natgillin/translations-raw huggingface dataset:
Hos alle de forsøgspersoner, der havde genotype 1-infektion, og som oplevede virologisk svigt, sås en eller flere af NS5A-substitutionerne L/M28M/T/V, Q30E/G/H/K/L/R, L31M, P32-deletion, H58C/D eller Y93H ved baseline, idet der hos 7 af forsøgspersonerne yderligere sås behandlingsrelateret NS5A-substitution M28A/G, P29Q/R, Q30K, H58D eller Y93H på tidspunktet for behandlingssvigt.
All of the genotype 1-infected virologic failure subjects had one or more NS5A substitutions L/M28M/T/V, Q30E/G/H/K/L/R, L31M, P32 deletion, H58C/D, or Y93H at baseline, with additional treatment-emergent NS5A substitutions M28A/G, P29Q/R, Q30K, H58D, or Y93H observed in 7 of the subjects at the time of failure.
Klinisk studie hos forsøgspersoner med nedsat nyrefunktion
Clinical Study in Renally Impaired Subjects
↑ simvastatin ↑ simvastatinsyre
↑ simvastatin acid
Simvastatin 5 mg én gang dagligt
Simvastatin 5 mg once daily
300/100 mg én gang dagligtb
300/100 mg once dailyb
Rifampicin 600 mg én gang dagligta
Rifampicin 600 mg once dailya
Maviret 100 mg/40 mg, tabletter glecaprevir/pibrentasvir
Maviret 100 mg/40 mg tablets glecaprevir/pibrentasvir
I TN-forsøgspersoner uden cirrose, som fik behandling af den anbefalede varighed på 8 uger, opnåede 97,5% (749/768) SVR12, mens 0,1% (1/768) oplevede virologisk svigt under behandling og 0,7% (5/755) oplevede recidiv efter behandling.
In TN subjects without cirrhosis who received the recommended duration of 8 weeks, 97.5% (749/768) achieved SVR12, while 0.1% (1/768) experienced on-treatment virologic failure and 0.7% (5/755) experienced post-treatment relapse.
De samlede SVR12-rater i VOYAGE-1 og VOYAGE-2 var henholdsvis 97,2% (352/362) og 99,4%
The overall SVR12 rates were 97.2% (352/362) and 99.4% (159/160) in VOYAGE-1 and VOYAGE-2, respectively.
Hos 7 af de 10 forsøgspersoner med genotype 1-infektion, der oplevede virologisk svigt, sås behandlingsrelateret NS3-substitution V36A/M, R155K/T, A156G/T/V eller D168A/T.
Among the 10 genotype 1-infected subjects with virologic failure, treatment-emergent NS3 substitutions V36A/M, R155K/T, A156G/T/V, or D168A/T were observed in 7 subjects.
Dosisjustering er ikke nødvendigt ved brug af levonorgestrel, norethidron eller norgestimat som progestagenprævention.
↑ EE ↑ norgestrel norethidrone or norgestimate as contraceptive progestagen.
• Hvis der er gået mindre end 18 timer, siden du skulle have taget din dosis Maviret, skal du tage den så hurtigt som muligt.
• If you notice within 18 hours of the time you usually take Maviret take the dose as soon as possible.
Hver filmovertrukket tablet indeholder 100 mg glecaprevir og 40 mg pibrentasvir.
Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
SVR Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidiva Andetb SVR ud fra cirrosestatus Ingen cirrose
SVR Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb SVR by cirrhosis status No Cirrhosis
(Cobicistats hæmning af P-gp, BCRP og OATP; elvitegravirs hæmning af OATP)
(P-gp, BCRP, and OATP inhibition by cobicistat, OATP inhibition by elvitegravir)
e. GT1, 4 fra MAGELLAN-1 del 1 - Maviret i 12 uger (n = 22); GT1,4 fra MAGELLAN-1, del 2 - Maviret i 12 uger (n = 44) eller 16 uger (n = 47).
e. GT1, 4 from MAGELLAN-1 Part 1 - Maviret for 12 weeks (n=22); GT1, 4 from MAGELLAN-1 Part 2Maviret for 12 weeks (n=44) or 16 weeks (n=47).
En lav dosis af statiner anbefales ved påbegyndelse af behandling med direkte virkende antivirale lægemidler.
A low dose of the statin is recommended at the initiation of the DAA treatment.
Bivirkningerne var overordnet set af samme art og sværhedsgrad hos forsøgspersoner med cirrose som hos forsøgspersoner uden cirrose.
The type and severity of adverse reactions in subjects with cirrhosis were overall comparable to those seen in subjects without cirrhosis.
Ved den kliniske dosis var AUC for glecaprevir 33 % højere hos forsøgspersoner med Child-Pugh A, 100 % højere hos forsøgspersoner med Child-Pugh B og 11 gange højere hos forsøgspersoner med Child-Pugh C sammenholdt med ikke-HCV-smittede forsøgspersoner med normal leverfunktion.
At the clinical dose, compared to non-HCV infected subjects with normal hepatic function, glecaprevir AUC was 33% higher in Child-Pugh A subjects, 100% higher in Child-Pugh B subjects, and increased to 11-fold in Child-Pugh C subjects.
Hos de 2.409 behandlede forsøgspersoner, der havde kompenseret leversygdom (med eller uden cirrose), og som var behandlingsnaive eller behandlingserfarne, hvad angår kombinationer af peginterferon, ribavirin og/eller sofosbuvir, var den mediane alder 53 år (interval: 19-88); 73,3 % var behandlingsnaive, 26,7 % var behandlingserfarne, hvad angår en kombination indeholdende enten sofosbuvir, ribavirin og/eller peginterferon; 40,3 % havde HCV genotype 1; 19,8 % havde HCV genotype 2; 27,8 % havde HCV genotype 3; 8,1 % havde HCV genotype 4; 3,4 % havde HCV genotype 5-6; 13,1 % var ≥ 65 år; 56,6 % var mænd; 6,2 % var sorte; 12,3 % havde cirrose; 4,3 % havde svært nedsat nyrefunktion eller terminal nyresygdom; 20,0 % havde et BMI på mindst 30 kg pr. m2; 7,7 % var HIV-1 smittede og det mediane HCV-RNA-niveau ved baseline var 6,2 log10 IE/ml.
Clinical studies in treatment-naïve or treatment-experienced subjects with or without cirrhosis Of the 2,409 subjects with compensated liver disease (with or without cirrhosis) treated who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir, the median age was 53 years (range: 19 to 88); 73.3% were treatment-naïve, 26.7% were treatment-experienced to a combination containing either sofosbuvir, ribavirin and/or peginterferon; 40.3% were HCV genotype 1; 19.8% were HCV genotype 2; 27.8% were HCV genotype 3; 8.1% were HCV genotype 4; 3.4% were HCV genotype 5-6; 13.1% were ≥65 years; 56.6% were male; 6.2% were Black; 12.3% had cirrhosis; 4.3% had severe renal impairment or end stage renal disease; 20.0% had a body mass index of at least 30 kg per m2; 7.7% had HIV-1 coinfection and the median baseline HCV RNA level was 6.2 log10 IU/mL
Pakning med 84 filmovertrukne tabletter (4 x 21 tabletter).
Pack containing 84 (4 x 21) film-coated tablets.
Hos patienter med kronisk hepatitis C-infektion uden cirrose var de geometriske gennemsnitlige AUC24-værdier 13.600 ng∙time/ml for glecaprevir og 459 ng∙time/ml for pibrentasvir efter 3 dages enkelstofsbehandling med enten glecaprevir 300 mg pr. dag (N = 6) eller pibrentasvir 120 mg pr. dag (N = 8).
In patients with chronic hepatitis C infection without cirrhosis, following 3 days of monotherapy with either glecaprevir 300 mg per day (N=6) or pibrentasvir 120 mg per day (N=8) alone, geometric mean AUC24 values were 13600 ng∙h/mL for glecaprevir and 459 ng∙h/mL for pibrentasvir.
Patienter, der har oplevet svigt af en tidligere behandling med en NS5A- og/eller en NS3/4A-hæmmer
Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor
Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Medianalderen for de 280 behandlede forsøgspersoner var 60 år (interval: 34 til 88); 81,8% havde HCV genotype 1; 10% havde HCV genotype 2; 4,6% havde HCV genotype 4; 0,4% havde HCV genotype 5; 3,2% havde HCV genotype 6; 60% var mænd; 9,6% var sorte.
Of the 280 subjects treated, the median age was 60 years (range: 34 to 88); 81.8% had HCV genotype 1, 10% had HCV genotype 2, 4.6% had HCV genotype 4, 0.4% had HCV genotype 5; 3.2% had HCV genotype 6; 60% were male; 9.6% were Black.
(Hæmning af OATP1B1/3, P-gp, BCRP, CYP3A)
(Inhibition of OATP1B1/3, P-gp, BCRP, CYP3A)
Serumværdierne af HCV-RNA blev målt i de kliniske studier ved brug af HCV-testen Roche COBAS AmpliPrep/COBAS Taqman (version 2.0) med en nedre kvantificeringsgrænse (LLOQ) på 15 IE/ml (undtagen for SURVEYOR-1 og SURVEYOR-2, der anvendte RT-PCR-analysen (Roche COBAS TaqMan real-time reverse transcriptase-PCR) v. 2.0 med en LLOQ på 25 IE/ml).
Serum HCV RNA values were measured during the clinical studies using the Roche COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of
Dosisjustering af Maviret er ikke nødvendig hos unge fra 12 til <18 år (se pkt.
No dose adjustment of Maviret is required in adolescents aged 12 to <18 years (see sections 5.1 and 5.2).
Anbefalet behandlingsvarighed Uden cirrose Med cirrose
Recommended treatment duration No cirrhosis
Hver tablet indeholder 100 mg glecaprevir og 40 mg pibrentasvir.
Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
I TN eller TE-PRS forsøgspersoner med kompenseret cirrose, som fik behandling af den anbefalede varighed, opnåede 97,0% (288/297) SVR12 (heraf opnåede 98,0% [192/196] af TN-patienter SVR12), mens 0,7% (2/297) oplevede virologisk svigt af behandling, og 1,0% (3/289) oplevede recidiv efter behandling.
In TN or TE-PRS subjects with compensated cirrhosis who received the recommended duration, 97.0% (288/297) achieved SVR12 (among which 98.0% [192/196] of TN subjects achieved SVR12), while 0.7% (2/297) experienced on-treatment virologic failure and 1.0% (3/289) experienced posttreatment relapse.
Hos 84 af de behandlede forsøgspersoner var medianalderen 59 år (interval: 24-79); 27% havde HCV-genotype 5, 73% havde HCV-genotype 6; 54% var kvinder, 30% var hvide, 68% var asiater; 90% var HCV BN og 11% havde kompenseret cirrose.
Of the 84 subjects treated, the median age was 59 years (range 24-79); 27% had HCV genotype 5, 73% had HCV genotype 6; 54% were female, 30% were White, 68% were Asian; 90% were HCV TN; 11% had compensated cirrhosis.
Medianalderen var 14 år (interval: 12 år til 17 år); 79% havde HCV-genotype 1, 6% havde HCV-genotype 2, 9% havde HCV-genotype 3, 6% havde HCV-genotype 4; 55% var kvinder; 11% var sorte; 77% var HCV-behandlingsnaive; 23% var interferon behandlingserfarne; 4% havde samtidig HIV-infektion; ingen havde cirrose; den gennemsnitlige vægt var 59 kg (interval: 32 kg til 109 kg).
The median age was 14 years (range: 12 to 17); 79% had HCV genotype 1, 6% had HCV genotype 2, 9% had HCV genotype 3, 6% had HCV genotype 4; 55% were female; 11% were Black; 77% were HCV treatment-naïve; 23% were treatment-experienced to interferon; 4% had HIV-coinfection; none had cirrhosis; the mean weight was 59 kg (range: 32 to 109 kg).
Klinisk forsøg Oversigt over forsøgsdesign Behandlingsnaive (BN) og PRS-behandlingserfarne (BE) forsøgspersoner uden cirrose GT1
Genotype (GT) Clinical study Summary of study design TN and PRS-TE subjects without cirrhosis
↑ norgestrel holdige lægemidler er kontraindiceret pga. risikoen for forhøjet ALAT (se pkt.
Co-administration of Maviret with ethinyloestradiolcontaining products is contraindicated due to the risk of ALT elevations (see section 4.3).
I TE-PRS forsøgspersoner uden cirrose, som fik behandling af den anbefalede varighed, opnåede 98,2% (215/219) SVR12, mens 0,5% (1/219) oplevede virologisk svigt ved behandling, og 1,4% (3/218) oplevede recidiv efter behandling.
In TE-PRS subjects without cirrhosis who received the recommended duration, 98.2% (215/219) achieved SVR12, while 0.5% (1/219) experienced on-treatment virologic failure and 1.4% (3/218) experienced post-treatment relapse.
Maviret i 8 uger (n = 351) eller 12 uger (n = 352) SURVEYOR-1 Maviret i 8 uger (n = 34)
ENDURANCE-1a Maviret for 8 weeks (n=351) or 12 weeks (n=352) SURVEYOR-1 Maviret for 8 weeks (n=34)
Sikkerheden og virkningen af Maviret givet i 8 uger til GT 1, 2, 4, 5 eller 6 behandlingsnaive personer med kompenseret cirrose blev evalueret i et enkelt-arms åbent studie (EXPEDITION-8).
Subjects with Genotype 1, 2, 4, 5, or 6 Infection with Cirrhosis who received 8 weeks of Maviret The safety and efficacy of Maviret given for 8 weeks in GT 1, 2, 4, 5 or 6 treatment naïve subjects with compensated cirrhosis was evaluated in a single-arm, open-label study (EXPEDITION-8).
Polymorfismer i NS3 ved baseline blev detekteret hos 1,1 % af genotype 1patienterne (9/845), 0,8 % af genotype 2-patienterne (3/398), 1,6 % af genotype 3-patienterne (10/613), 1,2 % af genotype 4-patienterne (2/164), 41,9 % af genotype 5-patienterne (13/31) og 2,9 % af genotype 6-patienterne (1/34).
Baseline polymorphisms in NS3 were detected in 1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), and 2.9% (1/34) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Ældre Det er ikke nødvendigt at justere dosis hos ældre patienter (se pkt.
Elderly No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).
Tél/Tel: +32 10 477811
Belgique/Belgien Tél/Tel: +32 10 477811
Polymorfismer i NS5A ved baseline blev detekteret hos 26,8 % af genotype 1-patienterne (225/841), 79,8 % af genotype 2-patienterne (331/415), 22,1 % af genotype 3patienterne (136/615), 49,7 % af genotype 4-patienterne (80/161), 12,9 % af genotype 5-patienterne (4/31) og 54,1 % af genotype 6-patienterne (20/37).
Baseline polymorphisms in NS5A were detected in 26.8% (225/841), 79.8% (331/415), 22.1% (136/615), 49.7% (80/161), 12.9% (4/31), and 54.1% (20/37) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
SURVEYOR-2d Maviret i 12 uger (kun BN, n = 64) eller 16 uger (kun BE, n = 51)
Maviret for 12 weeks (TN only, n=64) or 16 weeks (TE only, n=51)
b. GT2 fra SURVEYOR-2 del 1 og 2 - Maviret i 8 uger (n = 54) eller 12 uger (n = 25); GT2 fra SURVEYOR-2 del 4 - Maviret i 8 uger (n = 145).
b. GT2 from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=54) or 12 weeks (n=25); GT2 from SURVEYOR-2 Part 4 - Maviret for 8 weeks (n=145).
Af de 101 behandlede personer var medianalderen 58 år (interval 32-87); 53% havde HCV genotype 1; 27% havde HCV genotype 2; 15% havde HCV genotype 3; 4% havde HCV genotype 4; 59% var mænd; 73% var hvide; 80% var HCV-behandlings-naive; 13% havde cirrose og 65% havde en baseline fibrose tilstand på F0 eller F1; 7% var CKD stadium 3b; 17% var CKD stadium 4, og 76% var CKD-stadium 5 (alle modtog dialyse); 84 forsøgspersoner modtog 8 ugers behandling, 13 forsøgspersoner modtog 12 ugers behandling, og 4 forsøgspersoner modtog 16 ugers behandling.
Of the 101 subjects treated, the median age was 58 years (range 32-87); 53% had HCV genotype 1; 27% had HCV genotype 2; 15% had HCV genotype 3; 4% had HCV genotype 4; 59% were male; 73% were White; 80% were HCV treatment-naïve; 13% had cirrhosis and 65% had a baseline fibrosis state of F0 or F1; 7% were CKD stage 3b; 17% were CKD Stage 4, and 76% were CKD Stage 5 (all receiving dialysis); 84 subjects received 8 weeks of treatment, 13 subjects received 12 weeks of treatment, and 4 subjects received 16 weeks of treatment.
↑ lovastatinsyre
↑ lovastatin acid
50 mg enkeltdosis
50 mg single dose
ENDURANCE-2 Maviret (n = 202) eller placebo (n = 100) i 12 uger SURVEYOR-2b Maviret i 8 uger (n = 199) eller 12 uger (n = 25)
ENDURANCE-2 Maviret (n=202) or Placebo (n=100) for 12 weeks SURVEYOR-2b
(Hæmning af OATP1B1/3, P-gp, BCRP)
(Inhibition of OATP1B1/3, P-gp, BCRP)
10 mg én gang dagligt
10 mg once daily
Lovastatin 10 mg én gang dagligt
Lovastatin 10 mg once daily
• Hvis der er gået 18 timer eller derover, siden du skulle have taget din dosis Maviret, skal du vente med at tage en dosis til det næste planlagte tidspunkt.
• If you notice 18 hours or more after the time you usually take Maviret, wait and take the next dose at your usual time.
Studier med NS3/4A-proteasehæmmer- og/eller NS5A-hæmmer-erfarne forsøgspersoner med eller uden kompenseret cirrose
Studies in subjects with or without compensated cirrhosis who were treatment-experienced to NS3/4A protease and/or NS5A inhibitors
Patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt.
Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2).
• Hovedpine
• headache
Bivirkninger som hovedpine (17%), træthed (16%), kvalme (8%) og kløe (7%) blev set hos 5% eller flere af patienterne, der fik Maviret i 12 uger.
Adverse reactions observed in greater than or equal to 5% of subjects receiving Maviret for 12 weeks were headache (17%), fatigue (16%), nausea (8%) and pruritus (7%).
IT
NA
d. GT3 med cirrose fra SURVEYOR-2 del 2 - Maviret i 12 uger (n = 24) eller 16 uger (n = 4); GT3 med cirrose fra SURVEYOR-2 del 3 - Maviret i 12 uger (n = 40) eller 16 uger (n = 47).
d. GT3 with cirrhosis from SURVEYOR-2 Part 2 - Maviret for 12 weeks (n=24) or 16 weeks (n=4); GT3 with cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=40) or 16 weeks (n=47).
100 mg enkeltdosis
100 mg single dose
Øget eksponering for tacrolimus forventes.
↔ glecaprevir ↔ pibrentasvir tacrolimus exposure is expected.
c. GT3 uden cirrose fra SURVEYOR-2 del 1 og 2 - Maviret i 8 uger (n = 29) eller 12 uger (n = 54); GT3 uden cirrose fra SURVEYOR-2 del 3 - Maviret i 12 uger (n = 22) eller 16 uger (n = 22).
c. GT3 without cirrhosis from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=29) or 12 weeks (n=54); GT3 without cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=22) or 16 weeks (n=22).
(Hæmning af OATP1B1/3, BCRP)
(Inhibition of OATP1B1/3, BCRP)
Ved opkastning mindre end 3 timer efter indtagelse af Maviret bør der straks tages en ekstra dosis.
If vomiting occurs within 3 hours of dosing, an additional dose of Maviret should be taken.
Brug af anden medicin sammen med Maviret
Other medicines and Maviret
Pravastatin 10 mg én gang dagligt
Pravastatin 10 mg once daily
(Hæmning af P-gp/BCRP)
(P-gp/BCRP inhibition)
Den anbefalede dosis er tre tabletter Maviret 100 mg/40 mg samtidigt én gang dagligt for voksne og unge (fra 12 til <18 år).
The recommended dose for adults and adolescents (12 to <18 years old) is three tablets of Maviret 100mg/40mg taken together, once a day.
Et almindeligt fund hos patienter, der oplevede behandlingssvigt ved fornyet behandling med glecaprevir/pibrentasvir i MAGELLAN-1, var akkumulerende dobbeltklasse-resistens.
Accumulating double class resistance was a general finding for patients who failed re-treatment with glecaprevir/pibrentasvir in MAGELLAN-1.
(GT3 kun BE) (n=3)
16 weeks (GT3 TE only) (n=3)
Maviret i 8 uger (n=75) SURVEYOR-1 Maviret i 12 uger (n = 32) SURVEYOR-2c Maviret i 8 uger (n = 58)
ENDURANCE-4 Maviret for 12 weeks (n=121) ENDURANCE-5,6 Maviret for 8 weeks (n=75) SURVEYOR-1 Maviret for 12 weeks (n=32) SURVEYOR-2c
Træthed
Relapsec
Diarré, kvalme
Hepatic impairment
SVR12 hos forsøgspersoner uden cirrose 8 uger Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidivc Andetd SVR12 hos forsøgspersoner med cirrose 12 uger 8 uger Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidivc Andetd a. Andelen af forsøgspersoner med PRS-erfaring er hhv. 26 %, 14 %, 24 %, 0 % og 13 % for genotype 1, 2, 4, 5 og 6.
VF=virologic failure a. Percent of subjects with prior treatment experience to PRS is 26%, 14%, 24%, 0%, and 13% for genotypes 1, 2, 4, 5, and 6, respectively.
Samtidig administration med en række andre lægemidler frarådes; se pkt.
Co-administration is not recommended with several medicinal products as detailed in section 4.5.
Virkningsmekanisme
Method of administration
• Usædvanlig træthed
• feeling very tired (fatigue)
EXPEDITION-2 Maviret i 8 uger (n=137) eller 12 uger (n=16)
Maviret for 8 weeks (n=199) or 12 weeks (n=25)
Administration
Transport
Efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat
Efavirenz/emtricitab ine/tenofovir disoproxil fumarate 600/200/300 mg once daily
INR anbefales for alle vitamin Kantagonister pga. leverfunktionsændringer under behandling med
Close monitoring of INR is recommended with all vitamin K antagonists.
Virkning og anvendelse 2.
What Maviret is and what it is used for 2.
ENDURANCE-4 Maviret i 12 uger (n = 121) ENDURANCE
ENDURANCE-5,6 Maviret for 12 weeks (n=9)
Filmovertræk:
Film coating
Udseende og pakningsstørrelser
What Maviret looks like and contents of the pack
For så vidt angår doseringsanbefalinger med HIVantivirale stoffer, se pkt.
For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Forsøgspersoner med HCV genotype 3
HCV Subtype
I visse tilfælde forekommer dette ikke.
However, in some cases this does not happen.
• Risikostyringsplan (RMP) Ikke relevant.
• Risk Management Plan (RMP) Not applicable.
Alle patienter kom sig med konventionel behandling.
All patients recovered with conventional treatment.
* se nedenfor
* see below
Dato for første tilladelse: 29. juli 2004 Dato for seneste fornyelse af tilladelsen: 29. juli 2009
Date of first authorisation: 29 July 2004 Date of renewal: 29 July 2009
Disse er angivet nedenfor:
These are detailed below:
Følgende oplysninger er tiltænkt læger og sundhedspersonale:
The following information is intended for medical or healthcare professionals only:
PK-PD relation
PK-PD relationship
Ikke relevant
Not relevant
Dette kan medføre hjerteproblemer hos Deres barn.
This can cause heart problems in your baby.
EXP Fra et mikrobiologisk synspunkt bør produktet anvendes med det samme.
EXP From a microbiological point of view, the product should be used immediately
Udløbsdatoen EXP er den sidste dag i den nævnte måned.
The expiry date refers to the last day of that month.
For at lette administrationen kan der anvendes en infusionspumpe.
To facilitate the administration an infusion pump may be used.
Denne indlægsseddel blev sidst godkendt den
This leaflet was last approved in
Det centrale fordelingsvolumen kan afhænge af status for ductus og falder, efterhånden som ductus lukker.
The central volume of distribution may depend on the status of the ductus and decrease as the ductus closes.
Det tilsyneladende fordelingsvolumen er gennemsnitligt 200 ml/kg (62 til 350 ifølge forskellige undersøgelser).
The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies).
Rapporterede bivirkninger er angivet nedenfor efter system organklasse og efter hyppighed.
Reported adverse reactions are listed below, by system organ class and by frequency.
Pedea bør ikke gives i løbet af de første 6 timer af livet.
- Pedea should not be given in the first 6 hours of life.
Med undtagelse af en undersøgelse af akut toksicitet er der ikke udført yderligere undersøgelser hos juvenile dyr med Pedea.
With the exception of an acute toxicity study, no further studies have been carried out in juvenile animals with Pedea.
Den første injektion bør gives efter de første 6 levetimer.
The first injection should be given after the first 6 hours of life.
In vivo og in vitro undersøgelser indikerer, at S(+) isomeren er ansvarlig for den kliniske aktivitet.
In vivo and in vitro studies indicate that the S(+) isomer is responsible for the clinical activity.
Det er imidlertid vanskeligt at adskille dem fra ofte forekommende komplikationer hos præmature børn og komplikationer grundet sygdommen.
However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Clearance af begge enantiomerer øges med gestationsalderen, i det mindste i intervallet fra 24 til 28 uger.
The clearance of both enantiomers increases with gestational age, at least in the range of 24 to 28 weeks.
Ibuprofen er en racemisk blanding af S(+) og R(-) enantiomerer.
Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers.
Hvis dette er signifikant, kan behandlingen af Deres barn blive stoppet, indtil urinmængden vender tilbage til normal.
If this is significant, your baby's treatment may be stopped until the volume of urine returns to normal.
Efter åbning bør Pedea anvendes med det samme.
After opening, Pedea should be administered immediately.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som Deres barn har.
It may harm them, even if their symptoms are the same as your baby's.
Der er ingen prækliniske data, der kan betragtes som relevante for klinisk sikkerhed udover de data, der er inkluderet i andre afsnit af dette produktresumé.
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics.