FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of raltegravir 1,200 mg once daily with atazanavir resulted in increased raltegravir plasma levels; therefore, co-administration is not recommended (see section 4.5).
Danish: Administration af raltegravir 1.200 mg en gang dagligt sammen med atazanavir medførte øget plasmakoncentration af raltegravir.
English: raltegravir AUC  49 % raltegravir C12 hr  63 % raltegravir Cmax  44 %
Danish: raltegravir AUC  49% raltegravir C12t  63% raltegravir Cmax  44%
English: Isentress is also available in a 400 mg tablet, a chewable tablet and in granules for oral suspension.
Danish: Isentress fås også som en 400 mg tablet, en tyggetablet og som granulat til oral suspension.
English: Clean up
Danish: Oprydning
English: Response
Danish: Forberedelse
English: Isentress might interact with other medicines.
Danish: Isentress kan påvirke virkningen af anden medicin, ligesom anden medicin kan påvirke virkningen af Isentress.
English: ISENTRESS is also available in a chewable tablet formulation and in granules for oral suspension formulation.
Danish: ISENTRESS fås også som tyggetablet og som granulat til oral suspension.
English: Chewable tablet
Danish: Mave-tarm-kanalen
English: Viral Subtype Clade B
Danish: > 200 celler/mm Virusundertype Clade B Non-Clade B
English: In drug interaction studies, efavirenz did not have a clinically meaningful effect on the pharmacokinetics of raltegravir 1,200 mg once daily; therefore, other less potent inducers (e.g., efavirenz, nevirapine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with the recommended dose of raltegravir.
Danish: Derfor kan andre mindre potente inducere (f.eks. efavirenz, nevirapin, rifabutin, glukokortikoider, perikon, pioglitazon) anvendes sammen med den anbefalede dosis raltegravir.
English: ≤ 100,000 copies/mL CD4 count ≤ 200 cells/mm > 200 cells/mm Viral Subtype Clade B Non-Clade B 233 (205, 261)
Danish: Hiv-RNA > 100.000 kopier/ml ≤ 100.000 kopier/ml CD4-celletal ≤ 50 celler/mm > 50 og ≤ 200 celler/mm > 200 celler/mm Virusundertype Clade B Non-Clade B 189 (153; 225) 156 (121; 190)
English: Prevenar - Pharmaceutical Form(s) and Strength(s)
Danish: Prevenar - Lægemiddelform(er) och styrke
English: 4 µg Conjugated to CRM197 carrier protein ~ 20 µg
Danish: Konjugeret til CRM197 bærarproteinet
English: Streptococcus pneumoniae saccharide suspension of: Serotype 4 2 µg
Danish: * Et enkeltdosispræparat a 0.5 ml indeholder: Streptococcus pneumoniae saccharid suspension af:
English: 1 vial with 1 syringe and 2 needles
Danish: 1 hætteglas med 1 sprøjte og 2 nåle
English: Serotype 18C 2 µg
Danish: Serotype 18C
English: Serotype 9V 2 µg
Danish: Serotype 9V
English: 10 pre-filled syringes with separate needles
Danish: 10 fyldte injektionssprøjter med separate nåle
English: 5 x 10 pre-filled syringes l t o r
Danish: 5 x 10 fyldte injektionssprøjter
English: 1 pre-filled syringe with separate needle
Danish: 1 fyldt injektionssprøjte med separate nål
English: You may then hear or feel a click.
Danish: Du kan måske høre eller føle et klik.
English: ATC code: A10AB05.
Danish: ATC-kode: A10AB05.
English: Absorption, distribution and elimination
Danish: Absorption, distribution og elimination
English: This is normal and has no effect on the dose you just received.
Danish: Dette er normalt og har ingen indflydelse på den dosis, du lige har fået.
English: • Get an infection and/or a fever.
Danish: • Får en infektion og/eller feber
English: The observed improvements in HbA1c and the safety profiles were comparable between all age groups.
Danish: De observerede forbedringer i HbA1c og sikkerhedsprofilerne var sammenlignelige mellem alle aldersgrupper.
English: • Eat too little or miss a meal.
Danish: • Spiser for lidt eller springer et måltid over
English: • Do not leave the pen in a car or other place where it can get too hot or too cold.
Danish: • Efterlad ikke din pen i en bil eller andre steder, hvor der kan blive for varmt eller for koldt.
English: • This medicinal product should never be mixed with any other medicinal products.
Danish: • Dette lægemiddel må aldrig blandes med andre typer lægemidler.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af særlig betydning (f.eks. under bilkørsel eller ved betjening af maskiner).
English: I Select the dose you need.
Danish: I Vælg den dosis du har brug for.
English: Look through the insulin window.
Danish: Se gennem insulinvinduet.
English: How much insulin is left?
Danish: Hvor meget insulin er der tilbage?
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
Danish: Insulinbehovet falder normalt i første trimester og stiger efterfølgende i andet og tredje trimester.
English: See How and where to inject below for information.
Danish: Se Hvordan og hvor du skal injicere nedenfor for yderligere information.
English: The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day.
Danish: Det individuelle insulinbehov hos voksne og børn ligger normalt mellem 0,5 og 1,0 enheder/kg/dag.
English: 6 times.
Danish: 6 gange.
English: Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.
Danish: Dette lægemiddel må ikke anvendes til børn under 1 år, da der ikke er blevet udført kliniske studier hos børn under 1 år.
English: Dose counter stopped: 52 units left
Danish: Dosistæller stoppet: 52 enheder tilbage
English: These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Danish: Disse reaktioner kan blive mere alvorlige, eller måske ændre optagelsen af dit insulin, hvis du injicerer på et sådant sted.
English: The plunger goes in first.
Danish: Stemplet skal ind først.
English: The trials included 167 children aged 1-5 years, 260 aged 6-11 and 285 aged 12-17.
Danish: Studierne inkluderede 167 børn i alderen 1-5 år, 260 i alderen 6-11 år og 285 i alderen 12-17 år.
English: If in doubt, take the full dose with a new pen.
Danish: Hvis du er i tvivl, skal du tage din fulde dosis med en ny pen.
English: If you need more insulin than the units left in your pen, you can split your dose between two pens.
Danish: Hvis du har brug for mere insulin, end det antal enheder der er tilbage i din pen, kan du dele din dosis mellem to penne.
English: This is called acute painful neuropathy and is usually transient.
Danish: Dette kaldes akut smertefuld neuropati og er sædvanligvis forbigående.
English: ► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: ► Hvis du er gravid, tror du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: The insulin concentrations returned to baseline about 4 to 6 hours after dose.
Danish: Insulinkoncentrationerne vendte tilbage til baseline cirka 4-6 timer efter injektion.
English: Be very careful to calculate correctly if splitting your dose.
Danish: Vær meget omhyggelig med at udregne korrekt, hvis du opdeler din dosis.
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Der skal også indgives glucose intravenøst, hvis patienten ikke reagerer på glucagon inden for 10 til 15 minutter.
English: NovoRapid can be used in elderly patients.
Danish: NovoRapid kan anvendes til ældre patienter.
English: • Repeatedly inject less insulin than you need.
Danish: • Gentagne gange injicerer mindre insulin, end du har brug for
English: NovoRapid which has been frozen must not be used.
Danish: NovoRapid som har været frossen, må ikke anvendes.
English: Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the infusion bag.
Danish: Selvom det er stabilt over tid, vil en vis mængde insulin initialt blive absorberet af materialet i infusionsposen.
English: This should be kept in mind if treatment with the combination of pioglitazone and NovoRapid is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og NovoRapid overvejes.
English: If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Danish: Hvis du er blind eller har svækket syn og ikke kan aflæse dosistælleren på din pen, skal du ikke bruge denne pen uden hjælp.
English: Rare - Peripheral neuropathy (painful neuropathy)
Danish: Sjælden - Perifer neuropati (smertefuld neuropati)
English: The dose counter will show the exact number of units.
Danish: Dosistælleren vil vise det præcise antal enheder.
English: Usually the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Danish: De første symptomer på hyperglykæmi opstår normalt gradvist over en periode på timer eller dage.
English: You can turn the dose selector forwards or backwards.
Danish: Du kan dreje dosisvælgeren frem eller tilbage.
English: CSII should be administered in the abdominal wall.
Danish: CSII skal administreres i abdominalvæggen.
English: This could interrupt the injection.
Danish: Dette kan afbryde injektionen.
English: Do not refill your FlexPen.
Danish: Genfyld ikke din FlexPen.
English: Insulins and analogues for injection, fast-acting.
Danish: Insuliner og analoger til injektion, hurtigtvirkende.
English: This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Danish: Dette kan nedsætte risikoen for at udvikle hudfortykkelse eller sprækker i huden (se punkt 4 Bivirkninger).
English: *Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Danish: *Insulin aspart er fremstillet i Saccharomyces cerevisiae ved rekombinant DNA-teknologi.
English: These reactions are usually of transitory nature.
Danish: Disse bivirkninger er normalt af forbigående karakter.
English: However, Cmax differed between the age groups, stressing the importance of the individual titration of NovoRapid.
Danish: Cmax varierede dog mellem aldersgrupperne, hvilket understreger vigtigheden af individuel dosistitrering af NovoRapid.
English: Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar.
Danish: Fortæl relevante personer, at du har diabetes, og om hvilke konsekvenser det kan have, herunder risikoen for at besvime på grund af lavt blodsukker.
English: The safety and efficacy of NovoRapid in children below 1 year of age have not been established.
Danish: Sikkerhed og virkning af NovoRapid hos børn under 1 år er ikke klarlagt.
English: Do not use the pen if a drop of insulin still does not appear.
Danish: Brug ikke pennen, hvis en dråbe insulin stadig ikke kommer til syne.
English: Usual warning symptoms may disappear in patients with longstanding diabetes.
Danish: Sædvanlige advarselssymptomer kan udeblive hos patienter med mangeårig diabetes.
English: Ask your doctor about this.
Danish: Tal med lægen om det.
English: Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Danish: Insulin aspart absorberedes hurtigt hos begge aldersgrupper, med sammenlignelige tmax som hos voksne.
English: The risk of daytime hypoglycaemia was not significantly increased.
Danish: Risikoen for hypoglykæmi i dagtimerne var ikke væsentligt forøget.
English: After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Danish: Efter fødsel vender behovet for insulin normalt hurtigt tilbage til værdier fra før graviditet.
English: • Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).
Danish: • Drikker alkohol (se Brug af NovoRapid sammen med alkohol under punkt 2).
English: The cartridge may contain a minor amount of air in the form of small bubbles.
Danish: Cylinderampullen kan indeholde en mindre mængde luft i form af små luftbobler.
English: Make sure that you receive your full dose by using the right injection technique.
Danish: Vær sikker på, at du får hele din dosis ved at anvende den korrekte injektionsteknik.
English: Do not touch the dose counter with your fingers.
Danish: Undgå at røre ved dosistælleren med dine fingre.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD I VÆGT, VOLUMEN ELLER ENHEDER
English: If you stop the pump, the insulin effect will last for 3 to 5 hours.
Danish: Hvis du afbryder pumpen, vil effekten af insulin vare i 3 til 5 timer.
English: Changes in strength, brand (manufacturer), type, origin (animal, human insulin or human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Danish: Ændringer i styrke, mærke (fremstiller), type, oprindelse (animalsk, humaninsulin eller human insulinanalog) og/eller fremstillingsmetode (rekombinant DNA versus insulin af animalsk oprindelse) kan resultere i behov for ændring af dosis.
English: See c) Effects from diabetes in section 4.
Danish: Se c) Følger af diabetes under punkt 4.
English: • Always check that NovoRapid PumpCart looks the way it should (picture A).
Danish: • Kontrollér altid, at NovoRapid PumpCart ser ud som den skal (figur A).
English: Treatment with NovoRapid helps to prevent complications from your diabetes.
Danish: Behandling med NovoRapid hjælper med at forhindre komplikationer relateret til din diabetes.
English: • NovoRapid PumpCart should be kept out of reach of others, especially children.
Danish: • NovoRapid PumpCart skal opbevares uden for andres rækkevidde, især børn.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Danish: Tilpasning af dosis kan være nødvendig, hvis patienter øger deres fysiske aktivitet, ændrer deres normale diæt eller ved anden samtidig sygdom.
English: Pharmacotherapeutic group: Drugs used in diabetes.
Danish: Farmakoterapeutisk klassifikation: Lægemidler anvendt ved diabetes.
English: Pioglitazone (tablets used for the treatment of type 2 diabetes)
Danish: Pioglitazon (tabletter, der bruges til behandling af type 2-diabetes)
English: Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening.
Danish: Alvorlige allergiske reaktioner over for NovoRapid eller et af indholdsstofferne (kaldet systemisk allergisk reaktion) er en meget sjælden bivirkning, men kan være livstruende.
English: Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar.
Danish: Spis et måltid eller et mellemmåltid inden for 10 minutter efter injektionen for at undgå lavt blodsukker.
English: If no drop appears, repeat steps F to H up to 6 times.
Danish: Hvis der ikke kommer en dråbe til syne, gentages trin F til H op til 6 gange.
English: • Forget to inject your insulin or stop taking insulin.
Danish: • Glemmer at injicere dit insulin eller stopper med at tage insulin
English: In picture A the bottom of the plunger is hidden behind the white label band as it should be.
Danish: I figur A er bunden af stemplet skjult bag ved det hvide bånd, som det skal være.
English: However, the NovoRapid dose may need to be adjusted.
Danish: Det kan dog være nødvendigt at justere dosis af NovoRapid.
English: If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.
Danish: Hvis dit blodsukker er lavt eller højt, kan din koncentrations- og reaktionsevne være påvirket, og dermed også din evne til at køre bil eller arbejde med maskiner.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between NovoRapid and other insulin products.
Danish: Patienter skal instrueres i altid at kontrollere etiketten på insulinet før hver injektion, for at undgå utilsigtet forveksling mellem NovoRapid og andre insulinprodukter.
English: Important information about some of the ingredients of NovoRapid
Danish: Vigtig information om nogle af indholdsstofferne i NovoRapid
English: If it shows 80, at least 80 units are left in your pen.
Danish: Hvis den viser 80, er der mindst 80 enheder tilbage i din pen.
English: c) Effects from diabetes
Danish: c) Følger af diabetes
English: In a basal-bolus treatment regimen 50-70% of this requirement may be provided by NovoRapid and the remainder by intermediate-acting or long-acting insulin.
Danish: I et basal-bolus behandlingsregime kan 50-70% af dette behov dækkes med NovoRapid og resten med et insulinpræparat med mellemlang eller lang virkningstid.
English: • Eat more than usual.
Danish: • Spiser mere, end du plejer
English: Modern insulin products are improved versions of human insulin.
Danish: Moderne insulinpræparater er forbedrede versioner af humaninsuliner.
English: Administration in a pump system will require a comprehensive instruction by your healthcare professional.
Danish: Indgivelse via et pumpesystem kræver udførlig instruktion af sundhedspersonale.
English: See a) Summary of serious and very common side effects in section 4.
Danish: Se a) Oversigt over alvorlige og meget almindelige bivirkninger under punkt 4.
English: This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis.
Danish: Dette kan føre til meget højt blodsukker (alvorlig hyperglykæmi) og ketoacidose.
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Danish: Nogle lægemidler påvirker dit blodsukkerniveau og dette kan betyde, at din insulindosis skal ændres.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Danish: Patientens skift til en anden insulintype eller -mærke bør foregå under streng medicinsk kontrol.
English: No apparent effect of creatinine clearance values on AUC, Cmax, CL/F and tmax of insulin aspart was found.
Danish: Der blev ikke fundet nogen tydelig effekt af kreatininclerance-værdier på AUC, Cmax, CL/F og tmax for insulin aspart.
English: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Danish: Hvis du har nedsat nyre- eller leverfunktion, eller hvis du er over 65 år, skal du kontrollere dit blodsukker mere regelmæssigt og diskutere ændringer af din insulindosis med din læge.
English: You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
Danish: Du må aldrig injicere dig selv direkte ind i en vene (intravenøst) eller muskel (intramuskulært).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, gentoksicitet og reproduktions- og udviklingstoksicitet.
English: • Check the expiry date, which is stated on the label and the carton.
Danish: • Kontrollér udløbsdatoen, som står på etiketten og kartonen.
English: Since NovoRapid should be administered in immediate relation to a meal, the rapid onset of action should be considered in patients with concomitant diseases or treatment where a delayed absorption of food might be expected.
Danish: Da NovoRapid bør indgives umiddelbart i forbindelse med et måltid, skal den hurtigt indtrædende virkning tages i betragtning hos patienter med anden samtidig sygdom eller behandling, hvor der kan forventes forsinket absorption af levnedsmidler.
English: a) Summary of serious and very common side effects
Danish: a) Oversigt over alvorlige og meget almindelige bivirkninger
English: Alternatively, if your doctor recommends it, you may use your thigh or upper arm.
Danish: Hvis din læge anbefaler det, kan du alternativt bruge dit lår eller overarm.
English: When the pen contains less than 80 units, the dose counter stops at the number of units left.
Danish: Når pennen indeholder færre end 80 enheder, vil dosistælleren stoppe ved det antal enheder, der er tilbage.
English: NovoRapid can be used during pregnancy.
Danish: NovoRapid kan anvendes under graviditet.
English: It is therefore recommended that the diabetic patient always carries sugar-containing products.
Danish: Diabetespatienter anbefales derfor altid at være i besiddelse af sukkerholdige fødevarer.
English: Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when contemplating pregnancy.
Danish: Intensiveret blodglucosekontrol og monitorering af gravide kvinder med diabetes (type 1-diabetes, type 2-diabetes eller gestational diabetes) er anbefalet under hele graviditeten, og hvis graviditet påtænkes.
English: Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Danish: Betablokkere (til behandling af forhøjet blodtryk) kan svække eller fuldstændigt undertrykke de første advarselssignaler, der hjælper dig med at opdage lavt blodsukker.
English: If you try to put it back on, you may accidentally stick yourself with the needle.
Danish: Hvis du forsøger at sætte den tilbage på nålen, kan du være uheldig at stikke dig selv med nålen.
English: Do not change your insulin unless your doctor tells you to.
Danish: Du må ikke skifte insulin, medmindre din læge siger, du skal.
English: If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse.
Danish: Hvis du bemærker, at huden sprækker eller bliver tyk på injektionsstedet, skal du fortælle det til din læge eller sygeplejerske.
English: Adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Danish: Bivirkningerne anført nedenfor er baserede på data fra kliniske studier og klassificerede efter MedDRA med hensyn til frekvens og organsystemklasse.
English: Multipack: 2 x (5 x 3 ml)
Danish: Multipakning: 2 x (5 x 3 ml)
English: ► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
Danish: ► Når symptomerne på lavt blodsukker er forsvundet, eller når dit blodsukkerniveau er stabiliseret, kan du fortsætte med insulinbehandlingen som sædvanligt.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by physicians or other healthcare staff.
Danish: • Alvorlige hypoglykæmiske episoder, hvor patienten bliver bevidstløs, kan behandles med glucagon (0,5 til 1 mg) indgivet intramuskulært eller subkutant af en instrueret person, eller med intravenøs glucose indgivet af læger eller andet sundhedspersonale.
English: ► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
Danish: ► Hvis du har mistanke om begyndende hypoglykæmi (for lavt blodsukker) (se a) Oversigt over alvorlige og meget almindelige bivirkninger under punkt 4).
English: The time to maximum concentration is, on average, half of that for soluble human insulin.
Danish: Tiden det tager at opnå maximal koncentration er gennemsnitligt det halve af den tid det tager med opløseligt humaninsulin.
English: B Check that the insulin in your pen is clear and colourless.
Danish: B Kontrollér, at insulinet i din pen er klart og farveløst.
English: Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
Danish: Få hjælp fra en person med normalt syn, som er trænet i brugen af den fyldte FlexTouch pen.