natgillin/translations-raw huggingface dataset:
• tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal anhydrous silica
• jezgra tablete: laktoza hidrat, povidon, mikrokristalična celuloza, krospovidon, stearatna kiselina, koloidni bezvodni silicijev dioksid.
Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Nositelj odobrenja osigurat će implementaciju kartice s podsjetnikom za bolesnike o osteonekrozi čeljusti.
A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50ml/min.
Nije provedeno ispitivanje 15-minutne infuzije u bolesnika oboljelih od raka s klirensom kreatinina < 50 ml/min.
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.
Tablici 1 popisane su nuspojave iz 2 pivotalna ispitivanja faze III (Sprječavanje koštanih događaja u bolesnika s rakom dojke i koštanim metastazama: 286 bolesnika liječena lijekom Bondronat od 50 mg primijenjim peroralno) i iz iskustva nakon stavljanja lijeka na tržište.
Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Stevens-Johnsonov sindrom†, multiformni eritem†, bulozni dermatitis†
Dosage: Treatment of Tumour-induced Hypercalcaemia Bondronat is usually administered in a hospital setting.
Doziranje: Liječenje hiperkalcijemije nastale zbog tumora Bondronat se obično primjenjuje u bolničkim uvjetima.
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.
Ako imate povišenu razinu kalcija u krvi uzrokovanu tumorom, tada je preporučena doza jednokratna primjena 1 bočice (2 mg) ili 2 bočice (4 mg), ovisno o težini bolesti.
NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets.
NAZIV LIJEKA Bondronat 50 mg filmom obložene tablete.
Sleep disorder, anxiety, affection lability
Psihijatrijski poremećaji poremećaj spavanja, anksioznost, emocionalna labilnost
SMPR (per patient year)
SMPR (po bolesnikgodini)
Talk to your doctor, pharmacist or nurse before receiving Bondronat:
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Bondronat:
StevensJohnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
StevensJohnsonov sindrom†, multiformni eritem†, bulozni dermatitis†
• feeling thirsty, sore throat, changes in taste
• žeđ, grlobolja, promjene osjeta okusa
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 ocjenjivanju bolesnikova rizika za razvoj osteonekroze čeljusti potrebno je razmotriti sljedeće faktore rizika: - potentnost lijeka koji inhibira koštanu resorpciju (veći rizik kod primjene visoko potentnih spojeva), put primjene (veći rizik kod parenteralne primjene) i kumulativnu dozu inhibitora koštane resorpcije - rak, popratna stanja (npr. anemija, koagulopatije, infekcija), pušenje - istodobno primijenjene terapije: kortikosteroidi, kemoterapija, inhibitori angiogeneze,
• sleep problems, feeling anxious, emotional instability, or mood swings
• poremećaj spavanja, osjećaj tjeskobe, emotivna labilnost ili promjene raspoloženja
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Hypocalcaemia
- Preosjetljivost na ibandronatnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1. - Hipokalcijemija
Bondronat is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone‘metastases').
Bondronat se koristi za liječenje odraslih bolesnika i bit će Vam propisan ako imate rak dojke koji se proširio na kosti (što se naziva „koštane metastaze“).
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.
Da bi se izbjegle potencijalne inkompatibilnosti, Bondronat koncentrat za otopinu za infuziju smije se miješati samo izotoničnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze.
Bondronat contains the active substance ibandronic acid.
Bondronat sadrži djelatnu tvar ibandronatnu kiselinu.
What you need to know before you receive Bondronat
Što morate znati prije nego počnete primati Bondronat
There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Bondronat that was statistically significant compared to placebo.
U bolesnika liječenih lijekom Bondronat došlo je do značajnog pada biljega resorpcije kostiju u urinu (piridinolin i deoksipiridinolin) koji je bio statistički značajan u usporedbi s placebo grupom.
• It is given as an infusion into your vein
• Primit ćete ga u obliku infuzije u venu.
What Bondronat is and what it is used for What you need to know before you take Bondronat How to take Bondronat
Što je Bondronat i za što se koristi Što morate znati prije nego počnete primati Bondronat
Common (may affect up to 1 in 10 people): feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)
Česte (mogu se javiti kod manje od 1 na 10 osoba): • mučnina, žgaravica i nelagoda pri gutanju (upala jednjaka)
After reconstitution: Store at 2°C - 8°C (in a refrigerator).
Nakon rekonstitucije: čuvati na temperaturi 2°C - 8°C (u hladnjaku).
Bondronat works by reducing the amount of calcium that is lost from your bones.
Bondronat djeluje tako da smanjuje gubitak kalcija iz kostiju.
NAME OF THE MARKETING AUTHORISATION HOLDER Atnahs Pharma Netherlands B.V.
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Atnahs Pharma Netherlands B.V.
Table 1 Adverse Drug Reactions Reported for Oral Administration of Bondronat System Organ
Tablica 1 Nuspojave prijavljene uz peroralnu primjenu lijeka Bondronat Organski sustav
Care must be taken not to administer Bondronat concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage..
Potreban je oprez kako se Bondronat koncentrat za otopinu za infuziju ne bi primijenio intraarterijski ili paravenski, jer to može dovesti do oštećenja tkiva.
Bondronat 50 mg film-coated tablets ibandronic acid
Bondronat 50 mg filmom obložene tablete ibandronatna kiselina
Bondronat concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Bondronat koncentrat za otopinu za infuziju mora se primijeniti intravenskom infuzijom u trajanju od 2 sata.
To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Da bi se izbjegle potencijalne inkompatibilnosti, Bondronat koncentrat za otopinu za infuziju smije se razrijediti samo izotoničnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze.
For the prevention of skeletal events in patients with breast cancer and bone metastases, the Bondronat infusion is repeated at 3-4 week intervals.
Za sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama, infuzija lijeka Bondronat ponavlja se u intervalima od 3 - 4 tjedna.
There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Nema dokaza klinički značajnih međuetničkih razlike između azijata i bijelaca u izloženosti ibandronatnoj kiselini.
If you are not sure, talk to your doctor or pharmacist before taking Bondronat.
Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Bondronat.
• After dilution the infusion solution is stable for 24 hours at 2-8°C (in a refrigerator)
• Nakon razrjeđivanja, infuzijska otopina stabilna je 24 sata na temperaturi od 2-8 °C (u hladnjaku).
Talk to your doctor or pharmacist before taking Bondronat:
Obratite se svom liječniku ili ljekarniku prije nego primite Bondronat:
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use, for infusion after dilution
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku Primjena u venu infuzijom, nakon razrjeđivanja
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva svrbež
The median time to relapse (return of albumin-corrected serum calcium above 3.0 mmol/l) was 18 to 26 days.
Medijan vremena do recidiva (povratka razine kalcija u serumu korigiranog albuminom iznad 3,0 mmol/l) iznosi 18 do 26 dana.
- Patients should not lie down for 60 minutes after taking Bondronat.
Nakon uzimanja lijeka Bondronat bolesnik ne smije leći sljedećih 60 minuta.
The deterioration in Quality of Life was significantly less in Bondronat treated patients compared with placebo.
Pogoršanje kvalitete života bilo je znatno manje u bolesnika liječenih lijekom Bondronat nego u bolesnika koji su primali placebo.
There was also a 38% reduction in the risk of developing an SRE for Bondronat treated patients when compared with placebo (relative risk 0.62, p=0.003).
U usporedbi s placebo grupom, u bolesnika liječenih lijekom Bondronat rizika od razvoja SRE bio je za 38% manji (relativni rizik 0,62; p=0,003).
For patients with breast cancer and bone metastases, Bondronat infusion should be administered every 3-4 weeks.
U bolesnika s rakom dojke i koštanim metastazama, infuziju lijeka Bondronat treba primjenjivati svaka 3 - 4 tjedna.
• Store in the original package in order to protect from moisture
• Čuvati u originalnom pakiranju radi zaštite od vlage.
What you need to know before you take Bondronat
Što morate znati prije nego počnete uzimati Bondronat
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).
Unatoč tome, na temelju kliničke procjene za pojedinog bolesnika, preporučuje se praćenje bubrežne funkcije te kalcija, fosfata i magnezija u serumu, u bolesnika koji se liječe lijekom Bondronat (vidjeti dio 4.2).
Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Tablica 3 Sekundarni rezultati djelotvornosti (bolesnici s rakom dojke i koštanim metastazama)
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.
U bolesnika s istodobno prisutnim faktorima rizika preporučuje se prije liječenja lijekom Bondronat provesti pregled zuba i preventivne stomatološke zahvate te ocijeniti omjer koristi i rizika za svakog pojedinog bolesnika.
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).
Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni (vidjeti dio 4.4).
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.
Unatoč tome, na temelju kliničke procjene za pojedinog bolesnika, preporučuje se praćenje bubrežne funkcije te kalcija, fosfata i magnezija u serumu, u bolesnika koji se liječe lijekom Bondronat.
• tooth problems
• problemi sa zubima.
Table 1 Adverse Reactions Reported for Intravenous Administration of Bondronat System Organ
Tablica 1 Nuspojave prijavljene kod intravenske primjene lijeka Bondronat
The deterioration in Quality of Life and WHO performance status was significantly less in Bondronat treated patients compared with placebo.
Pogoršanje kvalitete života i općeg stanja prema WHO, bilo je znatno manje u bolesnika liječenih lijekom Bondronat nego u bolesnika koji su primali placebo.
• If you have any further questions, ask your doctor or pharmacist
• Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
• high levels of urea or high levels of parathyroid hormone in your blood
• visoke razine ureje i visoke razine hormona paratiroidne žlijezde u krvi.
• low calcium or phosphate levels in your blood
• snižena razina kalcija i fosfata u krvi
No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
Nije bilo dokaza izravne fetalne toksičnosti ili teratogenog učinka u štakora i zečeva kojima je ibandronatna kiselina primijenjena intravenski.
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.
Preporučena doza za sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama iznosi 6 mg intravenskom injekcijom svaka 3 - 4 tjedna.
• It helps to prevent your bones from breaking (fractures) • It also helps to prevent other bone problems that may need surgery or radiotherapy
• Pomaže spriječiti druge poteškoće s kostima koje bi mogle zahtijevati operaciju ili radioterapiju.
Data from this study demonstrated a significant advantage for intravenous Bondronat 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost lijeka Bondronat 6 mg danog intravenski, u odnosu na placebo u pogledu smanjivanja SRE, mjereno vremenski prilagođenim SMPR-om (p=0,004).
• fluid build up and swelling (‘lymphoedema')
• nakupljanje tekućine i naticanje (“limfni edem”)
Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Budući da je u nekliničkim ispitivanjima pri visokim dozama ustanovljeno da su bubrezi i jetra ciljni organi za toksičnost, potrebno je pratiti funkcije jetre i bubrega.
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).
Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost lijeka Bondronat 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE, mjereno SMPR-om (p=0,041).
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).
U bolesnika koji su nakon njegova stavljanja u promet primali Bondronat za onkološke indikacije, vrlo je rijetko prijavljena osteonekroza čeljusti (vidjeti dio 4.8).
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).
Za bolesnike s umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 i < 50 ml/min) preporučena je prilagodba doze na jednu 50 mg filmom obloženu tabletu svaki drugi dan (vidjeti dio 5.2).
Hypocalcaemia
- Hipokalcijemija
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni.
Very rare (may affect up to 1 in 10,000 people)
Vrlo rijetke (mogu se javiti kod manje od 1 na 10 000 osoba)
Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem tableta lijeka Bondronat od 50 mg ocijenjena je u dva randomizirana, placebom kontrolirana ispitivanja faze III u trajanju od 96 tjedana.
How to receive Bondronat
Kako uzimati Bondronat
Clear, colourless solution.
Bezbojna, bistra otopina.
• If you have any further questions, ask your doctor, pharmacist or nurse
• Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
EU/1/96/012/012: 5 vials
EU/1/96/012/012: 5 bočica
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vialwith a bromobutyl rubber stopper).
Bondronat je dostupan u pakiranjima od 1, 5 i 10 bočica (bočica od 6 ml, staklo tipa I, s čepom od bromobutilne gume).
Paraesthesia, dysgeusia (taste perversion)
Poremećaji živčanog sustava parestezija, disgeuzija (poremećaj okusa)
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
osteonekroza čeljusti†**, osteonekroza vanjskog slušnog kanala (nuspojava skupine bisfosfonata) †
This is because the medicine will only work if it is taken all the time.
Uzimajte Bondronat tijekom čitavog razdoblja koje Vam je propisao liječnik jer djeluje samo ako se uzima čitavo vrijeme.
Myocardial ischaemia, cardiovascular disorder, palpitations
Srčani poremećaji blok grane ishemija miokarda, poremećaji srca i krvnih žila, palpitacije
A flu-like syndrome consisting of fever, chills, bone and/or muscle ache-like pain has occurred.
Javljala se bolest slična gripi koja je uključivala vrućicu, zimicu i bolove u kostima/mišićima.
Talk to your doctor first if you want to drive, use machine or tools.
Želite li voziti, koristiti strojeve ili alate, posavjetujte se najprije sa svojim liječnikom.
EU/1/96/012/013: 10 vials
EU/1/96/012/013: 10 bočica
The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 18 - 19 days for the 2 mg and 4 mg doses.
Medijan vremena do pojave recidiva (povratka vrijednosti kalcija u serumu korigiranih albuminom na razinu višu od 3 mmol/l) iznosio je 18 - 19 dana za doze od 2 mg i 4 mg.
Hypocalcaemia** Hypophosphataemia
Poremećaji metabolizma i prehrane hipokalcijemija** hipofosfatemija
Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
U bolesnika koji peroralno primaju bisfosfonate prijavljeni su štetni događaji kao što su ezofagitis, vrijedovi jednjaka i erozije jednjaka, koji su u nekim slučajevima bili teški i zahtijevali su bolničko liječenje, rijetko s krvarenjem ili strikturom jednjaka ili perforacijom.
METHOD OF ADMINISTRATION Read the package leaflet before use
NAČIN PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku
Appropriate medical support and monitoring measures should be readily available when Bondronat intravenous injection is administered.
Prilikom primjene intravenske injekcije lijeka Bondronat moraju biti dostupne odgovarajuća medicinska podrška i mjere nadzora.
Albumin-corrected Serum calcium (mmol/l)
korigiran albuminom (mmol/l)
Albumin-corrected serum calcium (mmol/l)
kalcij u serumu korigiran albuminom (mmol/l)
Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial with a bromobutyl rubber stopper).
Bondronat je dostupan u pakiranju od 1 bočice (bočica od 2 ml, staklo tipa I, s čepom od bromobutilne gume).
No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem bubrega (klirens kreatinina ≥ 50 i < 80 ml/min).
Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Način i put primjene Bondronat koncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju.
Excipients with known effect Bondronat is essentially sodium free.
Pomoćne tvari s poznatim učinkom Bondronat sadrži zanemarive količine natrija.
See also dosage section above for patients with renal impairment
Vidjeti i gore opisan dio o doziranju za bolesnike s oštećenjem bubrega.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog hidrata).
Hypromellose Titanium dioxide (E 171) Talc
Film ovojnica: hipromeloza titanijev dioksid (E171) talk makrogol 6000
The median time to relapse (re-increase of serum albumin corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses.
Medijan vremena do pojave recidiva (povratka vrijednosti kalcija u serumu na razinu višu od 3 mmol/l) iznosio je 18-19 dana za doze od 2 mg i 4 mg.
Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
Sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem lijeka Bondronat u dozi od 6 mg intravenski, ocijenjena je u jednom randomiziranom, placebom kontroliranom ispitivanju faze III u trajanju od 96 tjedana.
Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Bondronat koncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bondronat for cancer-related conditions.
U bolesnika koji su primali Bondronat za liječenje stanja povezanih s rakom nakon njegova stavljanja na tržište, vrlo je rijetko prijavljena nuspojava koja se zove osteonekroza čeljusti (oštećenje kosti u čeljusti).
= Serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
= kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
What Bondronat looks like and contents of the pack Bondronat is a colourless, clear solution.
Bondronat je bezbojna, bistra otopina.
• stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
• bol u želucu i trbuhu, probavne smetnje, mučnina, povraćanje ili proljev (rijetka stolica)
Albumin-corrected Serum calcium (mg/dl)
ili kalcij u serumu korigiran albuminom (mg/dl)
How to store Bondronat
Kako čuvati Bondronat
Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Bondronat 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina
• aching joints, arthritis, or other joint problems
• bolovi u zglobovima, artritis ili drugi problemi sa zglobovima
= serum calcium (mmol/l) - [0.02 x albumin (g/l)] + Or
= kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] +
Chest pain, influenza-like illness, malaise, pain
Opći poremećaji i reakcije na mjestu primjene astenija bolovi u prsima, bolest nalik gripi, malaksalost, bol
Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Bondronat 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina
Ocular inflammation†**
Poremećaji oka upala oka†**
Atypical subtrochanteric and diaphyseal femoral fractures†
Poremećaji mišićnokoštanog sustava i vezivnog tkiva atipične suptrohanterične i dijafizealne frakture femura†
MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011: 1 vial
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/012/011: 1 bočica