FrancophonIA/ELRC3.0 huggingface dataset:
English: Laventair Ellipta was also shown to improve symptoms such as breathlessness and wheezing.
Slovenian: Zdravilo Laventair Ellipta prav tako dokazano lajšalo simptome, kot je težko ali piskajoče dihanje.
English: The Agency concluded that Laventair Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Slovenian: Zaključila je, da se je zdravilo Laventair Ellipta izkazalo za učinkovito pri izboljševanju delovanja pljuč in simptomov KOPB v primerjavi s placebom, posameznima učinkovinama in tiotropijem.
English: Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.
Slovenian: V štirih glavnih študijah so zdravilo Laventair Ellipta in kombinacijo z večjim odmerkom umeklidinijevega bromida in vilanterola primerjali s placebom (zdravilom brez učinkovine), vilanterolom samim, umeklidinijevim bromidom samim in drugim zdravilom za zdravljenje KOPB, imenovanim tiotropij.
English: Results showed that Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Slovenian: Rezultati so pokazali, da je zdravilo Laventair Ellipta po 24 tednih zdravljenja izboljšalo delovanje pljuč v smislu povečanja povprečne vrednosti FEV1 za 167 ml več kot placebo.
English: When inhaled, vilanterol reaches the receptors in the airways and activates them.
Slovenian: Ko bolnik vdihne vilanterol, ta doseže receptorje v dihalnih poteh in jih aktivira, zaradi česar se mišice dihalnih poti sprostijo.
English: Laventair Ellipta contains the active substances umeclidinium bromide and vilanterol.
Slovenian: Zdravilo vsebuje učinkovini umeklidinijev bromid in vilanterol.
English: Laventair Ellipta can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Laventair Ellipta je le na recept.
English: The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.
Slovenian: Po 24 tednih zdravljenja se je povprečna vrednost FEV1 ob uporabi zdravila Laventair Ellipta povečala za 90 ml več kot pri zdravljenju s tiotropijem.
English: How is Laventair Ellipta used?
Slovenian: Kako se zdravilo Laventair Ellipta uporablja?
English: How does Laventair Ellipta work?
Slovenian: Kako zdravilo Laventair Ellipta deluje?
English: < PC: {number} SN: {number} NN: {number} >
Slovenian: < PC: {številka} SN: {številka} NN: {številka} >
English: The response rate in these patients was about 52%.
Slovenian: Delež odziva pri teh bolnikih je bil okrog 52%.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09 Desember 2016
Slovenian: Datum prve odobritve: 20. april 2012 Datum zadnjega podaljašnja: 9. december 2016
English: However, such reports have been infrequent.
Slovenian: Vendar so bili takšni primeri redki.
English: In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Slovenian: Še zlasti ni bilo jasnih dokazov o učinkovitost glede incidence zlomov ali bolečin.
English: 20014 Nerviano (MI) Italy
Slovenian: 20014 Nerviano (MI) Italija
English: Any SRE (+TIH)
Slovenian: Katerikoli SRE (+TIH)
English: You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Slovenian: Zato morate biti previdni pri upravljanju motornih vozil, uporabi strojev in opravljanju drugih nalog, ki zahtevajo popolno pozornost.
English: Median time to normocalcaemia was 4 days.
Slovenian: Mediani čas do normokalciemije je bil 4 dni.
English: Your doctor will monitor this and take any necessary measures.
Slovenian: Zdravnik vas bo kontroliral in bo ustrezno ukrepal.
English: In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Slovenian: V večini primerov ni potrebno kakšno posebno zdravljenje in simptomi v kratkem (čez nekaj ur ali dni) izginejo.
English: The frequencies for each of these identified risks are shown in Table 1.
Slovenian: Pogostnosti vsakega od teh ugotovljenih tveganj prikazuje Preglednica 1.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet:
English: There is no evidence to suggest that any extra precautions are needed.
Slovenian: Ni dokazov, da bi bili potrebni posebni previdnostni ukrepi.
English: - Increased sweating.
Slovenian: - Povečano znojenje.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na voljo, so opisani v poglavju 5.1, a priporočil za odmerjanje ni mogoče dati.
English: - if you have or have had a kidney problem.
Slovenian: - če imate ali ste imeli kakšne težave z ledvicami.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2°C - 8°C.
English: Poor healing of these fractures has also been reported.
Slovenian: Opisano je tudi slabo celjenje teh zlomov.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če datum predložitve PSUR in posodobitve RMP sovpadata, se lahko predložita sočasno.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden dobite to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
English: Risk reduction of suffering from multiple events**
Slovenian: Zmanjšanje tveganja za pojav multiplih dogodkov** (%)
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Slovenian: Celotni telesni očistek je 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
English: NR 714
Slovenian: ND 714
English: The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Slovenian: Mehanizem večje incidence atrijske fibrilacije v tem enem kliničnem preskušanju ni znan.
English: Most patients had relief of symptoms after stopping treatment.
Slovenian: Pri večini bolnikov so simptomi po prenehanju zdravljenja minili.
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Slovenian: CLcr se izračuna iz vrednosti serumskega kreatinina po Cockcroft-Gaultovi formuli.
English: EU/1/12/759/001 1vial EU/1/12/759/002 4 vials EU/1/12/759/003 10 vials
Slovenian: EU/1/12/759/001 1viala EU/1/12/759/002 4 viale EU/1/12/759/003 10 vial
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Slovenian: Varnost in učinkovitost zoledronske kisline pri otrocih od 1 do 17 let starosti nista ugotovljeni.
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Slovenian: Simptomi so se pojavili v času od enega dneva do več mesecev po začetku zdravljenja.
English: - Confusion.
Slovenian: - Zmedenost.
English: • To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Slovenian: • Za znižanje količine kalcija v krvi pri odraslih, kadar je ta zaradi prisotnosti tumorja prevelika.
English: In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Slovenian: Hipokalciemija je v nekaterih primerih lahko življenjsko ogrožajoča (glejte poglavje 4.8).
English: * Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
Slovenian: * Vključuje vretenčne in nevretenčne zlome ** Upošteva vse skeletne dogodke, njihovo celotno število in čas do vsakega dogodka med preskušanjem.
English: Baseline Creatinine Clearance (ml/min)
Slovenian: Izhodiščni očistek kreatinina (ml/min)
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
English: Tell your doctor if you are or think that you may be pregnant.
Slovenian: Zdravniku morate povedati, če ste noseči, ali če mislite, da ste noseči.
English: Pack sizes: 1, 4 or 10 vials.
Slovenian: Pakiranja po 1, 4 ali 10 vial.
English: The following response rates were observed:
Slovenian: Ugotovili so naslednje deleže odziva:
English: Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Slovenian: Preglednica 5: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah TIH
English: Acute phase reaction, pain
Slovenian: Reakcija akutne faze, bolečina
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Slovenian: Če se pojavi hipokalciemija, hipofosfatemija ali hipomagneziemija, je lahko potrebno kratkotrajno zdravljenje z dodajanjem.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP .
English: - Sleepiness.
Slovenian: - Zaspanost.
English: - Low level of red blood cells (anaemia).
Slovenian: - Nizko število rdečih krvnih celic (anemija).
English: Nausea, vomiting, decreased appetite
Slovenian: Navzea, bruhanje, zmanjšan apetit
English: - 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.
Slovenian: - Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, odvisno od tega, kako izrazite so vaše težave z ledvicami.
English: Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Slovenian: Starost, telesna masa, spol in očistek kreatinina ne vplivajo na sistemsko izpostavljenost zoledronski kislini.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
Slovenian: V dolgoročnih študijah na živalih zoledronska kislina zavira resorpcijo kosti, ne da bi neugodno vplivala na nastajanje, mineralizacijo ali mehanske lastnosti kosti.
English: Pyrexia, fatigue
Slovenian: Pireksija, utrujenost
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Slovenian: Ti prečni ali kratki poševni zlomi se lahko pojavijo kjerkoli na stegnenici, od tik pod malim trohantrom do tik nad suprakondilarno razširitvijo.
English: Zoledronic acid Actavis is supplied as packs containing 1, 4 or 10 vials.
Slovenian: Zdravilo Zoledronska kislina Actavis je opremljeno v pakiranjih, ki vsebujejo 1, 4 ali 10 vial.
English: The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Slovenian: Najpogostejša ugotovitev v študijah večkratnih odmerkov je bilo povečanje primarne spongioze v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih; ta ugotovitev odraža farmakološki antiresorpcijski učinek zdravila.
English: Additional information on handling of Zoledronic acid Actavis, including guidance on preparation of reduced doses, is provided in section 4.2.
Slovenian: Dodatne informacije o ravnanju z zdravilom Zoledronska kislina Actavis, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
English: Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased.
Slovenian: Tumorji lahko pospešijo normalno spreminjanje kosti tako, da se poveča sproščanje kalcija iz kosti.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Slovenian: - Okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
English: From a microbiological point of view, the solution for infusion should be used immediately after dilution.
Slovenian: Z mikrobiološkega stališča je treba raztopino za infundiranje uporabiti takoj po redčenju.
English: Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
Slovenian: Zdravila Zoledronska kislina Actavis ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: abdominal pain, dry mouth.
Slovenian: stomatitis, suha usta.
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Slovenian: Pogostnost SRE (dogodki/človek-leto) je bila 0,628 z zoledronsko kislino in 1,096 s placebom.
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Slovenian: Podaljšanje časa infundiranja s 5 na 15 minut je povzročilo 30% znižanje koncentracije zoledronske kisline ob koncu infuzije, ni pa vplivalo na površino pod krivuljo plazemske koncentracije po času.
English: The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Slovenian: Obdobje zdravljenja v študiji je trajalo 12 mesecev; pred tem so bolniki opravili od 4- do 9-tedensko obdobje presejanja, med katerim so vsaj 2 tedna jemali vitamin D in dodatke elementarnega kalcija.
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: Za bolnike s hudo insuficienco jeter je kliničnih podatkov malo, zato za to populacijo bolnikov ni mogoče dati specifičnih priporočil.
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Actavis and inform your doctor about your dental treatment.
Slovenian: - če imate kakšno zobozdravstveno zdravljenje ali imate predviden kakšen zobozdravstveni poseg, morate svojemu zobozdravniku povedati, da dobivate zdravilo Zoledronska kislina Actavis in obvestite svojega zdravnika o zdravljenju zob.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Actavis properly.
Slovenian: Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako pravilno shranjevati zdravilo Zoledronska kislina Actavis.
English: - Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Slovenian: - Huda alergijska reakcija: kratka sapa, oteklost predvsem obraza in žrela.
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Slovenian: V opravljenih testih mutagenosti zoledronska kislina ni bila mutagena, testiranje kancerogenosti pa ni dalo nobenih dokazov o kancerogenem potencialu.
English: Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Slovenian: Omejeni farmakokinetični podatki pri otrocih s hudo osteogenesis imperfecta kažejo, da so farmakokinetične lastnosti zoledronske kisline pri otrocih v starosti od 3 do 17 let pri podobni ravni odmerjanja v mg/kg podobne kot pri odraslih.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Slovenian: - Zamegljen vid, solzenje, občutljivost oči za svetlobo.
English: - Low counts of white blood cells and blood platelets.
Slovenian: - Majhno število belih krvnih celic in krvnih ploščic.
English: If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Slovenian: Če se vam koncentracija kalcija preveč zniža, boste morda morali dobiti dodatni kalcij z infuzijo.
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Slovenian: Bolniki z nezdravljeno hiperkalciemijo imajo na splošno določeno mero okvare ledvic, zato jim je treba natančno kontrolirati delovanje ledvic.
English: - For single use only.
Slovenian: - Samo za enkratno uporabo.
English: The highest non-lethal single intravenous dose was 10 mg/kg bodyweight in mice and 0.6 mg/kg in rats.
Slovenian: Največji neletalni enkratni intravenski odmerek je bil 10 mg/kg telesne mase pri miših in 0,6 mg/kg pri podganah.
English: Proportion of patients with SREs p-value
Slovenian: Delež bolnikov s SRE (%) Vrednost p
English: - Painful redness and/or swelling of the eye.
Slovenian: - Boleča pordelost in/ali oteklost oči.
English: In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Slovenian: Poleg tega, da močno zavira resorpcijo kosti, ima zoledronska kislina tudi več protitumorskih lastnosti; te bi lahko pripomogle k njeni celotni učinkovitosti pri zdravljenju metastatske bolezni kosti.
English: Women of childbearing potential should be advised to avoid becoming pregnant.
Slovenian: Ženskam v rodni dobi je treba naročiti, naj pazijo, da ne bodo zanosile.
English: Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Slovenian: Bolnikom, ki nimajo previsoke koncentracije kalcija v krvi, bo zdravnik predpisal tudi dodatke kalcija in vitamina D, ki jih je treba jemati vsak dan.
English: Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Slovenian: Pozornost je treba nameniti možnemu pojavu hipomagneziemije med zdravljenjem.
English: - Sudden coldness with fainting, limpness or collapse.
Slovenian: - Nenadna hladnost z omedlevico, šibkostjo ali kolapsom.
English: Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): - Omedlevica zaradi nizkega krvnega tlaka.
English: MM/YYYY
Slovenian: MM. LLLL
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: Prejemniki 4 mg zoledronske kisline so navajali manjši porast bolečin kot prejemniki placeba in razlika je bila značilna 3., 9., 21. in 24. mesec.
English: The following information is intended for healthcare professionals only: How to prepare and administer Zoledronic acid Actavis
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Priprava in dajanje zdravila Zoledronska kislina Actavis
English: Follow carefully all instructions given to you by your doctor.
Slovenian: Natančno upoštevajte vsa zdravnikova navodila.
English: Contains mannitol, sodium citrate and water for injections.
Slovenian: Vsebuje manitol, natrijev citrat in vodo za injekcije.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Slovenian: - antiangiogena zdravila (uporabljana za zdravljenjue raka), ker kombinacijo le-teh z zoledronsko kislino povezujejo s povečanim tveganjem za osteonekrozo čeljustnic (ONČ).
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic acid Actavis belongs), or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na zoledronsko kislino, kakšen drug difosfonat (skupina zdravil, v katero spada zdravilo Zoledronska kislina Actavis) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Slovenian: Akutna odpoved ledvic, hematurija, proteinurija Pridobljen Fanconijev sindrom
English: If a lower dose of Zoledronic acid Actavis 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 nižji odmerek zdravila Zoledronska kislina Actavis, najprej izvlecite ustrezno količino, kot je označeno spodaj, in nato naprej redčite s 100 ml raztopine za infundiranje.
English: Tell your doctor about any of the following serious side effects straight away:
Slovenian: Zdravniku morate takoj povedati, če se vam pojavi kateri od naslednjih resnih neželenih učinkov:
English: - Difficulty in breathing with wheezing or coughing.
Slovenian: - Težko dihanje s piskanjem ali kašljem.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Slovenian: To so lahko znaki okvare čeljusti (osteonekroze).
English: Anxiety, sleep disturbance
Slovenian: Anksioznost, motnja spanja
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Slovenian: Reprodukcijske študije z zoledronsko kislino na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5.3).
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Slovenian: Naslednji neželeni učinki, navedeni v Preglednici 1, so zbrani iz kliničnih študij in iz postmarketinških poročil po pretežno kroničnemu zdravljenju s 4 mg zoledronske kisline:
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Slovenian: V zelo redkih primerih sta se med uporabo zoledronske kisline pojavili dremavost in zaspanost.
English: Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Slovenian: Ocenjeni učinki zdravljenja na MGK so bili podobni pri obeh učinkovinah, vendar načrt preskušanja ni bil dovolj robusten, da bi lahko potrdili neinferiornost zoledronske kisline.
English: 5 ml concentrate in a plastic vial made of clear, colourless oleofinic polymer closed with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Slovenian: 5 ml koncentrata v plastični viali iz prozornega, brezbarvnega oleofinskega polimera, zaprti z zamaškom iz brombutilne gume, prekrite s fluoropolimerom, in aluminijsko zaporsko s plastičnim snemnim delom.