natgillin/translations-raw huggingface dataset:
Anbefalinger for patienter med nedsat nyrefunktion opdateret i produktinformationen 
Recommendations for patients with kidney impairment updated in product information
Klare doseringsanbefalinger og overvågning før og under behandling skal sikre, at en eventuel øget risiko hos disse patienter minimeres. 
Clear dosing recommendations and monitoring before and during treatment aim to minimise any possible increased risk in these patients.
Efter at have gennemgået den videnskabelige litteratur, kliniske data, epidemiologiske undersøgelser og kliniske retningslinjer fra lægelige instanser er EMA imidlertid nået frem til, at den store patientpopulation med moderat nedsat nyrefunktion kan have gavn af metformin. 
However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Virksomheder, der markedsfører metforminholdige lægemidler, vil blive bedt om nøje at overvåge og analysere fremtidige tilfælde af laktatacidose og indberette disse ved kommende periodiske sikkerhedsindberetninger med henblik på at følge op på eventuelle ændringer i hyppigheden af denne bivirkning. 
Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Produktinformationen for metforminholdige lægemidler vil blive opdateret, så den afspejler de nye anbefalinger, og så det sikres, at alle patienter i EU får den samme vejledning. 
The product information for metformincontaining medicines will be updated to reflect the new recommendations and to ensure that the same advice is given to all patients in the EU.
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. 
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.
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. 
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.
Metformin er et lægemiddel, der bruges alene eller i kombination med andre lægemidler til behandling af type 2-diabetes. 
Metformin is a medicine used on its own or in combination with other medicines for the treatment of type 2 diabetes.
Information til sundhedspersoner 
Information for healthcare professionals
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. 
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.
Metformindosen bør tilpasses patientens nyrefunktion. 
The dose of metformin should be adapted depending on the patient's kidney function.
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). 
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).
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. 
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.
• 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. 
• 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.
Litteraturhenvisninger 
References
• 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. 
• 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.
Brugen hos patienter med en GFR < 30 ml/min er stadig kontraindiceret. 
Use in patients with GFR<30 ml/min is still contraindicated.
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. 
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.
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. 
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.
Roussel, R. et al., "Metformin use and mortality among patients with diabetes and atherothrombosis", Arch Intern Med, 2010, Vol. 170, s. 1892. 
Roussel, R. et al., ‘Metformin use and mortality among patients with diabetes and atherothrombosis', Arch Intern Med, 2010, Vol. 170, p. 1892.
• Reducering af dosis bør overvejes hos patienter med moderat nedsat nyrefunktion i henhold til doseringsanbefalingerne i den opdaterede produktinformation. 
• Reduced doses should be considered for patients with moderate reduction of kidney function according to dosage recommendations provided in the updated product information.
• 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. 
• 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.
• Metformin bruges alene eller sammen med andre lægemidler i tillæg til kost og motion til behandling af type 2-diabetes. 
• Metformin is used on its own or with other medicines, together with diet and exercise, for the treatment of type 2 diabetes.
• Indtil nu har metforminholdige lægemidler ikke været anbefalet til patienter med moderat til svært nedsat nyrefunktion. 
• Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
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. 
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.
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. 
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.
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. 
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.
Metformin anvendes i tillæg til kost og motion for at forbedre reguleringen af blodsukkeret. 
Metformin is used together with diet and exercise to improve control of blood glucose (sugar) levels.
et al., "Metformin in patients with type 2 diabetes and kidney disease: a systematic review", JAMA, 2014, Vol. 312, s. 2668. 
et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
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. 
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.
• Gennemgangen af metforminholdige lægemidler har vist, at de nu kan anvendes hos patienter med moderat nedsat nyrefunktion (GFR = 30-59 ml/min). 
• 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).
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. 
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.
Kontraindikationen for patienter med svært nedsat nyrefunktion fastholdes (GFR mindre end 30 ml/min). 
The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Disse lægemidler bør ikke bruges hos patienter med svært nedsat nyrefunktion (GFR mindre end 30 ml/min). 
These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Denne anbefaling er nu blevet ændret, så de godt må anvendes hos patienter med moderat nedsat nyrefunktion (GFR = 30-59 ml/min). 
This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
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. 
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.
Yderligere information om lægemidlet 
More about the medicine
Poliovirus (inaktiveret)3 Type 1 (Mahoney) 
Poliovirus (Inactivated)3 Type 1 (Mahoney)
3 Produceret på Vero-celler 
3 Produced on Vero cells
1 Adsorberet på aluminiumhydroxid, hydreret (0,6 mg Al3+) 2 Som nedre konfidensgrænse (p= 0,95) 
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
4 Eller ækvivalent antigen-mængde efter en passende immunokemisk metode 5 Fremstillet i Hansenula polymorpha gærceller ved hjælp af rekombinant DNA-teknologi 
4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Haemophilus influenzae type b polysaccharid 
Haemophilus influenzae type b polysaccharide
Hepatitis B overfladeantigen5 
Hepatitis B surface antigen5
Bordetella pertussis antigener Pertussis toxoid 
Bordetella pertussis antigens Pertussis Toxoid
--1 En dosis1 (0,5 ml) indeholder: Difteri toxoid 
--1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
(Polyribosylribitolphosphat) konjugeret til tetanus protein 
(Polyribosylribitol Phosphate) conjugated to Tetanus protein
Paknings-størrelse 
Immediate Packaging
Filamentøs hæmagglutinin 
Filamentous Haemagglutinin
Fyldt sprøjt 
1 pre-filled syringe
• nye neoplasmer 
• New neoplasm
Bilag IV Vilkår for markedsføringstilladelserne 
Conditions of the marketing authorisations
• intrakranielt aneurisme og intrakraniel blødning 
• Intracranial aneurysm and intracranial haemorrhage
Inden for to måneder efter Kommissionens afgørelse træffer indehaveren af markedsføringstilladelsen aftale med de nationale kompetente myndigheder om en tidsramme for indsendelse af risikohåndteringsplaner. 
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.
De nationale kompetente myndigheder sikrer, med referencemedlemsstaten som koordinerende instans, hvor dette er relevant, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser: 
National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
For alle lægemidler indeholdende somatropin skal indehaverne af markedsføringstilladelserne indsende/opdatere risikohåndteringsplaner, der afspejler følgende potentielle risici: 
The MAHs should submit/update the Risk Management Plans for all somatropin medicinal products to reflect the following potential risks:
• sekundære neoplasmer hos overlevende pædiatriske kræftpatienter 
• Second neoplasm in childhood cancer survivors
Der er en sol (for morgen) og en måne (for aften). 
(for the morning) and a moon (for the evening).
Dato for første tilladelse: 3.december, 2010 
Date of first authorisation: 3 December 2010
Erfaring med brug ud over 12 måneder er begrænset. 
Experience beyond 12 months is limited.
Omkring 30 % af episoderne svandt inden for 7 dage. 
About 30% of episodes resolved within 7 days.
Du har fået Possia fordi du har haft: 
You have been given Possia because you have had:
Mekanismen er endnu ikke forklaret. 
The mechanism has not been elucidated.
I absolutte termer var denne risiko større end hos den samlede PLATO-population. 
In absolute terms, this risk was higher than in the overall PLATO population.
d nominel signifikansværdi; alle andre er formelt statistisk signifikante ifølge prædefinerede hierarkiske tests. 
nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
Behandling af overdosering skal følge lokal medicinsk standardpraksis. 
Treatment of overdose should follow local standard medical practice.
En negativ RRR indikerer en stigning i relativ risiko. 
A negative RRR indicates a relative risk increase.
Mange forskellige typer af blødning kan blive forøget, f.eks.: 
Bleeding of many different kinds can be increased, for example:
• Du kan kontrollere, hvornår du sidst tog en tablet Possia, ved at kigge på blisterkortet. 
• You can check when you last took a tablet of Possia by looking on the blister.
De følgende bivirkninger kan forekomme ved denne medicin: 
The following side effects may happen with this medicine:
Din læge vil drøfte fordelene og risiciene ved at tage Possia i denne periode. 
Your doctor will discuss with you the benefits and risks of taking Possia during this time.
Possia må kun bruges til voksne. 
Possia is to be used in adults only.
Possia kan genoptages, når årsagen til blødningen er blevet identificeret og kontrolleret. 
Possia may be resumed after the cause of bleeding has been identified and controlled.
Desuden skal der fremsendes en opdateret RMP 
In addition, an updated RMP should be submitted:
Svære blødninger er dog ikke almindelige, men kan være livstruende. 
However, severe bleeding is uncommon, but can be life threatening.
• Hvis du har glemt at tage en dosis, skal du bare tage næste dosis som normalt. 
• If you forget to take a dose, just take your next dose as normal.
Patienter, der tager Possia, skal også tage ASA dagligt, medmindre det udtrykkeligt er kontraindiceret. 
Patients taking Possia should also take ASA daily, unless specifically contraindicated.
• BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Børn Possia anbefales ikke til børn og teenagere under 18 år. 
Possia is not recommended for children and adolescents under 18 years.
MI i alt inkluderer tavst MI, -dato for hændelsen er sat til dato for opdagelse. 
Total MI includes silent MI, with date of event set to date when discovered.
Dette beregnes som 3/9235, hvilket svarer til hyppighedskategorien ‘sjælden'. 
This is calculated as 3/9235 which equates to a frequency category of ‘rare'
Der er ingen eller utilstrækkelige data fra anvendelse af ticagrelor til gravide kvinder. 
There are no or limited amount of data from the use of ticagrelor in pregnant women.
Skift fra prasugrel til Possia er ikke undersøgt. 
Switching from prasugrel to Possia has not been investigated.
Der var ingen forskel i det samlede antal fatale blødninger. 
There was no difference in overall fatal bleeds.
• når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter 
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Minor Bleed: Kræver medicinsk intervention for at stoppe eller behandle blødningen. 
Minor Bleed: Requires medical intervention to stop or treat bleeding.
Den primære variabel af interesse var forekomsten af ventrikulære pauser på ≥3 sekunder. 
The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Der skal i tilfælde af blødning tages relevante støttende forholdsregler. 
If bleeding occurs appropriate supportive measures should be taken.
SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES 
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Disse små ændringer betragtes kun som havende minimal klinisk signifikans, og ticagrelor kan derfor gives med eller uden mad. 
These small changes are considered of minimal clinical significance; therefore, ticagrelor can be given with or without food.
Possia kan have en lignende indvirkning på lovastatin. 
Possia may have similar effect on lovastatin.
Holter-substudie 
Holter Substudy
Flere beslægtede bivirkningstermer er slået sammen i tabellen og omfatter de medicinske termer beskrevet nedenfor: 
Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below:
• Du må ikke tage en dobbeltdosis (to doser på samme tidspunkt) som erstatning for den glemte dosis. 
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
Din læge vil i reglen anbefale, at du også tager acetylsalicylsyre. 
Your doctor will usually also tell you to take acetylsalicylic acid.
Der blev derfor ikke identificeret en særlig risikogruppe for en undergruppe af blødninger. 
Thus no particular group was identified at risk for any subset of bleeding.
Administration Til oral anvendelse. 
For oral use.
• Blødning - lidt blødning er almindeligt. 
• Bleeding - some bleeding is common.
Fremstillere: 
Manufacturer:
ARR = absolut risikoreduktion; RRR = relativ risikoreduktion = (1-risikoraten) x 100 %. 
ARR = absolute risk reduction; RRR = relative risk reduction = (1-Hazard ratio) x 100%.
Søg straks læge, hvis du bemærker noget af det følgende - du kan have brug for akut lægebehandling: 
See a doctor straight away if you notice any of the following - you may need urgent medical
• Du kan tage tabletten med eller uden mad. 
• You can take the tablet with or without food.
Det er et stof, som indgår i mange lægemidler til at forebygge blodpropper. 
This is a substance present in many medicines used to prevent blood clotting.
Patienter med risiko for bradykardi-hændelser 
Patients at risk for bradycardic events
Den gennemsnitlige absolutte biotilgængelighed af ticagrelor blev estimeret til at være 36 %. 
The mean absolute bioavailability of ticagrelor was estimated to be 36%.
Sikkerhed og virkning af Possia hos børn under 18 år med den godkendte voksenindikation er ikke klarlagt. 
The safety and efficacy of Possia in children below the age of 18 in the approved adult indication has not been established.
Specielle populationer 
Special populations
Den systemiske eksponering for den aktive metabolit er ca. 30-40 % af den, der opnås for ticagrelor. 
The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Possia kan administreres med eller uden mad. 
Possia can be administered with or without food.
Figur 1 viser den estimerede risiko for den første forekomst af en hændelse ved det sammensatte effekt-endepunkt. 
Figure 1 shows the estimate of the risk to the first occurrence of any event in the composite efficacy
Tag Possia regelmæssigt, så længe din læge fortsat ordinerer det. 
Take Possia on a regular basis and for as long as your doctor keeps prescribing it.
• 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). 
• 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).
Dette skyldes den øgede risiko for blødning. 
This is because of the increased risk of bleeding.
Clopidogrel (%/år) N=9186 
Clopidogrel (%/year) N=9186
Andre mulige bivirkninger 
Other possible side effects
Det kan skyldes din hjertesygdom eller en anden årsag, eller det kan være en bivirkning til Possia. 
It might be due to your heart disease or another cause, or it might be a side effect of Possia.
RRRa (95 % CI) 
(95% CI)
• hvis du på noget som helst tidspunkt skal opereres (herunder tandoperationer), mens du tager Possia. 
• You are due to have surgery (including dental work) at any time while taking Possia.
Bivirkningerne er klassificeret i henhold til deres hyppighed samt systemorganklasse. 
Adverse reactions are classified according to frequency and System Organ Class.