FrancophonIA/ELRC3.0 huggingface dataset:
English: At two years 93.4 % (p<0.001) of patients receiving ibandronic acid 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Danish: Efter to år havde 93,4 % (p<0,001) af patienterne, som fik henholdsvis ibandronsyre 150 mg én gang om måneden og 78,4 % af patienterne, som fik ibandronsyre 2,5 mg daglig, stigninger i total hofte BMD over eller lig baseline.
English: • The other ingredients are: tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.
Danish: • Øvrige indholdsstoffer: tabletkerne: mikrokrystallinsk cellulose, povidon K-30, crospovidon (type A), kolloid vandfri silica, stearinsyre.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis (see section 4.8).
Danish: Knoglenekrose i kæben er blevet rapporteret meget sjældent efter markedsføring hos patienter ved behandling med Ibandronsyre Teva for osteoporose (se pkt.
English: Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Danish: Idet acetylsalicylsyre, non-steroide antiinflammatoriske lægemidler (NSAID) og bisphosphonater er forbundet med gastroinstestinal irritation, skal der udvises forsigtighed ved samtidig administration (se pkt.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Danish: Derfor bør den kontralaterale femur undersøges hos patienter, som behandles med bisphosphonater, og som har pådraget sig en fraktur af lårbensskaftet.
English: Ibandronic Acid Teva should not be used during pregnancy.
Danish: Ibandronsyre Teva bør ikke anvendes ved graviditet.
English: If you are taking a tablet each day, skip the missed dose completely.
Danish: Hvis du tager én tablet hver dag, spring da den glemte tablet over og fortsæt som normalt den næste dag.
English: In particular, products containing calcium, including milk and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Ibandronic Acid Teva, which is consistent with findings in animal studies.
Danish: Specielt produkter indeholdende calcium, herunder mælk og andre multivalente kationer (som f.eks. aluminium, magnesium, jern), vil sandsynligvis påvirke absorptionen af Ibandronsyre Teva.
English: Relative risk reduction of clinical vertebral fracture
Danish: Relativ Risiko Reduktion af kliniske vertebrale frakturer Hyppighed af kliniske vertebrale frakturer
English: • weakness.
Danish: • udslæt.
English: Special populations
Danish: Særlige populationer Nedsat leverfunktion
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Danish: Hver filmovertrukket tablet indeholder 150 mg ibandronsyre (som natrium monohydrat).
English: Ibandronic acid 2.5 mg daily (N=318)
Danish: Ibandronsyre 2,5 mg daglig (N=318)
English: Osteonecrosis of the jaw
Danish: • osteoporose i familien.
English: Hypocalcaemi a*
Danish: Hypokalcæmi*
English: What Ibandronic Acid Teva looks like and contents of the pack The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “50” on one side and plain on the other.
Danish: Ibandronsyre Teva filmovertrukne tabletter er hvide, bikonvekse, kapselformede, præget med “50” på den ene side og ingenting på den anden side.
English: Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water.
Danish: Indtag Ibandronsyre Teva mindst 6 timer efter, at du sidst har spist, drukket eller taget nogen form for anden medicin, vitaminer og mineraler eller kosttilskud andet end vand.
English: Pruritus
Danish: Kløe
English: METHOD AND ROUTE OF ADMINISTRATION Do not suck, chew or crush the tablets.
Danish: Tabletterne må ikke suttes, tygges eller knuses.
English: Ibandronic Acid Teva 150 mg film-coated tablets Ibandronic acid
Danish: Ibandronsyre Teva 150 mg filmovertrukne tabletter ibandronsyre
English: BMD
Danish: Trochanter BMD
English: Ibandronic acid 2.5 mg daily (N=294)
Danish: Ibandronsyre 2,5 mg daglig (N=294)
English: Ibandronic acid 2.5 mg daily (N=977)
Danish: Ibandronsyre 2,5 mg daglig (N=977)
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan forekomme hos 1 ud af 1.000 behandlede):
English: Bone pain *
Danish: Knoglesmerte *
English: Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for ibandronsyre eller over for et eller flere af hjælpestofferne anført i pkt.
English: • flatulence (farting, feeling bloated)
Danish: • luft i maven (luftafgang fra tarmen, følelse af oppustethed)
English: Ibandronic acid 2.5 mg daily (N=575)
Danish: Ibandronsyre 2.5 mg daglig (N=575)
English: Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid
Danish: Ibandronsyre Teva 50 mg filmovertrukne tabletter ibandronsyre
English: Cases of ONJ have been reported in the post-marketing setting for ibandronic acid.
Danish: Tilfælde af knoglenekrose i kæben er blevet rapporteret efter markedsføring hos patienter i behandling med ibandronsyre.
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Danish: BMD - gennemsnitlig ændring i forhold til baseline - lumbal columnaefter 3 år
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos 1 ud af 100 behandlede):
English: • itching or tingling skin (paraesthesia)
Danish: • kløe eller prikken i huden
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: Receptpligtigt lægemiddel.
English: Do not take Ibandronic Acid Teva with food.
Danish: Brug af Ibandronsyre Teva sammen med mad og drikke Indtag ikke Ibandronsyre Teva sammen med mad.
English: Asthenia
Danish: Hovedpine
English: • high levels of urea or high levels of parathyroid hormone in your blood.
Danish: • forhøjet koncentration i blodet af urinsyre eller hormoner fra biskjoldbruskkirtlen
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl især din læge eller på apoteket, hvis du tager noget af nedenstående medicin:
English: What Ibandronic Acid Teva is and what it is used for What you need to know before you take Ibandronic Acid Teva How to take Ibandronic Acid Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Ibandronsyre Teva Sådan skal du tage Ibandronsyre Teva Bivirkninger
English: Then you can have your first food and drink, and take any medicines or supplements (see section 3).
Danish: Efter indtagelse af tabletten skal du vente mindst 30 minutter, før du indtager mad, drikke, anden medicin, vitaminer og mineraler eller kosttilskud (se punkt 3).
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Danish: • Det aktive stof er ibandronsyre Hver filmovertrukket tablet indeholder 150 mg ibandronsyre (som natrium monohydrat).
English: Ibandronic Acid Teva should not be used during lactation.
Danish: Ibandronsyre Teva bør ikke anvendes i ammeperioden.
English: Keep taking Ibandronic Acid Teva for as long as your doctor tells you.
Danish: Hvis du holder op med at tage Ibandronsyre Teva Det er vigtigt, at du anvender Ibandronsyre Teva så længe, din læge har ordineret det. Ibandronsyre Teva kan kun afhjælpe din tilstand så længe, du fortsætter med at anvende det
English: Musculoskeletal and connective tissue disorders
Danish: Patienter med forstyrrelser i knogle- og mineralmetabolisme
English: • rash
Danish: • rygsmerter
English: Before receiving treatment, tell your doctor/nurse (health care professional) if: - you have any problems with your mouth or teeth such as poor dental health, gum disease or a planned tooth extraction.
Danish: Før du modtager behandlingen, fortæl din læge eller sygeplejerske, hvis: - du har problemer med din mund og tænder, såsom dårlig mundhygiejne, tandkødssygdom eller en planlagt tandudtrækning - du ikke modtager regelmæssig tandpleje eller ikke har været til kontrol i lang tid - du er ryger (dette kan øge risikoen for tandproblemer) - du tidligere har været i behandling med bisphosphat (anvendes til at behandle eller forbygge knoglelidelser) - du tager steroider (såsom prednisolon eller dexamethason) - du har kræft
English: (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
Danish: Dette kan være tegn på, at du har et blødende sår i den første del af tarmen (tolvfingertarmen), eller at mavens slimhinde er betændt (gastritis).
English: Relative Risk Reduction New morphometric vertebral fractures Incidence of new morphometric vertebral fractures
Danish: Hyppighed af nye morfometriske vertebrale frakturer
English: How to take Ibandronic Acid Teva
Danish: Sådan skal du tage Ibandronsyre Teva
English: ONJ can also occur after stopping treatment.
Danish: Knoglenekrose i kæben kan også forekomme efter behandlingen med IbandronsyreTeva er stoppet.
English: Ibandronic Acid Teva should not be used during breast-feeding.
Danish: Ibandronsyre Teva bør ikke anvendes under amning.
English: Posology
Danish: Rygsmerter
English: - If you can't stand or sit upright for at least one hour (60 minutes) at a time.
Danish: - hvis du har visse problemer med spiserøret/mavesækken, såsom indsnævring eller synkebesvær - hvis du ikke kan stå eller sidde oprejst i mindst én time (60 minutter) ad gangen - hvis du har eller nogensinde har haft lavt calciumindhold i blodet.
English: • asthma attacks
Danish: • astmaanfald.
English: - If you are allergic to ibandronic acid or any of the other ingredients of this medicine listed in section 6.
Danish: Tag ikke Ibandronsyre Teva - hvis du er allergisk over for ibandronsyre eller et af de øvrige indholdsstoffer (angivet i pkt.
English: Reproductive toxicity
Danish: Biotransformation
English: You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Danish: Du skal vente med at tage tabletten, indtil næste planlagte dosis, hvor du indtager tabletten som normalt.
English: Lumbar spine L2-L4
Danish: Lumbal L2-L4 BMD 3,9 [3,4, 4,3]
English: Paediatric population (see sections 4.2 and 5.1) There are no data on the use of ibandronic acid in patients less than 18 years old.
Danish: Der foreligger ingen data vedrørende brugen af ibandronsyre til patienter under 18 år.
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Danish: Da acetylsalicylsyre, NSAID-præparater og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed, hvis acetylsalicylsyre eller et NSAID-præparat administreres sammen med Ibandronsyre Teva (se pkt.
English: There are no data on the effects of ibandronic acid in humans.
Danish: Der foreligger ingen data vedrørende brugen af ibandronsyre til disse aldersgrupper.
English: Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Danish: Da acetylsalicylsyre, NSAID-præparater og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed, hvis acetylsalicylsyre eller et NSAID-præparat administreres sammen med Ibandronsyre Teva.
English: Osteonecrosis of the external auditory canal
Danish: Knoglenekrose i den ydre øregang
English: - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Danish: administrationsvej (højere risiko for parenteral administration) og kumulativ dosis af knogleresorption behandling - kræft, komorbide tilstande (f.eks. anæmi, koagulationsforstyrrelser, infektion), rygning - samtidig behandling: kortikosteroider, kemoterapi, angiogenesehæmmere, strålebehandling af hovede og hals - dårlig mundhygiejne, paradentose, dårligt passende tandproteser, tidligere tandsygdomme,
English: Musculoskele tal stiffness
Danish: Nyrer og urinveje
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Danish: • PRAC behandlede proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004 for så vidt angår de produkter, der er anført i bilag A
English: Overall conclusion
Danish: Overordnet konklusion
English: Hence, it is currently not possible to establish whether the increased amputation risk is a class effect or not.
Danish: Det er derfor ikke muligt på nuværende tidspunkt at fastslå, om den øgede amputationsrisiko er en klasseeffekt eller ej.
English: • The PRAC therefore considered that the risk may constitute a possible class effect;
Danish: • PRAC var derfor af den opfattelse, at risikoen kan skyldes en mulig klasseeffekt
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilslutter CHMP sig anbefalingens overordnede konklusioner og begrundelse.
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Danish: CANVAS- og CANVAS-R-undersøgelserne samt CREDENCE- og DECLAREundersøgelserne afsluttes efter planen i henholdsvis 2017 og 2020.
English: Grounds for PRAC recommendation
Danish: Begrundelse for PRAC's anbefaling
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Danish: Natriumglukose-co-transporter 2 (SGLT2)-hæmmere anvendes sammen med diæt og motion hos type 2-diabetikere, enten alene eller i kombination med andre diabetesmidler.
English: Annex IV Scientific conclusions
Danish: Bilag IV Videnskabelige konklusioner
English: All RMPs should be updated accordingly via an appropriate variation to be submitted no later than one month of the European Commission decision;
Danish: Alle risikostyringsplaner bør opdateres i overensstemmelse hermed gennem en variationsansøgning, der skal indsendes senest én måned efter Europa-Kommissionens afgørelse.
English: The European Commission (EC) triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 15 April 2016; the PRAC was requested to assess the impact on the benefit-risk balance of canagliflozin containing medicinal products, to assess whether this is a class issue and to issue a recommendation by 31 March 2017 on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked and whether provisional measures are necessary to ensure the safe and effective use of these medicinal products.
Danish: Den 15. april 2016 indledte Europa-Kommissionen en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004; PRAC blev anmodet om at vurdere indvirkningen på benefit/risk-forholdet for canagliflozinholdige lægemidler samt vurdere, om der er tale om en klasseeffekt, ligesom PRAC senest den 31. marts 2017 skulle fremsætte en anbefaling om, hvorvidt de relevante markedsføringstilladelser skal fastholdes, ændres, suspenderes eller tilbagekaldes, og hvorvidt det er nødvendigt med foreløbige foranstaltninger til at sikre en effektiv og sikker brug af disse lægemidler.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy.
Danish: CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelserne for Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance og Synjardy.
English: Consequently, the EC requested on 6 July 2016 to extend the current procedure to include all of the authorised products of the class of SGLT2 inhibitors.
Danish: Derfor anmodede Europa-Kommissionen den 6. juli 2016 PRAC om at udvide den igangværende procedure til at omfatte alle godkendte lægemidler i klassen af SGLT2-hæmmere.
English: All members of the class share the same mode of action and there is no confirmed underlying mechanism that is canagliflozin-specific.
Danish: Alle lægemidler i klassen har den samme virkningsmekanisme, og der er ingen bekræftet underliggende mekanisme, som er specifik for canagliflozin.
English: • Because no specific risk factors could be identified apart from general amputation risk factors potentially contributing to the events, the PRAC recommended that patients should be advised on routine preventative foot care and maintaining adequate hydration as a general advice to prevent amputation;
Danish: • Eftersom der ikke kunne identificeres nogen specifik risikofaktor, ud over generelle amputationsrisici, som muligvis kan bidrage til hændelserne, anbefalede PRAC som generelt råd til forebyggelse af amputation, at patienter bør rådgives om almindelig forebyggende fodpleje og fastholdelse af passende hydrering
English: The warning for canagliflozin also includes information that, in patients developing amputation preceding events, consideration may be given to discontinue treatment.
Danish: Advarslen for canagliflozins vedkommende omfatter også oplysning om, at det hos patienter, der udvikler tilstande, som kan føre til amputation, skal overvejes at seponere behandlingen.
English: PRAC noted that an increased amputation risk has only become apparent with canagliflozin so far, but one large cardiovascular outcome study (DECLARE) is still on-going for dapagliflozin and amputation events were not been systematically captured within the completed large cardiovascular outcome study conducted with empagliflozin (EMPA-REG).
Danish: PRAC bemærkede, at den øgede amputationsrisiko indtil videre kun er konstateret for canagliflozin; en stor undersøgelse af kardiovaskulære udfald (DECLARE) er imidlertid stadig i gang for dapagliflozin, og amputationshændelser er ikke systematisk registreret i den store undersøgelse af kardiovaskulære udfald, der er gennemført med empagliflozin (EMPA-REG).
English: • The PRAC was therefore of the view that the risk of lower limb amputation should be included in the product information for all products listed in Annex A, with a warning highlighting to healthcare professional and patients the importance of routine preventative foot care.
Danish: • PRAC var derfor af den opfattelse, at risikoen for amputation af nedre ekstremiteter bør tilføjes produktinformationen for alle de lægemidler, der er anført i bilag A, sammen med en advarsel, der gør sundhedspersoner og patienter opmærksomme på betydningen af almindelig forebyggende fodpleje.
English: Final analysis of these studies, after un-blinding, will provide further information on the benefit/risk of SGLT2 inhibitors particularly of the risk of lower limb amputations.
Danish: Den endelige analyse af disse undersøgelser vil efter afblinding give yderligere oplysninger om benefit/risk-forholdet for SGLT2hæmmere, især hvad angår risikoen for amputation af nedre ekstremiteter.
English: Further to the information received by the EMA, the Independent Data Monitoring Committee (IDMC) for the CANVAS and CANVAS-R studies, which has access to all un-blinded CV outcome and safety data, recommended that the study should continue, that action to minimize this potential risk should be taken and that participants should be informed adequately about this risk.
Danish: På grundlag af de oplysninger, som EMA modtog, og alle de afblindede data for udfald og sikkerhed, som det uafhængige datamonitoreringsudvalg (IDMC; Independent Data Monitoring Committee) for CANVAS- og CANVAS-R-undersøgelserne havde adgang til, anbefalede dette udvalg, at undersøgelsen fortsatte, at der blev iværksat foranstaltninger til at minimere denne risiko, og at forsøgspersonerne skulle informeres fyldestgørende om denne risiko.
English: Furthermore, the PRAC considered that a class effect could not be excluded, as all SGLT2 inhibitors share the same mechanism of action, as the potential mechanism leading to an increased amputation risk is not known, and as an underlying cause specific to canagliflozin containing medicines only cannot be identified at the moment.
Danish: Desuden er PRAC af den opfattelse, at en klasseeffekt ikke kan udelukkes, idet alle SGLT2-hæmmere har den samme virkningsmekanisme, idet den mekanisme, der fører til en øget amputationsrisiko, ikke er kendt, og idet en underliggende årsag relateret til canagliflozinholdige lægemidler alene ikke kan identificeres på nuværende tidspunkt.
English: • The PRAC was also of the opinion that a mechanism of action, allowing to understand which patients are at risk, is still unclear;
Danish: • PRAC var også af den opfattelse, at virkningsmekanismen stadig ikke kendes, og at det derfor ikke er muligt at vide, hvilke patienter der er i risiko
English: The mechanism of action that would allow understanding which patients are at risk is therefore still unclear.
Danish: Da virkningsmekanismen stadig ikke er kendt, vides det derfor ikke, hvilke patienter der er i risiko.
English: • The PRAC considered that the available data on amputation in the CANVAS and CANVAS-R trials confirm that treatment with canagliflozin may contribute to an increased risk of amputation of the lower limb, mainly of the toe;
Danish: • PRAC fandt, at de tilgængelige data om amputation i CANVAS- og CANVAS-R-undersøgelserne bekræfter, at behandling med canagliflozin kan bidrage til en øget risiko for amputation af nedre ekstremiteter, primært tæer
English: The PRAC therefore recommended that the variation to the terms of the marketing authorisation for the above listed products referred to in Annex A, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation, was warranted.
Danish: PRAC konkluderede derfor, at der er behov for ændring af betingelserne for markedsføringstilladelsen for de ovenfor nævnte lægemidler, der er anført i bilag A, for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III til PRAC's anbefaling.
English: The communication also asked healthcare professionals to consider treatment discontinuation in patients who develop amputation preceding events.
Danish: Sundhedspersonerne blev i henvendelsen også opfordret til at overveje seponering af behandlingen hos patienter, der udvikler tilstande, som kan føre til amputation.
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of lower limb amputation in patients treated with Sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes mellitus;
Danish: • PRAC gennemgik alle de data, der var indsendt af indehaverne af markedsføringstilladelse, i relation til risikoen for amputation af nedre ekstremiteter hos type 2-diabetikere i behandling med SGLT2-hæmmere
English: In addition, an analysis of the ongoing renal study CANVAS-R with a similar population as CANVAS showed a numerical imbalance with regards to amputation events.
Danish: Desuden havde en analyse af den igangværende undersøgelse af nyrehændelser (CANVAS-R) i en forsøgspopulation svarende til forsøgspopulationen i CANVAS vist en numerisk ubalance med hensyn til amputationshændelser.