FrancophonIA/ELRC3.0 huggingface dataset:
English: • hives (or “nettle rash”), hair loss, eczema, acne
Danish: • nældefeber, hårtab, eksem, acne
English: • experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Danish: • blodpropper i blodårerne (venerne), især i benene (symptomerne omfatter hævelse, smerte og rødme i benet).
English: dyspepsia, dry mouth, toothache swollen tongue, gastroenteritis, dysphagia,
Danish: Opsvulmet tunge, gastroenteritis, dysfagi, flatulens
English: disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paresthaesia neuroleptic malignant syndrome, cerebral ischaemia, unresponsive to stimuli c, loss of consciousness, depressed level of consciousness c,
Danish: Malignt neuroleptikasyndrom, cerebral iskæmi, manglende respons på stimuli c,
English: INVEGA is not for use in children and adolescents who are under 18 years for the treatment of schizoaffective disorder.
Danish: INVEGA er ikke beregnet til behandling af skizo-affektiv psykose hos børn og unge under 18 år.
English: The recommended starting dose for treating schizophrenia in adolescents 15 years and older is 3 mg once a day taken in the morning.
Danish: Den anbefalede startdosis til behandling af skizofreni hos unge på 15 år eller derover er 3 mg en gang dagligt om morgenen.
English: Do not store above 30 Keep the bottle tightly closed in order to protect from moisture
Danish: Hold beholderen tæt tillukket for at beskytte mod fugt
English: Schizoaffective Disorder Studies: Secondary Efficacy Parameter, Proportion of Subjects with Responder Status at LOCF End Point: Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Danish: Studier hos patienter med skizo-affektiv psykose: Sekundært virkningsparameter, Andel af forsøgspersoner med Responder Status ved LOCF-endepunkt: Studierne R076477-SCA-3001 og R076477-SCA-3002: Intent-to-Treat-analysesæt
English: In all three studies, INVEGA was superior to placebo on PSP and CGI-S. Efficacy was also evaluated by calculation of treatment response (defined as decrease in PANSS Total Score ≥ 30%) as a secondary endpoint.
Danish: Effekt blev også vurderet ved beregning af behandlingsrespons (defineret som reduktion i samlet PANSS-score ≥ 30 %) som et sekundært endepunkt.
English: 7 TABLET OPA-ALU-PVC/ALU BLISTER
Danish: BLISTERKORT AF OPA-ALUMINIUM-PVC/ALUMINIUM MED 7 TABLETTER
English: INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets
Danish: INVEGA 3 mg depottabletter INVEGA 6 mg depottabletter INVEGA 9 mg depottabletter INVEGA 12 mg depottabletter
English: vomiting, nausea,
Danish: Pruritus, udslæt
English: Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/aluminium push-through child-resistant blister.
Danish: Børnesikkert blisterkort af OPA (orienteret polyamid)-aluminium-PVC (polyvinylchlorid)/perforerbart aluminium.
English: dry mouth, toothache
Danish: mundtørhed, tandpine
English: tremor tardive dyskinesia,
Danish: Tardiv dyskinesi, krampeanfald e,
English: - if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
Danish: • hvis du tidligere har fået stillet diagnosen malignt neuroleptikumsyndrom (høj temperatur og muskelstivhed).
English: Each INVEGA 9 mg prolonged-release tablet contains 9 mg of paliperidone.
Danish: Hver INVEGA 9 mg depottablet indeholder 9 mg paliperidon.
English: low level of consciousness, shaking of the head
Danish: manglende respons på stimuli, lavt bevidsthedsniveau, hovedrysten
English: Schizoaffective Disorder Studies: Primary Efficacy Parameter, PANSS Total Score Change from Baseline from Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Danish: Studier hos patienter med skizo-affektiv psykose: Primær virkningsparameter, ændring i samlet PANSS-score i forhold til baseline i studierne R076477-SCA-3001 og R076477-SCA-3002: Intent-to-Treat-analysesæt
English: Paliperidone
Danish: Carnubavoks
English: Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only) Polyethylene Oxide 7000K Ferric Oxide (Red) (E172)
Danish: Butylhydroxytoluen (E321) Jernoxid (gul) E172 (kun 3 mg og 12 mg tabletter) Polyethylenoxid 7000K
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point - LOCF for Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Danish: Skizofreni-studier: Samlet PANSS-score - ændring fra baseline til effektmål - LOCF for studierne R076477-SCH-303, R076477-SCH-304 og R076477-SCH-305: intent-to-treat-analysesæt Placebo INVEGA 3 mg
English: Printing ink Iron oxide (black) (E172)
Danish: Jernoxid (rød) (E172)
English: Each prolonged-release tablet contains 9 mg of paliperidone.
Danish: Hver depottablet indeholder 9 mg paliperidon.
English: Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12”
Danish: Kapselformede beige tabletter, der består af tre lag og er 11 mm lange og 5 mm i diameter, med teksten ”PAL 6”
English: confusional state, libido decreased, anorgasmia, nervousness, nightmare catatonia, somnambulism, blunted affect
Danish: Søvnforstyrrelser, forvirringstilstand, nedsat libido, anorgasme, nervøsitet, mareridt
English: Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (red) (E172) Carnauba wax
Danish: Hypromellose Titandioxid (E171) Polyethylenglycol 400 Jernoxid (rød) (E172) Carnaubavoks
English: Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.
Danish: Hver INVEGA 12 mg depottablet indeholder 12 mg paliperidon.
English: Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Carnauba wax
Danish: Titandioxid (E171) Polyethylenglycol 400 Jernoxid (gul) (E172) Carnaubavoks
English: BOTTLE CARTON
Danish: Mave-tarmkanalen
English: Schizoaffective disorder
Danish: Skizo-affektiv psykose
English: Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
Danish: Hver INVEGA 6 mg depottablet indeholder 6 mg paliperidon.
English: • sore throat, cough, stuffy nose
Danish: • ondt i halsen, hoste, stoppet næse
English: Each prolonged-release tablet contains 12 mg of paliperidone.
Danish: Hver depottablet indeholder 12 mg paliperidon.
English: - Bottles: The tablets are supplied in a plastic bottle with a child-resistant plastic cap. Each bottle contains either 30 tablets or 350 tablets.
Danish: - Beholdere: Tabletterne udleveres i en plastbeholder med børnesikret låg.
English: Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Danish: Hver INVEGA 3 mg depottablet indeholder 3 mg paliperidon.
English: • lung congestion
Danish: Pulmonal kongestion
English: ischaemia, flushing
Danish: Abstinenssyndrom c, induration
English: Printing ink
Danish: Natriumindhold
English: Each prolonged-release tablet contains 3 mg of paliperidone.
Danish: Hver depottablet indeholder 3 mg paliperidon.
English: How to take INVEGA
Danish: Sådan skal du tage INVEGA
English: 30 prolonged-release tablets - EU/1/07/395/057 350 prolonged-release tablets - EU/1/07/395/058
Danish: 30 depottabletter - EU/1/07/395/057 350 depottabletter - EU/1/07/395/058
English: Each prolonged-release tablet contains 6 mg of paliperidone.
Danish: Hver depottablet indeholder 6 mg paliperidon.
English: 30 prolonged-release tablets - EU/1/07/395/063 350 prolonged-release tablets - EU/1/07/395/064
Danish: 30 depottabletter - EU/1/07/395/063 350 depottabletter - EU/1/07/395/064
English: diabetic coma balance disorder, coordination abnormal, head titubation
Danish: bevidsthedstab, nedsat bevidsthedsniveau c, diabetisk koma c, balanceforstyrrelse, unormal koordination, rytmisk rokkebevægelse af hovedet
English: 30 prolonged-release tablets - EU/1/07/395/061 350 prolonged-release tablets - EU/1/07/395/062
Danish: 30 depottabletter - EU/1/07/395/061 350 depottabletter - EU/1/07/395/062
English: Musculoskelet al and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis c, posture abnormal
Danish: Forhøjet kreatinkinase i blodet, muskelspasmer, stivhed i leddene, hævede led, muskelsvaghed, nakkesmerter
English: • blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Danish: Blodpropper kan løsrives og føres med blodet til lungerne, hvor de kan forårsage brystsmerter og åndedrætsbesvær.
English: 30 prolonged-release tablets - EU/1/07/395/059 350 prolonged-release tablets - EU/1/07/395/060
Danish: 30 depottabletter - EU/1/07/395/059 350 depottabletter - EU/1/07/395/060
English: EXP MM/YYYY
Danish: P-værdi (vs. aripiprazol)
English: Printing ink:
Danish: Blæk:
English: 14 prolonged-release tablets - EU/1/07/395/074 - CLEAR 28 prolonged-release tablets - EU/1/07/395/016 - CLEAR 30 prolonged-release tablets - EU/1/07/395/017 - CLEAR 49 prolonged-release tablets - EU/1/07/395/018 - CLEAR 56 prolonged-release tablets - EU/1/07/395/019 - CLEAR 98 prolonged-release tablets - EU/1/07/395/020 - CLEAR
Danish: 14 depottabletter - EU/1/07/395/074 - KLARE 28 depottabletter - EU/1/07/395/016 - KLARE 30 depottabletter - EU/1/07/395/017 - KLARE 49 depottabletter - EU/1/07/395/018 - KLARE 56 depottabletter - EU/1/07/395/019- KLARE 98 depottabletter - EU/1/07/395/020- KLARE
English: Bottles:
Danish: Tabletkerne:
English: Excipients
Danish: Prolaktin
English: 14 prolonged-release tablets - EU/1/07/395/070 28 prolonged-release tablets - EU/1/07/395/045 49 prolonged-release tablets - EU/1/07/395/046 56 prolonged-release tablets - EU/1/07/395/047 98 prolonged-release tablets - EU/1/07/395/048
Danish: 14 depottabletter - EU/1/07/395/070 28 depottabletter - EU/1/07/395/045 49 depottabletter - EU/1/07/395/046 56 depottabletter - EU/1/07/395/047 98 depottabletter - EU/1/07/395/048
English: • inflammation of the pancreas
Danish: • betændelse i bugspytkirtlen
English: Infections and infestations bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, influenza pneumonia, respiratory tract infection, cystitis, ear infection, tonsillitis eye infection, onychomycosis, cellulitis, acarodermatitis
Danish: Bronkitis, infektioner i øvre luftveje, sinusitis, urinvejsinfektion, influenza
English: 14 prolonged-release tablets - EU/1/07/395/071 - CLEAR 28 prolonged-release tablets - EU/1/07/395/011 - CLEAR 30 prolonged-release tablets - EU/1/07/395/012 - CLEAR 49 prolonged-release tablets - EU/1/07/395/013 - CLEAR 56 prolonged-release tablets - EU/1/07/395/014 - CLEAR 98 prolonged-release tablets - EU/1/07/395/015 - CLEAR
Danish: 14 depottabletter - EU/1/07/395/071 - KLARE 28 depottabletter - EU/1/07/395/011 - KLARE 30 depottabletter - EU/1/07/395/012 - KLARE 49 depottabletter - EU/1/07/395/013 - KLARE 56 depottabletter - EU/1/07/395/014- KLARE 98 depottabletter - EU/1/07/395/015- KLARE
English: 14 prolonged-release tablets - EU/1/07/395/075 - WHITE 28 prolonged-release tablets - EU/1/07/395/036 - WHITE 30 prolonged-release tablets - EU/1/07/395/037 - WHITE 49 prolonged-release tablets - EU/1/07/395/038 - WHITE 56 prolonged-release tablets - EU/1/07/395/039 - WHITE 98 prolonged-release tablets - EU/1/07/395/040 - WHITE
Danish: 14 depottabletter - EU/1/07/395/075 - HVIDE 28 depottabletter - EU/1/07/395/036- HVIDE 30 depottabletter - EU/1/07/395/037 - HVIDE 49 depottabletter - EU/1/07/395/038- HVIDE 56 depottabletter - EU/1/07/395/039 - HVIDE 98 depottabletter - EU/1/07/395/040 - HVIDE
English: 14 prolonged-release tablets - EU/1/07/395/066 - WHITE 28 prolonged-release tablets - EU/1/07/395/021 - WHITE 30 prolonged-release tablets - EU/1/07/395/022 - WHITE 49 prolonged-release tablets - EU/1/07/395/023 - WHITE 56 prolonged-release tablets - EU/1/07/395/024 - WHITE 98 prolonged-release tablets - EU/1/07/395/025 - WHITE
Danish: 14 depottabletter - EU/1/07/395/066 - HVIDE 28 depottabletter - EU/1/07/395/021- HVIDE 30 depottabletter - EU/1/07/395/022 - HVIDE 49 depottabletter - EU/1/07/395/023- HVIDE 56 depottabletter - EU/1/07/395/024 - HVIDE 98 depottabletter - EU/1/07/395/025 - HVIDE
English: 14 prolonged-release tablets - EU/1/07/395/076 28 prolonged-release tablets - EU/1/07/395/053 49 prolonged-release tablets - EU/1/07/395/054 56 prolonged-release tablets - EU/1/07/395/055 98 prolonged-release tablets - EU/1/07/395/056
Danish: 14 depottabletter - EU/1/07/395/076 28 depottabletter - EU/1/07/395/053 49 depottabletter - EU/1/07/395/054 56 depottabletter - EU/1/07/395/055 98 depottabletter - EU/1/07/395/056
English: Respiratory, thoracic and mediastinal disorders pharyngolarynge al pain, cough, nasal congestion dyspnoea, wheezing, epistaxis sleep apnoea syndrome, hyperventilation, pneumonia aspiration, respiratory tract congestion, dysphonia pulmonary congestion
Danish: synkope, psykomotorisk hyperaktivitet, postural svimmelhed, opmærksomhedforstyrrelse, dysartri, dysgeusi, hypæstesi, paræstesi
English: 14 prolonged-release tablets - EU/1/07/395/067 28 prolonged-release tablets - EU/1/07/395/041 49 prolonged-release tablets - EU/1/07/395/042 56 prolonged-release tablets - EU/1/07/395/043 98 prolonged-release tablets - EU/1/07/395/044
Danish: 14 depottabletter - EU/1/07/395/067 28 depottabletter - EU/1/07/395/041 49 depottabletter - EU/1/07/395/042 56 depottabletter - EU/1/07/395/043 98 depottabletter - EU/1/07/395/044
English: 14 prolonged-release tablets - EU/1/07/395/073 28 prolonged-release tablets - EU/1/07/395/049 49 prolonged-release tablets - EU/1/07/395/050 56 prolonged-release tablets - EU/1/07/395/051 98 prolonged-release tablets - EU/1/07/395/052
Danish: 14 depottabletter - EU/1/07/395/073 28 depottabletter - EU/1/07/395/049 49 depottabletter - EU/1/07/395/050 56 depottabletter - EU/1/07/395/051 98 depottabletter - EU/1/07/395/052
English: 14 prolonged-release tablets - EU/1/07/395/065 - CLEAR 28 prolonged-release tablets - EU/1/07/395/001 - CLEAR 30 prolonged-release tablets - EU/1/07/395/002 - CLEAR 49 prolonged-release tablets - EU/1/07/395/003 - CLEAR 56 prolonged-release tablets - EU/1/07/395/004 - CLEAR 98 prolonged-release tablets - EU/1/07/395/005 - CLEAR
Danish: 14 depottabletter - EU/1/07/395/065 - KLARE 28 depottabletter - EU/1/07/395/001 - KLARE 30 depottabletter - EU/1/07/395/002- KLARE 49 depottabletter - EU/1/07/395/003- KLARE 56 depottabletter - EU/1/07/395/004- KLARE 98 depottabletter - EU/1/07/395/005- KLARE
English: - if you are diabetic or prone to diabetes.
Danish: • hvis du har sukkersyge (diabetes) eller har øget risiko for at få sukkersyge.
English: Blood and lymphatic system disorders white blood cell count decreased, thrombocytopenia, anaemia, haematocrit decreased agranulocytosis c,
Danish: Nedsat leukocyttal, trombocytopeni, anæmi, nedsat hæmatokrit
English: Psychiatric disorders insomnia mania, agitation,
Danish: Søvnløshed e Mani, agitation, depression, angst
English: General disorders pyrexia, asthenia, fatigue face oedema, oedema e, chills, body temperature increased, gait abnormal, thirst, chest pain, chest discomfort, malaise hypothermia c, body temperature decreased c, drug withdrawal syndrome induration
Danish: Ansigtsødem, ødem e, kulderystelser, forhøjet kropstemperatur, unormal gang, tørst, brystsmerter, ubehag i brystet, utilpashed
English: 14 prolonged-release tablets - EU/1/07/395/072 - WHITE 28 prolonged-release tablets - EU/1/07/395/031 - WHITE 30 prolonged-release tablets - EU/1/07/395/032 - WHITE 49 prolonged-release tablets - EU/1/07/395/033 - WHITE 56 prolonged-release tablets - EU/1/07/395/034 - WHITE 98 prolonged-release tablets - EU/1/07/395/035 - WHITE
Danish: 14 depottabletter - EU/1/07/395/072 - HVIDE 28 depottabletter - EU/1/07/395/031- HVIDE 30 depottabletter - EU/1/07/395/032 - HVIDE 49 depottabletter - EU/1/07/395/033- HVIDE 56 depottabletter - EU/1/07/395/034 - HVIDE 98 depottabletter - EU/1/07/395/035 - HVIDE
English: 14 prolonged-release tablets - EU/1/07/395/068 - CLEAR 28 prolonged-release tablets - EU/1/07/395/006 - CLEAR 30 prolonged-release tablets - EU/1/07/395/007 - CLEAR 49 prolonged-release tablets - EU/1/07/395/008 - CLEAR 56 prolonged-release tablets - EU/1/07/395/009 - CLEAR 98 prolonged-release tablets - EU/1/07/395/010 - CLEAR
Danish: 14 depottabletter - EU/1/07/395/068 - KLARE 28 depottabletter - EU/1/07/395/006 - KLARE 30 depottabletter - EU/1/07/395/007- KLARE 49 depottabletter - EU/1/07/395/008- KLARE 56 depottabletter - EU/1/07/395/009- KLARE 98 depottabletter - EU/1/07/395/010- KLARE
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Danish: Butylhydroxytoluen (E321) Polyethylenoxid 7000K Jernoxid (rød) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat
English: Hepatic impairment
Danish: unormal kropsholdning
English: Hepatobiliary disorders transaminases increased gamma-glutamyltran sferase increased, hepatic enzyme increased jaundice
Danish: Diabetes mellitus d, hyperglykæmi, øget livvidde, anoreksi, forhøjede triglycerider i blodet
English: Butyl hydroxytoluene (E321) Ferric oxide (yellow) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Danish: Butylhydroxytoluen (E321) Jernoxid (gul) (E172) Polyethylenoxid 7000K Jernoxid (rød) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat
English: hyperglycaemia,
Danish: Hydroxyethylcellulose
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Ferric oxide (yellow) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Danish: Butylhydroxytoluen (E321) Polyethylenoxid 7000K Jernoxid (rød) (E172) Jernoxid (gul) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat
English: Metabolism and nutrition disorders weight increased, increased appetite, weight decreased, decreased appetite diabetes mellitus d,
Danish: Vægtøgning, øget appetit, vægttab, nedsat appetit
English: What is in this leaflet:
Danish: INVEGA indeholder:
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Iron oxide (black) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Danish: Butylhydroxytoluen (E321) Polyethylenoxid 7000K Jernoxid (rød) (E172) Jernoxid (sort) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat
English: hypersensitivity
Danish: Anafylaktisk reaktion, overfølsomhed
English: Change in PANSS Score Mean baseline (SD) Mean change (SD) P-value (vs Placebo) Diff. of LS Means (SE) Responder Analysis Responder, n (%) Non-responder, n (%) P value (vs Placebo)
Danish: Gennemsnitlig ændring (SD) P-værdi (vs. placebo) Forskel i gennemsnitlig LS (= least squares) (SE)
English: This leaflet was last revised in
Danish: De foreliggende data er beskrevet i pkt.
English: • bone or muscle ache, back pain, joint pain
Danish: • knogle- eller muskelsmerter, rygsmerter, ledsmerter
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, indehavere af markedsføringstilladelser i medlemsstaterne
English: Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Romania
Danish: 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti
English: Red Oak North South County Business Park Leopardstown
Danish: Red Oak North South County Business Park
English: Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal
Danish: Quinta da Fonte, 19 Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal
English: 174 56 Alimos Greece
Danish: 174 56 Alimos
English: 0.05% w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis
Danish: 0,05% w/w mometason-furoat (monohydrat) beregnet som vandfrit stof
English: Belgium MSD Belgium BVBA/SPRL Clos du Lynx 5
Danish: MSD Belgium BVBA/SPRL Clos du Lynx 5
English: 2031 BN Haarlem P.O.
Danish: 2031 BN Haarlem P.O. Box 581
English: Merck Sharp & Dohme S.A. Ag. Dimitriou 63
Danish: Grækenland Merck Sharp & Dohme S.A. Ag. Dimitriou 63
English: MERCK SHARP & DOHME ROMANIA S.R.L.
Danish: Rumænien MERCK SHARP & DOHME ROMANIA S.R.L.
English: Germany MSD SHARP & DOHME GMBH
Danish: MSD SHARP & DOHME GMBH
English: Denmark Merck Sharp & Dohme BV Waarderweg 39
Danish: Merck Sharp & Dohme BV Waarderweg 39
English: Merck Sharp & Dohme Ltd Hertford Road Hoddesdon
Danish: Storbritannien Merck Sharp & Dohme Ltd Hertford Road
English: Dublin 18
Danish: Leopardstown Dublin 18
English: In the MRP the United Kingdom is the Reference Member State and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Iceland, Luxembourg, The Netherlands, Portugal, Spain and Sweden are Concerned Member States.
Danish: I proceduren for gensidig anerkendelse er Det Forenede Kongerige referencemedlemsstaten, og Østrig, Belgien, Danmark, Finland, Frankrig, Grækenland, Tyskland, Italien, Irland, Island, Luxembourg, Nederlandene, Portugal, Spanien og Sverige er de berørte medlemsstater.
English: 15232 Halandri, Athens Greece
Danish: 15232 Halandri, Athens, Grækenland
English: Do not use Seretide after the expiry date which is stated on the label and carton.
Danish: Anvend ikke Seretide efter den udløbsdato, som er angivet på pakningen.
English: Two puffs twice a day
Danish: To pust to gange daglig
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SERETIDE EVOHALER AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF SERETIDE EVOHALER OG TILKNYTTEDE NAVNE (SE BILAG I)
English: • the CHMP considered the referral made under Article 6(13) of Commission Regulation (EC) N 1084/2003 for Seretide Evohaler and associated names (see Annex I)
Danish: • CPMP behandlede den indbringelse, der havde fundet sted i henhold til artikel 6, stk. 13, i Kommissionens forordning (EF) nr. 1084/2003, for Seretide Evohaler og tilknyttede navne (jf. bilag I),
English: Treatment with Seretide should not be stopped abruptly.
Danish: Behandling med Seretide bør ikke seponeres pludseligt.
English: Note: This Annex III (Summary of Product Characteristics, Labelling and Package Leaflet) is the one that was Annexed to the Commission Decision on this Article 6(13) referral for Seretide Evohaler and associated names.
Danish: Bemærk: Dette bilag III (Produktresumé, Etikettering og Indlægsseddel) var bilag til Europa-Kommissionens beslutning angående denne artikel 6(13) arbitreringssag vedrørende Seretide Evohaler og tilknyttede navne.
English: In several EU Member States Seretide Evohaler and associated names (see Annex I) are approved through the Mutual Recognition Procedure (MRP).
Danish: Seretide Evohaler og tilknyttede navne (se bilag I) er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: If your symptoms are well controlled using Seretide Evohaler twice daily, your doctor may decide to reduce your dose to once daily.
Danish: Hvis dine symptomer er velkontrollerede på Seretide Evohaler to gange daglig, kan din læge forsøge at nedsætte dosis til en gang daglig.
English: Zone Industrielle No.2, 23 Rue Lavoisier, la madeleine, 27000 Evreux, France.
Danish: Zone Industrielle No 2, 23 rue Lavoisier, La Madeleine 27000 Evreux, Frankrig
English: Adults and adolescents 12 years and older:
Danish: Voksne og unge fra 12 år