FrancophonIA/ELRC3.0 huggingface dataset:
English: pegylated interferon alfa-2b (1.5 µg/kg/ week) + ribavirin (800 mg)
Danish: pegyleret interferon alfa-2b (1,5 µg/kg/ uge) + ribavirin (800 mg)
English: Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Danish: Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer Ændring af mental tilstand
English: Periodontal (affecting gums) and dental disorders, altered mental status, loss of consciousness, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction) have been reported, but their frequency is unknown.
Danish: Periodontal (påvirkende gummerne) og tandlidelser, ændring i mental status, tab af bevidsthed, akutte overfølsomhedsreaktioner inklusive nældefeber (udslæt), angioødem (hævelse af hænder, fødder, ankler, ansigt, læber, mund eller hals, som kan medføre synkebesvær eller besværlig vejrtrækning), bronkokonstriktion og anafylaxis (en kraftig allergisk reaktion over hele kroppen) har været rapporteret, men deres hyppighed er ukendt.
English: Detailed instructions for subcutaneous administration are provided with this leaflet (see HOW TO SELF INJECT VIRAFERON at the end of the leaflet).
Danish: Detaljerede vejledninger i subkutan indgift gives med denne indlægsseddel (se HVORDAN INJICERER DE SELV VIRAFERON sidst i indlægssedlen).
English: Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials Very common (≥1/10) - Common (≥1/100, <1/10)
Danish: Bivirkninger rapporteret som værende meget almindelige eller almindelige i kliniske undersøgelser hos børn Meget almindelig (≥1/10) - Almindelig (≥1/100, <1/10)
English: Clean the rubber stopper on the top of the vial containing the Viraferon solution with a cleansing swab.
Danish: Rens gummimembranen øverst på hætteglasset, der indeholder den færdigtilberedte opløsning Viraferon, med en renseserviet.
English: Pack sizes of 1.
Danish: Pakningsstørrelse á 1.
English: Raynaud's disease, flushing, pallor
Danish: Raynauds syndrome, rødmen, bleghed
English: Viraferon treatment may be initiated if TSH levels can be maintained in the normal range by medication.
Danish: Viraferon behandling kan initieres, hvis TSH niveauet kan fastholdes indenfor normalområdet ved medicinsk behandling.
English: Very common: Common:
Danish: Meget almindelig: Almindelig:
English: Within its shelf-life, for the purpose of transport and/or to facilitate ambulatory use the non-reconstituted product can be kept at or below 25°C for a period up to four weeks before use.
Danish: Inden for holdbarhedsperioden, under transport og/eller for at lette ambulant brug, kan det ikke færdigtilberedte produkt opbevares ved stuetemperatur (op til 25°C) i op til 4 uger inden anvendelse.
English: Number of “turns” and “clicks” Corresponding doses (million IU) using Viraferon, solution for injection,
Danish: Antal “drejninger” og “klik” Korresponderende doser (millioner IE) ved brug af Viraferon injektionsvæske, opløsning, flerdosispen
English: Hyperglycaemia, hypertriglyceridaemia
Danish: Hyperglykæmi, hypertriglyceridæmi
English: If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Danish: Hvis præparatet ikke anvendes i løbet af denne syv dages periode, kan det ikke sættes tilbage i køleskabet, men skal destrueres.
English: The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Danish: Pennen er designet til at afgive sit indhold af 30 millioner IE i doser fra 2,5 til 10 millioner IE.
English: With the other hand, turn the cap in a clockwise direction indicated by the arrow in Diagram M. You will observe the push button rising, indicating the dose set.
Danish: Med den anden hånd drejes penhætten med uret i pilens retning som vist i Diagram M. De vil se trykknappen stige, visende den indstillede dosis.
English: Pack sizes of 1 and 10
Danish: Pakningsstørrelse á 1 og 10.
English: Once opened, the product may be stored for a maximum of 28 days at 2ºC - 8ºC.
Danish: Produktet kan, når det er åbnet, opbevares i maksimalt 28 dage ved 2°C - 8°C.
English: Chronic Hepatitis C: Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
Danish: Kronisk hepatitis C: Viraferon indgives subkutant i en dosis på 3 millioner IE tre gange om ugen (hver anden dag) til voksne patienter, både anvendt som monoterapi og i kombination med ribavirin.
English: For doses corresponding to full turns, the scale should line up with the correct dose marking.
Danish: For doser som svarer til hele omdrejninger, skal den pågældende streg på skalaen lige akkurat være synlig.
English: Pack of 1, 6 or 12.
Danish: Pakning á 1, 6 eller 12.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa2b on growth, development, sexual maturation, and behaviour (see section 4.4 and Rebetol SPC if Viraferon is to be administered in combination with ribavirin).
Danish: Ingen undersøgelser er blevet udført i unge dyr med henblik på at undersøge effekten af behandling med interferon alfa-2b på vækst, udvikling, seksuel modning og opførsel (se pkt.
English: Any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Unormal thyreoideafunktion på dette tidspunkt bør behandles med konventionel behandling.
English: Myalgia, arthralgia, musculoskeletal pain Arthritis
Danish: Myalgi, arthralgi, smerter i bevægeapparatet Arthritis
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Danish: Kvinder: amenorré, menoragi, menstruations forstyrrelser, vaginale problemer
English: Myocardial infarction, cardiac ischaemia Arrhythmia
Danish: Myocardieinfarkt, hjerteiskæmi Arytmi
English: Viraferon, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
Danish: Viraferon injektionsvæske, opløsning, flerdosispen injiceres subkutant efter at en kanyle er påsat og den ordinerede dosis er indstillet.
English: Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Danish: Fertile kvinder og deres partnere skal begge anvende en effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet.
English: The pharmacokinetics of Viraferon were studied in healthy volunteers following single 5 million IU/m2 and 10 million IU doses administered subcutaneously, at 5 million IU/m administered intramuscularly and as a
Danish: Farmakokinetikken af Viraferon blev undersøgt hos raske forsøgspersoner efter enkeltdoser på 5 millioner IE/m og 10 millioner IE indgivet subkutant, ved doser på 5 millioner IE/m indgivet intramuskulært og som en 30 minutters intravenøs infusion.
English: Be sure the tip of needle is in the Viraferon solution.
Danish: Se efter, at spidsen af kanylen er i Viraferon opløsningen.
English: Injury and poisoning Common:
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig:
English: (Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C).
Danish: (Se tillige ribavirin produktresume hvis Viraferon skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C).
English: Overall, in both studies, patients who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated interferon alfa-2b with ribavirin.
Danish: Der har været udført to undersøgelser af patienter med samtidig infektion af HIV og HCV. I begge undersøgelser var patienter, der fik Viraferon plus ribavirin overordnet mindre tilbøjelige til at respondere end patienter, der fik pegyleret interferon alfa-2b med ribavirin.
English: Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2).
Danish: Abort blev observeret i alle dosis grupper intramuskulære eller subkutane dosis på 2 millioner IE/m (7,5 millioner, 15 millioner og 30 millioner IE/kg), og var statistisk signifikant mod kontrolgruppen for medium- og højdosisgrupperne (svarende til 90 og 180 gange den anbefalede intramuskulære eller subkutane dosis på 2 millioner IE/m2).
English: HCV/HIV Coinfection: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Danish: Patienter, der samtidig er inficeret med HIV og modtager høj-aktiv anti-retroviral terapi (HAART), kan have øget risiko for at udvikle mælkesyreacidose.
English: Anaemia, neutropaenia Thrombocytopaenia, lymphadenopathy
Danish: Anæmi, neutropeni Thrombocytopeni, lymphadenopati
English: Viraferon is presented as a powder and solvent for solution for injection The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
Danish: Viraferon findes som pulver og solvens til injektionsvæske, opløsning Det hvide til cremefarvede pulver er emballeret i et 2 ml glas hætteglas og det klare og farveløse opløsningsmiddel findes i en 2 ml glas ampul.
English: To set the required dose, hold the pen horizontally by the barrel with one hand.
Danish: For at indstille den foreskrevne dosis, holdes pennen vandret med en hånd på cylinderen.
English: Collect necessary items before you begin: a vial of Viraferon powder for injection; an ampoule of solvent for Viraferon (water for injections 1 ml); a 2 ml syringe; a long needle (for example 0.8 × 40 mm [21 gauge 1.5 inch]) to be used to add water for injections to the Viraferon powder vial; a short needle (for example 0.3 × 13 mm [30 gauge 0.5 inch]) for the subcutaneous injection; a cleansing swab.
Danish: Saml det nødvendige udstyr, før De begynder: et hætteglas med Viraferon pulver til injektionsvæske, opløsning, en ampul med solvens til Viraferon (vand til injektionsvæsker 1 ml), en 2 ml sprøjte, en lang kanyle (for eksempel 0,8 × 40 mm [21 gauge 1,5 tomme]) til brug for at tilføre vand til injektionsvæsker til Viraferon pulver hætteglasset, en kort kanyle (for eksempel 0,3 × 13 mm [30 gauge 0,5 tomme]) til den subkutane injektion, en renseserviet.
English: Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia§
Danish: Pharyngitis*, viral infektion* Bronkitis, sinuitis, herpes simplex (resistent), rhinitis Lungebetændelse§
English: Clean the rubber top of the vial with a cleansing swab.
Danish: Rens gummimembranen med en renseserviet.
English: Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
Danish: Autoimmun hepatitis eller tidligere autoimmun sygdom.
English: Corresponding dose (million IU) using Viraferon 18 million IU/3 ml solution for injection
Danish: Korresponderende dosis (million IE) ved brug af Viraferon 18 million IE/3 ml injektionsvæske
English: Remove the needle guard from the syringe needle and check for air bubbles in the syringe.
Danish: Fjern kanylehætten fra sprøjtekanylen og se efter luftbobler i sprøjten.
English: Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia
Danish: Pharyngitis*, viral infektion* Bronkitis, sinuitis, herpes simplex (resistent), rhinitis Lungebetændelse
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2ºC - 8ºC.
Danish: Fra et mikrobiologisk synspunkt kan produktet når det er åbnet opbevares i maksimalt 28 dage ved 2°C - 8°C.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
Danish: 4.8) inklusive nethindehæmoragi, "uldtotter", og arterie- eller veneokklusion i nethinden er blevet rapporteret i sjældne tilfælde efter behandling med alfa interferoner.
English: Dosage indicator
Danish: Doseringsviser
English: Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Danish: Svampeinfektion, bakteriel infektion, pulmonal infektion, otitis media, tand absces, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis
English: p value a alfa-2b (100 or c µg/week) + ribavirin
Danish: p værdi pegyleret interferon alfa-2b (100 eller c µg/uge) + ribavirin
English: Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder
Danish: Diarré, opkastning, kvalme, mavesmerte Mundsår, ulcerativ stomatitis, stomatitis, smerte i øvre højre kvadrant, dyspepsi, glossitis, gastroøsofageal refluks, rektale forstyrrelser, gastrointestinale forstyrrelser, forstoppelse, løs afføring, tandpine, tandproblemer
English: Remove the needle from the vial and check for air bubbles in the syringe.
Danish: Fjern kanylen fra hætteglasset og se efter luftbobler i sprøjten.
English: The colour coding strip pink and the push button are at the bottom of the pen as it is held cap up.
Danish: Farvebåndet pink og trykknappen er i bunden af pennen, når den holdes med hætten opad.
English: What Viraferon looks like and contents of the pack
Danish: Viraferons udseende og pakningsstørrelse
English: Combination therapy with ribavirin: Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Danish: Kombinationsbehandling med ribavirin: Se tillige ribavirin produktresume hvis interferon alfa-2b skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C.
English: Your doctor or his/her assistant will instruct you how to self-inject Viraferon.
Danish: Læs venligst vejledningerne omhyggeligt og følg dem trin for trin. Deres læge eller hans/hendes assistent vil instruere Dem i, hvordan De selv injicerer Viraferon.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
Danish: Patienter med sygdomstegn eller symptomer, der er forenelige med autoimmune lidelser, bør evalueres nøje, og fordel versus risici ved fortsat interferonbehandling bør revurderes (se også pkt.
English: Volume (ml) Corresponding dose (million IU) using Viraferon 25 million IU/2.5 ml solution for injection
Danish: Korresponderende dosis (million IE) ved brug af Viraferon 25 million IE/2,5 ml injektionsvæske
English: Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia
Danish: Thrombocytopeni, lymphadenopati, lymphopeni Aplastisk anæmi
English: The colour coding strip blue and the push button are at the bottom of the pen as it is held cap up.
Danish: Farvebåndet blåt og trykknappen er i bunden af pennen, når den holdes med hætten opad.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Danish: På trods af disse foranstaltninger kan muligheden for at overføre infektion ikke helt udelukkes, når lægemidler fremstillet af humant blod eller plasma anvendes.
English: Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject Viraferon”).
Danish: Detaljerede instruktioner til den subkutane brug af præparatet følger med indlægsseddelen (se ”Hvordan injicerer De selv Viraferon”).
English: Viraferon is presented as a solution for injection The clear and colourless solution is contained in a glass vial.
Danish: Viraferon findes som injektionsvæske, opløsning Den klare og farveløse opløsning er emballeret i et glas hætteglas.
English: In the presence of thyroid dysfunction, Viraferon treatment may be continued if TSH levels can be maintained in the normal range by medication.
Danish: I tilfælde af thyreoideadysfunktion kan Viraferon-behandling fortsættes, hvis TSH-koncentrationen kan holdes i normalområdet ved relevant behandling.
English: As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration.
Danish: Det færdigtilberedte lægemiddel bør i lighed med alle parenterale lægemidler undersøges visuelt for partikler og misfarvning før brugen.
English: Headache, dizziness
Danish: Hovedpine, svimmelhed,
English: For short term travelling, the solution can be kept out of the refrigerator at or below 25°C for a period up to seven days before use.
Danish: For kortvarig transport kan opløsningen opbevares uden for køleskabet ved 25°C eller derunder i en periode op til syv dage før anvendelse.
English: For short term travelling, the non-reconstituted product can be kept out of the refrigerator at or below 25°C for a period up to four weeks before use.
Danish: For kortvarig transport kan det ikkefærdigtilberedte præparat opbevares uden for køleskabet ved 25°C eller derunder i en periode op til fire uger før anvendelse.
English: • chest pain or persistent and severe cough; irregular or rapid heartbeat; shortness of breath, confusion, difficulty remaining alert, numbness or tingling sensation or pain in hands or feet; seizure (convulsions); trouble sleeping, thinking or concentrating; altered mental state; suicidal thoughts, suicide attempt, changed behaviour or aggressive behaviour (sometimes directed against others), hallucinations; severe stomach pain; black or tar like stools; blood in stool or urine, severe nosebleed; waxy pallor, high sugar level in blood, fever or chills beginning after a few weeks of treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.
Danish: • brystsmerte eller vedvarende og svær hoste; uregelmæssige eller hurtige hjerteslag; åndedrætsbesvær, forvirring, besvær med at forblive opmærksom, følelsesløshed eller prikkende fornemmelse eller smerte i hænder eller fødder; anfald (kramper); besvær med at sove, tænke eller koncentrere sig, ændret mental status; selvmordstanker, selvmordsforsøg, ændret opførsel eller aggressiv opførsel (sommetider rettet mod andre), hallucinationer; kraftig mavesmerte; sorte eller tjærelignende afføringer; blod i afføring eller urin, kraftig næseblod; voksagtig bleghed, højt sukkerniveau i blodet, feber eller kulderystelser begyndende efter få ugers behandling, lavtsiddende ryg- eller sidesmerte, vanskelig vandladning, problemer med Deres øjne, syn eller hørelse, høretab, kraftig eller smertefuld rødme eller ømhed på Deres hud eller slimhinde.
English: §, rash maculopapular, rash erythematous, eczema, erythema, skin disorder Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Danish: §, maculopapulært udslæt, erytematøst udslæt, eksem, erytem, hudlidelser Stevens Johnson syndrom, toksisk epidermal nekrolyse, erytem multiforme
English: Injection site inflammation, injection site reaction, fatigue, rigors, fever
Danish: Inflammation på injektionsstedet, reaktion på injektionsstedet*, træthed, stivhed, feber
English: Commonly reported side effects (at least 1 in every 100 patients, but less than 1 in every 10 patients): thirst, dehydration, high blood pressure, migraines, swollen glands, flushing, menstrual problems, decreased sexual drive, vaginal problem, breast pain, pain in testicle, problems with thyroid gland, red gums, dry mouth, red or sore mouth or tongue, tooth ache or tooth disorder, herpes simplex (fever blisters), taste change, upset stomach, dyspepsia (heartburn), constipation, enlargement of liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, problem with your tear ducts, conjunctivitis (“pink eye”), agitation, sleepiness, sleepwalking, problem with behaviour, nervousness, stuffy or runny nose, sneezing, rapid breathing, pale or reddened skin, bruising, fingers and toes very sensitive to cold, problem with skin or nails, psoriasis (new or worsened), increased sweating, increased need to pass urine, fine shaking movements, decreased sensitivity to touch, arthritis.
Danish: Almindelige rapporterede bivirkninger (mindst 1 ud af 100 patienter, men mindre end 1 ud af 10 patienter: tørst, dehydrering, højt blodtryk, migræne, opsvulmede kirtler, rødmen, menstruationslidelser, nedsat seksuallyst, vaginallidelse, brystsmerte, testikelsmerte, skjoldbruskkirtel-lidelser, rødt tandkød, mundtørhed, rødme eller ømhed i mund eller tunge, tandpine eller tandlidelse, forkølelsessår (herpes simplex), ændret smagsopfattelse, mavetilfælde, halsbrand (dyspepsi), forstoppelse, forstørret lever (leverlidelser, undertiden alvorlige), løse afføringer, sengevædning hos børn, bihulebetændelse, bronkitis, øjensmerte, problemer med Deres tårekanaler, konjunktivitis ("røde øjne"), uro, søvnighed, søvngængeri, adfærdsproblemer, nervøsitet, tæt eller løbende næse, nysen, hurtigt åndedræt, bleg eller rødmende hud, blå mærker, kuldefølsomme fingre og tæer, hud- eller negleproblemer, psoriasis (ny eller forværret), øget svedtendens, øget vandladningstrang, let rysten, nedsat følsomhed ved berøring, gigt.
English: Common: Rarely:
Danish: Almindelig: Sjælden:
English: Viraferon is presented as a powder and solvent for solution for injection The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Danish: Viraferon findes som pulver og solvens til injektionsvæske, opløsning Det hvide til cremefarvede pulver er emballeret i et 2 ml glas hætteglas og det klare og farveløse opløsningsmiddel findes i en 2 ml glas ampul med 1 injektionsssprøjte, 2 kanyler og 1 renseserviet.
English: Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion Cerebrovascular haemorrhage, cerbrovascular ischaemia, seizure, impaired consciousness, encephalopathy, neuropathy, polyneuropathy
Danish: Svimmelhed, hovedpine, koncentrationsbesvær, mundtørhed søvnighed, smagsforstyrrelser Cerebrovaskulær blødning, cerebrovaskulær iskæmi, kramper, bevidsthedsforstyrrelse, encephalopati, neuropati, polyneuropati
English: Remove the needle guard.
Danish: Fjern kanylehætten.
English: Nervous system disorders§ Very common:
Danish: Nervesystemet§ Meget almindelig: Almindelig:
English: Vials must be reconstituted with 1 ml of water for injections.
Danish: Hætteglas skal færdigtilberedes med 1 ml vand til injektionsvæsker.