FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual Cyltezo dose for adults with ulcerative colitis is 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) at week 0 and 80 mg (as two 40 mg injections in one day) at week 2 and thereafter 40 mg every other week.
Danish: Den sædvanlige dosis Cyltezo til voksne med colitis ulcerosa er 160 mg i uge 0 (som fire 40 mg injektioner på en dag eller to 40 mg injektioner om dagen i to på hinanden følgende dage), og 80 mg (som to 40 mg injektioner på en dag) i uge to og herefter 40 mg hver anden uge.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Danish: Hvis hurtigere behandlingsrespons er nødvendigt, kan dit barns læge ordinere en startdosis på 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner på to på hinanden følgende dage) efterfulgt af 80 mg (som to 40 mg injektioner på en dag) to uger senere.
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later.
Danish: Den sædvanlige startdosis ved hidrosadenitis suppurativa er 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg 2 uger senere (som to 40 mg injektioner på en dag).
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Danish: Hos pædiatriske patienter med moderat til svær CD var åben adalimumab-induktionsdosis henholdsvis 160/80 mg eller 80/40 mg i uge 0 og 2, afhængigt af legemsvægt med en skillelinje ved 40 kg.
English: Keep the pre-filled syringe/pre-filled pen in the outer carton in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte/fyldte pen i den ydre karton for at beskytte mod lys.
English: Cyltezo in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Danish: ▪ behandling af moderat til alvorlig aktiv reumatoid artrit hos voksne patienter, hvor responset på sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været
English: Pancreatitis, dysphagia, face oedema
Danish: Nyreinsufficiens, hæmaturi
English: The recommended dose of Cyltezo for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Danish: Den anbefalede Cyltezo-dosis til voksne patienter er en startdosis på 80 mg subkutant, efterfulgt af 40 mg subkutant hver anden uge med start en uge efter den første dosis.
English: • Do not reuse a used pre-filled syringe.
Danish: • Den brugte injektionssprøjte må ikke genbruges.
English: Summary of the safety profile
Danish: 5.3 Prækliniske sikkerhedsdata
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se
English: NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Cyltezo 40 mg injektionsvæske, opløsning i fyldt pen
English: There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Danish: Det er ikke relevant at anvende adalimumab til børn i alderen under 4 år til denne indikation.
English: Beyond 16 weeks, patients with inadequate response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Danish: Patienter med utilstrækkeligt respons på Cyltezo 40 mg hver anden uge efter 16 ugers behandling eller mere kan have fordel af en stigning i dosis til 40 mg hver uge eller 80 mg hver anden uge.
English: • high blood measurements for lactate dehydrogenase;
Danish: • høje blodmålinger af lactatdehydrogenase • tilstedeværelse af autoantistoffer i blodet
English: Placebo (N = 28)
Danish: Placebo/MTX (N = 37)
English: Continued therapy should be carefully considered in a subject not responding by week 12.
Danish: Fortsat behandling skal overvejes nøje hos patienter, som ikke responderer inden for 12 uger.
English: • angioedema (localised swelling of the skin) • lichenoid skin reaction (itchy reddish-purple skin rash).
Danish: • lichenoid hudreaktion (kløende rød-lilla hududslæt)
English: There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Danish: Det er ikke relevant at anvende adalimumab til børn i alderen under 12 år til denne indikation.
English: • 1 pre-filled pen (0.8 mL sterile solution) in a blister, with 2 alcohol pads.
Danish: • 1 fyldt pen (0,8 ml steril opløsning) i et blister, med 2 alkoholservietter.
English: Discontinuation of Cyltezo therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Hos patienter med bekræftede signifikante hæmatologiske abnormiteter bør det overvejes at afbryde behandlingen med
English: • haematoma (a solid sweling with clotted blood);
Danish: • blodansamling (en fast hævelse af størknet blod)
English: If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and symptoms of your disease.
Danish: Hvis disse lægemidler ikke virker godt nok, kan du få Cyltezo for at mindske symptomerne på din
English: • autoantibodies present in the blood;
Danish: • forhøjede lipider i blodet
English: • Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Danish: • Aksial spondyloartritis uden radiografiske tegn på AS,
English: The recommended dose of Cyltezo is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Danish: Den anbefalede startdosis af Cyltezo er 80 mg (som to injektioner med 40 mg på samme dag), efterfulgt af 40 mg hver anden uge startende en uge efter den første dosis.
English: If these medicines do not work well enough, you will be given Cyltezo to treat your rheumatoid arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok, kan du få Cyltezo til behandling af din
English: • sensation disorders such as tingling, prickling or numbness; • symptoms of nerve root compression (including low back pain and leg pain);
Danish: • sure opstød (fordøjelsesbesvær, oppustethed, halsbrand) • Sjøgrens syndrom (inklusive tørre øjne og tør mund)
English: 73 % of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
Danish: 73 % af patienterne i Psoriasis-studie I
English: Asthma, dyspnoea, cough
Danish: Astma, dyspnø, hoste Ikke almindelig Lungeemboli
English: Nocturia
Danish: Stratum
English: Double Blind 32 weeks Adalimumab / MTX
Danish: Adalimumab/ MTX
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/mL during the induction period.
Danish: Hos patienter med Crohns sygdom blev der med en induktionsdosis på 80 mg adalimumab i uge 0 efterfulgt af 40 mg adalimumab i uge 2 opnået dal-serumkoncentrationer af adalimumab på ca.
English: NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in pre-filled pen
Danish: Cyltezo 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Cyltezo 40 mg injektionsvæske, opløsning i fyldt pen
English: NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Cyltezo 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Adalimumab 0.8 mg/kg eow N = 38
Danish: Adalimumab 0,8 mg/kg hver anden uge N = 38
English: One 0.8 mL pre-filled pen contains 40 mg adalimumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En fyldt 0,8 ml pen indeholder 40 mg adalimumab.
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more
Danish: Børn og unge fra 2 år der vejer 30 kg eller mere
English: The patients received 24 mg/m² body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Danish: 2 legemsoverfladeareal op til maksimalt 20 mg som subkutan injektion hver anden uge i mindst 24 uger.
English: Cyltezo dose for paediatric patients with uveitis
Danish: Cyltezo-dosis til patienter med uveitis
English: Crohn's disease in adults and children
Danish: Ikke-infektiøs uveitis hos voksne og børn
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among
Danish: Hyppigheden (95 % konfidensinterval) af lymfomer var 0,7 (0,2-2,7) pr.
English: • impotence;
Danish: • slagtilfælde
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Danish: • inflammation/betændelse i hudens blodkar (kutan vaskulitis)
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Danish: 1.000 patientår blandt de adalimumab-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: • 6 pre-filled pens (0.8 mL sterile solution), each in a blister, with 6 alcohol pads.
Danish: • 6 fyldte penne (0,8 ml steril opløsning), hver i et blister, med 6 alkoholservietter.
English: • 4 pre-filled pens (0.8 mL sterile solution), each in a blister, with 4 alcohol pads.
Danish: • 4 fyldte penne (0,8 ml steril opløsning), hver i et blister, med 4 alkoholservietter.
English: • 2 pre-filled pens (0.8 mL sterile solution), each in a blister, with 2 alcohol pads.
Danish: • 2 fyldte penne (0,8 ml steril opløsning), hver i et blister, med 2 alkoholservietter.
English: A similar safety profile was observed during retreatment as before withdrawal.
Danish: Under genbehandling var bivirkningsprofilen sammenlignelig med bivirkningsprofilen før
English: Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Danish: Børn og unge fra 6 år, der vejer fra 15 kg til mindre end 30 kg Cyltezo fås kun som 40 mg fyldt injektionssprøjte/fyldt pen.
English: Children and adolescents with Crohn's disease
Danish: Børn, unge og voksne med entesopatirelateret artrit
English: Cyltezo 40 mg solution for injection in pre-filled syringe
Danish: Cyltezo 40 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: Table 6:
Danish: Tabel 3:
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Danish: Hypertension, rødme, hæmatom Ikke almindelig Aorta-anurisme, vaskulær arteriel okklusion,
English: Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation.
Danish: Hæmatologiske tegn på kronisk inflammation forbedredes sædvanligvis hos patienter behandlet med
English: • 1 pre-filled syringe (0.8 mL sterile solution) in a blister, with 2 alcohol pads.
Danish: • 1 fyldt injektionssprøjte (0,8 ml steril opløsning) i et blister, med 2 alkoholservietter.
English: Efficacy results
Danish: Bivirkninger
English: The recommended Cyltezo dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1
Danish: Den anbefalede Cyltezo-dosis er 80 mg i uge 0, efterfulgt af 40 mg hver anden uge med start 1 uge efter den første dosis som subkutan injektion.
English: • 2 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 2 alcohol pads.
Danish: • 2 fyldte injektionssprøjter (0,8 ml steril opløsning), hver i et blister, med 2 alkoholservietter.
English: Placebo N = 49
Danish: PsA-studie II Placebo N = 49
English: • acid reflux disease;
Danish: • forhøjet urinsyre i blodet
English: • low blood potassium.
Danish: • lave blodmålinger af calcium
English: • 4 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 4 alcohol pads.
Danish: • 4 fyldte injektionssprøjter (0,8 ml steril opløsning), hver i et blister, med 4 alkoholservietter.
English: Pregnancy
Danish: Ældre
English: • 6 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 6 alcohol pads.
Danish: • 6 fyldte injektionssprøjter (0,8 ml steril opløsning), hver i et blister, med 6 alkoholservietter.
English: Cardiac arrest
Danish: • hjertetilfælde
English: Headache
Danish: Hjertestop
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE
English: Keep the syringe in the outer carton in order to protect from light.
Danish: Opbevar injektionssprøjten i den ydre karton for at beskytte mod lys.
English: ACR Responses in Placebo-Controlled Trials (Percent of Patients) RA Study II a**
Danish: ACR-respons i placebokontrollerede studier (Procentdel af patienter)
English: Musculoskeletal pain
Danish: • hudkræft
English: Table 21:
Danish: Tabel 12:
English: • sleep interruptions;
Danish: • søvnbesvær
English: Keep the syringes in the outer carton in order to protect from light.
Danish: Opbevar injektionssprøjterne i den ydre karton for at beskytte mod lys.
English: Adalimumab 40 mg eow N = 109
Danish: Adalimumab 40 mg hver anden uge N = 109
English: Inflammation
Danish: Injektionssteder
English: Adults with hidradenitis suppurativa
Danish: Voksne med psoriasis
English: Allergic reactions
Danish: Alvorlige infektioner
English: Elimination
Danish: Administration
English: Liver failure
Danish: Nedsat helingsevne
English: Hypertension, flushing, haematoma
Danish: Luftveje, thorax og mediastinum*
English: Children and adolescents with chronic non-infectious uveitis from 2 years of age Children and adolescents from 2 years of age weighing less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Danish: Børn og unge fra 2 år med kronisk ikke-infektiøs uveitis Børn og unge fra 2 år der vejer mindre end 30 kg
English: The inner part of the cap (the needle cover) of the syringe contains natural rubber (latex).
Danish: Beskyttelseshætten på injektionssprøjten indeholder latex Den indre del af hætten (beskyttelseshætten) på injektionssprøjten indeholder naturgummi (latex).
English: Table 24:
Danish: Tabel 26:
English: Low Dose 20/10 mg eow
Danish: Lavdosis 20/10 mg hver anden uge
English: • vasculitis (inflammation of blood vessels);
Danish: • dehydrering (væskemangel)
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients
Danish: I et adalimumab-studie med pædiatriske patienter blev der ikke observeret nogen maligniteter hos 60 pædiatriske patienter med en samlet eksponering på
English: Double-Blind Response at Week 12
Danish: Uge 26 Klinisk remission
English: Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement
Danish: Behandling ud over 12 uger skal nøje genovervejes hos patienter, som ikke responderer inden for
English: Absorption and distribution
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Leukocytosis, thrombocytopenia
Danish: Hepatosplenisk T-celle-lymfom
English: • pleural effusion (abnormal collection of fluid in the pleural space);
Danish: • unormal ophobning af væske mellem lungehinderne (pleuraeffusion)
English: Lipids increased
Danish: • stigning i leverenzymer
English: • erythema multiforme (inflammatory skin rash);
Danish: • neuropati (nerveskade)
English: • trouble breathing, swallowing;
Danish: • besvær med at trække vejret eller synke
English: System Organ Class Frequency
Danish: Erythema multiforme
English: Tell your doctor if - you are, you think you might be or are planning to become pregnant.
Danish: Fortæl Deres læge hvis De er, tror De er eller planlægger at blive gravid.
English: - if you have or have ever had bladder cancer.
Danish: hvis De har eller nogensinde har haft blærekræft.
English: Date of first authorisation: 11/10/2000 Date of latest renewal: 31/08/2010
Danish: Dato for første markedsføringstilladelse: 11.10.2000 Dato for seneste fornyelse: 31.08.2010
English: - if you have a problem with your liver or heart.
Danish: hvis De har problemer med Deres lever eller hjerte.
English: Take Glustin daily as prescribed.
Danish: Tag Glustin dagligt som foreskrevet.
English: - if you have blood in your urine that your doctor has not checked.
Danish: hvis De har blod i urinen, og Deres læge ikke har undersøgt årsagen.
English: Ísland Vistor hf.
Danish: Vistor hf.
English: Glustin helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Danish: Glustin hjælper med at kontrollere sukkerniveauet i Deres blod, hvis De har type 2-diabetes, ved at hjælpe Deres krop til bedre at udnytte den insulin, kroppen producerer.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glustin.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi De kan få ægløsning igen, når De tager Glustin.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheden er defineret som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you stop using Glustin, your blood sugar may go up.
Danish: Hvis De holder op med at tage Glustin, kan Deres blodsukker stige.
English: - if you have liver disease.
Danish: hvis De har leversygdom.
English: Glustin has no or negligible influence on the ability to drive and use machines.
Danish: Glustin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The safety and efficacy of Glustin in children and adolescents under 18 years of age have not been established.
Danish: Glutins sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Glustin.
Danish: Hvis De følger en særlig diabetesdiæt, skal De fortsætte med denne diæt, mens De tager Glustin.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Danish: Næsten halvdelen af patienterne havde tidligere haft en hjerteinfarkt og omkring 20 % havde haft et slagtilfælde.
English: Your doctor will ask you to have blood tests periodically during treatment with Glustin.
Danish: Deres læge vil bede Dem om at få taget blodprøver periodevis, mens De er i behandling med Glustin.
English: Talk to your doctor or pharmacist before taking Glustin (also see section 4) - if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Glustin (se også punkt 4) hvis De har vand i kroppen (ødemer) eller har problemer med hjertesvigt, specielt hvis De er over 75 år.
English: If you take Glustin with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Hvis De tager Glustin sammen med anden diabetesmedicin, er der en større risiko for, at Deres blodsukker falder til under det normale niveau (hypoglykæmi).
English: When Glustin is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Danish: Når Glustin tages sammen med andre lægemidler, der anvendes til behandling af sukkersyge (f.eks. insulin, chlorpropamid, glibenclamid, gliclazid, tolbutamid), vil Deres læge give Dem besked på, om De skal tage en mindre dosis af lægemidlerne.
English: - if you have cysts on your ovaries (polycystic ovary syndrome).
Danish: hvis De har cyster på æggestokkene (polycystisk ovariesyndrom).
English: Immune System Disorders hypersensitivity and allergic reactions1
Danish: Immuns ys te me t overfølsomhed og allergiske reaktioner1
English: MANUFACTURER'S BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Danish: Interaktion med præparater, der metaboliseres af disse enzymer, f.eks. orale kontraceptiva, cyclosporin, calciumkanalblokkere og HMGCoA-reduktasehæmmere, kan ikke forventes.
English: - if you have heart failure or have had heart failure in the past.
Danish: hvis De lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: Before you start taking Glustin you will have a blood sample taken to check your liver function.
Danish: Før De begynder at tage Glustin, vil De få taget en blodprøve til kontrol af leverfunktionen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glustin in all subsets of the paediatric population in type 2 diabetes mellitus.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Glustin i alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Glustin, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029).
Danish: Tilfælde af blærecancer blev rapporteret oftere i en metaanalyse af kontrollerede kliniske studier med pioglitazon (19 tilfælde hos 12.506 patienter, 0,15 %) end i kontrolgruppen (7 tilfælde hos 10.212 patienter, 0,0 7 %), HR = 2,64 (95 % CI 1,11-6,31; p = 0,029).
English: Environmental Risk Assessment (ERA) No environmental impact is anticipated from the clinical use of pioglitazone
Danish: Miljørisikovurdering Der forventes ingen virkninger på miljøet fra klinisk anvendelse af pioglitazon.
English: See section 2 “Glustin contains lactose monohydrate”.
Danish: Se punkt 2 ”Glustin indeholder lactosemonohydrat”.
English: Glustin contains pioglitazone.
Danish: Glustin indeholder pioglitazon.
English: You can usually continue to take other medicines whilst you are being treated with Glustin.
Danish: De kan normalt blive ved med at tage anden medicin, mens De får Glustin.
English: - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Glustin hvis De er allergisk over for pioglitazon eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).