FrancophonIA/ELRC3.0 huggingface dataset:
English: During a median of 18 months following discontinuation of teriparatide, there was a 41% reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
Danish: Med en median på 18 måneder efter seponering af behandlingen med teriparatid sås en reduktion på 41 % (p=0,004) i antallet af patienter med mindst en ny vertebral fraktur sammenlignet med placebo.
English: Write down the first injection date of each new cartridge.
Danish: Notér den første injektionsdato for hver ny cylinderampul.
English: If pregnancy occurs, teriparatide should be discontinued.
Danish: I tilfælde af graviditet bør behandlingen med teriparatid ophøre.
English: EU/1/16/1159/002 [3 cartridges] {Displayed in case of 1x and 3x cartridges only.
Danish: EU/1/16/1159/002 [3 cylinderampuller] {Vises kun for 1 x og 3 x cylinderampuller.
English: • Transport and store the Terrosa Pen with inserted cartridge at temperatures specified in the Terrosa package leaflet, provided separately.
Danish: • Transporter og opbevar Terrosa Pen med isat cylinderampul ved temperaturerne angivet i indlægssedlen for Terrosa, som leveres separat.
English: • Turn the dose knob clockwise until you see a droplet sign on the dose display.
Danish: • Drej doseringsknappen med uret, indtil du ser et dråbesymbol på doseringsdisplayet.
English: After 12 months, BMD had increased in the lumbar spine and total hip by 5% and 1%, respectively, compared with placebo.
Danish: Efter 12 måneder var BMD i lænderygsøjlen og i hoften steget med henholdsvis 5 % og 1 % sammenlignet med placebo.
English: For the first doses, inject Terrosa in a place where you can sit or lie down right away if you get dizzy.
Danish: Når De tager de første doser af Terrosa, så gør det et sted, hvor De har mulighed for at sidde eller ligge ned, hvis De skulle blive svimmel.
English: In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.
Danish: Hos patienter, som blev behandlet med teriparatid, blev BMD for lænderygsøjle, hofte og lårbenshals mellem 18 og 24 måneder øget yderligere med henholdsvis 1,7 %, 0,9 % og 0,4 %.
English: • Do not store the Terrosa Pen with a needle attached as this may cause air bubbles to form in the cartridge.
Danish: • Opbevar ikke Terrosa Pen med enisat kanyle, da dette kan medføre, at der dannes luftbobler i cylinderampullen.
English: After insertion of the cartridge into the pen, the combined pen and cartridge should be returned to the refrigerator immediately after use.
Danish: Efter cylinderampullen sættes i pennen, skal den kombinerede pen og cylinderampul lægges tilbage i køleskabet umiddelbart efter brug.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LID FOIL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP FOLIELÅG
English: Rarely, patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash and chest pain.
Danish: I sjældne tilfælde oplever patienter allergiske reaktioner i form af vejrtrækningsbesvær, hævelse af ansigtet, udslæt og brystsmerter.
English: - As soon as you have finished the injection, attach the outer needle protective cap on the pen needle and screw the cap anti-clockwise to remove the pen needle.
Danish: - Så snart injektionen er færdig, sæt den ydre beskyttelseshætte på pennens nål og skru hætten mod uret for at fjerne pennens nål.
English: - After inserting a new cartridge and before the first injection from this cartridge prime the pen according to the instructions which are provided.
Danish: - Efter indsættelse af en ny cylinderampul og inden den første injektion fra denne cylinderampul, skal pennen klargøres i henhold til den medfølgende brugsanvisning.
English: If you become pregnant while using Terrosa, Terrosa should be discontinued.
Danish: Hvis De bliver gravid, mens De bruger Terrosa, skal behandlingen med Terrosa ophøre.
English: A new, sterile pen needle must be used for every injection.
Danish: Der skal anvendes en ny steril kanyle til pennen til hver injektion.
English: All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Danish: Alle patienter fik tilbudt 1.000 mg calcium og 800 IE D-vitamin dagligt.
English: All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Danish: Alle patienter fik tilbudt 1.000 mg calcium dagligt og mindst 400 IE D-vitamin dagligt.
English: Batch (Lot) number of each cartridge and the date of its first injection should be recorded by the patient on a calendar.
Danish: Batchnummeret (lot-nummeret) på hver cylinderampul såvel som datoen for den første injektion skal registreres af patienten på en kalender.
English: Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral)
Danish: Mulige allergiske reaktioner lige efter injektion: akut dyspnø, mund/ansigtsødem, generaliseret urticaria, brystsmerter, ødem (hovedsagelig perifer)
English: Do not tilt the pen after the needle has been inserted into the skin.
Danish: Vip ikke pennen, når kanylen er blevet indført i huden.
English: Troubleshooting Follow the instructions given in the table if you have any questions regarding the use of Terrosa Pen:
Danish: Følg instruktionerne i tabellen, hvis du har spørgsmål angående brugen af Terrosa Pen: Spørgsmål
English: Terrosa must not be transferred to a syringe.
Danish: Terrosa må ikke overføres til en injektionssprøjte.
English: What Terrosa looks like and contents of the pack Terrosa is a colourless and clear solution.
Danish: Udseende og pakningsstørrelser Terrosa er en farveløs og klar opløsning.
English: If you forget to use Terrosa
Danish: Hvis De har glemt at bruge Terrosa
English: If you stop using Terrosa
Danish: Hvis De holder op med at bruge Terrosa
English: Teriparatide increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p<0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p<0.05).
Danish: Teriparatid øgede BMD i hoften (3,6 %) sammenlignet med alendronat (2,2 %) (p<0,01), såvel som i lårbenshalsen (3,7 %) sammenlignet med alendronat (2,1 %) (p<0,05).
English: Store it in the cartridge sleeve during the whole 28-day treatment period.
Danish: Opbevar den i hylstret til cylinderampullen under hele behandlingsperioden på 28 dage.
English: Each cartridge and pen should be used by only one patient.
Danish: Hver cylinderampul og pen er beregnet til brug af én patient.
English: Richter-Helm BioLogics GmbH & Co. KG Dengelsberg
Danish: Richter-Helm BioLogics GmbH & Co.
English: The expected effects of overdose include nausea, vomiting, dizziness, and headache.
Danish: De forventede virkninger af en overdosis omfatter kvalme, opkastning, svimmelhed og hovedpine.
English: At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5%, 2.6 % and 3.9% respectively.
Danish: Ved 24 måneder var den gennemsnitlige stigning i BMD fra baseline i lænderygsøjle, hofte og lårbenshals henholdsvis 10,5 %, 2,6 % og 3,9 %.
English: Do not use this medicine after the expiry date which is stated on the carton and the cartridge after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og pennen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving teriparatide.
Danish: I et stort klinisk forsøg blev der hos 2,8 % af de kvinder, der fik teriparatid, fundet antistoffer, der krydsreagerede med teriparatid.
English: It should be administered exclusively with the Terrosa Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions which are provided with the pen.
Danish: Lægemidlet skal udelukkende administreres ved brug af det genanvendelige Terrosa Pen-multidosis lægemiddeladministrationssystem og injektionsnåle, der er angivet som kompatible i den medfølgende brugsanvisning til pennen.
English: Read both the package leaflet of Terrosa cartridge and the instructions for use of the Terrosa Pen before use.
Danish: Læs både indlægssedlen for Terrosa cylinderampul og brugsvejledningen for Terrosa pen inden brug.
English: Small air bubbles are visible in the cartridge.
Danish: Der ses små luftbobler i cylinderampullen.
English: What you need to know before you use Terrosa
Danish: Det skal De vide, før de begynder at bruge Terrosa
English: After the first use, the cartridge should not be removed from the pen during the 28 days of usage.
Danish: Efter den bruges første gang, må cylinderampullen ikke fjernes fra pennen i anvendelsesperioden på 28 dage.
English: Terrosa contains sodium
Danish: Terrosa indeholder natrium
English: Terrosa cartridges are to be used in Terrosa Pen reusable, multidose pen device exclusively and must not be used with any other pen.
Danish: Terrosa cylinderampuller skal anvendes udelukkende i den genanvendelige Terrosa Pen til flere doser og må ikke anvendes med nogen anden pen.
English: - Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
Danish: - Patienter med maligne lidelser i skelettet eller knoglemetastaser frarådes behandling med teriparatid.
English: • low haemoglobin or red blood cell count (anaemia).
Danish: • lav hæmoglobin eller lavt antal af røde blodlegemer (blodmangel, anæmi)
English: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis
Danish: Urininkontinens, polyuri, imperiøs vandladning, nefrolitiasis
English: Some drops of medicine must be expelled from the needle tip.
Danish: Der skal afgives nogle dråber medicin fra kanylens spids.
English: Some patients get dizzy or get a fast heartbeat after the first few doses of Terrosa.
Danish: Nogle patienter oplever svimmelhed eller hjertebanken efter de første indsprøjtninger med Terrosa.
English: Once-daily administration of teriparatide increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Danish: Ved administration af teriparatid en gang dagligt øges remodelleringen af nyt knoglevæv på trabekulære og kortikale knogleoverflader ved fortrinsvist at stimulere osteoblastaktivitet frem for osteoklastaktivitet.
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.290.68), p<0.0001.
Danish: For de patienter der havde fået taget røntgenbillede af rygsøjlen ved baseline og som opfølgning, var hyppigheden af nye vertebrale frakturer 28/516 (5,4 %) hos teriparatid- og 64/533 (12,0 %) hos risedronatbehandlede patienter, relativ risiko (95 % CI) = 0,44 (0,29-0,68), p<0,0001.
English: Terrosa 20 micrograms/80 microliters solution for injection: 1 or 3 cartridge(s) packed in a plastic tray sealed with lid foil and packed in a carton.
Danish: Terrosa 20 mikrogram/80 mikroliter injektionsvæske, opløsning: 1 eller 3 cylinderampul(ler) pakket i en plastbakke forseglet med et folielåg og pakket i en karton.
English: Terrosa may increase calcium in your blood or urine.
Danish: Advarsler og forsigtighedsregler Terrosa kan øge kalk (calcium) i blodet eller urinen.
English: 3 mL cartridge (siliconised Type I glass), with a plunger stopper (bromobutyl) and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and packed in a carton.
Danish: 3 ml cylinderampul (silikonebehandlet type I glas) med en stempelprop (bromobutyl) og forsegling (aluminium og gummibeklædt segl) pakket i en plastbakke med folielåg pakket i en karton.
English: Osteoporosis is also common in patients receiving medicines called corticosteroids.
Danish: Knogleskørhed er også almindeligt forekommende hos patienter, der får lægemidler, som kaldes binyrebarkhormoner.
English: Do not remove the cartridge from the pen after first use.
Danish: Fjern ikke cylinderampullen fra pennen, efter den bruges første gang.
English: Storage and care of Terrosa Pen
Danish: Opbevaring og vedligeholdelse af Terrosa Pen
English: Talk to your doctor before or while using Terrosa:
Danish: Kontakt lægen, før De tager Terrosa:
English: Terrosa should not be used if the solution is cloudy, coloured or contains visible particles.
Danish: Terrosa må ikke bruges, hvis opløsningen er uklar, farvet eller indeholder synlige partikler.
English: Reset the pen by simply turning back the dose knob anticlockwise to the start position.
Danish: Nulstil pennen ved ganske enkelt at dreje doseringsknappen mod uret til startpositionen.
English: If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Terrosa.
Danish: Hvis De er kvinde i den fødedygtige alder, skal De anvende sikre præventionsmetoder, når de bruger Terrosa.
English: The threaded rod cannot be pushed back to the pen housing entirely.
Danish: Stangen med gevind kan ikke skubbes helt tilbage til pennens kabinet.
English: The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), p=0.0009.
Danish: Den akkumulerende hyppighed for samlede kliniske frakturer (kliniske vertebral og non-vertebral frakturer) var 4,8 % hos teriparatid- og 9,8 % hos risedronatbehandlede patienter, harzard ratioen (95 % CI) = 0,48 (0,32-0,74), p=0,0009.
English: Do not remove the cartridge from the pen during the 28 days of use.
Danish: Fjern ikke cylinderampullen fra pennen i løbet af de 28 dages behandling.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERAF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: • if you suffer from kidney stones or have had kidney stones.
Danish: Hvis De lider af nyresten eller har haft nyresten.
English: Terrosa can be injected at meal times.
Danish: Terrosa kan indsprøjtes i forbindelse med måltider.
English: Before inserting a cartridge in Terrosa Pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar.
Danish: Inden en cylinderampul sættes i Terrosa Pen, skriv cylinderampullens batchnummer (lot-nummer) og den første injektionsdato ned i en kalender.
English: • using cartridges other than Terrosa cartridges
Danish: • brug af andre cylinderampuller end Terrosa cylinderampullerne
English: Insert a new Terrosa cartridge into the cartridge holder, with the metal crimped cap of the cartridge first.
Danish: Indsæt en ny Terrosa cylinderampul i holderen med den bølgeformede metalhætte på cylinderampullen først.
English: Pack sizes:
Danish: Pakningsstørrelse:
English: Never store your pen with the needle attached.
Danish: Opbevar aldrig pennen med nålen påsat.
English: The dose knob cannot be turned clockwise up to the arrow sign.
Danish: Doseringsknappen kan ikke drejes med uret op til pilen.
English: At the 18 month endpoint, teriparatide significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p<0.001).
Danish: Ved 18 måneders endpoint havde teriparatid signifikant forøget BMD i lænderygsøjlen (7,2 %) sammenlignet med alendronat (3,4 %) (p<0,001).
English: Administration using the Terrosa Pen
Danish: Administration ved hjælp af Terrosa Pen
English: Insert the cartridge into the pen before the first use as detailed in the pen instructions.
Danish: Sæt cylinderampullen i pennen inden den første brug, som beskrevet i brugsanvisningen til pennen.
English: Preparing the pen for use - To ensure the correct administration of Terrosa always read the Instructions for Use of Terrosa Pen, which is included in the carton of the pen.
Danish: Klargøring af pennen til brug - Læs altid brugsanvisningen til Terrosa Pen, som følger med i pennens karton, for at garantere korrekt administration af Terrosa.
English: However, foetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 micrograms/kg.
Danish: Hos kaniner forekom dog fosterresorption og nedsat kuldstørrelse ved daglige doser på 3 til 100 mikrogram/kg.
English: If you are considering stopping Terrosa treatment, please discuss this with your doctor.
Danish: Hvis De overvejer at holde op med at bruge Terrosa, skal De tale med Deres læge om det først.
English: Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.
Danish: Det anbefales at give tilskud af calcium og D-vitamin til patienter, som ikke får tilstrækkeligt af disse i deres kost.
English: Before disposing of the Terrosa Pen always remove the pen needle and the cartridge.
Danish: Før du bortskaffer Terrosa Pen, skal du altid fjerne penkanylen og cylinderampullen.
English: However, for the treatment initiation a cartridge and pen pack should be used containing one carton of Terrosa cartridge and one carton of Terrosa Pen.
Danish: Men ved påbegyndelse af behandlingen skal der anvendes en pakke med cylinderampul og pen, der indeholder en karton med en Terrosa cylinderampul og en karton med en Terrosa Pen.
English: In this case, remove the pen needle, change the cartridge and proceed with priming according the pen preparation steps.
Danish: I dette tilfælde skal du fjerne penkanylen, udskifte cylinderampullen og fortsætte med klargøring i henhold til trinnene for klargøring af pennen.
English: Leave the cartridge in the pen.
Danish: Lad cylinderampullen blive i pennen.
English: Other medicines and Terrosa
Danish: Brug af anden medicin sammen med Terrosa
English: Teriparatide is a bone formation agent to treat osteoporosis.
Danish: Teriparatid er et knogledannende stof til behandling af osteoporose.
English: Terrosa cartridge and pen pack: 1 Terrosa cartridge packed in a plastic tray sealed with lid foil and packed in a carton and 1 Terrosa Pen packed into a separate carton.
Danish: Terrosa pakke med cylinderampul og pen: 1 Terrosa cylinderampul pakket i en plastbakke, forseglet med lågfolie og pakket i en karton og 1 Terrosa Pen pakket i en separat karton.
English: If pregnancy occurs, Terrosa should be discontinued.
Danish: I tilfælde af graviditet, bør brugen af Terrosa ophøre.
English: Keep the cartridge in the outer carton in order to protect from light.
Danish: Opbevar cylinderampullen i yderkartonen for at beskytte den mod lys.
English: The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb, headache and dizziness.
Danish: De mest almindelige bivirkninger hos patienter, der behandles med teriparatid, er kvalme, smerter i ekstremiteterne, hovedpine og svimmelhed.
English: INFORMATION IN BRAILLE Terrosa cartridge and pen
Danish: INFORMATION I BRAILLESKRIFT Terrosa cylinderampul og pen
English: Detailed and updated information on this product is available by scanning the QR code included below or the outer carton with a smartphone.The same information is also available on the following URL: www.terrosapatient.com
Danish: Detaljeret og opdateret information om produktet kan fås ved at scanne QR-koden angivet nedenfor eller på yderpakningen med en smartphone.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR CARTRIDGE AND PEN PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON FOR PAKKE MED CYLINDERAMPUL OG PEN
English: Do not transfer the medicine into a syringe.
Danish: Overfør ikke medicinen til en injektionssprøjte.
English: • a puncture-resistant sharps disposal container for used needles.
Danish: • En beholder til skarpe genstande til de brugte kanyler.
English: Make sure that the pen needle is attached correctly and sits firmly on the cartridge holder.
Danish: Sørg for, at pennens kanyle sidder korrekt fast og stramt på cylinderampulholderen.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not remove the cartridge from the pen during the 28 days of use.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Fjern ikke cylinderampullen fra pennen i løbet af brugsperioden på 28 dage.
English: Needle cannot be attached.
Danish: Kanylen kan ikke sættes fast.
English: It will also stop air going back into the cartridge and the needle from clogging.
Danish: Det forhindrer desuden luft i at komme ind i cylinderampullen såvel som tilstopning af nålen.
English: Each Terrosa cartridge contains 28 doses of fixed 80 microlitres Terrosa.
Danish: Hver Terrosa cylinderampul indeholder 28 doser á fastsat 80 mikroliter Terrosa.
English: After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9% and 4% compared with placebo (p<0.001).
Danish: Efter en median behandlingsperiode på 19 måneder var knoglemineraltætheden (BMD) øget med henholdsvis 9 % og 4 % i lænderygsøjlen og hoften sammenlignet med placebo (p<0,001).
English: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Danish: Eddikesyre; koncentreret, natriumacetattrihydrat, mannitol, metacresol, vand til injektionsvæsker, saltsyre (til pH-justering) og natriumhydroxid (til pH-justering).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/001 [1 cartridge] EU/1/16/1159/002 [3 cartridges] EU/1/16/1159/003 [cartridge and pen pack]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/16/1159/001 [1 cylinderampul] EU/1/16/1159/002 [3 cylinderampuller] EU/1/16/1159/003 [Pakke med cylinderampul og pen]
English: Write down the batch (Lot) number of each cartridge and its first injection date on a calendar.
Danish: Skriv batchnummeret (lotnummeret) på hver cylinderampul og den første injektionsdato ned i en kalender.
English: During dose dialling the pen does not provide an audible signal.
Danish: Pennen afgiver ikke et hørbart signal under justering af dosen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/001 [1 cartridge]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/16/1159/001 [1 cylinderampul]
English: Renal impairment Caution should be exercised in patients with moderate renal impairment.
Danish: Teriparatid bør anvendes med forsigtighed til patienter med moderat nedsat nyrefunktion.
English: - The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Danish: - Øvrige indholdsstoffer: Eddikesyre; koncentreret, mannitol, metacresol og natriumacetattrihydrat, saltsyre (til pH-justering), natriumhydroxid (til pH-justering), vand til injektionsvæsker.
English: Do not drop your pen and avoid knocking it against hard surfaces.
Danish: Undgå at tabe pennen og at lade den ramme ind i hårde overflader.
English: Legal manufacturer:
Danish: Fremstiller:
English: Removing the pen needle • Carefully attach the outer needle cap on the pen needle.
Danish: Fjernelse af penkanylen • Sæt forsigtigt den ydre nålehætte fast på penkanylen.
English: You should inject Terrosa shortly after you take the pen with inserted cartridge out of the refrigerator.
Danish: Giv Terrosa-injektionen umiddelbart efter pennen med cylinderampullen isat tages ud af køleskabet.
English: a The incidence of vertebral fractures was assessed in 448 placebo and 444 teriparatide patients who had baseline and follow-up spine radiographs.
Danish: Forkortelser: N = antal patienter randomiseret til hver behandlingsgruppe; KI = konfidensinterval a Hyppigheden af vertebrale frakturer blev vurderet hos 448 placebo- og 444 teriparatid-patienter, der havde fået taget røntgenbillede af rygsøjlen ved baseline og som opfølgning.
English: Do not use the pen if the cartridge is cloudy, discoloured or contains particles.
Danish: Brug ikke pennen, hvis cylinderampullen er uklar, misfarvet eller indeholder partikler.
English: • Press the push button until the dose indication has returned to the start position.
Danish: • Tryk på trykknappen, indtil dosisindikationen er vendt tilbage til startpositionen.