natgillin/translations-raw huggingface dataset:
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:
Strogo je potrebno pridržavati se sljedećih naputaka vezano za korištenje i odlaganje štrcaljki i ostalog oštrog medicinskog pribora:
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.
I dnevna 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.
If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.
Ako nehotice injicirate otopinu u tkivo oko vene, bolesnik može osjetiti lokalnu iritaciju, bol i upalu na mjestu primjene injekcije.
• not enough calcium and vitamin D in the diet
• nedovoljno kalcija i vitamina D u prehrani
• heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
• problemi sa srcem i cirkulacijom (uključujući palpitacije, srčani udar, hipertenziju (povišeni krvni tlak) i varikozne vene)
Treatment of tumour induced hypercalcaemia is most frequently associated with a rise in body temperature.
Liječenje hiperkalcijemije uzrokovanje tumorom je najčešće povezano s povišenjem tjelesne temperature.
Other things that can increase the risk of fractures include:
Ostali faktori koji mogu povećati rizik od osteoporoze su:
• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• imate imate bilo kakvih problema s ustima ili zubima, kao što je loša zubna higijena, bolesti desni ili planirano vađenje zuba
Ibandronic acid Accord 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.
Ibandronic acid Accord liječi osteoporozu onoliko dugo koliko primate liječenje, iako sami nećete moći vidjeti ni osjetiti razliku.
The solution for injection must be administered into a vein only, and not anywhere else in the body.
Otopina za injekciju mora se dati isključivo u venu i niti na jedno drugo mjesto na tijelu.
If you have 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.
Ako imate povišenu razinu kalcija u krvi uzrokovanu tumorom, tada preporučena doza iznosi jednokratna primjena 2 mg ili 4 mg, ovisno o težini bolesti.
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg ibandronic acid (154 patients).
Bolesnice s rakom dojke i radiološki potvrđenim koštanim metastazama randomizirane su za primanje placeba (158 bolesnica) ili 6 mg ibandronatne kiseline (154 bolesnica).
In the overall patient population of the study MF4411, 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 u ispitivanju MF4411 nije uočeno smanjenje broja ne-vertebralnih 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 ne-vertebralnih prijeloma za 69%.
PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless solution.
OBLIK Otopina za injekciju (injekcija) Bistra, bezbojna otopina.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Ibandronic Acid Accord').
Preporučuje se da se lijek upotrijebi odmah nakon pripreme za primjenu (vidjeti dio 5 ove upute o lijeku, “Kako čuvati Ibandronic acid Accord”).
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 učinaka postane zabrinjavajući ili traje dulje od nekoliko dana
While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Tijekom liječenja trebate održavati dobru zubnu higijenu (uključujući redovito pranje zuba) i odlaziti redovito na stomatološke kontrole.
• if you have heart problems and the doctor recommended to limit your daily fluid intake
• ako imate srčanih problema te vam je liječnik preporučio da ograničite dnevni unos tekućine
In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘“aminoglycoside”' such as gentamicin.
Posebno, obavijestite svog liječnika ili ljekarnika ukoliko u obliku injekcije primate antibiotik iz skupine aminoglikozida, poput gentamicina.
Overhydration should be avoided in patients at risk of cardiac failure.
Treba izbjegavati prekomjernu hidraciju u bolesnika u kojih postoji opasnost od zatajenja srca.
• If you have heart problems and the doctor recommended to limit your daily fluid intake.
• ako imate problema sa srcem i liječnik Vam je preporučio da ograničite dnevni unos tekućine.
• eating a balanced diet rich in calcium and vitamin D
• uravnoteženu prehranu bogatu kalcijem i vitaminom D
• it is given as an infusion into your vein.
• Primit ćete ga u obliku infuzije u venu.
• a skin growth called a ‘“benign skin neoplasm”'
• izraslina na koži zvana “dobroćudna novotvorina kože“
A tabular summary of these secondary efficacy results is presented in Table 3.
Sažetak sekundarnih rezultata djelotvornosti prikazan je u tablici 3.
Clinically meaningful reductions in serum CTX levels were observed at all time points measured.
Klinički značajna smanjenja razine CTX u serumu primijećena su u svim vremenskim razdobljima mjerenja.
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.
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 pojave osteonekroze vanjskog slušnog hodnika treba razmotriti u bolesnika koji primaju bisfosfonate i imaju simptome vezane za uho, uključujući kronične infekcije uha.
Bone resorption due to malignant disease is characterised 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.
Patients with known hypersensitivity to other bisphosphonates
Bolesnici s poznatom preosjetljivošću na druge bisfosfonate
• not enough walking or other weight-bearing exercise
• nedovoljno šetnji ili drugih aktivnosti koje uključuju podizanje tereta
Ibandronic acid Accord is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases').
Ibandronic acid Accord se koristi za liječenje odraslih bolesnika i bit će Vam propisan ako imate rak dojke koji se proširio na Vaše kosti (što se naziva „koštane metastaze“).
If a dose is missed, the injection should be administered as soon as convenient.
Ako je doza propuštena, injekcija se mora primijeniti što je prije moguće.
Lumbar spine L2-L4 BMD
BMD lumbalne kralježnice (L2-L4)
Less frequently, a decrease in serum calcium below normal range (hypocalcaemia) is reported.
Rjeđe je javljalo smanjenje kalcija u serumu ispod normalne razine (hipokalcijemija).
If you have breast cancer that has spread to your bones, then the recommended dose is 6 mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 6 mg svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
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 rendgenski vidljivih prijeloma kralježaka za 62% (p=0,0001) u razdoblju od tri godine, koliko je trajalo ispitivanje.
• a heart rhythm problem called ‘“bundle branch block”'
• problem sa srčanim ritmom zvan “blok grane”
Patients with disturbances of bone and mineral metabolism
Bolesnici s poremećajima metabolizma kosti i minerala
Ibandronic acid Accord may help lower the chances of breaking bones (fractures).
Ibandronic acid Accord može pomoći u smanjenju rizika prijeloma kostiju (fraktura).
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
Osteoporoza je bolest koja dovodi do stanjenja i slabljenja kosti, a uobičajena je u žena nakon postmenopauze.
Do not receive Ibandronic acid Accord if you are pregnant, planning to get pregnant or if you are breast-feeding.
Ne smijete primati Ibandronic acid Accord ako ste trudni, planirate zatrudnjeti ili ako dojite.
• Keep this container out of the reach of children.
• Takav spremnik držite izvan dohvata djece.
Strict adherence to the intravenous administration route is required (see section 4.4).
Obavezno je pridržavati se intravenskog puta primjene (vidjeti dio 4.4).
• serious, potentially life-threatening allergic reaction (see section 2).
• ozbiljna alergijska reakcija koja može biti opasna po život (vidjeti dio 2.)
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.
Ako liječite zube ili ćete se podvrći stomatološkom zahvatu (npr. vađenju zuba), obavijestite svog liječnika o tome, a stomatologa obavijestite da se liječite ibandronatnom kiselinom.
As no clinical data are available, dose recommendations cannot be given for patients with severe hepatic insufficiency (see section 4.2).
Budući da nisu dostupni klinički podaci, ne mogu se dati preporuke za doze u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
Ibandronic acid 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.
Intravenska injekcija ibandronatne kiseline 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.
Ibandronic acid Accord is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Ibandronic acid Accord je namijenjen samo za žene u postmenopauzi i ne smiju je uzimati žene koje još mogu imati djecu.
If you use more Ibandronic acid Accord than you should You may develop low levels of calcium, phosphorus or magnesium in the blood.
Ako primijenite više lijeka Ibandronic acid Accord nego što ste trebali Može se smanjiti razina kalcija, fosfora ili magnezija u krvi.
After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional.
Nakon dvosatne infuzije 2, 4 i 6 mg ibandronatne kiseline, farmakokinetički parametri proporcionalni su dozi.
It is supplied as packs containing 1, 5 or 10 vials with 6 ml of concentrate.
Isporučuje se u pakiranju od 1, 5 ili 10 bočica sa 6 ml koncentrata.
From a microbiological point of view, the solution for infusion should be used immediately.
S mikrobiološkog stajališta, otopinu za infuziju treba primijeniti odmah.
Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Koncentracija ibandronatne kiseline u plazmi povećava se proporcionalno dozi nakon intravenske primjene od 0,5 mg do 6 mg.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Važno je pokušati spriječiti nastanak osteonekroze čeljusti jer se radi o bolnom stanju čije liječenje može biti teško.
Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Smanjeno bubrežno izlučivanje kalcija može biti popraćeno padom razine fosfata u serumu, što ne zahtijeva terapijske mjere.
All Skeletal Related Events (SREs) Placebo n=158
Svi događaji vezani uz kosti (SRE) Placebo n=158
Ibandronic acid Accord is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures.
Ibandronic acid Accord Vam je propisan za liječenje postmenopauzalne osteoporoze, jer imate povećani rizik od prijeloma kostiju.
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 ibandronic acid (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 ibandronatnom kiselinom (vidjeti dio 4.2).
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Dokazano je smanjenje rizika od prijeloma kralježaka, a djelotvornost na prijelome vrata bedrene kosti nije ustanovljena.
Ibandronic acid Accord belongs to a group of medicines called bisphosphonates.
Ibandronic acid Accord pripada skupini lijekova koji se nazivaju bisfosfonati.
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 i neki su bolesnici osjećali bol u bedrima ili preponama, koja je često bila povezana s nalazom stres-fraktura na snimkama, tjednima, pa i mjesecima prije kliničke slike potpunoga prijeloma bedrene kosti.
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Sadrži 2D barkod s jedinstvenim identifikatorom.
• Place all used needles and syringes into a sharps container (puncture-proof disposable container).
• Sve upotrijebljene igle i štrcaljke odložite u spremnik za odlaganje oštrih predmeta (spremnik za odlaganje koji se ne može probiti ubodima).
This reduction in fractures was shown for the spine but not for the hip.
Dokazano je smanjenje prijeloma kralježaka, ali ne i kuka.
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.
One year data in study BM 16550
Podaci iz ispitivanja BM 16550 nakon jedne godine
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 16550.
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 16550
The anti-fracture effect was consistent over the duration of the study.
Učinak na sprječavanje prijeloma bio je nepromjenjen za vrijeme trajanja ispitivanja.
In a study in 130 patients with metastatic breast cancer the safety of ibandronic acid infused over 1 hour or 15 minutes was compared.
U ispitivanju 130 bolesnika s metastatskim rakom dojke uspoređivana je sigurnost primjene ibandronatne kiseline infuzijom u trajanju od 1 sata ili 15 minuta.
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na ibandronatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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).
Ako Vam se javi bilo koji od sljedećih simptoma, kao što je kratak dah/poteškoće s disanjem, osjećaj stezanja u grlu, oticanje jezika, omaglica, osjećaj gubljenja svijesti, crvenilo ili naticanje lica, osip po tijelu, mučnina ili povraćanje, trebate odmah obavijestiti svog liječnika ili medicinsku sestru (vidjeti dio 4).
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)
• ako ste alergični na ibandronatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Two year data in study BM 16550
Podaci iz ispitivanja BM 16550 nakon dvije godine
Toxic effects, e.g. signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Toksični učinci, npr. znakovi oštećenja bubrega, zapaženi su u pasa samo pri izloženosti dozama koje se smatraju znatno višima od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three-year fracture study (MF 4411).
Sigurnost peroralne primjene ibandronatne kiseline 2,5 mg jedanput dnevno ispitana je na 1251 bolesniku u četiri placebom kontrolirana klinička ispitivanja, od kojih je većina bolesnika bila prethodno uključena u pivotalno trogodišnje kliničko ispitivanje o prijelomima (MF 4411).
Increases at the hip compared to baseline were 2.8 % at the femoral neck, 3.4 % at the total hip, and 5.5 % at the trochanter.
Povećanja mineralne gustoće kosti kuka u usporedbi s početnim vrijednostima iznosila su 2,8% za vrat bedrene kosti, 3,4% za cijeli kuk i 5,5% za trohanter.
• a family history of osteoporosis
• osteoporoza u obiteljskoj anamnezi
This is because aminoglycosides and Ibandronic acid Accord can both lower the amount of calcium in your blood.
To je važno stoga što i aminoglikozidi i Ibandronic acid Accord mogu smanjiti razine kalcija u krvi.
The number of SREs was also significantly reduced with ibandronic acid 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Broj SRE bio je također znatno smanjen uz ibandronatnu kiselinu 6 mg, sa 40% smanjenim rizikom od pojave SRE u usporedbi s placebom (relativni rizik 0,6; p = 0,003).
It is supplied as packs containing 1, 5 or 10 vials.
Dostupno u pakiranjima od 1, 5 ili 10 bočica.
The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10 - 72 hours.
Raspon prividnog poluvijeka je širok, a prividni terminalni poluvijek u načelu ima raspon od 10 do 72 sata.
For storage conditions of the diluted medicinal product, see section 6.3.
Uvjete čuvanja razrijeđenog lijeka vidjeti u dijelu 6.3
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to ibandronic acid administration.
Tijekom liječenja, invazivne stomatološke zahvate treba izvoditi tek nakon pažljivog razmatranja i izbjegavati ih neposredno blizu primjene ibandronatne kiseline.
Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Nakon tri godine uočeno je povećanje BMD lumbalne kralježnice u usporedbi s placebom od 5,3% i 6,5% naspram početnih vrijednosti.
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Farmakoterapijska skupina: Pripravci za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA06
Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Oprez je potreban u bolesnika s poznatom preosjetljivošću na druge bisfosfonate.
There is no evidence that ibandronic acid is metabolized in animals or humans.
Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
• low calcium or phosphate levels in your blood
• smanjena razina kalcija i fosfata u krvi
After 5 years of receiving Ibandronic acid Accord, please consult with your doctor whether you should continue to receive Ibandronic acid Accord.
Nakon 5 godina primjene lijeka Ibandronic acid Accord posavjetujte se sa savojim liječnikom o tome trebate li ga nastaviti primati.
Due to the limited data available, ibandronic acid should not be used in all patients with end-stage renal disease.
Zbog dostupnih ograničenih podataka ibandronatnu kiselinu ne bi trebalo primjenjivati u bolesnika s terminalnom bolešću bubrega.
Both daily, intermittent (with a dose-free interval of 9 - 10 weeks per quarter) oral doses as well as intravenous doses of ibandronic acid in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption.
Dnevne kao i intermitentne peroralne doze (uz intervale od 9 do 10 tjedana po tromjesečju bez doze) kao i intravenske doze ibandronatne kiseline u žena u postmenopauzi proizvele su biokemijske promjene koje ukazuju na inhibiciju razgradnje kosti ovisnu o dozi.
In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 ml/min) and moderate (mean estimated CLcr= 41.2 ml/min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 ml/min).
U kliničkom farmakološkom ispitivanju WP18551, nakon intravenske primjene jedne doze od 6 mg (15-minutna infuzija) prosječni AUC0-24 se povećao za 14% u ispitanika s blagim (srednja procijenjena vrijednost CLcr = 68,1 ml/min) odnosno za 86% u ispitanika s umjerenim (srednja procijenjena vrijednost CLcr = 41,2 ml/min) oštećenjem bubrega u odnosu na zdrave dobrovoljce (srednja procijenjena vrijednost CLcr = 120 ml/min).
Ibandronic acid 6 mg n=154
Ibandronatna kiselina 6 mg n=154
The deterioration in Quality of Life was significantly less in ibandronic acid treated patients compared with placebo.
Pogoršanje kvalitete života bilo je znatno manje u bolesnika liječenih ibandronatnom kiselinom nego u bolesnika koji su primali placebo.
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
U ispitivanju su bile uključene žene od 55 do 80 godina koje su bile u postmenopauzi najmanje pet godina i u kojih je BMD lumbalne kralježnice iznosio od -2 do -5 SD manje od premenopauzalne srednje vrijednosti (T vrijednost) na barem jednom kralješku [L1-L4], a koje su imale od jednog do četiri postojeća prijeloma kralježaka.