FrancophonIA/ELRC3.0 huggingface dataset:
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: Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh s tabletami ibandronske kisline v odmerku 50 mg so raziskovali v dveh randomiziranih, s placebom kontroliranih preskušanjih faze III, ki so potekala 96 tednov.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji so neželeni učinki razvrščeni po padajoči resnosti.
English: * Mean change from baseline to last assessment.
Slovenian: * Povprečna sprememba od začetne do zadnje ocene.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Tablet ne sesajte, žvečite ali drobite.
English: Domaniewska 50 C 02-672 Warszawa Poland
Slovenian: Domaniewska 50 C 02-672 Warszawa Poljska
English: However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Slovenian: Zgodnje plazemske koncentracije hitro padejo, 10 % največje vrednosti dosežejo 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju.
English: There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003).
Slovenian: V primerjavi s placebom je bilo tveganje za nastanek SRE pri bolnikih, zdravljenih z ibandronsko kislino, za 38 % manjše (relativno tveganje 0,62, p = 0,003).
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic acid Sandoz.
Slovenian: Če vam zdravijo zobe ali boste imeli operacijo (npr. izdrtje zoba), o tem obvestite zdravnika, zobozdravniku pa povejte, da se zdravite z zdravilom Ibandronska kislina Sandoz.
English: The serum calcium level may fall to hypocalcaemic values.
Slovenian: Raven kalcija v serumu lahko pade na raven hipokalciemije.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Slovenian: O osteonekrozi čeljusti so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kot je ibandronska kislina (glejte poglavje 4.4).
English: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Slovenian: Pharmathen International S.A. Industrial Park Sapes, Street block 5 693 00 Sapes, Rodopi Grčija in
English: Interactions with other medicinal products
Slovenian: Medsebojno delovanje zdravila z drugimi zdravili
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that ibandronic acid has no or negligible influence on the ability to drive and use machines.
Slovenian: Na podlagi farmakodinamičnega in farmakokinetičnega profila ter poročanih neželenih učinkov se pričakuje, da ibandronska kislina nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid Sandoz.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete zdravilo Ibandronska kislina Sandoz.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Polyamide/Al/PVC - Aluminium foil blister
Slovenian: Pretisni omot poliamid/Al/PVC - aluminijasta folija
English: • if you have kidney problems
Slovenian: • če imate težave z ledvicami.
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: Presnovne interakcije niso verjetne, saj ibandronska kislina ne zavira glavnih jetrnih izoencimov P450 pri človeku in ne inducira jetrnega sistema citokroma P450 pri podganah (glejte poglavje 5.2).
English: • It helps to prevent your bones from breaking (fractures).
Slovenian: • Pomaga preprečevati zlome kosti.
English: Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Slovenian: Izpostavljenost ibandronski kislini je pri bolnikih z različnimi stopnjami ledvične okvare povezana s kreatininskim očistkom (CLcr).
English: Ibandronic acid Sandoz 50 mg film-coated tablets are supplied in Polyamide/Al/PVC - Aluminium foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box.
Slovenian: Filmsko obložene tablete Ibandronska kislina Sandoz 50 mg so na voljo v škatlah s pretisnimi omoti (poliamid/Al/PVC - aluminijasta folija) po 3, 6, 9, 28 ali 84 tablet.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Slovenian: Neželeni učinki so razvrščeni glede na organske sisteme in pogostnost po MedRA.
English: What Ibandronic acid Sandoz is and what it is used for What you need to know before you take Ibandronic acid Sandoz How to take Ibandronic acid Sandoz Possible side effects
Slovenian: Kaj je zdravilo Ibandronska kislina Sandoz in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ibandronska kislina Sandoz Kako jemati zdravilo Ibandronska kislina Sandoz Možni neželeni učinki
English: Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) †
Slovenian: osteonekroza čeljusti†** Osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov)
English: Ibandronic acid Sandoz therapy should only be initiated by physicians experienced in the treatment of cancer.
Slovenian: Zdravljenje z zdravilom Ibandronska kislina Sandoz lahko začne le zdravnik, ki ima izkušnje z zdravljenjem raka.
English: Temporary interruption of Ibandronic acid Sandoz treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Razmisliti je treba o začasni prekinitvi zdravljenja z zdravilom Ibandronska kislina Sandoz, dokler se stanje ne popravi in zmanjša vpliv ostalih dejavnikov tveganja, če je to mogoče.
English: Ibandronic acid Sandoz works by reducing the amount of calcium that is lost from your bones.
Slovenian: Zdravilo Ibandronska kislina Sandoz deluje tako, da zmanjša količino kalcija, ki ga izgubljate iz kosti.
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid Sandoz.
Slovenian: Jemanje zdravil, ki zmanjšajo želodčno kislino, kot so cimetidin in ranitidin, lahko učinke zdravila Ibandronska kislina Sandoz rahlo poveča.
English: • persistent eye pain and inflammation
Slovenian: • vztrajajoča bolečina in vnetje v očesu,
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Slovenian: Cilj raziskave je sestavljalo več, z okostjem povezanih dogodkov (SRE - skeletal related event):
English: - radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures
Slovenian: zdravljenje kosti z obsevanjem zaradi fraktur/pretečih fraktur; operacija kosti za zdravljenje fraktur; vertebralne frakture; nevertebralne frakture.
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany
Slovenian: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Nemčija
English: Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Slovenian: Združeni podatki teh študij so pokazali značilno prednost ibandronske kisline v odmerku 50 mg, dajane peroralno, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0,041).
English: If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Slovenian: Če menite, da bi lahko voda iz pipe (trdi vodi) vsebovala visoke ravni kalcija, se priporoča uporaba ustekleničene vode z majhno vsebnostjo mineralov.
English: Secondary Efficacy Endpoints
Slovenian: Sekundarni cilji raziskave učinkovitosti
English: Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Slovenian: Klinične študije niso pokazale dokazov slabšanja delovanja ledvic pri dolgotrajnem zdravljenju z ibandronsko kislino.
English: Do not take Ibandronic acid Sandoz with food or any other drinks except water as the medicine is less effective if it is taken with food or drink (see section 3).
Slovenian: Zdravilo Ibandronska kislina Sandoz skupaj s hrano in pijačo Skupaj z zdravilom Ibandronska kislina Sandoz ne zaužijte nobene hrane ali pijače, razen vode, saj se učinkovitost zdravila zmanjša, če ga vzamete skupaj s hrano ali pijačo (glejte poglavje 3).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz GmbH
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Slovenian: Ibandronska kislina se izloča skozi ledvice in ni izpostavljena nobeni biološki transformaciji.
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 motnjo ledvičnega delovanja (CLcr ≤ 30 ml/min), ki so peroralno prejemali 10 mg ibandronske kisline na dan 21 dni, so imeli 2 do 3-krat višje plazemske koncentracije kot osebe z normalno ledvično funkcijo (CLcr ≥ 80 ml/min).
English: Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany
Slovenian: Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Nemčija
English: These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Slovenian: Ti zlomi se pojavijo po majhni travmi ali brez nje in pri nekaterih bolnikih se pojavi bolečina stegna ali dimelj, pogosto povezana z lastnosti slikanja stresnih zlomov,
English: Ibandronic acid Sandoz tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Slovenian: Tablete Ibandronska kislina Sandoz vsebujejo laktozo, zato jih ne smemo dajati bolnikom z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze in galaktoze.
English: Elderly No dose adjustment is necessary (see section 5.2).
Slovenian: Starejši bolniki Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: • severe stomach pain.
Slovenian: • huda bolečina v želodcu.
English: Urinary concentrations of the bone resorption marker CTx (Cterminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Slovenian: Koncentracije označevalca resorpcije kosti CTx (C-terminalni telopeptid, ki se sprosti s kolagena tipa I) v seču so bile v skupini zdravljeni z ibandronsko kislino v primerjavi s placebom značilno znižane.
English: Also some other medicines can affect the way Ibandronic acid Sandoz works.
Slovenian: Prav tako lahko druga zdravila vplivajo na delovanje zdravila Ibandronska kislina Sandoz.
English: Very rare (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki (pojavijo se lahko pri do 1 od 10.000 bolnikov)
English: Ibandronic acid Sandoz is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Slovenian: Zdravilo Ibandronska kislina Sandoz je indicirano za preprečevanje z okostjem povezanih dogodkov (patološke frakture, zapleti, pri katerih je potrebno obsevanje ali kirurški poseg) pri odraslih bolnikih z rakom dojke in metastazami v kosteh.
English: • pain or sore in your mouth or jaw.
Slovenian: • bolečina ali razjeda v ustih ali čeljusti.
English: Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Slovenian: Sekundarni rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti).
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic acid Sandoz 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 možnega draženja in poslabšanja osnovne bolezni, je pri dajanju zdravila Ibandronska kislina Sandoz bolnikom z aktivnimi težavami v zgornjem delu prebavne cevi (npr. Barrettov požiralnik, disfagija, druge bolezni ezofagusa, gastritis, duodenitis ali razjede) potrebna previdnost.
English: This is because aminoglycosides and Ibandronic acid Sandoz can both lower the amount of calcium in your blood.
Slovenian: To je zato, ker lahko oboji, aminoglikozidi in zdravilo Ibandronska kislina Sandoz znižajo raven kalcija v krvi.
English: What Ibandronic acid Sandoz is and what it is used for
Slovenian: Kaj je zdravilo Ibandronska kislina Sandoz in za kaj ga uporabljamo
English: Posology The recommended dose is one 50 mg film-coated tablet daily.
Slovenian: Odmerjanje Priporočeni odmerek je ena 50 mg filmsko obložena tableta na dan.
English: Patients with known hypersensitivity to other bisphosphonates Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Slovenian: Bolniki z znano preobčutljivostjo za druge difosfonate Pri bolnikih z znano preobčutljivostjo za druge difosfonate je potrebna previdnost.
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Slovenian: Med zdravljenjem z difosfonati je treba bolnikom svetovati, da poročajo o vseh bolečinah v stegnih, kolkih ali dimljah, in pri vseh bolnikih, ki imajo te simptome, oceniti nepopolni zlom stegnenice.
English: Blood parathyroid hormone increased
Slovenian: Preiskave povečanje paratiroidnega hormona v krvi
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Slovenian: Rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti).
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Slovenian: Zdravilo Ibandronska kislina Sandoz vsebuje laktozo Če vam je zdravnik povedal, da nekaterih vrst sladkorja ne morete prenašati ali prebavljati (npr. če imate intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali težave z absorpcijo glukoze/galaktoze), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic acid Sandoz administration.
Slovenian: Invazivne zobozdravstvene posege se lahko med zdravljenjem opravi le po temeljitem razmisleku, zlasti se jim je treba izogibati v času blizu termina prejema zdravila Ibandronska kislina Sandoz.
English: There are no adequate data from the use of ibandronic acid in pregnant women.
Slovenian: Podatki o uporabi ibandronske kisline pri nosečnicah so nezadostni.
English: What you need to know before you take Ibandronic acid Sandoz
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ibandronska kislina Sandoz
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 čeljusti (ONJ), morata načrt zdravljenja v tesnem sodelovanju pripraviti lečeči zdravnik in zobozdravnik oziroma oralni kirurg, ki ima izkušnje z zdravljenjem osteonekroze čeljusti (ONJ).
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 status učinka po klasifikaciji Svetovne zdravstvene organizacije (SZO) sta bila pri bolnikih, zdravljenih z ibandronsko kislino, v primerjavi s placebom značilno manjša.
English: • Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
Slovenian: • Med jemanjem svoje tablete in naslednjo uro po tem (60 minut) morate ostati v pokončnem (stoječem ali sedečem) položaju.
English: In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Slovenian: Antagonisti H2 ali druga zdravila, ki povečajo želodčni pH Pri zdravih moških prostovoljcih in ženskah v postmenopavzi je intravenski ranitidin povečal biološko uporabnost ibandronske kisline za 20 % (kar je znotraj normalne variabilnosti biološke uporabnosti ibandronske kisline).
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: Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju potrebna previdnost.
English: glycerol dibehenate, colloidal anhydrous silica.
Slovenian: gliceroldibehenat, brezvodni koloidni silicijev dioksid.
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).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Slovenian: Najresnejši poročani neželeni učinki so anafilaktična reakcija/šok, atipični zlomi stegnenice, osteonekroza čeljusti, draženje v prebavilih in vnetje oči (glejte odstavek »Opis izbranih neželenih učinkov« in poglavje 4.4).
English: You can drive and use machines as it's expected that Ibandronic acid Sandoz has no or negligible effect on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Vozila in stroje smete upravljati, saj se pričakuje, da zdravilo Ibandronska kislina Sandoz nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in uporavljanja strojev.
English: Milk or antacids should be given to bind ibandronic acid.
Slovenian: Za vezavo ibandronske kisline je treba zaužiti mleko ali antacide.
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 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: Talk to your doctor first if you want to drive, use machine or tools.
Slovenian: Pred vožnjo in uporabo strojev ali orodja se posvetujte s svojim zdravnikom.
English: (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
Slovenian: (dvanajstniku) ali vnetja želodca (gastritis).
English: Ibandronic acid should not be used during lactation.
Slovenian: Ibandronske kisline se ne sme uporabljati med dojenjem.
English: Rare hereditary problems
Slovenian: Redke dedne bolezni
English: How to store Ibandronic acid Sandoz Contents of the pack and other information
Slovenian: Shranjevanje zdravila Ibandronska kislina Sandoz Vsebina pakiranja in dodatne informacije
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redki (pojavijo se lahko pri 1 od 1.000 bolnikov)
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 Sandoz.
Slovenian: Vsem bolnikom je treba naročiti, naj med zdravljenjem z zdravilom Ibandronska kislina Sandoz 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: 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, ki imajo atipični zlom stegnenice, je treba premisliti o prekinitvi zdravljenja z difosfonati na podlagi individualne ocene koristi in tveganja.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Slovenian: Zlomi so pogosto obojestranski; zato je treba pri bolnikih, ki se zdravijo s difosfonati, in imajo zlom srednjega dela stegnenic, pregledati tudi stegnenico na drugi nogi.
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.
Slovenian: Kljub temu je pri bolnikih, ki se zdravijo z ibandronsko kislino, priporočljivo, glede na klinično oceno posameznega bolnika, nadzirati njihovo ledvično funkcijo, kalcij v serumu ter fosfate in magnezij.
English: INFORMATION IN BRAILLE Ibandronic acid Sandoz 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ibandronska kislina Sandoz 50 mg
English: Hepatic impairment (see section 4.2)
Slovenian: Jetrna okvara (glejte poglavje 4.2)
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Slovenian: Pri zdravljenju z difosfonati so poročali o atipičnih subtrohanternih in diafizealnih stegneničnih zlomih, pretežno pri bolnikih, ki so se dolgo časa zdravili za osteoporozo.
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 potrebna previdnost (glejte poglavje 4.4).
English: D-83607 Holzkirchen Deutschland/Allemagne Tel: +49 8024/908-0 service@hexal.com
Slovenian: Tel: +49 8024/908-0 service@hexal.com
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment:
Slovenian: Če opazite kateri koli naslednji resni neželeni učinek, ki lahko zahteva nujno zdravstveno oskrbo, se takoj posvetujte z medicinsko sestro ali zdravnikom: