FrancophonIA/ELRC3.0 huggingface dataset:
English: See also instructions in SmPC Section 6.6.
Danish: Se også anvisningerne i produktresuméets punkt 6.6.
English: • To start a dose from IONSYS, press and release the dosing button twice within 3 seconds.
Danish: • Tryk to gange på doseringsknappen og slip den igen inden for 3 sekunder for at starte en dosis fra IONSYS.
English: Patients who completed 24 hours of IONSYS treatment in the seven controlled studies used a wide range of the available 80 doses, with a mean of 29.0 doses/patient (range of 0-93 doses) with the majority of patients (56.5%) using between 11 to 50 doses.
Danish: Gennemsnittet var 29,0 doser/patient (interval 0-93 doser), og størstedelen af patienterne (56,5%) brugte mellem 11 og 50 doser.
English: Preparation of the Application Site
Danish: Klargøring af påsætningsstedet
English: Depression Thinking abnormal thoughts
Danish: Depression Abnorme tanker
English: • IONSYS will ignore any button presses during the 10-minute dosing period.
Danish: • I disse 10 minutter vil IONSYS ignorere yderligere tryk på knappen.
English: Hold down dosing button until display goes blank 3.
Danish: Hold doseringsknappen nede, indtil displayet ryddes 3.
English: • To start a dose, press and release the dosing button 2 times within 3 seconds.
Danish: • Tryk to gange på doseringsknappen og slip den igen inden for 3 sekunder for at starte en dosis.
English: Also contains: glycol-modified polyethylene terephthalate, purified water, sodium hydroxide, polacrilin, polyvinyl alcohol, trisodium citrate dihydrate, anhydrous citric acid, cetylpyridinium chloride monohydrate, sodium chloride, silver foil, electrically conductive adhesive tape (ECAT), polyisobutylene/silver chloride/carbon black, polyisobutene, polyisobutylene, rosin ester, siliconised polyester.
Danish: Indeholder også glycolmodificeret polyethylenterephthalat, renset vand, natriumhydroxid, polacrilin, polyvinylalkohol, trinatriumcitratdihydrat, vandfri citronsyre, cetylpyridiniumchloridmonohydrat, natriumchlorid, sølvfolie, elektrisk ledende selvklæbende tape (ECAT), polyisobutylen/sølvchlorid/kønrøg(carbon black), polyisobuten, polyisobutylen, harpiksester, silikoniseret polyester
English: IONSYS 40 micrograms per dose transdermal system fentanyl
Danish: IONSYS 40 mikrogram pr. dosis transdermalt system fentanyl
English: The healthcare professional must ensure the patient understands that if they suspect a device failure or malfunction, they must inform a healthcare professional immediately.
Danish: Det skal sikres, at patienten forstår, at sundhedspersonalet straks skal informeres, hvis patienten har mistanke om funktionssvigt eller fejl ved systemet.
English: Do not drive, operate machines or power tools when you leave hospital if you experience any of these side effects.
Danish: Hvis du får disse bivirkninger, må du ikke køre bil, betjene maskiner eller el-værktøj, når du forlader hospitalet.
English: What IONSYS is used for
Danish: Det bruges IONSYS til
English: Open the tray by peeling back the tray lid.
Danish: Åbn bakken ved at trække tilbage i låget.
English: What IONSYS is
Danish: Det er IONSYS
English: • Call your doctor or nurse if you hear additional beeps.
Danish: • Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Hold down dosing button until beeping stops and display goes blank.
Danish: Hold doseringsknappen nede, indtil bippelyden standser, og displayet ryddes.
English: No soaps, oils, lotions, or any other agents that might irritate the skin or alter its absorption characteristics should be used to clean the application site.
Danish: Ved rengøring af påsætningsstedet må der ikke bruges sæber, olier, cremer eller andre midler, som kan irritere huden eller ændre dens evne til at absorbere.
English: • Fold the hydrogel housing in half with the sticky side facing
Danish: • Fold hydrogelhylsteret én gang med den klæbende side indad.
English: 6.6 Special precautions for disposal and other handling Contact with the hydrogel can be harmful to humans.
Danish: Kontakt med hydrogelen kan være skadelig for mennesker.
English: If you use more IONSYS than you should
Danish: Hvis du har brugt for meget IONSYS
English: Fold the hydrogel housing in half with the sticky side facing in. 3.
Danish: Fold hydrogelhylsteret én gang med den klæbende side indad.
English: • you are taking medicines used to help treat nausea and vomiting (such as aprepitant); • you are taking medicines used for high blood pressure or heart problems (such as diltiazem
Danish: • du tager lægemidler til behandling af for højt blodtryk eller hjerteproblemer (for eksempel diltiazem og verapamil)
English: The active substance in IONSYS is fentanyl hydrochloride.
Danish: Aktivt stof: fentanylhydrochlorid.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TRAY LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET PÅ BREV
English: Published literature indicates potential for increased fentanyl exposure in patients with genetic polymorphisms affecting CYP3A4 and CYP3A5, with a small variability in concentrations with transdermal administration; therefore, IONSYS should be used with caution in these patients (see section 5.2)
Danish: Det er beskrevet i litteraturen, at fentanyl-eksponeringen hos patienter med genetiske CYP3A4- og CYP3A5-polymorfier potentielt øges, med en lille variation i koncentrationen ved transdermal administration.
English: IONSYS should not be used in pregnancy unless clearly necessary.
Danish: IONSYS bør kun anvendes på tvingende indikation til gravide.
English: Each IONSYS system contains fentanyl hydrochloride equivalent to 9.7 mg of fentanyl and delivers 40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2 mg/24 hours).
Danish: Hvert IONSYS-system indeholder fentanylhydrochlorid svarende til 9,7 mg fentanyl og giver 40 mikrogram fentanyl pr. dosis, op til maksimalt 80 doser (3,2 mg/24 timer).
English: IONSYS should only be activated by the patient, to avoid potential overdosing.
Danish: For at undgå potentiel overdosering bør IONSYS kun aktiveres af patienten.
English: The other ingredients are: bottom housing unit: glycol-modified polyethylene terephthalate anode hydrogel: polacrilin, purified water, sodium hydroxide, polyvinyl alcohol cathode hydrogel: purified water, sodium chloride, sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetylpyridinium chloride anode electrode: layers of silver foil and electrically conductive adhesive tape cathode electrode: layers of polyisobutylene/silver chloride/carbon black composite material, silver foil, and electrically conductive adhesive tape skin adhesive: polybutene, polyisobutylene, and rosin ester protective liner: polyester film coated on one side with silicone.
Danish: Nederste hylsterenhed: - nederste hylsterdel: glykolmodificeret polyethylenterephthalat - anode-hydrogel: polacrilin, renset vand, natriumhydroxid og polyvinylalkohol - katode-hydrogel: renset vand, natriumchlorid, natriumcitrat, polyvinylalkohol, vandfri citronsyre, cetylpyridiniumchlorid - anode-elektrode: lag af sølvfolie og elektrisk ledende selvklæbende tape - katode-elektrode: lag af kompositmateriale med polyisobutylen/sølvchlorid/kønrøg, sølvfolie og elektrisk ledende selvklæbende tape - klæbemiddel mod huden: polybuten, polyisobutylen og harpiksester - afdækning: polyesterfilm belagt med silikone på den ene side.
English: IONSYS (fentanyl 40 micrograms per dose transdermal system, maximum of 80 doses (3.2 mg/24 hours)).
Danish: IONSYS (transdermalt system til fentanyl 40 mikrogram pr. dosis op til maksimalt 80 doser [3,2 mg/24 timer]).
English: However, only press the button
Danish: Tryk dog kun på knappen, når du har brug for smertelindring.
English: Application site reaction Pain
Danish: Kulderystelser Reaktion på påsætningsstedet Smerter
English: NAME OF THE MEDICINAL PRODUCT IONSYS 40 micrograms per dose transdermal system
Danish: LÆGEMIDLETS NAVN IONSYS 40 mikrogram pr. dosis transdermalt system
English: Troubleshooting
Danish: Sårkomplikationer
English: The most serious adverse reactions reported were hypotension and apnoea and all patients should be closely monitored for these.
Danish: De mest alvorlige bivirkninger, der er indberettet, er hypotension og apnø.
English: If it beeps at any other time, or more than once, tell your doctor or nurse immediately.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis systemet bipper på et andet tidspunkt eller mere end én gang.
English: • tingling, prickling, swelling or pain at site of IONSYS application
Danish: • stikken, prikken, hævelse eller smerter på stedet, hvor systemet er sat på
English: IONSYS should not be used if the seal on the tray or the sachet containing the Drug Unit is broken or damaged.
Danish: IONSYS må ikke anvendes, hvis forseglingen på bakken eller brevet med lægemiddelenheden er brudt eller beskadiget.
English: What IONSYS contains
Danish: IONSYS indeholder:
English: To initiate administration of a fentanyl dose, the patient should press and release the dosing button twice within 3 seconds.
Danish: Patienten skal trykke på doseringsknappen og slippe den igen to gange inden for 3 sekunder for at starte administration af en dosis fentanyl.
English: • Steady display number
Danish: • Konstant visning af tal på displayet
English: • pain, bumps, or dry skin at the patch site • fall in blood pressure when standing up
Danish: • smerter, buler eller tør hud på stedet, hvor systemet har siddet
English: How IONSYS works
Danish: Sådan virker IONSYS
English: • swelling of the abdomen, diarrhoea, burping/belching
Danish: • hævet mave, diaré, opstød/ræben
English: Bottom housing assembly: - bottom housing unit: glycol-modified polyethylene terephthalate - anode hydrogel: polacrilin, purified water, sodium hydroxide, polyvinyl alcohol - cathode hydrogel: purified water, sodium chloride, sodium citrate, polyvinyl alcohol,
Danish: Nederste hylsterenhed: glykolmodificeret polyethylenterephthalat Anode-hydrogel: polacrilin, renset vand, natriumhydroxid og polyvinylalkohol Katode-hydrogel: renset vand, natriumchlorid, natriumcitrat, polyvinylalkohol, vandfri citronsyre, cetylpyridiniumchlorid
English: Remember that only the patient may touch the dosing button.
Danish: Vejledning af patienten i anvendelse af IONSYS Husk, at kun patienten må røre ved doseringsknappen.
English: IONSYS will operate for 24 hours after the system is assembled or for 80 doses, whichever comes first, and then becomes inoperative.
Danish: IONSYS virker i 24 timer, efter at systemet er samlet, eller til 80 doser er brugt (førstkommende af de to tidspunkter), og virker derefter ikke længere.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION IONSYS 40 micrograms per dose transdermal system Fentanyl
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) IONSYS 40 mikrogram pr. dosis transdermalt system Fentanyl
English: Application of IONSYS
Danish: Anvendelse af IONSYS
English: • you have had a chest or upper abdominal operation
Danish: • du er blevet opereret i brystet eller den øverste del af maven
English: Fentanyl can pass into the breast milk and may cause side effects to the breast-fed child. You should not start breast-feeding until the IONSYS system has been removed for 24 hours.
Danish: Fentanyl kan passere ind i modermælken og give det ammende barn bivirkninger.
English: Migraine Paraesthesia Somnolence Syncope
Danish: Migræne Paræstesi Somnolens Synkope
English: Application site reaction Application site vesicles Pyrexia
Danish: Ødem på påsætningsstedet Pruritus på påsætningsstedet Reaktion på påsætningsstedet Vesikler på påsætningsstedet Pyreksi
English: • looking pale, feeling low in energy or tired • shortness of breath or interruptions in breathing
Danish: • bleghed, mangel på energi eller træthed
English: Remove the sachet and the controller.
Danish: Tag brevet og controlleren ud.
English: Uncommon Rare disorders
Danish: • nedtrykthed, unormale tanker
English: Hold down dosing button until display goes blank.
Danish: Hold doseringsknappen nede, indtil displayet ryddes.
English: anhydrous citric acid, cetylpyridinium chloride - anode electrode: layers of silver foil and electrically conductive adhesive tape - cathode electrode: layers of polyisobutylene/silver chloride/carbon black composite material,
Danish: Anode-elektrode: lag af sølvfolie og elektrisk ledende selvklæbende tape Katode-elektrode: lag af kompositmateriale med polyisobutylen/sølvchlorid/kønrøg, sølvfolie og elektrisk ledende selvklæbende tape
English: Pressing the button during delivery of a dose will not result in additional fentanyl being administered.
Danish: Der administreres ikke yderligere fentanyl, selvom der trykkes på knappen under tilførsel af en dosis.
English: The used IONSYS will be disposed of by medical staff.
Danish: Sundhedspersonalet vil sørge for bortskaffelse af brugt IONSYS.
English: Dose delivery
Danish: Tilførsel af dosis
English: IONSYS will operate for 24 hours after it is applied or for 80 doses, whichever comes first, and will then become inoperative.
Danish: IONSYS virker i 24 timer, efter at systemet er påsat, eller til 80 doser er brugt (førstkommende af de to tidspunkter), og virker derefter ikke længere.
English: • passing water (urinating) less frequently than normal • passing wind, difficulty passing stools
Danish: • mindre hyppig vandladning end normalt
English: Do not use if seal on the tray or the sachet containing the drug unit is broken or damaged.
Danish: Må ikke anvendes, hvis forseglingen på bakken eller brevet med lægemiddelenheden er brudt eller beskadiget.
English: NAME OF THE MEDICINAL PRODUCT IONSYS 40 micrograms per dose transdermal system Fentanyl
Danish: LÆGEMIDLETS NAVN IONSYS 40 mikrogram pr. dosis transdermalt system Fentanyl
English: Hearing impairment
Danish: Nedsat hørelse
English: • anxiety
Danish: • besvimelse
English: • pins and needles sensation
Danish: • unormal smagssans
English: The green light will switch off and the number of doses delivered will flash on and off. No more doses can be delivered after this and IONSYS will be removed by your doctor or nurse.
Danish: Herefter kan der ikke tilføres flere doser, og lægen eller sundhedspersonalet tager IONSYS af.
English: 5.6%)a, b 7.4%)a, b 4.0%)a, b a 95% Confidence Interval for difference in proportions The pre-specified equivalence boundary was ± 10%
Danish: 95% konfidensinterval for forskel i andele Den forud fastlagte ækvivalensgrænse var ± 10%
English: Hepatic or renal impairment
Danish: Svækket lever- eller nyrefunktion
English: How to use IONSYS
Danish: Sådan anvendes IONSYS
English: Disposal
Danish: Aftagning
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: A recessed dosing button is located on the Controller of IONSYS.
Danish: På IONSYS' controller sidder en forsænket doseringsknap.
English: Breast-feeding
Danish: FEN-PPA
English: Injection site pain Oedema
Danish: E-mail: medical.information@themedco.com
English: If using tape, apply it along the edges of IONSYS system, do not cover the dosing button or display.
Danish: Tapen må ikke dække doseringsknappen eller displayet.
English: • If you get any side effects, talk to your doctor or nurse.
Danish: • Hvis der er flere bip, skal lægen eller sundhedspersonalet kontaktes.
English: • itching skin
Danish: • smerter ved vandladning
English: If you feel faint or if you have difficulty in breathing while being treated with IONSYS, tell a doctor or nurse immediately.
Danish: Fortæl det straks til en læge eller sundhedspersonalet, hvis du føler dig mat eller får vejtrækningsbesvær, mens du behandles med IONSYS.
English: IONSYS Troubleshooting
Danish: Fejlfinding af IONSYS
English: • You will know the 10-minute dose is complete when the fast blinking green light returns to a slow blinking green light.
Danish: • Når det hurtigt blinkende grønne lys igen blinker langsomt,
English: • If you do accidentally touch the gels on the underside of the system:
Danish: Hvis der bruges tape, så sæt den på i kanterne af systemet.
English: • You will know the dose is being delivered when you see the fast blinking green light.
Danish: • Når det hurtigt blinkende grønne lys vises, ved man, at dosen er i gang med at blive tilført.
English: The recommended dose is one tablet twice a day.
Danish: Den anbefalede dosis er 1 tablet to gange dagligt.
English: Your doctor will tell you exactly how much Vipdomet you need to take.
Danish: Lægen vil fortælle dig, præcis hvor mange Vipdomet-tabletter du skal tage.
English: Metformin may act via 3 mechanisms:
Danish: Metformin kan virke via 3 forskellige mekanismer:
English: For symptoms see section “Warnings and precautions”.
Danish: For symptomer se punktet “Advarsler og forsigtighedsregler”.
English: These changes are not likely to be clinically significant (see below).
Danish: Det er ikke sandsynligt, at disse ændringer er klinisk relevante (se nedenfor).
English: Do not stop taking Vipdomet without consulting your doctor first.
Danish: Hold ikke op med at tage Vipdomet uden at tale med din læge først.
English: No metabolites have been identified in humans.
Danish: Der er ikke fundet nogen metabolitter i mennesker.
English: The mean volume of distribution (Vd) ranged between 63-276 L.
Danish: Det gennemsnitlige fordelingsvolumen (Vd) varierede mellem 63 og 276 liter.
English: The clinical relevance of these findings is unknown.
Danish: Den kliniske relevans af disse fund er ikke kendt.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerheds indberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende offentliggjort på den europæiske webportal for lægemidler.
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 available data).
Danish: Hyppigheden defineres 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - if you have or have had a disease of the pancreas.
Danish: • hvis du har eller har haft sygdom i bugspytkirtlen.
English: It also increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Det øger også transportkapaciteten for specifikke typer membranglucose-transportører (GLUT1 og GLUT4).
English: Crospovidone Type A Magnesium stearate
Danish: Crospovidon type A Magnesiumstearat
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter 'EXP'.
English: During treatment with Vipdomet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if have worsening kidney function
Danish: Under behandlingen med Vipdomet vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Danish: Nedsat nyrefunktion forekommer hyppigt hos ældre patienter og er asymptomatisk.
English: Microcrystalline cellulose Povidone K30
Danish: Mikrokrystallinsk cellulose Povidon K30
English: If no adequate strength of Vipdomet is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Vipdomet, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Reductions in HbA1c were similar across different subgroups including renal impairment, age, gender and body mass index, while differences between races (e.g. White and non-White) were small.
Danish: Reduktionerne i HbA1c var på samme niveau i de forskellige undergrupper, herunder nedsat nyrefunktion, alder, køn og body mass index (BMI), mens forskellene mellem racer (f.eks. hvide og ikke-hvide) var mindre.
English: A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities.
Danish: En begrænset mængde data om brug af metformin til gravide kvinder indikerer ikke en forøget risiko for medfødte anormaliteter.
English: Vipdomet should not be used during pregnancy.
Danish: Vipdomet bør ikke anvendes under graviditeten.
English: The effect of Vipdomet on fertility in humans has not been studied.
Danish: Vipdomets indvirkning på fertiliteten hos mennesker er ikke undersøgt.
English: Vipdomet should not be used in combination with a sulphonylurea, as the safety and efficacy of this combination have not been fully established.
Danish: Vipdomet må ikke anvendes sammen med sulfonylurinstof, da sikkerheden ved og virkningen af denne kombination ikke er fuldstændigt klarlagt.
English: In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Danish: Hos raske personer havde alogliptin ingen indvirkning på prothrombin-tid eller International Normalised Ratio (INR), når det blev administreret samtidigt med warfarin.
English: Vipdomet with alcohol
Danish: Brug af Vipdomet sammen med alkohol
English: - if you are taking Vipdomet with insulin or a thiazolidinedione.
Danish: • hvis du tager Vipdomet sammen med insulin eller et thiazolidindion.
English: In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient's clinical status.
Danish: I tilfælde af overdosering, skal der gives tilstrækkelig understøttende behandling, der afhænger af patientens kliniske status.
English: Your blood sugar levels may increase when you stop taking Vipdomet.
Danish: Dit blodsukker kan blive højere, når du holder op med at tage Vipdomet.
English: - metformin belongs to a group of medicines called biguanides which also help to lower blood sugar by lowering the amount of sugar made in the liver and helping insulin to work more effectively.
Danish: - metformin tilhører en gruppe af lægemidler, som kaldes biguanider, og som også hjælper med at sænke blodets sukkerindhold ved at sænke mængden af sukker, der produceres i leveren, og får insulinen til at virke mere effektivt.
English: You should not use Vipdomet if you are pregnant.
Danish: Du bør ikke tage Vipdomet, hvis du er gravid.
English: In controlled clinical studies, maximum metformin plasma levels (Cmax) did not exceed 4 microgram/mL even at maximum doses.
Danish: I kontrollerede kliniske studier oversteg det maksimale metforminplasmaniveau (Cmaks) ikke 4 mikrogram/ml selv ved de maksimale doser.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption and appears generally to be without clinical significance.
Danish: Længerevarende behandling med metformin er forbundet med et fald i absorptionen af B12-vitamin og anses generelt for at være uden klinisk betydning.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Danish: Det antages, at metforminabsorptionens farmakokinetik er ikke-lineær.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies; metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske studier; metformin reducerer serumniveauerne for totalkolesterol, LDL-kolesterol og triglycerider.
English: Insulin is known to cause hypoglycaemia.
Danish: Insulin er kendt for at forårsage hypoglykæmi.