natgillin/translations-raw huggingface dataset:
Pioglitazons virkninger kan medieres af en reduktion af insulinresistensen.
9 Pioglitazone effects may be mediated by a reduction of insulin resistance.
Pioglitazon synes at virke via aktivering af specifikke kernereceptorer (peroxisom proliferator- aktiveret receptor gamma), der medfører forøget insulinfølsomhed i lever -, fedt - og skeletmuskelceller hos dyr.
Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Reguleringen af fastende og postprandialt blodsukker forbedres hos patienter med type 2- diabetes mellitus.
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Et klinisk forsøg, hvor pioglitazon blev sammenlignet med gliclazid begge som monoterapi, blev forlænget til en varighed af to år for at undersøge hvornår behandlingen svigter (defineret som forekomst af HbA1c ≥ 8, 0% efter de første seks måneders behandling).
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Kaplan- Meier analyse viste kortere tid til behandlingssvigt hos patienter behandlet med gliclazid sammenlignet med pioglitazon.
Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Efter to år var glykæmisk kontrol (defineret som HbA1c < 8, 0%) opretholdt hos 69% af patienterne behandlet med pioglitazon sammenlignet med 50% af patienterne behandlet med gliclazid.
At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Patienter, der fik pioglitazon, havde en gennemsnitlig reduktion af HbA1c på 0, 45% sammenlignet med de patienter, der fortsatte på insulin alene, samtidig sås en reduktion af insulin dosis hos de pioglitazon behandlede.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
En HOMA analyse viste, at pioglitazon forbedrer beta- cellefunktionen samt øger insulinfølsomheden.
HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Pioglitazon gav konsekvent en statistisk signifikant reduktion i albumin/ kreatinin forholdet sammenlignet med baseline i kliniske forsøg løbende over et år.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
Effekten af pioglitazon (45 mg monoterapi versus placebo) er blevet undersøgt i et mindre 18 ugers klinisk forsøg hos type 2- diabetikere.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Der var små, men ikke klinisk signifikante stigninger i LDL- kolesterolniveauer.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
I kliniske forsøg af en varighed på op til to år reducerede pioglitazon total plasma triglycerider og frie fedtsyrer og forøgede HDL- kolesterolniveauer sammenlignet med placebo, metformin eller gliclazid.
In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide.
Pioglitazon forøgede ikke LDL- kolesterolniveauer statistisk signifikant sammenlignet med placebo, mens der blev set reduktioner med metformin og gliclazid.
Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
I et 20- ugers forsøg reducerede pioglitazon såvel faste triglycerider som postprandial hypertriglyceridæmi gennem en effekt på både absorberede og leversyntetiserede triglycerider.
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Disse effekter var uafhængige af pioglitazons virkning på glykæmi og var statistisk signifikant forskellige fra glibenclamid.
These effects were independent of pioglitazone’ s effects on glycaemia and were statistically significant different to glibenclamide.
Forsøgspopulationen havde en
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
10 gennemsnitsalder på 62 år, og den gennemsnitlige varighed af diabetes var 9, 5 år.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Omkring en tredjedel af patienterne fik insulin i kombination med metformin og/ eller sulfonylurinstof.
Approximately one third of patients were receiving insulin in combination with metformin and/ or a sulphonylurea.
Omkring halvdelen af forsøgspopulationen opfyldte mindst to af de cardiovaskulære inklusionskriterier.
Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Næsten alle patienterne (95%) var i behandling med cardiovaskulær medicin (beta- blokkere, ACE- hæmmere, angiotensin II- antagonister, kalciumkanal- blokkere, nitrater, diuretika, acetylsalisylsyre, statiner og fibrater).
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Selvom forsøget ikke kunne påvise dets primære endpoint, der var en sammensætning af generel dødelighed, ikke fatal hjerteinfarkt, slagtilfælde, akut koronarsyndrom, større benamputation, koronar revaskularisering og revaskularisering i benene, tyder resultaterne på, at der ikke er en langtids cardiovaskulær følgevirkning med hensyn til brug af pioglitazon.
10 Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non- fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Pioglitazon absorberes hurtigt efter peroral indgivelse, og maksimale plasmakoncentrationer af uomdannet pioglitazon opnås som regel 2 timer efter indgivelse.
Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Proportionale stigninger i plasmakoncentrationen sås for doser fra 2- 60 mg.
Proportional increases of the plasma concentration were observed for doses from 2 – 60 mg.
Steady- state opnås efter 4- 7 dages dosering.
Steady state is achieved after 4– 7 days of dosing.
Det beregnede fordelingsvolumen hos mennesker er 0, 25 1/ kg.
The estimated volume of distribution in humans is 0.25 l/ kg.
Pioglitazon og alle aktive metaboliter har en høj bindingsgrad til plasmaprotein (> 99%).
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Tre af de seks identificerede metabolitter er aktive (M- II, M- III og M- IV).
Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Når aktivitet, koncentrationer og proteinbinding tages med i betragtning, bidrager pioglitazon og metabolit M- III ligeligt til effekten.
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
På dette grundlag er M- IV’ s bidrag til effekten omkring tre gange pioglitazons, mens den relative effekt af M- II er minimal.
On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
In vitro- undersøgelser har ikke vist holdepunkter for, at pioglitazon hæmmer nogen undertype af cytokrom P450.
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
Der sker ingen induktion af de vigtigste inducerbare P450- isoenzymer 1A, 2C8/ 9 og 3A4 hos mennesket.
There is no induction of the main inducible P450 isoenzymes 1A, 2C8/ 9, and 3A4 in man.
4. 5).
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Efter peroral indgivelse af radioaktivt mærket pioglitazon hos mennesker genfandtes den mærkede del hovedsagelig i fæces (55%) og i en mindre mængde i urin (45%).
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
11 uomdannet pioglitazon er hos mennesket 5- 6 timer og for dets samlede, aktive metabolitter 16- 23 timer.
The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Steady- state- farmakokinetik er ens hos patienter på 65 år og derover og unge personer.
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Patienter med nedsat nyrefunktion:
11 Patients with renal impairment:
Hos patienter med nedsat nyrefunktion er plasmakoncentrationerne af pioglitazon og dets metabolitter lavere end dem, der ses hos personer med normal nyrefunktion, men perorale clearance af moderstoffet er den samme.
In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Derudover blev der observeret øget fedtaflejring og – infiltration.
In addition, increased fatty deposition and infiltration were observed.
Dette skyldtes, at pioglitazon mindskede den maternale hyperinsulinæmi og øgede insulinresistensen, som optræder under graviditet og derved reducerer tilgængeligheden af metaboliske substrater til fostervækst.
This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Hyperplasi af urinblæren sås ikke hos hunde eller aber behandlet i op til 12 måneder.
Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated for up to 12 months.
I en dyremodel af familiær adenomatøs polyposis (FAP) behandlet med to andre thiazolidindioner øgedes tumor mangfoldigheden i kolon.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
6. 1 Fortegnelse over hjælpestoffer
6.1 List of excipients
Carmellosecalcium Hyprolose Lactosemonohydrat Magnesiumstearat
Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate
12 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
6. 5 Emballage (art og indhold)
12 6.5 Nature and contents of container
Aluminium/ aluminium- blisterpakninger, pakninger a 14, 28, 30, 50, 56, 84, 90 og 98 tabletter.
Aluminium/ aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90 and 98 tablets.
6. 6 Særlige forholdsregler ved bortskaffelse
6.6 Special precautions for disposal
Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE Storbritannien
Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE United Kingdom
13.
Date of first authorisation:
13.
13-10-2000 Date of last renewal:
Oktober 2005.
13-10-2005
Actos 30 mg tabletter.
Actos 30 mg tablets.
Hver tablet indeholder 30 mg pioglitazon som hydroklorid.
Each tablet contains 30 mg of pioglitazone as hydrochloride.
Tabletterne er hvide til grålig hvide, runde, flade og mærket med ‘ 30 ’ på den ene side og ‘ ACTOS ’ på den anden side.
The tablets are white to off-white, round, flat and marked ‘ 30’ on one face and ‘ ACTOS’ on the other face.
- metformin, hos patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk
- metformin, in patients (particularly overweight patients) with insufficient glycaemic
- metformin og sulfonylurinstof, hos patienter (specielt overvægtige patienter) med utilstrækkelig
- metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient
I kombination med insulin kan den aktuelle insulindosis fortsættes efter pioglitazon behandlingen er påbegyndt.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
14 Ældre:
14 Elderly:
Monitorering af leverfunktion:
Monitoring of liver function:
Leverenzymer bør checkes forud for igangsættelse af behandling med pioglitazon hos alle patienter.
Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all
Behandling med pioglitazon bør ikke igangsættes hos patienter med forhøjede leverenzymer (ALT > 2, 5 X øvre normal grænse) 15 eller hos patienter med tegn på leversygdom.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
100 patientår hos de kvinder, der blev behandlet med en komparator.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
100 patientår) af de patienter, som fik behandling med komparator.
16 In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
17 Anvendelse ved amning:
Use in breast-feeding:
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
17 4.7 Effects on ability to drive and use machines
PIOGLITAZON I KOMBINATION SBEHANDLING MED METFORMIN
PIOGLITAZONE IN COMBINATION THERAPY WITH METFORMIN Blood and lymphatic system disorders
luft i maven
Investigations
Undersøgelser
weight increased
vægtøgning
arthralgia
18
18 Nervous system disorders
PIOGLITAZON I KOMBINATION SBEHANDLING MED SULFONYLURINSTOF
PIOGLITAZONE IN COMBINATION THERAPY WITH SULPHONYLUREA Ear and labyrinth disorders
19 Sygdomme i hud og subkutane væv
Skin and subcutaneous tissue disorders
Usædvanlig:
Uncommon: sweating
PIOGLITAZON I TRIPPEL KOMBINATIONSBEHANDLING MED METFORMIN OG SULFONYLURINSTOF
19 PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
Hyppigheden af ødemer i de sammenlignende grupper
Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
20 (sulfonylurinstof, metformin) var 2- 5%.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5%.
I kontrollerede kliniske forsøg med aktive stoffer som sammenligning var den gennemsnitlige vægtøgning 2- 3 kg i løbet af et år ved pioglitazon givet som monoterapi.
20 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
Reguleringen af fastende og postprandialt blodsukker forbedres hos patienter med type 2- diabetes mellitus.
21 Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
22 gennemsnitsalder på 62 år, og den gennemsnitlige varighed af diabetes var 9, 5 år.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Selvom forsøget ikke kunne påvise dets primære endpoint, der var en sammensætning af generel dødelighed, ikke fatal hjerteinfarkt, slagtilfælde, akut koronarsyndrom, større benamputation, koronar revaskularisering og revaskularisering i benene, tyder resultaterne på, at der ikke er en langtids cardiovaskulær følgevirkning med hensyn til brug af pioglitazon.
Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non- fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular
Dette sker fortrinsvis via cytokrom P450 2C8, selvom andreisoformer kan være involveret i mindre grad.
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
23 uomdannet pioglitazon er hos mennesket 5- 6 timer og for dets samlede, aktive metabolitter 16- 23 timer.
The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Patienter med nedsat leverfunktion:
23 Patients with hepatic impairment:
5. 4 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
24 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
6. 5 Emballage (art og indhold)
6.5 Nature and contents of container
6. 6 Særlige forholdsregler ved bortskaffelse
24 6.6 Special precautions for disposal
Actos 45 mg tabletter.
Actos 45 mg tablets.
Hver tablet indeholder 45 mg pioglitazon som hydroklorid.
Each tablet contains 45 mg of pioglitazone as hydrochloride.
Tabletterne er hvide til grålig hvide, runde, flade og mærket med ‘ 45 på den ene side og ‘ ACTOS ’ på den anden side.
The tablets are white to off-white, round, flat and marked ‘ 45’ on one face and ‘ ACTOS’ on the other face.
26 Ældre:
26 Elderly:
Behandling med pioglitazon bør ikke igangsættes hos patienter med forhøjede leverenzymer (ALT > 2, 5 X øvre normal grænse) 27 eller hos patienter med tegn på leversygdom.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
100 patientår) af de patienter, som fik behandling med komparator.
28 In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
29 Anvendelse ved amning:
Use in breast-feeding:
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
29 4.7 Effects on ability to drive and use machines
Sygdomme i nervesystemet
30 Nervous system disorders
31 Sygdomme i hud og subkutane væv
Skin and subcutaneous tissue disorders
PIOGLITAZON I TRIPPEL KOMBINATIONSBEHANDLING MED METFORMIN OG SULFONYLURINSTOF
31 PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
32 (sulfonylurinstof, metformin) var 2- 5%.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5%.
I kontrollerede kliniske forsøg med aktive stoffer som sammenligning var den gennemsnitlige vægtøgning 2- 3 kg i løbet af et år ved pioglitazon givet som monoterapi.
32 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
Reguleringen af fastende og postprandialt blodsukker forbedres hos patienter med type 2- diabetes mellitus.
33 Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
34 gennemsnitsalder på 62 år, og den gennemsnitlige varighed af diabetes var 9, 5 år.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
35 uomdannet pioglitazon er hos mennesket 5- 6 timer og for dets samlede, aktive metabolitter 16- 23 timer.
The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Patienter med nedsat leverfunktion:
35 Patients with hepatic impairment:
5. 5 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
36 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
6. 6 Særlige forholdsregler ved bortskaffelse
36 6.6 Special precautions for disposal
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
MARKTEING AUTHORISATION NUMBER(S)
37 BILAG II
37 ANNEX II
Takeda Ireland Limited Bray Business Park, Kilruddery County Wicklow Irland
Ireland.
Indehaveren af markedsføringstilladelsen indsender yderligere en 6 måneders periodisk sikkerhedsopdatering (PSUR) i september 2005 og derefter årlige PSUR’ er med mindre CHMP træffer anden afgørelse.
The Marketing Authorisation Holder will submit one additional 6 month Periodic Safety Update Report (PSUR) in September 2005 and thereafter yearly PSURs unless otherwise decided by the CHMP.
Indehaveren af markedsføringstilladelsen forpligter sig til at udføre pharmacovigilance- aktiviteter detaljeret i pharmacovigilance- planen.
The Marketing Authorisation Holder commits to performing the Pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Der skal foreligge en opdateret Risk Management Plan ifølge CHMPs guideline for Risk Management Systemer for lægemidler til humant brug.
An updated Risk Management Plan should be provided as per the CHMP guideline on Risk Management Systems for medicinal products for human use.
39 BILAG III
39 ANNEX III
41 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Actos 15 mg tabletter pioglitazon (som hydrochlorid)
Actos 15 mg tablets
ANVENDELSESMÅDE OG INDGIVELSESVEJ( E)
METHOD AND ROUTE(S) OF ADMINISTRATION
Udløbsdato:
Expiry date:
{måned/ år}
{month/ year}
EU/ 1/ 00/ 150/ 007 14 tabletter EU/ 1/ 00/ 150/ 001 28 tabletter EU/ 1/ 00/ 150/ 016 30 tabletter EU/ 1/ 00/ 150/ 002 50 tabletter EU/ 1/ 00/ 150/ 009 56 tabletter EU/ 1/ 00/ 150/ 017 84 tabletter EU/ 1/ 00/ 150/ 018 90 tabletter EU/ 1/ 00/ 150/ 003 98 tabletter
EU/ 1/ 00/ 150/ 007 14 tablets EU/ 1/ 00/ 150/ 001 28 tablets EU/ 1/ 00/ 150/ 016 30 tablets EU/ 1/ 00/ 150/ 002 50 tablets EU/ 1/ 00/ 150/ 009 56 tablets EU/ 1/ 00/ 150/ 017 84 tablets EU/ 1/ 00/ 150/ 018 90 tablets EU/ 1/ 00/ 150/ 003 98 tablets
Batch:
Batch number:
43 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Actos 30 mg tabletter pioglitazon (som hydrochlorid)
pioglitazone (as hydrochloride)
EU/ 1/ 00/ 150/ 008 14 tabletter EU/ 1/ 00/ 150/ 004 28 tabletter EU/ 1/ 00/ 150/ 019 30 tabletter EU/ 1/ 00/ 150/ 005 50 tabletter EU/ 1/ 00/ 150/ 010 56 tabletter EU/ 1/ 00/ 150/ 020 84 tabletter EU/ 1/ 00/ 150/ 021 90 tabletter EU/ 1/ 00/ 150/ 006 98 tabletter
EU/ 1/ 00/ 150/ 008 14 tablets EU/ 1/ 00/ 150/ 004 28 tablets EU/ 1/ 00/ 150/ 019 30 tablets EU/ 1/ 00/ 150/ 005 50 tablets EU/ 1/ 00/ 150/ 010 56 tablets EU/ 1/ 00/ 150/ 020 84 tablets EU/ 1/ 00/ 150/ 021 90 tablets EU/ 1/ 00/ 150/ 006 98 tablets
45 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Actos 45 mg tabletter pioglitazon (som hydrochlorid)
pioglitazone (as hydrochloride)
46 9.
46 9.
EU/ 1/ 00/ 150/ 011 14 tabletter EU/ 1/ 00/ 150/ 012 28 tabletter EU/ 1/ 00/ 150/ 022 30 tabletter EU/ 1/ 00/ 150/ 013 50 tabletter EU/ 1/ 00/ 150/ 014 56 tabletter EU/ 1/ 00/ 150/ 023 84 tabletter EU/ 1/ 00/ 150/ 024 90 tabletter EU/ 1/ 00/ 150/ 015 98 tabletter
EU/ 1/ 00/ 150/ 011 14 tablets EU/ 1/ 00/ 150/ 012 28 tablets EU/ 1/ 00/ 150/ 022 30 tablets EU/ 1/ 00/ 150/ 013 50 tablets EU/ 1/ 00/ 150/ 014 56 tablets EU/ 1/ 00/ 150/ 023 84 tablets EU/ 1/ 00/ 150/ 024 90 tablets EU/ 1/ 00/ 150/ 015 98 tablets
47 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Actos 15 mg tabletter pioglitazon (som HCl)
Actos 15 mg tablets
FORKORTELSER FOR UGEDAGE (KUN FOR PAKNINGER AF 14, 28, 56, 84 OG 98 TABLETTER)
ABBREVIATIONS FOR DAYS OF THE WEEK (PACK SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)