natgillin/translations-raw huggingface dataset:
Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Pri kuncih sicer niso ugotovili teratogenosti ali fetotoksičnosti, ugotovili pa so toksičnost za samice-matere.
You should not be given Zoledronic acid Actavis if you are pregnant.
Zdravila Zoledronska kislina Actavis ne smete dobiti, če ste noseči.
You should not be given Zoledronic acid Actavis:
Zdravila Zoledronska kislina Actavis ne smete dobiti:
Hypersensitivity reaction
Preobčutljivostna reakcija
How to store Zoledronic acid Actavis Contents of the pack and other information
Shranjevanje zdravila Zoledronska kislina Actavis Vsebina pakiranja in dodatne informacije
What Zoledronic acid Actavis is and what it is used for
Kaj je zdravilo Zoledronska kislina Actavis in za kaj ga uporabljamo
It is especially important that you tell your doctor if you are also taking: - 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.
- aminoglikozide (zdravila za zdravljenje hudih 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, kajti kombinacija aminoglikozidov in difosfonatov lahko preveč zniža koncentracijo kalcija v krvi.
An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Namenjeno je bilo preučitvi dolgoročne splošne in ledvične varnosti med uporabo zoledronske kisline enkrat ali dvakrat na leto v 12-mesečnem podaljšanju.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Med dejavniki, ki lahko povečajo možnost za poslabšanje delovanja ledvic, so dehidracija, že obstoječa ledvična okvara, več ciklov zdravljenja z zoledronsko kislino ali drugimi difosfonati, pa tudi uporaba drugih nefrotoksičnih zdravil.
Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Analiza multiplih dogodkov je pokazala, da je 4 mg zoledronske kisline v primerjavi s placebom zmanjšalo tveganje za SRE za 41% (razmerje tveganj=0,59, p=0,019).
- To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
- Za pripravo raztopine za infundiranje, ki vsebuje 4 mg zdravila Zoledronska kislina Actavis, koncentrat zdravila Zoledronska kislina Actavis (5,0 ml) dodatno redčite s 100 ml raztopine za infundiranje, ki ne vsebuje kalcija in drugih dvovalentnih kationov.
Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Preglednica 4: Rezultati učinkovitosti (pri raku dojke in multiplem mielomu)
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.
Farmakokinetičnih podatkov o zoledronski kislini pri bolnikih s hiperkalciemijo ali z insuficienco jeter ni. Zoledronska kislina in vitro ne zavira človeških encimov P450, ne kaže biotransformacije, v študijah na živalih pa se je v blatu pojavilo < 3% uporabljenega; to kaže, da delovanje jeter v farmakokinetiki zoledronske kisline nima pomembne vloge.
Medicinal product 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).
Bone pain, myalgia, arthralgia, generalised pain
Kostne bolečine, mialgija, artralgija, generalizirana bolečina
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 koreliral z očistkom kreatinina; ledvični očistek predstavlja 75± 33% očistka kreatinina, ki je bil pri 64 preučevanih bolnikih z rakom v povprečju 84 ± 29 ml/min
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Med dejavniki, ki lahko povečajo možnost poslabšanja delovanja ledvic, so dehidracija, predhodna okvara ledvic, večkratni ciklusi zdravljenja z zoledronsko kislino ali drugimi difosfonati, pa tudi sočasna uporaba nefrotoksičnih zdravil in čas infundiranja, krajši od priporočenega.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Poslabšanje delovanja ledvic, napredovanje v ledvično odpoved in dializo so bili zabeleženi pri bolnikih po začetnem ali enkratnem odmerku 4 mg zoledronske kisline (glejte poglavje 4.4).
- Skin reactions (redness and swelling) at the infusion site, rash, itching.
- Kožne reakcije (pordelost in oteklost) na mestu infundiranja, izpuščaj, srbenje.
Zoledronic acid 4 mg
Zoledronska kislina 4 mg
Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Dispneja, kašelj, bronhokonstrikcija
- Severe bone, joint and/or muscle pain, occasionally incapacitating.
- Hude bolečine v kosteh, sklepih in/ali mišicah, ki bolnika v nekaterih primerih onemogočijo.
Hypocalcaemia has been reported in patients treated with zoledronic acid.
Hipokalciemija Pri bolnikih, ki so bili zdravljeni z zoledronsko kislino, so poročali o hipokalciemiji.
- Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
- Rok trajanja po redčenju: Kemična in fizikalna stabilnost sta med uporabo dokazani 24 ur pri temperaturi od 2°C - 8°C in pri temperaturi 25°C po redčenju s 100 ml 0,9% m/v raztopine natrijevega klorida ali 100 ml 5% m/v glukoze.
- 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.
To avoid potential incompatibilities, Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Da bi se izognili potencialnim inkompatibilnostim, je treba zdravilo Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje redčiti z 0,9% m/v raztopino natrijevega klorida ali 5% m/v raztopino glukoze.
Placebo Zoledronic acid 4 mg
Placebo Zoledronska kislina 4 mg
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
- Visok krvni tlak, kratka sapa, omotica, tesnoba, motnje spanja, motnje okušanja, tresenje,
Prior to administration, 5 ml 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 or 5% w/v glucose solution).
Pred dajanjem zdravila je treba 5 ml koncentrata iz ene viale ali potrebno izvlečeno količino koncentrata dodatno redčiti s 100 ml raztopine za infundiranje brez kalcija (0,9% m/v raztopine natrijevega klorida ali 5% m/v raztopine glukoze).
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Med zdravljenjem z difosfonati so bili opisani atipični subtrohanterni in diafizni zlomi stegnenice, predvsem pri bolnikih, ki so prejemali dolgotrajno zdravljenje za osteoporozo.
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
- Potentnost difosfonatov (večje tveganje pri visoko potentnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek difosfonata.
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 5000 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
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Številni od teh bolnikov so prejemali tudi kemoterapijo in kortikosteroide in imeli znake lokalne okužbe, vključno z osteomielitisom.Večina poročil se nanaša na bolnike z rakom po ekstrakciji zoba ali kakšnem drugem dentalnem kirurškem posegu.
- The active substance is zoledronic acid.
- Zdravilna učinkovina je zoledronska kislina.
In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.
V klinične študije niso vključevali bolnikov s serumskim kreatininom > 400 mikromolov/l ali > 4,5 mg/dl.
Zoledronic acid 4 mg significantly reduced the proportion of patients experiencing at least one skeletal related event (SRE), delayed the median time to first SRE by > 5 months, and reduced the annual incidence of events per patient - skeletal morbidity rate.
Zoledronska kislina v odmerku 4 mg je značilno zmanjšala delež bolnikov, ki se jim je pojavil vsaj en z okostjem povezan dogodek (SRE), podaljšala je mediani čas do prvega SRE za > 5
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: Zavrtje osteoklastne resorpcije kosti, ki spremeni mikrookolje kostnega mozga, tako da postane manj primerno za rast tumorskih celic, antiangiogeno in protibolečinsko aktivnost.
Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card.
Bolnikom, ki prejemajo zdravilo Zoledronska kislina Actavis, je treba izročiti navodilo za uporabo in opozorilno kartico za bolnika.
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 študiji, ki je zajela bolnike z drugimi čvrstimi tumorji (razen raka dojke ali prostate) je 4 mg zoledronske kisline značilno zmanjšalo delež bolnikov z enim SRE, podaljšalo mediani čas do prvega
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 je treba dodatno redčiti v 100 ml sterilne 0,9% m/v raztopine natrijevega klorida ali 5% m/v raztopine glukoze.
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Omotica, parestezije,disgevzija, hipestezija, hiperestezija, tremor, zaspanost Konvulzije, hipestezija in tetanija (zaradi hipokalciemije)
Pruritus, rash (including erythematous and macular rash), increased sweating
Srbenje, izpuščaj (vključno z eritematoznim in makularnim izpuščajem), močnejše znojenje
Caution is advised when Zoledronic acid Actavis 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 zdravila Zoledronska kislina Actavis skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
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) so bile splošne varnostne značilnosti med vsem tremi terapevtskimi skupinami (4 in 8 mg zoledronske kisline oz.
Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Actavis.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Zoledronska kislina Actavis opravite zobozdravstveni pregled.
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
• Preobčutljivost za zdravilno učinkovino, za druge difosfonate ali katero koli pomožno snov,
Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Bolnice so bile enakomerno razdeljene v skupino, ki je prejemala zoledronsko kislino, in skupino, ki je prejemala placebo.
Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)*
Zoledronic acid Actavis contains sodium
Zdravilo Zoledronska kislina Actavis vsebuje natrij
In a third phase III randomised, double-blind trial, 4 mg zoledronic acid or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
V tretjem randomiziranem, dvojno slepem preskušanju III. faze so pri bolnicah/bolnikih z multiplim mielomom ali rakom dojke, ki so imeli vsaj eno kostno lezijo, primerjali 4 mg zoledronske kisline in 90 mg pamidronata na 3 do 4 tedne.
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 Actavis along with driving and operating of machinery.
Neželeni učinki, npr. omotica in zaspanost, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
(*p < 0,05) za primerjavo med zdravljenjema (4 mg zoledronske kisline v prim.
Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria Arthritis and joint swelling as a symptom of acute phase reaction
Astenija, periferni edemi, reakcije na mestu injiciranja (vključno z bolečino, draženjem, oteklostjo, zatrdlino), bolečina v prsih, povečanje telesne mase, anafilaktična reakcija/šok, urtikarija
Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - Glavobol in gripi podoben sindrom, ki obsega zvišano telesno temperaturo, utrujenost, šibkost,
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analiza multiplih dogodkov je pokazala za 36% manjše tveganje za pojav SRE med prejemniki 4 mg zoledronske kisline v primerjavi s placebom.
Zoledronic acid Actavis treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Pri bolnikih s TIH in hudo okvaro ledvic pride zdravljenje z zdravilom Zoledronska kislina Actavis v poštev šele po oceni tveganj in koristi zdravljenja.
- For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution”
Za pogoje shranjevanja zdravila Zoledronska kislina Actavis po redčenju, glejte “Rok trajanja po redčenju” zgoraj.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Poročali so o poslabšanju delovanja ledvic, napredovanju v ledvično odpoved in dializi po začetnem odmerku ali po enkratnem odmerku 4 mg zoledronske kisline.
Administration of 0.001 mg/kg/day subcutaneously in rats and 0.005 mg/kg intravenously once every 2-3 days in dogs for up to 52 weeks was also well tolerated.
Podgane so dobro prenašale tudi do 52-tedensko subkutano uporabo po 0,001 mg/kg/dan, psi pa enako dolgo intravensko dajanje po 0,005 mg/kg enkrat na 2-3 dni.
Other medicines and Zoledronic acid Actavis
Druga zdravila in zdravilo Zoledronska kislina Actavis
- Zoledronic acid Actavis must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
- Zdravilo Zoledronska kislina Actavis sme dati samo zdravstveni delavec, usposobljen za intravensko dajanje difosfonatov, tj. dajanje difosfonatov v veno.
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 se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, npr. z raztopino Ringerjevega laktata, in ga je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline (kot monohidrata).
The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, je bil pri prejemnicah 5 mg zoledronske kisline 1,3% (pri 51 od 3.862 bolnic) in pri prejemnicah placeba 0,6% (pri 22 od 3.852 bolnic).
- Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
- sočasna prisotnost raka ali drugih bolezni (na primer anemije, koagulopatije, okužbe), kajenje; - sočasno zdravljenje: kemoterapija, zaviralci angiogeneze (glejte poglavje 4.5), zdravljenje z obsevanjem vratu in glave, kortikosteroidi.
- History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
- Zobozdravstvene bolezni v anamnezi, slaba ustna higiena, peridontalne bolezni, invazivni zobozdravstveni postopki (na primer ekstrakcija zoba) in slabo prileganje protez.
Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Koncentrata zdravila Zoledronska kislina Actavis ne smete mešati z raztopinami, ki vsebujejo kalcij ali kakšne druge dvovalentne katione, npr. z raztopino Ringerjevega laktata.
Overhydration should be avoided in patients at risk of cardiac failure.
Bolniki s tveganjem za srčno popuščanje ne smejo biti prekomerno hidrirani.
• Breast-feeding (see section 4.6)
navedeno v poglavju 6.1 • Dojenje (glejte poglavje 4.6)
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, farmcevtom ali z medicinsko sestro.
Efficacy results are provided in Table 2.
Rezultate učinkovitosti prikazuje Preglednica 2.
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).
(≥ 1/100 do <1/10), občasni (≥1/1.000 do < 1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
En mililiter koncentrata vsebuje 0,8 mg zoledronske kisline (kot monohidrata).
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients that were given zoledronic acid as indicated in sections 4.1 and 4.2.
Med postmarketinško uporabo so bile pri bolnikih, ki so dobivali zoledronsko kislino, kot je navedeno v poglavjih 4.1 in 4.2, opisane hude bolečine v kosteh, sklepih in/ali mišicah, ki so bolnike v nekaterih primerih povsem onesposobile.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
klinične študije niso vključevali bolnikov s serumskim kreatininom > 265 mikromolov/l ali
No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/l or < 4.5 mg/dl (see section 4.4).
Bolnikom s TIH in serumskim kreatininom < 400 mikromolov/l ali < 4,5 mg/dl odmerka ni treba prilagoditi (glejte poglavje 4.4).
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
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analiza multiplih dogodkov je pokazala za 30,7% manjše tveganje za pojav SRE med prejemniki 4 mg zoledronske kisline kot med prejemniki placeba.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Zdravilo Zoledronska kislina Actavis vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar pomeni, da je praktično "brez natrija".
Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Pri bolnikih s sumom na atipičen zlom stegnenice je treba razmisliti o prenehanju zdravljenja z difosfonatom dokler ni opravljena ocena bolnikovega stanja; pri tem je treba upoštevati individualno oceno koristi in tveganja.
Efficacy results are provided in Table 4.
Rezultate učinkovitosti prikazuje Preglednica 4.
Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Pediatrična populacija Rezultati kliničnih preskušanj zdravljenja hude osteogenesis imperfecta pri pediatričnih bolnikih,
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Pred dajanjem zdravila Zoledronska kislina Actavis in po njem je treba preveriti stanje bolnikove hidracije in tako zagotoviti, da je ustrezno hidriran.
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.
Med kronično uporabo zoledronske kisline v priporočenih odmerkih za preprečevanje z okostjem povezanih dogodkov se lahko zviša kreatinin v serumu, vendar se to zgodi redkeje.
Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Možne neželene učinke zoledronske kisline na plodnost staršev in prve generacije F1 potomcev so ocenjevali na podganah.