FrancophonIA/ELRC3.0 huggingface dataset:
English: If you develop these symptoms, stop taking Bonviva and tell your doctor straight away (see section 3).
Croatian: Ako se ovi simptomi pojave, prekinite uzimati lijek Bonviva i odmah se obratite svom liječniku (vidjeti dio 3).
English: If you take more Bonviva than you should
Croatian: Ako uzmete više lijeka Bonviva nego što ste trebali
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Croatian: U multivarijatnoj analizi nije ustanovljeno da je dob neovisni faktor za bilo koji od ispitivanih farmakokinetskih parametara.
English: Never take two Bonviva tablets within the same week.
Croatian: Nikada ne smijete uzeti dvije tablete lijeka Bonviva u istome tjednu.
English: - Tablets should be swallowed whole with a glass of water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Croatian: - Tablete treba progutati cijele uz čašu vode (180 do 240 ml) dok bolesnik stoji ili sjedi u uspravnom položaju.
English: • do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus
Croatian: • nemojte leći; ukoliko ne ostanete u uspravnom položaju (stajati ili uspravno sjediti), dio lijeka može se vratiti u jednjak
English: No indication of carcinogenic potential was observed.
Croatian: Nisu zamijećeni znakovi moguće karcinogenosti.
English: Month 1 __/__/__ 3 film-coated tablets Month 2 __/__/__ 3 film-coated tablets Month 3 __/__/__ 3 film-coated tablets Note down the date you take your tablet
Croatian: Mjesec 1/_/_/_ 3 filmom obložene tablete Mjesec 2/_/_/_ 3 filmom obložene tablete Mjesec 3/_/_/_ 3 filmom obložene tablete Zabilježite datum kada uzimate tabletu
English: • Swallow your tablet whole, do not chew it, crush it or let it dissolve in your mouth.
Croatian: • Tabletu progutajte cijelu - nemojte je žvakati, drobiti ili otapati u ustima.
English: Please consult your doctor
Croatian: Posavjetujte se sa svojim liječnikom
English: Once you've taken your tablet, put a tick in the box on the sticker.
Croatian: Nakon što ste uzeli tabletu, stavite kvačicu u okvir na naljepnici.
English: Bonviva can treat osteoporosis only for as long as you keep receiving the treatment, even though you will not be able to see or feel a difference.
Croatian: Bonviva liječi osteoporozu onoliko dugo koliko primate liječenje, iako sami nećete moći vidjeti ni osjetiti razliku.
English: At the menopause, a woman's ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.
Croatian: Nakon menopauze ženini jajnici prestaju proizvoditi ženski hormon, estrogen, koji pomaže očuvanju zdravog skeleta.
English: • or the same day (such as the first Sunday of each month).
Croatian: • ili isti dan (na primjer prvu nedjelju u mjesecu).
English: • after you first get up for the day, and
Croatian: • nakon ustajanja ujutro
English: You should arrange an appointment to get the next injection as soon as possible.
Croatian: Morate se javiti liječniku i primiti sljedeću injekciju što je prije moguće.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: It's important to keep taking Bonviva every month, as long as your doctor prescribes it for you.
Croatian: Važno je uzimati lijek Bonviva svaki mjesec, dok god Vam to propisuje Vaš liječnik.
English: • After you've waited for an hour, you can have your first food and drink of the day.
Croatian: • Nakon jednog sata, možete konzumirati svoje prvo jelo ili piće toga dana.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2004
Croatian: Datum prvog odobrenja: 23. veljače 2004.
English: INFORMATION IN BRAILLE [Justification for not including Braille accepted]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU [Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma]
English: Elderly population (>65 years) No dose adjustment is required (see section 5.2).
Croatian: Starija populacija (>65 godina) Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Children and adolescents Do not give Bonviva to children or adolescents below 18 years.
Croatian: Djeca i adolescenti Bonviva se ne smije davati djeci ni adolescentima mlađima od 18 godina.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 mg/3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3mg/3ml
English: You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Bonviva tablet.
Croatian: Odaberite ili isti datum (npr. 1. u mjesecu) ili isti dan (npr. prva nedjelja u mjesecu) na koji ćete uzimati tabletu Bonviva.
English: To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long as your doctor prescribes it for you.
Croatian: Da biste imali koristi od liječenja, važno je da nastavite primati injekcije svaka tri mjeseca sve dok Vam ih liječnik propisuje.
English: This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 2).
Croatian: To je dokazano primarnom analizom nakon jedne godine i potvrdnom analizom nakon dvije godine (tablica 2).
English: The injection should be given into the vein by a physician or qualified/trained health care worker.
Croatian: Injekciju u venu mora dati liječnik ili kvalificiran zdravstveni radnik.
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).
Croatian: Kategorije učestalosti definirane su na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
Croatian: • svrbež, oticanje lica, usana, jezika i grla, uz otežano disanje
English: The extent of absorption is impaired when taken together with food or beverages (other than water).
Croatian: Stopa apsorpcije je smanjena ako se lijek uzima s hranom ili pićem (osim s vodom).
English: • Take your Bonviva tablet at least 6 hours after you last had anything to eat or drink except water.
Croatian: • Uzmite tabletu Bonviva najmanje 6 sati nakon zadnjeg jela ili pića, osim vode.
English: However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bonviva is administered with H2antagonists or other active substances which increase gastric pH.
Croatian: Međutim, budući da je to povećanje u okviru normalne varijabilnosti bioraspoloživosti ibandronatne kiseline, prilagodba doze nije potrebna kada se Bonviva primjenjuje s H2-antagonistima ili drugim lijekovima koji povećavaju pH želučane kiseline.
English: Bonviva It's important to keep taking Bonviva every month.
Croatian: Bonviva Vrlo je važno da lijek Bonviva uzimate svakog mjeseca.
English: What Bonviva contains
Croatian: Što Bonviva sadrži
English: Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Croatian: StevensJohnsonov sindrom†, multiformni eritem†, bulozni dermatitis†
English: Planning when to take Bonviva with peel-off stickers for your personal calendar What Bonviva is and what it is used for What you need to know before you take Bonviva How to take Bonviva
Croatian: Planiranje kada uzeti lijek Bonviva uz naljepnice za Vaš osobni kalendar Što je Bonviva i za što se koristi Što morate znati prije nego počnete uzimati lijek Bonviva Kako uzimati lijek Bonviva
English: • Dispose of the full container according to local requirements or as instructed by your healthcare professional.
Croatian: • Puni spremnik valja zbrinuti sukladno lokalnim propisima ili po naputku zdravstvenih radnika.
English: Patients should pay particular attention to and be able to comply with the dosing instructions (see section 4.2).
Croatian: Bolesnici trebaju obratiti posebnu pozornost i pridržavati se uputa o doziranju (vidjeti dio 4.2).
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6 %.
Croatian: Maksimalne zabilježene koncentracije u plazmi postignute su u vremenu od 0,5 do 2 sata (medijan 1 sat) nakon uzimanja lijeka natašte, a apsolutna bioraspoloživost bila je oko 0,6%.
English: • Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Bonviva.
Croatian: • dodatke koji sadrže kalcij, magnezij, željezo ili aluminij jer mogu utjecati na učinke lijeka Bonviva.
English: In case a dose is missed, patients should be instructed to take one Bonviva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days.
Croatian: Ako se preskoči jedna doza, bolesnici trebaju uzeti jednu Bonviva tabletu od 150 mg ujutro nakon što se toga prisjete, osim ako bi prema rasporedu sljedeću dozu trebali uzeti unutar narednih 7 dana.
English: Contains 154.6 mg anhydrous lactose (equivalent to 162.75 mg lactose monohydrate).
Croatian: Sadrži 154,6 mg bezvodne laktoze (što odgovara 162,75 mg laktoze hidrata).
English: Bonviva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference.
Croatian: Bonviva može zaustaviti gubitak kosti sprečavajući veći gubitak kosti i povećavajući masu kosti u većine žena koje je primjenjuju, čak i ako ne vide ili osjećaju razliku.
English: Bonviva is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures.
Croatian: Bonviva Vam je propisana za liječenje postmenopauzalne osteoporoze, jer imate povećani rizik od prijeloma.
English: • If you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys
Croatian: • ako imate ili ste ikada imali problema s bubrezima, zatajenjem bubrega, ili ako ste išli na dijalizu te ako imate bilo koju drugu bolest koja može utjecati na bubrege
English: INFORMATION IN BRAILLE Bonviva 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Bonviva 150 mg
English: Bonviva may help lower the chances of breaking bones (fractures).
Croatian: Bonviva može smanjiti rizik prijeloma kostiju (fraktura).
English: • If you are allergic to ibandronic acid, or any of the other ingredients of this medicine listed in section 6.
Croatian: • ako ste alergični na ibandronatnu kiselinu ili neki drugi sastojak ovog lijeka naveden u dijelu 6.
English: Medicinal product-Food Interaction
Croatian: Interakcija lijek-hrana
English: Biotransformation There is no evidence that ibandronic acid is metabolised in animals or humans.
Croatian: Biotransformacija Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
English: Your doctor may ask you to undergo a dental examination before starting treatment with Bonviva.
Croatian: Vaš liječnik može tražiti da prije početka liječenja lijekom Bonviva obavite stomatološki pregled.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite ili ne možete probaviti neke šećere (npr. ako patite od nepodnošenja galaktoze, nedostatka Lapp laktaze ili imate problema s apsorpcijom glukoze i galaktoze), posavjetujte se sa svojim liječnikom prije uzimanja ovog lijeka.
English: The tablets are supplied in blisters containing 1 or 3 tablets.
Croatian: Tablete su dostupne u blister pakiranjima s 1 ili 3 tablete.
English: After swallowing your monthly Bonviva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Croatian: Kada progutate svoju mjesečnu tabletu Bonviva, pričekajte jedan sat prije uzimanja bilo kojeg drugog lijeka, uključujući tablete za probavne smetnje te preparate koji sadrže kalcij, ili vitamine.
English: Bonviva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Croatian: Lijek Bonviva treba uzeti nakon noćnog gladovanja (barem 6 sati) i 1 sat prije uzimanja prve hrane ili pića (osim obične vode) na početku dana (vidjeti dio 4.5) te drugih oralnih lijekova ili nadomjesnih preparata (uključujući kalcij).
English: • If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Croatian: • Ako zaboravite uzeti tabletu ujutro na odabrani dan, nemojte je uzimati kasnije toga istog dana.
English: If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).
Croatian: Ako se pojavi neki od sljedećih simptoma: nedostatak zraka/otežano disanje, osjećaj stezanja u grlu, oticanje jezika, omaglica, osjećaj da ćete izgubiti svijest, crvenilo ili oticanje lica, osip po tijelu, mučnina i povraćanje, morate na to odmah upozoriti svog liječnika ili medicinsku sestru (vidjeti dio 4.).
English: Bonviva intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Croatian: Intravenska injekcija lijeka Bonviva smanjuje razinu C-telopeptida alfa-lanca kolagena tipa I (CTX) u serumu tijekom 3 do 7 dana od početka liječenja te razinu osteokalcina unutar 3 mjeseca.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Bonviva administration.
Croatian: Tijekom liječenja, invazivne stomatološke zahvate treba provoditi tek nakon pažljivog razmatranja, a izbjegavati ih u razdoblju blizu vremena primjene lijeka Bonviva.
English: Use the peel-off stickers below to mark the dates on your calendar.
Croatian: Naljepnice koje se ovdje nalaze koristite za označavanje datuma na kalendaru.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bonviva.
Croatian: Ako ste podvrgnuti liječenju zuba ili se morate podvrgnuti stomatološkom kirurškom zahvatu (npr. vađenju zuba), obavijestite svog liječnika o liječenju zuba i recite svom stomatologu da se liječite lijekom Bonviva.
English: There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population (see section 5.1 and 5.2).
Croatian: Bonviva nije bila značajno primjenjivana u djece mlađe od 18 godina pa nije ispitivana u ovoj populaciji (vidjeti dijelove 5.1 i 5.2).
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50 % of the circulating dose.
Croatian: U ljudi prividni terminalni volumen distribucije iznosi najmanje 90 l, dok se količina doze koja dospijeva do kosti procjenjuje na 40-50% cirkulirajuće doze.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne smiju uzimati ovaj lijek.
English: As renal function decreases with age this is the only factor to take into consideration (see renal impairment section).
Croatian: Kako se bubrežna funkcija smanjuje s godinama, to je jedini faktor koji treba uzeti u obzir (vidjeti dio vezan uz oštećenje funkcije bubrega).
English: Bonviva 150 mg film-coated tablets are supplied in blisters (PVC/PVDC, sealed with aluminium foil) containing 1 or 3 tablets.
Croatian: Bonviva 150 mg filmom obložene tablete dostupne su u blister pakiranjima (PVC/PVDC, prekriveno aluminijskom folijom) koja sadrže 1 ili 3 tablete.
English: • Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Croatian: • acetilsalicilatnu kiselinu i druge nesteroidne protuupalne lijekove (NSAID) (uključujući ibuprofen, diklofenaknatrij i naproksen) koji mogu nadražiti želudac i crijeva.
English: Do not take Bonviva with food.
Croatian: Ne uzimajte lijek Bonviva s hranom.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Croatian: Odmah se obratite svom liječniku i stomatologu ako primijetite bilo kakve tegobe s ustima ili zubima, poput rasklimanih zuba, boli ili oticanja, ranica koje ne cijele ili iscjetka, jer bi to mogli biti znakovi osteonekroze čeljusti.
English: In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity.
Croatian: U zdravih muških ispitanika i žena u postmenopauzi, intravenska primjena ranitidina uzrokovala je povećanje bioraspoloživosti ibandronatne kiseline za otprilike 20%, vjerojatno kao rezultat smanjene kiselosti želuca.
English: Studies in rats have shown some reproductive toxicity (see section 5.3).
Croatian: Ispitivanja u štakora pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: • not enough walking or other weight-bearing exercise
Croatian: • nedovoljno šetnji ili drugih fizičkih aktivnosti
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Croatian: Rizik od teških štetnih događaja na jednjaku čini se veći u bolesnika koji se ne pridržavaju uputa o doziranju i/ili koji nastavljaju peroralno primjenjivati bisfosfonate nakon pojave simptoma koji upućuju na iritaciju jednjaka.
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 - Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes
Croatian: - preosjetljivost na ibandronatnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1 - hipokalcijemija - nepravilnosti jednjaka koje dovode do zastoja u pražnjenju jednjaka kao što su strikture ili ahalazija - nemogućnost stajanja ili uspravnog sjedenja barem 60 minuta
English: Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Croatian: Vezanje na proteine plazme iznosi otprilike 85% do 87 % (određeno in vitro pri terapijskim koncentracijama lijeka) i stoga je mala vjerojatnost interakcije s drugim lijekovima zbog istiskivanja.
English: Bioavailability is reduced by about 90 % when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Croatian: Bioraspoloživost je smanjena za otprilike 90% kada se ibandronatna kiselina primjenjuje uz standardni doručak, u usporedbi s bioraspoloživosti opaženom u ispitanika koji su je primijenili natašte.
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 Bonviva.
Croatian: Mogu se javiti iritacija, upala ili vrijed jednjaka/cijevi koja povezuje usta sa želucem (ezofagus), često sa simptomima jake boli u prsima, jake boli nakon gutanja hrane i/ili pića, jake mučnine ili povraćanja, osobito ako ne popijete punu čašu vode i/ili ako legnete unutar jednog sata nakon uzimanja lijeka Bonviva.
English: In particular, products containing calcium, including milk, and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Bonviva, which is consistent with findings in animal studies.
Croatian: Osobito proizvodi koji sadrže kalcij, uključujući mlijeko, i ostale multivalentne katione (kao što su aluminij, magnezij i željezo) često mogu utjecati na apsorpciju lijeka Bonviva, što je u skladu s podacima iz ispitivanja provedenih u životinja.
English: • Keep this container out of the reach of children.
Croatian: • Takav spremnik držite dalje od dohvata djece.
English: • smoking, or drinking too much alcohol
Croatian: • pušenje ili prekomjerno konzumiranje alkohola
English: Some patients need to be especially careful when using Bonviva.
Croatian: Neki bolesnici trebaju biti osobito oprezni kod primjene lijeka Bonviva.
English: Do not make yourself vomit, and do not lie down - this could cause Bonviva to irritate your oesophagus.
Croatian: Nemojte izazivati povraćanje i nemojte leći jer bi Bonviva mogla nadražiti jednjak.
English: Bonviva contains lactose.
Croatian: Bonviva sadrži laktozu.
English: • If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
Croatian: • ako imate poremećaj metabolizma minerala (kao što je nedostatak vitamina D).
English: Solution for injection in pre-filled syringe:
Croatian: Otopina za injekciju u napunjenoj štrcaljki:
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 - Hypocalcaemia
Croatian: - preosjetljivost na ibandronatnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1 - hipokalcijemija
English: After 5 years of using Bonviva, please consult with your doctor whether you should continue to take Bonviva.
Croatian: Nakon 5 godina primjene lijeka Bonviva posavjetujte se sa svojim liječnikom o tome trebate li ga nastaviti uzimati.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Bonviva on an individual patient basis, particularly after 5 or more years of use.
Croatian: Potreba za nastavkom terapije treba se periodično reevaluirati vodeći računa o korisnim učincima i potencijalnim rizicima lijeka Bonviva za svakog pojedinog bolesnika, pogotovo nakon 5 ili više godina primjene.
English: tablet core: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6000
Croatian: jezgra tablete: laktoza hidrat, povidon, celuloza mikrokristalična, krospovidon, pročišćena stearatna kiselina, bezvodni koloidni silicijev dioksid ovojnica tablete: hipromeloza, titanijev dioksid (E 171), talk, makrogol 6000