natgillin/translations-raw huggingface dataset:
Hypoglykæmi Patienter som får AVAGLIM har risiko for dosisrelateret hypoglykæmi (se afsnit 4. 8).
Hypoglycaemia Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
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.
A switch to insulin should be considered in stress situations (e. g. trauma, surgery, infections).
3 Væskeretention og hjertesvigt Thiazolidinedioner kan forårsage væskeretention, som kan forværre eller fremskynde tegn og symptomer på kongestiv hjertesvigt.
3 Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Alle patienter, specielt patienter i samtidig behandling med insulin, patienter med risiko for hjertesvigt og patienter med reducerede kardiale reserver, bør overvåges for tegn og symptomer på bivirkninger, der er relateret til væskeretention, herunder vægtøgning og hjertesvigt.
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.
I kombination med insulin En forhøjet hyppighed af hjerteinsufficiens er blevet observeret i kliniske forsøg, hvor rosiglitazon er anvendt i kombination med insulin.
Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
Myokardieiskæmi Tilgængelig litteratur tyder på, at behandling med rosiglitazon kan sættes i forbindelse med øget risiko for myokardieiskæmi (se afsnit 4. 8).
Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Der er begrænsede oplysninger fra kliniske forsøg hos patienter med iskæmisk hjertesygdom og/ eller perifer karsygdom.
There are limited clinical trial data in patients with ischaemic heart disease and/ or peripheral arterial disease.
Akut koronarsyndrom (AKS) Der har ikke været inkluderet patienter med AKS i kontrollerede kliniske forsøg med rosiglitazon.
Acute Coronary Syndrome (ACS) Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
I betragtning af risikoen for udvikling af hjerteinsufficiens bør behandling med rosiglitazon ikke initieres hos patienter med akut hjertetilfælde, og det bør seponeres i den akutte fase (se afsnit 4. 3).
In view of the potential for development of heart failure in these patients, rosiglitazone should therefore not be initiated in patients having an acute coronary event and it should be discontinued during the acute phase (see section 4.3).
Monitorering af leverfunktionen Efter markedsføring af rosiglitazon har der været sjældne rapporter med hepatocellulær dysfunktion (se afsnit 4. 8).
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
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).
Herefter kontrolleres leverenzymerne af og til, baseret på klinisk vurdering.
Therefore, liver enzymes should be checked prior to the initiation of therapy with AVAGLIM in all patients and periodically thereafter based on clinical judgement.
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.
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.
Hvis ALAT niveauet forbliver > 3 gange den øvre normalgrænse, bør behandlingen afbrydes.
If ALT levels remain > 3X the upper limit of normal, therapy should be discontinued.
Hvis en patient udvikler symptomer, som tyder på hepatisk dysfunktion, herunder uforklarlig kvalme, opkastninger, abdominal smerte, træthed, anoreksi og/ eller mørk urin, bør leverenzymerne kontrolleres.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Øjenlidelser Post- marketing- rapporter har beskrevet nye tilfælde samt forværring af diabetisk maculaødem med synsforstyrrelser hos patienter i behandling med thiazolider, herunder rosiglitazon.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
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.
4 oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
4 Patienter med nedsat nyrefunktion Patienter med mild eller moderat nedsat nyrefunktion (kreatininclearance 30 til 80 ml/ min) kan have forøget risiko for hypoglykæmi (se afsnit 4. 2, 4. 3, 4. 4).
Patients with renal impairment Patients with mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min) may be at an increased risk of hypoglycaemia (see sections 4.2, 4.3 and 4.4).
Præmenopausale anovulatoriske kvinder Der er blevet givet rosiglitazon til præmenopausale kvinder i kliniske undersøgelser.
Premenopausal anovulatory women Premenopausal women have received rosiglitazone during clinical studies.
Skønt en hormonal ubalance er set i prækliniske undersøgelser (se afsnit 5. 3), så er der ikke observeret signifikante uønskede effekter i forbindelse med menstruelle forstyrrelser.
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Patienter bør være opmærksomme på risikoen for graviditet (se afsnit 4. 6).
Patients should be aware of the risk of pregnancy (see section 4.6).
Vægtøgning I kliniske undersøgelser med rosiglitazon har der været tegn på dosisrelateret vægtforøgelse, som var større ved kombinationsbehandling med insulin.
Weight gain In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Hæmotologisk monitorering Behandling med rosiglitazon er forbundet med en dosisrelateret reduktion i hæmoglobinniveauet.
Haematological monitoring Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
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.
Der bør derfor udvises forsigtighed, når patienter med G6PD- mangel behandles med glimepirid, og behandling med et stof fra en anden gruppe bør overvejes.
Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Knoglelidelser I et langtidsstudie blev der observeret en øget forekomst af frakturer (fødder, hænder og arme) hos kvindelige patienter, der blev behandlet med rosiglitazon som monoterapi (se afsnit 4. 8).
Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Den øgede forekomst blev observeret efter 1. års behandling og gennem resten af studiet.
This increased incidence was noted after the first year of treatment and remained during the course of the study.
Dette gælder især kvindelige patienter.
The risk of fracture should be considered in the care of patients, especially female patients, treated with rosiglitazone.
Rosiglitazon bør anvendes med forsigtighed under samtidig administration af CYP2C8 inhibitorer (f. eks. gemfibrozil) eller inducerende stoffer (f. eks. rifampicin).
Administration with other medicinal products Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e. g. gemfibrozil) or inducers (e. g. rifampicin).
Glimepirid bør anvendes med forsigtighed under samtidig administration af CYP2C9 inhibitorer (f. eks. fluconazol) eller inducerende stoffer (se afsnit 4. 5).
Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e. g. fluconazole) or inducers (see section 4.5).
Lactose- intolerans AVAGLIM tabletter indeholder lactose og bør derfor ikke gives til patienter med sjælden arvelig galactose intolerans, Lapps laktatmangel eller glucose- galactose malabsorption.
Lactose intolerance 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 malabsorption.
5 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Rosiglitazon In vitro studier har vist, at rosiglitazon primært metaboliseres af CYP2C8 og af CYP2C9 i mindre omfang.
5 Rosiglitazone In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Klinisk signifikante interaktioner med CYP2C9- substrater eller inhibitorer kan ikke forventes.
Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Samtidig administration af rosiglitazon og gemfibrozil (en hæmmer af CYP2C8) resulterede i en dobbelt stigning i rosiglitazon- plasmakoncentrationer.
Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Da der er risiko for en stigning i dosis - relaterede bivirkninger, kan det være nødvendigt at reducere dosis af rosiglitazon.
Since there is a potential for an increase in the risk of dose-related adverse reactions, a decrease in rosiglitazone dose may be needed.
Tæt monitorering af glykæmisk kontrol bør overvejes (se afsnit 4. 4).
Close monitoring of glycaemic control should be considered (see section 4.4).
Samtidig administration af rosiglitazon og rifampicin (en inducer af CYP2C8) resulterede i et fald på 66% i rosiglitazon plasmakoncentrationer.
Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Det kan ikke udelukkes at andre inducerende stoffer (f. eks. phenytoin, carbamazepin, phenobarbital og perikum) også påvirker effekten af rosiglitazon.
It cannot be excluded that other inducers (e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort) may also affect rosiglitazone exposure.
Der er ikke observeret klinisk relevante interaktioner med digoxin, CYP2C9- substratet warfarin, CYP3A4- substraterne nifedipine, ethinylestradiol eller norethisteron ved samtidig administration af rosiglitazon.
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
Glimepirid Samtidig administration af glimepirid og andre lægemidler kan føre til, at glimepirids hypoglykæmiske virkning forstærkes eller nedsættes på en måde, som ikke er ønsket.
Glimepiride If glimepiride is taken simultaneously with certain other medicines, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Metabolismen er kendt for at påvirkes af samtidig administration af CYP2C9 inducerende stoffer (f. eks. rifampicin) eller hæmmere (f. eks. fluconazol).
Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e. g. rifampicin) or inhibitors (e. g. fluconazole
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.
6 Hypoglykæmiske virkninger som resultat af den forstærkede hypoglykæmiske virkning kan opstå efter samtidig administration af glimepirid og f. eks.
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
fenylbutazon, azapropazon og oxyfenbutazon insulin og perorale antidiabetika metformin salicylater og p- aminosalicylsyre anabolske steroider og mandlige kønshormoner chloramphenicol kumarine antikoagulantia fenfluramin fibrater ACE- hæmmere fluoxetin allupurinol sympatolytika cyclo -, tro - og iphosphamider
phenylbutazone, azapropazon and oxyfenbutazone, insulin and oral antidiabetic products, metformin, salicylates and p-amino-salicylic acid, anabolic steroids and male sex hormones, chloramphenicol, coumarin anticoagulants, fenfluramine, fibrates, ACE inhibitors, fluoxetine, allopurinol, sympatholytics, cyclo-, tro-and iphosphamides,
sulfinpyrazon visse langtidsvirkende sulfonamider tetracykliner MAO- hæmmere quinoloner probenecid miconazol pentoxifyllin (høje parenterale doser) tritoqualin fluconazol
sulphinpyrazone, certain long acting sulphonamides, tetracyclines, MAO-inhibitors, quinolone antibiotics, probenecid, miconazol, pentoxifylline (high dose parenteral), tritoqualine, fluconazole.
Glimepirids hypoglykæmiske virkning nedsættes med en deraf følgende ringere metabolisk kontrol, hvis glimepirid administreres samtidigt med lægemidler, som indeholder følgende aktive stoffer:
6 Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
østrogener og gestagener saluretika, thiazid- diuretika thyreomimetika, glukokortikoider fenothiazinderivater, chlorpromazin adrenalin og sympatikomimetika nikotinsyre (høje doser) og nikotinsyrederivater laksantia (langtidsbrug) fenytoin, diazoxid glucagon, barbiturater og rifampicin acetozolamid
oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives, laxatives (long term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin, acetozolamide.
H2- antagonister, beta- blokkere, klonidin og reserpin kan enten forstærke eller svække den blodsukkersænkende virkning.
H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Under behandling med sympatolytika som beta- blokker, klonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulation reduceres eller helt mangle.
Under the influence of sympatholytic drugs such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Dyreforsøg har påvist reproduktionstoksisitet (se afsnit 5. 3).
Studies in animals have shown reproductive toxicity (see section 5.3).
7 Både rosiglitazon og glimepirid er påvist i mælken hos forsøgsdyr.
Both rosiglitazone and glimepiride have been detected in the milk of experimental animals.
AVAGLIM skal derfor ikke anvendes af ammende kvinder (se afsnit 4. 3).
Therefore, AVAGLIM should not be used during lactation.
Dog skal risikoen for hypoglykæmi tages i betragtning, når en patients kapacitet til at udføre opgaver, der kræver bedømmelsesformåen samt motoriske og kognitive evner (f. eks. bilkørsel) overvejes.
Nevertheless, the potential for hypoglycaemia should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (e. g. driving).
AVAGLIM Data fra dobbeltblinde undersøgelser bekræfter, at bivirkningsprofilen for samtidig administration af rosiglitazon og glimepirid er identisk med den kombinerede bivirkningsprofil for de to stoffer.
7 AVAGLIM Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
Data fra kliniske undersøgelser Bivirkningerne fra hvert behandlingsregime er opstillet nedenfor efter organklasse og absolut frekvens.
Clinical trial data Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Frekvenskategorier gør ikke rede for andre faktorer, herunder varighed af undersøgelsen, allerede kendte fysiske tilstande og baseline- karakteristika for patienterne.
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Frekvenserne er defineret som:
Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100, < 1/ 10) og ikke almindelig (≥ 1/ 1. 000, < 1/ 100).
Frequencies are defined as: very common ≥ 1/ 10; common ≥ 1/ 100, < 1/ 10; and uncommon ≥ 1/ 1000, < 1/ 100.
Tabel 1 viser bivirkningerne, der blev identificeret fra en population på mere end 5000 patienter behandlet med rosiglitazon i integrerede kliniske undersøgelser.
Table 1 lists adverse reactions identified from an integrated clinical trial population of over 5,000 rosiglitazone-treated patients.
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.
8 Tabel 1.
8 Table 1.
Frekvens af bivirkning efter behandlingsregime Rosiglitazon monoterapi Rosiglitazon med sulfonylurinstof
Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with sulphonylurea
Blod og lymfesystem
Blood and the lymphatic system disorders anaemia leucopaenia thrombocytopaenia
Anæmi Leukopeni Thrombocytopeni
Common
Metabolisme og ernæring Hypercholesterolæmi 1 Hypertriglyceridæmi Hyperlipidæmi Vægtøgning Øget appetit Hypoglykæmi
Metabolism and nutrition disorders hypercholesterolaemia1 hypertriglyceridaemia hyperlipaemia weight increase increased appetite hypoglycaemia
Almindelig Almindelig Almindelig Almindelig Ikke almindelig Meget almindelig
Common Common Common Common Uncommon Very common
Svimmelhed *
dizziness*
Hjerte Hjertesvigt2
Cardiac disorders cardiac failure2
Hjerteiskæmi3 *
cardiac ischaemia3*
* Frekvenskategorien for baggrundshyppigheden af disse bivirkninger, som er taget fra data fra placebo- grupper fra kliniske undersøgelser, er ” Almindelig ”.
*The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is'common '.
1 Hypercholesterolæmi blev rapporteret hos op til 5, 3% af de patienter, der blev behandlet med rosiglitazon (oral mono - eller dobbelterapi).
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone (monotherapy or dual oral therapy).
Det forhøjede totale cholesterolniveau blev forbundet med en forøgelse i både LDLc og HDLc, men forholdet total cholesterol: HDLc var uændret eller forbedret i langtidsundersøgelser.
The elevated total cholesterol levels were associated with increase in both LDLc and HDLc, but the ratio of total cholesterol: HDLc was unchanged or improved in long term studies.
2 Der er set en stigning i antallet af hjertesvigt, når rosiglitazon gives i kombination med sulfonylurinstof (enten i kombinations - eller i tripel- kombinationsbehandling), og forekomsten er højere ved 8 mg rosiglitazon sammenlignet med 4 mg rosiglitazon (som total daglig dosis).
2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Forekomsten af hjertesvigt, 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%.
En placebokontrolleret, etårig undersøgelse af patienter, der lider af hjertesvigt NYHA- klasse I- II, har vist en forværring eller mulig forværring af hjertesvigt 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 placebo- controlled 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.
3 I en retrospektiv analyse af de samlede data fra 42 kortvarige kliniske undersøgelser var forekomsten af hændelser, der var associeret med hjerteiskæmi, højere for behandlingsregimer med rosiglitazon end
This risk was increased when rosiglitazone was added to established insulin and
9 for komparatorerne, der bestod af både aktive stoffer og placebo.
9 in patients receiving nitrates for known ischaemic heart disease.
1000 personår for andre antidiabetiske stoffer [Hazard ratio 0, 93 (95% konfidensinterval 0, 80 - 1, 10)].
In a large observational study where patients were well-matched at baseline, the incidence of the composite endpoint myocardial infarction and coronary revascularization was 17.46 events per 1000 person years for rosiglitazone containing regimens and 17.57 events per 1000 person years for other anti-diabetic agents [Hazard ratio 0.93 (95% confidence interval 0.80 - 1.10)].
I tre store prospektive, randomiserede, kontrollerede kliniske langtidsundersøgelser (gennemsnitsvarighed 41 måneder; 14. 067 patienter) med sammenligning af rosiglitazon og andre godkendte perorale antidiabetika eller placebo er denne risiko hverken blevet be - eller afkræftet.
Three large long-term prospective randomised controlled clinical trials (mean duration 41 months; 14,067 patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.
Alt i alt kan der ikke drages nogen konklusion ud fra tilgængelige oplysninger om risikoen for myokardieiskæmi.
In their entirety, the available data on the risk of myocardial ischaemia are inconclusive.
Efter 1. års behandling blev der observeret en øget forekomst af frakturer hos kvindelige patienter, der blev behandlet med rosiglitazon (9, 3%; 2, 7 patienter pr.
4 In a long-term randomised (4 to 6 year) monotherapy study in recently diagnosed patients with type 2 diabetes mellitus, an increased incidence of bone fractures was noted after the first year of treatment in female patients taking rosiglitazone (9.3%, 2.7 patients per 100 patient years) vs metformin (5.1%, 1.5 patients per 100 patient years) or glyburide/ glibenclamide (3.5%, 1.3 patients per 100 patient years).