FrancophonIA/ELRC3.0 huggingface dataset:
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
Slovenian: Po uvedbi terapije je treba izmeriti serumski kreatinin pred vsakim odmerkom zoledronske kisline, terapijo pa je treba prekiniti, če se je ledvična funkcija poslabšala.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid.
Slovenian: • Pred dajanjem zoledronske kisline morajo biti bolniki, zlasti starejši in tisti, ki jemljejo diuretike, primerno hidrirani.
English: Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Slovenian: Dolgoročnejše večkratno dajanje v odmerkih okrog največjega nameravanega humanega terapevtskega odmerka zoledronske kisline je povzročilo toksične učinke v drugih organih, vključno z z gastrointestinalnim traktom, jetri, vranico in pljuči, in na mestih intravenskega injiciranja.
English: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil uvedbo opozorilne kartice za bolnika z opozorili glede osteonekroze čeljustnic.
English: − The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Slovenian: − Raztopino, ki vsebuje zoledronsko kislino, dajemo v obliki ene same 15-minutne intravenske infuzije z ločenim infuzijskim sistemom.
English: A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Slovenian: Pri nekaterih od teh bolnikov so se simptomi ponovili ob ponovni uporabi zoledronske kisline ali drugega difosfonata.
English: Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Slovenian: Študije z zoledronsko kislino pri živalih so pokazale vpliv na sposobnost razmnoževanja, med drugim tudi malformacije (glejte poglavje 5.3).
English: - Zoledronic Acid Hospira 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Slovenian: − Zdravilo Zoledronska kislina Hospira 4 mg/100 ml raztopina za infundiranje vsebuje 4 mg zoledronske kisline v 100 ml raztopine za infundiranje za takojšnjo uporabo pri bolnikih z normalnim delovanjem ledvic.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Slovenian: O zlomih dolgih kosti spodnjih okončin so pri bolnikih s hudo obliko osteogenesis imperfecta, ki so prejemali zoledronsko kislino, poročali v približno 24 % (zlom stegnenice) in v 14% (zlom golenice) v primerjavi z enakovrednimi bolniki, ki so prejemali pamidronat, pri katerih so o zlomu stegnenice poročali v 12 %, o zlomu golenice pa v 5 %: 43 % (32/74) v primerjavi z 41 % (31/76).
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), 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 5 mg and placebo, respectively.
Slovenian: V enem 3-letnem randomiziranem dvojno slepem kontroliranem preskušanju, v katerem so vrednotili učinkovitost in varnost zoledronske kisline pri zdravljenju postmenopavzalne osteoporoze (PMO), in sicer v odmerku 5 mg enkrat na leto v primerjavi s placebom, je bila celokupna incidenca atrijske fibrilacije pri bolnicah, ki so prejemale 5 mg zoledronske kisline, 2,5 % (pri 96 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 1,9 % (pri 75 od 3.852 bolnic).
English: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Slovenian: moteno delovanje ledvic, osteonekrozo čeljustnic, reakcijo akutne faze, hipokalciemijo, atrijsko fibrilacijo, anafilaksijo, intersticijsko bolezen pljuč.
English: - if you have had some or all of the parathyroid glands in your neck surgically removed.
Slovenian: − če so vam deloma ali v celoti kirurško odstranili žleze obščitnice,
English: - if you have had sections of your intestine removed.
Slovenian: − če so vam odstranili dele črevesa.
English: Do not mix Zoledronic Acid Hospira concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte koncentrata zdravila Zoledronska kislina Hospira z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: Zoledronic acid is not recommended in women of childbearing potential.
Slovenian: Uporaba zoledronske kisline ni priporočljiva pri ženskah v rodni dobi.
English: - For single use only.
Slovenian: − Samo za enkratno uporabo.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Slovenian: Pri zdravljenju z difosfonati so poročali o osteonekrozi zunanjega slušnega kanala, večinoma pri dolgoročnem zdravljenju.
English: − The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Slovenian: − Raztopine, ki vsebuje zoledronsko kislino se ne sme nadalje razredčiti ali jo dajati v mešanici z drugimi infuzijskimi raztopinami.
English: − Skin reactions (redness and swelling) at the infusion site, rash, itching.
Slovenian: − kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje,
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.
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov) gripa, okužbe zgornjih dihal, znižano število eritrocitov, izguba apetita, nespečnost, zaspanost, ki lahko vključuje upad pozornosti in zavesti, občutek mravljinčenja ali otrplosti, izjemna utrujenost, tresenje, začasna izguba zavesti, okužba ali draženje ali vnetje očesa z bolečino in rdečino, vrtoglavica, zvišan krvni tlak, zardevanje, kašelj, zadihanost, razdražen želodec, bolečine v trebuhu, zapeka, suha usta, zgaga, izpuščaj, čezmerno znojenje, srbenje, rdečina kože, bolečine v vratu, okorelost mišic, kosti in/ali sklepov, otekanje sklepov, mišični krči, bolečine v rami, bolečine v mišicah prsnega koša in v rebrih, vnetje sklepov, šibkost mišic, nenormalni izvidi preiskav ledvic, nenormalno pogosto uriniranje, otekanje rok, gležnjev ali stopal, žeja, zobobol, motnje okušanja.
English: * Includes vertebral and non-vertebral fractures
Slovenian: * zajema vertebralne in nevertebralne zlome
English: Hypophosphataemia
Slovenian: hipofosfatemija
English: The following precautions should be taken into account to minimise the risk of renal adverse reactions:
Slovenian: Da bi zmanjšali tveganje za neželene učinke na ledvice je treba upoštevati naslednje previdnostne ukrepe:
English: Zoledronic Acid Hospira must not be allowed to come into contact with any calcium-containing solutions.
Slovenian: Ne smete dovoliti, da bi zdravilo Zoledronska kislina Hospira prišlo v stik z raztopino, ki vsebuje kalcij.
English: Before stopping Zoledronic Acid Hospira therapy If you are considering stopping Zoledronic Acid Hospira treatment, please go to your next appointment and discuss this with your doctor.
Slovenian: Preden se prenehate zdraviti z zdravilom Zoledronska kislina Hospira Če razmišljate o tem, da bi se prenehali zdraviti z zdravilom Zoledronska kislina Hospira, se na naslednjem pregledu o tem pogovorite z zdravnikom.
English: − As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Slovenian: − zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije),
English: Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Slovenian: omotica, parestezija, disgevzija, hipestezija, hiperestezija, tremor, somnolenca
English: You should not be given Zoledronic Acid Hospira:
Slovenian: Zdravila Zoledronska kislina Hospira ne smete dobiti:
English: Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Slovenian: Zoledronska kislina spada v skupino difosfonatov, ki vsebujejo dušik, in deluje primarno na kost.
English: While on treatment, invasive dental procedures should be performed with caution and avoided in close proximity to zoledronic acid treatment.
Slovenian: Med zdravljenjem je potrebna previdnost pri izvajanju invazivnih zobozdravstvenih posegov, povsem pa se jim je treba izogibati v času blizu termina odmerjanja zoledronske kisline.
English: Adjusted dose (mg zoledronic acid)
Slovenian: Prilagojeni odmerek (mg zoledronske kisline)
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Slovenian: Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji), diuretike Henlejeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam, - katerakoli druga zdravila, ki vsebujejo zoledronsko kislino, ki se uporablja za zdravljenje osteoporoze in nerakavih kostnih obolenj, katerikoli drug difosfonat, saj skupni učinki jemanja teh zdravil skupaj z zdravilom Zoledronska kislina Hospira niso znani,
English: Common (may affect up to 1 in 10 people):− Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): glavobol in gripi podoben sindrom, ki ga sestavljajo zvišana telesna temperatura, utrujenost, šibkost,zaspanost, mrazenje in bolečine v kosteh, sklepih in/ali mišicah.
English: Renal impairment has been observed following the administration of zoledronic acid (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after zoledronic acid administration.
Slovenian: Po dajanju zoledronske kisline so opažali okvare ledvic (glejte poglavje 4.8), zlasti pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kar vključuje višjo starost bolnika, sočasno uporabo nefrotoksičnih zdravil, diuretično zdravljenje (glejte poglavje 4.5) ali dehidracijo po dajanju zoledronske kisline.
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Slovenian: Analiza večkratnih dogodkov je pokazala za 30,7 % zmanjšano tveganje za razvoj SRE v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
English: • Zoledronic acid should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Slovenian: • Pri sočasni uporabi zoledronske kisline z drugimi zdravili, ki lahko vplivajo na delovanje ledvic, je potrebna previdnost (glejte poglavje 4.5).
English: Zoledronic Acid Recommended Dose* 4.0 mg zoledronic acid
Slovenian: Priporočeni odmerek zoledronske kisline* 4,0 mg zoledronske kisline
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Slovenian: Pri bolnikih z zasevki v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic (opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednji odmerek zoledronske kisline (glejte tudi poglavje 4.4):
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 Hospira.
Slovenian: Če ste v postopku zdravljenja zoba ali ste v kratkem dogovorjeni za zobozdravstveni kirurški poseg (na primer puljenje zoba), zdravnika obvestite o zdravljenju zob, zobozdravniku pa povejte, da prejemate zdravilo Zoledronska kislina Hospira.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Patients being treated with Zoledronic Acid Hospira should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Slovenian: Bolniki, ki prejemajo zdravilo Zoledronska kislina Hospira, ne smejo sočasno prejemati teh zdravil ali katerihkoli drugih difosfonatov, saj skupni učinki navedenih učinkovin niso znani.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Hospira and will check your response to treatment at regular intervals.
Slovenian: Preden začnete zdravljenje z zdravilom Zoledronska kislina Hospira, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
English: Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Slovenian: Preglednica 5: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
English: Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate.
Slovenian: Zdravilo Zoledronska kislina Hospira (5 mg v 100 ml raztopine, pripravljene za infuzijo) se aplicira prek infuzijskega sistema in sicer s stalno hitrostjo infundiranja.
English: No dose adjustment is necessary in patients with creatinine clearance 35 ml/min.
Slovenian: Za bolnike z očistkom kreatinina ≥ 35 ml/min ni potrebno prilagajanje odmerjanja.
English: Placebo zoledronic acid
Slovenian: placebo zoledronska kislina
English: Zoledronic Acid Hospira contains the active substance zoledronic acid.
Slovenian: Zdravilo Zoledronska kislina Hospira vsebuje učinkovino zoledronsko kislino.
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
Slovenian: To zdravilo ne sme priti v stik z raztopinami, ki vsebujejo kalcij.
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).
Slovenian: Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: For storage conditions of the diluted solution for infusion, see section 6.3.
Slovenian: Za pogoje shranjevanja razredčene raztopine za infundiranje glejte poglavje 6.3.
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zoledronske kisline (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
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.
Slovenian: Ledvični očistek zoledronske kisline je bil postavljen v soodnosnost z očistkom kreatinina, ledvični očistek je predstavljal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih kazal povprečje 84 ± 29 ml/min (razpon od 22 do 143 ml/min).
English: − Sudden coldness with fainting, limpness or collapse.
Slovenian: − nenadni občutek mrazenja z izgubo zavesti, mlahavostjo ali kolapsom,
English: There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Slovenian: Po večkratnih odmerkih zdravila, danih vsakih 28 dni, se učinkovina ni kopičila v plazmi.
English: Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Slovenian: Kadar zoledronsko kislino dajemo z drugimi potencialno nefrotoksičnimi zdravili, je potrebna previdnost.
English: Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Slovenian: Preglednica 1: Priprava zmanjšanih odmerkov zdravila Zoledronska kislina Hospira 4 mg/100 ml raztopina za infundiranje
English: In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Slovenian: V študijah z intravenskim infundiranjem so dokazali ledvično prenosljivost za zoledronsko kislino pri podganah, ki so jim dajali odmerek 0,6 mg/kg v 15-minutnih infuzijah v 3-dnevnih presledkih (kumulativni odmerek je ustrezal ravnem AUC, ki so bile približno 6-krat večje od terapevtske izpostavljenosti pri človeku).
English: In the zoledronic acid treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Slovenian: V skupini, zdravljeni z zoledronsko kislino, so v 4. tednu in vsako naslednjo časovno točko v študiji v primerjavi s placebom opazili statistično pomembno izboljšanje rezultata bolečine (z uporabo vprašalnika BPI (Brief Pain Inventory) (slika 1).
English: − Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Slovenian: − v primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s svojim zdravnikom.
English: The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Slovenian: Difosfonati delujejo selektivno na kosti zaradi svoje velike afinitete do mineralizirane kosti.
English: Only clear solution free from particles and discoloration should be used.
Slovenian: Za uporabo je primerna samo bistra raztopina brez delcev in nespremenjene barve.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml odmerek zdravila Zoledronska kislina Hospira, kar v bistvu pomeni “brez natrija”.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema občasni anemija
English: − For single use only.
Slovenian: Samo za enkratno uporabo.
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Slovenian: Rezultati kliničnih preskušanj glede preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti
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 cancer patients studied.
Slovenian: Ledvični očistek zoledronske kisline je bil postavljen v soodnosnost z očistkom kreatinina, ledvični očistek je predstavljal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih z rakom kazal povprečje 84 ± 29 ml/min (razpon od 22 do 143 ml/min).
English: Not known (frequency cannot be estimated from the available data) Pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, these could be signs of bone damage in the jaw (osteonecrosis).
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) Bolečine v ustih in/ali čeljusti, oteklina ali slabo celjenje ranic v ustni votlini ali čeljusti, vnetje, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba - to so lahko znaki odmiranja kosti v čeljusti (osteonekroze).
English: In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
Slovenian: Psi, ki so jim v študijah infundirali enkratne odmerke, so dobro in brez učinkov na ledvice prenašali odmerek 1,0 mg/kg (6-kratna priporočena terapevtska izpostavljenost pri človeku na podlagi AUC), infundiran v času 15 minut.
English: Uncommon Hypertension, flushing Not known**
Slovenian: Žilne bolezni občasni hipertenzija, zardevanje pogostnost neznana**
English: Kidney disorders (e.g. decreased urine output) may occur.
Slovenian: Lahko pride do bolezni ledvic (na primer do zmanjšanega izločanja urina).
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost na učinkovino, katerega od difosfonatov ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zdravila Zoledronska kislina Hospira (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).