FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 19 November 2012 Date of latest renewal: 24 August 2017
Slovenian: Datum prve odobritve: 19. november 2012 Datum zadnjega podaljšanja: 24. avgust 2017
English: NR Not Reached
Slovenian: NR ni bil dosežen
English: This will help to prevent dehydration.
Slovenian: S tem boste preprečili dehidriranost.
English: Local reactions
Slovenian: Lokalne reakcije
English: However, such reports have been infrequent.
Slovenian: O takih primerih so poročali le redko.
English: Withdraw an appropriate volume of the concentrate needed, as follows:
Slovenian: Odvzemite ustrezni volumen koncentrata, ki ga potrebujete, kot sledi:
English: Some side effects could be serious
Slovenian: Nekateri neželeni učinki so lahko resni
English: (included in section 1 text)
Slovenian: (vključeno v besedilu v poglavju 1)
English: Patients who have received doses higher than those recommended should be carefully monitored.
Slovenian: Bolnike, ki so dobili večje odmerke od priporočenih, je treba skrbno spremljati.
English: It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Slovenian: Pomembno je, da ta nasvet natančno upoštevate, da se raven kalcija v vaši krvi v obdobju po infuziji ne zniža preveč.
English: Each pack contains one bag.
Slovenian: Vsako pakiranje vsebuje eno vrečo.
English: Hypotension (some of the patients had underlying risk factors)
Slovenian: hipotenzija (pri nekaterih od the bolnikov so bili že prej prisotni dejavniki tveganja)
English: This process is called remodelling.
Slovenian: Ta proces se imenuje kostna premena (remodeliranje).
English: There is no evidence to suggest that any extra precautions are needed.
Slovenian: Ni dokazov, ki bi nakazovali, da so potrebni posebni previdnostni ukrepi.
English: The infusion must be conducted according to standard medical practice.
Slovenian: Postopek infundiranja morate opraviti v skladu s standardno medicinsko prakso.
English: It is normal that old bone is removed and is replaced with new bone material.
Slovenian: Normalno je, da se stara kost odstranjuje in da jo nadomešča nova kostnina.
English: Each pack contains one vial with concentrate.
Slovenian: Vsako pakiranje vsebuje eno vialo s koncentratom.
English: Most patients had relief of symptoms after stopping treatment.
Slovenian: Pri večini bolnikov je prišlo do olajšanja simptomov po prekinitvi zdravljenja.
English: After opening: 24 hours at 2°C - 8°C
Slovenian: Po odprtju: 24 ur pri 2 °C - 8 °C
English: Your doctor will monitor this and take any necessary measures.
Slovenian: Zdravnik bo spremljal te vrednosti in ustrezno ukrepal,
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Tell your doctor if you are or think that you may be pregnant.
Slovenian: Povejte zdravniku, če ste noseči ali menite, da bi lahko bili noseči.
English: The frequency of hypocalcaemia was much lower following subsequent infusions.
Slovenian: Pogostnost hipokalciemije je bila pri nadaljnjih infuzijah precej nižja.
English: As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Slovenian: Ker so za bolnike s hudo insuficienco jeter na voljo le omejeni klinični podatki, za to skupino bolnikov ne moremo dati specifičnih priporočil.
English: No interaction studies with other medicinal products have been performed.
Slovenian: Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
English: The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
Slovenian: Običajni odmerek je 5 mg, ki vam ga v obliki enkratne infuzije da vaš zdravnik ali medicinska sestra.
English: Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Slovenian: Zdravnik vas bo poučil o simptomih, povezanih s hipokalciemijo.
English: Physicians should consider clinical monitoring for these patients.
Slovenian: Zdravniki naj pretehtajo potrebo po kliničnem spremljanju teh bolnikov.
English: - if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
Slovenian: − če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka),
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
Slovenian: To je zlasti pomembno pri bolnikih, ki prejemajo diuretike (tablete za odvajanje vode), in pri starejših bolnikih.
English: − Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Slovenian: − Zdravnik vam bo priporočil, da pred vsako infuzijo spijete dovolj vode, kar bo pomagalo preprečiti dehidracijo.
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Slovenian: V prvih 24 urah se izloči v urin 39 ± 16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
English: No symptomatic cases of hypocalcaemia were observed.
Slovenian: Simptomatskih primerov hipokalciemije niso opažali.
English: If the disease is not treated, bones may become deformed and painful, and may break.
Slovenian: Če bolezni ne zdravimo, se kost lahko deformira in začne boleti, lahko se tudi zlomi.
English: - if you are unable to take daily calcium supplements.
Slovenian: − če ne morete vsak dan jemati nadomestkov kalcija,
English: Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Slovenian: Neželeni učinki, povezani s prvo infuzijo, so zelo pogosti (pojavijo se pri več kot 30 % bolnikov), pri naslednjih infuzijah pa so manj pogosti.
English: Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Slovenian: Bolniki, ki so prejemali zoledronsko kislino 4 mg, so poročali o manjšem povečanju bolečine, kot bolniki, ki so prejemali placebo, razlika pa je postala pomembna v 3., 9., 21. in 24 mesecu.
English: − Low level of red blood cells (anaemia).
Slovenian: − nizko število rdečih krvnih celic (anemija).
English: The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Slovenian: Večina poročil se nanaša na bolnike z rakom po ekstrakciji zoba ali drugih zobozdravstvenih operativnih posegih.
English: - if you have severe kidney problems.
Slovenian: − če imate hude težave z ledvicami,
English: No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Slovenian: Prilagajanje odmerjanja ni potrebno, ker so vrednosti biološke uporabnosti, porazdelitve in izločanja iz telesa pri starejših bolnikih in mlajših preskušancih podobne.
English: Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Slovenian: Bolnike je treba poučiti o simptomih hipokalciemije in jim med obdobjem tveganja nuditi ustrezno klinično spremljanje.
English: Zoledronic Acid Hospira may work for longer than one year, and your doctor will let you know if you need to be treated again.
Slovenian: Zdravilo Zoledronska kislina Hospira lahko učinkuje dlje kot eno leto, zato vam bo zdravnik povedal, če vas je treba ponovno zdraviti.
English: − Increased sweating
Slovenian: − zvečano znojenje,
English: Risk reduction of suffering from multiple events** (%)
Slovenian: zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
English: * Common in Paget's disease only.
Slovenian: * pogosto samo pri Pagetovi bolezni.
English: Stable for 24 hours at 2
Slovenian: EXP Po redčenju stabilno 24 ur pri 2
English: − Fainting due to low blood pressure.
Slovenian: − izguba zavesti zaradi nizkega krvnega tlaka,
English: Teratology studies were performed in two species, both via subcutaneous administration.
Slovenian: Študije teratogenosti so opravili pri dveh živalskih vrstah, pri obeh s subkutano uporabo.
English: The symptoms are usually mild to moderate and go away within three days.
Slovenian: Simptomi so običajno blagi do zmerni in izzvenijo v treh dneh.
English: 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.
Slovenian: 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.
English: − Confusion.
Slovenian: − zmedenost,
English: Atypical fractures of the femur During post-marketing experience the following reactions have been reported (frequency rare):
Slovenian: Atipičen zlom stegnenice Med izkušnjami v obdobju trženja so poročali o naslednjih neželenih učinkih (pogostnost je redka):
English: Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Slovenian: Pamidronat 90 mg (n = 99) *vrednosti p v primerjavi s pamidronatom.
English: • 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).
Slovenian: • Posamezen odmerek zoledronske kisline ne sme presegati 5 mg, infuzija pa mora trajati najmanj 15 minut (glejte poglavje 4.2).
English: In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
Slovenian: V preskušanjih zdravljenja Pagetove bolezni so opažali simptomatsko hipokalciemijo pri približno 1 % bolnikov, pri katerih je tudi izzvenela.
English: 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.
Slovenian: 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.
English: These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Slovenian: Dobljeni rezultati so se skladali z dokazi biokemijskih označevalcev normalizacije kostne premene.
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Slovenian: Podatki o ponovnem zdravljenju Pagetove bolezni so omejeni (glejte poglavje 5.1).
English: Tell your doctor about any of the following side effects as soon as possible:
Slovenian: Čimprej povejte zdravniku za kateregakoli od naslednjih neželenih učinkov:
English: Painful redness and/or swelling of the eye.
Slovenian: − boleča rdečina in/ali oteklina očesa.
English: ** Accounts for all skeletal events, the total number as well as time to each event during the trial
Slovenian: ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem
English: − Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
Slovenian: − Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zoledronsko kislino.
English: - Patients with hypocalcaemia (see section 4.4).
Slovenian: - Bolniki s hipokalciemijo (glejte poglavje 4.4).
English: The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Slovenian: Mehanizem, na katerem temelji zvečana incidenca atrijske fibrilacije v tem edinem kliničnem preskušanju, ni znan.
English: This is especially important for the elderly and for patients receiving diuretic therapy.
Slovenian: To je posebno pomembno pri starejših in pri bolnikih, ki jemljejo tudi diuretike.
English: If you wear dentures you should make sure these fit properly.
Slovenian: Če imate zobno protezo, morate poskrbeti, da se ta dobro prilega dlesnim.
English: 1 intravenous bag
Slovenian: 1 intravenska vreča
English: Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Slovenian: Zato interakcije, ki bi bile posledica izrivanja zdravil, pretežno vezanih na beljakovine, niso verjetne.
English: In the clinical trials, renal deterioration was defined as follows:
Slovenian: V kliničnih preskušanjih so opredelili ledvično poslabšanje takole:
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Slovenian: Neželeni učinki, kot je na primer omotica, lahko vplivajo na sposobnost vožnje in upravljanja strojev.
English: The infusion time must not be less than 15 minutes.
Slovenian: Čas infundiranja ne sme biti krajši od 15 minut.
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Slovenian: Da bi zmanjšali tveganje za razvoj osteonekroze čeljustnic, je treba upoštevati nekaj previdnostnih ukrepov.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Slovenian: Rezultat bolečine za zoledronsko kislino je bil dosledno pod izhodiščno vrednostjo, zmanjšanje bolečine pa je spremljal trend zmanjšanja analgetičnega seštevka.
English: 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.
Slovenian: • 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).
English: − Low blood pressure.
Slovenian: − nizek krvni tlak,
English: − Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Slovenian: − huda okvara ledvic (običajno jo ugotovi zdravnik z določenimi specifičnimi krvnimi preiskavami),
English: Additional information on handling of Zoledronic Acid Hospira, including guidance on preparation of reduced doses, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina Hospira, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
English: 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.
Slovenian: 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.
English: If you feel dizzy while taking Zoledronic Acid Hospira, do not drive or use machines until you feel better.
Slovenian: Če ste med uporabo zdravila Zoledronska kislina Hospira omotični, ne vozite in ne upravljajte strojev, dokler vam ni bolje.
English: The infusion will take at least 15 minutes.
Slovenian: Infuzija traja vsaj 15 minut.
English: Concentrate for solution for infusion (sterile concentrate)
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat)
English: Clinical experience with acute overdose is limited.
Slovenian: Klinične izkušnje z akutnim prevelikim odmerjanjem so omejene.
English: Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Slovenian: Bolniki, ki so se odzvali na zdravljenje v 6-mesečni osnovni študiji, so veljali za primerne za podaljšano spremljanje.
English: Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Slovenian: osteonekroza čeljustnice (glejte poglavji 4.4 in 4.8 Učinki po skupinah)
English: Any SRE (+TIH)
Slovenian: Katerikoli SRE (+TIH) Zlomi*
English: 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.
Slovenian: 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.
English: Zoledronic acid should not be used during pregnancy.
Slovenian: Zoledronske kisline se ne sme uporabljati med nosečnostjo.
English: The mechanism behind the increased incidence of atrial fibrillation is unknown.
Slovenian: Mehanizem, na katerem temelji višja incidenca atrijske fibrilacije, ni znan.
English: - 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.
Slovenian: - Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina Hospira.
English: Arthritis and joint swelling as a symptom of acute phase reaction
Slovenian: Redki artritis in otekline sklepov kot simptom reakcije akutne faze
English: − Urticaria.
Slovenian: − koprivnica.
English: Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Slovenian: Histologijo kosti so ovrednotili pri 7 bolnikih s Pagetovo boleznijo 6 mesecev po zdravljenju s 5 mg zoledronske kisline.
English: The majority of these reactions occur within the first three days following zoledronic acid administration.
Slovenian: Večina teh učinkov je nastopila v prvih treh dneh po aplikaciji zoledronske kisline.
English: 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).
Slovenian: 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).
English: Zoledronic Acid Hospira can be given to people aged 65 years and over.
Slovenian: Zdravilo Zoledronska kislina Hospira se lahko daje bolnikom, starim 65 let in več.
English: Zoledronic Acid Hospira may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Slovenian: 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
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic Acid Hospira.
Slovenian: Skrbno se ravnajte po vseh navodilih zdravnika, farmacevta ali medicinske sestre, preden vam dajo zdravilo Zoledronska kislina Hospira.
English: It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat.
Slovenian: Pomembno je, da poskušamo preprečiti razvoj osteonekroze čeljustnic, saj je to zelo boleče stanje, ki ga je večkrat težko zdraviti.
English: 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.
Slovenian: 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.
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Slovenian: V primeru hipokalciemije je treba dati infuzijo kalcijevega glukonata kot je klinično indicirano.
English: In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Slovenian: Pri Pagetovi bolezni je kostna premena prehitra, nova kostnina pa se tvori nepravilno, zato je šibkejša od normalne.
English: 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.
Slovenian: 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.
English: Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
English: 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%).
Slovenian: 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 %).
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA08
English: − Difficulty in breathing with wheezing or coughing.
Slovenian: − težave z dihanjem s sopenjem ali kašljanjem,
English: 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.
Slovenian: 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.
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Slovenian: 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.
English: Clinical efficacy in the treatment of Paget's disease of the bone
Slovenian: Klinična učinkovitost pri zdravljenju Pagetove bolezni kosti
English: For information on the infusion of Zoledronic Acid Hospira, see section 6.6.
Slovenian: Za informacije o infundiranju zdravila Zoledronska kislina Hospira glejte poglavje 6.6.
English: 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)
Slovenian: 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)