FrancophonIA/ELRC3.0 huggingface dataset:
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: Meget sjældne bivirkninger (kan berøre op til 1 ud af 10.000 personer): - aplastisk anæmi, slagtilfælde (blodprop i hjernen eller hjerneblødniung), 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: • Remove the needle cap. You may see some liquid trickle out of the needle (see Figure 7).
Danish: Du kan eventuelt se noget væske pible ud fra kanylen (se Figur 7).
English: 3 mcg/kg/week (2 weeks)
Danish: 3 mikrog/kg/uge (2 uger)
English: Table 12 Predictive value of in-treatment Virologic Response while on ViraferonPeg 1.5 µg/kg/ribavirin 800-1,400 mg combination therapy Negative
Danish: Tabel 12 Prædiktiv værdi af virologisk respons ved kombinationsbehandling med ViraferonPeg 1,5 µg/kg + ribavirin 800-1.400 mg
English: Dysgeusia, syncope, disturbance in attention, somnolence, poor quality sleep
Danish: Dysgeusi, besvimelse, opmærksomhedsforstyrrelser, døsighed, dårlig søvnkvalitet
English: Thirty two percent (30/94) of subjects demonstrated > 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
Danish: 32 % (30/94) af forsøgspersonerne udviste >15 percentilreduktion på højdepercentilen for alderen 5 år efter afsluttet behandling (se pkt.
English: ViraferonPeg vials are for single use only.
Danish: ViraferonPeg hætteglas er kun til engangsbrug.
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment lower limit of detection=125IU/ml b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
Danish: a: Respons på behandling blev defineret som ikke detekterbar hcv-RNA 24 uger efter behandlingen, laveste grænse for detektion = 125 IE/ml.
English: Undetectable HCVRNA at treatment week 12 End of treatment response Relapse
Danish: Ikke-detekterbar hcv-RNA ved behandlingsuge 12 Respons ved afslutning af behandlingen Recidiv
English: Reminder: Please also read the “Do not take” section of the Package Leaflet for ribavirin and boceprevir before using them in combination with this medicine.
Danish: Bemærk: Læs også afsnittet "Tag ikke" i indlægssedlen for ribavirin og boceprevir, før du tager dem i kombination med dette lægemiddel.
English: By week 12 (n= 215) HCV-RNA negative or ≥ 2 log decrease in viral load
Danish: Ved uge 12 (n= 215) hcv-RNA negativ eller ≥ 2 log fald i virusbelastning
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 ViraferonPeg 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: HCV/HBV Coinfection
Danish: Co-infektion med HCV/HBV
English: P 1.5/R ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Danish: P 1,5/R ViraferonPeg (1,5 mikrogram/kg) + ribavirin (800 mg) P 0,5/R ViraferonPeg (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: If available, prescribers are advised to consult with a poison control centre (PCC).
Danish: Om nødvendigt, anbefales det at ordinerende læger kontakter forgiftningscentralen på H:S Bispebjerg Hospital.
English: 9/l (children and adolescents)
Danish: 9/1 (børn og unge)
English: Adults (bitherapy and monotherapy)
Danish: Voksne (2-stofsbehandling og monoterapi)
English: Colitis ischaemic
Danish: Iskæmisk colitis
English: Table 4 Effect of Peginterferon alfa-2b on Co-administered Medicines
Danish: Tabel 4 Peginterferon alfa-2b's virkning på samtidigt administreret medicin
English: Adults: Haemoglobin in Patients with history of stable cardiac disease
Danish: Voksne: Hæmoglobin hos patienter med tidligere stabil hjertesygdom Børn og unge: Ikke relevant
English: Healthy Subjects (N=24)
Danish: Raske forsøgspersoner (N=24)
English: ViraferonPeg should be administered as a subcutaneous injection.
Danish: ViraferonPeg skal gives som subkutan injektion.
English: Solvent: water for injections.
Danish: Solvens: Vand til injektionsvæsker.
English: • Wipe the top of the pre-filled pen where the needle is going to be attached with an alcohol swab (see Figure 4).
Danish: • Tør toppen på den fyldte pen med en renseserviet, der hvor kanylen skal sættes på (se Figur 4).
English: - 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: • DO NOT SHAKE TO MIX.
Danish: • RYST IKKE PENNEN.
English: • Remove the pre-filled pen from the carton.
Danish: • Tag den fyldte pen ud af pakningen.
English: Dyspepsia, gastroesophageal reflux disease, stomatitis, mouth ulceration, glossodynia, gingival bleeding, constipation, flatulence, haemorrhoids, cheilitis, abdominal distension, gingivitis, glossitis, tooth disorder
Danish: Dyspepsi, gastroøsofageal refluks, stomatitis, mundsår, glossalgi, gingival blødning, forstoppelse, flatulens, hæmorroider, cheilitis, abdominal udspiling, gingivitis, glossitis, tandlidelse
English: - a pre-filled pen (CLEARCLICK) - a needle ("Push-On Needle") - 2 alcohol swabs
Danish: Pakningen indeholder følgende, som du har brug for: - en fyldt pen (CLEARCLICK) - en kanyle (”Push-on Needle”) - 2 renseservietter
English: METAVIR Fibrosis score F2
Danish: METAVIR Fibrosescore
English: The following other side effects (not listed above) have occurred with the combination of this medicine and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART: - oral candidiasis (oral thrush), - defective metabolism of fat, - CD4 lymphocytes decreased, - appetite decreased, - back pain, - hepatitis, - limb pain, - and various laboratory blood values abnormalities.
Danish: Nedenstående andre bivirkninger (ikke nævnt ovenfor) er forekommet ved kombinationen af dette lægemiddel og ribavirin-kapsler (voksne) hos patienter med samtidig hcv/hiv infektion, der fik HAART: - svamp i mundhulen (trøske), - ufuldkommen fedtomsætning, - nedsat antal CD4 lymfocytter, - nedsat appetit, - rygsmerter, - leverbetændelse, - smerte i lemmer - og unormale blodprøver (laboratorieværdier.)
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 14).
Danish: Vedvarende virologisk respons (SVR) er defineret som ikke målbart hcv-RNA 24 uger efter endt behandling (Tabel 14).
English: Injection site reaction, injection site pruritus, injection site rash injection site dryness, injection site pain, feeling cold
Danish: Reaktioner på injektionsstedet, pruritus på injektionsstedet, udslæt på injektionsstedet, tørhed på injektionsstedet, smerter på injektionsstedet, kuldefølelse
English: Look carefully at the solution you prepared before you use it.
Danish: Se omhyggeligt på den tilberedte opløsning før indsprøjtning.
English: (8/194) of patients and decrease in platelets below 50,000/mm
Danish: Et fald i trombocytter til under 50.000/mm
English: Genotype 1 > 600,000 IU/ml
Danish: Genotype 1 > 600.000 IE/ml
English: 25 % of subjects included nausea, chills, insomnia, anaemia, pyrexia, myalgia, asthenia, pain, alopecia, anorexia, weight decreased, depression, rash and irritability.
Danish: Yderligere bivirkninger, der er rapporteret hos mere end 25 % af personerne, omfattede kvalme, kuldegysninger, søvnløshed, anæmi, feber, myalgi, asteni, smerte, alopeci, anoreksi, vægttab, depression, udslæt og irritabilitet.
English: Table 3c Reduced ViraferonPeg dose (0.5 g/kg) for the 1.0 g/kg monotherapy regimen in adults Body weight (kg)
Danish: Tabel 3c - Reduceret ViraferonPeg dosis (0,5 µg/kg) for 1,0 g/kg monoterapiregimenet hos voksne Legemsvægt (kg)
English: For disposal instructions, see section 5 “How to store ViraferonPeg”.
Danish: For bortskaffelse, se punkt 5 "Opbevaring".
English: Excipients with known effect: Each pre-filled pen contains 40 mg of sucrose per 0.5 ml.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver fyldt pen indeholder 40 mg saccharose per 0,5 ml.
English: Powder: disodium phosphate; anhydrous, sodium dihydrogen phosphate dihydrate; sucrose and polysorbate 80.
Danish: Pulver: Dinatriumphosphat; vandfri, natriumdihydrogenphosphatdihydrat; saccharose og polysorbat 80
English: Effect of Peginterferon alfa-2b on Co-administered Medicines
Danish: Peginterferon alfa-2b's virkning på samtidigt administreret medicin
English: You may hear clicking sounds as you dial.
Danish: Du kan eventuelt høre klikkelyde, mens du drejer.
English: It is considered that graft rejection reactions may be induced.
Danish: Transplantatafstødning kan fremkaldes.
English: The lowest ViraferonPeg 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 Tabel 2.
English: Table 3b Reduced ViraferonPeg dose (0.25 g/kg) for the 0.5 g/kg monotherapy regimen in adults Body weight (kg)
Danish: Tabel 3b - Reduceret ViraferonPeg dosis (0,25 µg/kg) for 0,5 g/kg monoterapiregimen hos voksne Legemsvægt (kg)
English: 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent
Danish: 1 hætteglas med pulver, 1 ampul med solvens, 1 injektionssprøjte, 2 kanyler og 1 renseserviet 4 hætteglas med pulver, 4 ampuller med solvens
English: ViraferonPeg 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: ViraferonPeg 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: 1 mcg/kg/week (4 weeks)
Danish: 1 mikrog/kg/uge (4 uger)
English: Genotype 1* By week 4*** (n=950) HCV-RNA negative
Danish: Genotype 1* Ved uge 4*** (n=950) hcv-RNA-negative hcv-RNAnegativeller ≥ 1 log fald i virusbelastnin
English: Metabolism and nutrition disorders Very common:
Danish: Hypothyreoidisme Metabolisme og ernæring Meget almindelig:
English: Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV, although the exact mechanism remains to be elucidated.
Danish: Til trods for at den nøjagtige mekanisme stadig mangler at blive belyst, er der set forværring af anæmi som følge af ribavirin, når zidovudin er en del af de lægemidler, der anvendes til behandling af hiv.
English: Adults - Dose to be administered
Danish: Voksne - dosering
English: Photosensitivity reaction, rash maculo-papular, skin exfoliation, pigmentation disorder, dermatitis atopic, skin discolouration Musculoskeletal and connective tissue disorders Very common:
Danish: Fotosensitivitetsreaktion, makulopapuløst udslæt, hudeksfoliation, pigmentsygdom, atopisk dermatitis, misfarvning af huden Knogler, led, muskler og bindevæv Meget almindelig:
English: SVR in patients with undetectable HCVRNA at treatment week 12
Danish: SVR i patienter med ikke detekterbar hcvRNA ved behandlingsuge
English: Discontinue ViraferonPeg if:
Danish: Seponer ViraferonPeg, hvis:
English: From pre-treatment to end of long-term followup among subjects treated for 24 or 48 weeks, height-for-age percentiles decreased 1.3 and 9.0 percentiles, respectively.
Danish: Blandt de børn, der blev behandlet i 24 eller 48 uger, reduceredes højdepercentilen for alderen henholdsvis 1,3 og 9,0 percentiler fra før behandling til afslutning af langtidsopfølgningen.
English: 15 SEC
Danish: 15 sek
English: Chest pain, chest discomfort, injection site pain, malaise, face oedema, oedema peripheral, feeling abnormal, thirst
Danish: Brystsmerter, ubehag i brystet, smerter på injektionsstedet, utilpashed, ansigtsødem, perifert ødem, unormal fornemmelse, tørst
English: Reduce only ribavirin daily dose (see note 1)
Danish: Reducer kun ribavirin daglig dosis (se note 1) hvis:
English: Hold the syringe with the needle in the vial pointing up.
Danish: Hold sprøjten med kanylen i hætteglasset opad.
English: Carton 150 micrograms
Danish: Karton 150 mikrogram
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare Nervous system disorders
Danish: Adfærdsforstyrrelser, depressiv stemning, følelsesmæssige forstyrrelser, angst, mareridt
English: Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80.
Danish: Hjælpestoffer: Dinatriumphosphat, vandfri; natriumdihydrogenphosphatdihydrat, saccharose og polysorbat 80.
English: Carton 80 micrograms
Danish: Karton 80 mikrogram
English: Loss of visual acuity or visual fields, retinal haemorrhage, retinopathy, retinal artery occlusion, retinal vein occlusion, optic neuritis, papilloedema, macular oedema
Danish: Tab af synsskarphed eller synsfelt, nethindehæmoragi, retinopati, nethindearterieokklusion, nethindeveneokklusion, optisk neuritis, papilødem, makuløst ødem
English: Abdominal pain, abdominal pain upper, vomiting, nausea
Danish: Mavesmerter, øvre mavesmerter, opkastning, kvalme
English: §, depression, aggression, affect lability, anger, agitation, anxiety, mood altered, restlessness, nervousness, insomnia
Danish: §, selvmordsforsøg § depression, aggressiv adfærd, affektlabilitet, vrede, agitation, uro, humørforandringer, rastløshed, nervøsitet, søvnløshed
English: Do not exceed the recommended dosage, and take it for as long as prescribed.
Danish: Overskrid ikke den anbefalede dosis, og brug den så længe som foreskrevet.
English: ViraferonPeg 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: ViraferonPeg leveres i forskellige pakningsstørrelser: - 1 hætteglas pulver til injektionsvæske, opløsning og 1 ampul solvens til injektion;
English: The solution should be clear and colourless before use.
Danish: Injektionsvæsken skal være klar og farveløs før brug.
English: ViraferonPeg contains sucrose
Danish: ViraferonPeg indeholder saccharose
English: - 12 vials of powder for solution for injection, 12 ampoules of solvent for parenteral use, 12 injection syringes, 24 injection needles and 12 cleansing swabs.
Danish: - 12 hætteglas pulver til injektionsvæske, opløsning, 12 ampuller solvens til parenteral brug, 12 injektionssprøjter, 24 kanyler og 12 renseservietter.
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.Virological response by week 4 is defined as at least 1-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: Very common side effects (may affect more than 1 in 10 people): - loss of appetite, dizziness, headache, vomiting, nausea, stomach pain, - hair loss, dry skin, pain in joints and muscles, redness at the site of injection, - feeling irritable, tired feeling, feeling unwell, pain, chills, fever, flu-like symptoms, weakness,
Danish: Meget almindelige bivirkninger (kan berøre flere end 1 ud af 10 personer): - tab af appetit, svimmelhed, hovedpine, opkast, kvalme, mavesmerter, - hårtab, tør hud, smerter i led og muskler, rødmen ved indsprøjtningsstedet, - irritabilitet, træthed, utilpashed, smerte, kulderystelser, feber, influenzalignende symptomer,
English: Serum Creatinine
Danish: Serumkreatinin
English: 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs
Danish: 12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter
English: • Hold the pre-filled pen upright with the dial on the bottom.
Danish: • Hold den fyldte pen opad, så doseringsknappen vender nedad.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Powder and solvent for solution for injection in pre-filled pen.
Danish: Pulver og solvens til injektionsvæske, opløsning i fyldt pen.
English: Sustained response
Danish: Overordnet respons
English: However, if HCV-RNA is still detectable at treatment week 24, discontinuation of therapy should be considered.
Danish: Dog bør det overvejes at afbryde behandlingen, hvis hcv-RNA stadig kan genfindes ved behandlingsuge 24.
English: • Neutrophil count
Danish: • Neutrofiler
English: Carton 50 micrograms
Danish: Karton 50 mikrogram
English: Dysphonia, epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain
Danish: Dysfoni, epistaxis, vejrtrækningsproblemer, tilstoppede luftveje, tilstoppede bihuler, tilstoppet næse, næseflåd, øget sekretion i øvre luftveje, faryngolaryngeale smerter
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Kontakt lægen eller apotekspersonalet, hvis du har yderligere spørgsmål vedrørende brugen af dette lægemiddel.
English: Co-administration of ribavirin and didanosine is not recommended.
Danish: Ribavirin bør ikke anvendes samtidig med didanosin.
English: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Danish: Stevens-Johnsons syndrom, toksisk epidermal nekrolyse, erythema multiforme Knogler, led, muskler og bindevæv Meget almindelig:
English: Carton 100 micrograms
Danish: Karton 100 mikrogram
English: Psoriasis, photosensitivity reaction, rash maculo-papular, dermatitis, erythematous rash, eczema, night sweats, hyperhidrosis, acne, furuncle, erythema, urticaria, abnormal hair texture, nail disorder
Danish: Psoriasis, fotosensitivitetsreaktion, makulopapuløst udslæt, dermatitis, erytematøst udslæt, eksem, nattesved, hyperhidrose, akne, furunkulose, erytem, urticaria, unormal hårstruktur, neglelidelse
English: Dental and periodontal disorders
Danish: Dentale og parodontale lidelser
English: ViraferonPeg is available in different pack sizes: - 1 pre-filled pen containing powder and solvent for solution for injection, 1 needle ("Push-On Needle"),
Danish: ViraferonPeg leveres i forskellige pakningsstørrelser: - 1 fyldt pen indeholdende pulver og solvens til injektionsvæske, opløsning, 1 kanyle (”Push-on
English: Retinal exudates
Danish: Retinale ekssudater
English: - are being treated with telbivudine (see section “Other medicines and ViraferonPeg”).
Danish: - er i behandling med telbivudin (se punktet "Brug af anden medicin sammen med
English: Package inserts of theophylline should be referred to when co-administering with the product (ViraferonPeg)
Danish: Der henvises til indlægssedlen for theophyllin, når det administreres sammen med ViraferonPeg.
English: P 1.5 P 1.0 P 0.5 I
Danish: Behandlingsregimen P 1,5 P 1,0 P 0,5 I
English: ViraferonPeg 120 mcg
Danish: ViraferonPeg 120 mikrog
English: Carton 120 micrograms
Danish: Peg Karton 120 mikrogram
English: Uncommon side effects (may affect up to 1 in 100 people): - wanting to harm yourself, - hallucinations,
Danish: Ikke almindelige bivirkninger (kan berøre op til 1 ud af 100 personer):
English: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with ViraferonPeg in combination with ribavirin.
Danish: Hos 12 % (23/194) af patienterne, der blev behandlet med ViraferonPeg i kombination med ribavirin, blev der rapporteret om anæmi (hæmoglobin < 9,4 g/dl).
English: ViraferonPeg 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;
Danish: ViraferonPeg 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: Inspect visually the reconstituted solution prior to administration: do not use if discolouration (change in the original colour of the solution) or particulate matter is present.
Danish: Anvend den ikke i tilfælde af misfarvning (ændring i den oprindelige farve af opløsningen) eller tilstedeværelse af bundfald.
English: ViraferonPeg is supplied as: - 1 pre-filled pen (CLEARCLICK) containing powder and solvent for solution for injection, 1 needle ("Push-On Needle"), 2 cleansing swabs; - 4 pre-filled pens (CLEARCLICK) containing powder and solvent for solution for injection, 4 needles ("Push-On Needle"),
Danish: ViraferonPeg leveres som: - 1 fyldt pen (CLEARCLICK) indeholdende pulver og solvens til injektionsvæske, opløsning, 1 kanyle (”Push-On Needle”), 2 renseservietter; - 4 fyldte penne (CLEARCLICK)indeholdende pulver og solvens til injektionsvæske, opløsning, 4 kanyler (”Push-On Needle”), 8 renseservietter; - 12 fyldte penne (CLEARCLICK) indeholdende pulver og solvens til injektionsvæske, opløsning, 12 kanyler (”Push-On Needle”), 24 renseservietter.
English: Therefore, each pre-filled pen contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Danish: Hver fyldt pen indeholder derfor en ekstra mængde solvens og ViraferonPeg-pulver for at sikre indgift af den anførte dosis i 0,5 ml ViraferonPeg injektionsvæske, opløsning.
English: Injection site erythema, fatigue, pyrexia, rigors, influenza-like illness, asthenia, pain, malaise, irritability
Danish: Erytem på injektionsstedet, træthed, feber, rigor, influenzalignende symptomer, asteni, smerter, utilpashed, irritabilitet
English: Sarcoidosis
Danish: Sarkoidose