natgillin/translations-raw huggingface dataset:
- Inclusion of cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion) as “very common” undesirable effects.
- Vključitev srčne valvulopatije (vključno z regurgitacijo) in sorodnimi motnjami (perikarditis in iztekanje perikardialne tekočine) med „zelo pogoste“ neželene učinke.
For bromocriptine, dihydroergocryptine and lisuride an increased risk cannot be excluded based on the amount of evidence available.
Pri uporabi bromokriptina, dihidroergokriptina in lizurida pa povečanega tveganja, na osnovi dostopnih podatkov, ni mogoče izključiti.
For pergolide and cabergoline, the majority (about two thirds) of case reports of valvulopathy occurred with doses ≥ 3mg / day.
V primeru pergolida in kabergolina se je večina (približno dve tretjini) poročil o posameznih primerih valvulopatije nanašala na primere uporabe odmerkov, ki so bili enaki ali večji od 3 mg/dan.
At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Odbor za zdravila za uporabo v humani medicini je na svojem zasedanju junija 2008 menil, da dokazi o tveganju fibroznih dogodkov, vključno z boleznimi zaklopke, kažejo, da tveganje ni enako pri vseh agonistih dopamina, pridobjenih iz rženega rožička.
As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Zaradi tega so zdravila, ki vsebujejo kabergolin in pergolid, indicirana le kot zdravljenje druge izbire pri Parkinsonovi bolezni, njihova uporaba pa je kontraindicirana pri bolnikih z dokazanimi težavami s srčnimi zaklopkami.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS
PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline, and pergolide (in particular at doses > 3mg/day), compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Rezultati študije Schade so pokazali višje prilagojeno razmerje stopnje pojavnosti (IRR) simptomatske regurgitacije valvul za kabergolin in pergolid (še posebej pri odmerkih, ki presegajo 3 mg/dan), v primerjavi z bromokriptinom, lizuridom ter agonistoma dopamina pramipeksol ter ropirinol, ki nista pridobljena iz rženega rožička in za katera ni bilo poročil o takih primerih.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin
Stopnja agonističnega delovanja na receptor 5-HT2B se razlikuje med posameznimi agonisti dopamina, ki so pridobljeni iz rženega rožička, in dobro ustreza razlikam v pojavnosti dogodkov fibroze v različnih skupinah zdravil, pridobljenih iz rženega rožička (C.Hofmann et al., Clin Neuropharmacol, 2006).
In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for bromocriptine, dihydroergocryptine and lisuride.
Zaradi razlik v stopnji tveganja med agonisti dopamina, pridobljenimi iz rženega rožička, je CHMP predlagal, da se za bromokriptin, dihidroergokriptin in lizurid izda ločeno mnenje.
- The CHMP recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets of the medicinal products containing cabergoline and pergolide (see Annex III).
- CHMP je priporočil dopolnitve ustreznih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo zdravil, ki vsebujejo kabergolin in pergolid (glejte Prilogo III).
Data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Podatki spontanih poročil kažejo, da so osebe, ki uporabljajo kabergolin in pergolid, bolj izpostavljene tveganju fibroznih dogodkov in valvulopatiji kot osebe, ki uporabljajo bromokriptin, lizurid ali dihidroergokriptin.
In view of the above, the CHMP recommended the maintenance of the marketing authorisation for cabergoline and pergolide containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Zaradi tega je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki vsebujejo kabergolin in pergolid, s tem da se dopolnijo informacije o teh zdravilih (Povzetek glavnih značilnosti zdravila in navodilo za uporabo), kot je navedeno spodaj.
Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Iz rženega rožička pridobljeni agonisti dopamina so povezani s povečanim tveganjem fibroznih motenj in obolenj srčnih zaklopk.
Cabergoline and pergolide belong to the class of ergot derived dopamine agonists, which also comprises bromocriptine, dihydroergocryptine and lisuride.
Kabergolin in pergolid spadata v skupino iz rženega rožička (ergot) pridobljenih agonistov dopamina, ki vključuje tudi bromokriptin, dihidroergokriptin in lizurid.
Comparative trials with non-ergot and ergot derived dopamine agonist are scarce.
Primerjalna preskušanja z agonisti dopamina, ki so pridobljeni iz rženega rožička, v primerjavi s tistimi, ki niso, so redka.
The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
CHMP je pregledal vse podatke o tveganju pojava fibroze in srčne valvulopatije iz kliničnih preskušanj, opazovalnih študij ter spontanih poročil, ki so jih dali na voljo imetniki dovoljenj za promet z zdravilom.
Cases of fibrotic reactions and valvulopathy have been reported with cabergoline and pergolide during clinical trials (open label study and randomised controlled studies).
Med kliničnimi preskušanji (odprte študije in randomizirane nadzorovane študije) s kabergolinom in pergolidom so poročali o primerih fibroznih reakcij in valvulopatije.
2nd line therapy in Parkinson's disease, and contraindicated for patients with evidence of valvulopathy.
CHMP je upošteval tudi, da so ta zdravila že indicirana samo kot zdravila za zdravljenje druge izbire pri Parkinsonovi bolezni in so kontraindicirana pri bolnikih z dokazano valvulopatijo.
For carbergoline and pergolide an increased risk of fibrotic events is considered well established.
Povečano tveganje fibroznih dogodkov je dobro potrjeno pri uporabi karbergolina in pergolida.
No cases were reported for bromocriptine, dihydroergocryptine and lisuride by MAHs.
Pri bromokriptinu, dihidroergokriptinu in lizuridu imetniki dovoljenj za promet z zdravilom niso poročali o takih primerih.
(Invented) name
(Izmisljeno) ime
4 vials
4 viale
Strength Pharmaceutical form
Farmacevtska oblik Pot uporabe Sticna ovojnina Vsebina
MA (EU) number
Stevilka (EU) dovoljenja za promet
This is not an exclusive list.
To ni izključni seznam.
The final study report shall be submitted by:
Končno poročilo o študiji se predloži do:
Date of first authorisation: 26th July 2017
Datum prve odobritve: 26. julij 2017
This allows the infection to be eliminated from the body.
To omogoči odstranitev okužbe iz telesa.
DORA (Part 1)
DORA (1. del)
Appropriate symptomatic treatment should be instituted immediately.
Takoj je treba uvesti ustrezno simptomatsko zdravljenje.
This is so that your doctor can decide if:
To je zato, da zdravnik lahko določi ali:
A risk to the suckling child cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
Patients should be instructed not to take a double dose.
Bolnike je treba poučiti, naj ne vzamejo dvojnega odmerka.
f. VOYAGE-1 and VOYAGE-2 were Asian regional studies.
f. VOYAGE-1 in VOYAGE-2 sta bili azijski regionalni študiji.
Take the medicine pack with you so that you can show the doctor what you have taken.
Pakiranje zdravila vzemite s seboj, da boste zdravniku lahko pokazali, kaj ste vzeli.
Do not take a double dose (two doses too close together).
Ne vzemite dvojnega odmerka (dveh odmerkov v zelo kratkem časovnem razmaku).
How much to take
Koliko vzeti
Do not give this medicine to children under 12 years of age.
Tega zdravila ne dajajte otrokom, mlajšim od 12 let.
The doctor may need to change your dose of these medicines.
Možno je, da bo zdravnik moral spremeniti odmerek teh zdravil.
• you are taking the following medicines:
• jemljete naslednja zdravila:
• you should take Maviret and for how long
• morate jemati zdravilo Maviret in kako dolgo,
The risk of failure was, as expected, highest for those exposed to both classes.
Tveganje za neuspeh je bilo po pričakovanjih največje pri bolnikih, ki so bili izpostavljeni obema skupinama.
Number of clinical isolates
Število kliničnih izolatov
Then take the next dose at your usual time.
Naslednji odmerek vzemite ob običajni uri.
If the combination is unavoidable, use can be considered if the benefit outweighs the risk with a close clinical monitoring.
Če je kombinacija neizogibna, se o uporabi lahko razmisli, kadar koristi prevladajo nad tveganji, skupaj z natančnim kliničnim spremljanjem.
Talk to your doctor if you have the following because your doctor may want to check you more closely:
Posvetujte se z zdravnikom, če imate kaj od naštetega, ker vas bo zdravnik morda želel natančneje spremljati:
Iron oxide red (E172)
rdeči železov oksid (E172)
Caution is recommended.
Priporočljiva je previdnost.
The presence of HIV-1 coinfection did not impact efficacy.
Prisotnost sočasne okužbe s HIV-1 ni vplivala na učinkovitost.
Not known: cannot be estimated from the available data • itching
Neznana pogostnost: ni mogoče oceniti iz razpoložljivih podatkov • srbenje
↔ ↔ ↔ No dose adjustment is required.
↔ ↔ ↔ Prilagoditev odmerka ni potrebna.
Non-interventional post-authorisation safety study (PASS):
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS):
b. Mean systemic exposure with moderate to high fat meals.
b. Povprečna sistemska izpostavljenost z zmerno do zelo mastnimi obroki.
• you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
• ste alergični na glekaprevir, pibrentasvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
Adults and adolescents aged 12 to <18 years
Odrasli in mladostniki, stari od 12 do <18 let
Do not take Maviret if any of the above apply to you.
Ne jemljite zdravila Maviret, če kar koli od zgoraj naštetega velja za vas.
Your doctor will tell you how long you need to take Maviret for.
Vaš zdravnik vam bo povedal, koliko časa morate jemati zdravilo Maviret.
• feeling weak or lack of energy (asthenia)
• občutek šibkosti ali pomanjkanja energije (astenija)
Larger increases may be expected when unbound concentration is considered.
Ob upoštevanju nevezane koncentracije je mogoče pričakovati večja povečanja.
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Za poslušanje ali če želite kopijo tega navodila v <Braillovi pisavi>, <večji pisavi> ali <avdio obliki>, se obrnite na predstavništvo imetnika dovoljenja za promet.
The safety and efficacy of Maviret in children aged less than 12 years have not yet been established.
Varnost in učinkovitost zdravila Maviret pri otrocih, mlajših od 12 let, še nista ugotovljeni.
Take all 3 tablets in 1 blister once daily with food
Vzemite vse 3 tablete v enem pretisnem omotu enkrat na dan s hrano.
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
(≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The effects of Maviret during pregnancy are not known.
Učinki zdravila Maviret med nosečnostjo niso znani.
Caution and therapeutic concentration monitoring of digoxin is recommended.
Priporočljiva sta previdnost in nadzor terapevtske koncentracije digoksina.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Maviret therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Maviret, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Bilirubin elevations were asymptomatic, transient, and typically occurred early during treatment.
Zvišanja bilirubina so bila asimptomatska, prehodna in so se praviloma pojavila zgodaj med zdravljenjem.
• Do not chew, crush or break the tablets as it may affect the amount of Maviret in your blood.
• Tablet ne žvečite, drobite ali lomite, saj lahko to vpliva na količino zdravila Maviret v vaši krvi.
Blood tests
Preiskave krvi
It is not known whether the two medicines in Maviret pass into breast milk.
Ni znano ali ti dve učinkovini v zdravilu Maviret prehajata v materino mleko.
SOF+DCV 12 weeks N=115
SOF+DCV 12 tednov N = 115
It is important not to miss a dose of this medicine.
Pomembno je, da ne pozabite vzeti odmerka tega zdravila.
Medicinal product by therapeutic areas/possible mechanism of interaction
Zdravila po terapevtskih področjih/možnih mehanizmih medsebojnega delovanja
This is due to liver function changes during treatment with Maviret.
To je posledica sprememb v delovanju jeter med zdravljenjem z zdravilom Maviret.
If you forget to take Maviret
Če ste pozabili vzeti zdravilo Maviret
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Very common: may affect more than 1 in 10 people
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
Your doctor will test your blood before, during and after your treatment with Maviret.
Zdravnik bo opravil preiskave krvi pred, med in po zdravljenju z zdravilom Maviret.
The most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.
Najpogosteje opisana neželena učinka (incidenca ≥ 10 %) sta bila glavobol in utrujenost.
Nervous system disorders Very common headache
Bolezni živčevja zelo pogosti glavobol
The adverse reactions are listed below by body system organ class and frequency.
Neželeni učinki so navedeni spodaj po organskem sistemu in pogostnosti.
The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Deleži odziva, ugotovljeni pri bolnikih, starih ≥ 65 let, so bili v vseh terapevtskih skupinah podobni kot pri bolnikih, starih < 65 let.
What Maviret is and what it is used for
Kaj je zdravilo Maviret in za kaj ga uporabljamo
Direct hyperbilirubinemia was reported in 0.3% of subjects.
ALT. Direktna hiperbilirubinemija je bila poročana pri 0,3 % preiskovancih.
Pravastatin dose should not exceed 20 mg per day and rosuvastatin dose should not exceed 5 mg per day.
Odmerek pravastatina ne sme preseči 20 mg na dan in odmerek rosuvastatina ne sme preseči 5 mg na dan.
If used, lovastatin should not exceed a dose of 20 mg/day and patients should be monitored.
Če je lovastatin uporabljen, odmerek ne sme preseči 20 mg/dan in bolnika je treba kontrolirati.
35 µg/250 µg once daily
35 µg/250 µg enkrat na dan
Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Zdravila, ki se uporabljajo kot kontracepcija in vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Maviret.
In case of overdose, the patient should be monitored for any signs and symptoms of toxicities (see section 4.8).
V primeru prevelikega odmerjanja je treba bolnika nadzirati glede morebitnih znakov in simptomov toksičnih učinkov (glejte poglavje 4.8).
Median EC50, nM (range)
Mediana EC50, nM (razpon)
HMG-COA REDUCTASE INHIBITORS Atorvastatin
ZAVIRALCI REDUKTAZE HMG-CoA atorvastatin
Fluvastatin, Pitavastatin
↑ rosuvastatin fluvastatin, pitavastatin
As liver function may change during treatment with Maviret, a close monitoring of International Normalised Ratio (INR) values is recommended.
Med zdravljenjem z zdravilom Maviret se lahko delovanje jeter spremeni, zato je priporočljivo natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR - International Normalised Ratio).
Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells.
Zdravilo Maviret deluje tako, da zaustavi razmnoževanje virusa hepatitisa C in okužbo novih celic.
A resistance algorithm predictive of the risk for failure by baseline resistance has not been established.
Algoritem odpornosti, ki predvidi tveganje za neuspeh glede na izhodiščno odpornost, ni bil ugotovljen.
d. Oxidative metabolites or their byproducts accounted for 26% of radioactive dose.
d. Na račun drugih oksidativnih presnovkov ali njihovih stranskih produktov je šlo 26 % radioaktivnega odmerka.
• ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings and tablets)
• zdravila z etinilestradiolom (kot so kontraceptivi, vključno z vaginalnimi obročki in tabletami);
The non-linear exposure increase <120 mg may be related to saturation of efflux transporters.
Nelinearno povečanje izpostavljenosti < 120 mg je morda povezano z zasičenjem iztočnih prenašalcev.
Maviret should not affect your ability to drive or use any tools or machines.
Zdravilo Maviret ne bi smelo vplivati na sposobnost vožnje, uporabe orodij ali strojev.
8 weeks
8 tednov
Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination.
Medsebojna delovanja s fluvastatinom in pitavastatinom so verjetna in pri sočasni uporabi je priporočljiva previdnost.
In order to evaluate the recurrence of hepatocellular carcinoma associated with Maviret, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Za ovrednotenje ponovnega pojava hepatocelularnega karcinoma, povezanega z zdravilom Maviret, mora imetnik dovoljenja za promet z zdravilom opraviti in predložiti rezultate varnostne študije z uporabo podatkov, ki izhajajo iz kohorte natančno opredeljene skupine bolnikov, na podlagi dogovorjenega protokola.
What you need to know before you take Maviret Do not take Maviret if:
Kaj morate vedeti, preden boste vzeli zdravilo Maviret Ne jemljite zdravila Maviret, če:
The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.
Mehanizem delovanja pibrentasvirja so opredelili na podlagi protivirusne aktivnosti v celični kulturi in s študijami mapiranja odpornosti proti zdravilu.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »Uporabno do« ali »EXP«.
Paediatric Population
Pediatrična populacija
Other medicines and Maviret
Druga zdravila in zdravilo Maviret
• atazanavir (for HIV infection)
• atazanavir (za zdravljenje okužbe s HIV);
The proportion of subjects treated with Maviret who permanently discontinued treatment due to adverse reactions was 0.1%.
Delež bolnikov, ki so zaradi neželenih učinkov trajno prenehali jemati zdravilo Maviret, je bil 0,1 %.
Contains lactose monohydrate.
Vsebuje laktozo monohidrat.
HIV-ANTIVIRAL AGENTS Atazanavir + ritonavir
PROTIVIRUSNA ZDRAVILA PROTI HIV atazanavir + ritonavir
Omeprazole 40 mg once daily (1 hour before breakfast)
↔ pibrentasvir omeprazol 40 mg enkrat na dan (1 uro pred zajtrkom)
Not studied.
Ni raziskano.
b. Includes a total of 154 subjects coinfected with HIV-1 in ENDURANCE-1 and EXPEDITION-2 who received the recommended duration.
b. Vključuje skupno 154 preiskovancev, sočasno okuženih s HIV-1 iz študij ENDURANCE-1 in EXPEDITION2, ki so prejeli zdravljenje v priporočenem trajanju.
Genotype 1, 2, 4, 5, and 6: Baseline polymorphisms in genotypes 1, 2, 4, 5 and 6 had no impact on treatment outcome.
Genotipi 1, 2, 4, 5 in 6: Izhodiščni polimorfizmi genotipov 1, 2, 4, 5 in 6 niso vplivali na izid zdravljenja.
c. Single dose administration of [14C]glecaprevir or [14C]pibrentasvir in mass balance studies.
c. Uporaba enega odmerka [14C]glekaprevirja ali [14C]pibrentasvirja v študijah masnega ravnovesja.
Expected: ↑ fluvastatin and ↑ pitavastatin
Pričakovano: ↑ fluvastatin in ↑ pitavastatin
Table 3: Interactions between Maviret and other medicinal products
Preglednica 3: Medsebojna delovanja zdravila Maviret in drugih zdravil
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Maviret.
Če kar koli od zgoraj navedenega velja za vas (ali pa niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Maviret.
The highest documented doses administered to healthy volunteers is 1,200 mg once daily for 7 days for glecaprevir and 600 mg once daily for 10 days for pibrentasvir.
Največji dokumentirani odmerek, uporabljen pri zdravih prostovoljcih, je 1200 mg enkrat na dan 7 dni za glekaprevir in 600 mg enkrat na dan 10 dni za pibrentasvir.
• atorvastatin or simvastatin (to lower blood cholesterol)
• atorvastatin ali simvastatin (za zniževanje holesterola v krvi);
Co-administration is not recommended with several medicinal products as detailed in section 4.5.
Sočasna uporaba ni priporočljiva z več zdravili, natančneje opisano v poglavju 4.5.
• rifampicin (for infections)
• rifampicin (za zdravljenje okužb);
This medicine does not require any special storage.
Za shranjevanje zdravila niso potrebna posebna navodila.
The adverse reactions observed were comparable with those observed in clinical studies of Maviret in adults.
Opaženi neželeni učinki so bili primerljivi s tistimi, ki so jih opazili v kliničnih študijah zdravila Maviret pri odraslih.
Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 7,48 mg laktoze (v obliki laktoze monohidrata).
Patients should be instructed to swallow tablets whole with food and not to chew, crush or break the tablets as it may alter the bioavailability of the agents (see section 5.2).
Bolnike je treba poučiti, naj tablete zaužijejo cele in s hrano; tablet ne smejo gristi, drobiti ali prelomiti, saj lahko to vpliva na biorazpoložljivost učinkovin (glejte poglavje 5.2).
See Table 3 for specific recommendations on interactions with sensitive substrates of P-gp, BCRP, and OATP1B1/3.
Glejte preglednico 3 za posebna priporočila o medsebojnem delovanju z občutljivimi substrati P-gp, BCRP in OATP1B1/3.
Studies in rats/mice with glecaprevir or pibrentasvir do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Študije z glekaprevirjem ali pibrentasvirjem na podganah/miših ne kažejo neposrednih ali posrednih škodljivih učinkov, kar zadeva toksične vplive na sposobnost razmnoževanja.
Exposures of glecaprevir and pibrentasvir in adolescents aged 12 to <18 years were comparable to those in adults from Phase 2/3 studies.
Izpostavljenost glekaprevirju in pibrentasvirju pri mladostnikih, starih od 12 do <18 let, je bila primerljiva s tistimi pri odraslih iz študij 2/3 faze.