FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen, som aftalt i version 4 af Risikohåndteringsplanen (RMP) anført i modul 1.8.2. i markedsføringstilladelsen, og i efterfølgende opdateringer af RMP, godkendt af CHMP.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘Pregnancy and
Danish: Hvis dette er tilfældet for dig, skal du bruge prævention for at undgå graviditet (se ”Graviditet og amning” senere i afsnit 2).
English: The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Danish: Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller med type 2-diabetes.
English: Concomitant administration should be considered before the patient is switched to AVAGLIM.
Danish: Samtidig administration bør overvejes før der skiftes til AVAGLIM.
English: In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during
Danish: Hos patienter med lavt baselineniveau for hæmoglobin før påbegyndelse af terapi, er der en øget risiko for
English: All patients, particularly those receiving concurrent insulin therapy, those at risk for heart failure and those with reduced cardiac reserve, should be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure.
Danish: Alle patienter, specielt patienter i samtidig behandling med insulin, patienter med risiko for hjerteinsufficiens og patienter med reducerede kardiale reserver, bør overvåges for tegn og symptomer på bivirkninger, der er relateret til væskeretention, herunder vægtøgning og hjerteinsufficiens.
English: The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Danish: Forekomsten af hjerteinsufficiens, når rosiglitazon gives i kombination med insulin (rosiglitazon gives for at understøtte insulinbehandling) er 2,4 % sammenlignet med 1,1 % for behandling med insulin alene.
English: which can be severe (agranulocytosis), reduction in the number of all types of blood cells
Danish: (granulocytopeni), som kan være alvorlig (agranulocytose), fald i antallet af alle typer
English: In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well
Danish: I kliniske undersøgelser blandt frivillige er rosiglitazon blevet givet som enkeltdoser op til 20 mg og var godt tålt.
English: Liver problems: Before you start taking Avaglim you will have a blood sample taken to check your liver function.
Danish: Leverproblemer: Inden og i løbet af behandlingen med Avaglim, vil din læge tage blodprøver for at tjekke din leverfunktion.
English: If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Danish: Hvis ALAT niveauet stiger til > 3 gange den øvre normalgrænse under behandling med rosiglitazon, bør leverenzymerne kontrolleres igen så hurtigt som muligt.
English: In addition, glimepiride seems to have pronounced extrapancreatic effects, also postulated for other sulphonylureas.
Danish: Glimepirid synes tillige at have en udtalt ekstrapankreatisk effekt, hvilket også hævdes for andre sulfonylurinstoffer.
English: − severe renal impairment i.e. creatinine clearance less than 30 ml/min (including renal dialysis).
Danish: - svært nedsat nyrefunktion, dvs. kreatininklearance < 30 ml/min (herunder nyredialyse)
English: Don't take extra tablets to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of
Danish: H2-antagonister, beta-blokkere, klonidin og reserpin kan enten forstærke eller svække den
English: If risk factors for hypoglycaemia are present (including renal insufficiency, low body weight, malnourishment, co-administration with certain other medicinal products (see section 4.5) or if the patient's life-style changes) it may be necessary to revert to concomitant therapy and down titrate the glimepiride dose.
Danish: Hvis risikofaktorer for hypoglykæmi er til stede (herunder nedsat nyrefunktion, lav kropsvægt, fejlernæring, samtidig administration med visse lægemidler (se afsnit 4.5) eller livsstilsændringer), kan det være nødvendigt at gå over til samtidig behandling med enkeltstofferne og en reduktion af glimepirid dosis kan være nødvendig.
English: Reproduction toxicology findings may be related to the pharmacodynamic action of glimepiride.
Danish: Reproduktionstoksiske fund er muligvis relateret til glimepirids farmakodynamiske virkning.
English: CYP2C9 has been shown to be involved in the biotransformation of glimepiride to M1. M1 is further metabolised to M2 by one or several cytosolic enzymes.
Danish: CYP2C9 har vist sig at være involveret i metabolismen af glimepirid til M1. M1 metaboliseres yderligere til M2 af et cytosolisk enzym.
English: After intravenous dosing in normal subjects, the volume of distribution was 8.8 l (113 ml/kg), and the total body clearance was 47.8 ml/min.
Danish: Efter intravenøs dosering hos normale personer er fordelingsvolumen ca. 8,8 liter (113 ml/kg) og den totale clearance er 48 ml/min.
English: The other ingredients are: sodium starch glycollate (Type A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400,
Danish: De øvrige indholdsstoffer er natriumstivelsesglycollat (type A), hypromellose (E464), mikrokrystallinsk cellulose (E460), lactosemonohydrat, magnesiumstearat, titandioxid (E171), macrogol 400, sort og/eller rød jernoxid (E172).
English: An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been
Danish: Et morbiditets/mortalitetsstudie er endnu ikke blevet tilendebragt med rosiglitazon, hvorfor langtidsfordelene associeret med forbedret glykæmisk kontrol ikke er blevet påvist.
English: No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with
Danish: Der er ikke observeret klinisk relevante interaktioner med digoxin, CYP2C9-substratet warfarin, CYP3A4-substraterne nifedipine, ethinylestradiol eller norethisteron ved samtidig administration af
English: † Patients who took designated treatment as randomised in combination with the correct background
Danish: † Patienter, der blev allokeret til behandling i kombination med den allerede givne behandling og med
English: In diabetic patients, good metabolic control over 24 hours can be
Danish: En enkelt dosis giver hos diabetikere en god metabolisk kontrol i 24 timer.
English: A total of 564 patients withdrew from cardiovascular follow-up, which accounted for 12.3% of rosiglitazone patients and 13% of control patients; representing 7.2% of patient-years lost for cardiovascular events follow-up and 2.0% of patient-years lost for all cause mortality follow-up.
Danish: I alt 564 patienter trak sig ud af den kardiovaskulære opfølgning, dvs. 12,3 % af patienterne på rosiglitazon og 13 % of patienterne i kontrolgruppen; det betyder, at 7,2 % patientår er blevet mistet mht. kardiovaskulær opfølgning og 2,0 % patientår mht. opfølgning af død uanset årsag.
English: Avaglim tablets come in different strengths.
Danish: Avaglim findes i forskellige styrker.
English: Always take Avaglim tablets exactly as your doctor has told you.
Danish: Tag altid Avaglim-tabletter nøjagtigt efter lægens anvisning.
English: It is unclear whether or not there is a direct association between rosiglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
Danish: Det er usikkert, om der er en direkte sammenhæng mellem behandling med rosiglitazon og maculaødem, men den behandlende læge bør være advaret om muligheden for maculaødem, hvis patienterne klager over synsforstyrrelser, og det bør overvejes, at henvise til en øjenlæge.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
Danish: Du kan finde yderligere information om Avaglim på Det europæiske Lægemiddelagenturs (EMEAs)
English: AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Danish: AVAGLIM er indiceret til behandling af type 2-diabetes mellitus patienter, som ikke kan opnå tilstrækkelig glykæmisk kontrol ved optimal dosis af sulfonylurinstof som monoterapi, og hvor metformin er uegnet på grund af kontraindikation eller intolerance.
English: Based on the experience with glimepiride and with other sulphonylureas the following interactions
Danish: På baggrund af erfaringer med glimepirid og andre sulfonylurinstoffer skal følgende interaktioner nævnes.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT
English: Glimepiride increases the activity of glycosyl-phosphatidylinositol-specific phospholipase C, which may be associated with drug-induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Danish: Glimepirid øger aktiviteten af glycosylphosphatidylinositolspecifikt phospholipase C, som kan være korreleret med den lægemiddelinducerede lipogenese og glycogenese i isolerede fedt- og muskelceller.
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
Danish: Rosiglitazon er en selektiv agonist ved PPARγ (peroxisomal proliferator aktiveret gamma) nuklearreceptor og hører hjemme i antidiabetikumgruppen thiazolidinedioner.
English: For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).
Danish: For patienter som ikke er tilstrækkeligt kontrollerede på glimeprid monoterapi (som regel 4 mg).
English: Patients unable to achieve glycaemic control on at least half-maximum dose of other sulphonylurea monotherapy (except chlorpropamide, see section 4.4).
Danish: For patienter som ikke kan opnå glykæmisk kontrol på mindst halvdelen af maksimal dosis af anden sulfonylurinstof monoterapi (undtagen chlorpropamid, se afsnit 4.4).
English: • if you are allergic (hypersensitive) to rosiglitazone, glimepiride, or any of the other ingredients of Avaglim (listed in Section 6), or to other medicines called sulphonylureas
Danish: • hvis du er overfølsom (allergisk) over for rosiglitazon, glimepirid eller et af de øvrige indholdsstoffer i Avaglim (se afsnit 6) eller over for sulfonylurinstoffer (såsom glibenclamid)
English: Very common side effects These may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger Disse kan påvirke mere end 1 ud af 10 patienter:
English: The decision whether to continue the patient on therapy with AVAGLIM should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om at lade patienten fortsætte behandling med AVAGLIM bør tages på baggrund af en klinisk vurdering baseret på løbende laboratorieundersøgelser.
English: Single oral doses of glimepiride in 14 healthy adult subjects had no clinically significant effect on the steady-state pharmacokinetics of rosiglitazone.
Danish: Enkelte perorale doser af glimepirid i 14 raske voksne personer havde ingen klinisk signifikant effekt på steady-state farmakokinetikken for rosiglitazon.
English: Immune system disorders (see Skin and subcutaneous tissue disorders)
Danish: Immunsystemet (se Sygdomme i hud og subkutane væv)
English: Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford,
Danish: Indehaveren af markedsføringstilladelsen: SmithKline Beecham Ltd, 980 Great West Road,
English: Therapy with AVAGLIM should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5X upper limit of normal) or with any other evidence of liver disease.
Danish: Behandling med AVAGLIM bør ikke indledes hos patienter med forhøjet baselineniveau af leverenzymer (ALAT > 2.5 gange den øvre normal) eller noget som helst andet tegn på leversygdom.
English: If hypoglycaemic symptoms occur, the patient should revert to concomitant therapy and adjust the glimepiride dose as appropriate.
Danish: Opstår der symptomer på hypoglykæmi bør patienten vende tilbage til samtidig behandling af enkeltstofferne og justere glimepirid dosis om nøvendigt.
English: Before therapy is initiated with AVAGLIM appropriate clinical evaluation should be made to assess the patient's risk of developing
Danish: Før behandling startes med AVAGLIM skal en klinisk evaluering af patientens risiko for at udvikle hypoglykæmi foretages
English: The major metabolite (a para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mice.
Danish: Den hyppigst forekommende metabolit (parahydroxy-sulfat) med høj affinitet til det opløselige humane PPARγ udviste relativ høj potens i en glucosetolerance-assay hos overvægtige mus.
English: Rosiglitazone 4 mg should be administered concomitantly with the dose of sulphonylurea already being taken.
Danish: Rosiglitazon bør administreres samtidigt med den dosis sulfonylurinstof, der allerede tages.
English: Frequencies are defined as: rare ≥1/10,000, <1/1000 and very rare <1/10,000 including isolated reports.
Danish: Frekvensen er defineret som: Sjælden (≥ 1/10.000, < 1/1.000) og meget sjælden (< 1/10.000) herunder isolerede rapporter.
English: As with other sulphonylureas, this effect is based on an improvement in responsiveness of pancreatic beta cells to the physiological glucose stimulus.
Danish: I lighed med andre sulfonylurinstoffer skyldes denne virkning en øget følsomhed for den fysiologiske glukosestimulation i pankreas β-celler.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates
Danish: En in vivo interaktionsundersøgelse med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9
English: Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
Danish: Patienter som får AVAGLIM har risiko for dosisrelateret hypoglykæmi (se afsnit 4.8).
English: This includes herbal medicines and other medicines you bought without a
Danish: Dette gælder også naturmedicin og anden medicin, som ikke er
English: There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT >2.5X upper limit of normal).
Danish: Der er begrænset erfaring med rosiglitazon hos patienter med forhøjede leverenzymer (ALAT > 2.5 gange den øvre grænse for normal).
English: AVAGLIM tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
Danish: AVAGLIM tabletter indeholder lactose og bør derfor ikke gives til patienter med sjælden arvelig galactose intolerans, Lapps laktatmangel eller glucose-galactose malabsorption.
English: AVAGLIM is contraindicated in patients with severe renal impairment (creatinine clearance less than
Danish: AVAGLIM er kontraindiceret hos patienter med svært nedsat nyrefunktion (kreatininclearance
English: The following data are findings in studies performed with rosiglitazone or glimepiride individually.
Danish: De følgende data er baseret på baggrund af undersøgelser med rosiglitazon og glimepirid individuelt.
English: Concomitant administration of rosiglitazone with the oral anti-diabetic agents metformin, glimepiride, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
Danish: Samtidig administration af de orale antidiabetiske præparater metformin, glimepirid, glibenclamid og acarbose resulterede ikke på nogen måde i klinisk relevante farmakokinetiske interaktioner med
English: Administration of the 4 mg/4 mg combination with food led to an increase in glimepiride exposure compared to that observed on administration in the fasted state.
Danish: Administration af 4 mg/4 mg kombinationen med samtidig fødeindtagelse førte til en stigning i eksponeringen med glimepirid sammenlignet med fastende administration.
English: Results from an vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.
Danish: Resultater fra in vivo interaktionsforsøg rapporteret i litteraturen viser, at glimepirid AUC forstørres til det dobbelte af fluconazol, en af de mest potente CYP2C9-hæmmere.
English: After oral administration, glimepiride is completely (100%) absorbed from the gastrointestinal tract.
Danish: Efter peroral administration absorberes glimepirid fuldstændig (100 %) fra mavetarmkanalen.
English: For AVAGLIM no preclinical or clinical data on exposed pregnancies or lactation are available.
Danish: Der foreligger ikke prækliniske eller kliniske data om eksponering for AVAGLIM under graviditet
English: Moreover in patients with congestive heart failure NYHA class I-II, a placebocontrolled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Danish: En placebokontrolleret, etårig undersøgelse af patienter, der lider af hjerteinsufficiens NYHAklasse I-II, har vist en forværring eller mulig forværring af hjerteinsufficiens hos 6,4 % af patienterne i behandling med rosiglitazon, sammenlignet med 3,5 % for placebo.
English: There are no data from the use of glimepiride in patients on renal dialysis (see section 4.3).
Danish: Der er ingen data fra behandling med glimepirid hos patienter i dialyse (se afsnit 4.3).
English: Overdose of sulphonylureas, including glimepiride, can result in severe life-threatening hypoglycaemia lasting 12 to 72 hours, which may recur after apparent recovery.
Danish: Efter indtagelse af en overdosis af sulfonylurinstoffer, herunder glimepirid, kan der optræde hypoglykæmi, som kan vare 12-72 timer, og som kan vende tilbage efter den indledende normalisering af blodglukose.
English: • reduction in the number of red blood cells, or a type of white blood cell (granulocytopaenia)
Danish: • fald i antallet af røde blodlegemer eller fald i antallet af en speciel type hvide blodlegemer
English: For rosiglitazone, Cmax values were decreased by approximately 32% with food.
Danish: Cmax for rosiglitazon blev formindsket med 32 % ved samtidig fødeindtagelse.
English: Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Danish: Under hver organklasse er bivirkningerne stillet op efter faldende frekvens for det monoterapeutiske rosiglitazon-behandlingsregime.
English: Rosiglitazone and glimepiride work together so your body makes better use of the insulin it produces, and this helps reduce your blood
Danish: Rosiglitazon og glimepirid virker i fællesskab således, at din krop bedre kan udnytte den insulin, den producerer.
English: Î Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or
Danish: Fortæl det til lægen så hurtigt som muligt, hvis du får nogen af disse symptomer - både hvis symptomerne forekommer for første gang eller hvis de bliver værre.
English: Closure of the potassium channels leads to depolarisation of the beta cell and results by opening of the calcium channels - to an increased influx of calcium into the cell.
Danish: Lukning af kaliumkanalen inducerer depolarisation af β-cellen og resulterer i en åbning af calciumkanalerne og en øget calcium-influx i cellen.
English: 11 Hypersensitivity reactions of the skin may occur as itching, rash and urticaria.
Danish: 11Der kan optræde overfølsomhedsreaktioner på huden, såsom kløe, udslæt og urticaria.
English: No adequate pharmacokinetic studies of glimepiride have been conducted in subjects with functional hepatic impairment.
Danish: Ingen tilstrækkelige farmakokinetiske undersøgelser af glimepirid er udført hos patienter med nedsat leverfunktion.
English: An increase in the rosiglitazone component to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
Danish: En øgning af rosiglitazon til 8 mg/dag bør foretages med forsigtighed og i forbindelse med passende kliniske evaluering for at vurdere patientens risiko for at udvikle bivirkninger, der er relateret til væskeretention (se afsnit 4.4 og 4.8).
English: The clinical trial program in support of this fixed dose combination only compared rosiglitazone and glimepiride to glimepiride monotherapy and not to monotherapy with other sulphonylureas.
Danish: Den kliniske undersøgelse, der understøtter denne fastdosis kombination, sammenlignede kun rosiglitazon og glimepirid med glimepirid monoterapi og ikke monoterapi med andre sulfonylurinstoffer.
English: Some medicines used to treat high blood pressure (such as beta-blockers, clonidine, guanethidine or reserpine) may make you less aware of the warning signs of low blood sugar (sweating; fast irregular
Danish: Nogle lægemidler til behandling af forhøjet blodtryk (såsom beta-blokkere, clonidin, guanethidin eller reserpin) kan sløre advarselssignaler på for lavt blodsukker (svedtendens og hurtig uregelmæssig hjertebanken).
English: The adjudicated primary endpoint was cardiovascular hospitalisation (which included hospitalisations for heart failure) or cardiovascular death.
Danish: Det vigtigste primære endepunkt var kardiovaskulær indlæggelse (herunder hjerteinsufficiens) og kardiovaskulær død.
English: In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/sulphonylureas).
Danish: I dobbeltblinde kliniske undersøgelser med rosiglitazon var forekomsten af stigninger i ALAT på mere end tre gange den øvre normale grænse af samme størrelse som ved placebo (0,2 %) og mindre end ved behandling med de lægemidler, som rosiglitazon blev sammenlignet med (0,5 % metformin/sulfonylurinstof).
English: • inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
Danish: • leverbetændelse (hepatitis), gulfarvning af huden (gulsot)
English: Extrapancreatic effects include an improvement in insulin sensitivity of peripheral tissue and a reduction in hepatic uptake of insulin.
Danish: Den ekstrapankreatiske virkning er f.eks. en øget insulinfølsomhed i de perifere væv og et fald i leverens
English: Pharmacotherapeutic group: Combinations of oral blood glucose lowering drugs, ATC code: A10BD04
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationspræparater, ATC-kode: A10BD04
English: Hepatic impairment: Following rosiglitazone treatment in cirrhotic patients with moderate (ChildPugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Danish: Nedsat leverfunktion: Hos cirrhotiske patienter med moderat (Child-Pugh B) nedsat leverfunktion, var ubundet Cmax og AUC 2-3 gange højere end hos normale personer.