natgillin/translations-raw huggingface dataset:
For more information about using Chanhold, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Chanhold glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite.
Uporabljena jakost in število odmerkov sta odvisna od mase zdravljene živali, živalske vrste, ki se jo zdravi, in vrste parazita.
There was no need for ‘bioequivalence' studies to investigate whether Chanhold is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Chanhold absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
Chanhold is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
Chanhold je zdravilo proti parazitom, ki se uporablja za zdravljenje in preprečevanje infestacij s paraziti, ki živijo na koži ali v dlaki mačk in psov, npr. z bolhami in garjami, ter za zatiranje črvastih parazitov, ki živijo v telesu.
This is because the composition of Chanhold is comparable to the reference medicine and when applied to the skin, the active substance in both products is expected to be absorbed in the same way.
Sestava zdravila Chanhold je namreč primerljiva sestavi referenčnega zdravila, in če se zdravilo nanese na kožo, se pričakuje, da se bo učinkovina iz obeh zdravil absorbirala na enak način.
Chanhold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Zdravilo Chanhold vsebuje selamektin, tj. zdravilo proti parazitom iz razreda avermektinov.
It is used in the following ways: to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
Uporablja se za: zdravljenje in preprečevanje infestacij z bolhami pri mačkah in psih, tako da ubije odrasle bolhe, njihove ličinke in jajčeca na živali ter v leglih brejih ali doječih mačk ali psic.
Safety information has been included in the summary of product characteristics and the package leaflet for Chanhold, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Chanhold in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Chanhold contains the active substance selamectin and is a ‘generic medicine'.
Zdravilo Chanhold vsebuje učinkovino selamektin in je generično zdravilo.
How has Chanhold been studied?
Kako je bilo zdravilo Chanhold raziskano?
How does Chanhold work?
Kako zdravilo Chanhold deluje?
Therefore, the Agency's view was that, as for Stronghold, the benefit of Chanhold outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Chanhold enako kot pri zdravilu Stronghold odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
preprečevanje obolenj pri mačkah in psih, ki jih povzroča srčna glista; zatiranje ušesnih garij pri mačkah in psih; zatiranje odraslih črevesnih glist in črevesnih trakulj pri mačkah; zatiranje odraslih črevesnih glist pri psih; zatiranje infestacij krvosesih uši pri mačkah in psih; zatiranje garij vrste Sarcoptes pri psih.
How is Chanhold used?
Kako se zdravilo Chanhold uporablja?
The precautions are the same as for the reference medicine since Chanhold is a generic medicine.
Ker je zdravilo Chanhold generično zdravilo, so previdnostni ukrepi enaki kot pri referenčnem zdravilu.
ATCvet code: QI06AH08.
Oznaka ATCvet :QI06AH08.
Date of first authorisation: 23/02/2005 Date of last renewal: 15/01/2010
Datum pridobitve dovoljenja za promet: 23/02/2005 Datum podaljšanja dovoljenja za promet: 15/01/2010
69800 SAINT-PRIEST FRANCE
69800 SAINT-PRIEST FRANCIJA
Special precautions for use in animals: Use in healthy animals only.
Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Osnovno cepljenje: - prva injekcija od osmega tedna starosti naprej, - druga injekcija 3 do 4 tedne pozneje.
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Izjemoma se lahko pojavi preobčutljivostna reakcija na mestu vnosa cepiva, ki jo je treba ustrezno simptomatsko zdraviti.
EXP (mm/yyyy)
EXP (mesec/leto)
A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Lahko se pojavi lokalna reakcija (šibka bolečina, srbež ali omejena oteklina), ki mine v največ 1 do 2 tednih.
1 cell culture infective dose 50%
150% infektivni odmerek za celično kulturo
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin.
The use is not recommended during lactation.
Uporaba ni priporočljiva v obdobju laktacije.
Per dose of 1 ml: Lyophilisate:
V odmerku po 1 ml: Liofilizat:
EU/2/04/051/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/051/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/2/04/0451/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/0451/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis and calicivirosis components.
Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti eno leto po osnovnem cepljenju, - nadaljnja ponovna cepljenja je potrebno opraviti v razmakih do 3 leta za komponente rinotraheitisa in kaliciviroze.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
Manufacturing authorisation holder responsible for batch release: MERIAL
Izdelovalec, odgovoren za sproščanje serij: MERIAL
Water for injections ..................................................................................................................... q.s.
Voda za injiciranje....................................................................................................................... q.s.
Use in healthy animals only.
Cepite le zdrave živali.
Per dose of 1 ml:
V odmerku po 1 ml:
Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Hidrolizat kazeina Hidrolizat kolagena Kalijev hidrogenfosfat Kalijev dihidrogenfosfat Kalijev hidroksid
Do not mix with Merial adjuvanted vaccine against rabies.
Ne mešajte z Merialovim adjuviranim cepivom proti steklini.
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs.
Aktivna imunizacija 8 tednov starih mačk in starejših: - Proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj - Proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj.
FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U.
FHV (sev F2) ...................................................................................................................... ≥ 104,9 CCID50 FCV (seva 431 in G1) ....................................................................................... ≥ 2,0 enot v testu ELISA
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Cepivo dokazano zmanjša izločanje kalici virusa mačk ob nastopu imunosti in do eno leto po cepljenju.
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto ali plastično zaporko.
Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Po rekonstituciji liofilizirane sestavine z vehiklom injicirajte odmerek (1 ml) cepiva v podkožje, po naslednjem razporedu:
Water for injection ...................................................................................................................... q.s.
Voda za injiciranje........................................................................................................................ q.s.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim adjuviranim cepivom proti steklini.
Store and transport refrigerated.
Shranjujte in prevažajte v hladilniku).
Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Liofilizat (10 x 1 odmerek) in vehikel (10 x 1 ml) Liofilizat (50 x 1 odmerek) in vehikel (50 x 1 ml)
The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis and calicivirosis components.
Trajanje imunosti je 3 leta po zadnjem ponovnem cepljenju za komponente rinotraheitisa in kaliciviroze.
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature, ki izjemoma lahko traja pet dni.
Stimulates active immunity against feline rhinotracheitis herpesvirus and feline calicivirus.
Vzpodbuja aktivno imunost proti herpesvirusu kužnega rinotraheitisa in kalicivirusu.
Where high levels of maternal antibodies against rhinotracheitis or calicivirosis components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
(na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam, ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
Vaccine against feline viral rhinotracheitis and feline calicivirosis.
Cepivo proti virusnemu rinotraheitisu in kalicivirusu.
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Pri normalnih pogojih uporabe se lahko občasno pojavijo prehodna apatija in neješčnost.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serij:
EXP (mm/yyyy) Once reconstituted use immediately.
EXP {mesec/leto} Rekonstituirano zdravilo uporabite takoj.
Purevax RC lyophilisate and solvent for suspension for injection
Purevax RC Liofilizat in vehikel za suspenzijo za injiciranje
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U.
Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................. ≥ 104,9 CCID501 Inaktivirani antigeni kalici virusamačk (seva FCV 431 in G1) ........................ ≥ 2,0 enot v testu ELISA
Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Vsebnik s 50 stekleničkami z 1 odmerkom liofilizata in 50 stekleničkami po 1 ml vehikla.
Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Vsebnik z 10 stekleničkami z 1 odmerkom liofilizata in 10 stekleničkami po 1 ml vehikla.
Purevax RC lyophilisate and solvent for suspension for injection.
Purevax RC liofilizat in vehikel za suspenzijo za injiciranje
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate bottle
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack containing 10 bottles of lyophilisate and 10 bottles of solvent Pack containing 50 bottles of lyophilisate and 50 bottles of solvent
Vsebnik z 10 stekleničkami liofilizata in 10 stekleničkami vehikla Vsebnik s 50 stekleničkami liofilizata in 50 stekleničkami vehikla
Gentamicin, at most ....................................................................................................................... 16.5 µg
Gentamicin, največ ........................................................................................................................ 16.5 µg
Do not use in pregnant animals.
Ne uporabite v obdobju brejosti.
Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Natrijev hidrogenfosfat Kalijev dihidrogenfosfat, brezvodni
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens .................................. ≥ 2.0 ELISA U.
Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in G1) ......................... ≥ 2,0 enot v testu ELISA
PACKAGE LEAFLET FOR:
Pomožna snov:
No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Po večkratnem dajanju drugi učinki, razen tistih ki so navedeni v poglavju »Neželeni učinki«, niso znani.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
NAVODILO ZA UPORABO ZA: Purevax RC liofilizat in vehikel za suspenzijo za injiciranje IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA
Less than 10% Less than 10% Less than 10%
manj kot 10% manj kot 10%
Use only if no other alternative is available.
Uporabljati samo, kadar ni druge možnosti.
Not studied.
Niso preučevali.
Elderly (above 65 years of age)
Starejši (stari več kot 65 let)
Ribavirin can affect your unborn baby.
Ribavirin lahko škoduje vašemu nerojenemu otroku.
6 cells/ml).
6 celic/ml).
- This medicine may pose a risk to the environment.
- To zdravilo lahko predstavlja tveganje za okolje.
Comparison based on historic controls.
Primerjava s podatki zgodovinskih kontrol.
* see section below for further details.
* Za podrobne podatke glejte spodnje poglavje.
The type of food is not important.
Vrsta hrane pri tem ni pomembna.
Alone or in combination with other substitutions (includes mixtures).
Samostojno ali v kombinaciji z drugimi substitucijami (vključuje mešanice).
Less than 1% of the administered dose was recovered in urine.
Manj kot 1% danega odmerka so prestregli v urinu.
Other double or triple mutations were observed with lower frequencies.
Druge dvojne in trojne mutacije so opažali manj pogosto.
Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Zdravnik bo morda moral zvečati pogostnost vaših krvnih preiskav, da bo preverjal kako dobro se strujuje vaša kri.
The type of food does not affect exposure to
Vrsta hrane ne vpliva na izpostavljenost
- Try to take OLYSIO at the same time each day.
- Zdravilo OLYSIO poskušajte jemati vsak dan ob istem času.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o
24 weeks N = 31
24 tednov n = 31
X represents multiple amino acids.
X predstavlja več aminokislin.
Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Substitucije, ki so jih opažali samo v kombinacijah z drugimi novimi substitucijami na enem ali več položajih NS3: 80,
Treatment duration
Trajanje zdravljenja
OLYSIO must not be used in children and adolescents (under 18 years of age) because it has not been studied in this age group.
Zdravila OLYSIO se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let), ker pri tej starostni skupini njegova uporaba ni raziskana.
This is important because it is not known whether simeprevir can pass into breast milk.
To je pomembno zato, ker ni znano, ali simeprevir lahko prehaja v materino mleko ali ne.
Patients with these combinations are also included in other rows describing the individual substitutions.
Bolniki z navedenimi kombinacijami so šteti tudi v drugih vrsticah, v katerih so navedene samostojne substitucije.
If you do, your medicine may not work properly.
Če zdravljenje prekinete, zdravilo morda ne bo ustrezno delovalo.
pruritus*, photosensitivity photosensitivity reaction*
fotosenzitivnostna fotosenzitivnostna reakcija*
Warnings and precautions
Opozorila in previdnosti ukrepi
The mechanism is not established.
Mehanizem tega pojava ni pojasnjen.
There were no grade 3 events reported.
O primerih stopnje 3 niso poročali.
- Always take OLYSIO with food.
- Zdravilo OLYSIO vedno vzemite skupaj s hrano.
Do not take OLYSIO if you are allergic to simeprevir or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila OLYSIO, če ste alergični na simeprevir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
There are no adequate and well-controlled studies with simeprevir in pregnant women.
Pri nosečnicah niso opravili primernih in dobro nadzorovanih študij s simeprevirjem.
Two patients had emerging single substitution I170T.
Pri dveh bolnikih je prišlo do enojne substitucije I170T.
EU/1/14/924/001 (7 capsules)
EU/1/14/924/001 (7 kapsul) EU/1/14/924/002 (28 kapsul)
You and your partner must use an effective method of contraception during treatment and for several months afterwards.
Vi in vaš partner morata med zdravljenjem in še nekaj mesecev po zaključku zdravljenja uporabljati učinkovito metodo kontracepcije.
OLYSIO contains lactose (a type of sugar).
Zdravilo OLYSIO vsebuje laktozo (vrsto sladkorja).
Increase in sofosbuvir exposure observed in the pharmacokinetic substudy is not clinically relevant.
Povečanje izpostavljenosti sofosbuvirju, ki so ga opažali v farmakokinetični podštudiji, ni klinično pomembno.
Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Vzročno povezavo je težko ugotoviti zaradi osnovne napredovale jetrne bolezni, kljub temu morebitnega tveganja ne moremo izključiti.
Number of patients enrolled
Število vključenih bolnikov
The adverse reactions are listed by system organ class (SOC) and frequency: 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
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti: 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),
OLYSIO should only be used during pregnancy or in women of childbearing potential if the benefit justifies the risk.
Zdravilo OLYSIO se lahko uporablja med nosečnostjo ali pri ženskah v rodnem obdobje le, kadar koristi opravičujejo tveganja.
Study C206
Študija C206
This medicinal product may pose a risk to the environment (see section 5.3).
To zdravilo lahko predstavlja tveganje za okolje (glejte poglavje 5.3).
Persistence of resistance-associated substitutions
Trajnost substitucij, ki so povezane z odpornostjo
What OLYSIO is and what it is used for
Kaj je zdravilo OLYSIO in za kaj ga uporabljamo
This is because OLYSIO and other medicines may interact with each other.
Zdravilo OLYSIO in druga zdravila lahko vplivajo druga na drugo.
This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite
To je posebej značilno, če se ob tem pojavi kateri od naslednjih simptomov: - siljenje na bruhanje (nauzea), bruhanje ali izguba apetita
In rodents, simeprevir elicited toxic effects in the liver, pancreas and gastrointestinal systems.
Pri glodalcih je simeprevir izzval toksične učinke na jetra, pankreas in gastrointestinalni sistem.
Cross-resistance is not expected between direct-acting antiviral agents with different mechanisms of action.
Navzkrižne odpornosti med zdravili z direktnim delovanjem na viruse z različnimi mehanizmi delovanja ni pričakovati.
What OLYSIO is and what it is used for What you need to know before you take OLYSIO
Kaj je zdravilo OLYSIO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO
Simeprevir must be taken with food (see section 4.2).
Simeprevir je treba jemati s hrano (glejte poglavje 4.2).
Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience:
Takoj obvestite zdravnika če jemljete zdravilo OLYSIO, sofosbuvir in katerokoli zdravilo za zdravljenje težav s srcem in se med zdravljenjem pojavijo:
Concentrations of digoxin should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Koncentracije digoksina je treba spremljati in njihove vrednosti uporabiti za titriranje odmerka digoksina do želenega kliničnega učinka.
The presence of 50% human serum reduced simeprevir replicon activity by 2.4-fold.
Prisotnost 50% človeškega seruma je zmanjšala aktivnost simeprevirja proti replikonu za 2,4-krat.
C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
C označenega simeprevirja zdravim osebam so povprečno 91% celotne radioaktivnosti prestregli v blatu.