natgillin/translations-raw huggingface dataset:
Fertavid 75 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 75 IU in 0.5 mL aqueous solution per vial.
Fertavid 75 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
OUTER CARTON TEXT Fertavid 150 IU/0.5 mL 1, 5 or 10 vials
BESEDILO NA ZUNANJI OVOJNINI Fertavid 150 i.e./0,5 ml 1, 5 ali 10 vial
One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Ena viala vsebuje 150 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 300 i.e./ml.
One vial contains 200 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Ena viala vsebuje 200 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 400 i.e./ml.
OUTER CARTON TEXT Fertavid 100 IU/0.5 mL 1, 5 or 10 vials
BESEDILO NA ZUNANJI OVOJNINI Fertavid 100 i.e./0,5 ml 1, 5 ali 10 vial
OUTER CARTON TEXT Fertavid 50 IU/0.5 mL 1, 5 or 10 vials
BESEDILO NA ZUNANJI OVOJNINI Fertavid 50 i.e./0,5 ml 1, 5 ali 10 vial
Step 4 - Inserting the needle
Četrti korak - vbod igle
VIAL TEXT Fertavid 75 IU/0.5 mL
BESEDILO NA VIALI Fertavid 75 i.e./0,5 ml
Fertavid 50 IU/0.5 mL solution for injection
Fertavid 50 i.e./0,5 ml raztopina za injiciranje
1 vial contains 0.5 mL follitropin beta corresponding to: 100 IU (200 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 100 i.e. (200 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
1 vial contains 0.5 mL follitropin beta corresponding to: 50 IU (100 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 50 i.e. (100 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
Fertavid 200 IU/0.5 mL injection follitropin beta
Fertavid 200 i.e./0,5 ml raztopina za injiciranje folitropin beta
Abdominal discomfort Constipation Diarrhoea
Bolezni živčevja pogosti glavobol
The injection site should be alternated to prevent lipoatrophy.
Menjajte mesto injiciranja, da ne pride do atrofije maščevja.
0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
0,72 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
Fertavid 100 IU/0.5 mL solution for injection
Fertavid 100 i.e./0,5 ml raztopina za injiciranje
Fertavid 600 IU/0.72 mL solution for injection follitropin beta
Fertavid 600 i.e./0,72 ml raztopina za injiciranje folitropin beta
One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Ena viala vsebuje 5 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
Fertavid 50 IU/0.5 mL injection follitropin beta
Fertavid 50 i.e./0,5 ml raztopina za injiciranje folitropin beta
Fertavid 150 IU/0.5 mL injection follitropin beta
Fertavid 150 i.e./0,5 ml raztopina za injiciranje folitropin beta
One vial contains 20 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Ena viala vsebuje 20 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Ena viala vsebuje 50 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 100 i.e./ml.
Fertavid 200 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 200 IU in 0.5 mL aqueous solution per vial.
Fertavid 200 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
Fertavid 900 IU/1.08 mL solution for injection follitropin beta
Fertavid 900 i.e./1,08 ml raztopina za injiciranje folitropin beta
0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
0,18 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
Fertavid 100 IU/0.5 mL injection follitropin beta
Fertavid 100 i.e./0,5 ml raztopina za injiciranje folitropin beta
Fertavid 150 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 150 IU in 0.5 mL aqueous solution per vial.
Fertavid 150 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
1,08 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
One vial contains 15 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Ena viala vsebuje 15 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
Fertavid 100 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 100 IU in 0.5 mL aqueous solution per vial.
Fertavid 100 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
This is thought to be due to differences in parental characteristics (e.g., maternal age, sperm characteristics) and multiple gestations.
Pogostnost prirojenih malformacij je pri postopkih oploditve z biomedicinsko pomočjo morda nekoliko večja kot pri naravnih zanositvah, kar je verjetno posledica različnih lastnosti staršev (npr. materina starost, značilnosti sperme) in večplodnih nosečnosti.
Fertavid 50 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 50 IU in 0.5 mL aqueous solution per vial.
Fertavid 50 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
Fertavid 150 IU/0.18 mL solution for injection follitropin beta
Fertavid 150 i.e./0,18 ml raztopina za injiciranje folitropin beta
One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Ena viala vsebuje 100 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 200 i.e./ml.
For use only with a pen injector called Puregon Pen.
subkutana (s.c.) uporaba Za uporabo le s peresnikom Puregon Pen.
One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Ena viala vsebuje 10 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
Step 3 - Preparing the area
Tretji korak - priprava mesta injiciranja
• Primary gonadal failure
• primarna odpoved spolnih žlez.
The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Poročevalec je bil dr. Karl Broich, soporočevalec pa je bil dr. Eric Abadie.
The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
Referenčna država članica je bila Nemčija, zadevne države članice pa so bile Avstrija, Francija, Nizozemska, Španija in Združeno kraljestvo.
London, 23 October 2007 EMEA/331678/2007
London, 23. oktober 2007 EMEA/331678/2007
International Non-Proprietary Name (INN): fentanyl
Mednarodno nelastniško ime (INN): fentanil
The Mutual Recognition Procedure started on 06 July 2006.
Postopek medsebojnega priznavanja se je začel 6. julija 2006.
Germany referred the reasons for disagreement to the EMEA on 20 December 2006.
Nemčija je razloge za nesoglasje predložila agenciji EMEA dne 20. decembra 2006.
The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Postopek arbitraže se je začel 24. januarja 2007 s sprejemom seznama vprašanj.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Te države članice niso mogle priti do sporazuma glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
The final opinion was converted into a Decision by the European Commission on 23 October 2007.
Evropska komisija je končno mnenje spremenila v odločbo dne 23. oktobra 2007.
The Marketing Authorisation Holder provided written explanations on 13 April 2007.
Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila dne 13. aprila 2007.
A positive opinion was adopted by consensus 19 July 2007.
Odbor je dne 19. julija 2007 soglasno izdal pozitivno mnenje.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Ta se nanaša na razširitev indikacije na bolnike brez raka, izbiro pretvornih tabel, vprašanje, ali bi bilo treba podati v podatkih o zdravilu tudi kontraindikacije za doječe matere in za medsebojna delovanja z opioidi z delnim agonističnim delovanjem, ter študije, ki so potrebne za dokazovanje biološke enakovrednosti z referenčnim zdravilom.
Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Glede predlagane indikacije, odmerjanja in kontraindikacij so bile v podatkih o zdravilu in pri dokazovanju biološke enakovrednosti odkrite znatne razlike, kar predstavlja resen zadržek glede javnega zdravja.
Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Fentanyl-ratiopharm 25/50/75/100 µg/h TTS in z njim povezana imena so opioidni analgetiki, indicirani za hude kronične bolečine, ki jih je mogoče primerno blažiti le z opioidnimi analgetiki.
During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h TTS and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem julija 2007 je bil CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Fentanyl-ratiopharm 25/50/75/100 µg/h TTS in z njim povezana imena ugodno, da ugovori, ki jih je imela Francija, ne bi smeli preprečiti izdaje dovoljenja za promet z zdravilom in da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo dopolniti.
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4) 1 ZA Fentanyl-ratiopharm 25/50/75/100 µg/h TTS in z njim povezana imena
Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Družba Ratiopharm GmbH je predložila vlogo za postopek medsebojnega priznavanja zdravila Fentanylratiopharm 25/50/75/100 µg/h TTS in z njim povezanih imen v obliki transdermalnega obliža na osnovi dovoljenja za promet z zdravilom, ki ga je Nemčija odobrila dne 4. aprila 2006.
Number of responders at end of treatment
Število odzivnih oseb ob koncu zdravljenja
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 November 2014
Datum prve odobritve: 17. november 2014
Ribavirin was discontinued in 19% of the patients.
Zdravljenje z ribavirinom so prekinili pri 19 % bolnikov.
Race: Black/ African American
Rasa: Črnci/afriški Američani
A carcinogenicity study in rats is ongoing.
Študija kancerogenosti pri podganah še poteka.
b. CPT = Child-Pugh-Turcotte.
b. CPT = po Child-Pugh-Turcotteu.
• if you are awaiting a liver transplant;
• če čakate na presaditev jeter;
g. This study was conducted in the presence of another two direct-acting antiviral agents.
g. Ta študija je bila opravljena v prisotnosti dveh drugih učinkovin z direktnim delovanjem na viruse.
h. Bioequivalence/Equivalence boundary 80-125%.
h. Meja bioekvivalence/ekvivalence 80-125 %.
Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine.
Ne vozite in ne upravljajte strojev, če se po jemanju vašega zdravila počutite utrujeno.
Distribution Ledipasvir is > 99.8% bound to human plasma proteins.
Ledipasvir se > 99,8-odstotno veže na humane beljakovine v plazmi.
* Includes patients co-infected with human immunodeficiency virus (HIV).
* Vključuje bolnike s sočasno okužbo z virusom virusom humane imunske pomanjkljivosti (HIV).
These studies did not include any control group not receiving ledipasvir/sofosbuvir.
Te študije niso vključevale nobene kontrolne skupine, ki ne bi prejemala ledipasvirja/sofosbuvirja.
The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Zdravilni učinkovini v zdravilu delujeta skupaj tako, da zavirata dve različni beljakovini, ki ju virus potrebuje za svojo rast in razmnoževanje, kar omogoča, da se okužba trajno odstrani iz telesa.
Study 0122 (ELECTRON-2) 6 25 0% (0/25)
Študija 0122 (ELECTRON-2) 6 25 0 % (0/25)
If this applies to you, do not take Harvoni and tell your doctor immediately.
Če to velja za vas, ne jemljite zdravila Harvoni in o tem takoj obvestite zdravnika.
10% of liver transplant recipients had a modification of their immunosuppressive agents.
Pri 10 % prejemikov presaditve jeter so spremenili imunosupresivna zdravila.
It is given to treat chronic (long-term) hepatitis C virus infection in adults of 18 years and older.
Daje se za kronično (dolgotrajno) zdravljenje okužbe z virusom hepatitisa C pri odraslih, starih 18 let in več.
SVR rates for selected subgroups Genotype
Stopnje SVR za izbrane podskupine Genotip
This includes herbal medicines and medicines obtained without a prescription.
To vključuje tudi zdravila rastlinskega izvora, ki ste jih dobili brez recepta.
The most common variants were Q30R, Y93H and L31M.
Najpogostejše različice so bile Q30R, Y93H in L31M.
Medicinal products that have a narrow therapeutic range and which are metabolised by these isoenzymes should be used with caution and carefully monitored.
Zdravila, ki imajo ozko terapevtsko širino in jih presnavljajo ti izoencimi, je treba uporabljati previdno in skrbno spremljati.
Treatment with Harvoni should be guided by an assessment of the potential benefits and risks for the individual patient.
Odločitev o zdravljenju z zdravilom Harvoni mora temeljiti na na oceni možnih koristi in tveganj za posameznega bolnika.
General disorders: Very common fatigue
Splošne težave: zelo pogosti utrujenost
CPT A = CPT score 5-6 (compensated), CPT B = CPT score 7-9 (decompensated), CPT C = CPT score 10-12 (decompensated).
CPT A = rezultat CPT 5-6 (kompenzirani), CPT B = rezultat CPT 7-9 (dekompenzirani), CPT C = rezultat CPT 10-12 (dekompenzirani).
In clinical studies - Genotype 1
V kliničnih študijah - genotip 1
That risk is even higher if ribavirin is used as part of the HCV treatment.
To tveganje je še večje, če se kot del HCV zdravljenja
• Do not take any other medicine that contains sofosbuvir, one of the active substances in Harvoni.
• Ne jemljite nobenih drugih zdravil, ki vsebujejo sofosbuvir, ki je ena od zdravilnih učinkovin v zdravilu Harvoni.
Metavir score F0-F3 96% (53/55) CPT A
Rezultat Metavir F0-F3 96 % (53/55) CPT Ab
Harvoni is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Uporaba zdravila Harvonise ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let, saj varnost in učinkovitost pri tej populaciji nista bili dokazani.
HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
HCV RNA < 6 milijonov i.e./ml HCV RNA ≥ 6 milijonov i.e./ml
Genotype 2, 3, 4, 5 and 6
Genotip 2, 3, 4, 5 in 6
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Neželeni učinki so po pogostnosti opredeljeni kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).
Harvoni (administered alone or in combination with ribavirin) has no or negligible influence on the ability to drive and use machines.
Zdravilo Harvoni (uporabljeno samo ali v kombinaciji z ribavirinom) nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
a. Povprečno razmerje (90-odstotni IZ) farmakokinetike s sočasno uporabljenimi študijskimi zdravili posamezno ali v kombinaciji.
d. 3/3 of these patients had cirrhosis.
d. 3 od teh 3 bolnikov so imeli cirozo.
Patients awaiting liver transplantation and post-liver transplant - SOLAR-1
Bolniki, ki čakajo na presaditev jeter in bolniki po presaditvi jeter - SOLAR-1
If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels.
Če bolnik začetnega odmerka ne prenaša dobro, je treba odmerek zmanjšati, kot je klinično indicirano, na podlagi vrednosti hemoglobina.
a. TE: number of treatment-experienced patients.
a. PZ: število predhodno zdravljenih bolnikov.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/958/001 28 filmsko obloženih tablet EU/1/14/958/002 84 (3 plastenke po 28) filmsko obloženih tablet
The safety and efficacy of sofosbuvir have not been established in patients with severe renal impairment or ESRD.
Varnosti in učinkovitost sofosbuvirja niso ocenili pri bolnikih s hudo ledvično okvaro ali ESRD.
Age (years): median (range) Male gender
Starost (v letih): mediana (razpon) Moški spol
INFORMATION IN BRAILLE Harvoni [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Harvoni [samo zunanja ovojnina]
(Inhibition of drug transporters OATP and BCRP)
(zaviranje prenašalcev OATP in BCRP)
Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus.
Povišane so tudi koncentracije atazanavirja, obstaja tveganje za zvišanje ravni bilirubina/ikterusa.
What Harvoni is and what it is used for What you need to know before you take Harvoni How to take Harvoni
Kaj je zdravilo Harvoni in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Harvoni Kako jemati zdravilo Harvoni
The European Medicines Agency has deferred the obligation to submit the results of studies with ledipasvir/sofosbuvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z ledipasvirjem/sofosbuvirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Ena filmsko obložena tableta vsebuje 156,8 mg laktoze (v obliki monohidrata) in 261 mikrogramov barvila sončno rumeno FCF aluminium lake.
Warnings and precautions Your doctor will know if any of the following conditions apply to you.
Zdravnik bo vedel, če se katero koli od naslednjih stanj nanaša na vas.
Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a, b
(90-odstotni interval zaupanja) za AUC, Cmax,
Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX65
Farmakoterapevtska skupina: zdravilo z direktnim delovanjem na viruse; oznaka ATC: J05AX65 Mehanizem delovanja
• rosuvastatin (a medicine used to treat high cholesterol).
• rosuvastatin (zdravilo, ki se uporablja za zdravljenje visokih ravni holesterola).
Cimetidine e
Cimetidine Nizatidin e
Age (years): median (range)
Starost (v letih): mediana (razpon)
Famotidine dosed 12 hours prior to Harvonid
Famotidin uporabljen 12 ur pred zdravilom Harvoni d
The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons.
40 % humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV, je pa aktivnost ledipasvirja proti HCV zmanjšala za 12-krat proti replikonom HCV genotipa 1a.
The safety and efficacy of Harvoni in children and adolescents aged less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Harvoni pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
No clinically relevant differences in ledipasvir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment.
Klinično pomembnih razlik v farmakokinetiki ledipasvirja med zdravimi osebami in bolniki s hudo ledvično okvaro niso opazili.
Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet.
Zdravilo Harvoni je zdravilo, ki vsebuje zdravilni učinkovini ledipasvir in sofosbuvir v eni sami tableti.
Seven patient populations are being evaluated (patients with decompensated cirrhosis [CPT B and C] pre-transplant; post-transplant, no cirrhosis; post-transplant CPT A; post-transplant CPT B; post-transplant CPT C; post-transplant fibrosing cholestatic hepatitis [FCH]).
Ocenjuje se sedem populacij bolnikov (bolniki z dekompenzirano cirozo [CPT B in C] pred presaditvijo; po presaditvi, brez ciroze; CPT A po presaditvi; CPT B po presaditvi; CPT C po presaditvi; fibrozni holestatski hepatitis po presaditvi [FCH]).
Harvoni + ribavirin for 12 weeks or
Zdravilo Harvoni + ribavirin 12 tednov ali
• statins used to treat high cholesterol.
• statini, ki se uporabljajo za zdravljenje visoke ravni holesterola.
The efficacy of Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) was evaluated in three open-label Phase 3 studies with data available for a total of 1,950 patients with genotype 1 CHC.
Učinkovitost zdravila Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) so ocenili v treh odprtih študijah 3. faze, pri čemer so podatki na voljo za skupaj 1.950 bolnikov s CHC genotipa 1.