natgillin/translations-raw huggingface dataset:
Alle patienter, specielt patienter som samtidigt behandles med insulin eller et sulfonylurinstof, 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 or sulphonylurea 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.
• når der modtages ny information, der kan have indflydelse på nuværende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
− When new information is received that may impact on the current Safety Specification,
Rosiglitazon bør anvendes med forsigtighed hos patienter med alvorlig nyreinsufficiens (kreatinin clearance < 30 ml/min).
Rosiglitazone should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Blod og lymfesystem anæmi
Blood and the lymphatic system disorders anaemia
Rosiglitazons metabolisme er omfattende, og ingen oprindelig del udskilles uændret.
Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Rosiglitazon var associeret med vægtøgning.
Rosiglitazone was associated with increases in weight.
Vægten skal nøje overvåges, da vægtøgning kan medføre væskeretention, der kan være associeret med hjerteinsufficiens.
Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure.
I kliniske undersøgelser hos frivillige er rosiglitazon blevet givet som enkeltdoser op til 20 mg og var veltollereret.
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Der er begrænset erfaring med rosiglitazon hos patienter med forhøjede leverenzymer (ALAT > 2.5X øvre grænse for normal).
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT >2.5X upper limit of normal).
Rosiglitazonbehandling påbegyndes sædvanligvis med 4 mg/dag.
Rosiglitazone therapy is usually initiated at 4 mg/day.
Rosiglitazon bør anvendes med forsigtighed under samtidig administration af CYP2C8 inhibitorer (f.eks. gemfibrozil) eller inducerende stoffer (f.eks. rifampicin).
Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Terapi med rosiglitazon bør ikke indledes hos patienter med forhøjet baselineniveau af leverenzymer (ALAT > 2.5x øvre grænse for normal) eller med hvilken som helst anden evidens på leversygdom.
Therapy with rosiglitazone 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.
Eftersom NSAID og rosiglitazon er associeret med væskeretention, kan samtidig administration forhøje risikoen for ødem.
Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Meget sjældne bivirkninger Disse kan påvirke op til 1 ud af 10.000 patienter:
Very rare side effects These may affect up to 1 in 10,000 people:
− svigtende hjertefunktion eller en anamnese med hjerteinsufficiens (NYHA klasse I til IV)
− cardiac failure or history of cardiac failure (NYHA class I to IV)
Avandia indeholder Lactose
Avandia contains lactose
Den glucosesænkende effekt indtræder langsomt stigende til næsten maksimal reduktion i fastende plasmaglucose (FPG) påviseligt efter ca. 8 ugers behandling.
The glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
I et monoterapistudie var forekomsten hos kvinder på rosiglitazon 9,3 % (2,7 patienter pr. 100 patientår) versus 5,1 % (1,5 patient pr. 100 patientår) hos kvinder på metformin eller 3,5 % (1,3 patient pr. 100 patientår) hos kvinder på glibenclamid.
In a monotherapy study, the incidence in females for rosiglitazone was 9.3% (2.7 patients per 100 patient years) vs 5.1% (1.5 patients per 100 patient years) for metformin or 3.5% (1.3 patients per 100 patient years) for glibenclamide.
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.
Hepatic impairment: In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Rosiglitazons maksimale plasmakoncentration ses ca. 1 time efter administration.
Rosiglitazone plasma concentrations peak at around 1 hour after dosing.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.ema.europa.eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency(EMEA) http://www.ema.europa.eu
Herudover bevarede rosiglitazon β-cellefunktion demonstreret ved stigning i antallet af de langerhanske øer og insulinindholdet og forhindrede udviklingen af udtalt hyperglykæmi i dyremodeller med diabetes type 2.
In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Væskeophobning og hjerteinsufficiens: Avandia kan være årsag til, at der ophobes væske i din krop, hvilket medfører hævelse og vægtøgning.
Fluid retention and heart failure: Avandia can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Nervesystemet svimmelhed*
Nervous system disorders dizziness*
Der foreligger ikke tilgængelige langtidsdata for virkning og sikkerhed hos børn.
No long-term efficacy and safety data are available in paediatric patients.
ADOPT (A Diabetes Outcome Progression Trial) var et multicenter, dobbeltblindet, kontrolleret studie med en behandlingsvarighed på 4-6 år (median varighed på 4 år), hvor rosiglitazon i doser på 4-8 mg/dag blev sammenlignet med metformin (500-2.000 mg/dag) og glibenclamid (2,5-15 mg/dag) hos 4.351 stof naive patienter, der fornyligt var diagnosticeret (≤ 3 år) med type 2-diabetes.
ADOPT (A Diabetes Outcome Progression Trial) was a multicentre, double-blind, controlled trial with a treatment duration of 4-6 years (median duration of 4 years), in which rosiglitazone at doses of 4 to 8 mg/day was compared to metformin (500 mg to 2000 mg/day) and glibenclamide (2.5 to 15 mg/day) in 4351 drug naive subjects recently diagnosed (≤3 years) with type 2 diabetes.
Frekvens af bivirkning under behandlingsregime RSG
Frequency of adverse reaction by treatment regimen RSG RSG + MET
Leverproblemer: Inden og i løbet af behandlingen med Avandia, vil din læge tage blodprøver for at tjekke din leverfunktion.
Liver problems: Before you start taking Avandia you will have a blood sample taken to check your liver function.
Stop med at tage Avandia.
Stop taking Avandia.
Behandling med rosiglitazon er associeret med en dosis-relateret reduktion i hæmoglobinniveauet.
Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Rosiglitazon reducerede signifikant risikoen for monoterapisvigt (FPG > 10,0 mmol/l) med 63 % i forhold til glibenclamid (HR 0,37, CI 0,30-0,45) og med 32 % i forhold til metformin (HR 0,68, CI 0,55-0,85) i studieforløbet (op til 72 måneders behandling).
Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68, CI 0.55-0.85) during the course of the study (up to 72 months of treatment).
Rosiglitazon stimulerede ikke udskillelsen af insulin fra pankreas eller gav hypoglykæmi hos rotter og mus.
Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Tabel 1 viser de bivirkninger, der er angivet i en oversigt over kliniske undersøgelser med mere end 5.000 patienter i behandling med rosiglitazon.
Table 1 lists adverse reactions identified from an overview of clinical trials involving over 5,000 rosiglitazone-treated patients.
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanien.
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Der er blevet givet rosiglitazon til præmenopausale kvinder i kliniske undersøgelser.
Premenopausal women have received rosiglitazone during clinical studies.
Avandia findes i forskellige styrker.
Avandia tablets come in different strengths.
Desuden observeredes forøget forekomst af knoglefrakturer hos kvinder i behandling med rosiglitazon (se afsnit 4.4 og 4.8).
An additional observation of an increased incidence of bone fractures was seen in women with rosiglitazone (see sections 4.4 and 4.8).
Kun metformingruppen opnåede statistisk signifikante forbedringer i HbA1c i forhold til baseline.
Improvement in HbA1c from baseline achieved statistical significance only in the metformin group.
Efter behandling med rosiglitazon blev der ikke noteret nye sikkerhedsanliggender hos børn set i forhold til voksne.
Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus.
Brug af rosiglitazon som tripel-kombinationsbehandling, i kombination med metformin og et sulfonylurinstof, kan være associeret med øget risiko for væskeretention og hjerteinsufficiens, såvel som hypoglykæmi (se afsnit 4.8).
The use of rosiglitazone in triple oral therapy, in combination with metformin and a sulphonylurea, may be associated with increased risks for fluid retention and heart failure, as well as hypoglycaemia (see section 4.8).
Udskillelse sker primært i urinen med ca. 2/3, og gennem fæces med ca. 25 % af doseringen.
The major route of excretion is the urine with approximately two-thirds of the dose being eliminated by this route, whereas faecal elimination accounts for approximately 25% of dose.
Som en konsekvens af forskellige men komplementære virkningsmekanismer, resulterede kombinationsbehandling med rosiglitazon og sulfonylurinstof eller metformin i additiv effekt på glykæmisk kontrol hos patienter med type 2-diabetes.
As a consequence of different but complementary mechanisms of action, dual oral therapy of rosiglitazone with a sulphonylurea or metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.
Insulin og rosiglitazon er begge forbundet med væskeretention, og samtidig administration kan øge risikoen for ødem og iskæmisk hjertesygdom.
Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Nye tilfælde eller forværring af maculaødem er i enkelte tilfælde set hos patienter i behandling med Avandia og tilsvarende lægemidler.
New or worse cases of macular oedema have occurred on rare occasions in people taking Avandia and similar medicines.
Ved at hjælpe din krop til bedre at kunne udnytte den insulin, kroppen producerer, hjælper Avandia med at sænke dit blodsukker til et normalt niveau.
Avandia helps to reduce your blood sugar towards a normal level, by helping your body make better use of the insulin it produces.
Rosiglitazon bør derfor ikke anvendes af kvinder, som ammer.
Rosiglitazone should therefore not be used in women who are breast-feeding.
Indeholder lactose (hver tablet indeholder ca. 209 mg).
Contains lactose (approximately 209 mg).
Forekomsten af hjerteinsufficiens i det dobbeltblinde hovedstudie var 1,4 % ved tripelkombinationsbehandling, sammenlignet med 0,4 % for metformin og sulfonylurinstof kombinationsbehandling.
The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus sulphonylurea dual therapy.
For at mindske risikoen for problemer, skal du være særlig opmærksom på visse symptomer, mens du tager Avandia.
You must look out for certain symptoms while you are taking Avandia, to reduce the risk of any problems.
Renset talkum
Purified talc
Til patienter, som får rosiglitazon i kombination med et sulfonylurinstof, bør øgning af rosiglitazon til 8 mg/dag 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).
In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone 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).
Dato for første tilladelse: 11. juli 2000.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 July 2000
Rosiglitazon er i høj grad proteinbundet og fjernes ikke ved hæmodialyse.
Rosiglitazone is highly protein bound and is not cleared by haemodialysis.
In vitro-studier har vist, at rosiglitazon primært metaboliseres af CYP2C8 og af CYP2C9 i mindre omfang.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Fortæl det til lægen så hurtigt som muligt, hvis du får disse symptomer.
Î Tell your doctor as soon as possible if you get these symptoms.
Indeholder lactose (hver tablet indeholder ca. 105 mg).
Contains lactose (approximately 105 mg).
Hvis du har taget for meget Avandia Kontakt lægen eller apoteket, hvis du kommer til at tage for mange tabletter.
If you take more Avandia than you should If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Tag ikke Avandia.
Don't take Avandia.
Ældre: I den farmakokinetiske analyse med poolet population sås alder ikke at have nogen signifikant indflydelse på farmakokinetikken.
Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Vær ekstra forsigtig med at tage Avandia Avandia bør ikke anvendes af personer under 18 år, da virkningen er ukendt hos denne patientgruppe.
Avandia is not recommended for people aged under 18, as the effectiveness in children has not been shown.
Filmovertræk (Opadry orange OY-L-23028): Hypromellose 6cP
Film coating (Opadry orange OY-L-23028): Hypromellose 6cP
I kliniske undersøgelser er der observeret en øget forekomst af hjerteinsufficiens, når rosiglitazon anvendes i kombination med insulin.
An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
Patienter med nedsat leverfunktion Rosiglitazon bør ikke anvendes til patienter med nedsat leverfunktion.
Patients with hepatic impairment Rosiglitazone should not be used in patients with hepatic impairment.
I den endelige analyse efter 5 år sås en justeret gennemsnitsreduktion i HbA1c fra baseline på 0,14 % hos patienter på rosiglitazon lagt oven i metformin over for en stigning på 0,17 % hos de patienter, der fik SU lagt oven i metformin i den randomiserede tostofbehandling (p < 0,0001 mht. forskel i behandling).
In the final analysis at 5 years, an adjusted mean reduction from baseline in HbA1c of 0.14% for patients on rosiglitazone added to metformin versus an increase of 0.17% for patients taking sulphonylurea added to metformin was seen during treatment with randomised dual-combination therapy (p<0.0001 for treatment difference).
EU/1/00/137/005 7 filmovertrukne tabletter EU/1/00/137/006 28 filmovertrukne tabletter EU/1/00/137/007 56 filmovertrukne tabletter EU/1/00/137/014 84 filmovertrukne tabletter EU/1/00/137/017 90 filmovertrukne tabletter EU/1/00/137/008 112 filmovertrukne tabletter EU/1/00/137/009 56 filmovertrukne tabletter, enkeltdosispakning
EU/1/00/137/005 7 tablets EU/1/00/137/006 28 tablets EU/1/00/137/007 56 tablets EU/1/00/137/014 84 tablets EU/1/00/137/017 90 tablets EU/1/00/137/008 112 tablets EU/1/00/137/009 56 tablet unit dose pack
• rifampicin (anvendes til at behandle tuberkulose og andre infektioner).
• rifampicin (used to treat tuberculosis and other infections) Î Tell a doctor or pharmacist if you are taking any of these.
Rosiglitazon er indiceret ved behandling af type 2-diabetes:
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE AVANDIA Det er vigtigt, at du følger din læges råd om diæt og levestil.
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandia.
hovedpine*
Common Common headache*
Der sås en signifikant stigning i hjerteinsufficiens (letal og ikkeletal) (HR 2,10, CI 1,35-3,27) og frakturer (risikoratio 1,57, CI 1,26-1,97) i forbindelse med de behandlinger, der indeholdt rosiglitazon sammenlignet med den aktive kontrolgruppe (se afsnit 4.4 og 4.8).
There was a significant increase in heart failure (fatal and nonfatal) (HR 2.10, CI 1.35-3.27) and bone fractures (Risk Ratio 1.57, CI 1.26-1.97) in rosiglitazonecontaining treatments compared to active control (see sections 4.4 and 4.8).
1Hyperkolesterolæmi var rapporteret hos op til 5,3 % af patienter behandlet med rosiglitazon (monoterapi, dobbelt- eller tripelterapi).
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone
Risikoen for fraktur så ud til at være større hos kvinder i forhold til kontrolgruppen [11,5 % versus 6,3 %, risikoratio 1,82 (95 % CI 1,26 - 1,97)] end hos mænd i forhold til kontrolgruppen [5,3 % versus 4,3 % (95 % CI 0,851,77)].
The risk of fracture appeared to be higher in females relative to control [11.5% vs 6.3%, Risk ratio 1.82 (95% CI 1.37 - 2.41)], than in males relative to control [5.3% vs 4.3%, Risk ratio 1.23 (95% CI 0.85 - 1.77)].
Du kan finde yderligere information om Avandia på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.ema.europa.eu/
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.ema.europa.eu
Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
If you forget to take Avandia Don't take extra tablets to make up for a missed dose.
Samtidig administration af rosiglitazon og gemfibrozil (en hæmmer af CYP2C8) resulterede i en tofoldig stigning i rosiglitazon plasmakoncentrationer.
Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Derfor bør leverenzymer kontrolleres forud for indledning af terapi med rosiglitazon hos alle patienter.
Therefore, liver enzymes should be checked prior to the initiation of therapy with rosiglitazone in all patients and periodically thereafter based on clinical judgement.
Af alle patienter i rosiglitazon-, glibenclamid- og metformingruppen trak henholdsvis 43 %, 47 % og 42 % patienter sig ud af studiet af grunde, som ikke skyldtes monoterapisvigt.
Overall, 43%, 47% and 42% of subjects in the rosiglitazone, glibenclamide and metformin groups respectively withdrew due to reasons other than monotherapy failure.
Rosiglitazons plasmaproteinbinding er høj (ca. 99,8 %) og påvirkes ikke af koncentration eller alder. Proteinbindingen af den hyppigst forekommende metabolit (para-hydroxy-sulfat) er meget høj (>99.99 %).
The protein binding of the major metabolite (para-hydroxy-sulphate) is very high (>99.99%).
Ikke almindelig hypoglykæmi
Uncommon hypoglycaemia
I en sub-analyse ved 18 måneder i den gruppe, hvor rosiglitazon blev givet i tostofbehandling, var denne kombinationsbehandling non-inferiør i forhold til kombinationen af SU og metformin til at reducere HbA1c.
In a sub-study at 18 months, add-on rosiglitazone dual therapy was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
Nye tilfælde og forværring af diabetisk maculaødem med synsforstyrrelser, er beskrevet i postmarketing rapporter hos patienter i behandling med thiazolider, herunder rosiglitazon.
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
I en prospektiv undersøgelse af forekomsten af hjerte-kar-sygdomme (gennemsnitlig opfølgning i 5,5 år) var de primære endepunkter, død eller indlæggelse pga. hjerte-karsygdomme, lige hyppige hos de patienter, der fik rosiglitazon, og de patienter, der fik aktive komparatorer [HR 0,99 (95 % CI 0,85 - 1,16)].
In a prospective cardiovascular outcomes study (mean follow-up 5.5 years) the primary endpoint events of cardiovascular death or hospitalisation were similar between rosiglitazone and active comparators [HR 0.99 (95% CI 0.85 - 1.16)].
7, 28, 84, 90 eller 112 filmovertrukne tabletter.
7, 28, 84, 90 or 112 film-coated tablets.
EU/1/00/137/010 7 filmovertrukne tabletter EU/1/00/137/011 28 filmovertrukne tabletter EU/1/00/137/015 84 filmovertrukne tabletter EU/1/00/137/018 90 filmovertrukne tabletter EU/1/00/137/012 112 filmovertrukne tabletter
EU/1/00/137/010 7 tablets EU/1/00/137/011 28 tablets EU/1/00/137/015 84 tablets EU/1/00/137/018 90 tablets EU/1/00/137/012 112 tablets
AVANDIA 2 mg filmovertrukne tabletter AVANDIA 4 mg filmovertrukne tabletter AVANDIA 8 mg filmovertrukne tabletter rosiglitazon
AVANDIA 2 mg film-coated tablets AVANDIA 4 mg film-coated tablets AVANDIA 8 mg film-coated tablets rosiglitazone
56 filmovertrukne tabletter, enkeltdosispakning
56 film-coated tablets, unit dose pack
Indeholder lactose (hver tablet indeholder ca. 108 mg).
Contains lactose (approximately 108 mg).
Jernoxid rød E172.
Iron oxide red E172.
Men alt i alt er foreliggende data om risikoen for myokardieiskæmi inkonklusive (se afsnit 4.8).
in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
Langtidsundersøgelser viser en øget forekomst af frakturer hos især kvindelige patienter, der tager rosiglitazon.
4 Long-term studies show an increased incidence of bone fracture in patients, particularly female patients, taking rosiglitazone.
I en anden langtidsundersøgelse sås der øget forekomst af frakturer hos patienter i den kombinerede rosiglitazongruppe i sammenligning med den aktive kontrolgruppe [8,3 % versus 5,3 %, risikoratio 1,57 (95 % CI 1,26 - 1,97)].
In another long-term study, there was an increased incidence of bone fracture for subjects in the combined rosiglitazone group compared to active control [8.3% vs 5.3%, Risk ratio 1.57 (95% CI 1.26 - 1.97)].
Filmovertræk (Opadry lyserød OY-L-24803): Hypromellose 6cP
Film coating (Opadry pink OY-L-24803): Hypromellose 6cP
Metabolisme og ernæring hypercholesterolæmi 1 Almindelig Almindelig hypertriglyceridæmi hyperlipidæmi vægtøgning øget appetit
Metabolism and nutrition disorders hypercholesterolaemia1 Common Common Common
Knogler, led, muskler og bindevæv frakturer4
Musculoskeletal and connective tissue disorders bone fractures4
Fortæl det til lægen så hurtigt som muligt, hvis du får nogen af disse symptomer.
Î Tell your doctor as soon as possible if you get any of these symptoms.
7 filmovertrukne tabletter 28 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 112 filmovertrukne tabletter
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/137/005-009, EU/1/137/014, EU/1/137/017
MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
Tabletterne findes i blisterpakninger indeholdende 7, 28, 84, 90 og 112 filmovertrukne tabletter.
The tablets are provided in blister packs containing 7, 28, 84, 90 or 112 film-coated tablets.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016