FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.1 List of excipients metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections
Danish: 6.1 Hjælpestoffer metacresol mannitol iseddike natriumacetattrihydrat vand til injektionsvæsker
English: NEEDLE PARTS (Needles Not Included)
Danish: DELE TIL NÅLEN (Nåle medfølger ikke)
English: When immediate-release exenatide was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin.
Danish: Når exenatid opløsning til injektion blev brugt i kombination med basal insulin, var hyppigheden og typen af andre bivirkninger, som blev observeret, sammenlignelige med dem, som blev observeret i kontrollerede kliniske studier med exenatid som monoterapi, med metformin og/eller sulfonylurinstof eller et thiazolidindion med eller uden metformin.
English: Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients > 70 years.
Danish: Exenatid opløsning til injektion bør bruges med forsigtighed, og dosisøgning fra 5 μg til 10 μg bør foregå forsigtigt hos patienter >70 år.
English: In the 30-week placebo-controlled clinical trials, concomitant use of immediate-release exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Danish: I de placebokontrollerede, kliniske 30-ugers studier, var samtidig brug af exenatid opløsning til injektion og HMG CoAreduktasehæmmere ikke forbundet med konsekvente ændringer i lipidprofilerne (se pkt.
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide (10 mcg BID) did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Danish: Administration af oral kontraception (kombination af 30 µg ethinylestradiol og 150 µg levonorgestrel) én time før exenatid opløsning til injektion (10 µg to gange dagligt) ændrede ikke AUC, Cmax eller Cmin af hverken ethinylestradiol eller levonorgestrel.
English: Its use is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhoea.
Danish: Brug af lægemidlet er ofte forbundet med gastrointestinale bivirkninger, herunder kvalme, opkastning og diaré.
English: • Point the needle of the pen up and away from you.
Danish: • Hold nålen opad og pegende væk fra dig.
English: System organ class /adverse reaction terms
Danish: Systemorganklasse/ bivirkning
English: After four weeks, their dose was increased to 10 mcg BID.
Danish: Efter fire uger blev dosis øget til 10 µg 2 gange daglig.
English: When this medicine is used with a medicine that contains a sulphonylurea or an insulin, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur very commonly.
Danish: Hvis dette lægemiddel anvendes med et lægemiddel, som indeholder sulfonylurinstof eller insulin, er det meget almindeligt, at der kan forekomme episoder med lavt blodsukker (hypoglykæmi, generelt let til moderat).
English: Make sure that the 10 with the line under it is in the centre of the dose window.
Danish: Vær sikker på, at 10 med stregen under er i midten af doseringsvinduet.
English: ready to pull dose knob out ready to turn to dose position ready to inject 10 micrograms (mcg)
Danish: klar til at trække doseringsknappen ud klar til at dreje til doseringspositionen klar til at injicere 10 mikrogram (µg)
English: In a pharmacokinetic study in patients with type 2 diabetes, administration of exenatide (10 mcg) resulted in a mean increase of exenatide AUC by 36% in 15 elderly subjects aged 75 to 85 years compared to 15 subjects aged 45 to 65 years likely related to reduced renal function in the older age group (see section 4.2).
Danish: I et farmakokinetisk studie med patienter med type 2-diabetes medførte administrationen af exenatid (10 μg) en middelstigning i AUC for exenatid på 36 % hos 15 ældre forsøgspersoner i alderen 75-85 år sammenlignet med 15 forsøgspersoner i alderen 45-65 år, hvilket sandsynligvis var relateret til nedsat nyrefunktion i gruppen af ældre (se pkt.
English: ready to pull dose knob out ready to turn to dose position ready to inject 5 micrograms (mcg)
Danish: klar til at trække doseringsknappen ud klar til at dreje til doseringspositionen klar til at injicere 5 mikrogram (µg)
English: See the accompanying Pen User Manual for instructions for using the Byetta Pen.
Danish: Se den medfølgende brugsanvisning for at få instruktioner i brug af Byetta-pennen.
English: Of the immediate-release exenatide patients, 12% were treated with a thiazolidinedione and immediate-release exenatide and 82% were treated with a thiazolidinedione, metformin and immediate-release exenatide.
Danish: I gruppen af patienter behandlet med exenatid opløsning til injektion blev 12 % behandlet med thiazolidindion og exenatid opløsning til injektion, og 82 % blev behandlet med thiazolidindion, metformin og exenatid opløsning til injektion.
English: There were no clinically relevant differences in incidence or severity of hypoglycaemia with exenatide compared to placebo, in combination with a thiazolidinedione, with or without metformin.
Danish: Der var ingen klinisk relevante forskelle i incidensen eller graden af hypoglykæmi med exenatid sammenlignet med placebo, i kombination med thiazolidindion med eller uden metformin.
English: Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Danish: Byetta 5 mikrogram: Hver dosis indeholder 44 μg metacresol.
English: STEP 4 Inject the Dose
Danish: TRIN 4 Injektion af dosis
English: Immediate-release exenatide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio.
Danish: Exenatid opløsning til injektion skal anvendes med forsigtighed til patienter, som er i behandling med orale lægemidler, der enten kræver hurtig absorption i mave-tarm-kanalen eller lægemidler med et smalt terapeutisk indeks.
English: Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) Hypoglycaemia (with a sulphonylurea) Decreased appetite Dehydration, generally associated with nausea, vomiting and/or diarrhoea.
Danish: Hypoglykæmi (med metformin og sulfonylurinstof) Hypoglykæmi (med sulfonylurinstof) Nedsat appetit Dehydrering, generelt associeret med kvalme, opkastning og/eller diaré Nervesystemet Hovedpine
English: The effect of immediate-release exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Danish: Den langsommere ventrikeltømning, som exenatid opløsning til injektion forårsager, kan muligvis reducere absorptionsgraden og -hastigheden af orale lægemidler.
English: PRE-FILLED PEN LABEL
Danish: ETIKET TIL FYLDT PEN
English: If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) can occur.
Danish: Når dette lægemiddel anvendes i kombination med sulfonylurinstoffer eller insulin, kan det medføre lavt blodsukker (hypoglykæmi).
English: STEP A Check the Pen
Danish: TRIN A Kontrol af pennen
English: In a single-dose pharmacokinetic study in 13 patients with type 2 diabetes and between the ages of 12 and 16 years, administration of exenatide (5 mcg) resulted in slightly lower mean AUC (16% lower) and Cmax (25% lower) compared to those observed in adults.
Danish: I et farmakokinetisk enkeltdosisstudie med 13 patienter med type 2-diabetes i alderen 12 til 16 år resulterede administration af exenatid (5 µg) i lidt lavere middelværdier af AUC (16 % lavere) og Cmax (25 % lavere) sammenlignet med værdierne, som blev set hos voksne.
English: • Hives and difficulties to breathe
Danish: • nældefeber og åndedrætsbesvær
English: Immediate-release exenatide has shown no adverse effects on lipid parameters.
Danish: Exenatid opløsning til injektion har ikke vist nogen bivirkninger på lipidparametre.
English: No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min).
Danish: Der er ikke behov for dosisjustering hos patienter med let nedsat nyrefunktion (kreatinin-clearance 5080 ml/min).
English: In clinical trials, background therapies included metformin, a sulphonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products.
Danish: I kliniske studier omfattede baggrundsbehandling med metformin, et sulfonylurinstof, en thiazolidindion eller en kombination af orale glucosesænkende lægemidler.
English: In patients at increased risk of hypoglycaemia reducing the dose of basal insulin should be considered (see section 4.8).
Danish: Hos patienter med øget risiko for hypoglykæmi skal det overvejes at reducere dosis af basal insulin (se pkt.
English: Since immediate-release exenatide has been marketed, acute pancreatitis has been reported with a frequency not known and acute renal failure has been reported uncommonly (see section 4.4).
Danish: Siden markedsføring af exenatid opløsning til injektion er der indberettet akut pancreatitis med ikke kendt hyppighed og akut nyreinsufficiens i hyppigheden ikke almindelig (se pkt.
English: You may remove them with an alcohol wipe or alcohol swab.
Danish: Disse kan fjernes med en spritvædet serviet eller en spritvædet vatpind.
English: There were no episodes of major hypoglycaemia in the immediate-release exenatide arm.
Danish: Der var ingen episoder af svær hypoglykæmi i exenatid opløsning til injektion-armen.
English: The immediate-release exenatide arm compared to placebo had significantly lowered postprandial blood glucose excursions at the morning meal (- 2.0 versus0.2 mmol/l) and evening meal (- 1.6 versus + 0.1 mmol/l), there was no difference between treatments at midday.
Danish: Sammenlignet med placebo-armen havde exenatid opløsning til injektion-armen signifikant nedsatte postprandiale blodglucoseudsving ved morgenmåltidet (- 2,0 versus - 0,2 mmol/l) og ved aftensmåltidet (- 1,6 versus + 0,1 mmol/l).
English: Immediate-release exenatide lowered HbA1c from 8.21 (n=228) and 8.6% (n=222) by 1.13 and 1.01% while insulin glargine lowered from 8.24 (n=227) by 1.10% and biphasic insulin aspart from 8.67 (n=224) by 0.86%.
Danish: Exenatid opløsning til injektion sænkede HbA1c fra 8,21 (n=228) og 8,6 % (n=222) med 1,13 og 1,01 % mens insulin glargin nedsatte fra 8,24 (n=227) med 1,1 % og bifasisk insulin aspart fra 8,67 (n=224) med 0,86 %.
English: Each dose contains 10 micrograms exenatide.
Danish: Hver dosis indeholder 10 mikrogram exenatid.
English: • Remove the needle after each injection.
Danish: • Fjern nålen efter hver injektion.
English: • Avoid tightly pinching the skin before injecting.
Danish: • Klem ikke huden for hårdt sammen før indsprøjtningen.
English: • Use a Byettapen for only 30 days after setting up a new pen for first use.
Danish: • Byetta-pennen kan kun anvendes i 30 dage efter klargøring af en ny pen til første ibrugtagning.
English: Other medicines and Byetta
Danish: Brug af anden medicin sammen med Byetta
English: • The dose knob was not turned all the way.
Danish: • Doseringsknappen blev ikke drejet langt nok.
English: Read the package leaflet and pen user manual before use.
Danish: Læs indlægssedlen og brugsanvisningen til pennen inden brug.
English: In patients where existing therapy also included a sulphonylurea the incidence of patients with at least one minor hypoglycaemic episode was 48% and 54% respectively and one patient reported major hypoglycaemia.
Danish: Hos patienter, hvor den eksisterende behandling også omfattede sulfonylurinstof, havde henholdsvis 48 % og 54 % af patienterne mindst en let hypoglykæmisk episode, og en patient indberettede svær hypoglykæmi.
English: Byetta is used with other diabetic medicines called metformin, sulphonylureas, thiazolidinediones and basal or long acting insulins.
Danish: Byetta bruges sammen med anden diabetesmedicin kaldet metformin, sulfonylurinstoffer, thiazolidindion-præparater og basal eller langtidsvirkende insulin.
English: The New Pen Setup is done only once, just before each new pen is used for the first time.
Danish: Klargøring af ny pen skal kun udføres én gang, lige før hver ny pen anvendes første gang.
English: Each dose contains 5 micrograms exenatide.
Danish: Hver dosis indeholder 5 mikrogram exenatid.
English: In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Danish: I de kliniske studier, hvor patienterne fik kombinationsbehandling med sulfonylurinstof, havde de patienter, som havde let nedsat nyrefunktion en forøget forekomst af hypoglykæmi sammenlignet med patienter med normal nyrefunktion.
English: In insulin-comparator controlled studies in which metformin and a sulphonylurea were concomitant medicinal products, the incidence for these adverse reactions was similar for insulin- and immediate-release exenatide-treated patients.
Danish: I insulin-komparatorkontrollerede studier, i hvilke metformin og sulphonylurinstof blev givet som kombinationslægemidler, var incidensen for disse bivirkninger sammenlignelig for insulinbehandlede patienter og patienter behandlet med exenatid opløsning til injektion.
English: If pancreatitis is suspected, exenatide should be discontinued; if acute pancreatitis is confirmed, exenatide should not be restarted.
Danish: Hvis akut pancreatitis bliver bekræftet, må exenatid-behandling ikke genoptages.
English: In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin, metformin and sulphonylurea or metformin and pioglitazone, HbA1c was lowered by 1.2% (n=170) and by 1.4% (n=167) respectively from a baseline of 8.2%.
Danish: I et studie af 24 ugers varighed, hvor enten insulin lispro protamin suspension eller insulin glargin blev føjet til den eksisterende behandling med exenatid opløsning til injektion og metformin, metformin og sulfonylurinstof eller metformin og pioglitazon, blev HbA1c sænket med henholdsvis 1,2 % (n=170) og 1,4 % (n=167) fra et baseline-niveau på 8,2 %.
English: - If you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.
Danish: - Hvis du har en alvorlig nyresygdom eller er i dialyse, bør du ikke bruge dette lægemiddel.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKEANVENDT LÆGEMIDLER SAMT AFFALD HERAF
English: Dysgeusia
Danish: Svimmelhed Dysgeusi
English: This medicine should not be used if breast-feeding.
Danish: Dette lægemiddel må ikke bruges, hvis du ammer.
English: How do I store my Byetta pen?
Danish: Hvordan opbevarer jeg min Byetta-pen?
English: Mannitol, glacial acetic acid, sodium acetate trihydrate, water for injections.
Danish: Mannitol, iseddike, natriumacetattrihydrat, vand til injektionsvæsker.
English: - Firmly push the injection button in all the way until it stops.
Danish: Tryk injektionsknappen helt ind, indtil den stopper.
English: In a 30-week study, when immediate-release exenatide or placebo was added to existing basal insulin therapy (insulin glargine), the dose of basal insulin was decreased by 20% in patients with an HbA1c ≤ 8.0%, per protocol design in order to minimize the risk of hypoglycaemia.
Danish: I et studie af 30 ugers varighed, hvor exenatid opløsning til injektion eller placebo blev føjet til den eksisterende behandling med basal insulin (insulin glargin), blev dosis af basal insulin nedsat med 20 % hos patienter med HbA1c ≤ 8,0 % i henhold til protokoldesignet for at mindske risikoen for hypoglykæmi.
English: - If you have severe problems with slowstomach emptying or food digestion, asthe use of this medicine is not recommended.
Danish: - Hvis du har store problemer med at fordøje maden eller med langsom tømning af mavesækken, bør du ikke bruge dette lægemiddel.
English: Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Danish: I situationer, hvor du kan være til fare for dig selv eller andre (f.eks. ved bilkørsel eller brug af maskiner), bør du være opmærksom på, at din koncentrationsevne måske er nedsat.
English: • White particles may appear on the outside tip of the cartridge during normal use.
Danish: • Under normal brug kan der forekomme hvide partikler udvendigt på spidsen af cylinderampullen.
English: Immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) resulted in statistically significant reductions from baseline HbA1c compared to placebo (-0.7% versus +0.1%) as well as significant reductions in body weight (-1.5 versus 0 kg) in the 16 week study.
Danish: Exenatid opløsning til injektion (5 µg to gange dagligt i 4 uger, efterfulgt af 10 µg to gange dagligt) resulterede i en statistisk signifikant reduktion af HbA1c fra baseline sammenlignet med placebo (-0,7 % versus +0,1 %) samt signifikant reduktion af legemsvægt (-1,5 versus 0 kg) i 16 ugers studiet.
English: However, if you are also using a sulphonylurea or an insulin your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea or insulin.
Danish: Din læge kan dog bede dig om at tjekke dit blodsukkerniveau, hvis du også bruger et sulfonylurinstof-præparat eller insulin, for at tilpasse dosis af sulfonylurinstof eller insulin.
English: Clinical studies with immediate-release exenatide have indicated improved beta-cell function, using measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Danish: Kliniske studier med exenatid opløsning til injektion har indikeret forbedringer i betacellefunktion, ved brug af indikatorer som homeostasemodelvurdering for betacellefunktion (HOMA-B) og proinsulin til insulinforholdet samt matematisk modellering baseret på postprandial glucose- og insulinniveauer.
English: Each cartridge is assembled into a disposable pen-injector (pen).
Danish: Hver cylinderampul er samlet til en injektionspen (pen) til engangsbrug.
English: The most frequent adverse reactions were mainly gastrointestinal related (nausea, vomiting and diarrhoea).
Danish: De hyppigste utilsigtede lægemiddelreaktioner var fortrinsvis relateret til mave-tarm-kanalen (kvalme, opkastning og diaré).
English: What you need to know before you use Byetta
Danish: Det skal du vide, før du begynder at tage Byetta
English: Byetta with food
Danish: Brug af Byetta sammen med mad
English: 5 mcg: Each pre-filled pen contains 60 doses (approximately 1.2 ml of solution).
Danish: 5 mikrogram: Hver fyldt pen indeholder 60 doser (indeholdende ca. 1,2 ml opløsning).
English: In studies in patients treated with immediate-release exenatide and a sulphonylurea (with or without metformin), the incidence of hypoglycaemia was increased compared to placebo (23.5% and 25.2% versus 12.6% and 3.3%) and appeared to be dependent on the doses of both immediate-release exenatide and the sulphonylurea.
Danish: I studier med patienter, som fik behandling med exenatid opløsning til injektion og sulfonylurinstof (med eller uden metformin), blev incidensen af hypoglykæmi forøget i forhold til placebo (23,5 % og 25,2 % i forhold til 12,6 % og 3,3 %).
English: Mean daily blood glucose values were similar between immediate-release exenatide and insulin.
Danish: Den gennemsnitlige daglige blodglucoseværdi var sammenlignelig for exenatid opløsning til injektion og insulin.
English: • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin and
Danish: • Du har langsomt talt til 5, mens du holdt injektionsknappen inde, og nålen stadig sad i huden, og er i midten af doseringsvinduet.
English: • Firmly push the injection button in all the way.
Danish: • Tryk injektionsknappen helt i bund.
English: If part of and part of are in the dose window and the dose knob cannot be pushed in:
Danish: Hvis del af og del af er i doseringsvinduet, og doseringsknappen ikke kan trykkes ind:
English: In these studies the incidence of hypoglycaemia was similar for immediate-release exenatide and insulin treatment.
Danish: Incidensen af hypoglykæmi i disse studier var sammenlignelig for behandling med exenatid opløsning til injektion og insulinbehandling.
English: • If the pen is stored with a needle attached, air bubbles may form in the cartridge.
Danish: • Hvis pennen opbevares med nålen påsat, kan der dannes luftbobler i cylinderampullen.
English: Patients may experience hypoglycaemia when immediate-release exenatide is used with a sulphonylurea.
Danish: Patienterne kan få hypoglykæmi, når exenatid opløsning til injektion bruges sammen med et sulfonylurinstof.
English: If and part of the are in the dose window and the dose knob cannot be pushed in:
Danish: Hvis og en del af er i doseringsvinduet, og doseringsknappen ikke kan trykkes ind:
English: • For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.
Danish: • Ved din næste dosis, skal du sørge for at trykke injektionsknappen ind og holde den inde og langsomt tælle til 5, før du fjerner nålen fra huden.
English: • Never push the injection button on the pen unless a needle is attached.
Danish: • Tryk ikke på injektionsknappen på pennen, uden at der er sat en nål på pennen.
English: - Each millilitre (ml) of the solution for injection contains 0.25 milligrams (mg) of exenatide.
Danish: - Hver milliliter (ml) af injektionsvæsken, opløsningen indeholder 0,25 miligram (mg) exenatid.
English: ABOUT INJECTION NEEDLES
Danish: OM INJEKTIONSNÅLE
English: Hydroxy Methyl Glutaryl Coenzyme A (HMG CoA) reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and tmax was delayed about 4 h when immediate-release exenatide (10 mcg BID) was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
Danish: Hydroxy Methyl Glutaryl Co-enzym A (HMG CoA)-reduktasehæmmere Når exenatid opløsning til injektion (10 μg to gange dagligt) blev indgivet samtidig med en enkeltdosis lovastatin (40 mg), blev lovastatin AUC og Cmax reduceret med hhv. ca. 40 % og 28 %, og tmax blev forsinket med ca. 4 t, sammenlignet med lovastatin indgivet alene.
English: Immediate-release exenatide lowered HbA1c by 1.7% from a baseline of 8.3% while placebo lowered HbA1c by 1.0% from a baseline of 8.5%.
Danish: Exenatid opløsning til injektion sænkede HbA1c med 1,7 % fra et baseline-niveau på 8,3 %, mens placebo sænkede HbA1c med 1,0 % fra et baselineniveau på 8,5 %.
English: • Store your Byettapen properly.
Danish: • Opbevar din Byetta-pen rigtigt.
English: - The other ingredients are metacresol, (44micrograms/dose in Byetta 5micrograms solution for injection and 88 micrograms/dose in Byetta 10 micrograms solution for injection), mannitol,
Danish: - Øvrige indholdsstoffer: metacresol (44 mikrogram/dosis i Byetta 5 mikrogram injektionsvæske, opløsning og 88 mikrogram/dosis i Byetta 10 mikrogram injektionsvæske, opløsning), mannitol, iseddike, natriumacetattrihydrat og vand til injektionsvæsker (se punkt 2).
English: In patients with moderate renal impairment (creatinine clearance 30-50 ml/min), dose escalation from 5 mcg to 10 mcg should proceed conservatively (see section 5.2).
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatinin-clearance 30-50 ml/min) bør en dosisøgning fra 5 μg til 10 μg foregå forsigtigt (se pkt.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan ske hos flere end 1 ud af 10 patienter):
English: Most adverse reactions associated with immediate-release exenatide were mild to moderate in intensity.
Danish: De fleste bivirkninger forbundet med exenatid opløsning til injektion var lette til moderate i styrke.