FrancophonIA/ELRC3.0 huggingface dataset:
English: - bleeding after surgery or from cuts and wounds that is more than normal (common) - bleeding from your stomach lining (ulcer) (uncommon).
Danish: - sort afføring eller blod i afføringen (almindelig) - ophostning af blod, blod i opkast (ikke almindelig) - blødning fra skeden, i større mængder eller på andre tidspunkter end din normale - blødning efter en operation eller efter flænger og sår ud over det sædvanlige almindelig) - blødning fra maveslimhinden (mavesår) (ikke almindelig)
English: Switching data
Danish: Data vedr.
English: Possia 90 mg tablets ticagrelor
Danish: LÆGEMIDLETS NAVN Possia 90 mg tabletter ticagrelor
English: For further information, please refer to section 5.1.
Danish: Yderligere oplysninger: se pkt.
English: Ear haemorrhage, Vertigo
Danish: Øreblødning Vertigo
English: Each film coated tablet contains 90 mg ticagrelor.
Danish: Hver Possia filmovertrukken tablet indeholder 90 mg ticagrelor.
English: Keep this medicine out of the reach and sight of children.
Danish: Opbevar dette lægemiddel utilgængeligt for børn.
English: • Abdominal pain
Danish: Abdominalsmerter Kvalme
English: • PVC-PVDC/Al perforated unit dose transparent blister of 10 tablets; cartons of 100x1 tablets (10 blisters).
Danish: • PVC-PVDC-Al perforerede, gennemsigtige blisterkort med enkeltdoseringer a 10 tabletter i
English: Definite stent thrombosis d
Danish: Klar stenttrombose
English: Wound haemorrhage, Traumatic haemorrhage
Danish: Blødning fra sår Traumatisk blødning
English: Surgery
Danish: Apopleksi
English: Cerebral haemorrhage, Haemorrhage intracranial, Haemorrhagic stroke, Dyspnoea, Dyspnoea exertional, Dyspnoea at rest, Nocturnal dyspnoea Gastrointestinal haemorrhage, Rectal haemorrhage, Intestinal haemorrhage, Melaena, Occult blood Gastrointestinal ulcer haemorrhage, Gastric ulcer haemorrhage, Duodenal ulcer haemorrhage, Peptic ulcer
Danish: Blødende gastrointestinal ulcus, blødende ulcus ventriculi, blødende ulcus duodeni, blødende ulcus f
English: The increase in ventricular pauses in the acute phase of ACS was more pronounced in ticagrelor patients with history of CHF (9.2% versus 5.4% in patients without CHF history; for clopidogrel patients, 4.0% in those with versus 3.6% in those without CHF history) This imbalance did not occur at one month: 2.0% versus 2.1% for ticagrelor patients with and without CHF history respectively; and 3.8% versus 1.4% with clopidogrel.
Danish: Denne ubalance forekom ikke efter en måned: 2,0 % versus 2,1 % for ticagrelor patienter henholdsvis med og uden hjerteinsufficiens i anamnesen, og 3,8 % versus 1,4 % med clopidogrel.
English: Manufacturer: AstraZeneca AB Gärtunavägen SE-151 85
Danish: AstraZeneca AB Gärtunavägen
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Subkutan eller dermal blødningf Blå mærkerg
English: You may be at increased risk of bleeding.
Danish: Tag medicinpakningen med. Du kan have forøget risiko for blødning
English: The superiority of ticagrelor over clopidogrel in reducing major CV events was not significantly affected by patient CYP2C19 or ABCB1 genotype.
Danish: At ticagrelor var bedre end clopidogrel til at reducere alvorlige CV-hændelser blev ikke signifikant påvirket af patientientens
English: Musculoskeletal and connective tissue disorders
Danish: Koronar bypass-relateret blødning
English: • Moderate to severe hepatic impairment (see section 4.2, 4.4 and 5.2).
Danish: 4.2, 4.4 og 5.2).
English: Figure 1 - Time to first occurrence of CV death, MI and Stroke (PLATO)
Danish: CV-dødsfald/MI (tavst MI undtaget) eller apopleksi
English: Of these AEs 0.05% for ticagrelor vs. 0.02% for clopidogrel were considered causally related by investigators.
Danish: Disse hændelser blev af investigatorerne betragtet som kausalt relaterede hos 0,05 % af ticagrelor-patienterne vs. 0,02 af clopidogrel-patienterne .
English: Tell your doctor or pharmacist if you are taking any of the following medicines: • more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high
Danish: • mere end 40 mg daglig af enten simvastatin eller lovastatin (til behandling af for højt kolesterol)
English: Others
Danish: Øjne
English: Check with your doctor, pharmacist or dentist before taking Possia if: • You have an increased risk of bleeding because of:
Danish: Kontakt lægen, apotekspersonalet eller tandlægen, før du tager Possia:
English: Other concomitant therapy
Danish: Anden samtidig behandling
English: Patients with hepatic impairment
Danish: Pædiatriske patienter
English: Take the medicine pack with you.
Danish: Læs indlægssedlen inden brug.
English: Possia 90 mg film coated tablets
Danish: LÆGEMIDLETS NAVN Possia 90 mg filmovertrukne tabletter
English: Common
Danish: Køn
English: Hyperuricaemia, Blood uric acid increased
Danish: Hjerneblødning, intrakraniel blødning, hæmoragisk apopleksi,
English: • Feeling or being sick
Danish: • Kvalme eller opkastning
English: If you get any side effects, talk to your doctor or pharmacist, but do not stop taking Possia until you have spoken to them.
Danish: Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: Offset of Action
Danish: Invasiv plan
English: Subcutaneous haematoma, Skin haemorrhage, Haemorrhage subcutaneous, Petechiae Contusion, Haematoma, Ecchymosis, Increased tendency to bruise, Traumatic haematoma Haematuria, Blood urine present, Haemorrhage urinary tract Vessel puncture site haemorrhage, Vessel puncture site haematoma, Injection site haemorrhage, Puncture site haemorrhage, Catheter site haemorrhage
Danish: Kontusion, hæmatom, ekkymose, øget tendens til blå mærker, traumatisk hæmatom h
English: Sweden
Danish: España
English: How much to take
Danish: Hvor meget skal du tage
English: In very rare cases, a fatal outcome has been reported.
Danish: I meget sjældne tilfælde er der rapporteret om fatale udfald.
English: Risk Management Plan
Danish: Risikohåndteringsplan
English: FURTHER INFORMATION
Danish: YDERLIGERE OPLYSNINGER
English: These two medicines are used to treat type 2 diabetes.
Danish: Disse to lægemidler bruges til at behandle type 2-diabetes.
English: Do not use Avandamet after the expiry date shown on the pack.
Danish: Brug ikke Avandamet efter den udløbsdato, der står på pakningen.
English: Overweight patients should continue their energy-restricted diet.
Danish: Overvægtige patienter bør fortsætte deres energibegrænsede diæt.
English: The most common are breaks in feet, hands and arms.
Danish: Det mest almindelige er brud i fødderne, hænderne og armene.
English: The usual laboratory tests for diabetes monitoring should be performed regularly.
Danish: Sædvanlige laboratorietests til diabetesmonitorering bør udføres regelmæssigt.
English: 56 tablets.
Danish: 56 tabletter.
English: Allergic reactions: These are very rare in people taking Avandamet.
Danish: Allergiske reaktioner: Disse forekommer meget sjældent hos personer, som tager Avandamet.
English: Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Danish: Forsigtighed tilrådes hos patienter over 75 år på grund af begrænset erfaring i denne patientgruppe.
English: • swollen ankles or feet.
Danish: • hævede ankler eller fødder.
English: Similar effects have been seen with other thiazolidinediones.
Danish: Lignende effekter er blevet observeret med andre thiazolidinedioner.
English: Randomised Treatment†
Danish: Randomiseret behandling†
English: After about 8 weeks your doctor may need to increase your dose.
Danish: Efter 8 uger kan din læge vurdere, at din dosis skal øges.
English: Combination with insulin
Danish: I kombination med insulin
English: If you stop taking Avandamet, your blood sugar will not be controlled, and you may become unwell.
Danish: Hvis du holder op med at tage Avandamet, vil dit blodsukker ikke længere være under kontrol, og du kan blive utilpas.
English: It is best to take Avandamet with food, or just after food.
Danish: Det er bedst at tage Avandamet sammen med et måltid eller lige efter et måltid.
English: Post-marketing data
Danish: Post-marketingdata
English: The mean Vd ranged between 63 - 276 l.
Danish: Det gennemsnitlige fordelingsvolumen (Vd) var mellem 63 - 276 l.
English: Data with AVANDAMET is also consistent with this combined adverse reaction profile.
Danish: Data for AVANDAMET er også konsistent med denne kombinerede bivirkningsprofil.
English: Diagnosis:
Danish: Diagnose:
English: Date of first authorisation: 20 October 2003 Date of latest renewal: 20 October 2008
Danish: Dato for første markedsføringstilladelse: 20. oktober 2003 Dato for seneste fornyelse: 20. oktober 2008
English: See ‘Conditions you need to look out for' in Section 4.
Danish: Se “Bivirkninger du skal være opmærksom på” i afsnit 4.
English: The red blood cells most likely represent a secondary compartment of distribution.
Danish: De røde blodlegemer udgør sandsynligvis et sekundært fordelingsrum.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Danish: Patienten bør informeres og hyppigere monitorering af blodsukkeret udføres, specielt i begyndelsen af behandlingen.
English: These can lead to severe loss of water (dehydration).
Danish: Disse kan medføre et alvorligt væsketab (dehydrering).
English: All patients should continue their diet with regular distribution of carbohydrate intake during the day.
Danish: Alle patienter bør fortsætte deres diæt med jævn fordeling af kulhydratindtagelsen i løbet af dagen.
English: This is more likely if you are also taking other medicines for your diabetes (like insulin), if you have kidney problems, or if you are over 65.
Danish: Risikoen er større, hvis du også tager andre lægemidler til behandling af din diabetes (såsom insulin), hvis du har nyreproblemer eller hvis du er over 65 år.
English: Glycaemic control should be monitored closely.
Danish: Glykæmisk kontrol bør monitoreres tæt.
English: Monitoring of liver function
Danish: Monitorering af leverfunktionen
English: The total daily dose of AVANDAMET should be given in two divided doses.
Danish: Den totale daglige dosis af AVANDAMET skal gives som to adskilte doser.
English: If a patient wishes to become pregnant or if pregnancy occurs, treatment with AVANDAMET should be discontinued unless the expected benefit to the mother outweighs the potential risk to the foetus.
Danish: Hvis en patient ønsker at blive gravid eller bliver gravid, bør behandlingen med AVANDAMET afbrydes, hvis ikke de forventede fordele for moderen overstiger den potentielle risiko for fostret.
English: Patients should be aware of the risk of pregnancy (see section 4.6).
Danish: Patienter bør være opmærksomme på risikoen for graviditet (se afsnit 4.6).
English: It is not known whether breast-feeding will lead to exposure of the infant to the medicinal product.
Danish: Det vides ikke, om amning vil kunne medføre, at barnet eksponeres for lægemidlet.
English: The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Danish: Rosiglitazons distributionsvolumen er cirka 14 l hos raske frivillige.
English: Children and adolescents
Danish: Børn og unge:
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Danish: Nedsat nyrefunktion hos ældre patienter forekommer ofte og asymptomatisk.
English: Rosiglitazone can be increased to 8 mg/day after 8 weeks if greater glycaemic control is required.
Danish: Rosiglitazon kan øges til 8 mg/dag efter 8 uger, hvis bedre glykæmisk kontrol er påkrævet.
English: For the different dosage regimens, AVANDAMET is available in appropriate strengths.
Danish: Til de forskellige doseringsregimer er Avandamet tilgængelig i passende styrker.
English: • if you have severe breathing difficulties
Danish: • hvis du har alvorlige vejrtrækningsproblemer
English: The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Danish: Den interpersonelle variation var stor med en 7-dobling forskel i ubundet AUC mellem patienterne.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis var den genfundne ikkeabsorberede fraktion i fæces 20-30 %.
English: Like all medicines, Avandamet can cause side effects, but not everybody gets them.
Danish: BIVIRKNINGER Avandamet kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Certain medicines are especially likely to affect the amount of sugar in your blood:
Danish: Specielt forventes det, at følgende lægemidler vil påvirke dit blodsukker:
English: These small changes are not clinically significant and, therefore, it is not necessary to administer rosiglitazone at any particular time in relation to meals.
Danish: Disse små variationer er ikke klinisk signifikante, og det er derfor ikke nødvendigt at indgive rosiglitazon på et bestemt tidspunkt i relation til måltider.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with an NSAID.
Danish: Der bør udvises særlig forsigtighed i situationer, hvor nyrefunktionen kan blive forringet, for eksempel, når der indledes antihypertensiv eller diuretisk behandling, eller ved opstart af behandling med NSAID.
English: There are no adequate data from the use of rosiglitazone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af rosiglitazon hos gravide kvinder.
English: After oral administration, metformin absorption is saturable and incomplete.
Danish: Efter oral administration er metforminabsorptionen mættet og ufuldstændig.
English: Plasma protein binding is negligible.
Danish: Plasmaproteinbindingen er ubetydelig.
English: Overall, these increases were generally mild to moderate and usually did not require discontinuation of treatment.
Danish: Overordnet var disse stigninger generelt milde til moderate og som regel kunne behandlingen fortsættes.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Danish: Det antages, at farmakokinetikken for metforminabsorption er non-lineær.
English: The mean duration of diabetes in these patients was approximately 7 years.
Danish: Patienterne havde i gennemsnit haft diabetes i ca. 7 år.
English: Therefore, AVANDAMET should not be used during pregnancy.
Danish: AVANDAMET bør derfor ikke anvendes under graviditet.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Metformin øger transportkapaciteten af specifikke membranglucosetransportører (GLUT-1 og GLUT-4).
English: Symptoms of heart failure include:
Danish: Symptomerne på hjerteinsufficiens omfatter:
English: • rifampicin (used to treat tuberculosis and other infections)
Danish: • rifampicin (anvendes til at behandle tuberkulose og andre infektioner)
English: No metabolites have been identified in humans.
Danish: Der er ikke fundet metabolitter hos mennesker.
English: Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Danish: Tag tabletterne på samme tidspunkt hver dag og følg din læges råd om diæt.
English: Avandamet tablets contain a small amount of lactose.
Danish: Avandamet-tabletter indeholder en lille mængde lactose.
English: If you have been diagnosed with angina (chest pain), or peripheral arterial disease (reduced blood flow to the legs):
Danish: Hvis du har angina (brystsmerter) eller perifer arteriel sygdom (nedsat blodomløb i benene):
English: Both rosiglitazone and metformin have been detected in the milk of experimental animals.
Danish: Både rosiglitazon og metformin er påvist i mælken hos forsøgsdyr.
English: • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting)
Danish: • hvis du har haft diabetisk ketoacidose (en komplikation til diabetes, der medfører hurtigt vægttab, kvalme eller opkastning)
English: Take Avandamet for as long as your doctor recommends.
Danish: Tag Avandamet så længe som lægen anbefaler det.
English: Food decreases the extent and slightly delays the absorption of metformin.
Danish: Fødeindtagelse mindsker graden og forsinker i mindre grad absorptionen af metformin.
English: AVANDAMET is contraindicated in patients with:
Danish: AVANDAMET er kontraindiceret til patienter med:
English: Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.
Danish: Lactacidose er en meget sjælden, men alvorlig, metabolisk komplikation, der kan forekomme på grund af metforminophobning.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: Ifølge CHMP-retningslinjier for risikohåndteringssystemer i forbindelse med lægemidler til mennesker, skal en opdateret RMP indsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety Update Report, PSUR).
English: The ingredients may pass into breast milk and so may harm your baby.
Danish: Indholdsstofferne kan blive udskilt i modermælken og skade dit barn.
English: If jaundice is observed, therapy should be discontinued.
Danish: Hvis gulsot observeres, bør behandlingen afbrydes.
English: Î Check with your doctor if you think any of these apply to you.
Danish: Tal med din læge, hvis du mener nogen af disse gælder for dig.
English: While you take Avandamet your doctor needs to know:
Danish: Når du tager Avandamet, skal din læge vide:
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Danish: Tæt monitorering af glykæmisk kontrol bør overvejes (se afsnit 4.4).
English: The terminal half-life for radioactivity was about 130 h indicating that elimination of metabolites is very slow.
Danish: Den endelige halveringstid for radioaktivitet var omkring 130 timer, hvilket indikerede en meget langsom elimination af metabolitter.
English: Your kidney function will be checked
Danish: Din nyrefunktion vil blive kontrolleret
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Blod peak er lavere end plasma peak og nås på cirka samme tidspunkt.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Danish: Det stimulerer ikke insulinsekretionen og medfører derfor ikke hypoglykæmi.
English: People with type 2 diabetes either don't make enough insulin (a hormone that controls blood sugar levels), or don't respond normally to the insulin their body makes.
Danish: Personer med type 2-diabetes producerer ikke nok insulin (et hormon som regulerer blodsukkeret) eller reagerer ikke normalt på den insulin, som deres krop producerer.
English: The elevated total cholesterol levels were associated with an increase in both LDLc and HDLc, but the ratio of total cholesterol: HDLc was unchanged or improved in long term studies.
Danish: Det forhøjede totale cholesterolniveau blev forbundet med en forøgelse i både LDLc og HDLc, men forholdet af total cholesterol: HDLc var uændret eller forbedret i langtidsundersøgelser.
English: Talk to your doctor if you want to stop.
Danish: Tal med din læge, hvis du ønsker at stoppe behandlingen.
English: Opaque blisters (PVC/PVdC/aluminium).
Danish: Uigennemsigtige blisterpakninger (PVC/PVdC/aluminium).
English: The absorption of rosiglitazone is not affected by increases in gastric pH.
Danish: Absorption af rosiglitazon påvirkes ikke ved stigninger i gastrisk pH.
English: *The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is 'common'.
Danish: *Frekvenskategorien for baggrundshyppigheden af disse bivirkninger, som er taget fra placebogrupper fra kliniske undersøgelser, er ”Almindelig”.
English: Avandamet your doctor needs to know' later in Section 2)
Danish: skal din læge vide” senere i afsnit 2)
English: • chest pain (angina)
Danish: • brystsmerter (angina)
English: • getting tired easily after light physical activity such as walking
Danish: • hurtig træthed efter let fysisk aktivitet såsom gang
English: Additional data are necessary to determine whether there is an increased risk of fracture in males after a longer period of follow-up.
Danish: Yderligere data er nødvendige for at fastslå, om der er en øget risiko for fraktur hos mænd efter en længere opfølgningsperiode.
English: Î Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Danish: Fortæl det til lægen så hurtigt så muligt, hvis du får nogen af disse symptomer - både hvis symptomerne forekommer for første gang eller hvis de bliver værre.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Danish: Ved de sædvanlige metformindoser og doseringsskemaer nås steady state plasmakoncentrationer indenfor 24-48 timer, og de er sædvanligvis mindre end 1 µg/ml.
English: This includes herbal medicines and other medicines you bought without a prescription.
Danish: Dette gælder også naturmedicin og anden medicin, som ikke er købt på recept.
English: This food-effect is not considered clinically significant.
Danish: Denne føde-påvirkning er ikke vurderet som værende klinisk signifikant.
English: Limited data are available with regard to overdose of rosiglitazone in humans.
Danish: Begrænsede data er tilgængelige vedrørende overdosering af rosiglitazon hos mennesker.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage medicinen.
English: However, this raises no safety concern regarding target or special populations as hepatic impairment is contraindicated and the phase III clinical studies included a considerable number of elderly patients and patients with mild to moderate renal impairment.
Danish: Dette udgør dog ikke noget sikkerhedsproblem for patientpopulationen eller specielle populationer, eftersom nedsat leverfunktion er kontraindiceret, og de kliniske fase III studier omfattede et betragteligt antal ældre patienter og patienter med mild til moderat nedsat nyrefunktion.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske undersøgelser: metformin reducerer total-kolesterol, LDLc og triglyceridniveauer.
English: 7 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Danish: 7Langtidsbehandling med metformin har været sat i sammenhæng med fald i vitamin B12 absorption, hvilket muligvis meget sjældent resulterer i klinisk signifikant vitamin B12 mangel (f.eks. Megaloblastisk anæmi).
English: In the event of an overdose, it is recommended that appropriate supportive treatment is initiated as dictated by the patient's clinical status.
Danish: I tilfælde af overdosis anbefales det, at der gives støttende behandling afhængig af patientens kliniske status.
English: These may be signs of liver problems:
Danish: Følgende symptomer kan være tegn på leverproblemer:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: † Patients who took designated treatment as randomised in combination with the correct background treatment and with evaluable data.
Danish: † Patienter, der blev allokeret til behandling i kombination med den allerede givne behandling og med målbare data.
English: The incidence of all adverse events relating to liver and biliary systems was <1.5% in any treatment group and similar to placebo.
Danish: Forekomsten af alle bivirkningerne relateret til lever- og galdevejene var < 1,5 % i alle behandlingsgrupper og svarende til placebo.