FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Ibandronic Acid Teva.
Slovenian: Glede na klinično oceno posameznega bolnika pa se pri bolnikih, ki se zdravijo z zdravilom Ibandronska kislina Teva, priporoča spremljanje delovanja ledvic, serumske koncentracije kalcija, fosfata in magnezija.
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).
Slovenian: Najbolj resni neželeni učinki so anafilaktične reakcije/šok, atipični zlomi stegnenice, osteonekroza čeljustnic, draženje prebavil in vnetje oči (glejte odstavek “Opis izbranih neželenih učinkov” in poglavje 4.4).
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov Spol
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of ibandronic acid in these age groups.
Slovenian: Pediatrična populacija (glejte poglavji 4.2 in 5.1) O uporabi ibandronske kisline pri tej skupini bolnikov ni podatkov.
English: This is because aminoglycosides and Ibandronic Acid Teva can both lower the amount of calcium in your blood.
Slovenian: Aminoglikozidi in zdravilo Ibandronska kislina Teva lahko znižajo koncentracijo kalcija v krvi.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Slovenian: 50 mg tabletami ibandronske kisline so raziskovali v dveh randomiziranih, s placebom nadzorovanih preskušanjih faze III, ki so potekala 96 tednov.
English: Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Slovenian: Zaradi možnosti draženja požiralnika se bruhanje ne sme izzvati, bolnik pa mora ostati v povsem pokončnem položaju.
English: Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see sections 4.4 and 5.2).
Slovenian: Zdravilo Ibandronska kislinaTeva se pri bolnikih, ki imajo kreatininski očistek pod 30 ml/min, ne priporoča zaradi pomanjkanja kliničnih izkušenj (glejte poglavji 4.4 in 5.2).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Ibandronic Acid Teva 50 mg: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Ibandronska kislina Teva 50 mg: Predpisovanje in izdaja zdravila je pod omejenimi pogoji in na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Slovenian: Antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke Od več kot 1.500 bolnikov, vključenih v študijo BM 16549, ki je primerjala mesečno jemanje ibandronske kisline z dnevnim, je po enem letu 14 % bolnikov uporabljalo antagoniste histaminskih receptorjev H2 ali zaviralce protonske črpalke, po dveh letih pa 18 % bolnikov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/003 1 film-coated tablet EU/1/10/642/004 3 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/642/003 1 filmsko obložena tableta EU/1/10/642/004 3 filmsko obložene tablete 13.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Ibandronic Acid Teva.
Slovenian: Vsem bolnikom je treba naročiti, naj med zdravljenjem z zdravilom Ibandronska kislina Teva skrbijo za dobro ustno higieno in redno opravljajo preglede pri zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečina, oteklina, slabo celjenje ali izcedek iz ran, pa naj takoj obvestijo zdravnika.
English: Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Slovenian: Bolezni prebavil* ezofagitis, gastritis, gastroezofagealna refluksna bolezen, dispepsija, driska, abdominalna bolečina, navzea ezofagitis,
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Slovenian: Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu prebavil hitra, koncentracije v plazmi naraščajo v odvisnosti od odmerka do peroralnega vnosa 50 mg, pri večjih vnosih pa so opazili večje poraste koncentracij v plazmi od sorazmernih z odmerkom.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Hipokalciemija
English: Therefore dosage adjustment is not necessary in patients with hepatic impairment.
Slovenian: Zato bolnikom z okvaro jeter ni treba prilagoditi odmerkov.
English: Clinical efficacy
Slovenian: UČINKOVITO UPORABO ZDRAVILA
English: The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Slovenian: Za bolnike, pri katerih se razvije osteonekroza čeljustnic, morata načrt zdravljenja v tesnem sodelovanju pripraviti lečeči zdravnik in zobozdravnik oziroma oralni kirurg, ki ima izkušnje z zdravljenjem osteonekroze čeljustnic.
English: Subjects with severe renal impairment (CLcr ≤ 30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Slovenian: Bolniki s hudo ledvično okvaro (CLcr ≤ 30 ml/min), ki so peroralno prejemali 10 mg ibandronske kisline dnevno 21 dni, so imeli 2-3- krat večje plazemske koncentracije kot bolniki z normalnim delovanjem ledvic (CLcr ≥ 80 ml/min).
English: - If you are allergic to ibandronic acid or any of the other ingredients of this medicine listed in section 6.
Slovenian: - če ste alergični na ibandronsko kislino ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: Fri.
Slovenian: • izpuščaj.
English: At two years the median relative change was -68 % and -62 %, in the 150 mg monthly and 2.5 mg daily arms respectively.
Slovenian: Po dveh letih je bila mediana relativne spremembe -68 % za mesečno odmerjanje 150 mg in -62 % za dnevno odmerjanje 2,5 mg.
English: Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Slovenian: vključno z ezofagealnimi ulceracijami ali zožitvami ter disfagijo, bruhanje, flatulenca duodenitis
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta
English: Do not take Ibandronic Acid Teva if you are pregnant or breast feeding.
Slovenian: Ne jemljite zdravila Ibandronska kislina Teva, če ste noseči ali dojite.
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Slovenian: Dodatno ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega citokroma P450.
English: This could be a sign of an ulcer of the first section of the bowel
Slovenian: Te so lahko znak, da razjeda v začetnem delu črevesa (dvanajstniku)
English: SMPR (per patient year)
Slovenian: vrednost p stopnja hitrosti obolevnosti okostja (na bolnikova leta)
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Slovenian: Pri zdravljenju z difosfonati so poročali o osteonekrozi zunanjega sluhovoda, predvsem v povezavi z dolgotrajnim zdravljenjem.
English: Studies in rats have shown some reproductive toxicity (see section 5.3).
Slovenian: Študije na podganah so pokazale, da zdravilo nekoliko vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Slovenian: osteonekroza zunanjega sluhovoda (neželeni učinek skupine difosfonatov)
English: After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Slovenian: Po intravenskem dajanju odmerka 0,5 mg se je pri bolnikih s hudo okvaro ledvic skupni očistek zmanjšal za 67 %, ledvični očistek za 77 %, neledvični očistek pa za 50 %.
English: The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone.
Slovenian: Jetra niso pomembna za očistek ibandronske kisline, ker se ta ne presnavlja, ampak izloča skozi ledvice in prevzema v kostno tkivo.
English: Due to limited clinical experience, Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Slovenian: Zaradi malo kliničnih izkušenj zdravila Ibandronska kislina Teva ne priporočamo bolnikom, ki imajo kreatininski očistek manjši kot 30 ml/min (glejte poglavje 5.2).
English: Talk to your doctor before taking Ibandronic Acid Teva: - If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
Slovenian: - Če imate kakršne koli motnje presnove mineralov (kot je pomanjkanje vitamina D).
English: • new pain, weakness or discomfort in your thigh, hip or groin.
Slovenian: • nova bolečina, šibkost ali nelagodje v stegnu, kolku ali dimljah.
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na podganah so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Ibandronic acid 50 mg n=287
Slovenian: ibandronska kislina (50 mg) n = 287
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or greater than 30 ml/min), as shown in study BM 16549 where the majority of patients had mild to moderate renal impairment.
Slovenian: prilagajanje odmerkov ni potrebno, kar se je pokazalo v študiji BM 16549, kjer je večina bolnikov imela blago do zmerno okvaro ledvic.
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of medicinal products (bisphosphonates).
Slovenian: Neželeni učinki ibandronske kisline v študijah vpliva na sposobnost za razmnoževanje pri podganah so bili značilni za to skupino zdravil (difosfonati).
English: Uncommon (may affect less than 1 in 100 people):
Slovenian: Občasni (pojavijo se lahko pri manj kot 1 od 100 bolnikov):
English: Anaphylactic reaction/shock*
Slovenian: anafilaktična reakcija/šok†
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva B.V.
English: You may have early signs of severe jaw problems (necrosis
Slovenian: Lahko imate zgodnje znake resnih težav s čeljustmi
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Patients with known hypersensitivity to other bisphosphonates Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Slovenian: Previdnost je potrebna pri bolnikih z znano preobčutljivostjo za druge difosfonate.
English: Table 2: Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16549.
Slovenian: Preglednica 2: povprečna relativna sprememba od izhodiščne vrednosti MKG ledvene hrbtenice, kolka, stegneničnega vratu in trohantra po enem letu (primarna analiza) in dveh letih zdravljenja
English: How to store Ibandronic Acid Teva Content of the pack and other information
Slovenian: Shranjevanje zdravila Ibandronska kislina Teva Vsebina pakiranja in dodatne informacije
English: Biotransformation There is no evidence that ibandronic acid is metabolised in animals or humans.
Slovenian: Biotransformacija Ni dokazov, da bi se ibandronska kislina pri ljudeh ali živalih presnavljala.
English: Osteonecrosis of the external auditory canal
Slovenian: Osteonekroza zunanjega sluhovoda
English: Ibandronic Acid Teva 150 mg: Medicinal product subject to medical prescription.
Slovenian: Ibandronska kislina Teva 150 mg: Predpisovanje in izdaja zdravila je le na recept.
English: There are no data on the effects of ibandronic acid in humans.
Slovenian: O vplivu ibandronske kisline pri ljudeh ni podatkov.
English: Posology The recommended dose is one 50 mg film-coated tablet daily.
Slovenian: Odmerjanje Priporočeni odmerek je ena 50 mg filmsko obložena tableta dnevno.
English: No specific information is available on the treatment of overdose with Ibandronic Acid Teva.
Slovenian: Na voljo ni nobenih posebnih podatkov o zdravljenju prevelikega odmerka zdravila Ibandronska kislina Teva.
English: Children and adolescents Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.
Slovenian: Zdravilo Ibandronska kislina Teva se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
English: • tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid;
Slovenian: Jedro tablete: mikrokristalna celuloza povidon K-30 krospovidon (tipa A) koloidni brezvodni silicijev dioksid stearinska kislina
English: However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Ibandronic Acid Teva is administered with H2-antagonists or other active substances which increase gastric pH.
Slovenian: Ker je to povečanje v mejah normalne variabilnosti biološke uporabnosti ibandronske kisline, pri sočasnem jemanju zdravila Ibandronska kislina Teva s H2-antagonisti ali drugimi zdravili,
English: However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer.
Slovenian: Vendar lahko preveliko peroralno odmerjanje povzroči neželene dogodke v zgornjih prebavilih, kot so razdražen želodec, zgaga, ezofagitis, gastritis ali razjeda.
English: They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it's less likely to cause irritation.
Slovenian: Zasnovana so tako, da bo tableta Ibandronska kislina Teva hitro dosegla vaš želodec.
English: Ibandronic Acid Teva is only for use in postmenopausal women and must not be taken by women of childbearing potential.
Slovenian: Zdravilo Ibandronska kislina Teva lahko uporabljajo samo ženske v postmenopavzi, ženske v rodni dobi pa ga ne smejo uporabljati.
English: However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Slovenian: Glede na podatke o tej skupini zdravil lahko preveliko peroralno odmerjanje povzroči neželene učinke v zgornjem delu prebavil (kot so razdražen želodec, dispepsija, ezofagitis, gastritis ali razjeda) ali hipokalciemijo.
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: Ibandronska kislina povzroči progresivno čisto povečanje kostne mase in zmanjša incidenco zlomov, tako da pri ženskah po menopavzi zmanjša povečano razmerje med razgradnjo in tvorbo kosti in ga približa razmerju pred menopavzo.
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid Teva therapy.
Slovenian: Pred začetkom zdravljenja z zdravilom Ibandronska kislina Teva je treba učinkovito zdraviti hipokalciemijo ter druge motnje kosti in presnove mineralov.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with ibandronic acid 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Slovenian: Pri teh bolnikih je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so se zdravili z ibandronsko kislino 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg vsak dan.
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Slovenian: Pri bolnikih, pri katerih obstaja sum na atipičen zlom stegnenice, je treba razmisliti o prekinitvi zdravljenja z difosfonati do pregleda, na katerem bo ovrednoteno razmerje med koristmi in tveganji za posameznega bolnika.
English: • if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
Slovenian: - če ste alergični na ibandronsko kislino ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6);
English: While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Slovenian: Čeprav v nadzorovanih kliničnih raziskavah niso opazili povečanega tveganja, pa so v obdobju po prihodu zdravila na trg poročali o razjedah želodca in dvanajstnika v povezavi s peroralnimi difosfonati.
English: H2 blockers or proton pump inhibitors
Slovenian: Antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke
English: Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost na ibandronsko kislino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic Acid Teva tablets.
Slovenian: Pripravki, ki vsebujejo kalcij in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom in hrano, lahko vplivajo na absorpcijo zdravila Ibandronska kislina Teva tablete.
English: How to take Ibandronic Acid Teva).
Slovenian: Kako jemati zdravilo Ibandronska kislina Teva).
English: Sun.
Slovenian: Teva.
English: The liver has no significant role in the clearance of ibandronic acid which is not metabolised but is cleared by renal excretion and by uptake into bone.
Slovenian: Jetra niso pomembna za očistek ibandronske kisline, ker se ta ne presnavlja, ampak izloča skozi ledvice in z vstopanjem v kostno tkivo.
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Slovenian: Ta cilj raziskave je sestavljalo več z okostjem povezanih dogodkov:
English: - Patients should not lie down for 1 hour after taking Ibandronic Acid Teva.
Slovenian: - Bolnik se ne sme uleči še eno uro po tem, ko je vzel zdravilo Ibandronska kislinaTeva.
English: Blood parathyroid hormone increased
Slovenian: Preiskave zvišan paratiroidni hormon v krvi
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid Teva is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Slovenian: Zaradi draženja in možnosti poslabšanja že obstoječe bolezni je potrebna pri bolnikih z obstoječimi težavami v zgornjem delu prebavil (npr. Barrettov požiralnik, disfagija ali druge bolezni požiralnika, gastritis, duodenitis ali razjede) previdnost pri uporabi zdravila Ibandronska kislina Teva.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja pruritus
English: Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 1 or 3 tablets.
Slovenian: Zdravilo Ibandronska kislina Teva je na voljo v pretisnih omotih (PVC/Aclar/PVC in aluminij) v kartonskih škatlah, ki vsebujejo 1 ali 3 tablete.
English: Tabulated list of adverse reactions
Slovenian: Tabelarični prikaz neželenih učinkov
English: In reproductive studies in rats by the oral route, ibandronic acid decreased fertility.
Slovenian: V študijah vplivov na sposobnost razmnoževanja pri podganah, v katerih so ibandronsko kislino dajali peroralno, je ta zmanjšala plodnost.
English: Do not pass it on to others.
Slovenian: ne vzemite drugih zdravil.
English: Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 28 or 84 tablets.
Slovenian: Zdravilo Ibandronska kislina Teva je na voljo v pretisnih omotih (PVC/Aclar/PVC in aluminij) v kartonskih škatlah, ki vsebujejo 28 ali 84 tablet.
English: If you forget to take Ibandronic Acid Teva
Slovenian: Če ste pozabili vzeti zdravilo Ibandronska kislina Teva
English: • dry mouth, strange taste in your mouth or difficulty swallowing
Slovenian: - suha usta, čuden okus v ustih, težave pri požiranju, - anemija (slabokrvnost),
English: However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Slovenian: Vendar se zgodnje koncentracije v plazmi hitro znižajo; 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju dosežejo 10 % najvišje vrednosti.
English: Ibandronic acid 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Slovenian: Ibandronska kislina v odmerku 150 mg enkrat mesečno se je v dveletni dvojno slepi, multicentrični študiji (BM 16549) pri ženskah z osteoporozo v postmenopavzi (izhodiščna T-vrednost MKG ledvene hrbtenice pod -2,5 SD) glede povišanja MKG izkazala za najmanj enako učinkovito kakor ibandronska kislina v odmerku 2,5 mg enkrat dnevno.
English: Ibandronic acid 150 mg once monthly
Slovenian: ibandronska kislina 150 mg enkrat mesečno
English: Relative Risk Reduction New morphometric vertebral fractures
Slovenian: zmanjšanje relativnega tveganja novi zlomi vretenc (določeno morfometrično)
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving ibandronic acid 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Slovenian: Po enem letu (primarna analiza) se je 91,3 % (p = 0,005) bolnikom, ki so prejemali 150 mg ibandronske kisline enkrat mesečno, MKG ledvene hrbtenice povišala ali ostala enaka izhodiščni vrednosti (bolniki, odzivni na povišanje MKG) v primerjavi s 84,0 % bolnikov, ki so prejemali 2,5 mg ibandronske kisline dnevno.
English: Since Nonsteroidal Anti-Inflammatory medicinal products and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Slovenian: Ker nesteroidna protivnetna zdravila in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem peroralnem jemanju teh zdravil potrebna previdnost.
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Slovenian: Pri bolnikih z nezaceljenimi odprtimi lezijami mehkih tkiv v ustih je treba odložiti začetek zdravljenja ali začetek novega ciklusa zdravljenja.