natgillin/translations-raw huggingface dataset:
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.
Et morbiditets/ mortalitetsstudie er endnu ikke blevet tilendebragt med rosiglitazon, hvorfor langtidsfordelene associeret med forbedret glykæmisk kontrol ikke er blevet demonstreret.
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Ved 18 måneder, i et igangværende langtids- sammenligningsstudie, var rosiglitazon, i kombinationsbehandling med metformin eller sulfonylurinstof, ikke- inferiør over for kombinationen af sulfonylurinstof plus metformin til sænkning af HbAlc.
At 18 months, in an ongoing long term comparator study, rosiglitazone in dual oral therapy with metformin or a sulphonylurea was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
Et aktivt kontrolleret klinisk studie (rosiglitazon op til 8 mg daglig eller metformin op til 2000 mg daglig) af 24 ugers varighed blev udført med 197 børn (mellem 10 og 17 år) med type 2- diabetes.
An active controlled clinical trial (rosiglitazone up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 197 children (10-17 years of age) with type 2 diabetes.
Rosiglitazon viste ikke non- inferiority i forhold til metformin.
Rosiglitazone failed to demonstrate non-inferiority to metformin.
Prospektive studier, som tester den cardiovaskulære langtidseffekt hos patienter, som får rosiglitazon er endnu ikke blevet tilendebragt.
There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone.
Rosiglitazons maksimale plasmakoncentration ses ca.
Absorption Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
1 time efter administration.
Rosiglitazone plasma concentrations peak at around 1 hour after dosing.
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% to 28%) and a delay in tmax (ca.1.75 h) were observed compared to dosing in the fasting state.
14 liter hos raske frivillige.
Distribution The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
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%).
10 Metabolisme Rosiglitazons metabolisme er omfattende, og ingen oprindelig del udskilles uændret.
Metabolism Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Bidraget fra den hyppigst forekommende metabolit (para- hydroxy- sulfat) til den samlede antidiabetiske aktivitet af rosiglitazon er ikke fuldt ud belyst hos mennesket, og det kan ikke udelukkes, at metabolitten bidrager til aktiviteten.
10 overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
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 a minor contribution by CYP2C9.
Et in vivo interaktionsstudie med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9- substrater in vivo.
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
3- 4 timer.
Elimination Total plasma clearance of rosiglitazone is around 3 l/ h and the terminal elimination half-life of rosiglitazone is approximately 3 to 4 hours.
Akkumulation 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 (para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
I den farmakokinetiske analyse med poolet population sås alder ikke at have nogen signifikant indflydelse på farmakokinetikken.
In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Farmakokinetiske analyser, inkluderede 96 pædiatriske patienter mellem 10 og 18 år som vejede fra 35 til 178 kg, foreslog samme gennemsnits CL/ F hos børn og voksne.
Population pharmacokinetic analysis including 96 paediatric patients aged 10 to 18 years and weighing 35 to 178 kg suggested similar mean CL/ F in children and adults.
Individuelle CL/ F for den pædiatriske gruppe var i samme område som individuelle data for voksne.
Individual CL/ F in the paediatric population was in the same range as individual adult data.
CL/ F syntes at være uafhængig af alder, men øgedes med stigende vægt i den pædiatriske gruppe.
CL/ F seemed to be independent of age, but increased with weight in the paediatric population.
Hos cirrhotiske patienter med moderat (Child- Pugh B) nedsat leverfunktion, var ubundet Cmax og AUC 2- 3 gange højere end hos normale personer.
In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Bivirkninger observeret i dyrestudier med mulig relevans for klinisk brug var følgende:
Adverse effects observed in animal studies with possible relevance to clinical use were as follows:
Desuden hæmmede
In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
11 rosiglitazon den østradiole og progesterone syntese i ovarierne og sænkede plasmaniveauet af disse hormoner, hvilket resulterede i effekter på østrus/ 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).
I en dyremodel for familiær adenomatøs polyposis (FAP) gav behandling med rosiglitazon i doser på 200 gange den farmakologiske aktive dosis anledning til forøget tumormangfoldighed i colon.
11 In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
Natriumstivelsesglycollat (type A) Hypromellose Mikrokrystallinsk cellulose Lactosemonohydrat Magnesiumstearat.
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
Filmovertræk (Opadry lyserød OY- L- 24802):
Film coating (Opadry pink OY-L-24802):
Hypromellose 6cP Titandioxid E171 Macrogol 3000 Lactosemonohydrat Glyceroltriacetat Jernoxid rød E172.
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Lactose monohydrate Glycerol triacetate Iron oxide red E172.
Uigennemsigtige blisterpakninger (PVC/ Aluminium).
Opaque blister packs (PVC/ aluminium).
Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
Any unused product should be disposed of in accordance with local requirements.
Dato for seneste fornyelse af tilladelsen:
11 July 2000 Date of latest renewal:
11. juli 2005.
11 July 2005
105 mg).
Excipient Contains lactose (approximately 105 mg).
Orange filmovertrukne tabletter præget med "GSK" på den ene side og "4" på den anden side.
Orange film-coated tablets debossed with “ GSK” on one side and "4" on the other side.
− Rosiglitazon er indiceret ved behandling af type 2- diabetes:
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
Rosiglitazonbehandling påbegyndes sædvanligvis med 4 mg/ dag.
Rosiglitazone therapy is usually initiated at 4 mg/ day.
Rosiglitazon kan indgives en eller to gange daglig.
Rosiglitazone may be taken with or without food.
14 Rosiglitazon kan tages sammen med eller uden mad.
14 Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
15 Kombination med insulin I kliniske undersøgelser er der observeret en øget forekomst af hjertesvigt, når rosiglitazon anvendes 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).
15 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).
16 Tripel- kombinationsbehandling 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).
Triple oral therapy 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).
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).
16 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).
17 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Dyreforsøg har påvist reproduktionstoksicitet (se afsnit 5. 3).
17 shown reproductive toxicity (see section 5.3).
18 Tabel 1.
18 Table 1.
anæmi leukopeni trombocytopeni agranulocytose
Blood and the lymphatic system disorders anaemia leucopaenia thrombocytopaenia granulocytopaenia
19 Forekomsten af hjertesvigt i det dobbeltblinde hovedstudie var 1, 4% ved tripel - kombinationsbehandling, 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 19 sulphonylurea dual therapy.
20 Tabel 2.
20 Table 2.
Angiødem Hudreaktioner (for eksempel nældefeber, kløe, udslæt)
Skin and subcutaneous tissue disorders (see Immune system disorders) angioedema skin reactions (e. g. urticaria, pruritis, rash) 5
Sjældne tilfælde af forhøjede leverenzymer og hepatocellulær dysfunktion er rapporteret.
Rare cases of elevated liver enzymes and hepatocellular dysfunction cases a fatal outcome has been reported.
I meget sjældne tilfælde er der rapporteret om fatale udfald.
In very rare
A10 BG 02 Rosiglitazon er en selektiv agonist ved PPARγ (peroxisomal proliferator aktiveret gamma) nuklearreceptor og hører hjemme i antidiabetikumgruppen thiazolidinedioner.
A10 BG 02
21 Prækliniske data Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller med diabetes type 2.
Preclinical data The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Den hyppigst forekommende metabolit (para- hydroxy - sulfat) med høj affinitet til det opløselige humane PPARγ udviste relativ høj potens i en glucosetolerance- assay hos overvægtige mus.
The major metabolite (para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mouse.
8 ugers behandling.
21 Clinical trials data 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.
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.
Metabolismen sker primært gennem N- demetylation og hydroxylation, efterfulgt af konjugation med sulfat og glukoronsyre.
The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with
Bidraget fra den hyppigst forekommende metabolit (para- hydroxy- sulfat) til den samlede antidiabetiske aktivitet af rosiglitazon er ikke fuldt ud belyst hos mennesket, og det kan ikke udelukkes, at metabolitten bidrager til aktiviteten.
The contribution of the major metabolite (para-hydroxy-sulphate) to the overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
En stigning i plasmavolumen ledsaget af et fald i parametre vedrørende røde blodlegemer samt en stigning i
An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
I en dyremodel for familiær adenomatøs polyposis (FAP) gav behandling med rosiglitazon i doser på 200 gange den farmakologiske aktive dosis anledning til forøget tumormangfoldighed i colon.
23 In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
Natriumstivelsesglycollat (type A) Hypromellose Mikrokrystallinsk cellulose Lactosemonohydrat Magnesiumstearat
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
Filmovertræk (Opadry orange OY- L- 23028):
Film coating (Opadry orange OY-L-23028):
Hypromellose 6cP Titandioxid E171 Macrogol 3000 Renset talkum Lactosemonohydrat Glyceroltriacetat Jernoxid rød E172 Jernoxid gul E172
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Purified talc Lactose monohydrate Glycerol triacetate Iron oxide red E172 Iron oxide yellow E172.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Any unused product should be disposed of in accordance with local requirements.
24 6. 6 Regler for destruktion
24 7.
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien.
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
EU/ 1/ 00/ 137/ 005- 009, EU/ 1/ 137/ 014, EU/ 1/ 137/ 017
EU/ 1/ 00/ 137/ 005-009, EU/ 1/ 00/ 137/ 014, EU/ 1/ 00/ 137/ 017
209 mg).
Excipient Contains lactose (approximately 209 mg).
Rødbrune filmovertrukne tabletter præget med "GSK" på den ene side og "8" på den anden side.
Red-brown film-coated tablets debossed with “ GSK” on one side and "8" on the other side.
Til patienter, som får rosiglitazon i kommbination 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).
26 Rosiglitazon kan tages sammen med eller uden mad.
26 Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
27 Kombination med insulin I kliniske undersøgelser er der observeret en øget forekomst af hjertesvigt, når rosiglitazon anvendes 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).
27 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).
28 Tripel- kombinationsbehandling 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).
Triple oral therapy 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).
Beslutningen om at påbegynde tripel - kombinationsbehanding bør inkludere en overvejelse om alternativt at skifte patienter over på insulin.
The decision to initiate triple oral therapy should include consideration of the alternative to switch the patient to insulin.
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).
28 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).
29 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.
Dyreforsøg har påvist reproduktionstoksicitet (se afsnit 5. 3).
29 shown reproductive toxicity (see section 5.3).
30 Tabel 1.
30 Table 1.
hjerteiskæmi2 *
cardiac ischaemia3*
Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions oedema
Forekomsten af hjertesvigt i det dobbeltblinde hovedstudie var 1, 4% ved tripel - kombinationsbehandling, 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 31 sulphonylurea dual therapy.
32 Tabel 2.
32 Table 2.
33 Prækliniske data Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller med diabetes type 2.
Preclinical data The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
8 ugers behandling.
33 Clinical trials data 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.
Bidraget fra den hyppigst forekommende metabolit (para- hydroxy- sulfat) til den samlede antidiabetiske aktivitet af rosiglitazon er ikke fuldt ud belyst hos mennesket, og det kan ikke udelukkes, at metabolitten bidrager til aktiviteten.
The contribution of the major metabolite (para-hydroxy-sulphate) to the overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be
I en dyremodel for familiær adenomatøs polyposis (FAP) gav behandling med rosiglitazon i doser på 200 gange den farmakologiske aktive dosis anledning til forøget tumormangfoldighed i colon.
In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200
Filmovertræk (Opadry lyserød OY- L- 24803):
Film coating (Opadry pink OY-L-24803):
36 6. 6 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency(EMEA) http: / /www. emea. europa. eu
Du Terras 53100 Mayenne Frankrig
Du Terras 53100 Mayenne France
Efter forlængelsen af markedsføringstilladelsen vil indehaveren af markedsføringstilladelsen indsende én yderligere 6 måneders Periodic Safety Update Report (PSUR) og derefter årlige PSURs, medmindre andet er bestemt at CHMP.
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit one additional 6 month Periodic Safety Update Report (PSUR) and thereafter yearly PSURs unless otherwise decided by the CHMP.
Indehaveren af markedsføringstilladelsen forpligter sig til, at fremsende pharmacovigilance planer beskrevet i Pharmacovigilanceplanen.
The Marketing Authorisation Holder commits to performing the pharmacovigilance activities detailed in the Pharmacovigilance Plan.
En opdateret Risk Management Plan skal fremsendes som beskrevet i CHMP Guideline on Risk Management Systems for medicinal products for human use.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
41 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Indeholder laktose, se indlægsseddel for yderligere information
Contains lactose, see leaflet for further information
56 filmovertrukne tabletter 112 filmovertrukne tabletter 168 filmovertrukne tabletter 180 filmovertrukne tabletter 56 filmovertrukne tabletter, enkeltdosispakning
56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 180 film-coated tablets 56 film-coated tablets, unit dose pack
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E) Oral anvendelse Læs indlægssedlen før brug Følg altid lægens anvisninger
For oral use Read the package leaflet before use Use only as directed by your doctor
EU/ 1/ 00/ 137/ 002 56 filmovertrukne tabletter EU/ 1/ 00/ 137/ 003 112 filmovertrukne tabletter EU/ 1/ 00/ 137/ 013 168 filmovertrukne tabletter EU/ 1/ 00/ 137/ 016 180 filmovertrukne tabletter EU/ 1/ 00/ 137/ 004 56 filmovertrukne tabletter, enkeltdosispakning
EU/ 1/ 00/ 137/ 002 EU/ 1/ 00/ 137/ 003 EU/ 1/ 00/ 137/ 013 EU/ 1/ 00/ 137/ 016 EU/ 1/ 00/ 137/ 004
Lot
LOT
43 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Oral anvendelse Læs indlægssedlen før brug Følg altid lægens anvisninger
For oral use Read the package leaflet before use Use only as directed by your doctor
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 EU/ 1/ 00/ 137/ 006 EU/ 1/ 00/ 137/ 007 EU/ 1/ 00/ 137/ 014 EU/ 1/ 00/ 137/ 017 EU/ 1/ 00/ 137/ 008 EU/ 1/ 00/ 137/ 009
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 EU/ 1/ 00/ 137/ 011 EU/ 1/ 00/ 137/ 015 EU/ 1/ 00/ 137/ 018 EU/ 1/ 00/ 137/ 012
Lad derfor være med at give Avandia til andre.
It may harm them, even
Avandias virkning og hvad du skal bruge det til 2.
What Avandia is and what it is used for 2.
Sådan skal du tage Avandia 4.
Before you take Avandia 3.
Bivirkninger 5.
How to take Avandia 4.