natgillin/translations-raw huggingface dataset:
134 Latvija Novartis Pharma Services Inc.
Latvija Novartis Pharma Services Inc.
135 INDLÆGSSEDDEL:
133 PACKAGE LEAFLET:
Anvendelse af anden medicin Hvis du tager eller for nylig har taget andre lægemidler, bør du oplyse din læge eller apotek herom, også hvis der er tale om ikke- receptpligtige lægemidler (f. eks. paracetamol), inklusive naturlægemidler (for eksempel prikbladet perikum).
St.
Visse lægemidler kan påvirke virkningen af Glivec, når de anvendes samtidig.
John’ s Wort) Certain medicines may interfere with the effect of Glivec when taken together.
Du bør konsultere din 137 læge eller apoteket, hvis du er usikker.
You should check with your doctor or pharmacist if you are not sure.
Hvor meget skal du indtage Voksne:
135 How much to take Adults:
50 ml til en 100 mg tablet og 200 ml til en 400 mg tablet) • Omrør med en ske indtil tabletterne er fuldstændig opløst • Drik straks hele glassets indhold.
If you are unable to swallow the tablets, you can dissolve them in a glass of mineral water or apple juice: • Put the required number of tablet(s) in a sufficient quantity of liquid (approximately 50 ml for a 100 mg tablet and 200 ml for a 400 mg tablet) • Stir with a spoon until the tablets have dissolved completely • Immediately drink the whole content of the glass.
138 Hvis du glemmer at tage Glivec Glemmer du at tage medicinen, så tag den straks du husker det, den dag du glemte det og fortsæt så med den planlagte dosering.
136 If you forget to take Glivec Take the missed dose as soon as you remember on the day you missed, then continue with your normal schedule.
139 Andre mulige bivirkninger:
Other possible side effects:
Appetitløshed, svimmelhed, søvnløshed, betændelse af øjets bindehinde, øget tåreflåd, smagsforstyrrelser, næseblod, smerte eller opsvulmen af maven, luft i maven, forstoppelse, kløe, usædvanligt hårtab eller udtyndning af håret, natlig svedtendens, svaghed, følelsesløshed i hænder og fødder, halsbrand, sløret syn, sår i munden, hævede led og ledsmerter, vægttab, mundtørhed, tør hud, tørre øjne, nedsat følsomhed i huden, øget følsomhed i huden, hedeture og kulderystelser.
137 sweats, weakness, numbness of the hands or feet, heartburn, blurred vision, mouth ulceration, joint swelling and joint pain, decreased weight, dry mouth, dry skin, dry eye, decreased skin sensitivity, increased skin sensitivity, hot flushes, chills.
Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apotek.
If any of the side effects gets serious or if you notice any other side effects not listed in this leaflet, please inform your doctor or pharmacist.
Produktets udseende og pakningsstørrelse Glivec 400 mg filmovertrukne tabletter er meget mørkegule til brun- orange ovale tabletter præget med ” NVR ” på den ene side og ” SL ” på den anden side.
What Glivec looks like and contents of the pack Glivec 400 mg film-coated tablets are very dark yellow to brownish-orange oval tablets with “ NVR” on one side and “ SL” on the other side.
140 België/ Belgique/ Belgien Novartis Pharma N. V.
België/ Belgique/ Belgien Novartis Pharma N. V.
Glubrava er et lægemiddel, der leveres som hvide, aflange tabletter, og som indeholder to aktive stoffer, pioglitazon (15 mg) og metformin hydrochlorid (850 mg).
Glubrava is a medicine that is available as white, oblong tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Lægemidlet er identisk med Competact, som allerede er godkendt i Den Europæiske Union (EU).
This medicine is the same as Competact, which is already authorised in the European Union (EU).
Firmaet, som fremstiller Competact, har givet tilladelse til, at dets videnskabelige oplysninger må anvendes for Glubrava.
The company that makes Competact has agreed that its scientific data can be used for Glubrava.
Glubrava anvendes til patienter (navnlig overvægtige patienter), som lider af ikke- insulinkrævende diabetes (type 2 - diabetes).
Glubrava is used in patients (particularly those who are overweight) who have non insulin-dependent diabetes (type 2 diabetes).
Glubrava anvendes til patienter, som ikke er tilfredsstillende kontrolleret udelukkende med metformin (et lægemiddel mod diabetes) ved den højest mulige dosis.
Glubrava is used in patients who are not satisfactorily controlled on metformin (an anti-diabetes medicine) used on its own and at the maximum possible dose.
Den sædvanlige dosis Glubrava er én tablet to gange dagligt.
The usual dose of Glubrava is one tablet taken twice a day.
Hvis Glubrava tages sammen med eller lige efter et måltid, kan dette reducere eventuelle maveproblemer forårsaget af metformin.
Taking Glubrava with or just after food may reduce any stomach problems caused by metformin.
Ældre patienter, som behandles med Glubrava, skal have deres nyrefunktion kontrolleret regelmæssigt.
Elderly patients should have their kidney function monitored regularly.
Type 2- diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere glukosekoncentrationen i blodet.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood.
Glubrava indeholder to aktive stoffer, som hver især virker forskelligt.
Glubrava contains two active substances, which each have a different mode of action.
Hvordan blev Glubrava undersøgt?
Reproduction is authorised provided the source is acknowledged. took the combination.
HbA1c- niveauerne faldt yderligere med 0, 64 til 0, 89% i forhold til niveauerne, når der kun anvendes metformin.
In all studies, adding pioglitazone 30 mg to metformin gave an improvement in the control of blood glucose, with levels of HbA1c which were further decreased by 0.64 to 0.89% compared to the levels on metformin alone.
De hyppigste bivirkninger af Glubrava (ses hos mellem 1 og 10 patienter ud af 100) er anæmi (lavt antal røde blodlegemer), synsforstyrrelser, vægtforøgelse, artralgi (ledsmerter), hovedpine, hæmaturi (blod i urinen) og erektil dysfunktion (problemer med at få erektion).
The most common side effects of Glubrava (seen in between 1 and 10 patients in 100) are anaemia (low red blood cells), visual disturbance, weight increase, arthralgia (joint pain), headache, haematuria (blood in the urine) and erectile dysfunction (problems getting an erection).
Den fuldstændige liste over de indberettede bivirkninger ved Glubrava fremgår af indlægssedlen.
For the full list of all side effects reported with Glubrava, see the Package Leaflet.
Glubrava bør ikke anvendes til personer, der kan være overfølsomme (allergiske) over for pioglitazon, metformin eller et eller flere af de øvrige indholdsstoffer, og til patienter med hjerteinsufficiens eller lever - eller nyreproblemer.
Glubrava should not be used in people who may be hypersensitive (allergic) to pioglitazone, metformin or any of the other ingredients, and in patients who have heart failure, or problems with their liver or their kidneys.
Glubrava bør ikke anvendes til patienter med sygdomme, der medfører mangelfuld ilttilførsel til vævet, f. eks. som følge af et nyligt hjertetilfælde eller chok.
Glubrava should not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Glubrava bør ikke anvendes i tilfælde af alkoholforgiftning, diabetisk ketoacidose (højt ketonindhold), sygdomme, der kan påvirke nyrerne, og under amning.
Glubrava should not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may affect the kidneys, and during breast-feeding.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at der var påvist tilstrækkelig effekt af pioglitazon og metformin hos type 2- diabetes, og at Glubrava forenkler behandlingen og forbedrer overholdelsen af anvendelsesbestemmelserne, når der kræves en kombination af de aktive indholdsstoffer.
The Committee for Medicinal products for Human Use (CHMP) concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Glubrava simplifies treatment and improves compliance when a combination of the active substances is required.
Udvalget besluttede, at fordelene ved Glubrava er større end risiciene ved behandling af type 2 - diabetes.
They decided that Glubrava’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Glubrava.
They recommended that Glubrava be given marketing authorisation.
Andre oplysninger om Glubrava:
Other information about Glubrava:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Glubrava til Takeda Global Research and Development Centre (Europe) Ltd den 11. december 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Glubrava to Takeda Global Research and Development Centre (Europe) Ltd on 11 December 2007.
Den fuldstændige EPAR om Glubrava findes her.
The full EPAR for Glubrava is available here.
Dette sammendrag blev sidst ajourført i 03- 2008.
This summary was last updated in 03-2008.
EU- nummer EU/ 1/ 07/ 421/ 001 EU/ 1/ 07/ 421/ 002 EU/ 1/ 07/ 421/ 003 EU/ 1/ 07/ 421/ 004 EU/ 1/ 07/ 421/ 005 EU/ 1/ 07/ 421/ 006 EU/ 1/ 07/ 421/ 007 EU/ 1/ 07/ 421/ 008 EU/ 1/ 07/ 421/ 009
EU Number EU/ 1/ 07/ 421/ 001 EU/ 1/ 07/ 421/ 002 EU/ 1/ 07/ 421/ 003 EU/ 1/ 07/ 421/ 004 EU/ 1/ 07/ 421/ 005 EU/ 1/ 07/ 421/ 006 EU/ 1/ 07/ 421/ 007 EU/ 1/ 07/ 421/ 008 EU/ 1/ 07/ 421/ 009
Navn 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg
Strength 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg
Styrke Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava
Pharmaceutical Form Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Paknings- størrelse 14 28 30 50 56 60 90 98 180
Package size 14 28 30 50 56 60 90 98 180
Glubrava 15 mg/ 850 mg filmovertrukket tablet.
Glubrava 15 mg/ 850 mg film-coated tablets.
Glubrava er indiceret til behandling af type 2 diabetes mellitus- patienter, særligt hos overvægtige patienter, som ikke kan opnå tilstrækkelig glykæmisk kontrol ved deres maksimalt tolererede dosis af oral metformin alene.
Glubrava is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Den normale dosis af Glubrava er 30 mg pioglitazon dagligt plus 1700 mg metforminhydrochlorid dagligt (givet som en Glubrava- tablet med 15 mg/ 850 mg 2 gange dagligt).
Dosage in adults The usual dose of Glubrava is 30 mg/ day pioglitazone plus 1700 mg/ day of metformin hydrochloride (this dosage is achievable with one tablet of Glubrava 15 mg/ 850 mg, taken twice a day).
Et direkte skift fra metformin monoterapi til Glubrava kan overvejes, hvis det vurderes klinisk passende.
When clinically appropriate, direct change from metformin monotherapy to Glubrava may be considered.
De gastrointestinale symptomer forbundet med metformin kan reduceres, hvis Glubrava tages med, eller umiddelbart efter, et måltid.
Taking Glubrava with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
4. 3 og 4. 4).
Elderly As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Glubrava should have their renal function monitored regularly (see sections 4.3 and 4.4).
4. 3 og 4. 4).
Patients with renal impairment Glubrava should not be used in patients with renal failure or renal dysfunction (creatinine clearance < 60 ml/ min)(see sections 4.3 and 4.4).
4. 3 og 4. 4).
Patients with hepatic impairment Glubrava should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Der er ingen tilgængelige data om brugen af pioglitazon hos personer under 18 år, og brugen af Glubrava anbefales derfor ikke til denne aldersgruppe.
2 Children and adolescents There are no data available on the use of pioglitazone in patients under 18 years of age and therefore the use of Glubrava in this age group is not recommended.
Lactacidose er en meget sjælden, men alvorlig, metabolisk komplikation, der kan forekomme på grund af metforminophobning.
Lactic acidosis Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.
Lactacidose er karakteriseret ved acidotisk dyspnø, mavesmerter og hypotermi efterfulgt af koma.
Diagnosi Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Da metformin udskilles via nyrerne, bør serum- kreatininkoncentrationen bestemmes regelmæssigt:
Renal Function As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly:
Pioglitazon kan forårsage væskeretention, hvilket kan forværre eller forårsage hjerteinsufficiens.
3 Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Ved behandling af patienter, der har mindst én risikofaktor for udvikling af hjerteinsufficiens (f. eks. tidligere hjerteinfarkt eller symptomgivende koronar arteriel sygdom), bør lægen starte med den lavest
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose and increase the dose gradually.
Patienterne bør observeres med henblik på tegn og symptomer på hjerteinsufficiens, vægtøgning og ødem.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema particularly those with reduced cardiac reserve.
Der er spontant rapporterede tilfælde af hjerteinsufficiens, hvor pioglitazon har været anvendt i kombination med insulin, eller, hvor pioglitazon har været anvendt hos patienter med hjerteinsufficiens i anamnesen.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Da insulin og pioglitazon er associeret med væskeretention, kan samtidig indgivelse af insulin og Glubrava øge risikoen for ødemer.
Since insulin and pioglitazone are associated with fluid retention, concomitant administration of insulin and Glubrava may increase the risk of oedema.
Glubrava bør seponeres, hvis der opstår en forværring i hjertestatus.
Glubrava should be discontinued if any deterioration in cardiac status occurs.
4. 8).
Monitoring of Liver Function There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8).
Behandling med Glubrava bør ikke igangsættes hos patienter med forhøjede leverenzymer (ALT > 2, 5 X øvre normal grænse) eller hos patienter med tegn på leversygdom.
Therapy with Glubrava 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.
Hvis ALT- niveauer øges til 3 X den øvre, normale grænse under Glubrava- behandling, bør leverenzymniveauerne vurderes igen så hurtigt som muligt.
If ALT levels are increased to 3 X upper limit of normal during Glubrava therapy, liver enzyme levels should be reassessed as soon as possible.
I kliniske forsøg med pioglitazon var der tegn på dosisrelateret vægtøgning, hvilket kan skyldes fedtophobning og i nogle tilfælde som følge af væskeretention.
Weight Gain In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Dette er foreneligt med blodfortynding.
Haematology There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Patienter, der er i behandling med pioglitazon kombineret med sulfonylurinstof, kan have risiko for dosisrelateret hypoglykæmi, og det kan være nødvendigt at reducere dosis af sulfonylurinstof.
Hypoglycaemia Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose- related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
Der er efter markedsføringen blevet rapporteret om nyudbrud eller forværring af diabetisk makulært ødem med nedsat synsevne med thiazolidinedioner, herunder pioglitazon.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Passende oftalmologisk henvisning bør overvejes.
It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Behandlingen bør sædvanligvis ikke genoptages før efter 48 timer.
4 Surgery As Glubrava contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not be usually resumed earlier than 48 hours afterwards.
Intravaskulær administration af jodholdige kontrastmidler ved radiologiske undersøgelser kan føre til nyreinsufficiens.
Administration of iodinated contrast agent The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
4. 5).
Therefore, due to the metformin active substance, Glubrava should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Som en konsekvens af forøget insulinvirkning kan behandling med pioglitazon hos patienter med polycystisk ovariesyndrom måske resultere i fornyet ovulation.
Polycystic ovarian syndrome As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
I en poolet analyse af bivirkningsrapporter om knoglefrakturer fra randomiserede, kontrollerede, dobbeltblindede kliniske forsøg med over 8100 patienter på pioglitazon og 7400 patienter på komparator, der blev behandlet i op til 3, 5 år, blev der set en forøget incidens af frakturer hos kvinder.
Others An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Der er ikke udført formelle interaktionsundersøgelser med Glubrava.
There have been no formal interaction studies for Glubrava.
5 Der er rapporter om, at samtidig administration af pioglitazon og gemfibrozil (en hæmmer af cytochrom P450 2C8) har resulteret i en stigning på 3 gange i AUC for pioglitazon.
5 Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Der er øget risiko for lactacidose ved akut alkoholforgiftning (særligt i tilfælde af faste, fejlernæring eller leverinsufficiens) på grund af indholdet af metformin i Glubrava (se pkt.
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Glubrava (see section 4.4).
Behandlingen bør dog kun genoptages, hvis nyrefunktionen er revurderet og fundet normal.
Metformin should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.
Glucokortikoider (indgivet systemisk og lokalt), beta- 2- agonister og diuretika har intern hyperglykæmisk aktivitet.
Combinations requiring precautions for use Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Der findes ingen tilgængelige prækliniske eller kliniske data for eksponering af gravide og ammende for Glubrava.
For Glubrava no preclinical or clinical data on exposed pregnancies or lactation are available.
Der foreligger ikke tilstrækkelige humane data om brugen af pioglitazon hos gravide kvinder.
Risk related to pioglitazone There are no adequate human data from the use of pioglitazone in pregnant women.
5. 3).
Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3).
Dyreforsøg har ikke afsløret teratogen effekt.
Risk related to metformin Animal studies have not revealed teratogenic effects.
Glubrava må dog ikke anvendes under graviditet eller hos kvinder i den fødedygtige alder, som ikke anvender svangerskabsforebyggende foranstaltninger.
However, Glubrava should not be used during pregnancy and in women of child-bearing age not using contraceptive measures.
Hvis en patient ønsker at blive gravid eller bliver gravid, skal behandlingen med Glubrava afbrydes.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Glubrava should be discontinued.
4. 3).
Glubrava must therefore not be used in women who are breast-feeding (see section 4.3).
6 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
6 4.7 Effects on ability to drive and use machines
5. 2).
There have been no therapeutic clinical trials conducted with Glubrava tablets however bioequivalence of Glubrava with co-administered pioglitazone and metformin has been demonstrated (see section 5.2).
PIOGLITAZON I KOMBINATIONSBEHANDLING MED METFORMIN
PIOGLITAZONE IN COMBINATION THERAPY WITH METFORMIN
Gastrointestinale sygdomme Usædvanlig:
Gastrointestinal disorders Uncommon:
Sygdomme i bevægeapparatet og bindevæv Almindelig:
Musculoskeletal system and connective tissue disorders Common:
Sygdomme i nyre og urinveje Almindelig:
Renal and urinary Common:
hæmaturi
disorders haematuria
7 I kliniske forsøg med pioglitazon var hyppigheden af forhøjelser i ALT større end tre gange den øvre grænse for normal lig med placebo men mindre end det observerede i sammenligningsgrupperne med metformin og sulfonylurinstof.
7 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Øjensygdomme Makulært ødem:
Eye disorders Macular oedema:
Stofskiftesygdomme og ernæringsbetingede sygdomme:
Metabolism and nutrition disorders Very rare:
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Lactic acidosis (see 4.4 Special warnings and precautions for use).
Almindelig:
Nervous system disorders Common:
Isolerede rapporter:
Hepatobiliary disorders Isolated reports:
Meget sjælden:
Skin and subcutaneous tissue disorders Very rare:
Der blev udført en poolet analyse af bivirkningsrapporter om knoglefrakturer fra randomiserede, komparatorkontrollerede, dobbeltblindede kliniske forsøg med over 8100 patienter i den pioglitazonbehandlede gruppe og 7400 patienter i den komparatorbehandlede gruppe, der blev
A higher rate of
8 behandlet i op til 3, 5 år.
8 fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Der blev observeret en øget hyppighed af frakturer hos kvinder, der tog pioglitazon (2, 6%) sammenlignet med komparator (1, 7%).
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
A10BD05
A10BD05.