FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole
Swedish: DEKLARATION AV AKTIV(A) SUBSTANS(ER) En tablett innehåller 30 mg aripiprazol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
Swedish: NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING EU/1/15/1029/042
English: Aripiprazole Sandoz 15 mg tablets
Swedish: Aripiprazole Sandoz 15 mg tabletter
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 30 mg
Swedish: INFORMATION I PUNKTSKRIFT Ytterkartong: Aripiprazole Sandoz 30 mg
English: Aripiprazole Sandoz 30 mg tablets Lactose monohydrate Maize starch
Swedish: Aripiprazole Sandoz 30 mg tabletter Laktosmonohydrat Majsstärkelse
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
Swedish: INFORMATION I PUNKTSKRIFT Aripiprazole Sandoz 5 mg
English: Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
Swedish: Aripiprazole Sandoz 10 mg tabletter EU/1/15/1029/015 (10 tabletter) EU/1/15/1029/016 (14 tabletter) EU/1/15/1029/017 (16 tabletter) EU/1/15/1029/018 (28 tabletter) EU/1/15/1029/019 (30 tabletter) EU/1/15/1029/020 (35 tabletter) EU/1/15/1029/021 (56 tabletter) EU/1/15/1029/022 (70 tabletter) EU/1/15/1029/023 (14 x 1 tabletter) EU/1/15/1029/024 (28 x 1 tabletter) EU/1/15/1029/025 (49 x 1 tabletter) EU/1/15/1029/026 (56 x 1 tabletter) EU/1/15/1029/027 (98 x 1 tabletter) EU/1/15/1029/028 (100 tabletter)
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
Swedish: LÄKEMEDLETS NAMN Aripiprazole Sandoz 20 mg tabletter aripiprazol
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg
Swedish: INFORMATION I PUNKTSKRIFT Aripiprazole Sandoz 15 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
Swedish: LÄKEMEDLETS NAMN Aripiprazole Sandoz 30 mg tabletter aripiprazol
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg
Swedish: INFORMATION I PUNKTSKRIFT Aripiprazole Sandoz 10 mg
English: Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets)
Swedish: Aripiprazole Sandoz 15 mg tabletter EU/1/15/1029/029 (10 tabletter) EU/1/15/1029/030 (14 tabletter) EU/1/15/1029/031 (16 tabletter) EU/1/15/1029/032 (28 tabletter) EU/1/15/1029/033 (30 tabletter) EU/1/15/1029/034 (35 tabletter) EU/1/15/1029/035 (56 tabletter) EU/1/15/1029/036 (70 tabletter) EU/1/15/1029/037 (14 x 1 tabletter) EU/1/15/1029/038 (28 x 1 tabletter) EU/1/15/1029/039 (49 x 1 tabletter) EU/1/15/1029/040 (56 x 1 tabletter) EU/1/15/1029/041 (98 x 1 tabletter) EU/1/15/1029/042 (100 tabletter)
English: INFORMATION IN BRAILLE Outer carton:Aripiprazole Sandoz 5 mg
Swedish: INFORMATION I PUNKTSKRIFT Ytterkartong: Aripiprazole Sandoz 5 mg
English: Aripiprazole Sandoz 15 mg tablets Lactose monohydrate Maize starch
Swedish: Aripiprazole Sandoz 15 mg tabletter Laktosmonohydrat Majsstärkelse
English: Aripiprazole Sandoz 10 mg tablets Lactose monohydrate Maize starch
Swedish: Aripiprazole Sandoz 10 mg tabletter Laktosmonohydrat Majsstärkelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
Swedish: NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING EU/1/15/1029/028
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg
Swedish: INFORMATION I PUNKTSKRIFT Ytterkartong: Aripiprazole Sandoz 10 mg
English: EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
Swedish: EU/1/15/1029/015 10 tabletter EU/1/15/1029/016 14 tabletter EU/1/15/1029/017 16 tabletter EU/1/15/1029/018 28 tabletter EU/1/15/1029/019 30 tabletter EU/1/15/1029/020 35 tabletter EU/1/15/1029/021 56 tabletter EU/1/15/1029/022 70 tabletter EU/1/15/1029/023 14 x 1 tabletter EU/1/15/1029/024 28 x 1 tabletter EU/1/15/1029/025 49 x 1 tabletter EU/1/15/1029/026 56 x 1 tabletter EU/1/15/1029/027 98 x 1 tabletter
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
Swedish: INFORMATION I PUNKTSKRIFT Ytterkartong: Aripiprazole Sandoz 15 mg
English: EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
Swedish: EU/1/15/1029/001 10 tabletter EU/1/15/1029/002 14 tabletter EU/1/15/1029/003 16 tabletter EU/1/15/1029/004 28 tabletter EU/1/15/1029/005 30 tabletter EU/1/15/1029/006 35 tabletter EU/1/15/1029/007 56 tabletter EU/1/15/1029/008 70 tabletter EU/1/15/1029/009 14 x 1 tabletter EU/1/15/1029/010 28 x 1 tabletter EU/1/15/1029/011 49 x 1 tabletter EU/1/15/1029/012 56 x 1 tabletter EU/1/15/1029/013 98 x 1 tabletter
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
Swedish: LÄKEMEDLETS NAMN Aripiprazole Sandoz 5 mg tabletter aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
Swedish: LÄKEMEDLETS NAMN Aripiprazole Sandoz 10 mg tabletter aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
Swedish: LÄKEMEDLETS NAMN Aripiprazole Sandoz 15 mg tabletter aripiprazol
English: Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Swedish: Aripiprazole Sandoz 5 mg tabletter Laktosmonohydrat Majsstärkelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
Swedish: NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING EU/1/15/1029/014
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole
Swedish: DEKLARATION AV AKTIV(A) SUBSTANS(ER) En tablett innehåller 15 mg aripiprazol.
English: EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
Swedish: EU/1/15/1029/029 10 tabletter EU/1/15/1029/030 14 tabletter EU/1/15/1029/031 16 tabletter EU/1/15/1029/032 28 tabletter EU/1/15/1029/033 30 tabletter EU/1/15/1029/034 35 tabletter EU/1/15/1029/035 56 tabletter EU/1/15/1029/036 70 tabletter EU/1/15/1029/037 14 x 1 tabletter EU/1/15/1029/038 28 x 1 tabletter EU/1/15/1029/039 49 x 1 tabletter EU/1/15/1029/040 56 x 1 tabletter EU/1/15/1029/041 98 x 1 tabletter
English: EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
Swedish: EU/1/15/1029/048 10 tabletter EU/1/15/1029/049 14 tabletter EU/1/15/1029/050 16 tabletter EU/1/15/1029/051 28 tabletter EU/1/15/1029/052 30 tabletter EU/1/15/1029/053 35 tabletter EU/1/15/1029/054 56 tabletter EU/1/15/1029/055 70 tabletter EU/1/15/1029/056 14 x 1 tabletter EU/1/15/1029/057 28 x 1 tabletter EU/1/15/1029/058 49 x 1 tabletter EU/1/15/1029/059 56 x 1 tabletter EU/1/15/1029/060 98 x 1 tabletter
English: If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Swedish: Du får inte både amma och ta läkemedlet samtidigt.
English: Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets)
Swedish: Aripiprazole Sandoz 5 mg tabletter EU/1/15/1029/001 (10 tabletter) EU/1/15/1029/002 (14 tabletter) EU/1/15/1029/003 (16 tabletter) EU/1/15/1029/004 (28 tabletter) EU/1/15/1029/005 (30 tabletter) EU/1/15/1029/006 (35 tabletter) EU/1/15/1029/007 (56 tabletter)
English: Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets)
Swedish: Aripiprazole Sandoz 30 mg tabletter EU/1/15/1029/048 (10 tabletter) EU/1/15/1029/049 (14 tabletter) EU/1/15/1029/050 (16 tabletter) EU/1/15/1029/051 (28 tabletter) EU/1/15/1029/052 (30 tabletter) EU/1/15/1029/053 (35 tabletter) EU/1/15/1029/054 (56 tabletter) EU/1/15/1029/055 (70 tabletter) EU/1/15/1029/056 (14 x 1 tabletter)
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Swedish: hydroxipropylcellulosa, magnesiumstearat, röd järnoxid (E172).
English: Constipation Dyspepsia Nausea
Swedish: Obehagskänsla i buken
English: This summary was last updated in 03-2012.
Swedish: Denna sammanfattning aktualiserades senast 03-2012.
English: The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Swedish: Det offentliga europeiska utredningsprotokollet (EPAR) för PegIntron finns i sin helhet på EMA:s webbplats ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Swedish: De vanligaste biverkningarna hos vuxna (uppträder hos fler än 1av 10 patienter) är virusinfektioner, faryngit (halsont), anemi (lågt antal röda blodkroppar), neutropeni (låg halt neutrofiler, en sorts vita blodkroppar), aptitförlust, depression, ångest, emotionell labilitet (humörsvängningar), koncentrationssvårigheter, insomnia (sömnsvårigheter), huvudvärk, yrsel, dyspné (andnöd), hosta, kräkningar, illamående, magsmärtor, diarré, muntorrhet, alopeci (håravfall), pruritus (klåda), torr hud, hudutslag, myalgi (muskelvärk), artralgi (ledvärk), muskuloskeletal smärta (ont i musklerna och skelettet), reaktioner på injektionsstället, inflammation på injektionsstället, trötthet, asteni (orkeslöshet), irritabilitet, frossbrytningar, pyrexi (feber), influensaliknande symtom och viktnedgång.
English: PegIntron is also linked to weight loss and reduced growth in children and adolescents.
Swedish: PegIntron har också samband med viktnedgång och minskad tillväxt hos barn och ungdomar.
English: This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Swedish: Detta är en sammanfattning av det offentliga europeiska utredningsprotokollet (EPAR) för PegIntron.
English: Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
Swedish: Eftersom PegIntron har samband med sådana biverkningar som depression måste patienterna övervakas noggrant under behandlingen.
English: Other information about PegIntron:
Swedish: Mer information om PegIntron:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PegIntron.
Swedish: Det förklarar hur Kommittén för humanläkemedel (CHMP) bedömt läkemedlet och hur den kommit fram till sitt ställningstagande om att bevilja godkännande för försäljning och sina rekommendationer om hur läkemedlet ska användas.
English: The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Swedish: Den 25 maj 2000 beviljade Europeiska kommissionen ett godkännande för försäljning av PegIntron som gäller i hela Europeiska unionen.
English: The first study involved previously untreated patients while the second study involved patients who had failed previous treatment.
Swedish: I den första studien ingick tidigare obehandlade patienter medan det i den andra studien ingick patienter med misslyckad tidigare behandling.
English: The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Swedish: CHMP fann att fördelarna med PegIntron är större än riskerna och rekommenderade att PegIntron skulle godkännas för försäljning.
English: In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Swedish: När det gäller vuxna (18 år och äldre) kan PegIntron ges till patienter som inte tidigare har behandlats eller vars tidigare behandling har misslyckats.
English: What benefit has PegIntron shown during the studies?
Swedish: Vilken nytta har PegIntron visat vid studierna?
English: PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Swedish: PegIntron ska inte ges till patienter med ett allvarligt medicinskt tillstånd, allvarliga leverproblem, sköldkörtelsjukdom som inte är under kontroll, epilepsi eller andra problem i centrala nervsystemet.
English: PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Swedish: PegIntron får inte ges till personer som är överkänsliga (allergiska) mot något interferon eller något annat innehållsämne.
English: Treatment with PegIntron should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. PegIntron is given once a week as an injection under the skin.
Swedish: Behandling med PegIntron ska inledas och övervakas av läkare med erfarenhet av att behandla patienter med hepatit C. PegIntron ges en gång per vecka som injektion under huden.
English: Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
Swedish: Trippelbehandling medförde en ökning med cirka 30 procent av antalet tidigare obehandlade patienter som svarade snabbt på behandlingen och som var botade.
English: The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Swedish: Kombinationen PegIntron och ribavirin har också undersökts i en studie där 1 354 vuxna med tidigare misslyckad behandling deltog, och i en studie med 107 barn och ungdomar i åldern 3-17 år som inte tidigare hade behandlats.
English: PegIntron is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Swedish: PegIntron används för att behandla långvarig hepatit C (en leversjukdom som beror på en infektion med hepatit C-virus) hos patienter från tre års ålder och uppåt.
English: Why has PegIntron been approved?
Swedish: Varför har PegIntron godkänts?
English: Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with PegIntron and ribavirin.
Swedish: Ungefär en fjärdedel av de vuxna vars tidigare behandling misslyckats och ungefär två tredjedelar av barnen och ungdomarna svarade på behandling med PegIntron och ribavirin.
English: PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Swedish: PegIntron kan ges som trippelbehandling i kombination med ribavirin och boceprevir till vuxna med typ 1 hepatit C vars lever är skadad men fortfarande kan fungera normalt (kompenserad leversjukdom).
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Swedish: Hos andra vuxna med hepatit C-virus i blodet, däribland patienter som också är infekterade med humant immunbristvirus (hiv), ges PegIntron antingen med ribavirin (dubbelbehandling) eller ensamt om de inte kan ta ribavirin.
English: PegIntron peginterferon alfa-2b
Swedish: Peginterferon alfa-2b
English: In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Swedish: Till vuxna ges det i kombinationsbehandlingar med en dos på 1,5 mikrogram PegIntron per kilo kroppsvikt, eller 0,5 till 1 mikrogram per kilo när det ges ensamt.
English: PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Swedish: PegIntron, med eller utan ribavirin, har jämförts med interferon alfa-2b i fem huvudstudier där totalt över 6 000 vuxna patienter med tidigare obehandlad hepatit C deltog, varav 328 patienter hade cirros och 507 patienter även var infekterade med hiv.
English: It is available as a powder and solvent that are made up into a solution for injection, and as a single-use prefilled pen.
Swedish: Det finns som pulver och vätska som bereds till en injektionsvätska samt som en förfylld injektionspenna för engångsbruk.
English: The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Swedish: Interferon alfa-2b i PegIntron framställs med en metod som kallas rekombinant DNA-teknik, vilket innebär att det framställs av en bakterie som har fått en gen (DNA) som gör att den kan producera interferon alfa-2b.
English: For the full list of all side effects reported with PegIntron, see the package leaflet.
Swedish: Förteckningen över samtliga biverkningar som rapporterats för PegIntron finns i bipacksedeln.
English: PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
Swedish: PegIntron är ett läkemedel som innehåller den aktiva substansen peginterferon alfa-2b.
English: The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Swedish: Kombinationen av PegIntron och ribavirin var effektiv vid behandling av patienter med cirros och för hivinfekterade patienter.
English: Peginterferon alfa-2b is similar to interferon alfa-2b, which has been available in the European Union (EU) for a number of years.
Swedish: Peginterferon alfa-2b liknar interferon alfa-2b, som har funnits på marknaden i Europeiska unionen under flera år.
English: In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Swedish: I PegIntron har interferon alfa-2b ”pegylerats” (belagts med en kemikalie som kallas polyetylenglykol).
English: What is PegIntron?
Swedish: Vad är PegIntron?
English: The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Swedish: Den aktiva substansen i PegIntron, peginterferon alfa-2b, tillhör gruppen interferoner.
English: What is the risk associated with PegIntron?
Swedish: Vilka är riskerna med PegIntron?
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Swedish: Det finns också en tydlig ökning av antalet botade patienter med långvarig typ 1 hepatit C när de får trippelbehandling av PegIntron i kombination med ribavirin och boceprevir.
English: What is PegIntron used for?
Swedish: Vad används PegIntron för?
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
Swedish: I studierna av trippelbehandling av patienter med typ 1 hepatit C och kompenserad leversjukdom visade sig PegIntron i kombination med ribavirin och boceprevir vara effektivare än dubbelkombinationen av PegIntron med ribavirin ensamt.
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Swedish: I två huvudstudier med 1 503 vuxna patienter med typ 1 hepatit C och kompenserad leversjukdom undersökte effekten av PegIntron i en trippelbehandling i kombination med ribavirin och boceprevir jämfört med PegIntron och ribavirin ensamt.
English: For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Swedish: Mer information om behandling med PegIntron finns i bipacksedeln (ingår också i EPAR).
English: Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately.
Swedish: Beroende på biverkningarnas svårighetsgrad kan det bli nödvändigt att helt avbryta behandlingen (inräknat boceprevir).
English: How is PegIntron used?
Swedish: Hur används PegIntron?
English: In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Swedish: Hos barn och ungdomar som fick PegIntron och ribavirin i kombination var biverkningarna desamma som för vuxna.
English: How has PegIntron been studied?
Swedish: Hur har PegIntrons effekt undersökts?