FrancophonIA/ELRC3.0 huggingface dataset:
English: C) anidulafungin (~88 mg) was administered to healthy subjects.
Slovenian: V kliničnem preskušanju posamičnega odmerka so zdravim preskušancem dali radioaktivno označen C) anidulafungin (~88 mg).
English: In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred.
Slovenian: Klinično pomembne jetrne nenormalnosti so se pojavile pri nekaterih bolnikih z resnimi osnovnimi boleznimi, ki so sočasno z anidulafunginom dobivali več zdravil.
English: Table of Adverse Reactions System Organ
Slovenian: Preglednica neželenih učinkov Organski sistem Zelo pogosti
English: ECALTA 100 mg powder for concentrate for solution for infusion Anidulafungin
Slovenian: ECALTA 100 mg prašek za koncentrat za raztopino za infundiranje anidulafungin
English: The solution should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Raztopino je treba pred uporabo vizualno pregledati, da ne vsebuje delcev in ni obarvana.
English: Common to
Slovenian: Občasni do
English: 30 mL 100 mL 130 mL 1.4 mL/ min
Slovenian: 1,4 ml/min
English: General pharmacokinetic characteristics
Slovenian: Splošne farmakokinetične značilnosti
English: 6 Week Follow-up Calculated as anidulafungin minus fluconazole With or without concurrent candidaemia c
Slovenian: Spremljanje po 6 tednih izračunano kot anidulafungin minus flukonazol s sočasno kandidemijo ali brez nje c intraabdominalni prikazani so podatki bolnikov z enim samim patogenom na začetku preskušanja e
English: Skin and Subcutaneous Tissue Disorders
Slovenian: Bolezni kože in podkožja izpuščaj, pruritus urtikarija
English: Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a nonclinical (rat) study (see section 5.3).
Slovenian: V neklinični študiji (na podganah) so zabeležili poslabšanje z infundiranjem povezanih reakcij med sočasno uporabo anestetikov (glejte poglavje 5.3).
English: The contents of the vial must be reconstituted with water for injections and subsequently diluted with ONLY 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
Slovenian: Vsebino viale morate rekonstituirati z vodo za injekcije in nato razredčiti SAMO z raztopino 9 mg/ml (0,9 %) natrijevega klorida za infundiranje ali raztopino 50 mg/ml (5 %) glukoze za infundiranje.
English: Patients were randomised to receive either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or fluconazole (800 mg intravenous loading dose followed by 400 mg intravenous daily), and were stratified by APACHE II score (≤20 and >20) and the presence or absence of neutropaenia.
Slovenian: Bolnike so randomizirali na prejemanje bodisi anidulafungina (200 mg intravenski polnilni odmerek, ki mu je sledila aplikacija po 100 mg na dan intravensko) bodisi flukonazola (800 mg intravenski polnilni odmerek, ki mu je sledila aplikacija po 400 mg na dan intravensko).
English: ECALTA must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose for infusion.
Slovenian: Zdravilo ECALTA morate rekonstituirati z vodo za injekcije in nato razredčiti SAMO z raztopino 9 mg/ml (0,9 %) natrijevega klorida za infundiranje ali raztopino 50 mg/ml (5 %) glukoze za infundiranje.
English: EUCAST Breakpoints
Slovenian: Mejne vrednosti po odboru EUCAST
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Slovenian: 6.1 Seznam pomožnih snovi fruktoza manitol polisorbat 80 vinska kislina natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
English: Infusion solution
Slovenian: Raztopina za infundiranje
English: The reconstituted solution may be stored up to 25°C for up to 24 hours prior to further dilution.
Slovenian: Rekonstituirano raztopino lahko pred nadaljnjim redčenjem hranite do največ 24 ur pri temperaturi do največ 25 °C.
English: - If you get any side effects, talk to your doctor, or pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Respiratory, Thoracic and Mediastinal Disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bronhospazem, dispneja
English: Parenterally administered anidulafungin was effective against Candida species in immunocompetent and immunocompromised mouse and rabbit models.
Slovenian: Pri imunokompetentnih in imunsko oslabelih miših in kuncih je bil parenteralno aplicirani anidulafungin učinkovit proti vrstam Candida.
English: Powder for concentrate for solution for infusion
Slovenian: 1 viala prašek za koncentrat za raztopino za infundiranje
English: A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Slovenian: Prvi dan je treba aplicirati en sam 200 mg polnilni odmerek, potem pa po 100 mg na dan. Trajanje zdravljenja mora temeljiti na kliničnem odzivu bolnika.
English: After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified.
Slovenian: Če po nadaljnjem razredčenju ugotovite prisotnost delcev ali obarvanje, morate raztopino zavreči.
English: A successful global response was defined as both clinical and microbiologic success EOIVT, End of Intravenous Treatment; EOT, End of All Treatment
Slovenian: EOIVT - konec intravenskega zdravljenja; EOT - konec celotnega zdravljenja
English: Hepatic metabolism of anidulafungin has not been observed.
Slovenian: Presnove anidulafungina v jetrih niso opazili.
English: No dose limiting toxicity was observed in a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (3 x Upper Limit of Normal (ULN)).
Slovenian: Pri 3 od 10 preskušancev se je pojavilo prehodno, asimptomatsko zvišanje transaminaz ( 3-kratna zgornja meja normale (ZMN)).
English: The reconstituted solution may be stored at up to 25°C for up to 24 hours.
Slovenian: Rekonstituirana raztopina Rekonstituirano raztopino lahko hranite do največ 24 ur pri temperaturi do 25 °C.
English: Talk to your doctor or pharmacist or nurse before using ECALTA.
Slovenian: Pred začetkom uporabe zdravila ECALTA se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: ECALTA 100 mg powder for concentrate for solution for infusion anidulafungin
Slovenian: ECALTA 100 mg prašek za koncentrat za raztopino za infundiranje anidulafungin i.v.
English: Total infusion volume
Slovenian: Celotna količina za infundiranjeB
English: Posology
Slovenian: škatla
English: The reconstituted solution may be stored up to 25C for up to 24 hours.
Slovenian: Rekonstituirano raztopino lahko hranite do največ 24 ur pri temperaturi do 25 C.
English: Insufficient evidence
Slovenian: DRUGI PODATKI
English: The powder is white to off-white.
Slovenian: Prašek bele do belkaste barve.
English: Rare to
Slovenian: Pogosti do
English: Pleural cavity
Slovenian: Okvara ledvic
English: Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.
Slovenian: Pri zdravih preskušancih in bolnikih, zdravljenih z anidulafunginom, so poročali o zvišanih ravneh jetrnih encimov.
English: How to store ECALTA
Slovenian: Shranjevanje zdravila ECALTA
English: Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, noncomparative studies.
Slovenian: V analizi združenih podatkov iz 4 prospektivnih, odprtih, neprimerjalnih preskušanj s podobnim načrtom so ocenili bolnike z mikrobiološko potrjeno invazivno kandidozo (populacija MITT) in nevtropenijo.
English: Ask your doctor or pharmacist for advice before taking ECALTA while breast-feeding.
Slovenian: Preden v obdobju dojenja uporabite zdravilo ECALTA, se posvetujte z zdravnikom ali farmacevtom.
English: - if you are given anaesthetics during your treatment with ECALTA.for signs of an allergic reaction such as itching, wheezing, blotchy skin - for signs of an infusion-related reaction which could include a rash, hives, itching, redness, - for shortness of breath/breathing difficulties, dizziness or lightheadedness
Slovenian: - glede znakov alergijske reakcije, kot so srbenje, piskajoče dihanje, lisasta koža.
English: Contact your doctor immediately if you become pregnant while taking ECALTA.
Slovenian: Če med zdravljenjem z zdravilom ECALTA zanosite, se nemudoma posvetujte z zdravnikom.
English: Fructose
Slovenian: c absces
English: Within 4 years after Commission decision
Slovenian: V štirih letih po sklepu Komisije
English: Within 3 months after Commission decision
Slovenian: V treh mesecih po sklepu Komisije
English: From the date of notification of the Commission Decision
Slovenian: Od dneva obvestila o sklepu Komisije
English: Methotrexate-containing products for oral use with at least one indication requiring once weekly dosing Each MAH should operate a risk management system to be described in a risk management plan (RMP) which shall be submitted to the relevant Competent Authorities.
Slovenian: Zdravila, ki vsebujejo metotreksat, za peroralno uporabo z vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden Vsi imetniki dovoljenj za promet z zdravilom morajo upravljati sistem za obvladovanje tveganja, ki ga je treba opisati v načrtu za obvladovanje tveganj (RMP), tega pa je treba predložiti zadevnim pristojnim organom.
English: The RMP should reflect the following additional risk minimisation measures to address the important identified risk of medication errors resulting in overdose: - educational material(s) for healthcare professionals developed in accordance with the key elements agreed; - the agreed patient card.
Slovenian: Načrt za obvladovanje tveganj mora odražati naslednje ukrepe za zmanjšanje tveganja, ki obravnavajo pomembno ugotovljeno tveganje za napake pri uporabi zdravila, ki privedejo do prevelikega odmerjanja: - izobraževalna gradiva za zdravstvene delavce, pripravljena v skladu s ključnimi dogovorjenimi elementi; - dogovorjena bolnikova kartica.
English: All methotrexate-containing products Each MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Slovenian: Vsa zdravila, ki vsebujejo metotreksat Vsi imetniki dovoljenj za promet z zdravilom morajo uvesti dogovorjene vprašalnike za spremljanje vseh napak pri uporabi zdravila, ki privedejo do prevelikega odmerjanja.
English: MAHs should replace any bottle or tube used as immediate packaging by blisters.
Slovenian: Pri formulacijah v obliki tablet je treba uvesti tudi naslednji ukrep: imetniki dovoljenj za promet z zdravilom morajo stekleničke ali epruvete, ki se uporabljajo kot stična ovojnina, nadomestiti s pretisnimi omoti.
English: Your doctor will decide which is best for you.
Slovenian: Vaš zdravnik bo odločil, kaj je za vas najbolje.
English: · Risk Management plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: The recommended treatment duration is 6 weeks.
Slovenian: Priporočen čas zdravljenja je 6 tednov.
English: It is unlikely to be serious.
Slovenian: Zelo malo je verjetno, da bi to imelo resne posledice.
English: This multidose preparation can be used for several patients.
Slovenian: Ta večodmerni pripravek lahko uporabimo za več bolnikov.
English: Please discuss this with your doctor.
Slovenian: Prosimo, da se o tem pogovorite s svojim zdravnikom.
English: Other in-use storage times and conditions are the responsibility of the user.
Slovenian: Drugačen čas shranjevanja raztopine in drugi pogoji shranjevanja so odgovornost uporabnika.
English: (See instruction for use at the end of this leaflet)
Slovenian: (Glejte navodila na koncu tega navodila za uporabo.)
English: It needs to be treated at once.
Slovenian: To reakcijo je treba takoj zdraviti.
English: · If you do not hear a click, look to see that the needle is fully covered by the safety shield.
Slovenian: • Če ne slišite klika, poglejte, če je igla v celoti pokrita z varnostno zaščito.
English: Treatment must be started under the supervision of your doctor.
Slovenian: Zdravljenje je treba začeti pod nadzorom zdravnika.
English: Poorly controlled hypertension.
Slovenian: Slabo nadzorovana hipertenzija.
English: Make sure you always hold the syringe as shown in the picture below.
Slovenian: Prepričajte se, da vedno držite brizgo, kot je prikazano na sliki.
English: In this case dose increases may be necessary.
Slovenian: V tem primeru bodo morda potrebni večji odmerki.
English: Children will start by following the same guidelines.
Slovenian: Otroci bodo začeli z zdravljenjem po enakih navodilih.
English: In this case, proceed to step 19 and contact your healthcare provider.
Slovenian: V tem primeru nadaljujte s korakom 19 in se obrnite na zdravstvenega delavca.
English: Appropriate dose titration should be considered.
Slovenian: Upoštevati je treba primerno titracijo odmerka.
English: These may be signs of severely elevated blood pressure (hypertensive crisis), even if your blood pressure is usually normal or low.
Slovenian: To so lahko znaki zelo povišanega krvnega tlaka (hipertenzivne krize), čeprav je vaš krvni tlak običajno normalen ali nizek.
English: This is a multidose preparation from which different single doses can be withdrawn over a period of 1 month after dissolution.
Slovenian: To je večodmerni pripravek, iz katerega lahko odvzamemo več enkratnih odmerkov v 1 mesecu po raztopitvi.
English: Your doctor will always record the exact product you are using.
Slovenian: Zdravnik bo vedno zabeležil natančno tisto zdravilo, ki ga uporabljate.
English: 8 Wash your hands with soap and water.
Slovenian: 8 Roke si umijte z milom in vodo.
English: The first dose is usually given to you under medical supervision, because of the possibility of an allergic reaction.
Slovenian: Prvi odmerek boste prejeli pod zdravniškim nadzorom, ker obstaja možnost alergične reakcije.
English: (4) Replace the needle by a new one (the new needle should have the size which you normally use for injections).
Slovenian: (4) Iglo zamenjajte z novo (nova igla naj ima tako velikost, kot jo običajno uporabljate za injekcije).
English: D-82377 Penzberg Germany
Slovenian: D-82377 Penzberg Nemčija
English: Do not inject within 5 cm (2 inches) area directly around your belly button.
Slovenian: Ne injicirajte v območju 5 cm (2 palcev) okoli popka.
English: (7) Hold the OPC (One-Point-Cut) ampoule with the blue point upwards.
Slovenian: (7) Držite ampulo OPC (one point cut) z modro piko kvišku.
English: · Gently twist until it is fully attached (C)
Slovenian: • Rahlo jo privijte, dokler ni popolnoma pritrjena (C).
English: · Do not speed up the warming process in any way, and do not put the syringe in a microwave or in warm water.
Slovenian: • Na noben način ne pospešujte postopka ogrevanja in injekcijske brizge ne dajajte v mikrovalovno pečico ali v toplo vodo.
English: Your doctor will take regular blood samples.
Slovenian: Zdravnik vam bo redno jemal vzorce krvi.
English: · Subcutaneous administration (under the skin).
Slovenian: • subkutano dajanje (pod kožo).
English: Patients with cancer
Slovenian: Bolniki z rakom
English: These reactions were usually mild to moderate and went away within a few hours or days.
Slovenian: Te reakcije so bile večinoma blage do zmerne in so izginile po nekaj urah ali dneh.
English: In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: · If needed, you may cover the injection site with a small bandage.
Slovenian: • Če je treba, lahko mesto injiciranja prekrijete z majhnim obližem.
English: Blood pressure monitoring
Slovenian: Kontrola krvnega tlaka
English: Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
Slovenian: Na nalepko napišite datum priprave raztopine in rok uporabnosti (rok uporabnosti je 1 mesec po rekonstituciji).
English: 1 Find a well-lighted, clean, flat, working surface.
Slovenian: 1 Poiščite dobro osvetljeno, čisto in ravno delovno površino.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.
Slovenian: Pod nobenim pogojem ne smemo brizge uporabiti za več kot en odmerek; zdravilo je samo za enkratno uporabo.
English: Do not use glass materials for injection, use only plastic materials.
Slovenian: Za injiciranje ne uporabljajte steklenih materialov, ampak samo plastične.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Slovenian: Epoetini niso odobreni za zdravljenje anemije, povezane s hepatitisom C.
English: Subcutaneous and intravenous use.
Slovenian: Subkutana in intravenska uporaba.
English: [units]
Slovenian: (enote)
English: First wash your hands!
Slovenian: Pred uporabo si skrbno umijte roke!
English: 9 Select a vein.
Slovenian: 9 Izberite veno.
English: 18 Move the safety shield forward 90°, away from the syringe barrel (A).
Slovenian: 18 Varnostno zaščito premaknite za 90° naprej, stran od valja injekcijske brizge (A).
English: This should avoid a blockage in the tubing of the dialysis system.
Slovenian: To bo preprečilo zamašitev cevi dializnega sistema.
English: Your healthcare provider will show you how to prepare and inject NeoRecormon properly before you use it for the first time.
Slovenian: Vaš zdravstveni delavec naj vam pokaže, kako pravilno pripraviti in injicirati zdravilo NeoRecormon, preden ga prvič uporabite.
English: Warnings and precautions
Slovenian: Opozorila in previdnostni ukrepi:
English: However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
Slovenian: V nadzorovanih kliničnih študijah povečane incidence preobčutljivostnih reakcij niso opazili.
English: Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Slovenian: Epoetin beta je pridobljen s specializirano genetsko tehnologijo in deluje popolnoma enako kakor naravni hormon eritropoetin.
English: 17 There may be a little bleeding at the injection site.
Slovenian: 17 Na mestu injiciranja se lahko pojavi manjša krvavitev.
English: Remark: If the syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger.
Slovenian: Opomba: Če injekcijska brizga ne doseže sobne temperature, to lahko to povzroči neprijetno injiciranje in otežuje potiskanje bata.
English: Water for injections.
Slovenian: voda za injekcije.
English: The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
Slovenian: Potrebna količina vnaprej darovane krvi je izražena v enotah, pri čemer je ena enota v nomogramu enakovredna 180 ml rdečih krvničk.
English: Your doctor might prescribe acetylsalicylic acid or modify the shunt.
Slovenian: Zdravnik vam lahko predpiše acetilsalicilno kislino ali spremeni spoj.
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 updatespublished on the European medicines web-portal
Slovenian: 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: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Slovenian: Kot pri vseh rastnih dejavnikih, obstaja tudi pri epoetinih bojazen, da bi lahko vzpodbujali rast tumorjev.
English: During the entire treatment period, a PCV of 48 % should not be exceeded.
Slovenian: Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48 %.
English: This can be treated by your doctor.
Slovenian: To lahko vaš zdravnik pozdravi.
English: ·Do not inject into a red or swollen area.
Slovenian: • Ne injicirajte v rdečo ali otečeno področje.
English: Depending on your individual situation a blood transfusion may be preferable.
Slovenian: Od vsakega posameznega primera je odvisno ali je morda transfuzija krvi primernejša.
English: The terminal half-life is higher than after intravenous administration, with an average of 13 - 28 hours.
Slovenian: Končni razpolovni čas je daljši kot pri intravenskem vnosu, in sicer znaša v povprečju 13−28 ur.
English: The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality, cardiovascular morbidity, or end stage renal disease (ESRD).
Slovenian: Študija ni dosegla primarnega cilja - dokazati zmanjšanje tveganja za splošno umrljivost, srčnožilno obolevnost ali končno ledvično odpoved (KLO).
English: Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula.
Slovenian: Obe spremenljivki določata endogeno rezervo rdečih krvničk, ki jo lahko izračunamo z naslednjo formulo:
English: Maintenance phase
Slovenian: Vzdrževalna stopnja
English: The injections of epoetin beta will increase the amount of blood that can be taken from your body before surgery and given back during or after the operation (this is an autologous transfusion).
Slovenian: Injekcije epoetina beta bodo povečale količino krvi, ki vam jo lahko pred operacijo odvzamejo in nato po operaciji ali med njo ponovno vrnejo (to imenujemo avtologna transfuzija).
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Slovenian: To povzroči hudo slabokrvnost, katere simptomi vključujejo neobičajno utrujenost in pomanjkanje energije.
English: As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
Slovenian: Ker so v posameznih primerih opazili preobčutljivostne reakcije, priporočamo, naj bolnik prejme prvi odmerek pod zdravniškim nadzorom.
English: · Medicines should not be disposed of via wastewater or household waste.
Slovenian: • Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Slovenian: V dve študiji so bili vključeni bolniki, ki so se zdravili s kemoterapijo.
English: Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Slovenian: To je treba upoštevati pri bolnikih s hudo obliko fenilketonurije.
English: Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.
Slovenian: Vendar moramo pri odmerjanju upoštevati priporočeno shemo odmerjanja, ker individualnega odziva na zdravilo ni mogoče napovedati.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Slovenian: O takih primerih so poročali pri bolnikih s hepatitisom C, zdravljenih z interferonom in ribavirinom, pri sočasni uporabi epoetinov.
English: Therefore, it is recommended that the platelet count be determined at least once a week in these patients.
Slovenian: Zato je pri teh bolnikih število trombocitov priporočljivo določati vsaj enkrat na teden.
English: The dose worked out by your doctor will be given twice per week for 4 weeks.
Slovenian: Odmerek, ki ga je določil vaš zdravnik, boste prejemali dvakrat na teden 4 tedne.