FrancophonIA/ELRC3.0 huggingface dataset:
English: Bitherapy: Predictability of sustained virological response - Patients infected with virus genotype 1 who fail to achieve undetectable HCV-RNA or demonstrate adequate virological response at week 4 or 12 are highly unlikely to become sustained virological responders and should be evaluated for discontinuation (see also section 5.1).
Danish: 2-stofsbehandling: Forudsigelighed for vedvarende virologisk respons - Patienter inficeret med virus genotype 1, som ikke opnår ikke-detekterbar hcv-RNA eller demonstrerer tilstrækkeligt virologisk respons ved uge 4 eller 12, har meget lille sandsynlighed for at blive vedvarende virologisk responderende og bør evalueres for seponering (se også pkt.
English: Table 3b Reduced PegIntron dose (0.25 g/kg) for the 0.5 g/kg monotherapy regimen in adults Body weight (kg)
Danish: Tabel 3b - Reduceret PegIntron-dosis (0,25 µg/kg) for 0,5 g/kg monoterapiregimenet hos voksne Legemsvægt (kg)
English: Please refer to the respective SmPCs of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with PegIntron and ribavirin.
Danish: For de antiretrovirale lægemidler, der skal tages samtidig med hcv-behandling, henvises der til disses respektive SPCer for kendskab og håndtering af toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med PegIntron og ribavirin.
English: PegIntron in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Danish: PegIntron i kombination med ribavirin (2-stofsbehandling) er indiceret til behandling af CHCinfektion hos voksne patienter, der ikke tidligere har været i behandling, inklusive patienter med klinisk stabil hiv-co-infektion, og til voksne patienter, hvor tidligere kombinationsbehandling med interferon alfa (pegyleret eller non-pegyleret) plus ribavirin eller interferon alfa monoterapi er mislykkedes (se pkt.
English: There are no data available regarding potential effects of PegIntron treatment on male or female fertility.
Danish: Fertilitet Der foreligger ingen data vedrørende mulig påvirkning af fertiliteten ved behandling med PegIntron.
English: P 1.5/R PegIntron (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R PegIntron (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Danish: P 1,5/R PegIntron (1,5 mikrogram/kg) + ribavirin (800 mg) P 0,5/R PegIntron (1,5 til 0,5 mikrogram/kg) + ribavirin (1.000/1.200 mg) I/R Interferon alfa-2b (3 MIE) + ribavirin (1.000/1.200 mg)
English: The intended dose of 1.5 g/kg of PegIntron to be used in combination with ribavirin may be delivered in weight categories with the PegIntron strengths according to Table 1.
Danish: Den foreskrevne dosis PegIntron 1,5 g/kg til anvendelse i kombination med ribavirin kan indgives efter vægtkategorier og styrken af PegIntron, som anført i Tabel 1.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om PegIntron findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron in combination with ribavirin (bitherapy or tritherapy) (see section 4.3).
Danish: Patienter med kreatininclearance < 50 ml/minut må ikke behandles med PegIntron i kombination med ribavirin (2-stofs- eller 3-stofsbehandling) (se pkt.
English: Please refer to the ribavirin and boceprevir Summary of Product Characteristics (SmPCs) when PegIntron is to be used in combination with these medicines.
Danish: Se produktresumeer (SPC'er) for ribavirin og boceprevir, når PegIntron skal bruges i kombination med disse lægemidler.
English: Hypotension, pallor
Danish: Hypotension, bleghed
English: Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.
Danish: Se SPC for ribavirin kapsler eller oral opløsning, når PegIntron skal anvendes i kombination med ribavirin.
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two PegIntron/ribavirin regimens [PegIntron 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with ribavirin 800 to 1,400 mg p.o. daily (in two divided doses)] and peginterferon alfa-2a 180 µg subcutaneously once weekly with ribavirin 1,000 to 1,200 mg p.o. daily (in two divided doses) in 3,070 treatment-naïve adults with chronic hepatitis C genotype 1.
Danish: Et stort randomiseret studie sammenlignede sikkerhed og effekt af behandling i 48 uger med to PegIntron/ribavirin regimer [PegIntron 1,5 μg/kg og 1 μg/kg subkutant en gang ugentligt begge i kombination med ribavirin 800 til 1.400 mg p.o. dagligt (fordelt på to doser)] og peginterferon alfa-2a 180 μg subkutant en gang ugentligt med ribavirin 1.000 til 1.200 mg per os dagligt (fordelt på to doser) hos 3.070 behandlingsnaive voksne med kronisk hepatitis C genotype 1.
English: For adult patients who use 0.5 g/kg PegIntron monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half as shown in Table 3b.
Danish: Hos voksne patienter, som anvender PegIntron 0,5 g/kg som monoterapi, kan dosisreduktion ske ved at reducere det ordinerede volumen med halvdelen som vist i Tabel 3b.
English: The dose of PegIntron for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Danish: Dosen af PegIntron i monoterapi bør reduceres hos patienter med moderat eller stærkt nedsat nyrefunktion (se pkt.
English: Predictability of sustained virological response - Naïve patients: Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.
Danish: Forudsigelighed med hensyn til vedvarende virologisk respons - Naive patienter: Det virologiske respons ved uge 12, defineret som et fald på mindst 2-log virusbelastning eller ikke-detekterbart niveau af hcv-RNA.
English: Before reconstitution, this medicine may appear either as a white tablet-shaped solid that is whole or in pieces, or as a white powder.
Danish: Færdigtilberedning af PegIntron pulver til injektionsvæske Før færdigtilberedning vil dette lægemiddel være et hvidt, tabletformet fast stof, der kan være i et eller flere stykker, eller som et hvidt pulver.
English: For HCV/HIV co-infected patients receiving PegIntron in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Danish: Bivirkninger, der blev rapporteret i de større studier med en hyppighed > 5 %, var oral candidiasis (14 %), erhvervet lipodystrofi (13 %), nedsat CD4-lymfocytter (8 %), nedsat appetit (8 %), forhøjet gammaglutamyltransferase (9 %), rygsmerter (5 %), forhøjet amylase i blodet (6 %), forhøjet mælkesyre i blodet (5 %), cytolytisk hepatitis (6 %), øget lipase (6 %) og smerter i lemmerne (6 %).
English: Therefore, it is recommended that children and adolescent patients receiving PegIntron/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
Danish: Det anbefales derfor, at behandlingen af børn og unge patienter, der får PegIntron/ribavirin kombination, afbrydes, hvis deres uge 12 hcv-RNA falder < 2 log10 i forhold til før behandlingen, eller hvis de har detekterbar hcv-RNA i behandlingsuge 24.
English: You must not use PegIntron if any of the conditions above should apply to you, or the child you are caring for.
Danish: Du må ikke tage PegIntron, hvis du, eller det barn, du har ansvar for, har en eller flere af ovenstående sygdomme.
English: Please refer to the ribavirin SmPC when PegIntron is to be used in combination with ribavirin.
Danish: Se SPC for ribavirin, når PegIntron skal bruges i kombination med ribavirin.
English: PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy (see section 5.1).
Danish: PegIntron i kombination med ribavirin og boceprevir (3-stofsbehandling) er indiceret til behandling af kronisk hepatitis C (CHC) genotype 1-infektion hos voksne patienter (18 år og ældre) med kompenseret leversygdom, der ikke tidligere har været i behandling, eller hvor tidligere behandling er mislykkedes (se pkt.
English: PegIntron is indicated in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA.
Danish: PegIntron er, i kombination med ribavirin, indiceret til behandling af børn i alderen 3 år eller ældre samt unge, som lider af tidligere ubehandlet kronisk hepatitis C uden leverdekompensation, og som er positive for hcv-RNA.
English: Table 12 Predictive value of in-treatment Virologic Response while on PegIntron 1.5 µg/kg/ribavirin 800-1,400 mg combination therapy Negative
Danish: Tabel 12 Prædiktiv værdi af virologisk respons ved kombinationsbehandling med PegIntron 1,5 µg/kg + ribavirin 800-1.400 mg
English: Response week 12 was defined as undetectable HCV-RNA after 12 weeks of treatment.
Danish: 12 ugers respons på behandlingen blev defineret som ikke målbart hcv-RNA efter 12 ugers behandling.
English: Response at end of treatment 49 % 41 % 33 % 24 % 65 % 56 % 54 % Sustained response
Danish: Vedvarende respons 23 %* 25 % 18 % 12 % 54 %**
English: - Take the long needle and place it firmly on to the tip of the syringe.
Danish: • Tag den lange kanyle og sæt den fast på spidsen af sprøjten.
English: (8/194) of patients and decrease in platelets below 50,000/mm
Danish: Et fald i trombocytter under 50.000/mm
English: Study 1) (see section 5.1).
Danish: I forsøg 1 (se pkt.
English: Table 4Effect of Peginterferon alfa-2b on Co-administered Medicines
Danish: Tabel 4 Peginterferon alfa-2b's virkning på samtidigt administreret medicin
English: - Hypersensitivity to the active substance or to any interferon or to any of the excipients listed in section 6.1; - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4); - Severe, debilitating medical conditions; - Autoimmune hepatitis or a history of autoimmune disease; - Severe hepatic dysfunction or decompensated cirrhosis of the liver; - Pre-existing thyroid disease unless it can be controlled with conventional treatment; - Epilepsy and/or compromised central nervous system (CNS) function; - HCV/HIV patients with cirrhosis and a Child-Pugh score ≥ 6.
Danish: 4.4); - Alvorlige, svækkende sygdomstilstande; - Autoimmun hepatitis eller tidligere autoimmun sygdom; - Alvorligt nedsat leverfunktion eller dekompenseret levercirrose; - Forud eksisterende thyroideasygdom, medmindre den kan kontrolleres med standardbehandling; - Epilepsi og/eller påvirket centralnervesystem (CNS)-funktion; - hcv/hiv-patienter med cirrose og en Child-Pugh score ≥ 6.
English: Genotype 1* By week 4*** (n=950) HCV-RNA negative
Danish: Genotype 1* Ved uge 4*** (n=950) hcv-RNA-negative hcv-RNA negativ eller ≥ 1 log fald i virusbelastnin
English: It is recommended that children and adolescent patients receiving PegIntron/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
Danish: Det anbefales, at behandling af børn og unge patienter, der får PegIntron/ribavirin i kombination, afbrydes,hvis deres uge 12 hcv-RNA falder< 2 log10i forhold til før behandlingen, eller hvis de har detekterbar hcv-RNA i behandlingsuge 24.
English: - hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease).
Danish: • reaktivering af hepatitis B hos patienter med samtidig infektion med HCV og HBV (tilbagevenden af hepatitis B-sygdom).
English: What PegIntron contains
Danish: PegIntron indeholder:
English: CD4 lymphocytes decrease
Danish: Fald i CD4 lymfocytter
English: Preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3 of Rebetol SmPC if PegIntron is to be administered in combination with ribavirin).
Danish: Prækliniske toksicitetsresultater hos unge dyr viste en mindre dosisrelateret nedsættelse i den overordnede vækst hos neonatale rotter behandlet med ribavirin (se pkt.
English: After administering the dose, discard the PegIntron pre-filled pen (CLEARCLICK) and any unused solution contained in it.
Danish: Efter indsprøjtningen af dosis kasseres PegIntron fyldt pen (CLEARCLICK) med en eventuel rest af opløsning.
English: The following treatment-related adverse reactions were reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including PegIntron monotherapy or PegIntron/ribavirin.
Danish: Følgende behandlingsrelaterede bivirkninger blev rapporteret hos voksne i kliniske undersøgelser eller via post-marketing overvågning hos patienter behandlet med peginterferon alfa-2b, herunder PegIntron monoterapi eller PegIntron/ribavirin.
English: For adult patients who use 1.0 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 3c.
Danish: Hos voksne patienter, som anvender PegIntron 1,0 g/kg som monoterapi, kan dosisreduktion ske ved at reducere det ordinerede volumen med halvdelen eller ved at anvende en lavere styrke, som vist i Tabel 3c.
English: weakness, - difficult breathing, pharyngitis (sore throat), coughing, - stomach pain, vomiting, nausea, diarrhoea, loss of appetite, loss of weight, dry mouth, - hair loss, itching, dry skin, rash, irritation or redness (and rarely, skin damage) at the site of injection, - decreases in the number of red blood cells (that may cause fatigue, shortness of breath,
Danish: virusinfektion, svaghed, - vejrtrækningsbesvær, faryngitis (ondt i halsen), hoste, - mavesmerter, opkastning, kvalme, diarré, appetitløshed, vægttab, mundtørhed, - hårtab, kløe, tør hud, udslæt, irritation eller rødme (og i sjældne tilfælde hudskade) på injektionsstedet, - nedsat antal røde blodlegemer (som kan føre til svaghed, vejrtrækningsbesvær, svimmelhed),
English: Paediatric population (bitherapy only) - Duration of treatment
Danish: Pædiatrisk population (kun 2-stofsbehandling) - Behandlingsvarighed Genotype 1:
English: Adults - Dose to be administered
Danish: Voksne - Dosering
English: If you take telbivudine with this medicine or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher.
Danish: Hvis du tager telbivudin sammen med dette lægemiddel eller en anden form for interferonmedicin til injektion, har du større risiko for at få perifer neuropati (følelsesløshed,
English: PegIntron is supplied as: - 1 vial of powder for solution for injection and 1 ampoule of solvent for parenteral use; - 1 vial of powder for solution for injection, 1 ampoule of solvent for parenteral use, 1 injection syringe, 2 injection needles and 1 cleansing swab; - 4 vials of powder for solution for injection and 4 ampoules of solvent for parenteral use; - 4 vials of powder for solution for injection, 4 ampoules of solvent for parenteral use, 4 injection syringes, 8 injection needles and 4 cleansing swabs; - 6 vials of powder for solution for injection and 6 ampoules of solvent for parenteral use.
Danish: PegIntron leveres som: - 1 hætteglas pulver til injektionsvæske, opløsning og 1 ampul solvens til parenteral brug; - 1 hætteglas pulver til injektionsvæske, opløsning, 1 ampul solvens til parenteral brug, 1 injektionssprøjte, 2 kanyler og 1 renseserviet; - 4 hætteglas pulver til injektionsvæske, opløsning og 4 ampuller solvens til parenteral brug; - 4 hætteglas pulver til injektionsvæske, opløsning, 4 ampuller solvens til parenteral brug, 4 injektionssprøjter, 8 kanyler og 4 renseservietter; - 6 hætteglas pulver til injektionsvæske, opløsning og 6 ampuller solvens til parenteral brug.
English: PegIntron strength (µg/0.5 ml)
Danish: PegIntron styrke (µg/0,5 ml)
English: Very common side effects (may affect more than 1 in 10 people): - feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, - headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection,
Danish: Meget almindelige bivirkninger (kan berøre flere end 1 ud af 10 personer): - depressionsfølelse, irritabilitet, besvær med at falde i søvn eller sove igennem, følelse af angst eller nervøsitet, koncentrationsbesvær, humørsvingninger, - hovedpine, svimmelhed, træthedsfølelse, kulderystelser, feber, influenzalignende symptomer,
English: PegIntron is available in different pack sizes: - 1 pre-filled pen containing powder and solvent for solution for injection, 1 needle ("Push-On Needle"),
Danish: PegIntron leveres i forskellige pakningsstørrelser: - 1 fyldt pen indeholdende pulver og solvens til injektionsvæske, opløsning, 1 kanyle (”Push-on
English: nd dose reduction of PegIntron is to 20 g/m 2/week.
Danish: PegIntron er til 20 μg/m 2/uge.
English: • Genotype 2 or 3:
Danish: Genotype 2 eller 3:
English: Sustained response
Danish: Tidligere respons Recidiv
English: Carton 120 micrograms
Danish: Karton 120 mikrogram
English: Table 6 Adverse reactions reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including PegIntron monotherapy or PegIntron + ribavirin
Danish: Tabel 6 Bivirkninger, der er rapporteret hos voksne i kliniske forsøg eller efter markedsføring, hos patienter behandlet med peginterferon alfa-2b, inklusive PegIntron-monoterapi eller PegIntron + ribavirin
English: Very rare side effects (may affect up to 1 in 10,000 people): - aplastic anaemia, stroke (cerebrovascular events), toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin).
Danish: • aplastisk anæmi, slagtilfælde (blodprop i hjernen eller hjerneblødning hændelser), toksisk epidermal nekrolyse/Stevens-Johnsons syndrom/erythema multiforme (et spektrum af udslæt af varierende sværhedsgrad inklusive dødsfald, som kan være forbundet med blister i mund, næse, øjne og andre slimhindemembraner og afstødning af det berørte område af huden).
English: - changes in taste, diarrhoea, stomach upset, oral pain,
Danish: • smagsforandringer, diarré, maveonde, mundsmerter,
English: 2 cleansing swabs; - 4 pre-filled pens containing powder and solvent for solution for injection, 4 needles ("Push-On Needle"),
Danish: Needle”), 2 renseservietter; - 4 fyldte penne indeholdende pulver og solvens til injektionsvæske, opløsning, 4 kanyler (”Push on Needle”), 8 renseservietter;
English: PegIntron strength (g/0.5 ml)
Danish: PegIntron styrke (g/0,5 ml)
English: 2 injection needles and 1 cleansing swab; - 4 vials of powder for solution for injection and 4 ampoules of solvent for injection; - 4 vials of powder for solution for injection, 4 ampoules of solvent for injection, 4 injection syringes, 8 injection needles and 4 cleansing swabs; - 6 vials of powder for solution for injection and 6 ampoules of solvent for injection; - 12 vials of powder for solution for injection, 12 ampoules of solvent for injection, 12 injection syringes, 24 injection needles and 12 cleansing swabs.
Danish: - 4 hætteglas pulver til injektionsvæske, opløsning, 4 ampuller solvens til injektion, 4 injektionssprøjter, 8 kanyler og 4 renseservietter; - 6 hætteglas pulver til injektionsvæske, opløsning og 6 ampuller solvens til injektion; - 12 hætteglas pulver til injektionsvæske, opløsning, 12 ampuller solvens til injektion, 12 injektionssprøjter, 24 kanyler og 12 renseservietter.
English: o Taking this medicine in combination with ribavirin and an anti-HIV medicine(s) may increase the risk of lactic acidosis, liver failure, and blood abnormalities: reduction in number of red blood cells, white blood cells and blood clotting cells called platelets.
Danish: • Hvis dette lægemiddel tages i kombination med ribavirin og et eller flere anti-hiv-lægemiddel(ler) kan risikoen øges for mælkesyreacidose, leversvigt og udvikling af blodabnormiteter: reduktion i antallet af røde blodlegemer, hvide blodlegemer og blodkoagulerende celler kaldet blodplader.
English: Package inserts of theophylline should be referred to when co-administering with the product (PegIntron)
Danish: Der henvises til indlægssedlen for theophyllin, når det administreres sammen med PegIntron.
English: decrease in rate of growth (height and weight for age), - decreases in red blood cells that may cause fatigue, shortness of breath, dizziness.
Danish: • nedsat antal røde blodlegemer som kan skabe træthed, åndenød, svimmelhed.
English: PegIntron 120 mcg
Danish: PegIntron 120 mikrog
English: Gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Danish: • Stik kanylen gennem gummimembranen på PegIntron hætteglasset og placer forsigtigt kanylespidsen mod glasvæggen i hætteglasset uden at røre den rensede membran på hætteglasset med hænderne.
English: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with PegIntron in combination with ribavirin.
Danish: Hos 12 % (23/194) af patienterne, der blev behandlet med PegIntron i kombination med ribavirin, blev der rapporteret om anæmi (hæmoglobin < 9,4 g/dl).
English: The lowest PegIntron strength available is 50 g/0.5 ml; therefore for patients prescribed 0.5 g/kg/week, doses must be adjusted by volume as shown in Table 2.
Danish: Doser til patienter, der ordineres 0,5 g/kg/uge, skal således justeres ved volumen, som vist i Tabel2.
English: PegIntron 150 mcg
Danish: PegIntron 150 mikrog
English: PegIntron is available in different pack sizes: - 1 vial of powder for solution for injection and 1 ampoule of solvent for injection; - 1 vial of powder for solution for injection, 1 ampoule of solvent for injection, 1 injection syringe,
Danish: PegIntron leveres i forskellige pakningsstørrelser: - 1 hætteglas pulver til injektionsvæske, opløsning og 1 ampul solvens til injektion; - 1 hætteglas pulver til injektionsvæske, opløsning, 1 ampul solvens til injektion, 1 injektionssprøjte, 2 kanyler og 1 renseserviet; - 4 hætteglas pulver til injektionsvæske, opløsning og 4 ampuller solvens til injektion;
English: Therefore, each pre-filled pen contains an excess amount of solvent and PegIntron powder to ensure delivery of the labelled dose in 0.5 ml of PegIntron, solution for injection.
Danish: Hver fyldt pen indeholder derfor en ekstra mængde solvens og PegIntron-pulver for at sikre indgift af den anførte dosis i 0,5 ml PegIntron injektionsvæske, opløsning.
English: For disposal instructions, see section 5 “How to store PegIntron”.
Danish: For bortskaffelse, se punkt 5 "Opbevaring".