FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) lowtrauma hip fracture who were followed for an average of 2 years on study treatment.
Croatian: Incidencija kliničkih prijeloma, uključujući vertebralne prijelome, nevertebralne prijelome i prijelome kuka, bila je procijenjena u 2127 muškaraca i žena u dobi od 50 do 95 godina (srednja dob 74,5 godina) s nedavnim (unutar 90 dana) prijelomom kuka nakon manje traume koji su praćeni u prosjeku 2 godine tijekom liječenja u ispitivanju.
English: Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Croatian: Reproduktivna ispitivanja na životinjama sa zoledronatnom kiselinom pokazala su reproduktivnu toksičnost uključujući pojavu malformacija (vidjeti dio 5.3).
English: If you missed a dose of Zoledronic acid Teva Pharma Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Croatian: Ako ste propustili dozu Zoledronatne kiseline Teva Pharma Obratite se svom liječniku ili javite u bolnicu što je prije moguće kako biste ugovorili novi termin.
English: Teva Pharmaceuticals Ireland, L-Irlanda Tel: +353 51 321740
Croatian: Teva Pharmaceuticals Ireland, L-Irlanda Τel: +353 51 321740
English: If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Croatian: Ako je otopina bila u hladnjaku, pustite da prije primjene dosegne sobnu temperaturu.
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar, bilo koji bisfosfonat ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Pharma, as directed by your healthcare provider.
Croatian: Važno je da popijete najmanje 2 čaše tekućine (kao što je voda), u roku od nekoliko sati prije primanja Zoledronatne kiseline Teva Pharma, prema uputama zdravstvenog radnika.
English: Zoledronic acid Teva Pharma may also cause other side effects Very common: may affect more than 1 in 10 people Fever.
Croatian: Zoledronatna kiselina Teva Pharma može uzrokovati i druge nuspojave Vrlo često: mogu se javiti u više od 1 na 10 ljudi Vrućica
English: Placebo (N=3,861) event rate
Croatian: Placebo (N=3861) stopa događaja
English: How to store Zoledronic acid Teva Pharma Contents of the pack and other information
Croatian: Kako čuvati Zoledronatnu kiselinu Teva Pharma Sadržaj pakiranja i druge informacije
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
Croatian: U ispitivanjima osteoporoze (PFT, HORIZON - Recurrent Fracture Trial [RFT]) objedinjene incidencije fibrilacije atrija bile su usporedive kod zoledronatne kiseline (2,6%) i placeba (2,1%).
English: In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
Croatian: U ispitivanjima s intravenskom bolus injekcijom doze koje su se dobro podnosile smanjivale su se s povećanjem trajanja ispitivanja: dozu od 0,2 i 0,02 mg/kg na dan dobro su podnosili štakori, odnosno psi tijekom 4 tjedna, no nakon 52 tjedna primjene štakori su podnosili dozu od samo 0,01 mg/kg, a psi samo od 0,005 mg/kg.
English: • Contraindication in patients with creatinine clearance < 35 ml/min
Croatian: • Kontraindicirana je u bolesnika s klirensom kreatinina < 35 ml/min
English: Marketing Authorisation Holder Teva B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Teva B.V.
English: Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely.
Croatian: Zbog toga, interakcije nastale istiskivanjem lijekova koji su u velikoj mjeri vezani na proteine nisu vjerojatne.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Croatian: Bubrežni klirens zoledronatne kiseline uspoređen je s klirensom kreatinina, pri čemu je bubrežni klirens predstavljao 75 ± 33% kliresna kreatinina, što je pokazalo srednju vrijednost od 84 ± 29 ml/min (raspon od 22 do 143 ml/min) u 64 ispitivana bolesnika.
English: In patients with Paget's disease: symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Croatian: U bolesnika s Pagetovom bolešću zabilježeni su simptomi uzrokovani niskom razinom kalcija u krvi, kao što su grčevi mišića, utrnulost ili trnci, osobito u području oko usta.
English: Zoledronic acid Teva Pharma is supplied in packs of 1 bottle and multipacks of 5 (5 x 1) or 10 (10 x 1) bottles.
Croatian: Zoledronatna kiselina Teva Pharma dostupna je u pakiranjima od 1 boce i višekratnim pakiranjima od 5 (5 x 1) ili 10 (10 x 1) boca.
English: It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids used to treat inflammation, and Paget's disease of the bone in adults.
Croatian: Pripada skupini lijekova koji se nazivaju bisfosfonati i koristi se za liječenje žena u postmenopauzi i odraslih muškaraca s osteoporozom ili za liječenje osteoporoze izazvane liječenjem kortikosteroidima korištenim u liječenju upale te za liječenje Pagetove bolesti kostiju u odraslih.
English: The physician educational material should contain the following key messages:
Croatian: Edukacijski materijal za liječnike treba sadržavati sljedeće ključne poruke:
English: Non-vertebral fracture (1) *p-value <0.001, **p-value <0.0001 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Croatian: Nevertebralni prijelom (1) *p-vrijednost <0,001, **p-vrijednost <0,0001 (1) isključujući prijelom prsta ruke, prsta noge i lica (2) uključujući kliničke torakalne i kliničke lumbalne vertebralne prijelome
English: The patient educational material should contain the following key messages:
Croatian: Edukacijski materijal za bolesnike treba sadržavati sljedeće ključne poruke:
English: The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma.
Croatian: Preporučena doza je jednokratna intravenska infuzija od 5 mg Zoledronatne kiseline Teva Pharma.
English: - Do not use this medicine if you notice any discolouration or particles in the solution.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite promjenu boje otopine ili čestice u otopini.
English: What Zoledronic acid Teva Pharma is and what it is used for
Croatian: Što je Zoledronatna kiselina Teva Pharma i za što se koristi
English: The educational programme contains the following:
Croatian: Edukacijski materijal sastoji se od sljedećeg:
English: Multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Croatian: Višeslojna poliolefin/stiren-etilen-butilen (SEB) vrećica sa SFC polipropilenskim infuzijskim otvorom zatvorenim gumenim čepom i kapicom.
English: The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Croatian: Incidencija prijeloma bila je 8 bolesnika liječenih zoledronatnom kiselinom u odnosu na 7 bolesnika liječenih risedronatom (p=0,8055).
English: In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1).
Croatian: U bolesnika s nedavnim prijelomom kuka nakon manje traume preporučuje se primjena infuzije zoledronatne kiseline najmanje dva tjedana nakon oporavka prijeloma kuka (vidjeti dio 5.1).
English: Zoledronic acid Teva Pharma is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Croatian: Zoledronatna kiselina Teva Pharma je kontraindicirana u bolesnika s klirensom kreatinina < 35 ml/min (vidjeti dijelove 4.3 i 4.4).
English: Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic acid Teva Pharma.
Croatian: Vaš liječnik može predložiti da obavite pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Teva Pharma.
English: Zoledronic acid Teva Pharma must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate.
Croatian: Zoledronatna kiselina Teva Pharma ne smije se miješati niti primjenjivati intravenski s drugim lijekovima te se mora dati putem zasebne infuzijske cjevčice s odzračivanjem uz konstantnu brzinu infuzije.
English: Nausea, vomiting, diarrhoea
Croatian: Mučnina, povraćanje, proljev
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Croatian: Stopa ozbiljnih štetnih događaja fibrilacije atrija bila je veća u bolesnika koji su primali zoledronatnu kiselinu (1,3%) (51 od 3862), u usporedbi s bolesnicima koji su primali placebo (0,6%) (22 od 3852).
English: In patients treated with zoledronic acid, no osteomalacia, marrow fibrosis or woven bone formation was detected.
Croatian: U bolesnica liječenih zoledronatnom kiselinom nisu otkriveni osteomalacija, fibroza srži niti stvaranje nelamelarne kosti.
English: Zoledronic acid Teva Pharma is supplied in multipacks of 5 (5 x 1) or 10 (10 x 1) bags .
Croatian: Zoledronatna kiselina Teva Pharma dostupna je u višestrukim pakiranjima od 5 (5 x 1) ili 10 (10 x 1) vrećica.
English: Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Croatian: Atipični subtrohanterični i dijafizealni prijelomi bedrene kosti † (nuspojava skupine bisfosfonata)
English: What Zoledronic acid Teva Pharma looks like and contents of the pack Zoledronic acid Teva Pharma is a clear and colourless solution.
Croatian: Kako Zoledronatna kiselina Teva Pharma izgleda i sadržaj pakiranja Zoledronatna kiselina Teva Pharma je bistra i bezbojna otopina.
English: Zoledronic acid Teva Pharma must not be allowed to come into contact with any calcium-containing solutions.
Croatian: Zoledronatna kiselina Teva Pharma ne smije doći u kontakt s otopinama koje sadržavaju kalcij.
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
Croatian: Manje često Periferni edem, žeđ, reakcija akutne faze, bol u prsištu koja nije vezana uz srce Nepoznato** Dehidracija kao posljedica simptoma nakon primjene doze kao što su vrućica, povraćanje i proljev
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
Croatian: U HORIZON-PFT (Pivotal Fracture Trial) ispitivanju (vidjeti dio 5.1) ukupna incidencija atrijske fibrilacije bila je 2,5% (96 od 3862) i 1,9% (75 od 3852) u bolesnika koji su primali zoledronatnu kiselinu, odnosno placebo.
English: Caution is indicated when Zoledronic acid Teva Pharma is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Croatian: Oprez je indiciran kad se Zoledronatna kiselina Teva Pharma primjenjuje zajedno s lijekovima koji mogu značajno utjecati na bubrežnu funkciju (npr. aminoglikozidi ili diuretici koji mogu uzrokovati dehidraciju) (vidjeti dio 4.4).
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Croatian: Glavobolja, omaglica, mučnina, povraćanje, proljev, bol u mišićima, bol u kostima i/ili zglobovima, bol u leđima, rukama ili nogama, simptomi nalik gripi (npr. umor, zimica, bol u zglobovima i mišićima), zimica, osjećaj umora i gubitak interesa, slabost, bol, opće loše osjećanje, oticanje i/ili bol na mjestu infuzije.
English: Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Croatian: Klinička djelotvornost u liječenju postmenopauzalne osteoporoze (PFT) Djelotvornost i sigurnost primjene zoledronatne kiseline u dozi od 5 mg jednom na godinu tijekom tri uzastopne godine dokazane su kod žena u postmenopauzi (7736 žena u dobi od 65 do 89 godina) s jednim od dva uvjeta: BMD T-vrijednost vrata bedrene kosti ≤ -1,5 te najmanje dva blaga ili jedan umjereno teški postojeći vertebralni prijelom; ili BMD T-vrijednost vrata bedrene kosti ≤ -2,5 sa znakovima postojećeg(ih) vertebralnog(ih) prijeloma ili bez njih.
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Croatian: Izgledi za razvoj ovih nuspojava smanjuju se sa sljedećim dozama Zoledronatne kiseline Teva Pharma.
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Croatian: Objedinjene incidencije ozbiljnih štetnih događaja fibrilacije atrija bile su 1,3% za zoledronatnu kiselinu i 0,8% za placebo.
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Pharma.
Croatian: Liječnik Vam mora napraviti krvnu pretragu kako bi Vam provjerio bubrežnu funkciju prije svake doze Zoledronatne kiseline Teva Pharma.
English: What Zoledronic acid Teva Pharma is and what it is used for What you need to know before you are given Zoledronic acid Teva Pharma How Zoledronic acid Teva Pharma is given
Croatian: Što je Zoledronatna kiselina Teva Pharma i za što se koristi Što morate znati prije nego primite Zoledronatnu kiselinu Teva Pharma
English: The use of Zoledronic acid Teva Pharma in children and adolescents has not been studied.
Croatian: Nije ispitana primjena Zoledronatne kiseline Teva Pharma u djece i adolescenata.
English: Patients must be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Croatian: Bolesnici moraju biti prikladno hidrirani prije primjene Zoledronatne kiseline Teva Pharma.
English: Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Croatian: Zoledronatna kiselina značajno je smanjila srednju vrijednost broja dana s ograničenom aktivnošću te dana provedenih u krevetu zbog boli u leđima za 17,9 dana odnosno 11,3 dana u usporedbi s placebom, odnosno srednju vrijednost broja dana s ograničenom aktivnošću zbog prijeloma za 2,9 i broja dana provedenih u krevetu zbog prijeloma za 0,5 dana u odnosu na placebo (za sve p<0,01).
English: Zoledronic acid Teva Pharma is administered via a vented infusion line and given slowly at a constant infusion rate.
Croatian: Zoledronatna kiselina Teva Pharma primjenjuje se polako putem infuzijske linije s odzračivanjem uz konstantnu brzinu infuzije.
English: What you need to know before you are given Zoledronic acid Teva Pharma
Croatian: Što morate znati prije nego primite Zoledronatnu kiselinu Teva Pharma
English: In case you recently broke your hip, it is recommended that Zoledronic acid Teva Pharma is administered two or more weeks after your hip repair surgery.
Croatian: U slučaju da ste nedavno imali prijelom kuka, preporučuje se primjena infuzije Zoledronatne kiselina Teva Pharma dva ili više tjedana nakon kirurškog zahvata.
English: The use of Zoledronic acid Teva Pharma in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Croatian: Primjena Zoledronatne kiseline Teva Pharma u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 35 ml/min) kontraindicirana je zbog povećanog rizika od zatajenja bubrega u toj populaciji.
English: Zoledronic acid-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Croatian: U bolesnica u dobi od 75 godina i više koje su primale zoledronatnu kiselinu zabilježen je smanjen rizik od prijeloma za 60% u odnosu na bolesnice koje su primale placebo (p<0,0001).
English: Re-treatment consists of an additional intravenous infusion of 5 mg Zoledronic acid Teva Pharma after an interval of one year or longer from initial treatment in patients who have relapsed.
Croatian: U bolesnika s relapsom ponovno se liječenje sastoji od primjene dodatne intravenske infuzije od 5 mg Zoledronatne kiseline Teva Pharma nakon intervala od godinu dana ili dulje nakon početnog liječenja.
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Croatian: Oštećenje funkcije bubrega zapaženo je nakon primjene zoledronatne kiseline, osobito u bolesnika s otprije ugroženom bubrežnom funkcijom ili dodatnim rizičnim faktorima (npr. poodmakla dob, onkološki bolesnici na kemoterapiji, istovremena primjena nefrotoksičnih lijekova, istovremena diuretska terapija, teška dehidracija), od kojih je većina primala dozu od 4 mg svaka 3-4 tjedna, no zapaženo je i u bolesnika nakon jednokratne primjene.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
Croatian: Prijavljeni su slučajevi osteonekroze čeljusti, pretežito u bolesnika s rakom liječenih lijekovima koji inhibiraju resorpciju kosti, uključujući zoledronatnu kiselinu (vidjeti dio 4.4).
English: Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth,
Croatian: Manje često Dispepsija, bol u gornjem dijelu abdomena, bol u abdomenu, gastroezofagealna refluksna bolest, konstipacija, suha usta, ezofagitis,
English: The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Croatian: Ukupan postotak bolesnika koji su imali nuspojave nakon prve, druge, odnosno treće infuzije iznosio je 44,7%, 16,7% i 10,2%.
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Croatian: U objedinjenim rezultatima zapaženo je slično sniženje u težini boli i zbrojevima interferencije boli nakon 6 mjeseci u odnosu na početne vrijednosti za zoledronatnu kiselinu i risedronat.
English: The hip fracture event rate was 1.44% for zoledronic acidtreated patients compared to 2.49% for placebo-treated patients.
Croatian: Stopa prijeloma kuka iznosila je 1,44% u bolesnika koji su liječeni zoledronatnom kiselinom u odnosu na 2,49% u onih koji su primali placebo.
English: At least one new vertebral fracture (0-1 year)
Croatian: Najmanje jedan novi vertebralni prijelom (0-1 godina)
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Croatian: Manje često Povišen kreatinin u krvi, polakizurija, proteinurija
English: • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
Croatian: • Potrebno je uzimati primjerenu nadoknadu kalcija i vitamina D, baviti se primjerenom fizičkom aktivnošću, izbjegavati pušenje i zdravo se hraniti
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Zoledronic acid Teva Pharma (see section 4.3).
Croatian: Postojeća se hipokalcijemija mora prije uvođenja terapije Zoledronatnom kiselinom Teva Pharma liječiti odgovarajućim unosom kalcija i vitamina D (vidjeti dio 4.3).
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Zoledronatna kiselina Teva Pharma Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • Zoledronic acid Teva Pharma should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Croatian: • Potreban je oprez kad se Zoledronatna kiselina Teva Pharma primjenjuje zajedno s drugim lijekovima koji mogu utjecati na bubrežnu funkciju (vidjeti dio 4.5).
English: At least one new vertebral fracture (0-3 year)
Croatian: Najmanje jedan novi vertebralni prijelom (0-3 godine)
English: • Contraindication in pregnancy and in breast-feeding women
Croatian: • Kontraindicirana je u trudnica i dojilja
English: What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid.
Croatian: Što Zoledronatna kiselina Teva Pharma sadrži - Djelatna tvar je zoledronatna kiselina.
English: Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Croatian: Bolest nalik gripi, zimica, umor, astenija, bol, malaksalost, reakcija na mjestu primjene infuzije
English: Osteonecrosis of the external auditory canal† (bisphosphonate class adverse reaction)
Croatian: Vrlo rijetko Osteonekroza vanjskog slušnog kanala† (nuspojava skupine bisfosfonata).
English: At least one new vertebral fracture (0-2 year)
Croatian: Najmanje jedan novi vertebralni prijelom (0-2 godine)
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Croatian: Manje često Bol u vratu, mišićno-koštana ukočenost, oticanje zgloba, spazam mišića, bol u ramenima, mišićno-koštana bol u prsištu, mišićno-koštana bol, ukočenost zgloba, artritis, slabost mišića
English: • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Croatian: • Ključni znakovi i simptomi ozbiljnih štetnih događaja
English: In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.4).
Croatian: U bolesnika s Pagetovom bolešću, snažno se preporučuje osigurati uzimanje odgovarajućeg nadomjestka kalcija, koji odgovara količini od najmanje 500 mg elementarnog kalcija, dvaput dnevno, tijekom najmanje 10 dana nakon primjene Zoledronatne kiseline Teva Pharma (vidjeti dio 4.4).