FrancophonIA/ELRC3.0 huggingface dataset:
English: Anxiety disorders and symptoms Depressed mood disorders and disturbances Mood disorders and disturbances NEC*
Danish: Lidelser og forstyrrelser med nedtrykthed Affektive lidelser og forstyrrelser IKA* * IKA: ikke klassificeret andetsteds
English: 1.74 (1.41, 2.14), P<0.0001
Danish: 1,77 (1,46, 2,14), P<0,0001 1,74 (1,41, 2,14), P<0,0001
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline film-coated tablets, heat sealed card
Danish: Blisterpakning med 14 x 0,5 mg og 28 x 0,5 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
English: You should ask your doctor or pharmacist for advice before taking CHAMPIX.
Danish: Kontakt lægen, før De tager CHAMPIX.
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 1 mg film-coated tablets
Danish: CHAMPIX 1 mg filmovertrukne tabletter
English: Ear and labyrinth disorders
Danish: Øre og labyrint Ikke almindelig
English: 1.41 (1.11, 1.79), P=0.0047
Danish: 1,49 (1,20, 1,85), P=0,0003 1,41 (1,11, 1,79), P=0,0047
English: However, the use of varenicline, bupropion and NRT in the psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs included zero).
Danish: Forekomsten af hændelser for det sammensatte endepunkt var højere for hver af de aktive behandlinger sammenlignet med placebo, men brugen af vareniclin, bupropion og nikotinplaster i den psykiatriske kohorte var ikke forbundet med en signifikant øget risiko for NPS bivirkninger i det sammensatte primære endepunkt sammenlignet med placebo (95 % CI inkluderede nul).
English: Eye disorders Uncommon Rare
Danish: Øjne Ikke almindelig
English: Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders
Danish: Forhøjet blodtryk, hedestigninger
English: 0.5 mg
Danish: CHAMPIX 0,5 mg
English: Common: may affect up to 1 in 10 people o Chest infection, inflammation of the sinuses o Increased weight, decreased appetite, increased appetite o Sleepiness, dizziness, changes in the way things taste o Shortness of breath, cough o Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache,
Danish: - Betændelse i brystkassen, betændelse i bihuler - Vægtstigning, manglende appetit, øget appetit - Søvnighed, svimmelhed, ændret smagssans - Stakåndethed, hoste - Halsbrand, opkastning, forstoppelse, diarré, oppustethed, mavesmerter, tandpine, dårlig fordøjelse, luft i maven, tør mund - Udslæt, kløe - Ledsmerter, muskelsmerter, rygsmerter - Smerter i brystmusklerne, udmattethed
English: Varenicline N=1026 n (%)
Danish: N=1026 n (%)
English: Heat sealed card pack containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets- inner and outer labelling
Danish: Varmeforseglet kortpakning indeholdende 2 blisterpakninger med 28 eller 4 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
English: PCTFE/PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PCTFE/PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 eller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning og PCTFE/PVCblister med aluminiumsfolie i to sekundære varmeforseglede kortpakninger indeholdende 56 x 1 mg filmovertrukne tabletter.
English: PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Danish: PVC-blister med aluminiumsfolie, indeholdende 112 x 1 mg filmovertrukne tabletter i en karton.
English: CA* wk 15-24
Danish: CA* uge 13-24
English: Varenicline N=990 n (%)
Danish: N=990 n (%)
English: Heat sealed card pack containing either 2 or 4 blister packs of 14 x 0.5 mg varenicline film-coated tablets or 2 blister packs of 28 x 0.5 mg varenicline film-coated tablets- inner and outer labelling
Danish: Varmeforseglet kortpakning, indeholdende enten 2 eller 4 blisterpakninger hver med 14 x 0,5 mg vareniclin filmovertrukne tabletter eller 2 blisterpakninger hver med 28 x 0,5 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS One blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Danish: En blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
English: Silica, Colloidal Anhydrous
Danish: Ledstivhed, costochondritis
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 112 x 1 mg filmovertrukne tabletter i en karton.
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
Danish: Varmeforseglet kortpakning, indeholdende 1 blisterpakning med 11 x 0,5 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Danish: - Startpakning, der indeholder 2 blisterkort; 1 gennemsigtig blisterkort med 11 x CHAMPIX 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 28 eller 2 gennemsigtige blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
Danish: - Startpakning, der indeholder 2 blisterkort; 1 gennemsigtigt blisterkort med 11 x CHAMPIX 0,5 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en karton.
English: EU/1/06/360/023
Danish: EU/1/06/360/012 EU/1/06/360/023
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Danish: PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en karton.
English: Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Danish: Hver filmovertrukken tablet indeholder 1 mg vareniclin (som tartrat).
English: PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
Danish: PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 meller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning og PVC-blister med aluminiumsfolie i to sekundære varmeforseglede kortpakninger indeholdende 56 x 1 mg filmovertrukne tabletter.
English: PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Danish: PVC-blister med aluminiumsfolie, indeholdende 140 x 1 mg filmovertrukne tabletter i en karton.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en karton.
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Danish: PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en karton.
English: Varenicline vs Bupropion 1.49 (1.20, 1.85), P=0.0003
Danish: Bupropion kontra placebo 2,26 (1,80, 2,85), P<0,0001 1,87 (1,46, 2,39), P<0,0001 NRT vs placebo
English: EU/1/06/360/003 EU/1/06/360/008 EU/1/06/360/012 EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
Danish: Startpakninger: EU/1/06/360/003 EU/1/06/360/008 EU/1/06/360/012 EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg and 28 x 1 mg varenicline film-coated tablets, heat sealed card
Danish: Blisterpakning med 14 x 1 mg og 28 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 28 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 140 x 1 mg filmovertrukne tabletter i en karton.
English: Heat sealed card pack containing either 2 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 2 blister packs of 28 x 1 mg varenicline film-coated tablets- inner and outer labelling
Danish: Varmeforseglet kortpakning, indeholdende enten 2 eller 4 blisterpakninger hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 2 blisterpakninger hver med 28 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 56 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en karton.
English: PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PVC-blister med aluminiumsfolie, indeholdende 28 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PVC-blister med aluminiumsfolie, indeholdende 56 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: The results showed a similar incidence of combined neuropsychiatric adverse events, other than sleep disorders, in patients treated with varenicline compared to patients treated with placebo, with a risk ratio (RR) of 1.01 (95% CI: 0.89-1.15).
Danish: Resultaterne viste samme incidens af kombinerede neuropsykiatriske bivirkninger - bortset fra søvnlidelser - hos patienter, der blev behandlet med vareniclin, sammenlignet med de patienter, der fik placebo.
English: 2.00 (1.54, 2.59), P<0.0001
Danish: 2,00 (1,54, 2,59), P<0,0001 1,77 (1,33, 2,36), P<0,0001
English: Conjunctivitis, eye pain
Danish: Konjunktivitis, øjensmerter
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 eller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en karton.
English: Feeling abnormala Hostilitya Agitationb Aggression b
Danish: Føler sig unormal Fjendtlighed
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Danish: PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en karton.
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
Danish: Varmeforseglet kortpakning, indeholdende 1 blisterpakning med 11 x 0,5 mg and 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
English: Placebo N=999 n (%)
Danish: N=999 n (%)
English: Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets Cellulose, Microcrystalline
Danish: Tabletkerne - CHAMPIX 0,5 mg og 1 mg filmovertrukne tabletter
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 eller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
Danish: Aftrapning af dosis kan overvejes i de tilfælde, hvor der er høj risiko for, at patienten vil begynde at ryge igen (se pkt.
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling.
Danish: Varmeforseglet kortpakning indeholdende 1 blisterpakning med 11 x 0,5 mg og 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Danish: PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
English: Rare: may affect up to 1 in 1,000 people o Excessive thirst o Feeling unwell or unhappy, slow thinking o Stroke o Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern o Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light,
Danish: Forøget muskelspænding, talebesvær, koordinationsbesvær, nedsat smagssans, ændret søvnmønster - Synsforstyrrelser, misfarvning i øjenæblet, forstørrede pupiller, lysfølsomhed, nærsynethed, øjne der løber i vand
English: Erythema Multiforme, angioedema Musculoskeletal and connective tissue disorders Common
Danish: Alvorlige hudreaktioner, herunder Stevens-Johnsons syndrom og erythema multiforme, angioødem Knogler, led, muskler og bindevæv Almindelig
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets, heat sealed card
Danish: Blisterpakning med 11 x 0,5 mg og 14 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
English: PHARMACEUTICAL FORM AND CONTENTS Maintenance pack containing
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: What CHAMPIX looks like and contents of the pack CHAMPIX 0.5 mg film-coated tablets are white, film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 0.5”
Danish: - CHAMPIX 0,5 mg filmovertrukne tabletter er hvide, filmovertrukne, kapselformede tabletter, mærket ”Pfizer” på den ene side og ”CHX 0.5” på den anden.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Danish: HDPE tabletbeholder, indeholdende 56 x 0,5 mg vareniclin filmovertrukne tabletter
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets
Danish: Blisterkort med 11 x 0,5 mg vareniclin filmovertrukne tabletter
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets, heat sealed card
Danish: Blisterpakning med 11 x 0,5 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
English: Common Uncommon
Danish: Hjerte Ikke almindelig
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg varenicline (as tartrate).
Danish: Hver tablet indeholder 0,5 mg vareniclin (som tartrat).
English: Tablets' core
Danish: Tabletkerne
English: CA* wk 13-24 70.6% 49.8% 20.8% CA* wk 13-52 44.0% 37.1% 6.9%
Danish: CA* uge 9-12 45,0%
English: Package leaflet: Information for the user CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets Varenicline
Danish: CHAMPIX 0,5 mg filmovertrukne tabletter CHAMPIX 1 mg filmovertrukne tabletter Vareniclin
English: A.
Danish: Eller
English: In some cases as a result of stopping smoking, with or without CHAMPIX, an adjustment of the dose of other medicines may be necessary.
Danish: Det kan være nødvendigt både med og uden behandling med CHAMPIX.
English: In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with CHAMPIX.
Danish: Kramperne sås både hos patienter med og uden kramper i anamnesen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Danish: Blisterpakning med 14 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
English: EU/1/06/360/014
Danish: EU/1/06/360/003 EU/1/06/360/014
English: NPS AE Primary Endpoint Components n Anxietya Depression a
Danish: Komponenter i sammensat primært endepunkt for NPS AE, n (%): Angst Depression Føler sig unormal
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Danish: CHAMPIX findes i følgende pakningsstørrelser: - Startpakning, der indeholder 2 blisterkort, 1 gennemsigtig blisterkort med 11 x CHAMPIX 0,5 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets
Danish: Blisterkort med 14 x 1 mg vareniclin filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Danish: HDPE tabletbeholder, indeholdende 56 x 1 mg vareniclin filmovertrukne tabletter
English: Odomzo is continued as long as it has a beneficial effect or until it can no longer be taken because of side effects.
Danish: Odomzo tages, så længe det har en gavnlig virkning, eller indtil det ikke længere kan tages på grund af bivirkninger.
English: This is a summary of the European public assessment report (EPAR) for Odomzo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Odomzo.
English: The full EPAR and risk management plan summary for Odomzo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Odomzo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching.
Danish: De almindeligste bivirkninger ved Odomzo (som kan påvirke mere end 1 ud af 10 personer) er muskelspasmer, hårtab, smagsforstyrrelser, træthed, kvalme, opkastning, muskel- og knoglesmerter, mavepine, hovedpine, diarré, vægttab, appetitløshed og kløe.
English: In addition, the company will send a letter to doctors when Odomzo is launched.
Danish: Endvidere vil virksomheden sende en skrivelse til læger, når Odomzo er frigivet.
English: Odomzo is available as capsules (200 mg) and the recommended dose is one capsule taken once a day at least two hours after the last meal and an hour before the next.
Danish: Odomzo fås som kapsler (200 mg), og den anbefalede dosis er én kapsel, taget en gang dagligt mindst to timer efter sidste måltid og en time før det næste.
English: A risk management plan has been developed to ensure that Odomzo is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Odomzo anvendes så sikkert som muligt.
English: The Committee considered that the benefits of Odomzo had been shown for patients with locally advanced disease.
Danish: Udvalget fandt, at fordelene ved Odomzo var blevet påvist for patienter med lokalt fremskreden sygdom.
English: Substances that affect the Hedgehog pathway can result in serious harm to an unborn baby.
Danish: Stoffer, der påvirker Hedgehog-signaleringsvejen, kan resultere i alvorlig skade på et ufødt barn.