FrancophonIA/ELRC3.0 huggingface dataset:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use, for infusion after dilution
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku Primjena u venu infuzijom, nakon razrjeđivanja
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva svrbež
English: The median time to relapse (return of albumin-corrected serum calcium above 3.0 mmol/l) was 18 to 26 days.
Croatian: Medijan vremena do recidiva (povratka razine kalcija u serumu korigiranog albuminom iznad 3,0 mmol/l) iznosi 18 do 26 dana.
English: - Patients should not lie down for 60 minutes after taking Bondronat.
Croatian: Nakon uzimanja lijeka Bondronat bolesnik ne smije leći sljedećih 60 minuta.
English: The deterioration in Quality of Life was significantly less in Bondronat treated patients compared with placebo.
Croatian: Pogoršanje kvalitete života bilo je znatno manje u bolesnika liječenih lijekom Bondronat nego u bolesnika koji su primali placebo.
English: There was also a 38% reduction in the risk of developing an SRE for Bondronat treated patients when compared with placebo (relative risk 0.62, p=0.003).
Croatian: U usporedbi s placebo grupom, u bolesnika liječenih lijekom Bondronat rizika od razvoja SRE bio je za 38% manji (relativni rizik 0,62; p=0,003).
English: For patients with breast cancer and bone metastases, Bondronat infusion should be administered every 3-4 weeks.
Croatian: U bolesnika s rakom dojke i koštanim metastazama, infuziju lijeka Bondronat treba primjenjivati svaka 3 - 4 tjedna.
English: • Store in the original package in order to protect from moisture
Croatian: • Čuvati u originalnom pakiranju radi zaštite od vlage.
English: What you need to know before you take Bondronat
Croatian: Što morate znati prije nego počnete uzimati Bondronat
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat (see section 4.2).
Croatian: Unatoč tome, na temelju kliničke procjene za pojedinog bolesnika, preporučuje se praćenje bubrežne funkcije te kalcija, fosfata i magnezija u serumu, u bolesnika koji se liječe lijekom Bondronat (vidjeti dio 4.2).
English: Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Croatian: Tablica 3 Sekundarni rezultati djelotvornosti (bolesnici s rakom dojke i koštanim metastazama)
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bondronat in patients with concomitant risk factors.
Croatian: U bolesnika s istodobno prisutnim faktorima rizika preporučuje se prije liječenja lijekom Bondronat provesti pregled zuba i preventivne stomatološke zahvate te ocijeniti omjer koristi i rizika za svakog pojedinog bolesnika.
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Croatian: Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni (vidjeti dio 4.4).
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat.
Croatian: Unatoč tome, na temelju kliničke procjene za pojedinog bolesnika, preporučuje se praćenje bubrežne funkcije te kalcija, fosfata i magnezija u serumu, u bolesnika koji se liječe lijekom Bondronat.
English: • tooth problems
Croatian: • problemi sa zubima.
English: Table 1 Adverse Reactions Reported for Intravenous Administration of Bondronat System Organ
Croatian: Tablica 1 Nuspojave prijavljene kod intravenske primjene lijeka Bondronat
English: The deterioration in Quality of Life and WHO performance status was significantly less in Bondronat treated patients compared with placebo.
Croatian: Pogoršanje kvalitete života i općeg stanja prema WHO, bilo je znatno manje u bolesnika liječenih lijekom Bondronat nego u bolesnika koji su primali placebo.
English: • If you have any further questions, ask your doctor or pharmacist
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: • high levels of urea or high levels of parathyroid hormone in your blood
Croatian: • visoke razine ureje i visoke razine hormona paratiroidne žlijezde u krvi.
English: • low calcium or phosphate levels in your blood
Croatian: • snižena razina kalcija i fosfata u krvi
English: No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
Croatian: Nije bilo dokaza izravne fetalne toksičnosti ili teratogenog učinka u štakora i zečeva kojima je ibandronatna kiselina primijenjena intravenski.
English: The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenous injection given every 3-4 weeks.
Croatian: Preporučena doza za sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama iznosi 6 mg intravenskom injekcijom svaka 3 - 4 tjedna.
English: • It helps to prevent your bones from breaking (fractures) • It also helps to prevent other bone problems that may need surgery or radiotherapy
Croatian: • Pomaže spriječiti druge poteškoće s kostima koje bi mogle zahtijevati operaciju ili radioterapiju.
English: Data from this study demonstrated a significant advantage for intravenous Bondronat 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Croatian: Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost lijeka Bondronat 6 mg danog intravenski, u odnosu na placebo u pogledu smanjivanja SRE, mjereno vremenski prilagođenim SMPR-om (p=0,004).
English: • fluid build up and swelling (‘lymphoedema')
Croatian: • nakupljanje tekućine i naticanje (“limfni edem”)
English: Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Croatian: Budući da je u nekliničkim ispitivanjima pri visokim dozama ustanovljeno da su bubrezi i jetra ciljni organi za toksičnost, potrebno je pratiti funkcije jetre i bubrega.
English: Pooled data from these studies demonstrated a significant advantage for Bondronat 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Croatian: Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost lijeka Bondronat 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE, mjereno SMPR-om (p=0,041).
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bondronat for oncology indications (see section 4.8).
Croatian: U bolesnika koji su nakon njegova stavljanja u promet primali Bondronat za onkološke indikacije, vrlo je rijetko prijavljena osteonekroza čeljusti (vidjeti dio 4.8).
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended (see section 5.2).
Croatian: Za bolesnike s umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 i < 50 ml/min) preporučena je prilagodba doze na jednu 50 mg filmom obloženu tabletu svaki drugi dan (vidjeti dio 5.2).
English: Hypocalcaemia
Croatian: - Hipokalcijemija
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Croatian: Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni.
English: Very rare (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetke (mogu se javiti kod manje od 1 na 10 000 osoba)
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Croatian: Sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem tableta lijeka Bondronat od 50 mg ocijenjena je u dva randomizirana, placebom kontrolirana ispitivanja faze III u trajanju od 96 tjedana.
English: How to receive Bondronat
Croatian: Kako uzimati Bondronat
English: Clear, colourless solution.
Croatian: Bezbojna, bistra otopina.
English: • If you have any further questions, ask your doctor, pharmacist or nurse
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: EU/1/96/012/012: 5 vials
Croatian: EU/1/96/012/012: 5 bočica
English: Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vialwith a bromobutyl rubber stopper).
Croatian: Bondronat je dostupan u pakiranjima od 1, 5 i 10 bočica (bočica od 6 ml, staklo tipa I, s čepom od bromobutilne gume).
English: I.V.
Croatian: A.
English: Paraesthesia, dysgeusia (taste perversion)
Croatian: Poremećaji živčanog sustava parestezija, disgeuzija (poremećaj okusa)
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Croatian: osteonekroza čeljusti†**, osteonekroza vanjskog slušnog kanala (nuspojava skupine bisfosfonata) †
English: This is because the medicine will only work if it is taken all the time.
Croatian: Uzimajte Bondronat tijekom čitavog razdoblja koje Vam je propisao liječnik jer djeluje samo ako se uzima čitavo vrijeme.
English: Myocardial ischaemia, cardiovascular disorder, palpitations
Croatian: Srčani poremećaji blok grane ishemija miokarda, poremećaji srca i krvnih žila, palpitacije
English: A flu-like syndrome consisting of fever, chills, bone and/or muscle ache-like pain has occurred.
Croatian: Javljala se bolest slična gripi koja je uključivala vrućicu, zimicu i bolove u kostima/mišićima.
English: Talk to your doctor first if you want to drive, use machine or tools.
Croatian: Želite li voziti, koristiti strojeve ili alate, posavjetujte se najprije sa svojim liječnikom.
English: EU/1/96/012/013: 10 vials
Croatian: EU/1/96/012/013: 10 bočica
English: The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 18 - 19 days for the 2 mg and 4 mg doses.
Croatian: Medijan vremena do pojave recidiva (povratka vrijednosti kalcija u serumu korigiranih albuminom na razinu višu od 3 mmol/l) iznosio je 18 - 19 dana za doze od 2 mg i 4 mg.
English: Hypocalcaemia** Hypophosphataemia
Croatian: Poremećaji metabolizma i prehrane hipokalcijemija** hipofosfatemija
English: Atnahs Pharma Netherlands B.V. Strawinskylaan 3127
Croatian: Strawinskylaan 3127
English: Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Croatian: U bolesnika koji peroralno primaju bisfosfonate prijavljeni su štetni događaji kao što su ezofagitis, vrijedovi jednjaka i erozije jednjaka, koji su u nekim slučajevima bili teški i zahtijevali su bolničko liječenje, rijetko s krvarenjem ili strikturom jednjaka ili perforacijom.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku
English: Appropriate medical support and monitoring measures should be readily available when Bondronat intravenous injection is administered.
Croatian: Prilikom primjene intravenske injekcije lijeka Bondronat moraju biti dostupne odgovarajuća medicinska podrška i mjere nadzora.
English: Albumin-corrected Serum calcium (mmol/l)
Croatian: korigiran albuminom (mmol/l)
English: Albumin-corrected serum calcium (mmol/l)
Croatian: kalcij u serumu korigiran albuminom (mmol/l)
English: Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial with a bromobutyl rubber stopper).
Croatian: Bondronat je dostupan u pakiranju od 1 bočice (bočica od 2 ml, staklo tipa I, s čepom od bromobutilne gume).
English: No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem bubrega (klirens kreatinina ≥ 50 i < 80 ml/min).
English: Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Croatian: Način i put primjene Bondronat koncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju.
English: Excipients with known effect Bondronat is essentially sodium free.
Croatian: Pomoćne tvari s poznatim učinkom Bondronat sadrži zanemarive količine natrija.
English: See also dosage section above for patients with renal impairment
Croatian: Vidjeti i gore opisan dio o doziranju za bolesnike s oštećenjem bubrega.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: Hypromellose Titanium dioxide (E 171) Talc
Croatian: Film ovojnica: hipromeloza titanijev dioksid (E171) talk makrogol 6000
English: The median time to relapse (re-increase of serum albumin corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses.
Croatian: Medijan vremena do pojave recidiva (povratka vrijednosti kalcija u serumu na razinu višu od 3 mmol/l) iznosio je 18-19 dana za doze od 2 mg i 4 mg.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
Croatian: Sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem lijeka Bondronat u dozi od 6 mg intravenski, ocijenjena je u jednom randomiziranom, placebom kontroliranom ispitivanju faze III u trajanju od 96 tjedana.
English: Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Croatian: Bondronat koncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bondronat for cancer-related conditions.
Croatian: U bolesnika koji su primali Bondronat za liječenje stanja povezanih s rakom nakon njegova stavljanja na tržište, vrlo je rijetko prijavljena nuspojava koja se zove osteonekroza čeljusti (oštećenje kosti u čeljusti).
English: = Serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
Croatian: = kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
English: What Bondronat looks like and contents of the pack Bondronat is a colourless, clear solution.
Croatian: Bondronat je bezbojna, bistra otopina.
English: • stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
Croatian: • bol u želucu i trbuhu, probavne smetnje, mučnina, povraćanje ili proljev (rijetka stolica)
English: Albumin-corrected Serum calcium (mg/dl)
Croatian: ili kalcij u serumu korigiran albuminom (mg/dl)
English: How to store Bondronat
Croatian: Kako čuvati Bondronat
English: Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Croatian: Bondronat 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: • aching joints, arthritis, or other joint problems
Croatian: • bolovi u zglobovima, artritis ili drugi problemi sa zglobovima
English: = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + Or
Croatian: = kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] +
English: Chest pain, influenza-like illness, malaise, pain
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija bolovi u prsima, bolest nalik gripi, malaksalost, bol
English: Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Croatian: Bondronat 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: Ocular inflammation†**
Croatian: Poremećaji oka upala oka†**
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva atipične suptrohanterične i dijafizealne frakture femura†
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011: 1 vial
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/012/011: 1 bočica
English: • Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Croatian: • sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama - treba ga dodati u 100 ml izotonične otopine natrijevog klorida ili u 100 ml 5%-tne otopine glukoze i primijeniti infuzijom u trajanju od najmanje 15 minuta.
English: Metabolism and nutrition disorders
Croatian: Poremećaj metabolizma i prehrane hipokalcijemija**
English: NAME OF THE MEDICINAL PRODUCT Bondronat 2 mg concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Bondronat 2 mg koncentrat za otopinu za infuziju.
English: Neoplasms benign, malignant and unspecified
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine dobroćudne novotvorine na koži
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog hidrata)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog hidrata)
English: One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate)
Croatian: Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: Marketing Authorisation Holder Atnahs Pharma Netherlands B.V. Strawinskylaan 3127
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Atnahs Pharma Netherlands B.V.
English: Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate)
Croatian: Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetke (mogu se javiti kod manje od 1 na 1000 osoba)
English: Your doctor may do regular blood tests while you are receiving Bondronat.
Croatian: Za vrijeme liječenja lijekom Bondronat liječnik će Vam vjerojatno provoditi redovite krvne pretrage kako bi provjerio primate li odgovarajuću dozu lijeka.
English: Hypothermia
Croatian: Hipokalcijemija
English: at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Croatian: Nadalje, budući da, pri terapijskim koncentracijama, vezanje ibandronatne kiseline za proteine plazme iznosi otprilike 87%, nije vjerojatno da će hipoproteinemija u bolesnika s teškom bolesti jetre dovesti do klinički značajnih povećanja koncentracije slobodne ibandronatne kiseline u plazmi.
English: Cystitis, vaginitis, oral candidiasis
Croatian: Infekcije i infestacije infekcija cistitis, vaginitis, oralna kandidijaza
English: One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate)
Croatian: Jedna bočica sa 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: NAME OF THE MEDICINAL PRODUCT Bondronat 6 mg concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Bondronat 6 mg koncentrat za otopinu za infuziju.
English: Common (may affect up to 1 in 10 people):
Croatian: Česte (mogu se javiti kod manje od 1 na 10 osoba):
English: • Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Croatian: • Sprječavanje koštanih poremećaja - dodati u 100 ml izotonične otopine natrijevog klorida ili u 100 ml 5%-tne otopine glukoze te primijeniti infuzijom u trajanju od najmanje 15 minuta.
English: Pyrexia, influenza-like illness**, oedema peripheral, asthenia, thirst
Croatian: Opći poremećaji i reakcije na mjestu primjene vrućica, bolest nalik gripi**, edemi okrajina, astenija, žeđ hipotermija
English: In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
Croatian: U bolesnika s umjerenom hiperkalcijemijom (kalcij u serumu korigiran albuminom <3 mmol/l ili <12 mg/dl) doza od 2 mg je učinkovita.
English: Posology Prevention of skeletal events in patients with breast cancer and bone metastases
Croatian: Klinička ispitivanja sprječavanja koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama
English: 5 How to store Bondronat Contents of the pack and other information
Croatian: Kako Bondronat izgleda i sadržaj pakiranja
English: Your doctor may do regular blood tests while you are taking Bondronat.
Croatian: Za vrijeme liječenja lijekom Bondronat, liječnik će Vam vjerojatno provoditi redovite krvne pretrage kako bi provjerio primate li odgovarajuću dozu lijeka.
English: A statistically significant improvement in bone pain score was shown for intravenous Bondronat 6 mg compared to placebo.
Croatian: Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost lijeka Bondronat 6 mg danog intravenski, u odnosu na placebo u pogledu smanjivanja
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease) All Skeletal Related Events (SREs) Placebo n=158
Croatian: Svi događaji vezani uz kosti (SRE) Placebo n=158
English: Uncommon Rare
Croatian: Vrlo rijetko Nepoznato
English: To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by
Croatian: Da biste kalcij u serumu korigiran albuminom i izražen u mmol/l pretvorili u mg/dl, vrijednost pomnožite sa 4.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 28 filmom obloženih tableta 84 filmom obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/012/011
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Nemojte sisati, žvakati niti drobiti tablete
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Croatian: Za bolesnike s rakom dojke i koštanim metastazama koji se liječe radi sprječavanja koštanih poremećaja te s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min), se preporučuje prilagodba doze (vidjeti dio 4.2).