FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended initial daily dose of EXJADE dispersible tablets in patients with non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight.
Slovenian: Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila EXJADE v obliki disperzibilnih tablet 10 mg/kg telesne mase.
English: • The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Slovenian: • Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet na začetku zdravljenja 7 mg na kilogram telesne mase.
English: An initial daily dose of 10 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
Slovenian: Začetni dnevni odmerek 10 mg/kg je lahko primeren za bolnike, pri katerih ni treba znižati ravni železa v organizmu in prejemajo manj kot 7 ml/kg/mesec koncentriranih eritrocitov (približno
English: • The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 mg per kilogram body weight.
Slovenian: • Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila EXJADE v obliki disperzibilnih tablet na začetku zdravljenja 10 mg na kilogram telesne mase.
English: The recommended initial daily dose of EXJADE film-coated tablets in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Slovenian: Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila EXJADE v obliki filmsko obloženih tablet 7 mg/kg telesne mase.
English: Do not swallow whole or chew.
Slovenian: Ne pogoltnite cele tablete in je ne žvečite.
English: Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes
Slovenian: Preglednica 2 Priporočeni odmerki pri sindromih talasemije, ki niso odvisni od transfuzij filmsko obložene tablete/zrnca disperzibilne tablete koncentracija železa v jetrih*
English: EXJADE 250 mg dispersible tablets deferasirox
Slovenian: EXJADE 250 mg disperzibilne tablete deferasiroks
English: • The usual daily dose for EXJADE granules at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Slovenian: • Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila EXJADE v obliki zrnc na začetku zdravljenja 14 mg na kilogram telesne mase.
English: • The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Slovenian: • Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila EXJADE v obliki zrnc na začetku zdravljenja 7 mg na kilogram telesne mase.
English: The recommended initial daily dose of EXJADE granules in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Slovenian: Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila EXJADE v obliki zrnc 7 mg/kg telesne mase.
English: Monitoring your EXJADE treatment
Slovenian: Shranjevanje zdravila EXJADE
English: EU/1/06/356/010 294 (3 packs of 98) dispersible tablets
Slovenian: 294 (3 pakiranja po 98) disperzibilnih tablet
English: What EXJADE looks like and contents of the pack EXJADE is supplied as film-coated tablets.
Slovenian: Zdravilo EXJADE je na voljo v obliki filmsko obloženih tablet.
English: In patients treated with doses greater than 30 mg/kg, dose reductions in steps of 5 to 10 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
Slovenian: Ko bolniki, ki se zdravijo z odmerki nad 30 mg/kg, dosežejo urejenost (na primer koncentracijo feritina v serumu vztrajno pod 2.500 µg/l skupaj s trendom zniževanja s časom), je treba razmisliti o postopnem zniževanju odmerka v korakih po 5 do 10 mg/kg.
English: Granules in sachet (granules)
Slovenian: • tesnoba (anksioznost)
English: - if you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”).
Slovenian: Pred začetkom jemanja zdravila EXJADE se posvetujte z zdravnikom ali farmacevtom: - če imate težave z ledvicami ali z jetri, - če imate težave s srcem zaradi preobremenitve z železom, - če opazite izrazito zmanjšanje izločanja urina (znak težav z ledvicami), - če dobite hud izpuščaj, če začnete težko dihati, postanete omotični ali začnete otekati pretežno v obraz in grlo/žrelo (znaki hude alergične reakcije, glejte tudi poglavje 4 “Možni neželeni učinki”), - če opazite kombinacijo katerih koli izmed naslednjih simptomov: izpuščaj, rdeča koža,
English: Deferasirox
Slovenian: Učinkovina je deferasiroks.
English: Cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving deferasirox, with the onset of the reaction occurring in the majority of cases within the first month of treatment (see section 4.8).
Slovenian: Poročali so o primerih resnih preobčutljivostnih reakcij (kot sta anafilaksija in angioedem) pri bolnikih, ki so prejemali deferasiroks.
English: Before initiation of therapy
Slovenian: - ko je dosežen cilj zdravljenja
English: The CHMP opinion will now be sent to the European Commission for a legally binding decision applicable in all EU Member States.
Slovenian: Mnenje CHMB bo posredovano Evropski komisiji v sprejetje pravno zavezujočega sklepa, ki bo veljal v vseh državah članicah EU.
English: Healthcare professionals will also receive a letter in the coming weeks reminding them of the problem.
Slovenian: Zdravstveni delavci bodo v naslednjih tednih prejeli dopis, v katerem bodo opozorjeni na težavo.
English: More information about Noxafil can be found on the Agency's website: ema.europa.eu/Find_medicine.
Slovenian: Več informacij o zdravilu Noxafil je na voljo na spletni strani agencije: ema.europa.eu/Find_medicine.
English: This review was conducted by EMA's Committee for Medicinal Products for Human Use (CHMP) in the context of a procedure known as a ‘type II variation'.
Slovenian: Ta pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA v okviru postopka, znanega kot „sprememba tipa II“.
English: • Noxafil is a medicine used to treat serious infections caused by fungi, when other medicines cannot be used or are not effective.
Slovenian: • Noxafil je zdravilo, ki se uporablja za zdravljenje resnih okužb, ki jih povzročajo glive, kadar se druga zdravila ne smejo uporabljati ali niso učinkovita.
English: • Patients who have any concerns about their medicine should speak to their pharmacist or the prescriber.
Slovenian: • Bolniki, ki imajo kakršne koli pomisleke o svojem zdravilu, naj se posvetujejo s farmacevtom ali zdravnikom, ki jim je predpisal zdravilo.
English: It is used when other medicines do not work or cannot be given, to treat adults with the serious fungal infections invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis.
Slovenian: Uporablja se, kadar druga zdravila niso učinkovita ali se ne smejo dajati, za zdravljenje odraslih z resnimi glivičnimi okužbami, kot so invazivna aspergiloza, fuzarioza, kromomikoza, micetom ali kokcidioidomikoza.
English: • When the medicine is given by mouth, it can be given either as tablets or a liquid, but the dose needed when using the tablets (how much and how often) is different from the one needed when using the liquid.
Slovenian: • Kadar se zdravilo daje peroralno, se lahko daje bodisi v obliki tablet bodisi tekočine, vendar je odmerjanje pri uporabi tablet (koliko in kako pogosto) drugačno kot pri uporabi tekočine.
English: It is also used in patients with weakened immune systems (such as transplant patients) to treat thrush (fungal infection of the throat or mouth due to Candida) or prevent invasive fungal infections.
Slovenian: Uporablja se tudi pri bolnikih z oslabljenim imunskim sistemom (npr. pri bolnikih po transplantaciji) za zdravljenje soora (okužbe v grlu ali ustih, ki jo povzroča gliva Candida) ali za preprečevanje invazivnih glivičnih okužb.
English: Prescriptions should indicate which dose form is intended
Slovenian: Na receptu mora biti navedeno, katera farmacevtska oblika je predvidena
English: • The usual dose of tablets is three tablets (300 mg) twice a day on the first day, then 300 mg once a day.
Slovenian: • Običajni odmerek tablet so tri tablete (300 mg) dvakrat na dan prvi dan, nato pa 300 mg enkrat na dan.
English: Noxafil, a medicine for serious fungal infections, is available by mouth as tablets (100 mg) and oral suspension (40 mg/ml), but the recommended doses for the two forms are different.
Slovenian: Noxafil, zdravilo za resne glivične okužbe, je na voljo za peroralno jemanje v obliki tablet (100 mg) in peroralne suspenzije (40 mg/ml), vendar se priporočena odmerka med tema formulacijama razlikujeta.
English: • Patients should not switch between taking Noxafil tablets and Noxafil oral suspension without talking to their doctor or pharmacist first as it may result in a decreased effectiveness or an increased risk of side effects.
Slovenian: • Bolniki ne smejo zamenjevati tablet in peroralne suspenzije zdravila Noxafil, ne da bi se najprej posvetovali z zdravnikom ali farmacevtom, saj se lahko zmanjša učinkovitost ali poveča tveganje za neželene učinke.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016 EMA/425762/2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24.
English: Noxafil is an antifungal medicine containing the active substance posaconazole, a member of the group of triazole antifungals.
Slovenian: Noxafil je protiglivično zdravilo, ki vsebuje zdravilno učinkovino posakonazol, ki spada v skupino triazolnih protiglivičnih zdravil.
English: It contains the active substance posaconazole.
Slovenian: Vsebuje zdravilno učinkovino posakonazol.
English: Prescribers are advised to make clear which form is intended when they write a prescription, and pharmacists should ensure that the correct form is dispensed.
Slovenian: Zdravnikom, ki predpisujejo zdravilo, svetujemo, naj v receptu jasno navedejo, katero formulacijo predpisujejo, farmacevti pa morajo poskrbeti, da pravo formulacijo tudi izdajo.
English: Doses of the liquid (200 mg, one 5-ml spoonful) are taken three or four times a day.
Slovenian: Zdravilo v obliki tekočine (200 mg, ena 5-ml žlica) se jemlje trikrat ali štirikrat na dan.
English: • Medication errors have been reported following erroneous switching, resulting in over- or underdosage and consequent dose-related toxicity or lack of efficacy.
Slovenian: • Po zmotni zamenjavi so poročali o napakah pri uporabi zdravila, kar je privedlo do premajhnega ali prevelikega odmerjanja in posledične toksičnosti, povezane z odmerkom, ali neučinkovitosti.
English: Some patients have mistakenly received oral solution instead of tablets, leading to underdosing and to a potential lack of effect.
Slovenian: Nekateri bolniki so po pomoti prejeli peroralno suspenzijo namesto tablet, kar je privedlo do premajhnega odmerjanja in možne neučinkovitosti.
English: • There have been cases where patients were provided with the wrong form of the medicine, and so took the wrong dose, resulting either in side effects or in the medicine not being effective.
Slovenian: • Obstajajo primeri bolnikov, ki so prejeli napačno formulacijo zdravila in so tako jemali napačen odmerek, zato so imeli bodisi neželene učinke bodisi zdravilo ni bilo učinkovito.
English: • Noxafil tablets and oral suspension are not interchangeable due to the differences between these two formulations in the frequency of dosing, administration with food and plasma drug concentration achieved.
Slovenian: • Tablete in peroralna suspenzija zdravila Noxafil niso zamenljive, saj se formulaciji razlikujeta po pogostnosti odmerjanja, dajanjem s hrano in doseženimi koncentracijami učinkovine v plazmi.
English: It is available as a solution for infusion (drip) into a vein, but also as tablets and oral suspension for use by mouth.
Slovenian: Na voljo je kot raztopina za infundiranje (kapalno infuzijo) v veno ter v obliki tablet in peroralne suspenzije za jemanje skozi usta.
English: The recommended oral dosage is 300 mg once a day with the tablets (after a loading dose of 300 mg twice daily on day 1) and 200 mg three to four times a day (600 to 800 mg daily) with the oral suspension.
Slovenian: Za tablete je priporočeni peroralni odmerek 300 mg enkrat na dan (po polnilnem odmerku 300 mg dvakrat na dan prvi dan), pri peroralni suspenziji pa 200 mg trikrat do štirikrat na dan (600 do 800 mg na dan).
English: • It is important that the dosage form as well as the relevant dose be specified on the prescription, and that pharmacists ensure the correct oral dosage form is dispensed.
Slovenian: • Pomembno je, da sta na receptu navedena farmacevtska oblika in ustrezni odmerek ter da farmacevt izda pravilno formulacijo.
English: Similarly, there are reports of patients given tablets instead of oral solution, leading to overdosage and side effects.
Slovenian: Podobno obstajajo tudi poročila o bolnikih, ki so prejeli tablete namesto peroralne suspenzija, kar je privedlo do prevelikega odmerjanja in neželenih učinkov.
English: Product information for Noxafil (posaconazole) is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose.
Slovenian: Informacije o zdravilu za zdravilo Noxafil (posakonazol) je treba posodobiti in poudariti opozorilo, da farmacevtski obliki za peroralno dajanje nista zamenljivi v istem odmerku.
English: The product information is therefore to be updated to strengthen existing warnings that the two forms cannot be simply interchanged, and the packaging will also be changed to distinguish the two forms more clearly and to carry a warning statement that they should not be substituted for one another without adjusting the dose.
Slovenian: Zunanja škatla bo spremenjena tako, da bo mogoče formulaciji še lažje razlikovati, vključeno pa bo tudi opozorilo, da se ne moreta preprosto zamenjati, ne da bi se prilagodil tudi odmerek.
English: • The SmPC and patient information leaflet for Noxafil are being updated to strengthen warnings about the differences between the two formulations, and the outer cartons will be revised to further differentiate the two and to include a warning statement that they cannot be simply substituted without adjusting the dose.
Slovenian: • Povzetek glavnih značilnosti zdravila Noxafil in navodilo za njegovo uporabo bosta posodobljena tako, da bodo poudarjena opozorila o razlikah med formulacijama.
English: These reactions will resolve within a maximum of 23 days.
Slovenian: Te reakcije bodo izginile v največ 23 dneh.
English: In the event of contact, wash with clean water.
Slovenian: V primeru stika, umijte s čisto vodo.
English: Avoid contact with skin or eyes.
Slovenian: Izogibajte se stiku s kožo ali očmi.
English: ATCvet code: QJ01DD90.
Slovenian: Oznaka ATCvet: QJ01DD90.
English: When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).
Slovenian: Pri upoštevanju strategije zdravljenja, je primerno, da razmislite o izboljšanju postopka upravljanja s čredo in uporabite podporno terapijo s primernimi lokalnimi proizvodi (npr. razkužila).
English: If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.
Slovenian: Če se klinični znaki ne izboljšajo v 48 urah po zdravljenju, ponovno preverite diagnozo in terapijo bolezenskega stanja.
English: Opaque white to light brown suspension.
Slovenian: Motna bela do rahlo rjava suspenzija.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Pomožne snovi, navedene v poglavju 6.1 SPC, priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadaju v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene v tem zdravilu za uporabo v veterinarski medicini.
English: Take appropriate precautions to avoid intra-arterial or intravenous injection.
Slovenian: Potrebna je previdnost, da se izognete intraarterijskemu ali intravenskemu injiciranju.
English: To ensure a correct dosage, bodyweight should be accurately determined to avoid under-dosing.
Slovenian: Za zagotovitev pravilnega odmerka je potrebno natančno določiti telesno težo, da se izognete prenizkemu odmerjanju.
English: Antiinfectious agents / Antibiotics
Slovenian: Protimikrob na zdravila/anti biotiki
English: Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur
Slovenian: Vsote vseh ostankov z ohranjeno betalaktam sko strukturo kot desfurojilceftiofur
English: No effects on the reproductive performance were observed in both species.
Slovenian: Učinki na reprodukcijo pri obeh vrstah niso bili opaženi.
English: In very rare cases, sudden death has been reported following administration of the product.
Slovenian: V zelo redkih primerih so poročali o nenadni smrti po dajanju zdravila.
English: Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
Slovenian: Močno stresajte stekleničko 30 sekund ali dokler se vsa vidna usedlina ne resuspendira.
English: In cattle, although Naxcel has not been specifically tested for overdoses, no signs of systemic toxicity related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium for five days.
Slovenian: Kljub temu, da Naxcel pri govedu ni bil specifično preizkušen v prekomernem odmerjanju, znaki sistemske toksičnosti, povezane s ceftiofurjem, niso bili opazni po 55 mg/kg parenteralnem dnevnem prekomernem odmerjanju natrijevega ceftiofuriorata pet dni.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki po EXP.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke,tudi tiste ki niso navedeni v tem navodilu za uporabo, ali mislite da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Slovenian: Uporaba zdravila naj temelji na predhodnih mikrobioloških preskušanjih občutljivosti in naj bo v skladu z uradnimi in lokalnimi doktrinami protimikrobnega zdravljenja.
English: Visible swellings have been noted at the injection site in about two thirds of treated animals, two days after injection in field conditions.
Slovenian: Na mestu injiciranja so bile opazne vidne otekline pri približno dveh tretjinah zdravljenih živali, dva dni po injiciranju, v pogojih v praksi.
English: In cattle, ceftiofur is active against the following micro-organisms which are involved in acute postpartum (puerperal) metritis: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum; and interdigital necrobacillosis: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
Slovenian: Pri govedu ceftiofur deluje proti naslednjim mikroorganizmom, ki povzročajo akutni poporodni (puerperalni) metritis: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum in interdigitalno nekrobacilozo: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
English: Diagram of the head showing the direction for the base of the ear injections administered toward the animal's opposite eye.
Slovenian: Skica glave, ki prikazuje smer dajanja injekcij od baze ušesa proti nasprotnemu očesu živali.
English: Protein binding of ceftiofur and its major metabolite is high, approximately 70% - 90%.
Slovenian: Vezava ceftiofurja in njegovega glavnega metabolita na proteine je visoka, okoli 70 - 90 %.
English: Date of last renewal: 26/05/2010.
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 26/05/2010.
English: Once broached, use within 28 days.
Slovenian: Načeto zdravilo porabite v 28 dneh.
English: • Hold the syringe and insert the needle behind the animal's ear so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animal's opposite eye (see
Slovenian: • Držite brizgo in vstavite iglo za ušesom živali tako, da sta igla in brizga usmerjeni v namišljeni liniji, ki kaže skozi glavo proti nasprotnemu očesu živali (glej sliko 2)
English: Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Slovenian: Otekline obraza, ustnic ali oči oziroma težave pri dihanju so resni simptomi, zato nemudoma poiščite zdravniško pomoč.
English: Ceftiofur (as crystalline free acid)
Slovenian: Ceftiofur (kot kristalinična prosta kislina)
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite priloženo navodilo.
English: Therapeutic classification
Slovenian: Druge določbe Terapevtska razvrstitev
English: OTHER INFORMATION Naxcel is available in 50 ml or 100 ml vials.
Slovenian: DRUGE INFORMACIJE Naxcel je na voljo v 50 ml in 100 ml vialah.
English: Pregnancy and fertility:
Slovenian: Brejost in plodnost:
English: It is recommended to limit injection volumes to a maximum of 30 ml per injection site.
Slovenian: Priporočljivo je, da omejite injiciran volumen na največ 30 ml na mesto injiciranja.
English: • Take appropriate precautions to avoid intra-arterial or intravenous injection, such as restraining appropriately the animal (chute or head restraint for example) and using appropriate needles [1 inch (2.54 cm) long, 16 gauge].
Slovenian: • Potrebna je previdnost, da se izognete intraarterijskemu ali intravenskemu injiciranju, tako da primerno fiksirate žival (npr. v jaslih z možnostjo zaklepa glave ali z nosno zadrgo, s prijemom za smrček ali glavo) in uporabite ustrezne igle [dolžina 1 palec (2,54 cm), dimenzija 16 G (gauge)].
English: • Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae,
Slovenian: • Zdravljenje bakterijskih respiratornih obolenj, ki so povezana z Actinobacillus pleuropneumoniae,
English: Date of first authorisation: 08/10/2009.
Slovenian: Datum pridobitve dovoljenja za promet: 08.10.2009.
English: Maximum concentrations in plasma (about 5 µg/ml) occurred from 12 hours following administration.
Slovenian: Najvišja koncentracija v plazmi (okoli 5 μg/ml) je dosežena 12 ur po dajanju.
English: Occasionally, transient local swelling may occur following intramuscular injection.
Slovenian: Po intramuskularnem dajanju se občasno lahko pojavi prehodna lokalna oteklina.
English: Resolution has been observed at 56 days post-injection.
Slovenian: Spremembe izginejo v 56 dneh po dajanju.
English: Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa.
Slovenian: Preobčutljivost na peniciline lahko vodi do navzkrižne reakcije na cefalosporine in obratno.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Slovenian: Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.