natgillin/translations-raw huggingface dataset:
Prescribers should consult the section Patients with Renal Impairment (see section 4.2) for recommendations on dosing and administration in this patient group. 
Propisivači mogu pronaći preporuke za doziranje i primjenu u toj skupini bolesnika u odjeljku Bolesnici s oštećenjem bubrega (vidjeti dio 4.2).
Appropriate medical support and monitoring measures should be readily available when Iasibon intravenous injection is administered. 
Prilikom primjene intravenske injekcije lijeka Iasibon moraju biti dostupne odgovarajuća medicinska podrška i mjere nadzora.
• Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours 
• liječenje hiperkalcijemije nastale zbog tumora - treba ga dodati u 500 ml izotonične otopine natrijevog klorida ili u 500 ml 5%-tne otopine glukoze i primijeniti infuzijom u trajanju od 2 sata.
Tel: +385 1 30 111 28 
PROXIMUM d.o.o. Tel: +385 1 30 111 28
The deterioration in Quality of Life and WHO performance status was significantly less in Ibandronate treated patients compared with placebo. 
Pogoršanje kvalitete života i općeg stanja, prema WHO, bilo je znatno manje u bolesnika liječenih ibandronatom nego u bolesnika koji su primali placebo.
Children and adolescents Iasibon should not be used in children and adolescents below the age of 18 years. 
Djeca i adolescenti Iasibon se ne smije davati djeci i adolescentima mlađim od 18 godina.
• pelvic pain, discharge, itching or pain in the vagina 
• bolovi u zdjelici, vaginalni iscjedak, svrbež ili bol u rodnici
• The other ingredients are sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections. 
• Drugi sastojci su natrijev klorid, ledena acetatna kiselina, natrijev acetat trihidrat i voda za injekcije.
The Star Medicines Importers Co. Ltd Τηλ: +357 25371056 
Ltd Τηλ: +357 25371056
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDS) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration. 
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.
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. 
Osteonekroza čeljusti primijećena je i u bolesnika s osteoporozom koji su uzimali peroralne bisfosfonate.
Sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections. 
Natrijev klorid, ledena acetatna kiselina, natrijev acetat trihidrat i voda za injekcije.
• 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. 
• prevencija koštanih događaja 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.
Asthma exacerbation 
• napadaj astme
No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits. 
Reproduktivna toksičnost: Nije bilo dokaza izravne fetalne toksičnosti ili teratogenog učinka u štakora i zečeva kojima je ibandronatna kiselina primijenjena intravenski ili peroralno.
Store in the original package in order to protect from moisture 
POSEBNE MJERE ČUVANJA Čuvati u originalnom pakovanju radi zaštite od vlage
The number of SREs was also significantly reduced with Ibandronate 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003). 
6 mg, s 40% smanjenim rizikom od pojave SRE u usporedbi s placebom (relativni rizik 0,6; p = 0,003).
Hypophosphatae mia 
hipofosfatemija
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenousibandronic acid. 
Slučajevi anafilaktičke reakcije/šoka, uključujući događaje sa smrtnim ishodom, prijavljeni su u bolesnika liječenih intravenski primijenjenom ibandronatnom kiselinom.
Common (may affect up to 1 in 10 people): 
Česte (mogu se javiti kod do 1 na 10 osoba):
Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates. 
Osteonekroza čeljusti primijećena je u bolesnika liječenih bisfosfonatima.
No data are available (see section 5.1 and section 5.2). 
Nema dostupnih podataka. (vidjeti dijelove 5.1 i 5.2) Način primjene
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dosage. 
U većine bolesnika s teškom hiperkalcijemijom (kalcij u serumu korigiran albuminom* ≥3 mmol/l ili ≥12 mg/dl) prikladna je jednokratna doza od 4 mg.
Dose: Treatment of tumour-induced hypercalcaemia 
Doziranje:Liječenje hiperkalcijemije nastale zbog tumora
Pallini Attiki, 15351 Greece 
Pallini Attiki, 15351
• kidney cyst (fluid-filled sac in the kidney) 
• bubrežna cista (vrećica puna tekućine u bubregu)
15351 Pallini, Attiki Greece 
15351 Pallini, Attiki
A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50 ml/min. 
Nije provedeno ispitivanje 15-minutne infuzije u bolesnika oboljelih od raka s klirensom kreatinina <50 ml/min.
Hypersensitivity bronchospasm†, angioedema† 
Poremećaji imunološko g sustava preosjetljivost†, bronhospazam†, angioedem†,
In patients with moderate hypercalcaemia (albumincorrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose. 
U bolesnika s umjerenom hiperkalcijemijom (kalcij u serumu korigiran albuminom <3 mmol/l ili <12 mg/dl) doza od 2 mg je učinkovita.
A flu-like syndrome consisting of fever, chills, bone and/or muscle ache-like pain has occurred. 
Javljala se bolest slična gripi koja je uključivala vrućicu, zimicu i stalne tupe bolove u kostima i/ili mišićima.
To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by 4. 
Da biste kalcij u serumu korigiran albuminom i izražen u mmol/l pretvorili u mg/dl, vrijednost pomnožite sa 4.
NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film coated tablets 
NAZIV GOTOVOG LIJEKA Iasibon 50 mg filmom obložene tablete
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration. 
Nakon peroralne primjene apsorpcija ibandronatne kiseline u gornjem dijelu probavnog trakta je brza.
In subjects with severe renal impairment (mean estimated CLcr = 21.2 mL/min), dose-adjusted mean AUC0-24h was increased by 110% compared to healthy volunteers. 
Kod ispitanika s teškim oštećenjem bubrega (srednja procijenjena vrijednost CLcr = 21,2 ml/min), srednja vrijednost AUC0-24h prilagođena dozi, je bila povećana za
Anaemia 
• anemija
Blood parathyroid hormone increased 
Pretrage povećana razina paratiroidnog hormona u krvi
Posology Prevention of skeletal events in patients with breast cancer and bone metastases 
Doziranje Prevencija koštanih događaja u bolesnika s rakom dojke i koštanim metastazama
No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits. 
Reproduktivna toksičnost: Nije bilo dokaza izravne fetalne toksičnosti ili teratogenog učinka u štakora i kunića kojima je ibandronatna kiselina primijenjena intravenski.
- radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures 
- radioterapija kostiju radi liječenja prijeloma/mogućih prijeloma - operacija kostiju zbog liječenja prijeloma
Uncommon (may affect less than 1 in 100 people) 
Manje česte (mogu se javiti kod manje od 1 na 100 osoba)
Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis 
dispepsija, gastrointestinalna bol, poremećaj zuba gastroenteritis, gastritis, ulceracija usta, disfagija, heilitis
METHOD OF ADMINISTRATION Read the package leaflet before use 
NAČIN PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku
See also dosage section above for patients with renal impairment 
Vidjeti i prethodni dio o doziranju za bolesnike s oštećenjem bubrega.
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis for the jaw, and ocular inflammation (see paragraph “description of selected adverse reactions” and section 4.4). 
Najozbiljnije prijavljene nuspojave su anafilaktička reakcija/šok, atipični prijelomi bedrene kosti, osteonekroza čeljusti i upala oka (vidjeti odlomak „Opis odabranih nuspojava“ i dio 4.4).
• aching joints, arthritis, or other joint problems 
• tupi bolovi u zglobovima, artritis ili drugi problemi sa zglobovima
Rare (may affect up to 1 in 1,000 people) 
Rijetke (mogu se javiti kod do 1 na 1000 osoba)
Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks. 
Prevencija koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem tableta ibandronata od 50 mg ocijenjena je u dva randomizirana, placebom kontrolirana ispitivanja, u fazi III, u trajanju od 96 tjedana.
Your doctor may do regular blood tests while you are receiving Iasibon. 
Za vrijeme liječenja lijekom Iasibon, liječnik će Vam vjerojatno provoditi redovite krvne pretrage kako bi provjerio primate li odgovarajuću dozu ovog lijeka.
Iasibon contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”. 
Iasibon sadrži manje od 1 mmol natrija (23 mg) po dozi, odnosno zanemarive količine natrija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
• After dilution the infusion solution is stable for 24 hours at 2-8 °C (in a refrigerator). 
• Nakon razrjeđivanja infuzijska otopina stabilna je 24 sata na temperaturi od 2-8 °C (u hladnjaku).
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary. 
Bolesnicima s blagim oštećenjem bubrega (CLcr ≥50 i <80 ml/min) nije potrebna prilagodba doze.
Very rare (may affect up to 1 in 10,000 people) 
Vrlo rijetke (mogu se javiti kod do 1 na 10 000 osoba)
They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats. 
Nuspojave ibandronatne kiseline opažene u ispitivanjima reproduktivne toksičnosti u štakora bili su očekivani za ovu skupinu lijekova (bisfosfonati) i uključivale su smanjeni broj mjesta implantacije, poremećaj prirodnog poroda (distocija), povećanje visceralnih varijacija (sindrom bubrega, zdjelice i mokraćovoda) te abnormalnosti zubi u F1 potomstvu štakora.
that is bleeding, or that your stomach is inflamed (gastritis) 
To može biti znak krvarenja čira u početnom dijelu crijeva (dvanaesniku) ili upale želuca (gastritis)
What you need to know before you receive Iasibon 
Što morate znati prije nego počnete primati Iasibon
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva poremećaj kože,
Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth 
mučnina krvarenje, vrijed na dvanaesniku, gastritis, otežano gutanje, suha usta
Acetylsalicylic acid and NSAIDs 
Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi
INFORMATION IN BRAILLE Iasibon 50 mg 
16. PODACI NA BRAILLEOVOM PISMU Iasibon 50 mg
Iasibon should not be used during breast-feeding. 
Iasibon se ne smije koristiti za vrijeme dojenja.
Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Iasibon tablets. 
Interakcije lijeka i hrane Proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij i željezo),
How to take Iasibon 
Kako uzimati Iasibon
If you have breast cancer that has spread to your bones, then the recommended dose is 3 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes. 
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 3 ampule (6 mg) svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
• skin rash 
• osip kože
Iasibon 1 mg is supplied as pack containing 1 ampoule (2 ml type I glass ampoule). 
Iasibon 1 mg je dostupan u pakiranju od 1 ampule (ampula od 2 ml, staklo tipa I).
Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min). 
Ukupni klirens ibandronatne kiseline bio je smanjen na 44 ml/min u bolesnika s teškim oštećenjima bubrega u usporedbi sa 129 ml/min kod osoba s normalnom funkcijom bubrega.
If you have breast cancer that has spread to your bones, then the recommended dose is 6 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes. 
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 6 ampula (6 mg) svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator) 
Nakon razrjeđivanja otopina za infuziju je stabilna 24 sata na 2 °C - 8 °C (u hladnjaku)
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements 
To možete spriječiti tako da se pridržavate sljedećih uputa: • Uzmite tabletu ujutro odmah nakon ustajanja, prije uzimanja prvog jutarnjeg obroka, pića,
• stomach and tummy pain, indigestion, being sick vomiting or having diarrhoea (loose bowels) 
• bol u želucu i trbuhu, probavne smetnje, mučnina, povraćanje ili proljev (rijetka stolica)
Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate) 
Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
Iasibon 2 mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule). 
Iasibon 2 mg je dostupan u pakiranju od 1 ampule (ampula od 4 ml, staklo tipa I).
Injury, poisoning and procedural complications 
Ozljede, trovanja i proceduralne k lik ij ozljeda, bol na mjestu injiciranja
Blood alkaline phosphatase increase, weight decrease 
Pretrage povišena razina gama GT-a, povišena razina kreatinina povišene razine alkalne fosfataze u krvi, smanjenje tjelesne težine
Iasibon concentrate for solution for infusion should be administered as an intravenous infusion. 
Iasibonkoncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju.
If you have breast cancer that has spread to your bones, then the recommended dose is 1 vial (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes. 
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 1 bočica (6 mg) svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. 
Nema podataka o tome smanjuje li prekid liječenja bisfosfonatima rizik od osteonekroze čeljusti u bolesnika kojima su potrebni zubarski zahvati.
Care must be taken not to administer Iasibon concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.. 
Potreban je oprez kako se Iasibon koncentrat za otopinu za infuziju ne bi primijenio intraarterijski ili paravenski, jer to može dovesti do oštećenja tkiva.
INFORMATION IN BRAILLE Iasibon 1 mg 
16. PODACI NA BRAILLEOVOM PISMU Iasibon 1 mg
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronate 
Tablica 1 Nuspojave prijavljene uz peroralnu primjenu ibandronata Organsk i sustav
INFORMATION IN BRAILLE Iasibon 6 mg 
16. PODACI NA BRAILLEOVOM PISMU Iasibon 6 mg
All Skeletal Related Events (SREs) Placebo n=277 
Placebo n=277
Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid 
Tablica 1 Nuspojave prijavljene kod intravenske primjene ibandronatne kiseline Organski sustav Često
Not known anaphylactic reaction/shock† 
anafilaktička reakcija/šok†**
Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with a duration of 96 weeks. 
Prevencija koštanih događaja u bolesnika s rakom dojke i koštanim metastazama davanjem ibandronata u dozi od 6 mg intravenski ocijenjena je u jednom randomiziranom, placebom kontroliranom ispitivanju, u fazi III, u trajanju od 96 tjedana.
Marketing Authorisation Holder Pharmathen S.A. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A.
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. 
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.
Albumin-corrected serum calcium (mmol/l) = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 or Albumin-corrected serum calcium (mg/dl) =serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)] 
kalcij u serumu korigiran albuminom (mmol/l) = kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
You may have early signs of severe jaw problems (necrosis 
To mogu biti rani znakovi teških problema čeljusne kosti (nekroze, tj. odumiranja koštanog kiva).
- Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes 
- Nepravilnosti jednjaka koje dovode do zastoja u pražnjenju jednjaka kao što su striktura ili ahalazija.
Do not take Iasibon - if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6 - if you have problems with your food pipe /gullet (oesophagus) such as narrowing or difficulty swallowing - if you cannot stand or sit upright for at least one hour (60 minutes) at a time - if you have or ever had low calcium in your blood. 
• ako ste alergični na ibandronatnu kiselinu ili neki sastojak ovog lijeka naveden u dijelu 6 • ako imate probleme s jednjakom (ezofagusom), kao što su suženje ili teškoće prilikom gutanja
Chest pain, influenzalike illness, malaise, pain 
Opći poremećaj i i reakcije na mjestu primjene astenija bolovi u prsima, bolest nalik gripi, malaksalost, bol
Talk to your doctor or pharmacist before taking Iasibon: 
obratite se svom liječniku ili ljekarniku prije nego uzmete Iasibon.
What Iasibon looks like and contents of the pack Iasibon is a colourless, clear solution. 
Kako Iasibon izgleda i sadržaj pakiranja
Read the package leaflet before use Intravenous use, for infusion after dilution 
Primjena u venu infuzijom, nakon razrjeđivanja
INFORMATION IN BRAILLE Iasibon 2 mg 
16. PODACI NA BRAILLEOVOM PISMU Iasibon 2 mg
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dose adjustment is necessary. 
Za bolesnike s blagim oštećenjem bubrega (klirens kreatinina ≥50 i <80 ml/min) nije potrebna prilagodba doze.
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2). 
Za bolesnike s rakom dojke i koštanim metastazama koji se liječe radi prevencije koštanih događaja te s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min) preporučuje se prilagodba doze (vidjeti dio 4.2).
NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A
Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections 
6.1 Popis pomoćnih tvari natrijev klorid acetatna kiselina, ledena natrijev acetat trihidrat voda za injekcije
(see section 4.2). 
(pogledajte dio 4.).
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Hypocalcaemia 
- Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Iasibon'). 
Preporučuje se da se lijek upotrijebi odmah nakon razrjeđivanja (pogledajte dio 5. ove upute o lijeku,
Treatment of tumour-induced hypercalcaemia 
Liječenje hiperkalcijemije nastale zbog tumora
Cellulose, microcrystalline Crospovidone Maize starch pregelatinised Glycerol dibehenate Silica, anhydrous colloidal 
Jezgra tablete: povidon celuloza, mikrokristalična krospovidon škrob, prethodno geliran gliceroldibehenat silicijev dioksid, koloidni, bezvodni
Iasibon 1 mg concentrate for solution for infusion ibandronic acid 
Iasibon 1 mg koncentrat za otopinu za infuziju ibandronatna kiselina
For patients with breast cancer and bone metastases, Iasibon infusion should be administered every 3-4 weeks. 
U bolesnika s rakom dojke i koštanim metastazama, infuziju lijeka Iasibon treba primjenjivati svaka 3
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section 5.2): 
Za bolesnike s rakom dojke i koštanim metastazama te s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (klirens kreatinina <30 ml/min) koji se liječe radi prevencije koštanih događaja, treba slijediti sljedeće preporuke za doziranje (vidjeti dio 5.2): Klirens kreatinina (ml/min)
Hypocalcaemia 
- Hipokalcijemija.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Pharmathen S.A. 
Nositelj odobrenja za stavljanje gotovog lijeka u promet Pharmathen S.A.
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed: 
Za bolesnike s rakom dojke i koštanim metastazama te s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) koji se liječe radi prevencije koštanih događaja, treba slijediti sljedeće preporuke za doziranje:
NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion 
NAZIV LIJEKA Iasibon 6 mg koncentrat za otopinu za infuziju
Hypocalcaemia* 
(hipokalcijemija).
• bruising 
• modrice
QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ampula s 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion ibandronic acid 
NAZIV LIJEKA Iasibon 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina
QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ampula s 1 ml koncentrata za otopinu za infuziju sadrži 1 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).