FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of the lower dose of VANTAVO (alendronate 70 mg/vitamin D3 2,800 IU) plus an additional 2,800 IU Vitamin D3 for a total of 5,600 IU (the amount of vitamin D3 in the higher dose of VANTAVO) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women.
Danish: Effekten af den lave dosis af VANTAVO (alendronat 70 mg/D3-vitamin 2.800 IE) plus yderligere 2.800 IE D3-vitamin til i alt 5.600 IE (mængden af D3-vitamin i den høje dosis af VANTAVO) en gang ugentligt blev påvist i en 24 ugers ekstensionsundersøgelse, der inkluderede 619 postmenopausale kvinder med osteoporose.
English: VANTAVO is only intended for use in postmenopausal women.
Danish: VANTAVO er kun beregnet til kvinder efter overgangsalderen.
English: Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Danish: Olestra, mineralske olier, orlistat og galdesyremidler (colestyramin, colestipol) kan svække optagelsen af D-vitamin.
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Danish: VANTAVO anbefales ikke til patienter med nedsat nyrefunktion, hvor kreatinin-clearance er <35 ml/min (se pkt.
English: The bioavailability of the 2800 IU vitamin D3 in VANTAVO is similar to 2800 IU vitamin D3 administered alone.
Danish: Biotilgængeligheden for 2.800 IE D3-vitamin i VANTAVO er lig med 2.800 IE D3-vitamin, administreret alene.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med VANTAVO Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har gjort det for nylig eller måske vil gøre det.
English: • a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures
Danish: • Tandsygdom i anamnesen, dårlig mundhygiejne, sygdom i parodontiet, invasive dentale indgreb og dårlig tilpasning af tandproteser.
English: In case of overdose with VANTAVO, milk or antacids should be given to bind alendronate.
Danish: I tilfælde af overdosering med VANTAVO bør der indtages mælk eller antacida for at binde alendronat.
English: Excipients with known effect Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 63 mg lactose (som vandfrit lactose) og 16 mg saccharose.
English: In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the VANTAVO (70 mg/2800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70).
Danish: I denne undersøgelse øgedes de gennemsnitlige 25-hydroxyvitamin D niveauer hos patienter med D-vitaminmangel ved baseline (25-hydroxyvitamin D, 22,5 til 37,5 nmol/l [9 til <15 ng/ml]) fra 30 nmol/l (12,1 ng/ml) til 40 nmol/l (15,9 ng/ml) ved uge 15 i VANTAVO (70 mg/2.800 IE) gruppen (n=75) og faldt fra 30 nmol/l (12,0 ng/ml) ved baseline til 26 nmol/l (10,4 ng/ml) ved uge 15 i gruppen med alendronat alene (n=70).
English: Take one tablet once a week.
Danish: Tag én tablet én gang ugentligt.
English: Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast.
Danish: I forhold til intravenøs referencedosis er den perorale biotilgængelighed for alendronat, når det administreres efter en nats faste og 2 timer før et standardiseret morgenmåltid, 0,64 % for kvinder ved doser fra 5-70 mg. Biotilgængeligheden reduceredes til ca. 0,46 % og 0,39 %, når alendronat administreredes en time, eller en halv time, før et standardiseret morgenmåltid.
English: The equivalence of intake of 5,600 IU of vitamin D3 weekly in VANTAVO to daily dosing of vitamin D 800 IU has not been studied.
Danish: Ækvivalensen mellem indtagelse af 5.600 IE D3-vitamin ugentligt i VANTAVO og daglig dosering af D-vitamin 800 IE er ikke undersøgt.
English: Return to taking one tablet once a week, as originally scheduled on your chosen day.
Danish: Fortsæt med at tage én tablet om ugen, på den ugedag, du oprindeligt har valgt.
English: The equivalence of intake of 2800 IU of vitamin D3 weekly in VANTAVO to daily dosing of vitamin D 400 IU has not been studied.
Danish: Ækvivalensen mellem indtagelse af 2.800 IE D3-vitamin ugentligt i VANTAVO og daglig dosering af D-vitamin 400 IE er ikke undersøgt.
English: After 24-weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher in the Vitamin D3 5,600 group (69 nmol/l [27.6 ng/ml]) than in the Vitamin D3 2,800 group (64 nmol/l [25.5 ng/ml]).
Danish: Efter 24 ugers behandling var de gennemsnitlige serum 25-hydroxyvitamin D niveauer signifikant højere i D3-vitamin 5.600 gruppen (69 nmol/l [27,6 ng/ml]) end i D3-vitamin 2.800 gruppen (64 nmol/l [25,5 ng/ml]).
English: Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Danish: Dette lægemiddel indeholder lactose og saccharose og bør ikke anvendes til patienter med sjælden arvelig fructoseintolerance, arvelig galactoseintolerance, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency), glucose/galactose malabsorption eller sucrase-isomaltasemangel.
English: VANTAVO 70 mg 5600 IU
Danish: VANTAVO 70 mg 5600 IE
English: Excipients with known effect Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 62 mg lactose (som vandfrit lactose) og 8 mg saccharose.
English: Microcrystalline cellulose (E460) Lactose anhydrous Medium chain triglycerides Gelatin
Danish: Mikrokrystallinsk cellulose (E460) Lactose, vandfri
English: • headache; dizziness,
Danish: • Hårtab, kløe.
English: †, pruritus Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Danish: Udslæt med lysoverfølsomhed, alvorlige hudreaktioner inklusive Steven Johnsons syndrom og toksisk epidermal nekrolyse
English: VANTAVO should not be used during breast-feeding.
Danish: VANTAVO må ikke anvendes under amning.
English: The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with VANTAVO (70 mg/2800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Danish: Procentdelen af patienter med D-vitaminmangel (serum 25-hydroxyvitamin D  22,5 nmol/l [9 ng/ml]) var signifikant reduceret med 92 % med VANTAVO (70 mg/2.800 IE) versus alendronat alene (henholdsvis 1 % versus 13 %).
English: • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,
Danish: • Halsbrand, synkebesvær, synkesmerter, sårdannelse i spiserøret (øsofagus - det rør der forbinder din mund med maven), som kan medføre smerter i brystet, halsbrand eller synkebesvær/synkesmerter.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Danish: Når du har slugt VANTAVO tabletten, må du ikke lægge dig ned - du skal forblive oprejst (siddende, stående eller gående) i mindst 30 minutter.
English: • narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach),
Danish: • Indsnævring af spiserøret (øsofagus - det rør der forbinder din mund med maven).
English: Common abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena
Danish: Almindelig Abdominalsmerter, dyspepsi, obstipation, diarré, flatulens, øsofageal ulcus*, dysfagi*, abdominal udspiling, syreregurgitation.
English: After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the VANTAVO (70 mg/2800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
Danish: Efter 15 ugers behandling var de gennemsnitlige serum 25hydroxyvitamin D niveauer signifikant højere (26 %) i VANTAVO (70 mg/2.800 IE) gruppen (56 nmol/l [23 ng/ml]) end i gruppen med alendronat alene (46 nmol/l [18,2 ng/ml]).
English: • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
Danish: • Mavesmerter, ubehagsfølelse i maven eller opstød efter at have spist, forstoppelse, oppustet mave, diarré, øget luftafgang fra tarmen.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan berøre mere end 1 person ud af 10):
English: Osteonecrosis of the jaw
Danish: Osteonekrose af øregangen
English: Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Danish: Overdosering kan forårsage hypokalcæmi, hypophosphatæmi og øvre gastrointestinale bivirkninger som mavebesvær, halsbrand, øsofagitis, gastritis eller ulcus.
English: VANTAVO 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
Danish: VANTAVO 70 mg/5.600 IE tabletter er modificeret rektangulære, hvide/beige tabletter, der er mærket med omridset af en knogle på den ene side og ”270” på den anden side.
English: Common alopecia
Danish: Almindelig Alopeci †, kløe
English: BLISTER FOR VANTAVO 70 mg/2,800 IU
Danish: BLISTERTEKST TIL VANTAVO 70 mg/2.800 IE
English: • irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,
Danish: • Irritation eller betændelse i spiserøret (øsofagus - det rør der forbinder din mund med maven)
English: In healthy adult subjects (males and females), following administration of VANTAVO 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Danish: Ved administration af VANTAVO 70 mg/5.600 IE tabletter efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum-koncentration-tid (AUC0-80 timer) for D3-vitamin (ikke justeret for endogene D3-vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 490,2 ngtime/ml.
English: VANTAVO 70 mg/2,800 IU tablets
Danish: VANTAVO 70 mg/2.800 IE tabletter
English: Patients in the Vitamin D3 2,800 group received VANTAVO (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received VANTAVO (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Danish: Patienter i D3-vitamin 2.800 gruppen fik VANTAVO (70 mg/2.800 IE) (n=299), og patienter i D3-vitamin 5.600 gruppen fik VANTAVO (70 mg/2.800 IE) plus yderligere
English: Laboratory test findings
Danish: Laboratoriefund
English: Modified capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '710' on the other.
Danish: Modificeret kapselformede, hvide/beige tabletter mærket med et omrids af en knogle på den ene side og ”710” på den anden.
English: BLISTER FOR VANTAVO 70 mg/5,600 IU
Danish: BLISTERTEKST TIL VANTAVO 70 mg/5.600 IE
English: In healthy adult subjects (males and females), following administration of VANTAVO 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Danish: Ved administration af VANTAVO 70 mg/2.800 IE tabletter efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum-koncentration-tid (AUC0-120 timer) for D3-vitamin (ikke justeret for endogene D3-vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 296,4 ngtime/ml.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne (kan berøre op til 1 person ud af 1.000):
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjældne (kan berøre op til 1 person ud af 10.000):
English: VANTAVO 70 mg/2800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
Danish: VANTAVO 70 mg/2.800 IE tabletter er modificeret kapselformede hvide/beige tabletter mærket med omridset af en knogle på den ene side og ”710” på den anden side.
English: VANTAVO 70 mg/5,600 IU tablets
Danish: VANTAVO 70 mg/5.600 IE tabletter
English: • bone, muscle and/or joint pain which is severe.
Danish: • Knogle- muskel- og/eller ledsmerter, som kan være voldsomme.
English: EU/1/09/572/006 (2 tablets) EU/1/09/572/007 (4 tablets) EU/1/09/572/008 (12 tablets)
Danish: EU/1/09/572/006 (2 tabletter) EU/1/09/572/007 (4 tabletter) EU/1/09/572/008 (12 tabletter)
English: Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270' on the other.
Danish: Modificeret rektangulære, hvide/beige tabletter mærket med et omrids af en knogle på den ene side og ”270” på den anden.
English: EU/1/09/572/001 (2 tablets) EU/1/09/572/002 (4 tablets) EU/1/09/572/003 (6 tablets) EU/1/09/572/004 (12 tablets)
Danish: EU/1/09/572/001 (2 tabletter) EU/1/09/572/002 (4 tabletter) EU/1/09/572/003 (6 tabletter) EU/1/09/572/004 (12 tabletter)
English: Very common musculoskeletal (bone, muscle or joint) pain which is sometimes severe Common joint swelling Rare osteonecrosis of the jaw
Danish: Meget almindelig Muskuloskeletale (knogle, muskel eller led) smerter, som kan være voldsomme
English: VANTAVO 70 mg/5,600 IU tablets EU/1/09/572/006 - 2 tablets EU/1/09/572/007 - 4 tablets EU/1/09/572/008 - 12 tablets
Danish: VANTAVO 70 mg/5.600 IE tabletter EU/1/09/572/006 - 2 tabletter EU/1/09/572/007 - 4 tabletter EU/1/09/572/008 - 12 tabletter
English: insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with VANTAVO (70 mg/2800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Danish: Procentdelen af patienter med D-vitaminmangel (serum 25-hydroxyvitamin D < 37,5 nmol/l [<15 ng/ml]) var signifikant reduceret med 62,5 % med VANTAVO (70 mg/2.800 IE) versus alendronat alene (henholdsvis 12 % versus 32 %) efter uge 15.
English: The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin.
Danish: Kroppen kan kun optage kalk ordentligt fra maden, hvis der er nok D-vitamin til stede.
English: How to take VANTAVO
Danish: Sådan skal du tage VANTAVO
English: VANTAVO 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Danish: VANTAVO 70 mg/2.800 IE tabletter Aluminium/aluminiumblisterkort i æsker med 2, 4, 6 eller 12 tabletter.
English: It is likely that certain medicines or food additives may prevent the vitamin D in VANTAVO from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
Danish: Disse omfatter kunstige fedterstatninger, mineralske olier, slankemidlet orlistat og de kolesterolsænkende lægemidler colestyramin og colestipol.
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Danish: På grund af manglende erfaring bør VANTAVO ikke gives til patienter med nedsat nyrefunktion, hvor kreatinin-clearance er <35 ml/min.
English: VANTAVO 70 mg/2800 IU tablets VANTAVO 70 mg/5,600 IU tablets
Danish: VANTAVO 70 mg/2.800 IE, tabletter VANTAVO 70 mg/5.600 IE, tabletter
English: VANTAVO 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Danish: VANTAVO 70 mg/5.600 IE tabletter Aluminium/aluminiumblisterkort i æsker med 2, 4 eller 12 tabletter.
English: Patients may experience certain adverse reactions (for example, blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Danish: Patienter kan opleve visse bivirkninger ved VANTAVO (f.eks. sløret syn, svimmelhed og svære knogle-, muskel- eller ledsmerter (se pkt.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan berøre op til 1 person ud af 10):
English: Pharmacokinetic properties
Danish: 5.2 Farmakokinetiske egenskaber
English: VANTAVO 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
Danish: VANTAVO 70 mg/5.600 IE tabletter fås i pakninger med 2, 4 eller 12 tabletter.
English: VANTAVO 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
Danish: VANTAVO 70 mg/2.800 IE tabletter fås i pakninger med 2, 4, 6 eller 12 tabletter.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (kan berøre op til 1 person ud af 100):
English: Take one tablet once a week
Danish: Tag 1 tablet 1 gang ugentligt
English: VANTAVO 70 mg/2800 IU tabletsVANTAVO 70 mg/5,600 IU tablets Alendronic acid / colecalciferol
Danish: VANTAVO 70 mg/2.800 IE tabletter VANTAVO 70 mg/5.600 IE tabletter alendronsyre/cholecalciferol
English: Renal impairment
Danish: †, perifert ødem
English: MARKETING AUTHORISATION HOLDER(S)
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlægsseddel blev senest ændret
English: The percentage of patients with vitamin D
Danish: Meget få fødevarer indeholder D-vitamin.
English: Each VANTAVO 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Danish: Hver VANTAVO 70 mg/2.800 IE tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 70 mikrogram (2.800 IE) cholecalciferol (D3-vitamin).
English: If you think any of these apply to you, do not take the tablets.
Danish: Tag ikke tabletterne, hvis du mener, at noget af ovenstående passer på dig.
English: VANTAVO 70 mg/5600 IU tablets alendronic acid /colecalciferol
Danish: VANTAVO 70 mg/5.600 IE tabletter Alendronsyre/cholecalciferol
English: Each VANTAVO 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3)
Danish: Hver VANTAVO 70 mg/5.600 IE tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 140 mikrogram (5.600 IE) cholecalciferol (D3-vitamin).
English: 70 mg/5600 IU tablets alendronic acid/colecalciferol
Danish: 70 mg/5600 IE tabletter alendronsyre/cholecalciferol
English: 70 mg/2800 IU tablets alendronic acid/colecalciferol
Danish: 70 mg/2800 IE tabletter alendronsyre/cholecalciferol
English: Common asthenia
Danish: Almindelig Asteni
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Danish: Hver tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 140 mikrogram (5.600 IE) cholecalciferol (D3-vitamin).
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Danish: Hver tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 70 mikrogram (2.800 IE) cholecalciferol (D3-vitamin).
English: Excipients
Danish: PRODUKTRESUME
English: VANTAVO 70 mg/2800 IU tablets alendronic acid /colecalciferol
Danish: VANTAVO 70 mg/2.800 IE tabletter Alendronsyre/cholecalciferol
English: What VANTAVO is and what it is used for What you need to know before you take VANTAVO How to take VANTAVO
Danish: Det skal du vide, før du begynder at tage VANTAVO Sådan skal du tage VANTAVO Bivirkninger
English: Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Danish: Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
English: It reduces the risk of spine and hip fractures.
Danish: Alendronat nedsætter risikoen for hoftebrud samt brud på rygsøjlen.
English: THU
Danish: TI
English: Very rare osteonecrosis of the external auditory canal
Danish: Almindelig Vertigo Meget sjælden Osteonekrose af øregangen (klassebivirkning for bisphosphonater)
English: The recommended dose is 400 mg once a month.
Danish: Den anbefalede dosis er 400 mg én gang om måneden.
English: It must not be injected into a vein or under the skin.
Danish: Det må ikke gives ved injektion i en vene eller under huden.
English: The full EPAR for Abilify Maintena can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Abilify Maintena findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abilify Maintena den 15. november 2013.
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Danish: Dets nøjagtige virkningsmekanisme kendes ikke, men det bindes til en række receptorer på overfladen af nervecellerne i hjernen.
English: After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks.
Danish: Efter den første injektion bør den daglige behandling med 10-20 mg aripiprazol gennem munden fortsætte i to uger.
English: This is a summary of the European public assessment report (EPAR) for Abilify Maintena.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Abilify Maintena.
English: ‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Danish: At det er et depotpræparat, betyder, at det aktive stof frigives langsomt i flere uger efter injektionen.
English: Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided.
Danish: Behandling i over to uger med lægemidler, der fremskynder nedbrydningen af aripiprazol, bør undgås.
English: In one main study involving adults whose disease had already been stabilised on treatment with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.
Danish: I én hovedundersøgelse med voksne, hvis sygdom i forvejen var blevet stabil på behandling med aripiprazol indtaget gennem munden, kom der i løbet af 26 uger tilbagefald af symptomer hos 22 (8,3 %) af de 265 patienter, der blev behandlet med Abilify Maintena, sammenholdt med 21 (7,9 %) af de 266 patienter, der var behandlet med aripiprazol taget gennem munden.