FrancophonIA/ELRC3.0 huggingface dataset:
English: Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when naturally produced lactic acid builds up in the blood faster than it can be removed.
Danish: Metformin kan øge risikoen for en sjælden, men alvorlig, komplikation, der hedder laktatacidose, og som optræder, når naturligt forekommende mælkesyre ophobes i blodet hurtigere, end det kan fjernes.
English: For example, dapagliflozin/metformin (Ebymect, Xigduo) is not recommended in patients with GFR<60 ml/min; canagliflozin/metformin (Vokanamet) and empagliflozin/metformin (Synjardy) are not recommended in patients with GFR<45 ml/min and should not be started in patients with GFR<60 ml/min.
Danish: For eksempel er dapagliflozin/metformin (Ebymect, Xigduo) ikke anbefalet hos patienter med GFR < 60 ml/min; canagliflozin/metformin /Vokanamet) og empagliflozin/metformin (Synjardy) er ikke anbefalet hos patienter med GFR < 45 ml/min og bør ikke anvendes hos patienter med GFR < 60 ml/min.
English: Metformin is a medicine used on its own or in combination with other medicines for the treatment of type 2 diabetes.
Danish: Metformin er et lægemiddel, der bruges alene eller i kombination med andre lægemidler til behandling af type 2-diabetes.
English: Information for healthcare professionals
Danish: Information til sundhedspersoner
English: Currently, the product information states that metformin must not be used in patients with reduced kidney function because these patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove metformin efficiently enough.
Danish: I den aktuelle produktinformation står der, at metformin ikke må anvendes hos patienter med nedsat nyrefunktion, da disse patienter anses for at have en højere risiko for at udvikle laktatacidose, idet deres nyrer ikke fjerner metformin tilstrækkeligt effektivt.
English: The dose of metformin should be adapted depending on the patient's kidney function.
Danish: Metformindosen bør tilpasses patientens nyrefunktion.
English: The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Danish: Følgende lægemidler, der indeholder en kombination af metformin og andre aktive stoffer i samme tablet, er godkendt centralt af EMA: pioglitazon/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) og empagliflozin/metformin (Synjardy).
English: If these products are used in patients with reduced kidney function, restrictions and efficacy regarding the other active substance in the combination, the feasibility of dose adjustment and the alternative of using individual tablets should be considered.
Danish: Hvis disse produkter anvendes hos patienter med nedsat nyrefunktion, bør man overveje restriktionerne for og virkningen af det andet aktive stof i kombinationen, muligheden for dosisjustering og alternativet med brug af enkeltstoftabletter.
English: • Some fixed-dose combination products are still not recommended in patients with moderately reduced kidney function because the other active substance in the combination should not be used in these patients.
Danish: • Nogle fastdosis-kombinationsprodukter er stadig ikke anbefalede hos patienter med nedsat nyrefunktion, fordi det andet aktive stof i kombinationen ikke bør anvendes hos disse patienter.
English: References
Danish: Litteraturhenvisninger
English: • Patients with reduced kidney function may be at higher risk of lactic acidosis, a rare but serious side effect of metformin medicines caused by build-up of lactic acid in the blood.
Danish: • Patienter med nedsat nyrefunktion kan have en højere risiko for laktatacidose, der er en sjælden, men alvorlig bivirkning ved metforminholdige lægemidler, som skyldes ophobning af mælkesyre i blodet.
English: Use in patients with GFR<30 ml/min is still contraindicated.
Danish: Brugen hos patienter med en GFR < 30 ml/min er stadig kontraindiceret.
English: The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
Danish: Produktinformationen for disse lægemidler vil blive opdateret for så vidt angår den aktuelle kontraindikation, og der vil blive givet oplysninger om doser, overvågning og forsigtighedsregler hos patienter med nedsat nyrefunktion.
English: The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Danish: Anbefalingerne er et resultat af EMA's gennemgang af metforminholdige lægemidler som følge af bekymringer over, at den aktuelle videnskabelige evidens ikke berettiger en kontraindikation hos patienter med moderat nedsat nyrefunktion.
English: Roussel, R. et al., ‘Metformin use and mortality among patients with diabetes and atherothrombosis', Arch Intern Med, 2010, Vol. 170, p. 1892.
Danish: Roussel, R. et al., "Metformin use and mortality among patients with diabetes and atherothrombosis", Arch Intern Med, 2010, Vol. 170, s. 1892.
English: • Reduced doses should be considered for patients with moderate reduction of kidney function according to dosage recommendations provided in the updated product information.
Danish: • Reducering af dosis bør overvejes hos patienter med moderat nedsat nyrefunktion i henhold til doseringsanbefalingerne i den opdaterede produktinformation.
English: • These latest recommendations will result in harmonisation of product information about the use of metformin in patients with reduced kidney function and the precautions for lactic acidosis across the EU.
Danish: • Disse seneste anbefalinger vil medføre en harmonisering af produktinformationen for brug af metformin hos patienter med nedsat nyrefunktion og forsigtighedsregler vedrørende laktatacidose i hele EU.
English: • Metformin is used on its own or with other medicines, together with diet and exercise, for the treatment of type 2 diabetes.
Danish: • Metformin bruges alene eller sammen med andre lægemidler i tillæg til kost og motion til behandling af type 2-diabetes.
English: • Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
Danish: • Indtil nu har metforminholdige lægemidler ikke været anbefalet til patienter med moderat til svært nedsat nyrefunktion.
English: On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 30-59 ml/min) for the treatment of type 2 diabetes.
Danish: Den 13. oktober 2016 konkluderede Det Europæiske Lægemiddelagentur (EMA), at metforminholdige lægemidler nu kan anvendes hos patienter med moderat nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) = 30-59 ml/min) til behandling af type 2-diabetes.
English: However, for patients with only moderately reduced kidney function any risk can be minimised by careful checking of dose and monitoring, allowing these patients to get the benefits these medicines can provide.
Danish: For de patienter, der blot har en moderat nedsat nyrefunktion, kan en eventuel risiko dog minimeres ved nøje at tilpasse dosis og overvåge for eventuelle bivirkninger, således at disse patienter også kan få gavn af disse lægemidler.
English: Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol. 61, p. 1253.
Danish: Solini, A. et al., "Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study", J Am Geriatr Soc, 2013, Vol. 61, s. 1253.
English: Metformin is used together with diet and exercise to improve control of blood glucose (sugar) levels.
Danish: Metformin anvendes i tillæg til kost og motion for at forbedre reguleringen af blodsukkeret.
English: et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
Danish: et al., "Metformin in patients with type 2 diabetes and kidney disease: a systematic review", JAMA, 2014, Vol. 312, s. 2668.
English: Ekström, N. et al., ‘Effectiveness and safety of metformin in 51675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register', BMJ Open, 2012, 2:e001076.
Danish: Gennemgangen omfattede data fra en lang række undersøgelser, herunder: Ekström, N. et al., "Effectiveness and safety of metformin in 51675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register", BMJ Open, 2012, 2:e001076.
English: • The review of metformin-containing medicines concluded that they can now be used in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Danish: • Gennemgangen af metforminholdige lægemidler har vist, at de nu kan anvendes hos patienter med moderat nedsat nyrefunktion (GFR = 30-59 ml/min).
English: et al., ‘Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study', Diabetes Care, 2014, Vol. 37 (8), p. 2218.
Danish: et al., "Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study", Diabetes Care, 2014, Vol. 37 (8), s. 2218.
English: The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Danish: Kontraindikationen for patienter med svært nedsat nyrefunktion fastholdes (GFR mindre end 30 ml/min).
English: These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Danish: Disse lægemidler bør ikke bruges hos patienter med svært nedsat nyrefunktion (GFR mindre end 30 ml/min).
English: This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Danish: Denne anbefaling er nu blevet ændret, så de godt må anvendes hos patienter med moderat nedsat nyrefunktion (GFR = 30-59 ml/min).
English: et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
Danish: et al., "Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study", Diabetes Care, 2014, Vol. 37 (8), s. 2291.
English: More about the medicine
Danish: Yderligere information om lægemidlet
English: Content (concentration)
Danish: Indhold (Koncentration)
English: Poliovirus (Inactivated)3 Type 1 (Mahoney)
Danish: Poliovirus (inaktiveret)3 Type 1 (Mahoney)
English: 3 Produced on Vero cells
Danish: 3 Produceret på Vero-celler
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Danish: 1 Adsorberet på aluminiumhydroxid, hydreret (0,6 mg Al3+) 2 Som nedre konfidensgrænse (p= 0,95)
English: 4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Danish: 4 Eller ækvivalent antigen-mængde efter en passende immunokemisk metode 5 Fremstillet i Hansenula polymorpha gærceller ved hjælp af rekombinant DNA-teknologi
English: Haemophilus influenzae type b polysaccharide
Danish: Haemophilus influenzae type b polysaccharid
English: Hepatitis B surface antigen5
Danish: Hepatitis B overfladeantigen5
English: Bordetella pertussis antigens Pertussis Toxoid
Danish: Bordetella pertussis antigener Pertussis toxoid
English: --1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
Danish: --1 En dosis1 (0,5 ml) indeholder: Difteri toxoid
English: (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Danish: (Polyribosylribitolphosphat) konjugeret til tetanus protein
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage
English: Immediate Packaging
Danish: Paknings-størrelse
English: Filamentous Haemagglutinin
Danish: Filamentøs hæmagglutinin
English: 1 pre-filled syringe
Danish: Fyldt sprøjt
English: • New neoplasm
Danish: • nye neoplasmer
English: Conditions of the marketing authorisations
Danish: Bilag IV Vilkår for markedsføringstilladelserne
English: • Intracranial aneurysm and intracranial haemorrhage
Danish: • intrakranielt aneurisme og intrakraniel blødning
English: The MAHs within 2 months of the Commission Decision should liaise with the National Competent Authorities to agree on the timelines for submission of the Risk Management Plans.
Danish: Inden for to måneder efter Kommissionens afgørelse træffer indehaveren af markedsføringstilladelsen aftale med de nationale kompetente myndigheder om en tidsramme for indsendelse af risikohåndteringsplaner.
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
Danish: De nationale kompetente myndigheder sikrer, med referencemedlemsstaten som koordinerende instans, hvor dette er relevant, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: The MAHs should submit/update the Risk Management Plans for all somatropin medicinal products to reflect the following potential risks:
Danish: For alle lægemidler indeholdende somatropin skal indehaverne af markedsføringstilladelserne indsende/opdatere risikohåndteringsplaner, der afspejler følgende potentielle risici:
English: • Second neoplasm in childhood cancer survivors
Danish: • sekundære neoplasmer hos overlevende pædiatriske kræftpatienter
English: (for the morning) and a moon (for the evening).
Danish: Der er en sol (for morgen) og en måne (for aften).
English: Date of first authorisation: 3 December 2010
Danish: Dato for første tilladelse: 3.december, 2010
English: Experience beyond 12 months is limited.
Danish: Erfaring med brug ud over 12 måneder er begrænset.
English: About 30% of episodes resolved within 7 days.
Danish: Omkring 30 % af episoderne svandt inden for 7 dage.
English: You have been given Possia because you have had:
Danish: Du har fået Possia fordi du har haft:
English: The mechanism has not been elucidated.
Danish: Mekanismen er endnu ikke forklaret.
English: In absolute terms, this risk was higher than in the overall PLATO population.
Danish: I absolutte termer var denne risiko større end hos den samlede PLATO-population.
English: nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
Danish: d nominel signifikansværdi; alle andre er formelt statistisk signifikante ifølge prædefinerede hierarkiske tests.
English: Treatment of overdose should follow local standard medical practice.
Danish: Behandling af overdosering skal følge lokal medicinsk standardpraksis.
English: A negative RRR indicates a relative risk increase.
Danish: En negativ RRR indikerer en stigning i relativ risiko.
English: Bleeding of many different kinds can be increased, for example:
Danish: Mange forskellige typer af blødning kan blive forøget, f.eks.:
English: • You can check when you last took a tablet of Possia by looking on the blister.
Danish: • Du kan kontrollere, hvornår du sidst tog en tablet Possia, ved at kigge på blisterkortet.
English: The following side effects may happen with this medicine:
Danish: De følgende bivirkninger kan forekomme ved denne medicin:
English: Your doctor will discuss with you the benefits and risks of taking Possia during this time.
Danish: Din læge vil drøfte fordelene og risiciene ved at tage Possia i denne periode.
English: Possia is to be used in adults only.
Danish: Possia må kun bruges til voksne.
English: Possia may be resumed after the cause of bleeding has been identified and controlled.
Danish: Possia kan genoptages, når årsagen til blødningen er blevet identificeret og kontrolleret.
English: In addition, an updated RMP should be submitted:
Danish: Desuden skal der fremsendes en opdateret RMP
English: However, severe bleeding is uncommon, but can be life threatening.
Danish: Svære blødninger er dog ikke almindelige, men kan være livstruende.
English: • If you forget to take a dose, just take your next dose as normal.
Danish: • Hvis du har glemt at tage en dosis, skal du bare tage næste dosis som normalt.
English: Patients taking Possia should also take ASA daily, unless specifically contraindicated.
Danish: Patienter, der tager Possia, skal også tage ASA dagligt, medmindre det udtrykkeligt er kontraindiceret.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Possia is not recommended for children and adolescents under 18 years.
Danish: Børn Possia anbefales ikke til børn og teenagere under 18 år.
English: Total MI includes silent MI, with date of event set to date when discovered.
Danish: MI i alt inkluderer tavst MI, -dato for hændelsen er sat til dato for opdagelse.
English: This is calculated as 3/9235 which equates to a frequency category of ‘rare'
Danish: Dette beregnes som 3/9235, hvilket svarer til hyppighedskategorien ‘sjælden'.
English: There are no or limited amount of data from the use of ticagrelor in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ticagrelor til gravide kvinder.
English: Switching from prasugrel to Possia has not been investigated.
Danish: Skift fra prasugrel til Possia er ikke undersøgt.
English: There was no difference in overall fatal bleeds.
Danish: Der var ingen forskel i det samlede antal fatale blødninger.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: Minor Bleed: Requires medical intervention to stop or treat bleeding.
Danish: Minor Bleed: Kræver medicinsk intervention for at stoppe eller behandle blødningen.
English: The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Danish: Den primære variabel af interesse var forekomsten af ventrikulære pauser på ≥3 sekunder.
English: If bleeding occurs appropriate supportive measures should be taken.
Danish: Der skal i tilfælde af blødning tages relevante støttende forholdsregler.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES
English: These small changes are considered of minimal clinical significance; therefore, ticagrelor can be given with or without food.
Danish: Disse små ændringer betragtes kun som havende minimal klinisk signifikans, og ticagrelor kan derfor gives med eller uden mad.
English: Possia may have similar effect on lovastatin.
Danish: Possia kan have en lignende indvirkning på lovastatin.
English: Holter Substudy
Danish: Holter-substudie
English: Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below:
Danish: Flere beslægtede bivirkningstermer er slået sammen i tabellen og omfatter de medicinske termer beskrevet nedenfor:
English: • Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis (to doser på samme tidspunkt) som erstatning for den glemte dosis.
English: Your doctor will usually also tell you to take acetylsalicylic acid.
Danish: Din læge vil i reglen anbefale, at du også tager acetylsalicylsyre.
English: Thus no particular group was identified at risk for any subset of bleeding.
Danish: Der blev derfor ikke identificeret en særlig risikogruppe for en undergruppe af blødninger.
English: For oral use.
Danish: Administration Til oral anvendelse.
English: • Bleeding - some bleeding is common.
Danish: • Blødning - lidt blødning er almindeligt.
English: Manufacturer:
Danish: Fremstillere:
English: ARR = absolute risk reduction; RRR = relative risk reduction = (1-Hazard ratio) x 100%.
Danish: ARR = absolut risikoreduktion; RRR = relativ risikoreduktion = (1-risikoraten) x 100 %.
English: See a doctor straight away if you notice any of the following - you may need urgent medical
Danish: Søg straks læge, hvis du bemærker noget af det følgende - du kan have brug for akut lægebehandling:
English: • You can take the tablet with or without food.
Danish: • Du kan tage tabletten med eller uden mad.
English: This is a substance present in many medicines used to prevent blood clotting.
Danish: Det er et stof, som indgår i mange lægemidler til at forebygge blodpropper.
English: Patients at risk for bradycardic events
Danish: Patienter med risiko for bradykardi-hændelser
English: The mean absolute bioavailability of ticagrelor was estimated to be 36%.
Danish: Den gennemsnitlige absolutte biotilgængelighed af ticagrelor blev estimeret til at være 36 %.
English: The safety and efficacy of Possia in children below the age of 18 in the approved adult indication has not been established.
Danish: Sikkerhed og virkning af Possia hos børn under 18 år med den godkendte voksenindikation er ikke klarlagt.
English: Special populations
Danish: Specielle populationer
English: The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Danish: Den systemiske eksponering for den aktive metabolit er ca. 30-40 % af den, der opnås for ticagrelor.
English: Possia can be administered with or without food.
Danish: Possia kan administreres med eller uden mad.
English: Figure 1 shows the estimate of the risk to the first occurrence of any event in the composite efficacy
Danish: Figur 1 viser den estimerede risiko for den første forekomst af en hændelse ved det sammensatte effekt-endepunkt.
English: Take Possia on a regular basis and for as long as your doctor keeps prescribing it.
Danish: Tag Possia regelmæssigt, så længe din læge fortsat ordinerer det.
English: • Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not already have in place a device that paces your heart (pacemaker).
Danish: • hvis din puls er unormalt langsom (sædvanligvis under 60 slag i minuttet), og du ikke allerede har fået indopereret et apparat, der sikrer regelmæssig hjerterytme (pacemaker).
English: This is because of the increased risk of bleeding.
Danish: Dette skyldes den øgede risiko for blødning.
English: Clopidogrel (%/year) N=9186
Danish: Clopidogrel (%/år) N=9186
English: Other possible side effects
Danish: Andre mulige bivirkninger
English: It might be due to your heart disease or another cause, or it might be a side effect of Possia.
Danish: Det kan skyldes din hjertesygdom eller en anden årsag, eller det kan være en bivirkning til Possia.
English: (95% CI)
Danish: RRRa (95 % CI)
English: • You are due to have surgery (including dental work) at any time while taking Possia.
Danish: • hvis du på noget som helst tidspunkt skal opereres (herunder tandoperationer), mens du tager Possia.