natgillin/translations-raw huggingface dataset:
Inability to stand or sit upright for at least 60 minutes 
Nemogućnost stajanja ili uspravnog sjedenja barem 60 minuta.
The most frequently reported adverse reactions are arthralgia and influenza-like symptoms. 
Najčešće prijavljivane nuspojave su artralgija i simptomi slični gripi.
The primary pharmacological effects of ibandronic acid on bone are not directly related to actual plasma concentrations, as demonstrated by various studies in animals and humans. 
Primarni farmakološki učinci ibandronatne kiseline na kost nisu izravno vezani uz stvarne koncentracije u plazmi, kao što su to pokazala razna ispitivanja u životinja i ljudi.
In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased normal bone mass compared with untreated animals. 
U mladih (brzorastućih) štakora također je inhibirana endogena resorpcija kosti, što dovodi do povećanja normalne koštane mase u usporedbi s neliječenim životinjama.
Influenza-like illness 
Bolest slična gripi
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
Podrobnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
Do not throw away any medicines via wastewater or household waste. 
Lijekovi se ne smiju uklanjati putem otpadnih voda ili kućnog otpada.
Mutagenicity/Carcinogenicity: 
Mutagenost/karcinogenost:
- For the next hour (60 minutes) after you've taken your tablet do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus do not eat anything do not drink anything (except water if you need it) do not take any other medicines 
- Sljedeći sat (60 minuta) nakon uzimanja tablete nemojte leći; ukoliko ne ostanete u uspravnom položaju (stajati ili uspravno sjediti), dio lijeka može se vratiti u jednjak nemojte ništa jesti nemojte ništa piti (osim obične vode, ako trebate)
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN 
POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN POGLEDA
Water with a high concentration of calcium should not be used. 
Ne smije se koristiti voda s visokom koncentracijom kalcija.
This belongs to a group of medicines called bisphosphonates. 
Ona pripada skupini lijekova koji se nazivaju bisfosfonati.
Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration. 
Stoga, uzimanje takvih proizvoda, uključujući hranu, mora biti odgođeno najmanje 30 minuta nakon peroralnog uzimanja lijeka.
Other disturbances of bone and mineral metabolism should also be effectively treated. 
Ostali poremećaji koštanog i mineralnog metabolizma trebaju se također učinkovito liječiti.
Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or increased mechanical strength even at doses in the toxic range. 
Dnevna kao i intermitentna (uz produljene intervale bez doze) dugotrajna primjena u štakora, pasa i majmuna povezana je sa stvaranjem nove kosti normalne kvalitete i zadržanom ili povećanom mehaničkom čvrstoćom, čak i pri dozama unutar toksičnog raspona.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2010 
Datum prvog odobrenja: 17. rujna 2010.
• Swallow the tablet whole. 
- Progutajte tabletu cijelu.
Paraesthesia, dysgeusia (taste perversion) 
Parestezija, disgeuzija (poremećaj okusa)
Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74 % with reduction to a median inhibition of 56 % seen 28 days following the fourth dose. 
Nakon treće i četvrte doze medijan najviše inhibicije šestog dana nakon primanja doze iznosio je 74%, sa smanjenjem medijana inhibicije na 56% 28-og dana nakon primanja četvrte doze.
Mean relative changes from baseline % [95 % CI] 
Srednja relativna vrijednost promjene od početne vrijednosti % [95% CI]
If you are not sure, talk to your doctor or pharmacist before taking Ibandronic Acid Teva. 
Ukoliko niste sigurni, posavjetujte se sa svojim liječnikom ili ljekarnikom prije uzimanja Ibandronatne kiseline Teva.
The serum calcium level may fall to hypocalcaemic values. 
Razine kalcija u serumu mogu pasti do hipokalcemičnih vrijednosti.
This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p<0.001)). 
Ovo smanjivanje razina CTx u urinu bitno korelira s primarnom mjerom ishoda djelotvornosti SMPR (Kendall-tau-b (p<0,001)).
Ibandronic Acid Teva with food and drink 
Ibandronatna kiselina Teva s hranom i pićem
This was a composite endpoint which had the following skeletal related events (SREs) as sub-components: 
To je bila ukupna mjera ishoda u sklopu koje su se pratili sljedeći događaji vezani uz kosti (SRE = engl. skeletal related events):
All Skeletal Related Events (SREs) 
Svi događaji vezani uz kosti (SRE)
• serious, potentially life-threatening allergic reaction 
• ozbiljna alergijska reakcija koja može biti opasna po život
Hypersensitivity reaction 
Reakcija preosjetljivosti
Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. 
Životinjski modeli potvrđuju da je ibandronatna kiselina visoko potentan inhibitor osteoklastične aktivnosti.
• asthma attacks 
• napadaji astme
Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid Teva therapy. 
Bolesnici s poremećajima metabolizma kosti i minerala Hipokalcijemiju i ostale poremećaje metabolizma kostiju i minerala potrebno je učinkovito liječiti prije početka terapije Ibandronatnom kiselinom Teva.
All patients received 500 mg calcium and 400 IU vitamin D daily. 
Sve su bolesnice primale 500 mg kalcija i 400 IU vitamina
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Ibandronic Acid Teva on an individual patient basis, particularly after 5 or more years of use. 
Potreba za nastavkom terapije treba se periodično reevaluirati vodeći računa o korisnim učincima i potencijalnim rizicima Ibandronatne kiseline Teva za svakog pojedinog bolesnika, pogotovo nakon 5 ili više godina primjene.
At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation. 
Pri dozama koje su bile znatno veće od farmakološki učinkovitih doza, ibandronatna kiselina nije imala utjecaja na mineralizaciju kostiju.
Talk to your doctor before taking Ibandronic Acid Teva: - If you have any disturbances of mineral metabolism (such as vitamin D deficiency). 
Vašim liječnikom prije uzimanja Ibandronatne kiselina Teva: - Ako imate poremećaj metabolizma minerala (kao što je nedostatak vitamina D).
Swensweg 5, 2031 GA Haarlem The Netherlands 
Swensweg 5, 2031 GA Haarlem Nizozemska
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom 
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Velika Britanija
- After you've waited for an hour, you can have your first food and drink of the day. 
Nakon jednog sata, možete konzumirati svoje prvo jelo ili piće toga dana.
Patients should then return to taking their dose once a month on their originally scheduled date. 
Bolesnici bi se potom trebali vratiti uzimanju svoje doze jedanput mjesečno prema prvotnom rasporedu.
Ask your doctor or pharmacist for advice before taking this medicine. 
Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
Then you can have your first food and drink, and take any medicines or supplements (see section 3). 
Tek tada možete jesti ili piti, odnosno uzeti neki drugi lijek ili dodatak (vidjeti dio 3).
With no further dosing, there is a loss of suppression of biochemical markers of bone resorption. 
Bez daljnjeg doziranja dolazi do gubitka supresije biokemijskih biljega razgradnje kosti.
What Ibandronic Acid Teva is and what it is used for What you need to know before you take Ibandronic Acid Teva How to take Ibandronic Acid Teva Possible side effects 
Što je Ibandronatna kiselina Teva i za što se koristi Što morate znati prije nego počnete uzimati Ibandronatnu kiselinu Teva Kako uzimati Ibandronatnu kiselinu Teva Moguće nuspojave
A tabular summary of the secondary efficacy results is presented in Table 3. 
Sažetak sekundarnih rezultata djelotvornosti prikazan je u tablici 3.
Ibandronic Acid Teva is less effective if it's taken with food. 
Ibandronatna kiselina Teva je manje učinkovita ako se uzme s hranom.
If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. 
Ako imate blage probleme s bubrezima, Vaš vam liječnik može smanjiti dozu na jednu tabletu svaki drugi dan.
Ibandronic Acid Teva is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. 
Ibandronatna kiselina Teva Vam je propisana za liječenje postmenopauzalne osteoporoze jer imate povećani rizik od prijeloma.
The vertebral fracture risk reduction was very consistent with that seen in the overall population. 
Smanjenje rizika prijeloma kralježaka odgovaralo je smanjenju zamijećenom u ukupnoj populaciji.
This medicine does not require any special storage conditions. 
Lijek ne zahtjeva posebne uvjete čuvanja.
Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures. 
Neovisni faktori rizika, na primjer, niska mineralna gustoća kosti, dob, prethodni prijelomi, prijelomi u obitelji, brza koštana pregradnja i nizak indeks tjelesne mase, moraju se uzeti u obzir prilikom prepoznavanja žena s povećanim rizikom od prijeloma uzrokovanih osteoporozom.
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. 
Ovi prijelomi nastaju uslijed neznatne traume ili bez traume, dok su neki bolesnici osjećali bol u bedrima ili preponama, koja je često bila povezana sa snimkama stres-fraktura, tjednima, pa čak i mjesecima prije kliničke slike potpunog prijeloma bedrene kosti.
The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances. 
Čini se da put izlučivanja putem bubrega ne obuhvaća poznate kisele ni bazne transportne sustave uključene u izlučivanje drugih djelatnih tvari.
- If you can't stand or sit upright for at least one hour (60 minutes) at a time. 
- Ako ne možete stajati ili uspravno sjediti neprekidno barem jedan sat (60 minuta).
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. 
Ako se sljedeća planirana doza treba uzeti unutar narednih sedam dana, bolesnici bi trebali pričekati do te doze i zatim nastaviti uzimati jednu tabletu mjesečno prema prvotnom rasporedu.
As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates. 
S obzirom da izračunate vrijednosti u velikoj mjeri ovise o trajanju ispitivanja, primijenjenoj dozi te osjetljivosti metode, stvarni terminalni poluvijek vjerojatno je znatno dulji, slično drugim bisfosfonatima.
In case a dose is missed, patients should be instructed to take one Ibandronic Acid Teva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days. 
Ako se preskoči jedna doza, bolesnici trebaju uzeti jednu tabletu Ibandronatne kiseline Teva od 150 mg ujutro nakon što se toga prisjete, osim ako bi prema rasporedu sljedeću dozu trebali uzeti unutar narednih sedam dana.
2031 GA Haarlem The Netherlands 
2031 GA Haarlem Nizozemska
Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days 
Obratite se medicinskoj sestri ili liječniku ako se neki od tih simptoma pojača ili traje dulje od nekoliko dana
After taking your tablet, wait at least 30 minutes. 
Nakon što ste uzeli tabletu, pričekajte najmanje 30 minuta.
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3). 
U inicijalnom trogodišnjem randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju prijeloma (MF 4411) dokazano je da postoji statistički značajno i medicinski relevantno smanjenje pojave novih prijeloma kralježaka utvrđenih rendgenski, morfometrički i klinički (tablica 3).
Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration. 
Nadalje, budući da pri terapijskim koncentracijama vezanje ibandronatne kiseline za proteine plazme iznosi otprilike 87%, nije vjerojatno da će hipoproteinemija u bolesnika s teškom bolesti jetre dovesti do klinički značajnih povećanja koncentracije slobodne ibandronatne kiseline u plazmi.
If you are taking a tablet each day, skip the missed dose completely. 
Ako uzimate jednu tabletu dnevno, preskočite propuštenu dozu.
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients). 
Bolesnice s rakom dojke i radiološki potvrđenim koštanim metastazama randomizirane su za primanje placeba (277 bolesnica) ili 50 mg ibandronatne kiseline (287 bolesnica).
Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. 
Ibandronatna kiselina eliminira se isključivo renalnom sekrecijom i nije podložna nikakvom obliku biotransformacije.
- Water is the only drink that should be taken with Ibandronic Acid Teva. 
- Voda je jedino piće s kojim se Ibandronatna kiselina Teva smije uzimati.
One year data in study BM 16549 Two year data in study BM 
Podaci iz ispitivanja BM 16549 nakon dvije godine
Metabolism and nutrition disorders 
Poremećaj metabolizma i prehrane
What Ibandronic Acid Teva is and what it is used for 
Što je Ibandronatna kiselina Teva i za što se koristi
If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic Acid Teva. 
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 Ibandronatna kiselina Teva.
Bone resorption due to malignant disease is characterized by excessive bone resorption that is not balanced with appropriate bone formation. 
Resorpcija kostiju uzrokovana zloćudnom bolesti karakterizirana je pretjeranom resorpcijom kostiju koja nije uravnotežena s odgovarajućim formiranjem kostiju.
This regimen reduced the occurrence of new radiographic vertebral fractures by 62 % (p=0.0001) over the three year duration of the study. 
Takvo je liječenje smanjilo pojavu novih rendgenskih vidljivih prijeloma kralježaka za 62% (p=0,0001) u razdoblju od tri godine, koliko je trajalo ispitivanje.
Bone mineral density (BMD) 
Mineralna gustoća kosti (BMD - Bone mineral density)
- If you have any swallowing or digestive problems. 
- Ako imate problema s gutanjem ili probavom.
Water may be taken at any time during the course of Ibandronic Acid Teva treatment (see section 4.5). 
Voda se smije uzimati bilo kada za vrijeme trajanja liječenja Ibandronatnom kiselinom Teva (vidjeti dio 4.5).
Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3-6 months. 
Biokemijski biljezi koštane pregradnje (kao što je CTX u urinu i serumski osteokalcin) pokazali su očekivani obrazac snižavanja do premenopauzalnih razina te su dosegnuli najviše sniženje tijekom 3 do 6 mjeseci.
Table 2: Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16549. 
Tablica 2: Srednja relativna vrijednost promjene od početne vrijednosti BMD lumbalne kralježnice, cijelog kuka, vrata bedrene kosti i trohantera nakon jedne godine (primarna analiza) i dvije godine liječenja (populacija po protokolu) u ispitivanju BM 16549.
In the overall patient population of the study MF 4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed. 
U ukupnoj populaciji bolesnika ispitivanja MF4411 nije uočeno smanjenje broja nevertebralnih prijeloma, no čini se da je dnevna doza ibandronata djelotvorna u visokorizičnoj populacijskoj podskupini (T-vrijednost BMD za vrat bedrene kosti < -3,0), u kojoj je primijećeno smanjenje rizika od nevertebralnih prijeloma za 69%.
The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton. 
Inhibicija endogene resorpcije kosti dokazana je i u kinetskim ispitivanjima s 45Ca te otpuštanjem radioaktivnog tetraciklina prethodno ugrađenog u skelet.
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p<0.0001). 
Značajan učinak na prijelome kralježaka dodatno ukazuje i statistički značajno smanjenje gubitka visine u usporedbi s placebom (p<0,0001).
If you have severe kidney problems, your doctor may reduce your dose to one tablet each week. 
Ako imate tešku bolest bubrega liječnik vam može smanjiti dozu na jednu tabletu tjedno.
Ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures. 
Ibandronatna kiselina 2,5 mg primijenjena dnevno pokazala je statistički značajno i medicinski relevantno smanjenje pojave novih prijeloma kralježaka.
After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine. 
Nakon početne sistemske izloženosti, ibandronatna kiselina se vrlo brzo veže uz kost ili se izlučuje u urin.
Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic Acid Teva tablets. 
Lijekove i nadomjesne pripravke (uključujući kalcij) također bi trebalo izbjegavati prije uzimanja tableta Ibandronatne kiseline Teva.
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing. 
• svrbež, oticanje lica, usana, jezika i grla, uz otežano disanje.
• severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty in swallowing. 
• jaka bol u prsima, jaka bol nakon gutanja hrane ili pića, jaka mučnina ili povraćanje, otežano gutanje.
This includes: - eating a balanced diet rich in calcium and vitamin D, - walking or any other weight-bearing exercise, - not smoking; and not drinking too much alcohol. 
Takav način obuhvaća: - uravnoteženu prehranu bogatu kalcijem i vitaminom D - kretanje i druge tjelesne aktivnosti - nepušenje i nekonzumiranje prekomjernih količina alkohola.
Caution is advised when bisphosphonates are administered with aminoglycosides, since both substances can lower serum calcium levels for prolonged periods. 
Potreban je oprez pri primjeni bisfosfonata s aminoglikozidima, budući da obje tvari mogu smanjiti razine kalcija u serumu na dulje vrijeme.
- Swallow your tablet whole, - do not chew it, crush it or let it dissolve in your mouth. 
- Tabletu progutajte cijelu - nemojte je žvakati, drobiti ili otapati u ustima.
Do not take Ibandronic Acid Teva if you are pregnant, planning to get pregnant or if you are breast-feeding. 
Ne uzimajte Ibandronatnu kiselinu Teva ako ste trudni, planirate zatrudnjeti ili ako dojite.
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. 
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.
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or greater than 30 ml/min), as shown in study BM 16549 where the majority of patients had mild to moderate renal impairment. 
Nisu potrebne prilagodbe doze za bolesnike s blagim ili umjerenim oštećenjem funkcije bubrega (CLcr jednak ili veći od 30 ml/min), kao što pokazuje studija BM 16549, u kojoj je većina bolesnika imala blago do umjereno oštećenje funkcije bubrega.
Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet, - smoking, or drinking too much alcohol, - not enough walking or other weight-bearing exercise, - a family history of osteoporosis. 
Ostali faktori koji mogu povećati rizik od osteoporoze su: - nedovoljno kalcija i vitamina D u prehrani - pušenje ili prekomjerno konzumiranje alkohola - nedovoljno kretanja ili nedostatak drugih tjelesnih aktivnosti - oboljeli od osteoporoze u obitelji.
The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections. 
Mogućnost osteonekroze vanjskog slušnog kanala potrebno je razmotriti u bolesnika koji primaju bisfosfonate, a koji imaju simptome koji zahvaćaju uho uključujući kronične infekcije uha.
Calcium supplements, antacids and some oral medicinal products containing multivalent cations 
Suplementi kalcija, antacidi i neki peroralni lijekovi koji sadrže multivalentne katione
Once you've eaten, it's OK to lie down if you wish, and to take any other medication you need. 
Ako želite, nakon jela možete leći ili uzeti druge lijekove koje morate uzeti.
In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen. 
U ovom ispitivanju, ibandronatna kiselina je ispitivana u oralnoj dozi od 2,5 mg jedanput dnevno i u intermitentnoj dozi od 20 mg kao eksplorativni režim primjene.
Talk to a nurse or a doctor straight away if you notice any of the following serious side effectsyou may need urgent medical treatment: 
Razgovarajte odmah s medicinskom sestrom ili liječnikom ako primijetite bilo koju od slijedećih ozbiljnih nuspojava - možda će Vam biti potrebna hitna medicinska pomoć:
- The tablets should be swallowed whole with a full glass of water (180 to 240 ml) while the patient is standing or sitting in an upright position. 
- Tablete treba progutati cijele uz punu čašu vode (180 do 240 ml) dok bolesnik stoji ili sjedi u uspravnom položaju.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic Acid Teva administration. 
Tijekom liječenja, invazivne stomatološke zahvate treba provoditi tek nakon pažljivog razmatranja, a izbjegavati ih u razdoblju blizu vremena primjene lijeka Ibandronatna kiselina Teva.
The usual dose of Ibandronic Acid Teva is one tablet each day. 
Uobičajena doza Ibandronatne kiseline Teva je jedna tableta dnevno.