FrancophonIA/ELRC3.0 huggingface dataset:
English: You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.
Danish: Du bør gå regelmæssigt til tandlægen under din behandling, og du skal kontakte din læge eller tandlæge, hvis du oplever problemer med din mund eller tænder såsom løse tænder, smerter eller hævelser.
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone,
Danish: Kontakt lægen hvis du får smerter, svaghed eller ubehag i låret, hoften eller lysken, idet det kan være tidlige tegn på et muligt brud på lårbensknoglen.
English: What is VANTAVO?
Danish: Hvad er VANTAVO?
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Danish: Den behandlende læges kliniske vurdering bør være vejledende for den enkelte patients behandlingsplan og være baseret på individuel fordel/risiko vurdering.
English: Rare hypersensitivity reactions including urticaria and angioedema
Danish: Overfølsomhedsreaktioner inklusive urticaria og angioødem
English: For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Danish: For patienter, hvor dentale indgreb er nødvendige, findes der ingen tilgængelige data, der viser, om seponering af behandling med bisphosphonat reducerer risikoen for kæbeosteonekrose.
English: Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager's hump') and loss of mobility.
Danish: Knoglebrud opstår som regel i hoften, rygsøjlen eller håndleddet og kan medføre ikke kun smerte, men også betydelige problemer såsom foroverbøjet stilling (pukkelryg) og tab af bevægelighed.
English: Vitamin D3 may increase the magnitude of hypercalcaemia and/or hypercalciuria when administered to patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis).
Danish: D3-vitamin kan øge sværhedsgraden af hyperkalcæmi og/eller hyperkalciuri, når det gives til patienter med sygdomme, der er forbundet med ureguleret overproduktion af calcitriol (f.eks. leukæmi, lymphoma, sarcoidosis).
English: No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/kg in animals.
Danish: Der er ikke vist mætning af knogleoptagelsen efter kronisk dosering med kumulative, intravenøse doser på op til 35 mg/kg hos dyr.
English: In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Danish: Hos patienter med kendt Barretts øsofagus bør receptudskriveren overveje fordele og mulige risici ved alendronat individuelt hos patienten.
English: In addition, a statistically significant reduction was found in the incidence of hip fractures (1.1 % vs. 2.2 %, a reduction of
Danish: Derudover fandtes statistisk signifikant reduktion i incidensen af hoftefrakturer (1,1 % versus 2,2 %, en reduktion på 51 %).
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Danish: Hos patienter, der udvikler kæbeosteonekrose under behandling med bisphosphonat, kan dental kirurgi forværre tilstanden.
English: The following instructions should be followed exactly in order to minimise the risk of oesophageal irritation and related adverse reactions (see section 4.4):
Danish: Følgende instruktioner skal følges nøjagtigt for at minimere risikoen for øsofagusirritation og relaterede bivirkninger (se pkt.
English: The following adverse reactions have been reported during clinical studies and/or post-marketing use with alendronate.
Danish: Nedenstående bivirkninger er indberettet i forbindelse med kliniske undersøgelser med alendronat og/eller efter markedsføring.
English: There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Danish: Der var ingen forskelle i middel serumcalcium, phosphat eller 24-timers urincalcium mellem behandlingsgrupperne.
English: Uncommon eye inflammation (uveitis, scleritis, or episcleritis)
Danish: Ikke almindelig Øjenbetændelse (uveitis, scleritis eller episcleritis)
English: Preclinical studies show that alendronate that is not deposited in bone is rapidly excreted in the urine.
Danish: Prækliniske undersøgelser viser, at alendronat, der ikke deponeres i knoglen, hurtigt udskilles i urinen.
English: Hypocalcaemia must be corrected before initiating therapy with VANTAVO (see section 4.3).
Danish: Hypokalcæmi skal korrigeres før behandling med VANTAVO indledes (se pkt.
English: They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Danish: De må ikke tage 2 tabletter samme dag, men skal fortsætte med at tage 1 tablet 1 gang ugentligt på den oprindeligt valgte ugedag.
English: Colecalciferol
Danish: Cholecalciferol
English: Circulating vitamin D3 is bound to vitamin D-binding protein.
Danish: Cirkulerende D3-vitamin bindes til vitamin D-bindende protein.
English: Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min.
Danish: Efter en enkelt intravenøs dosis på 10 mg er renal clearance 71 ml/minut, og systemisk clearance overstiger ikke 200 ml/min.
English: The risk of severe oesophageal adverse reactions appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation.
Danish: Risikoen for alvorlige, øsofageale bivirkninger synes større hos patienter, der ikke tager alendronat som foreskrevet, og/eller som fortsætter med at tage alendronat efter at have udviklet symptomer, der tyder på øsofageal irritation.
English: Alendronate studies
Danish: Alendronat undersøgelser
English: Do not lie down until after your first food of the day.
Danish: Du må ikke lægge dig ned, før du har fået dagens første måltid.
English: • potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above)
Danish: • Potensen af bisphosphonat (højest for zoledronsyre), administrationsvej (se ovenfor) og kumulativ dosis
English: These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction.
Danish: Dette kan være tegn på knogleskade i kæben (knoglenekrose), der generelt er forbundet med forsinket sårheling og infektion, ofte efter tandudtrækning.
English: The safety and efficacy of VANTAVO in children less than 18 years of age have not been established.
Danish: VANTAVOs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Insufficiency is associated with negative calcium balance, bone loss, and increased risk of skeletal fracture.
Danish: Insufficiens er forbundet med negativ calciumbalance, knogletab og øget risiko for knoglefraktur.
English: In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 % and 10 %, respectively, of patients taking alendronate 10 mg/day versus approximately 12 % and 3 % of those taking placebo.
Danish: Der er i kliniske undersøgelser set asymptomatiske, milde og forbigående fald i serumcalcium og serumphosphat hos henholdsvis 18 % og 10 % af de patienter, der fik alendronat 10 mg/dag, versus hos ca. 12 % og 3 % af de patienter, der fik placebo.
English: Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a greater risk of fractures.
Danish: Alvorlig D-vitaminmangel kan forårsage muskelsvaghed, som kan føre til fald og større risiko for knoglebrud.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates.
Danish: Kæbeosteonekrose, som normalt er associeret med tandudtrækning og/eller lokal infektion (inklusive osteomyelitis), er rapporteret hos cancerpatienter, som modtager behandlingsregimer, inklusive primært intravenøst administrerede bisphosphonater.
English: Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4).
Danish: Patienterne skal have supplerende calcium, hvis indtagelsen fra kosten ikke er tilstrækkelig (se pkt.
English: In this study alendronate daily reduced the incidence of  1 new vertebral fracture by 47 % (alendronate 7.9 % vs. placebo 15.0 %).
Danish: I denne undersøgelse reducerede alendronat 1 gang dagligt incidensen af  1 ny vertebral fraktur med 47 % (alendronat 7,9 % versus placebo 15,0 %).
English: Vitamin D3 is required for normal bone formation.
Danish: D3-vitamin er nødvendig for den normale knogleopbygning.
English: When you get out of bed on the day you have chosen, and before taking your first food, drink or other medicines, swallow (do not crush or chew the tablet or allow it to dissolve in your mouth) one VANTAVO tablet with a full glass of water (not mineral water).
Danish: Når du står op på den valgte ugedag, og før du indtager dagens første måltid, drikkevarer eller anden medicin, skal du sluge én VANTAVO tablet (ikke knuse eller tygge tabletten eller lade den opløse i munden) med et helt glas postevand (ikke mineralvand).
English: Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ml).
Danish: Koncentrationen af alendronat i plasma efter terapeutiske, orale doser er under analysegrænsen (<5 ng/ml).
English: Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations (SD) below the mean value of a normal young population or as a previous fragility fracture, irrespective of BMD.
Danish: Osteoporose er defineret som knoglemineraltætheden (BMD) for columna spinalis eller hofte på 2,5 standarddeviationer (SD) under middelværdien for en normal ung population eller som tidligere skørhedsfraktur uden hensyntagen til BMD.
English: VANTAVO studies
Danish: VANTAVO undersøgelser
English: Preclinical studies have shown preferential localisation of alendronate to sites of active resorption.
Danish: Prækliniske undersøgelser har vist, at alendronat primært lokaliseres til steder med aktiv resorption.
English: Alendronate can cause local irritation of the upper gastrointestinal mucosa.
Danish: Alendronat kan forårsage lokal irritation af slimhinderne i den øvre del af gastrointestinalkanalen.
English: Studies in rats have shown that treatment with alendronate during pregnancy was associated with dystocia in dams during parturition which was related to hypocalcaemia.
Danish: Undersøgelser med rotter har vist, at behandling med alendronat under graviditet var associeret med hypocalciæmirelateret dystocia hos hunrotter.
English: The recommended dose is one tablet once weekly.
Danish: Den anbefalede dosis er en tablet en gang ugentligt.
English: The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
Danish: Den vigtigste funktion for 1,25 dihydroxyvitamin D3 er at øge den intestinale absorption af både calcium og phosphat såvel som at regulere serumcalcium, renal calcium og phosphatudskillelsen, knogleopbygningen og knogleresorptionen.
English: Colecalciferol (vitamin D3)
Danish: Cholecalciferol (D3-vitamin)
English: Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased.
Danish: På grund af alendronats positive virkning på øgning i knoglemineraltætheden, kan der opstå fald i serumcalcium og serumphosphat, især hos patienter, der tager glukokortikoider, da calciumabsorptionen kan være nedsat.
English: Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems.
Danish: Visse lægemidler mod gigt eller langvarige smerter, NSAID (f.eks. acetylsalicylsyre eller ibuprofen) kan medføre fordøjelsesproblemer.
English: Instruction Card
Danish: Instruktionskort
English: You may be advised to have a dental check-up before starting treatment with VANTAVO.
Danish: Du kan blive rådet til et tandlægebesøg, før du begynder behandling med VANTAVO.
English: Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Danish: Omdannelse til det aktive calcium-mobiliserende hormon 1,25-dihydroxyvitamin D3 (calcitriol) i nyrerne reguleres stramt.
English: • transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,
Danish: • Forbigående influenzalignende symptomer som for eksempel ømme muskler, generel utilpashed og nogle gange feber, sædvanligvis i starten af behandlingen.
English: Your doctor has prescribed VANTAVO to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
Danish: Din læge har ordineret VANTAVO til at behandle din knogleskørhed, og fordi du er i risiko for Dvitaminmangel.
English: 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking VANTAVO and contact your doctor.
Danish: Hvis du udvikler synkebesvær, synkesmerter, brystsmerter eller ny/forværret halsbrand, skal du stoppe med at tage VANTAVO og kontakte din læge.
English: Early on, osteoporosis usually has no symptoms.
Danish: Tidligt i forløbet har knogleskørhed som regel ingen symptomer.
English: Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking VANTAVO.
Danish: Irritation, betændelse eller sårdannelse i spiserøret (øsofagus - det rør der forbinder din mund med maven), ofte med symptomer så som brystsmerter, halsbrand, synkebesvær eller synkesmerter opstår især, hvis patienten ikke drikker et helt glas vand, og/eller hvis man lægger sig ned inden 30 minutter, efter man har taget VANTAVO.
English: • your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
Danish: • Din læge har fortalt dig, at du har Barretts øsofagus (en tilstand med celleforandringer i nederste del af spiserøret),
English: ; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Danish: ; atypiske subtrochantære og diafyseale femurfrakturer (bisphosphonat klassebivirkning)
English: 2 tablets 4 tablets 12 tablets
Danish: 2 tabletter 4 tabletter 12 tabletter
English: Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements.
Danish: Din læge kan rådgive dig om kosten eller om, hvorvidt du bør tage kosttilskud.
English: Choose the day of the week that best fits your schedule.
Danish: Vælg den ugedag, der passer dig bedst.
English: In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate.
Danish: Der er i kliniske forsøg ikke vist aldersrelateret forskel i alendronats virkning eller sikkerhedsprofil.
English: • you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care,
Danish: • Du har dårlig mundhygiejne, tandkødslidelser, planlagt tandudtrækning, eller hvis du ikke får regelmæssig tandpleje,
English: A. MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling.
Danish: Under behandling med bisphosphonat bør patienten opfordres til at opretholde en god mundhygiejne, rutinemæssigt gå til tandlæge og rapportere alle orale symptomer såsom tandmobilitet, smerter eller hævelse.
English: 2 tablets 4 tablets 6 tablets 12 tablets
Danish: 2 tabletter 4 tabletter 6 tabletter 12 tabletter
English: In studies, rats given high doses showed an increased incidence of incomplete foetal ossification.
Danish: I undersøgelser har rotter, der har fået høje doser, øget incidens af inkomplet føtal ossifikation.
English: Vitamin D3 is produced in the skin by conversion of 7-dehydrocholesterol to vitamin D3 by ultraviolet light.
Danish: D3-vitamin dannes i huden ved omdannelse af 7-dehydrocholesterol til D3-vitamin ved hjælp af ultraviolet lys.
English: • VANTAVO should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml).
Danish: • VANTAVO skal tages, efter patienten er stået op, og det skal tages sammen med et helt glas postevand (mindst 200 ml).
English: - Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
Danish: - Øsofagusabnormaliteter og andre faktorer, som forsinker øsofagustømning, såsom striktur eller akalasi.
English: However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption) (see section 4.8).
Danish: Der har dog været sjældne rapporter om symptomatisk hypokalcæmi, som nogle gange har været alvorligt, og som ofte er forekommet hos patienter med prædisponering (f.eks. hypoparatyroidisme, Dvitaminmangel og calcium malabsorption) (se pkt.
English: Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation.
Danish: Alendronatnatrium er et bisphosphonat, der hæmmer osteoklasters knogleresorption uden direkte virkning på knogleopbygningen.
English: Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
Danish: Patienten må ikke knuse eller tygge tabletten eller lade tabletten opløse i munden på grund af risiko for orofaryngeale ulcerationer.
English: VANTAVO must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
Danish: VANTAVO skal tages sammen med almindeligt postevand (ikke mineralvand) mindst 30 minutter før indtagelse af dagens første måltid, drikkevarer eller lægemidler (inklusive antacida, calciumtilskud og vitaminer).
English: In this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37 % of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0 % vs. placebo 2.2 %, a reduction of 56 %) and in the incidence of  1 vertebral fracture (2.9 % vs. 5.8 %, a reduction of 50 %).
Danish: I denne undersøgelse observeredes en signifikant forskel i en analyse af subgruppen af osteoporotiske kvinder (37 % af global population som havde osteoporose svarende til ovennævnte definition) i incidensen af hoftefrakturer (alendronat 1,0 % versus placebo 2,2 %, en reduktion på 56 %) og i incidensen af  1 vertebral fraktur (2,9 % versus 5,8 %, en reduktion på 50 %).
English: The mean BMD increases were 2.3 % and 2.9 % at the femoral neck and 2.9 % and 3.1 % at the total hip in the 70 mg once weekly and 10 mg daily groups, respectively.
Danish: Gennemsnitlige stigninger i BMD var 2,3 % og 2,9 % ved collum femoris og 2,9 % og 3,1 % i hele hoften i henholdsvis 70 mg gruppen og 10 mg gruppen.
English: Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Danish: Selvom knoglebrud sædvanligvis gør ondt, kan knoglebrud i rygsøjlen forblive ubemærket, indtil patienten får sammenfald i ryggen.
English: Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3).
Danish: Alendronat givet til gravide rotter forårsagede dystocia relateret til hypokalcæmi (se pkt.
English: The bone formed during treatment with alendronate is of normal quality.
Danish: Knoglemassen, der dannes under behandling med alendronat, har normal knoglestruktur.
English: VANTAVO is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Danish: VANTAVO er indiceret til behandling af postmenopausal osteoporose hos kvinder med risiko for Dvitaminmangel.
English: The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.
Danish: Der er ikke undersøgt, om variabler, såsom tiden fra seponering af behandling med bisphosphonat til undfangelse, den specifikke type bisphosphonat samt indgivelsesmåde (intravenøs versus oral), har indflydelse på risikoen.
English: Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Danish: Der kan derfor muligvis forventes en noget større akkumulering af alendronat i knogler hos mennesker med nedsat nyrefunktion (se pkt.
English: Currently available data for alendronic acid in the paediatric population is described in section 5.1.
Danish: De foreliggende data for alendronsyre hos den pædiatriske population er beskrevet i pkt.
English: Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
Danish: Patienten skal derfor vente mindst 30 minutter efter indtag af alendronat, før der indtages andre perorale lægemidler (se pkt.
English: Frequency in Clinical Trials was similar in the medicinal product and placebo group.
Danish: I kliniske forsøg var hyppigheden i gruppen, der fik lægemidlet, sammenlignelig med gruppen, der fik placebo.
English: • you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer,
Danish: • Du tager angiogenesehæmmere (hæmmer nydannelse af blod- og lymfekar) (f.eks. bevacizumab eller thalidomid), som anvendes ved behandling af cancer,
English: Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3).
Danish: Dyreforsøg har vist hyperkalcæmi og toksicitet i forbindelse med reproduktion ved høje doser af D-vitamin (se pkt.
English: Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
Danish: Patienterne skal informeres om, at risikoen for øsofagusproblemer kan øges, hvis disse instruktioner ikke følges.
English: Stopping smoking Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Danish: Rygning synes at øge hastigheden for knogletabet og kan derfor øge risikoen for knoglebrud.
English: • unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Danish: • Usædvanlige brud på lårbensknoglen, primært hos patienter i langtidsbehandling for knogleskørhed, kan forekomme i sjældne tilfælde.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om VANTAVO findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.