natgillin/translations-raw huggingface dataset:
Desuden hæmmede rosiglitazon den østradiole syntese og progesteronsyntesen i ovarierne og sænkede plasmaniveauet af disse hormoner, hvilket indvirkede på brunst/menstruationscyklus og fertilitet (se afsnit 4.4). 
In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/menstrual cycles and fertility (see section 4.4).
Akkumulering af metabolitterne i plasma kan forventes efter gentagen dosering, specielt hvad angår den hyppigste metabolit (para-hydroxy-sulfat), hvor en 8-dobling kan forventes. 
Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (a para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
I tilfælde af overdosis anbefales det, at der gives støttende behandling, alt afhængig af patientens kliniske status. 
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Forbedret glykæmisk kontrol var også associeret med et signifikant fald i frie fedtsyrer. 
Improved glycaemic control was also associated with significant decreases in free fatty acids.
• allergiske reaktioner, betændelse af blodkar (allergisk vaskulit) 
• allergic reactions, inflammation of blood vessels (allergic vasculitis)
Avaglim-tabletter er en kombination af to forskellige lægemidler kaldet rosiglitazon og glimepirid. 
Avaglim tablets are a combination of two different medicines called rosiglitazone and glimepiride.
Risikoen er større hos især kvinder, der har taget rosiglitazon i mere end et år. 
The chances of this happening may be higher in people, particularly women, taking rosiglitazone for more than one year.
Glimepirid kan enten forstærke eller svække virkningen af kumarinderivater. 
Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Administration af rosiglitazon sammen med fødevarer resulterede ikke i nogen ændring i den generelle optagelse (AUC), selvom der sås et svagt fald i Cmax (cirka 20 % til 28 %) og en forsinkelse i tmax (ca. 1,75 time) sammenlignet med administration i fastende tilstand. 
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasted state.
8Baseret på viden om andre sulfonylurinstoffer, kan hyoglykæmi være længerevarende. 
8 Based on what is known of other sulphonylureas, hypoglycaemia may be prolonged.
Hvor det vurderes klinisk passende, kan et direkte skift fra glimepirid monoterapi til AVAGLIM overvejes. 
Where clinically appropriate, direct change from glimepiride monotherapy to AVAGLIM may be considered.
De aktive stoffer er rosiglitazon og glimepirid. 
The active substances are rosiglitazone and glimepiride.
• lille stigning af kolesterol i blodet, øget fedtindhold i blodet. 
• small increases in blood cholesterol, increased amount of fats in the blood
Avaglim kan, ligesom andre lægemidler til behandling af diabetes, forværre eksisterende tilstande eller forårsage alvorlige bivirkninger. 
Avaglim and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Fremstiller: Glaxo Wellcome S.A., Avenida de Extremadura, 3, 09400 Aranda de Duero, Burgos, 
Manufacturer: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos,
AVAGLIM bør ikke anvendes til personer under 18 år, da der ikke er tilgængelige data om sikkerhed 
AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Desuden fandtes rosiglitazon ikke gentoxisk i en række in vivo og in vitro genotoxicitetsundersøgelser, og der var ikke nogen evidens på colontumorer i livstidsundersøgelser af rosiglitazon hos to gnaverarter. 
In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
Indtagelse af alkohol kan forstærke eller svække glimepirids hypoglykæmiske virkning på uforudsigelig 
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable
Behandling af patienter som har G6PD-mangel med sulfonylurinstoffer kan medføre hæmolytisk anæmi. 
Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia.
En mere udtalt glucosesænkende effekt blev observeret hos overvægtige patienter. 
A more pronounced glucose-lowering effect was observed in obese patients.
Behandling med AVAGLIM bør være individuelt tilpasset den enkelte patient. 
AVAGLIM therapy should be individualised for each patient.
Den kliniske relevans af denne observation er endnu 
The clinical relevance of this observation has not been fully elucidated.
Glimepirid metaboliseres af cytochrome P450 2C9 (CYP2C9). 
Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9).
Det tilrådes, at patienter i behandling med rosiglitazon og chlorpropamid ikke skiftes til AVAGLIM, da chlorpropamid har en lang halveringstid, hvilket øger risikoen for hypoglykæmi. 
It is advised that patients established on rosiglitazone and chlorpropamide concomitant therapy should not switch to AVAGLIM as chlorpropamide has a long half-life which may increase the risk of hypoglycaemia.
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. 
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
Hvis dette er tilfældet for dig, skal du bruge prævention for at undgå graviditet (se ”Graviditet og amning” senere i afsnit 2). 
If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘Pregnancy and
Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller med type 2-diabetes. 
The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Samtidig administration bør overvejes før der skiftes til AVAGLIM. 
Concomitant administration should be considered before the patient is switched to AVAGLIM.
Hos patienter med lavt baselineniveau for hæmoglobin før påbegyndelse af terapi, er der en øget risiko for 
In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during
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. 
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.
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. 
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
(granulocytopeni), som kan være alvorlig (agranulocytose), fald i antallet af alle typer 
which can be severe (agranulocytosis), reduction in the number of all types of blood cells
I kliniske undersøgelser blandt frivillige er rosiglitazon blevet givet som enkeltdoser op til 20 mg og var godt tålt. 
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well
Leverproblemer: Inden og i løbet af behandlingen med Avaglim, vil din læge tage blodprøver for at tjekke din leverfunktion. 
Liver problems: Before you start taking Avaglim you will have a blood sample taken to check your liver function.
Hvis ALAT niveauet stiger til > 3 gange den øvre normalgrænse under behandling med rosiglitazon, bør leverenzymerne kontrolleres igen så hurtigt som muligt. 
If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Glimepirid synes tillige at have en udtalt ekstrapankreatisk effekt, hvilket også hævdes for andre sulfonylurinstoffer. 
In addition, glimepiride seems to have pronounced extrapancreatic effects, also postulated for other sulphonylureas.
- svært nedsat nyrefunktion, dvs. kreatininklearance < 30 ml/min (herunder nyredialyse) 
− severe renal impairment i.e. creatinine clearance less than 30 ml/min (including renal dialysis).
Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet. 
Don't take extra tablets to make up for a missed dose.
H2-antagonister, beta-blokkere, klonidin og reserpin kan enten forstærke eller svække den 
H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of
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. 
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.
Reproduktionstoksiske fund er muligvis relateret til glimepirids farmakodynamiske virkning. 
Reproduction toxicology findings may be related to the pharmacodynamic action of glimepiride.
CYP2C9 har vist sig at være involveret i metabolismen af glimepirid til M1. M1 metaboliseres yderligere til M2 af et cytosolisk enzym. 
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.
Efter intravenøs dosering hos normale personer er fordelingsvolumen ca. 8,8 liter (113 ml/kg) og den totale clearance er 48 ml/min. 
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.
De øvrige indholdsstoffer er natriumstivelsesglycollat (type A), hypromellose (E464), mikrokrystallinsk cellulose (E460), lactosemonohydrat, magnesiumstearat, titandioxid (E171), macrogol 400, sort og/eller rød jernoxid (E172). 
The other ingredients are: sodium starch glycollate (Type A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400,
Et morbiditets/mortalitetsstudie er endnu ikke blevet tilendebragt med rosiglitazon, hvorfor langtidsfordelene associeret med forbedret glykæmisk kontrol ikke er blevet påvist. 
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been
Der er ikke observeret klinisk relevante interaktioner med digoxin, CYP2C9-substratet warfarin, CYP3A4-substraterne nifedipine, ethinylestradiol eller norethisteron ved samtidig administration af 
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with
† Patienter, der blev allokeret til behandling i kombination med den allerede givne behandling og med 
† Patients who took designated treatment as randomised in combination with the correct background
En enkelt dosis giver hos diabetikere en god metabolisk kontrol i 24 timer. 
In diabetic patients, good metabolic control over 24 hours can be
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. 
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.
Avaglim findes i forskellige styrker. 
Avaglim tablets come in different strengths.
Tag altid Avaglim-tabletter nøjagtigt efter lægens anvisning. 
Always take Avaglim tablets exactly as your doctor has told you.
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. 
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.
Du kan finde yderligere information om Avaglim på Det europæiske Lægemiddelagenturs (EMEAs) 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
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. 
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.
På baggrund af erfaringer med glimepirid og andre sulfonylurinstoffer skal følgende interaktioner nævnes. 
Based on the experience with glimepiride and with other sulphonylureas the following interactions
MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Glimepirid øger aktiviteten af glycosylphosphatidylinositolspecifikt phospholipase C, som kan være korreleret med den lægemiddelinducerede lipogenese og glycogenese i isolerede fedt- og muskelceller. 
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.
Rosiglitazon er en selektiv agonist ved PPARγ (peroxisomal proliferator aktiveret gamma) nuklearreceptor og hører hjemme i antidiabetikumgruppen thiazolidinedioner. 
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.
For patienter som ikke er tilstrækkeligt kontrollerede på glimeprid monoterapi (som regel 4 mg). 
For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).
For patienter som ikke kan opnå glykæmisk kontrol på mindst halvdelen af maksimal dosis af anden sulfonylurinstof monoterapi (undtagen chlorpropamid, se afsnit 4.4). 
Patients unable to achieve glycaemic control on at least half-maximum dose of other sulphonylurea monotherapy (except chlorpropamide, see section 4.4).
• 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) 
• 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
Meget almindelige bivirkninger Disse kan påvirke mere end 1 ud af 10 patienter: 
Very common side effects These may affect more than 1 in 10 people:
Beslutningen om at lade patienten fortsætte behandling med AVAGLIM bør tages på baggrund af en klinisk vurdering baseret på løbende laboratorieundersøgelser. 
The decision whether to continue the patient on therapy with AVAGLIM should be guided by clinical judgement pending laboratory evaluations.
Enkelte perorale doser af glimepirid i 14 raske voksne personer havde ingen klinisk signifikant effekt på steady-state farmakokinetikken for rosiglitazon. 
Single oral doses of glimepiride in 14 healthy adult subjects had no clinically significant effect on the steady-state pharmacokinetics of rosiglitazone.
Immunsystemet (se Sygdomme i hud og subkutane væv) 
Immune system disorders (see Skin and subcutaneous tissue disorders)
Indehaveren af markedsføringstilladelsen: SmithKline Beecham Ltd, 980 Great West Road, 
Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford,
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. 
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.
Opstår der symptomer på hypoglykæmi bør patienten vende tilbage til samtidig behandling af enkeltstofferne og justere glimepirid dosis om nøvendigt. 
If hypoglycaemic symptoms occur, the patient should revert to concomitant therapy and adjust the glimepiride dose as appropriate.
Før behandling startes med AVAGLIM skal en klinisk evaluering af patientens risiko for at udvikle hypoglykæmi foretages 
Before therapy is initiated with AVAGLIM appropriate clinical evaluation should be made to assess the patient's risk of developing
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. 
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.
Rosiglitazon bør administreres samtidigt med den dosis sulfonylurinstof, der allerede tages. 
Rosiglitazone 4 mg should be administered concomitantly with the dose of sulphonylurea already being taken.
Frekvensen er defineret som: Sjælden (≥ 1/10.000, < 1/1.000) og meget sjælden (< 1/10.000) herunder isolerede rapporter. 
Frequencies are defined as: rare ≥1/10,000, <1/1000 and very rare <1/10,000 including isolated reports.
I lighed med andre sulfonylurinstoffer skyldes denne virkning en øget følsomhed for den fysiologiske glukosestimulation i pankreas β-celler. 
As with other sulphonylureas, this effect is based on an improvement in responsiveness of pancreatic beta cells to the physiological glucose stimulus.
En in vivo interaktionsundersøgelse med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9 
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates
Patienter som får AVAGLIM har risiko for dosisrelateret hypoglykæmi (se afsnit 4.8). 
Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
Dette gælder også naturmedicin og anden medicin, som ikke er 
This includes herbal medicines and other medicines you bought without a
Der er begrænset erfaring med rosiglitazon hos patienter med forhøjede leverenzymer (ALAT > 2.5 gange den øvre grænse for normal). 
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT >2.5X upper limit of normal).
AVAGLIM tabletter indeholder lactose og bør derfor ikke gives til patienter med sjælden arvelig galactose intolerans, Lapps laktatmangel eller glucose-galactose malabsorption. 
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
AVAGLIM er kontraindiceret hos patienter med svært nedsat nyrefunktion (kreatininclearance 
AVAGLIM is contraindicated in patients with severe renal impairment (creatinine clearance less than
De følgende data er baseret på baggrund af undersøgelser med rosiglitazon og glimepirid individuelt. 
The following data are findings in studies performed with rosiglitazone or glimepiride individually.
Samtidig administration af de orale antidiabetiske præparater metformin, glimepirid, glibenclamid og acarbose resulterede ikke på nogen måde i klinisk relevante farmakokinetiske interaktioner med 
Concomitant administration of rosiglitazone with the oral anti-diabetic agents metformin, glimepiride, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
Administration af 4 mg/4 mg kombinationen med samtidig fødeindtagelse førte til en stigning i eksponeringen med glimepirid sammenlignet med fastende administration. 
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.
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. 
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.
Efter peroral administration absorberes glimepirid fuldstændig (100 %) fra mavetarmkanalen. 
After oral administration, glimepiride is completely (100%) absorbed from the gastrointestinal tract.
Der foreligger ikke prækliniske eller kliniske data om eksponering for AVAGLIM under graviditet 
For AVAGLIM no preclinical or clinical data on exposed pregnancies or lactation are available.
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. 
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.
Der er ingen data fra behandling med glimepirid hos patienter i dialyse (se afsnit 4.3). 
There are no data from the use of glimepiride in patients on renal dialysis (see section 4.3).
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. 
Overdose of sulphonylureas, including glimepiride, can result in severe life-threatening hypoglycaemia lasting 12 to 72 hours, which may recur after apparent recovery.
• fald i antallet af røde blodlegemer eller fald i antallet af en speciel type hvide blodlegemer 
• reduction in the number of red blood cells, or a type of white blood cell (granulocytopaenia)
Cmax for rosiglitazon blev formindsket med 32 % ved samtidig fødeindtagelse. 
For rosiglitazone, Cmax values were decreased by approximately 32% with food.
Under hver organklasse er bivirkningerne stillet op efter faldende frekvens for det monoterapeutiske rosiglitazon-behandlingsregime. 
Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.