FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Slovenian: Zdravilo je treba dajati v mesečnih razmikih v obdobjih leta, ko so bolhe ali klopi prisotni, in v vsak mesec pri garjavici vrste Demodex canis, dokler ni uspešno pozdravljena (in potrjena z negativnimi rezultati dveh kožnih brisov, vzetih v enomesečnem razmiku), ter vsak mesec dva meseca zapored pri garjavici vrste Sarcoptes scabiei oziroma dlje, če klinični znaki in brisi kože nakazujejo, da zdravljenje ni bilo uspešno.
English: What is NexGard and what is it used for?
Slovenian: Kaj je zdravilo NexGard in za kaj se uporablja?
English: What are the risks associated with NexGard?
Slovenian: Kakšna tveganja so povezana z zdravilom NexGard?
English: What benefits of NexGard have been shown in studies?
Slovenian: Kakšne koristi je zdravilo NexGard izkazalo v študijah?
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Slovenian: V terenski študiji, ki so jo opravili v EU in v katero so vključili 146 psov z bolhami in/ali klopi, je bila ena sama uporaba zdravila NexGard učinkovita proti bolham in klopom pri psih v obdobju do 30 dni po zdravljenju.
English: After being given, its actions last for at least 5 weeks against fleas and up to one month against ticks.
Slovenian: Po uporabi zdravilo proti bolham deluje najmanj pet tednov, proti klopom pa od enega meseca.
English: The active substance in NexGard, afoxolaner, acts as an ‘ectoparasiticide'.
Slovenian: Učinkovina v zdravilu NexGard, afoksolaner, deluje kot ektoparaziticid.
English: This results in uncontrolled activity of the nervous system and the paralysis and
Slovenian: tem povzroči nenadzorovano delovanje živčnega sistema ter paralizo in smrt bolh, klopov in garjavcev.
English: NexGard is a medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Slovenian: NexGard je zdravilo, ki je namenjeno zdravljenju infestacij z bolhami in klopi ter garjavice vrste Demodex canis in Sarcoptes scabiei (kožne garjavosti, ki jo povzročata dve vrsti garjavcev) pri psih.
English: NexGard is available as chewable tablets in four different strengths for use in dogs of different weights.
Slovenian: Zdravilo NexGard je na voljo v obliki žvečljivih tablet štirih različnih jakosti, namenjenih za uporabo pri psih z različno telesno maso.
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with NexGard.
Slovenian: V drugo terensko študijo, opravljeno v EU, so vključili 31 psov z garjavico vrste Demodex canis, ki so jih trikrat zapored mesečno zdravili z zdravilom NexGard.
English: NexGard contains the active substance afoxolaner.
Slovenian: Zdravilo NexGard vsebuje učinkovino afoksolaner.
English: How does NexGard work?
Slovenian: Kako zdravilo NexGard deluje?
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with NexGard.
Slovenian: V tretjo terensko študijo so vključili 38 psov z garjavico vrste Sarcoptes scabiei, ki so zdravilo NexGard prejeli enkrat na mesec dva meseca zapored.
English: How is NexGard used?
Slovenian: Kako se zdravilo NexGard uporablja?
English: NexGard is given as a tablet of the appropriate strength for the dog's bodyweight.
Slovenian: Zdravilo NexGard se daje v obliki tablet, in sicer v jakosti, ki ustreza telesni masi psa.
English: Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product.
Slovenian: Da bi otrokom preprečili neposreden stik z zdravilom, je treba iz pretisnega omota jemati vsako žvečljivo tableto posebej.
English: > 3 hours to ≤ 7 days
Slovenian: > 3 ure do ≤ 7 dni
English: YES NO
Slovenian: DA NE
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 06 September 2015
Slovenian: Datum prve odobritve: 01. september 2010 Datum zadnjega podaljšanja: 01. september 2015
English: These patients should be monitored closely.
Slovenian: Takšne bolnike je treba skrbno nadzorovati.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčka/dojenčka ni mogoče izključiti.
English: It will be given to you into your vein over 10 minutes.
Slovenian: Dobili ga boste v veno v teku 10 minut.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 4.2.
English: Variations of colour within this range do not affect potency.
Slovenian: Sprememba barve v tem razponu ne vpliva na učinek.
English: The company will start to include the pre-infusion check list in packs packed at the packaging site as soon as possible but at the latest on 15 November 2012.
Slovenian: Kontrolni seznam bo s strani podjetja vključen v pakiranja zdravila na mestu, kjer poteka pakiranje, in sicer čim prej, vendar najkasneje do 15. novembra 2012.
English: Efficacy versus amiodarone (AVRO)
Slovenian: Učinkovitost v primerjavi z amiodaronom (AVRO):
English: • Bradycardia
Slovenian: • bradikardija
English: These reactions occurred around the time of infusion, were transient and were rarely treatment limiting.
Slovenian: Te reakcije so se pojavile okrog časa infundiranja, bile so prehodne in so redko omejile zdravljenje.
English: Detailed information on warnings and precautions relating to side effects that could occur are presented in section 4.
Slovenian: Podrobne informacije o opozorilih in previdnostnih ukrepih v zvezi z neželenimi učinki, ki se lahko pojavijo, so predstavljene v poglavju 4.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita istočasno.
English: By 90 minutes after the start of infusion, this difference was reduced to 8.1 msec.
Slovenian: Do 90. minute po začetku infundiranja se je ta razlika zmanjšala na 8,1 ms.
English: Overall, BRINAVESS was effective in 70.2% (1,359/1,936) of these patients.
Slovenian: V celoti gledano je bil BRINAVESS učinkovit pri 70,2% (1.359/1.936) teh bolnikov.
English: Does the patient have a systolic blood pressure < 100 mm Hg?
Slovenian: Ali ima bolnik sistolični krvni tlak < 100 mm Hg?
English: If any of the above apply to you (or you are not sure), talk to your doctor.
Slovenian: Če kaj od navedenega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom.
English: Patients who did not respond to treatment were managed by the physician using standard care.
Slovenian: Bolnike, ki se na zdravljenje niso odzvali, je zdravnik obravnaval v skladu s standardno oskrbo.
English: Patients with body weight > 113 kg:
Slovenian: Bolniki s telesno maso > 113 kg:
English: In patients with hepatic impairment, exposures were elevated by 9 to 25 %.
Slovenian: Pri bolnikih z okvaro jeter je bila izpostavljenost za 9 do 25 % večja.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Slovenian: Seznam neželenih učinkov Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000
English: Key elements to be included in the educational material:
Slovenian: Ključni elementi, ki morajo biti vključeni v izobraževalnem gradivu: 1.
English: With continuation of the medicine infusion as recommended above, the majority of these patients continue to convert to sinus rhythm.
Slovenian: Z nadaljevanjem infundiranja zdravila, kot je priporočeno zgoraj, večina teh bolnikov preide v sinusni ritem.
English: 5928 LC Venlo
Slovenian: 5928 LC Venlo Nizozemska
English: If you are not sure, talk to your doctor before you use this medicine.
Slovenian: Če niste prepričani, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: Your doctor may decide to stop the infusion if he observes any of the following abnormal changes of:
Slovenian: Zdravnik se lahko odloči za prenehanje infundiranja zdravila, če opazi naslednje nenormalne spremembe:
English: When giving BRINAVESS, follow these instructions:
Slovenian: Pri dajanju zdravila upoštevajte naslednja navodila:
English: Vernakalant is extensively and rapidly distributed in the body, with a volume of distribution of approximately 2 l/kg.
Slovenian: Vernakalant se v telesu hitro in obsežno porazdeli; volumen porazdelitve je približno 2 l/kg.
English: The European Medicines Agency has waived the obligation to submit the results of studies with vernakalant in all subsets of the paediatric population in atrial fibrillation (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z vernakalantom za vse podskupine pediatrične populacije za atrijsko fibrilacijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: (≥ 1/1,000 to < 1/100).
Slovenian: do < 1/100).
English: Information on how to prepare the solution is available at the end of this leaflet.
Slovenian: Informacije o pripravi raztopine so na voljo na koncu tega navodila za uporabo.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenem na evropskem spletnem portalu o zdravilih.
English: • if you are allergic to vernakalant hydrochloride or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na vernakalantijev klorid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Tell your doctor if you have a pacemaker.
Slovenian: Zdravniku morate povedati, če imate srčni spodbujevalnik.
English: Geodis Logistics Netherlands B.V. Columbusweg 16
Slovenian: Geodis Logistics Netherlands B.V.
English: No patients with NYHA III/IV were included in the study.
Slovenian: V študijo niso bili vključeni bolniki z NYHA III/IV.
English: Cumulative doses above 565 mg have not been evaluated.
Slovenian: Kumulativni odmerki, večji od 565 mg, niso bili ovrednoteni.
English: In general, bradycardia responded well to discontinuation of treatment and/or administration of atropine.
Slovenian: Na splošno so se bolniki, pri katerih se je pojavila bradikardija, dobro odzvali na prenehanje zdravljenja in/ali uporabo atropina.
English: • pain in your mouth or throat
Slovenian: • bolečina v ustih ali grlu
English: In the remaining patients, electrical cardioversion can be recommended.
Slovenian: Za preostale bolnike je mogoče priporočiti elektrokonverzijo.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Preden začnete uporabljati to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25 °C.
Slovenian: Razredčeni sterilni koncentrat je kemično in fizikalno stabilen 12 ur pri temperaturi do vključno 25 °C.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah.
English: For atrial fibrillation lasting less than 48 hours, immediate cardioversion was allowed.
Slovenian: Za atrijsko fibrilacijo, ki je trajala manj kot 48 ur, je bila dovoljena takojšnja kardioverzija.
English: To ensure proper administration, a sufficient amount of BRINAVESS 20 mg/ml should be prepared at the outset of therapy to deliver the initial and second infusion should it be warranted.
Slovenian: Za zagotovitev pravilnega dajanja je treba že na začetku zdravljenja pripraviti dovolj zdravila BRINAVESS 20 mg/ml, da je mogoče dati začetno infuzijo in drugo infuzijo, če se ta izkaže za potrebno.
English: If these events occur during the first infusion of vernakalant, patients should not receive the second dose.
Slovenian: Če se takšni dogodki pojavijo med prvo infuzijo vernakalanta, bolniki ne smejo dobiti drugega odmerka tega zdravila.
English: However, a syringe pump is acceptable provided that the calculated volume can be accurately given within the specified infusion time.
Slovenian: Sprejemljiva pa je tudi injekcijska črpalka, če je izračunana količina lahko natančno aplicirana v določenem času za infundiranje.
English: Pharmacotherapeutic group: Cardiac therapy, other antiarrhythmics class I and III; ATC code: C01BG11.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni srca, drugi antiaritmiki skupine I in III; oznaka ATC: C01BG11.
English: Do not use this medicine if you notice particulate matter or discolouration.
Slovenian: Tega zdravila ne uporabite, če v njem opazite delce ali če je obarvano.
English: Studies in animal have shown malformations after repeated oral exposure (see section 5.3).
Slovenian: Študije na živalih so po ponavljajoči se peroralni izpostavljenosti pokazale malformacije (glejte poglavje 5.3).
English: The Marketing Authorisation Holder shall provide a check list in each pack, the text of which is included in Annex IIIA.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora vsakemu pakiranju priložiti kontrolni seznam, katerega besedilo se nahaja v Dodatku IIIA.
English: If any of the following signs or symptoms occurs, the administration of vernakalant should be discontinued and these patients should receive appropriate medical management:
Slovenian: Če se pojavi kateri koli od naslednjih znakov ali simptomov, je treba z dajanjem vernakalanta prenehati, bolniki pa morajo biti deležni ustrezne terapevtske obravnave:
English: Its use in these patients is not recommended.
Slovenian: Zato pri bolnikih s temi boleznimi njegove uporabe ni mogoče priporočiti.
English: ACT III BRINAVESS Placebo P-Value† BRINAVESS Placebo P-Value†
Slovenian: BRINAVESS placebo vrednost p†
English: The Marketing Authorisation Holder must agree about the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pred distribucijo doseči dogovor z nacionalnim pristojnim organom glede vsebine in oblike izobraževalnega gradiva, skupaj z načrtom komunikacije.
English: If your heart beat has not returned to normal 15 minutes after the end of your first dose, you may be given a second dose.
Slovenian: Če se vam srčni utrip ne normalizira v 15 minutah po koncu prvega odmerka, lahko dobite drugi odmerek.
English: Pharmacodynamics effects
Slovenian: Farmakodinamični učinki
English: Treatment with vernakalant did not affect the response rate to electrical cardioversion (including the median number of shocks or joules required for successful cardioversion) in cases when attempted within 2 to 24 hours of study medicine administration.
Slovenian: Zdravljenje z vernakalantom ni vplivalo na delež odziva na elektrokonverzijo (vključno z medianim številom šokov ali joulov, potrebnih za ustrezno kardioverzijo) v primerih, ko je bila ta poskušana v 2 do 24 urah po uporabi raziskovanega zdravila.
English: BRINAVESS vials are for single use only and must be diluted prior to administration.
Slovenian: Viale BRINAVESS so samo za enkratno uporabo in jih je pred dajanjem treba razredčiti.
English: The check list will be provided with an adhesive in order to be placed on the infusion container.
Slovenian: Kontrolni seznam bo opremljen z lepilom, da se ga lahko pritrdi na vsebnik infuzije.
English: - If you have any further questions, ask your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom
English: Does the patient have hypersensitivity to the active substance or to any of the excipients?
Slovenian: Ali je bolnik preobčutljiv na učinkovino ali katero koli pomožno snov?
English: Does the patient have severe aortic stenosis?
Slovenian: Ali ima bolnik hudo aortno stenozo?
English: If you have very low blood pressure or slow heart rate or certain changes in your ECG while using this medicine, your doctor will stop your treatment.
Slovenian: Če imate med prejemanjem tega zdravila zelo nizek krvni tlak, zelo počasen srčni utrip ali določene spremembe na EKG, bo zdravnik zdravljenje prekinil.
English: If such signs develop, with or without symptomatic hypotension or bradycardia, the infusion should be stopped immediately.
Slovenian: Če se taki znaki pojavijo, s simptomatsko hipotenzijo ali bradikardijo ali brez nje, je treba z infundiranjem takoj prenehati.
English: Uncommon: Blood pressure diastolic increased
Slovenian: Občasni: zvišanje diastoličnega krvnega tlaka
English: The Cmax and AUC were dose proportional between 0.5 mg/kg and 5 mg/kg.
Slovenian: Cmax in AUC sta bila v območju od 0,5 mg/kg in 5 mg/kg sorazmerni odmerku.
English: Conversion of atrial fibrillation in patients with longer-duration atrial fibrillation (> 7 days and ≤ 45 days) assessed as a secondary efficacy endpoint in a total of 185 patients did not show statistically significant differences between vernakalant and placebo.
Slovenian: Prehod iz atrijske fibrilacije pri bolnikih z dolgotrajnejšo atrijsko fibrilacijo (> 7 dni in ≤ 45 dni), ocenjen kot sekundarni opazovani dogodek učinkovitosti pri skupaj 185 bolnikih, se ni statistično značilno razlikoval med vernakalantom in placebom.
English: Resumption or initiation of oral maintenance antiarrhythmic therapy after this time period can be considered (see sections 4.3 and 4.4).
Slovenian: Ponoven začetek ali uvedba peroralnega vzdrževalnega antiaritmičnega zdravljenja pride v poštev po tem obdobju (glejte poglavji 4.3 in 4.4).
English: Uncommonly, cases of severe hypotension have been observed.
Slovenian: Občasno so opazili primere hude hipotenzije.
English: Step 2: Dilution of concentrate
Slovenian: 2. korak: Redčenje koncentrata
English: Does the patient have heart failure class NYHA III or NYHA IV?
Slovenian: Ali ima bolnik srčno popuščanje v razredu NYHA III ali NYHA IV?
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se zdravila ne uporabi takoj, je za shranjevanje po pripravi in pogoje pred uporabo odgovoren uporabnik; čas shranjevanja pri temperaturi od 2 °C do 8 °C običajno ne sme presegati 24 ur, razen če je priprava potekala v nadzorovanih in validiranih aseptičnih pogojih.
English: Before giving you this medicine, your doctor will decide whether to test your blood to see how well it clots and also to see your potassium level.
Slovenian: Preden boste dobili to zdravilo, bo zdravnik presodil, ali vam je treba narediti preiskavo krvi, da bi ugotovili, kako dobro se strjuje in kakšna je koncentracija kalija.
English: Other diseases and conditions not studied
Slovenian: Druge bolezni in neraziskana stanja
English: • if you have had new or worsening chest pain (angina) diagnosed by your doctor as an acute coronary syndrome in the last 30 days or you have had a heart attack in the last 30 days
Slovenian: • če se vam je v zadnjih 30 dneh na novo pojavila bolečina v prsih (angina pektoris), ali se vam je takšna bolečina poslabšala, kar je zdravnik diagnosticiral kot akutni koronarni sindrom, ali če ste v zadnjih 30 dneh imeli srčni napad.
English: • A sudden drop in blood pressure or heart rate, with or without symptomatic hypotension or bradycardia
Slovenian: • nenaden padec krvnega tlaka ali srčne frekvence, z ali brez simptomatske hipotenzije ali bradikardije
English: The mean elimination half-life of vernakalant in patients was approximately 3 hours in CYP2D6 extensive metabolisers and approximately 5.5 hours in poor metabolisers.
Slovenian: Povprečni eliminacijski razpolovni čas vernakalanta pri bolnikih je približno 3 ure pri dobrih metabolizatorjih s CYP2D6 in približno 5,5 ure pri slabih metabolizatorjih.
English: Vernakalant has been administered to patients with an uncorrected QT less than 440 msec without an increased risk of torsade de pointes.
Slovenian: Vernakalant so dajali bolnikom z nekorigiranim QT manj kot 440 ms brez večjega tveganja za pojav torsade de pointes.
English: During atrial fibrillation, the frequency- and voltage-dependent block of sodium channels further focuses the action of the medicine toward rapidly activating and partially depolarized atrial tissue rather than toward the normally polarized ventricle beating at lower heart rates.
Slovenian: Med atrijsko fibrilacijo od frekvence in napetosti odvisna blokada natrijevih kanalov dodatno osredotoči delovanje zdravila na hitro aktivirajoče se in delno depolarizirano tkivo preddvorov, ne pa na normalno polarizirane prekate, ki utripajo z manjšo srčno frekvenco.
English: In clinical studies, the need for anticoagulation prior to administration of vernakalant was assessed as per clinical practice of the treating physician.
Slovenian: V kliničnih študijah je bila potreba po antikoagulantnem zdravljenju pred dajanjem vernakalanta določena glede na klinično prakso lečečega zdravnika.
English: • if you have an abnormally slow heart rate or skipped heart beats and do not have a pacemaker, or you have conduction disturbance called QT prolongation - which can be seen on an ECG by your doctor
Slovenian: • če imate nenormalno počasen srčni utrip ali izpuščene srčne utripe, pa nimate srčnega spodbujevalnika, ali če imate prevodno motnjo, imenovano podaljšanje QT; to motnjo lahko zdravnik vidi na posnetku EKG.
English: There are no data from the use of vernakalant hydrochloride in pregnant women.
Slovenian: Podatkov o uporabi vernakalantijevega klorida pri nosečnicah ni.
English: The higher cardioversion rate in SPECTRUM as compared to clinical phase 3 studies (70.2% vs 47% to 51%) is correlated with a shorter duration of the duration of the index atrial fibrillation period (median duration of 11.1 hours in SPECTRUM vs 17.7 to 28.2 hours in clinical studies).
Slovenian: Višja stopnja kardioverzije v študiji SPECTRUM v primerjavi s kliničnimi študijami faze 3 (70,2% v primerjavi z 47% do 51%) je povezana s krajšim trajanjem obdobja indeksne atrijske fibrilacije (mediana trajanja 11,1 ure v študiji SPECTRUM v primerjavi s 17,7 do 28,2 ure v kliničnih študijah).
English: Treatment success (responder) was defined as conversion of atrial fibrillation to sinus rhythm within 90 minutes.
Slovenian: Uspeh zdravljenja (odzivni bolnik) je bil opredeljen kot prehod iz atrijske fibrilacije v sinusni ritem v 90 minutah.
English: There is no relevant use of vernakalant in children and adolescents < 18 years of age in the current indication and therefore it should not be used in this population.
Slovenian: Za trenutno indikacijo vernakalanta pri otrocih in mladostnikih, starih < 18 let, ni primerne uporabe, zato se ga pri tej populaciji ne sme uporabljati.
English: For atrial fibrillation lasting longer than 48 hours, anticoagulation was required as per treatment guidelines.
Slovenian: Za atrijsko fibrilacijo, ki je trajala več kot 48 ur, je bilo zahtevano antikoagulantno zdravljenje v skladu s terapevtskimi smernicami.