natgillin/translations-raw huggingface dataset:
5-ml plastic vial made of clear, cycloolefine copolymer with chlorobutyl rubber stopper and aluminium cap with flip-off component.
5-mililitrska plastična viala iz brezbarvnega cikloolefinskega kopolimera z zamaškom iz klorobutilne gume in aluminijasto zaporko z zaščitnim pokrovčkom.
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 %).
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Za bolnike z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zoledronske kisline (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
• Since no data are available on the compatibility of Zoledronic Acid Accord with other intravenously administered substances, Zoledronic Acid Accord must not be mixed with other medications/substances and should always be given through a separate infusion line.
Ker o združljivosti zdravila Zoledronska kislina Accord z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina Accord 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 z znaki poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta možno nevarnost.
Patients being treated with Zoledronic Acid Accord should not be treated with Aclasta or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Bolniki, ki prejemajo zdravilo Zoledronska kislina Accord, ne smejo sočasno prejemati še zdravila Aclasta ali kateregakoli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
EU/1/13/834/003
EU/1/13/834/001 EU/1/13/834/002 EU/1/13/834/003
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 poročali o naslednjih neželenih učinkih (pogostnost je redka): atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice (za difosfonate značilen neželeni učinek).
• Do not use Zoledronic Acid Accord after the expiry date stated on the pack.
Zdravilo Zoledronska kislina Accord ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Ledvični očistek zoledronske kisline je bil postavljen v soodnosnost z očistkom kreatinina, ledvični očistek je predstavljal 75  33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih z rakom kazal povprečje 84  29 ml/min (razpon od 22 do 143 ml/min).
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zoledronska kislina Accord, da se prepriča, da so ustrezno hidrirani.
The active substance in Zoledronic Acid Accord is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Zdravilna učinkovina v zdravilu Zoledronska kislina Accord je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
• The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Raztopino, ki vsebuje zoledronsko kislino, dajemo v obliki ene same 15-minutne intravenske infuzije z ločenim infuzijskim sistemom.
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Pri uporabi zoledronske kisline za odobrene indikacije so ugotovili naslednja pomembna tveganja: moteno delovanje ledvic, osteonekrozo čeljustnic, reakcijo akutne faze, hipokalciemijo, atrijsko fibrilacijo, anafilaksijo, intersticijsko bolezen pljuč.
Caution is advised when Zolendronc Acid Accord is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Pri dajanju zdravila Zoledronska kislina Accord skupaj z zdravili, za katera je znano, da povzročajo hipokalciemijo, je potrebna previdnost, saj lahko delujejo sinergistično in povzročijo hudo hipokalciemijo (glejte poglavje 4.5).
The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 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.
319, Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
North Harrow, Middlesex HA1 4HF Velika Britanija
Baseline creatinine clearance (ml/min) 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).
Priporočeni odmerek zdravila zoledronske kisline * 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).
Mannitol (E421) Sodium citrate Water for injections
6.1 Seznam pomožnih snovi manitol (E421) natrijev citrat voda za injekcije
Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
bradikardija, aritmija (zaradi hipokalciemije)
What you need to know before you are given Zoledronic Acid Accord
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Accord
What you need to know before you are given Zoledronic Acid Accord 3.
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Accord 3.
Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Possible Side Effects
Možni neželeni učinki
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
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.
Risk reduction of suffering from multiple events** (%)
vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
How Zoledronic Acid Accord is used 4.
Kako se zdravilo Zoledronska kislina Accord uporablja 4.
What Zoledronic Acid Accord looks like and contents of the pack Zoledronic Acid Accord is supplied as a liquid concentrate in a vial.
Izgled zdravila Zoledronska kislina Accord in vsebina pakiranja Zdravilo Zoledronska kislina Accord je v obliki tekočega koncentrata v viali.
Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Pri doječih ženskah je uporaba zoledronske kisline kontraindicirana (glejte poglavje 4.3).
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)
Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Pred uporabo zoledronske kisline moramo bolnike oceniti, da zagotovimo, da so ustrezno hidrirani.
Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Ne mešajte koncentrata zdravila Zoledronska kislina Accord z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
• if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid Accord belongs), or any of the other ingredients of this medicine
Zdravila Zoledronska kislina Accord ne smete dobiti: - če dojite, - če ste alergični na zoledronsko kislino, kak drug difosfonat (skupina snovi, ki ji pripada zdravilo Zoledronska kislina Accord) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What Zoledronic Acid Accord is and what it is used for 2.
Kaj je zdravilo Zoledronska kislina Accord in za kaj ga uporabljamo 2.
INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Številni izmed njih so imeli znake lokalne okužbe, med katere sodi tudi osteomielitis.
• As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
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.
Pri uporabi zoledronske kisline skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
• To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Accord concentrate (5ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Infuzijsko raztopino, ki vsebuje 4 mg zoledronske kisline, pripravite tako, da koncentrat zdravila Zoledronska kislina Accord (5 ml) razredčite s 100 ml infuzijske raztopine, ki ne vsebuje kalcija ali drugih dvovalentnih kationov.
Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Zdravilo Zoledronska kislina Accord vsebuje isto učinkovino (zoledronsko kislino) kot zdravilo Aclasta.
Intravenous use.
Intravenska uporaba po redčenju.
The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
In vivo: Inhibicijo osteoklastne resorpcije kosti, ki spremeni mikrookolje kostnega mozga, tako da je le-to manj ugodno za rast tumorskih celic, protiangiogeno aktivnost in protibolečinsko aktivnost.
Zoledronic Acid Accord is not recommended for use in adolescents and children below the age of 18 years.
Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina Accord ni priporočena.
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Odvzeto količino koncentrata morate dodatno razredčiti v 100 ml sterilne 0,9-odstotne m/v raztopine natrijevega klorida ali 5-odstotne m/v raztopine glukoze.
Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Povprečne spremembe od izhodišča na BPI lestvici, označene so statistično značilne vrednosti p (*p<0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)
4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zdravilo Zoledronska kislina Accord smejo predpisovati in dajati bolnikom samo zdravstveni delavci, ki imajo izkušnje z uporabo intravenskih difosfonatov.
• 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.
• Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
- Zdravilo Zoledronska kislina Accord vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
What Zoledronic Acid Accord is and what it is used for
Kaj je zdravilo Zoledronska kislina Accord in za kaj ga uporabljamo
Very common Hypocalcaemia Common:
hipokalciemija pogosti:
• Severe bone, joint and/or muscle pain, occasionally incapacitating.
hude bolečine v kosteh, sklepih in/ali mišicah, ki bolnika včasih onesposobijo.
After dilution: From a microbiological point of view, the product should be used immediately.
Po rekonstituiranju in redčenju: z mikrobiološkega stališča je rekonstituirano in razredčeno raztopino za infundiranje najbolje uporabiti takoj.
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina, ki se uporablja za razredčenje, bodisi 0,9odstotna m/v raztopina natrijevega klorida bodisi 5-odstotna m/v raztopina glukoze.
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.
BPI: povprečne spremembe od izhodišča odporni proti začetnemu zdravljenju (zoledronska kislina 4 mg, 8 mg ali pamidronat 90 mg), ponovno zdravljenih z 8 mg zoledronske kisline.
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Tega zdravila ne smete mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Zoledronic Acid Accord contains sodium
Zoledronska kislina Accord vsebuje natrij
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Poročali so o osteonekrozi čeljustnic pri bolnikih, predvsem pri tistih z rakom, ki se zdravijo z zdravili, ki zavirajo resorpcijo kosti, kot je zoledronska kislina.
The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Večina primerov, o katerih so poročali, je bila povezana z zobozdravniškimi postopki, na primer ekstrakcijo zoba.
Very common ( 1/10)
Zelo pogosti (1/10)
p-value Skeletal morbidity rate p-value
vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
Zoledronic Acid Accord concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Koncentrata zdravila Zoledronska kislina Accord se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Patients must be maintained well hydrated prior to and following administration of zoledronic acid.
Bolniki morajo biti pred in po dajanju zoledronske kisline dobro hidrirani.
Renal impairment TIH:
Srčne bolezni občasni:
Instructions for preparing reduced doses of Zoledronic Acid Accord Withdraw an appropriate volume of the concentrate needed, as follows: 4.4 ml for 3.5 mg dose
Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Accord: Odvzemite ustrezni volumen tekočega koncentrata, kot sledi:
Proportion of patients with SREs (%) p-value
večkratnih dogodkov** (%) vrednost p
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Poročali so o razvoju aritmij in nevroloških neželenih učinkih (vključno s konvulzijami, hipestezijo in tetanijo), do katerih je prišlo zaradi hude hipokalciemije.
To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Da se izognete možnim nezdružljivostim, razredčite koncentrat zoledronske kisline z 0,9-odstotno m/v raztopino natrijevega klorida za injiciranje ali 5-odstotno m/v raztopino glukoze.
Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution).
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred dajanjem je treba 5-mililitrski koncentrat iz ene viale ali po navodilih odvzet volumen koncentrata razredčiti s 100 ml infuzijske raztopine v kateri ni kalcija (0,9-odstotna m/v raztopina natrijevega klorida za injiciranje ali 5-odstotna m/v raztopina glukoze).
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
vendar je natančen molekularni mehanizem, ki privede do inhibicije osteoklastne aktivnosti, še nejasen.
Rare ( 1/10.000 to < 1/1.000)
Redki (1/10.000 do <1/1.000)
For storage conditions of the reconstituted solution for infusion, see section 6.3.
Za pogoje shranjevanja rekonstituirane raztopine za infundiranje glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
• Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji), diuretike Henlejeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam, - druga zdravila, ki prav tako vsebujejo zoledronsko kislino in jih uporabljamo pri zdravljenju osteoporoze in drugih nerakavih bolezni kosti, ali kateregakoli od drugih difosfonatov, saj učinki navedenih zdravil v kombinaciji z zdravilom Zoledronska kislina Accord niso znani, - antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zoledronsko kislino povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion
IME ZDRAVILA Zoledronska kislina Accord 4 mg/5 ml koncentrat za raztopino za infundiranje
Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Zoledronska kislina Accord 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
How to store Zoledronic Acid Accord 6.
Shranjevanje zdravila Zoledronska kislina Accord 6.
How Zoledronic Acid Accord is used
Kako se zdravilo Zoledronska kislina Accord uporablja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
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.
Pri bolnikih s spremljajočimi dejavniki tveganja je treba pred začetkom zdravljenja z difosfonati razmisliti o zobozdravniškem pregledu z ustreznimi preventivnimi zobozdravstvenimi ukrepi.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom > 265 µmol/l ali > 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
(listed in section 6).
navedeno v poglavju 6.1
• 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.
Občasni (lahko se pojavijo pri 1 od 100 ljudi): bolečina v ustih, zobeh in/ali čeljusti, oteklina ali ranice v ustni votlini, odrevelenost ali občutek pritiska v čeljusti ali majanje zoba, kar so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
Median time to SRE (days)
SREs (%) vrednost p mediana časa do SRE (dnevi)
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zoledronic Acid Accord.
Pri bolnikih, ki so se zdravili z zdravilom Zoledronska kislina Accord, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
• Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Pogosti (lahko se pojavijo pri 1 od 10 ljudi): glavobol in gripi podoben sindrom, ki ga sestavljajo zvišana telesna temperatura, utrujenost, šibkost, zaspanost, mrazenje in bolečine v kosteh, sklepih in/ali mišicah.
Common (1/100 to <1/10)
Pogosti (1/100 do <1/10)
The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Omenjeno reakcijo opisujejo tudi z izrazoma "gripi podobni simptomi" in "simptomi po odmerjanju".
• The usual single dose given is 4 mg zoledronic acid.
Koliko zdravila Zoledronska kislina Accord se daje - Običajni posamezni odmerek je 4 mg zoledronske kisline.
Radiation therapy to bone zoledronic acid 4 mg
zdravljenje kosti z obsevanjem zoledronska kislina 4 mg