natgillin/translations-raw huggingface dataset:
On the basis of the scientific conclusions for zoledronic acid (indicated for cancer and fractures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing zoledronic acid (indicated for cancer and fractures) is unchanged subject to the proposed changes to the product information
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za zoledronsko kislino (indicirano za zdravljenje raka in zlomov) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zoledronsko kislino (indicirano za zdravljenje raka in zlomov) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including convulsions, hypoaesthesia and tetany (see section 4.4).
Poleg tega obstajajo dokazi o povezanosti hipokalciemije in posledičnih nevroloških dogodkov, o katerih so poročali v teh primerih in so vključevali konvulzije, hipestezijo in tetanijo (glejte poglavje 4.4).
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Takoj obvestite zdravnika in zobozdravnika, če se pri vas pojavijo kakršne koli težave v zvezi z usti ali zobmi, na primer majanje zob, bolečina ali otekanje, neceljenje ran ali izcedek, ker so to lahko znaki stanja, ki se imenuje osteonekroza čeljustnic.
*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
* Odmerke so izračunali tako, da so predpostavili tarčno AUC 0,66 (mg•hr/l) (CLcr=75 ml/min).
- 4.1 ml for 3.3 mg dose
4,1 ml za odmerek 3,3 mg,
In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5,000 ng/ml.
V študiji in vitro je imela zoledronska kislina nizko afiniteto za celične sestavine humane krvi, pri čemer je znašala povprečna vrednost razmerja med koncentracijo v krvi in koncentracijo v plazmi 0,59 v razponu koncentracij od 30 ng/ml do 5.000 ng/ml.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06 - 0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,060,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
What you need to know before you are given Zoledronic acid medac
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac
Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Začasna prekinitev zdravljenja z zoledronsko kislino pride v poštev, dokler se stanje ne razreši in se dejavniki tveganja, ki prispevajo z razvoju bolezni, ne ublažijo, če je to mogoče.
− In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, antiadhesion/invasion activity.
- In vitro: inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku,
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid medac.
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina medac.
The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46).
Analiza posameznih poročil o varnosti iz kliničnih študij, spontanih poročil in literature je razkrila 62 primerov osteonekroze v povezavi z zoledronsko kislino na drugih anatomskih lokacijah.
• Since no data are available on the compatibility of Zoledronic acid medac with other intravenously administered substances, Zoledronic acid medac must not be mixed with other medications/substances and should always be given through a separate infusion line.
• Ker o združljivosti zdravila Zoledronska kislina medac z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina medac ne smete mešati z drugimi zdravili ali snovmi in jo morate vedno dajati po ločenem infuzijskem sistemu.
Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with zoledronic acid outweighs the possible risk.
Bolnike s tumorsko povzročeno hiperkalciemijo (TIH) in znaki poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta možno tveganje.
The following risk factors should be considered when evaluating an individual's risk of developing ONJ:
Pri oceni tveganja za razvoj osteonekroze čeljustnic pri posamezniku je treba upoštevati naslednje dejavnike tveganja:
To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Za oceno učinkov 4 mg zoledronske kisline v primerjavi s pamidronatom 90 mg so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih študij pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
The solution must be allowed to reach 20°C to 23.5°C before administration.
Pred dajanjem mora raztopina doseči temperaturo med 20 °C in 23,5 °C.
Withdraw an appropriate volume of the solution needed, as follows: - 4.4 ml for 3.5 mg dose
Odvzemite ustrezni volumen potrebne raztopine, kot sledi: 4,4 ml za odmerek 3,5 mg,
In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
V združeni analizi podatkov o varnosti zdravila iz registracijskih preskušanj zoledronske kisline pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti, so bile pogostnosti neželenih dogodkov, ki so vključevali okvaro ledvic in pri katerih je obstajal sum, da so povezani z zoledronsko kislino (torej neželenih učinkov), naslednje: multipli mielom (3,2 %), rak prostate (3,1 %), rak dojke (4,3 %), tumor na pljučih in drugi čvrsti tumorji (3,2 %).
- 3.8 ml for 3.0 mg dose
3,8 ml za odmerek 3,0 mg.
METHOD AND ROUTE(S) OF ADMINISTRATION Dilute before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo razredčite.
• Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
• rak, sočasne druge bolezni (npr. anemija, koagulopatije, infekcija), kajenje.
- Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
• Zdravljenje odraslih bolnikov s tumorsko povzročeno hiperkalciemijo (TIH - tumour-induced hypercalcaemia).
The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
17 let) s hudo obliko osteogenesis imperfecta (tipov I, III in IV) so primerjali z intravenskim pamidronatom v eni mednarodni, multicentrični, randomizirani, odprti študiji s 74 oziroma 76 bolniki v vsaki od zdravljenih skupin.
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, tj. zdravilo je v bistvu "brez natrija".
The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Rezultati so dokazali, da je zoledronska kislina 4 mg pokazala učinkovitost za preprečevanje z okostjem povezanih dogodkov (SRE), ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
Your doctor will carry out blood tests before you start treatment with Zoledronic acid medac and will check your response to treatment at regular intervals.
Preden začnete zdravljenje z zdravilom Zoledronska kislina medac, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
- Difficulty in breathing with wheezing or coughing.
- oteženo dihanje s piskanjem ali kašljem,
Anxiety, sleep disturbance Confusion
anksioznost, motnje spanja redki:
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.
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.
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.
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.
The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Primarni cilj opazovanja v študiji je bila odstotna sprememba mineralne gostote kosti ledvenega dela hrbtenice po 12 mesecih zdravljenja glede na izhodišče.
• For single use only.
• Zdravilo je namenjeno samo za enkratno uporabo.
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.
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.
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).
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).
Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zdravila zoledronska kislina za odobrene indikacije.
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
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
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.
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.
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
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
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.
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.
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)
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).
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.
Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov): - zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
- 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).
- antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zdravilom Zoledronska kislina medac povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia
hiperkaliemija, hipernatriemija
In use stability: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 2-8°C and 25°C.
Stabilnost med uporabo: dokazana je bila 24-urna kemična in fizična stabilnost razredčenega zdravila pri 2-8 °C in 25 °C.
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.
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.
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:
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:
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - počasno bitje srca,
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).
- preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti),
Instructions for preparing reduced doses of zoledronic acid
Navodila za pripravo zmanjšanih odmerkov zoledronske kisline:
Median time to SRE (days)
čas v študiji (tedni)
• The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
• Raztopine, ki vsebuje zoledronsko kislino, ne smete nadalje redčiti ali mešati z drugimi infuzijskimi raztopinami.
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid medac to ensure that they are adequately hydrated.
Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zoledronska kislina medac, da se prepriča, da so ustrezno hidrirani.
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.
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.
• 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.
• 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.
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - preobčutljivostne reakcije,
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
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.
3.0 mg* *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
*Odmerki so preračunani s predpostavko, da je ciljna AUC 0,66 (mg•h/l) (za CLcr=75 ml/min).
Zoledronic acid medac treatment should be resumed at the same dose as that given prior to treatment interruption.
Zdravljenje z zdravilom Zoledronska kislina medac je treba spet začeti z enakim odmerkom, kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
One vial contains 4 mg zoledronic acid.
Ena viala vsebuje 4 mg zoledronske kisline.
• 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.
• 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.
Marketing Authorisation Holder and Manufacturer medac
Imetnik dovoljenja za promet z zdravilom in izdelovalec medac Gesellschaft für klinische
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
- intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih), - simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov.
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
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
− For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of
- pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 µmol/l), zvišanje za
One vial contains 5 ml of concentrate for solution for infusion.
Ena viala vsebuje 5 ml koncentrata za raztopino za infundiranje.
• 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.
• 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.
- 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.
- 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,
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.
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.
Pamidronate 90 mg
Pam 90 mg
Zoledronic acid treatment should be resumed at the same dose as that prior to treatment interruption.
Zdravljenje z zoledronsko kislino je treba spet začeti z enakim odmerkom, kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
- Severe bone, joint and/or muscle pain, occasionally incapacitating.
- hude bolečine v kosteh, sklepih in/ali mišicah, ki bolnika včasih onesposobijo,
Dyspnoea, cough, bronchoconstriction Interstitial lung disease
dispneja, kašelj, bronhokonstrikcija redki:
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:
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:
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:
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:
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
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).
1 x5ml vial.
1 x 5 ml viala.
Instructions for preparing reduced doses of Zoledronic acid medac
Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina medac
• The solution containing Zoledronic acid medac is given as a single 15-minute intravenous infusion.
• Raztopino, ki vsebuje zdravilo Zoledronska kislina medac, dajemo v obliki ene same 15minutne intravenske infuzije z ločenim infuzijskim sistemom.
- Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
- v primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s svojim zdravnikom.