natgillin/translations-raw huggingface dataset:
Aripiprazole Sandoz 20 mg tabletter Hver tablet indeholder 20 mg aripiprazol.
Aripiprazole Sandoz 20 mg tablets Each tablet contains 20 mg aripiprazole.
Aripiprazole Sandoz-tabletter indeholder
What Aripiprazole Sandoz tablets contain
Hjælpestof(fer), som behandleren skal være opmærksom på 65,97 mg lactosemonohydrat per tablet.
Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Aripiprazole Sandoz 20 mg tabletter Blisterpakninger i æsker: 14, 28, 49, 56, 98 tabletter
Blister packs in cartons: 14, 28, 49, 56, 98 tablets
Lyserød, plettet, rund tablet, med en omtrentlig diameter på 9,0 mm, præget med ”SZ” på den ene side og med ”449” på den anden side.
Pink coloured, mottled, round shaped tablet, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and “449” on the other side.
I et randomiseret, dobbeltblindet, placebokontrolleret 10-ugers studie gennemført i Sydkorea blev aripiprazols virkning hos pædiatriske patienter med Tourettes syndrom (aripiprazol: n = 32, placebo: n = 29) undersøgt inden for et fleksibelt dosisområde på 2-20 mg/dag med en startdosis på 2 mg.
The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n=32, placebo: n=29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-Korea.
Gul, plettet, rund tablet, med en omtrentlig diameter på 7,0 mm, præget med ”SZ” på den ene side og med ”447” på den anden side.
Yellow coloured, mottled, round shaped tablet, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side.
Aripiprazole Sandoz 30 mg tabletter Hver tablet indeholder 30 mg aripiprazol.
Aripiprazole Sandoz 30 mg tablets Each tablet contains 30 mg aripiprazole.
Aripiprazole Sandoz 20 mg tabletter er hvide, runde tabletter med en omtrentlig diameter på 7,8 mm, præget med ”SZ” på den ene side og med ”448” på den anden side.
Aripiprazole Sandoz20mg tablets are white coloured, round shaped tablets, with an approximate diameter of 7.8mm, debossed with “SZ” on one side and “448” on the other side.
Blå, plettet, rund tablet, med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med”444” på den anden side.
Blue coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Hver tablet indeholder 20 mg aripiprazol.
Each tablet contains 20 mg of aripiprazole.
I den pædiatriske population (10-17 år) med bipolær lidelse, som fik behandling i op til 30 uger, var incidensen af lav serum-prolaktin hos piger (< 3 ng/ml) og drenge (< 2 ng/ml) henholdsvis 28,0 % og
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 28.0% and 53.3%, respectively.
Aripiprazole Sandoz 30 mg tabletter er lyserøde, plettede, runde tabletter med en omtrentlig diameter på 9,0 mm, præget med ”SZ” på den ene side og med ”449” på den anden side.
Aripiprazole Sandoz30mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 9.0mm, debossed with “SZ” on one side and “449” on the other side.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg aripiprazol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of aripiprazole.
Ikke almindelig Ikke kendt muskler og bindevæv
Musculoskeletal and connective tissue disorders
Aripiprazole Sandoz 5 mg tabletter er blå, plettede, runde tabletter med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med ”444” på den anden side.
Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Aripiprazole Sandoz 5 mg tabletter Hver tablet indeholder 5 mg aripiprazol.
Aripiprazole Sandoz 5 mg tablets Each tablet contains 5 mg aripiprazole.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 30 mg aripiprazol
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole
Lyserød, plettet, rund tablet, med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med ”446” på den anden side.
Pink coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side.
Aripiprazole Sandoz 10 mg tabletter Hver tablet indeholder 10 mg aripiprazol.
Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg aripiprazole.
Disse typer medicin kan øge risikoen for bivirkninger eller reducere virkningen af Aripiprazole Sandoz.
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Sandoz; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz you should see your doctor.
Aripiprazole Sandoz 15 mg tabletter er gule, plettede, runde tabletter med en omtrentlig diameter på 7,0 mm, præget med ”SZ” på den ene side og med ”447” på den anden side.
Aripiprazole Sandoz15mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0mm, debossed with “SZ” on one side and “447” on the other side.
Aripiprazole Sandoz 30 mg tabletter
Aripiprazole Sandoz 30 mg tablets
Aripiprazole Sandoz 20 mg tabletter
Aripiprazole Sandoz 20 mg tablets
Aripiprazole Sandoz 15 mg tabletter Hver tablet indeholder 15 mg aripiprazol.
Aripiprazole Sandoz 15 mg tablets Each tablet contains 15 mg aripiprazole.
Det skal du vide, før du begynder at tage Aripiprazole Sandoz Sådan skal du tage Aripiprazole Sandoz Bivirkninger
What Aripiprazole Sandoz tablets are and what they are used for What you need to know before you take Aripiprazole Sandoz tablets How to take Aripiprazole Sandoz tablets Possible side effects
• hjerte-kar-sygdom, hjerte-kar-sygdom i familien, slagtilfælde eller mini-slagtilfælde, unormalt blodtryk
stroke or "mini" stroke, abnormal blood pressure
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg aripiprazol
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole
Aripiprazole Sandoz 10 mg tabletter er lyserøde, plettede, runde tabletter med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med ”446” på den anden side.
Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0mm, debossed with “SZ” on one side and “446” on the other side.
Aripiprazole Sandoz 10 mg tabletter
Aripiprazole Sandoz 10 mg tablets
Aripiprazole Sandoz 5 mg tabletter
Aripiprazole Sandoz 5 mg tablets
hydroxypropylcellulose, magnesiumstearat, indigotin aluminiumlak (E132).
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
Aripiprazole Sandoz 30 mg tabletter Lactosemonohydrat Majsstivelse
Aripiprazole Sandoz 30 mg tablets Lactose monohydrate Maize starch
Aripiprazole Sandoz 15 mg tabletter
Aripiprazole Sandoz 15 mg tablets
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) 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) EU/1/15/1029/014 (100 tabletter)
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)
Aripiprazole Sandoz 20 mg tabletter Lactosemonohydrat Majsstivelse
Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/061
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 20 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 20 mg
hydroxypropylcellulose, magnesiumstearat.
Hydroxypropyl cellulose
Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Domaniewska 50C 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/042
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 30 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 30 mg
Nyrer og urinveje
indinavir, ritonavir)
INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 30 mg
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 30 mg
LÆGEMIDLETS NAVN Aripiprazole Sandoz 20 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
Aripiprazole Sandoz 10 mg tabletter Lactosemonohydrat Majsstivelse
Aripiprazole Sandoz 10 mg tablets Lactose monohydrate Maize starch
Aripiprazole Sandoz 15 mg tabletter Lactosemonohydrat Majsstivelse
Aripiprazole Sandoz 15 mg tablets Lactose monohydrate Maize starch
INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 5 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
LÆGEMIDLETS NAVN Aripiprazole Sandoz 30 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 15 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg
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/1/15/1029/015 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
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)
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)
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) 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) EU/1/15/1029/061 (100 tabletter)
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)
INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 5 mg
INFORMATION IN BRAILLE Outer carton:Aripiprazole Sandoz 5 mg
INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 10 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg
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
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
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/028
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
LÆGEMIDLETS NAVN Aripiprazole Sandoz 5 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 10 mg
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg
INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 15 mg
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
LÆGEMIDLETS NAVN Aripiprazole Sandoz 15 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
LÆGEMIDLETS NAVN Aripiprazole Sandoz 10 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
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/1/15/1029/029 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
Aripiprazole Sandoz 5 mg tabletter Lactosemonohydrat Majsstivelse
Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/014
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
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
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
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
UNIQUE IDENTIFIER - 2D BARCODE [Only Carton for bottle:]
Kontakt lægen eller apoteket, hvis du mener, virkningen af Aripiprazole Sandoz er for kraftig eller for svag.
If you have the impression that the effect of Aripiprazole Sandozis too strong or too weak, talk to your doctor or pharmacist.
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)
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)
hydroxypropylcellulose, magnesiumstearat, rød jernoxid (E172).
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for PegIntron den 25. maj 2000.
The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for PegIntron.
This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Den fuldstændige EPAR for PegIntron findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for PegIntron.
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.
Hos voksne er de hyppigst forekommende bivirkninger ved PegIntron (set hos flere end 1 ud af 10 patienter) virusinfektion, faryngitis (ondt i halsen), anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer), appetitløshed, depression, angst, emotionel labilitet (humørsvingninger), nedsat koncentrationsevne, insomni (søvnbesvær), hovedpine, svimmelhed, dyspnø (vejrtrækningsbesvær), hoste, opkastning, kvalme, mavesmerter, diarré, mundtørhed, alopeci (hårtab), kløe, tør hud, udslæt, muskelsmerter, ledsmerter, smerter i muskler og knogler, reaktioner på injektionsstedet, betændelse på injektionsstedet, træthed, asteni (svaghed), irritabilitet, kulderystelser, pyreksi (feber), influenzalignende sygdom og vægttab.
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.
Da PegIntron sættes i forbindelse med bivirkninger som depression, skal patienterne overvåges nøje under behandlingen.
Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
PegIntron sættes ligeledes i forbindelse med vægttab og nedsat vækst hos børn og unge.
PegIntron is also linked to weight loss and reduced growth in children and adolescents.
CHMP besluttede, at fordelene ved PegIntron er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for PegIntron.
The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvis du ønsker yderligere oplysninger om behandling med PegIntron, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Andre oplysninger om PegIntron
Other information about PegIntron:
Behandlingen med PegIntron bør indledes og overvåges af en læge med erfaring i behandling af patienter med hepatitis C. PegIntron gives en gang om ugen som indsprøjtning under huden.
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.
Hos voksne (fra 18. år) kan PegIntron anvendes til ikke tidligere behandlede patienter eller hvor en tidligere behandling har slået fejl.
In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Hos voksne gives det i kombinationsbehandling sammen med ribavirin i en dosis på 1,5 mikrogram pr. kg legemsvægt, eller det anvendes alene i en dosis på 0,5 eller 1,0 mikrogram/kg legemsvægt.
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.
Kombinationen af PegIntron og ribavirin blev også undersøgt i en undersøgelse, der omfattede 1 354 voksne, hvis tidligere behandling var slået fejl, og i en undersøgelse, der omfattede 107 børn og unge mellem tre og 17 år, som ikke var blevet behandlet før.
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.
Hvilken risiko er der forbundet med PegIntron?
What is the risk associated with PegIntron?
PegIntron må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogen interferoner eller andre af indholdsstofferne.
PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Omkring en fjerdedel af de voksne, hvis tidligere behandling var slået fejl, og omkring to tredjedele af børnene og de unge responderede på behandling med PegIntron og ribavirin.
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.
Den tredobbelte behandling resulterede i en stigning på cirka 30 % i antallet af tidligere ubehandlede patienter, der reagerede hurtigt på behandlingen og blev helbredt.
Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
PegIntron må ikke anvendes hos patienter med en alvorlig sygdomstilstand, alvorlige leverproblemer, ukontrollerede skjoldbruskkirtelsygdomme, epilepsi eller andre problemer med centralnervesystemet.
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.