FrancophonIA/ELRC3.0 huggingface dataset:
English: Kidney injury has been seen in patients who received filgrastim.
Danish: Der er blevet observeret nyreskader hos patienter, som fik filgrastim.
English: Discontinue Grastofil
Danish: Seponér Grastofil
English: • osteoporosis (bone disease),
Danish: • osteoporose (knoglesygdom)
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Danish: Kanylehætten på den fyldte injektionssprøjte indeholder tørt naturgummi (et latexderivat), som kan forårsage allergiske reaktioner.
English: The recommended dose of Grastofil is 0.5 MU/kg/day (5 micrograms/kg/day).
Danish: Den anbefalede Grastofil dosis er 0,5 ME/kg/dag (5 mikrogram/kg/dag).
English: Please tell your doctor before starting treatment if you have:
Danish: Inden behandling påbegyndes, skal du fortælle det til lægen, hvis du har:
English: It is supplied in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle.
Danish: Sprøjten har 1/40 trykte markeringer fra 0,1 ml til 1 ml på cylinderen.
English: • inflammation of the lungs (interstitial lung disease)
Danish: • betændelse i lungerne (interstitiel lungesygdom)
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomised studies, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Danish: Der blev ikke påvist nogen virkning på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet i en metaanalyse af allogene transplantationsstudier, som omfattede resultaterne fra 9 prospektive randomiserede studier, 8 retrospektive studier og 1 case-kontrolleret studie.
English: Nausea a
Danish: Kvalme a
English: • worsening of rheumatoid arthritis
Danish: • forværring af leddegigt (reumatoid artritis)
English: • generalised weakness (asthenia)
Danish: • generel svaghed (asteni)
English: Telephone +385/1.3764.111
Danish: STADA d.o.o Tel: +385/1.3764.111
English: • pain when passing urine (dysuria)
Danish: • smerter under vandladning (dysuri)
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in cancer patients treated with filgrastim.
Danish: Der er blevet indberettet pseudopodagra (chondrocalcinose) hos cancerpatienter, der blev behandlet med filgrastim.
English: Excipient with known effect
Danish: Kemoterapi med kendt cytotoksisk virkning
English: The recommended dose of Grastofil for PBPC mobilisation when used alone is 1.0 MU/kg/day (10 micrograms/kg/day) for 5-7 consecutive days.
Danish: Den anbefalede Grastofil dosis til PBPC-mobilisering er 1,0 ME/kg/dag (10 mikrogram/kg/dag) i 5-7 på hinanden følgende dage, når Grastofil anvendes alene.
English: > 5.0 x 10
Danish: 9/l til > 5,0 x 10
English: How long will I have to take Grastofil?
Danish: Så længe skal du tage Grastofil
English: • inflammation of the lung (bronchitis)
Danish: • betændelse i lungerne (bronkitis)
English: For infusions Grastofil should be diluted in 20 mL of 5% glucose solution (see section 6.6).
Danish: Til infusioner skal Grastofil fortyndes i 20 ml af en 5 % glukose-opløsning (se pkt.
English: Analysis includes patients receiving BM transplant during this period
Danish: Analysen omfatter studier med knoglemarvstransplantationer i denne periode.
English: Respiratory failure a
Danish: Respirationssvigt a
English: • to increase the number of white blood cells after a bone marrow transplant to help prevent infections
Danish: • til at øge antallet af hvide blodlegemer efter en knoglemarvstransplantation for at hjælpe med at forebygge infektioner
English: In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1-2 days after initiation of Grastofil therapy.
Danish: Der blev typisk set en forbigående stigning i neutrofiltallet 1-2 dage efter, at behandlingen med Grastofil var påbegyndt hos de patienter, som fik cytotoksisk kemoterapi.
English: Grastofil should be diluted in 20 mL of 5% glucose solution (see section 6.6).
Danish: Grastofil bør fortyndes i 20 ml 5 % glukose-opløsning (se pkt.
English: Each mL of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim.
Danish: Hver ml opløsning indeholder 96 millioner enheder (ME) (svarende til 960 mikrogram [μg]) filgrastim.
English: (Chondrocalcinosis Pyrophosphate)
Danish: (chondrocalcinose )
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, eller sygeplejerske.
English: In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen, this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.
Danish: Et forhøjet antal hvide blodlegemer og et nedsat antal blodplader, der sænker blodets størkningsevne (trombocytopeni) kan observeres hos normale stamcelledonorer.
English: Leukocytosis White blood cell counts of 100 x 10
Danish: Leukocytose Der er blevet observeret leukocyttal på 100 x 10
English: Suomi/Finland
Danish: Suomi
English: Vomiting a, e
Danish: Opkastning a, e
English: Cutaneous vasculitis a
Danish: Kutan vaskulitis a
English: 9/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Danish: 9/l) hos 35 % af forsøgspersonerne, der blev undersøgt.
English: Each syringe of 0.5 mL solution contains 48 MU (480 micrograms) of filgrastim (960 micrograms/mL).
Danish: Hver sprøjte med 0,5 ml opløsning indeholder 48 MU (480 mikrogram) filgrastim (960 mikrogram/ml).
English: Each pre-filled syringe contains 48 MU (480 μg) filgrastim in 0.5 mL solution.
Danish: Hver fyldt injektionssprøjte indeholder 48 ME (480 μg) filgrastim i 0,5 ml opløsning.
English: • upper respiratory tract infection
Danish: • infektion i de øvre luftveje
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger kan findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Meta-Analysis a
Danish: Metaanalyse a
English: Each pre-filled syringe contains 0.5 mL solution.
Danish: Hver fyldt injektionssprøjte indeholder 0,5 ml opløsning.
English: Interstitial lung disease a
Danish: Interstitiel lungesygdom a
English: PRE-FILLED SYRINGE
Danish: Makulopapuløst udslæt
English: Thrombocytopenia has been reported in patients receiving filgrastim.
Danish: Trombocytopeni er blevet indberettet hos patienter, der fik filgrastim.
English: Paediatric SCN patients
Danish: Pædiatriske patienter med SCN
English: • bleeding from the lung (pulmonary haemorrhage)
Danish: • blødning fra lungen (lungeblødning)
English: Diarrhoea a, e
Danish: Mave-tarm-kanalen Diarré a, e
English: How Grastofil is given
Danish: Sådan gives Grastofil
English: Each syringe of 0.5 mL solution contains 30 MU (300 micrograms) of filgrastim (600 micrograms/mL).
Danish: Hver sprøjte med 0,5 ml opløsning indeholder 30 MU (300 mikrogram) filgrastim (600 mikrogram/ml).
English: Each mL of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Danish: Hver ml opløsning indeholder 60 millioner enheder (ME) (svarende til 600 mikrograms [μg]) filgrastim.
English: Oedema peripheral e
Danish: Perifert ødem e
English: Solution for injection/infusion.
Danish: Injektions-/ infusionsvæske, opløsning
English: The Grastofil syringe has a scale on the syringe barrel.
Danish: Sprøjtecylinderen med Grastofil er forsynet med en skala.
English: Latvija STADA Arzneimittel AG
Danish: STADA Arzneimittel AG Teл.
English: Each pre-filled syringe contains 30 MU (300 μg) filgrastim in 0.5 mL solution.
Danish: Hver fyldt injektionssprøjte indeholder 30 ME (300 μg) filgrastim i 0,5 ml opløsning.
English: Grastofil can be removed from the refrigerator and left at room temperature (not above 25℃) for a single period of up to 15 days that ends within the labelled expiry date.
Danish: Inden for opbevaringstiden (se den påtrykte udløbsdato) kan Grastofil tages ud af køleskabet og opbevares ved stuetemperatur (ikke over 25 °C) i en enkelt periode på op til 15 dage.
English: Oropharyngeal pain a, e
Danish: Orofaryngeale smerter a, e
English: BN
Danish: BRM
English: Check with your doctor, nurse or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Danish: Det anbefales ikke at anvende filgrastim i perioden 24 timer før til 24 timer efter kemoterapi på grund af de hurtigt delende myeloide cellers følsomhed over for myelosuppressiv cytotoksisk kemoterapi.
English: How to use Grastofil
Danish: Sådan skal du bruge Grastofil
English: Fatigue a
Danish: Træthed a
English: Magyarország STADA Arzneimittel AG Telephone +49/6101.603.0
Danish: Magyarország STADA Arzneimittel AG Tel.: +49/6101.603.0
English: Capillary leak syndrome a
Danish: Kapillær lækagesyndrom a
English: Long-term administration may be required to maintain the ANC > 2.0 x 10
Danish: For at opretholde et ANC > 2,0 x 9/l kan langtidsbehandling være nødvendig.
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Danish: Tegn og symptomer omfatter udslæt i håndflader eller fodsåler samt sår i munden, maven, leveren, på huden eller i dine øjne, lunger, skede og led.
English: STADA Arzneimittel AG Telephone +49/6101.603.0
Danish: STADA Arzneimittel AG Tel +49/6101.603.0
English: EU/1/13/877/003 1 prefilled syringe EU/1/13/877/004 5 prefilled syringes
Danish: EU/1/13/877/003 1 fyldt injektionssprøjte EU/1/13/877/004 5 fyldte injektionssprøjter
English: Mucosal inflammation a
Danish: Slimhindebetændelse a
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Danish: Det har vist sig, at sværhedsgraden og varigheden af trombocytopeni efter myelosuppressiv eller myeloablativ kemotrapi nedsættes ved brug af PBPC, som er mobiliseret af filgrastim.
English: What Grastofil looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: What Grastofil is and what it is used for What you need to know before you use Grastofil How to use Grastofil
Danish: Det skal du vide, før du begynder at bruge Grastofil Sådan skal du bruge Grastofil Bivirkninger
English: EU/1/13/877/001 1 prefilled syringe EU/1/13/877/002 5 prefilled syringes
Danish: EU/1/13/877/001 1 fyldt injektionssprøjte EU/1/13/877/002 5 fyldte injektionssprøjter
English: In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10
Danish: Langtidsbehandling med Grastofil er indiceret til at øge neutrofiltallet og til at nedsætte hyppigheden og varigheden af infektionsrelaterede hændelser hos børn og voksne med svær medfødt, cyklisk eller idiopatisk neutropeni med et absolut neutrofiltal (ANC) på ≤ 0,5 x 10
English: If you use more Grastofil than you should
Danish: Hvis du har brugt for meget Grastofil
English: In clinical studies and the post-marketing setting pulmonary adverse reactions including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
Danish: I kliniske studier og efter markedsføring er der blevet indberettet pulmonale bivirkninger, herunder interstitiel lungesygdom, lungeødem og lungeinfiltration.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10 9/L prior to leukapheresis; in general apheresis should not be performed if platelets are
Danish: Hvis det er nødvendigt med mere end én leukaferese, skal man være særlig opmærksom på donorer, som har et trombocyttal <100 x10
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan ramme op til 1 ud af 10 persone):
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Danish: Filgrastim skal gives med forsigtighed til patienter med sekundær AML, da der foreligger begrænsede data om sikkerhed og virkning hos disse patienter.
English: Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy
Danish: Beskrivelse af udvalgte bivirkninger) Omfatter knoglesmerter, rygsmerter, artralgi, myalgi, smerter i ekstremiteter, muskuloskeletale smerter, muskuloskeletale smerter i brystet, nakkesmerter Der blev observeret tilfælde efter markedsføring hos patienter, der gennemgik knoglemarvstransplantation eller PBPC-mobilisering Uønskede hændelser med en højere forekomst hos filgrastimpatienter, sammenlignet med placebo, og forbundet med sequelae af underliggende malignitet eller cytotoksisk kemoterapi
English: Fluid volume disturbances
Danish: Væskevolumenforstyrrelser
English: Grastofil 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe filgrastim
Danish: Grastofil 48 ME/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte filgrastim
English: The cells are collected using a process called apheresis (ay-fer-ree-sis).
Danish: Cellerne høstes med en procedure, der kaldes aferese.
English: Asthenia a
Danish: Hovedpine a
English: Cough a
Danish: Hoste a
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1).
Danish: Der er indberettet tilfælde af GvHD og dødsfald blandt patienter, der fik G-CSF efter allogen knoglemarvstransplantation (se pkt.
English: • bone density decreased
Danish: • nedsat knogletæthed
English: Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe filgrastim
Danish: Grastofil 30 ME/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte filgrastim
English: Haematuria
Danish: Paræstesi
English: Urine abnormality
Danish: Urinanomali
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan ramme op til 1 ud af 100 personer)
English: (mucosal inflammation)
Danish: (chondrocalcinose)
English: Pain a
Danish: Smerter a
English: Publication
Danish: Administration
English: Capillary leak syndrome
Danish: Kapillær lækagesyndrom
English: Grastofil 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe
Danish: Grastofil 48 ME/0,5 ml injektions-/ infusionsvæske, opløsning, i en fyldt injektionssprøjte
English: Patients with renal/hepatic impairment
Danish: Patienter med nedsat nyre- eller leverfunktion
English: There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section Description of selected adverse reactions)
Danish: ; Beskrivelse af udvalgte bivirkninger Der har været rapporter om GvHD og dødsfald hos patienter efter allogen knoglemarvstransplantation (se pkt.
English: ANC > 1.0 x 10
Danish: ANC > 1,0x10 9/l i 3 på hinanden følgende dage
English: Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe
Danish: Grastofil 30 ME/0,5 ml injektions-/ infusionsvæske, opløsning, i en fyldt injektionssprøjte
English: Hypoaesthesia
Danish: Hypoæstesi
English: b a
Danish: Udslæt a
English: The European Commission granted a marketing authorisation valid throughout the European Union for Galvus on 26 September 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Galvus den 26. september 2007.
English: The full EPAR for Galvus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Galvus findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Galvus.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Galvus.
English: Other information about Galvus
Danish: Andre oplysninger om Galvus
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Galvus.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Galvus.
English: Galvus is a medicine that contains the active substance vildagliptin.
Danish: Galvus er et lægemiddel, der indeholder det aktive stof vildagliptin.
English: In adults, the recommended dose of Galvus is:
Danish: Den anbefalede dosis af Galvus til voksne er:
English: For more information about treatment with Galvus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Galvus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.
Danish: Til patienter med moderate eller svære nyresygdomme er den anbefalede dosis 50 mg en gang dagligt.
English: The most common side effect with Galvus (seen in between 1 and 10 patients in 100) is dizziness.
Danish: Den hyppigste bivirkning af Galvus (som ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed.
English: Galvus should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them.
Danish: Galvus skal derfor kun anvendes hos patienter, hos hvem metformin er uhensigtsmæssigt enten på grund af de bivirkninger, der indtræffer, eller fordi de har en tilstand, som gør, at metformin ikke er hensigtsmæssigt for dem.
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Galvus and at regular intervals during treatment.
Danish: Da vildagliptin er blevet sat i forbindelse med leverproblemer, skal patienterne undersøges, for at man kan kontrollere deres leverfunktion inden behandlingen med Galvus og med regelmæssige mellemrum under behandlingen.
English: The CHMP also considered the use of Galvus on its own and concluded that it was effective in reducing blood glucose but less so than metformin.
Danish: CHMP analyserede også anvendelsen af Galvus alene og konkluderede, at det var effektivt til at reducere blodsukkeret, dog i mindre grad end metformin.
English: The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Danish: Det aktive stof i Galvus, vildagliptin, er en dipeptidylpeptidase-IV (DPP-IV)- hæmmer.
English: Galvus is used to treat type 2 diabetes mellitus.
Danish: Galvus anvendes til behandling af type 2 diabetes .
English: What is the risk associated with Galvus?
Danish: Hvilken risiko er der forbundet med Galvus?
English: A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
Danish: en lavere dosis sulfonylurinstof bør også overvejes for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
English: Why has Galvus been approved?
Danish: Hvorfor blev Galvus godkendt?
English: The CHMP noted that Galvus was effective as an add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
Danish: CHMP bemærkede, at Galvus var effektivt som tillægsbehandling til metformin, thiazolidinedion eller et sulfonylurinstof (som dobbelt behandling), til et sulfonylurinstof og metformin (som tredobbelt behandling) eller til insulin med eller uden metformin, og konkluderede, at fordelene ved tillægsbehandlingen opvejer risiciene.
English: Galvus has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Danish: Galvus blev anvendt i elleve hovedundersøgelser, der tilsammen omfattede over 5 000 patienter med type 2-sukkersyge, hvis blodsukker ikke var tilfredsstillende reguleret.
English: What is Galvus?
Danish: Hvad er Galvus?
English: • one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
Danish: • en tablet om morgenen og en tablet om aftenen (100 mg pr. dag), når det tages alene, sammen med metformin, et thiazolidindion, metformin og et sulfonylurinstof eller insulin (med eller uden metformin),
English: Four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Danish: I fire undersøgelser blev virkningen af Galvus, 50 eller 100 mg dagligt i 24 uger, sammenlignet med placebo som tillægsbehandling til enten metformin (544 patienter), thiazolidindionet pioglitazon (463 patienter), sulfonylurinstoffet glimepirid (515 patienter) eller insulin (296 patienter).
English: When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels.
Danish: Som tillægsbehandling til anden medicin til behandling af type 2-sukkersyge var Galvus bedre end placebo til at sænke indholdet af HbA1c.
English: What is Galvus used for?
Danish: Hvad anvendes Galvus til?
English: • on its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin;
Danish: • alene (monoterapi) til patienter, hvis sukkersyge ikke kan kontrolleres tilstrækkeligt med diæt og motion, og for hvem behandling med metformin ikke anses for egnet,
English: What benefit has Galvus shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Galvus?
English: How has Galvus been studied?
Danish: Hvordan blev Galvus undersøgt?
English: In the study comparing Galvus with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Galvus.
Danish: Galvus anvendt alene var effektivt til at reducere indholdet af HbA1c, dog mindre effektivt end de lægemidler, det blev sammenlignet med. I den undersøgelse, der sammelignede Galvus med metformin, blev der opnået væsentligt bedre resultater med metformin: et fald i indholdet af HbA1c på 1,5 procent efter 52 uger sammenlignet med et fald på ca. 1 procent hos patienter behandlet med Galvus.