FrancophonIA/ELRC3.0 huggingface dataset:
English: Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.
Bulgarian: Преди да предприемат имунизация на кучета в райони със слабо или никакво наличие на Leishmania infantum ветеринарните лекари трябва да направят оценка на съотношението полза/риск.
English: Why has CaniLeish been approved?
Bulgarian: Какви са основанията за одобряване на CaniLeish?
English: The company presented data from three main studies involving over 3,000 patients.
Bulgarian: Фирмата представи данни от три основни проучвания, обхващащи над 3000 пациенти.
English: The main measure of effectiveness was a reduction in symptoms of 20% or more, based on a standard rating score (ACR-20), after 16 weeks of treatment.
Bulgarian: Основната мярка за ефективност е намаляването на симптомите с 20% или повече въз основа на стандартен скор на оценка (ACR-20) след 16 седмици на лечение.
English: 10 November 2017 EMA/727596/2017 EMEA/H/C/004165
Bulgarian: EMA/727596/2017 EMEA/H/C/004165
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
Bulgarian: В писмото, с което фирмата уведомява Агенцията за оттеглянето на заявлението, се посочва, че предвид необходимостта от допълнителни клинични данни и факта, че се предлагат други лечения, блокиращи действието на интерлевкин-6, фирмата желае да даде приоритет на други програми от своето портфолио.
English: It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Bulgarian: То се предлага под формата на инжекционен разтвор в предварително напълнени писалки и спринцовки (50 mg).
English: The CHMP's main concern was that the long-term safety of Plivensia had not been well characterised due to limitations in the design of the main studies.
Bulgarian: Основната забележка на СНМР е, че дългосрочната безопасност на Plivensia не е добре охарактеризирана поради ограничения в дизайна на основните проучвания.
English: What is Plivensia?
Bulgarian: Какво представлява Plivensia?
English: Plivensia is a medicine that contains the active substance sirukumab.
Bulgarian: Plivensia е лекарство, което съдържа активното вещество сирукумаб (sirukumab).
English: The active substance in Plivensia, sirukumab, is a monoclonal antibody, a type of protein which has been designed to block a molecule called interleukin-6.
Bulgarian: Активното вещество в Plivensia, сирукумаб, е моноклонално антитяло - вид протеин, разработен да блокира молекула, наречена интерлевкин-6.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven long-term safety, the benefits of Plivensia did not outweigh its risks, and that further studies were needed.
Bulgarian: Поради това към момента на оттеглянето становището на CHMP е, че ползите от Plivensia не превишават рисковете поради липса на доказана дългосрочна безопасност, и че са необходими допълнителни проучвания.
English: The company informed the CHMP that it will discontinue the ongoing long-term extension study with Plivensia in patients with rheumatoid arthritis.
Bulgarian: Фирмата уведоми СНМР, че ще прекрати провежданото понастоящем дългосрочно разширено проучване с Plivensia при пациенти с ревматоиден артрит.
English: The third study compared Plivensia with adalimumab (a monoclonal antibody targeting a chemical messenger called tumour necrosis factor - TNF) in patients who could not take methotrexate or whose condition had not responded adequately to methotrexate; the study looked at the improvement in how patients' joints worked (based on a standard rating score called DAS28-ESR) after 24 weeks of treatment.
Bulgarian: Третото проучване сравнява Plivensia с адалимумаб (моноклонално антитяло, насочено към химичен куриер, наречен тумор-некротизиращ фактор - TNF) при пациенти, които не могат да приемат метотрексат или чието състояние не се повлиява адекватно от метотрексат; проучването разглежда подобряването на работата на ставите на пациентите (въз основа на стандартен скор на оценка, наречен DAS28-ESR) след 24 седмици на лечение.
English: Plivensia was to be used with methotrexate (a DMARD) or alone if the patient could not take methotrexate.
Bulgarian: Plivensia трябва да се използва с метотрексат (БМАЛ) или самостоятелно, ако пациентът не може да приема метотрексат.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Plivensia could not have been approved for the treatment of moderate to severe rheumatoid arthritis.
Bulgarian: Въз основа на прегледа на данните и отговорите на фирмата по списъците с въпроси на CHMP, към момента на оттеглянето CHMP има известни забележки и изразява предварителното становище, че Plivensia не може да бъде одобрен за лечение на умерен до тежък ревматоиден артрит.
English: Plivensia was expected to be used in adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Bulgarian: Plivensia се очаква да се използва при възрастни с умерен до тежък ревматоиден артрит, заболяване, което причинява възпаление на ставите.
English: How does Plivensia work?
Bulgarian: Как действа Plivensia?
English: What was Plivensia expected to be used for?
Bulgarian: За какво се очаква да се използва Plivensia?
English: By blocking interleukin-6, sirukumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Bulgarian: Като блокира интерлевкин-6 сирукумаб намалява възпалението и другите симптоми, свързани с ревматоиден артрит.
English: The medicine was to be used in patients when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) had not worked well enough or had led to troublesome side effects.
Bulgarian: Лекарството трябва да се използва при пациенти, когато лечението с едно или повече лекарства, известни като болест-модифициращи антиревматични лекарства (БМАЛ), не е било достатъчно успешно или е довело до обезпокоителни нежелани лекарствени реакции.
English: Two studies compared Plivensia with placebo (a dummy treatment) in patients with moderate to severe rheumatoid arthritis for whom treatment with a DMARD or with an anti-TNF agent (another type of medicine for rheumatoid arthritis) had not worked well enough or had led to troublesome side effects.
Bulgarian: Две проучвания сравняват Plivensia с плацебо (сляпо лечение) при пациенти с умерен до тежък ревматоиден артрит, при които лечението с БМАЛ или с анти-TNF агент (друг вид лекарство за ревматоиден артрит) не е било достатъчно успешно или е довело до обезпокоителни нежелани лекарствени реакции.
English: On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Bulgarian: Комитета по лекарствените продукти за хуманна употреба (CHMP), че желае да оттегли заявлението си за разрешаване за употреба на Plivensia, показан за лечение на ревматоиден артрит.
English: You can take [Invented name] with or without food.
Bulgarian: Du kan ta [Legemidlets navn] med eller uten mat.
English: - Patients below 18 years of age.
Bulgarian: - Pasienter under 18 år.
English: It is important that you complete the course of treatment, even if you begin to feel better after a few days.
Bulgarian: Det er viktig at du fullfører behandlingen, selv om du føler deg bedre etter noen få dager.
English: Do not take a double dose to make up for a forgotten dose.
Bulgarian: Du må ikke ta en dobbelt dose som erstatning for en glemt dose.
English: 5 - 10 days
Bulgarian: 5-10 dager
English: There is no indication of oxidative metabolism.
Bulgarian: Det finnes ingen indikasjon på oksidativ metabolisme.
English: The duration of treatment depends upon the type of infection.
Bulgarian: Behandlingens varighet avhenger av typen infeksjon.
English: Absorption and Bioavailability
Bulgarian: Absorpsjon og biotilgjengelighet
English: Children and adolescents
Bulgarian: Barn og ungdom
English: Streptococcus Groups A, B, C, G
Bulgarian: Streptococcus Gruppe A, B, C, G
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Bulgarian: til offisielle retningslinjer for riktig bruk av antibakterielle midler.
English: 3 from 3 h up to 36 h post dose 4 at the end of infusion
Bulgarian: 3 fra 3 timer opp til 36 timer etter dosering 4 ved avsluttet
English: The recommended dose and duration of treatment should not be exceeded (see section 2.
Bulgarian: Anbefalt dose og behandlingstid skal ikke overskrides (se pkt. 2.
English: In this situation adequate therapeutic measures should be initiated immediately.
Bulgarian: I slike tilfeller skal passende tiltak iverksettes umiddelbart.
English: Driving and using machines [Invented name] may make you feel dizzy or light-headed.
Bulgarian: Kjøring og bruk av maskiner [Legemidlets navn] kan gjøre deg svimmel eller omtåket.
English: If you are affected in this way do not drive or operate machinery.
Bulgarian: Hvis du kjenner dette må du ikke kjøre eller bruke maskiner.
English: If you are unsure about what to do, consult your doctor or pharmacist.
Bulgarian: Hvis du er usikker på hva du skal gjøre, spør lege eller apotek.
English: Consult your doctor if you wish to stop taking your tablets before the end of the course of treatment.
Bulgarian: Kontakt legen din dersom du ønsker å slutte å ta tablettene før behandlingstidens slutt.
English: H. influenzae and M. catarrhalis
Bulgarian: influenzae og M. catarrhalis
English: He/she may wish to perform an ECG to measure your heart rhythm.
Bulgarian: Han/hun kan ønske å ta et EKG for å undersøke hjerterytmen din.
English: and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
Bulgarian: og krevende mikroorganismer (M100-S17, 2007) og MIC-brytningspunkter for anaerober (M11-A7, 2007):
English: If you take more than the prescribed one tablet a day, seek medical advice immediately and, if possible, take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
Bulgarian: Dersom du tar mer enn den forskrevne dosen på en tablett daglig, søk medisinsk råd snarest, og hvis mulig, ta med resterende tabletter, pakningen eller dette pakningsvedlegget og vis legen eller apoteket hva du har tatt.
English: Higher plasma concentrations are observed in healthy volunteers with low body weight (such as women) and in elderly volunteers.
Bulgarian: Høyere plasmakonsentrasjoner er sett i friske frivillige med lav kroppsvekt (f.eks. kvinner) samt hos eldre frivillige.
English: The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Bulgarian: Anbefalt dose (400 mg én gang daglig) og behandlingstiden for den aktuelle indikasjonen skal ikke overskrides.
English: [Invented name] is an antibiotic belonging to the quinolone family.
Bulgarian: [Legemidlets navn] er en antibiotika som tilhører kinolonfamilien.
English: In vitro Susceptibility Data
Bulgarian: Data for følsomhet in vitro
English: Anaphylactic reactions can progress to a life-threatening shock, even after the first administration.
Bulgarian: Anafylakstiske reaksjoner kan utvikles til livstruende sjokk, selv etter første administrering.
English: However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity.
Bulgarian: Studier har imidlertid vist at moxifloxacin har en lavere risiko for fotosensitivitet.
English: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organism
Bulgarian: EUCAST kliniske MIC-brytningspunkter for moxifloxacin (31.12.2006): Organisme
English: The absolute bioavailability amounts to approximately 91%.
Bulgarian: Den absolutte biotilgjengeligheten er ca.
English: 4.3 Contraindications
Bulgarian: 4.3 Kontraindikasjoner
English: Organism
Bulgarian: Organisme
English: * intravenous administration of a single 400 mg dose 1 10 h after administration
Bulgarian: intravenøs administrering av en 400 mg enkeltdose 1 10 timer etter administrering
English: If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Bulgarian: Hvis det ikke skjer noen forbedring i symptomene etter 3 dagers behandling, må du kontakte legen din.
English: - If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.
Bulgarian: - dersom du har alvorlig leversykdom eller forhøyde leverenzymer (transaminaser) mer enn 5 ganger øvre normalverdi.
English: At steady-state the exposure within the dosing interval is approximately 30% higher than after the first dose.
Bulgarian: innen doseintervallet ca 30 % høyere enn etter første dose.
English: They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where interpretative criteria remain to be determined (Gram-negative anaerobes).
Bulgarian: som ikke har fått artspesifikt brytningspunkt og skal ikke brukes for arter der det gjenstår å bestemme tolkningskriteriene (grammegative anaerober).
English: - If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for your doctor to monitor your blood clotting times.
Bulgarian: - Hvis du samtidig bruker orale antikoagulantia (f.eks. warfarin), kan det være nødvendig for legen å kontrollere din koagulasjonstid.
English: Contact your doctor if you are not sure if you belong to a patient group described below.
Bulgarian: Kontakt legen din hvis du er usikker på om du tilhører en pasientgruppe
English: Commonly susceptible species
Bulgarian: Vanligvis følsomme arter
English: If you experience palpitations or irregular heart beat during the period of treatment, you should inform your doctor immediately.
Bulgarian: Dersom du opplever hjertebank eller uregelmessige hjerteslag i behandlingsperioden må du informere legen din umiddelbart.
English: Effect on the intestinal flora in humans
Bulgarian: Effekt på tarmflora hos menneske
English: Streptococcus pyogenes* (Group A)
Bulgarian: Streptococcus pyogenes* (Gruppe A)
English: Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/l, respectively.
Bulgarian: Cmax og Cmin konsentrasjonene ved steady state (400 mg en gang daglig) var 3,2 og henholdsvis 0.6 mg/l.
English: Following oral administration moxifloxacin is rapidly and almost completely absorbed.
Bulgarian: Etter oral administrering absorberes moxifloxacin rask og nesten fullstendig.
English: Moxifloxacin is contraindicated in children and adolescents (< 18 years).
Bulgarian: Moxifloxacin er kontraindisert hos barn og ungdom (<18 år).
English: Therefore it is recommended that these medicines are not used together.
Bulgarian: Samtidig bruk av disse legemidlene anbefales derfor ikke.
English: ANNEX III AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET (RELEVANT SECTIONS ONLY)
Bulgarian: VEDLEGG III TILLEGG TIL PREPARATOMTALE OG PAKNINGSVEDLEGG (KUN RELEVANTE AVSNITT)
English: Cross-resistance is observed with other fluoroquinolones.
Bulgarian: Kryssresistens er sett med andre fluorokinoloner.
English: If you stop taking this medicine too soon your infection may not be completely cured, the infection may return or your condition may get worse, and you may also create a bacterial resistance to the antibiotic.
Bulgarian: Dersom du stopper behandlingen for raskt kan infeksjonen være utilstrekkelig behandlet, og infeksjonen blusser opp igjen eller din allmenntilstand forverres og du kan også utvikle bakteriell resistens mot antibiotika.
English: * Non-species related breakpoints have been determined mainly on the basis of pharmacokinetic/pharmacodynamic data and are independent of MIC distributions of specific species.
Bulgarian: * Ikke artsrelaterte brytningspunkt er i hovedsak bestemt på bakgrunn av PK/PD-data og er uavhengig av MIC-fordelingen for spesifikke arter.
English: Non-species related breakpoints*
Bulgarian: Ikke artsrelaterte brytningspunkt*
English: Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
Bulgarian: Pasientene bør uansett advares mot UV-eksponering eller mye og/eller sterkt sollys under behandling med moxifloxacin.
English: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Bulgarian: tablett skal svelges hel med tilstrekkelig mengde væske og kan tas uavhengig av måltid.
English: Mechanism of resistance
Bulgarian: Resistensmekanisme
English: Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.
Bulgarian: Andre resistensmekanismer, som permeabilitetsbarriærer (vanlige hos Pseudomonas aeruginosa) og effuksmekanismer, kan også påvirke følsomheten for moxifloxacin.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms Staphylococcus aureus (methicillin-resistant)+
Bulgarian: Arter hvor ervervet resistens kan være et problem Aerobe grampositive mikroorganismer Staphylococcus aureus (meticillin-resistent)+
English: Therefore, you should adhere to the dosage.
Bulgarian: Derfor må du følge doseanbefalingene.
English: It is recommended that you take the tablet at approximately the same time each day.
Bulgarian: til omtrent samme tid hver dag.
English: Swallow the tablet as a whole (to mask the bitter taste) and with plenty of liquid.
Bulgarian: Tabletten skal svelges hel (for å skjule den bitre smaken) og sammen med rikelig mengde væske.
English: - Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.
Bulgarian: - Hypersensitivitet og allergiske reaksjoner har vært rapportert for fluorokinoloner inkludert moxifloxacin etter første administrering.
English: In clinical trials the tablets have been studied for up to 14 days treatment.
Bulgarian: i kliniske studier med inntil 14 dagers behandling.
English: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Bulgarian: Farmakokinetiske studier gjort på pasienter med nedsatt leverfunksjon (Child Pugh A,B) har ikke kunnet vise om det er noen forskjeller sammenlignet med friske forsøkspersoner.
English: 4.4 Special warnings and precautions for use
Bulgarian: 4.4 Advarsler og forsiktighetsregler
English: If you do not take your tablet on one day, take your normal dose (one tablet) on the next day.
Bulgarian: ta den vanlige dosen (en tablett) neste dag.
English: Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Bulgarian: Farmakokinetikken er lineær for enkeltdoser i området 50 -800 mg og opp til 600 mg en gang daglig i 10 dager.
English: - [Invented name] may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are currently being treated with corticosteroids.
Bulgarian: - [Legemidlets navn] kan i noen tilfeller forårsake smerte og betennelse i sener, spesielt hvis du er eldre eller hvis du samtidig behandles med kortikosteroider.
English: Therefore, moxifloxacin should be used with caution in these patients.
Bulgarian: Moxifloxacin skal derfor brukes med forsiktighet hos disse pasientene.
English: Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin.
Bulgarian: Resistensmekanismen som inaktiverer penicilliner, cefalosporiner, aminoglykosider, makrolider og tetracykliner interfererer ikke med den antibakterielle aktiviteten til moxifloxacin.
English: Distribution
Bulgarian: Distribusjon
English: - Quinolones have been shown to cause photosensitivity reactions in patients.
Bulgarian: - Kinoloner har forårsaket fotosensitivitetsreaksjoner hos visse pasienter.
English: The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp.
Bulgarian: Følgende forandringer i tarmfloraen er sett hos friske frivillige etter oral administrering av moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., og Klebsielle spp. minsket, det
English: Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
Bulgarian: Nedsatt leverfunksjon var assosiert med høyer eksponering for M1 i plasma, mens eksponering for uforandret legemiddel var sammenlignbart med den hos friske forsøkspersoner.
English: were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp.. For Bacteroides fragilis there was an increase.
Bulgarian: samme gjorde anaerobe Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., og Peptostreptococcus spp.. For Bacteroides fragilis var det en økning.
English: Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp.
Bulgarian: Clinical and Laboratory Standards Institute™ (CLSI) MIC- og diskdiffusjonsbrytningspunkter for Staphylococcus spp.
English: Anaerobes
Bulgarian: Anaerober
English: Elimination
Bulgarian: Eliminasjon
English: - [Invented name] may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (see section 4.
Bulgarian: - [Legemidlets navn] kan gi en rask og alvorlig leverbetennelse som kan føre til livstruende leversvikt (se pkt 4. Mulige bivirkninger).
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including [Invented name].
Bulgarian: - Du kan utvikle diaré under behandling eller etter behandling med antibiotika, også [Legemidlets navn].
English: Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
Bulgarian: 24-53 ml/min hvilket tyder på en delvis tubulær reabsorpsjon av legemidlet.
English: Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Bulgarian: Leverfunksjonstester/undersøkelser bør utføres ved tegn på nedsatt leverfunksjon.
English: The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min.
Bulgarian: 12 timer. Total clearance etter en 400 mg dose varierer mellom 179 og 246 ml/min.
English: No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in patients with kidney problems.
Bulgarian: Man trenger ikke endre dosen hos eldre pasienter, pasienter med lav kroppsvekt eller pasienter med nyreproblemer.
English: Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B)
Bulgarian: Staphylococcus aureus* (meticillin-følsomme) Streptococcus agalactiae (Gruppe B)
English: #ESBL-producing strains are commonly resistant to fluoroquinolones +Resistance rate > 50% in one or more countries
Bulgarian: #ESBL-produserende stammer er vanligvis resistente mot fluorokinoloner. +Resistensfrekvens > 50%
English: Do not take [Invented name] if you are pregnant or breast-feeding.
Bulgarian: Ta derfor ikke [Legemidlets navn]
English: The magnitude of QT prolongation may increase with increasing concentrations of the drug.
Bulgarian: Graden av QT-forlengelse kan øke med økende dose.