FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: (lægemiddelovervågning eller risikominimering) er nået.
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Danish: Den ydre side af bagsidelaget er beige og påtrykt ”Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h eller 8 mg/24 h”.
English: Leganto may decrease blood pressure when you stand up
Danish: Leganto kan nedsætte blodtrykket, når De rejser Dem opdette kan forværres af den medicin, som anvendes til at sænke blodtrykket.
English: • generalised rash
Danish: • generaliseret udslæt
English: • feeling irritable
Danish: • irritabilitet
English: Leganto 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 8 mg/24 h'.
Danish: Leganto 8 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Leganto 8 mg/24 h”.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige bivirkninger: kan forekomme hos op til 1 ud af 100 personer
English: The precise mechanism of action of rotigotine as a treatment of RLS is unknown.
Danish: Rotigotins præcise virkningsmekanisme ved behandling af restless legs-syndrom er ikke kendt.Det menes, at rotigotins virkning primært udøves via dopaminreceptorer.
English: Leganto 1 mg/24 h transdermal patch Leganto 3 mg/24 h transdermal patch
Danish: Leganto 1 mg/24 timer depotplaster Leganto 3 mg/24 timer depotplaster
English: dry mouth e, abdominal pain e, diarrhoea c
Danish: Forstoppelsee, mundtørhede, abdominalsmer tere, diarré
English: Sleep attacks/sudden onset of sleep, sexual desire disorders a
Danish: Søvnanfald/plu dselig søvn, forstyrret seksuel adfærda
English: The outside is tan-coloured and is imprinted with Leganto 4 mg/24 h Leganto 6 mg/24 h or Leganto 8 mg/24 h.
Danish: Ydersiden er beige og påtrykt Leganto 4 mg/24 h eller Leganto 6 mg/24 h eller Leganto 8 mg/24 h.
English: Warnings and precautions Talk to your doctor or pharmacist before using Leganto.
Danish: Kontakt lægen eller apotekspersonalet, før De bruger Leganto.
English: Abdominal pain
Danish: Abdominalsme rter
English: • 8 mg/24 h: Each patch releases 8 mg of rotigotine per 24 hours.
Danish: • 8 mg/24 timer Hvert plaster afgiver 8 mg rotigotin pr. 24 timer.
English: The outside is tan-coloured and is imprinted with Leganto 1 mg/24 h or 3 mg/24 h.
Danish: Ydersiden er beige og påtrykt Leganto 1 mg/24 h eller Leganto 3 mg/24 h.
English: At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects receiving placebo (Difference rotigotine versus placebo 25%, CI95% 13%; 36%, difference pramipexole versus placebo 32%, CI95% 21%; 43%, difference pramipexole versus rotigotine 7%, CI95% -2%; 17%).
Danish: Ved slutningen af vedligeholdelsesbehandlingen sås en bedring på mindst 30% hos 60% af forsøgspersonerne, som fik rotigotin, 67% af patienterne, som fik pramipexol og 35% af patienterne, som fik placebo (forskel rotigotin vs.placebo 25%, CI95% 13%; 36%, forskel pramipexol vs.placebo 32%, CI95% 21%; 43%, forskel pramipexol vs. rotigotin 7%, CI95%-2%; 17%).Middelreduktionen i “off”-tid var 2,5 timer i rotigotin-armen, 2,8 timer i pramipexol-armen og 0,9 timer i placebo-armen.
English: • 4 mg/24 h:
Danish: • 4 mg/24 timer:
English: Application site skin reactions may occur and are usually mild or moderate in intensity.
Danish: Intensiteten af disse er som regel lette eller moderate.
English: A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h.
Danish: En daglig enkeltdosis bør indledes med 4 mg/24t og øges i ugentlige trin på 2mg/24t, til der opnås en effektiv dosis.
English: • To help avoid the skin reactions, you should put the patch on a different area of skin every day,
Danish: • For at undgå hudreaktioner, bør De sætte plasteret på forskellige steder hver dag, og kun bruge det samme område igen efter 14 dage.
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h'.
Danish: Den ydre side af bagsidelaget er beige og påtrykt ”Leganto 2 mg/24 h”.
English: Tell your doctor if you get any changes in behaviour, thinking or both, that are listed below.
Danish: Fortæl det til lægen, hvis De oplever ændringer i Deres adfærd, tankegang eller begge dele, se nedenstående liste.
English: pathological gambling, stereotypy/ punding, binge eating/eating disorder b, compulsive shopping c)
Danish: ludomani, stereotypi/tvan gshandlinger, uhæmmet madindtagelse/ spiseforstyrrels eb, overdrevent indkøbsmønster
English: The strengths are 1 mg/24 h, 2 mg/24 h, 3 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h. The patches of 1 mg/24 h and 3 mg/24 h are used for the treatment of Restless Leg Syndrome, while the patches of 4 mg/24 h, 6 mg/24 h and 8 mg/24 h are used for the treatment of Parkinson's disease.
Danish: Plastrene på 1 mg/24 timer og 3 mg/24 timer bruges til behandlingen afrestless legs-syndrom, mens plastrene på 4 mg/24 timer, 6 mg/24 timer og 8 mg/24 timer bruges til behandlingen af Parkinsons sygdom.
English: Convulsion Dropped head syndrome c
Danish: Dropped head syndromc
English: A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h.
Danish: En daglig enkeltdosis bør indledes med 2 mg/24 t og øges i ugentlige trin på 2 mg/24 t, til der opnås en effektiv dosis.
English: AST, ALT, GGT), weight increased, heart rate increased, CPK increased d
Danish: ASAT, ALAT, GGT), vægtøgning, øget puls, forhøjet CKd
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation,
Danish: erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, eksfoliation,
English: How to use the patch
Danish: Hvordan anvendes plasteret?
English: This makes the S-shaped break in the liner open up.
Danish: • Bøj plasteret på midten, så der kommer en S-formet åbning i den aftagelige beskyttelsesfilm.
English: At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001).
Danish: Der sås en forbedring på 20% hos 48% af patienterne, som fik rotigotin og hos 19% af patienterne, som fik placebo (forskel 29%, CI95% 18%; 39%, p<0,0001).
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditions a
Danish: erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, eksfoliation, urticaria, overfølsomhed) , asteniske
English: • Press the sticky side of the patch firmly into place.
Danish: • Pres plasterets klæbende side mod huden med et fast tryk.
English: • Each patch releases 2 mg of rotigotine per 24 hours.
Danish: • Hvert plaster afgiver 2 mg rotigotin pr. 24 timer.
English: - this effect may be worsened by the medicines used to lower blood pressure.
Danish: Leganto kan nedsætte blodtrykket, når De rejser Dem op dette kan forværres af den medicin, som anvendes til at sænke blodtrykket.
English: Leganto 2 mg/24 h Leganto 4 mg/24 h Leganto 6 mg/24 h Leganto 8 mg/24 h Transdermal patch
Danish: Leganto 2 mg/24 timer Leganto 4 mg/24 timer Leganto 6 mg/24 timer Leganto 8 mg/24 timer
English: Leganto 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 6 mg/24 h'.
Danish: Leganto 6 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Leganto 6 mg/24 h”.
English: Leganto 8 mg/24 h transdermal patch Each patch releases 8 mg of rotigotine per 24 hours.
Danish: Leganto 8 mg/24 timer depotplaster Hvert plaster afgiver 8 mg rotigotin pr. 24 timer.
English: 7 transdermal patches of Leganto 6 mg/24 h
Danish: 7 depotplastre med Leganto 6 mg/24 timer
English: Leganto 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Danish: Leganto 2 mg/24 timer 4 mg/24 timer 6 mg/24 timer 8 mg/24 timer
English: Hiccups
Danish: Hikkee
English: • falling
Danish: • fald
English: Each patch releases 1 mg of rotigotine per 24 hours.
Danish: Hvert plaster afgiver 1 mg rotigotin pr. 24 timer.
English: BOX OF 7 PATCHES - WEEK 1
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 7 PLASTRE - UGE 1
English: Observed in 2011 data pool of double-blind placebo-controlled studies e
Danish: Fald a) Overordnet begreb (high level term) b) Observeret i åbne studier c) Observeret efter markedsføring d) Observeret i data pool af dobbeltblinde, placebokontrollerede studier i 2011
English: Leganto 8 mg/24 h transdermal patch EU/1/11/695/046
Danish: Leganto 8 mg/24 timer depotplaster EU/1/11/695/046
English: Nausea, vomiting Constipation, dry mouth, dyspepsia
Danish: Forstoppelse, mundtørhed, dyspepsi
English: Discontinuation rate
Danish: Bivirkningstabel
English: Leganto 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 4 mg/24 h'.
Danish: Leganto 4 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Leganto 4 mg/24 h”.
English: Perception disturbances a
Danish: Bevidsthedsfor styrrelser NEC a (inkl.
English: 7 transdermal patches of Leganto 8 mg/24 h
Danish: 7 depotplastre med Leganto 8 mg/24 timer
English: The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Danish: Ydersiden er beige og påtrykt Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h eller 8 mg/24 h.
English: What Leganto is used for
Danish: Sådan skal Leganto -plasteret bruges
English: Leganto 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
Danish: Leganto 1 mg/24 timer depotplaster Hvert plaster afgiver 1 mg rotigotin pr. 24 timer.
English: BOX OF 7 PATCHES - WEEK 2
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 7 PLASTRE - UGE 2
English: Leganto 8 mg/24 h
Danish: Leganto 8 mg/24 timer
English: Each patch releases 8 mg of rotigotine per 24 hours.
Danish: Hvert plaster afgiver 8 mg rotigotin pr. 24 timer.
English: SACHET LABEL - WEEK 1
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV ETIKET - UGE 1
English: 7 transdermal patches of Leganto 4 mg/24 h
Danish: 7 depotplastre med Leganto 4 mg/24 timer
English: The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h.
Danish: Ydersiden er beige og påtrykt Leganto 2 mg/24 h.
English: Leganto is available in different strength patches which release the medicine over 24 hours.The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Danish: Styrkerne er: 1 mg/24 timer, 2 mg/24 timer og 3 mg/24 timer til behandlingen afrestless legs-syndrom.
English: BOX OF 7 PATCHES - WEEK 3
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 7 PLASTRE - UGE 3
English: BOX OF 7 PATCHES - WEEK 4
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 7 PLASTRE - UGE 4
English: SACHET LABEL - WEEK 2
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV ETIKET - UGE 2
English: Each patch releases 6 mg of rotigotine per 24 hours.
Danish: Hvert plaster afgiver 6 mg rotigotin pr. 24 timer.
English: • 6 mg/24 h: Each patch releases 6 mg of rotigotine per 24 hours.
Danish: • 6 mg/24 timer Hvert plaster afgiver 6 mg rotigotin pr. 24 timer.
English: • If the patch has irritated your skin, keep that area protected from direct sunlight.
Danish: • Beskyt det pågældende hudområde mod direkte sollys, hvis plasteret har irriteret huden.
English: • delusion
Danish: • kvalme
English: • Thigh or hip.
Danish: • Lår eller hofte.
English: ANNEX I
Danish: BILAG I PRODUKTRESUME
English: • headache
Danish: • hikke
English: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and
Danish: Poly(dimethylsiloxan, trimethylsilylsilikat)-copolymerisat, Povidone K90,
English: leganto 6 mg/24 h
Danish: Leganto 6 mg/24 timer
English: • 3 mg/24 h: Each patch releases 3 mg of rotigotine per 24 hours.
Danish: • 3 mg/24 timer Hvert plaster afgiver 3 mg rotigotin pr. 24 timer.
English: Leganto 6 mg/24 h transdermal patch EU/1/11/695/037
Danish: Leganto 6 mg/24 timer depotplaster EU/1/11/695/037
English: Leganto 1 mg/24 h transdermal patch EU/1/11/695/001
Danish: Leganto 1 mg/24 timer depotplaster EU/1/11/695/001
English: SACHET LABEL - WEEK 4
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV ETIKET - UGE 4
English: Leganto 3 mg/24 h transdermal patch EU/1/11/695/019
Danish: Leganto 3 mg/24 timer depotplaster EU/1/11/695/019
English: Leganto 2 mg/24 h
Danish: Leganto 2 mg/24 timer
English: Hepatic and renal impairment
Danish: • træthed eller svimmelhed
English: Renal impairment
Danish: Sanseforstyrrel sera
English: • 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
Danish: • 2 mg/24 timer: Hvert plaster afgiver 2 mg rotigotin pr. 24 timer.
English: • From the second week your daily dose will be increased by 2 mg each week - until you get to the right maintenance dose for you.
Danish: • Fra uge 2 vil den daglige dosis blive øget med 2 mg hver uge - indtil den passende vedligeholdelsesdosis er nået for Dem.
English: hallucination, hallucination visual, hallucination auditory, illusion), nightmare e,
Danish: hallucinationer, visuelle hallucinationer, auditive hallucinationer, illusioner), mareridte, paranoiae, forvirringe, psykotisk lidelsee, vrangforestillin gere, deliriume
English: Leganto 6 mg/24 h transdermal patch Each patch releases 6 mg of rotigotine per 24 hours.
Danish: Leganto 6 mg/24 timer depotplaster Hvert plaster afgiver 6 mg rotigotin pr. 24 timer.
English: Leganto 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Danish: Leganto 4 mg/24 timer depotplaster Hvert plaster afgiver 4 mg rotigotin pr. 24 timer.
English: • feeling agitated
Danish: • rastløs uro
English: • From the second week, your daily dose may be increased by 1 mg each week - until you get to the right maintenance dose for you.
Danish: • Fra uge 2 kan Deres daglige dosis øges med 1 mg hver uge - indtil den passende vedligeholdelsesdosis er nået for Dem.
English: leganto 4 mg/24 h
Danish: Leganto 4 mg/24 timer
English: • Your starting dose will be one 1 mg/24 h patch each day.
Danish: • Deres startdosis vil være et 1 mg/24 timer plaster hver dag.
English: Leganto 8 mg/24 h transdermal patch rotigotine
Danish: Leganto 8 mg/24 timer depotplaster rotigotin
English: Each patch releases 3 mg of rotigotine per 24 hours.
Danish: Hvert plaster afgiver 3 mg rotigotin pr. 24 timer.
English: What Leganto is and what it is used for What you need to know before you use Leganto How to use Leganto
Danish: Det skal De vide, før De begynder at bruge Leganto Sådan skal De bruge Leganto Bivirkninger
English: Treatment discontinuation
Danish: Behandling
English: Leganto 4 mg/24 h transdermal patch EU/1/11/695/028
Danish: Leganto 4 mg/24 timer depotplaster EU/1/11/695/028
English: Leganto 3 mg/24 h transdermal patch Each patch releases 3 mg of rotigotine per 24 hours.
Danish: Leganto 3 mg/24 timer depotplaster Hvert plaster afgiver 3 mg rotigotin pr. 24 timer.
English: Transdermal patch
Danish: Mave-tarmkanalen
English: Each patch releases 4 mg of rotigotine per 24 hours.
Danish: Hvert plaster afgiver 4 mg rotigotin pr. 24 timer.
English: EU/1/11/695/007 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/007 [84 depotplastre (3 pakninger a 28)]
English: • From the second week your daily dose may be increased by 2 mg each week - until you get to the right maintenance dose for you.
Danish: • Fra uge 2 kan den daglige dosis blive øget med 2 mg hver uge - indtil den passende vedligeholdelsesdosis er nået for Dem.
English: Each patch releases 2 mg of rotigotine per 24 hours.
Danish: Hvert plaster afgiver 2 mg rotigotin pr. 24 timer.
English: SACHET LABEL - WEEK 3
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV ETIKET - UGE 3
English: Leganto 2 mg/24 h transdermal patch Each patch releases 2 mg of rotigotine per 24 hours.
Danish: Leganto 2 mg/24 timer depotplaster Hvert plaster afgiver 2 mg rotigotin pr. 24 timer.
English: • 2 mg/24 h:
Danish: • 6 mg/24 timer:
English: • Your starting daily dose will be one 4 mg/24 h patch each day.
Danish: • Deres startdosis vil være et 4 mg/24 timer plaster hver dag.
English: EU/1/11/695/016 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/016 [84 depotplastre (3 pakninger a 28)]
English: Leganto 6 mg/24 h transdermal patch rotigotine
Danish: Leganto 6 mg/24 timer depotplaster rotigotin
English: MedDRA
Danish: Dosering
English: Leganto 4 mg/24 h transdermal patch Leganto 6 mg/24 h transdermal patch Leganto 8 mg/24 h transdermal patch
Danish: Leganto 4 mg/24 timer depotplaster Leganto 6 mg/24 timer depotplaster Leganto 8 mg/24 timer depotplaster
English: EU/1/11/695/043 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/043 [84 depotplastre (3 pakninger a 28)]
English: Leganto 3 mg/24 h transdermal patch rotigotine
Danish: Leganto 3 mg/24 timer depotplaster rotigotin
English: leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Danish: INFORMATION I BRAILLESKRIFT leganto 2 mg/24 timer, 4 mg/24 timer, 6 mg/24 timer, 8 mg/24 timer
English: • constipation, dry mouth
Danish: • forstoppelse, mundtørhed
English: EU/1/11/695/052 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/052 [84 depotplastre (3 pakninger a 28)]
English: Leganto 4 mg/24 h transdermal patch rotigotine
Danish: Leganto 4 mg/24 timer depotplaster rotigotin
English: • Your starting daily dose will be one 2 mg/24 h patch each day.
Danish: • Deres startdosis vil være et 2 mg/24 timer plaster hver dag.
English: EU/1/11/695/025 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/025 [84 depotplastre (3 pakninger a 28)]
English: Leganto 2 mg/24 h transdermal patch Rotigotine
Danish: Leganto 2 mg/24 timer depotplaster rotigotin
English: Dizziness e, disturbances in consciousness NECe (incl.
Danish: Perifert ødem, asteniske tilstandea (inkl.
English: Somnolence, dizziness, headache
Danish: Nervesystemet Døsighed, svimmelhed, hovedpine
English: Multipack: 84 (3 packs of 28) transdermal patches
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 84 (3 pakninger a 28) depotplastre.
English: Heat application
Danish: Varmepåvirkning
English: EU/1/11/695/034 [84 transdermal patches (3 packs of 28)]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/034 [84 depotplastre (3 pakninger a 28)]
English: • feeling sick (nausea), vomiting
Danish: • kvalme, opkastning
English: Do not breast-feed during treatment with Leganto.This is because rotigotine may pass into your breast milk and affect your baby.
Danish: Graviditet og amning Brug ikke Leganto, hvis De er gravid da rotigotins effekt på graviditet og det ufødte barn ikke kendes.
English: If you use more Leganto than you should
Danish: Hvis De har brugt for mange Leganto-plastre
English: EU/1/11/695/001 [7 transdermal patches] EU/1/11/695/003 [28 transdermal patches] EU/1/11/695/004 [30 transdermal patches]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/001[7 depotplastre]
English: EU/1/11/695/037 [7 transdermal patches] EU/1/11/695/039 [28 transdermal patches] EU/1/11/695/040 [30 transdermal patches]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/037[7 depotplastre]
English: EU/1/11/695/028 [7 transdermal patches] EU/1/11/695/030 [28 transdermal patches] EU/1/11/695/031 [30 transdermal patches]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/695/028 [7 depotplastre]
English: This summary was last updated in 08-2007.©EMEA 2007
Danish: Dette sammendrag blev sidst ajourført i 08-2007.©EMEA 2007
English: Hypersensitivity (allergic reactions) has sometimes been seen.
Danish: Overfølsomhed (allergiske reaktioner) er undertiden forekommet.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eut http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Additionally, any improvement in skin lesions was monitored.
Danish: Desuden blev forbedringen i hudforandringerne overvåget.
English: The marketing authorisation was renewed on 16 July
Danish: Markedsføringstilladelsen blev fornyet den 16. juli 2006.
English: The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for CEPROTIN med gyldighed i hele Den Europæiske Union til Baxter AG den 16. juli 2001.
English: As the company had supplied the additional information requested, the 'Exceptional Circumstances' ended on 28 July 2006.
Danish: Da firmaet har fremlagt de supplerende oplysninger, der var anmodet om, ophørte markedsføringstilladelsen med at være ”under særlige omstændigheder” den 28. juli 2006.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger på grundlag af CHMPs anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: The full EPAR for CEPROTIN is available here.
Danish: Den fuldstændige EPAR for CEPROTIN findes her.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) CEPROTIN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) CEPROTIN EPAR - sammendrag for offentligheden
English: CEPROTIN was originally authorised under 'Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease.
Danish: CEPROTIN blev oprindelig godkendt på "særlige vilkår", da det ikke på daværende tidspunkt var muligt at undersøge lægemidlet fuldstændigt, fordi så få patienter havde fået stillet denne diagnose.
English: The Committee recommended that CEPROTIN be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for CEPROTIN.
English: CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
Danish: CEPROTIN gives ved intravenøs injektion (indsprøjtning i en vene) med en indsprøjtningshastighed på højst 2 ml i minuttet undtagen til børn med kropsvægt under 10 kg, for hvilke indsprøjtningshastigheden ikke må være over 0,2 ml pr. kg kropsvægt pr. minut.
English: It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Formålet er at forklare, hvordan Udvalget for Humanmedicinske Lægemidlers (CHMP) vurdering af de gennemførte undersøgelser førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.