natgillin/translations-raw huggingface dataset:
Not known (frequency cannot be estimated from the available data) • asthma attack
Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
This belongs to a group of medicines called bisphosphonates.
Ta spada v skupino zdravil, ki se imenujejo difosfonati.
When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Pri jemanju 30 minut pred obrokom, je zmanjšanje biološke uporabnosti približno 30-%.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Pomembno je, da nastanek osteonekroze čeljusti (ONJ) poskusimo preprečiti, saj je to boleče stanje, ki ga je težko zdraviti.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Da bi zmanjšali tveganje za razvoj osteonekroze čeljusti, morate upoštevati nekatere previdnostne ukrepe.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2011
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26. julij 2011 Datum zadnjega podaljšanja: 13. april 2016
Poor healing of these fractures has also been reported.
Poročali so tudi o slabšem celjenju zlomov.
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, Bisphosphonates, ATC Code: M05BA06.
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA06.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
EDINSTVENA OZNAKA - V ČLOVEKU BERLJIVI OBLIKI PC: {številka}
Ibandronic acid 50 mg n=287
ibandronska kislina 50 mg n = 287
- The tablets should be swallowed whole with a full glass of water (180 to 240 ml) while the patient is standing or sitting in an upright position.
Tablete je treba pogoltniti cele s polnim kozarcem vode (180 do 240 ml), bolnik mora pri tem stati ali sedeti pokončno.
This helps to stop your bones from getting weaker.
To pomaga preprečiti šibkost kosti.
Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
V predkliničnih študijah so učinke opazili samo pri izpostavljenosti, ki je dovolj presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Then you can have your first food and drink, and take any medicines or supplements (see section 3).
Potem lahko zaužijete prvi obrok in pijačo ter vzamete katera koli zdravila ali prehranska dopolnila (glejte poglavje 3).
If you develop these symptoms, stop taking Ibandronic acid Sandoz and tell your doctor straight away (see sections 3 and 4).
Če se pojavijo ti simptomi, prenehajte jemati zdravilo Ibandronska kislina Sandoz in takoj obvestite svojega zdravnika (glejte poglavji 3 in 4).
All Skeletal Related Events (SREs) Placebo n=277
Vsi z okostjem povezani dogodki (SREs) placebo n = 277
If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Če jemljete tableto vsak drugi dan ali enkrat na teden, se posvetujte s farmacevtom ali zdravnikom.
6, Dervenakion EL-15351 Pallini Attiki Greece
6, Dervenakion EL-15351 Pallini Attiki Grčija
Ibandronic acid Sandoz tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Zdravilo Ibandronska kislina Sandoz tablete je treba vzeti po postu prek noči (najmanj 6 ur) pred prvim zaužitjem hrane ali pijače v dnevu.
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.
• Tableto vzemite takoj, ko vstanete, preden zaužijete prvo hrano, pijačo ali druga zdravila v dnevu.
LIST OF EXCIPIENTS The tablets also contain lactose.
SEZNAM POMOŽNIH SNOVI Tableta vsebuje tudi laktozo.
Do not take Ibandronic acid Sandoz if you are pregnant, planning to get pregnant or if you are breastfeeding.
Zdravila Ibandronska kislina Sandoz ne smete jemati, če ste noseči, načrtujete zanositev ali dojite.
You may have early signs of a possible unusual fracture of the thigh bone.
Morda imate zgodnje znake neobičajnega zloma stegnenice.
Water with a high concentration of calcium should not be used.
Voda z veliko vsebnostjo kalcija se ne sme uporabljati.
Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Zmanjšano izločanje kalcija skozi ledvice lahko spremlja znižanje ravni fosfatov v serumu, ki ne zahteva terapevtskih ukrepov.
ONJ can also occur after stopping treatment.
Osteonekroza čeljusti (ONJ) se lahko pojavi tudi po končanem zdravljenju.
Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products due to displacement is unlikely.
Vezava na plazemske beljakovine pri ljudeh je pri terapevtskih koncentracijah približno 87-%, zato je medsebojno delovanje z drugimi zdravili zaradi izpodrivanja malo verjetno.
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
• srbenje, otekanje obraza, ustnic, jezika in žrela z oteženim dihanjem.
If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
Če imate hude težave z ledvicami, lahko vaš zdravnik zmanjša odmerek na eno tableto na teden.
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Industrial Park Sapes, Rodopi Prefecture, Block No. 5, Rodopi 69300 Grčija
This could be a sign of an ulcer of the first section of the bowel
To je lahko znak krvaveče razjede na prvem delu črevesa
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake Uporabno do/EXP.
The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established.
Varnost in učinkovitost ibandronske kisline pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
V nasprotnem primeru bi se lahko nekaj zdravila vrnilo nazaj v požiralnik/grlo (ezofagus).
Then you can have your first food and drink, and take any medicines or supplements.
Nato lahko zaužijete prvo hrano in pijačo ter vzamete vsa druga zdravila ali dodatke.
Medicinal product-Food Interactions
Interakcije zdravila s hrano
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Ti transverzni ali kratki poševni zlomi se lahko pojavijo kjerkoli vzdolž stegnenice, od tik pot malim trohanterjem do tik nad suprakondilarno razširitvijo.
How much to take
Koliko zdravila uporabiti
If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day.
Če imate zmerne težave z ledvicami, lahko vaš zdravnik zmanjša odmerek na eno tableto vsak drugi dan.
You may be having a serious, potentially life threatening allergic reaction.
morebitno smrtno nevarno alergijsko reakcijo;
In some cases, these events did not resolve until the ibandronic acid was discontinued.
V nekaterih primerih se dogodki niso pomirili do ukinitve ibandronske kisline.
At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation.
Pri odmerkih, ki so bili znatno višji od farmakološko učinkovitih odmerkov, ibandronska kislina ni vplivala na mineralizacijo kosti.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Takoj se posvetujte z zdravnikom in zobozdravnikom, če imate kakršne koli težave v ustih ali z zobmi, kot so majavost zob, bolečina, oteklina in slabo celjenje ali izcedek iz ran, saj so to lahko znaki osteonekroze čeljusti.
Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Ibandronic acid Sandoz in patients less than 18 years old.
Pediatrična populacija (glejte poglavji 4.2 in 5.1) O uporabi zdravila Ibandronska kislina Sandoz pri bolnikih, mlajših od 18 let, ni podatkov.
The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Pri oceni bolnikovega tveganja za razvoj osteonekroze čeljusti (ONJ) je treba upoštevati naslednje dejavnike tveganja: - potentnost zdravila, ki zavira resorpcijo kosti (večje tveganje pri visoko potentnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek zdravila, ki zavira resorpcijo kosti; - sočasna prisotnost raka ali drugih bolezni (npr. anemije, koagulopatije, okužbe), kajenje; - 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.
Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romania
Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romunija
Take Ibandronic acid Sandoz at least 6 hours after you last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.
Zdravilo Ibandronska kislina Sandoz vzemite vsaj 6 ur po zadnjem zaužitju hrane, pijače ali katerega koli drugega zdravila ali prehranskega dopolnila (npr. zdravil, ki vsebujejo kalcij (mleko), aluminij, magnezij in železo), razen vode.
If you take more Ibandronic acid Sandoz than you should If you take too many tablets talk to a doctor or go to hospital straight away.
Če ste vzeli večji odmerek zdravila Ibandronska kislina Sandoz, kot bi smeli Če ste vzeli preveč tablet, o tem takoj obvestite svojega zdravnika ali pojdite v bolnišnico.
Frequency categories are defined using the following convention: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Pogostnost je opredeljena tako: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100),
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 Sandoz tablets.
Pripravki, ki vsebujejo kalcij in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom in hrano, lahko vplivajo na absorpcijo tablet Ibandronska kislina Sandoz.
The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Primarni cilj raziskave je bil stopnja hitrosti obolevnosti okostja (SMPR - skeletal morbidity period rate).
After taking your tablet, wait at least 30 minutes.
Ko vzamete tableto, počakajte vsaj 30 minut.
- tablet coat: titanium dioxide, lactose monohydrate, hypromellose, macrogol 4000
- Obloga tablet: titanov dioksid, laktoza monohidrat, hipromeloza, makrogol 4000.
- Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration.
Bolniki tablet ne smejo žvečiti, sesati ali drobiti ker se lahko pojavi ulceracija žrela.
The usual dose of Ibandronic acid Sandoz is one tablet each day.
Običajni odmerek zdravila Ibandronska kislina Sandoz je ena tableta na dan.
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients).
Bolnice z rakom dojke in radiološko potrjenimi metastazami v kosteh so prejemale placebo (277 bolnic) ali 50 mg zdravila Ibandronska kislina (278 bolnic).
• new pain, weakness or discomfort in your thigh, hip or groin.
• nova bolečina, šibkost ali neugodje v stegnu, kolku ali dimljah.
This is because Ibandronic acid Sandoz can affect the way some other medicines work.
To je zato, ker lahko zdravilo Ibandronska kislina Sandoz vpliva na način delovanja nekaterih drugih zdravil.
Ibandronic acid Sandoz tablets is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called “bone metastases”).
Tablete zdravila Ibandronska kislina Sandoz se uporabljajo pri odraslih in vam bodo predpisane, če imate raka dojke, ki se je razširil v kosti (kar pomeni«kostne metastaze»).
Water may be taken at any time during the course of Ibandronic acid Sandoz treatment (see section 4.5).
Vodo lahko med zdravljenjem z zdravilom Ibandronska kislina Sandoz pijemo kadarkoli (glejte poglavje 4.5).
If you are taking a tablet each day, skip the missed dose completely.
Če jemljete eno tableto na dan, povsem izpustite izpuščeni odmerek.
Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic acid Sandoz.
Lahko se pojavijo draženje, vnetje ali razjede požiralnika (ezofagusa), pogosto s simptomi hude bolečine v prsnem košu, hude bolečine po požiranju hrane in/ali pijače, hude slabosti ali bruhanja, zlasti če ne spijete polnega kozarca vode in/ali če se v eni uri po uporabi zdravila Ibandronska kislina Sandoz uležete.
Children and adolescents Ibandronic acid Sandoz should not be used in children and adolescents below the age of 18 years.
Zdravila Ibandronska kislina Sandoz ne smemo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water.
Tableto vzemite vsaj 6 ur po zaužitju zadnje hrane, pijače, drugih zdravil ali prehranskih dopolnil, razen vode.
The other ingredients are: - tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised,
Druge sestavine zdravila so: - Jedro tablet: povidon, mikrokristalna celuloza, krospovidon, koruzni škrob (predgelirani),
Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with Ibandronic acid Sandoz 50 mg administered orally), and from post-marketing experience.
Preglednica 1 vsebuje neželene učinke iz 2 ključnih študij 3. faze (preprečevanje skeletnih učinkov pri bolnikih z rakom dojke in kostnimi metastazami: 286 bolnikov, zdravljenih s peroralnim zdravilom Ibandronic acid Sandoz 50 mg) in izkušenj v obdobju trženja.
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.
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.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V vsaki kategoriji so neželeni učinki razvrščeni po padajoči resnosti.
* Mean change from baseline to last assessment.
* Povprečna sprememba od začetne do zadnje ocene.
METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Tablet ne sesajte, žvečite ali drobite.
However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Zgodnje plazemske koncentracije hitro padejo, 10 % največje vrednosti dosežejo 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju.
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).
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).
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.
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.
The serum calcium level may fall to hypocalcaemic values.
Raven kalcija v serumu lahko pade na raven hipokalciemije.
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.)
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).
Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Pharmathen International S.A. Industrial Park Sapes, Street block 5 693 00 Sapes, Rodopi Grčija in
Interactions with other medicinal products
Medsebojno delovanje zdravila z drugimi zdravili
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.
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.
If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid Sandoz.
Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete zdravilo Ibandronska kislina Sandoz.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Polyamide/Al/PVC - Aluminium foil blister
Pretisni omot poliamid/Al/PVC - aluminijasta folija
• if you have kidney problems
• če imate težave z ledvicami.
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).
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).
• It helps to prevent your bones from breaking (fractures).
• Pomaga preprečevati zlome kosti.
Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Izpostavljenost ibandronski kislini je pri bolnikih z različnimi stopnjami ledvične okvare povezana s kreatininskim očistkom (CLcr).
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.
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.
Adverse reactions are listed according to MedDRA system organ class and frequency category.
Neželeni učinki so razvrščeni glede na organske sisteme in pogostnost po MedRA.
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
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
Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) †
osteonekroza čeljusti†** Osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov)
Ibandronic acid Sandoz therapy should only be initiated by physicians experienced in the treatment of cancer.
Zdravljenje z zdravilom Ibandronska kislina Sandoz lahko začne le zdravnik, ki ima izkušnje z zdravljenjem raka.
Temporary interruption of Ibandronic acid Sandoz treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
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.
Ibandronic acid Sandoz works by reducing the amount of calcium that is lost from your bones.
Zdravilo Ibandronska kislina Sandoz deluje tako, da zmanjša količino kalcija, ki ga izgubljate iz kosti.
Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid Sandoz.
Jemanje zdravil, ki zmanjšajo želodčno kislino, kot so cimetidin in ranitidin, lahko učinke zdravila Ibandronska kislina Sandoz rahlo poveča.
• persistent eye pain and inflammation
• vztrajajoča bolečina in vnetje v očesu,
This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Cilj raziskave je sestavljalo več, z okostjem povezanih dogodkov (SRE - skeletal related event):
- radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures
zdravljenje kosti z obsevanjem zaradi fraktur/pretečih fraktur; operacija kosti za zdravljenje fraktur; vertebralne frakture; nevertebralne frakture.
Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany
Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Nemčija
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).
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).
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.
Če menite, da bi lahko voda iz pipe (trdi vodi) vsebovala visoke ravni kalcija, se priporoča uporaba ustekleničene vode z majhno vsebnostjo mineralov.
Secondary Efficacy Endpoints
Sekundarni cilji raziskave učinkovitosti
Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Klinične študije niso pokazale dokazov slabšanja delovanja ledvic pri dolgotrajnem zdravljenju z ibandronsko kislino.
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).
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).
NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz GmbH
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz GmbH
Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Ibandronska kislina se izloča skozi ledvice in ni izpostavljena nobeni biološki transformaciji.