natgillin/translations-raw huggingface dataset:
Healthcare professionals are advised not to dispose of unused Zoledronic Acid Hospira via the domestic sewage system.
Zdravstvenim delavcem se odsvetuje odstranjevanje neuporabljenega zdravila Zoledronska kislina Hospira prek gospodinjskega kanalizacijskega sistema.
When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Pri uvajanju zdravljenja z zoledronsko kislino pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CLcr).
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Zoledronska kislina se ne veže v veliki meri na beljakovine plazme (vezana je približno v 43-55 %), vezava pa je neodvisna od koncentracije.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Celotni sistemski očistek je 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa ali telesna masa.
− The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
− Razredčeno raztopino za infundiranje zdravila Zoledronska kislina Hospira je treba uporabiti takoj, da se prepreči mikrobna kontaminacija.
Five of the 6 patients had SAP within the normal range at month 6 (Late Observation Carried Forward, LOCF).
Pri petih od teh šestih bolnikov je bila vrednost alkalne fosfataze v serumu po 6 mesecih v okviru normalnih vrednosti (po principu zadnje izmerjene vrednosti prenesene naprej (Last Observation Carried Forward, LOCF)).
Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.
Ponovno zdravljenje Pagetove bolezni: Po začetnem zdravljenju Pagetove bolezni z zoledronsko kislino so pri bolnikih, ki se odzovejo na zdravljenje, opazili dolgotrajne remisije.
Zoledronic Acid Hospira, 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 Hospira, nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dati v obliki ene intravenske infuzije, ki traja najmanj 15 minut.
There were no statistically significant differences between the two zoledronic acid doses.
Med obema odmerkoma zoledronske kisline ni bilo statistično pomembnih razlik.
The use of Zoledronic Acid Hospira in children and adolescents has not been studied.
Uporabe zdravila Zoledronska kislina Hospira pri otrocih in mladostnikih niso preučili.
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
V preskušanjih osteoporoze (v PFT, v študiji HORIZON - študiji ponovnih zlomov (Recurrent Fracture Trial [RFT]) sta bili združeni incidenci atrijske fibrilacije primerljivi med zoledronsko kislino (2,6 %) in placebom (2,1 %).
− Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
− huda alergijska reakcija: zadihanost, otekanje zlasti v obraz in žrelo oziroma grlo.
For the treatment of Paget's disease, zoledronic acid should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Za zdravljenje Pagetove bolezni smejo zoledronsko kislino predpisovati samo zdravniki, ki imajo izkušnje z zdravljenjem Pagetove bolezni kosti.
Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Preden prejmete zdravilo Zoledronska kislina Hospira, povejte zdravniku, farmacevtu ali medicinski sestri, če: - imate težave v ustih oziroma z zobmi, kot so slabo zdravstveno stanje zob, bolezni dlesni ali načrtovana ekstrakcija (puljenje) zoba; - nimate urejene redne oskrbe zob oziroma že dolgo niste bili na zobozdravstvenem pregledu; - ste kadilec (saj to lahko povečuje tveganje za težave z zobmi); - ste že kdaj prej prejemali katerega od difosfonatov (ki jih uporabljamo za zdravljenje ali preprečevanje bolezni kosti); - prejemate zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon); - imate raka.
In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following zoledronic acid administration.
V kliničnih preskušanjih pri osteoporozi je pri 0,2 % bolnikov prišlo do opaznega znižanja koncentracij kalcija v serumu (manj kot 1,87 mmol/l) po aplikaciji zoledronske kisline.
Figure 1: Mean changes from baseline in BPI scores.
Slika 1: Povprečne spremembe od izhodišča po rezultatu BPI.
In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
Pri bolnikih z blago do zmerno okvaro ledvic je treba pripraviti zmanjšane odmerke kot je opisano v nadaljevanju.
The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Delež vseh bolnikov, pri katerih je prišlo do neželenih učinkov, je bil po prvi infuziji 44,7 %, po drugi infuziji 16,7 %, po tretji infuziji pa 10,2 %.
This medicine contains 16 mmol (or 360 mg) sodium per dose.
To zdravilo vsebuje 16 mmol (ali 360 mg) natrija na odmerek.
The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid.
Incidenca teh učinkov je izrazito upadla pri naslednjih letnih odmerjanjih zoledronske kisline.
Zoledronic acid 4 mg (N=86)
Zoledronska kislina 4 mg (n = 86)
Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Ker človek ne presnavlja zoledronske kisline in ker so ugotovili, da ta učinkovina v manjši meri ali pa sploh ne deluje kot neposredno delujoči in/ali ireverzibilni, od presnove odvisni, zaviralec encimov P450, ni verjetno, da bi zoledronska kislina zmanjšala presnovni očistek snovi, ki se presnavljajo prek encimskega sistema citokrom P450.
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 ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja hudo ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
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 SRE, ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure.
Zoledronsko kislino povezujejo z okvaro ledvic ki se kaže kot poslabšanje delovanja ledvic (zvišanje vrednosti kreatinina v serumu) in v redkih primerih z akutno odpovedjo ledvic.
The early disposition phases (α and β, with t½ values above) presumably represent rapid uptake into bone and excretion via the kidneys.
Obe zgodnji obdobji prisotnosti zdravila v obtoku (α in β, z zgoraj navedenima vrednostma t½) sta po vsej verjetnosti obdobji hitrega privzema v kostnino in izločanja preko ledvic.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Zoledronska kislina se ne veže v veliki meri na beljakovine v plazmi (vezana je približno v 43 - 55 %) zato interakcije, ki bi bile posledica izrinjanja zdravil, pretežno vezanih na beljakovine, niso verjetne.
Zoledronic Acid Hospira 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).
Priporočeni odmerek zdravila Zoledronska kislina Hospira* 4,0 mg zoledronske kisline 3,5 mg* zoledronske kisline 3,3 mg* zoledronske kisline 3,0 mg* zoledronske kisline * Odmerke so izračunali s predvidenim ciljnim AUC 0,66 (mg•hr/l) (CLcr = 75 ml/min).
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).
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 odločitvi glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da začne zdravljenje učinkovati šele po 2-3 mesecih.
− Severe bone, joint and/or muscle pain, occasionally incapacitating.
− hude bolečine kosti, sklepov in/ali mišic, občasna onesposobljenost.
Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment.
Šest bolnikov, pri katerih je prišlo do terapevtskega odziva 6 mesecev po zdravljenju z zoledronsko kislino, kasneje v obdobju podaljšanega spremljanja pa do recidiva bolezni, je ponovno prejelo zoledronsko kislino, pri čemer je interval med začetnim in ponovnim zdravljenjem v povprečju znašal 6,5 let.
Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zoledronske kisline za odobrene indikacije.
The following properties have been demonstrated in preclinical studies:
V predkliničnih raziskavah so dokazali sledeče lastnosti:
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 SRE, izračunano iz celotnega števila SRE dogodkov (brez hiperkalciemije; prilagojenega na predhodne zlome), deljenega s celotnim obdobjem tveganja.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of zoledronic acid (see section
Zaradi hitrega začetka delovanja zoledronske kisline na kostno premeno se utegne razviti prehodna hipokalciemija, ki je včasih simptomatska in ki je navadno najbolj izražena v prvih 10 dneh po infuziji zoledronske kisline (glejte poglavje 4.8).
Median time to relapse (re-increase of albumin-corrected serum calcium 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Mediana časa do ponovnega pojava bolezni (ponovno zvišanje za albumin korigiranega serumskega kalcija ≥ 2,9 mmol/l) je bila pri bolnikih, zdravljenih z zoledronsko kislino, 30 do 40 dni, pri tistih, ki so bili zdravljeni s pamidronatom 90 mg, pa 17 dni (vrednosti p: 0,001 za 4 mg in 0,007 za 8 mg zoledronske kisline).
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
* zajema vertebralne in nevertebralne zlome ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Najpogostejša ugotovitev v študijah večkratnih odmerkov je bilo zvečanje primarne spongiozne kostne substance v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih; ta ugotovitev odseva farmakološki antiresorpcijski učinek zdravila.
- After opening the bag, the product should be used immediately in order to avoid microbial contamination.
- Ko steklenico odprete, morate zdravilo porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Hospira properly (see section
Vaš zdravnik, medicinska sestra ali farmacevt vedo, kako je treba zdravilo Zoledronska kislina Hospira pravilno shranjevati (glejte poglavje 6).
• Monitoring of serum creatinine should be considered in at-risk patients.
• Pri bolnikih s povečanim tveganjem je treba razmisliti o spremljanju koncentracije kreatinina v serumu.
In patients with Paget's disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Pri bolnikih s Pagetovo boleznijo so zaradi nizke koncentracije kalcija v krvi poročali o simptomih, kot so mišični krči, odrevenelost ali občutek zbadanja, posebno v predelu okrog ust.
Clinical experience with acute overdose of zoledronic acid is limited.
Klinične izkušnje z akutnim prevelikim odmerjanjem zoledronske kisline so omejene.
Very common (may affect more than 1 in 10 people): − Low level of phosphate in the blood.
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): − nizka koncentracija fosfata v krvi.
- Do not use this medicine after the expiry date which is stated on the carton.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is supplied as a liquid concentrate (referred to as a ‘concentrate for solution for infusion' or ‘sterile concentrate') in a vial.
Izgled zdravila Zoledronska kislina in vsebina pakiranja Zdravilo Zoledronska kislina Hospira je tekoči koncentrat (imenovan "koncentrat za raztopino za infundiranje" ali "sterilni koncentrat") v viali.
- Pregnancy and breast-feeding (see section 4.6).
- Nosečnost in dojenje (glejte poglavje 4.6).
Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of medicinal product with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Majhno zvečanje AUC(0-24hr) za okrog 30 do 40 %, ki so ga opazili pri bolnikih z blago do zmerno ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem, in odsotnost kopičenja zdravila ob večkratnih odmerkih, ne glede na ledvično delovanje, kažeta, da prilagajanje odmerka zoledronske kisline pri blagi (Clcr = 50 do 80 ml/min) in zmerni ledvični okvari z znižanim očistkom kreatinina do 35 ml/min ni potrebno.
The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Priporočeni odmerek je ena intravenska infuzija s 5 mg zoledronske kisline.
Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodelling and no evidence of mineralisation defects.
Rezultati biopsije kosti so pokazali, da je kost normalne kvalitete brez znakov okvare remodeliranja ali motenj mineralizacije.
• 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).
It belongs to a group of medicines called bisphosphonates and is used to treat Paget's disease of the bone in adults.
Pripada skupini zdravil, ki se imenujejo difosfonati in jih uporabljamo za zdravljenje bolnikov s Pagetovo boleznijo kosti.
In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2).
V preskušanju za preprečevanje kliničnih zlomov po nedavnem zlomu kolka niso rutinsko merili ravni vitamina D, vendar je večina bolnikov pred dajanjem zoledronske kisline prejela začetni odmerek vitamina D (glejte poglavje 4.2).
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 študiji, nadzorovani s placebom, so primerjali zoledronsko kislino 4 mg s placebom za preprečevanje z okostjem povezanih dogodkov (SREs - skeletal related events) pri bolnikih z rakom prostate.
− if you have or have had a kidney problem.
− če imate ali ste v preteklosti imeli težave z ledvicami.
- Zoledronic Acid Hospira is ready for use.
- Zdravilo Zoledronska kislina Hospira je že pripravljeno za uporabo.
Very common (may affect more than 1 in 10 people):− Low level of phosphate in the blood.
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): nizka koncentracija fosfata v krvi.
In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the zoledronic acid and placebo treatment groups over three years.
V kliničnih preskušanjih pri osteoporozi sta bili v treh letih sprememba očistka kreatinina (ki so jo merili enkrat letno pred odmerjanjem) in incidenca odpovedi ter okvare ledvic primerljivi med skupinama z zoledronsko kislino in s placebom.
Zoledronic acid was teratogenic in the rat at subcutaneous doses 0.2 mg/kg.
Zoledronska kislina je bila teratogena pri podganah pri subkutanih odmerkih ≥ 0,2 mg/kg.
100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap
100 ml polipropilenske vreče s polipropilenskim odtržnim vhodom, na katerem je pokrov, z zunanjo ovojnino iz poliestra/polipropilena
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 močno podaljšana v primerjavi s placebom (p = 0,007).
Aseptic techniques must be followed during preparation of the infusion.
Med pripravo infuzije je treba uporabljati aseptične tehnike.
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Hospira properly.
Vaš zdravnik, farmacevt in medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Hospira pravilno shranjevati.
- 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
- 4,4 ml za odmerek 3,5 mg - 4,1 ml za odmerek 3,3 mg - 3,8 ml za odmerek 3,0 mg
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2,10 mmol/l) prišlo pri 2,3 % bolnikov, ki so prejemali zoledronsko kislino v obsežnem kliničnem preskušanju, v primerjavi z 21 % pri bolnikih, ki so prejemali zoledronsko kislino v preskušanjih zdravljenja Pagetove bolezni.
In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
V drugi raziskavi, v katero so bili vključeni čvrsti tumorji, razen raka dojke in prostate, je zoledronska kislina 4 mg pomembno zmanjšala delež bolnikov, ki so doživeli SRE, podaljšala mediano časa do prvega SRE za > 2 meseca in zmanjšala stopnjo obolevnosti skeleta.
Pam 90 mg zoledronic acid
Pam 90 mg zoledronska kislina
Solution for infusion 1 intravenous bag
raztopina za infundiranje 1 intravenska vreča
− 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.
In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Bolnikom, pri katerih se med zdravljenjem pokažejo znaki poslabšanja ledvične funkcije, je treba zoledronsko kislino ukiniti.
Zoledronic Acid Hospira works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Zdravilo Zoledronska kislina Hospira deluje tako, da normalizira proces kostne premene, omogoči tvorbo normalne kostnine in tako kostem povrne čvrstost.
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 nadaljevali z zdravljenjem z zoledronsko kislino šele, ko se je koncentracija kreatinina vrnila na raven, ne za več kot 10% višjo od izhodiščne vrednosti (glejte poglavje 4.4).
- Anti-angiogenic medicines (used to treat cancer), since the combination of these with Zoledronic Acid Hospira 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 Hospira povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
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 referenčnega zdravila, 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).
What you need to know before you are given Zoledronic Acid Hospira
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Hospira
It comes in 100 ml plastic bags as a readyto-use solution for infusion.
Na voljo je v 100 ml plastičnih vrečah kot raztopina za infundiranje, pripravljena za uporabo.