FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Alendronate HEXAL - if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients of Alendronate HEXAL - if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing - if you cannot stand or sit upright for at least 30 minutes - if your doctor has told you that you have low blood calcium
Danish: Tag ikke Alendronat HEXAL - Hvis du er overfølsom (allergisk) over for natriumalendronattrihydrat eller et af de øvrige indholdsstoffer i Alendronat HEXAL - hvis du har særlige problemer med struben (oesophagus - det rør, som forbinder din mund med din mave) som f. eks. en forsnævring eller besvær med at synke - Hvis du ikke kan stå eller sidde oprejst i mindst 30 minutter - hvis din læge har fortalt dig, at indholdet af kalcium i dit blod er lavt
English: Do not lie down within 30 minutes of taking Alendronat HEXAL
Danish: Man må ikke ligge ned i de første 30 minutter efter man har indtaget alendronat HEXAL.
English: Gastrointestinal Abdominal pain Dyspepsia
Danish: Gastrointestinale sygdomme Abdominalsmerter Dyspepsi
English: Oesophageal side effects (in some cases severe and requiring hospitalisation) such as oesophagitis, oesophageal ulcers or oesophageal erosions, in rare cases followed by oesophageal stricture, have been reported in patients receiving treatment with alendronate.
Danish: Der er rapporter om bivirkninger i spiserøret (der i nogle tilfælde var alvorlige og krævede hospitalsindlæggelse), såsom oesophagitis, oesophagal ulcus og oesophagal erosion, i sjældne tilfælde efterfulgt af spiserørsforsnævring, hos patienter i behandling med alendronat.
English: Stopping smoking
Danish: Rygeophør
English: In addition, BMD at the femoral neck and total body was maintained.
Danish: BMD i lårbenshalsen og den samlede BMD kunne opretholdes.
English: It reduces the risk of spine and hip fractures.
Danish: Det reducerer risikoen for ryg- og hoftebrud.
English: In this study alendronate daily reduced the incidence of ≥1 new vertebral fracture by 47 % (alendronate 7.9 % versus placebo 15.0 %).
Danish: I denne undersøgelse reducerede alendronat, administreret 1 gang dagligt, forekomsten af ≥1 ny vertebralfraktur med 47 % (alendronat 7,9 % mod placebo 15,0 %).
English: Alendronate HEXAL has been shown to reduce the risk of spine and hip fractures in women and spine fractures in men.
Danish: Alendronat HEXAL har vist at kunne reducere risikoen for brud på ryg og hofte hos kvinder og brud på ryggen hos mænd.
English: Compared with an intravenous reference dose, the mean oral bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg given after an overnight fast and two hours before a standardised breakfast.
Danish: Den gennemsnitlige, perorale biotilgængelighed for alendronat var - sammenlignet med en intravenøs referencedosis - på 0,64 % hos kvinder ved doser fra 5-70 mg, når det blev administreres efter en nats faste og 2 timer før et standardiseret morgenmåltid.
English: Alendronate can cause local irritation to the upper gastrointestinal mucosa.
Danish: Alendronat kan forårsage lokal irritation af slimhinden i den øvre del af mavetarmkanalen.
English: “Treatment of osteoporosis in men at increased risk of fracture.
Danish: "Behandling af osteoporose hos mænd med forhøjet risiko for frakturer.
English: You should not take Alendronate HEXAL if you are breast-feeding.
Danish: Du bør ikke tage Alendronat HEXAL, hvis du ammer.
English: Alendronate reduces the risk of vertebral and hip fractures.
Danish: Alendronat mindsker risikoen for vertebral- og hoftefrakturer.
English: Nervous system disorders: Common (≥1/100, <1/10): Headache
Danish: Nervesystemet: Almindelig (≥1/100 og <1/10): Hovedpine.
English: No effect on nonvertebral fractures was seen.
Danish: Der sås ingen effekt på ikke-vertebrale frakturer.
English: How to store Alendronate HEXAL Further information
Danish: Sådan opbevarer du Alendronat HEXAL Yderligere oplysninger
English: Treatment of post-menopausal osteoporosis.
Danish: Behandling af postmenopausal osteoporose.
English: What Alendronate HEXAL looks like and contents of the pack Alendronate HEXAL are available as white to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Danish: Alendronat HEXALs udseende og pakningstørrelse Alendronat HEXAL er hvide til råhvide, kapselformede tabletter, som er præget med "AN 10" på den ene side og "Arrow-logo" på den anden side.
English: In addition, alendronate 10 mg and alendronate 5 mg were effective irrespective of age (<65 years as against ≥65 years), gender, baseline BMD, baseline bone turnover and concomitant use of a number of common medicines.
Danish: Dette galt også for både alendronat 10 mg og 5 mg uanset alder (både <65 år og ≥65 år), køn, BMD ved baseline, gennemsnitlig knogleomsætning ved baseline eller samtidig brug af forskellige andre almindeligt brugte lægemidler.
English: The active substance in Alendronate HEXAL tablets, sodium alendronate trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption without any direct effect on bone formation.
Danish: Det aktive indholdsstof i Alendronat HEXAL-tabletterne, natriumalendronattrihydrat, er et bisphosphonat, som hæmmer osteoklasternes knogleresorption uden at have en direkte effekt på knogleformationen.
English: Treatment of post-menopausal osteoporosis
Danish: Behandling af postmenopausal osteoporose
English: The studies indicated that alendronate 10 mg daily could increase bone mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis.
Danish: Undersøgelserne viste, at alendronat 10 mg dagligt kan øge knoglemineraltætheden både i vertebrae og i andre knogler hos mænd med primær osteoporose.
English: If you forget to take Alendronate HEXAL
Danish: Hvis du har glemt at tage Alendronat HEXAL
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <[To be completed nationally]>
Danish: DATO FOR ÆNDRING AF TEKSTEN <MM/ÅR> <[Udfyldes nationalt]>
English: Treatment of osteoporosis in men at increased risk of fracture.
Danish: Behandling af osteoporose hos mænd med øget risiko for frakturer.
English: If taken at the same time, it is likely that foods and drinks (including mineral water), calcium supplements, antacids and some oral medicines will affect the absorption of alendronate.
Danish: Hvis Alendronat indtages samtidig med mad og drikke (herunder kulsyreholdigt mineralvand), kalciumtilskud, antacida og visse peroralt administrerede lægemidler, er det sandsynligt, at absorptionen af alendronat påvirkes.
English: Acid regurgitation Nausea
Danish: Syreregurgitation Kvalme
English: Alendronate given to pregnant rats caused hypocalcaemia-related dystocia (see section 5.3).
Danish: Alendronat, som blev administreret til gravide rotter, forårsagede hypokalcæmi-relateret fødselshindring (se pkt.
English: Eye disorders: Rare (≥1/10,000, <1/1000): Uveitis, scleritis, episcleritis
Danish: Øjne: Sjælden (≥1/10.000 og <1/1.000): Uveitis, scleritis, episcleritis.
English: Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5).
Danish: Andre drikke end postvand (herunder også mineralvand), mad og nogle former for lægemidler kan muligvis nedsætte absorptionen af alendronat (se pkt.
English: The increases in BMD with alendronate 10 mg once daily were the same as for alendronate 5 mg once daily in all patients, with the exception of postmenopausal women who were not being treated with oestrogen.
Danish: Ved administration af alendronat 10 mg 1 gang dagligt svarede den øgede BMD hos alle patienter til den, der fremkom ved administration af alendronat 5 mg 1 gang dagligt med undtagelse af postmenopausale kvinder, som ikke var i østrogenbehandling.
English: Rare (≥1/10,000, <1/1000): Oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUB (perforations, ulcers, bleeding), a causal relationship cannot be ruled out.
Danish: Sjælden (≥1/10.000 og <1/1.000): Oesophagusstriktur*, oropharyngeal ulceration*, øvre gastrointestinale PUB (perforationer, ulcera, blødning), kausal sammenhæng kan ikke udelukkes.
English: Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Danish: Det gør som regel ondt, hvis man får et brud på en hvirvel, men et sådan brud kan også forblive uopdaget, indtil man pludselig begynder at tabe sig i højden.
English: Osteoporosis is a thinning and weakening of the bones.
Danish: Osteoporose er en sygdom, der får knoglerne til at blive tyndere og svagere.
English: • Patients should not lie down within 30 minutes of taking Alendronate HEXAL tablets.
Danish: • Patienterne må ikke ligge ned i de første 30 minutter efter indtagelsen af Alendronat HEXAL
English: Taking Alendronate HEXAL with food and drink It is likely that food and beverages (including mineral water) will make Alendronate HEXAL less effective if taken at the same time.
Danish: Brug af Alendronat HEXAL sammen med mad og drikke Det er sandsynligt, at virkningen af Alendronat HEXAL nedsættes, hvis det indtages samtidig med mad og drikke (herunder mineralvand).
English: Studies in female rats showed that treatment with alendronate during pregnancy was associated with dystocia during parturition, which was related to hypocalcaemia.
Danish: Forsøg med hunrotter viste, at behandling med alendronat under drægtighed var associeret med hypokalcæmirelateret fødselshindring.
English: To assist delivery to the stomach and thus reduce the risk of irritation/side effects locally and in the oesophagus (see section 4.4)
Danish: Transport af alendronat til ventriklen lettes med følgende forholdsregler, hvorhved risikoen for irritation/bivirkninger lokalt og i oesophagus mindskes (se pkt.
English: Severe bone, muscle and/or joint pain rash made worse by sunlight, transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment hypersensitivity reactions including nettle rash and angio-oedema symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
Danish: udslæt, som forværres af sollys, forbigående influenza-lignende symptomer, som f.eks. ondt i musklerne, generel utilpashed og nogen gange feber, som almindeligvis opstår ved behandlingens begyndelse, overfølsomhedsreaktioner, herunder nældefeber og angioødem (hævelser især i ansigtet munden og svælget), symptomer på lavt kalciumindhold i blodet, herunder muskelkramper eller muskelsammentrækninger og/eller en prikkende fornemmelse i fingrene eller omkring munden.
English: Take special care with Alendronate HEXAL Tell your doctor - if you suffer from kidney problems - if you have any swallowing or digestive problems - if you have low blood calcium levels.
Danish: Vær ekstra forsigtig med at tage Alendronat HEXAL Fortæl det til din læge - hvis du har problemer med dine nyrer - hvis du har besvær med at synke eller har fordøjelsesproblemer - hvis indholdet af kalcium i dit blod er lavt
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET (PRODUKTRESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN
English: Skin rash with photosensitivity.
Danish: Udslæt med lysoverfølsomhed.
English: Pregnancy and breast-feeding You should not take Alendronate HEXAL if you are or think you may be pregnant.
Danish: Graviditet og amning Du bør ikke tage Alendronat HEXAL, hvis du er eller tror du er gravid.
English: Talk to your doctor before you take Alendronate HEXAL if you have or have had pain or swelling of your gums and/or jaw, numbness of the jaw, if the jaw feels heavy or if you have lost a tooth.
Danish: Du skal tale med din læge, før du tager Alendronat HEXAL, hvis du har eller har haft smerter eller hævelse i gummerne og/eller kæben.
English: During post-marketing experience the following side effects have been reported (frequency unknown):
Danish: De følgende bivirkninger (ukendt frekvens) er blevet rapporteret efter markedsføringen:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated.
Danish: Der er påvist et fald i forekomsten af vertebrale frakturer, men ikke af andre frakturer.
English: Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.
Danish: Der er rapporter om knogle-, led og muskelsmerter hos patienter, der tager bisphosphonater.
English: What Alendronate HEXAL contains
Danish: Alendronat HEXAL indeholder:
English: Common: headache abdominal pain uncomfortable feeling in the stomach or belching after eating constipation full or bloated feeling in the stomach diarrhoea flatulence 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 bone, muscle and/or joint pain
Danish: Almindelig: hovedpine mavepine, ubehagelig fornemmelse i maven eller opstød efter at have spist, forstoppelse, fornemmelse af at have en fuld eller oppustet mave, diaré, afgang af tarmluft, halsbrand, besvær med at synke, smerter efter synkning, sår i struben ((oesophagus - det rør, som forbinder din mund med din mave), som kan føre til smerter i brystet, halsbrand eller besvær med at synke eller smerter efter synkning, smerter i knogler, muskler og/eller led
English: Alendronate HEXAL should be swallowed whole
Danish: Alendronat HEXAL skal synkes hel!
English: Common (≥1/100, <1/10): Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcers*, dysphagia*, abdominal distension, acid regurgitation.
Danish: Almindelig (≥1/100 og <1/10): Abdominalsmerter, dyspepsi, obstipation, diaré, flatulens, oesophagus ulcus*, dysfagi*, abdominal udspiling, syreregurgitation.
English: Rare: blurred vision, pain or redness in the eye narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach) mouth ulcers when the tablets have been chewed or sucked stomach or peptic ulcers (sometimes severe or with bleeding) but it is not sure whether these were caused by Alendronate HEXAL.
Danish: Sjælden: sløret syn, smerter i øjnene eller røde øjne, forsnævring af struben (oesophagus - det rør, som forbinder din mund med din mave), sår i munden, når tabletterne er blevet tygget eller suttet på; mavesår (nogen gange alvorlige eller med blødning), men det er ikke sikkert, om det er Alendronat HEXAL, der har udløst disse symptomer.
English: Hypocalcaemia, hypophosphataemia and upper gastrointestinal side effects such as upset stomach, heartburn, oesophagitis, gastritis or ulcer can occur on oral overdosage.
Danish: Peroral overdosering kan forårsage hypokalcæmi, hypofosfatæmi og symptomer i den øvre gastrointestinalkanal, som f.eks. mavetilfælde, halsbrand, oesophagitis, gastritis eller ulcus.
English: Alendronate HEXAL and associated names (see Annex I) 10 mg tablets [See Annex I - To be completed nationally]
Danish: Alendronat HEXAL og tilhørende navne (Se bilag I) 10 mg tabletter [Se bilag I - Udfyldes nationalt]
English: Uncommon (≥1/1000, <1/100): Nausea, vomiting, gastritis, oesophagitis* oesophageal erosions*, melaena.
Danish: Ikke almindelig (≥1/1.000 og <1/100): Kvalme, opkastning, gastritis, oesophagitis*, oesophageale erosioner*, melæna.
English: The active substance is alendronate sodium trihydrate.
Danish: Aktivt stof: Natriumalendronattrihydrat.
English: To obtain satisfactory absorption of alendronate
Danish: Tilfredsstillende absorption af alendronat opnås med følgende forholdsregler:
English: The fracture-preventing effect of increasing bone density with alendronate 10 mg or alendronate 5 mg in corticosteroidinduced osteoporosis has not been established.
Danish: Det er endnu ikke godtgjort at øgningen af knoglemineraltætheden med alendronat 10 mg eller alendronat 5 mg har en profylaktiske effekt mod frakturer ved kortikosteroidudløst osteoporose.
English: The active substance in Alendronate HEXAL 10 mg tablets, alendronic acid as sodium alendronate trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption without any direct effect on bone formation.
Danish: Det aktive stof i Alendronat HEXAL, tabletter, 10 mg, er alendronsyre som natriumalendronat (trihydrat), som er et biphosphonat, der hæmmer den osteoklastiske knogleresorption og er uden direkte virkning på knogledannelsen.
English: For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily.
Danish: Den anbefalede dosis til postmenopausale kvinder, som ikke er i østrogenbehandling, er 10 mg en gang dagligt.
English: Following a single intravenous dose of (14C) 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: Elimination Efter enkelt intravenøs dosis (14C)-alendronat, udskilles ca. 50 % af radioaktiviteten i urinen inden for
English: Each tablet contains 10 mg alendronic acid as alendronate sodium trihydrate.
Danish: Hver tablet indeholder 10 mg alendronsyre (som natriumaledronattrihydrat)
English: Driving and using machines Alendronate HEXAL should not affect your ability to drive or operate machines.
Danish: Det er usandsynligt, at Alendronat HEXAL har indflydelse på din evne til at føre motorkøretøj eller bruge maskiner.
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Danish: Der er ligeledes rapporter om osteonekrose af kæben hos osteoporosepatienter, der behandles peroralt med bisphosphonater.
English: Very rare: severe skin reactions perforation of the gullet (oesophagus - the tube that connects your mouth with your stomach) was reported in isolated cases
Danish: Der har været rapporter om sjældne tilfælde af perforation af struben (oesophagus - det rør, som forbinder din mund med din mave)
English: Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/min, as there is no experience of this.
Danish: Alendronat anbefales ikke til patienter med nedsat nyrefunktion, hvis GFR er mindre end 35 ml/min.
English: Uncommon (≥1/1000, <1/100): Rash, pruritus, erythema.
Danish: Ikke almindelig (≥1/1.000, <1/100): Udslæt, kløe, erythem.
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: Der er ingen tilgængelig dokumentation for, at ophør med bisphosphonatbehandlingen nedsætter risikoen for at udvikle osteronekrose i kæben hos patienter med behov for tandbehandling.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates.
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, bisphosphonater, ATCkode: M 05 BA 04.
English: Do not lie down until after your first food of the day.
Danish: Du må først lægge dig ned, når du har spist morgenmad.
English: Use in impaired renal function
Danish: Brug ved nedsat nyrefunktion::
English: Alendronate HEXAL tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day.
Danish: Alendronat HEXAL-tabletterne skal indtages fastende med postevand umiddelbart efter, at patienten er stået op om morgenen og mindst 30 minutter før, der indtages nogen former for mad, drikke eller andre lægemidler.
English: - Do not take with mineral water (still or sparkling).
Danish: - Du må ikke tage tabletten med mineralvand (hverken med eller uden kulsyre) - Du må ikke tage tabletten sammen med kaffe eller te.
English: Rare: ≥ 1/10,000 - < 1/1,000
Danish: Sjælden: ≥ 1/10.000, < 1/1.000.
English: Common: ≥ 1/100 - < 1/10
Danish: Almindelig: ≥ 1/100, < 1/10.
English: Alendronate HEXAL must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day!
Danish: Alendronat Hexal skal indtages fastende med postevand, så snart man er stået op om morgenen, mindst 30 minutter før der indtages mad, drikke eller anden medicin.
English: - the literature provided by the applicant provide evidence that 10 mg daily could increase bone mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis, - an effect on non-vertebral fractures has nonetheless not been demonstrated in this population.
Danish: - den af ansøgeren forelagte litteratur dokumenterer, at 10 mg dagligt kan øge mineraltætheden både i vertebrae og i andre knogler hos mænd med primær osteoporose - virkning på ikke-vertebrale frakturer er imidlertid ikke påvist i denne population anbefalede CHMP følgende indikation, der er i overensstemmelse med retningslinjen for vurdering af lægemidler til behandling af primær osteoporose (CHMP/EWP/552/95 Rev.2):
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: Det er sandsynligt at eliminationen af alendronat via nyrerne vil være reduceret hos patienter med nyreinsufficiens, ligesom den er hos dyr, men der foreligger ingen klinisk dokumentation for dette.
English: It is very important to follow instructions 1), 2), 3) and 4) to help the Alendronate HEXAL reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagusthe tube that connects your mouth with your stomach).
Danish: På den måde opnår du, at Alendronat HEXAL når ned i din mave meget hurtigt, og du kan derved nedsætte risikoen for at der opstår irritation i struben (oesophagus - det rør, som forbinder din mund med din mave).
English: Gastric ulcer Oesophageal ulcer Musculoskeletal Musculoskeletal pain (bone, muscle or joints) Muscle cramps Neurological Headache
Danish: Oesophagus ulcus Bevægeapparat og bindevæv Smerter i bevægeapparatet og bindevæv (knogler, muskler eller led)
English: Please see package leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose: Se indlægssedlen for yderligere information.
English: “How to take Alendronate HEXAL”.
Danish: 3 "Sådan skal du tage Alendronat HEXAL".
English: NAME OF THE MEDICINAL PRODUCT Alendronate HEXAL and associated names (see Annex I) 10 mg tablets [See Annex I - To be completed nationally] Alendronic acid
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Alendronat HEXAL og tilhørende navne (Se bilag I) 10 mg tabletter [Se bilag I - Udfyldes nationalt] Alendronsyre
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 10 mg alendronsyre (som natriumalendronattrihydrat) Hjælpestof: 103,95 mg laktosemonohydrat per tablet.
English: Despite no increased risk having been observed in extensive clinical trials, following marketing of the original preparation there have been reports of rare cases of gastric and duodenal ulcers, some of them severe and with complications.
Danish: Der har været rapporter om sjældne tilfælde af ulcus ventriculi og ulcus duodeni, nogle alvorlige og med komplikationer, efter markedsføringen af originalproduktet, selvom der i omfattende kliniske undersøgelser ikke er observeret en forøget risiko.
English: STATEMENT OF ACTIVE SUBSTANCE One tablet contains 10 mg alendronic acid (as sodium alendronate trihydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg alendronsyre (som natriumalendronattrihydrat)