natgillin/translations-raw huggingface dataset:
Klinisk resistens Analyse af patienter med virologisk tilbagefald (bekræftet øgning af ≥ 1 log10 kopier/ ml HBV DNA fra nadir) i det pivotale studie( NV- 02B- 007) i uge 48 indikerede, at henholdsvis 5% (23/ 458) og 2% (5/ 222) af de HBeAg- positive og HBeAg- negative telbivudinbehandlede patienter havde virologisk tilbagefald med målbare HBV- resistensmutationer.
Clinical resistance Analysis of patients with virological rebound (confirmed increase of ≥ 1 log10 copies/ ml HBV DNA from nadir) in the pivotal study (NV-02B-007) at week 48 indicated that, among HBeAg-positive and HBeAg-negative patients, 5% (23/ 458) and 2% (5/ 222), of telbivudine recipients, respectively, had virological rebound with detectable HBV resistance mutations.
De kumulative hyppigheder af genotypisk bekræftet telbivudinresistens efter 104 uger var 25, 1% (115/ 458) for HBeAg- positive patienter og 10, 8% (24/ 222) for HBeAg- negative patienter.
The cumulative rates of genotypically confirmed telbivudine resistance by week 104 were 25.1% (115/ 458) for HBeAg-positive patients and 10.8% (24/ 222) for HBeAg-negative patients.
Genotypisk analyse af 203 vurderbare prøvepar med HBV DNA≥ 1000 kopier/ ml i uge 104 viste, at den primære mutation, som var forbundet med telbivudinresistens, var rtM204I ofte forbundet med mutationerne rtL180M og rtL801/ V og sjældent med mutationerne rtV27A, rtL82M, rtV173L, rtT184I og rtA200V.
Genotypic analysis of 203 evaluable sample pairs with HBV DNA ≥ 1,000 copies/ ml at week 104 demonstrated that the primary mutation associated with telbivudine resistance was rtM204I, often associated with mutations rtL180M and rtL80I/ V and infrequently with rtV27A, rtL82M, rtV173L, rtT184I and rtA200V.
Baseline faktorer, som var forbundet med udvikling af genotypisk lægemiddelresistens, inkluderede: lamivudinbehandling, højere baseline HBV DNA, lavere baseline serum ALT, og øget kropsvægt/ BMI.
Baseline factors associated with development of genotypic drug resistance included: lamivudine treatment, higher baseline HBV DNA, lower baseline serum ALT, and increased body weight/ BMI.
Parametre der, under behandling i uge 24, kunne forudsige udvikling af lægemiddelresistent virus efter 104 uger, var HBV DNA > 300 kopier/ ml og øgning af serum ALT.
On-treatment response parameters at week 24 that predicted emergence of drug resistant virus by week 104 were HBV DNA > 300 copies/ ml and elevation of serum ALT.
Hos patienter med viralt gennembrud efter 104 uger var resistens- raten lavere i patienter med HBV DNA < 300 kopier/ ml i uge 24, end i patienter med HBV DNA ≥ 300 kopier/ ml i uge 24.
When considering patients with viral breakthrough by 104 weeks, the rate of resistance was lower in patients with HBV DNA < 300 copies/ ml at week 24 than in patients with HBV DNA ≥ 300 copies/ ml at week 24.
I HbeAg - positive patienter med HBV DNA < 300 kopier/ ml i uge 24, var resitensen1% (3/ 203) ved 48 uger og 9% (18/ 203) i uge 104, mens hos patienter med HBV DNA ≥ 300 kopier/ ml var resistensen 8% (20/ 247) ved 48 uger og 39% (97/ 247) i uge 104.
In HBeAg positive patients with HBV DNA < 300 copies/ ml at week 24, resistance was 1% (3/ 203) at 48 weeks and 9% (18/ 203) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ ml resistance was 8% (20/ 247) at 48 weeks and 39% (97/ 247) at week 104.
Hos HbeAg- negative patienter med HBV DNA < 300 kopier/ ml i uge 24, var resistensen 0% (0/ 177) ved 48 uger og 5% (9/ 177) i uge 104, mens hos patienter med HBV DNA ≥ 300 kopier/ ml var resistensen 11% (5/ 44) ved 48 uger og 34% (15/ 44) i uge 104.
In HBeAg- negative patients with HBV DNA < 300 copies/ ml at week 24, resistance was 0% (0/ 177) at 48 weeks and 5% (9/ 177) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ ml resistance was 11% (5/ 44) at 48 weeks and 34% (15/ 44) at week 104.
Krydsresistens Der er set krydsresistens hos HBV- nukleosidanaloger.
Cross-resistance Cross-resistance has been observed among HBV nucleoside analogues (see section 4.4).
Ved cellebaserede analyser havde lamivudinresistente HBV- stammer med enten rtM204I- mutationen eller rtL180M/ rtM204V - dobbeltmutationen ≥ 1. 000 gange mindre følsomhed for telbivudin.
In cell-based assays, lamivudine-resistant HBV strains containing either the rtM204I mutation or the rtL180M/ rtM204V double mutation had ≥ 1,000-fold reduced susceptibility to telbivudine.
4. 4).
HBV encoding the adefovir resistance-associated substitutions rtN236T or rtA181V had 0.5- and 3.7-fold change in susceptibility to telbivudine in cell culture, respectively (see section 4.4).
Farmakokinetikken for enkeltdosis - og flerdosis telbivudin blev vurderet på raske forsøgspersoner og patienter med kronisk hepatitis B.
The single- and multiple-dose pharmacokinetics of telbivudine were evaluated in healthy subjects and in patients with chronic hepatitis B.
Telbivudins farmakokinetik blev ikke evalueret med den anbefalede dosis på 600 mg i patienter med kronisk hepatitis B.
The pharmacokinetics of telbivudine were not evaluated with the recommended dose of 600 mg in patients with chronic hepatitis B.
Telbivudins farmakokinetik er dog den samme hos begge populationer.
However telbivudine pharmacokinetics are similar between both populations.
Koncentrationen forekom gennemsnitligt 3, 0 timer efter dosis.
12 Absorption Following oral administration of a 600 mg single dose of telbivudine to healthy subjects (n = 42), the peak plasma concentration (Cmax) of telbivudine was 3.2 ± 1.1 μ g/ ml (mean ± SD) and occurred at median 3.0 hours post dose.
Telbivudinarealet under plasmakoncentration/ tid- kurven (AUC0- ∞) var 28, 0 ± 8, 5 μg t/ ml (middel ± SD).
The telbivudine area under the plasma concentration-time curve (AUC0-∞) was 28.0 ± 8.5 μ g h/ ml (mean ± SD).
30%.
Inter-subject variability (CV%) for measures of systemic exposures (Cmax, AUC) was typically approximately 30%.
Virkning af mad på oral absorption Telbivudinabsorption og - eksponering blev ikke påvirket, når en enkeltdosis på 600 mg blev indgivet sammen med mad.
Effect of food on oral absorption Telbivudine absorption and exposure were unaffected when a single 600 mg dose was administered with food.
Fordeling In vitro- bindingen af telbivudin til humane plasmaproteiner er lav (3, 3%).
Distribution In vitro binding of telbivudine to human plasma proteins is low (3.3%).
Biotransformation Der blev ikke detekteret metabolitter af telbivudin efter administration af 14C- telbivudin til mennesker.
Biotransformation No metabolites of telbivudine were detected following administration of 14C-telbivudine in humans.
Telbivudin er ikke et substrat, en hæmmer eller inducer af det cytokrome P450 (CYP450) - enzymsystem.
Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system.
Elimination Efter at have nået maksimal koncentration aftog eliminationen af telbivudin fra plasma bieksponentielt med en terminal eliminationshalveringstid (t1/ 2) på 41, 8 ± 11, 8 timer.
Elimination After reaching peak concentration, plasma disposition of telbivudine declined in an bi-exponential manner with a terminal elimination half-life (t1/ 2) of 41.8 ± 11.8 hours.
42% af dosis genfindes i urinen over 7 dage efter en oral enkeltdosis på 600 mg telbivudin.
Approximately 42% of the dose is recovered in the urine over 7 days following a single 600 mg oral dose of telbivudine.
4. 2).
As renal excretion is the predominant route of elimination, patients with moderate to severe renal dysfunction and those undergoing haemodialysis require a dose interval adjustment (see section 4.2).
Linearitet/ non- linearitet Telbivudins farmakokinetik er dosisproportional gennem området 25 til 1. 800 mg.
Linearity / non-linearity Telbivudine pharmacokinetics are dose proportional over the range of 25 to 1,800 mg.
Steady- state blev opnået efter 5- 7 dage efter administration 1 gang dagligt med en omtrentlig 1, 5 gange stor akkumulation ved systemisk eksponering, hvilket tyder på en effektiv akkumulationshalveringstid på ca.
Steady state was achieved after 5 to 7 days of once-daily administration with an approximate 1.5-fold accumulation in systemic exposure, suggesting an effective accumulation half-life of approximately 15 hours.
0, 2- 0, 3 µg/ ml.
Following once-daily administration of telbivudine 600 mg, steady-state trough plasma concentrations were approximately 0.2-0.3 μ g/ ml.
Specielle populationer Køn Der er ingen signifikante kønsrelaterede forskelle i telbivudins farmakokinetik.
Special populations Gender There are no significant gender-related differences in telbivudine pharmacokinetics.
Pædiatriske og geriatriske patienter Der er ikke udført farmakokinetiske undersøgelser med pædiatriske eller ældre forsøgspersoner.
Paediatrics and geriatrics Pharmacokinetic studies have not been conducted in paediatric or elderly subjects.
Nedsat nyrefunktion Telbivudins enkeltdosisfarmakokinetik (200, 400 og 600 mg) er blevet vurderet hos patienter (uden kronisk hepatitis B) med forskellige grader af nedsat nyrefunktion (målt ved kreatininclearance).
Renal impairment The single-dose pharmacokinetics of telbivudine (200, 400 and 600 mg) have been evaluated in patients (without chronic hepatitis B) with various degrees of renal impairment (as assessed by creatinine clearance).
4. 2 og 4. 4).
Based on the results shown in Table 8, adjustment of the dose interval for telbivudine is recommended in patients with creatinine clearance of < 50 ml/ min (see sections 4.2 and 4.4).
13 Tabel 8
13 Table 8
Farmakokinetiske parametre (middel ± SD) for telbivudin hos forsøgspersoner med forskellige grader af nyrefunktion
Pharmacokinetic parameters (mean ± SD) of telbivudine in subjects with various degrees of renal function
Nyrefunktion (kreatininclearance i ml/ min)
Renal function (creatinine clearance in ml/ min)
Normal Mild (50- 80) Moderat Svær (< 30)
Normal Mild (50-80) Moderate Severe (< 30)
(n = 8)
(n = 8)
(30- 49)
(30-49)
Cmax (µg/ ml)
Cmax (μ g/ ml)
AUC0- ∞ (μg• t/ ml)
AUC0-∞ (μ g• h/ ml)
23%.
Renally impaired patients on haemodialysis Haemodialysis (up to 4 hours) reduces systemic telbivudine exposure by approximately 23%.
Efter justering af dosisinterval iht. kreatininclearance er yderligere dosismodifikation ikke nødvendig under rutinemæssig hæmodialyse (se pkt.
Following dose interval adjustment for creatinine clearance, no additional dose modification is necessary during routine haemodialysis (see section 4.2).
Nedsat leverfunktion Telbivudins farmakokinetik efter en enkelt dosis på 600 mg er blevet undersøgt hos patienter (uden kronisk hepatitis B) med forskellige grader af nedsat leverfunktion.
Hepatic impairment The pharmacokinetics of telbivudine following a single 600 mg dose have been studied in patients (without chronic hepatitis B) with various degrees of hepatic impairment.
Telbivudins farmakokinetik var den samme for forsøgspersoner med nedsat leverfunktion og personer uden nedsat leverfunktion.
There were no changes in telbivudine pharmacokinetics in hepatically impaired subjects compared to unimpaired subjects.
4. 2).
Results of these studies indicate that no dosage adjustment is necessary for patients with hepatic impairment (see section 4.2).
Tabletkerne Cellulose, mikrokrystallinsk Povidon Natriumstivelsesglycolat Silica, kolloid vandfri Magnesiumstearat
Tablet core Cellulose microcrystalline Povidone Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate
Filmovertræk Titandioxid (E171) Macrogol Talcum Hypromellose
Tablet film coat Titanium dioxide (E171) Macrogol Talc Hypromellose
PVC/ PVDC- blister
PVC/ aluminium blisters
28 eller 98 filmovertrukne tabletter
28 or 98 film-coated tablets
Sebivo 20 mg/ ml oral opløsning
Sebivo 20 mg/ ml oral solution
47 mg natrium.
A 600 mg dose (30 ml) of oral solution contains approximately 47 mg sodium.
Voksne Den anbefalede dosis Sebivo er 30 ml, svarende til 600 mg, 1 gang dagligt, taget oralt med eller uden mad.
Adults The recommended dose of Sebivo is 30 ml, providing a dose equivalent to 600 mg, once daily, taken orally, with or without food.
16 Nedsat nyrefunktion Justering af den anbefalede dosis af telbivudin er ikke nødvendig hos patienter, hvis kreatininclearance er ≥ 50 ml/ min.
16 Renal impairment No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is ≥ 50 ml/ min.
Hos patienter med kompenseret leversygdom ledsages denne forhøjelse af serum- ALT i reglen ikke af
In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
Hepatitiseksacerbationer er også beskrevet hos patienter, som har afsluttet behandling af hepatitis B.
17 Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B.
3% af de inkluderede patienter havde cirrose), skal telbivudin anvendes med særlig forsigtighed hos patienter med cirrose.
18 Patients with cirrhosis without decompensation Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
47 mg natrium per 600 mg dosis (30 ml), hvilket der skal tages hensyn til hos patienter på kontrolleret natrium diæt.
Sebivo oral solution contains approximately 47 mg sodium per 600 mg dose (30 ml), which should be taken into consideration by patients on a controlled sodium diet.
Telbivudins farmakokinetik ved steady- state var uændret efter multidosisadministration i kombination
The combination of telbivudine with these medicinal products should be used with caution.
19 med lamivudin, adefovir, dipivoxil, tenofovirdisoproxilfumarat, ciclosporin eller pegyleret interferon alfa- 2a.
The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, 19 ciclosporin or pegylated interferon-alfa 2a.
Der kunne ikke drages nogen definitiv konklusion vedrørende telbivudins virkninger på det pegylerede interferons farmakokinetik på grund af høj interindividuel koncentrationsvariabilitet for pegyleret interferon alfa- 2a.
No definitive conclusion could be drawn regarding the effects of telbivudine on the pharmacokinetics of pegylated interferon due to high interindividual variability of pegylated interferon alfa 2a concentrations.
20 Tabel 2
20 Table 2
Kliniske bivirkninger hos patienter med kronisk hepatitis B, behandlet med telbivudin 600 mg i de samlede 104 ugers studier NV- 02B- 007 (GLOBE) og NV- 02B - 015 *
Clinical adverse reactions in patients with chronic hepatitis B, treated with telbivudine 600 mg in the pooled 104-week NV-02B-007 (GLOBE) and NV-02B-015 studies *
4. 4).
21 Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti- hepatitis B therapy including telbivudine (see section 4.4).
Hæmmere af nukleosid - og nukleotid- revers- transkiptase, ATC - kode:
Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code:
Den antivirale aktivitet af telbivudin in vitro blev vurderet i den HBV- eksprimerende humane hepatoma- cellelinje 2. 2. 15.
The in vitro antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15.
I studiet indgik 1. 367 nukleosidnaive HBeAg- positive og HBeAg- negative patienter med kronisk hepatitis B.
22 NV-02B-007 GLOBE study The NV-02B-007 GLOBE study is a randomised, double-blind, multinational phase III study of telbivudine compared to lamivudine for a treatment period of 104 weeks in 1,367 nucleoside-naïve chronic hepatitis B HBeAg-positive and HBeAg-negative patients.
23 Tabel 5
23 Table 5
HBeAg- positiv (n = 921) Telbivudin Lamivudin 600 mg 100 mg (n = 384) 1 (n = 386) 1 respons2
HBeAg-positive (n = 921) HBeAg-negative (n = 446) Telbivudine Lamivudine Telbivudine Lamivudine 600 mg 100 mg 600 mg 100 mg (n = 384)1 (n = 386)1 (n = 199)1 (n = 207)1
HBeAg- negativ (n = 446) Telbivudin Lamivudin 600 mg 100 mg (n = 199) 1 (n = 207) 1
Histological response2
24 Kliniske resultater ved uge 104 Der blev demonstreret varig effekt hos patienter i fortsat telbivudinbehandling, idet kliniske resultater, i uge 104 hos patienter behandlet med telbivudin, var i overensstemmelse med dem, der blev observeret efter 52 uger
24 Clinical results at week 104 Overall, clinical results at week 104 in telbivudine-treated patients were consistent with those at week 52, demonstrating durability of efficacy responses for telbivudine-treated patients with continued treatment.
25 NV- 02B- 015 studiet Resultaterne af effekt og sikkerhed fra 007 GLOBE studiet blev bekræftet i NV- 02B- 015 studiet.
25 Study NV-02B-015 The efficacy and safety results of the 007 GLOBE study were confirmed in study NV-02B-015.
Koncentrationen forekom gennemsnitligt 3, 0 timer efter dosis.
26 Absorption Following oral administration of a 600 mg single dose of telbivudine to healthy subjects (n = 42), the peak plasma concentration (Cmax) of telbivudine was 3.2 ± 1.1 μ g/ ml (mean ± SD) and occurred at median 3.0 hours post dose.
Filmovertrukne tabletter indeholdende 600 mg telbivudin er bioækvivalent med 30 ml telbivudin oral opløsning (20 mg/ ml).
Film-coated tablets containing 600 mg telbivudine are bioequivalent to 30 ml telbivudine oral solution (20 mg/ ml).
27 Tabel 8
27 Table 8
Benzoesyre Saccharinnatrium Passionsfrugtsmagstof Natriumhydroxid Citronsyre, vandfri Vand, renset
Benzoic acid Sodium saccharin Passion fruit flavouring Sodium hydroxide Citric acid anhydrous Water, purified
28 6. 4 Særlige opbevaringsforhold
28 6.3 Shelf life
300 ml brun glasflaske med børnesikret låg, inklusiv en polyethylen forseglingsskive og en sikkerhedsring samt en polypropylen doseringskop præget med målestreger fra 5 til 30 ml med inddelinger på 5 ml.
300 ml brown glass bottle with a child-resistant closure, including a polyethylene sealing disc and a guarantee ring and a polypropylene dosing cup with embossed graduations of 5 to 30 ml in 5 ml increments.
EU/ 1/ 07/ 388 / …
EU/ 1/ 07/ 388/…
26, rue de la Chapelle F- 68330 Huningue Frankrig
26, rue de la Chapelle F-68330 Huningue France
August 2008) præsenteret i Modul 1. 8. 2. af ansøgningen om markedsføringstilladelse, er på plads og fungerer, før og mens produktet er på markedet
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 (19 August 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og yderligere pharmacovigilanceaktiviteter beskrevet i pharmacovigilanceplanen, som aftalt i version 2 (12. februar 2008) af Risk Management Planen (RMP) præsenteret i Modul 1. 8. 2. af ansøgningen om markedsføringstilladelsen og efterfølgende opdateringer til RMPen aftalt med CHMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 (12 February 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMP- Guidelinen om risk management- systemer for humane lægemidler skal den opdaterede RMP indsendes samtidig med den næste sikkerhedsopdatering (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Derudover skal en opdateret RMP indsendes • når ny information, der kan have indflydelse på den nuværende sikkerhedsspecifikation, pharmacovigilanceplan eller risikominimeringsaktiviteter, bliver tilgængelig • inden for 60 dage efter en vigtig (pharmacovigilance eller risikominimering) milepæl er nået • på opfordring fra EMEA
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
36 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Sebivo 20 mg/ ml oral opløsning Telbivudin
Sebivo 20 mg/ ml oral solution Telbivudine
1 flaske indeholdende 300 ml oral opløsning 1 kop
1 bottle containing 300 ml oral solution 1 cup
Sebivo 20 mg/ ml [kun karton]
Sebivo 20 mg/ ml [folding box only]
Sebivo 600 mg filmovertrukne tabletter Telbivudin
Sebivo 600 mg film-coated tablets Telbivudine
- Lægen har ordineret Sebivo til dig personligt.
- This medicine has been prescribed for you.
Virkning og anvendelse 2.
What Sebivo is and what it is used for 2.
Det skal du vide, før du begynder at tage Sebivo 3.
Before you take Sebivo 3.
Sådan skal du tage Sebivo 4.
How to take Sebivo 4.
Opbevaring 6.
How to store Sebivo 6.
VIRKNING OG ANVENDELSE
WHAT SEBIVO IS AND WHAT IT IS USED FOR
Hepatitis B forårsages af infektion med hepatitis B- virus, som mangedobles i leveren og forårsager leverskade.
Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage.
Det resulterer i mindre leverskade og forbedret leverfunktion.
Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE SEBIVO
BEFORE YOU TAKE SEBIVO
Tag ikke Sebivo
Do not take Sebivo
- hvis du er overfølsom (allergisk) over for telbivudin eller et af de øvrige indholdsstoffer (se
- if you are allergic (hypersensitive) to telbivudine or any of the other ingredients of Sebivo
6).
(listed in section 6).
Hvis du mener, du er allergisk, skal du spørge lægen til råds.
If you think you may be allergic, ask your doctor for advice.
Vær ekstra forsigtig med at tage Sebivo
Take special care with Sebivo
- hvis du har eller har haft nyreproblemer.
- if you have or have had any kidney problems.
Din læge vil muligvis bestille laboratorietests for at
Your doctor may order laboratory tests to check
kontrollere din nyrefunktion før og under behandlingen.
your kidneys are working properly before and during treatment.
Resultatet af disse tests er afgørende for, hvor tit du skal tage Sebivo – derfor vil din læge måske råde dig til at ændre det.
Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.
- hvis du lider af levercirrose (en alvorlig lidelse, der forårsager ” ardannelse ” på leveren).
- if you suffer from cirrhosis of the liver (a serious condition which causes liver “ scarring”).
I så
In
fald vil lægen gerne føre særlig tæt kontrol med din tilstand.
this case your doctor will want to monitor you more closely.
- hvis du tager medicin, som kan give muskelproblemer (snak med lægen eller apoteket, hvis der
- if you are taking any medicines that may cause muscle problems (talk to your doctor or
er noget, du er i tvivl om).
pharmacist if you are unsure).
- hvis du er inficeret med HIV, hepatitis C eller D eller hvis du er blevet behandlet med medicin
- if you are infected with HIV, hepatitis C or D, or are being treated with any antiviral medicines.
til behandling af infektioner, der skyldes virus (antiviral medicin).
If any of these applies to you, tell your doctor before you take Sebivo.
40 Hvis noget at dette gælder for dig, skal du fortælle din læge det, før du tager Sebivo.
40
I
- Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy).
sjældne tilfælde kan Sebivo forårsage følelsesløshed, prikken, smerte og/ eller brændende fornemmelser i armene og/ eller benene (perifer neuropati) Kontakt straks din læge, hvis du oplever nogen af disse symptomer.
If you experience any of these symptoms, call your doctor immediately.