natgillin/translations-raw huggingface dataset:
Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Zoledronske kisline se ne priporoča bolnikom, ki imajo že pred uvedbo zdravljenja hudo ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
While being treated with Zoledronic acid Mylan, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
V času zdravljenja z zdravilom Zoledronska kislina Mylan morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
- if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
- če imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob.
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) Kateri koli SRE (+TIH)
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino, za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Zoledronic acid has been associated with reports of renal dysfunction.
Zoledronsko kislino povezujejo s poročili o ledvični disfunkciji.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2ºC - 8ºC, razen, če je bilo redčenje izvedeno v nadzorovanih in validiranih aseptičnih pogojih.
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Neravnovesja, ki so ga opažali v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z zoledronsko kislino v odmerku 4 mg vsake 3 - 4 tedne pri onkoloških bolnikih.
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of zoledronic acid.
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zoledronske kisline.
- From a microbiological point of view, the diluted solution for infusion should be used immediately.
Z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
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 poročanj v obdobju trženja, ki so sledili pretežno kroničnemu zdravljenju s 4-miligramsko zoledronsko kislino:
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Preglednica 6: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta1
In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
V študijah faze I za ugotavljanje odmerka pri bolnikih z blago do zmerno hiperkalciemijo, povzročeno s tumorjem (TIH), so bili testirani učinkoviti odmerki v razponu približno 1,2 - 2,5 mg.
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Intravensko aplicirana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/2 0,24 ure in t1/2 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2 146 ur.
How to store Zoledronic acid Mylan Your doctor, pharmacist or nurse knows how to store Zoledronic acid Mylan properly.
Shranjevanje zdravila Zoledronska kislina Mylan Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Mylan pravilno shranjevati.
Healthcare professionals are advised not to dispose of unused Zoledronic acid Mylan via the domestic sewage system.
Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina Mylan ne izlijejo v gospodinjske odplake.
The following conventional classification is used: 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).
Kategorije pogostnosti so opredeljene 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).
For instructions on the dilution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6.
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Delež bolnic z vsaj enim SRE (razen hiperkalciemije) je bil v skupini, zdravljeni z zoledronsko kislino 29,8 % v primerjavi s skupino s placebom, kjer je bil 49,6 % (p = 0,003).
Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
V skupini, zdravljeni z zoledronsko kislino, mediana časa do pojava prvega SRE ob koncu študije še ni bila dosežena, bila je signifikantno podaljšana v primerjavi s placebom (p = 0,007).
While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Čeprav se nevarnost zmanjša, če se 4-miligramski odmerek zoledronske kisline daje v času, ki ni krajši od 15 minut, lahko kljub temu nastopi poslabšanje ledvične funkcije.
Zoledronic acid Mylan is supplied as packs containing 1, 4 or 10 vials or as multipacks comprising 4 packs, each containing 1 vial.
Zdravilo Zoledronska kislina Mylan je na voljo v ovojnini, ki vsebuje 1 vialo, 4 viale ali 10 vial ali v obliki skupnega pakiranja s 4 vialami, od katerih vsako vsebuje po 1 vialo.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da nastopi učinek zdravljenja čez 2 - 3 mesece.
Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zoledronic acid Mylan along with driving and operating of machinery.
Neželena učinka, kot sta na primer vrtoglavica in zaspanost, lahko vplivata na sposobnost vožnje in upravljanja s stroji, zato je ob uporabi zdravila Zoledronska kislina Mylan potrebna previdnost.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C.
Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2 ºC8 ºC.
In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 μmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 μmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Glede na možni vpliv zoledronske kisline na delovanje ledvic ob pomanjkanju kliničnih podatkov o varnosti pri bolnikih s hudo izhodiščno okvaro ledvic (v kliničnih študijah opredeljeno z vrednostmi serumskega kreatinina ≥ 400 µmol/l ali ≥ 4,5 mg/dl za bolnike s tumorsko povzročeno hiperkalciemijo - TIH - oziroma z vrednostmi serumskega kreatinina ≥ 265 µmol/l ali ≥ 3,0 mg/dl za bolnike z rakom in zasevki v kosteh) in glede na samo omejene farmakokinetične podatke pri bolnikih s hudo izhodiščno okvaro ledvic (očistek kreatinina < 30 ml/min), se uporabe zoledronske kisline pri bolnikih s hudo okvaro ledvic ne priporoča.
The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Priporočeni odmerek za hiperkalciemijo (za albumin korigirana vrednost serumskega kalcija ≥ 12,0 mg/dl ali 3,0 mmol/l) je enkratni odmerek 4 mg zoledronske kisline.
Zoledronic acid Mylan contains the same active substance as found in medicinal products indicated for treatment of osteoporosis and Paget´s disease of the bone.
Zdravilo Zoledronska kislina Mylan vsebuje isto učinkovino (zoledronsko kislino) kot zdravila, ki so indicirana za zdravljenje osteoporoze in Pagetove bolezni kosti.
Adverse reactions are ranked under headings of frequency, the most frequent first, 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).
Neželeni učinki so razvrščeni glede na padajočo pogostnost, najprej najpogostejši, skladno 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).
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
vrtoglavica, parestezija, disgevzija, hipestezija, hiperestezija, tremor, somnolenca zelo redki:
Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
- Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
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.
Po uvedbi terapije je treba izmeriti vrednosti serumskega kreatinina pred vsakim odmerkom zoledronske kisline, terapijo pa je treba prekiniti v primeru poslabšanja funkcije ledvic.
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
V kliničnih študijah so z zdravljenjem z zoledronsko kislino nadaljevali šele, ko se je vrednost kreatinina vrnila na raven, ki ne presega izhodiščne vrednosti za več kot 10 % (glejte poglavje 4.4).
Instructions for preparing reduced doses of Zoledronic acid Mylan: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Mylan: Odvzemite ustrezni volumen rekonstituirane raztopine (4 mg/5 ml), kot sledi: - 4,4 ml za odmerek 3,5 mg
Zoledronic acid Mylan 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 Mylan 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, v času.
What Zoledronic acid Mylan is and what it is used for What you need to know before you are given Zoledronic acid Mylan How Zoledronic acid Mylan is used Possible side effects
Kaj je zdravilo Zoledronska kislina Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Zoledronska kislina Mylan Kako jemati zdravilo Zoledronska kislina Mylan Možni neželeni učinki
Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom nadzorovanem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek 4 mg zoledronske kisline na razmerje pogostnosti z okostjem povezanih dogodkov (SRE), izračunano iz celotnega števila SRE dogodkov (brez hiperkalciemije; prilagojenega na predhodne zlome), deljenega s celotnim obdobjem tveganja.
Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Zdravljenje z zoledronsko kislino je treba ponovno začeti z enakim odmerkom kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 4 (4 packs of 1) vials of 5 ml
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje Skupno pakiranje: 4 (4 pakiranja po 1 vialo) viale s 5 ml
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
driska, zaprtje, bolečine v trebuhu, dispepsija, stomatitis, suha usta
Intravenous use.
Po redčenju intravenska uporaba.
What Zoledronic acid Mylan looks like and contents of the pack Zoledronic acid Mylan is a clear and colourless concentrate for solution for infusion.
Izgled zdravila Zoledronska kislina Mylan in vsebina pakiranja Zoledronska kislina Mylan je bister in brezbarven koncentrat za raztopino za infundiranje.
Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
4,0 mg zoledronske kisline 3,5 mg* zoledronske kisline 3,3 mg* zoledronske kisline 3,0 mg* zoledronske kisline * Odmerke so izračunali tako, da so predpostavili tarčno AUC 0,66 (mg•hr/l) (CLcr = 75 ml/min).
Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Pozornost je potrebna, saj med zdravljenjem obstaja možnost za razvoj hipomagneziemije.
Patients being treated with Zoledronic acid Mylan should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Bolniki, ki prejemajo zdravilo Zoledronska kislina Mylan, ne smejo sočasno prejemati še teh zdravil ali kateregakoli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Mylan to ensure that they are adequately hydrated.
Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zoledronska kislina Mylan, da se prepriča, da so ustrezno hidrirani.
What you need to know before you are given Zoledronic acid Mylan
Kaj morate vedeti, preden boste prejeli zdravilo Zoledronska kislina Mylan
- Since no data are available on the compatibility of Zoledronic acid Mylan with other intravenously administered substances, Zoledronic acid Mylan must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
- Ker o združljivosti zdravila Zoledronska kislina Mylan z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina Mylan ne smete mešati z drugimi zdravili ali snovmi in jo morate vedno dajati po ločenem infuzijskem sistemu.
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):
Pri bolnikih z zasevki v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic (za to skupino bolnikov opredeljeno kot CLcr 30 - 60 ml/min), se priporoča naslednji odmerek zoledronske kisline (glejte tudi poglavje 4.4), kot sledi:
What Zoledronic acid Mylan is and what it is used for
Kaj je zdravilo Zoledronska kislina Mylan in za kaj ga uporabljamo
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 90 mg pamidronatom so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih študij pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
V kliničnih preskušanjih pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH) je bil celotni varnostni profil v vseh treh zdravljenih skupinah (4 mg, 8 mg zoledronska kislina in 90 mg pamidronat ) podoben glede na vrste in izraženost.
Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zdravljenje z zoledronsko kislino pri bolnikih s TIH in pridruženo hudo ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
The active substance in Zoledronic acid Mylan is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Zdravilna učinkovina v zdravilu Zoledronska kislina Mylan je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
How much Zoledronic acid Mylan is given - The usual single dose given is 4 mg zoledronic acid.
Koliko zdravila Zoledronska kislina Mylan boste prejeli - Običajni posamezni odmerek je 4 mg zoledronske kisline.
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 z znaki poslabšanja ledvične funkcije, je treba ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta možno tveganje.
Zoledronic acid Mylan must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zdravilo Zoledronska kislina Mylan smejo predpisovati in dajati bolnikom samo zdravstveni delavci, ki imajo izkušnje z uporabo intravenskih difosfonatov.
Dyspnoea, cough, bronchoconstriction
dispneja, kašelj, bronhokonstrikcija redki :
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Pri bolnikih, pri katerih se med zdravljenjem z difosfonati razvije osteonekroza čeljustnic, utegne stomatološka operacija stanje poslabšati.
0.5 mg/dl or 44 μmol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
< 124µmol/l), zvišanje za 0,5 mg/dl ali 44 µmol/l; - pri bolnikih s patološkimi vrednostmi izhodiščnega kreatinina (> 1,4 mg/dl ali > 124µmol/l),
Proportion of patients with SREs (%) p-value
N delež bolnic/bolnikov s SREs (%) vrednost p mediana časa do SRE (dnevi)
Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Po uvedbi zdravljenja se pri bolnikih z zasevki v kosteh in blago do zmerno ledvično okvaro priporoča uporaba nižjih odmerkov zoledronske kisline.
In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 μmol/l), an increase of
V kliničnih preskušanjih je bilo ledvično poslabšanje opredeljeno, kot sledi: - pri bolnikih z normalnimi vrednostmi izhodiščnega serumskega kreatinina (< 1,4 mg/dl ali
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) BOX OF 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS
PODATKI NA ZUNANJI OVOJNINI (BREZ PODATKOV ZA “BLUE BOX”) ŠKATLA ZA 1 VIALO KOT DEL SKUPNEGA PAKIRANJA S 4 VIALAMI
117 allée des Parcs 69800 SAINT-PRIEST France
MYLAN S.A.S 117 allée des Parcs 69800 SAINT-PRIEST FRANCIJA
Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - huda okvara ledvic (običajno jo ugotovi zdravnik z določenimi specifičnimi krvnimi preiskavami), - nizka raven kalcija v krvi.
In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
V kliničnih preskušanjih je bilo 69 bolnikov, pri katerih se je bolezen ponovno pojavila ali so bili odporni proti začetnemu zdravljenju (4 mg, 8 mg zoledronska kislina ali 90 mg pamidronat ), ponovno zdravljenih z 8 mg zoledronske kisline.
Other medicines and Zoledronic acid Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
Druga zdravila in Zoledronska kislina Mylan Obvestite zdravnika, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo, tudi če ste ga dobili brez recepta.
During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Med izkušnjami v obdobju trženja so redko poročali o naslednjih neželenih učinkih: atipičnih subtrohanternih zlomih stegnenice in zlomih diafize stegnenice (za difosfonate značilen neželeni učinek).
BOX OF 10 VIALS
Škatla z 10 vialami
How to store Zoledronic acid Mylan Contents of the pack and other information
Shranjevanje zdravila Zoledronska kislina Mylan Vsebina pakiranja in dodatne informacije
Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
Čeprav redkeje, se zvišanje vrednosti serumskega kreatinina pojavlja tudi pri nekaterih bolnikih, ki kronično prejemajo zoledronsko kislino v priporočenih odmerkih za preprečevanje z okostjem povezanih dogodkov.
15 ml colourless type I glass vial with a bromobutyl rubber stopper and an aluminium crimp cap with plastic flip-off component.
15-mililitrska brezbarvna steklena viala, tipa I, z brombutilnim gumijastim zamaškom in aluminijasto zaporko s plastičnim zaščitnim pokrovčkom.
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Bolnikom je treba pred vsakim odmerkom zoledronske kisline določiti vrednost serumskega kreatinina.