FrancophonIA/ELRC3.0 huggingface dataset:
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
Slovenian: Povprečno je zdravljenje z zdraviloma darunavir/ ritonavir 800/100 mg enkrat na dan trajalo 162,5 tednov.
English: Darunavir is expected to increase these antiarrhythmic plasma concentrations.
Slovenian: Pričakovati je, da darunavir zvišuje plazemsko koncentracijo navedenih antiaritmikov.
English: Ask your doctor if you are unsure about the severity of your liver disease.
Slovenian: Če niste prepričani, kako resna je vaša bolezen jeter, vprašajte zdravnika.
English: Never suppressed subjects
Slovenian: Bolniki, pri katerih nikoli ni bilo odziva
English: Darunavir co-administered with low dose ritonavir and raltegravir can be used without dose adjustments.
Slovenian: Darunavir skupaj z majhnim odmerkom ritonavirja in z dolutegravirjem se lahko uporablja brez prilagajanja odmerkov.
English: However, dizziness has been reported in some patients during treatment with regimens containing darunavir co-administered with low dose ritonavir and should be borne in mind when considering a patient's ability to drive or operate machinery (see section 4.8).
Slovenian: To je treba upoštevati pri oceni bolnikove sposobnosti za vožnjo in upravljanje strojev (glejte poglavje 4.8).
English: PROTON PUMP INHIBITORS Omeprazole
Slovenian: ZAVIRALCI PROTONSKE ČRPALKE omeprazol
English: Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis) Saquinavir (HIV infection).
Slovenian: Povejte svojemu zdravniku, če jemljete: - fenobarbital, fenitoin (za preprečevanje epileptičnih napadov) - deksametazon (kortikosteroid) - efavirenz(za zdravljenje okužbe z virusomHIV) - boceprevir (za zdravljenje okužbe z virusom hepatitisa C) - rifapentin, rifabutin (zdravili za zdravljenje nekaterih okužb, kot je tuberkuloza) - sakvinavir(za zdravljenje okužbe z virusomHIV)
English: Musculoskeletal abnormalities
Slovenian: Mišično-skeletni neželeni učinki
English: It is not recommended to combine darunavir co-administered with low dose ritonavir with saquinavir.
Slovenian: Kombiniranje darunavirja z majhnim odmerkom ritonavirja in s sakvinavirjem ni priporočljivo.
English: Boosted darunavir and didanosine can be used without dose adjustments.
Slovenian: Okrepljen darunavir in navedeni NRTI se lahko uporabljajo brez prilagajanja odmerkov.
English: ANTIFUNGALS Voriconazole
Slovenian: ANTIMIKOTIKI vorikonazol
English: Given that digoxin has a narrow therapeutic index, it is recommended that the lowest possible dose of digoxin should initially be prescribed gp)
Slovenian: ki sočasno prejemajo okrepljen darunavir, na začetku prejemajo najnižji možni odmerek digoksina.
English: median CD4+ cell count change from baseline (x 10
Slovenian: Povprečna sprememb a št. celic CD4+ glede na začetno vrednost (x 10
English: Renal impairment No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerka ni potrebno (glejte poglavji 4.4 in
English: Darunavir co-administered with low dose ritonavir can be co-administered with proton pump inhibitors without dose adjustments.
Slovenian: Darunavir z majhnim odmerkom ritonavirja lahko uporabljamo sočasno z zaviralci protonske črpalke, brez prilagajanja odmerka.
English: For dosage recommendations in children see the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.The dose of cobicistat to be used with darunavir has not been established in this patient population.
Slovenian: Navodila za odmerjanje pri otrocih so navedena v Povzetku glavnih značilnosti zdravila Darunavir Krka 600 mg tablete.
English: In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with darunavir co-administered with low dose ritonavir.
Slovenian: V kliničnih preskušanjih z darunavirjem in z majhnim odmerkom ritonavirja so opazili tudi reaktivacijo virusov herpes simplex in herpes zoster.
English: 600 mg once daily efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction)
Slovenian: 600 mg enkrat na dan efavirenz AUC ↑ 21 % efavirenz Cmin ↑ 17 % efavirenz Cmax ↑ 15 % darunavir AUC ↓ 13 % darunavir Cmin ↓ 31 % darunavir Cmax ↓ 15 %
English: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Slovenian: HIV-1 RNK < 50 kopij/ml Sprememba št. celic CD4+ glede na začetno vrednost, v odstotkih Povprečna sprememba št. celic CD4+ glede na začetno vrednost pripisane vrednosti, izračunane z uporabo algoritma TLOVR neodzivni bolniki (NC (Non Completer) = F (Failure))
English: Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Slovenian: 800/400/100 mg dvakrat na dan darunavir: primerjava jemanja učinkovin darunavir/ritonavir 400/100 mg dvakrat na dan s kombinacijo indinavir/darunavir/ritonavir 800/400/100 mg dvakrat na dan sakvinavir 1.000 mg dvakrat na dan darunavir AUC ↓ 26 % darunavir Cmin ↓ 42 % darunavir Cmax ↓ 17 % sakvinavir AUC ↓ 6 % sakvinavir Cmin ↓ 18 % sakvinavir Cmax ↓ 6 % sakvinavir: primerjava jemanja učinkovin sakvinavir/ritonavir 1.000/100mgdvakrat na dan s kombinacijo sakvinavir/darunavir/ritonavir 1.000/400/100 mg dvakrat na dan darunavir: primerjava jemanja učinkovin darunavir/ritonavir 400/100 mg dvakrat na dan s kombinacijo sakvinavir/darunavir/ritonavir 1.000/400/100 mg dvakrat na dan
English: Yellowish brown, oval, biconvex film-coated tablets, engraved with a mark S1 on one side.
Slovenian: Rumenkasto rjave, ovalne, izbočene filmsko obložene tablete z vtisnjeno oznako S1 na eni strani.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Darunavir Krka.
Slovenian: Pred začetkom jemanja zdravila Darunavir Krka se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Co-administration of darunavir with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba darunavirja skupaj z majhnim odmerkom ritonavirja in alfuzosina je kontraindicirana (glejte poglavje 4.3).
English: Darunavir co-administered with low dose ritonavir and nevirapine can be used without dose adjustments.
Slovenian: Darunavir z majhnim odmerkom ritonavirja lahko kombinirate z nevirapinom brez prilagajanja odmerkov.
English: Dose adjustment for buprenorphine may not be necessary when coadministered with boosted darunavir but a careful clinical monitoring for signs of opiate toxicity is recommended.
Slovenian: Zaradi možnosti pojava znakov opioidne toksičnosti je priporočljivo skrbno klinično spremljanje.
English: Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)
Slovenian: - rifabutin(proti bakterijskim okužbam) - sildenafil, vardenafil, tadalafil (proti motnjam erekcije ali visokemu krvnemu tlaku v pljučnem krvnem obtoku) - amitriptilin, desipramin, imipramin, nortriptilin,paroksetin, sertralin, trazodon
English: Brownish red, oval, biconvex film-coated tablets, engraved with a mark S3 on one side.
Slovenian: Rjavkasto rdeče, ovalne, izbočene filmsko obložene tablete z vtisnjeno oznako S3 na eni strani.
English: Dapoxetine
Slovenian: Dojenje
English: When administration of rosuvastatin and boosted darunavir is required, it is recommended to start with the lowest possible dose of rosuvastatin and titrate up to the desired clinical effect while monitoring for safety.
Slovenian: Če je potrebna sočasna uporaba rosuvastatina in okrepljenega darunavirja, je priporočljivo, da zdravljenje začnete z najnižjim možnim odmerkom rosuvastatina, ki ga nato, ob spremljanju varnosti, zvečujete do kliničnega učinka.
English: Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when darunavir coadministered with low dose ritonavir is given in combination with efavirenz.
Slovenian: Kadar se darunavir z majhnim odmerkom ritonavirja uporablja v kombinaciji z efavirenzem, bo zaradi zvečane izpostavljenosti efavirenzu morda potrebno klinično spremljanje zaradi možnosti pojava toksičnosti za osrednji živčni sistem.
English: Boosted darunavir is expected to increase these antipsychotic plasma concentrations.
Slovenian: Pričakovati je, da okrepljen darunavir zviša plazemske koncentracije teh antipsihotikov.
English: Number of mutations from the list of mutations associated with a diminished response to darunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V)
Slovenian: Število mutacij s seznama mutacij, ki so povezane z zmanjšanim odzivom na darunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L ali M, T74P, L76V, I84V ali L89V) stopnja spremembe (FC) EC50 “bolniki, ki še niso/niso prvič jemali ENF” so bolniki, ki še niso jemali ENF ali pa so ga uporabljali, vendar ne prvič “bolniki, ki so prvič jemali ENF” so bolniki, ki so v preskušanju prvič uporabili ENF
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The dose is either:
Slovenian: Odmerek za otroke, stare 3 leta ali več in s telesno maso najmanj 40 kg, ki še niso prejemali protiretrovirusnih zdravil (to bo določil otrokov zdravnik) - Običajni odmerek zdravilaDarunavir Krka je 800mg(dve tableti zdravila
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking darunavir co-administered with cobicistat.
Slovenian: Pri bolnikih, ki jemljejo darunavir sočasno s kobicistatom, je priporočljivo skrbno spremljanje bolnika in prilagoditev odmerka metformina.
English: Imputations according to the TLOVR algorithm.
Slovenian: pripisane vrednosti, izračunane z uporabo algoritma TLOVR
English: darunavir/ ritonavir 800/100 mg once daily N=343
Slovenian: TITAN 48. teden darunavir/ritonavir 800/100 mg enkrat na dan n = 343
English: Outcomes darunavir/ ritonavir 800/100 mg once daily N=343
Slovenian: Izidi darunavir ritonavir mg enkrat na dan n = 343
English: Systemic dexamethasone should be used with caution when combined with darunavir co-administered with low dose ritonavir.
Slovenian: Pri sočasni uporabi sistemsko danega deksametazona in darunavirja skupaj z majhnim odmerkom ritonavirja je potrebna previdnost.
English: rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39% sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) The interaction trial showed a comparable daily systemic exposure for rifabutin between treatment at 300 mg once daily alone and 150 mg once every other day in combination with darunavir/ritonavir (600/100 mg twice daily) with an about 10fold increase in the daily exposure to the active metabolite 25-O-desacetylrifabutin.
Slovenian: simeprevir simeprevir AUC ↑ 159 % simeprevir Cmin ↑ 358 % simeprevir Cmax ↑ 79 % darunavir AUC ↑ 18 % darunavir Cmin ↑ 31 % darunavir Cmax ↔ Odmerek simeprevirja v tej interakcijski študiji je bil 50 mg ob sočasni uporabi s kombinacijo darunavir/ritonavir, v primerjavi s skupino, ki je uporabila samo 150 mg simeprevirja.
English: Do not stop taking Darunavir Krka without talking to your doctor first Anti-HIV medicine may make you feel better.
Slovenian: Če ste prenehali jemati zdravilo Darunavir Krka Zdravila za zdravljenje okužbe s HIV lahko izboljšajo vaše počutje, vendar kljub izboljšanju počutja ne smete prenehati z jemanjem zdravila Darunavir Krka.
English: Boosted darunavir is expected to increase these antiarrhythmic plasma concentrations.
Slovenian: Pričakovati je, da okrepljen darunavir zvišuje plazemsko koncentracijo navedenih antiaritmikov.
English: Clinical monitoring is recommended when co-administering boosted darunavir with these antidepressants and a dose adjustment of the antidepressant may be needed.
Slovenian: Ob uvedbi sočasnega zdravljenja z okrepljenim darunavirjem prilagajanje odmerka metadona ni potrebno.
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when coadministered with darunavir with low dose ritonavir.
Slovenian: Pri sočasni uporabi z darunavirjem skupaj z majhnim odmerkom ritonavirja je potrebna previdnost, priporočljivo pa je spremljanje terapevtskih koncentracij navedenih antiaritmikov, če je na voljo.
English: With baseline HIV-RNA <
Slovenian: Odziv (HIV-1 RNK
English: HIV-1 RNA < 50 copies/ml All patients
Slovenian: HIV-1 RNK < 50 kopij/ml Z začetno konc.
English: The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 74 treatmentexperienced paediatric patients, aged 6 to 17 years and weighing at least 20 kg, showed that the administered weight-based doses of darunavir /ritonavir resulted in darunavir exposure comparable to that in adults receiving darunavir /ritonavir 600/100 mg twice daily (see section 4.2).
Slovenian: Pri 74 pediatričnih bolnikih (starih 6 do 17 let in s telesno maso najmanj 20 kg), ki so že bili zdravljeni s protiretrovirusnimi zdravili, so farmakokinetični podatki darunavirja v kombinaciji z ritonavirjem dvakrat na dan pokazali, da je bila, po zaužitju na osnovi telesne mase določenih odmerkov, izpostavljenost darunavirju primerljiva izpostavljenosti pri odraslih, ki so dvakrat na dan prejemali 600/100 mg odmerek kombinacije darunavir/ritonavir (glejte poglavje 4.2).
English: A lower dose of the β-blocker should be considered.
Slovenian: Treba je razmisliti tudi o zmanjšanju odmerka antagonista adrenergičnih receptorjev beta.
English: Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) Maybe you will require a different dose of Darunavir Krka which cannot be administered with these 400 or 800 milligram tablets.
Slovenian: Morda boste potrebovali odmerek, ki se ga ne da doseči s tabletami po 400 ali 800 mg. Na voljo so druge jakosti zdravila Darunavir Krka.
English: Darunavir with low dose ritonavir with triazolam or oral midazolam is contraindicated (see section 4.3)
Slovenian: Sočasna uporaba darunavirja z majhnim odmerkom ritonavirja in triazolama ali peroralnega triazolama je kontraindicirana (glejte poglavje 4.3)
English: Non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Slovenian: Z analizo po 48 tednih zdravljenja so dokazali neinferiornost (pri vnaprej določeni 12 % meji neinferiornosti) virološkega odziva (določen kot odstotek bolnikov s plazemsko koncentracijo HIV-1 RNK < 50 kopij/ml) na zdravljenje s kombinacijo darunavir/ritonavir tako za populacijo, ki je bila vključena v preskušanje (ITTIntent-To-Treat), kot tudi za populacijo, ki je preskušanje zaključila skladno s protokolom (OP - On Protocol).
English: administered with darunavir with low dose ritonavir resulting in the potential for increased adverse events usually associated with these agents.
Slovenian: Koncentracije teh zdravil se lahko pri sočasnem dajanju z darunavirjem skupaj z majhnim odmerkom ritonavirja zvišajo, kar lahko zveča možnost za neželene učinke, ki se običajno pojavljajo pri uporabi teh zdravil.
English: Co-administration of boosted darunavir with dapoxetine is contraindicated.
Slovenian: Sočasna uporaba okrepljenega darunavirja in dapoksetina je kontraindicirana.
English: 5.How to store Darunavir Krka
Slovenian: Shranjevanje zdravila Darunavir Krka
English: The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 14 treatmentexperienced paediatric patients, aged 3 to < 6 years and weighing at least 15 kg to < 20 kg, showed that weight-based dosages resulted in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 600/100 mg twice daily (see section 4.2).
Slovenian: Pri 14 pediatričnih bolnikih (starih 3 do < 6 let in s telesno maso najmanj 15 kg do < 20kg), ki so že bili zdravljeni s protiretrovirusnimi zdravili, so farmakokinetični podatki darunavirja v kombinaciji z ritonavirjem dvakrat na dan pokazali, da je bila na osnovi telesne mase določenih odmerkov, izpostavljenost darunavirju primerljiva izpostavljenosti pri odraslih, ki so dvakrat na dan prejemali 600/100 mg odmerek kombinacije darunavir/ritonavir (glejte poglavje 4.2).
English: OR
Slovenian: po
English: Darunavir co-administered with low dose ritonavir and rilpivirine can be used without dose adjustments.
Slovenian: Darunavir z majhnim odmerkom ritonavirja lahko uporabljate z rilpivirinom brez prilagajanja odmerkov.
English: When administration of pravastatin and boosted darunavir is required, it is recommended to start with the lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety.
Slovenian: Če je potrebna sočasna uporaba pravastatina in okrepljenega darunavirja, je priporočljivo, da zdravljenje začnete z najnižjim možnim odmerkom pravastatina, ki ga nato, ob spremljanju varnosti, zvečujete do kliničnega učinka.
English: The effects of other medicines might be influenced if you take Darunavir Krka.
Slovenian: Zdravilo Darunavir Krka lahko vpliva na učinke drugih zdravil.
English: Concomitant use of boosted darunavir with lovastatin and simvastatin is therefore contraindicated (see section 4.3).
Slovenian: Sočasna uporaba okrepljenega darunavirja in triazolama oziroma peroralnega triazolama je kontraindicirana (glejte poglavje 4.3).
English: The concomitant use with boosted darunavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Slovenian: Bolnike je treba spremljati zaradi tveganja za dolgotrajno ali zakasnjeno depresijo dihanja
English: Clotrimazole
Slovenian: Starostniki
English: An increase of systemic exposure to darunavir was observed when darunavir co-administered with 100 mg ritonavir was co-administered with rifabutin (150 mg once every other day).
Slovenian: Pri sočasni uporabi darunavirja s 100 mg ritonavirja in rifabutina (150 mg rifabutina enkrat vsak drugi dan) so opažali zvečanje sistemske izpostavljenosti darunavirju.
English: Lopinavir/ ritonavir 800/200 mg per day N=346
Slovenian: lopinavir ritonavir mg na dan n = 346
English: Darunavir given with low dose ritonavir may be considered as an alternative.
Slovenian: Kot alternativno zdravljenje se lahko uporabi zdravilo darunavir z majhnim odmerkom ritonavirja.
English: Co administration of darunavir coadministered with cobicistat and bosentan is not recommended.
Slovenian: Sočasna uporaba darunavirja s kobicistatom in z bosentanom ni priporočljiva.
English: The weight-based dose regimen for darunavir and ritonavir is provided in the tables above.
Slovenian: Odmerek zdravil darunavirja in ritonavirja glede na telesno maso je naveden v zgornjih preglednicah.
English: Darunavir exposure (and also ritonavir exposure) may increase on stopping St John's wort.
Slovenian: Po prekinitvi uporabe šentjanževke se lahko izpostavljenost darunavirju (in tudi ritonavirju) zveča.
English: Caution should be exercised when clarithromycin is combined with boosted darunavir.
Slovenian: Pri uporabi klaritromicina v kombinaciji z okrepljenim darunavirjem je potrebna previdnost.
English: ART-experienced adult patients The recommended dose regimens are as follows: In ART-experienced patients with no darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10 6/l
Slovenian: - pri bolnikih z izkušnjami z ART, ki nimajo mutacij, povezanih z odpornostjo proti darunavirju (DRV-RAM)*, in imajo plazemsko koncentracijo HIV-1 RNK < 100.000 kopij/ml in število celic CD4+ ≥ 100 celic x 10
English: Alternative or additional contraceptive measures are recommended when oestrogen-based contraceptives are co-administered with darunavir and low dose ritonavir.
Slovenian: Pri sočasni uporabi estrogenskih kontraceptivov in darunavirja z majhnim odmerkom ritonavirja je priporočljiva uporaba alternativnih ali dodatnih kontracepcijskih metod.
English: Darunavir co-administered with low dose ritonavir and didanosine can be used without dose adjustments.
Slovenian: Kombinacija darunavirja z majhnim odmerkom ritonavirja in didanozinom se lahko uporablja brez prilagajanja odmerkov.
English: Dose adjustment for buprenorphine may not be necessary when coadministered with darunavir/ritonavir but a careful clinical monitoring for signs of opiate toxicity is recommended.
Slovenian: Ob sočasni uporabi z zdraviloma darunavir/ritonavir verjetno ne bo treba prilagajati odmerkov buprenorfina.
English: Other mean CD4+ cell count change from baseline (x 10
Slovenian: Povprečna sprememba št. celic CD4+ glede na začetno vrednost (x 10
English: daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Slovenian: 300 mg enkrat na dan atazanavir AUC ↔ atazanavir Cmin ↑ 52 % atazanavir Cmax ↓ 11 % darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ atazanavir: primerjava jemanja učinkovin atazanavir/ritonavir 300/100 mg enkrat na dan s kombinacijo atazanavir 300 mg enkrat na dan in darunavir/ritonavir 400/100 mg dvakrat na dan darunavir: primerjava jemanja učinkovin darunavir/ritonavir 400/100 mg dvakrat na dan s kombinacijo darunavir/ritonavir 400/100 mg dvakrat na dan in atazanavir 300 mg enkrat na dan
English: It is not possible to administer all paediatric dosages with this product.
Slovenian: Odmerka kobicistata za uporabo z darunavirjem pri tej populaciji niso določili.
English: People taking Darunavir Krka may develop a skin rash.
Slovenian: Pri ljudeh, ki jemljejo zdravilo Darunavir Krka, se lahko pojavi izpuščaj, ki lahko postane hud ali življenju nevaren.
English: Concentrate for solution for injection
Slovenian: Velikost pakiranja koncentrat za raztopino za injiciranje intravitrealna uporaba raztopina za injiciranje intravitrealna uporaba
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 January 2017
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 09 januar 2017
English: Currently available data are described in section 5.1.
Slovenian: Podatki, ki so trenutno na voljo, so opisani v poglavju 5.1.
English: Komárom, 2900 Hungary
Slovenian: Komárom, 2900 Madžarska
English: Children and adolescents This medicine is not indicated for use by children and adolescents under the age of 18.
Slovenian: Otroci in mladostniki To zdravilo ni namenjeno zdravljenju otrok in mladostnikov, mlajših od 18 let.
English: 2 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Slovenian: 2 Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela predhodno prisotne srčno-žilne dejavnike tveganja.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: NE vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
English: The tablets can be taken with or without food.
Slovenian: Tableti lahko vzamete s hrano ali brez nje.
English: Swallow the tablets whole with a drink of water.
Slovenian: Pogoltnite celi tableti z nekaj vode.
English: Across all clinical studies, reports of changes in colour vision were rare (< 0.1%).
Slovenian: V vseh kliničnih študijah so bila poročila o spremembah barvnega vida redka (< 0,1%).
English: Severe hypotension (< 90/50 mm Hg).
Slovenian: Huda hipotenzija (< 90/50 mm Hg)