natgillin/translations-raw huggingface dataset:
Administration of Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Primjena Ibandronic acid Accord 3 mg otopine za injekciju u napunjenoj štrcaljki Ibandronic acid Accord 3 mg otopina za injekciju u napunjenoj štrcaljki injicira se intravenski u trajanju od 15 do 30 sekundi.
• 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 500 ml 5%-tne otopine glukoze i primijeniti infuzijom u trajanju od 2 sata.
All patients must receive supplemental calcium and vitamin D.
Svi bolesnici moraju primiti dodatne količine kalcija i vitamina D.
Clinical studies in the treatment of tumour-induced hypercalcaemia
Klinička ispitivanja u liječenju hiperkalcijemije nastale zbog tumora
Each ml of solution contains 1 mg ibandronic acid.
Jedan ml otopine sadrži 1 mg ibandronatne kiseline.
For total hip BMD, 82.3 % of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1 % of patients receiving 2.5 mg daily orally (p=0.02).
Što se tiče vrijednosti BMD cijelog kuka, 82,3% bolesnika koji su primali injekciju od 3 mg svaka tri mjeseca, odgovorili su na liječenje nakon jedne godine, u usporedbi s 75,1% bolesnika koji su primali peroralnu dozu od 2,5 mg jedanput dnevno (p=0,02).
Clinical studies in the prevention of skeletal events in patients with breast cancer and bone metastases
Klinička ispitivanja prevencije koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama
6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with pink flip-off cap.
Staklena bočica od 6 ml (staklo tip I), s etilen tetrafluoroetilenskim gumenim čepom i aluminijskim prstenom s „flip-off“ kapicom ružičaste boje.
Other medicines and Ibandronic Acid Accord
Drugi lijekovi i Ibandronic acid Accord
Sleep disorder, anxiety, affection lability
Psihijatrijski poremećaji poremećaj spavanja, anksioznost, afektivna labilnost
Prescribers should consult the section Patients with Renal Impairment below 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 u nastavku.
dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
U ispitivanjima primjene svakodnevne intravenske doze nije bilo dokaza izravne toksičnosti za plod ili teratogenih učinaka ibandronatne kiseline u zečeva i štakora.
Ibandronic acid concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Koncentrat ibandronatne kiseline za otopinu za infuziju treba primijeniti kao intravensku infuziju u trajanju od 2 sata.
Up to now there is no experience of acute poisoning with Ibandronic acid Accord concentrate for solution for infusion.
Do sada nije bilo slučajeva akutnog trovanja Ibandronic acid Accord koncentratom za otopinu za infuziju.
6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with lavender flip-off cap.
Staklena bočica od 6 ml (staklo tip I), s etilen tetrafluoroetilenskim gumenim čepom i aluminijskim prstenom s „flip-off“ kapicom boje lavande.
Gastritis, Dyspepsia, Diarrhoea, Abdominal pain, Nausea, Constipation
Poremećaji probavnog sustava gastritis, dispepsija, proljev, bol u abdomenu, mučnina, konstipacija
All patients must receive adequate supplemental calcium and vitamin D.
Svi bolesnici moraju primiti odgovarajuće dodatne količine kalcija i vitamina D.
Ibandronic acid 3 mg injection every 3 months Bone mineral density (BMD)
Injekcija ibandronatne kiseline od 3 mg svaka tri mjeseca Mineralna gustoća kosti (BMD - Bone mineral density)
Other disturbances of bone and mineral metabolism should also be effectively treated before starting ibandronic acid injection therapy.
Ostale poremećaje metabolizma kostiju i minerala također se mora učinkovito liječiti prije početka terapije injekcijama ibandronatne kiseline.
• kidney cyst(fluid-filled sac in the kidney)
• bubrežna cista (vrećica u bubregu ispunjena tekućinom)
No specific information is available on the treatment of overdosage with ibandronic acid injection.
Nisu dostupne specifične informacije o liječenju u slučajevima predoziranja injekcijom ibandronatne kiseline.
Calcium containing solutions should not be mixed with Ibandronic acid Accord concentrate for solution for infusion.
Otopine koje sadrže kalcij ne smiju se miješati s Ibandronic acid Accord koncentratom za otopinu za infuziju.
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Osteonekroza čeljusti primijećena je vrlo rijetko nakon stavljanja lijeka u promet u bolesnika koji su primali ibandronatnu kiselinu za onkološke indikacije (vidjeti dio 4.8).
In order to avoid potential incompatibilities, Ibandronic acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Da bi se izbjegle potencijalne inkompatibilnosti, Ibandronic acid Accord koncentrat za otopinu za infuziju smije se miješati samo izotoničnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze.
Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Posology
Bolesnicima koji se liječe ibandronatnom kiselinom treba dati uputu o lijeku i karticu s podsjetnicima za bolesnika.
See also dosage section above for patients with renal impairment - Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
Pogledajte i poglavlje iznad o doziranju u bolesnika s oštećenjem bubrega. liječenje hiperkalcijemije nastale zbog tumora - treba ga dodati u 500 ml izotonične otopine natrijevog klorida ili u 500 ml 5%-tne otopine glukoze te primijeniti infuzijom u trajanju od 2 sata.
To avoid potential incompatibilities Ibandronic acid concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Da bi se izbjegle potencijalne inkompatibilnosti, Ibandronic acid koncentrat za otopinu za infuziju smije se razrijediti samo izotoničnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze.
Incidence of new morphometric vertebral fractures
Incidencija novih prijeloma kralježaka, utvrđeni morfometrički
ibandronic acid 3 mg injection every 3 months (N=365)
Injekcija ibandronatne kiseline od 3 mg svaka 3 mjeseca (N=365)
Talk to your doctor first if you want to drive, use machines or tools.
Ukoliko želite voziti, koristiti strojeve ili alate, posavjetujte se najprije sa svojim liječnikom.
Metabolism and nutrition disorders
Poremećaj metabolizma i prehrane hipokalcijemija*
What Ibandronic acid Accord looks like and contents of the pack Ibandronic acid Accord 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Kako Ibandronic acid Accord izgleda i sadržaj pakiranja Ibandronic acid Accord 3 mg otopina za injekciju u napunjenoj štrcaljki bistra je i bezbojna otopina.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava anemija, krvna diskrazija
Phlebitis/ thrombophlebitis
Krvožilni poremećaji flebitis/tromboflebitis
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.
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.
The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2 % in the 3 mg injection every 3 months arm and 67.2 % in the 2.5 mg daily orally arm (p=0.007).
Udio bolesnika koji je imao povećanu ili nepromijenjenu BMD lumbalne kralježnice i cijelog kuka nakon jedne godine iznosio je 76,2% u bolesnika koji su primali injekciju od 3 mg svaka tri mjeseca te 67,2% u bolesnika koji su primali peroralno liječenje od 2,5 mg jedanput dnevno (p=0,007).
For patients with mild renal impairment (CLcr ≥50 and <80 ml/min) no dosage adjustment is necessary.
Za bolesnike s blagim oštećenjem bubrega (Clcr ≥50 i <80 ml/min) nije potrebna prilagodba doze.
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 ibandronic acid for cancer-related conditions.
Nuspojava koja se zove ostenekroza čeljusti (oštećenje kosti vilice) zabilježena je vrlo rijetko nakon stavljanja lijeka u promet u bolesnika koji su primali ibandronatnu kiselinu za zdravstvena stanja povezana s rakom.
ibandronic acid 3 mg injection every 3 months (N=334)
Injekcija ibandronatne kiseline od 3 mg svaka 3 mjeseca (N=334)
Hypocalcaemia
hipokalcijemija
(N=974)
Placebo (n=974)
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for osteoporosis (see section 4.8).
Osteonekroza čeljusti primijećena je vrlo rijetko nakon stavljanja lijeka u promet u bolesnika koji su primali ibandronatnu kiselinu za osteoporozu (vidjeti dio 4.8).
Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting ibandronic acid therapy for metastatic bone disease.
Hipokalcijemiju i ostale poremećaje metabolizma kostiju i minerala potrebno je učinkovito izliječiti prije početka liječenja metastatske bolesti kostiju ibandronatnom kiselinom.
• persistent eye pain and inflammation (if prolonged)
• bol u oku ili upala oka koji ne prestaju (ako traju dulje)
• being unable to pass water (urine), cystitis (bladder inflammation)
• poteškoće s mokrenjem, cistitis (upala mokraćnog mjehura)
Ibandronic acid solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Otopina ibandronatne kiseline za injekciju ne smije se miješati s otopinama koje sadrže kalcij kao ni s drugim lijekovima za intravensku primjenu.
Ibandronic acid Accord contains sodium
Ibandronic acid Accord sadrži natrij
Ibandronic acid Accord contains the active substance ibandronic acid.
Ibandronic acid Accord sadrži djelatnu tvar, ibandronatnu kiselinu.
Solution for injection 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
4 napunjene štrcaljke + 4 injekcijske igle
Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid
Tablica 1 Nuspojave lijeka prijavljene kod intravenske primjene ibandronatne kiseline Klasifikacija organskih sustava
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
Overdose No specific information is available on the treatment of overdosage with Ibandronic acid Accord.
Nisu dostupni specifični podaci o liječenju u slučajevima predoziranja lijekom Ibandronic acid Accord.
Due to the limited clinical experience, ibandronic acid is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Ibandronatna kiselina se ne preporučuje bolesnicima s teškim oštećenjem funkcije bubrega zbog ograničenih kliničkih iskustava (vidjeti poglavlja 4.2 i 4.4).
It is supplied in glass vials (type I) with rubber stopper and aluminium seals with flip-off cap.
Dostupna je u staklenim bočicama (staklo tipa I) s gumenim čepom i aluminijskim prstenom s „flipoff“ kapicom.
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
Ibandronic acid was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Pedijatrijska populacija (vidjeti dijelove 4.2 i 5.2) Ibandronatna kiselina nije ispitivana na pedijatrijskoj populaciji, stoga nisu dostupni podaci o djelotvornosti i sigurnosti primjene u ovoj skupini bolesnika.
A 15 minute infusion time has not been studied in cancer patients with CLcr <50 ml/min.
Nije provedeno ispitivanje 15-minutne infuzije u bolesnika oboljelih od raka s Clcr <50 ml/min.
A 15 minute infusion time has not been studied in cancer patients with CLCr <50 ml/min.
Nije provedeno ispitivanje 15-minutne infuzije u bolesnika oboljelih od raka s CLCr <50 ml/min.
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
osteonekroza čeljusti†** osteonekroza vanjskog slušnog hodnika (nuspojava bisfosfonata)†
If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
At two years, 80.1 % and 68.8 % of patients met this criterion in the 3 mg every 3 months injection arm and the 2.5 mg daily arm (p=0.001).
Nakon dvije godine taj je kriterij zadovoljilo 80,1% bolesnika koji su primali injekciju od 3 mg svaka tri mjeseca odnosno 68,8% bolesnika koji su primali 2,5 mg jedanput dnevno (p=0,001).
Up to now there is no experience of acute poisoning with ibandronic acid concentrate for solution for infusion.
Do sada nije bilo slučajeva akutnog trovanja koncentratom ibandronatne kiseline za otopinu za infuziju.
Sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Natrijev klorid, natrijev acetat trihidrat, ledena acetatna kiselina i voda za injekcije.
Blood alkaline phosphatase increase, weight decrease
Pretrage povišena razina gama-GT-a, povišena razina kreatinina povećanje alkalne fosfataze u krvi, smanjenje tjelesne težine
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 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).
2 mg 4 mg 6 mg For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Za ove bolesnike i doziranje, medijan vremena do postizanja normalne razine kalcija u krvi iznosio je 4 do 7 dana.
Albumin-corrected serum calcium (mg/dl)
kalcij u serumu korigiran albuminom (mmol/l)
Uncommon (may affect less than 1 in 100 people)
Manje često (mogu se javiti u manje od 1 na 100 osoba )
For intravenous use only.
Isključivo za primjenu u venu.
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 (Clcr≥30 i <50 ml/min) ili teškim oštećenjem bubrega (Clcr <30 ml/min) koji se liječe radi sprječavanja koštanih poremećaja, treba slijediti sljedeće preporuke za doziranje:
Care must be taken not to administer ibandronic acid injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Potreban je oprez pri primjeni kako se injekcija ibandronatne kiseline ne bi primijenila intraarterijski ili paravenozno, što može dovesti do oštećenja tkiva.
Relative Risk Reduction New morphometric vertebral fractures
Smanjenje relativnog rizika Novi prijelomi kralježaka, utvrđeni morfometrički
ibandronic acid 2.5 mg daily (N=575)
Ibandronatna kiselina 2,5 mg jedanput dnevno (n=575)
* Mean change from baseline to last assessment.
p=0,004 * Srednja vrijednost promjene od početne vrijednosti do zadnje procjene.
Rare (may affect up to 1 in 1000 people): • hives
Rijetko (mogu se javiti u manje od 1 na 1000 osoba) • koprivnjača
Ibandronic acid 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, noninferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Dvogodišnje, randomizirano, dvostruko slijepo, multicentrično, ispitivanje neinferiornosti (BM 16550) u žena s osteoporozom (početna T-vrijednost mineralne gustoće kosti lumbalne kralježnice manja od -2,5 SD) i u postmenopauzi (1386 žena od 55 do 80 godina) pokazalo je da intravenska injekcija ibandronatne kiseline od 3 mg koja se primjenjuje svaka tri mjeseca barem jednako djelotvorna kao peroralno primijenjena ibandronatna kiselina od 2,5 mg koja se uzima jedanput dnevno.
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka s 3 ml otopine sadrži 3 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
Care must be taken not to administer ibandronic acid concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Potreban je oprez kako se koncentrat ibandronatne kiseline za otopinu za infuziju ne bi primijenio intraarterijski ili paravenski, jer to može dovesti do oštećenja tkiva.
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
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.
Neoplasms benign, malignant, and unspecified
Dobroćudne, zloćudne i nespecificirane novotvorine dobroćudne novotvorine kože
= serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 Or
= kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8 ili kalcij u serumu korigiran albuminom (mg/dl)
In the prevention of skeletal events in patients with breast cancer and bone metastases, treatment is most frequently associated with asthenia followed by rise in body temperature and headache.
U većini slučajeva nije potrebno posebno liječenje, a simptomi se povlače nakon nakoliko sati/dana.U sprječavanju koštanih događaja u bolesnika s rakom dojke i koštanim metastazama liječenje je najčešće povezano s astenijom praćenom porastom tjelesne temperature i glavoboljom.
EU/1/12/798/005 1 pre-filled syringe EU/1/12/798/006 4 pre-filled syringe
EU/1/12/798/005 1 napunjena štrcaljka EU/1/12/798/006 4 napunjene štrcaljke
Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Ibandronic acid therapy should only be initiated by physicians experienced in the treatment of cancer.
Liječenje ibandronatnom kiselinom smiju započeti samo liječnici s iskustvom u liječenju raka.
• One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
• Jedna napunjena štrcaljka s 3 ml otopine sadrži 3 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
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 sprječavanja koštanih poremećaja, treba slijediti sljedeće preporuke za doziranje (vidjeti dio 5.2):
• The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
• Drugi sastojci su natrijev klorid, acetatna kiselina, natrijev acetat trihidrat i voda za injekcije.
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.
Therefore, ibandronic acid should not be used during pregnancy.
Stoga se ibandronatna kiselina ne smije koristiti u trudnoći.
Ibandronic acid Accord 6 mg concentrate for solution for infusion Each vial contains 6 ml of concentrate.
Ibandronic acid Accord 6 mg koncentrat za otopinu za infuziju Jedna bočica sadrži 6 ml koncentrata.
Pyrexia,Influenz a-like illness**, oedema peripheral, asthenia, thirst
Opći poremećaji i reakcije na mjestu primjene pireksija, bolest slična gripi**, edemi okrajina, astenija, žeđ hipotermija
Ocular inflammation*†
Poremećaji oka upala oka*†
The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
Čini se da put izlučivanja putem bubrega ne obuhvaća poznate kisele ni bazne transportne sustave uključene u izlučivanje drugih djelatnih tvari (vidjeti dio 4.5).
Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Ibandronic acid Accord 2 mg koncentrat za otopinu za infuziju Jedna bočica sadrži 2 ml koncentrata.
Do not use Ibandronic acid Accord
Nemojte primjenjivati lijek Ibandronic acid Accord
Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance (CLcr).
Bubrežni klirens ibandronatne kiseline u bolesnika s različitim stupnjevima oštećenja funkcije bubrega linearno je povezan s klirensom kreatinina.
Excipient with known effect Ibandronic acid injection is essentially sodium free.
Pomoćna tvar s poznatim učinkom Injekcija ibandronatne kiseline sadrži zanemarive količine natrija.
Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Poremećaji probavnog sustava proljev, povraćanje, dispepsija, gastrointestinalna bol, poremećaji zuba gastroenteritis, gastritis, ulceracija usta, disfagija, heilitis
Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.
Ibandronic acid Accord koncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju
• The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
• Drugi sastojci su natrijev klorid, natrijev acetat trihidrat, ledena acetatna kiselina i voda za injekcije.
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Ibandronatna kiselina je indicirana u odraslih za sprječavanje koštanih poremećaja (patološki prijelomi, komplikacije na kostima koje zahtijevaju radioterapiju ili operaciju) u bolesnika s rakom dojke i koštanim metastazama liječenje hiperkalcijemije nastale kao posljedica tumora s metastazama ili bez njih 4.2 Doziranje i način primjene
ibandronic acid 2.5 mg daily (N=334)
Ibandronatna kiselina 2,5 mg jedanput dnevno (N=334)
Excipients: sodium chloride, acetic acid, glacial, sodium acetate trihydrate and water for injections.
Pomoćne tvari: natrijev klorid, acetatna kiselina, ledena, natrijev acetat trihidrat i voda za injekcije.
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
• simptomi nalik gripi, uključujući vrućicu, tresavicu i drhtanje, osjećaj nelagode, bol u kostima,