FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the patient Hyrimoz 40 mg solution for injection in pre-filled pen adalimumab
Danish: Indlægsseddel: Information til brugeren Hyrimoz 40 mg injektionsvæske, opløsning i fyldt pen
English: Hyrimoz 40 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Danish: Hyrimoz 40 mg injektionsvæske, opløsning (injektion) i fyldt injektionssprøjte leveres som en 0,8 ml klar til lettere opaliserende, farveløs til let gullig injektionsvæske.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hyrimoz (see section 4.4).
Danish: Før initiering af behandling med Hyrimoz rådes øjenlæger til at rådføre sig med en passende specialist (se pkt.
English: Hyrimoz is administered by subcutaneous injection.
Danish: Hyrimoz administreres ved subkutan injektion.
English: Hyrimoz 40 mg / 0.8 ml injection adalimumab SC
Danish: Hyrimoz 40 mg / 0,8 ml injektion adalimumab s.c.
English: Hyrimoz 40 mg solution for injection in pre-filled syringe Hyrimoz 40 mg solution for injection in pre-filled pen
Danish: Hyrimoz 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Hyrimoz 40 mg injektionsvæske, opløsning i fyldt pen
English: The recommended dose of Hyrimoz for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Danish: Den anbefalede Hyrimoz-dosis til patienter fra 6 år med entesopatirelateret artrit er baseret på legemsvægt (tabel 2).
English: In monotherapy, some patients who experience a decrease in their response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Danish: Ved behandling med Hyrimoz alene kan det være en fordel for visse patienter, der oplever faldende respons på Hyrimoz 40 mg hver anden uge, at øge dosis til 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: Hyrimoz 40 mg injection adalimumab
Danish: Hyrimoz 40 mg injektion adalimumab s.c.
English: The recommended Hyrimoz dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Danish: Den anbefalede Hyrimoz-dosis er 80 mg subkutant i uge 0, efterfulgt af 40 mg subkutant hver anden uge med start 1 uge efter den første dosis.
English: There is no relevant use of Hyrimoz in children aged less than 2 years in this indication.
Danish: Det er ikke relevant at bruge Hyrimoz til patienter under 2 år til denne indikation.
English: 5 How to store Hyrimoz Contents of the pack and other information Instructions for use
Danish: Pakningsstørrelser og yderligere oplysninger Brugsvejledning
English: Hyrimoz is used to treat psoriatic arthritis in adults.
Danish: Hyrimoz bruges til at behandle psoriasisartrit hos voksne.
English: paleness.
Danish: Hyrimoz.
English: The recommended Hyrimoz induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Danish: Det anbefalede Hyrimoz dosis-induktionsregime til voksne patienter med moderat til svær colitis ulcerosa er 160 mg i uge 0 (givet som fire 40 mg injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage) og 80 mg i uge 2 (givet som to 40 mg injektioner på en dag).
English: The recommended dose of Hyrimoz for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Danish: Den anbefalede Hyrimoz-dosis til voksne patienter med uveitis er en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: Consequently, Hyrimoz can be used during breastfeeding..
Danish: Hyrimoz kan som konsekvens heraf anvendes ved amning.
English: The recommended Hyrimoz dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Danish: Det anbefalede Hyrimoz dosisregime til voksne patienter med hidrosadenitis suppurativa (HS) er 160 mg på dag 1 (givet som fire injektioner af 40 mg på en dag eller som to injektioner af 40 mg pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg to uger senere på dag 15 (givet som to injektioner af 40 mg på en dag).
English: Each pen contains 40 mg/0.8 ml of Hyrimoz.
Danish: Hver pen indeholder 40 mg/0,8 ml
English: You should record the date when your pre-filled syringe is first removed from the refrigerator, and the date after which it should be discarded.
Danish: Du skal registrere den dato, hvor din fyldte injektionssprøjte først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres.
English: Figure A: Hyrimoz SensoReady pen parts
Danish: Figur A: Delene i Hyrimoz SensoReady pen I Figur A er pennen vist med hætten fjernet.
English: Beyond 16 weeks, patients with inadequate response to Hyrimoz 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 Hyrimoz 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: If you use more Hyrimoz than you should
Danish: Hvis du har taget for meget Hyrimoz
English: How should you store Hyrimoz?
Danish: Sådan skal du opbevare Hyrimoz:
English: The recommended dose of Hyrimoz 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 Hyrimoz-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: How to use Hyrimoz
Danish: Sådan skal du tage Hyrimoz
English: Hyrimoz dose for paediatric patients with uveitis Patient weight
Danish: Hyrimoz-dosis til pædiatriske patienter med uveitis Patientvægt
English: The recommended dose of Hyrimoz 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 Hyrimoz er 80 mg (som to 40 mg injektioner på en dag), efterfulgt af 40 mg hver anden uge startende en uge efter den første dosis.
English: Discontinuation of Hyrimoz 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 Hyrimoz.
English: The usual Hyrimoz dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Danish: Den anbefalede startdosis Hyrimoz til voksne med colitis ulcerosa er 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner pr. dag i to på hinanden følgende dage), derefter 80 mg (som to 40 mg injektioner) to uger senere, og herefter 40 mg hver anden uge.
English: Each syringe contains 40 mg/0.8 ml of Hyrimoz.
Danish: Hver sprøjte indeholder 40 mg/0,8 ml
English: Hyrimoz 40 mg solution for injection in pre-filled pen adalimumab
Danish: Hyrimoz 40 mg injektionsvæske, opløsning i fyldt pen adalimumab
English: Hyrimoz 40 mg solution for injection in pre-filled syringe adalimumab
Danish: Hyrimoz 40 mg injektionsvæske, opløsning i fyldt sprøjte adalimumab
English: What Hyrimoz is and what it is used for What you need to know before you use Hyrimoz How to use Hyrimoz
Danish: Det skal du vide, før du begynder at tage Hyrimoz Sådan skal du tage Hyrimoz Bivirkninger
English: Each 0.8 ml single-dose pre-filled pen contains 40 mg of adalimumab.
Danish: Hyrimoz 40 mg injektionsvæske, opløsning i fyldt pen Hver fyldt 0,8 ml enkeltdosis pen indeholder 40 mg adalimumab.
English: Take Actos daily as prescribed.
Danish: Tag Actos dagligt som foreskrevet.
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: This is to check that your liver is working normally.
Danish: Dette sker for at checke, at Deres lever fungerer normalt.
English: - if you have or have ever had bladder cancer.
Danish: - hvis De har eller nogensinde har haft blærekræft.
English: Actos with food and drink
Danish: Brug af Actos sammen med mad og drikke
English: Two-year clinical studies have shown maintenance of this effect.
Danish: Kliniske studier af en varighed på to år har vist at denne effekt bibeholdes.
English: Your doctor will tell you the dose to take.
Danish: Deres læge vil fortælle Dem hvilken dosis, De skal tage.
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Danish: De skal tjekke Deres vægt med jævne mellemrum; hvis vægten stiger, underret da Deres læge.
English: However if you miss a dose, just carry on with the next dose as normal.
Danish: Hvis De glemmer en dosis, skal De imidlertid bare fortsætte med den næste dosis som normalt.
English: - if you have a problem with your liver or heart.
Danish: - hvis De har problemer med Deres lever eller hjerte.
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: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Actos.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi De kan få ægløsning igen, når De tager Actos.
English: If you stop using Actos, your blood sugar may go up.
Danish: Hvis De holder op med at tage Actos, kan Deres blodsukker stige.
English: Actos 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: Actos 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: Date of first authorisation: 13/10/2000 Date of latest renewal: 31/08/2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 13.10.2000 Dato for seneste fornyelse: 31.08.2010
English: Your doctor will ask you to have blood tests periodically during treatment with Actos.
Danish: Deres læge vil bede Dem om at få taget blodprøver periodevis, mens De er i behandling med Actos.
English: nausea or vomiting).
Danish: kvalme eller opkastning).
English: See leaflet for further information.
Danish: Se indlægsseddel for yderligere information.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Actos.
Danish: Hvis De følger en særlig diæt på grund af Deres diabetes, skal De fortsætte med denne diæt, mens De tager Actos.
English: Do not take a double dose to make up for a forgotten tablet.
Danish: De må ikke tage en dobbeltdosis som erstatning for glemte enkeltdoser.
English: Pioglitazone is contraindicated in patients with:
Danish: Pioglitazon er kontraindiceret hos patienter med:
English: The estimated volume of distribution in humans is 0.25 L/kg.
Danish: Det beregnede fordelingsvolumen hos mennesker er 0,25 1/kg.
English: - if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
Danish: - hvis De har haft diabetisk ketoacidose (en komplikation ved diabetes, der giver hurtigt vægttab,
English: The safety and efficacy of Actos in children and adolescents under 18 years of age have not been established.
Danish: Actos sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Your doctor will advise you to discontinue this medicine.
Danish: Deres læge vil råde Dem til at stoppe med at tage denne medicin.
English: Before you start taking Actos you will have a blood sample taken to check your liver function.
Danish: Før De begynder at tage Actos, vil De få taget en blodprøve til kontrol af leverfunktionen.
English: In some cases weight increase may be a symptom of cardiac failure; therefore weight should be closely monitored.
Danish: I nogle tilfælde kan vægtøgning være et symptom på hjertesvigt, så derfor bør vægten monitoreres nøje.
English: - if you have liver disease.
Danish: - hvis De har leversygdom.
English: You can usually continue to take other medicines whilst you are being treated with Actos.
Danish: De kan normalt blive ved med at tage anden medicin, mens De får Actos.
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: Actos has no or negligible influence on the ability to drive and use machines.
Danish: Actos påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Actos contains pioglitazone.
Danish: Actos indeholder pioglitazon.
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: If you take Actos with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Hvis De tager Actos sammen med anden diabetesmedicin, er der en større risiko for, at Deres blodsukker falder til under det normale niveau (hypoglykæmi).
English: This medicine does not require any special storage precautions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: de la Industria 30 28108 Alcobendas (Madrid) Spain
Danish: de la Industria 30 28108 Alcobendas (Madrid) Spanien
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.
Danish: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irland.
English: See section 2 “Actos contains lactose monohydrate”.
Danish: Se punkt 2 ”Actos indeholder lactosemonohydrat”.
English: Use in children and adolescents under 18 years is not recommended.
Danish: Børn og unge Actos anbefales ikke til børn og unge under 18 år.
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT-niveauer forbliver > 3 x den øvre normale grænse, bør behandlingen seponeres.
English: Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Danish: Epidemiologiske studier har også antydet en let øget risiko for blærecancer hos diabetespatienter behandlet med pioglitazon, selv om ikke alle studier fandt en statistisk signifikant øget risiko
English: not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Danish: ikke kendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data) - forhøjede leverenzymer - allergiske reaktioner
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Danish: Disse fund blev observeret i forskellige dyrearter ved plasmakoncentrationer  4 gange den kliniske udsættelse.
English: Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
Danish: Pioglitazon bør seponeres, hvis der opstår en forværring i kardiel status.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Actos in all subsets of the paediatric population in type 2 diabetes mellitus.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Actos hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: If you forget to take Actos
Danish: Hvis De har glemt at tage Actos
English: de la Industria 30, 28108 Alcobendas (Madrid), Spain
Danish: de la Industria 30, 28108 Alcobendas (Madrid), Spanien.
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Danish: Denne studie viste et øget antal rapporter om hjertesvigt, men det førte ikke til en øget dødelighed i studien.
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: - if you have cysts on your ovaries (polycystic ovary syndrome).
Danish: - hvis De har cyster på æggestokkene (polycystisk ovariesyndrom).
English: If you stop taking Actos
Danish: Hvis De holder op med at tage Actos
English: When Actos 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 Actos 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: This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
Danish: Dette lægemiddel vil ikke påvirke Deres evne til at køre bil eller arbejde med maskiner, men vær forsigtig, hvis De får synsforstyrrelser.
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, ciclosporin, calciumblokkere og HMGCoA-reduktasehæmmere, kan ikke forventes.
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: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Actos, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: very common (may affect more than 1 in 10 people) - decreased blood sugar (hypoglycaemia)
Danish: meget almindelige (kan påvirke mere end 1 ud af 10 behandlede) - lavt blodsukker (hypoglykæmi)
English: Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark
Danish: Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Danmark
English: The other side effects that have been experienced by some patients taking Actos are:
Danish: Andre bivirkninger, der er forekommet hos nogle patienter, når de har taget Actos:
English: If ALT levels are increased to 3 x upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Danish: Hvis ALAT-niveauer øges til 3 x den øvre normale grænse under pioglitazonbehandling, bør leverenzymniveauer vurderes igen så hurtigt som muligt.
English: 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.
Danish: 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.
English: However, certain medicines are especially likely to affect the amount of sugar in your blood: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these.
Danish: Visse typer medicin er dog særlig tilbøjelige til at påvirke blodsukkeret: - gemfibrozil (til at sænke kolesteroltallet) - rifampicin (mod tuberkulose og andre infektioner) Fortæl det til lægen eller på apoteket, hvis De får et af disse lægemidler.
English: Takeda Pharmaceuticals Slovakia s.r.o.
Danish: Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Danish: Næsten alle patienterne (95 %) var i behandling med lægemidler for kardiovaskulær sygdom (betablokkere, angiotensinkonverterende enzym (ACE)-hæmmere, angiotensin II-antagonister, calciumantagonister, nitrater, diuretika, acetylsalisylsyre, statiner og fibrater).
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Danish: Hyppigheden af ødemer i de sammenlignende grupper (sulfonylurinstof, metformin) var 2-5 %.
English: However, the incidences of oedema, weight gain and heart failure were increased.
Danish: Forekomsten af ødemer, vægtøgning og hjertesvigt var dog øget.
English: In animal fertility studies there was no effect on copulation, impregnation or fertility index.
Danish: I dyreforsøg fandt man ingen effekt på kopulation, befrugtning eller fertilitetsindeks.
English: 5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Danish: 5 Der blev rapporteret ødemer hos 6-9 % af patienterne, der blev behandlet i et år med pioglitazon i kontrollerede kliniske studier.
English: Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Actos.
Danish: Der er rapporteret om allergiske reaktioner med ukendt hyppighed (kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Actos.
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
Danish: - hvis De lider af en særlig diabetisk øjenlidelse, som hedder makulaødem (væskeansamling i det bagerste af øjet).
English: Actos may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Danish: Actos kan anvendes alene til patienter, som ikke er i stand til at tage metformin, og hos hvem diæt og motion ikke har været i stand til at kontrollere blodsukkeret, eller det kan anvendes som supplement til andre lægemidler (såsom metformin, sulfonylurinstof eller insulin), hvis disse ikke har været i stand til at kontrollere blodsukkeret tilstrækkeligt.
English: Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Danish: Da der er en risiko for en stigning i dosisrelaterede bivirkninger, kan det være nødvendigt med en nedsættelse af pioglitazon dosis, når gemfibrozil gives samtidigt.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister pack after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.