FrancophonIA/ELRC3.0 huggingface dataset:
English: years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
Slovenian: jih je imelo protitelesa anti-HBs ≥ 10 mi.e./ml.
English: I.M.
Slovenian: (HPV).
English: The full EPAR for Zoledronic acid Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Actavis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina Actavis, veljavno po vsej Evropski uniji, izdala 20. aprila 2012.
English: For more information about treatment with Zoledronic acid Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zoledronska kislina Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Slovenian: Poleg tega bo družba, ki trži zdravilo Zoledronska kislina Actavis, pripravila kartico, s katero bo bolnike seznanila s tveganji osteonekroze čeljustnice (poškodbe čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih ali majanje zob) in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
English: Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Zoledronska kislina Actavis generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: This means that Zoledronic acid Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zometa.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Actavis.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Slovenian: Pri uporabi zdravila za preprečevanje z okostjem povezanih zapletov se infundiranje lahko ponovi vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D. Pri bolnikih s kostnimi metastazami (rakom, ki se je razširil na kost), ki imajo blage do zmerne težave z ledvicami, je priporočljiv manjši odmerek zdravila.
English: The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes.
Slovenian: Običajni odmerek zdravila Zoledronska kislina Actavis je ena 4-miligramska infuzija v trajanju vsaj 15 minut.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Actavis has been shown to be comparable to Zometa.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Zoledronska kislina Actavis primerljivo z zdravilom Zometa.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Actavis?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoledronska kislina Actavis?
English: A risk management plan has been developed to ensure that Zoledronic acid Actavis is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Zoledronska kislina Actavis je bil pripravljen načrt obvladovanja tveganj.
English: Zoledronic acid Actavis can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Slovenian: Zdravilo Zoledronska kislina Actavis se lahko uporablja za preprečevanje zapletov, povezanih z okostjem, pri odraslih z napredovalim rakom, ki vpliva na kosti.
English: Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg).
Slovenian: Zoledronska kislina Actavis je zdravilo, ki vsebuje zdravilno učinkovino zoledronsko kislino (4 mg).
English: Zoledronic acid Actavis can also be used to treat the hypercalcaemia caused by tumours.
Slovenian: Zdravilo Zoledronska kislina Actavis se lahko uporablja tudi za zdravljenje hiperkalcemije, ki jo povzročajo tumorji.
English: What are the benefits and risks of Zoledronic acid Actavis?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina Actavis?
English: Zoledronic acid Actavis must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Slovenian: Zdravilo Zoledronska kislina Actavis smejo uporabljati le zdravniki z izkušnjami z uporabo te vrste zdravil za intravensko uporabo.
English: The Committee recommended that Zoledronic acid Actavis be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Zoledronska kislina Actavis izda dovoljenje za promet.
English: Zoledronic acid Actavis is a ‘generic medicine'.
Slovenian: Zdravilo Zoledronska kislina Actavis je „generično zdravilo“.
English: By preventing the breakdown of bones, Zoledronic acid Actavis also helps to reduce the amount of calcium released into the blood.
Slovenian: Zdravilo Zoledronska kislina Actavis s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Zometa odtehtajo znana tveganja.
English: Other information about Zoledronic acid Actavis
Slovenian: Druge informacije o zdravilu Zoledronska kislina Actavis
English: Zoledronic acid Actavis zoledronic acid
Slovenian: Zoledronska kislina Actavis zoledronska kislina
English: The active substance in Zoledronic acid Actavis, zoledronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina zdravila Zoledronska kislina Actavis, zoledronska kislina, je difosfonat.
English: No additional studies were needed as Zoledronic acid Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Slovenian: Ker je zdravilo Zoledronska kislina Actavis generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Zometa, niso bile potrebne nobene dodatne študije.
English: Why has Zoledronic acid Actavis been approved?
Slovenian: Zakaj je bilo zdravilo Zoledronska kislina Actavis odobreno?
English: How has Zoledronic acid Actavis been studied?
Slovenian: Kako je bilo zdravilo Zoledronska kislina Actavis raziskano?
English: What is Zoledronic acid Actavis used for?
Slovenian: Za kaj se zdravilo Zoledronska kislina Actavis uporablja?
English: How is Zoledronic acid Actavis used?
Slovenian: Kako se zdravilo Zoledronska kislina Actavis uporablja?
English: What is Zoledronic acid Actavis?
Slovenian: Kaj je zdravilo Zoledronska kislina Actavis?
English: How does Zoledronic acid Actavis work?
Slovenian: Kako zdravilo Zoledronska kislina Actavis deluje?
English: It is particularly important that you mention any of the following medicines.
Slovenian: Zlasti je pomembno, da omenite katero koli izmed naslednjih zdravil.
English: if you are pregnant.
Slovenian: - če ste noseči.
English: In men, no data are available.
Slovenian: Podatki za moške niso na voljo.
English: Do not give this medicine to children and adolescents from birth up to age of 18 years as safety and efficacy in children and adolescents have not been established.
Slovenian: Ne dajajte tega zdravila otrokom in mladostnikom od rojstva do 18. leta starosti, saj varnost in učinkovitost pri otrocih in mladostnikih nista bili dokazani.
English: Distribution into testes is relatively low.
Slovenian: Distribucija v testise je relativno nizka.
English: Time to recovery
Slovenian: Čas do okrevanja
English: The dosage of the medicine will be adjusted in accordance with the results of these tests.
Slovenian: Odmerek zdravila se prilagodi v skladu z rezultati teh testov.
English: Therefore you should talk to your doctor if you are planning to become pregnant in the future; your eggs may need to be frozen.
Slovenian: Zato morate pogovoriti s svojim zdravnikom, če nameravate zanositi v prihodnosti; morda bo treba vaša jajčeca zamrzniti.
English: The usual dose is:
Slovenian: Običajni odmerek:
English: Plasma concentrations decrease rapidly during the first two hours and slowly thereafter.
Slovenian: Plazemske koncentracije se hitro zmanjšujejo v prvih dveh urah, potem pa se zmanjšujejo počasi.
English: Contraception in men and women
Slovenian: Kontracepcija pri moških in ženskah
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojne oblasti države članice lahko informacije o zdravilu pozneje posodobijo ob sodelovanju referenčne države članice, če je to potrebno, skladno s postopki, določenimi v 4. poglavju naslova III Direktive 2001/83/ES.
English: There are insufficient data that allows for dose adjustment recommendations.
Slovenian: Ni dovolj podatkov, da bi bilo mogoče podati priporočila za prilagajanje odmerkov.
English: {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Slovenian: {Ime in naslov} {Tel.} {Faks} {E-pošta}
English: Most complete remissions will occur following the initial course of induction therapy.
Slovenian: Večina popolnih remisij se bo zgodila po prvem krogu indukcijskega zdravljenja.
English: If you suffer from these side effects, do not drive any vehicles and/or use any machines.
Slovenian: Če trpite zaradi teh neželenih učinkov, ne vozite vozil in/ali ne upravljajte s stroji.
English: In cases of overdosage patients should be monitored closely.
Slovenian: V primerih prevelikega odmerka je treba bolnike skrbno spremljati.
English: Safety and efficacy have not been established.
Slovenian: Varnost in učinkovitost nista bili dokazani.
English: The individual dose of Novantrone is calculated by your doctor.
Slovenian: Posamezni odmerek zdravila Novantrone izračuna vaš zdravnik.
English: Its presumed mechanism of action in MS is immunosuppression.
Slovenian: Njegov domnevni mehanizem delovanja pri MS je imunosupresija.
English: - Blood poisoning (sepsis).
Slovenian: - zastrupitev krvi (sepsa),
English: Recovery > 21 days
Slovenian: Izboljšanje > 21 dni
English: To date, only isolated cases of severe local reactions (necroses) have been described due to extravasation.
Slovenian: Do danes so znani le posamezni primeri hude lokalne reakcije (nekroza) zaradi ekstravazacije.
English: Infection (including fatal outcome)
Slovenian: Okužba (vključno s smrtnim izidom)
English: Any duration
Slovenian: Ne glede na trajanje
English: Recovery ≤ 21 days
Slovenian: Izboljšanje ≤ 21 dni
English: Particular care should be given to assuring full haematological recovery before undertaking consolidation therapy (if this treatment is used) and patients should be monitored closely during this phase.
Slovenian: Posebno pozornost je treba nameniti zagotavljanju popolnega hematološkega okrevanja, preden se začne konsolidacijsko zdravljenje (če je to zdravljenje načrtovano), in bolnike je v tej fazi treba skrbno spremljati.
English: A reduction of neurologic disability worsening and frequency of clinical relapses was observed.
Slovenian: Opaženo je bilo zmanjšanje poslabšanja nevrološke prizadetosti in pogostnosti kliničnih relapsov.
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Slovenian: Če jemljete katero od teh zdravil, vam bo vaš zdravnik morda moral predpisati drugo zdravilo.
English: Cardiac function for cancer patients should be carefully monitored during treatment.
Slovenian: Srčno funkcijo pri bolnikih z rakom je treba med zdravljenjem skrbno spremljati.
English: Repeat prior dose
Slovenian: Ponovite predhodni odmerek
English: In addition your blood will be tested regularly during the treatment.
Slovenian: Poleg tega boste med zdravljenjem redno opravljali krvne teste.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so rezultat postopka predložitve, na katerega se nanaša odločitev Komisije.
English: Opportunistic infections
Slovenian: Oportunistična okužba
English: Also the time course over which the cumulative dose was given ranged from 3 to 24 months.
Slovenian: Tudi časovni potek, v katerem je bilo dano zdravilo, je bil v razponu od 3 do 24 mesecev.
English: Of the material recovered in urine, 65 % was unchanged active substance.
Slovenian: Od materiala v urinu je bilo 65 % nespremenjene zdravilne učinkovine.
English: Withhold until recovery, then repeat prior dose.
Slovenian: Ne dajajte do izboljšanja, potem ponovite predhodni odmerek.
English: This is in general a transient neutropenia with the lowest count of leucocytes at day 10 after the infusion and recovered around day 20.
Slovenian: Na splošno gre za prehodno nevtropenijo z najnižjim številom levkocitov na 10. dan po infuziji in z okrevanjem okoli 20. dneva.
English: The table below is based on safety data derived from clinical trials and spontaneous reporting in oncological indications and from clinical trials, post authorisation safety studies and spontaneous reporting for patients treated for multiple sclerosis.
Slovenian: Spodnja tabela temelji na podatkih o varnosti, ki izhajajo iz kliničnih raziskav in spontanih poročil o onkoloških indikatorjih, ter iz kliničnih raziskav, študij o varnosti zdravila po pridobitvi dovoljenja in spontanih poročil o bolnikih, zdravljenih zaradi multiple skleroze.
English: If this happens, the infusion must be stopped and restarted in another vein.
Slovenian: V tem primeru je treba infuzijo prekiniti in jo namestiti v drugo veno.
English: Your doctor will decide precisely which subsequent dosage you need.
Slovenian: Zdravnik bo natančno določil, kateri naslednji odmerek potrebujete.
English: Your doctor may need to adjust your treatment or stop Novantrone temporarily or permanently.
Slovenian: Zdravnik bo morda moral prilagoditi vaše zdravljenje z zdravilom Novatrone ali ga začasno ali trajno ustaviti.
English: Patients should be informed about risks, symptoms and signs of acute leukaemia and prompted to seek medical attendance if any such symptoms should occur even after the five year period has passed.
Slovenian: Bolnike je treba poučiti o tveganjih, simptomih in znakih akutne levkemije ter jim naročiti, naj poiščejo zdravniško pomoč, če se pojavijo takšni simptomi, tudi po petih letih.
English: No effects were observed on pup development or fertility in the two generation study in rats.
Slovenian: Učinkov na razvoj mladičev ali plodnost v študijah dveh generacij podgan niso ugotovili.
English: There is little experience in children and adolescents.
Slovenian: Izkušenj z zdravljenjem otrok in mladostnikov je malo.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
English: Haematological parameters should be regularly monitored (see section 4.4).
Slovenian: Hematološke parametre je treba redno spremljati (glejte poglavje 4.4).
English: There does not seem to be relevant differences in pharmacokinetics of mitoxantrone between elderly and young adult patients.
Slovenian: Ni opaziti pomembnih razlik v farmakokinetiki mitoksantrona med starejšimi in mlajšimi odraslimi bolniki.
English: LVEF evaluation is recommended at regular intervals and/or if signs or symptoms of congestive heart failure develop.
Slovenian: Ocena LVEF se priporoča v rednih časovnih presledkih in/ali pri znakih ali simptomih razvoja kongestivnega srčnega popuščanja.
English: The remaining 35 % was composed of monocarboxylic and dicarboxylic acid derivatives and their glucuronide conjugates.
Slovenian: Preostalih 35 % so sestavljali derivati monokarboksilne in dikarboksilne kisline ter njihovih glukuronidnih konjugatov.
English: 4.7 Effects on ability to drive and use machines Mitoxantrone has minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Mitoksantron nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: You should also tell your doctor if you are already taking Novantrone and you are prescribed a new medicine that you have not already taken at the same time as Novantrone.
Slovenian: Prav tako morate svojemu zdravniku povedati, če že prejemate zdravilo Novantrone in vam želi predpisati novo zdravilo, ki ga še niste jemali istočasno kot zdravilo Novantrone.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including sulphites that may be produced during the manufacturing of mitoxantrone.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, vključno s sulfiti, ki lahko nastanejo med proizvodnjo mitoksantrona.
English: A cumulative dose of 72 mg/m² is still effective and associated with less cardiotoxicity than higher cumulative doses.
Slovenian: Kumulativni odmerek 72 mg/m² je še vedno učinkovit in povezan z manjšo kardiotoksičnostjo kot višji kumulativni odmerki.
English: The medicine also suppresses the immune system and is used because of this effect to treat a specific form of multiple sclerosis when there are no alternative treatment options.
Slovenian: Zdravilo zavira tudi imunski sistem in se zaradi tega učinka uporablja za zdravljenje posebne oblike multiple skleroze, kadar ni druge možnosti zdravljenja.
English: • if you use Novantrone in high doses (>14 mg/m2 per day x 3 days).
Slovenian: • če jemljete zdravilo Novantrone v velikih odmerkih (> 14 mg/m2 na dan x 3 dni).
English: Extravasation*
Slovenian: Ekstravazacija*
English: Your doctor will decide exactly what dosage you need.
Slovenian: Zdravnik bo natančno določil, kakšen odmerek potrebujete.
English: Differences in the estimates may be due to the availability of data at late times after doses, weighing of the data and assay sensitivity.
Slovenian: Razlog za razlike v ocenah so lahko razpoložljivost podatkov kasneje po prejetih odmerkih, presoja podatkov in občutljivost analiz.
English: Single and repeat toxicity studies were conducted in mouse, rat, dog, rabbits, and monkey.
Slovenian: Študije toksičnosti po enkratnih in ponavljajočih odmerkih so bile opravljene na miših, podganah, psih, kuncih in opicah.
English: Your doctor will carry out blood tests more often, in which he will in particular monitor the number of white blood cells (neutrophilic leucocytes) in the blood:
Slovenian: Vaš zdravnik bo pogosteje opravljal krvne preiskave, v katerih bo zlasti spremljal število belih krvnih celic (nevtrofilnih levkocitov):
English: This treatment should be used only after assessment of the benefit-risk, particularly concerning the haematological and cardiac risks (see section 4.4).
Slovenian: To zdravljenje se lahko uvede le po oceni koristi in tveganj, zlasti hematoloških tveganj in tveganj za srce (glejte poglavje 4.4).
English: Novantrone may cause damage to your unborn child.
Slovenian: Zdravilo Novantrone lahko škoduje vašemu nerojenemu otroku.
English: Therapy with mitoxantrone should be accompanied by close and frequent monitoring of haematological and chemical laboratory parameters, as well as frequent patient observation.
Slovenian: Zdravljenje z mitoksantronom mora spremljati natančno in pogosto spremljanje hematoloških in kemijskih laboratorijskih parametrov, kot tudi pogosto opazovanje s strani bolnika.
English: Many of the reported half-life values for the elimination phase are between 10 and 40 hours, but several other authors have reported much longer values of between 7 and 12 days.
Slovenian: Številni avtorji študij so poročali o razpolovni dobi faze izločanja med 10 in 40 urami, medtem ko je več drugih poročalo o veliko daljši razpolovni dobi 7 do 12 dni.
English: This is caused by possible side effects, such as confusion or feeling tired (see section 4).
Slovenian: Tako je zaradi morebitnih neželenih učinkov, kot sta zmedenost ali utrujenost (glejte poglavje 4).
English: The first course was given approximately 6 weeks after the final induction course; the second was generally administered 4 weeks after the first.
Slovenian: Prvi krog zdravljenja so dali približno 6 tednov po zadnjem krogu indukcijskega zdravljenja; drugi je bil običajno 4 tedne po prvem.
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000
Slovenian: Pogostnost je bila določena skladno z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Women of childbearing potential should be informed about increased risk of transitory or persistent amenorrhoea (see section 4.6).
Slovenian: Ženske v rodni dobi je treba seznaniti s povečanim tveganjem za prehodno ali trajno amenorejo (glejte poglavje 4.6).
English: Novantrone must not be used during pregnancy for treatment of multiple sclerosis (specifically in the first three months of the pregnancy).
Slovenian: Novantrone se ne sme uporabljati med nosečnostjo za zdravljenje multiple skleroze (še posebej v prvih treh mesecih nosečnosti).
English: This may occur either during or months to years after therapy with Novantrone.
Slovenian: To se lahko zgodi bodisi med zdravljenjem ali več mesecev in let po zdravljenju z zdravilom Novantrone.
English: This dosage is given in 21 day-cycles, for induction therapy in AML during three consecutive days, for consolidation therapy during two days.
Slovenian: Ta odmerek je bil dan v 21-dnevnih ciklih, pri indukcijskem zdravljenju AML v treh zaporednih dneh, za konsolidacijsko zdravljenje tekom dveh dni.