FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with Bondronat 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with Bondronat 6 mg), and from post-marketing experience.
Slovenian: Preglednica 1 prikazuje neželene učinke iz ključne študije faze III (zdravljenje tumorsko povzročene hiperkalciemije: 311 bolnikov se je zdravilo z zdravilom Bondronat 2 mg ali 4 mg; preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh: 152 bolnikov se je zdravilo z zdravilom Bondronat 6 mg) in iz obdobja po prihodu zdravila na trg.
English: What you need to know before you receive Bondronat
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Bondronat
English: • aching joints, arthritis, or other joint problems
Slovenian: • bolečine v sklepih, artritis ali druge težave s sklepi,
English: Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer.
Slovenian: Zdravljenje z zdravilom Bondronat lahko začnejo le zdravniki, ki imajo izkušnje z zdravljenjem raka.
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 vplivov na sposobnost za razmnoževanje pri podganah so bili pričakovano značilni za to skupino zdravil (difosfonati).
English: • tooth problems
Slovenian: • težave z zobmi.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bondronat 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 Bondronat bolnikom z aktivnimi težavami v zgornjem delu prebavne cevi (npr. Barrettov požiralnik, disfagija, druge bolezni ezofagusa, gastritis, duodenitis ali razjede) potrebna previdnost.
English: You may have early signs of a possible unusual fracture of the thigh bone
Slovenian: To so lahko zgodnji znaki možnega netipičnega zloma stegnenice.
English: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Slovenian: Za klinično pomembne medetnične razlike v biološki uporabnosti ibandronske kisline med Azijci in Kavkazijci ni dokazov.
English: If you have a raised calcium level in your blood due to a tumour,then the recommended dose is a single administration of 2 mg or 4 mg depending on the severity of your illness.
Slovenian: Če imate zvišano koncentracijo kalcija v krvi zaradi tumorja, je priporočeni odmerek 2 mg ali 4 mg v enkratnem odmerku, odvisno od resnosti bolezni.
English: For treatment of tumour induced hypercalcaemia, Bondronat concentrate for solution for infusion is generally given as a single infusion.
Slovenian: Za zdravljenje tumorsko povzročene hiperkalciemije običajno dajemo koncentrat za raztopino za infundiranje Bondronat kot enkratno infuzijo.
English: • a high level of alkaline phosphatase in your blood
Slovenian: • visoka koncentracija alkalne fosfataze v krvi,
English: Your doctor will work out how much Bondronat you will be given depending on your illness.
Slovenian: Glede na vašo bolezen bo vaš zdravnik določil, kolikšen odmerek zdravila Bondronat boste prejeli.
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 na druge difosfonate Previdnost je potrebna pri bolnikih z znano preobčutljivostjo na druge difosfonate.
English: Method of administration For intravenous administration.
Slovenian: Način uporabe Za intravensko uporabo.
English: • a skin growth called a ‘benign skin neoplasm”
Slovenian: • rast kože, imenovana benigna neoplazma kože,
English: Prior to treatment with Bondronat the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Slovenian: Pred začetkom zdravljenja z zdravilom Bondronat je potrebna zadostna rehidracija bolnika z natrijevim kloridom 9 mg/ml (0,9 %).
English: Bondronat concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Slovenian: Zdravilo Bondronat koncentrat za raztopino za infundiranje je treba aplicirati v obliki intravenske infuzije 2 uri.
English: Patients treated with Bondronat should be given the package leaflet and the patient reminder card.
Slovenian: Bolnikom, ki prejemajo zdravilo Bondronat, je treba izročiti navodilo za uporabo in opozorilno kartico za bolnika.
English: In the dose range recommended for treatment, the following response rates with the respective confidence intervals have been shown in clinical trials for patients with baseline albumin-corrected serum calcium  3.0 mmol/l after adequate rehydration.
Slovenian: V razponih odmerkov, priporočenih za zdravljenje, so med kliničnimi preskušanji za bolnike, ki so pred začetkom zdravljenja imeli korigirani kalcij v serumu  3,0 mmol/l po ustrezni rehidraciji, ugotovili naslednje hitrosti odziva in intervale zaupanja.
English: Clinical studies in the treatment of tumour-induced hypercalcaemia Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Slovenian: Klinične študije zdravljenja tumorsko povzročene hiperkalciemije Klinične študije hiperkalciemije zaradi malignosti so pokazala, da je za zaviralni učinek ibandronske kisline na tumorsko povzročeno osteolizo in še posebno na hiperkalciemijo, povzročeno s tumorjem, značilno znižanje serumskega kalcija in zmanjšano izločanje kalcija z urinom.
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: - Patients should not lie down for 60 minutes after taking Bondronat.
Slovenian: - Po zaužitju zdravila Bondronat bolniki 60 minut ne smejo leči.
English: Hypersensitivity†, bronchospasm†, angioedema†, Anaphylactic reaction/shock†**
Slovenian: Bolezni imunskega sistema preobčutljivost†, bronhospazem†, angioedem†, anafilaktična reakcija/šok†**
English: • a heart rhythm problem called ‘bundle branch block'
Slovenian: • težava s srčnim ritmom, imenovana kračni blok,
English: If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 1 vial (2 mg) or 2 vials (4 mg), depending on the severity of your illness.
Slovenian: Če imate zvišano koncentracijo kalcija v krvi zaradi tumorja, je priporočeni odmerek 1 viala (2 mg) ali 2 viali (4 mg) v enkratnem odmerku, odvisno od resnosti bolezni.
English: Bondronat 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: Bondronat je indiciran pri odraslih za preprečevanje z okostjem povezanih dogodkov (patološke frakture; zapleti, pri katerih je potrebno obsevanje ali kirurški poseg) pri bolnikih z rakom dojke in metastazami v kosteh.
English: - Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases
Slovenian: - preprečevanje z okostjem povezanih dogodkov (patološke frakture, zapleti, pri katerih je potrebno obsevanje ali kirurški poseg) pri bolnikih z rakom dojke in metastazami v kosteh;
English: No specific information is available on the treatment of overdosage with Bondronat.
Slovenian: Za ravnanje pri prevelikem odmerjanju z zdravilom Bondronat ni posebnih priporočil.
English: Sleep disorder, anxiety, affection lability
Slovenian: Psihiatrične motnje motnje spanca, anksioznost, čustvena labilnost
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 Bondronat.
Slovenian: Vsem bolnikom je treba naročiti, naj med zdravljenjem z zdravilom Bondronat 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: 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: pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek zdravila, ki zavira resorpcijo kosti; - sočasna prisotnost raka ali drugih bolezni (na primer 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: • The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections
Slovenian: • Pomožne snovi so natrijev klorid, ocetna kislina, natrijev acetat in voda za injekcije.
English: If you have breast cancer that has spread to your bones, then the recommended dose is 3 vials (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Slovenian: Če imate raka dojke, ki se je razširil na kosti, je priporočeni odmerek 3 viale (6 mg) vsake 3-4 tedne, kot vsaj 15-minutna infuzija v veno.
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 Bondronat 50 mg administered orally), and from post-marketing experience.
Slovenian: Preglednica 1 prikazuje neželene učinke iz dveh ključnih študij faze III (preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh: 286 bolnikov se je zdravilo z zdravilom Bondronat 50 mg, dajanim peroralno) in iz obdobja po prihodu zdravila na trg.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets.
Slovenian: Pred jemanjem tablet Bondronat se je prav tako treba izogibati jemanjem drugih zdravil in dodatkov (vključno s kalcijem).
English: What Bondronat is and what it is used for What you need to know before you receive Bondronat How to receive Bondronat
Slovenian: Kaj je zdravilo Bondronat in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Bondronat Kako boste prejeli zdravilo Bondronat Možni neželeni učinki
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 Bondronat (see section 4.2).
Slovenian: Vseeno pa je glede na klinično oceno posameznega bolnika pri zdravljenju z zdravilom Bondronat priporočljivo spremljati delovanje ledvic, serumski kalcij, fosfat in magnezij (glejte poglavje 4.2).
English: Mutagenicity/Carcinogenicity:
Slovenian: Mutagenost in kancerogeni potencial:
English: This is because NSAIDs, and Bondronat can both irritate your stomach and gut
Slovenian: NSAID in zdravilo Bondronat lahko dražijo želodec in črevo;
English: • low calcium or phosphate levels in your blood
Slovenian: • nizka koncentracija kalcija ali fosfatov v krvi,
English: EU/1/96/012/012: 5 vials
Slovenian: EU/1/96/012/012: 5 vial
English: Do not receive this medicine if any of the above apply to you.
Slovenian: Če se kar koli od zgoraj naštetega nanaša na vas, tega zdravila ne smete prejeti.
English: EU/1/96/012/013: 10 vials
Slovenian: EU/1/96/012/013: 10 vial
English: Bondronat is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases').
Slovenian: Zdravilo Bondronat uporabljamo pri odraslih in vam ga bodo predpisali, če imate raka dojke, ki se je razširil na kosti (metastaze v kosteh).
English: • low calcium levels in your blood
Slovenian: • nizke koncentracije kalcija v krvi,
English: Patients with cardiac impairment Overhydration should be avoided in patients at risk of cardiac failure.
Slovenian: Bolniki z okvaro srca Pri bolnikih z nevarnostjo srčnega popuščanja se je treba izogibati hiperhidraciji.
English: In order to avoid potential incompatibilities, Bondronat concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Slovenian: Da bi se izognili možnim inkompatibilnostim, lahko koncentrat za raztopino za infundiranje Bondronat razredčimo le z izotonično raztopino natrijevega klorida ali 5-% raztopino glukoze.
English: Excipients with known effect Bondronat is essentially sodium free.
Slovenian: Pomožne snovi z znanim učinkom Zdravilo Bondronat je praktično brez natrija.
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Bondronat System Organ
Slovenian: Neželeni učinki, o katerih so poročali pri peroralnem dajanju zdravila Bondronat Organski sistem
English: If you have breast cancer that has spread to your bones, then the recommended dose is 1 vial (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Slovenian: Če imate raka dojke, ki se je razširil na kosti, je priporočeni odmerek 1 viala (6 mg) vsake 3-4 tedne, kot vsaj 15-minutna infuzija v veno.
English: • mouth ulcers, swollen lips (‘cheilitis'), oral thrush
Slovenian: • ustne razjede, otekle ustnice (heilitis), ustni oprh,
English: What Bondronat looks like and contents of the pack The film-coated tablets are of oblong shape and white to off-white in colour, engraved L2/IT.
Slovenian: Filmsko obložene tablete so podolgovate oblike in bele do sivo bele barve z oznako L2/IT.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Atnahs Pharma Netherlands B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Atnahs Pharma Netherlands B.V.
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: • fluid in your lungs
Slovenian: • nabiranje tekočine v pljučih,
English: Paraesthesia, dysgeusia (taste perversion)
Slovenian: Bolezni živčevja parestezija, disgevzija (motnje čuta za okus)
English: This is because aminoglycosides and Bondronat can both lower the amount of calcium in your blood.
Slovenian: Aminoglikozidi in zdravilo Bondronat lahko znižajo koncentracijo kalcija v krvi.
English: Bondronat should not be mixed with calcium containing solutions.
Slovenian: Zdravila Bondronat ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
English: Bondronat contains the active substance ibandronic acid.
Slovenian: Zdravilo Bondronat vsebuje zdravilno učinkovino ibandronsko kislino.
English: • Store in the original package in order to protect from moisture
Slovenian: • Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: For patients with breast cancer and bone metastases, Bondronat infusion should be administered every 3-4 weeks.
Slovenian: Bolniki z rakom dojke in metastazami v kosteh morajo prejeti infuzijo zdravila Bondronat vsake 3 do 4 tedne.
English: Reproductive toxicity:
Slovenian: Vplivi na sposobnost za razmnoževanje:
English: Bondronat 50 mg film-coated tablets ibandronic acid
Slovenian: Bondronat 50 mg filmsko obložene tablete ibandronska kislina
English: What Bondronat is and what it is used for What you need to know before you take Bondronat How to take Bondronat
Slovenian: Kaj je zdravilo Bondronat in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Bondronat Kako jemati zdravilo Bondronat Možni neželeni učinki
English: What Bondronat contains
Slovenian: Kaj vsebuje zdravilo Bondronat
English: NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets.
Slovenian: IME ZDRAVILA Bondronat 50 mg filmsko obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011: 1 vial
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/012/011: 1 viala
English: If you take too many tablets talk to a doctor or go to hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Bondronat, kot bi smeli Če ste vzeli večji odmerek, se posvetujte z zdravnikom ali pojdite takoj v bolnišnico.
English: Up to now there is no experience of acute poisoning with Bondronat concentrate for solution for infusion.
Slovenian: Ni poročil o primerih akutnega prevelikega odmerjanja s koncentratom za raztopino za infundiranje Bondronat.
English: A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50ml/min.
Slovenian: 15-minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina < 50 ml/min, niso proučevali.
English: Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Slovenian: Klinične študije pri bolnikih z rakom dojke in metastazami v kosteh so pokazale, da je zaviralni učinek na osteolizo kosti odvisen od odmerka, ki se izraža z označevalci resorpcije kosti ter da so dogodki povezani z okostjem odvisni od odmerka.
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Slovenian: Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bondronat in patients with concomitant risk factors.
Slovenian: Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Bondronat priporočljivo opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
English: What you need to know before you take Bondronat
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Bondronat
English: Bioavailability was reduced by approximately 75% when Bondronat tablets were administered 2 hours after a standard meal.
Slovenian: Ko so tablete Bondronat jemali 2 uri po standardnem obroku, je bila biološka uporabnost zmanjšana za približno 75 %.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended (see section 5.2).
Slovenian: Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) se priporoča prilagoditev odmerka na eno 50 mg filmsko obloženo tableto vsak drugi dan (glejte poglavje 5.2).
English: • high levels of urea or high levels of parathyroid hormone in your blood
Slovenian: • visoke koncentracije sečnine ali visoke koncentracije obščitniškega hormona v krvi.
English: Pooled data from these studies demonstrated a significant advantage for Bondronat 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 zdravila Bondronat 50 mg, danega peroralno, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0,041).
English: The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenous injection given every 3-4 weeks.
Slovenian: Priporočeni odmerek za preprečevanje dogodkov, povezanih z okostjem pri bolnikih z rakom dojke in metastazami v kosteh, je 6 mg intravensko, danih vsake 3 do 4 tedne.
English: The number of SREs was also significantly reduced with Bondronat 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Bondronat 6 mg, je bilo število SRE značilno zmanjšano, tveganje za nastanek SRE pa 40 % manjše (relativno tveganje 0,6, p = 0,003) v primerjavi s placebom.
English: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Bondronat infusion is repeated at 3-4 week intervals.
Slovenian: Za preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh infuzijo zdravila Bondronat ponovimo v 3- do 4-tedenskih intervalih.
English: Myocardial ischaemia, cardiovascular disorder, palpitations
Slovenian: Srčne bolezni kračni blok srčnomišična ishemija, kardiovaskularna bolezen, palpitacije
English: Fasting should be continued for at least 30 minutes after taking the tablet.
Slovenian: • počakajte vsaj 30 minut, ko vzamete tableto.
English: • If you have any further questions, ask your doctor or pharmacist
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: However, no dosage adjustment is required when Bondronat is administered with H2-antagonists or medicinal products that increase gastric pH.
Slovenian: Pri sočasnem jemanju zdravila Bondronat s H2-antagonisti ali drugimi zdravili, ki zvečajo pH želodca, pa prilagajanje odmerkov ni potrebno.
English: Cerebrovascular disorder, nerve root lesion, amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia
Slovenian: Bolezni živčevja glavobol, omotica, motnje čuta za okus cerebrovaskularna bolezen, lezija živčnih korenov, amnezija, migrena, nevralgija, hipertonija, hiperastezija, parestezija okoli ust, parozmija
English: The deterioration in Quality of Life was significantly less in Bondronat treated patients compared with placebo.
Slovenian: Poslabšanje kakovosti življenja je bilo pri bolnikih zdravljenih z zdravilom Bondronat v primerjavi s placebom značilno manjše.
English: Neoplasms benign, malignant and unspecified
Slovenian: Benigne, maligne in neopredeljene novotvorbe benigna kožna neoplazma
English: Hypromellose Titanium dioxide (E 171) Talc
Slovenian: Obloga tablet: hipromeloza titanov dioksid (E 171) smukec makrogol 6000
English: = Serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
Slovenian: = koncentracija kalcija v serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
English: Bondronat contains lactose
Slovenian: Zdravilo Bondronat vsebuje laktozo.
English: Your doctor may do regular blood tests while you are receiving Bondronat.
Slovenian: Med zdravljenjem z zdravilom Bondronat bo zdravnik verjetno naredil običajne preiskave krvi, da bo preveril, če prejemate pravi odmerek zdravila.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bondronat for oncology indications (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Bondronat za indikacije v onkologiji, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).