FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take more Januvia than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Danish: Hvis De har taget for meget Januvia Kontakt straks Deres læge, hvis De har taget mere end den foreskrevne dosis af dette lægemiddel.
English: Uncommon: dry mouth
Danish: Ikke almindelig: Tør mund.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.
Danish: Der har dog været rapporter om svimmelhed og døsighed, hvilket kan påvirke Deres evne til at køre bil eller betjene maskiner.
English: Januvia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Danish: Januvia tilhører en klasse af orale anti-hyperglykæmiske lægemidler, der kaldes dipeptidylpeptidase4-(DPP-4)-hæmmere.
English: What you need to know before you take Januvia
Danish: Det skal De vide, før De begynder at tage Januvia
English: When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når Januvia anvendes i kombination med et sulfonylurinstof eller sammen med insulin, kan en lavere dosis af sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
English: No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig til patienter med let til moderat leverinsufficiens.
English: Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain
Danish: Nogle patienter har oplevet følgende bivirkninger, når de har taget sitagliptin alene i kliniske studier eller ved anvendelse efter markedsføring alene og/eller sammen med anden diabetesmedicin: Almindelige: Lavt blodsukker, hovedpine, infektion i øvre luftveje, stoppet næse eller snue og ondt i halsen, betændelse i led og den tilgrænsende knogle, smerter i arme eller ben.
English: In addition, after 12 weeks, the mean reductions in HbA1c (sitagliptin -0.59 %; placebo -0.18 %) and FPG (sitagliptin -25.5 mg/dL; placebo -3.0 mg/dL) were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Danish: Desuden var den gennemsnitlige reduktion i HbA1c (sitagliptin -0,59%; placebo -0,18%) efter 12 uger og FPG (sitagliptin -25,5 mg/dl; placebo3,0 mg/dl) generelt de samme som i andre monoterapiundersøgelser hos patienter med normal nyrefunktion (se pkt.
English: By enhancing active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in a glucose-dependent manner.
Danish: Ved at øge de aktive inkretinniveauer øger sitagliptin insulinfrigørelsen og reducerer glucagonniveauet afhængigt af glucosekoncentrationen.
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily.
Danish: Til patienter med svær nyreinsufficiens (GFR ≥15 til <30 ml/min) eller med nyresygdom i slutstadiet (ESRD) (GFR <15 ml/min), inklusive patienter som har behov for hæmodialyse eller peritonealdialyse, er dosis 25 mg Januvia en gang dagligt.
English: Januvia has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Danish: Januvia er ikke undersøgt hos patienter med svær leverinsufficiens, og der bør udvises forsigtighed (se pkt.
English: What Januvia contains
Danish: Januvia indeholder:
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
Danish: Hvis De tager dette lægemiddel sammen med medicin, der kaldes sulfonylurinstof eller sammen med insulin, kan det medføre for lavt blodsukker (hypoglykæmi), hvilket kan påvirke Deres evne til at køre bil og betjene maskiner, eller hvis De arbejder uden sikkert fodfæste.
English: The usual recommended dose is: one 100 mg film-coated tablet once a day by mouth
Danish: Den almindelige anbefalede dosis er: - En 100 mg filmovertrukken tablet.
English: If bullous pemphigoid is suspected, Januvia should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Januvia seponeres.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Januvia is 50 mg once daily.
Danish: Til patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) er dosis 50 mg Januvia en gang dagligt.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Januvia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Danish: Hypoglykæmi i kombination med andre anti-hyperglykæmiske lægemidler Der er foretaget kliniske undersøgelser af Januvia som monoterapi og som del af kombinationsbehandling med lægemidler, der ikke er kendt for at medføre hypoglykæmi (dvs. metformin og/eller en PPAR-agonist).
English: Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Danish: Nogle patienter har oplevet følgende bivirkninger, efter at sitagliptin er blevet føjet til metformin: Almindelige (kan berøre op til 1 ud af 10): Lavt blodsukker, kvalme, øget luftafgang fra tarmen, opkastning.
English: How to take Januvia
Danish: Sådan skal De tage Januvia
English: Paediatric No studies with Januvia have been performed in paediatric patients.
Danish: Børn Der er ikke udført undersøgelser med anvendelse af Januvia til børn.
English: Januvia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Danish: Januvia indeholder det aktive stof sitagliptin, som tilhører en klasse af lægemidler, som kaldes DPP-4hæmmere (dipeptylpeptidase-4-hæmmere).
English: Mean change from baseline HbA1c
Danish: Gennemsnitlig ændring fra baseline HbA1c (%)
English: For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
Danish: Januvia er indiceret til at forbedre den glykæmiske kontrol:
English: - type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
Danish: - Komplikation til diabetes med forhøjet blodsukker, hurtigt vægttab, kvalme eller opkastning (diabetisk ketoacidose).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Januvia Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: HbA1c (%) at week 24.
Danish: HbA1C (%) i 24. uge
English: What Januvia is and what it is used for What you need to know before you take Januvia How to take Januvia
Danish: Det skal De vide, før De begynder at tage Januvia Sådan skal De tage Januvia Bivirkninger
English: Januvia 25 mg tablets Sitagliptin
Danish: Januvia 25 mg tabletter sitagliptin
English: * All Patients Treated Population (an intention-to-treat analysis).
Danish: * Population; alle behandlede patienter (analyse med henblik på behandling) Gennemsnit ved mindste kvadraters metode justeret for status for tidligere antihyperglykæmisk behandling og baselineværdi.
English: Januvia 100 mg tablets Sitagliptin
Danish: Januvia 100 mg tabletter sitagliptin
English: Januvia 50 mg tablets Sitagliptin
Danish: Januvia 50 mg tabletter sitagliptin
English: EU/1/07/383/013 14 film-coated tablets EU/1/07/383/014 28 film-coated tablets EU/1/07/383/023 30 film-coated tablets EU/1/07/383/015 56 film-coated tablets EU/1/07/383/016 84 film-coated tablets EU/1/07/383/024 90 film-coated tablets EU/1/07/383/017 98 film-coated tablets EU/1/07/383/018 50 x 1 film-coated tablets
Danish: EU/1/07/383/013 14 filmovertrukne tabletter EU/1/07/383/014 28 filmovertrukne tabletter EU/1/07/383/023 30 filmovertrukne tabletter EU/1/07/383/015 56 filmovertrukne tabletter EU/1/07/383/016 84 filmovertrukne tabletter EU/1/07/383/024 90 filmovertrukne tabletter EU/1/07/383/017 98 filmovertrukne tabletter EU/1/07/383/018 50 x 1 filmovertrukne tabletter
English: EU/1/07/383/001 14 film-coated tablets EU/1/07/383/002 28 film-coated tablets EU/1/07/383/019 30 film-coated tablets EU/1/07/383/003 56 film-coated tablets EU/1/07/383/004 84 film-coated tablets EU/1/07/383/020 90 film-coated tablets EU/1/07/383/005 98 film-coated tablets EU/1/07/383/006 50 x 1 film-coated tablets
Danish: EU/1/07/383/001 14 filmovertrukne tabletter EU/1/07/383/002 28 filmovertrukne tabletter EU/1/07/383/019 30 filmovertrukne tabletter EU/1/07/383/003 56 filmovertrukne tabletter EU/1/07/383/004 84 filmovertrukne tabletter EU/1/07/383/020 90 filmovertrukne tabletter EU/1/07/383/005 98 filmovertrukne tabletter EU/1/07/383/006 50 x 1 filmovertrukne tabletter
English: EU/1/07/383/007 14 film-coated tablets EU/1/07/383/008 28 film-coated tablets EU/1/07/383/021 30 film-coated tablets EU/1/07/383/009 56 film-coated tablets EU/1/07/383/010 84 film-coated tablets EU/1/07/383/022 90 film-coated tablets EU/1/07/383/011 98 film-coated tablets EU/1/07/383/012 50 x 1 film-coated tablets
Danish: EU/1/07/383/007 14 filmovertrukne tabletter EU/1/07/383/008 28 filmovertrukne tabletter EU/1/07/383/021 30 filmovertrukne tabletter EU/1/07/383/009 56 filmovertrukne tabletter EU/1/07/383/010 84 filmovertrukne tabletter EU/1/07/383/022 90 filmovertrukne tabletter EU/1/07/383/011 98 filmovertrukne tabletter EU/1/07/383/012 50 x 1 filmovertrukne tabletter
English: Januvia 100 mg film-coated tablets
Danish: Januvia 100 mg filmovertrukne tabletter
English: Januvia 25 mg film-coated tablets
Danish: Januvia 25 mg filmovertrukne tabletter
English: Januvia 100 mg film-coated tablets Sitagliptin
Danish: Januvia 100 mg filmovertrukne tabletter sitagliptin
English: Januvia 50 mg film-coated tablets
Danish: Januvia 50 mg filmovertrukne tabletter
English: Januvia 25 mg film-coated tablets Sitagliptin
Danish: Januvia 25 mg filmovertrukne tabletter sitagliptin
English: Januvia 50 mg film-coated tablets Sitagliptin
Danish: Januvia 50 mg filmovertrukne tabletter sitagliptin
English: Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
Danish: Population; alle behandlede patienter (analyse med henblik på behandling) Gennemsnit ved mindste kvadraters metode justeret for status for tidligere antihyperglykæmisk behandling og baselineværdi.
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentra tion)
English: The physician educational programme should contain the following key elements:
Danish: Lægernes træningsprogram skal indeholde følgende nøgleelementer:
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) implement, prior to the launch, an educational programme for physicians aiming to ensure proper injection placement to minimize occurrence of injection-related adverse events and to inform on expected and potential risks associated with the treatment
Danish: Medlemslandende skal sikre, at indehaveren af markedsføringstilladelsen (MAH) inden markedsføring implementerer et træningsprogram for læger for at sikre korrekt injektionsplacering for at minimere tilfælde af injektionsrelaterede bivirkninger og at informere om forventede og potentielle risici i forbindelse med behandlingen.
English: • The need to inform the patient about the signs and symptoms associated with the treatment and when to seek attention from the health care provider.
Danish: • Nødvendigheden af at informere patienterne om tegn og symptomer, som er forbundet med behandingen, og hvor når de skal søge behandling hos lægen
English: • Proper amount of volumes for both reconstitution and injection differences in the metocarpophalangeal (MP) and proximal interphalangeal (PIP) joints.
Danish: • Korrekt størrelse af volumen for både rekonstitution og injektionsforskelle for metocarpophalangeale (MP) og proximal interphalangeale (PIP) led.
English: • Reminder of the need to report adverse events, including medication errors.
Danish: • Påmindelse om nødvendigheden af at rapportere bivirkninger herunder medicinske fejl.
English: • Injection technique and dosing interval.
Danish: • Injektionsteknik og doseringsinterval.
English: • Recognition and treatment of severe immune-mediated reaction, including anaphylaxis.
Danish: • Erkendelse og behandling af alvorlige immunmedierede reaktioner, herunder anafylaksi.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY MEMBER STATES
Danish: ANNEX BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENDE
English: • Information on bleeding risk in patients with coagulation disorders including those on concurrent anti-coagulation therapy.
Danish: • Information om blødningsrisiko hos patienter med koagulationssygdomme herunder patienter I
English: • Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders.
Danish: krydsreaktion herunder udviklingen af muskuloskeletalt syndrome og forværring/initiering af autoimmune sygdomme.
English: • The summary of product characteristics and the patient information leaflet
Danish: • Produktresumé og Indlægsseddel
English: You may need to read it again
Danish: Du kan få brug for at læse den igen
English: 79539, Germany
Danish: 79539, Tyskland
English: • At the request of the European Medicines Agency.
Danish: • På anmodning fra Det Europæiske Lægemiddelagentur
English: It is important that you take Bondronat at the right time and in the right way.
Danish: Det er vigtigt, at du tager Bondronat på det rigtige tidspunkt og på den rigtige måde.
English: • you are a smoker (as this may increase the risk of dental problems)
Danish: • du er ryger (dette kan øge risikoen for tandproblemer)
English: Do not let the tablet dissolve in your mouth
Danish: Lad ikke tabletten opløses i munden
English: Number of events (per patient)
Danish: Antal hændelser (per patient)
English: The expiry date refers to the last day of that month
Danish: EXP. Udløbsdatoen er den sidste dag i den nævnte måned
English: • you have cancer.
Danish: • du har kræft
English: The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Danish: Analysen af SMPR var tidsjusteret og tog højde for at en eller flere hændelser opstået i en enkelt 12 ugers periode, kunne være potentielt relateret.
English: **See further information below †Identified in post-marketing experience.
Danish: ** Se yderligere information nedenfor † Identificeret efter markedsføring.
English: SMPR (per patient year)
Danish: SMPR (per patientår)
English: • you don't receive routine dental care or have not had a dental check up for a long time
Danish: • du ikke modtager regelmæssig tandpleje eller ikke har været til kontrol i lang tid
English: • Take your tablet with a full glass of water only (about 200 mL).
Danish: • Tag din tablet med et stort glas vand (ca. 200 ml).
English: Your doctor will work out how much Bondronat you will be given depending on your illness.
Danish: Lægen vil bedømme, hvor meget Bondronat du skal have afhængigt af din sygdom.
English: • if you are allergic to any other bisphosphonates
Danish: • hvis du er allergisk over for andre bisphosphonater
English: 1077 ZX Amsterdam Netherlands
Danish: 1077 ZX Amsterdam Holland
English: Bondronat is indicated in adults for
Danish: Bondronat er indiceret til voksne til:
English: If you develop these symptoms, stop taking Bondronat and tell your doctor straight away (see sections 3 and 4).
Danish: Hvis du udvikler disse symptomer, skal du stoppe med at tage Bondronat og straks kontakte din læge (se punkt 3 og 4).
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Danish: Dette var et sammensat endepunkt, som havde følgende skeletrelaterede hændelser (SREs) inkluderet:
English: - Patients should not lie down for 60 minutes after taking Bondronat.
Danish: - Patienterne må ikke lægge sig ned før 60 minutter efter indtagelse af Bondronat.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimization) milestone being reached.
Danish: • Når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Do not take Bondronat if you are pregnant, planning to get pregnant or if you are breast-feeding.
Danish: Du må ikke få Bondronat, hvis du er gravid eller planlægger at blive gravid, eller hvis du ammer.
English: The usual dose of Bondronat is one tablet each day.
Danish: Den sædvanlige dosis Bondronat er én tablet dagligt.
English: Method of administration For intravenous administration.
Danish: Administration Til intravenøs administration.
English: No specific information is available on the treatment of overdosage with Bondronat.
Danish: Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med Bondronat.
English: Multiple events were therefore counted only once for the purposes of the analysis.
Danish: Multiple hændelser blev derfor kun talt én gang for analyseformålet.
English: Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Danish: Man skal også være opmærksom på den mulige samtidige tilstedeværelse af hypomagnesæmi.
English: If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Danish: Hvis du tager én tablet hver anden dag eller én gang om ugen, spørg da din læge eller apoteketspersonalet til råds.
English: Milk or antacids should be given to bind Bondronat.
Danish: Der bør indtages mælk eller antacida med henblik på at binde Bondronat.
English: They are available in packs of 28 and 84 tablets.
Danish: De fås i pakninger med 28 eller 84 tabletter.
English: You may be having a serious, potentially life threatening allergic reaction (see section 2)
Danish: Du kan have fået en alvorlig allergisk reaktion, som kan være livstruende (se punkt 2)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 1996
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25. juni 1996 Dato for seneste fornyelse: 25. juni 2006
English: Urinary CTx **
Danish: Urin-CTx**
English: Do not receive this medicine if any of the above apply to you.
Danish: Du må ikke få denne medicin, hvis noget af ovenstående passer på dig.
English: This helps to stop your bones from getting weaker.
Danish: Det modvirker at dine knogler bliver svagere.
English: If you wear dentures you should make sure these fit properly.
Danish: Hvis du bruger proteser bør du sørge for, at de passer ordentligt.
English: The primary endpoint of the trial was the skeletal morbidity period rate (SMPR).
Danish: Det primære endepunkt i studiet var skeletal morbidity period rate (SMPR).
English: Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.
Danish: Lægen kan vælge at justere din dosis og den tid, den intravenøse infusion tager, hvis du har nyreproblemer.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets.
Danish: Medicin og kosttilskud (herunder calcium) skal ligeledes undgås inden indtagelse af Bondronat-tabletter.
English: If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre svære overfølsomheds/allergiske reaktioner, skal injektionen øjeblikkelig afbrydes og passende behandling initieres.
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Bondronat tablets.
Danish: Produkter indeholdende calcium og andre multivalente kationer (som f.eks. aluminium, magnesium, jern), herunder mælk og føde, vil sandsynligvis påvirke absorptionen af Bondronat-tabletter.
English: - Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration.
Danish: - Patienterne må ikke tygge, sutte eller knuse tabletterne på grund af risiko for orofaryngeal ulceration.
English: • acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
Danish: • acetylsalicylsyre, non-steroide anti-inflammatoriske stoffer kaldet NSAIDer, såsom ibuprofen eller naproxen.
English: Water may be taken at any time during the course of Bondronat treatment (see section 4.5).
Danish: Vand kan indtages på ethvert tidspunkt under Bondronat-behandlingen (se pkt.
English: Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Danish: På grund af risikoen for øsofageal irritation bør opkastning ikke induceres, og patienten bør forblive i oprejst stilling.
English: Investigations Gamma-GT increased, creatinine increased
Danish: Forhøjet gamma-GT, forhøjet kreatinin
English: Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer.
Danish: Behandling med Bondronat bør kun initieres af læger med erfaring med behandling af kræft.
English: No systemic accumulation was observed when ibandronic acid was administered intravenously once every 4 weeks for 48 weeks to patients with metastatic bone disease.
Danish: Der fandtes ingen systemisk akkumulation når ibandronsyre blev indgivet intravenøst én gang hver 4. uge i 48 uger til patienter med metastaserende knoglesygdom.
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Danish: Som for andre bisphosphonater, blev nyrerne identificeret som det primære målorgan for den systemiske toksisitet.
English: • After taking your tablet, wait at least 30 minutes.
Danish: • Efter indtagelse af tabletten skal du vente mindst 30 minutter.
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Danish: Den renale clearance (ca. 60 ml/min hos raske postmenopausale kvinder) udgør 50-60 % af den totale clearance og er relateret til kreatininclearance.