natgillin/translations-raw huggingface dataset:
Ketobemidon Tabel 2: Anbefalet initialdosis af transdermalt fentanyl ud fra daglig peroral morphindosis (for patienter med behov for opioidrotation) Peroral morphindosis (mg/døgn) 
Table 2: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Fentanyl-ratiopharm kan have livstruende bivirkninger hos personer, der ikke regelmæssigt får opioider på recept. 
Bear in mind that the design of this medicinal product could be tempting to a child. Fentanyl-ratiopharm can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Smerter i urinblæren, oliguri. 
cystalgia, oliguria.
Tremor, paræstesi, taleforstyrrelser. 
Uncommon: tremor, paraesthesia, speech disorder.
Opbevares utilgængeligt for børn. 
is recommended for adults.
DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION [To be completed nationally]
- hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer. 
Do not use Fentanyl-ratiopharm - if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product.
Psykiske forstyrrelser Meget almindelige: 
Psychiatric disorders Very common: somnolence.
Håret fjernes med saks og må ikke barberes af. 
To remove hair, scissors should be used instead of razors.
Hud og subkutane væv Meget almindelige: 
Skin and subcutaneous tissue disorders Very common: sweating, pruritus.
Klæbelag af polyacrylat 
Polyacrylate adhesive layer
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. 
Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.
Diamorphin Pethidin Codein Buprenorphin 
Diamorphine Pethidine
Fentanyl bør ikke gives samtidig med buprenorphin, nalbuphin eller pentazocin. 
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Øjne Meget sjældne: 
Eye disorders Very rare:
Efter brug foldes plastrene sammen på midten med klæbefladerne mod hinanden. 
Used patches should be folded in half with the sticky sides together.
Hvis De holder op med at bruge Fentanyl-ratiopharm 
If you stop using Fentanyl-ratiopharm
Hvis De har glemt at bruge Fentanyl-ratiopharm 
If you forget to use Fentanyl-ratiopharm
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. 
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).
De brugte plastre lægges tilbage i yderemballagen og bortskaffes eller indleveres om muligt på apoteket. 
Put back used patches in the outer package and discard or whenever possible hand in to your pharmacist.
Abstinenssymptomer kan bestå i kvalme, opkastning, diaré og kuldegysninger. 
Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.
Anvendelse til ældre Ældre bør observeres nøje, og doseringen reduceres efter behov (se pkt. 
Use in elderly patients Elderly should be observed carefully and the dose reduced if necessary (see sections 4.4 and 5.2).
Derfor bør amningen indstilles i mindst 72 timer efter fjernelse af Fentanyl-ratiopharm. 
Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Fentanyl udskilles i modermælk, og amning bør derfor indstilles under behandling med Fentanylratiopharm (se også pkt. 
As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
1 plaster på 15 cm2 indeholder 8,25 mg fentanyl. 
Each patch of 15 cm2 contains 8.25 mg fentanyl.
Uregelmæssig hjerterytme (rytmeforstyrrelser), udvidede blodkar, hikke, vandophobning i væv, kuldefornemmelse. 
Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
Da ydersiden af depotplasteret er beskyttet af vandtæt folie, kan patienten have det på i brusebad. 
As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
1 plaster på 7,5 cm2 indeholder 4,125 mg fentanyl. 
Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Fentanyl bør ikke anvendes samtidig med buprenorphin, nalbuphin eller pentazocin (se også pkt. 
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section
Kløen går normalt væk i løbet af et døgns tid, når plasteret tages af. 
Itching will usually disappear within one day after the patch has been removed.
Aktivt stof 
Active substance Parenteral (im) Oral
Nyrer og urinveje Ikke almindelige: 
Renal and urinary disorders Uncommon: urinary retention.
- Da ydersiden af depotplasteret er beskyttet af vandtæt folie, kan patienten have det på i brusebad. 
- As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
1 plaster på 30 cm2 indeholder 16,5 mg fentanyl. 
Each patch of 30 cm2 contains 16.5 mg fentanyl.
Tal med Deres læge, hvis De bliver gravid under behandlingen med Fentanyl ratiopharm depotplaster. 
If you get pregnant during treatment with Fentanyl-ratiopharm, consult your doctor.
Eftersom indbringelsen vedrørte: 
In this leaflet:
Derfor vil lægen måske give Dem ekstra smertemedicin, indtil Deres fentanyl depotplaster opnår sin fulde virkning. 
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.
1 plaster på 22,5 cm2 indeholder 12,375 mg fentanyl. 
Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Udslæt og rødmen går normalt væk i løbet af et døgns tid, når plasteret tages af. 
Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
- Find et jævnt, ubestrålet område på overkroppen eller overarmen, hvor huden er fri for hår, småsår, knopper eller andre uregelmæssigheder. 
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.
Svedudbrud, pruritus. 
Very common: sweating, pruritus.
12.375 mg/22.5 cm² som frigiver 75 mikrogram per time 
75 µg/h transdermal patch transdermal use 12.375 mg/22.5 cm² which release 75 µg fentanyl per hour
Patienter med nedsat lever- eller nyrefunktion bør observeres nøje, og dosis reduceres efter behov (se pkt. 
Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see section 4.4).
Anafylaksi. 
arrhythmia.
Afhængighed 
Drug dependence
Det brugte plaster foldes sammen og smides ud eller afleveres på apoteket. 
Fold used patches and discard or return to the pharmacy.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 depotplaster 
PHARMACEUTICAL FORM AND CONTENTS 1 transdermal patch
Hovedpine, svimmelhed. 
Very common: headache, dizziness.
Virkningen vil være længere om at indtræffe efter en intramuskulær eller subkutan injektion end efter intravenøs administration. 
Following intramuscular or subcutaneous administration the onset of action will be slower compared with intravenous administration.
Endelig må dosisproportionalitet forventes, da Fentanyl "ratiopharm" er et matrixplaster, fra hvilket afgivelsen er proportional med overfladearealet. 
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.
Nedsat nyrefunktion 
Impaired liver function
Patienter med nedsat leverfunktion bør holdes under nøje observation, og om nødvendigt reduceres dosis. 
Patients with hepatic impairment should be observed carefully and the dose reduced if necessary.
[20 depotplastre:] Dato 
[20 transdermal patches:] Date
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 
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
Bevidsthedssvækkelse, hovedpine, svimmelhed, kvalme, opkastning, forstoppelse, svedudbrud, kløe. 
Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.
Spørg lægen eller apoteket, hvis der er noget, De er i tvivl om eller følger Dem usikker på. 
You should check with your doctor or pharmacist if you are not sure.
16.5 mg/30 cm² som frigiver 100 mikrogram per time 
100 µg/h transdermal patch transdermal use 16.5 mg/30 cm² which release 100 µg fentanyl per hour
1 depotplaster frigiver 100 mg fentanyl i timen. 
Each patch releases 100 micrograms fentanyl per hour.
[5 depotplastre:] Dato 
[5 transdermal patches:] Date
4.125 mg/7.5 cm² som frigiver 25 mikrogram per time 
25 µg/h transdermal patch transdermal use 4.125 mg/7.5 cm² which release 25 µg fentanyl per hour
De må ikke anvende disse lægemidler sammen med Fentanylratiopharm, da det kan øge deres giftige virkning (toksicitet). 
If these medicines are taken together this may enhance their toxicity.
De kan blive utilpas, hvis De stopper brugen af plastrene. 
If you do stop using the patches you may feel unwell.
8.25 mg/15 cm² som frigiver 50 mikrogram per time 
50 µg/h transdermal patch transdermal use 8.25 mg/15 cm² which release 50 µg fentanyl per hour
Vær ekstra forsigtig med at bruge Fentanyl-ratiopharm 
Take special care with Fentanyl-ratiopharm
4.4 "sideløbende anvendelse anbefales ikke" i stedet for som en kontraindikation. 
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.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster frigiver 100 mikrogram fentanyl i timen. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each patch releases 100 micrograms fentanyl per hour.
1 depotplaster frigiver 75 mg fentanyl i timen. 
Each patch releases 75 micrograms fentanyl per hour.
Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I) 
Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I)
[3 depotplastre:] Dato 
[3 transdermal patches:] Date
Klæbelag: Klæbelag af polyacrylat 
Polyacrylate adhesive layer Polypropylene foil
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 100 mikrogram fentanyl i timen. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 100 micrograms fentanyl per hour.
Luftveje, thorax og mediastinum Ikke almindelige: 
Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, hypoventilation.
[10 depotplastre:] Dato 
[10 transdermal patches:] Date
Merckle GmbH 
Transdermal patch
Urinretention. 
anaphylaxis.
SÅDAN SKAL DE BRUGE FENTANYL-RATIOPHARM 
HOW TO USE Fentanyl-ratiopharm
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster frigiver 25 mikrogram fentanyl i timen. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each patch releases 25 micrograms fentanyl per hour.
SÅDAN OPBEVARER DE FENTANYL-RATIOPHARM 
HOW TO STORE Fentanyl-ratiopharm
CHMP tilsluttede sig, at stærkt virkende opioider under særlige omstændigheder kan tænkes at være til gavn til denne indikation. 
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.
Nervesystemet Meget almindelige: 
Nervous system disorders
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 75 mikrogram fentanyl i timen. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 75 micrograms fentanyl per hour.
1 depotplaster frigiver 25 mg fentanyl i timen. 
Each patch releases 25 micrograms fentanyl per hour.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 100 µg/h“. 
Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 100 µg/h“.
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. 
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).
Fentanilo Matrix ratiomed 100microgramos/h parches transdérmicos EFG Storbritannien Ribofen 100 microgram/hr Transdermal patch Tyskland 
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
Hvis De glemmer at skifte plasteret, skal De gøre det, så snart De kommer i tanke om det. 
If you forget, then change your patch as soon as you remember.
6.7 Emballagetype og pakningsstørrelser Depotplastrene er pakket hver for sig i breve. 
Each transdermal patch is packed in a separate sachet.
- Lægen har ordineret Fentanyl-ratiopharm til Dem personligt. 
Your doctor will decide which strength of Fentanyl-ratiopharm is most suitable for you.
Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I) 
Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 25 mikrogram fentanyl i timen. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 25 micrograms fentanyl per hour.
1 depotplaster frigiver 50 mg fentanyl i timen. 
Each patch releases 50 micrograms fentanyl per hour.
Før De begynder at bruge Fentanyl-ratiopharm, skal De fortælle det til Deres læge, hvis De har en af følgende sygdomme. 
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.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 75 µg/h“. 
Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 75 µg/h“.
Ændring eller stop i behandlingen bør kun ske i samråd med lægen. 
Do not discontinue treatment without consulting your doctor.
Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Hvis De står for at skulle bedøves, bør De fortælle lægen eller tandlægen, at 
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Amning 
Codeine
Brug ikke Fentanyl-ratiopharm 
BEFORE YOU USE Fentanyl-ratiopharm
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 50 mikrogram fentanyl i timen. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 50 micrograms fentanyl per hour.
Meget sjældne hos færre end 1 ud af 10.000 patienter, inklusive enkeltstående rapporter 
The assessment of side effects is based on the following frequency data: Very common more than 1 in 10 patients
Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl 
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
Nederlandene ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland 
The Netherlands ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 50 µg/h“. 
Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 50 µg/h“.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 25 µg/h“. 
Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 25 µg/h“.
Peroralt 
Morphine
Fentanilo Matrix ratiomed 75 microgramos/h parches transdérmicos EFG Storbritannien Ribofen 75 microgram/hr Transdermal patch Tyskland 
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
Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Tyskland ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland 
Germany ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl 
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
Fentanyl-ratiopharm 50 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] 
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-ratiopharm 50 µg/h TTS og andre berørte navne (se Vedlæg I) 
Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I)
Fentanyl-ratiopharm 25 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Det Forenede Kongerige ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland 
United Kingdom ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Fentanyl-ratiopharm 50 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl 
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
Særlige populationer 
Paediatric population
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her. 
- 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.
Frankrig ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Tyskland 
France ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Fentanyl-ratiopharm 25 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt] fentanyl 
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
Fentanyl-ratiopharm 25 µg/h TTS og andre berørte navne (se Vedlæg I) 
Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I)
Ludwig-Merkle-Str. 3 
Ketobemidone 10
LISTE OVER HJÆLPESTOFFER 
Adhesive layer
Fentanilo Matrix ratiomed 50 microgramos/h parches transdérmicos EFG Storbritannien Ribofen 50 microgram/hr Transdermal patch Tyskland 
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
FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Klæbelag Klæbelag af polyacrylat Bagsidefolie Polypropylenfolie Blåt blæk Beskyttelsesfolie Polyethylenterephthalatfolie (silikonebehandlet) 6.2 Uforligeligheder Ikke relevant. 
Adhesive layer: Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)
Dyspnø, hypoventilation. 
Uncommon: diarrhoea.
Fentanilo Matrix ratiomed 25 microgramos/h parches transdérmicos EFG Storbritannien Ribofen 25 microgram/hr Transdermal patch Tyskland 
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
De indebærer en større risiko for bivirkninger, og lægen vil måske give Dem en lavere dosis fentanyl. 
Significant increases in body temperature can potentially increase fentanyl absorption rate.
registrering af et fremstillingssted for det aktive stof, det færdige lægemiddel og batchfrigivelse. 
Registration of a manufacturing site for the active substance, finished product and batch release.
For at suspenderingen kan ophæves, skal indehaveren af markedsføringstilladelsen for MACI forelægge følgende: 
For the suspension to be lifted, the marketing authorisation holder for MACI shall provide the following:
Betingelser for ophævelse af suspenderingen af fremstillingstilladelsen 
Conditions for lifting the suspension of the manufacturing authorisation
Den 8. oktober 2012 
8 October 2012
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 8. oktober 
The final opinion was converted into a Decision by the European Commission on 8 October 2012.
Indbringelsesproceduren blev indledt den 11. november 2010. 
The referral procedure started on 11 November 2010.
Udvalget vedtog ved flertalsafgørelse en positiv udtalelse den 14. juni 2012. 
The Committee adopted a positive opinion by majority on 14 June 2012.
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. 
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.
Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 12. august 2011 og den 14. februar 2012. 
Written explanations were provided by the marketing authorisation holders on 12 August 2011 and 14 February 2012.
Mundtlige redegørelser blev afgivet den 14. maj 2012. 
Oral explanations were given on 14 May 2012.
Som følge af, at der var truffet divergerende nationale afgørelser af medlemsstaterne vedrørende f.eks. måldyrearter, indikationer, mængder som skal indgives, samt tilbageholdelsestider i forbindelse med godkendelserne af Baytril 10 % oral opløsning og relaterede navne, indbragte Det Forenede Kongerige den 15. oktober 2010 sagen for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF med henblik på at fjerne divergenserne mellem de nationalt godkendte produktinformationer i hele Den Europæiske Union. 
Due to divergent national decisions taken by Member States with respect to e.g. target species, indications, amounts to be administered and withdrawal periods concerning the authorisations of Baytril 10% oral solution and its associated names, on 15 October 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised product information across the European Union.