FrancophonIA/ELRC3.0 huggingface dataset:
English: Urinary concentrations of the bone resorption marker CTx (Cterminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Danish: Koncentrationen af urinmarkører for knogleresorption CTx (C-terminaltelopeptid frigjort fra Type I kollagen) blev signifikant reduceret i ibandronsyregruppen i forhold til placebo.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på de(n) fremstiller(e), der er ansvarlig(e) for batchfrigivelse
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.
Danish: Det samlede ibandronsyreclearance var reduceret til 44 ml/min hos patienter med svært nedsat nyrefunktion sammenlignet med 129 ml/min hos patienter med normal nyrefunktion.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic acid Sandoz is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Danish: På grund af den mulige irriterende effekt og risikoen for forværring af den underliggende sygdom bør der udvises forsigtighed, når Ibandronsyre Sandoz gives til patienter med aktive øvre gastrointestinale problemer (f.eks. diagnosticeret Barretts øsofagitis, dysfagi, andre sygdomme i spiserøret, gastritis, duodenitis eller ulcus).
English: Method of administration For oral use.
Danish: Administration Til oral anvendelse
English: Ibandronic acid Sandoz works by reducing the amount of calcium that is lost from your bones.
Danish: Ibandronsyre Sandoz virker ved at nedsætte mængden af calcium, der mistes fra knoglerne.
English: You can drive and use machines as it's expected that Ibandronic acid Sandoz has no or negligible effect on your ability to drive and use machines.
Danish: Du kan køre bil og betjene maskiner, da det forventes at Ibandronsyre Sandoz ikke eller kun i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.
English: This is because Ibandronic acid Sandoz can affect the way some other medicines work.
Danish: Dette er fordi, Ibandronsyre Sandoz kan påvirke måden, hvorpå andre medicintyper virker.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I de prækliniske undersøgelser blev der kun set effekter efter doser, der i væsentlig grad overstiger den maksimale humane eksponering, hvilket indikerer ubetydelig relevans mhp.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Ibandronic acid Sandoz.
Danish: Alle patienter bør opfordres til at opretholde god mundhygiejne, gennemgå rutinemæssige tandundersøgelser og straks rapportere eventuelle symptomer, såsom løse tænder, smerter eller hævelser samt sår der væsker og/eller ikke heler under behandling med Ibandronsyre Sandoz.
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid Sandoz.
Danish: Tages der medicin, der reducerer mavesyre, såsom cimetidin og ranitidin, kan disse øge virkningen af Ibrandronsyre Sandoz en smule.
English: - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes - Hypocalcaemia - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Anormaliteter i spiserøret, som forsinker tømning af spiserøret, såsom forsnævring eller akalasi - Manglende evne til at stå eller sidde oprejst i mindst 60 minutter - Hypokalkæmi - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Ibandronic acid Sandoz is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Danish: Ibandronsyre Sandoz er indiceret til voksne til forebyggelse af knoglerelaterede hændelser (patologiske frakturer, knoglekomplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser.
English: Domaniewska 50 C 02-672 Warszawa Poland
Danish: Domaniewska 50 C 02-672 Warszawa Polen
English: Ocular inflammation
Danish: Øjeninflammation
English: Ibandronic acid Sandoz tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Ibandronsyre Sandoz tabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Danish: Stevens-Johnson syndrom†, mangeartet erytem†, blæreformet dermatitis†
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Danish: styrken af lægemidlet, der hæmmer knogleresorption (højere risiko for højpotente stoffer), 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 hoved og hals dårlig mundhygiejne, paradentose, dårligt passende tandproteser, tidligere tandsygdomme, invasive tandbehandlinger f.eks. tandudtrækning
English: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Danish: Der er blevet rapporteret øjeninflammationshændelser såsom uveitis, episcleritis og scleritis ved behandling med ibandronsyre.
English: Your doctor may do regular blood tests while you are taking Ibandronic acid Sandoz.
Danish: Din læge kan ønske at tage blodprøver regelmæssigt, mens du tager Ibandronsyre Sandoz.
English: Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Danish: Sammenfattende resultater fra disse undersøgelse viste en signifikant fordel for ibandronsyre 50 mg p.o. frem for placebo, til reduktion af SREs målt ved den tidsjusterede SMPR (p=0,041).
English: Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water.
Danish: Tag tabletten mindst 6 timer efter du sidst spiste, drak, tog anden medicin eller kosttilskud undtagen vand.
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic acid Sandoz and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Danish: Læger skal være opmærksomme på tegn eller symptomer, som tyder på en øsofageal reaktion, og patienterne skal instrueres i at stoppe behandlingen med Ibandronsyre Sandoz og kontakte lægen, hvis de udvikler dysfagi, odynofagi, retrosternal smerte eller nyopstået eller forværret halsbrand.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Danish: Der er blevet rapporteret atypiske subtrokantære og diafyse femurfrakturer ved bifosfonatbehandling, primært hos patienter, der modtager langvarig behandling for osteoporose.
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany
Danish: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Tyskland
English: Do not take Ibandronic acid Sandoz with food or any other drinks except water as the medicine is less effective if it is taken with food or drink (see section 3).
Danish: Ibandronsyre Sandoz sammen med mad og drikke Tag ikke Ibandronsyre Sandoz sammen med mad eller andre drikke end vand, fordi medicinen er mindre effektiv, hvis den tages sammen med mad og drikke (se pkt.
English: • pain or sore in your mouth or jaw.
Danish: • smerter eller ømhed i munden eller kæben.
English: If you develop these symptoms, stop taking Ibandronic acid Sandoz and tell your doctor straight away (see sections 3 and 4).
Danish: Hvis du oplever disse symptomer, skal du holde op med at tage Ibandronsyre Sandoz, og straks fortælle dette til din læge (se pkt.
English: glycerol dibehenate, colloidal anhydrous silica.
Danish: glyceroldibehenat, kolloid vandfri silica.
English: Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral.
Danish: Den selektive virkning på knoglevævet er baseret på bifosfonaters høje affinitet til knoglemineraler.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sandoz GmbH
English: Also some other medicines can affect the way Ibandronic acid Sandoz works.
Danish: Anden medicin kan desuden påvirke måden, som Ibandronsyre Sandoz virker på.
English: Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Danish: Kliniske undersøgelser har ikke vist tegn på svækkelse af nyrefunktionen ved langvarig behandling med ibandronsyre.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that ibandronic acid has no or negligible influence on the ability to drive and use machines.
Danish: På baggrund af den farmakodynamiske og farmakokinetiske profil og de rapporterede bivirkninger forventes Ibandronsyre Sandoz ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
Danish: Fremstillere Pharmathen S.A. Dervenakion 6 Pallini 15351
English: Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany
Danish: Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Tyskland
English: Subjects with severe renal impairment (CLcr  30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Danish: Patienter med svært nedsat nyrefunktion (kreatinclearance < 30 ml/min), som fik 10 mg peroral ibandronsyre dagligt i 21 dage, havde 2-3 gange højere plasmakoncentrationer end personer med normal nyrefunktion (kreatinclearance > 80 ml/min).
English: Milk or antacids should be given to bind ibandronic acid.
Danish: Der bør indtages mælk eller antacida med henblik på at binde Ibandronsyre Sandoz.
English: Then you can have your first food and drink, and take any medicines or supplements.
Danish: Derefter kan du indtage mad, drikkevarer og anden medicin eller kosttilskud.
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Danish: Der er rapporteret om tilfælde af anafylaksi/anafylaktisk chok, inklusive dødelige tilfælde, hos patienter behandlet med intravenøs ibandronsyre.
English: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Danish: Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Grækenland og
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic acid Sandoz.
Danish: Informer din læge, hvis du er i gang med en tandbehandling eller vil få foretaget en tandoperation (f.eks. tandudtrækning), og fortæl ligeledes din tandlæge, at du er i behandling med Ibandronsyre Sandoz.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton
English: This is because aminoglycosides and Ibandronic acid Sandoz can both lower the amount of calcium in your blood.
Danish: aminoglykosider og Ibandronsyre Sandoz begge kan sænke mængden af calcium i blodet.
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjælden (kan forekomme hos 1 ud af 10.000 mennesker)
English: Chest pain, influenza-like illness, malaise, pain
Danish: Brystsmerter, influenzaligne nde sygdom, utilpashed, smerter
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Danish: Atypisk subtrokantære og diafyse femurfrakturer
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for cancer-related conditions.
Danish: En bivirkning kaldet knoglenekrose i kæben (skader på knoglen i kæben) er blevet rapporteret meget sjældent i post-marketing perioden hos patienter ved behandling med ibandronsyre til kræftrelaterede forhold.
English: Temporary interruption of Ibandronic acid Sandoz treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Hvis det er muligt, bør det overvejes at seponere behandlingen med Ibandronsyre Sandoz midlertidigt, indtil tilstanden forbedres og risikofaktorerne for knoglenekrose i kæben er reduceret.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (kan forekomme hos op til 1 ud af 1000 mennesker)
English: • Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
Danish: • Du skal indtage tabletten i oprejst stilling (stående eller siddende) og forblive oprejst i en time (60 minutter) efter, at du har taget din tablet.
English: Each film-coated tablet contains 0.86 mg lactose (as lactose monohydrate).
Danish: Hver filmovertrukket tablet indeholder 0,86 mg lactose (som lactosemonohydrat).
English: • if you have any swallowing or digestion problems
Danish: • hvis du har synke- eller fordøjelsesbesvær
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 og ikke-steroide antiinflammatoriske lægemidler (NSAID-præparater) og bifosfonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed ved samtidig behandling med sådanne præparater.
English: If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid Sandoz.
Danish: Hvis du er usikker, skal du spørge din læge eller apotekspersonalet, før du tager Ibandronsyre Sandoz.
English: Anaphylactic reaction/shock
Danish: Anafylaksi/anafylaktisk chok
English: • severe adverse skin reactions
Danish: • alvorlige hudreaktioner.
English: Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic acid Sandoz.
Danish: Din læge kan bede dig om at gennemgå et tandeftersyn før du starter med Ibandronsyre Sandozbehandling.
English: Reporting of suspected adverse reactions
Danish: Rapportering om mistænkelige bivirkninger
English: Keep taking Ibandronic acid Sandoz for as long as your doctor tells you.
Danish: Hvis du holder op med at tage Ibandronsyre Sandoz Fortsæt med at tage Ibandronsyre Sandoz så længe, som din læge ordinerer det.
English: Primary Efficacy Endpoints
Danish: Primære effektparametre
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 og ikke-steroide antiinflammatoriske lægemidler (NSAID-præparater) og bifosfonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed ved samtidig behandling med sådanne præparater (se pkt.
English: Uncommon (may affect less than 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos færre end 1 ud af 100 mennesker)
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of medicinal products (bisphosphonates).
Danish: Bivirkningerne af ibandronsyre hos rotter i reproduktions toksicitetsundersøgelserne var de samme som for bifosfonatklassen.
English: INFORMATION IN BRAILLE Ibandronic acid Sandoz 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Ibandronsyre Sandoz 50 mg
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Danish: De mest alvorlige rapporterede bivirkninger omfatter anafylaksi/anafylaktisk chok, atypiske femurfrakturer, knoglenekrose i kæben, gastrointestinal irritation og øjeninflammation (se afsnittet ”Beskrivelse af udvalgte bivirkninger” og pkt.
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Ibandronic acid Sandoz in patients less than 18 years old.
Danish: 5.1) Der findes ikke data vedrørende brugen af Ibandronsyre Sandoz til patienter under 18 år.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Danish: Knoglenekrose i kæben er blevet rapporteret meget sjældent efter markedsføring hos patienter ved behandling med ibandronsyre til onkologiske indikationer (se pkt.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicin i afløbet, toilettet eller skraldespanden.
English: Ibandronic acid Sandoz contains lactose
Danish: Ibandronsyre Sandoz indeholder laktose
English: • It helps to prevent your bones from breaking (fractures).
Danish: Det hjælper med at forebygge knoglebrud
English: Ibandronic acid Sandoz contains the active substance ibandronic acid.
Danish: Ibandronsyre Sandoz indeholder det aktive stof ibandronsyre.
English: Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2).
Danish: Derudover hæmmer ibandronsyre ikke de vigtigste humane hepatiske P450-isoenzymer og inducerer ikke det hepatiske det hepatiske cytokromsystem P450-system hos rotter
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Ibandronsyre Sandoz kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Description of selected adverse reactions
Danish: Beskrivelse af udvalgte bivirkninger Hypokalkæmi
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic acid Sandoz administration.
Danish: Invasive tandbehandlinger bør kun udføres efter nøje vurdering under behandling med Ibandronsyre Sandoz.
English: • severe stomach pain.
Danish: • alvorlige mavesmerter.
English: What Ibandronic acid Sandoz looks like and contents of the pack The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister.
Danish: De filmovertrukne tabletter er hvide, runde, bikonvekse tabletter og leveres i polyamid/aluminium/PVCaluminium blisterpakninger.
English: Not known
Danish: Meget sjælden Ukendt
English: Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) †
Danish: Knoglenekrose i kæben†** Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater)†
English: Do not pass it on to others.
Danish: Lad derfor være med at give
English: Cellulose, microcrystalline Crospovidone Maize starch pregelatinised Glycerol dibehenate Silica, anhydrous colloidal
Danish: Pregelatineret majsstivelse Glyceroldibehenat Silica, kolloid vandfri
English: Macrogol 4000
Danish: Lactosemonohydrat Macrogol 4000
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Danish: Tal med din læge, hvis lægen har fortalt dig, at du ikke tåler eller kan fordøje visse sukkerarter (f.eks. hvis du lider af galaktoseintolerans, LAPP laktasemangel eller har problemer med glukose/galaktoseoptagelse).
English: What Ibandronic acid Sandoz contains - The active substance is ibandronic acid.
Danish: Ibandronsyre Sandoz indeholder - Aktivt stof: ibandronsyre.
English: If you forget to take Ibandronic acid Sandoz
Danish: Hvis du har glemt at tage Ibandronsyre Sandoz
English: Medicinal product-Food Interactions
Danish: Lægemiddelinteraktion
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 50 mg ibandronsyre (som ibandronnatrium monohydrat).
English: Secondary Efficacy Endpoints
Danish: Sekundære effektparametre
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Tabulated list of adverse reactions
Danish: Tabelleret liste med bivirkninger
English: Water may be taken at any time during the course of Ibandronic acid Sandoz treatment (see section 4.5).
Danish: Vand kan dog indtages på et hvilket som helst tidspunkt i behandlingen med Ibandronsyre Sandoz.
English: What you need to know before you take Ibandronic acid Sandoz
Danish: Det skal du vide, før du begynder at tage Ibandronsyre Sandoz
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: • Brug ikke Ibandronsyre Sandoz efter den udløbsdato, der står på blisterpakningen og æsken efter
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment:
Danish: Hold op med at tage Ibandronsyre Sandoz og kontakt straks en læge, hvis du opdager en af de følgende alvorlige bivirkninger - du kan have behov for akut medicinsk behandling: Almindelig (kan forekomme hos op til 1 ud af 10 mennesker)
English: Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
Danish: Hver filmovertrukket tablet indeholder 50 mg ibandronsyre (som ibandronnatrium monohydrat).
English: • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
Danish: • en type antibiotisk injektion kaldet ”aminoglykosid” såsom gentamicin.