FrancophonIA/ELRC3.0 huggingface dataset:
English: In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
Slovenian: V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p < 0,001).
English: In patients with a recent low trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
Slovenian: Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pred prvo infuzijo zoledronske kisline priporočen večji začetni odmerek vitamina D 50.000 do 125.000 i.e. peroralno ali intramuskularno.
English: After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Slovenian: Po odpiranju: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome
Slovenian: Preglednica 4 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/772/005 1 bottle
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/772/005 1 plastenka
English: What Zoledronic acid Teva Pharma looks like and contents of the pack Zoledronic acid Teva Pharma is a clear and colourless solution.
Slovenian: Izgled zdravila Zoledronska kislina Teva Pharma in vsebina pakiranja Zdravilo Zoledronska kislina Teva Pharma je bistra brezbarvna raztopina.
English: ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8).
Slovenian: O osteonekrozi čeljustnic so po začetku trženja zdravila poročali pri bolnikih, ki so zaradi osteoporoze prejemali zdravilo Zoledronska kislina Teva Pharma (glejte poglavje 4.8).
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Slovenian: Verjetnost, da pride do teh neželenih učinkov, se pri nadaljnjih odmerjanjih zdravila Zoledronska kislina Teva Pharma zmanjšuje.
English: The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Slovenian: V skupini z zoledronsko kislino je bila incidenca zlomov 8 v primerjavi z incidenco 7 v skupini z risedronatom (p = 0,8055).
English: • Patient educational material
Slovenian: • Komplet podatkov o zdravilu za bolnika
English: Solution for infusion 1 bag of 100 ml.
Slovenian: raztopina za infundiranje Ena plastenka s 100 ml.
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.
Slovenian: Pomembno je, da v nekaj urah pred prejemom zdravila Zoledronska kislina Teva Pharma popijete vsaj 2 kozarca tekočine (na primer vode), kakor vam naroči zdravstveni delavec, s katerim sodelujete.
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.
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov Glavobol, omotičnost, slabost, bruhanje, driska, bolečine v mišicah, bolečine v kosteh in/ali sklepih, bolečine v hrbtu, rokah ali nogah, gripi podobni simptomi (na primer utrujenost, mrazenje, bolečine v sklepih in mišicah), mrazenje, občutek utrujenosti in pomanjkanje zanimanja, šibkost, bolečine, slabo počutje, otekanje in/ali bolečina na mestu infundiranja.
English: At least one new vertebral fracture (0-1 year)
Slovenian: vsaj en nov zlom vretenca (v prvem letu)
English: In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96%; p<0.001).
Slovenian: V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p < 0,001).
English: Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years
Slovenian: Preglednica 3 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
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.
Slovenian: Mogoče vam bo zdravnik svetoval, da vsaj prvih deset dni po prejemu zdravila Zoledronska kislina Teva Pharma jemljete dodatke kalcija in vitamina D (na primer v obliki tablet).
English: - Zoledronic acid Teva Pharma 5 mg solution for infusion is ready for use.
Slovenian: - Zdravilo Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vialah je že pripravljena za uporabo.
English: It comes in a polyolefin/styreneethylene-butylene (SEB) foil bag with a foil over pouch.
Slovenian: Pakirana je v 100 ml večplastno, vrečo iz poliolefin/stiren-etilen-butilena (SEB) obdano s folijsko vrečo.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors.
Slovenian: Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Zoledronska kislina Teva Pharma priporočeno opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
English: - After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Slovenian: - Po odprtju vreče sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
English: Each bag contains 100 ml of solution.
Slovenian: Vsaka vreča vsebuje 100 ml raztopine.
English: Not known** Renal impairment.
Slovenian: neznana**
English: Zoledronic acid Teva Pharma is contraindicated during breast-feeding (see section 4.3).
Slovenian: Uporaba zdravila Zoledronska kislina Teva Pharma v času dojenja je kontraindicirana (glejte poglavje 4.3).
English: The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Slovenian: Na voljo je v pakiranjih po 1, 5 in 10 plastenk.V pakiranjih po 5 in 10 plastenk je vsaka plastenka posebej pakirana v zunanjo ovojnino.
English: Zoledronic acid (N=3,875) event rate
Slovenian: Zoledronska kislina (N=1.065) delež dogodkov (%)
English: What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid.
Slovenian: Kaj vsebuje zdravilo Zoledronska kislina Teva Pharma - Zdravilna učinkovina je zoledronska kislina.
English: • Transient increase in serum creatinine may be greater in patients with underlying impaired renal
Slovenian: • Pri bolnikih s predhodno zmanjšanim delovanjem ledvic je lahko prehodno zvišanje koncentracije kreatinina v serumu bolj izrazito.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Zoledronska kislina Teva Pharma Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
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).
Slovenian: Poleg tega je v primerjavi s placebom statistično značilno znižala povprečno število dni z omejeno aktivnostjo zaradi zlomov za 2,9 dni in število dni, v katerih je zaradi zlomov potreben počitek v postelji, za 0,5 dni (v vseh primerih p < 0,01).
English: Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
Slovenian: Zdravljenje z odmerkom zoledronske kisline 5 mg na leto je statistično značilno znižalo vrednosti kostno specifične alkalne fosfataze po 12 mesecih za 30 % glede na izhodišče.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena plastenka s 100 ml raztopine vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: Puh/Tel: +358 20 180 5900
Slovenian: Sími: +358 20 180 5900
English: At least one new vertebral fracture (0-2 year)
Slovenian: vsaj en nov zlom vretenca (v prvih dveh letih)
English: At least one new vertebral fracture (0-3 year)
Slovenian: vsaj en nov zlom vretenca (v prvih treh letih)
English: Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma.
Slovenian: O osteonekrozi čeljustnic so poročali tudi v okviru uporabe v času trženja zdravila Zoledronska kislina Teva Pharma.
English: Zoledronic acid Teva Pharma contains the active substance zoledronic acid.
Slovenian: Zdravilo Zoledronska kislina Teva Pharma vsebuje zdravilno učinkovino zoledronsko kislino.
English: In addition, 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 4.2).
Slovenian: Skupaj z dajanjem zdravila Zoledronska kislina Teva Pharma je priporočeno zadostno uživanje kalcija in vitamina D. Poleg tega je zelo priporočljivo bolnikom s Pagetovo boleznijo zagotoviti zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zdravila Zoledronska kislina Teva Pharma (glejte poglavje 4.2).
English: How to prepare and administer Zoledronic acid Teva Pharma
Slovenian: Kako pripraviti in dati bolniku zdravilo Zoledronska kislina Teva Pharma
English: - Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. - Store below 30°C.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vreči poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: - After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Slovenian: - Po odprtju plastenke sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
English: The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03).
Slovenian: Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zoledronsko kislino, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p < 0,03).
English: Solution for infusion
Slovenian: Način uporabe intravenska uporaba
English: Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease.
Slovenian: Bolnikom s Pagetovo boleznijo je priporočljivo izmeriti vrednost kalcija v serumu pred infuzijo zdravila Zoledronska kislina Teva Pharma.
English: How Zoledronic acid Teva Pharma is given
Slovenian: Kako se daje zdravilo Zoledronska kislina Teva Pharma
English: Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma.
Slovenian: Zdravnik mora pred vsakim odmerkom zdravila Zoledronska kislina Teva Pharma opraviti krvne preiskave, da preveri delovanje vaših ledvic (raven kreatinina).
English: Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Slovenian: Zoledronsko kislino so prejemali enkrat na leto, dokler ni vsaj pri 211 bolnikih v študiji prišlo do dokazanega kliničnega zloma. Koncentracij vitamina D niso merili rutinsko, vendar je večina bolnikov 2 tedna pred infuzijo prejela večji začetni odmerek vitamina D (50.000 do 125.000 i.e. peroralno ali intramuskularno).
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1. 000 bolnikov Redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle
Slovenian: EU/1/12/772/001 skupno pakiranje po 5 plastenk EU/1/12/772/002 skupno pakiranje po 10 plastenk EU/1/12/772/005 1 plastenka
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag contains 5 mg zoledronic acid (as monohydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vreča vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: - Do not use this medicine after the expiry date which is stated on the carton and bag after EXP.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Slovenian: • Pred odmerjanjem zdravila Zoledronska kislina Teva Pharma morajo biti bolniki, zlasti starejši in tisti, ki jemljejo diuretike, primerno hidrirani.
English: How to store Zoledronic acid Teva Pharma
Slovenian: Shranjevanje zdravila Zoledronska kislina Teva Pharma
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Slovenian: Bolezni sečil zvišana vrednost kreatinina v krvi, polakisurija, proteinurija okvara ledvic; pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kot so višja starost bolnika, sočasna uporaba nefrotoksičnih zdravil, diuretičnega zdravljenja ali dehidracija v času po infuziji, so poročali o redkih primerih odpovedi ledvic, pri kateri je potrebna dializa, in redkih primerih s smrtnim izidom (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
English: Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Slovenian: Očesne bolezni očesna hiperemija konjunktivitis, bolečina v očesu uveitis, episkleritis, iritis neznana** vnetje beločnice in vnetje obočesnih tkiv
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles
Slovenian: EU/1/12/772/001 skupno pakiranje po 5 plastenk EU/1/12/772/002 skupno pakiranje po 10 plastenk
English: Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth,
Slovenian: Bolezni prebavil navzea, bruhanje, driska dispepsija, bolečine v zgornjem delu trebuha, bolečine v trebuhu, gastroezofagealna refluksna bolezen, obstipacija, suha usta,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA POSAMIČNEGA PAKIRANJA (z modrim okencem)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI PRIMARNA ŠKATLA (brez modrega okenca)
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis.
Slovenian: Pri bolnikih, ki so zaradi osteoporoze prejemali zdravilo Zoledronska kislina Teva Pharma v času trženja zdravila, so poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnic (odmiranje kosti v čeljustnic).
English: Placebo (N=3,861) event rate
Slovenian: Izid placebo (N=3.861) delež dogodkov absolutno znižanje deleža zlomov % (IZ)
English: - if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
Slovenian: Zoledronska kislina Teva Pharma (navedeni v poglavju 6), - če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka), - če imate hude težave z ledvicami, - če ste noseči, - če dojite.
English: Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Slovenian: kateri koli klinični zlom (1) klinični zlom vretenca (2) nevretenčni zlom (1) *vrednost p < 0,05, **vrednost p < 0,01
English: Patients must be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Slovenian: Preden bolniki dobijo zdravilo Zoledronska kislina Teva Pharma, morajo biti primerno hidrirani.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG
Slovenian: PODATKI NA PRIMARNI OVOJNINI VREČA
English: Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential.
Slovenian: Ženske v rodni dobi Zdravila Zoledronska kislina Teva Pharma ne uporabljajte pri ženskah v rodni dobi.
English: Nausea, vomiting, diarrhoea
Slovenian: vnetje požiralnika, zobobol, gastritis#
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.
Slovenian: V združenih rezultatih so v teku 6 mesecev za zoledronsko kislino in risedronat ugotovili podobno zmanjšanje rezultatov ugotavljanja intenzivnosti bolečine in njenega oviranja vsakdanjih aktivnosti glede na izhodišče.
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.
Slovenian: Po uporabi zoledronske kisline so opazili okvaro ledvic, posebno pri bolnikih s predhodno ledvično disfunkcijo ali z dodatnimi dejavniki tveganja (npr. višja starost bolnika, onkološki bolniki s kemoterapijo, spremljajoča nefrotoksična zdravila, spremljajoče diuretično zdravljenje, huda dehidracija).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags
Slovenian: IME ZDRAVILA Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vrečah
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: You may eat normally on the day you are treated with Zoledronic acid Teva Pharma, This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Slovenian: To je zlasti pomembno pri bolnikih, ki jemljejo diuretike (zdravila za odvajanje vode), in pri starejših bolnikih (starih 65 let ali več).
English: Tel.: +36 1 288 64 00
Slovenian: Magyarország Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
English: proteinuria
Slovenian: Dojenje
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila Zoledronska kislina Teva Pharma.
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Pri bolnicah, ki so prejemale zdravilo Zoledronska kislina Teva Pharma zaradi postmenopavzalne osteoporoze, so poročali o nepravilnem bitja srca (atrijski fibrilaciji).
English: One bag contains 5 mg zoledronic acid (as monohydrate).
Slovenian: Ena plastenka vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: Each bag contains 5 mg zoledronic acid (as monohydrate).
Slovenian: Ena vreča vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.
Slovenian: Skupaj z dajanjem zdravila Zoledronska kislina Teva Pharma se priporoča zadostno uživanje kalcija in vitamina D.
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid
Slovenian: Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vrečah zoledronska kislina
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Pharma.
Slovenian: Zdravnik mora pred vsakim odmerjanjem zdravila Zoledronska kislina Teva Pharma s krvnimi preiskavami pregledati delovanje vaših ledvic.
English: Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Slovenian: Očesne bolezni očesna hiperemija konjunktivitis, bolečina v očesu uveitis, episkleritis, iritis vnetje beločnice in vnetje obočesnih tkiv
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (z modrim okencem)
English: Very rare
Slovenian: EDINSTVENA OZNAKA
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
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti pireksija gripi podobna bolezen, mrzlica, utrujenost, astenija, bolečine, splošno slabo počutje, reakcija na mestu injiciranja periferni edemi, žeja, reakcija akutne faze vnetja, nekardiogena bolečina v prsnem košu neznana** dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska
English: You may eat normally on the day you are treated with Zoledronic acid Teva Pharma.
Slovenian: Na dan, ko dobite zdravilo Zoledronska kislina Teva Pharma, lahko normalno jeste.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each bag contains 5 mg zoledronic acid (as monohydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena plastenka vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid
Slovenian: Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje zoledronic acid
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Teva Pharma or after stopping treatment.
Slovenian: Če pride do navedenih simptomov v času zdravljenja ali po zaključku zdravljenja z zdravilom Zoledronska kislina Teva Pharma, takoj obvestite svojega zdravnika in zobozdravnika.