natgillin/translations-raw huggingface dataset:
Børn, som vejer mere end 40 kg, og som kan sluge kapsler, kan behandles med en voksendosis på 75 mg to gange daglig i 5 dage som et alternativ til den anbefalede dosis Tamiflu-suspension.
Children weighing &gt; 40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
Børn, der vejer &gt; 40 kg og som kan sluge kapsler, kan som forebyggende behandling også tage 75 mg kapsler én gang daglig i 10 dage som et alternativ til den anbefalede dosis af Tamiflu oral suspension.
Children weighing &gt; 40 kg and who are able to swallow capsules may receive prophylaxis with a 75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension.
Der er på nuværende tidspunkt ingen tilgængelige data, som muliggør en dosisanbefaling til for tidligt fødte børn ( &lt; 36 ugers postfosteralder).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Der er på nuværende tidspunkt ingen tilgængelige data, som muliggør en dosisanbefaling til for tidligt fødte børn ( &lt; 36 ugers fosteralder).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
De kliniske data viser, at en profylaktisk dosis ækvivalent til halvdelen af den daglige behandlingsdosis er klinisk effektiv til at forebygge influenza (se pkt.
This is based upon clinical data in children &gt; 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza (see Section 5.2 for exposure simulation)..
Sammenlignet med placebo, nedsatte oseltamivir tiden til lindring af alle symptomer med 0,7 dage (95 % konfidensinterval: 0,1 - 1,6 dage, p = 0,022) og varigheden af feber (≥ 37,8 °C), hoste og forkølelse med en dag (95 % konfidensinterval: 0,4 - 1,7 dage, p &lt; 0,001).
Oseltamivir reduced the time to alleviation of all symptoms by 0.7 days (95 % CI 0.1 - 1.6 days; p = 0.022) and the duration of fever (≥ 37.8 °C), cough and coryza by one day (95 % CI 0.41.7 days; p &lt; 0.001) compared to placebo.
&gt; 6 til 7 kg
&gt; 6 to 7 kg
&gt; 8 til 9 kg
&gt; 8 to 9 kg
&gt; 7 til 8 kg
&gt; 7 to 8 kg
Behandling med oseltamivir påbegyndt senest 48 timer efter symptomstart, nedsatte tiden indtil helbredelse af sygdommen signifikant (defineret som samtidig tilbagevenden til normal sundhed og aktivitet og lindring af feber, hoste og forkølelse) med 1,5 dag (95 % konfidensinterval: 0,6 - 2,2 dage: p &lt; 0,0001), sammenlignet med placebo.
Treatment of influenza in children: In a study of otherwise healthy children (65 % influenza-positive) aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or coryza, 67 % of influenza-positive patients were infected with influenza A and 33 % with influenza B. Oseltamivir treatment, started within 48 hours of onset of symptoms, significantly reduced the time to freedom from illness (defined as the simultaneous return to normal health and activity and alleviation of fever, cough and coryza) by 1.5 days (95 % CI 0.6 - 2.2 days; p &lt; 0.0001) compared to placebo.
En vejledende brochure, der giver svar på eventuelle spørgsmål om følgende emner:
A Q &amp; A document, providing answers to potential questions on the following topics:
Bivirkningerne er anført herunder i henhold til foretrukken MedDRA-terminologi efter systemorganklasser og hyppighed (hyppigheder defineres som: meget almindelig ≥1/10, almindelig ≥1/100 til &lt; 1/10, ikke almindelig ≥ 1/1.000 til &lt; 1/100, sjælden (≥
Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to &lt; 1/10, uncommon ≥ 1/1,000 to &lt; 1/100, rare (≥1/10,000 to
I det andet pivotale studie (studie 2) var det primære endepunkt SPID30, som ligeledes var statistisk signifikant sammenlignet med placebo (p &lt; 0,0001).
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p &lt; 0.0001).
I det pivotale, kliniske studie (studie 1) var det primære endepunkt den gennemsnitlige sum af forskellene i smerteintensitet fra doseringen til 60 minutter efter, inklusive (SPID60), som var statistisk signifikant sammenlignet med placebo (p &lt; 0,0001).
In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p &lt; 0.0001).
1/10.000 til &lt; 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
&lt; 1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness:
Belatacept er ikke blevet undersøgt hos patienter med Panel Reactive Antibody (PRA) &gt; 30% (som ofte har behov for øget immunsuppression).
Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) &gt; 30% (who often require increased immunosuppression).
Infusion af den fÃ¸rste dosis bÃ¸r gives umiddelbart i den prÃ¦operative periode eller under operationen, men inden afslutning af transplantatets vaskulÃ¦re anastomose.
Infusion of the first dose should be given in the immediate preoperative period or during surgery, but before completion of the transplant vascular anastomoses.
Hyppigheden er defineret som følger: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til &lt; 1/10); Ikke almindelige (≥ 1/1.000 til  1/100).
The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100).
Ved år 3 var recidiverende AR ens for begge grupper ( &lt; 3%) og subklinisk AR, som blev identificeret ved protokolbiopsi ved år 1, var 5% i begge grupper.
By Year 3 recurrent AR was similar across groups ( &lt; 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Inflammation i maven og tarmene, som oftest forÃ¥rsaget af en virus Maveproblemer
Inflammation of the stomach and intestines, usually caused by a virus Upset stomach
Information til lÃ¦ger og sundhedspersonale om beregning af dosis, klargÃ¸ring og indgivelse af NULOJIX er anfÃ¸rt sidst i indlÃ¦gssedlen.
Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
Studie 2: Recipienter til donornyrer efter extended criteria Extended criteria donorer blev defineret som afdøde donorer med mindst et af følgende kriterier: (1) donoralder ≥ 60 år; (2) donoralder ≥ 50 år og anden komorbiditet hos donor (≥ 2 af følgende: slagtilfælde, hypertension, serumkreatinin &gt; 1,5 mg/dl); (3) donation efter hjertedød eller (4) forventet kold iskæmi-tid på ≥ 24 timer.
Study 2: Recipients of Extended Criteria Donor Kidneys Extended criteria donors were defined as deceased donors with at least one of the following: (1) donor age ≥ 60 years; (2) donor age ≥ 50 years and other donor comorbidities (≥ 2 of the following: stroke, hypertension, serum creatinine &gt; 1.5 mg/dl); (3) donation after cardiac death or (4) anticipated cold ischemia time of ≥ 24 hours.
Belatacept er ikke undersøgt hos patienter med PRA &gt; 30% (se pkt.
Belatacept has not been studied in patients with PRA &gt; 30% (see section 4.2).
Maligniteter og Post-transplantation lymfoproliferativ sygdom (PTLD) Hyppigheden af maligniteter ved år 1 og 3 er vist i tabel 3 med undtagelse af tilfælde af PTLD, som vises ved år 1 og &gt; 3 år (gennemsnitligt antal dage for follow-up var 1199 dage for belatacept MI, 1206 dage for belatacept LI og 1139 dage for ciclosporin).
Malignancies and post-transplant lymphoproliferative disease Year 1 and 3 frequencies of malignancies are shown in Table 3, except for cases of PTLD which are presented at 1 year and &gt; 3 years (median days of follow-up were 1,199 days for belatacept MI, 1,206 days for belatacept LI, and 1,139 days for ciclosporin).
Infektioner, der involverede CNS, var hyppigere i belatacept MI-gruppen (8 tilfÃ¦lde herunder ovennÃ¦vnte tilfÃ¦lde af PML; 1,7%) end i belatacept LI-gruppen (2 tilfÃ¦lde; 0,4%) og ciclosporingruppen (1 tilfÃ¦lde; 0,2%).
Infections involving the CNS were more frequent in the belatacept MI group (8 cases, including the PML case discussed above; 1.7%) than the belatacept LI (2 cases, 0.4%) and ciclosporin (one case; 0.2%) groups.
InfusionsvÃ¦sken skal anvendes sammen med et sterilt, ikke-pyrogent filter med lav proteinbindingsgrad (porestÃ¸rrelse 0,2-1,2 Î¼m).
The solution for infusion is to be used in conjunction with a sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 µm to 1.2 µm).
Donororganer efter standardkriterier blev defineret som organer fra en levende donor eller en afdød donor med forventet kold iskæmi-tid på &lt; 24 timer, som ikke kunne defineres som extended criteria donororganer.
Study 1: Recipients of Living Donor and Standard Criteria Deceased Donor Kidneys Standard criteria donor organs were defined as organs from a living donor, or a deceased donor with anticipated cold ischemia time of &lt; 24 hours and not meeting the definition of extended criteria donor organs.
a Andel af patienter med målt GFR &lt; 60 ml/min/1,73 m2 eller med fald i målt GFR ≥ 10 ml/min/1,73 m2 fra måned 3 til måned 12. b Målt GFR blev bestemt ved iothalamat udelukkende ved år 1 og 2 c Beregnet GFR blev beregnet ved MDRD-formlen ved måned 1, år 1, 2 og 3
aProportion of Patients with Measured GFR &lt; 60 ml/min/1.73 m2 or with a Decrease in Measured GFR ≥ 10 ml/min/1.73 m2 from Month 3 to Month 12. b Measured GFR was assessed by iothalamate at Year 1 and 2 only c Calculated GFR was assessed by MDRD formula at Month 1, Years 1, 2, and 3
I en præ-defineret poolet analyse af studie 1 og 2 ved år 1 var hyppigheden for nyopstået diabetes mellitus (NODM), defineret som brug af antidiabetika i ≥ 30 dage eller ≥ 2 fastende plasmaglucoseværdier &gt; 126 mg/dl (7,0 mmol/l) efter transplantation, 5% med belatacept og 10% med ciclosporin.
In a prespecified pooled analysis of Studies 1 and 2 at Year 1, the incidence of new onset diabetes mellitus (NODM), defined as use of an antidiabetic agent for ≥ 30 days or ≥ 2 fasting plasma glucose values &gt; 126 mg/dl (7.0 mmol/l) post-transplantation, was 5% with belatacept and 10% with ciclosporin.
InfusionsvÃ¦sken kan opbevares i hÃ¸jst 4 ud af de 24 timer ved under 25Â°C.
The solution for infusion may be stored for a maximum of 4 hours of the total 24 hours below 25°C.
Tid til død, tab af transplantat eller GFR &lt; 30 ml/min./1,73 m2 blev analyseret over den 7-årige periode: I Studie 1 blev der observeret en reduktion på ca. 60 % i risikoen for død, tab af transplantat eller GFR &lt; 30 ml/min./1,73 m2 hos patienter i belataceptgrupperne sammenlignet med patienter i ciclosporingruppen.
The time to death, graft loss, or GFR &lt; 30 mL/min/1.73 m2 was analyzed over the 7-year period: in Study 1, approximately 60% reduction in the risk of death, graft loss, or GFR &lt; 30 mL/min/1.73 m2 was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Infusionsrelaterede reaktioner Der er rapporteret om anafylaksi efter markedsfÃ¸ringen (se pkt.
Infusion-related reactions Anaphylaxis has been reported post marketing(see section 4.4).
Infektionssymptomer kan omfatte feber; uforklarligt vÃ¦gttab; hÃ¦vede kirtler; forkÃ¸lelsessymptomer som f.eks. lÃ¸bende nÃ¦se eller ondt i halsen; hoste med slim; blod i slimen; Ã¸repine; rÃ¸de sÃ¥r eller afskrabninger; varm og sivende pus.
Infection symptoms may include fever; unexplained weight loss; swollen glands; cold symptoms such as a runny nose or sore throat; cough with sputum; blood in your sputum; earache; cuts or scrapes that are red; warm and oozing pus.
Infusionen skal vÃ¦re afsluttet inden for 24 timer efter rekonstituering af pulveret.
Infusion must be completed within 24 hours of reconstitution of the powder.
Infektion med rundorm, diarreinfektion med Giardia parasit Nyresygdom, der er forÃ¥rsaget af en virus (polyomavirus-relateret nefropati), betÃ¦ndelsestilstand i nyrerne, ardannelse i nyrerne, sammentrÃ¦kning af de smÃ¥ kanaler i nyrerne, betÃ¦ndelsestilstand i blÃ¦rerne med blÃ¸dning
Infection with the strongyloides worm, diarrheal infection with Giardia parasite Kidney disease that is caused by a virus (polyomavirus-associated nephropathy), inflammation of the kidneys, scarring of the kidneys, shrinkage of the small tubes in the kidney, inflammation of the bladder with bleeding
I studie 2 ved år 3 var gennemsnitligt beregnet GFR 11 ml/min/1,73 m2 højere med belatacept og henholdsvis 27% og 44% af patienterne nåede CKD-stadium 4/5 (GFR &lt; 30 ml/min/1,73 m2) med belatacept versus ciclosporin.
In Study 2 by Year 3, mean calculated GFR was 11 ml/min/1.73 m2 higher with belatacept, and 27% and 44% of patients reached CKD stage 4/5 (GFR &lt; 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Infusionen af NULOJIX skal vÃ¦re afsluttet inden for 24 timer efter rekonstituering af pulveret.
The NULOJIX infusion must be completed within 24 hours of reconstitution of the powder.
I studie 1 ved år 3 var gennemsnitligt beregnet GFR 21 ml/min/1,73 m2 højere med belatacept og henholdsvis 10% og 20% af patienterne nåede CKD-stadium 4/5 (GFR &lt; 30 ml/min/1,73 m2) med belatacept versus ciclosporin.
Progression of Chronic Kidney Disease (CKD) Staging In Study 1 by Year 3, mean calculated GFR was 21 ml/min/1.73 m2 higher with belatacept, and 10% and 20% of patients reached CKD stage 4/5 (GFR &lt; 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Infektioner og parasitÃ¦re sygdomme
Infections and infestations Serious infections Viral infections
Infektion i blodet eller vÃ¦vet, luftvejsinfektioner, lungebetÃ¦ndelse, influenza, bihulebetÃ¦ndelse, lÃ¸bende nÃ¦se, ondt i halsen, smerter i munden/omkring svÃ¦lget, herpesvirusinfektioner, helvedesild og andre virusinfektioner, sÃ¥r i munden, trÃ¸ske, nyreinfektion, svampeinfektion pÃ¥ huden, svampeinfektion under neglene og andre svampeinfektioner, hudinfektion, infektion i blÃ¸dt vÃ¦v, infektion i sÃ¥r, infektion begrÃ¦nset til Ã©t omrÃ¥de, langsom heling, blÃ¥ mÃ¦rker, ophobning af lymfevÃ¦ske omkring den transplanterede nyre
Fluid in the lungs, wheezing, chest pain or angina, enlarged heart muscle (bottom of the heart) Infection of the blood or tissues, respiratory infections, pneumonia, flu, sinus inflammation, runny nose, sore throat, pain in the mouth/throat region, herpes virus infections, shingles and other viral infections, mouth sores, thrush, kidney infection, fungal skin infections,fungal infections of the nails and other fungal infections, skin infection, infection of soft tissues, wound infection,
INFORMATION I BRAILLESKRIFT &lt; Fritaget fra krav om blindeskrift &gt;
INFORMATION IN BRAILLE Justification for not including Braille accepted.
INFORMATION I BRAILLESKRIFT Sovaldi [Kun pÃ¥ den ydre emballage]
INFORMATION IN BRAILLE Sovaldi [Outer packaging only]
Sovaldis sikkerhed og virkning hos børn og unge i alderen &lt; 18 år er endnu ikke klarlagt.
The safety and efficacy of Sovaldi in children and adolescents aged &lt; 18 years have not yet been established.
De virologiske responsrater for de første 41 patienter, der blev transplanteret med HCV-rna &lt; LLOQ er beskrevet i tabel 17.
The virologic response rates of the 41 subjects transplanted with HCV RNA &lt; LLOQ is described in Table 17.
I studie 0126 var fald i hæmoglobin i løbet af behandlingen meget almindelig, og 32,5 % (13/40 personer) oplevede et fald i hæmoglobin til &lt; 10 g/dl, hvoraf 1 havde et fald til &lt; 8,5 g/dl.
In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 subjects) experiencing a decline in haemoglobin to &lt; 10 g/dL, 1 of whom also had a decline to &lt; 8.5 g/dL.
almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til
Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to
I en samlet analyse med 991 patienter, som fik sofosbuvir i fase III-studier, kvalificerede 226 patienter sig til resistensanalyse på grund af virologisk svigt eller tidlig seponering af studielægemidlet, samt at de havde HCV-rna &gt; 1.000 IE/ml.
In a pooled analysis of 991 subjects who received sofosbuvir in Phase 3 studies, 226 subjects qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA &gt; 1,000 IU/mL.
Patienterne fik enten ikke antiretroviral behandling med et CD4+ celletal på &gt; 500 celler/mm3, eller de havde virologisk supprimeret hiv-1 med et CD4+ celletal &gt; 200 celler/mm3.
Subjects were either not on antiretroviral therapy with a CD4+ cell count &gt; 500 cells/mm3 or had virologically suppressed HIV-1
Patienterne blev randomiseret i forholdet 1:1 og stratificeret efter cirrose (til stede versus ikke til stede), HCV-genotype (2 versus 3) og baseline HCV-rna-niveau ( &lt; 6 log10 IE/ml versus ≥ 6 log10 IE/ml).
Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level ( &lt; 6 log10 IU/mL versus ≥6 log10 IU/mL).
I forhold til personer med normal nyrefunktion (eGFR &gt; 80 ml/min/1,73 m2) var sofosbuvir AUC0-inf 61 %, 107 % og 171 % højere ved let, moderat og svært nedsat nyrefunktion, mens GS-331007 AUC0-inf var hhv. 55 %, 88 % og 451 % højere.
Relative to subjects with normal renal function (eGFR &gt; 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Tabel 17: Virologisk respons efter transplantation hos patienter med HCV-rna &lt; LLOQ på tidspunktet for levertransplantationen
Table 17: Virologic response post-transplant in subjects with HCV RNA &lt; LLOQ at the time of liver transplantation
Sofosbuvirs farmakokinetik blev undersøgt hos HCV-negative personer med let (eGFR ≥ 50 og &lt; 80 ml/min/1,73m2), moderat (eGFR ≥ 30 og &lt; 50 ml/min/1,73m2), svært nedsat nyrefunktion (eGFR &lt; 30 ml/min/1,73 m2) og personer med ESRD, der krævede hæmodialyse efter en enkelt 400 mg dosis sofosbuvir.
The pharmacokinetics of sofosbuvir were studied in HCV negative subjects with mild (eGFR ≥50 and &lt; 80 mL/min/1.73 m2), moderate (eGFR ≥30 and &lt; 50 mL/min/1.73 m2), severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Hovedparten af patienterne havde HCV-genotype 1, 44 patienter havde CPT klasse A og 17 personer havde CPT klasse B. Ud af disse 61 patienter gennemgik 44 patienter levertransplantation efter op til 48 ugers behandling med sofosbuvir og ribavirin, 41 havde HCV-rna &lt; LLOQ på tidspunktet for transplantationen.
An interim analysis was conducted on 61 subjects who received sofosbuvir and ribavirin; the majority of subjects had HCV genotype 1, 44 subjects were CPT class A and 17 subjects were CPT class B. Of these 61 subjects, 44 subjects underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA &lt; LLOQ at the time of transplantation.
Samlet SVR12 Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidiva Andetb a. Benævnelsen for recidiv er antallet af patienter med HCV-rna &lt; LLOQ ved deres seneste vurdering under behandling.
Overall SVR12 Outcome for subjects without SVR12 On-treatment virologic failure Relapsea Otherb a. The denominator for relapse is the number of subjects with HCV RNA &lt; LLOQ at their last on-treatment assessment.
Information om lÃ¦gemiddelinteraktion for Sovaldi med mulige samtidige lÃ¦gemidler er opsummeret i tabel 3 nedenfor (hvor 90 % konfidensintervallet (CI) af forholdet af det geometriske mindste kvadraters gennemsnit (GLSM) var inden for âââ, strakte sig over âââ eller strakte sig under âââ de Ã¦kvivalensgrÃ¦nser, der var bestemt pÃ¥ forhÃ¥nd).
Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 3 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Sikkerheden af Sovaldi er ikke blevet vurderet hos personer med svært nedsat nyrefunktion (eGFR &lt; 30 ml/min/1,73 m2) eller ESRD, der kræver hæmodialyse.
The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Sikkerheden og den passende dosis af Sovaldi er ikke blevet klarlagt hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] &lt; 30 ml/min/1,73 m2) eller nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse (se pkt.
The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt; 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
b. Benævnelsen for recidiv er antallet af patienter med HCV-rna &lt; LLOQ ved deres seneste vurdering under behandling.
b. The denominator for relapse is the number of subjects with HCV RNA &lt; LLOQ at their last on-treatment assessment.
Patienterne fik 400 mg sofosbuvir og vægtbaseret ribavirin (1.000 mg til patienter, der vejede &lt; 75 kg eller 1.200 mg for patienter, der vejede ≥ 75 kg).
Subjects received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for subjects weighing &lt; 75 kg or 1,200 mg for subjects weighing ≥75 kg).
Andetb a. Benævnelsen for recidiv er antallet af patienter med HCV-rna &lt; LLOQ ved deres seneste vurdering under behandling.
Otherb a. The denominator for relapse is the number of subjects with HCV RNA &lt; LLOQ at their last on-treatment assessment.
Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir udgjorde sofosbuvir og GS-331007 ca. hhv. 4 %
After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and &gt; 90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Hvis personerne opretholdt hæmoglobinniveau ≥ 12 g/dl, blev ribavirindosis øget ved uge 2, 4 og op til hver 4. uge, indtil den passende vægtbaserede dosis (1.000 mg dagligt hos personer &lt; 75 kg, 1.200 mg dagligt hos personer ≥ 75 kg) blev nået.
and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in subjects &lt; 75 kg, 1,200 mg daily in subjects ≥75 kg).
Biotilgængeligheden af sarolaner efter oral indgift var høj ( &gt; 85 %).
The bioavailability of sarolaner following oral dosing was high at &gt; 85%.
til hunde 1,3-2,5 kg til hunde &gt; 2,5-5 kg til hunde &gt; 5-10 kg til hunde &gt; 10-20 kg til hunde &gt; 20-40 kg til hunde &gt; 40-60 kg
for dogs 1.3-2.5 kg for dogs &gt; 2.5-5 kg for dogs &gt; 5-10 kg for dogs &gt; 10-20 kg for dogs &gt; 20-40 kg for dogs &gt; 40-60 kg
MiPet Easecto 5 mg tyggetabletter til hunde på 1,3-2,5 kg MiPet Easecto 10 mg tyggetabletter til hunde på &gt; 2,5-5 kg MiPet Easecto 20 mg tyggetabletter til hunde på &gt; 5-10 kg MiPet Easecto 40 mg tyggetabletter til hunde på &gt; 10-20 kg MiPet Easecto 80 mg tyggetabletter til hunde på &gt; 20-40 kg MiPet Easecto 120 mg tyggetabletter til hunde på &gt; 40-60 kg sarolaner
MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs &gt; 2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs &gt; 5-10 kg MiPet Easecto 40 mg chewable tablets for dogs &gt; 10-20 kg MiPet Easecto 80 mg chewable tablets for dogs &gt; 20-40 kg MiPet Easecto 120 mg chewable tablets for dogs &gt; 40-60 kg sarolaner