FrancophonIA/ELRC3.0 huggingface dataset:
English: Ledipasvir 30 mg once daily ledipasvir AUC 1.92 (1.77-2.07) ↑ ledipasvir Cmax 1.81 (1.69-2.94) ↑ ledipasvir Cmin not studied simeprevir AUC 2.69 (2.44-2.96) ↑ simeprevir Cmax 2.61 (2.34-2.86) ↑ simeprevir Cmin not studied
Slovenian: ledipasvir 30 mg enkrat na dan ledipasvir AUC 1,92 (1,77-2,07) ↑ ledipasvir Cmax 1,81 (1,69-2,94) ↑
English: In study HPC2002, photosensitivity reactions (grouped term) was reported in 7.1% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 5.6% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Slovenian: V študiji HPC2002 so o fotosenzitivnih reakcijah (skupni termin) po poročali pri 7,1% bolnikov, ki so12 tednov prejemali simeprevir in sofosbuvir brez ribavirina, v primerjavi s 5,6% bolnikov, ki so 12 tednov prejemali simeprevir s sofosbuvirjem in ribavirinom Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: med 12-tedenskim zdravljenjem s simeprevirjem so o fotosenzitivnih reakcijah poročali pri 4,7% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 0,8% bolnikov, zdravljenih s placebom (vse stopnje, združeni podatki iz študij faze 3).
English: OLYSIO 150 mg hard capsules simeprevir
Slovenian: Navodilo za uporabo OLYSIO 150 mg trde kapsule simeprevir
English: Decreased plasma concentrations of simeprevir are expected.
Slovenian: Pričakovano je zmanjšanje koncentracije simeprevirja v plazmi.
English: Table 19: Treatment outcome in treatment-naïve HCV genotype 1 infected patients (pooled data studies C208 and C216)
Slovenian: Preglednica 22: Izid zdravljenja pri bolnikih, okuženih s HCV genotipa 1 in s sočasno okužbo s HIV-1 (študija C212)
English: Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO.
Slovenian: Pred uvedbo zdravljenja z zdravilom OLYSIO preberite povzetek glavnih značilnosti zdravila sočasno predpisanih zdravil.
English: Buprenorphine Naloxone
Slovenian: buprenorfin nalokson
English: Grade 2 and 3 adverse reactions were reported in 3.5% (n = 10) and 0.3% (n = 1) of patients, respectively, receiving 12 weeks simeprevir with sofosbuvir; no grade 4 adverse reactions were reported.
Slovenian: (n = 10) oziroma pri 0,3% (n = 1) bolnikov, ki so 12 tednov prejemali simeprevir in sofosbuvir.
English: Baseline HCV RNA levels > 800,000 IU/ml
Slovenian: Mediane izhodiščne koncentracije HCV RNA (log10
English: 1 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Slovenian: 1 Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno koncentracijo HCV RNK ob dejanskem zaključku zdravljenja in z najmanj eno meritvijo koncentracije HCV RNK v času spremljanja po zaključku zdravljenja.
English: had non-CC IL28B alleles (CT or TT); 33% were treatment-naïve, and 68% were treatment-experienced.
Slovenian: genotipa 1b, 86% jih je imelo ne- CC IL28B alele (CT ali TT), 76% bolnikov se ni odzvalo na predhodno zdravljenje s peginterferonom alfa in ribavirinom in 24% jih še ni prejemalo zdravljenja.
English: Genotype 1, treatment-naïve or null responders3, with compensated cirrhosis or without cirrhosis
Slovenian: genotip 1, predhodno nezdravljeni bolniki ali bolniki brez odziva3, s kompenzirano cirozo ali brez ciroze
English: Bepridil
Slovenian: Izpuščaj
English: Ranitidine
Slovenian: Dojenje
English: * Skin rash may affect more than 1 in 10 people (very common) when OLYSIO is used in combination with sofosbuvir for 24 weeks.
Slovenian: - zvečana koncentracija bilirubina v krvi (bilirubin je barvilo, ki nastaja v jetrih) * Kadar se zdravilo OLYSIO v kombinaciji s sofosbuvirjem jemlje 24 tednov, se kožni izpuščaj lahko pojavi pri več kot 1 od 10 bolnikov (zelo pogosto).
English: No meaningful changes in QTc interval were observed with either the recommended dose of 150 mg once daily or the supratherapeutic dose of 350 mg once daily.
Slovenian: 150 mg enkrat na dan niti pri supraterapevtskem odmerku 350 mg enkrat na dan. Pediatrična populacija
English: OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 48 weeks).
Slovenian: Uporaba zdravila OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom: bolnike s sočasno okužbo s HCV/HIV-1 je treba zdraviti enako dolgo kot bolnike, ki so okuženi samo s HCV, razen v primeru bolnikov s sočasno okužbo z obema virusoma in s cirozo: ti bolniki naj po zaključenem
English: Q80R3
Slovenian: D168E D168V Q80R3
English: Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis:
Slovenian: Bolniki brez ciroze: 8 ali 12 tednov SMV + sofosbuvir; Bolniki s cirozo: 12 tednov SMV + sofosbuvir
English: Rifampicin1 600 mg once daily rifampicin AUC 1.00 (0.93-1.08) ↔ rifampicin Cmax 0.92 (0.80-1.07) ↔ rifampicin Cmin not studied 25-desacetyl-rifampicin AUC 1.24 (1.13-1.36) ↑ 25-desacetyl-rifampicin Cmax 1.08 (0.98-1.19) ↔ 25-desacetyl-rifampicin Cmin not studied simeprevir AUC 0.52 (0.41-0.67) ↓ simeprevir Cmax 1.31 (1.03-1.66) ↑ simeprevir Cmin 0.08 (0.06-0.11) ↓
Slovenian: AUC rifampicina 1,00 (0,93-1,08) ↔ Cmax rifampicina 0,92 (0,80-1,07) ↔ Cmin rifampicina niso preučevali AUC 25-dezacetil-rifampicina 1,24 (1,13-1,36)
English: Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir based on interim data from an ongoing phase 2 study in HCV infected post-liver transplant patients (see section 4.5).
Slovenian: Na osnovi vmesnih podatkov še potekajoče študije faze 2 pri bolnikih po presaditvi jeter, okuženih s HCV (glejte poglavje 4.5), sočasna uporaba zdravila OLYSIO s ciklosporinom ni priporočljiva, ker pomembno zveča izpostavljenost simeprevirju.
English: (mild to moderate CYP3A4 enzyme inhibition)
Slovenian: (šibko do zmerno zaviranje CYP3A4)
English: (moderate CYP3A4 enzyme induction)
Slovenian: (zmerna indukcija CYP3A4)
English: Significantly increased plasma concentrations of simeprevir are expected.
Slovenian: Pričakuje se pomembno zvečanje koncentracije simeprevirja v plazmi.
English: Genotype 1, prior relapsers2, with compensated cirrhosis or without cirrhosis
Slovenian: genotip 1, bolniki s ponovitvijo bolezni2, s kompenzirano cirozo ali brez ciroze
English: In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
Slovenian: Prisotnost polimorfizma NS3 Q80K (glejte poglavje 5.1), pri bolnikih s HCV genotipa 1 brez ciroze ni vplivala na učinkovitost simeprevirja v kombinaciji s sofosbuvirjem med priporočenim 12-tedenskem zdravljenjem.
English: METAVIR fibrosis score
Slovenian: Stopnja fibroze po klasifikaciji METAVIR F0-2
English: 3 The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Slovenian: Medsebojno delovanje med simeprevirjem in tem zdravilom so ocenjevali v farmakokinetični podštudiji v okviru študije faze 2 pri 22 bolnikih, okuženih s HCV. 3 V tej interakcijski študiji so 50 mg simeprevirja v kombinaciji z darunavirjem oziroma ritonavirjem primerjali s 150 mg simeprevirja samostojno.
English: The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
Slovenian: 64% je bilo moških, 81% belcev, 19% črne rase ali afroameričanov in 21% latinskoameriške etnične skupine; 37% jih je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,7 log10 i.e./ml; 75% ni imelo ciroze (ocena fibroze po klasifikaciji METAVIR F0-3), 25% jih je imelo cirozo (ocena fibroze po klasifikaciji METAVIR F4); 78% je bilo okuženih s HCV genotipa 1a,
English: Pooled phase 3 studies simeprevir + peginterferon alfa + ribavirin N = 152 n (%)
Slovenian: simeprevir + peginterferon alfa + ribavirin N = 152 n (%)
English: Increased simeprevir concentrations may occur due to inhibition of OATP1B1 by atorvastatin.
Slovenian: Zaradi zaviranja OATP1B1 z atorvastatinom se lahko pričakuje zvečanje koncentracij simeprevirja.
English: nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Slovenian: - sildenafil ali tadalafil za zdravljenje pljučne arterijske hipertenzije - midazolam ali triazolam (če ju zaužijete) za zdravljenje nespečnosti ali za lajšanje tesnobe
English: Outcome for patients without SVR12 On-treatment failure Viral relapse1
Slovenian: Rezultati zdravljenja pri bolnikih, ki niso dosegli SVR12 neuspeh v času zdravljenja ponovitev bolezni2 brez podatkov o SVR125
English: Mild increases in simeprevir concentrations may occur due to inhibition of CYP3A4 by amiodarone.
Slovenian: Zaradi zaviranja CYP3A4 z amiodaronom lahko pride do blagega zvečanja koncentracij simeprevirja v plazmi.
English: tacrolimus AUC 0.83 (0.59-1.16) ↓ tacrolimus Cmax 0.76 (0.65-0.90) ↓ tacrolimus Cmin not studied simeprevir AUC 1.85 (1.18-2.91) ↑6 simeprevir Cmax 1.79 (1.22-2.62) ↑6 simeprevir Cmin not studied6
Slovenian: AUC simeprevirja 1,85 (1,18-2,91) ↑6 Cmax simeprevirja 1,79 (1,22-2,62) ↑6
English: Outcome for patients without SVR12 On-treatment failure Viral relapse2
Slovenian: SVR12 Izid zdravljenja pri bolnikih brez SVR12
English: Table 22: Treatment outcome in HCV genotype 1 infected patients with HIV-1 co-infection
Slovenian: Preglednica 19: Izid zdravljenja pri predhodno nezdravljenih bolnikih, okuženih s HCV
English: 1 In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
Slovenian: HCV genotipa 1a razmislite o testiranju na prisotnost polimorfizma Q80K (glejte poglavje 4.4).
English: 3 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable)
Slovenian: 3 Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno (ali nepotrjeno zaznavno) koncentracijo HCV RNK ob dejanskem zaključku zdravljenja.
English: The following side effects may happen with OLYSIO when used in combination with peginterferon alfa and ribavirin:
Slovenian: Pri jemanju zdravila OLYSIO skupaj s peginterferonom alfa in ribavirinom se lahko pojavijo naslednji neželeni učinki:
English: Increased plasma concentrations of simeprevir are expected.
Slovenian: Pričakovano je zvečanje koncentracije simeprevirja v plazmi.
English: - digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
Slovenian: - itrakonazol, flukonazol, ketokonazol, posakonazol ali vorikonazol (če zdravilo zaužijete ali ga prejmete z injekcijo) za zdravljenje glivičnih okužb
English: It is not recommended to co-administer OLYSIO with darunavir/ritonavir.
Slovenian: OLYSIO z darunavirjem oziroma ritonavirjem ni priporočljiva.
English: The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people: - itching of the skin - skin rash* - constipation - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Slovenian: Pri jemanju zdravila OLYSIO skupaj s sofosbuvirjem se lahko pojavijo naslednji neželeni učinki: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov: - srbenje kože
English: The company wanted the authorisation to be recognised in Belgium, Germany, Italy, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Slovenian: Družba je želela, da se dovoljenje za promet z zdravilom prizna v Belgiji, Nemčiji, Italiji, Španiji, na Švedskem in v Združenem kraljestvu (zadevne države članice).
English: Ref. EMEA/CHMP/71684/2009 EMEA/H/A-29/1105
Slovenian: EMEA/CHMP/466894/2009 rev. EMEA/H/A-29/1105
English: The review was carried out under an ‘Article 29' referral1.
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom1 iz člena 29.
English: Dr Robert James Hemmings
Slovenian: dr. Robert James Hemmings dr. Tomas Salmonson
English: Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Ciclosporin IDL in povezana imena kapsule, ki vsebujejo ciklosporin v odmerku 25 mg, 50 mg in 100 mg
English: Prof. Pieter de Graeff
Slovenian: prof. Pieter de Graeff dr. Ondřej Slanař
English: However, because the concerned Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 2 December 2008.
Slovenian: Ker pa zadevne države članice niso dosegle soglasja, je nizozemski regulatorni organ 2. decembra 2008 zadevo napotil na CHMP v arbitražo.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Ciclosporin IDL and the reference medicine had not been sufficiently demonstrated.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru Odbora je CHMP menil, da biološka enakovrednost med zdravilom Ciclosporin IDL in referenčnim zdravilom ni bila zadostno dokazana.
English: Ciclosporin IDL is a generic medicine that is based on a reference medicine authorised in Germany (Sandimmun Optoral 25 mg capsules).
Slovenian: Zdravilo Ciclosporin IDL je generično zdravilo, ki temelji na referenčnem zdravilu, odobrenem v Nemčiji (Sandimmun Optoral 25 mg kapsule).
English: An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue, such as psoriasis (a disease causing red, scaly patches on the skin), atopic dermatitis (eczema, an itchy red rash), nephrotic syndrome (a kidney disease) and rheumatoid arthritis (inflammation of the joints).
Slovenian: Avtoimunska bolezen je bolezen, ki jo povzroča obrambni sistem telesa, ki napade normalno tkivo, kot so psoriaza (bolezen, ki povzroča rdeče, luskaste zaplate na koži), atopični dermatitis (ekcem, srbeč rdeč izpuščaj), nefrotski sindrom (obolenje ledvic) in revmatoidni artritis (vnetje sklepov).
English: London, 23 April 2009 Doc.
Slovenian: London, 22 julija 2010 Ref. dok.
English: It is used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Slovenian: Uporablja se pri bolnikih, pri katerih je bila opravljena presaditev, za preprečevanje zavrnitve presadka (ko imunski sistem napade presajeni organ).
English: In addition the Committee has also recommended that the marketing authorisation for Ciclosporin IDL in the Netherlands and other member states in the EU where the product has been authorised should be suspended until satisfactory bioequivalence data are obtained.
Slovenian: Poleg tega je Odbor priporočil, da je treba dovoljenje za promet z zdravilom Ciclosporin IDL na Nizozemskem in v drugih državah članicah EU, v katerih je zdravilo pridobilo dovoljenje za promet, začasno umakniti, dokler ne bodo na voljo zadostni podatki o biološki enakovrednosti.
English: Why was Ciclosporin IDL reviewed?
Slovenian: Zakaj je bilo zdravilo Ciclosporin IDL pregledano?
English: It is also used to treat or prevent graft-versus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Slovenian: Uporablja se tudi za zdravljenje ali preprečevanje bolezni presadka proti gostitelju (ko imunski sistem presajenega organa napade bolnikova tkiva).
English: The company International Drug Licensing (IDL) submitted Ciclosporin IDL for mutual recognition on the basis of the initial authorisation granted by the Netherlands on 10 August 2007.
Slovenian: Družba International Drug Licensing (IDL) je dne 10. avgusta 2007 predložila vlogo za medsebojno priznavanje zdravila Ciclosporin IDL na podlagi prvotnega dovoljenja za promet, odobrenega na Nizozemskem.
English: The grounds for the referral were that five of the concerned Member States did not agree that enough evidence had been presented to show that Ciclosporin IDL was ‘bioequivalent' to the reference medicine.
Slovenian: Podlaga za napotitev je bila, ker se pet zadevnih držav članic ni strinjalo, da so bili predloženi zadostni dokazi o biološki enakovrednosti zdravila Ciclosporin IDL referenčnemu zdravilu.
English: Ciclosporin IDL is also used to treat autoimmune diseases.
Slovenian: Zdravilo Ciclosporin IDL se uporablja tudi za zdravljenje avtoimunskih bolezni.
English: What is Ciclosporin IDL?
Slovenian: Kaj je zdravilo Ciclosporin IDL?
English: The CHMP therefore concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.
Slovenian: CHMP je zato zaključil, da koristi zdravila Ciclosporin IDL ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne odobri.
English: It acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in auto-immune diseases, normal tissue.
Slovenian: Zdravilna učinkovina zdravila Ciclosporin IDL, ciklosporin, deluje na nekatere posebne celice v imunskem sistemu, imenovane celice T, ki so odgovorne za to, da napadajo presajene organe ali, pri avtoimunskih boleznih, normalno tkivo.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ciclosporin IDL.
Slovenian: Evropska agencija za zdravila je 23. aprila 2009 po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Ciclosporin IDL zaključila arbitražni postopek.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Ciclosporin IDL ne odtehtajo njegovih tveganj ter da se dovoljenje za promet z zdravilom, odobreno na Nizozemskem, ne more priznati v drugih državah članicah EU in da je treba zato dovoljenje za promet z zdravilom na Nizozemskem začasno umakniti.
English: Company responses provided on: 16 January 2009 Opinion date:
Slovenian: Odgovori družbe, poslani dne:
English: 18 December 2008
Slovenian: Datum začetka napotitvenega posto 18. december 2008
English: Ciclosporin IDL is an immunosuppressive medicine.
Slovenian: Ciclosporin IDL je imunosupresivno zdravilo (zdravilo, ki zmanjšuje delovanje imunskega sistema, tj. naravne obrambe telesa).
English: A European Commission decision on this opinion will be issued in due course.
Slovenian: Evropska komisija je odločbo izdala 22. julija 2010.
English: The active substance in Ciclosporin IDL, ciclosporin, is an immunosuppressive agent.
Slovenian: Družba International Drug Licensing, ki trži zdravilo Ciclosporin IDL, je zahtevala ponovno presojo mnenja.
English: 2 protective mats
Slovenian: 2 zaščitni podlogi
English: Powder: 500 U; Solvent: 5 ml
Slovenian: prašek: 500 U; vehikel: 5 ml
English: Intravenous use powder: vial (glass); solvent: vial (glass)
Slovenian: 500 U prašek in vehikel za raztopino za injiciranje intravenska uporaba prašek: viala (steklo); vehikel: viala (steklo)
English: 2 powder vials 2 solvent vials 2 filter transfer devices
Slovenian: 2 viali s praškom 2 viali z vehiklom 2 pripravi za prenos s filtrom 2 10 ml brizgi za enkratno uporabo 2 kompleta za punkcijo vene
English: It may be used:
Slovenian: Uporablja se lahko:
English: This summary was last updated in September 2019.
Slovenian: Povzetek je bil nazadnje posodobljen septembra 2019.
English: The veterinarian will decide if additional treatment is needed.
Slovenian: Veterinar bo presodil, ali je potrebno kakršno koli dodatno zdravljenje.
English: Further information on Bravecto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
Slovenian: Nadaljnje informacije o zdravilu Bravecto so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
English: Bravecto received a marketing authorisation valid throughout the EU on 11 February 2014.
Slovenian: Zdravilo Bravecto je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 11. februarja 2014.
English: Other information about Bravecto
Slovenian: Druge informacije o zdravilu Bravecto
English: The European Medicines Agency decided that Bravecto's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je odločila, da so koristi zdravila Bravecto večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
English: People handling the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.
Slovenian: Osebe med uporabo zdravila ne smejo kaditi, jesti ali piti in si morajo po uporabi zdravila temeljito umiti roke.
English: What is Bravecto and what is it used for?
Slovenian: Kaj je zdravilo Bravecto in za kaj se uporablja?
English: What are the risks associated with Bravecto?
Slovenian: Kakšna tveganja so povezana z zdravilom Bravecto?
English: Used pipettes should be disposed of immediately.
Slovenian: Uporabljene merilne kapalke je treba nemudoma zavreči.
English: What benefits of Bravecto have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Bravecto izkazalo v študijah?
English: In case of eye contact, the affected area should be rinsed immediately with water.
Slovenian: V primeru stika z očmi je treba prizadeto področje nemudoma izprati z vodo.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Slovenian: Zavira normalno prehajanje nabitih kloridnih delcev (ionov) v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gama-aminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata sporočila med živci (živčna prenašalca).
English: An overview of Bravecto and why it is authorised in the EU
Slovenian: Pregled zdravila Bravecto in zakaj je odobreno v EU
English: Why is Bravecto authorised in the EU?
Slovenian: Zakaj je zdravilo Bravecto odobreno v EU?
English: For ear mite infestations, a veterinary check is advised 28 days after treatment.
Slovenian: Za zdravljenje infestacij z ušesnimi garjami je priporočljiv veterinarski pregled 28 dni po zdravljenju.
English: Contact with skin and/or eyes should be avoided including hand to eye contact.
Slovenian: Treba se je izogibati stiku s kožo in/ali očmi ter dotiku oči z rokami.