natgillin/translations-raw huggingface dataset:
If a lower dose of Zoledronic Acid Hospira is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Če je potreben manjši odmerek zdravila Zoledronska kislina Hospira, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
− Confusion.
− zmedenost,
Atypical fractures of the femur During post-marketing experience the following reactions have been reported (frequency rare):
Atipičen zlom stegnenice Med izkušnjami v obdobju trženja so poročali o naslednjih neželenih učinkih (pogostnost je redka):
Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Pamidronat 90 mg (n = 99) *vrednosti p v primerjavi s pamidronatom.
• A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
• Posamezen odmerek zoledronske kisline ne sme presegati 5 mg, infuzija pa mora trajati najmanj 15 minut (glejte poglavje 4.2).
In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
V preskušanjih zdravljenja Pagetove bolezni so opažali simptomatsko hipokalciemijo pri približno 1 % bolnikov, pri katerih je tudi izzvenela.
It is especially important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Posebno pomembno je, da vaš zdravnik ve za vsa zdravila, ki jih jemljete, zlasti, če jemljete kakršnakoli zdravila, za katera je znano, da škodujejo ledvicam (npr. aminoglikozidi) ali diuretike (tablete za odvajanje vode), ki lahko povzročijo dehidracijo.
These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Dobljeni rezultati so se skladali z dokazi biokemijskih označevalcev normalizacije kostne premene.
Limited data on re-treatment of Paget's disease are available (see section 5.1).
Podatki o ponovnem zdravljenju Pagetove bolezni so omejeni (glejte poglavje 5.1).
Tell your doctor about any of the following side effects as soon as possible:
Čimprej povejte zdravniku za kateregakoli od naslednjih neželenih učinkov:
Painful redness and/or swelling of the eye.
− boleča rdečina in/ali oteklina očesa.
** Accounts for all skeletal events, the total number as well as time to each event during the trial
** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem
− Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
− Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zoledronsko kislino.
- Patients with hypocalcaemia (see section 4.4).
- Bolniki s hipokalciemijo (glejte poglavje 4.4).
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Mehanizem, na katerem temelji zvečana incidenca atrijske fibrilacije v tem edinem kliničnem preskušanju, ni znan.
This is especially important for the elderly and for patients receiving diuretic therapy.
To je posebno pomembno pri starejših in pri bolnikih, ki jemljejo tudi diuretike.
If you wear dentures you should make sure these fit properly.
Če imate zobno protezo, morate poskrbeti, da se ta dobro prilega dlesnim.
1 intravenous bag
1 intravenska vreča
Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Zato interakcije, ki bi bile posledica izrivanja zdravil, pretežno vezanih na beljakovine, niso verjetne.
In the clinical trials, renal deterioration was defined as follows:
V kliničnih preskušanjih so opredelili ledvično poslabšanje takole:
Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Neželeni učinki, kot je na primer omotica, lahko vplivajo na sposobnost vožnje in upravljanja strojev.
The infusion time must not be less than 15 minutes.
Čas infundiranja ne sme biti krajši od 15 minut.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Da bi zmanjšali tveganje za razvoj osteonekroze čeljustnic, je treba upoštevati nekaj previdnostnih ukrepov.
The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Rezultat bolečine za zoledronsko kislino je bil dosledno pod izhodiščno vrednostjo, zmanjšanje bolečine pa je spremljal trend zmanjšanja analgetičnega seštevka.
At the request of the European Medicines Agency, Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
− Low blood pressure.
− nizek krvni tlak,
− Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
− huda okvara ledvic (običajno jo ugotovi zdravnik z določenimi specifičnimi krvnimi preiskavami),
Additional information on handling of Zoledronic Acid Hospira, including guidance on preparation of reduced doses, is provided in section 4.2.
Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina Hospira, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Za bolnike, pri katerih je zobozdravstveni poseg potreben, ni na voljo nikakršnih podatkov, ki bi kazali na to, ali prekinitev difosfonatnega zdravljenja zmanjša tveganje za osteonekrozo čeljustnic.
If you feel dizzy while taking Zoledronic Acid Hospira, do not drive or use machines until you feel better.
Če ste med uporabo zdravila Zoledronska kislina Hospira omotični, ne vozite in ne upravljajte strojev, dokler vam ni bolje.
The infusion will take at least 15 minutes.
Infuzija traja vsaj 15 minut.
Concentrate for solution for infusion (sterile concentrate)
koncentrat za raztopino za infundiranje (sterilni koncentrat)
Clinical experience with acute overdose is limited.
Klinične izkušnje z akutnim prevelikim odmerjanjem so omejene.
Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Bolniki, ki so se odzvali na zdravljenje v 6-mesečni osnovni študiji, so veljali za primerne za podaljšano spremljanje.
Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
osteonekroza čeljustnice (glejte poglavji 4.4 in 4.8 Učinki po skupinah)
Any SRE (+TIH)
Katerikoli SRE (+TIH) Zlomi*
In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo.
V obsežnem kliničnem preskušanju s 7.736 bolniki so o osteonekrozi čeljustnic poročali pri enem bolniku, ki je prejemal zoledronsko kislino, in pri enem bolniku, ki je prejemal placebo.
Zoledronic acid should not be used during pregnancy.
Zoledronske kisline se ne sme uporabljati med nosečnostjo.
The mechanism behind the increased incidence of atrial fibrillation is unknown.
Mehanizem, na katerem temelji višja incidenca atrijske fibrilacije, ni znan.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Hospira.
- Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina Hospira.
Arthritis and joint swelling as a symptom of acute phase reaction
Redki artritis in otekline sklepov kot simptom reakcije akutne faze
− Urticaria.
− koprivnica.
Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Histologijo kosti so ovrednotili pri 7 bolnikih s Pagetovo boleznijo 6 mesecev po zdravljenju s 5 mg zoledronske kisline.
The majority of these reactions occur within the first three days following zoledronic acid administration.
Večina teh učinkov je nastopila v prvih treh dneh po aplikaciji zoledronske kisline.
After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Po 6 mesecih je zoledronska kislina pokazala 96-odstotno (169/176) oziroma 89-odstotno odzivnost (156/176) oziroma pogostost normalizacije vrednosti serumske alkalne fosfataze (SAP) v primerjavi s 74 % (127/171) oziroma 58 % (99/171) pri risedronatu (v vseh primerih p < 0,001).
Zoledronic Acid Hospira can be given to people aged 65 years and over.
Zdravilo Zoledronska kislina Hospira se lahko daje bolnikom, starim 65 let in več.
Zoledronic Acid Hospira may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Zdravilo Zoledronska kislina Hospira lahko povzroča tudi druge neželene učinke Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) povišana telesna temperatura
Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic Acid Hospira.
Skrbno se ravnajte po vseh navodilih zdravnika, farmacevta ali medicinske sestre, preden vam dajo zdravilo Zoledronska kislina Hospira.
It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat.
Pomembno je, da poskušamo preprečiti razvoj osteonekroze čeljustnic, saj je to zelo boleče stanje, ki ga je večkrat težko zdraviti.
The incidence of post-dose symptoms occurring within the first three days after administration of Zoledronic Acid Hospira can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic Acid Hospira administration.
Incidenco simptomov po odmerjanju, ki nastopijo v prvih treh dneh po aplikaciji zdravila Zoledronska kislina Hospira, je mogoče znižati z jemanjem paracetamola ali ibuprofena kmalu po aplikaciji zdravila Zoledronska kislina Hospira.
In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
V primeru hipokalciemije je treba dati infuzijo kalcijevega glukonata kot je klinično indicirano.
In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Pri Pagetovi bolezni je kostna premena prehitra, nova kostnina pa se tvori nepravilno, zato je šibkejša od normalne.
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 along with driving and operating of machinery.
Neželeni učinki, kot na primer omotica in somnolenca, lahko vplivajo na sposobnost vožnje in upravljanja strojev, zato je ob uporabi zoledronske kisline potrebna previdnost pri vožnji in upravljanju strojev.
Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
Incidence of individual adverse reactions following the first infusion was: fever (17.1%), myalgia (7.8%), flu-like symptoms (6.7%), arthralgia (4.8%) and headache (5.1%).
Po prvi infuziji so bile incidence posameznih neželenih učinkov naslednje: zvišana telesna temperatura (17,1 %), mialgija (7,8 %), gripi podobni simptomi (6,7 %), artralgija (4,8 %) in glavobol (5,1 %).
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA08
− Difficulty in breathing with wheezing or coughing.
− težave z dihanjem s sopenjem ali kašljanjem,
Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic Acid Hospira.
Vaš zdravnik vam bo morda svetoval, da jemljete nadomestke kalcija in vitamina D (npr. tablete) vsaj prvih deset dni po tem, ko ste dobili zdravilo Zoledronska kislina Hospira.
In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
V kliničnih študijah so zoledronsko kislino dajali sočasno z običajno uporabljanimi zdravili proti raku, diuretiki, antibiotiki in analgetiki, ne da bi prišlo do klinično očitnega medsebojnega delovanja.
Clinical efficacy in the treatment of Paget's disease of the bone
Klinična učinkovitost pri zdravljenju Pagetove bolezni kosti
For information on the infusion of Zoledronic Acid Hospira, see section 6.6.
Za informacije o infundiranju zdravila Zoledronska kislina Hospira glejte poglavje 6.6.
Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Neželene učinke s pogostnostjo < 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8)
How often Zoledronic Acid Hospira is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic Acid Hospira every three to four weeks.
Kako pogosto se daje zdravilo Zoledronska kislina Hospira - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina Hospira vsake tri do štiri tedne.
Treatment of Paget's disease of the bone in adults.
Zdravljenje Pagetove bolezni kosti pri odraslih.
How much Zoledronic Acid Hospira is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Koliko zdravila Zoledronska kislina Hospira se daje - Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed.
Ponovno zdravljenje pomeni dodatno intravensko infundiranje 5 mg zoledronske kisline po enoletnem ali daljšem intervalu od začetnega zdravljenja pri bolnikih, pri katerih se je bolezen ponovila.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem,ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic Acid Hospira.
Večina neželenih učinkov, kot so vročina z mrzlico, bolečine v mišicah in sklepih in glavobol, nastopi v prvih treh dneh po odmerku zdravila Zoledronska kislina Hospira.
The mean time of ending the Extended Observation Period due to the need for Paget's re-treatment from the initial dose was longer for zoledronic acid (7.7 years) than for risedronate (5.1 years).
Povprečen čas od začetnega zdravljenja do prekinitve sodelovanja v podaljšanem obdobju opazovanja zaradi potrebe po ponovnem zdravljenju Pagetove bolezni je bil daljši pri uporabi zoledronske kisline (7,7 let) kot pri uporabi risedronata (5,1 let).
While the risk is reduced with a dose of zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Čeprav se tveganje zmanjša, če odmerek zoledronske kisline dajemo več kot 15 minut, lahko kljub temu nastopi poslabšanje ledvične funkcije.
- 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.
- Do not use this medicine after the expiry date which is stated on the carton and bag.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vreči.
Teratogenicity was observed in rats at doses 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Teratogenost so ugotovili pri podganah v odmerkih ≥0,2 mg/kg, ki se je kazala v obliki zunanjih, visceralnih in skeletnih malformacij.
Zoledronic acid has been associated with reports of renal dysfunction.
Zoledronsko kislino povezujejo s poročili o disfunkciji ledvic.
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Neželeni učinki v preglednici 1 so razvrščeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Možnost osteonekroze zunanjega slušnega kanala je treba upoštevati pri bolnikih, ki prejemajo difosfonate in pri katerih se pojavljajo simptomi bolezni ušesa, vključno s kroničnimi vnetji ušesa.
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, ki imajo tudi hudo ledvično okvaro, lahko pride v poštev šele po oceni tveganj in koristi zdravljenja.
Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
preobčutljivostne reakcije, vključno z redkimi primeri bronhokonstrikcije, urtikarije in angioedema in z zelo redkimi primeri anafilaktične reakcije/šoka
† Identified in post-marketing experience.
† ugotovljeno z izkušnjami v obdobju po prihodu zdravila na trg.
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Statistično pomembne razlike so označene (*p < 0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Pri bolnikih z okvaro ledvic lahko pride do povečane sistemske izpostavljenosti sočasnim zdravilom, ki se izločajo predvsem preko ledvic.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Že obstoječo hipokalciemijo je treba zdraviti z zadostnim vnosom kalcija in vitamina D še pred uvedbo zdravljenja z zoledronsko kislino (glejte poglavje 4.3).
− Low level of calcium in the blood.
− nizka raven kalcija v krvi.
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 4 mg je pomembno zmanjšala delež bolnikov, ki so doživeli vsaj po en SRE, odložila mediano časa nastopa prvega SRE za > 5 mesecev in zmanjšala letno incidenco dogodkov na bolnika - stopnjo obolevnosti skeleta.
In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Pri bolnikih z multiplim mielomom se utegne zvečati tveganje za disfunkcijo ledvic, kadar zoledronsko kislino uporabljamo v kombinaciji s talidomidom.
Musculoskeletal pain
Mišičnoskeletna bolečina
Low levels of phosphate in the blood.
Nizke vrednosti fosfatov v krvi.
The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Večina teh učinkov je bila blagih do zmernih, izzveneli so v treh dneh po nastopu.
Special populations (see section 4.2)
Posebne skupine bolnikov (glejte poglavje 4.2)
Elevated bone turnover is a characteristic of Paget's disease of the bone.
Povečana kostna premena je značilnost Pagetove bolezni kosti.
− Blurred vision, tearing of the eye, eye sensitivity to light.
− zamegljen vid, solzenje oči, občutljivost na svetlobo,
− Hypersensitivity reactions.
− preobčutljivostne reakcije,
- In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, anti-adhesion/invasion activity.
- In vitro: Inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku, anti-adhezijsko in anti-invazijsko aktivnost.
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 dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t½α 0,24 in t½β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t½γ 146 ur.
If you experience any of the above side effects, you should contact your doctor immediately.
Če opazite katerega od zgoraj navedenih neželenih učinkov, takoj obvestite svojega zdravnika.
No teratological or embryo/foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/kg due to decreased serum calcium levels.
Pri kuncih niso opazili teratogenih učinkov ali učinkov na zarodek ali plod, čeprav je bila toksičnost za mater pri odmerku 0,1 mg/kg znatna zaradi znižanih koncentracij kalcija v serumu.
Zoledronic acid 8 mg (N=90)
Zoledronska kislina 8 mg (n = 90)
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Skupni telesni očistek je 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Najbolj pomemebno molekularno ciljno mesto zoledronske kisline v osteoklastu je encim farnezil pirofosfat-sintaza.
Zoledronic Acid Hospira is not recommended for anyone under 18 years of age.
Zdravilo Zoledronska kislina Hospira ni priporočljivo za nikogar, ki je star manj kot 18 let.
Your doctor will advise you and decide how long you should be treated with Zoledronic Acid Hospira.
Zdravnik vam bo svetoval in presodil, kako dolgo vas je treba zdraviti z zdravilom Zoledronska kislina Hospira.