FrancophonIA/ELRC3.0 huggingface dataset:
English: - The unopened bottle does not require any special storage conditions.
Croatian: - Neotvorena boca ne zahtijeva posebne uvjete čuvanja.
English: It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat.
Croatian: Važno je nastojati i spriječiti pojavu ONJ jer je to bolno stanje koje može biti teško liječiti.
English: • in post-menopausal women
Croatian: • u žena u postmenopauzi
English: Hypocalcaemia* Uncommon Decreased appetite
Croatian: Hipokalcijemija * Manje često Smanjen apetit
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve infromacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: - After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Croatian: - Nakon otvaranja boce, lijek treba odmah primijeniti kako bi se izbjeglo mikrobiološko onečišćenje.
English: Zoledronic acid Teva Pharma may work for longer than one year, and your doctor will let you know if you need to be treated again.
Croatian: Zoledronatna kiselina Teva Pharma može djelovati duže od godinu dana, a liječnik će Vam reći ako se trebate ponovo liječiti.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Croatian: Farmakoterapijska skupina: pripravci za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA08
English: This is especially important for the elderly (≥ 65 years) and for patients receiving diuretic therapy.
Croatian: To je osobito važno za starije osobe (≥ 65 godina) i bolesnike koji primaju diuretsku terapiju.
English: Zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Croatian: Zoledronatna kiselina je primijenjena jedanput godišnje dok u barem 211 bolesnika u ispitivanoj populaciji nisu potvrđeni klinički prijelomi.
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Croatian: To je osobito važno u bolesnika koji uzimaju diuretike („tablete za mokrenje“) i u starijih bolesnika (u dobi od 65 godina ili više).
English: • in adult men at increased risk of fracture.
Croatian: • u odraslih muškaraca s povećanim rizikom od prijeloma.
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Croatian: Nuspojave, kao što je omaglica, mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: • A single dose of Zoledronic acid Teva Pharma should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Croatian: • Jednokratna doza Zoledronatne kiseline Teva Pharma ne smije biti veća od 5 mg, a trajanje infuzije treba biti najmanje 15 minuta (vidjeti dio 4.2).
English: Ask your doctor, pharmacist or nurse for advice before using this medicine.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego što primijenite ovaj lijek.
English: The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Croatian: Pakiranja sa 5 i 10 boca dostupna su samo kao višestruka pakiranja koja sadrže 5 ili 10 pakiranja, od kojih svako sadrži 1 bocu.
English: It must not be mixed or given intravenously with any other medicinal products.
Croatian: Ne smije se miješati ili primjenjivati intravenski s drugim lijekovima.
English: • Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diurectic therapy
Croatian: • Potrebno je osigurati primjerenu hidraciju bolesnika, osobito onih starije dobi i onih koji primaju terapiju diureticima
English: Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Croatian: Nepoznato** Osteonekroza čeljusti (vidjeti dijelove 4.4 i 4.8 Učinci skupine)
English: • in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Croatian: • u odraslih muškaraca s povećanim rizikom od prijeloma, uključujući one koji su nedavno imali prijelom kuka nakon manje traume.
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 određene 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: It is important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Croatian: Važno je da Vaš liječnik zna za sve lijekove koje uzimate, naročito ako uzimate lijekove za koje je poznato da štetno djeluju na bubrege (npr. aminoglikozidi) ili ako uzimate diuretike (“tablete za mokrenje”) koji mogu uzrokovati dehidraciju.
English: • Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity
Croatian: • Kontraindicirana je u trudnica i dojilja zbog moguće teratogenosti
English: • Patient educational material
Croatian: • Edukacijskog materijala za bolesnike
English: You must not be given Zoledronic acid Teva Pharma if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Croatian: Zoledronatnu kiselinu Teva Pharma ne smijete primati ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Croatian: Zoledronatna kiselina se u provedenim ispitivanjima mutagenosti nije pokazala mutagenom, dok ispitivanje kancerogenosti nije dalo nikakve dokaze o kancerogenom potencijalu.
English: If you feel dizzy while taking Zoledronic acid Teva Pharma, do not drive or use machines until you feel better.
Croatian: Ako osjećate omaglicu dok uzimate Zoledronatnu kiselinu Teva Pharma, nemojte upravljati vozilima ili strojevima dok se ne budete osjećali bolje.
English: After opening: 24 hours at 2°C - 8°C
Croatian: Nakon otvaranja: 24 sata na 2°C - 8°C
English: It is currently unclear whether Zoledronic acid Teva Pharma causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid Teva Pharma.
Croatian: Trenutačno nije jasno uzrokuje li Zoledronatna kiselina Teva Pharma te nepravilne otkucaje srca, ali morate se javiti liječniku ako osjetite takve simptome nakon što primite Zoledronatnu kiselinu Teva Pharma.
English: Other products containing zoledronic acid as an active substance are available for oncology indications.
Croatian: Ostali lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar dostupni su za onkološke indikacije.
English: Not known** Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Croatian: Nepoznato** Reakcije preosjetljivosti uključujući rijetke slučajeve bronhokonstrikcije, urtikarije i angioedema, i vrlo rijetko anafilaktičku reakciju/šok
English: • Transient increase in serum creatinine may be greater in patients with underlying impaired renal
Croatian: • Prolazni porast kreatinina u serumu može biti veći u bolesnika koji imaju predležeću oštećenu funkciju bubrega.
English: For information on the infusion of Zoledronic acid Teva Pharma, see section 6.6.
Croatian: Za informacije o infuziji Zoledronatne kiseline Teva Pharma vidjeti dio 6.6.
English: • Physician educational material
Croatian: • Edukacijskog materijala za liječnike
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Zoledronic acid Teva Pharma on an individual patient basis, particularly after 5 or more years of use.
Croatian: Potrebu za nastavkom liječenja potrebno je ponovno procijeniti periodički na osnovi odnosa koristi i potencijalnih rizika Zoledronatne kiseline Teva Pharma u svakog pojedinačnog bolesnika, a posebno nakon 5 ili više godina primjene.
English: Zoledronic acid (N=3,875) event rate
Croatian: Zoledronatna kiselina (N=3875) stopa događaja
English: Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Croatian: Histologija kostiju procijenjena je u 7 bolesnika s Pagetovom bolešću šest mjeseci nakon liječenja sa 5 mg zoledronatne kiseline.
English: Zoledronic acid Teva Pharma is also used in patients who have recently broken their hip in a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.
Croatian: Zoledronatna kiselina Teva Pharma se također koristi u bolesnika koji su nedavno slomili svoj kuk pri maloj traumi kao što je pad pa imaju stoga povećan rizik za sljedeće lomove kosti.
English: If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic acid Teva Pharma.
Croatian: Ako ste uslijed liječenja kod zubara ili ako idete na kirurški zahvat zuba (npr. vađenje zuba), obavijestite svog liječnika o Vašem liječenju kod zubara i obavijestite svog zubara da se liječite Zoledronatnom kiselinom Teva Pharma.
English: While being treated with Zoledronic acid Teva Pharma, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Croatian: Za vrijeme liječenja Zoledronatnom kiselinom Teva Pharma, morate održavati dobru oralnu higijenu (uključujući redovito pranje zuba) i obavljati rutinske preglede kod zubara.
English: It comes in a clear plastic bottle.
Croatian: Lijek je dostupan u prozirnim plastičnim bocama.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Croatian: • Bolesnici, osobito stariji i oni koji primaju diuretsko liječenje, moraju biti prikladno hidrirani prije primjene Zoledronatne kiseline Teva Pharma.
English: Zoledronic acid Teva Pharma with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Pharma, as directed by your doctor.
Croatian: Zoledronatna kiselina Teva Pharma s hranom i pićem Pazite da popijete dovoljno tekućine (najmanje jednu ili dvije čaše) prije i nakon liječenja Zoledronatnom kiselinom Teva Pharma, prema uputama liječnika.
English: Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months Outcome
Croatian: Tablica 2 Sažetak djelotvornosti s obzirom na vertebralne prijelome u 12., 24. i 36. mjesecu Ishod
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Teva Pharma or after stopping treatment.
Croatian: Odmah se obratite svom liječniku i zubaru ako primijetite takve simptome za vrijeme liječenja Zoledronatnom kiselinom Teva Pharma ili nakon prestanka liječenja.
English: Before stopping Zoledronic acid Teva Pharma therapy If you are considering stopping Zoledronic acid Teva Pharma treatment, please go to your next appointment and discuss this with your doctor.
Croatian: Prije prestanka uzimanja Zoledronatne kiseline Teva Pharma Ako razmišljate o prekidu liječenja Zoledronatnom kiselinom Teva Pharma, molimo dođite na sljedeći termin i o toj odluci razgovarate sa svojim liječnikom.
English: Zoledronic acid Teva Pharma is not recommended for anyone under 18 years of age.
Croatian: Zoledronatna kiselina Teva Pharma ne preporuča se osobama mlađima od 18 godina.
English: The incidence of delayed hip fracture healing was comparable between zoledronic acid (34 [3.2%]) and placebo (29 [2.7%]).
Croatian: Incidencija odgođenog zarastanja prijeloma kuka bila je usporediva za zoledronatnu kiselinu (34 [3,2%]) i placebo (29 [2,7%]).
English: For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma administered once a year.
Croatian: Za liječenje osteoporoze u postmenopauzi, osteoporoze u muškaraca i liječenje osteoporoze povezane s dugotrajnim liječenjem sistemskim glukokortikoidima, preporučena doza je jednokratna intravenska infuzija od 5 mg Zoledronatne kiseline Teva Pharma primijenjena jedanput u godini dana.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Pharma properly.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako pravilno čuvati Zoledronatnu kiselinu Teva Pharma.
English: Zoledronic acid Teva Pharma works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Croatian: Zoledronatna kiselina Teva Pharma djeluje tako što vraća proces preoblikovanja kosti u normalu osiguravajući stvaranje normalne kosti, čime kosti postaju snažnije.
English: Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid compared to placebo.
Croatian: Analiza mikrokompjuteriziranom tomografijom (μCT) pokazala je povećani volumen trabekularne kosti i očuvanje arhitekture trabekularne kosti u bolesnica liječenih zoledronatnom kiselinom u usporedbi s onima koje su primale placebo.
English: • Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Zoledronic acid Teva Pharma
Croatian: • Potrebno je izračunati klirens kreatinina na temelju stvarne tjelesne težine korištenjem Cockcroft-Gaultove formule prije svakog liječenja Zoledronatnom kiselinom Teva Pharma
English: Patients being treated with Zoledronic acid Teva Pharma should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Croatian: Bolesnici koji se liječe Zoledronatnom kiselinom Teva Pharma ne smiju se istovremeno liječiti tim lijekovima ili nekim drugim bisfosfonatima jer nisu poznati kombinirani učinci tih lijekova.
English: At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in postmenopausal women in the HORIZON-PFT study.
Croatian: Nakon 24 mjeseca zapaženo je slično značajno povećanje od 3,6% BMD-a cijelog kuka u bolesnika liječenih zoledronatnom kiselinom u usporedbi s učincima zapaženima u žena u postmenopauzi u ispitivanju HORIZON-PFT.
English: Special populations Patients with renal impairment
Croatian: Posebne populacije Bolesnici s oštećenjem funkcije bubrega
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid Teva Pharma.
Croatian: Pažljivo slijedite sve upute koje Vam je dao Vaš liječnik, ljekarnik ili medicinska sestra prije nego što počnete uzimati Zoledronatnu kiselinu Teva Pharma.
English: Talk to your doctor, pharmacist or nurse before you are given Zoledronic acid Teva Pharma: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic acid Teva Pharma (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Zoledronatnu kiselinu Teva Pharma: - ako se liječite bilo kojim lijekom koji sadrži zoledronatnu kiselinu, koja je također djelatna tvar u Zolenodratnoj kiselini Teva Pharma (zoledronatna kiselina se koristi u odraslih bolesnika s određenim tipovima raka kako bi se spriječile komplikacije s kostima ili smanjenje udjela kalcija). - ako imate ili ste imali problema s bubrezima.
English: Cyclic olefin polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Croatian: Plastična boca od cikloolefinskog polimera (COP) s klorobutil/butilnim gumenim čepom i aluminijskom kapicom s ljubičastim plastičnim flip off diskom.
English: The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic acid Teva Pharma.
Croatian: Većina nuspojava, poput vrućice i zimice, bolova u mišićima ili zglobovima te glavobolje, javlja se unutar prva tri dana nakon primjene doze Zoledronatne kiseline Teva Pharma.
English: • Need to infuse Zoledronic acid Teva Pharma slowly over a period of no less than 15 minutes
Croatian: • Infuziju Zoledronatne kiseline Teva Pharma potrebno je primjenjivati polako u vremenu ne manjem od 15 minuta
English: The Marketing Authorisation Holder (MAH) shall provide an educational programme targeting all physicians who are expected to prescribe/use Zoledronic acid Teva Pharma for the treatment of osteoporosis prior to the launch in Member States.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će edukacijski program usmjeren na sve liječnike za koje se očekuje da će propisivati/primjenjivati Zoledronatnu kiselinu Teva Pharma u liječenju osteoporoze prije stavljanja na tržište država članica.
English: Uncommon Hypertension, flushing Not known** Hypotension (some of the patients had underlying risk factors)
Croatian: Manje često Hipertenzija, navale crvenila Nepoznato** Hipotenzija (neki od bolesnika s podležećim rizičnim faktorima)
English: Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.
Croatian: Ponovno liječenje Pagetove bolesti: nakon početnog liječenja Pagetove bolesti zoledronatnom kiselinom, zapaženo je produljeno razdoblje remisije u bolesnika koji su odgovorili na liječenje.
English: Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Zoledronic acid Teva Pharma (see section 4.8).
Croatian: Zbog brzog nastupa učinka zoledronatne kiseline na pregradnju kosti, može se razviti prolazna hipokalcijemija, koja je katkada simptomatska, a obično je najjača unutar prvih 10 dana nakon infuzije Zoledronatne kiseline Teva Pharma (vidjeti dio 4.8).
English: In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was noninferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
Croatian: U drugom ispitivanju u muškaraca (ispitivanje CZOL446M2308) godišnja infuzija zoledronatne kiseline nije bila lošija od tjedne primjena alendronata s obzirom na postotak promjene BMD-a lumbalne kralježnice nakon 24 mjeseca u odnosu na početne vrijednosti.
English: The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Croatian: Selektivno djelovanje bisfosfonata na kost zasniva se na njihovom visokom afinitetu prema mineraliziranoj kosti.
English: Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic acid Teva Pharma.
Croatian: Liječnik Vam može savjetovati da uzimate nadomjestke kalcija i vitamina D (na primjer tablete) najmanje prvih deset dana nakon primjene Zoledronatne kiseline Teva Pharma.
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authorities in
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora prije distribucije edukacijskog programa s nadležnim nacionalnim tijelom u državama članicama dogovoriti sadržaj i format edukacijskog materijala, zajedno s komunikacijskim planom.
English: It is supplied in multipacks containing 5 or 10 bags.
Croatian: Dostupna je u višestrukim pakiranjima sa 5 ili 10 vrećica.
English: Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Pharma.
Croatian: On će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Zoledronatnom kiselinom Teva Pharma.
English: oesophagitis, toothache, gastritis#
Croatian: zubobolja, gastritis#
English: For osteoporosis, Zoledronic acid Teva Pharma works for one year.
Croatian: U slučaju osteoporoze, Zoledronatna kiselina Teva Pharma djeluje tijekom godine dana.
English: The incidence of post-dose symptoms occuring within the first three days after administration of Zoledronic acid Teva Pharma can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic acid Teva Pharma administration.
Croatian: Incidencija simptoma nakon doze koji se javljaju u roku od prva tri dana nakon primjene Zoledronatne kiseline Teva Pharma može se smanjiti primjenom paracetamola ili ibuprofena ubrzo nakon primjene Zoledronatne kiseline Teva Pharma.
English: For the treatment of Paget's disease, Zoledronic acid Teva Pharma should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Croatian: Za liječenje Pagetove bolesti, Zoledronatnu kiselinu Teva Pharma smiju propisivati samo liječnici koji imaju iskustva u liječenju Pagetove bolesti kosti.
English: In both women and men, Zoledronic acid Teva Pharma strengthens the bone and therefore makes it less likely to break.
Croatian: I u žena i u muškaraca Zoledronatna kiselina Teva Pharma jača kost i na taj način smanjuje vjerojatnost prijeloma.
English: Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Croatian: Gripa, infekcije gornjih dišnih putova, snižen broj crvenih krvnih stanica, gubitak apetita, nesanica, pospanost koja može uključivati smanjenu pažnju i svijest, trnci ili utrnulost, izraziti umor, drhtanje, privremeni gubitak svijesti, infekcija oka ili iritacija ili upala uz bol i crvenilo, osjećaj vrtnje, povišen krvni tlak, crvenilo uz osjećaj vrućine, kašalj, nedostatak zraka, nelagoda u trbuhu, bol u trbuhu, zatvor, suha usta, žgaravica, kožni osip, pojačano znojenje, svrbež, crvenilo kože, bol u vratu, ukočenost mišića, kostiju i/ili zglobova, oticanje zgloba, grčevi mišića, bol u ramenu, bol u prsnim mišićima i rebrima, upala zgloba, mišićna slabost, poremećene vrijednosti bubrežnih pretraga, neuobičajeno često mokrenje, oticanje šaka, gležnjeva ili stopala, žeđ, zubobolja, poremećaji okusa.