FrancophonIA/ELRC3.0 huggingface dataset:
English: - Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Croatian: - reakcije probavnog sustava, kao što su mučnina i povraćanje, kao i gubitak apetita
English: Pyrexia, fatigue Acute phase reaction, pain
Croatian: pireksija, umor reakcija akutne faze, bol
English: After dilution of the concentrate the prepared solution should be clear, colourless and free of visible particles.
Croatian: Nakon razrjeđenja koncentrata pripremljena otopina treba biti bistra, bezbojna i bez vidljivih čestica.
English: • The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
Croatian: • Ukupno vrijeme od razrjeđenja i čuvanja u hladnjaku do završetka primjene ne smije biti dulje od 24 sata.
English: The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46).
Croatian: Analizom pojedinačnih izvješća o sigurnosti iz kliničkih ispitivanja, spontanih prijava i literature dobivena su 62 slučaja osteonekroze na drugim anatomskim mjestima povezana sa zoledronatnom kiselinom, gdje se većina događaja pojavila na kuku/bedrenoj kosti (46).
English: - Low level of red blood cells (anaemia).
Croatian: - konjunktivitis - smanjeni broj crvenih krvnih stanica (anemija).
English: Additional information on handling of Zoledronic acid medac, including guidance on preparation of reduced doses, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zoledronatnom kiselinom medac, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
English: There are no site specific risk factors for osteonecrosis apart from additional oral risk factors for osteonecrosis of the jaw.
Croatian: Nema faktora rizika za osteonekrozu koji su specifični za neko mjesto osim dodatnog oralnog faktora rizika za osteonekrozu čeljusti.
English: Hypersensitivity reaction Angioneurotic oedema
Croatian: reakcija preosjetljivosti angioneurotski edem
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid medac.
Croatian: Ako već imate hipokalcemiju, ona se mora korigirati prije uvođenja prve doze Zoledronatne kiseline medac.
English: - Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Croatian: - Uočeno je da se osteonekroza također vrlo rijetko pojavila i na drugim kostima osim čeljusti, naročito na kuku ili bedrima.
English: • Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Croatian: • rak, komorbidna stanja (npr. anemija, koagulopatije, infekcija), pušenje.
English: In use stability: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 2-8°C and 25°C.
Croatian: Stabilnost u primjeni: dokazana kemijska i fizikalna stabilnost nakon razrjeđivanja iznosi 24 sata na temperaturi od 2 - 8°C i 25°C.
English: - Low level of calcium in the blood.
Croatian: - niska razina fosfata u krvi.
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 a condition called osteonecrosis of the jaw.
Croatian: Odmah se obratite svom liječniku i zubaru ako imate bilo kakav problem u ustima ili sa zubima, kao što je klimanje zuba, bol ili oticanje, ranice koje ne zacjeljuju ili iscjedak, jer to mogu biti znakovi stanja koje se zove osteonekroza čeljusti.
English: After first opening and dilution: From a microbiological point of view the medicinal product should be used immediately.
Croatian: Nakon prvog otvaranja i razrjeđenja: s mikrobiološkog stanovišta, lijek treba odmah primijeniti.
English: • History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures.
Croatian: • stomatološka povijest bolesti, lošu oralnu higijenu, periodontalnu bolest, invazivne zahvate na zubima (npr. vađenje zuba) i zubne proteze koje loše prijanjaju.
English: - Low blood pressure.
Croatian: - nesvjestica zbog niskog krvnog tlaka
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving and operating of machinery.
Croatian: Nuspojave poput omaglice i somnolencije mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima te je stoga potreban oprez kad se tijekom primanja zoledronatne kiseline upravlja vozilima i radi sa strojevima.
English: Increasing the infusion time from 5 to 15 minutes caused a 30 % decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Croatian: Produljenje trajanja infuzije s 5 na 15 minuta prouzročilo je 30%-tno sniženje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo nikakvog učinka na površinu ispod krivulje koncentracije u plazmi u vremenu mjerenja.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid medac via the domestic sewage system.
Croatian: Zdravstvenim radnicima se savjetuje da ne bacaju neiskorištenu Zoledronatnu kiselinu medac u otpadne vode.
English: The reports of osteonecrosis at other sites with zoledronic acid suggest similarity in reporting frequency (femur>knee>humerus) as compared to the commonly affected sites of osteonecrosis based on anatomical factors.
Croatian: Prijave osteonekroze na drugim mjestima sa zoledronatnom kiselinom ukazuju na sličnu učestalost u prijavljivanju (bedrena kost>koljeno>nadlaktična kost) u odnosu na uobičajeno zahvaćena mjesta osteonekrozom temeljena na anatomskom značajkama.
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Croatian: Hipokalcemija je važan prepoznat rizik primjene zoledronatne kiseline u odobrenim indikacijama.
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2,000 ng/ml of zoledronic acid.
Croatian: Vezanje za proteine plazme je nisko, s nevezanom frakcijom u rasponu od 60% kod 2 ng/ml do 77% kod 2000 ng/ml zoledronatne kiseline.
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Croatian: hipertenzija, hipotenzija, fibrilacija atrija, hipotenzija s posljedičnom sinkopom ili cirkulacijskim kolapsom bradikardija, srčana aritmija (kao posljedica hipokalcemije)
English: If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
Croatian: Ako se otopina ne primijeni odmah, potrebno ju je čuvati u hladnjaku na temperaturi od 2°C do 8°C.
English: Over the first 24 hours, 39 ± 16 % of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Croatian: Tijekom prva 24 sata, 39±16% primijenjene doze otkrije se u mokraći, dok se preostali dio u načelu veže za koštano tkivo.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o procjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za zoledronatnu kiselinu (indiciranu za rak i prijelome), znanstveni su zaključci CHMP-a sljedeći:
English: Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Croatian: Izvucite odgovarajući volumen potrebnog koncentrata na sljedeći način: 4,4 ml za dozu od 3,5 mg
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including convulsions, hypoaesthesia and tetany (see section 4.4).
Croatian: Nadalje, postoje dokazi o povezanosti između hipokalcemije i sekundarnih neuroloških događaja zabilježenih u tim slučajevima, uključujući konvulzije, hipoesteziju i tetaniju (vidjeti dio 4.4).
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Croatian: Vrijeme nastupa je ≤3 dana nakon infuzije zoledronatne kiseline, a reakcija se još zove “sindrom sličan gripi” ili simptomi “nakon doziranja”.
English: There is preponderance of specific location (head of femur, humerus and medial condyle of femur) due to local anatomical features.
Croatian: Postoji prevaga određenih lokacija (glava bedrene kosti, nadlaktična kost i medijalni kondil bedrene kosti) zbog lokalnih anatomskih značajki.
English: Within three days after zoledronic acid administration, an acute phase reaction has been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Croatian: Tijekom tri dana nakon primjene zoledronatne kiseline je zabilježena reakcija akutne faze sa simptomima koji uključuju bol u kostima, vrućicu, umor, artralgiju, mialgiju, tresavicu i artritis s posljedičnim oticanjem zglobova; ti se simptomi obično povuku u roku od nekoliko dana (vidjeti opis odabranih nuspojava).
English: Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.
Croatian: Bolesnici koji primaju kemoterapiju i/ili radioterapiju, uzimaju steroide, imaju planiran zubarski kirurški zahvat, ne obavljaju redovite zubarske preglede, imaju bolest desni, puše ili su prethodno bili liječeni bisfosfonatom (primjenjuje se za liječenje ili sprječavanje koštanih poremećaja) mogu imati viši rizik za razvoj osteonekroze čeljusti.
English: How to store Zoledronic acid medac Contents of the pack and other information
Croatian: Kako čuvati Zoledronatnu kiselinu medac Sadržaj pakiranja i druge informacije
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Croatian: Utvrđeni su sljedeći važni rizici primanja zoledronatne kiseline u odobrenim indikacijama: oštećenje funkcije bubrega, osteonekroza čeljusti, reakcija akutne faze, hipokalcemija, fibrilacija atrija, anafilaksija i intersticijska bolest pluća.
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Croatian: Označene su statistički značajne razlike (*p < 0,05) između dvije terapije (4 mg zoledronatne kiseline naspram placebu)
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba): - Kao posljedica niskih vrijednosti kalcija: nepravilan rad srca (srčana aritmija; kao posljedica hipokalcemije).
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja zoledronatne kiseline u svim podskupinama pedijatrijske populacije u liječenju hiperkalcemije izazvane tumorom i sprječavanju događaja povezanih s koštanim sustavom u bolesnika s uznapredovalom zloćudnom bolešću koja zahvaća kosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: On the basis of the scientific conclusions for zoledronic acid (indicated for cancer and fractures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing zoledronic acid (indicated for cancer and fractures) is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za zoledronatnu kiselinu (indiciranu za rak i prijelome), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) zoledronatnu kiselinu (indiciranu za rak i prijelome) nepromijenjen, uz predložene izmjene informacija o lijeku.
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5,000 ng/ml.
Croatian: U in vitro ispitivanju, zoledronatna kiselina je pokazala niski afinitet za stanice ljudske krvi, uz srednju vrijednost omjera koncentracije u krvi prema plazmi od 0,59 za raspon koncentracije od 30 ng/ml do 5000 ng/ml.
English: * Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not reached
Croatian: ** Odnosi se na sve koštane događaje, njihov ukupni broj i vrijeme do svakog pojedinog događaja tijekom ispitivanja.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Croatian: U bolesnika s multiplim mijelomom, rizik od poremećaja funkcije bubrega može biti povećan kad se zoledronatna kiselina primjenjuje u kombinaciji s talidomidom.
English: • From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Croatian: • S mikrobiološkog stanovišta, otopina za infuziju treba se odmah primijeniti nakon prvog otvaranja.
English: There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Croatian: Pronašla se brža normalizacija korigiranog kalcija u serumu 4. dana za 8 mg zoledronatne kiseline i 7. dana za 4 mg i 8 mg zoledronatne kiseline.
English: - are having dental treatment or are due to undergo dental surgery; tell your dentist that you are being treated with Zoledronic acid medac and inform your doctor about your dental treatment.
Croatian: - ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom medac, a svog liječnika da se liječite kod zubara.
English: Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili u čeljusti koje ne zacjeljuju, iscjedak, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
English: • Since no data are available on the compatibility of Zoledronic acid medac with other intravenously administered substances, Zoledronic acid medac must not be mixed with other medications/substances and should always be given through a separate infusion line.
Croatian: • Budući da nema dostupnih podataka o kompatibilnosti Zoledronatne kiseline medac s drugim tvarima za intravensku primjenu, Zoledronatna kiselina medac ne smije se miješati s drugim lijekovima/tvarima i uvijek se mora primjenjivati kroz zasebnu infuzijsku liniju
English: You will be given adequate calcium and vitamin D supplements.
Croatian: Dobiti ćete odgovarajuće nadomjeske kacija i vitamina D.
English: The active substance in Zoledronic acid medac is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Croatian: Djelatna tvar u Zoledronatnoj kiselini medac je zoledronatna kiselina, koja pripada skupini tvari koje se zovu bisfosfonati.
English: The cases from safety database did report multiple risk factors including underlying malignancy, bone metastases; concomitant therapy with steroids, angiogenesis inhibitors, radiotherapy but the exact underlying cause for the osteonecrosis was not ascertained.
Croatian: Slučajevi iz sigurnosne baze podataka prijavljuju više faktora rizika, uključujući podležeću malignu bolest, metastaze u kostima; istodobnu terapiju steroidima, inhibitorima angiogeneze, radioterapiju ali točan podležeći uzrok za osteonekrozu nije utvrđen.
English: Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Croatian: dispneja, kašalj, bronhokonstrikcija intersticijska bolest pluća
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Croatian: *Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg•h/l) (klirens kreatinina = 75 ml/min).
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.
Croatian: Ne smije se dopustiti da lijek dođe u kontakt s otopinama koje sadrže kalcij i ne smije ga se miješati niti davati intravenski s nijednim drugim lijekom kroz istu infuzijsku liniju.
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Croatian: Na temelju pregleda slučajeva kako u kliničkim ispitivanjima, tako i nakon stavljanja lijeka u promet, postoji dovoljno dokaza koji podupiru povezanost između terapije zoledronatnom kiselinom, zabilježenog slučaja hipokalcemije i sekundarnog razvoja srčane aritmije.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zoledronic acid medac (see section 4.4).
Croatian: Slučajevi osteonekroze čeljusti pretežno su zabilježeni u onkoloških bolesnika liječenih lijekovima koji inhibiraju resorpciju kosti, kao što je Zoledronatna kiselina medac (vidjeti dio 4.4).
English: Instructions for preparing reduced doses of zoledronic acid
Croatian: Upute za pripremu sniženih doza zoledronatne kiseline
English: Thrombocytopenia, leukocytopenia Pancytopenia
Croatian: anemija trombocitopenija, leukopenija pancitopenija
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid medac.
Croatian: Liječnik Vam može preporučiti da prije početka liječenja Zoledronatnom kiselinom medac obavite zubarski pregled.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Croatian: - antiangiogenim lijekovima (primjenjuju se za liječenje raka), budući da je kombinacija ovih lijekova sa zoledronatnom kiselinom povezana s povećanim rizikom od osteonekroze čeljusti.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Croatian: Savjetuje se oprez kod primjene bisfosfonata s aminoglikozidima, kalcitoninom ili diureticima Henleove petlje, budući da ovi lijekovi mogu imati aditivan učinak i sniziti razinu kalcija u serumu dulje nego što je potrebno (vidjeti dio 4.4).
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Croatian: Savjetuje se oprez kad se zoledronatna kiselina primjenjuje s antiangiogenim lijekovima, budući da je u bolesnika istovremeno liječenih ovim lijekovima opaženo povećanje incidencije osteonekroze čeljusti.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Croatian: zimice i bolova u kostima, zglobovima i/ili mišićima; u većini slučajeva nije potrebno posebno liječenje, i simptomi nestaju nakon kratkog vremena (nekoliko sati ili dana)
English: Patients treated with Zoledronic acid medac should be given the package leaflet and the patient reminder card.
Croatian: Bolesnicima liječenima Zoledronatnom kiselinom medac treba dati Uputu o lijeku i karticu s podsjetnikom za bolesnika.
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia.
Croatian: Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba): - Kao posljedica niskih razina kalcija: napadaji, utrnulost i tetanija (kao posljedica hipokalcemije).
English: What Zoledronic acid medac is and what it is used for What you need to know before you are given Zoledronic acid medac How Zoledronic acid medac is used Possible side effects
Croatian: Što je Zoledronatna kiselina medac i za što se koristi Što morate znati prije nego primite Zoledronatnu kiselinu medac Kako primjenjivati Zoledronatnu kiselinu medac
English: Remove the following amount of Zoledronic acid medac solution for infusion (ml)
Croatian: Izvucite sljedeću količinu Zoledronatne kiseline medac otopine za infuziju (ml)
English: After first opening, Zoledronic acid medac solution for infusion should preferably be used immediately.
Croatian: Nakon prvog otvaranja, Zoledronatnu kiselinu medac otopinu za infuziju potrebno je po mogućnosti odmah primijeniti.
English: After dilution: From a microbiological point of view the medicinal product should be used immediately.
Croatian: Nakon razrjeđenja: s mikrobiološkog stanovišta, lijek treba odmah primijeniti.
English: Landeggerstrasse 7 A-2491 Neufeld/Leitha Austria medac
Croatian: 2491 Neufeld / Leitha Austrija medac
English: Caution is advised when zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Croatian: Savjetuje se oprez kod primjene zoledronatne kiseline s lijekovima za koje je poznato da uzrokuju hipokalcemiju, budući da mogu imati sinergistički učinak s posljedičnom teškom hipokalcemijom (vidjeti dio 4.5).
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic acid medac.
Croatian: Dodatno, bilo je sporadičnih prijava osteonekroze drugih anatomskih mjesta, uključujući kuk i bedrenu kost, koje su bile prijavljene pretežno u odraslih bolesnika oboljelih od raka liječenih
English: - Zoledronic acid medac must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Croatian: - Zoledronatnu kiselinu medac smije davati samo zdravstveni radnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.
English: What Zoledronic acid medac is and what it is used for
Croatian: Što je Zoledronatna kiselina medac i za što se koristi
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
Croatian: - intersticijska bolest pluća (upala tkiva oko plućnih mjehurića ispunjenih zrakom) - simptomi nalik gripi uključujući artritis i oticanje zglobova
English: The package leaflet is updated accordingly.
Croatian: Uputa o lijeku se ažurira u skladu s tim.