natgillin/translations-raw huggingface dataset:
1 kanyle + 2 renseservietter
1 pen + 1 injection needle + 2 cleansing swabs
EU/ 1/ 00/ 131/ 032 PegIntron
EU/ 1/ 00/ 131/ 032
Pulver og solvens til injektionsvæske, opløsning i injektionspen
Powder and solvent for solution for injection
Pulver og solvens: tokammerampul (glas) i en injektionspen
pre-filled pen (cartridge, glass) Solvent: ampoule (glass)
50 µg (50 µg/ 0
0.5 ml (50 µg/ 0.5 ml)
4 penne + 4 kanyler + 8 renseservietter
4 pens + 4 injection needles + 8 cleansing swabs
Subkutan Pulver og solvens:
Subcutaneous use
injektionsvæske, opløsning i injektionspen
pre-filled pen (cartridge, glass) Solvent: ampoule (glass)
tokammerampul (glas) i en injektionspen
0.5 ml (50 µg/ 0.5 ml)
6 kanyler + 12 renseservietter
6 pens + 6 injection needles + 12 cleansing swabs
EU/ 1/ 00/ 131/ 034 PegIntron
EU/ 1/ 00/ 131/ 034
12 penne + 12 kanyler + 24 renseservietter
12 pens + 12 injection needles + 24 cleansing swabs
EU/ 1/ 00/ 131/ 035 PegIntron
EU/ 1/ 00/ 131/ 035
80 µg (80 µg/ 0, 5 ml)
0.5 ml (80 µg/ 0.5 ml)
1 pen + 1 kanyle + 2 renseservietter
1 pen + 1 injection needle + 2 cleansing swabs
EU/ 1/ 00/ 131/ 036 PegIntron
EU/ 1/ 00/ 131/ 036
EU/ 1/ 00/ 131/ 037 PegIntron
EU/ 1/ 00/ 131/ 037
6 penne + 6 kanyler + 12 renseservietter
6 pens + 6 injection needles + 12 cleansing swabs
EU/ 1/ 00/ 131/ 038 PegIntron
EU/ 1/ 00/ 131/ 038
EU/ 1/ 00/ 131/ 039 PegIntron
EU/ 1/ 00/ 131/ 039
100 µg (100 µg/ 0, 5 ml)
0.5 ml (100 µg/ 0.5 ml)
EU/ 1/ 00/ 131/ 040 PegIntron
EU/ 1/ 00/ 131/ 040
EU/ 1/ 00/ 131/ 041 PegIntron
EU/ 1/ 00/ 131/ 041
EU/ 1/ 00/ 131/ 042 PegIntron
EU/ 1/ 00/ 131/ 042
EU/ 1/ 00/ 131/ 043 PegIntron
EU/ 1/ 00/ 131/ 043
120 µg (120 µg/ 0, 5 ml)
0.5 ml (120 µg/ 0.5 ml)
EU/ 1/ 00/ 131/ 044 PegIntron
EU/ 1/ 00/ 131/ 044
EU/ 1/ 00/ 131/ 045 PegIntron
EU/ 1/ 00/ 131/ 045
EU/ 1/ 00/ 131/ 046 PegIntron
EU/ 1/ 00/ 131/ 046
EU/ 1/ 00/ 131/ 047 PegIntron
EU/ 1/ 00/ 131/ 047
150 µg (150 µg/ 0, 5 ml)
0.5 ml (150 µg/ 0.5 ml)
EU/ 1/ 00/ 131/ 048 PegIntron
EU/ 1/ 00/ 131/ 048
EU/ 1/ 00/ 131/ 049 PegIntron
EU/ 1/ 00/ 131/ 049
EU/ 1/ 00/ 131/ 050 PegIntron
EU/ 1/ 00/ 131/ 050
i Injektionssæt = injektionssprøjte + 2 kanyler + renseserviet.
1 Injection set = injection syringe + 2 injection needles + cleansing swab.
5/ 5
6/ 6
Hvert hætteglas PegIntron, pulver til injektionsvæske, opløsning, indeholder 50 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of PegIntron, powder for solution for injection contains 50 micrograms of peginterferon alfa-2b as measured on a protein basis.
Hvert hætteglas giver 50 mikrogram/ 0, 5 ml peginterferon alfa- 2b efter tilberedning som anbefalet.
Each vial provides 50 micrograms/ 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Det aktive stof er en covalent konjugering af rekombinant interferon alfa- 2b * med monomethoxypolyethylenglycol.
The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Potensen af dette lægemiddel bør ikke sammenlignes med et andet pegyleret eller ikke- pegyleret protein i samme terapeutiske gruppe.
The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class.
5. 1. * produceret ved hjælp af rDNA teknologi i E. coli celler indeholdende et genetisk fremstillet plasmahybrid med et interferon alfa- 2b gen fra humane leukocytter
For more information, see section 5.1. *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes
PegIntron indeholder 40 mg sucrose per 0, 5 ml.
PegIntron contains 40 mg of sucrose per 0.5 ml.
Pulver og solvens til injektionsvæske, opløsning Hvidt pulver.
Powder and solvent for solution for injection White powder.
4. 4).
PegIntron is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection (see section 4.4).
Den bedste måde at anvende PegIntron ved denne indikation er i kombination med ribavirin.
The best way to use PegIntron in this indication is in combination with ribavirin.
5. 1).
This combination is indicated in naïve patients including patients with clinically stable HIV co- infection and in patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Interferon monoterapi, inklusive PegIntron, er hovedsageligt indiceret i tilfælde af intolerance eller kontraindikation over for ribavirin.
Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.
Se venligst også produktresume (SPC) for ribavirin, når PegIntron skal anvendes i kombination med ribavirin.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when PegIntron is to be used in combination with ribavirin.
Dosis, der skal indgives PegIntron bør indgives som en ugentlig subkutan injektion.
Dose to be administered PegIntron should be administered as a once weekly subcutaneous injection.
Den indgivne dosis afhænger af, om den anvendes i kombination med ribavirin eller som monoterapi.
The dose administered depends on whether it is used in combination with ribavirin or as monotherapy.
2 Kombinationsbehandling PegIntron 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
2 Combination therapy PegIntron 1.5 micrograms/ kg/ week in combination with ribavirin capsules.
Den foreskrevne dosis PegIntron 1, 5 μg/ kg til anvendelse i kombination med ribavirin kan indgives ifølge kategorier efter patientens vægt og styrken af pen/ hætteglas, som anført i Tabel 1.
The intended dose of 1.5 μ g/ kg of PegIntron to be used in combination with ribavirin may be delivered in weight categories with the pen/ vial strengths according to Table 1.
Tabel 1 - Dosering ved kombinationsbehandling
Table 1 - Dosing for Combination Therapy
Ribavirin kapsler
Ribavirin Capsules
Styrke af
Vial/ Pen Strength
Indgives en
Administer
Total daglig
Total Daily
Antal kapsler
Number of
hætteglas/ pen (μg/ 0, 5ml)
(μ g/ 0.5ml)
gang om ugen (ml)
Once Weekly (ml)
dose (mg)
Dose (mg)
(200 mg)
Capsules (200 mg)
2 morgen, 2 aften b:
2 morning, 2 evening b:
2 morgen, 3 aften c:
2 morning, 3 evening c:
3 morgen, 3 aften d:
3 morning, 3 evening d:
3 morgen, 4 aften
3 morning, 4 evening
1. 000 1. 000 1. 200 1. 400
1,000 1,000 1,200 1,400
Behandlingsvarighed - Naive patienter Forudsigelighed for vedvarende virologisk respons:
Duration of treatment – Naïve patients Predictability of sustained virological response:
5. 1). • Genotype 1:
Patients infected with virus genotype 1 who fail to achieve virological response at Week 12 are highly unlikely to become sustained virological responders (see also section 5.1). • Genotype 1:
For patienter, som udviser virologisk respons ved uge 12, bør behandling fortsættes i en yderligere ni måneders periode (det vil sige i alt 48 uger).
For patients who exhibit virological response at week 12, treatment should be continued for another nine month period (i. e., a total of 48 weeks).
I undergruppen af patienter med genotype 1 og lav virusmængde (< 600. 000 IU/ ml) som bliver HCV- RNA negative ved behandlingsuge 4 og som stadig er HCV- RNA negative ved uge 24, kan behandlingen enten stoppe efter denne 24 ugers behandlingsperiode eller blive videreført i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i. e. overall 48 weeks treatment duration).
Imidlertid kan en samlet 24 ugers behandlingsperiode være forbundet med større risiko for relaps frem for en 48 ugers behandlingsperiode (se afsnit 5. 1). • Genotype 2 eller 3:
However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1). • Genotypes 2 or 3:
Det anbefales, at alle patienter behandles i 24 uger, undtaget er HCV/ HIV co- inficerede patienter, der bør modtage 48 ugers behandling. • Genotype 4:
It is recommended that all patients be treated for 24 weeks, except for HCV/ HIV co-infected patients who should receive 48 weeks of treatment. • Genotype 4:
Patienter inficeret med genotype 4 betragtes generelt som sværere at behandle, og begrænsede undersøgelsesresultater (n=66) tyder på, at de er forenelige med en behandlingsvarighed som for genotype 1.
In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment as for genotype 1.
Samtidig infektion med HCV/ HIV Den anbefalede doseringsvarighed af HCV/ HIV co- inficerede patienter er 48 uger uanset genotype.
HCV/ HIV Co-infection The recommended duration of dosing for HCV/ HIV co-infected patients is 48 weeks, regardless of genotype.
Forudsigelighed af respons og non- respons ved HCV/ HIV co- infektion Tidlig virologisk respons i Uge 12, defineret som et 2 log viralt fald i load eller ikke- detekterbare niveauer af HCV- RNA, har vist sig at være forudsigeligt for et vedvarende respons.
Predictability of response and non-response in HCV/ HIV Co-infection Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
En positiv
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with PegIntron in combination with ribavirin was 99% (67/ 68; Study 1) (see section 5.1).
3 forudsigelig værdi på 50% (52/ 104; Undersøgelse 1) blev observeret for HCV/ HIV co- inficerede patienter, der modtog kombinationsbehandling.
A positive predictive value of 50% (52/ 104; Study 1) was observed for HCV/ HIV co-infected patients receiving combination therapy.
Behandlingsvarighed – Genbehandling Forudsigelighed af vedvarende virologisk respons:
3 Duration of treatment - Retreatment Predictability of sustained virological response:
Alle patienter, uanset genotype, der har vist serum HCV- RNA under de målbare grænser i Uge 12, bør modtage 48 ugers behandling.
All patients, irrespective of genotype, who have demonstrated serum HCV-RNA below the limits of detection at Week 12 should receive 48 weeks of therapy.
Det er ikke sandsynligt, at genbehandlede patienter, hvor det er mislykket at opnå virologisk respons i Uge 12, vil have vedvarende virologiske reaktioner efter 48 ugers behandling (se også pkt.
Retreated patients who fail to achieve virological response at Week 12 are unlikely to become sustained virological responders after 48 weeks of therapy (see also section 5.1).
Genbehandling af mere end 48 ugers varighed for ikke- responderende patienter med genotype 1 er ikke blevet undersøgt med kombinationsbehandling med pegyleret interferon alfa- 2b og ribavirin.
Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
PegIntron monoterapi Ved monoterapi er PegIntron regimen 0, 5 eller 1, 0 mikrogram/ kg/ uge.
PegIntron monotherapy As monotherapy the PegIntron regimen is 0.5 or 1.0 microgram/ kg/ week.
Doser til patienter, der foreskrives 0, 5 μg/ kg/ uge, skal således justeres ved volumen, som vist i Tabel 2.
The lowest vial or pen strength available is 50 μ g/ 0.5 ml; therefore for patients prescribed 0.5 μ g/ kg/ week, doses must be adjusted by volume as shown in Table 2.
For dosen 1, 0 μg/ kg kan der foretages en tilsvarende justering af volumen, eller der kan anvendes hætteglas med andre styrker, som vist i Tabel 2.
For the 1.0 μ g/ kg dose, similar volume adjustments can be made or alternate vial strengths can be used as shown in Table 2.
PegIntron monoterapi blev ikke undersøgt i HCV/ HIV co- inficerede patienter.
PegIntron monotherapy was not studied in HCV/ HIV co-infected patients.
Tabel 2 - Monoterapi dosering
Table 2- Monotherapy Dosing
Indgives en gang Styrke af
Administer Vial/ Pen Once Weekly Strength
Indgives en gang
Administer Once Weekly
om ugen hætteglas/ pen (ml) (μg/ 0, 5ml)
(ml) (μ g/ 0.5ml)
om ugen (ml)
(ml)
Mindste indgift med pen er 0, 3 ml. ** Ved patienter > 120 kg anvendes hætteglas med 80 μg/ 0, 5 ml.
Minimum delivery for pen is 0.3 ml. ** For patients > 120 kg, use 80 μ g/ 0.5 ml vial
Behandlingsvarighed Hos patienter, som udviser virologisk respons ved uge 12, bør behandlingen fortsættes i en periode på mindst tre måneder mere (svarende til totalt seks måneder).
Duration of treatment For patients who exhibit virological response at Week 12, treatment should be continued for at least another three-month period (i. e., a total of six months).
Beslutningen om at forlænge behandlingen til et års behandling bør træffes på grundlag af andre prognostiske faktorer (såsom alder > 40 år, hankøn, bridging fibrose).
The decision to extend therapy to one year of treatment should be based on prognostic factors (e. g., genotype, age > 40 years, male gender, bridging fibrosis).
Dosisjustering for alle patienter Hvis der udvikles alvorlige bivirkninger eller unormale laboratorieværdier under behandling med PegIntron monoterapi eller PegIntron i kombination med ribavirin, justeres doserne af hvert lægemiddel efter behov, indtil bivirkningerne aftager.
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during treatment with PegIntron monotherapy or PegIntron in combination with ribavirin, modify the dosages of each product as appropriate, until the adverse reactions abate.
Da efterlevelse kan være vigtig for udfaldet af behandlingen, bør dosis være så tæt på den anbefalede standard dosis som muligt.
As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
4 Kombinationsbehandling - vejledninger for dosisreduktion
4 Combination Therapy Dose Reduction Guidelines
Tabel 2a Dosisjusteringsvejledninger for kombinationsbehandling (med ribavirin)
Table 2a Dose modification guidelines for combination therapy (with ribavirin)
Reducer kun
Reduce only
Reducer kun PegIntron
Reduce only PegIntron
Kombinations -
Discontinue
600 mg/ dag *
ribavirin dose to 600 mg/ day* if:
hvis: hvis:
dose to one-half dose if:
behandling, hvis:
combination therapy if:
Hæmoglobin Hæmoglobin hos
Haemoglobin Haemoglobin in:
patienter med tidligere stabil hjertesygdom Hvide blodlegemer Neutrofile
Patients with history of stable cardiac disease White blood cells Neutrophils
≥ 2 g/ dl fald i hæmoglobin under en hvilken som helst 4 ugers periode under behandling (permanent dosisreduktion) - < 1, 5 x 109/ l - < 0, 75 x 109/ l 9
≥ 2
< 4
<
12 g/ dl efter ugers dosis - reduktion < 1, 0 x 109/ l < 0, 5 x 109/ l
12 g/ dl after four weeks of dose reduction < 1.0 x 109/ l < 0.5 x 109/ l
Blodplader Bilirubin – direkte Bilirubin - indirekte
Platelets Bilirubin – direct Bilirubin - indirect
< 25 x 109/ l 2, 5 x ULN ** > 4 mg/ dl (i > 4 uger)
< 25 x 109/l 2.5 x ULN** > 4 mg/ dl (for > 4 weeks)
- -
*
ALT/ AST
Creatinine ALT/ AST
- -
- - - -
x baseline og
> 2.0 mg/ dl 2 x baseline and > 10 x ULN**
> 10 x ULN ** * Patienter, hvis dosis af ribavirin er reduceret til 600 mg daglig får en 200 mg kapsel om morgenen og to 200 mg kapsler om aftenen. ** Øvre grænse for normalområdet
Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening. ** Upper limit of normal
Dosisreduktion af PegIntron kan ske ved enten at reducere det foreskrevne volumen med halvdelen eller ved at bruge en lavere styrke, som anført i Tabel 2b.
Dose reduction of PegIntron may be accomplished by either reducing the prescribed volume by one- half or by utilizing a lower dose strength as shown in Table 2b.
Tabel 2b – Reduceret PegIntron dosering ved kombinationsbehandling
Table 2b – Reduced PegIntron Dosing for Combination Therapy
Vægt (kg)
Body Weight
Mål for den
Target Reduced
Styrke af
Vial/ Pen
Indgives en gang
Administer
Indgiven
Amount
reducerede dosis (μg)
Dose (μ g)
hætteglas/ pen (μg/ 0, 5ml)
Once Weekly
om ugen (ml)
Delivered
mængde (μg)
(μ g/ 0.5 ml)
* Hætteglas skal anvendes.
*Must use vial.
Mindste indgift med pen er 0, 3 ml.
Minimum delivery for pen is 0.3 ml.
PegIntron monoterapi - vejledninger for dosisreduktion
Dose modification guidelines for patients who use PegIntron monotherapy are shown in Table 3a.
Vejledninger for dosisjustering hos patienter, som anvender PegIntron monoterapi, fremgår af Tabel 3a.
Table 3a Dose modification guidelines for PegIntron monotherapy
5 Tabel 3a Dosisjusteringsvejledninger for PegIntron monoterapi Laboratorieværdier
Laboratory values
Afbryd PegIntron, hvis:
Discontinue PegIntron if:
Dosisreduktion hos patienter, som anvender PegIntron 0, 5 μg/ kg som monoterapi, skal ske ved at reducere det foreskrevne volumen med halvdelen.
5 Dose reduction for patients who use 0.5 μ g/ kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
Hætteglasset 50 μg/ 0, 5 ml skal om nødvendigt anvendes, da pennen som minimum kun kan afgive et volumen på 0, 3 ml.
The 50 μ g/ 0.5 ml vial must be used if necessary since the pen can only deliver a minimum volume of 0.3 ml.
Hos patienter, som anvender PegIntron 1, 0 μg/ kg som monoterapi, kan dosisreduktion ske ved at reducere det foreskrevne volumen med halvdelen eller ved at bruge en lavere styrke, som vist i Tabel 3b.
For patients who use 1.0 μ g/ kg PegIntron monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Tabel 3b – Reduceret PegIntron dosis for 1, 0 μg/ kg monoterapiregimen
Table 3b – Reduced PegIntron Dose for the 1.0 μ g/ kg Monotherapy Regimen
reducerede dosis (μg)
(kg)
hætteglas/ pen (μg/ 0, 5ml)
Dose (μ g)
om ugen (ml)
Strength
mængde (μg)
Once Weekly
30- 35
Delivered
50 *
(μ g/ 0.5ml)
0, 15
(ml)
15
(μ g)
Anvendelse ved nedsat nyrefunktion:
Use in renal impairment:
Hos patienter med moderat nedsat nyrefunktion (creatinin clearance 30- 50 ml/ minut) bør initialdosis af PegIntron reduceres med 25%.
In patients with moderate renal dysfunction (creatinine clearance 30- 50 ml/ minute), the starting dose of PegIntron should be reduced by 25%.
Patienter med kraftigt nedsat nyrefunktion (creatinin clearance 15- 29 ml/ minut) bør have initialdosis af PegIntron reduceret med 50%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/ minute) should have the starting dose of PegIntron reduced by 50%.
5. 2).
Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/ minute (see section 5.2).
Patienter med kraftigt nedsat nyrefunktion, inklusive dem i hæmodialyse, bør monitoreres omhyggeligt.
Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Hvis nyrefunktionen nedsættes under behandling, bør PegIntron behandlingen afbrydes.
If renal function decreases during treatment, PegIntron therapy should be discontinued.
Patienter med creatinin clearance < 50 ml/ minut må ikke behandles med PegIntron i kombination med ribavirin (se ribavirin SPC).
Patients with creatinine clearance < 50 ml/ minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SPC).
Når det gives i kombination med ribavirin, bør personer med nedsat nyrefunktion monitoreres mere omhyggeligt med hensyn til udviklingen af anæmi.
When administered in combination with ribavirin, subjects with impaired renal function should be more carefully monitored with respect to the development of anaemia.
6 Anvendelse ved nedsat leverfunktion:
Use in hepatic impairment:
Sikkerhed og effekt ved PegIntron behandling er ikke blevet vurderet hos patienter med alvorlig leverfunktionsforringelse, derfor må PegIntron ikke anvendes til disse patienter.
The safety and efficacy of PegIntron therapy has not been evaluated in patients with severe hepatic dysfunction, therefore PegIntron must not be used for these patients.
Anvendelse hos ældre (i alderen ≥ 65 år):
Use in the elderly (≥ 65 years of age):
5. 2).
Data from elderly patients treated with a single dose of PegIntron suggest no alteration in PegIntron dose is necessary based on age (see section 5.2).
Anvendelse hos patienter i alderen under 18 år:
Use in patients under the age of 18 years:
5. 2).
There is no experience in children (see section 5.2).
- Overfølsomhed over for det aktive stof eller over for et hvilket som helst interferon eller over
- Hypersensitivity to the active substance or to any interferon or to any of the excipients;
for et eller flere af hjælpestofferne;
6
- Anamnese med alvorlig forud eksisterende hjertesygdom, inklusive ustabil eller ukontrolleret
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease
4. 4);
in the previous six months (see section 4.4);
- Alvorlige, svækkende sygdomstilstande;
- Severe, debilitating medical conditions;
- Autoimmun hepatitis eller tidligere autoimmun sygdom;
- Autoimmune hepatitis or a history of autoimmune disease;
- Alvorligt nedsat leverfunktion eller dekompenseret levercirrhose;
- Severe hepatic dysfunction or decompensated cirrhosis of the liver;
- Forud eksisterende thyroideasygdom med mindre den kan kontrolleres med standardbehandling;
- Pre-existing thyroid disease unless it can be controlled with conventional treatment;
- Epilepsi og/ eller påvirket centralnervesystem (CNS) funktion;
- Epilepsy and/ or compromised central nervous system (CNS) function;
- Initiering af PegIntron er kontraindiceret i HCV/ HIV patienter med cirrhose og en Child- Pugh
- Initiation of PegIntron is contraindicated in HCV/ HIV patients with cirrhosis and a Child-Pugh
score ≥ 6.
score ≥ 6.
Se også produktresumeet (SPC) for ribavirin hvis PegIntron skal gives i kombination med ribavirin hos patienter med kronisk hepatitis C.
Also see ribavirin Summary of the Product Characteristics (SPC) if PegIntron is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Psykiatriske lidelser og lidelser i centralnervesystemet (CNS):
Psychiatric and Central Nervous System (CNS):
Alvorlig CNS- påvirkning, særlig depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under PegIntron behandling, og selv efter behandlingsophør især under 6- måneders opfølgningsperioden.
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Andre CNS virkninger inklusive aggressiv opførsel (sommetider rettet mod andre), bipolare lidelser, mani, forvirring og ændret mental tilstand er blevet set med alfa interferoner.
Other CNS effects including aggressive behaviour (sometimes directed against others), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med PegIntron afbrydes, og at patienten følges med passende psykiatrisk intervention.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Patienter med eksisterende eller tidligere alvorlige psykiatriske tilstande:
Patients with existence of, or history of severe psychiatric conditions: