natgillin/translations-raw huggingface dataset:
In vitro blev det ikke observeret, at telaprevir udøver relevant hæmning af alkoholdehydrogenase. 
No relevant inhibition by telaprevir of alcohol dehydrogenase was observed in vitro.
Studie 110 var et randomiseret, dobbeltblindt, placebokontrolleret fase 2-studie, som blev udført hos patienter, der var co-inficeret med kronisk hepatitis C af genotype 1 og hiv, og som var behandlingsnaive for hepatitis C. Enten fik disse patienter ikke antiretroviral behandling (CD4 
Study 110 was a phase II randomised, double-blind, placebo-controlled study conducted in patients with chronic genotype 1 HCV/HIV co-infection who were treatment-naïve for hepatitis C. Patients were either not on antiretroviral therapy (CD4 count ≥ 500 cells/mm
↑ midazolam (intravenøst) AUC 3,40 (3,04-3,79) Cmax 1,02 (0,80-1,31) 
↑ midazolam (intravenous) AUC 3.40 (3.04-3.79) Cmax 1.02 (0.80-1.31)
Tal med lægen, hvis du har problemer med at synke hele 
Tell your health care provider if you have problems swallowing whole tablets.
Lever og galdeveje almindelige hyperbilirubinæmi 
Hepatobiliary disorders common hyperbilirubinaemia
I de fleste lægemiddelinteraktionsstudier anvendtes en telapravir-dosis på 750 mg hver 8. time. 
Most drug-drug interaction studies have been performed with a telaprevir dose of 750 mg every 8 hours (q8h).
Populationen af non-responders omfattede 2 undergrupper: patienter med tidligere partial response (≥ 2 log10 reduktion i HCV-RNA i uge 12, men uden ikkedetekterbart HCV-RNA ved afsluttet behandlingen med et pegyleret interferon og ribavirin) og patienter med tidligere null response (<2 log10 reduktion i HCV-RNA i uge 12 af den tidligere behandling med pegyleret interferon og ribavirin). 
The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin).
- hævede blodårer i endetarmen eller dens udmunding (rektum eller anus) (hæmorider), smerter i 
- swollen veins in the rectum or anus (haemorrhoids), pain in the anus or rectum;
Nævneren er antallet af patienter med HCV RNA < 25 IE/ml på det planlagte tidspunkt for behandlingsafslutning eller manglende vurdering af HCV RNA på det planlagte tidspunkt for behandlingsafslutning og HCV RNA < 25 IE/ml i opfølgningsperioden fra det planlagte tidspunkt for behandlingsafslutning og fremefter. 
The denominator is the number of patients with HCV RNA < 25 IU/ml at planned end of treatment or a missing HCV RNA assessment at planned end of treatment and HCV RNA < 25 IU/ml during follow-up from planned end of treatment onwards.
- smagsforandringer - besvimelse - kløe omkring endetarmen, blødninger omkring eller nær endetarmen (anus eller rektum), en lille rift i huden inde i anus, som kan give smerter og/eller blødning under afføring, - rød, tør, skællende hud med revner (eksem), udslæt med rød, tør, skællende hud med revner 
- itching around or near the anus, bleeding around or near the anus or rectum, a small tear in the skin that lines the anus that may cause pain and/or bleeding during bowel movements; - red, cracked, dry, scaly skin (eczema), rash with red, cracked, dry, scaly skin (exfoliative rash); - swelling of the face, swelling of the arms and/or legs (oedema);
til at behandle hiv-infektioner (CCR5antagonist) 
to decrease blood pressure (calcium channel blockers) to treat HIV infections (CCR5 antagonist)
↑ ketoconazol (400 mg) AUC 1,46 (1,35-1,58) Cmax 1,23 (1,14-1,33) 
↑ ketoconazole (400 mg) AUC 1.46 (1.35-1.58) Cmax 1.23 (1.14-1.33)
Administration af INCIVO kan øge den systemiske eksponering for lægemidler, der er substrater for CYP3A eller P-gp. 
Administration of INCIVO may increase systemic exposure to medicinal products that are substrates of CYP3A or P-gp, which could increase or prolong their therapeutic effect and adverse reactions.
ANTIVIRALE MIDLER MOD HIV: REVERS TRANSKRIPTASEHÆMMERE Ved co-administration bør der gives telaprevir 1,125 mg hver 8. time (se pkt. 
HIV-ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS If co-administered, telaprevir 1,125 mg q8h should be used (see section 4.4).
Studiet var designet til sammenligning af SVR-rater hos patienter med ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 og 12, som blev behandlet med INCIVO i 12 uger i kombination med pegyleret interferon-alfa-2a og ribavirin i enten 24 uger (T12/PR24-regimet) eller 48 uger (T12/PR48-regimet). 
The study was designed to compare SVR rates in patients with undetectable HCV RNA ( target not detected) at weeks 4 and 12 who were treated with INCIVO for 12 weeks in combination with peginterferon alfa-2a and ribavirin for either 24 weeks (T12/PR24 regimen) or 48 weeks (T12/PR48 regimen).
Patienterne blev randomiseret til en af de tre behandlingsgrupper i forholdet 2:2:1: Samtidig start (T12/PR48): INCIVO fra dag 1 til og med uge 12. 
Patients were randomised in a 2:2:1 ratio to one of three treatment groups: simultaneous start (T12/PR48): INCIVO from day 1 through week 12; delayed start (T12(DS)/PR48): INCIVO from week 5 through week 16; Pbo/PR48: placebo through week 16.
Rifabutin og telaprevir anbefales ikke anvendt samtidig. 
The concomitant use of rifabutin and telaprevir is not recommended.
Forlænget QTinterval er rapporteret i forbindelse med telithromycin (se pkt. 
QT interval prolongation has been reported with telithromycin (see section 4.4).
Øget klinisk monitorering med laboratorieundersøgelser tilrådes (se pkt. 
Increased clinical and laboratory monitoring are warranted (see section 4.4).
Alle patienter fik pegyleret interferon-alfa-2a og ribavirin i 48 uger. 
All patients received peginterferon alfa-2a and ribavirin for 48 weeks.
Der foreligger ingen kliniske data om fornyet behandling af patienter, som oplevede svigt af behandling baseret på HCV-NS3-4A-proteasehæmmere (se pkt. 
There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see section 5.1).
Tag INCIVO sammen med pegyleret interferon-alfa og ribavirin i 12 uger. 
Take INCIVO with peginterferon alfa and ribavirin for 12 weeks.
Se også ribavirins produktresumé. 
See also the Summary of Product
Studiets primære formål var at vurdere den antivirale virkning af INCIVO, peginterferon alfa-2a og ribavirin hos patienter med samtidig HCV/hiv-1-infektion, målt som SVR12. 
The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV/HIV-1 co-infected patients as measured by SVR12.
IR 
Men
YDERKARTON (pakning med 1 beholder) 
OUTER CARTON (1-bottle pack)
Efter gennemførelse af behandlingen med INCIVO stiger hæmoglobinværdierne gradvist. 
Haemoglobin values gradually improve after completion of INCIVO dosing.
Efter markedsføring er der observeret toksisk epidermal nekrolyse (TEN), også med et dødeligt forløb (se pkt. 
Toxic epidermal necrolysis (TEN) including fatal outcome has been observed in post-marketing experience (see section 4.8).
HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF 
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Din læge fastsætter den rette behandling. 
Your doctor will decide on the appropriate dose regimen for you.
Patienter, der tager INCIVO hver 8. time, skal informeres om, at hvis de glemmer at tage en dosis INCIVO, og det opdages inden for 4 timer efter det sædvanlige tidspunkt, skal den foreskrevne dosis INCIVO tages hurtigst muligt sammen med føde. 
When administered every 8 hours (q8h), in case a dose of INCIVO is missed within 4 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible.
Leverfibrose ved baseline Ingen eller minimal fibrose Portal fibrose 
Baseline liver fibrosis No fibrosis or minimal fibrosis
Forsigtighed tilrådes, og klinisk monitorering af patienterne anbefales. 
Caution is warranted and clinical monitoring of patients is recommended.
Stigninger i serumurat er meget almindelige under behandling med INCIVO i kombination med pegyleret interferon-alfa og ribavirin. 
Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin.
5.1 for oplysninger om resultater opnået med patienter med samtidig hiv-infektion. 
For outcomes obtained in HIV co-infected patients, see section 5.1.
Hvis INCIVO seponeres på grund af en hudreaktion, må behandlingen ikke genoptages. 
If discontinued due to a skin reaction, INCIVO must not be restarted.
Vedrørende særlige doseringsvejledninger for pegyleret interferon-alfa og ribavirin henvises til produktresuméerne for disse lægemidler. 
For specific dosage instructions for peginterferon alfa and ribavirin, the Summary of Product Characteristics for these medicinal products should be consulted.
Nyrer og urinveje ikke almindelige forhøjet serumkreatinin b, prærenal azotæmi med eller uden akut nyresvigt perifert ødem, abnorm smag af lægemidlet de placebokontrollerede fase 2- og fase 3-studier (poolede data) omfattede 1.346 HCV-inficerede patienter incidensen er baseret på hyppigheden af indberetttede bivirkninger (se også Abnorme laboratorieundersøgelser 
General disorders and administration site conditions common oedema peripheral, product taste abnormal the placebo-controlled Phase 2 and Phase 3 Studies (pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates (additionally, see Laboratory abnormalities below)
Der ses sammenlignelig eksponering for telaprevir under samtidig brug af enten pegyleret interferon-alfa-2a og ribavirin eller pegyleret interferon-alfa-2b og ribavirin. 
Telaprevir exposure is comparable during co-administration with either peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Kontrolregimet (Pbo/PR) havde en fast behandlingsvarighed på 48 uger med telaprevir-matchende placebo i de første 12 uger og pegyleret interferon-alfa-2a og ribavirin i 48 uger. 
The control regimen (Pbo/PR) had a fixed treatment duration of 48 weeks, with telaprevir-matching placebo for the first 12 weeks and peginterferon alfa-2a and ribavirin for 48 weeks.
BEHOLDERENS ETIKET (pakning med 4 beholdere) 
BOTTLE LABEL (4-bottle pack)
3 vedrørende lægemidler, som er kontraindiceret ved behandling med INCIVO. 
See also section 4.3 for medicinal products which are contraindicated with INCIVO.
Forsigtighed tilrådes ved brug af INCIVO sammen med klasse Ic-antiarytmika propafenon og flecainid, og behandlingen skal følges med passende klinisk kontrol inklusive ekg-vurderinger (se 
INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring (see section 4.4).
↑ ketoconazol (200 mg) AUC 2,25 (1,93-2,61) Cmax 1,75 (1,51-2,03) 
↑ ketoconazole (200 mg) AUC 2.25 (1.93-2.61) Cmax 1.75 (1.51-2.03)
Samtidig infektion med HCV og hiv-1 (humant immundefektvirus) Patienter med samtidig HCV- og hiv-1-infektion skal behandles på samme måde som patienter, der kun er inficeret med HCV. Der skal omhyggeligt tages højde for lægemiddelinteraktioner, se pkt. 
HCV/Human immunodeficiency virus type (HIV)-1 co-infection HCV/HIV-1 co-infected patients should be treated in the same way as HCV mono-infected patients.
I placebokontrollerede fase 2- og 3-studier holdt 1,9% af patienterne op med at tage INCIVO på grund af anæmi, og 0,9% af patienterne holdt op med at tage INCIVO kombinationsbehandling på grund af anæmi sammenlignet med 0,5% af dem, der fik pegyleret interferon-alfa og ribavirin (se pkt. 
In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued INCIVO alone due to anaemia, and 0.9% of patients discontinued INCIVO combination treatment due to anaemia compared to 0.5% receiving peginterferon alfa and ribavirin (see section 4.4).
I de placebokontrollerede fase 2- og 3-studier blev der rapporteret transfusion under behandlingsfasen med INCIVO/placebo hos 2,5% af de patienter, der fik kombinationsbehandling med INCIVO, og hos 0,7% af de patienter, der fik pegyleret interferon-alfa og ribavirin alene. 
In the placebo-controlled Phase 2 and 3 trials, transfusions were reported during the INCIVO/placebo treatment phase in 2.5% of patients receiving INCIVO combination treatment and 0.7% in patients receiving peginterferon alfa and ribavirin alone.
Hos patienter, som havde ikke-detekterbart HCV-RNA (HCVRNA ikke påvist) i uge 4 og 12, var der ingen yderligere fordel ved at udvide behandlingen med pegyleret interferon-alfa-2a og ribavirin til 48 uger (forskel i SVR-rater 2%, 95% konfidensinterval: 
In patients who had undetectable HCV RNA (target not detected) at weeks 4 and 12, there was no additional benefit to extending peginterferon alfa-2a and ribavirin treatment to 48 weeks (difference in SVR rates of 2%; 95% confidence interval: -4%, 8%).
Under behandlingsfasen med INCIVO/placebo var de hyppigst rapporterede bivirkninger (incidens ≥ 5,0%) i INCIVO-gruppen, som havde en sværhedsgrad på mindst grad 2, anæmi, udslæt, pruritus, 
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 2 in severity in the INCIVO group (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and
Der er rapporteret forlængelse af QT-intervallet og torsades de pointes ved brug af methadon (se pkt. 
QT interval prolongation and Torsade de Pointes have been reported with methadone (see section 4.4).
Studie C216 var et randomiseret, dobbeltblindt, placebokontrolleret, fase 3-studie, der omfattede patienter, som ikke opnåede SVR med tidligere behandling med pegyleret interferon-alfa-2a og ribavirin eller pegyleret interferon-alfa-2b og ribavirin. 
Study C216 was a randomised, double-blind, placebo-controlled, Phase 3 study conducted in patients who did not achieve SVR with prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Udslættet kan være ledsaget af kløe. 
There may be itching with the rash.
Bivirkningerne af de enkelte produkter fremgår af de respektive produktresuméer. 
Refer to their respective Summary of Product Characteristics for their associated adverse reactions.
I løbet af den samlede behandlingsfase blev ribavirin-dosis yderligere nedsat hos 36,5% af patienterne, 41,9% fik ESA'er, og 21,6% fik blodtransfusioner (se pkt. 
To manage anaemia, at initiation of INCIVO treatment a lower starting dose of ribavirin (600 mg/day) was used; during the overall treatment phase the ribavirin dose was further reduced in 36.5% of patients, 41.9% received ESAs and 21.6% received blood transfusions (see sections 4.4 and 4.5, Immunosuppressants).
I studier med rotter og med hunde sås samme histopatologiske fund i leveren, og ikke alle forsvandt igen i observationsperioden. 
Histopathological findings in the liver were similar in both rat and dog studies, of which not all were fully resolved after recovery.
til at behandle urinsur gigt (antiinflammatoriske midler mod akut arthritis) til at behandle visse infektioner (antibiotika mod mycobakterier) sovemidler og/eller angstdæmmende midler (benzodiazepiner) sovemidler og/eller angstdæmmende midler (ikke-benzodiazepiner) 
to treat inflammatory arthritis (anti-gout agents) to treat certain infections (antimycobacterials) to help you sleep and/or relieve anxiety (benzodiazepines) to help you sleep and/or relieve anxiety (non-benzodiazepine sedatives)
kriterier for fortsættelse eller seponering af behandling med telaprevir og de øvrige komponenter i behandlingen. 
• Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other treatment components.
Under INCIVO-behandlingen rapporteredes der om hændelser med udslæt (af alle grader) hos 55% af de patienter, som fik INCIVOkombinationsbehandling, og hos 33% af de patienter, som kun fik pegyleret interferon-alfa og 
During INCIVO treatment, rash events (all grades) were reported in 55% of patients who received INCIVO combination treatment and in 33% of patients who received peginterferon alfa and ribavirin.
I tabel 7 vises responsraterne for de anbefalede T12/PR- og Pbo/PR48-grupper. 
Table 7 shows the response rates for the recommended T12/PR and the Pbo/PR48 groups.
Samtidig infektion med hepatitis C og hepatitis B-virus Der foreligger ingen data om anvendelse af INCIVO til patienter, som er co-inficeret med både 
HCV/HBV (hepatitis B virus) co-infection There are no data on the use of INCIVO in patients with HCV/HBV co-infection.
I kliniske placebokontrollede fase 2- og 3-studier øgedes den samlede incidens og sværhedsgrad af anæmi med INCIVO-kombinationsbehandling sammenlignet med pegyleret interferon-alfa og ribavirin alene. 
In placebo-controlled Phase 2 and 3 clinical trials, the overall incidence and severity of anaemia increased with INCIVO combination treatment compared to peginterferon alfa and ribavirin alone.
Udseende og pakningsstørrelser Filmovertrukne tabletter. 
What INCIVO looks like and contents of the pack Film-coated tablet.
I placebokontrollerede fase 2- og 3-studier rapporteredes anæmi (af alle grader) hos 32,1% af de patienter, som fik INCIVO-kombinationsbehandling, og hos 14,8% af de patienter, som kun fik pegyleret interferon-alfa og ribavirin. 
In placebo-controlled Phase 2 and 3 trials, anaemia (all grades) was reported in 32.1% of patients who received INCIVO combination treatment and in 14.8% of patients who received peginterferon alfa and ribavirin.
Patienter med ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 og 12 
Patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
Hjælpestof, som behandleren skal være opmærksom på: 2,3 mg natrium pr. filmovertrukket tablet. 
Excipient: 2.3 mg of sodium per film-coated tablet.
In vitro fandtes der ingen relevant telaprevir-relateret induktion af CYP1A2-, CYP2B6-, CYP2C- og CYP3A-isozymer. 
No relevant induction by telaprevir of CYP1A2, CYP2B6, CYP2C, and CYP3A isozymes was observed in vitro.
Hæmoglobin bør kontrolleres med jævne mellemrum før og under kombinationsbehandling med INCIVO (se pkt. 
Haemoglobin should be monitored at regular intervals prior to and during INCIVO combination treatment (see section 4.4, Laboratory tests).
Virologisk svigt under behandlingen blev defineret som udløsning af en virologisk stopregel og/eller med viralt 
On-treatment virologic failure was defined as meeting a virologic stopping rule and/or having viral breakthrough.
I placebokontrollerede fase 2og 3-studier steg den samlede incidens og sværhedsgrad af udslæt, når INCIVO blev givet sammen med pegyleret interferon-alfa og ribavirin. 
In placebo-controlled Phase 2 and 3 trials, the overall incidence and severity of rash increased when INCIVO was co-administered with peginterferon alfa and ribavirin.
Der henvises også til produktresuméet for ribavirin vedrørende patienter med CrCl < 50 ml/min (se også 
Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCL < 50 ml/min
Dette lægemiddel indeholder 2,3 mg natrium pr. tablet, og patienter, som får en diæt med kontrolleret natriumindhold, skal tage hensyn hertil. 
This medicine contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet. Tell your doctor if you have to take care of your salt intake and follow a
Dosisjustering er ikke nødvendig ved co-administration. 
If co-administered, no dose adjustment is required.
Under fasen med INCIVO-/placebo-behandling var de hyppigst rapporterede bivirkninger (incidens ≥ 1,0%) i INCIVO-gruppen, som havde en sværhedsgrad på mindst grad 3, anæmi, udslæt, trombocytopeni, lymfopeni, pruritus og kvalme. 
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 3 in the INCIVO group (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia,
Hypromelloseacetatsuccinat, calciumhydrogenphosphat (vandfrit), mikrokrystallinsk cellulose, vandfri kolloid silica, natriumlaurilsulfat, croscarmellosenatrium, natriumstearylfumarat. 
hypromellose acetate succinate, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulphate, croscarmellose sodium, sodium polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172)
Ved indledning og seponering af behandling med INCIVO skal doser af co-administreret tacrolimus eller ciclosporin justeres markant (se pkt. 
At the initiation and discontinuation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly adjusted (see sections 4.4 and 4.5, Immunosuppressants).
Hvis det først opdages mere end 4 timer efter det sædvanlige tidspunkt for indgift af INCIVO, skal den glemte dosis springes over, og det sædvanlige behandlingsskema følges. 
If the missed dose is noticed more than 4 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule.
til at behandle hiv-infektioner (revers transkriptasehæmmere) fluvastatin, pitavastatin, pravastatin, rosuvastatin til at sænke kolesteroltallet (HMG-CoAreduktasehæmmere) hormonale kontraceptiva hormonsubstitution/hormonterapi medicin til at undertrykke immunsystemet (immunsupprimerende midler), medicin mod visse gigtsygdomme eller til at undgå problemer ved organtransplantation salmeterol til at forbedre vejrtrækningen ved astma (betaagonister til inhalation) 
abacavir, efavirenz, tenofovir disoproxil to treat HIV infections (reverse transcriptase inhibitors) to lower cholesterol levels (HMG CoA reductase inhibitors) all types of hormonal contraceptives (‘the pill') hormonal contraceptives hormone replacement therapy to lower your immune system (immunosuppressants), medicines used in some rheumatic diseases or to avoid problems with organ transplants to improve breathing for asthma (inhaled beta agonists) to treat type II diabetes (blood glucose lowering medicine) for the treatment of opioid (narcotic) dependence to treat erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension (PDE-5 inhibitors)
Anbefalinger for overvågning af kutane reaktioner og seponering af behandling med INCIVO, ribavirin og pegyleret interferon-alfa ved alvorligt udslæt 
Recommendations for Monitoring of Cutaneous Reactions and Discontinuation of INCIVO, Ribavirin and Peginterferon alfa for Severe Rash
Den observerede resistensprofil i studie HPC3006 hos behandlingsnaive og behandlingserfarne HCV-1-inficerede levertransplantatmodtagere i stabil behandling med de immunsupprimerende midler tacrolimus eller ciclosporin svarede til resistensprofilen hos HCV-inficerede patienter, der ikke havde gennemgået en levertransplantation. 
The resistance profile observed in Study HPC3006 in treatment-naïve and treatment-experienced HCV-1 infected liver transplant recipients who were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A was similar to the resistance profile in HCV-infected patients without a liver transplant.
Plastbeholderen er forsynet med et børnesikret låg, der åbnes som følger: - Tryk plastskruelåget ned, mens det drejes mod uret. 
Push the plastic screw cap down while turning it counter clockwise.
Efter afslutningen af INCIVO-behandlingen skal kontraceptionsrekommendationerne i produktresumeet for ribavirin følges 
Following completion of INCIVO therapy contraceptive recommendations should be followed as in the Summary of Product Characteristics for ribavirin, and as described below.
Studie 106 var et randomiseret, dobbeltblindt, placebokontrolleret, fase 2-studie med patienter, som oplevede behandlingssvigt med pegyleret interferon-alfa-2a og ribavirin eller pegyleret interferon-alfa-2b og ribavirin. 
Study 106 was a randomised, double-blind, placebo-controlled, Phase 2 study that enrolled patients who had failed prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.