can be taken with or without food.
Croatian: Način primjene Januvia se može uzimati s hranom ili bez nje.
English: What Januvia is and what it is used for What you need to know before you take Januvia How to take Januvia
Croatian: Što je Januvia i za što se koristi Što morate znati prije nego počnete uzimati lijek Januvia Kako uzimati lijek Januvia
English: Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Croatian: Januvia se ne smije primjenjivati u bolesnika s dijabetesom tipa 1 ili za liječenje dijabetičke ketoacidoze.
English: For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
Croatian: U odraslih bolesnika s dijabetesom mellitus tipa 2, Januvia je indicirana za poboljšanje regulacije glikemije:
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake "EXP".
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Januvia may be administered with or without food.
Croatian: Budući da istodobno uzimanje sitagliptina s punomasnim obrokom nema učinka na farmakokinetiku, Januvia se može uzimati s hranom ili bez nje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Januvia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Januvia u jednoj ili više podskupina pedijatrijske populacije za dijabetes mellitus tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted.
Croatian: Posumnja li se na pankreatitis, mora se prekinuti primjena lijeka Januvia i drugih lijekova za koje se sumnja da bi ga mogli izazvati; potvrdi li se akutni pankreatitis, liječenje lijekom Januvia ne smije se ponovno započeti.
English: What you need to know before you take Januvia
Croatian: Što morate znati prije nego počnete uzimati lijek Januvia
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
Croatian: S obzirom da se doza prilagođava temeljem bubrežne funkcije, preporučuje se procijeniti bubrežnu funkciju prije uvođenja lijeka Januvia te periodično nakon toga.
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Croatian: Prolazni fizički znakovi povezani s liječenjem, od kojih neki upućuju na neurotoksičnost, poput disanja otvorenih usta, salivacije, povraćanja bijele pjene, ataksije, drhtanja, smanjene aktivnosti i/ili pogrbljenog držanja tijela, opaženi su kod pasa pri razinama izloženosti otprilike 23 puta većima od razina kliničke izloženosti.
English: Incidenc e rate per 100 patientyears* N (%)
Croatian: Stopa incidencije na 100 bolesnikgodina* N (%)
English: Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Croatian: Januvia je također indicirana kao dodatak inzulinu (sa ili bez metformina) kada dijeta i tjelovježba uz stabilnu dozu inzulina ne omogućuju odgovarajuću regulaciju glikemije.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Januvia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Croatian: Hipoglikemija pri uzimanju u kombinaciji s drugim antihiperglikemijskim lijekovima U kliničkim ispitivanjima lijeka Januvia kao monoterapije ili kao dio kombinirane terapije s lijekovima za koje nije poznato da uzrokuju hipoglikemiju (tj. metforminom i/ili agonistom PPAR), stope prijavljenih hipoglikemija u bolesnika koji su uzimali sitagliptin bile su podjednake onoj u bolesnika koji su uzimali placebo.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with a sulphonylurea or with insulin.
Croatian: Bolesnike se također mora upozoriti na rizik od hipoglikemije kad se Januvia uzima u kombinaciji sa sulfonilurejom ili s inzulinom.
English: If you stop taking Januvia
Croatian: Ako prestanete uzimati lijek Januvia
English: Januvia has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Croatian: Januvia nije ispitivana u bolesnika s teškim oštećenjem funkcije jetre, te je potreban oprez (vidjeti dio 5.2).
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Januvia administered concomitantly.
Croatian: Kada se uzima u kombinaciji s metforminom i/ili agonistom PPAR, mora se zadržati ista doza metformina i/ili agonista PPAR, uz istodobnu primjenu lijeka Januvia.
English: If you forget to take Januvia
Croatian: Ako ste zaboravili uzeti lijek Januvia
English: When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Croatian: Kada se Januvia uzima u kombinaciji sa sulfonilurejom ili inzulinom, može se razmotriti niža doza sulfonilureje ili inzulina kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.4).
English: Januvia has no or negligible influence on the ability to drive and use machines.
Croatian: Januvia ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Croatian: U nekih su se bolesnika liječenih metforminom nakon dodavanja sitagliptina javile sljedeće nuspojave: Često (mogu se javiti u do 1 na 10 osoba): nizak šećer u krvi, mučnina, vjetrovi, povraćanje Manje često (mogu se javiti u do 1 na 100 osoba): bol u trbuhu, proljev, zatvor, omamljenost
English: No dose adjustment for Januvia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Croatian: Nije potrebna prilagodba doze lijeka Januvia u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (Child-Pugh rezultat ≤ 9).
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Croatian: Hipoglikemija je primijećena kad se sitagliptin uzimao u kombinaciji s inzulinom ili sulfonilurejom.
English: Januvia should not be used during breast-feeding.
Croatian: Januvia se ne smije uzimati tijekom dojenja.
English: Januvia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Croatian: Januvia sadrži djelatnu tvar sitagliptin, koja pripada skupini lijekova koji se zovu DPP-4 inhibitori (inhibitori dipeptidil-peptidaze 4), koji snižavaju razine šećera u krvi u odraslih bolesnika sa šećernom bolešću tipa 2.
English: Paediatric No studies with Januvia have been performed in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja lijeka Januvia u pedijatrijskih bolesnika.
English: If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
Croatian: Propusti li bolesnik dozu lijeka Januvia, treba je uzeti čim se sjeti.
English: Januvia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Croatian: Januvia pripada skupini oralnih antihiperglikemijskih lijekova koji se zovu inhibitori dipeptidil-peptidaze 4 (DPP-4).
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega (GFR ≥ 15 do < 30 ml/min) ili onih u završnoj fazi bubrežne bolesti, (engl. end stage renal disease, ESRD) (GFR < 15 ml/min), uključujući i one kojima je potrebna hemodijaliza ili peritonealna dijaliza, doza lijeka Januvia je 25 mg jedanput na dan.
English: If a hypersensitivity reaction is suspected, Januvia should be discontinued.
Croatian: Pri sumnji na reakciju preosjetljivosti mora se prekinuti uzimanje lijeka Januvia.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Januvia (see section 4).
Croatian: U bolesnika koji su uzimali lijek Januvia prijavljeni su slučajevi upale gušterače (pankreatitis) (pogledajte dio 4.).
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Januvia is 50 mg once daily.
Croatian: U bolesnika s umjerenim oštećenjem funkcije bubrega (GFR ≥ 30 do < 45 ml/min) doza lijeka Januvia je 50 mg jedanput na dan.
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
Croatian: Kako bi se postigle koncentracije sitagliptina u plazmi slične onima u bolesnika s normalnom funkcijom bubrega, preporučuju se niže doze u bolesnika s GFR-om < 45 ml/min, kao i u bolesnika u završnoj fazi bubrežne bolesti kojima je potrebna hemodijaliza ili peritonealna dijaliza (vidjeti dio 4.2 i 5.2).
English: How to take Januvia
Croatian: Kako uzimati lijek Januvia
English: Frequency not known arthropathy
Croatian: Učestalost nuspojave artropatija nepoznata učestalost
English: How to store Januvia
Croatian: Kako čuvati lijek Januvia
English: If bullous pemphigoid is suspected, Januvia should be discontinued.
Croatian: Pri sumnji na bulozni pemfigoid treba prekinuti liječenje lijekom Januvia.
English: It is important to stay on the diet and exercise recommended by your doctor while taking Januvia.
Croatian: Dok uzimate lijek Januvia, važno je da se pridržavate preporuka svog liječnika o dijeti i tjelovježbi.
English: Januvia 25 mg tablets Sitagliptin
Croatian: Januvia 25 mg tablete sitagliptin
English: EU/1/07/383/013 EU/1/07/383/014 EU/1/07/383/015 EU/1/07/383/016 EU/1/07/383/017 EU/1/07/383/018 EU/1/07/383/023 EU/1/07/383/024
Croatian: EU/1/07/383/015 EU/1/07/383/016 EU/1/07/383/017 EU/1/07/383/018 EU/1/07/383/023 EU/1/07/383/024
English: EU/1/07/383/001 EU/1/07/383/002 EU/1/07/383/003 EU/1/07/383/004 EU/1/07/383/005 EU/1/07/383/006 EU/1/07/383/019 EU/1/07/383/020
Croatian: EU/1/07/383/003 EU/1/07/383/004 EU/1/07/383/005 EU/1/07/383/006 EU/1/07/383/019 EU/1/07/383/020
English: Januvia 100 mg tablets Sitagliptin
Croatian: Januvia 100 mg tablete sitagliptin
English: EU/1/07/383/007 EU/1/07/383/008 EU/1/07/383/009 EU/1/07/383/010 EU/1/07/383/011 EU/1/07/383/012 EU/1/07/383/021 EU/1/07/383/022
Croatian: EU/1/07/383/009 EU/1/07/383/010 EU/1/07/383/011 EU/1/07/383/012 EU/1/07/383/021 EU/1/07/383/022
English: Januvia 50 mg tablets Sitagliptin
Croatian: Januvia 50 mg tablete sitagliptin
English: EU/1/07/383/013 14 film-coated tablets EU/1/07/383/014 28 film-coated tablets EU/1/07/383/023 30 film-coated tablets EU/1/07/383/015 56 film-coated tablets EU/1/07/383/016 84 film-coated tablets EU/1/07/383/024 90 film-coated tablets EU/1/07/383/017 98 film-coated tablets EU/1/07/383/018 50 x 1 film-coated tablets
Croatian: EU/1/07/383/013 14 filmom obloženih tableta EU/1/07/383/014 28 filmom obloženih tableta EU/1/07/383/023 30 filmom obloženih tableta EU/1/07/383/015 56 filmom obloženih tableta EU/1/07/383/016 84 filmom obloženih tableta EU/1/07/383/024 90 filmom obloženih tableta EU/1/07/383/017 98 filmom obloženih tableta EU/1/07/383/018 50 x 1 filmom obložena tableta
English: EU/1/07/383/007 14 film-coated tablets EU/1/07/383/008 28 film-coated tablets EU/1/07/383/021 30 film-coated tablets EU/1/07/383/009 56 film-coated tablets EU/1/07/383/010 84 film-coated tablets EU/1/07/383/022 90 film-coated tablets EU/1/07/383/011 98 film-coated tablets EU/1/07/383/012 50 x 1 film-coated tablets
Croatian: EU/1/07/383/007 14 filmom obloženih tableta EU/1/07/383/008 28 filmom obloženih tableta EU/1/07/383/021 30 filmom obloženih tableta EU/1/07/383/009 56 filmom obloženih tableta EU/1/07/383/010 84 filmom obloženih tableta EU/1/07/383/022 90 filmom obloženih tableta EU/1/07/383/011 98 filmom obloženih tableta EU/1/07/383/012 50 x 1 filmom obložena tableta
English: EU/1/07/383/001 14 film-coated tablets EU/1/07/383/002 28 film-coated tablets EU/1/07/383/019 30 film-coated tablets EU/1/07/383/003 56 film-coated tablets EU/1/07/383/004 84 film-coated tablets EU/1/07/383/020 90 film-coated tablets EU/1/07/383/005 98 film-coated tablets EU/1/07/383/006 50 x 1 film-coated tablets
Croatian: EU/1/07/383/001 14 filmom obloženih tableta EU/1/07/383/002 28 filmom obloženih tableta EU/1/07/383/019 30 filmom obloženih tableta EU/1/07/383/003 56 filmom obloženih tableta EU/1/07/383/004 84 filmom obloženih tableta EU/1/07/383/020 90 filmom obloženih tableta EU/1/07/383/005 98 filmom obloženih tableta EU/1/07/383/006 50 x 1 filmom obložena tableta
English: Januvia 100 mg film-coated tablets
Croatian: Januvia 100 mg filmom obložene tablete
English: Januvia 25 mg film-coated tablets Sitagliptin
Croatian: Januvia 25 mg filmom obložene tablete sitagliptin
English: Januvia 25 mg film-coated tablets
Croatian: Januvia 25 mg filmom obložene tablete
English: Januvia 50 mg film-coated tablets
Croatian: Januvia 50 mg filmom obložene tablete
English: Januvia 100 mg film-coated tablets Sitagliptin
Croatian: Januvia 100 mg filmom obložene tablete sitagliptin
English: Mean change from baseline HbA1c
Croatian: Srednja vrijednost promjene u odnosu na početni HbA1c (%)
English: Januvia 50 mg film-coated tablets Sitagliptin
Croatian: Januvia 50 mg filmom obložene tablete sitagliptin
English: MA (EU) number (Invented) name
Croatian: 10 (10 x 1) boca (višestrukog pakiranja)
English: You may need to read it again
Croatian: Možda ćete je trebati ponovno pročitati.
English: • At the request of the European Medicines Agency.
Croatian: • Na zahtjev Europske agencije za lijekove;
English: 79539, Germany
Croatian: 79539, Njemačka
English: The expiry date refers to the last day of that month
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: • you are a smoker (as this may increase the risk of dental problems)
Croatian: • ako ste pušač (to može povećati rizik od problema sa zubima)
English: Bondronat is indicated in adults for
Croatian: Bondronat je indiciran u odraslih za
English: Acetic acid (99%)
Croatian: Acetatna kiselina (99%)
English: Bondronat with food and drink
Croatian: Bondronat s hranom i pićem
English: Date of latest renewal: 25 June 2006
Croatian: Datum posljednje obnove odobrenja: 25. lipnja 2006.
English: - Water is the only drink that should be taken with Bondronat.
Croatian: Voda je jedino piće s kojim se Bondronat smije uzimati.
English: • if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Croatian: • ako ne možete stajati ili uspravno sjediti neprekidno barem jedan sat (60 minuta)
English: Other medicines and Bondronat
Croatian: Drugi lijekovi i Bondronat
English: • you have cancer.
Croatian: • ako bolujete od raka.
English: The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Croatian: Analiza SMPR-a bila je vremenski usklađena i uzimala je u obzir mogućnost da bi jedan ili više događaja u razdoblju od 12 tjedana mogli biti povezani.
English: If you develop these symptoms, stop taking Bondronat and tell your doctor straight away (see sections 3 and 4).
Croatian: Ako se ovi simptomi pojave, prekinite uzimati lijek Bondronat i odmah se obratite svom liječniku (vidjeti dijelove 3 i 4).
English: even if their signs of illness are the same as yours
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: • Do not use this medicine if you notice that the solution is not clear or contains particles
Croatian: • Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra ili sadrži čestice.
English: Do not take Bondronat with food or any other drinks except water as Bondronat is less effective if it is taken with food or drink (see section 3).
Croatian: Nemojte uzimati Bondronat s hranom i nikakvim drugim napitkom osim vode jer je Bondronat manje djelotvoran ako se uzima s hranom ili pićem (vidjeti dio 3.).
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu da biste nadoknadili dozu koju ste propustili.
English: In most cases a raised serum calcium level can be reduced to the normal range within 7 days.
Croatian: U većini slučajeva povišena razina kalcija u serumu može se smanjiti na normalnu razinu unutar 7 dana.
English: The usual dose of Bondronat is one tablet each day.
Croatian: Uobičajena doza lijeka Bondronat je jedna tableta dnevno.
English: • rise in body temperature
Croatian: • porast tjelesne temperature.
English: What Bondronat is and what it is used for
Croatian: Što je Bondronat i za što se koristi
English: Do not take Bondronat if you are pregnant, planning to get pregnant or if you are breast-feeding.
Croatian: Ne uzimajte Bondronat ako ste trudni, planirate zatrudnjeti ili ako dojite.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimization) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: This is because Bondronat can affect the way some other medicines work.
Croatian: To je zato što Bondronat može utjecati na djelovanje drugih lijekova.
English: Before receiving treatment, tell your doctor/nurse (health care professional) if:
Croatian: Prije nego započnete liječenje obavijestite svog liječnika/medicinsku sestru (zdravstvenog radnika):
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: • obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: • It helps to prevent your bones from breaking (fractures)
Croatian: • Pomaže spriječiti prijelome kostiju (frakture)
English: Do not take Bondronat:
Croatian: Nemojte uzimati Bondronat:
English: Water may be taken at any time during the course of Bondronat treatment (see section 4.5).
Croatian: Voda se smije uzimati bilo kada za vrijeme trajanja liječenja lijekom Bondronat (vidjeti dio 4.5).
English: What Bondronat contains
Croatian: Što Bondronat sadrži
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, za vrijeme skladištenja i uvjete prije uporabe odgovoran je korisnik a normalno ne bi trebali biti duži od 24 sata na temperaturi od 2 do 8°C, izuzev u slučaju da je rekonstitucija izvršena u kontroliranim i validiranim aseptičkim uvjetima.