FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore a number of risk minimisation measures in relation to PML are in place for Tysabri.
Slovenian: Zato so za zdravilo Tysabri vzpostavljeni številni ukrepi za zmanjševanje tveganja v povezavi s PML.
English: Published data suggest that patients considered as having a high risk for PML development and who continue natalizumab treatment beyond 2 years of treatment may benefit from more frequent MRI screening e.g. every 3 to 6 months.
Slovenian: Objavljeni podatki kažejo, da bolnikom, za katere velja, da imajo večje tveganje za pojav PML, in ki se z natalizumabom zdravijo več kot 2 leti, lahko koristijo pogostejša slikanja z MR, npr. na 3 do 6 mesecev.
English: It is important to update the package leaflet concerning the risk of PML up to 6 months following Tysabri discontinuation.
Slovenian: Pomembno je, da se navodilo za uporabo posodobi z informacijami, da tveganje za PML traja 6 mesecev po prenehanju zdravljenja z zdravilom Tysabri.
English: • The PRAC also concluded that, in patients who have not received prior immunosuppressant therapy and are anti-JCV antibody positive, the level of anti-JCV antibody response (index) is associated with risk of developing PML.
Slovenian: • odbor je zaključil tudi, da je pri bolnikih, ki se predhodno niso zdravili z imunosupresivi in so pozitivni na protitelesa proti JCV, odziv (indeks) protiteles proti JCV povezan s tveganjem za pojav PML.
English: The Committee, as a consequence, recommended the variation to the terms of the marketing authorisation for Tysabri.
Slovenian: Odbor je posledično priporočil spremembo pogojev dovoljenja za promet z zdravilom Tysabri.
English: Available data to date suggest that anti-JCV antibody index is correlated with the risk of PML in anti-JCV antibody positive patients with no prior immunosuppressant use.
Slovenian: Podatki, ki so na voljo do zdaj, kažejo, da je indeks protiteles proti JCV povezan s tveganjem za PML pri bolnikih, pozitivnih na protitelesa proti JCV, ki se pred tem niso zdravili z imunosupresivi.
English: For patients without prior immunosuppressant use and with high anti-JCV antibody index, no further antibody testing is required, as more frequent MRI screening should be considered if natalizumab treatment is continued for more than 2 years.
Slovenian: Pri bolnikih, ki se predhodno niso zdravili z imunosupresivi in imajo visok indeks protiteles proti JCV, dodatno testiranje za protitelesa ni potrebno, ker je treba razmisliti o pogostejšem slikanju z magnetno resonanco, če zdravljenje z natalizumabom traja več kot 2 leti.
English: Biomarkers for PML development
Slovenian: Biološki označevalci za pojav PML
English: PML development after discontinuation of natalizumab
Slovenian: Pojav PML po prenehanju zdravljenja z natalizumabom
English: In patients with MRI lesions suggestive for PML, the MRI protocol should be extended to include contrast-enhanced T1-weighted imaging to detect inflammatory features and the possible coincidence of PML and PML-IRIS (Immune Reconstitution Inflammatory Syndrome), particularly during follow up.
Slovenian: Pri bolnikih z lezijami na MRS, ki kažejo na PML, je treba protokol MRS razširiti še na kontrastno, T1-obteženo slikanje, s katerim odkrivamo vnetne značilnosti in morebitno sopojavnost PML in PML-IRIS (vnetnega sindroma imunske obnove), zlasti v obdobju spremljanja.
English: Anti-JCV antibody index for guiding MRI monitoring frequency
Slovenian: Indeks protiteles proti JCV za določanje pogostnosti spremljanja z MRS
English: There is no significant impact of the second generation assay on the risk estimates within the algorithm.
Slovenian: Na ocene tveganja znotraj algoritma test druge generacije nima pomembnega vpliva.
English: • The PRAC recommended that patients with low anti-JCV antibody index who have not received prior immunosuppressant therapy should be retested every six months once they reach the 2-year treatment point.
Slovenian: • odbor je priporočil, da se bolniki z nizkim indeksom protiteles proti JCV, ki se predhodno niso zdravili z imunosupresivi, testirajo na šest mesecev, ko dolžina zdravljenja doseže 2 leti;
English: • As a consequence, the PRAC recommended that more frequent MRI screening for PML (e.g. every 3-6 months) using an abbreviated MRI protocol should be considered in patients at higher risk of development of PML.
Slovenian: • posledično je odbor priporočil, da se pri bolnikih z višjim tveganjem za pojav PML razmisli o pogostejšem slikanju z MR za PML (npr. na 3-6 mesecev) po skrajšanem protokolu MRS;
English: In addition patients without prior immunosuppressant use and a low antibody index should also be tested every 6 months if they are treated beyond 2 years.
Slovenian: Poleg tega je treba bolnike, ki se predhodno niso zdravili z imunosupresivi in imajo nizek indeks protiteles, zdravijo pa se že več kot 2 leti, testirati na 6 mesecev.
English: For natalizumab-treated patients with MS, who are at high risk of PML, brain MRI screening using a protocol that includes FLAIR (fluidattenuated inversion recovery), T2-weighted and diffusion -weighted imaging is recommended.
Slovenian: Za bolnike z MS, ki se zdravijo z natalizumabom in imajo visoko tveganje za PML, se priporoča MRS možganov po protokolu, ki vključuje slikanje s FLAIR (sekvenco, ki izniči signal tekočine), T2-obteženo in difuzijsko obteženo slikanje.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Tysabri remains favourable subject to the amendments to the product information described above.
Slovenian: Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravila Tysabri še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
English: There seems to be consensus among experts that routine MRI screening for suspected PML lesions can be conducted without gadolinium-enhancement.
Slovenian: Strokovnjaki se strinjajo, da se rutinsko slikanje z MR za odkrivanje morebitnih lezij PML lahko opravlja brez gadolinijevega kontrasta.
English: In view of the above, the Committee considered that the benefit-risk balance of Tysabri remains favourable subject to the agreed amendments to the product information and additional risk minimisation measures.
Slovenian: Z upoštevanjem zgoraj navedenega je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Tysabri še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in dodatni ukrepi za zmanjševanje tveganja.
English: Anti-JCV antibody ELISA
Slovenian: Test ELISA za protitelesa proti JCV
English: Considering the dire diagnosis of PML a high level of vigilance and a low threshold even for invasive diagnostic measures and interventions such as MRI is warranted for managing patients with high risk for PML development.
Slovenian: Zaradi hude diagnoze PML sta pri obravnavi bolnikov z visokim tveganjem za pojav PML potrebna visoka stopnja nadzora in nizek prag, tudi za invazivne diagnostične ukrepe in posege, kot je MRS.
English: It is acknowledged that high expertise is necessary to identify small and asymptomatic PML lesions via MRI.
Slovenian: Upoštevati je treba, da je za prepoznavanje majhnih in asimptomatskih lezij PML s pomočjo MRS potrebna visoka raven strokovnega znanja.
English: In view of all of the above, the PRAC concluded that the benefit-risk balance of Tysabri remains favourable subject to amendments to the product information and additional risk minimisation measures as described below.
Slovenian: Z upoštevanjem zgoraj navedenega je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravila Tysabri še naprej ugodno, pod pogojem, da se upoštevajo spodaj opisane spremembe informacij o zdravilu in dodatni ukrepi za zmanjševanje tveganja.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Tysabri.
Slovenian: Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Tysabri.
English: MRI is considered to be a sensitive method to identify even small and asymptomatic PML lesions.
Slovenian: Asimptomatske primere PML so odkrili z rutinskim MRS. MRS velja za občutljivo metodo za odkrivanje tudi majhnih in asimptomatskih lezij PML.
English: 5 x 1 dose 10 x 1 dose
Slovenian: 1 odmerek 5 x 1 odmerek 10 x 1 odmerek
English: 37008 Carbajosa de la Sagrada Salamanca
Slovenian: 37008 Carbajosa de la Sagrada
English: SPECIAL STORAGE CONDITIONS Store at 2-8 °C, protected from light.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri 2-8 °C, zaščiteno pred svetlobo.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands
Slovenian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009
English: METHODS AND ROUTE OF ADMINISTRATION i.m.
Slovenian: NAČIN IN POT(I) UPORABE i.m.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Intervet International B.V.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under 4.6 have been observed except for some depression at the day of vaccination 4.11 Withdrawal period(s)
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v 4.6, razen blage depresivnosti na dan cepljenja.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: O varnosti in učinkovitosti sočasne uporabe cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO "SAMO ZA ŽIVALI" IN POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET GLEDE OSKRBE IN UPORABE
English: Poligono Ind. El Montalvo I C/Zeppelin 6, Parcela 38
Slovenian: C/Zeppelin 6, Parcela 38
English: Phosphate buffer
Slovenian: Fosfatni pufer
English: A/equine-2/ Newmarket/2/93
Slovenian: A/konjski-2/ Newmarket/2/93
English: Intervet International B.V. Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 NL-5831 AN Boxmeer Nizozemska
English: The first revaccination (third dose) is given 5 months after the primary vaccination course.
Slovenian: Prvo revakcinacijo (tretji odmerek) opravimo 5 mesecev po osnovnem cepljenju.
English: A/equine-2/South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU).
Slovenian: A/konjski-2/Južna Afrika/4/03 (50 AU), A/konjski-2/Newmarket/2/93 (50 AU)
English: In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, for up to 3 days in exceptional circumstances.
Slovenian: V zelo redkih primerih se lahko pojavi vročina, včasih z letargijo in neješčnostjo, ki traja 1 dan, izjemoma do 3 dni.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Slovenian: Kadar je povečana ogroženost zaradi okužbe ali premajhen vnos kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6
English: 4.2 Indications for use, specifying the target species Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi
English: Revaccination
Slovenian: Revakcinacija
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use.
Slovenian: Cepivo pred uporabo ogrejte na sobno temperaturo.
English: Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Slovenian: Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi
English: IMMUNOLOGICAL PROPERTIES To stimulate active immunity against Equine influenza ATC-vet code: QI05AA01
Slovenian: Oznaka ATC-vet: QI05AA01
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza [a clear pictogram of a horse]
Slovenian: Equilis Prequenza (jasen piktogam konja)
English: Influenza Onset of immunity:
Slovenian: Influenca Razvoj imunosti:
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti ni vključena v Uredbo(ES) št.
English: A/equine-2/ South Africa/4/03
Slovenian: A/konjski-2/ Južna Afrika/4/03 50 AU1
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza, suspension for injection, for horses
Slovenian: Equilis Prequenza, suspenzija za injiciranje, za konje
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years 6.4 Special precautions for storage
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
English: Antigenic units Adjuvant Purified saponin
Slovenian: Dodatek Prečiščeni saponin
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: B. POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM GLEDE OSKRBE IN UPORABE
English: 2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course 12 months after the first revaccination
Slovenian: 5 mesecev po osnovnem cepljenju 12 mesecev po prvi revakcinaciji
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE Lot (številka)
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY'
Slovenian: BESEDILO “SAMO ZA ŽIVALI”
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/056/001-004
Slovenian: EU/2/05/056/001-004
English: Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Slovenian: Zloženka z 10 vialami po 1 ml Zloženka z 1, 5 ali 10 napolnjenimi brizgmi z iglami.
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains, A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Slovenian: Za ohranjanje ravni imunosti proti influenci konjev priporočamo izmenično uporabo, v razmikih po 12 mesecev, ustreznega cepiva proti influenci konj, ki vsebuje seve A/konjski- 2/Južna Afrika/4/03 in
English: SPECIAL WARNINGS Read the package leaflet before use
Slovenian: POSEBNO(A) OPOZORILO(A) Pred uporabo preberite navodilo za uporabo.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: INDICATION(S) Active immunisation of horses against equine influenza.
Slovenian: Aktivna imunizacija konj proti influenci konj
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the sight and reach of children
Slovenian: BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSELGJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
English: EXPIRY DATE EXP {number}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {številka}
English: 1 ml.
Slovenian: V odmerku po 1 ml :
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza suspension for injection for horses
Slovenian: Equilis Prequenza, suspenzija za injiciranje za konje
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Administer one dose (1ml), by strict intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Slovenian: • Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje Revakcinacija
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND ANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza
Slovenian: Equilis Prequenza
English: PACKAGE SIZE 1 dose
Slovenian: Shema 1
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 1 ml:
Slovenian: V odmerku po 1 ml:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: It must also not be used together with certain medicines such as:
Slovenian: Ne sme se jemati tudi sočasno z določenimi zdravili, kot so:
English: This overview was last updated in 03-2019.
Slovenian: Pregled je bil nazadnje posodobljen 03-2019.
English: Further information on Maviret can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Maviret.
Slovenian: Nadaljnje informacije o zdravilu Maviret so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Maviret.
English: The recommended dose is three tablets once a day, with food, for 8, 12 or 16 weeks.
Slovenian: Priporočeni odmerek so tri tablete, ki se jemljejo enkrat na dan skupaj s hrano 8, 12 ali 16 tednov.
English: Maviret received a marketing authorisation valid throughout the EU on 26 July 2017.
Slovenian: Za zdravilo Maviret je bilo 26. julija 2017 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: A negative test result means that the virus was not found.
Slovenian: Negativni rezultat testa pomeni, da virus ni bil odkrit.
English: What measures are being taken to ensure the safe and effective use of Maviret?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Maviret?
English: The European Medicines Agency therefore decided that Maviret's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Maviret večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In addition, results showed that the way the medicine was absorbed, modified and removed from the body was similar to that in adults.
Slovenian: Poleg tega so rezultati pokazali, da je bil način absorpcije, modifikacije in odstranjevanja zdravila iz telesa podoben kot pri odraslih.
English: The medicine's effectiveness in clearing genotype 3 was slightly lower than for other genotypes (95%).
Slovenian: Učinkovitost zdravila pri odstranjevanju genotipa 3 je bila nekoliko nižja od učinkovitosti pri drugih genotipih (95 %).
English: Maviret (glecaprevir / pibrentasvir)
Slovenian: Maviret (glekaprevir/pibrentasvir)
English: Other information about Maviret
Slovenian: Druge informacije o zdravilu Maviret
English: Based on data available in adults, it is expected that Maviret is also effective in children with genotypes 5 and 6.
Slovenian: Na podlagi razpoložljivih podatkov pri odraslih se pričakuje, da bo zdravilo Maviret učinkovito tudi pri otrocih z genotipoma 5 in 6.
English: As for all medicines, data on the use of Maviret are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Maviret stalno spremljajo.
English: What is Maviret and what is it used for?
Slovenian: Kaj je zdravilo Maviret in za kaj se uporablja?
English: Why is Maviret authorised in the EU?
Slovenian: Zakaj je zdravilo Maviret odobreno v EU?
English: What benefits of Maviret have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Maviret izkazalo v študijah?
English: The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or whether they have received previous treatments with pegylated interferon and ribavirin, with or without sofosbuvir, or sofosbuvir and ribavirin.
Slovenian: Trajanje zdravljenja je odvisno od tega, ali je pri bolnikih prisotna ciroza jeter (brazgotinjenje jeter) oziroma ali so bili predhodno zdravljeni s pegiliranim interferonom in ribavirinom, skupaj s sofosbuvirjem ali brez njega, ali s sofosbuvirjem in ribavirinom.
English: What are the risks associated with Maviret?
Slovenian: Kakšna tveganja so povezana z zdravilom Maviret?
English: Results were similar for genotypes 2 and 4-6.
Slovenian: Za genotip 2 in genotipe od 4 do 6 so bili rezultati podobni.
English: Glecaprevir blocks the action of a protein called NS3/4A protease, while pibrentasvir blocks a protein called NS5A.
Slovenian: Glekaprevir zavira delovanje beljakovine, imenovane proteaza NS3/4A, medtem ko pibrentasvir zavira delovanje beljakovine, imenovane NS5A.
English: An overview of Maviret and why it is authorised in the EU
Slovenian: Pregled zdravila Maviret in zakaj je odobreno v EU
English: Side effects reported with Maviret are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Maviret, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The most common side effects with Maviret (which may affect more than 1 in 10 people) are headache and tiredness.
Slovenian: Najpogostejša neželena učinka zdravila Maviret (ki lahko pojavita pri več kot 1 bolniku od 10) sta glavobol in utrujenost.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Maviret have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Maviret upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Maviret has been shown to be highly effective in clearing the hepatitis C virus from the blood, particularly in patients who have not been treated previously or who do not have cirrhosis.
Slovenian: Zdravilo Maviret se je izkazalo za zelo učinkovito pri odstranjevanju virusa hepatitisa C iz krvi, še posebno pri bolnikih, ki predhodno še niso bili zdravljeni ali nimajo ciroze.
English: Maviret is available as tablets that contain 100 mg glecaprevir and 40 mg pibrentasvir.
Slovenian: Zdravilo Maviret je na voljo v obliki tablet, ki vsebujejo 100 mg glekaprevirja in 40 mg pibrentasvirja.
English: • rifampicin (antibiotic usually used to treat tuberculosis);
Slovenian: • rifampicin (antibiotik, ki se običajno uporablja za zdravljenje tuberkuloze);