FrancophonIA/ELRC3.0 huggingface dataset:
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Omenjene države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen proizvodov je naveden v dodatku I. Znanstveni zaključki so podani v dodatku II skupaj s povzetkom glavnih značilnosti zdravila v dodatku III.
English: The Marketing Authorisation Holder provided written explanations on 19 July 2007 and on 17 October 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 19. julija 2007 in 17. oktobra 2007.
English: London, 01 April 2008 EMEA/CHMP/180097/2008
Slovenian: London, 01.04.08 EMEA/180095/2008
English: Furthermore, it could not be accepted that no data on the use of Menitorix or on antibody persistence beyond the second year of life was provided.
Slovenian: Poleg tega je nesprejemljivo, da ni bilo predloženih nobenih podatkov o uporabi cepiva Menitorix ali prisotnosti protiteles po drugem letu starosti.
English: During their November 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Menitorix, that the objections raised by Greece, Poland and Spain should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem novembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Menitorix ugodno, ter da ugovori, ki so jih podale Grčija, Poljska in Španija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom, ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
English: Common Name: Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate) conjugated to tetanus toxoid and Neisseria meningitidis serogroup C (MenC) polysaccharide conjugated to tetanus toxoid
Slovenian: Splošno ime: Haemophilus influenzae tipa b polisaharid (poliribosil ribitol fosfat) konjugiran na toksoid tetanusa in Neisseria meningitidis serogroup C (MenC) polisaharid konjugiran na toksoid tetanusa
English: Public health objections were raised because no immunological correlates of protection were established for MenC conjugates and because the submission of data on pre-licensure effectiveness were required to cover infant and toddler use.
Slovenian: Pomisleki glede javnega zdravja so bili sproženi so, ker za konjugiran MenC ni bilo določenih imunoloških korelatov zaščite in ker je bila za uporabo pri dojenčkih in majhnih otrocih zahtevana predložitev podatkov o učinkovitosti zdravila pred izdajo licence.
English: Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of Powder and Solvent for Solution for Injection is a vaccine, indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) in infants from the age of 2 months and children up to the age of 2 years.
Slovenian: Menitorix, 5 mikrogramov PRP z 12,5 mikrograma TT, 5 mikrogramov PSC s 5 mikrogrami TT v obliki praška in vehikla za raztopino za injiciranje je cepivo, namenjeno za preprečevanje invazivnih bolezni, ki jih povzročata Haemophilus influenzae tipa b (Hib) in Neisseria meningitidis skupine C (MenC) pri dojenčkih, starejših od dveh mesecev, in otrocih do drugega leta starosti.
English: GlaxoSmithKline Biologicals submitted applications for mutual recognition of Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of powder and solvent for solution for injection, on the basis of the marketing authorisation granted by the United Kingdom on 19 December 2005.
Slovenian: Družba GlaxoSmithKline Biologicals je predložila vlogo za medsebojno priznavanje cepiva Menitorix, 5 mikrogramov PRP z 12,5 mikrogrami TT, 5 mikrogramov PSC s 5 mikrogrami TT v obliki praška in vehikla za raztopino za injiciranje, na podlagi dovoljenja za promet z zdravilom, ki ga je izdalo Združeno kraljestvo dne 19. decembra 2005.
English: Article 29(4) of Directive 2001/83/EC, as amended.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 1. aprila 2008. Člen 29(4) Direktive 2001/83/ES, kakor je bila spremenjena.
English: Then carry on as usual the next day.
Slovenian: Nato nadaljujte naslednji dan kot običajno.
English: You can help stop this happening by doing the following:
Slovenian: To lahko pomagate preprečiti z naslednjimi ukrepi:
English: This is because the medicine will only work if it is taken all the time.
Slovenian: To je zato, ker zdravilo deluje le, če ga jemljete ves čas.
English: Do not lie down.
Slovenian: Ne lezite.
English: This is to check that you are being given the right amount of medicine.
Slovenian: S tem bo preverjal, ali jemljete pravilno količino zdravila.
English: Do not let the tablet dissolve in your mouth.
Slovenian: Ne dovolite, da se tableta raztopi v ustih.
English: **See further information below †Identified in post-marketing experience.
Slovenian: **Glejte spodaj za več podatkov †Opredeljeno v izkušnjah iz obdobja trženja.
English: • you are a smoker (as this may increase the risk of dental problems)
Slovenian: • ste kadilec (kajenje lahko poveča tveganje za težave z zobovjem);
English: Do not take this medicine if any of the above apply to you.
Slovenian: Ne jemljite tega zdravila, če karkoli od naštetega velja za vas.
English: SMPR (per patient year)
Slovenian: SMPR (na bolnikova leta)
English: Drink a full glass of milk before you go. Do not make yourself sick.
Slovenian: Spijte poln kozarec mleka, preden greste.
English: • It also helps to prevent other bone problems that may need surgery or radiotherapy.
Slovenian: • Prav tako pomaga preprečevati druge težave s kostmi, ki lahko zahtevajo kirurški poseg ali obsevanje.
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Slovenian: Ker se ledvična funkcija z leti zmanjšuje, je to edini dejavnik, ki ga je treba upoštevati (glejte odstavek ledvične okvare).
English: • if you have high or low blood levels of vitamin D or any other minerals
Slovenian: • če imate visoke ali nizke ravni vitamina D ali drugih mineralov v krvi,
English: 3 film-coated tablets 6 film-coated tablets 9 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Slovenian: 3 filmsko obložene tablete 6 filmsko obloženih tablet 9 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet
English: • Take your tablet with a full glass of water only (about 200 mL).
Slovenian: • Svojo tableto vzemite z vodo (približno 200 ml).
English: Not known (frequency cannot be estimated from the available data) • asthma attack
Slovenian: Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: This belongs to a group of medicines called bisphosphonates.
Slovenian: Ta spada v skupino zdravil, ki se imenujejo difosfonati.
English: When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Slovenian: Pri jemanju 30 minut pred obrokom, je zmanjšanje biološke uporabnosti približno 30-%.
English: It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Slovenian: Pomembno je, da nastanek osteonekroze čeljusti (ONJ) poskusimo preprečiti, saj je to boleče stanje, ki ga je težko zdraviti.
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Slovenian: Da bi zmanjšali tveganje za razvoj osteonekroze čeljusti, morate upoštevati nekatere previdnostne ukrepe.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26. julij 2011 Datum zadnjega podaljšanja: 13. april 2016
English: Poor healing of these fractures has also been reported.
Slovenian: Poročali so tudi o slabšem celjenju zlomov.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, Bisphosphonates, ATC Code: M05BA06.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA06.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Slovenian: EDINSTVENA OZNAKA - V ČLOVEKU BERLJIVI OBLIKI PC: {številka}
English: Ibandronic acid 50 mg n=287
Slovenian: ibandronska kislina 50 mg n = 287
English: - 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.
Slovenian: Tablete je treba pogoltniti cele s polnim kozarcem vode (180 do 240 ml), bolnik mora pri tem stati ali sedeti pokončno.
English: This helps to stop your bones from getting weaker.
Slovenian: To pomaga preprečiti šibkost kosti.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: 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.
English: Then you can have your first food and drink, and take any medicines or supplements (see section 3).
Slovenian: Potem lahko zaužijete prvi obrok in pijačo ter vzamete katera koli zdravila ali prehranska dopolnila (glejte poglavje 3).
English: If you develop these symptoms, stop taking Ibandronic acid Sandoz and tell your doctor straight away (see sections 3 and 4).
Slovenian: Če se pojavijo ti simptomi, prenehajte jemati zdravilo Ibandronska kislina Sandoz in takoj obvestite svojega zdravnika (glejte poglavji 3 in 4).
English: All Skeletal Related Events (SREs) Placebo n=277
Slovenian: Vsi z okostjem povezani dogodki (SREs) placebo n = 277
English: If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Slovenian: Če jemljete tableto vsak drugi dan ali enkrat na teden, se posvetujte s farmacevtom ali zdravnikom.
English: 6, Dervenakion EL-15351 Pallini Attiki Greece
Slovenian: 6, Dervenakion EL-15351 Pallini Attiki Grčija
English: 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.
Slovenian: Zdravilo Ibandronska kislina Sandoz tablete je treba vzeti po postu prek noči (najmanj 6 ur) pred prvim zaužitjem hrane ali pijače v dnevu.
English: • Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.
Slovenian: • Tableto vzemite takoj, ko vstanete, preden zaužijete prvo hrano, pijačo ali druga zdravila v dnevu.
English: LIST OF EXCIPIENTS The tablets also contain lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Tableta vsebuje tudi laktozo.
English: Do not take Ibandronic acid Sandoz if you are pregnant, planning to get pregnant or if you are breastfeeding.
Slovenian: Zdravila Ibandronska kislina Sandoz ne smete jemati, če ste noseči, načrtujete zanositev ali dojite.
English: You may have early signs of a possible unusual fracture of the thigh bone.
Slovenian: Morda imate zgodnje znake neobičajnega zloma stegnenice.
English: Water with a high concentration of calcium should not be used.
Slovenian: Voda z veliko vsebnostjo kalcija se ne sme uporabljati.
English: Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Slovenian: Zmanjšano izločanje kalcija skozi ledvice lahko spremlja znižanje ravni fosfatov v serumu, ki ne zahteva terapevtskih ukrepov.
English: ONJ can also occur after stopping treatment.
Slovenian: Osteonekroza čeljusti (ONJ) se lahko pojavi tudi po končanem zdravljenju.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products due to displacement is unlikely.
Slovenian: Vezava na plazemske beljakovine pri ljudeh je pri terapevtskih koncentracijah približno 87-%, zato je medsebojno delovanje z drugimi zdravili zaradi izpodrivanja malo verjetno.
English: • itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
Slovenian: • srbenje, otekanje obraza, ustnic, jezika in žrela z oteženim dihanjem.
English: If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
Slovenian: Če imate hude težave z ledvicami, lahko vaš zdravnik zmanjša odmerek na eno tableto na teden.
English: Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Slovenian: Industrial Park Sapes, Rodopi Prefecture, Block No. 5, Rodopi 69300 Grčija
English: This could be a sign of an ulcer of the first section of the bowel
Slovenian: To je lahko znak krvaveče razjede na prvem delu črevesa
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake Uporabno do/EXP.
English: The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost ibandronske kisline pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
Slovenian: V nasprotnem primeru bi se lahko nekaj zdravila vrnilo nazaj v požiralnik/grlo (ezofagus).
English: Then you can have your first food and drink, and take any medicines or supplements.
Slovenian: Nato lahko zaužijete prvo hrano in pijačo ter vzamete vsa druga zdravila ali dodatke.
English: Medicinal product-Food Interactions
Slovenian: Interakcije zdravila s hrano
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Slovenian: Ti transverzni ali kratki poševni zlomi se lahko pojavijo kjerkoli vzdolž stegnenice, od tik pot malim trohanterjem do tik nad suprakondilarno razširitvijo.
English: How much to take
Slovenian: Koliko zdravila uporabiti
English: If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day.
Slovenian: Če imate zmerne težave z ledvicami, lahko vaš zdravnik zmanjša odmerek na eno tableto vsak drugi dan.
English: You may be having a serious, potentially life threatening allergic reaction.
Slovenian: morebitno smrtno nevarno alergijsko reakcijo;
English: In some cases, these events did not resolve until the ibandronic acid was discontinued.
Slovenian: V nekaterih primerih se dogodki niso pomirili do ukinitve ibandronske kisline.
English: At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation.
Slovenian: Pri odmerkih, ki so bili znatno višji od farmakološko učinkovitih odmerkov, ibandronska kislina ni vplivala na mineralizacijo kosti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Pediatrična populacija (glejte poglavji 4.2 in 5.1) O uporabi zdravila Ibandronska kislina Sandoz pri bolnikih, mlajših od 18 let, ni podatkov.
English: 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
Slovenian: 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.
English: Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romania
Slovenian: Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romunija
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Pogostnost je opredeljena tako: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100),
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 Sandoz tablets.
Slovenian: 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.
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Slovenian: Primarni cilj raziskave je bil stopnja hitrosti obolevnosti okostja (SMPR - skeletal morbidity period rate).
English: After taking your tablet, wait at least 30 minutes.
Slovenian: Ko vzamete tableto, počakajte vsaj 30 minut.
English: - tablet coat: titanium dioxide, lactose monohydrate, hypromellose, macrogol 4000
Slovenian: - Obloga tablet: titanov dioksid, laktoza monohidrat, hipromeloza, makrogol 4000.
English: - Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration.
Slovenian: Bolniki tablet ne smejo žvečiti, sesati ali drobiti ker se lahko pojavi ulceracija žrela.
English: The usual dose of Ibandronic acid Sandoz is one tablet each day.
Slovenian: Običajni odmerek zdravila Ibandronska kislina Sandoz je ena tableta na dan.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients).
Slovenian: Bolnice z rakom dojke in radiološko potrjenimi metastazami v kosteh so prejemale placebo (277 bolnic) ali 50 mg zdravila Ibandronska kislina (278 bolnic).
English: • new pain, weakness or discomfort in your thigh, hip or groin.
Slovenian: • nova bolečina, šibkost ali neugodje v stegnu, kolku ali dimljah.
English: This is because Ibandronic acid Sandoz can affect the way some other medicines work.
Slovenian: To je zato, ker lahko zdravilo Ibandronska kislina Sandoz vpliva na način delovanja nekaterih drugih zdravil.
English: 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”).
Slovenian: 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»).
English: Water may be taken at any time during the course of Ibandronic acid Sandoz treatment (see section 4.5).
Slovenian: Vodo lahko med zdravljenjem z zdravilom Ibandronska kislina Sandoz pijemo kadarkoli (glejte poglavje 4.5).
English: If you are taking a tablet each day, skip the missed dose completely.
Slovenian: Če jemljete eno tableto na dan, povsem izpustite izpuščeni odmerek.
English: 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.
Slovenian: 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.
English: Children and adolescents Ibandronic acid Sandoz should not be used in children and adolescents below the age of 18 years.
Slovenian: Zdravila Ibandronska kislina Sandoz ne smemo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water.
Slovenian: Tableto vzemite vsaj 6 ur po zaužitju zadnje hrane, pijače, drugih zdravil ali prehranskih dopolnil, razen vode.
English: The other ingredients are: - tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised,
Slovenian: Druge sestavine zdravila so: - Jedro tablet: povidon, mikrokristalna celuloza, krospovidon, koruzni škrob (predgelirani),
English: 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.
Slovenian: 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.