FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60 %.
Danish: Samtidig administration af alendronat og kaffe eller appelsinjuice reducerede biotilgængeligheden med ca. 60 %.
English: • have been told you have trouble absorbing minerals in your stomach or intestines
Danish: • Du har fået at vide, at du har svært ved at optage mineraler i maven eller tarmen
English: It is important that you take VANTAVO for as long as your doctor prescribes the medicine.
Danish: Det er vigtigt, at du tager VANTAVO, så længe din læge foreskriver medicinen.
English: Many of these patients were also receiving chemotherapy and corticosteroids.
Danish: Mange af disse patienter fik også kemoterapi og kortikosteroider.
English: Elimination Following a single intravenous dose of [
Danish: Elimination Efter enkelt intravenøs dosis [
English: The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Danish: Jo tidligere en kvinde når overgangsalderen, jo større er risikoen for knogleskørhed.
English: Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Danish: Alendronat tilhører en gruppe ikke-hormonelle lægemidler, som kaldes bisphosphonater.
English: Consult your doctor before you begin any exercise programme.
Danish: Kontakt din læge før du begynder på et træningsprogram.
English: • if your doctor has told you that you have low blood calcium.
Danish: • hvis din læge har fortalt dig, at dit kalkindhold i blodet er lavt.
English: In both cases, the excreted radioactivity was almost exclusively as metabolites of the parent.
Danish: I begge tilfælde bestod den udskilte radioaktivitet næsten udelukkende af metabolitter fra modermetabolitten.
English: Therefore no dose adjustment is necessary for the elderly.
Danish: Dosisjustering er derfor ikke nødvendig til ældre patienter.
English: • you have, or have recently had, any swallowing or digestive problems,
Danish: • Du har eller for nylig har haft synkebesvær eller fordøjelsesproblemer,
English: These side effects may worsen if patients continue to take VANTAVO after developing these symptoms.
Danish: Disse bivirkninger kan forværres, hvis patienten fortsætter med at tage VANTAVO efter at have udviklet sådanne symptomer.
English: Patients with malabsorption may not adequately absorb vitamin D3.
Danish: Patienter med malabsorption kan måske ikke optage tilstrækkeligt D3-vitamin.
English: There are no or limited amount of data from the use of alendronate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra brug af alendronat til gravide kvinder.
English: Talk to your doctor or pharmacist before taking VANTAVO if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager VANTAVO hvis:
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bisphosphonates, combinations, ATC code: M05BB03
Danish: Farmakoterapeutisk gruppe: Lægemidler til behandling af knoglesygdomme, bisphosphonater, kombinationer, ATC-kode: M05BB03
English: • if you cannot stand or sit upright for at least 30 minutes,
Danish: • hvis du ikke er i stand til at stå eller sidde oprejst i mindst 30 minutter,
English: See your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:
Danish: Kontakt straks lægen, hvis du bemærker en eller flere af følgende bivirkninger, som kan være alvorlige, og som kan kræve akut lægehjælp:
English: A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
Danish: For en undergruppe genopstod symptomerne, da de igen fik det samme lægemiddel eller andet bisphosphonat.
English: Talk to your doctor first and follow the advice given.
Danish: Tal med din læge og følg lægens råd.
English: Remember, take VANTAVO once each week on that same day for as long as your doctor prescribes it.
Danish: Husk at tage VANTAVO én gang om ugen på den samme ugedag, så længe din læge foreskriver det.
English: If left untreated, however, it can result in broken bones.
Danish: Men hvis det ikke bliver behandlet, kan det resultere i knoglebrud.
English: Biotransformation There is no evidence that alendronate is metabolised in animals or humans.
Danish: Biotransformation Der er ingen tegn på, at alendronat metaboliseres i dyr eller mennesker.
English: The percentage of patients with hypercalciuria at the end of the 24-week extension was not statistically different between treatment groups.
Danish: Procentdelen af patienter med hyperkalciuri ved slutningen af 24-ugers ekstensionsperioden var ikke statistisk signifikant mellem behandlingsgrupperne.
English: How to take VANTAVO tablets
Danish: Hvordan du skal tage VANTAVO tabletterne
English: C]alendronate, approximately 50 % of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Danish: C] alendronat, udskilles ca. 50 % af radioaktiviteten i urinen inden for 72 timer og kun lidt eller ingen radioaktivitet genfindes i fæces.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of VANTAVO on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af VANTAVO for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Non-kliniske data har ikke afsløret særlig risiko for mennesker, baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved gentagne doser, genotoksicitet og carcinogent potentiale.
English: The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Danish: Det gennemsnitlige steady-state fordelingsvolumen, ikke medregnende knogler, er mindst 28 liter hos mennesker.
English: Don't lie down, eat, drink or take other medicines for at least 30 minutes.
Danish: Du må ikke lægge dig ned eller spise, drikke eller tage anden medicin i mindst 30 minutter.
English: It is unknown whether alendronate/metabolites are excreted in human milk.
Danish: Det er ukendt, om alendronat/metabolitter udskilles i human mælk.
English: No specific information is available on the treatment of overdose with alendronate.
Danish: Der er ingen specifik information vedrørende behandling af overdosering med alendronat.
English: What is alendronate?
Danish: Hvad er alendronat?
English: • Do not take with juice or milk.
Danish: • Tag ikke tabletten med juice eller mælk.
English: There are no data on foetal risk in humans.
Danish: Der er ingen data vedrørende føtal risiko hos mennesker.
English: What is VANTAVO used for?
Danish: Hvad anvendes VANTAVO til?
English: Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected.
Danish: Osteoklasteraktiviteten hæmmes, men rekruttering eller tilhæftning af osteoklaster påvirkes ikke.
English: - Hypocalcaemia.
Danish: - Hypokalcæmi.
English: • Do not take with coffee or tea.
Danish: • Tag ikke tabletten med kaffe eller te.
English: These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Danish: Disse transverse eller korte oblikke frakturer kan forekomme hvor som helst på femur, fra lige under trochanter minor til lige over det suprakondylære svaj.
English: Contact your doctor and dentist if you experience such symptoms,
Danish: Kontakt din læge eller tandlæge, hvis du oplever disse symptomer.
English: - Inability to stand or sit upright for at least 30 minutes.
Danish: - Manglende evne til at stå eller sidde oprejst i mindst 30 minutter.
English: Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years.
Danish: Bisphosphonater inkorporeres i knoglematrix, hvorfra de gradvist frigives over en årelang periode.
English: The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use (see section 5.2).
Danish: Mængden af bisphosphonat, der inkorporeres i knoglerne hos voksne, og dermed den mængde, der er tilgængelig for frigivelse tilbage til systemisk cirkulation, er direkte relateret til dosis og varigheden af bisphosphonatbehandlingen (se pkt.
English: Urine and serum calcium should be monitored in these patients.
Danish: Urin og serumcalcium bør monitoreres hos disse patienter.
English: It contains important information reminding you how to take VANTAVO properly.
Danish: Det angiver vigtig information, som vil minde dig om, hvordan du skal tage VANTAVO korrekt.
English: VANTAVO is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
Danish: VANTAVO er kun beregnet til anvendelse hos postmenopausale kvinder, og bør derfor ikke anvendes under graviditet eller af ammende kvinder.
English: In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
Danish: I osteoporoseundersøgelserne var alendronat effektivt, når det administreredes mindst 30 minutter før dagens første måltid eller indtag af drikkevarer.
English: Bone and mineral metabolism Causes of osteoporosis other than oestrogen deficiency and ageing should be considered.
Danish: Knogle- og mineralmetabolisme Andre årsager til osteoporose end østrogenmangel og aldring bør overvejes.
English: A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.
Danish: For en lille procentdel af D3vitamin sker der en glucuronidisering før elimination.
English: VANTAVO has no or negligible direct influence on the ability to drive and use machines.
Danish: VANTAVO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: An Instruction Card is included in the carton for VANTAVO.
Danish: Der er vedlagt et instruktionskort i VANTAVO pakningen.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakning og blister.
English: Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product.
Danish: Andre lidelser, som påvirker mineralmetabolismen (såsom D-vitaminmangel og hypoparathyroidisme), skal også behandles effektivt, før behandling med dette lægemiddel initieres.
English: Most patients had relief of symptoms after stopping treatment.
Danish: De fleste patienter oplevede symptomlindring efter seponering af behandlingen.
English: Therefore, caution should be used when these medicines are taken at the same time as VANTAVO.
Danish: Derfor bør der udvises forsigtighed, når disse lægemidler tages samtidigt med VANTAVO.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis din læge har fortalt, at der er nogle sukkerarter, du ikke kan tåle, skal du kontakte lægen, før du tager denne medicin.
English: In post-marketing experience, these symptoms have rarely been severe and/or incapacitating (see section 4.8).
Danish: I henhold til erfaring efter markedsføring har disse symptomer sjældent været alvorlige og/eller invaliderende (se pkt.
English: Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone.
Danish: Knoglebrud kan opstå under normale daglige aktiviteter, såsom løft eller som følge af mindre skader, som ikke sædvanligvis bevirker brud på normale knogler.
English: • taste disturbance.
Danish: • Smagsforstyrrelser.
English: The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Danish: Terminal halveringstid hos mennesker vurderes til at være over 10 år, vurderet på baggrund af den langsomme frigivelse af alendronat fra skelettet.
English: It is very important to follow instructions 2), 3), 4) and 5) to help the VANTAVO tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Danish: Det er meget vigtigt, at du følger instruktionerne 2), 3), 4) og -5) for at VANTAVO-tabletten hurtigt kan komme ned i maven og for at nedsætte risikoen for irritation af spiserøret (øsofagus - det rør der forbinder din mund med maven).
English: Since Non Steroidal Anti-Inflammatory Drug (NSAID) use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Danish: Da anvendelse af non-steroide anti-inflammatoriske lægemidler (NSAID) er forbundet med gastrointestinal irritation, bør forsigtighed udvises ved samtidig brug af alendronat.
English: It is important to maintain good oral hygiene when being treated with VANTAVO.
Danish: Det er vigtigt at opretholde en god mundhygiejne, når du er i behandling med VANTAVO.
English: Mark the day of the week that best fits your schedule: MON
Danish: Markér den ugedag, der passer dig bedst: MA
English: FIT consisted of two placebo-controlled studies using alendronate daily (5 mg daily for two years and 10 mg daily for either one or two additional years):
Danish: FIT bestod af 2 placebokontrollerede undersøgelser med alendronat (5 mg dagligt i 2 år og 10 mg dagligt i yderligere enten 1 eller 2 år):
English: Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine.
Danish: Undersøgelser med rotter viser, at alendronat forbigående distribueres i blødt væv efter intravenøs administration af 1 mg/kg, men herefter hurtigt redistribueres til knogler eller udskilles i urinen.
English: As a result, bone loss occurs and bones become weaker.
Danish: Som resultat opstår knogletab, og knoglerne bliver svagere.
English: Store in the original blister in order to protect from moisture and light.
Danish: Opbevares i den originale blisterpakning for at beskytte mod fugt og lys.
English: In the absence of adequate sunlight exposure, vitamin D3 is an essential dietary nutrient.
Danish: Ved mangel på tilstrækkelig eksponering for sollys er D3-vitamin et væsentligt kosttilskud.
English: However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Danish: Der er dog en teoretisk risiko for fosterskader, fortrinsvis af knoglemæssig karakter, hvis en kvinde bliver gravid efter afsluttet behandlingsforløb med bisphosphonat.
English: • FIT 2: A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture.
Danish: • FIT 2: En 4-årig undersøgelse af 4.432 patienter med lav knoglemasse, men uden vertebral fraktur ved baseline.
English: Lesser amounts are distributed to adipose and muscle tissue and stored as vitamin D3 at these sites for later release into the circulation.
Danish: Mindre mængder distribueres til det adipøse væv og muskelvævet og oplagres som D3-vitamin på disse steder for senere frigivelse til kredsløbet.
English: You must wait at least 30 minutes before taking any food and beverages except water.
Danish: Du skal vente mindst 30 minutter, før du indtager mad eller drikke, med undtagelse af vand.
English: This medicinal product should not be used in children less than 18 years of age because no data are available for the alendronic acid/colecalciferol combination.
Danish: Dette lægemiddel bør ikke gives til børn under 18 år, da der ikke foreligger data vedrørende kombinationen alendronsyre/cholecalciferol.
English: The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).
Danish: Effekten af alendronat på knoglemasse og frakturincidens hos postmenopausale kvinder blev undersøgt i to initiale virkningsundersøgelser med identisk design (n=994) samt i undersøgelsen ”Fracture Intervention Trial” (FIT: n=6.459).
English: Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Danish: På grund af risiko for øsofageal irritation bør opkastning ikke induceres, og patienten skal forblive oprejst.
English: Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not anticipated to interfere with the excretion of other medicinal products by those systems in humans.
Danish: Alendronat udskilles hos rotter ikke via nyrernes syre- eller basetransportsystem og forventes derfor ikke hos mennesker at interferere med andre lægemidlers udskillelse via disse systemer.
English: Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years.
Danish: Alendronatnatrium er undersøgt hos et lille antal patienter under 18 år med osteogenesis imperfecta.
English: Colecalciferol and some of its active metabolites pass into breast milk.
Danish: Cholecalciferol og nogle af dets aktive metabolitter udskilles i modermælk.
English: Therefore, it is important that you follow the advice given in section 3 and wait at least 30 minutes before taking any other oral medicines or supplements.
Danish: Det er derfor vigtigt, at du følger instruktionen i punkt 3 og venter 30 minutter, før du tager anden medicin eller tilskud.
English: • you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of such conditions as asthma, rheumatoid arthritis, and severe allergies,
Danish: • Du tager kortikosteroider (f.eks. prednison eller dexamethason), som anvendes ved behandling af visse sygdomme såsom astma, reumatoid artrit og svære allergier,
English: Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate.
Danish: D-vitaminmangel udvikles, når både eksponering for sollys og indtaget gennem kosten er utilstrækkelig.
English: The relevance to humans is unknown.
Danish: Det vides ikke, om dette er relevant for mennesker.
English: Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/day.
Danish: D-vitamin toksicitet er ikke blevet dokumenteret under kronisk behandling hos generelt raske voksne ved en dosis på mindre end 10.000 IE/dag.
English: If you take more VANTAVO than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Danish: Hvis du ved en fejltagelse kommer til at tage for mange tabletter, skal du drikke et helt glas mælk og straks kontakte din læge.
English: The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw:
Danish: Følgende risikofaktorer bør tages i betragtning, når den enkelte patients risiko for udvikling af osteonekrose i kæben vurderes:
English: The content of vitamin D in VANTAVO is not suitable for correction of vitamin D deficiency.
Danish: Indholdet af D-vitamin i VANTAVO er ikke velegnet til opretning af D-vitaminmangel.
English: Results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.
Danish: Resultaterne er utilstrækkelige til at understøtte brugen af alendronatnatrium til pædiatriske patienter med osteogenesis imperfecta.
English: At doses far higher than the human therapeutic range, reproductive toxicity has been observed in animal studies.
Danish: Ved doser, der er meget højere end virkningsbredden for mennesker, er der observeret reproduktionstoksicitet i dyreundersøgelser.
English: • cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking
Danish: • Cancer, kemoterapi, strålebehandling, kortikosteroider, angiogenesehæmmere, rygning
English: Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast.
Danish: Biotilgængeligheden var negligeabel, hvad enten alendronat blev administreret sammen med eller op til 2 timer efter et standardiseret morgenmåltid.
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with VANTAVO.
Danish: Hos patienter med disse lidelser bør serumcalcium og symptomer på hypokalcæmi monitoreres under behandling med VANTAVO.
English: • Patients should not lie down for at least 30 minutes after taking VANTAVO and until after the first food of the day.
Danish: • Patienten må ikke ligge ned de første 30 minutter efter indtagelse af VANTAVO og før dagens første måltid er indtaget.
English: Following absorption, vitamin D3 enters the blood as part of chylomicrons.
Danish: Efter absorption går D3-vitamin ind i blodet som en del af chylomikronerne.
English: Read the Package Leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: Vitamin D is an essential nutrient, required for calcium absorption and healthy bones.
Danish: D-vitamin er et vigtigt næringsstof, som er nødvendigt for kalkoptagelsen og sunde knogler.
English: Due to the nature of the disease process in osteoporosis, VANTAVO is intended for long-term use.
Danish: På grund af sygdomsprocessen ved osteoporose er VANTAVO beregnet til langtidsbehandling.
English: • you are undergoing chemotherapy or radiotherapy,
Danish: • Du får kemoterapi eller strålebehandling,
English: Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.
Danish: Yderligere tilskud af D-vitamin bør overvejes på individuel basis, idet der tages hensyn til indtagelsen af D-vitamin fra vitaminer og kosttilskud.
English: VANTAVO should not be used during pregnancy.
Danish: VANTAVO må ikke anvendes under graviditet.
English: Rare symptomatic hypocalcaemia, often in association with predisposing conditions.
Danish: Symptomatisk hypokalcæmi, ofte i forbindelse med prædisponerende faktorer
English: • FIT 1: A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture.
Danish: • FIT 1: En 3-årig undersøgelse af 2.027 patienter som havde mindst én vertebral (kompressions) fraktur ved baseline.
English: Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function.
Danish: Der foreligger ingen kliniske data herfor, men det er sandsynligt at eliminationen af alendronat via nyrerne, ligesom hos dyr, vil være reduceret hos patienter med nedsat nyrefunktion.
English: In a clinical study of healthy adults a 4,000 IU daily dose of vitamin D3 for up to five months was not associated with hypercalciuria or hypercalcaemia.
Danish: I en klinisk undersøgelse med raske voksne blev en D3vitamin dosis på 4.000 IE/dag givet i op til fem måneder ikke forbundet med hyperkalciuri eller hyperkalcæmi.
English: When radioactive vitamin D3 was administered to healthy subjects, the mean urinary excretion of radioactivity after 48 hours was 2.4 %, and the mean faecal excretion of radioactivity after 4 days was 4.9 %.
Danish: Når radioaktivt D3-vitamin administreredes til raske forsøgspersoner, var den gennemsnitlige radioaktivitet i urinen efter 48 timer 2,4 %, og den gennemsnitlige radioaktivitet i fæces efter 4 dage var 4,9 %.
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status.
Danish: En undersøgelse af tænderne med hensigtsmæssig præventiv tandlægebehandling bør overvejes før behandling med bisphosphonater hos patienter med dårlig tandstatus.