FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibandronic acid Accord contains the active substance ibandronic acid.
Slovenian: Zdravilo Ibandronska kislina Accord vsebuje zdravilno učinkovino ibandronsko kislino.
English: Strict adherence to the intravenous administration route is required (see section 4.4).
Slovenian: Zdravilo moramo dajati izključno intravensko (glejte poglavje 4.4).
English: 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).
Slovenian: Delež bolnikov, ki se jim je MKG lumbalne hrbtenice in kolka povišala ali ostala enaka izhodiščni vrednosti po enem letu je bil 76,2 % v skupini, ki je prejemala 3-mg injekcijo vsake 3 mesece, in 67,2 % v skupini, ki je prejemala 2,5 mg na dan peroralno (p = 0,007).
English: You can drive and use machines as it's expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Lahko vozite in upravljate s stroji, saj pričakujemo, da zdravilo Ibandronska kislina Accord nima vpliva ali pa ima zanemarljiv vpliv na vašo sposobnost vožnje in upravljanja s stroji.
English: What Ibandronic Acid Accord is and what it is used for
Slovenian: Kaj je zdravilo Ibandronska kislina Accord in za kaj ga uporabljamo
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna raztopina
English: Talk to your doctor first if you want to drive, use machines or tools.
Slovenian: Če želite voziti ali upravljati s stroji, se prej posvetujte z zdravnikom.
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with lavender flip-off cap.
Slovenian: 6 ml viala iz stekla (tipa I) z etilen tetrafluoroetilenskim gumijastim zamaškom in aluminijastim pokrovčkom s »flip-off« zaporko v barvi sivke.
English: EXP: Read the package leaflet for the shelf life after dilution.
Slovenian: EXP: Za rok uporabnosti zdravila po razredčitvi glejte navodilo za uporabo.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega za sproščanje serij Accord Healthcare Ltd.
English: Incidence of new morphometric vertebral fractures
Slovenian: Incidenca novih zlomov vretenc (določeno morfometrično)
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Slovenian: osteonekroza čeljustnic†** osteonekroza zunanjega slušnega kanala (neželeni učinek na difosfonate)†
English: 5 vials (6 mg/6 ml) 10 vials (6 mg/6 ml)
Slovenian: 5 vial (6 mg/6 ml)
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.
Slovenian: Mediana časa do relapsa (ponovnega zvišanja korigiranega kalcija v serumu nad 3 mmol/l) je bila 18 do 19 dni za 2 mg in 4 mg odmerke.
English: There is no relevant use of ibandronic acid in children below 18 years, and ibandronic acid was not studied in this population (see section 5.1 and 5.2).
Slovenian: Ibandronske kisline pri tej populaciji bolnikov niso proučevali (glejte poglavji 5.1 in 5.2).
English: 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.
Slovenian: Ibandronska kislina Accord 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi se daje intravensko 15 do 30 sekund.
English: • Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours.
Slovenian: • zdravljenje tumorsko povzročene hiperkalciemije − dodamo k 500 ml izotonične raztopine natrijevega klorida ali k 500 ml 5-% raztopine dekstroze in infundiramo 2 uri.
English: Pyrexia,Influenz a-like illness**, oedema peripheral, asthenia, thirst
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, gripi podobna bolezen**, periferni edem, astenija, žeja hipotermija
English: Children and adolescents Ibandronic acid Accord must not be used in children or adolescents below 18 years.
Slovenian: Zdravila Ibandronska kislina Accord se ne sme uporabljati pri otrocih ali mladostnikih, mlajših od 18 let.
English: Overdose No specific information is available on the treatment of overdosage with Ibandronic acid Accord.
Slovenian: Specifičnih informacij o zdravljenju prevelikega odmerjanja zdravila Ibandronska kislina Accord ni na voljo.
English: If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Posology
Slovenian: Bolniki, ki se zdravijo z ibandronsko kislino, morajo dobiti navodilo za uporabo in opozorilno kartico za bolnika.
English: If you are not sure, talk to your doctor or pharmacist before having Ibandronic acid Accord.
Slovenian: Če ste negotovi, se, preden boste prejeli zdravilo Ibandronska kislina Accord, posvetujte z zdravnikom ali farmacevtom.
English: No specific information is available on the treatment of overdosage with ibandronic acid injection.
Slovenian: Specifičnih informacij o zdravljenju prevelikega odmerjanja ibandronske kisline ni na voljo.
English: 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.
Slovenian: Paziti je treba, da koncentrata za raztopino za infundiranje zdravila Ibandronska kislina Accord ne dajemo intraarterijsko ali paravensko, ker lahko to vodi v poškodbo tkiva.
English: 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.
Slovenian: Da se izognemo možnim nezdružljivostim, lahko koncentrat za raztopino za infundiranje Ibandronska kislina Accord razredčimo le z izotonično raztopino natrijevega klorida ali 5 % raztopino glukoze.
English: The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 2).
Slovenian: Primarna analiza podatkov iz študije BM 16550 po enem letu in potrditvena analiza po dveh letih sta pokazali, da v povprečnem zvišanju MKG ledvene hrbtenice, kolka, stegneničnega vratu in trohantra 3-mg injekcija, dana vsake 3 mesece ni manj učinkovita kot 2,5 mg peroralno na dan (preglednica 2).
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
Slovenian: Pri večini bolnikov s hudo hiperkalciemijo (korigirani kalcij v serumu *  3 mmol/l ali  12 mg/dl) zadošča enkratni odmerek 4 mg.
English: There are no data on the use of ibandronic acid in patients less than 18 years old.
Slovenian: O uporabi ibandronske kisline pri bolnikih, starih manj kot 18 let, ni podatkov.
English: To avoid potential incompatibilities Ibandronic acid concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Slovenian: Da bi se izognili možnim inkompatibilnostim, lahko koncentrat ibandronske kisline za raztopino za infundiranje razredčimo le z izotonično raztopino natrijevega klorida ali 5 % raztopino glukoze.
English: Children and adolescents Ibandronic acid Accord should not be used in children and adolescents below the age of 18 years.
Slovenian: Zdravilo Ibandronska kislina Accord se ne sme uporabljati pri otrocih in mladostnikih starih manj kot 18 let.
English: Rare (may affect up to 1 in 1000 people): • hives
Slovenian: Redki (pojavijo se pri največ 1 od 1000 bolnikov): • koprivnica.
English: 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).
Slovenian: Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh, ki se zdravijo zaradi preprečevanja z okostjem povezanih dogodkov, se priporoča prilagoditev odmerka (glejte poglavje 4.2).
English: Sodium chloride Sodium acetate trihydrate Glacial acetic acid Water for injections
Slovenian: Natrijev klorid Natrijev acetat trihidrat Koncentrirana ocetna kislina Voda za injekcije
English: (N=974)
Slovenian: placebo (n = 974)
English: EU/1/12/798/005 1 pre-filled syringe EU/1/12/798/006 4 pre-filled syringe
Slovenian: EU/1/12/798/005 1 napolnjena injekcijska brizga EU/1/12/798/006 4 napolnjene injekcijske brizge
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).
Slovenian: Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje Ena viala z 2 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki 2,25 mg natrijevega ibandronata monohidrata).
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija, diskrazija krvi
English: ibandronic acid 3 mg injection every 3 months (N=365)
Slovenian: ibandronska kislina 3 mg v obliki injekcije vsake 3 mesece (n = 365)
English: Patients with cardiac impairment
Slovenian: Bolniki s srčno okvaro
English: Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck
Slovenian: rak, sočasne bolezni (npr. anemijo, koagulopatije, okužbo), kajenje, sočasna zdravljenja: kortikosteroide, kemoterapijo, zaviralce angiogeneze, radioterapijo glave in vratu, slabo ustno higieno, periodontalno bolezen, slabo prilegajoče se zobne proteze, že obstoječo zobno bolezen, invazivne zobozdravstvene posege, npr. ekstrakcijo zob.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 μmol/l (2.3 mg/dl) or where creatinine clearance (measured or estimated) is equal or greater than 30 ml/min.
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo serumski kreatinin enak ali manjši kot 200 µmol/l (2,3 mg/dl) ali očistek kreatinina (izmerjen ali ocenjen) enak ali večji kot 30 ml/min, prilagajanje odmerkov ni potrebno.
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).
Slovenian: Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki 6,75 mg natrijevega ibandronata monohidrata).
English: • stomach pain (such as gastritis) or tummy pain, , indigestion, nausea, having diarrhoea (loose bowels) or constipation
Slovenian: • bolečina v želodcu (kot je npr. gastritis) ali trebuhu, slaba prebava, slabost, driska ali zaprtje,
English: Uncommon (may affect less than 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri manj kot 1 od 100 bolnikov):
English: EU/1/12/798/002 EU/1/12/798/003 EU/1/12/798/004
Slovenian: EU/1/12/798/001 EU/1/12/798/002 EU/1/12/798/003 EU/1/12/798/004
English: ibandronic acid 3 mg injection every 3 months (N=334)
Slovenian: ibandronska kislina 3 mg v obliki injekcije vsake 3 mesece (n = 334)
English: One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Slovenian: Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Slovenian: Ena viala vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: Ibandronic acid concentrate for solution for infusion should not be mixed with calcium containing solutions.
Slovenian: Koncentrata ibandronske kisline za raztopino za infundiranje ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
English: Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 3 mg injection every 3 months or ibandronic acid 2.5 mg daily in the phase III studies BM16550 and MF 4411, and in post-marketing experience.
Slovenian: Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16550 in MF4411 ter po prihodu zdravila na trg prejemale ibandronsko kislino 3 mg v obliki injekcije vsake 3 mesece ali ibandronsko kislino 2,5 mg na dan.
English: Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2).
Slovenian: Ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega citokroma P450, zato presnovna medsebojna delovanja niso verjetna (glejte poglavje 5.2).
English: Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid
Slovenian: Neželeni učinki o katerih so poročali pri intravenskem dajanju ibandronske kisline
English: Elderly (see section 4.2) In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Slovenian: Multivariantna analiza je pokazala, da starost za vse preizkušane farmakokinetične parametre ni neodvisen dejavnik.
English: Appropriate medical support and monitoring measures should be readily available when ibandronic acid intravenous injection is administered.
Slovenian: Pri dajanju intravenske injekcije ibandronske kisline mora biti na voljo ustrezna medicinska podpora in nadzor.
English: There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Slovenian: Farmakokinetika ibandronske kisline pri bolnikih, ki niso na hemodializi, ni poznana.
English: Very rare (may affect up to 1 in 10000 people):
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: 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).
Slovenian: Po enem letu je bilo na MKG kolka odzivnih 82,3 % bolnikov, ki so prejemali 3-mg injekcijo vsake 3 mesece, in 75,1 % bolnikov, ki so jemali 2,5 mg na dan peroralno (p = 0,02).
English: Blood alkaline phosphatase increase, weight decrease
Slovenian: Preiskave zvišana γGT, zvišan kreatinin zvišane koncentracije alkalne fosfataze v krvi, znižanje telesne mase
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Slovenian: Oznaka ATC: M05BA06
English: Deafness
Slovenian: Odmerek
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion Each vial contains 6 ml of concentrate.
Slovenian: Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje Ena viala vsebuje 6 ml koncentrata.
English: Cases of ONJ have been reported in the post marketing setting for ibandronic acid.
Slovenian: O primerih osteonekroze čeljustnice so poročali v obdobju po začetku trženja za ibandronsko kislino.
English: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with ibandronic acid that was statistically significant compared to placebo.
Slovenian: V primerjavi s placebom se je pri bolnikih, zdravljenih z ibandronsko kislino, v urinu pojavilo statistično značilno izrazito zmanjšanje označevalcev kostne resorpcije (piridinolina in deoksipiridinolina).
English: Prevention of skeletal events in patients with breast cancer and bone metastases
Slovenian: Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh
English: Prescribers should consult the section Patients with Renal Impairment below for recommendations on dosing and administration in this patient group.
Slovenian: Pri tej skupini bolnikov morajo predpisovalci upoštevati navodila za odmerjanje in način uporabe iz poglavja Bolniki z ledvično okvaro spodaj.
English: • fluid build up and swelling (‘“lymphoedema”')
Slovenian: • zastajanje tekočin in otekanje (limfni edem);
English: 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:
Slovenian: Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh je treba upoštevati naslednja priporočila za odmerjanje, da se prepreči z okostjem povezane dogodke:
English: Relative Risk Reduction New morphometric vertebral fractures
Slovenian: Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
English: For lumbar spine BMD, 92.1 % of patients receiving 3 mg injection every 3 months increased or maintained their BMD after 1 year of treatment (i.e. were responders) compared with 84.9 % of patients receiving oral 2.5 mg daily (p=0.002).
Slovenian: MKG ledvene hrbtenice se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 92,1 % bolnikov (t. i. odzivni bolniki), ki so prejemali 3-mg injekcijo vsake 3 mesece, in 84,9 % bolnikov, ki so prejemali 2,5 mg na dan peroralno (p = 0,002).
English: Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Slovenian: Povzroči progresivno čisto povečanje kostne mase in zmanjša incidenco zlomov, tako da pri ženskah v postmenopavzi zmanjša povečano razmerje med razgradnjo in tvorbo kosti in ga približa razmerju pred menopavzo.
English: How to receive Ibandronic acid Accord 4.
Slovenian: Kako prejemati zdravilo Ibandronska kislina Accord 4.
English: • One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Slovenian: • Ena napolnjena injekcijska brizga s 3 ml raztopine vsebuje 3 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: Sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Slovenian: Natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina in voda za injekcije.
English: 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).
Slovenian: Po dveh letih je tem kriterijem zadostilo 80,1 % bolnikov v skupini, ki je prejemala 3 mg vsake 3 mesece, in 68,8 % bolnikov v skupini, ki je prejemala 2,5 mg na dan (p = 0,001).
English: 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):
Slovenian: Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh je treba upoštevati naslednja priporočila za odmerjanje, da se prepreči z okostjem povezane dogodke (glejte poglavje 5.2):
English: It is supplied in glass vials (type I) with rubber stopper and aluminium seals with flip-off cap.
Slovenian: Zdravilo je na voljo v vialah iz stekla (tipa I) z gumijastim zamaškom in aluminijastim pokrovčkom s »flip-off« zaporko.
English: Therefore, ibandronic acid should not be used during pregnancy.
Slovenian: Zato se ibandronske kisline med nosečnostjo ne sme uporabljati.
English: ibandronic acid 2.5 mg daily (N=575)
Slovenian: ibandronska kislina 2,5 mg enkrat na dan (n = 575)
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with ibandronic acid 3 mg injection.
Slovenian: Tudi dveletno zdravljenje s 3-mg injekcijo ibandronske kisline je pokazalo pričakovano zmanjšanje kostne premene, normalno kakovost kosti in odsotnost motenj mineralizacije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 6 mg sterile concentrate ibandronic acid
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ibandronska kislina Accord 6 mg sterilni koncentrat ibandronska kislina i.v.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Slovenian: Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje Ena viala vsebuje 2 ml koncentrata.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 2 mg sterile concentrate ibandronic acid
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ibandronska kislina Accord 2 mg sterilni koncentrat ibandronska kislina i.v.
English: Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Slovenian: Pri bolnikih, zdravljenih z ibandronsko kislino, dano intravensko, so poročali o primerih resnih, včasih smrtnih, alergijskih reakcij.
English: Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones.
Slovenian: Zdravilo Ibandronska kislina Accord zavira izločanje kalcija iz kosti.
English: Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Slovenian: Bolezni prebavil diareja, bruhanje, dispepsija, gastrointesti nalna bolečina, bolezen zob gastroenteritis, gastritis, ulceracija ust, disfagija, heilitis
English: Ibandronic acid 3 mg injection every 3 months Bone mineral density (BMD)
Slovenian: Ibandronska kislina 3 mg v obliki injekcije, dane vsake 3 mesece Mineralna kostna gostota (MKG)
English: Up to now there is no experience of acute poisoning with ibandronic acid concentrate for solution for infusion.
Slovenian: Ni poročil o primerih akutnega prevelikega odmerjanja s koncentratom ibandronske kisline za raztopino za infundiranje.
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Slovenian: • uporabljenje injekcijske igle in injekcijske brizge odvrzite v zabojnik za ostre predmete;
English: Ibandronic acid should not be used during pregnancy.
Slovenian: Ibandronske kisline se med nosečnostjo ne sme uporabljati.
English: 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).
Slovenian: Pri bolnikih, ki so prejemali ibandronsko kislino za onkološke indikacije, so v obdobju po začetku trženja v zelo redkih primerih poročali o osteonekrozi čeljustnice (glejte poglavje 4.8).
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/min).
Slovenian: Za bolnike z blago ali zmerno ledvično okvaro (CLcr enak ali večji kot 30 ml/min) prilagajanje odmerkov ni potrebno.
English: PRE-FILLED SYRINGE
Slovenian: Atipičen zlom stegnenice
English: Do not receive Ibandronic acid Accord
Slovenian: Ne prejemajte zdravila Ibandronska kislina Accord:
English: One year data in study BM 16550
Slovenian: Enoletni podatki iz študije BM
English: • gallstones
Slovenian: • žolčni kamni;