FrancophonIA/ELRC3.0 huggingface dataset:
English: Causes of osteoporosis other than oestrogen deficiency, ageing and glucocorticoid use should be considered.
Danish: Andre årsager til osteoporose end østrogenmangel, tiltagende alder eller brug af glukokortikoider bør overvejes.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Danish: Hvid til råhvid, kapselformet tablet præget med "AN10" på den ene side og "Arrow-logo" på den anden side.
English: Animal studies revealed effects on foetal bone formation at high doses.
Danish: Dyreforsøg har påvist, at der er en negativ virkning på den føtale knogledannelse ved høje doser.
English: The CHMP has recommended the granting of the Marketing Authorisation and the amendment of the Summary of Product Characteristics, labelling, package leaflet of the Reference Member State accordingly for Alendronate HEXAL and associated names (see Annex I) 10 mg tablets.
Danish: CHMP anbefalede udstedelse af markedsføringstilladelse og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel i overensstemmelse hermed for Alendronat HEXAL og tilknyttede navne (se bilag I), tabletter, 10 mg.
English: 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate HEXAL and contact your doctor.
Danish: 5) Hvis du får besvær med at synke eller smerter efter synkning, hvis du får smerter i brystet, eller hvis du får ny eller forværret halsbrand, så skal du holde op med at tage Alendronat HEXAL og kontakte lægen.
English: sucked or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration.
Danish: Tabletterne må ikke tygges, suges eller opløses i munden på grund af risiko for oropharyngeal ulceration.
English: Important information about some of the ingredients of Alendronate HEXAL Alendronate HEXAL contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Alendronat HEXAL Alendronat HEXAL indeholder laktose.
English: Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Danish: Cancerdiagnose, kemoterapi, strålebehandling, behandling med kortikosteroider og dårlig tandhygiene anses ligeledes for at være risikofaktorer (se pkt.
English: Osteonecrosis of the jaw is generally associated with tooth extraction and/or local infection (including osteomyelistis).
Danish: Osteonekrose i kæben er generelt forbundet med tandudtrækning og/eller lokal infektion (herunder osteomyelitis).
English: Hypocalcaemia must be corrected before treatment with alendronate is initiated (see section 4.3).
Danish: Hypokalcæmi skal korrigeres før en behandling med alendronat indledes (se pkt.
English: Preclinical studies have demonstrated a preference for localisation of alendronate to sites where active resorption takes place.
Danish: Prækliniske undersøgelser har vist, at alendronat primært lokaliseres til steder med aktiv resorption.
English: What is Alendronate HEXAL and what is it used for Before you take Alendronate HEXAL How to take Alendronate HEXAL Possible side effects
Danish: Alendronat HEXALs virkning og hvad du skal bruge det til Det skal du vide, før du begynder at tage Alendronat HEXAL Sådan skal du tage Alendronat HEXAL Bivirkninger
English: • Alendronate HEXAL tablets should be swallowed whole.
Danish: • Alendronat HEXAL-tabletterne skal synkes hele.
English: Always take Alendronate HEXAL exactly as your doctor has told you.
Danish: Tag altid Alendronat HEXAL nøjagtigt efter lægens anvisning.
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 påvist mætning af optagelsen via knoglerne efter kronisk dosering med kumulative, intravenøse doser på op til 35 mg/kg hos dyr.
English: Two studies from Orwell and Ringe demonstrated that compared respectively with placebo or alfacalcidol, alendronate treatment reduced the incidence of vertebral fractures in men with osteoporosis.
Danish: To undersøgelser af Orwell og Ringe viste, at alendronat i forhold til placebo eller alfacalcidol medfører lavere incidens af vertebrale frakturer hos mænd med osteoporose.
English: For other populations, see summary of product characteristics for preparations that contain 5 mg alendronate.
Danish: For andre populationer henvises til produktresumeer med formulationer, der indeholder 5 mg alendronat.
English: • FIT 2: A four-year study with 4432 patients who had a low bone mass but had not had any vertebral fracture at the start of the study.
Danish: • FIT 2: En 4-årig undersøgelse af 4.432 patienter med lav knoglemasse men uden vertebralfraktur ved baseline.
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Danish: Behandlingsplanen for den enkelte patient bør baseres på den behandlende læges kliniske vurdering af fordele og ricisi.
English: Alendronate HEXAL is not recommended for use in children due to a lack of data on safety and efficacy.
Danish: Børn: Alendronat HEXAL bør ikke anvendes til børn pga. manglende dokumentation for sikkerhed og virkning.
English: In the patients treated with alendronate, the proportion of patients who suffered one or more vertebral fractures was reduced by 48 % (alendronate 3.2 % versus placebo 6.2 %).
Danish: Hos de patienter, som blev behandlet med alendronat, blev den andel af patienter, der fik en eller flere vertebralfrakturer, reduceret med 48% (alendronat 3,2 % mod placebo 6,2 %).
English: In two three-year studies of almost identical design, with post-menopausal women (alendronate 10 mg: n=196; placebo: n=397) the overall safety profiles for alendronate 10 mg daily and placebo were similar.
Danish: I to næsten identisk tilrettelagte treårige undersøgelser med postmenopausale kvinder (alendronat 10 mg: n=196; placebo: n=397) lignede den overordnede sikkerhedsprofil for alendronat 10 mg sikkerhedsprofilen for placebo.
English: In healthy persons, oral prednisolone (20 mg three times daily for five days) did not result in any clinically meaningful change in the oral bioavailability of alendronate (a mean increase ranging from 20 % to 44 %).
Danish: Hos raske forsøgspersoner førte peroral administreret prednison (20 mg 3 gange dagligt i 5 dage) ikke til nogen klinisk relevant forandring af alendronats perorale biotilgængelighed (gennemsnitlig stigning fra 20-44 %).
English: Preclinical studies show that the active substance that is not deposited in bone is rapidly excreted in the urine.
Danish: Prækliniske undersøgelser viser, at den mængde lægemiddel, der ikke deponeres i knoglen, hurtigt udskilles i urinen.
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 større akkumulering af alendronat i knoglerne hos patienter med nedsat nyrefunktion (se pkt.
English: Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not thought to interfere with the excretion of other active substances by those systems in humans.
Danish: Hos rotter udskilles alendronat ikke via nyrernes syre-base-transportsystem og derfor forventes det ikke, at det interfererer med andre lægemidlers udskillelse via disse systemer hos mennesker.
English: Please read the package leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: Use in impaired hepatic function No dose adjustment is necessary.
Danish: Brug ved nedsat levefunktion: Dosisjustering er ikke nødvendig.
English: Most patients had relief of symptoms after stopping treatment.
Danish: Hos de fleste patienter blev symptomerne bedre, når behandlingen blev seponeret.
English: Patients should be given a calcium and vitamin D supplement if the diet is inadequate (see section
Danish: Patienterne bør have et kalcium- og vitamin D-tilskud, hvis der ikke indtages nok gennem føden (se pkt.
English: Bioavailability decreased to an estimated 0.46 % and 0.39 % when alendronate was given an hour or half an hour before a standardised breakfast.
Danish: Biotilgængeligheden blev reduceret til ca. 0,46 % og 0,39 %, når alendronat blev administreret en time, eller en halv time, før et standardiseret morgenmåltid.
English: In postmarketing experience, these symptoms have rarely been seen and/or incapacitating (see section 4.8).
Danish: Erfaringerne efter markedsføring har vist, at disse symptomer er sjældne og/eller ikke bevægelseshæmmende (se pkt.
English: The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate.
Danish: Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, lactosemonohydrat, croscarmellosenatrium, magnesiumstearat.
English: dizziness swelling in the hands or legs lack or loss of strength osteonecrosis (death of bone tissue)
Danish: svimmelhed hævelser af hænder eller i benene tab af eller mangel på kræfter osteonekrose (dødt knoglevæv) hævelse af led
English: Alendronate has no influence on the ability to drive and use machines.
Danish: Alendronat påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Alendronate 10 mg and 5 mg were effective irrespective of the dose or duration of steroid use.
Danish: Både alendronat 10 mg og 5 mg havde en god virkning, uanset steroiddosens størrelse eller varigheden af steroidbehandlingen.
English: It is not known whether alendronate is excreted into breast milk in humans.
Danish: Det vides ikke, om alendronat udskilles i modermælk.
English: Nervous system disorders: dizziness
Danish: Nervesystemet: Svimmelhed
English: Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Danish: Det lader til at rygning medvirker til en hurtigere nedbrydning af knoglemassen, og rygning kan derfor øge risikoen for, at du får et brud på en knogle.
English: The FIT study included two placebo-controlled trials in which alendronate was given daily (5 mg daily for two years and 10 mg daily for a further one or two years).
Danish: FIT-studiet bestod af to placebokontrollerede undersøgelser med alendronat (5 mg dagligt i 2 år og 10 mg dagligt i yderligere enten 1 eller 2 år):
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: Bruddene på knoglerne sker som regel i hoften, rygsøjlen eller håndleddet og kan ikke kun føre til smerter, men også til alvorligere problemer som f.eks. foroverbøjet holdning og besvær med at bevæge sig.
English: Adverse reactions reported by the investigators as possibly, probably or definitely related to the active substance are presented below if they occurred in ≥ 1 % of any in the treatment groups in the one-year study or in ≥ 1 % of the patients who were treated with alendronate 10 mg per day and with an incidence higher than in patients who were treated with placebo in three-year studies.
Danish: Bivirkninger, der blev indberettet af investigatorerne, som værende mulige, sandsynlige eller med sikkerhed relaterede til lægemidlet er vist nedenfor, såfremt forekomsten i behandlingsgrupperne i den 1-årige undersøgelse var ≥1 % ,eller såfremt forekomsten i en af de 3-årige undersøgelser var ≥1 % hos de patienter, som var i behandling med alendronat 10 mg dagligt, og denne forekomst var større end hos de patienter, der fik placebo:
English: Laboratory values: In clinical trials, asymptomatic, slight and transient decreases in serum calcium and serum phosphate were observed in approx. 18 and 10 % respectively of the patients taking alendronate 10 mg/day versus 12 and 3 % respectively of those taking placebo.
Danish: Laboratoriefund: Der er i kliniske forsøg set asymptomatiske, milde og forbigående fald i serumkalcium og serumfosfat hos henholdsvis ca. 18 % og 10 % af de patienter, der fik alendronat 10 mg/dag, mod ca. 12 % og 3 % af de patienter, der fik placebo.
English: Your doctor has prescribed Alendronate HEXAL to treat your osteoporosis.
Danish: Din læge har ordineret Alendronat HEXAL for at behandle din sygdom, der hedder osteoporose.
English: In a retrospective analysis (assessed by quantitative radiography) one new fracture (0.8 %) was documented among patients treated with alendronate, compared with 6 new fractures (7.1 %) for placebo (p=0.017).
Danish: I en retrospektiv analyse (kvantitativ røntgenvaluering) blev der dokumenteret en ny fraktur (0,8 %) blandt de patienter, der var blevet behandlet med alendronat, over for 6 nye frakturer (7,1 %) med placebo (p=0,017).
English: 4) Do not take Alendronate HEXAL at bedtime or before getting up for the day.
Danish: 4) Du må ikke tage Alendronat HEXAL ved sengetid eller før du står op om morgenen.
English: Transient symptoms as in an acute phase reaction (myalgia, malaise and in rare cases fever) usually in connection with the start of treatment.
Danish: Forbigående symptomer som ved en akutfasereaktion (myalgi, generel utilpashed og i sjældne tilfælde feber) sædvanligvis i forbindelse med initiering af behandlingen.
English: A number of patients in the clinical trials received oestrogen (intravaginally, transdermally or orally) concomitantly with alendronate.
Danish: I de kliniske undersøgelser fik et antal patienter østrogen (intravaginalt, transdermalt eller peroralt) samtidig med alendronat.
English: In osteoporosis studies alendronate was effective when it was given at least 30 minutes before the first meal or drink of the day.
Danish: I osteoporose-undersøgelser havde alendronat effekt når det blev administreret mindst 30 minutter før dagens første måltid eller indtag af drikkevarer.
English: INFORMATION IN BRAILLE Alendronate HEXAL [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT Alendronat HEXAL [Udfyldes nationalt]
English: 1) After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronate HEXAL with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).
Danish: 1) Når du er stået op om morgenen skal du - før du spiser eller drikker noget eller tager anden medicin - tage Alendronat HEXAL med et helt glas postevand (ikke mineralvand) (mindst 200 ml postevand).
English: In view of the indication, alendronate should not be used by breast-feeding women.
Danish: På baggrund af indikationen bør alendronat ikke anvendes af kvinder, der ammer.
English: Alendronate HEXAL is effective only if taken when your stomach is empty.
Danish: Alendronat HEXAL er kun virksomt, hvis du tager det på tom mave.
English: The risk of severe oesophageal side effects is thought to be greater in patients who do not take alendronate correctly and/or continue to take alendronate after developing symptoms indicative of oesophageal irritation.
Danish: Risikoen for at få alvorlige spiserørsbivirkninger synes større hos patienter, der ikke tager alendronat som foreskrevet og/eller fortsætter med at tage alendronat efter at have udviklet symptomer, der tyder på spiserørsirritation.
English: Early on, osteoporosis usually has no symptoms.
Danish: I begyndelsen har man som regel ingen symptomer.
English: The patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.
Danish: Patienterne skal instrueres i at stoppe behandlingen med alendronat og søge læge, hvis de udvikler symptomer på oesophagusirritation såsom fx dysfagi, smerter ved synkning, retrosternal smerte, ny eller forværret halsbrand.
English: Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations below the mean value of a normal young population or as a previous fragility fracture, irrespective of bone mineral density.
Danish: Osteoporose defineres som en knoglemineraltæthed (BMD, bone mineral density) i rygrad eller hofte, der er 2,5 standarddeviationer under gennemsnitsværdien for en normal yngre population, eller som en tidligere skørhedsfraktur uanset BMD.
English: In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
Danish: Der er ikke fundet aldersrelaterede forskelle med hensyn til alendronats effekt- eller sikkerhedsprofiler i kliniske undersøgelser.
English: In this study, in a subgroup analysis of osteoporotic women (37 % of the total population who fulfilled the definition of osteoporosis given above) a significant difference was seen in the incidence of hip fractures (alendronate 1.0 % versus placebo 2.2 %, a reduction of 56 %) and in the incidence of ≥1 vertebral fracture (2.9 % versus 5.8 %, a reduction of 50 %).
Danish: I denne undersøgelse blev der observeret en signifikant forskel ved en analyse af subgruppen af kvinder med osteoporose (37 % af den samlede population, som havde osteoporose, der svarede til den ovennævnte definition) i forekomsten af hoftefrakturer (alendronat 1,0 % mod placebo 2,2 %, en reduktion på 56 %) og i forekomsten af ≥1 vertebralfraktur (2,9 % mod 5,8 %, en reduktion på 50 %).
English: Relative to placebo, BMD increased significantly in the spine (2.41 %), femoral neck (2.19 %) and trochanter (1.65 %) in patients who were treated with alendronate 5 mg once daily.
Danish: I forhold til placebo var der en signifikant øgning af BMD i rygrad (2,41 %), lårbenshals (2,19 %) og trochanter (1,65 %) hos de patienter, der blev behandlet med alendronat 5 mg 1 gang dagligt.
English: • Alendronate HEXAL tablets should not be taken at bedtime or before arising for the day.
Danish: • Alendronat HEXAL-tabletter må ikke indtages ved sengetid,eller før man står op.
English: No dose adjustment is necessary in patients with a glomerular filtration rate (GFR) greater than 35 ml/min.
Danish: Dosisjustering er ikke nødvendig hos patienter med en glomerulær filtrationshastighed (GFR), der er større end 35 ml/min.
English: WHAT IS ALENDRONATE HEXAL AND WHAT IT IS USED FOR
Danish: ALENDRONAT HEXALS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> <[To be completed nationally]>
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN <DD,MM,ÅR> <DD, måned, ÅR> [Udfyldes nationalt]
English: Osteoporosis in men: The recommended dosage is 10 mg once daily.
Danish: Osteoporose hos mænd: Den anbefalede dosis er 10 mg en gang dagligt.
English: The efficacy of alendronate 10 mg and alendronate 5 mg once daily in men and women treated with steroids (at least 7.5 mg/day of prednisone or equivalent, median dose 10 mg/day) was demonstrated in two one-year studies of practically identical design.
Danish: Virkningen af alendronat 10 mg og alendronat 5 mg, administreret 1 gang dagligt til mænd og kvinder, som blev behandlet med steroider (mindst 7,5 mg/dagligt af lægemidlet prednisolon eller ækvivalent lægemiddel, median dosis 10 mg/dagligt) blev undersøgt i to enårige næsten identisk tilrettelagte undersøgelser.
English: After two years of treatment with alendronate 10 mg/day, BMD increased on average by 5.3 % in the spine, by 2.6 % in the femoral neck, by 3.1 % in the trochanter, and by 1.6 % for the skeleton as a whole, relative to placebo (p<0.001 for all measurement points).
Danish: Efter 2 års behandling med alendronat 10 mg dagligt øgedes BMD med gennemsnitligt 5,3 % i rygraden, med 2,6 % i lårbenshalsen, med 3,1 % i trochanter og med 1,6 % i skelettet som helhed, i forhold til placebo (p<0,001 for alle måleværdier).
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Danish: Hos patienter, der udvikler osteonekrose af kæben under behandlingen med bisphosphonater, kan oralkirugi forværre tilstanden.
English: Very rare, not known: perforation of the oesophagus was reported in isolated cases
Danish: Meget sjælden, ikke kendt: Der findes enkeltstående rapporter om oesophagusperforation.
English: In the initial efficacy studies, the increases in BMD with alendronate 10 mg daily relative to placebo after three years were 8.8 %, 5.9 % and 7.8 % at the spine, femoral neck and trochanter respectively.
Danish: I de indledende effekt-undersøgelser var de gennemsnitlige stigninger i BMD efter 3 års behandling med alendronat 10 mg dagligt på henholdsvis 8,8 %; 5,9 % og 7,8 % i rygrad, lårbenshals og trochanter, sammenlignet med placebo.
English: Rare (≥1/10,000, <1/1000): Hypersensitivity reactions including urticaria and angioedema.
Danish: Sjælden (≥1/10.000, <1/1.000): Overfølsomhedsreaktioner, herunder urticaria og angioødem.
English: A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated.”
Danish: Reduktion af frakturincidensen er påvist for vertebrale frakturer, men ikke for ikke-vertebrale frakturer".
English: These are usually slight and asymptomatic.
Danish: Disse er sædvanligvis mindre og uden symptomer.
English: General disorders and administration site conditions: asthenia, peripheral oedema
Danish: Almene symptomer og reaktioner på administrationsstedet: Asteni, perifert ødem
English: Osteoporosis in men with increased risk of fracture The efficacy of alendronate 10 mg once daily in men (31-87 years, mean age 63 years, n=241) with osteoporosis was evaluated in a two-year study.
Danish: Effekten at alendronat 10 mg administreret 1 gang dagligt hos mænd (31-87 år gamle, gennemsnitsalder 63 år, n=241) med osteroporose blev evalueret i en toårig undersøgelse.
English: 6) After swallowing your Alendronate HEXAL, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
Danish: 6) Når du har taget din Alendronat HEXAL-tablet, skal du vente mindst 30 minutter inden du spiser morgenmad, drikker noget eller tager anden medicin, herunder også syrehæmmende medicin, kalciumtilskud og vitaminpræparater.
English: In these women the increases (relative to placebo) with alendronate 10 mg once daily were greater than for alendronate 5 mg once daily in the spine (4.11 % versus 1.56 %) and trochanter (2.84 % versus 1.67 %).
Danish: Hos denne gruppe kvinder var øgningen (i forhold til placebo) større med alendronat 10 mg 1 gang dagligt end med alendronat 5 mg 1 gang dagligt i rygrad (4,11 % mod 1,56 %) og trochanter (2,84 % mod 1,67 %).
English: As there is a risk of worsening of the underlying disease, caution should be observed if alendronate is given to patients with active upper gastrointestinal tract problems, such as dysphagia, oesophageal disease, gastritis, duodenitis or ulcers, or in cases of recent (during the last year) severe gastrointestinal disease such as gastric ulcer, active gastrointestinal bleeding or surgery in the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Danish: På grund af risiko for forværring af den underliggende sygdom, skal der udvises forsigtighed, når alendronat administreres til patienter med aktive symptomer i den øvre gastrointestinalkanal, som fx dysfagi, oesophagussygdom, gastritis, duodenitis, ulcera eller nylig (indenfor det sidste år) svær gastrointestinal sygdom så som peptisk ulcus, aktiv gastrointestinal blødning eller til patienter, der har fået foretaget kirurgiske indgreb i den øvre gastrointestinalkanal ud over pyloroplastik (se pkt.
English: Bone formed during treatment with alendronate is of normal quality.
Danish: Knoglemassen, der dannes under behandling med alendronat, har normal knoglestruktur.
English: Very common: ≥ 1/10
Danish: Meget almindelig:≥ 1/10