FrancophonIA/ELRC3.0 huggingface dataset:
English: • The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose,
Danish: - Øvrige indholdsstoffer: Tris-base, Tris-hydrochlorid, L-argininhydrochlorid, saccharose,
English: Restoration of thrombin generation
Danish: Reetablering af trombingenerering
English: Attach ancillary equipment (i.e., extension tubing, air filters, IV pump) in preparation for administration.
Danish: Påmontér hjælpeudstyr (det vil sige forlængerslange, luftfiltre, i.v.-pumpe) til klargøring til administration.
English: • Same number of 20 mL (or larger) solvent syringes equipped with a 20 gauge (or larger) needle.
Danish: • Samme antal 20 ml (eller større) sprøjter til opløsningsmiddel udstyret med en 20-gauge (eller større) kanyle.
English: • disturbance of taste
Danish: • smagsforstyrrelse
English: FXa inhibitors did not affect andexanet alfa pharmacokinetics at therapeutic levels.
Danish: FXainhibitorer påvirkede ikke farmakokinetikken for andexanet alfa ved terapeutiske niveauer.
English: Attach ancillary equipment (i.e., extension tubing, air filters, syringe driver) in preparation for administration.
Danish: Påmontér hjælpeudstyr (det vil sige forlængerslange, luftfiltre, sprøjtepumpe) til klargøring til administration.
English: After treatment with Ondexxya, your doctor will decide when to restart anticoagulant therapy.
Danish: Efter behandling med Ondexxya vil din læge beslutte, hvornår du igen skal påbegynde behandling med antikoagulant.
English: The second column provides the list of adverse reactions from the interim results of the Phase IIIb/IV ANNEXA-4 study, including 352 patients with acute major bleeding treated with andexanet alfa.
Danish: Den anden søjle viser en liste over bivirkninger fra interimresultaterne i fase IIIb/IV ANNEXA-4-studiet, der indbefattede 352 patienter med akut større blødning, som blev behandlet med andexanet alfa.
English: Reversal of anticoagulation in healthy subjects aged 50-75 (Studies 14-503 and 14-504) In a prospective, randomized, placebo-controlled study, healthy subjects with a median age of 56.5 years on apixaban 5 mg twice daily received andexanet alfa (n=24) administered as a 400 mg IV bolus immediately followed by a 4 mg per minute IV infusion for 120 minutes (480 mg) or placebo (n=8).
Danish: Revertering af antikoagulation hos raske forsøgspersoner i alderen 50-75 (studie 14-503 og 14-504) I et prospektivt, randomiseret, placebokontrolleret studie fik raske forsøgspersoner med en medianalder på 56,5 år, der var på apixaban 5 mg to gange dagligt, andexanet alfa (n = 24) administreret som en 400 mg-i.v.-bolus umiddelbart efterfulgt af en 4 mg pr. minut i.v.-infusion i 120 minutter (480 mg) eller placebo (n = 8).
English: Reversal of FXa inhibitor anticoagulation in patients with acute major bleeding In Study 14-505 (ANNEXA-4), a Phase IIIb/IV multinational, prospective, single-arm, open-label study, Ondexxya was administered to 352 patients on FXa inhibitors who presented with acute major bleeding.
Danish: Revertering af FXa-inhibitor-antikoagulation hos patienter med akut større blødning I studie 14-505 (ANNEXA-4), som var et multinationalt, prospektivt, åbent fase IIIb/IVenkeltarmstudie blev Ondexxya administreret til 352 patienter på FXa-inhibitorer, som oplevede en akut større blødning.
English: Restoration of thrombin generation to within normal ranges (defined as one standard deviation from baseline levels) within two minutes and maintained for 20 hours was achieved with bolus only and bolus plus infusion for low-dose andexanet alfa in subjects on apixaban.
Danish: Forsøgspersoner på apixaban opnåede reetablering af trombingenerering til inden for normalområderne (defineret som én standardafvigelse fra baselineniveauer) inden for to minutter, som blev opretholdt i 20 timer, med bolus alene og bolus plus infusion med lavdosis-andexanet alfa.
English: After you have received Ondexxya, your doctor will decide when to restart your anticoagulant treatment.
Danish: Efter du har fået Ondexxya, vil lægen beslutte, hvornår du igen skal starte på din behandling med antikoagulant.
English: Andexanet alfa is to be reconstituted and the 10 mg/mL solution then transferred to a suitable IV bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low protein-binding filter.
Danish: Andexanet alfa skal rekonstitueres og 10 mg/ml-opløsningen herefter overføres til en egnet i.v.-pose, der består af polyolefin (PO)- eller polyvinylchlorid (PVC)-materiale, uden yderligere fortynding før administration ved hjælp af i.v.-infusion ved anvendelse af et 0,2 eller 0,22 mikron indsat polyethersulfon (PES) eller tilsvarende lavproteinbindende filter.
English: Cardiovascular causes of death (n=27) included: haemorrhagic stroke (n=6), ischaemic stroke (n=5), sudden cardiac death (including unwitnessed) (n=5), cardiomechanical/pump failure (n=4), myocardial infarction (n=2), bleeding other than haemorrhagic stroke (n=1), and other cardiovascular causes (n=4).
Danish: Kardiovaskulære årsager til dødsfald (n = 27) indbefattede: hæmoragisk apopleksi (n = 6), iskæmisk apopleksi (n = 5), pludselig hjertedød (herunder ikkebevidnede) (n = 5), kardiomekanisk/pumpe-svigt (n = 4), myokardieinfarkt (n = 2), anden blødning end hæmoragisk apopleksi (n = 1) og andre kardiovaskulære årsager (n = 4).
English: Low dose
Danish: Lav dosis
English: How Ondexxya is used
Danish: Sådan bruges Ondexxya
English: Paediatric population The pharmacokinetics of andexanet alfa has not been studied in paediatric patients.
Danish: Pædiatrisk population Farmakokinetikken for andexanet alfa er ikke blevet undersøgt hos pædiatriske patienter.
English: No clinical evaluation for apixabantreated subjects with high-dose andexanet alfa and no evaluation for rivaroxaban-treated subjects with low-dose andexanet alfa was performed in these studies.
Danish: Der er ikke udført klinisk evaluering af apixabanbehandlede forsøgspersoner med højdosis-andexanet alfa eller af rivaroxabanbehandlede forsøgspersoner med lavdosis-andexanet alfa i disse studier .
English: Studies to evaluate the mutagenic and carcinogenic potential of andexanet alfa have not been performed.
Danish: Der er ikke udført studier til evaluering af mutageniciteten og karcinogeniciteten af andexanet alfa.
English: Wipe the rubber stopper of each vial with an alcohol swab.
Danish: Aftør gummiproppen på hvert hætteglas med en spritserviet.
English: Initial intravenous bolus
Danish: Tabel 1: Doseringsprogrammer Indledende intravenøs bolus
English: Insert the syringe needle through the centre of the rubber stopper.
Danish: Indfør sprøjtekanylen gennem midten af gummiproppen.
English: Animal reproductive and developmental studies have not been conducted with andexanet alfa.
Danish: Der er ikke udført studier af reproduktion og udvikling hos dyr med andexanet alfa.
English: In order to substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of a global randomised controlled clinical trial to investigate the use of andexanet versus standard of care treatment in patients with intracranial haemorrhage (ICH) taking apixaban, rivaroxaban, or edoxaban (study 18-513).
Danish: Indehaveren af markedsføringstilladelsen skal til underbyggelse af korrelationen mellem biomarkøren (anti-FXa-aktivitet) og hæmostatisk virkning og til klarlæggelse af risikoen for tromboser og tromboemboliske hændelser indsende resultaterne af et globalt randomiseret kontrolleret klinisk studie til undersøgelse af brugen af andexanet versus standardbehandling til patienter med intrakraniel blødning (ICH), der tager apixaban, rivaroxaban eller edoxaban (studie 18-513).
English: It reverses the effects of certain anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban).
Danish: Det modvirker virkningen af visse antikoagulanter, der kaldes faktor Xa-hæmmere (apixaban eller rivaroxaban).
English: Once all required vials are reconstituted, the reconstituted solution is withdrawn from each vial, using the large volume (60 mL or larger) syringe equipped with a 20 gauge (or larger) needle.
Danish: Når alle nødvendige hætteglas er rekonstitueret, trækkes den rekonstituerede opløsning op fra hvert hætteglas ved anvendelse af sprøjten med stort volumen (60 ml eller større) udstyret med en 20-gauge (eller større) kanyle.
English: Ondexxya 200 mg powder for solution for infusion
Danish: Ondexxya 200 mg pulver til infusionsvæske, opløsning
English: Ondexxya 200 mg powder for solution for infusion andexanet alfa
Danish: Ondexxya 200 mg pulver til infusionsvæske, opløsning andexanet alfa
English: In prospective, randomized, placebo-controlled, dose-ranging studies in healthy subjects, the dose and dose regimen of andexanet alfa required to reverse anti-FXa activity and restore thrombin generation for FXa inhibitors (apixaban or rivaroxaban) were determined.
Danish: Prospektive, randomiserede, placebokontrollerede dosisbestemmende studier med raske forsøgspersoner har fastlagt hvilken dosis af og hvilket doseringsprogram for andexanet alfa, der er nødvendig til revertering af anti-FXa-aktivitet og reetablering af trombingenerering for FXainhibitorer (apixaban eller rivaroxaban).
English: Urticaria common
Danish: Urticaria almindelig
English: Among the rivaroxaban-treated subjects in Study 14-504, the percent change in anti-FXa activity was -96.72% (± 1.838%) for the andexanet alfa group and -44.75% (± 11.749%) for the placebo group (p < 0.0001 ), the latter reflecting the intrinsic clearance of the anticoagulant.
Danish: Blandt de rivaroxabanbehandlede forsøgspersoner i studie 14-504 var den procentvise ændring i antiFXa-aktivitet -96,72 % (± 1,838 %) for andexanet alfa-gruppen og -44,75 % (± 11,749 %) for placebogruppen (p < 0,0001), hvor sidstnævnte afspejler den iboende clearance af antikoagulanten.
English: Other medicines and Ondexxya
Danish: Brug af anden medicin sammen med Ondexxya
English: Hypersensitivity to the active substance or to any other ingredients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Bolus strengths of andexanet alfa being necessary to achieve mean unbound apixaban (400 mg bolus) and unbound rivaroxaban concentrations (800 mg bolus) below the anticipated respective threshold for no anticoagulant effect were twice as high for rivaroxaban (20 mg QD) compared to apixaban (5 mg BID), due to the differential PK characteristics and dose levels of respective FXa inhibitor.
Danish: Bolusstyrker af andexanet alfa, der var nødvendige til opnåelse af gennemsnitlige koncentrationer af ubundet apixaban (400 mg-bolus) og ubundet rivaroxaban (800 mg-bolus) under den forventede respektive grænse for ingen antikoagulativ virkning, var to gange så høj for rivaroxaban (20 mg QD)
English: In a similar study, subjects with a median age of 57 years on rivaroxaban 20 mg daily received andexanet alfa (n=26) administered as an 800 mg IV bolus immediately followed by an 8 mg per minute IV infusion for 120 minutes (960 mg) or placebo (n=13).
Danish: I et tilsvarende studie fik forsøgspersoner med en medianalder på 57 år, der var på rivaroxaban 20 mg dagligt, andexanet alfa (n = 26) administreret som en 800 mg-i.v.-bolus umiddelbart efterfulgt af en 8 mg pr. minut i.v.-infusion i 120 minutter (960 mg) eller placebo (n = 13).
English: > 5 mg/ Unknown
Danish: > 5 mg/ ukendt
English: Andexanet alfa will not reverse the effects of non-FXa inhibitors (see section 5.1).
Danish: Andexanet alfa vil ikke revertere virkningerne af ikke-FXa-inhibitorer (se pkt.
English: > 10 mg/ Unknown
Danish: > 10 mg/ ukendt
English: Pruritus generalised common
Danish: Generaliseret pruritus almindelig
English: Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thrombotic events.
Danish: Patienter, der behandles med FXa-inhibitorterapi, har tilgrundliggende sygdomstilstande, der prædisponerer dem for trombotiske hændelser.
English: Among the apixaban-treated subjects in Study 14-503, the percent change in anti-FXa activity was -92.34% (± 2.809%) for the andexanet alfa group and -32.70% (± 5.578%) for the placebo group (p < 0.0001), the latter reflecting the intrinsic clearance of the anticoagulant.
Danish: Blandt de apixabanbehandlede forsøgspersoner i studie 14-503 var den procentvise ændring i antiFXa-aktivitet -92,34 % (± 2,809 %) for andexanet alfa-gruppen og -32,70 % (± 5,578 %) for placebogruppen (p < 0,0001), hvor sidstnævnte afspejler den iboende clearance af antikoagulanten.
English: Thrombotic events
Danish: Tromboemboliske hændelser
English: In order to further substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of ANNEXA-4, an interventional non-randomized, multicentre, prospective, open-label, single-group study in patients with acute major bleeding.
Danish: Indehaveren af markedsføringstilladelsen skal til yderligere underbyggelse af korrelationen mellem biomarkøren (anti-FXa-aktivitet) og hæmostatisk virkning og til klarlæggelse af risikoen for tromboser og tromboemboliske hændelser indsende resultaterne af ANNEXA-4, et ikke-randomiseret, prospektivt, åbent multicenter-interventionsstudie med en enkelt gruppe hos patienter med akut større blødning.
English: Dyspnoea common
Danish: Dyspnø almindelig
English: Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events.
Danish: Patienter, der behandles med FXa-inhibitorterapi, har tilgrundliggende sygdomstilstande, der prædisponerer dem for tromboemboliske hændelser.
English: Each vial contains 200 mg of andexanet alfa*.
Danish: Hvert hætteglas indeholder 200 mg andexanet alfa*.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.
English: Using a 20 mL (or larger) syringe and a 20 gauge (or larger) needle, withdraw 20 mL of water for injections.
Danish: Udtræk ved anvendelse af en 20 ml (eller større) sprøjte med en 20-gauge (eller større) kanyle 20 ml vand til injektionsvæsker.
English: Package Leaflet: Information for the patient and user Ondexxya 200 mg powder for solution for infusion andexanet alfa
Danish: Indlægsseddel: Information til patienten og brugeren Ondexxya 200 mg pulver til infusionsvæske, opløsning andexanet alfa Dette lægemiddel er underlagt supplerende overvågning.
English: Each vial contains 200 mg of andexanet alfa.
Danish: Hvert hætteglas indeholder 200 mg andexanet alfa.
English: Abdominal discomfort common
Danish: Abdominalt ubehag almindelig
English: Pharmacotherapeutic group: All other therapeutic products, antidotes.
Danish: Farmakoterapeutisk klassifikation: Alle andre terapeutiske produkter, modgifte, ATC-kode: V03AB38
English: It is unknown whether andexanet alfa is excreted in human milk.
Danish: Det er ukendt, om andexanet alfa udskilles i modermælk.
English: Pyrexia common
Danish: Pyreksi almindelig
English: Palpitations common
Danish: Palpitationer almindelig
English: Thrombotic events have been reported following treatment with andexanet alfa (see sections 4.8 and 5.1).
Danish: Der er rapporteret trombotiske hændelser efter behandling med andexanet alfa (se pkt.
English: Acute myocardial infarction uncommon
Danish: Akut myokardieinfarkt ikke almindelig
English: Timing of last dose before Ondexxya initiation
Danish: Tidsrum siden sidste dosis før start på Ondexxya < 8 timer eller ukendt
English: Cerebral infarction uncommon
Danish: Cerebralt infarkt ikke almindelig
English: Name and address of the manufacturer of the biological active substance Lonza Biologics Porrino, S.L.
Danish: Lonza Biologics Porrino, S.L.
English: Abdominal pain common
Danish: Abdominalsmerter almindelig
English: Peripheral coldness common
Danish: Perifer kuldefølelse almindelig
English: Name and address of the manufacturer responsible for batch release Portola Netherlands B.V.
Danish: Portola Netherlands B.V.
English: Myocardial infarction uncommon
Danish: Myokardieinfarkt ikke almindelig
English: Cerebrovascular accident uncommon
Danish: Cerebrovaskulær hændelse ikke almindelig
English: Ondexxya is administered as an IV bolus at a target rate of approximately 30 mg/min over 15 to 30 minutes, followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Danish: Ondexxya administreres som en i.v.-bolus ved en målhastighed på ca. 30 mg/min over 15 til 30 minutter, efterfulgt af administration af en kontinuerlig infusion af 4 mg (lav dosis) eller 8 mg (høj dosis) pr. minut i 120 minutter (se tabel 1).
English: No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in renally impaired patients.
Danish: Der er ikke udført studier til undersøgelse af farmakokinetikken for andexanet alfa hos patienter med nedsat nyrefunktion.
English: Iliac artery occlusion uncommon
Danish: Okklusion af arteria iliaca ikke almindelig
English: Ischaemic stroke common
Danish: Iskæmisk apopleksi almindelig
English: Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1).
Danish: Andexanet alfa administreres som en intravenøs bolus ved en målhastighed på ca. 30 mg/min over 15 minutter (lav dosis) eller 30 minutter (høj dosis), efterfulgt af administration af en kontinuerlig infusion af 4 mg/min (lav dosis) eller 8 mg/min (høj dosis) i 120 minutter (se tabel 1).
English: No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in patients with hepatic impairment.
Danish: Der er ikke udført studier til undersøgelse af farmakokinetikken for andexanet alfa hos patienter med nedsat leverfunktion.
English: Dizziness postural common
Danish: Postural svimmelhed almindelig
English: After an appropriate number of vials of Ondexxya has been reconstituted, the reconstituted solution (10 mg/mL) is transferred to a suitable empty intravenous bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution (see section 6.6) prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low proteinbinding filter.
Danish: Efter rekonstitution af et passende antal hætteglas med Ondexxya overføres den rekonstituerede opløsning (10 mg/ml) til en egnet tom intravenøs pose, der består af polyolefin (PO)- eller polyvinylchlorid (PVC)-materiale, uden yderligere fortynding (se pkt.
English: • if you are allergic to andexanet alfa or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for andexanet alfa eller et af de øvrige indholdsstoffer i Ondexxya
English: Deep vein thrombosis uncommon
Danish: Dyb venetrombose ikke almindelig
English: Transient ischaemic attack uncommon
Danish: Transitorisk iskæmisk attak ikke almindelig
English: Headache common
Danish: Hovedpine almindelig
English: Flushing very common
Danish: Rødmen meget almindelig
English: Pulmonary embolism uncommon
Danish: Lungeemboli ikke almindelig
English: The recommended dose regimen of Ondexxya is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3).
Danish: Det anbefalede dosisprogram for Ondexxya er baseret på dosen af rivaroxaban, som patienten tager på tidspunktet for revertering af antikoagulation, samt hvor længe det er siden patientens sidste dosis rivaroxaban (se tabel 3).
English: The recommended dose regimen of Ondexxya is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2).
Danish: Det anbefalede dosisprogram for Ondexxya er baseret på dosen af apixaban, som patienten tager på tidspunktet for revertering af antikoagulation, samt hvor længe det er siden patientens sidste dosis apixaban (se tabel 2).
English: The recommended dose regimen of andexanet alfa is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3).
Danish: Det anbefalede dosisprogram for andexanet alfa er baseret på dosen af rivaroxaban, som patienten tager på tidspunktet for revertering af antikoagulation, samt hvor længe det er siden patientens sidste dosis rivaroxaban (se tabel 3).
English: The recommended dose regimen of andexanet alfa is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2).
Danish: Det anbefalede dosisprogram for andexanet alfa er baseret på dosen af apixaban, som patienten tager på tidspunktet for revertering af antikoagulation, samt hvor længe det er siden patientens sidste dosis apixaban (se tabel 2).
English: Andexanet alfa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min over 15 (low dose) or 30 minutes (high dose), immediately followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Danish: bolus ved en målhastighed på ca. 30 mg/min over 15 minutter (lav dosis) eller 30 minutter (høj dosis), umiddelbart efterfulgt af administration af en kontinuerlig infusion af 4 mg (lav dosis) eller 8 mg (høj dosis) pr. minut i 120 minutter (se tabel 1).
English: What you need to know before you receive Ondexxya 3.
Danish: Virkning og anvendelse Det skal du vide, før du får Ondexxya Sådan bruges Ondexxya Bivirkninger
English: • chest discomfort
Danish: • ubehag i brystkassen
English: • excessive sweating
Danish: • kraftig svedproduktion
English: Using a 20 mL (or larger) syringe and a 20 gauge (or larger) needle, withdraw 20 mL of water for injection.
Danish: Udtræk ved anvendelse af en 20 ml (eller større) sprøjte med en 20-gauge (eller større) kanyle
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: - Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Pruritus common
Danish: Pruritus almindelig
English: Breast-feeding
Danish: FXainhibitor
English: Mannitol
Danish: Dosering
English: not less than 3.99 log10 PFU**
Danish: ≥ 3,99 log10 PFU**
English: *50% cell culture infectious dose **plaque-forming units
Danish: * 50 % cellekultur infektiøs dosis ** plaque-forming units
English: (3) Produced in human diploid (MRC-5) cells.
Danish: 3) Fremstillet i humane diploide (MRC-5) celler.
English: (1) Produced in chick embryo cells.
Danish: 1) Fremstillet i kyllingefosterceller.
English: (2) Produced in human diploid lung (WI-38) fibroblasts.
Danish: 2) Fremstillet i human diploid lungefibroblast (WI-38).
English: Varicella virus3 Oka/Merck strain (live, attenuated)
Danish: Varicellavirus3 Oka/Merck stamme (levende, svækket)
English: § Measles virus1 Enders' Edmonston strain (live, attenuated)
Danish: Mæslingevirus1 Enders Edmonston stamme (levende, svækket)
English: EU number
Danish: MF (EU)-nummer (Særnavn) Navn
English: 10 vials + 10 pre-filled syringes with attached needle
Danish: 10 hætteglas + 10 fyldte injektionssprøjter med fastgjort nål
English: 1 vial + 1 pre-filled syringe + 2 needles
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 2 nåle
English: Content Package size
Danish: Indhold (Koncentration)
English: 1 vial + 1 pre-filled syringe + 1 needle
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 1 nål