natgillin/translations-raw huggingface dataset:
Actos 15 mg tabletter er hvide til grålighvide, runde, konvekse tabletter, der er mærkede med ‘15' på den ene side og ‘ACTOS' på den anden side.
− Actos 15 mg tablets are white to off-white, round, convex tablets marked ‘15' on one face and
Actos 30 mg tabletter er hvide til grålighvide, runde, flade tabletter, der er mærkede med ‘30' på den ene side og ‘ACTOS' på den anden side.
− Actos 30 mg tablets are white to off-white, round, flat tablets marked ‘30' on one face and
Tabletterne er hvide til grålig hvide, runde, flade og mærket med ‘45' på den ene side og ‘ACTOS' på den anden side.
The tablets are white to off-white, round, flat and marked ‘45' on one face and ‘ACTOS' on the other face.
Hver Actos 30 mg tablet indeholder 30 mg pioglitazon (som hydrochlorid).
Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Tabletterne er hvide til grålig hvide, runde, flade og mærket med ‘30' på den ene side og ‘ACTOS' på den anden side.
The tablets are white to off-white, round, flat and marked ‘30' on one face and ‘ACTOS' on the other face.
Actos indeholder lactosemonohydrat Kontakt lægen, før De tager Actos, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Actos.
Udseende og pakningsstørrelser
What Actos looks like and contents of the pack
Hvis De har taget for meget Actos
If you take more Actos than you should
Hver Actos 45 mg tablet indeholder 45 mg pioglitazon (som hydrochlorid).
Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Det skal De vide, før De begynder at tage Actos Sådan skal De tage Actos Bivirkninger
What Actos is and what it is used for What you need to know before you take Actos How to take Actos
Tabletterne er hvide til grålig hvide, runde, konvekse og mærket med ‘15' på den ene side og ‘ACTOS' på den anden side.
The tablets are white to off-white, round, convex and marked ‘15' on one face and ‘ACTOS' on the other face.
Hver Actos 15 mg tablet indeholder 15 mg pioglitazon (som hydrochlorid).
Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
EU/1/00/150/011 14 tabletter EU/1/00/150/012 28 tabletter EU/1/00/150/022 30 tabletter EU/1/00/150/013 50 tabletter EU/1/00/150/014 56 tabletter EU/1/00/150/023 84 tabletter EU/1/00/150/024 90 tabletter EU/1/00/150/015 98 tabletter EU/1/00/150/029 112 tabletter EU/1/00/150/030 196 tabletter
EU/1/00/150/011 14 tablets EU/1/00/150/012 28 tablets EU/1/00/150/022 30 tablets EU/1/00/150/013 50 tablets EU/1/00/150/014 56 tablets EU/1/00/150/023 84 tablets EU/1/00/150/024 90 tablets EU/1/00/150/015 98 tablets EU/1/00/150/029 112 tablets EU/1/00/150/030 196 tablets
Kontakt hurtigst muligt Deres læge, hvis De oplever nogle af disse bivirkninger, særligt hvis De er over 65 år.
If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Indtages gennem munden.
Oral use.
6.6 Regler for bortskaffelse og anden håndtering Ingen særlige forholdsregler ved bortskaffelse.
No special requirements for disposal.
EU/1/00/150/008 14 tabletter EU/1/00/150/004 28 tabletter EU/1/00/150/019 30 tabletter EU/1/00/150/005 50 tabletter EU/1/00/150/010 56 tabletter EU/1/00/150/020 84 tabletter EU/1/00/150/021 90 tabletter EU/1/00/150/006 98 tabletter EU/1/00/150/027 112 tabletter EU/1/00/150/028 196 tabletter
EU/1/00/150/008 14 tablets EU/1/00/150/004 28 tablets EU/1/00/150/019 30 tablets EU/1/00/150/005 50 tablets EU/1/00/150/010 56 tablets EU/1/00/150/020 84 tablets EU/1/00/150/021 90 tablets EU/1/00/150/006 98 tablets EU/1/00/150/027 112 tablets EU/1/00/150/028 196 tablets
EU/1/00/150/007 14 tabletter EU/1/00/150/001 28 tabletter EU/1/00/150/016 30 tabletter EU/1/00/150/002 50 tabletter EU/1/00/150/009 56 tabletter EU/1/00/150/017 84 tabletter EU/1/00/150/018 90 tabletter EU/1/00/150/003 98 tabletter EU/1/00/150/025 112 tabletter EU/1/00/150/026 196 tabletter
EU/1/00/150/007 14 tablets EU/1/00/150/001 28 tablets EU/1/00/150/016 30 tablets EU/1/00/150/002 50 tablets EU/1/00/150/009 56 tablets EU/1/00/150/017 84 tablets EU/1/00/150/018 90 tablets EU/1/00/150/003 98 tablets EU/1/00/150/025 112 tablets EU/1/00/150/026 196 tablets
Kontakt hurtigst muligt Deres læge, hvis De oplever denne bivirkning.
If you experience this side effect, talk to your doctor as soon as possible.
LÆGEMIDLETS NAVN Actos 30 mg tabletter pioglitazon
Actos 30 mg tablets pioglitazone
LÆGEMIDLETS NAVN Actos 15 mg tabletter pioglitazon
Actos 15 mg tablets pioglitazone
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda (logo)
Takeda (logo)
LÆGEMIDLETS NAVN Actos 45 mg tabletter pioglitazon
Actos 45 mg tablets pioglitazone
Nedsat leverfunktion
Weight gain
Der er rapporter om, at samtidig administration af pioglitazon og rifampicin (en inducer af CYP2C8) har resulteret i en 54 % nedsættelse af AUC for pioglitazon.
is reported to result in a 54% decrease in AUC of pioglitazone.
Knogler, led, muskler og bindevæv knoglefraktur almindelig almindelig almindelig almindelig almindelig artralgi almindelig almindelig almindelig rygsmerter almindelig
common common common common common arthralgia common common common back pain common
Navneliste, lægemiddelform, medicinske produkters styrke, indgivelsesvej og ansøgere i medlemslande
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States
Bilag I Liste over nationalt godkendte lægemidler
Annex I List of nationally authorised medicinal products
Kapsel, Hård
Capsule, Hard
Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Farmaceutyczne "polpharma" Spolka Akcyjna
Opløsning til injektion/Infusion
Solution For Injection/Infusion
Oral opløsning
Oral Solution
Suppositorie
Suppository
Novalgine I.M./I.V.
Sanofi Belgium Novalgine I.M./I.V.
Sanofi Belgium
Sanofi Belgium Novalgine
Stada Arzneimittel Ag
Stada Arzneimittel Ag Metamistad
Sanofi Rumænien Srl
Sanofi Romania Srl
Pulver til oral opløsning
Powder For Oral Solution
Sanofi-Aventis Slovakiet Sro
Sanofi-Aventis Slovakia Sro
Kodein Phosphat Sesquihydrat 0.03g in form of Kodein Phosphat Hemihydrat 0.02873g, Metamizolnatrium 0.9g, Caffein og Natriumbenzoat 0.1g / Suppositorie
Codeine Phosphate Sesquihydrate 0.03g in form of Codeine Phosphate Hemihydrate 0.02873g, Metamizole Sodium 0.9g, Caffeine And Sodium Benzoate 0.1g / suppository
Filmovertrukket Tablet
Film-Coated Tablet
Goodwill Pharma Ltd
Goodwill Pharma Ltd Metapyrin
Metamizolnatrium 0.9g Suppositorie, Caffein 0.05g Suppositorie, Kodein Phosphat Hemihydrat 0.03g Suppositorie
Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository
Chemax Pharma Ltd
Chemax Pharma Ltd Диалгин
Metamizolnatriummonohydrat 0.525g/ml
Metamizole Sodium Monohydrate 0.525g/ml
Metamizolnatrium 1g Suppositorie Suppositorie
Metamizole Sodium 1g Suppository
Metamizolnatriummonohydrat 25mg Drop
Metamizole Sodium Monohydrate 25mg Drop
Pitofenon Hydrochlorid 10mg, Metamizolnatrium 1g
Hydrochloride 10mg, Metamizole Sodium 1g
Metamizolnatrium 200mg Suppositorie
Metamizole Sodium 200mg Suppository
Metamizolnatrium 450mg Tablet, Caffein 50mg Tablet
Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Pulver til oral opløsning i brev
Powder For Oral Solution In Sachet
Drotaverin Hydrochlorid 40mg Tablet, Metamizolnatrium 400mg Tablet, Caffein 60mg Tablet
Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Metamizolnatrium 300mg Tablet, Paracetamol 200mg Tablet, Caffein 30mg Tablet, Kodein Phosphat 20mg Tablet
Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet
Metamizolnatrium 1g/2ml
Metamizole Sodium 1g/2ml
Thiamin Hydrochlorid 38.75mg Tablet, Metamizolnatrium 500mg Tablet, Caffein 50mg Tablet
Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Metamizolnatrium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffein 50mg Tablet, Kodein Phosphat Hemihydrat 10mg Tablet
Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet
Metamizolnatrium Kalceks
Metamizol Kalceks
Metamizolnatriummonohydrat 2,5 g/5 ml
Metamizole Sodium Monohydrate 2,5 g/5 ml
Cyanocobalamin 0.5mg Tablet, Metamizolnatrium 500mg Tablet, Thiamin Nitrat 75mg Tablet, Pyridoxin Hydrochlorid 50mg Tablet
Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet
Kodein Phosphat Sesquihydrat 0.03g Suppositorie, Metamizolnatrium 0.09g Suppositorie, Caffein og Natriumbenzoat 0.1g Suppositorie, Kodein Phosphat Hemihydrat 0.02873g Suppositorie
Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.09g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository
Metamizolnatriummonohydrat 1000mg Suppositorie
Metamizole Sodium Monohydrate 1000mg Suppository
Metamizolnatrium 500mg Tablet, Triacetonamin Tosilat 20mg Tablet
Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Metamizolmagnesium 2g/5ml
Metamizole Magnesium 2g/5ml
Metamizolmagnesium 575mgg
Metamizole Magnesium 575mgg
Metamizolmagnesium 500mg Kapsel
Metamizole Magnesium 500mg Capsule
Intravenøs anvendelse
Parenteral Use
Laboratorios Normon, S.A. Metamizol Normon Metamizolmagnesium 2g/5ml
Metamizol Normon Metamizole Magnesium 2g/5ml
Metamizolnatrium 250mg Tablet, Hyoscin ButylBromid 10mg Tablet
Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Metamizolnatrium 300mg Suppositorie
Metamizole Sodium 300mg Suppository
Metamizolnatrium 100mg Suppositorie
Metamizole Sodium 100mg Suppository
Metamizolnatriummonohydrat 500mg/ml, Pitofenon Hydrochlorid 5mg/ml
Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml
Pitofenon Hydrochlorid 5mg, Metamizolnatrium 500mg
Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg
Intramuskulær anvendelse | Intravenøs anvendelse | Parenteral anvendelse
Intramuscular Use | Intravenous Use
Metamizolmagnesium 2000mg /5ml
Metamizole Magnesium 2000mg /5ml
Metamizolnatrium 500mg/ml
Metamizole 500mg/ml
Metamizolmagnesium Hexahydrat 575mg Kapsel
Metamizole Magnesium Hexahydrate 575mg Capsule
Metamizolnatriummonohydrat 527mg Tablet, Pitofenon Hydrochlorid 5.25mg Tablet, Fenpiverinium Bromid 0.1mg Tablet
Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Pitofenon Hydrochlorid 2mg/ml, Fenpiverinium Bromid 0.02mg/ml, Metamizolnatrium 500mg/ml
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml
Metamizol 575mg Kapsel
Metamizole 575mg Capsule
Stadapharm Gmbh
Stadapharm Gmbh Metamizol Stada
Teva Czech Industries s.r.o Algifen Neo
Teva Czech Industries S.R.O
Metamizolnatrium 500mg
Metamizole Sodium 500mg
Metamizol Heumann Metamizolnatriummonohydrat 500mg/ml
Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml
Pitofenon Hydrochlorid 2mg/ml, Metamizolnatrium 500mg/ml
Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml
Abz-Pharma Gmbh
Abz-Pharma Gmbh Novaminsulfon
Aliud Pharma Gmbh
Aliud Pharma Gmbh Metamizol Al
Analgin Sopharma Metamizolnatrium 500mg Tablet
Metamizol Sintocalmin Metamizole 500mg Tablet
Pitofenon Hydrochlorid 5mg Tablet, Fenpiverinium Bromid 0.1mg Tablet, Metamizolnatrium 500mg Tablet
Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Bruse Tablet
Coated Tablet
Metamizol Heumann Metamizolnatriummonohydrat 500mg Tablet
Metamizol Heumann Metamizole Sodium Monohydrate 500mg
Laboratorios Alter, S.A.
Laboratorios Normon, S.A.
Pitofenon Hydrochlorid 5mg/ml, Metamizolnatrium 500mg/ml
Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml
Metamizolmagnesium 575mg Kapsel
Metamizole Magnesium 575mg Capsule
Metamizolnatriummonohydrat 500mg Tablet, Pitofenon Hydrochlorid 5mg Tablet, Fenpiverinium Bromid 0.1mg Tablet
Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Novaminsulfon Metamizolnatrium 500g/ml
Metamizole Sodium 500g/ml
Pitofenon Hydrochlorid 5mg Tablet, Metamizolnatrium 500mg Tablet, Fenpipramid Bromomethylat 0.1mg Tablet
Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet
Pitofenon Hydrochlorid 10mg/5ml, Fenpiverinium Bromid 0.1mg/5ml, Metamizolnatrium 2500mg/5ml
Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml
Диалгин Джуниор Metamizolnatriummonohydrat 250mg Brev
Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg
Metamizolnatriummonohydrat 1000mg Brev
Metamizole Sodium Monohydrate 1000mg Sachet
Novalgine
Zaklady
Диалгин Експрес Metamizolnatrium 500mg Brev, Caffein 50mg Brev
Metamizole Sodium 500mg Sachet, Caffeine 50mg Sachet
Laboratorios Normon, S.A. Metamizol Normon Metamizolmagnesium 575mg Kapsel
Metamizol Normon Metamizole Magnesium 575mg Capsule
Algi-Mabo Adultos Metamizolmagnesium 1000mg Suppositorie
Metamizole Magnesium 1000mg Suppository
Metamizolnatriummonohydrat 0.5g/ml, Pitofenon Hydrochlorid 2mg/ml, Fenpiverinium Bromid 0.02mg/ml
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml
Laboratorios Cinfa, S.A.
Laboratorios Cinfa, S.A. Metamizol Cinfa
Metamizol Aristo Metamizolnatriummonohydrat 500mg/ml
Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/ml
Metamizole Abz
Abz-Pharma Gmbh Metamizole Abz
Pharma Gmbh
Pharma Gmbh Metagelan
Metamizol Aristo Metamizolmagnesium 575mg Kapsel
Metamizol Kern Pharma Metamizole Magnesium 575mg Capsule
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Please tell us what you think about this information by answering a few questions - it will only take a couple of minutes of your time:
Tre af tilfældene var dødelige.
Three of the cases were fatal.
Fortæl os, hvor nyttige du fandt disse oplysninger
Tell us how well we did with this information
Størstedelen af patienterne i EU er blevet behandlet i Tyskland.
The majority of EU patients have been treated in Germany.
EMA vil afslutte sin grundige gennemgang og offentliggøre det endelige resultat.
EMA will complete its in-depth review and make public the final outcome.
Den 7. marts 2018 EMA/134289/2018
8 March 2018 EMA/155367/2018
Dokumentation for risiko for alvorlige inflammatoriske hjernesygdomme
Evidence indicates risk of serious inflammatory brain disorders
Gennemgangen af Zinbryta blev indledt den 26. februar 2018 på anmodning af Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004.
The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.
Størstedelen af tilfældene indtraf inden for otte måneder efter initiering af behandlingen.
Most cases occurred within 8 months of starting treatment.
• Zinbryta vil blive tilbagekaldt fra apoteker og hospitaler i hele EU.
• Zinbryta will be recalled from pharmacies and hospitals across the EU.
Disse kan være tegn på en reaktion over for Zinbryta.
These could be signs of a reaction to Zinbryta.
Zinbryta blev godkendt i 2016 til behandling af tilbagevendende former af multipel sklerose.
Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Sådanne reaktioner kan indtræffe i seks måneder, efter at behandlingen er ophørt.
These reactions can occur for 6 months after treatment has been stopped.
Til dato er over 8.000 patienter verden over blevet behandlet med Zinbryta.
To date over 8,000 patients have been treated with Zinbryta worldwide.
Oplysninger til sundhedspersonale
Information for healthcare professionals
Zinbryta kan desuden have sammenhæng med svære immunreaktioner, der berører flere andre organer.
Zinbryta may also be linked to severe immune reactions affecting several other organs.
Den indledende gennemgang foretages af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som vil fremsætte et sæt anbefalinger.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
• Lægen vil foretage regelmæssige blodprøver i op til seks måneder efter at have stoppet behandlingen med henblik på at kontrollere for bivirkninger.
• Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
Efter en gennemgang i 2017 af lægemidlets virkninger på leveren blev dets anvendelse begrænset til patienter, hos hvem der er forsøgt mindst to andre sygdomsmodificerende behandlinger, og som ikke kan behandles med andre midler mod multipel sklerose.
Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
Der bør følges op på patienter, hvis behandling standses, i mindst 6 måneder (se nærmere herom nedenfor).
Patients stopping treatment must be followed up for at least 6 months (see more details below).
En indledende gennemgang af den foreliggende dokumentation tyder på, at de iagttagne immunreaktioner i de indberettede tilfælde kan have sammenhæng med anvendelsen af Zinbryta.
A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta.
Virksomheden, der markedsfører Zinbryta (Biogen Idec Ltd), har allerede frivilligt anmodet om tilbagekaldelse af lægemidlets markedsføringstilladelse og underrettet EMA om, at den har til hensigt at standse de kliniske studier.
The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine's marketing authorisation and has informed EMA of its intention to stop clinical studies.
Den foreliggende dokumentation peger desuden på, at Zinbryta kan have sammenhæng med andre immunmedierede lidelser, såsom bloddyskrasier, thyroiditis eller glomerulonefritis.
Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Sundhedspersoner bør straks kontakte de patienter, der på nuværende tidspunkt er i behandling med Zinbryta, og bør ophøre med behandlingen og tage stilling til alternativer.
Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives.
Hidtil har EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) gennemgået 12 tilfælde af immunmedierede inflammatoriske lidelser, herunder encephalitis.
To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
En tidligere PRAC-gennemgang i 2017 viste, at der kan indtræffe uforudsigelig og potentielt dødelig immunmedieret leverskade med Zinbryta i op til seks måneder efter behandlingens ophør, og konkluderede, at der bør følges op på patienter, der ophører med behandlingen.
A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.
Start spørgeundersøgelsen
Start the survey
• Sig det straks til lægen, hvis du har eller oplever symptomer som vedvarende høj temperatur, svær hovedpine, kvalme, træthed, gulfarvning af hud eller øjne, og opkastning.
• Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
• Tag ikke flere injektioner af Zinbryta.
• Do not take another injection of Zinbryta.
Det Europæiske Lægemiddelagentur (EMA) har anbefalet, at lægemidlet mod multipel sklerose Zinbryta (daclizumab beta) øjeblikkelig suspenderes og tilbagekaldes efter 12 indberetninger om alvorlige inflammatoriske hjernesygdomme i hele verden, herunder encephalitis og meningoencephalitis.
On 6 March 2018, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.
• Bed patienterne om straks at indberette symptomer på leverskader, såsom langvarig feber, svær hovedpine, træthed, gulsot, kvalme eller opkastning.
• Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting.
• Hvis du deltager i et klinisk studie med Zinbryta, skal du kontakte den læge, der behandler dig i studiet.
• If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
• Hvis du er i behandling med Zinbryta, skal du kontakte lægen for at drøfte din behandling.
• If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
For at beskytte patienternes helbred anbefaler EMA øjeblikkelig suspendering af lægemidlets markedsføringstilladelse i EU og tilbagekaldelse af partier fra apoteker og hospitaler.
To protect patients' health, the marketing authorisation in the EU of Zinbryta is now suspended and batches are to be recalled from pharmacies and hospitals.
Ingen nye patienter bør sættes i behandling med Zinbryta.
No new patients should start treatment with Zinbryta.
Overvej andre behandlinger efter omstændighederne.
Consider alternative treatments as appropriate.
PRAC's anbefaling om at suspendere Zinbryta og tilbagekalde produktet sendes til EuropaKommissionen med henblik på en retligt bindende afgørelse.
The PRAC's recommendation to suspend Zinbryta and recall the product was sent to the European Commission, which issued a legally binding decision on 8 March 2018.
• Sæt ikke nye patienter i behandling med Zinbryta.
• Do not start any new patients on Zinbryta.
alt efter hvad der er klinisk indiceret, i op til seks måneder efter den sidste dosis Zinbryta.
• Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
• Kontakt snarest muligt de af dine patienter, der på nuværende tidspunkt er i behandling med
• Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment.
De harmoniserede områder er følgende:
The areas harmonised include:
Den ændrede information til læger og patienter findes her.
The amended information to doctors and patients is available here.
Nasonex og relaterede navne markedsføres i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Kroatien, Cypern1, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige samt Island og Norge.
Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Europa-Kommissionen vedtog en afgørelse, der er retligt bindende i hele EU, den 19. januar 2015.
The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.
Den virksomhed, der markedsfører disse lægemidler, er Merck Sharp & Dohme.
The company that markets these medicines is Merck Sharp & Dohme.
Hvad er Nasonex?
What is Nasonex?
Den 19. januar 2015 EMA/39886/2015
EMA/39886/2015