FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2,000 ng/ml of zoledronic acid.
Slovenian: Vezava na beljakovine v plazmi je majhna, tako da nevezana frakcija predstavlja od 60 % pri koncentraciji zoledronske kisline 2 ng/ml do 77 % pri koncentraciji 2.000 ng/ml.
English: Chemical and physical in-use stability has been demonstrated for glass bottles, polyethylene, polyvinylchloride and polypropylene infusion lines and infusion bags (prefilled with sodium chloride 9 mg/ml (0.9 %) solution for injection or 5 % w/v glucose solution) for 96 hours at 2-8°C and 25°C.
Slovenian: Kemična in fizična stabilnost med uporabo je bila dokazana za steklenice, infuzijske vrečke in infuzijske linije iz polivinilklorida, polietilena in polipropilena (napolnjene z 9 mg/ml (0,9-odstotno) raztopino natrijevega klorida za injekcije ali 5 % m/v raztopino glukoze) za 96 ur pri 2 do 8 °C in 25 °C.
English: The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Slovenian: Primarni cilj opazovanja v študiji je bila odstotna sprememba mineralne gostote kosti ledvenega dela hrbtenice po 12 mesecih zdravljenja glede na izhodišče.
English: • For single use only.
Slovenian: • Zdravilo je namenjeno samo za enkratno uporabo.
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Slovenian: V prvi randomizirani, dvojno slepi raziskavi, kontrolirani s placebom, so primerjali zoledronsko kislino 4 mg s placebom za preprečevanje z okostjem povezanih dogodkov (SRE - skeletal related event) pri bolnikih z rakom prostate.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Slovenian: Kadar difosfonate dajemo sočasno z aminoglikozidi, kalcitoninom ali diuretiki Henlejeve zanke je priporočljiva previdnost, ker utegnejo imeti te učinkovine aditiven učinek, kar bi imelo za posledico nižje koncentracije serumskega kalcija za dalj časa, kot je potrebno (glejte poglavje 4.4).
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Slovenian: Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zdravila zoledronska kislina za odobrene indikacije.
English: What Zoledronic acid medac is and what it is used for What you need to know before you are given Zoledronic acid medac How Zoledronic acid medac is used Possible side effects
Slovenian: Kaj je zdravilo Zoledronska kislina medac in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac Kako uporabljati zdravilo Zoledronska kislina medac
English: Patients being treated with Zoledronic acid medac should not be treated with such medicinal products concomitantly or any other bisphosphonate, since the combined effects of these agents are unknown.
Slovenian: Bolniki, ki prejemajo zdravilo Zoledronska kislina medac, ne smejo sočasno prejemati takih zdravil ali katerega koli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 4 BOTTLES CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 10 BOTTLES
Slovenian: PODATKI NA ZUNANJI OVOJNINI (BREZ PODATKOV ZA “BLUE BOX”) ŠKATLA ZA 1 STEKLENICO KOT DEL SKUPNEGA PAKIRANJA S 4 STEKLENICAMI ŠKATLA ZA 1 STEKLENICO KOT DEL SKUPNEGA PAKIRANJA Z 10 STEKLENICAMI
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3 % of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Slovenian: Zoledronska kislina in vitro ne zavira humanih encimov s P450, ne kaže biotransformacije, v raziskavah na živalih pa so iz blata prestregli < 3 % danega odmerka, kar kaže, da funkcija jeter nima pomembne vloge v farmakokinetiki zoledronske kisline.
English: 1 Adverse events occurring with frequencies < 5 % were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
Slovenian: hipofosfatemija Neželene učinke s pogostnostjo < 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia.
Slovenian: Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov): - zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Slovenian: - antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zdravilom Zoledronska kislina medac povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
English: Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia
Slovenian: hiperkaliemija, hipernatriemija
English: EXP:
Slovenian: PC:
English: In use stability: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 2-8°C and 25°C.
Slovenian: Stabilnost med uporabo: dokazana je bila 24-urna kemična in fizična stabilnost razredčenega zdravila pri 2-8 °C in 25 °C.
English: Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Slovenian: Zdravilo Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje, nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za zoledronsko kislino (indicirano za zdravljenje raka in zlomov) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - počasno bitje srca,
English: Gesellschaft für klinische
Slovenian: medac Gesellschaft für klinische
English: It is used: - to prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Slovenian: - preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti),
English: Instructions for preparing reduced doses of zoledronic acid
Slovenian: Navodila za pripravo zmanjšanih odmerkov zoledronske kisline:
English: Median time to SRE (days)
Slovenian: čas v študiji (tedni)
English: • The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Slovenian: • Raztopine, ki vsebuje zoledronsko kislino, ne smete nadalje redčiti ali mešati z drugimi infuzijskimi raztopinami.
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic acid medac to ensure that they are adequately hydrated.
Slovenian: Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zoledronska kislina medac, da se prepriča, da so ustrezno hidrirani.
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.
Slovenian: 6.2 Inkompatibilnosti Zdravilo ne sme priti v stik z raztopinami, ki vsebujejo kalcij, in se ne sme mešati ali dati intravensko z drugimi zdravili v isti infuzijski liniji.
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Slovenian: • Infuzijsko raztopino, ki vsebuje 4 mg zoledronske kisline, pripravite tako, da dodatno razredčite koncentrat (5,0 ml) s 100 ml infuzijske raztopine, ki ne vsebuje kalcija ali drugih dvovalentnih kationov.
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - preobčutljivostne reakcije,
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Slovenian: Med zdravljenjem se smejo invazivni zobozdravstveni posegi opraviti le po skrbnem premisleku, neposredno pred dajanjem ali po dajanju zdravila Zoledronska kislina medac pa se jim moramo izogibati.
English: 3.0 mg* *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Slovenian: *Odmerki so preračunani s predpostavko, da je ciljna AUC 0,66 (mg•h/l) (za CLcr=75 ml/min).
English: Zoledronic acid medac treatment should be resumed at the same dose as that given prior to treatment interruption.
Slovenian: Zdravljenje z zdravilom Zoledronska kislina medac je treba spet začeti z enakim odmerkom, kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
English: One vial contains 4 mg zoledronic acid.
Slovenian: Ena viala vsebuje 4 mg zoledronske kisline.
English: • Zoledronic acid medac 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: • Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje vsebuje 4 mg zoledronske kisline v 100 ml infuzijske raztopine, ki je že pripravljena za uporabo pri bolnikih z normalno ledvično funkcijo.
English: Marketing Authorisation Holder and Manufacturer medac
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec medac Gesellschaft für klinische
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
Slovenian: - intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih), - simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) CARTON FOR 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS CARTON FOR 1 VIAL AS PART OF A MULTIPACK COMPRISING 10 VIALS
Slovenian: PODATKI NA ZUNANJI OVOJNINI (BREZ PODATKOV ZA “BLUE BOX”) ŠKATLA ZA 1 VIALO KOT DEL SKUPNEGA PAKIRANJA S 4 VIALAMI ŠKATLA ZA 1 VIALO KOT DEL SKUPNEGA PAKIRANJA Z 10 VIALAMI
English: − For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of
Slovenian: - pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 µmol/l), zvišanje za
English: One vial contains 5 ml of concentrate for solution for infusion.
Slovenian: Ena viala vsebuje 5 ml koncentrata za raztopino za infundiranje.
English: • Studies with glass bottles, several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution) showed no incompatibility with zoledronic acid.
Slovenian: • Študije s steklenicami, več vrstami infuzijskih vrečk in infuzijskih linij, izdelanih iz polivinilklorida, polietilena in polipropilena (napolnjenih z 9 mg/ml (0,9-odstotno) raztopino natrijevega klorida za injekcije ali 5-odstotno m/v raztopino glukoze), niso pokazale nezdružljivosti z zoledronsko kislino.
English: - Other medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid medac are unknown.
Slovenian: - druga zdravila, ki prav tako vsebuje zoledronsko kislino, in jih uporabljamo pri zdravljenju osteoporoze in drugih nerakavih bolezni kosti, ali katerega koli od drugih difosfonatov, saj učinki navedenih zdravil v kombinaciji z zdravilom Zoledronska kislina medac niso znani,
English: The management plan for patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Slovenian: Obravnava bolnikov, pri katerih se razvije osteonekroza čeljustnic, se mora načrtovati v tesnem sodelovanju med lečečim zdravnikom in zobozdravnikom ali čeljustnim kirurgom, ki ima izkušnje z osteonekrozo čeljustnic.
English: Pamidronate 90 mg
Slovenian: Pam 90 mg
English: Zoledronic acid treatment should be resumed at the same dose as that prior to treatment interruption.
Slovenian: Zdravljenje z zoledronsko kislino je treba spet začeti z enakim odmerkom, kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
English: - Severe bone, joint and/or muscle pain, occasionally incapacitating.
Slovenian: - hude bolečine v kosteh, sklepih in/ali mišicah, ki bolnika včasih onesposobijo,
English: Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Slovenian: dispneja, kašelj, bronhokonstrikcija redki:
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Slovenian: Naslednji neželeni učinki, navedeni v preglednici 2, so zbrani iz kliničnih študij in iz poročil v obdobju trženja zdravila, ki so sledili pretežno kroničnemu zdravljenju s 4-miligramsko zoledronsko kislino:
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Slovenian: Naslednji neželeni učinki, navedeni v preglednici 1, so zbrani iz kliničnih študij in iz poročil v obdobju trženja zdravila, ki so sledili pretežno kroničnemu zdravljenju s 4-miligramsko zoledronsko kislino:
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
Slovenian: Zdravljenje z zoledronsko kislino se sme spet začeti šele, ko se serumski kreatinin vrne na vrednost, ki ni za več kot 10 % večja od izhodiščne (glejte poglavje 4.2).
English: 1 x5ml vial.
Slovenian: 1 x 5 ml viala.
English: Instructions for preparing reduced doses of Zoledronic acid medac
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina medac
English: • The solution containing Zoledronic acid medac is given as a single 15-minute intravenous infusion.
Slovenian: • Raztopino, ki vsebuje zdravilo Zoledronska kislina medac, dajemo v obliki ene same 15minutne intravenske infuzije z ločenim infuzijskim sistemom.
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: Zoledronic acid medac 4 mg/100 ml solution for infusion must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Zdravila Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje se ne sme mešati z drugimi infuzijskimi raztopinami in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: METHOD OF ADMINSTRATION Dilute before use.
Slovenian: POSTOPEK UPORABE Pred uporabo razredčite.
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 skupna pojavnost 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: If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2 °C - 8 °C.
Slovenian: Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo in mora biti v hladilniku pri 2 ºC−8 ºC.
English: Patients treated with Zoledronic acid medac should be given the package leaflet and the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Zoledronska kislina medac, morajo prejeti navodilo za uporabo in opozorilno kartico za bolnika.
English: Spezialpräparate mbH
Slovenian: Gesellschaft für klinische Spezialpräparate mbH
English: If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
Slovenian: Če raztopine ne uporabite takoj, jo je treba shraniti v hladilnik pri temperaturi
English: In patients with mild to moderate renal impairment, reduced Zoledronic acid medac 4 mg/100 ml solution for infusion doses are recommended (see section “Posology” above and section 4.4).
Slovenian: Za bolnike z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zdravila Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
English: • Do not use Zoledronic acid medac after the expiry date stated on the bottle and carton after
Slovenian: • Zdravila Zoledronska kislina medac ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in škatli poleg oznake Uporabno do.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Slovenian: Preglednica 6: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
English: - Zoledronic acid medac must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Slovenian: - Zdravilo Zoledronska kislina medac vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
English: Zoledronic acid 4 mg reduced the risk of SREs by 41 % in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Slovenian: Pri analizi večkratnih dogodkov se je pokazalo, da je zoledronska kislina v odmerku 4 mg zmanjšala tveganje za SRE za 41 % (razmerje tveganj = 0,59, p=0,019) v primerjavi s placebom.
English: Zoledronic acid recommended dose*
Slovenian: Priporočeni odmerek zoledronske kisline*
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Slovenian: Pri uporabi zdravila zoledronska kislina skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
English: Multipack: 4 x 1 bottle of 100 ml Multipack: 10 x 1 bottle of 100 ml
Slovenian: raztopina za infundiranje Skupno pakiranje: 4 x 1 steklenica s 100 ml
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 naslednje odmerke zoledronske kisline (glejte tudi poglavje 4.4):
English: One bottle contains 100 ml of solution.
Slovenian: Ena steklenica vsebuje 100 ml raztopine.
English: • From a microbiological point of view, the diluted solution for infusion should be used immediately.
Slovenian: • Z mikrobiološkega stališča je rekonstituirano in razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila Zoledronska kislina medac, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: After dilution: From a microbiological point of view the medicinal product should be used immediately.
Slovenian: Po redčenju: z mikrobiološkega stališča je razredčeno zdravilo najbolje uporabiti takoj.
English: Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - bolečina v ustih, zobeh in/ali čeljusti, oteklina ali neceljenje ran v ustni votlini ali čeljusti, izcedek, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba, kar so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
English: − For patients with normal baseline serum creatinine (< 1.4 mg/dl or 124 µmol/l), an increase of
Slovenian: - pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1,4 mg/dl ali < 124 µmol/l),
English: There is preponderance of specific location (head of femur, humerus and medial condyle of femur) due to local anatomical features.
Slovenian: Določene lokacije prevladujejo zaradi lokalnih anatomskih lastnosti (glava stegnenice, nadlahtnica in medialni kondil stegnenice).
English: Zoledronic acid medac contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Zoledronska kisilna medac vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Slovenian: Pri bolnikih s spremljajočimi dejavniki tveganja sta pred začetkom zdravljenja z difosfonati priporočljiva zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in individualna ocena razmerja med koristjo in tveganjem.
English: Talk to your doctor before you are given Zoledronic acid medac, if you - have or have had a kidney problem.
Slovenian: Preden vam dajo zdravilo Zoledronska kislina medac, se posvetujte z zdravnikom, če: - imate ali ste imeli težave z ledvicami,
English: - The other ingredients are: mannitol, sodium citrate, water for injections.
Slovenian: - Druge sestavine zdravila so manitol, natrijev citrat, voda za injekcije.
English: Zoledronic acid medac is not recommended for use in adolescents and children below the age of 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina medac ni priporočena.
English: Plastic vial made of clear, colourless cycloolefine copolymer with Type I bromobutyl rubber stopper and sealed with aluminium polypropylene flip-off seal.
Slovenian: Plastična viala, izdelana iz prozornega, brezbarvnega cikloolefinskega kopolimera tipa I, z zamaškom iz bromobutilne gume, prevlečena z aluminijasto polipropilensko odtržno zaporko.