FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: tremor, paraesthesia, speech disorder.
Danish: Tremor, paræstesi, taleforstyrrelser.
English: is recommended for adults.
Danish: Opbevares utilgængeligt for børn.
English: DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION [To be completed nationally]
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Do not use Fentanyl-ratiopharm - if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product.
Danish: - hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer.
English: Psychiatric disorders Very common: somnolence.
Danish: Psykiske forstyrrelser Meget almindelige:
English: To remove hair, scissors should be used instead of razors.
Danish: Håret fjernes med saks og må ikke barberes af.
English: Skin and subcutaneous tissue disorders Very common: sweating, pruritus.
Danish: Hud og subkutane væv Meget almindelige:
English: Polyacrylate adhesive layer
Danish: Klæbelag af polyacrylat
English: Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.
Danish: Data fra intravenøse forsøg med fentanyl tyder på, at ældre patienter kan have nedsat clearance og forlænget halveringstid, og at de desuden kan være mere følsomme over for det aktive stof end yngre patienter.
English: Diamorphine Pethidine
Danish: Diamorphin Pethidin Codein Buprenorphin
English: The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Danish: Fentanyl bør ikke gives samtidig med buprenorphin, nalbuphin eller pentazocin.
English: Eye disorders Very rare:
Danish: Øjne Meget sjældne:
English: Used patches should be folded in half with the sticky sides together.
Danish: Efter brug foldes plastrene sammen på midten med klæbefladerne mod hinanden.
English: If you stop using Fentanyl-ratiopharm
Danish: Hvis De holder op med at bruge Fentanyl-ratiopharm
English: If you forget to use Fentanyl-ratiopharm
Danish: Hvis De har glemt at bruge Fentanyl-ratiopharm
English: the CHMP has recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet which are set out in Annex III for Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names (see Annex I).
Danish: anbefalede CHMP på grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og den faglige drøftelse i udvalget udstedelse af de markedsføringstilladelse(r) og ændring af det produktresumé og den etikettering og indlægsseddel, der fremgår af bilag III, for Fentanyl "ratiopharm" og tilknyttede navne - se bilag I.
English: Put back used patches in the outer package and discard or whenever possible hand in to your pharmacist.
Danish: De brugte plastre lægges tilbage i yderemballagen og bortskaffes eller indleveres om muligt på apoteket.
English: Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.
Danish: Abstinenssymptomer kan bestå i kvalme, opkastning, diaré og kuldegysninger.
English: Use in elderly patients Elderly should be observed carefully and the dose reduced if necessary (see sections 4.4 and 5.2).
Danish: Anvendelse til ældre Ældre bør observeres nøje, og doseringen reduceres efter behov (se pkt.
English: Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Danish: Derfor bør amningen indstilles i mindst 72 timer efter fjernelse af Fentanyl-ratiopharm.
English: As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Danish: Fentanyl udskilles i modermælk, og amning bør derfor indstilles under behandling med Fentanylratiopharm (se også pkt.
English: Each patch of 15 cm2 contains 8.25 mg fentanyl.
Danish: 1 plaster på 15 cm2 indeholder 8,25 mg fentanyl.
English: Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
Danish: Uregelmæssig hjerterytme (rytmeforstyrrelser), udvidede blodkar, hikke, vandophobning i væv, kuldefornemmelse.
English: As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
Danish: Da ydersiden af depotplasteret er beskyttet af vandtæt folie, kan patienten have det på i brusebad.
English: Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Danish: 1 plaster på 7,5 cm2 indeholder 4,125 mg fentanyl.
English: The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section
Danish: Fentanyl bør ikke anvendes samtidig med buprenorphin, nalbuphin eller pentazocin (se også pkt.
English: Itching will usually disappear within one day after the patch has been removed.
Danish: Kløen går normalt væk i løbet af et døgns tid, når plasteret tages af.
English: Active substance Parenteral (im) Oral
Danish: Aktivt stof
English: Renal and urinary disorders Uncommon: urinary retention.
Danish: Nyrer og urinveje Ikke almindelige:
English: - As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
Danish: - Da ydersiden af depotplasteret er beskyttet af vandtæt folie, kan patienten have det på i brusebad.
English: Each patch of 30 cm2 contains 16.5 mg fentanyl.
Danish: 1 plaster på 30 cm2 indeholder 16,5 mg fentanyl.
English: If you get pregnant during treatment with Fentanyl-ratiopharm, consult your doctor.
Danish: Tal med Deres læge, hvis De bliver gravid under behandlingen med Fentanyl ratiopharm depotplaster.
English: In this leaflet:
Danish: Eftersom indbringelsen vedrørte:
English: Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your fentanyl transdermal patch starts working completely.
Danish: Derfor vil lægen måske give Dem ekstra smertemedicin, indtil Deres fentanyl depotplaster opnår sin fulde virkning.
English: Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Danish: 1 plaster på 22,5 cm2 indeholder 12,375 mg fentanyl.
English: Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
Danish: Udslæt og rødmen går normalt væk i løbet af et døgns tid, når plasteret tages af.
English: How to apply Fentanyl-ratiopharm - Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes.
Danish: - Find et jævnt, ubestrålet område på overkroppen eller overarmen, hvor huden er fri for hår, småsår, knopper eller andre uregelmæssigheder.
English: Very common: sweating, pruritus.
Danish: Svedudbrud, pruritus.
English: 75 µg/h transdermal patch transdermal use 12.375 mg/22.5 cm² which release 75 µg fentanyl per hour
Danish: 12.375 mg/22.5 cm² som frigiver 75 mikrogram per time
English: Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see section 4.4).
Danish: Patienter med nedsat lever- eller nyrefunktion bør observeres nøje, og dosis reduceres efter behov (se pkt.
English: arrhythmia.
Danish: Anafylaksi.
English: Drug dependence
Danish: Afhængighed
English: Fold used patches and discard or return to the pharmacy.
Danish: Det brugte plaster foldes sammen og smides ud eller afleveres på apoteket.
English: PHARMACEUTICAL FORM AND CONTENTS 1 transdermal patch
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 depotplaster
English: Very common: headache, dizziness.
Danish: Hovedpine, svimmelhed.
English: Following intramuscular or subcutaneous administration the onset of action will be slower compared with intravenous administration.
Danish: Virkningen vil være længere om at indtræffe efter en intramuskulær eller subkutan injektion end efter intravenøs administration.
English: Finally, since Fentanyl ratiopharm is a matrix patch for which the release is proportional to the surface area, dose proportionality is expected and a bioequivalence study with the highest strength is not deemed necessary, nor an additional replicate design study.
Danish: Endelig må dosisproportionalitet forventes, da Fentanyl "ratiopharm" er et matrixplaster, fra hvilket afgivelsen er proportional med overfladearealet.
English: Impaired liver function
Danish: Nedsat nyrefunktion
English: Patients with hepatic impairment should be observed carefully and the dose reduced if necessary.
Danish: Patienter med nedsat leverfunktion bør holdes under nøje observation, og om nødvendigt reduceres dosis.
English: [20 transdermal patches:] Date
Danish: [20 depotplastre:] Dato
English: This applies, for example, to: - medicines used for treating anxiety (tranquillisers) - medicines used for treating depression (antidepressants) - medicines used for treating psychological disorders (neuroleptics) - anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Fentanyl-ratiopharm - medicines used for treating sleep disorders (hypnotics, sedatives) - medicines used for treating allergies or travel sickness (antihistamines/antiemetics) - other strong-acting painkillers (opioids) - alcohol
Danish: De får Fentanyl-ratiopharm - medicin mod søvnforstyrrelser (hypnotika, sedativa) - medicin til behandling af allergi eller transportsyge (antihistaminer/antiemetika) - andre stærkt virkende smertestillende midler (opioider) - alkohol
English: Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.
Danish: Bevidsthedssvækkelse, hovedpine, svimmelhed, kvalme, opkastning, forstoppelse, svedudbrud, kløe.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket, hvis der er noget, De er i tvivl om eller følger Dem usikker på.
English: 100 µg/h transdermal patch transdermal use 16.5 mg/30 cm² which release 100 µg fentanyl per hour
Danish: 16.5 mg/30 cm² som frigiver 100 mikrogram per time
English: Each patch releases 100 micrograms fentanyl per hour.
Danish: 1 depotplaster frigiver 100 mg fentanyl i timen.
English: [5 transdermal patches:] Date
Danish: [5 depotplastre:] Dato
English: 25 µg/h transdermal patch transdermal use 4.125 mg/7.5 cm² which release 25 µg fentanyl per hour
Danish: 4.125 mg/7.5 cm² som frigiver 25 mikrogram per time
English: If these medicines are taken together this may enhance their toxicity.
Danish: De må ikke anvende disse lægemidler sammen med Fentanylratiopharm, da det kan øge deres giftige virkning (toksicitet).
English: If you do stop using the patches you may feel unwell.
Danish: De kan blive utilpas, hvis De stopper brugen af plastrene.
English: 50 µg/h transdermal patch transdermal use 8.25 mg/15 cm² which release 50 µg fentanyl per hour
Danish: 8.25 mg/15 cm² som frigiver 50 mikrogram per time
English: Take special care with Fentanyl-ratiopharm
Danish: Vær ekstra forsigtig med at bruge Fentanyl-ratiopharm
English: Therefore, the CHMP recommends that, according to the above mentioned guideline, this aspect should be mentioned in section 4.5 of the SPC with cross reference to section 4.4 “concomitant use not recommended” rather than a contra-indication.
Danish: 4.4 "sideløbende anvendelse anbefales ikke" i stedet for som en kontraindikation.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each patch releases 100 micrograms fentanyl per hour.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster frigiver 100 mikrogram fentanyl i timen.
English: Each patch releases 75 micrograms fentanyl per hour.
Danish: 1 depotplaster frigiver 75 mg fentanyl i timen.
English: Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I)
English: [3 transdermal patches:] Date
Danish: [3 depotplastre:] Dato
English: Polyacrylate adhesive layer Polypropylene foil
Danish: Klæbelag: Klæbelag af polyacrylat
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 100 micrograms fentanyl per hour.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 100 mikrogram fentanyl i timen.
English: Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, hypoventilation.
Danish: Luftveje, thorax og mediastinum Ikke almindelige:
English: [10 transdermal patches:] Date
Danish: [10 depotplastre:] Dato
English: Transdermal patch
Danish: Merckle GmbH
English: anaphylaxis.
Danish: Urinretention.
English: HOW TO USE Fentanyl-ratiopharm
Danish: SÅDAN SKAL DE BRUGE FENTANYL-RATIOPHARM
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each patch releases 25 micrograms fentanyl per hour.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster frigiver 25 mikrogram fentanyl i timen.
English: HOW TO STORE Fentanyl-ratiopharm
Danish: SÅDAN OPBEVARER DE FENTANYL-RATIOPHARM
English: Besides controversial literature results on the efficacy and safety of fentanyl transdermal in chronic non cancer pain, the CHMP recognised that, in special circumstances, strong opioids could be of help for the treatment of this condition.
Danish: CHMP tilsluttede sig, at stærkt virkende opioider under særlige omstændigheder kan tænkes at være til gavn til denne indikation.
English: Nervous system disorders
Danish: Nervesystemet Meget almindelige:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 75 micrograms fentanyl per hour.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 75 mikrogram fentanyl i timen.
English: Each patch releases 25 micrograms fentanyl per hour.
Danish: 1 depotplaster frigiver 25 mg fentanyl i timen.
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 100 µg/h“.
Danish: Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 100 µg/h“.
English: After switching from previously prescribed opioid analgesics to Fentanyl-ratiopharm or after abrupt discontinuation of therapy patients may show opioid withdrawal symptoms (for instance: nausea, vomiting, diarrhoea, anxiety and shivering).
Danish: Symptomer på opioidabstinenser (fx kvalme, opkastning, diaré, angst og kuldegysninger) kan forekomme hos patienter efter skift fra de hidtil anvendte opioidanalgetika til Fentanyl-ratiopharm eller efter brat seponering af lægemidlet.
English: Fentanyl-ratio 100µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 µg/uur United Kingdom Ribofen 100 microgram/hr Transdermal patch
Danish: Fentanilo Matrix ratiomed 100microgramos/h parches transdérmicos EFG Storbritannien Ribofen 100 microgram/hr Transdermal patch Tyskland
English: If you forget, then change your patch as soon as you remember.
Danish: Hvis De glemmer at skifte plasteret, skal De gøre det, så snart De kommer i tanke om det.
English: Each transdermal patch is packed in a separate sachet.
Danish: 6.7 Emballagetype og pakningsstørrelser Depotplastrene er pakket hver for sig i breve.
English: Your doctor will decide which strength of Fentanyl-ratiopharm is most suitable for you.
Danish: - Lægen har ordineret Fentanyl-ratiopharm til Dem personligt.
English: Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 25 micrograms fentanyl per hour.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 25 mikrogram fentanyl i timen.
English: Each patch releases 50 micrograms fentanyl per hour.
Danish: 1 depotplaster frigiver 50 mg fentanyl i timen.
English: Before starting to use Fentanyl-ratiopharm you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of fentanyl.
Danish: Før De begynder at bruge Fentanyl-ratiopharm, skal De fortælle det til Deres læge, hvis De har en af følgende sygdomme.
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 75 µg/h“.
Danish: Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 75 µg/h“.
English: Do not discontinue treatment without consulting your doctor.
Danish: Ændring eller stop i behandlingen bør kun ske i samråd med lægen.
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Danish: Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt]
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis De står for at skulle bedøves, bør De fortælle lægen eller tandlægen, at
English: Codeine
Danish: Amning
English: BEFORE YOU USE Fentanyl-ratiopharm
Danish: Brug ikke Fentanyl-ratiopharm
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 50 micrograms fentanyl per hour.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 50 mikrogram fentanyl i timen.
English: The assessment of side effects is based on the following frequency data: Very common more than 1 in 10 patients
Danish: Meget sjældne hos færre end 1 ud af 10.000 patienter, inklusive enkeltstående rapporter
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Danish: Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl
English: The Netherlands ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Danish: Nederlandene ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 50 µg/h“.
Danish: Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 50 µg/h“.
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 25 µg/h“.
Danish: Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 25 µg/h“.
English: Morphine
Danish: Peroralt
English: Fentanyl-ratio 75 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 µg/uur United Kingdom Ribofen 75 microgram/hr Transdermal patch
Danish: Fentanilo Matrix ratiomed 75 microgramos/h parches transdérmicos EFG Storbritannien Ribofen 75 microgram/hr Transdermal patch Tyskland
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Danish: Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt]
English: Germany ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Danish: Tyskland ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Danish: Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Danish: Fentanyl-ratiopharm 50 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt]
English: Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 50 µg/h TTS og andre berørte navne (se Vedlæg I)
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Danish: Fentanyl-ratiopharm 25 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt]
English: United Kingdom ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Danish: Det Forenede Kongerige ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Danish: Fentanyl-ratiopharm 50 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl
English: Paediatric population
Danish: Særlige populationer
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: France ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Danish: Frankrig ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Danish: Fentanyl-ratiopharm 25 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl
English: Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 25 µg/h TTS og andre berørte navne (se Vedlæg I)
English: Ketobemidone 10
Danish: Ludwig-Merkle-Str. 3
English: Adhesive layer
Danish: LISTE OVER HJÆLPESTOFFER
English: Fentanyl-ratio 50 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 µg/uur United Kingdom Ribofen 50 microgram/hr Transdermal patch
Danish: Fentanilo Matrix ratiomed 50 microgramos/h parches transdérmicos EFG Storbritannien Ribofen 50 microgram/hr Transdermal patch Tyskland
English: Adhesive layer: Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Klæbelag Klæbelag af polyacrylat Bagsidefolie Polypropylenfolie Blåt blæk Beskyttelsesfolie Polyethylenterephthalatfolie (silikonebehandlet) 6.2 Uforligeligheder Ikke relevant.
English: Uncommon: diarrhoea.
Danish: Dyspnø, hypoventilation.
English: Fentanyl-ratio 25 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 µg/uur United Kingdom Ribofen 25 microgram/hr Transdermal patch
Danish: Fentanilo Matrix ratiomed 25 microgramos/h parches transdérmicos EFG Storbritannien Ribofen 25 microgram/hr Transdermal patch Tyskland
English: Significant increases in body temperature can potentially increase fentanyl absorption rate.
Danish: De indebærer en større risiko for bivirkninger, og lægen vil måske give Dem en lavere dosis fentanyl.
English: Registration of a manufacturing site for the active substance, finished product and batch release.
Danish: registrering af et fremstillingssted for det aktive stof, det færdige lægemiddel og batchfrigivelse.
English: For the suspension to be lifted, the marketing authorisation holder for MACI shall provide the following:
Danish: For at suspenderingen kan ophæves, skal indehaveren af markedsføringstilladelsen for MACI forelægge følgende:
English: Conditions for lifting the suspension of the manufacturing authorisation
Danish: Betingelser for ophævelse af suspenderingen af fremstillingstilladelsen
English: 8 October 2012
Danish: Den 8. oktober 2012
English: The final opinion was converted into a Decision by the European Commission on 8 October 2012.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 8. oktober
English: The referral procedure started on 11 November 2010.
Danish: Indbringelsesproceduren blev indledt den 11. november 2010.
English: The Committee adopted a positive opinion by majority on 14 June 2012.
Danish: Udvalget vedtog ved flertalsafgørelse en positiv udtalelse den 14. juni 2012.
English: The Committee appointed Mrs Ruth Kearsley, who was later replaced by Ms Helen Jukes, as rapporteur and Dr Lotte Winther, who was later replaced by Dr Ellen-Margrethe Vestergaard, as co-rapporteur.
Danish: Udvalget udpegede Ruth Kearsley, der efterfølgende blev afløst af Helen Jukes, som rapportør, og dr. Lotte Winther, der senere blev afløst af dr. Ellen-Margrethe Vestergaard, som co-rapportør.