natgillin/translations-raw huggingface dataset:
Since Vedrop has been approved under exceptional circumstances, the company that markets the medicine is required to provide further data on the safety and effectiveness of Vedrop in patients with congenital or hereditary chronic cholestasis.
Ker je zdravilo Vedrop pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, priskrbela nadaljnje podatke o varnosti in učinkovitosti zdravila Vedrop pri bolnikih s kongenitalno ali dedno kronično holestazo.
This can increase vitamin E levels in the blood and help to prevent damage to the nervous system due to vitamin E deficiency.
Pri tem se povečajo ravni vitamina E v krvi in preprečijo poškodbe živčnega sistema, nastale zaradi pomanjkanja vitamina E.
Congenital or hereditary chronic cholestasis is an inherited disease causing problems with the flow of bile from the liver to the gut.
Kongenitalna ali dedna kronična holestaza je dedna bolezen, ki povzroča težave pri prehajanju žolča iz jeter v črevesje.
Vedrop can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating patients with congenital or hereditary chronic cholestasis.
Predpisovanje in izdaja zdravila Vedrop je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kongenitalno ali dedno kronično holestazo.
What information is still awaited for Vedrop?
Katere informacije o zdravilu Vedrop še pričakujemo?
For practical information about using Vedrop, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vedrop naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut.
Uporablja se pri otrocih, mlajših od 18 let, s kongenitalno ali dedno kronično holestazo, pri katerih absorpcija vitamina E iz črevesja ne poteka.
Patients with cholestasis may have low vitamin E levels because they have problems absorbing fats from the gut.
Ravni vitamina E pri bolnikih s holestazo so morda nizke zato, ker imajo težave z absorpcijo maščob iz črevesja.
Vedrop contains the active substance tocofersolan.
Zdravilo Vedrop vsebuje zdravilno učinkovino tokofersolan.
How does Vedrop work?
Kako zdravilo Vedrop deluje?
How is Vedrop used?
Kako se zdravilo Vedrop uporablja?
Bile is a fluid produced in the liver that helps to absorb fats from the gut.
Žolč je tekočina, ki jo tvorijo jetra in sodeluje pri absorpciji maščob iz črevesja.
Vedrop is available as a solution to be given by mouth.
Zdravilo Vedrop je na voljo v obliki raztopine, ki se daje peroralno.
The main measures of effectiveness were the level of vitamin E in the blood and the number of children whose neurological symptoms improved or stayed the same.
Vsi bolniki so imeli pomanjkanje vitamina E, ki se ni odzvalo na druga peroralna zdravljenja z vitaminom E. Glavno merilo učinkovitosti so bile ravni vitamina E v krvi in število otrok, pri katerih so se nevrološki simptomi izboljšali ali ostali nespremenjeni.
Usually this is for at least 6 to 12 months and may be for many years.
Običajno traja vsaj od 6 do 12 mesecev in lahko tudi več let.
You must use an effective method of contraception.
Uporabljati morate učinkovito metodo kontracepcije.
b All No Effect Boundaries are 70%-143%.
b Vse meje brez učinka so 70 %-143 %.
The clinical relevance of these substitutions is not known.
Klinična pomembnost teh substitucij ni znana.
Date of first authorisation: 09 January 2017
Datum prve odobritve: 09. januar 2017
Wait and take the next dose at the regular time.
Počakajte in naslednji odmerek vzemite ob običajnem času.
The recommended dose is one tablet once a day with food.
Priporočeni odmerek je ena tableta enkrat na dan s hrano.
a All interaction studies are conducted in healthy volunteers.
a Vse študije interakcij so opravili pri zdravih prostovoljcih.
Appropriate precautions must continue to be used.
Še naprej je treba uporabljati ustrezne previdnostne ukrepe.
Treatment should continue for as long as your doctor tells you.
Zdravljenje nadaljujte tako dolgo, kot vam predpiše zdravnik.
Age, gender and ethnicity
Starost, spol in etnična pripadnost
Keep the tablet bottle with you so that you can easily describe what you have taken.
Vsebnik s tabletami imejte s seboj, da boste znali opisati, kaj ste vzeli.
• Swelling of the face, lips, tongue or throat (angioedema)
• otekanje obraza, ustnic, jezika ali grla (angioedem)
Experience beyond 48 weeks in Study 108 and Study 110
Izkušnje po 48. tednih v študiji 108 in študiji 110
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Pogostnosti so opredeljene kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10) ali občasni (≥ 1/1.000 do < 1/100).
Talk to your doctor if you are taking:
Posvetujte se z zdravnikom, če jemljete:
With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Če traja zdravljenje dlje kot 2 leti, se priporoča redno ocenjevanje, s katerim se potrdi, da je nadaljevanje izbrane terapije še naprej ustrezno za bolnika.
Patients with creatinine clearance < 30 mL/min
Bolniki s kreatininskim očistkom < 30 ml/min
• Take care not to pass on your hepatitis B to other people.
• Poskrbite, da hepatitisa B ne boste prenesli na druge ljudi.
You must continue to take precautions to avoid this.
Še naprej morate z ustreznimi ukrepi poskrbeti, da to preprečite.
Keep the bottle tightly closed.
Vsebnik shranjujte tesno zaprto.
• if you are allergic to tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na tenofoviralafenamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Other types of medicines
Druge vrste zdravil
Exacerbation of hepatitis
Poslabšanje hepatitisa
Regular reassessment is recommended after treatment discontinuation to detect virological relapse.
Priporoča se redno ocenjevanje po prekinitvi zdravljenja za odkrivanje virološkega relapsa.
Tests may also show: • Increased level of a liver enzyme (ALT) in the blood
Preskusi lahko pokažejo tudi naslednje učinke: • povečana raven jetrnega encima (ALT) v krvi
Study 110 (HBeAg-Positive)
Študija 110 (HBeAg-pozitivni)
Discuss with your doctor the precautions needed to avoid infecting others.
Z zdravnikom se posvetujte o ustreznih ukrepih, s katerimi boste preprečili prenos okužbe na druge.
Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku in škatli poleg oznake „EXP“.
d A sensitive CYP3A4 substrate.
d Občutljiv substrat CYP3A4.
If you feel dizzy when taking Vemlidy, do not drive and do not use any tools or machines.
Če ste omotični po jemanju zdravila Vemlidy, ne vozite in ne uporabljajte orodij ali strojev.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Effects on drug levels.a,b Mean ratio (90% confidence interval) for AUC, Cmax, Cmin
Učinek na raven zdravila.a,b Povprečno razmerje (90-% interval zaupanja) za AUC, Cmax, Cmin
If you are not sure whether you have HIV, your doctor should offer you HIV testing before you start taking Vemlidy for hepatitis B.
Če niste prepričani, ali imate HIV, vam mora zdravnik ponuditi testiranje za HIV, preden začnete jemati zdravilo Vemlidy za hepatitis B.
There is insufficient information on the effects of tenofovir in newborns/infants.
Ni dovolj podatkov o učinku tenofovirja na novorojenčke/dojenčke.
Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Jetrni izbruhi so posebno resni in so včasih pri bolnikih z dekompenzirano boleznijo jeter smrtni.
Study 108 (HBeAg-Negative)
Študija 108 (HBeAg-negativni)
Table 5: HBV DNA and additional efficacy parameters at Week 96a
Preglednica 5: HBV DNA in dodatni parametri učinkovitosti v 96. tednua
If you stop taking Vemlidy, you will need regular health checks and blood tests for several months to check your hepatitis B infection.
Če prenehate jemati zdravilo Vemlidy, boste morali hoditi na redne zdravstvene preglede in krvne preiskave še več mesecev, da se vaša okužba s hepatitisom B preverja.
EU/1/16/1154/001 30 film-coated tablets EU/1/16/1154/002 90 (3 bottles of 30) film-coated tablets
EU/1/16/1154/001 30 filmsko obloženih tablet EU/1/16/1154/002 90 (3 HDPE vsebniki po 30) filmsko obloženih tablet
The adverse reactions are listed below by body system organ class and frequency based on the Week 96 analysis.
Neželeni učinki so spodaj navedeni po organskih sistemih in pogostnosti, na osnovi analize v 96. tednu.
Differences in pharmacokinetics according to gender were not considered to be clinically relevant.
Farmakokinetične razlike glede na spol niso bile upoštevane kot klinično pomembne.
Treatment discontinuation Treatment discontinuation may be considered as follows (see section 4.4):
O prekinitvi zdravljenja je možno razmisliti kot sledi (glejte poglavje 4.4):
Your doctor may need to carry out blood tests to monitor your liver function.
Vaš zdravnik bo morda moral redno izvajati krvne preiskave, s katerimi bo spremljal delovanje vaših jeter.
A risk to the breast-fed newborns/infants cannot be excluded; therefore, Vemlidy should not be used during breast-feeding.
Tveganja za dojenega novorojenčka/otroka ne moremo izključiti, zato se zdravilo Vemlidy med dojenjem ne sme uporabljati.
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum alanine aminotransferase (ALT).
Spontana poslabšanja kroničnega hepatitisa B so relativno pogosta; za njih so značilna prehodna povečanja serumske alanin aminotransferaze (ALT).
After initiating antiviral therapy, serum ALT may increase in some patients.
Po uvedbi protivirusnega zdravljenja se lahko serumska ALT pri nekaterih bolnikih poveča.
The binding of tenofovir to human plasma proteins is less than 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Vezava tenofovirja na človeške plazemske beljakovine je bila manj kot 0,7 % in je neodvisna od koncentracij za razpon 0,01-25 μg/ml.
Angioedema1, urticaria1
Občasni angioedem1, urtikarija1
Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.
Odrasli in mladostniki (stari 12 let in več s telesno maso vsaj 35 kg): ena tableta enkrat na dan.
The binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Vezava tenofoviralafenamida na človeške plazemske beljakovine v vzorcih, zbranih med kliničnimi študijami, je bila približno 80 %.
Each tablet contains 95 mg lactose (as monohydrate).
Ena tableta vsebuje 95 mg laktoze (v obliki monohidrata).
• Talk to your doctor if you also have hepatitis C or D. Vemlidy has not been tested on patients who have hepatitis C or D as well as hepatitis B.
• Posvetujte se z zdravnikom, če imate tudi hepatitis C ali D. Zdravilo Vemlidy ni bilo testirano na bolnikih, ki imajo poleg hepatitisa B tudi hepatitis C ali D.
Vemlidy film-coated tablets should be taken with food.
Zdravilo Vemlidy filmsko obložene tablete je treba jemati s hrano.
After Week 96, patients either remained on their original blinded treatment or received open-label Vemlidy.
Po 96. tednu so bolniki bodisi nadaljevali z izvornim slepim zdravljenjem ali pa so odprto prejemali zdravilo Vemlidy.
Treatment outcomes of Study 108 and Study 110 through Week 48 are presented in Table 3 and Table 4.
Izidi zdravljenja za študijo 108 in študijo 110 do konca 48. tedna so predstavljeni v preglednici 3 in preglednici 4.
 If any of these side effects get serious tell your doctor.
 Če kateri od teh neželenih učinkov postane resen, to povejte zdravniku.
Animal studies do not indicate harmful effects of tenofovir alafenamide on fertility.
Študije na živalih ne kažejo škodljivih učinkov tenofoviralafenamida na plodnost.
It is not an inhibitor or inducer of CYP3A in vivo.
In vivo ni zaviralec ali induktor CYP3A.
• Talk to your doctor before you stop taking Vemlidy for any reason, particularly if you are experiencing any side effects or you have another illness.
• Posvetujte se z zdravnikom, preden prenehate jemati zdravilo Vemlidy zaradi katerega koli razloga, zlasti če se pojavijo kateri koli neželeni učinki ali imate drugo bolezen.
Patients should be informed that dizziness has been reported during treatment with Vemlidy.
Bolnike je treba obvestiti, da so med zdravljenjem z zdravilom Vemlidy poročali o omotici.
Changes in measures of renal function
Spremembe v izmerjenem delovanju ledvic
The European Medicines Agency has deferred the obligation to submit the results of studies with Vemlidy in one or more subsets of the paediatric population in the treatment of chronic hepatitis B (see sections 4.2 and 5.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Vemlidy za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa B (za podatke o uporabi pri pediatrični populaciji glejte poglavji 4.2 in 5.2).
Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population (see section 5.2).
Zato je treba pri tej populaciji bolnikov skrbno nadzirati hepatobiliarne in ledvične parametre (glejte poglavje 5.2).
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Pri bolnikih s kompenzirano boleznijo jeter teh povečanj serumske ALT na splošno ne spremlja povečanje koncentracij bilirubina v serumu ali jetrna dekompenzacija.
As a result, the amounts of Vemlidy or other medicines in your blood may change.
To lahko posledično vpliva na količino zdravila Vemlidy ali drugih zdravil v vaši krvi.
The mean age was 46 years, 61% were male, 72% were Asian, 25% were White and 2% (8 subjects) were Black.
Povprečna starost je bila 46 let, 61 % je bilo moških, 72 % je bilo Azijcev, 25 % je bilo belcev in 2 % (8 oseb) je bilo črncev.
It is recommended that you do not breast-feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.
Priporočljivo je, da ne dojite ter tako preprečite prehajanje tenofoviralafenamida ali tenofovirja na dojenčka z materinim mlekom.
However, in animal studies it has been shown that tenofovir is secreted into milk.
Vendar pa so študije na živalih pokazale, da se tenofovir izloča v mleko.
• Talk to your doctor if you also have HIV.
• Zdravniku povejte tudi, če ste okuženi z virusom HIV.
It is not known whether tenofovir alafenamide is an inhibitor of other UGT enzymes.
Ni znano, ali je tenofoviralafenamid zaviralec drugih encimov UGT.
The primary efficacy endpoint in both studies was the proportion of patients with plasma HBV DNA levels below 29 IU/mL at Week 48.
Primarni opazovani dogodek učinkovitosti v obeh študijah je bil delež bolnikov z ravnmi HBV DNA v plazmi pod 29 i.e./ml v 48. tednu.
At Week 96, viral suppression as well as biochemical and serological responses were maintained with continued tenofovir alafenamide treatment (see Table 5).
V 96. tednu so se virusna supresija ter biokemični in serološki odziv ohranili z nadaljevanjem zdravljenja s tenofoviralafenamidom (glejte preglednico 5).
Pharmacotherapeutic group: Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors; ATC code: J05AF13.
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidni in nukleotidni zaviralci reverzne transkriptaze; oznaka ATC: J05AF13.
If you stop taking Vemlidy Do not stop taking Vemlidy without your doctor's advice.
Če ste prenehali jemati zdravilo Vemlidy Ne prenehajte jemati zdravila Vemlidy brez zdravnikovega nasveta.
A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Nefrotoksičnost Možnega tveganja nefrotoksičnosti kot posledice kronične izpostavljenosti nizkim ravnem tenofovirja zaradi odmerjanja tenofoviralafenamida ni mogoče izključiti (glejte poglavje 5.3).
The use of Vemlidy once daily in patients with CrCl ≥ 15 mL/min but < 30 mL/min and in patients with CrCl < 15 mL/min who are receiving haemodialysis is based on very limited pharmacokinetic data and on modelling and simulation.
Uporaba zdravila Vemlidy enkrat na dan pri bolnikih s CrCl ≥ 15 ml/min, a < 30 ml/min, in pri bolnikih s CrCl < 15 ml/min, ki prejemajo hemodializo, temelji na zelo omejenih farmakokinetičnih podatkih in na modeliranju ter simulaciji.
Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Tenofovir se s hemodializo učinkovito odstrani z ekstrakcijskim razmerjem približno 54 %.
Vemlidy does not reduce the risk of passing on hepatitis B to others through sexual contact or blood contamination.
Zdravilo Vemlidy ne zmanjša tveganja za prenos hepatitisa B na druge s spolnim odnosom ali kontaminacijo s krvjo.
If you accidentally take more than the recommended dose of Vemlidy you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Če ste pomotoma zaužili odmerek zdravila Vemlidy, višji od priporočenega, obstaja povečano tveganje za pojav možnih neželenih učinkov (glejte poglavje 4, Možni neželeni učinki).
This may stop your medicines from working properly, or may make any side effects worse.
Zaradi tega vaša zdravila morda ne bodo pravilno delovala ali pa se bodo neželeni učinki okrepili.
Effect of tenofovir alafenamide on other medicinal products
Učinek tenofoviralafenamida na druga zdravila
Before starting treatment and during treatment, your doctor may order blood tests to monitor how your kidneys work.
Pred začetkom zdravljenja in med njim bo morda zdravnik opravil krvne preiskave, s katerimi bo spremljal delovanje vaših ledvic.
Vemlidy has no or negligible influence on the ability to drive and use machines.
Zdravilo Vemlidy ne vpliva ali ima zanemarljiv vpliv na sposobnost upravljanja vozil in strojev.
Drug interaction information for Vemlidy with potential concomitant medicinal products is summarised in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”; twice daily as “b.i.d.”, single dose as “s.d.”, once daily as “q.d.”; and intravenously as “IV”).
Informacije o medsebojnem delovanju zdravil za zdravilo Vemlidy z možnimi sočasnimi zdravili je povzeto spodaj v preglednici 1 (povečanje je označeno kot „↑“, zmanjšanje kot „↓“, brez spremembe kot „↔“; dvakrat na dan kot „b.i.d.“, enkratni odmerek kot „s.d.“, enkrat na dan kot „q.d.“ in intravensko kot „i.v.“).
Tell your doctor immediately if you become pregnant.
Zdravnika takoj obvestite, če zanosite.
Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications.
Pri bolnikih z boleznijo jeter, ki se zdravijo zaradi hepatitisa B s protivirusnim zdravilom, je tveganje za hude in potencialno smrtne zaplete jeter večje.
You can still infect others when taking this medicine.
Kljub jemanju tega zdravila lahko še vedno okužite druge.
In patients who are co-infected with HBV and HIV, Vemlidy should be co-administered with other antiretroviral agents to ensure that the patient receives an appropriate regimen for treatment of HIV (see section 4.5).
Pri bolnikih s sočasno okužbo s HBV in HIV se mora zdravilo Vemlidy dajati skupaj z drugimi protiretrovirusnimi zdravili, da se zagotovi, da bolnik prejema ustrezni režim zdravljenja okužbe s HIV (glejte poglavje 4.5).
The mechanism of tumour formation in mice and potential relevance for humans is uncertain.
Mehanizem nastajanja tumorjev pri miših in možen pomen za človeka nista znana.
• In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4).
• Pri HBeAg pozitivnih bolnikih brez ciroze se zdravljenje daje vsaj 6 do 12 mesecev po potrjeni serokonverziji HBe (izguba HBeAg in izguba HBV DNA z zaznavo anti-HBe) ali do serokonverzije HBs ali do izgube učinkovitosti (glejte poglavje 4.4).
What Vemlidy is and what it is used for
Kaj je zdravilo Vemlidy in za kaj ga uporabljamo
This is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI).
To je protivirusno zdravilo, znano kot nukleotidni zaviralec reverzne transkriptaze (NtRTI, nucleotide reverse transcriptase inhibitor).
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at the high dose of 600 mg/kg/day.
Dolgotrajna študija peroralne kancerogenosti pri miših je pokazala majhno incidenco tumorjev dvanajsternika, kar je verjetno povezano z velikimi lokalnimi koncentracijami v prebavilih pri visokih odmerkih 600 mg/kg/dan.
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Študije o vplivu na sposobnost razmnoževanja pri podganah in kuncih niso pokazale učinka na parametre parjenja, plodnosti, brejosti in ploda.
Vemlidy may interact with other medicines.
Zdravilo Vemlidy lahko medsebojno deluje z drugimi zdravili.
 If this applies to you, do not take Vemlidy and tell your doctor immediately.
 Če to velja za vas, ne jemljite zdravila Vemlidy in se takoj posvetujte z zdravnikom.
The use of Vemlidy may be considered during pregnancy, if necessary.
Če je potrebno, se lahko pretehta možnost uporabe zdravila Vemlidy med nosečnostjo.
• Talk to your doctor before you restart taking Vemlidy tablets.
• Posvetujte se z zdravnikom, preden nadaljujete jemanje tablet zdravila Vemlidy.
Central laboratory ULN for ALT are as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males ≥ 69 years; ≤ 34 U/L for females 18 to < 69 years and ≤ 32 U/L for females ≥ 69 years.
ULN centralnega laboratorija za ALT znaša: ≤ 43 e./l za moške, stare od 18 do < 69 let, in ≤ 35 e./l za moške ≥ 69 let; ≤ 34 e./l za ženske, stare od 18 do < 69 let, in ≤ 32 e./l za ženske, stare ≥ 69 let.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Pri bolnikih z napredovalo boleznijo jeter ali cirozo se prekinitev zdravljenja ne priporoča, saj lahko poslabšanje hepatitisa po zdravljenju povzroči jetrno dekompenzacijo.
The drug interactions described are based on studies conducted with tenofovir alafenamide, or are potential drug interactions that may occur with Vemlidy.
Opisano medsebojno delovanje zdravil temelji na študijah, izvedenih s tenofoviralafenamidom, ali na možnem medsebojnem delovanju zdravil, do katerega lahko pride z zdravilom Vemlidy.
Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Rumena, okrogla, filmsko obložena tableta s premerom 8 mm z oznako „GSI“ na eni strani tablete in „25“ na drugi strani tablete.
Contact your doctor or nearest emergency department immediately for advice.
Nemudoma se povežite z zdravnikom ali urgentnim oddelkom bolnišnice.
• In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
• Pri HbeAg negativnih bolnikih brez ciroze se zdravljenje daje vsaj do serokonverzije HBs ali do znakov izgube učinkovitosti.