FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking Ibandronic Acid Teva
Slovenian: Če ste prenehali jemati zdravilo Ibandronska kislina Teva
English: Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Slovenian: Pri sočasnem uživanju ibandronske kisline s standardnim zajtrkom se biološka uporabnost zmanjša za okoli 90 % v primerjavi z biološko uporabnostjo, ki so jo opazili pri teščih bolnikih.
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Slovenian: Peroralno aplicirani difosfonati lahko povzročijo lokalno draženje sluznice zgornjega dela prebavil.
English: - If you have any swallowing or digestive problems.
Slovenian: - Če imate težave s požiranjem ali prebavne motnje.
English: Do not take Ibandronic Acid Teva if you are pregnant, planning to get pregnant or if you are breast-feeding.
Slovenian: Nosečnost in dojenje Zdravila Ibandronska kislina Teva ne smete jemati, če ste noseči, poskušate zanostit ali če dojite.
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Slovenian: Primarni cilj raziskave je bil stopnja hitrosti obolevnosti okostja.
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Slovenian: Zato priporočamo, da bolnik zaužije tablete po postu prek noči (post naj traja najmanj 6 ur), po zaužitem odmerku pa naj počaka še najmanj 30 minut pred pitjem ali hranjenjem (glejte poglavje 4.2).
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic Acid
Slovenian: Preglednica 1: neželeni učinki, o katerih so poroča pri peroralni uporabi ibandronske kisline
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (at least 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Slovenian: Zato se priporoča, da bolnik vzame tablete po nočnem postu (post naj traja najmanj 6 ur), po vzetem odmerku pa mora miniti še vsaj 30 minut, preden bolnik zaužije pijačo ali hrano (glejte poglavje 4.2).
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic Acid Teva in patients with concomitant risk factors.
Slovenian: Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Ibandronska kislina Teva priporočljivo opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
English: A statistically significant improvement in bone pain score was shown for ibandronic acid 50 mg compared to placebo.
Slovenian: V primerjavi s placebom se je pri ibandronski kislini v 50 mg odmerkih pokazalo statistično pomembno izboljšanje rezultata pri bolečinah v kosteh.
English: - Patients should not chew , suck or crush the tablet because of a potential for oropharyngeal ulceration.
Slovenian: - Bolnik tablete ne sme žvečiti, sesati ali drobiti, ker obstaja nevarnost za nastanek razjede v ustih in žrelu.
English: Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: Early plasma levels fall quickly reaching 10 % of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Slovenian: Zgodnje koncentracije v plazmi se hitro znižajo, 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju dosežejo 10 % največje vrednosti.
English: Headache Dizziness
Slovenian: Vnetje oči
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - supplements containing calcium, magnesium, iron or aluminium - acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
Slovenian: Še posebej obvestite svojega zdravnika ali farmacevta, če jemljete katere koli izmed naslednjih zdravil: - dodatke, ki vsebujejo kalcij, magnezij, železo ali aluminij.
English: No dose adjustment is required (see section 5.2).
Slovenian: Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Slovenian: Če upoštevamo strožji kriterij, ki združuje MKG ledvene hrbtenice in kolka, je bilo po enem letu odzivnih 83,9 % (p < 0,001) bolnikov, ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 65,7 % bolnikov, ki so prejemali 2,5 mg ibandronske kisline dnevno.
English: PVC/Aclar/PVC - Aluminium blisters in cardboard boxes of 28 or 84 tablets.
Slovenian: Pretisni omoti iz PVC/Aclar/PVC in aluminija v kartonskih škatlah, ki vsebujejo 28 ali 84 tablet.
English: Children and adolescents Do not give Ibandronic Acid Teva to children or adolescents below 18 years.
Slovenian: Zdravila Ibandronska kislina Teva ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
English: This is because NSAIDs and Ibandronic Acid Teva can both irritate your stomach and gut
Slovenian: NSAID in zdravilo Ibandronska kislina Teva, ki lahko dražijo želodec in črevo.
English: Ibandronic acid 2.5 mg daily
Slovenian: Ibandronska kislina v odmerku 2,5 mg dnevno
English: So be especially careful if you take painkillers or anti-inflammatories while you're taking Ibandronic Acid Teva.
Slovenian: Zato morate biti še posebej previdni, če med jemanjem zdravila Ibandronska kislina Teva vzamete tudi zdravila za lajšanje bolečin ali protivnetna zdravila.
English: Ibandronic Acid Teva contains the active substance ibandronic acid.
Slovenian: Zdravilo Ibandronska kislina Teva vsebuje zdravilno učinkovino ibandronsko kislino.
English: Subjects with severe renal failure (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Slovenian: Bolniki s hudo motnjo delovanja ledvic (CLcr manjši kot 30 ml/min), ki so 21 dni prejemali peroralno 10 mg ibandronske kisline dnevno, so imeli 2- do 3-krat višje koncentracije v plazmi kot osebe z normalno ledvično funkcijo.
English: Primary efficacy endpoints
Slovenian: Primarni cilj raziskave učinkovitosti
English: It contains the active substance ibandronic acid.
Slovenian: Vsebuje zdravilno učinkovino ibandronsko kislino.
English: What Ibandronic Acid Teva looks like and contents of the pack
Slovenian: Izgled zdravila Ibandronska kislina Teva in vsebina pakiranja
English: PVC/Aclar/PVC - Aluminium blisters in cardboard boxes of 1 or 3 tablets.
Slovenian: Pretisni omoti iz PVC/Aclar/PVC in aluminija v kartonskih škatlah, ki vsebujejo 1 ali 3 tablete.
English: Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal.
Slovenian: Ko so tablete z ibandronsko kislino jemali 2 uri po standardnem obroku, je bila biološka uporabnost zmanjšana za približno 75 %.
English: Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM 16549 and MF 4411 and in post-marketing experience.
Slovenian: Preglednica 1: neželeni učinki, ki so se pojavili pri ženskah po menopavzi, ki so v fazi III, BM 16549 in MF 4411, prejemale 150 mg ibandronske kisline enkrat mesečno ali 2,5 mg ibandronske kisline dnevno, ter po prihodu zdravila na trg organski sistem pogosti občasni redki zelo redki
English: If you are not sure, talk to your doctor or pharmacist before taking Ibandronic Acid Teva.
Slovenian: Če ste negotovi, se preden boste prejeli zdravilo Ibandronska kislina Teva, posvetujte s svojim zdravnikom ali farmacevtom.
English: There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Slovenian: O klinično pomembnih medetničnih razlikah v biološki uporabnosti ibandronske kisline med Azijci in belci ni dokazov.
English: BMD - mean change relative to baseline total hip at year 3
Slovenian: MKG - povprečna sprememba glede na izhodiščno vrednost kolka po treh letih
English: The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “I150” on one side and plain on the other.
Slovenian: Ibandronska kislina Teva filmsko obložene tablete so bele, bikonveksne, v obliki kapsul, z vtisnjeno oznako »I150« na eni strani in gladke na drugi.
English: The deterioration in Quality of Life and WHO performance status was significantly less in ibandronic acid treated patients compared with placebo.
Slovenian: Poslabšanje kakovosti življenja in stanja telesne zmogljivosti po klasifikaciji Svetovne zdravstvene organizacije (SZO) je bilo pri bolnikih, zdravljenih z ibandronsko kislino,
English: No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Slovenian: Okvara ledvic Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in < 80 ml/min) prilagajanje odmerkov ni potrebno.
English: Paraesthesia, dysgeusia (taste perversion)
Slovenian: Bolezni živčevja parastezije, disgevzija (sprememba okusa)
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effectsyou may need urgent medical treatment:
Slovenian: Če opazite katere od naštetih resnih neželenih učinkov, se takoj posvetujte z medicinsko sestro ali zdravnikom - morda boste potrebovali nujno medicinsko zdravljenje:
English: How to take Ibandronic Acid Teva
Slovenian: Kako jemati zdravilo Ibandronska kislina Teva
English: However, no dosage adjustment is required when Ibandronic Acid Teva is administered with H2-antagonists or medicinal products that increase gastric pH.
Slovenian: Pri sočasnem jemanju zdravila Ibandronska kislina Teva s H2-antagonisti ali drugimi zdravili, ki povečajo vrednost pH želodca, prilagajanje odmerkov ni potrebno.
English: Elderly (see section 4.2)
Slovenian: Starostniki (glejte poglavje 4.2)
English: Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
Slovenian: Za vse bolnike je pomemben zadosten vnos kalcija in vitamina D. Če je vnos s hrano nezadosten, morajo bolniki jemati dodatke kalcija oziroma vitamina D.
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje hipokalciemija
English: Frequency categories are defined using the following convention: very common (>1/10), common
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti po MedDRA. Glede na pogostnost so neželeni učinki opredeljeni kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
English: Special populations Renal impairment
Slovenian: Posebne skupine bolnikov Okvara ledvic
English: Ibandronic Acid Teva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they will not be able to see or feel a difference.
Slovenian: S tem kostno maso poveča pri večini bolnic, ki ga jemljejo, čeprav same ne bodo videle ali čutile razlike.
English: Talk to your doctor or pharmacist before taking Ibandronic Acid Teva: - if you are allergic to any other bisphosphonates - if you have any swallowing or digestion problems - if you have high or low blood levels of vitamin D or any other minerals - if you have kidney problems.
Slovenian: - če imate visoke ali nizke koncentracije vitamina D ali drugih mineralov v krvi, - če imate težave z ledvicami.
English: • weakness.
Slovenian: • koprivnica.
English: There is no relevant use of Ibandronic Acid Teva in children below 18 years, and Ibandronic Acid Teva was not studied in this population (see section 5.1 and section 5.2).
Slovenian: Zdravila Ibandronska kislinaTeva pri tej populaciji niso preučevali (glejte poglavji 5.1 in 5.2).
English: Therefore, patients should fast overnight (at least 6 hours) before taking Ibandronic Acid Teva and continue fasting for 1 hour following intake of Ibandronic Acid Teva (see section 4.2).
Slovenian: Zato morajo bolniki jemati zdravilo Ibandronska kislina Teva zjutraj na prazen želodec (po vsaj 6 urah brez obroka), po zaužitju zdravila pa morajo biti še eno uro tešči (glejte poglavje 4.2).
English: • flu-like symptoms, feeling generally unwell or in pain
Slovenian: - gripi podobni simptomi, občutek slabega počutja ali bolečine,
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Slovenian: Pri bolnikih zdravljenih z intravensko ibandronsko kislino so poročali o primerih anafilaktične reakcije/šoku, vključno z dogodki s smrtnim izidom.
English: Hepatic impairment
Slovenian: Atipičen zlom stegnenice
English: • heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having, diarrhoea (loose bowels) muscle cramps, stiffness of your joints and limbs
Slovenian: • zgaga, neugodje pri požiranju, bolečina v želodcu ali trebuhu (lahko zaradi vnetja želodca),
English: No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits.
Slovenian: Po intravenskem ali peroralnem zdravljenju z ibandronsko kislino pri podganah in kuncih niso opazili neposrednih škodljivih vplivov na plod ali teratogenih učinkov.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Slovenian: Absorpcija Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu prebavil hitra.
English: In the overall patient population of the study MF 4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
Slovenian: ugotovili pa so, da je bila ibandronska kislina v dnevnih odmerkih učinkovita pri podskupini bolnikov z velikim tveganjem (T-vrednost MKG stegneničnega vratu pod -3,0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69 %.
English: White, biconvex, capsule-shaped film-coated tablets, engraved “50” on one side and plain on the other.
Slovenian: Bela, bikonveksna, filmsko obložena tableta v obliki kapsule, z vtisnjeno oznako »50« na eni strani in gladka na drugi.
English: Teva Nederland B.V. Tel: +31 800 0228 400
Slovenian: Tel: +31 800 0228 400
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).
Slovenian: Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost (glejte poglavje 4.4).
English: - Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Slovenian: - acetilsalicilno kislino in druga nesteroidna protivnetna zdravila (vključno z ibuprofenom,
English: Taking your monthly tablet
Slovenian: Jemanje tablete enkrat mesečno
English: - Take one Ibandronic Acid Teva 150 mg tablet once a month.
Slovenian: - Enkrat mesečno vzemite eno 150 mg tableto Ibandronska kislina Teva.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Hepatic impairment No dose adjustment is required (see section 5.2).
Slovenian: Okvara jeter Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: Chest pain, influenza-like illness, malaise, pain
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija bolečina v prsih, bolezen podobna gripi, splošno slabo počutje, bolečine
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol omotica
English: White, biconvex, capsule-shaped film-coated tablets, engraved “I150” on one side and plain on the other.
Slovenian: Bela, bikonveksna, filmsko obložena tableta v obliki kapsule, z vtisnjeno oznako »I150« na eni strani in gladka na drugi.
English: Paediatric population (see section 4.2 and section 5.2) Ibandronic acid was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Slovenian: Ibandronske kisline pri pediatričnih bolnikih niso proučevali, zato za to skupino bolnikov ni na voljo podatkov o učinkovitosti in varnosti.
English: Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration.
Slovenian: Zato bolnik po peroralnem jemanju zdravila najmanj 30 minut ne sme zaužiti takih pripravkov oziroma hrane.
English: Asthenia
Slovenian: ZDRAVILA
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Slovenian: Po dveh letih je 87,1 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat mesečno, in 70,5 % bolnikov, ki so prejemali 2,5 mg dnevno, zadostilo kriterijem za odzivnost.
English: - Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
Slovenian: - Bolnik tablete ne sme žvečiti ali sesati, ker obstaja nevarnost za nastanek razjede v ustih in žrelu.
English: Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • huda bolečina v prsnem košu, huda bolečina po požiranju hrane ali pijače, huda slabost ali bruhanje, težave pri požiranju.
English: Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones.
Slovenian: Zdravilo Ibandronska kislina Teva zavira izločanje kalcija iz kosti.
English: Talk to your doctor first if you want to drive, use machine or tools.
Slovenian: Če želite voziti ali upravljati s stroji, se prej posvetujte s svojim zdravnikom.
English: Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Slovenian: Če zaužijemo hrano ali pijačo, preden je minilo 60 minut od jemanja ibandronske kisline,
English: This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
Slovenian: vnetje ali razjedo v požiralniku (ezofagusu).
English: For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Slovenian: Razlik v incidenci neželenih učinkov v zgornjem delu prebavil pri teh bolnikih ni bilo, čeprav so nekateri jemali 150 mg enkrat mesečno in drugi 2,5 mg enkrat dnevno.
English: Ibandronic acid 2.5 mg daily (N=977)
Slovenian: ibandronska kislina 2,5 mg dnevno (n = 977)
English: You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Slovenian: - Če ste pozabili vzeti tableto na vaš izbrani dan in je vaš načrtovani odmerek čez več kot 7 dni… vzemite eno tableto naslednje jutro, potem, ko se spomnite, nato jemanje tablet nadaljujte enkrat na mesec, na izbrane dni, ki ste si jih označili na koledarju.
English: Ibandronic acid 2.5 mg daily (N=575)
Slovenian: ibandronska kislina 2,5 mg dnevno (n = 575)
English: Hypersensitivi ty†, bronchospasm angioedema†, anaphylactic reaction/shock
Slovenian: Bolezni imunskega sistema poslabšanje astme preobčutljivostna reakcija anafilaktična reakcija/šok*
English: Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Slovenian: Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost.
English: Ibandronic Acid Teva should not be used during pregnancy.
Slovenian: Ibandronska kislina Teva se ne sme uporabljati med nosečnostjo.
English: Do not chew, suck or crush the tablet.
Slovenian: Tablete ne smete sesati, žvečiti ali drobiti.
English: Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
Slovenian: bolečine v trebuhu, dispepsija, navzea krvavitev, razjeda na dvanajstniku, gastritis, disfagija, suha usta
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Slovenian: Po dveh letih je bilo odzivnih 93,5 % bolnikov (p = 0,004), ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 86,4 % bolnikov, ki so prejemali 2,5 mg ibandronske kisline dnevno.
English: The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Ibandronska kislina Teva pri otrocih in mladostnikih, starih manj kot
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic Acid Teva and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Slovenian: Zdravniki morajo biti pozorni na znake ali simptome, ki opozarjajo na možno reakcijo v požiralniku,bolnikom pa je treba naročiti, da naj v primeru če se pri njih pojavijo disfagija,
English: At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Slovenian: 78,7 % bolnikov (p = 0,002), ki so prejemali 150 mg enkrat mesečno, in 65,6 % bolnikov, ki so jemali 2,5 mg dnevno.
English: - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Slovenian: - sočasno zdravljenje: kortikosteroidi, kemoterapija, zaviralci angiogeneze, obsevanje glave in vratu; - slaba ustna higiena, parodontalna bolezen, slabo prileganje proteze, zobozdravstvene bolezni v anamnezi, invazivni zobozdravstveni poseg, npr. izdrtje zoba.
English: Aminoglycosides
Slovenian: Aminoglikozidi
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Slovenian: Razpon opaženih navideznih razpolovnih časov je širok ter odvisen od odmerka in občutljivosti metode.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for oncology indications (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Ibandronska kislina Teva za indikacije v onkologiji, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).
English: 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).
Slovenian: Pri bolnikih s hudo ledvično okvaro se je celokupni očistek ibandronske kisline zmanjšal na 44 ml/min, v primerjavi z 129 ml/min pri bolnikih z normalnim delovanjem ledvic.
English: There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter ni farmakokinetičnih podatkov za ibandronsko kislino.