FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR ADROVANCE 70 mg/5,600 IU
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ADROVANCE 70 mg/5.600 IE
English: The equivalence of intake of 5,600 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 800 IU has not been studied.
Danish: Ækvivalensen mellem indtagelse af 5.600 IE D3-vitamin ugentligt i ADROVANCE og daglig dosering af D-vitamin 800 IE er ikke undersøgt.
English: • ADROVANCE should not be taken at bedtime or before arising for the day.
Danish: • ADROVANCE må ikke tages ved sengetid, eller før patienten er stået op om morgenen.
English: ADROVANCE is only intended for use in postmenopausal women.
Danish: ADROVANCE er kun beregnet til kvinder efter overgangsalderen.
English: Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Danish: Antiepileptika, cimetidin og thiazider kan øge katabolismen af D-vitamin.
English: The equivalence of intake of 2,800 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 400 IU has not been studied.
Danish: Ækvivalensen mellem indtagelse af 2.800 IE D3-vitamin ugentligt i ADROVANCE og daglig dosering af D-vitamin 400 IE er ikke undersøgt.
English: After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the ADROVANCE (70 mg/2,800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
Danish: Efter 15 ugers behandling var de gennemsnitlige serum 25-hydroxyvitamin D niveauer signifikant højere (26 %) i ADROVANCE (70 mg/2.800 IE) gruppen (56 nmol/l [23 ng/ml]) end i gruppen med alendronat alene (46 nmol/l [18,2 ng/ml]).
English: ADROVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Danish: ADROVANCE anbefales ikke til patienter med nedsat nyrefunktion, hvor kreatinin-clearance er < 35 ml/min (se pkt.
English: The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Danish: Procentdelen af patienter med D-vitaminmangel (serum 25-hydroxyvitamin D < 22,5 nmol/l [< 9 ng/ml]) var signifikant reduceret med 92 % med ADROVANCE (70 mg/2.800 IE) versus alendronat alene (henholdsvis 1 % versus 13 %).
English: If you miss a dose, just take one tablet on the morning after you remember.
Danish: Hvis du glemmer at tage en tablet, skal du blot tage en ADROVANCE tablet om morgenen, efter du er kommet i tanke om det.
English: ADROVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
Danish: ADROVANCE 70 mg/2.800 IE tabletter er modificeret kapselformede, hvide/beige tabletter, der er mærket med omridset af en knogle på den ene side og ”710” på den anden side.
English: ADROVANCE 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
Danish: ADROVANCE 70 mg/5.600 IE tabletter er modificeret rektangulære, hvide/beige tabletter, der er mærket med omridset af en knogle på den ene side og ”270” på den anden side.
English: The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Danish: Procentdelen af patienter med D-vitaminmangel (serum 25-hydroxyvitamin D < 37,5 nmol/l [< 15 ng/ml]) var signifikant reduceret med 62,5 % med ADROVANCE (70 mg/2.800 IE) versus alendronat alene (henholdsvis 12 % versus 32 %) efter uge 15.
English: In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Danish: Ved administration af ADROVANCE 70 mg/5.600 IE tabletter efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum-koncentration-tid (AUC0-80 timer) for D3vitamin (ikke justeret for endogene D3-vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 490,2 ngtime/ml.
English: Patients may experience certain adverse reactions (for example blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Danish: Patienter kan opleve visse bivirkninger (for eksempel sløret syn, svimmelhed og svære knogle-, muskel- eller ledsmerter (se pkt.
English: EU/1/06/364/001 (2 tablets) EU/1/06/364/002 (4 tablets) EU/1/06/364/003 (6 tablets) EU/1/06/364/004 (12 tablets)
Danish: EU/1/06/364/001 (2 tabletter) EU/1/06/364/002 (4 tabletter) EU/1/06/364/003 (6 tabletter) EU/1/06/364/004 (12 tabletter)
English: • bone, muscle and/or joint pain which is severe.
Danish: • Knogle-, muskel- og/eller ledsmerter, som kan være voldsomme.
English: BLISTER FOR ADROVANCE 70 mg/2,800 IU
Danish: BLISTERTEKST TIL ADROVANCE 70 mg/2.800 IE
English: ADROVANCE 70 mg/2,800 IU tablets
Danish: ADROVANCE 70 mg/2.800 IE tabletter
English: In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Danish: Ved administration af ADROVANCE 70 mg/2.800 IE tabletter efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum-koncentration-tid (AUC0-120 timer) for D3vitamin (ikke justeret for endogene D3-vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 296,4 ngtime/ml.
English: ADROVANCE 70 mg/5,600 IU tablets EU/1/06/364/006 - 2 tablets EU/1/06/364/007 - 4 tablets EU/1/06/364/008 - 12 tablets
Danish: ADROVANCE 70 mg/5.600 IE tabletter EU/1/06/364/006 - 2 tabletter EU/1/06/364/007 - 4 tabletter EU/1/06/364/008 - 12 tabletter
English: ADROVANCE 70 mg/5,600 IU tablets
Danish: ADROVANCE 70 mg/5.600 IE tabletter
English: ADROVANCE 70 mg/2,800 IU tablets ADROVANCE 70 mg/5,600 IU tablets
Danish: ADROVANCE 70 mg/2.800 IE tabletter ADROVANCE 70 mg/5.600 IE tabletter
English: EU/1/06/364/003 - 6 tablets
Danish: EU/1/06/364/003 - 6 tabletter
English: EU/1/06/364/006 (2 tablets) EU/1/06/364/007 (4 tablets) EU/1/06/364/008 (12 tablets)
Danish: EU/1/06/364/006 (2 tabletter) EU/1/06/364/007 (4 tabletter) EU/1/06/364/008 (12 tabletter)
English: BLISTER FOR ADROVANCE 70 mg/5,600 IU
Danish: BLISTERTEKST TIL ADROVANCE 70 gm/5.600 IE
English: EU/1/06/364/004 - 12 tablets
Danish: EU/1/06/364/004 - 12 tabletter
English: ADROVANCE should not be used during breast-feeding.
Danish: ADROVANCE må ikke anvendes under amning.
English: How to take ADROVANCE
Danish: Sådan skal du tage ADROVANCE
English: ADROVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Danish: ADROVANCE 70 mg/2.800 IE tabletter Aluminium/aluminiumblisterkort i æsker med 2, 4, 6 eller 12 tabletter.
English: There is important additional information about how to take ADROVANCE in the package leaflet.
Danish: I indlægssedlen er der yderligere vigtige informationer om, hvordan du skal tage ADROVANCE.
English: It is likely that certain medicines or food additives may prevent the vitamin D in ADROVANCE from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
Danish: Disse omfatter kunstige fedterstatninger, mineralske olier, slankemidlet orlistat og de kolesterolsænkende lægemidler colestyramin og colestipol.
English: EU/1/06/364/002 - 4 tablets
Danish: EU/1/06/364/002 - 4 tabletter
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med ADROVANCE Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: ADROVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Danish: ADROVANCE 70 mg/5.600 IE tabletter Aluminium/aluminiumblisterkort i æsker med 2, 4 eller 12 tabletter.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Danish: Når du har slugt ADROVANCE tabletten, må du ikke lægge dig ned - du skal forblive oprejst (siddende, stående eller gående) i mindst 30 minutter.
English: ADROVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
Danish: ADROVANCE 70 mg/2.800 IE tabletter fås i pakninger med 2, 4, 6 eller 12 tabletter.
English: ADROVANCE 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
Danish: ADROVANCE 70 mg/5.600 IE tabletter fås i pakninger med 2, 4 eller 12 tabletter.
English: Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270' on the other.
Danish: Modificeret rektangulære, hvide/beige tabletter mærket med et omrids af en knogle på den ene side og ”210” på den anden.
English: Each ADROVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Danish: Hver ADROVANCE 70 mg/2.800 IE tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 70 mikrogram (2.800 IE) cholecalciferol (D3-vitamin).
English: ADROVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Danish: På grund af manglende erfaring bør ADROVANCE ikke gives til patienter med nedsat nyrefunktion, hvor kreatinin-clearance er < 35 ml/min.
English: Each ADROVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Danish: Hver ADROVANCE 70 mg/5.600 IE tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 140 mikrogram (5.600 IE) cholecalciferol (D3-vitamin).
English: What ADROVANCE looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: ADROVANCE 70 mg/2,800 IU tablets alendronic acid /colecalciferol
Danish: ADROVANCE 70 mg/2.800 IE tabletter alendronsyre/cholecalciferol
English: ADROVANCE 70 mg/5,600 IU tablets alendronic acid/colecalciferol
Danish: ADROVANCE 70 mg/5600 IE tabletter alendronsyre/cholecalciferol
English: ADROVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol
Danish: ADROVANCE 70 mg/5.600 IE tabletter alendronsyre/cholecalciferol
English: ADROVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol
Danish: ADROVANCE 70 mg/2800 IE tabletter alendronsyre/cholecalciferol
English: The educational material contains the following:
Danish: Undervisningsmaterialet omfatter følgende:
English: The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch of the new indication in their territory.
Danish: Det enkelte medlemsland skal aftale det endelige uddannelsesmateriale med MAH (indehaveren af markedsføringstilladelsen), før den nye indikation markedsføres i området.
English: The physician information should contain the following key elements:
Danish: Lægeinformationen skal indeholde følgende hovedelementer:
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Danish: Medlemslandene skal sørge for, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, der er beskrevet herunder, implementeres.
English: • Aseptic techniques to minimise the risk of infection
Danish: • Aseptiske teknikker for at minimere infektionsrisiko
English: • Key signs and symptoms of serious adverse events including increased intraocular pressure and ocular hypertension
Danish: • Vigtige tegn og symptomer på alvorlige uønskede hændelser, herunder forhøjet intraokulært tryk og okulær hypertension
English: • What are the steps following treatment with Ozurdex
Danish: • Information om, hvilke trin der følger efter behandlingen med Ozurdex
English: The Member States shall ensure that the provision of educational material implemented for the authorised indication of treatment of adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), is extended to the potential prescribers concerned by the new indication: treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.
Danish: MAH skal sikre, at udlevering af det implementerede undervisningsmateriale for den godkendte indikation: "behandling af voksne patienter med maculaødem efter enten retinal grenveneokklusion (BRVO) eller retinal centralveneokklusion (CRVO)", tillige sker til potentielle behandlere af patienter, der opfylder den nye indikation: "behandling af voksne patienter med inflammation i det posteriore segment af øjet, der viser sig som ikke-infektiøs uveitis".
English: • How to prepare for Ozurdex treatment
Danish: • Information om, hvordan man forbereder sig til Ozurdex-behandling
English: • Key signs and symptoms of IVT injection related adverse events including increased intraocular pressure, glaucoma, ocular hypertension, cataract, traumatic cataract related to injection technique, vitreous detachment, vitreous haemorrhage, endophthalmitis,
Danish: • Vigtige tegn og symptomer på uønskede hændelser i forbindelse med IVT-injektionen, herunder forhøjet intraokulært tryk, glaukom, okulær hypertension, katarakt, traumatisk katarakt relateret til injektionsteknik, glaslegemeløsning, corpus vitreum-blødning, endoftalmitis, nethindeløsning, nethinderift, mekanisk fejl ved udstyr og forkert anbringelse af implantat
English: • Patient monitoring after IVT injection
Danish: • Patientkontrol efter IVT-injektion
English: • Management of IVT injection related adverse events The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements:
Danish: Informationspakken til patienter skal leveres både i form af en patientinformationsfolder og en lyd-cd, der indeholder følgende hovedelementer:
English: • Techniques for the intravitreal injection
Danish: • Teknikker til intravitreal injektion
English: • Intravitreal injection procedure video
Danish: • Video med intravitreal injektionsprocedure
English: • Intravitreal injection procedure pictogram
Danish: • Illustration af intravitreal injektionsprocedure
English: This is common, and nothing to worry about.
Danish: Det er almindeligt og ikke noget at være bekymret for.
English: The red area will fade over the next few days to a week.
Danish: Det rødlige område vil forsvinde inden for få dage til en uge.
English: Important things to be aware of
Danish: Vigtige ting, du skal være opmærksom på
English: 2 years Use immediately after opening.
Danish: 2 år Anvendes straks efter åbning.
English: Tell your patient the following:
Danish: Fortæl patienten følgende:
English: This may affect serum concentrations.
Danish: Dette kan påvirke serumkoncentrationerne.
English: The mean systemic bioavailability is 87%.
Danish: Den gennemsnitlige systemiske biotilgængelighed er 87%.
English: 80 doses
Danish: 80 doser
English: The table below represents the different error messages that may occur, together with the probable cause and the action to be taken.
Danish: Nedenstående tabel viser de forskellige fejlmeddelelser, der kan forekomme, sammen med den sandsynlige årsag og den foranstaltning, der skal træffes.
English: The maximum treatment duration is 72 hours, although the majority of patients should only need one system.
Danish: Den maksimale behandlingsvarighed er 72 timer, men størstedelen af patienterne bør kun have behov for et enkelt system.
English: Do not let these touch your mouth or eyes.
Danish: Gelen må ikke berøre din mund eller dine øjne.
English: • abnormal dreams or hallucinations (seeing or hearing things that are not there)
Danish: • unormale drømme eller hallucinationer (ser og hører ting, som ikke findes)
English: This side of the system contains material called “gels” which you should not normally come into contact with.
Danish: Denne side af systemet indeholder et materiale, der kaldes for en “gel”, som du ikke normalt ikke bør komme i kontakt med.
English: - Do not take it off or attempt to put it back on yourself.
Danish: - Forsøg ikke selv at tage det af eller sætte det på igen.
English: EXP Use immediately after opening.
Danish: EXP Anvendes straks efter åbning.
English: Take care not to touch the hydrogels.
Danish: Pas på ikke at berøre hydrogelerne.
English: • Do not let your family or friends start IONSYS for you.
Danish: • Du må ikke lade familie eller venner starte IONSYS for dig.
English: • Each dose will last for 10 minutes.
Danish: • Hver dosis varer 10 minutter.
English: Probable cause
Danish: Sandsynlig årsag
English: The Healthcare provider educational Programme shall contain the following key messages:
Danish: Oplæringsprogrammet til sundhedspersonser skal omfatte følgende centrale punkter:
English: The next dose cannot be initiated until the previous 10-minute delivery period is complete.
Danish: Næste dosis kan ikke startes, før den foregående doseringsperiode på 10 minutter er afsluttet.
English: There was no indication of teratogenic effects in studies in two species (rats and rabbits).
Danish: Der var ingen tegn på teratogene effekter i forsøg med to arter (rotter og kaniner).
English: Physical status
Danish: Fysisk status
English: Low battery or defective system
Danish: Lavt batteriniveau eller defekt system
English: p-value C-2001-011 27 % (64/235) 57 % (116/204) <0.0001
Danish: p-værdi C-2001-011 27% (64/235) 57% (116/204) <0,0001
English: The half-life of the antagonist may be short; therefore, repeated administration or infusion of the antagonist may be necessary.
Danish: Antagonistens halveringstid kan være kort, hvorfor gentagen administration eller infusion af antagonisten kan være påkrævet.
English: An alternative application site should be chosen.
Danish: Der skal vælges et andet påsætningssted.
English: Do not use the system.
Danish: Brug ikke systemet.
English: Long-lasting or any non-opioid analgesics were not permitted.
Danish: Langtidsvirkende eller non-opioide analgetika var ikke tilladt.
English: Fentanyl has a well-known abuse potential.
Danish: Fentanyl har et velkendt misbrugspotentiale.
English: The plasma protein binding of fentanyl is 80% to 85%.
Danish: Fentanyls plasmaproteinbinding er 80% til 85%.
English: A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Danish: En mutagen risiko ved anvendelsen af terapeutiske doser forekommer usandsynlig, idet virkningerne kun forekom ved høje koncentrationer.
English: Concomitant use of analgesics was not allowed after 3 hours in Studies C-2000-007 and CAPSS-320.
Danish: Samtidig anvendelse af analgetika var ikke tilladt efter 3 timer i studie C-2000-007 og CAPSS-320.
English: Abuse or intentional misuse of IONSYS may result in overdose and/or death.
Danish: Forkert brug eller tilsigtet misbrug af IONSYS kan medføre overdosering og/eller dødsfald.
English: Contact with the hydrogel should be avoided.
Danish: Kontakt med hydrogelen skal undgås.
English: Information for the Healthcare Professional: Instructions for use and disposal
Danish: Oplysninger til læger og sundhedspersonale: Instruktioner til anvendelse og bortskaffelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1050/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1050/001
English: Each patient and investigator was asked to rate the patient's method of pain control as either poor, fair, good, or excellent.
Danish: Hver patient og investigator blev bedt om at klassificere smertelindringsmetoden som enten dårlig, rimelig, god eller meget god.
English: • blue skin colour (lips and finger tips)
Danish: • blåfarvning af huden (læber og fingerspidser)
English: Dose proportionality has been demonstrated from 25 to 60 micrograms per dose.
Danish: Der er påvist dosisproportionalitet fra 25 til 60 mikrogram pr. dosis.
English: to <1/1,000).
Danish: 1/10.000 til < 1/1.000).
English: Do not use the system 2.
Danish: Brug ikke systemet 2.
English: The used system should be handled carefully by the sides and top.
Danish: Det brugte system skal håndteres forsigtigt ved at tage fat i siderne og på toppen.
English: No specific dose adjustment is required in elderly patients.
Danish: Specifik dosisjustering er ikke nødvendig hos ældre patienter.
English: Prolonged contact with water could affect system performance and cause the system to fall off.
Danish: Længerevarende kontakt med vand kan påvirke systemets ydeevne og medføre, at det falder af.
English: Patients should not wear more than one system at a time.
Danish: Patienten bør ikke bære mere end ét system ad gangen.
English: Table 2 Active Comparator Trials (n=2569) Evaluable Patients
Danish: Tabel 2 Studie med aktiv komparator (n=2569) Evaluerbare patienter
English: Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Danish: Virkningerne på embryoet skyldtes maternel toksicitet og ikke direkte virkninger af stoffet på embryoet under udvikling.
English: Some medicines can affect the way IONSYS works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke den måde, IONSYS virker på, eller gøre det mere sandsynligt, at du får bivirkninger.
English: In this situation, special patient care and observation are appropriate.
Danish: I denne situation er særlig forsigtighed og observation af patienten nødvendig.
English: • you have any difficulty hearing as you will need to be able to hear the device's ‘beep(s)' to know if it is working properly or if there is a problem
Danish: • du har problemer med at høre, da du skal kunne høre systemets bippelyde for at vide, om det virker korrekt, eller hvis der er et problem
English: A single IONSYS system provided a sufficient number of doses for 99% of the studied patients over 24 hours.
Danish: Et enkelt IONSYS-system gav et tilstrækkeligt antal doser for 99% af de undersøgte patienter i 24 timer.
English: You can take a dose whenever you need it for your pain, or just before you do an activity that may increase your pain (such as physical therapy, getting out of bed, etc.).
Danish: Du kan tage en dosis, når som helst du har brug for det til lindring af smerter eller umiddelbart inden en aktivitet, der kan forhøje smerterne (for eksempel fysioterapi, når du skal ud af sengen osv.).
English: You must tell your doctor before using IONSYS if you are pregnant or planning to become pregnant.
Danish: Du skal fortælle det til lægen, inden du bruger IONSYS, hvis du er gravid eller planlægger at blive gravid.
English: In summary, the limited size of the overall paediatric exposure is insufficient to guide safe and effective dosing of IONSYS in patients younger than 18 years of age.
Danish: Kort sagt er den begrænsede størrelse af den samlede pædiatriske eksponering ikke tilstrækkelig til at give vejledning til en sikker og effektiv dosering af IONSYS til patienter under 18 år.
English: • Blinking red light for 15 seconds
Danish: • Blinkende rødt lys i 15 sekunder
English: Error message/feedback
Danish: Fejlmeddelelse/feedback