FrancophonIA/ELRC3.0 huggingface dataset:
English: If treatment with Metalyse is nevertheless considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Danish: Hvis behandling med Metalyse alligevel anses for at være nødvendig, skal genoplivningsudstyr være inden for umiddelbar rækkevidde.
English: In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
Danish: I tilfælde af hjerneblødning er tilstande relateret til nervesystemet blevet rapporteret f.eks. døsighed, taleforstyrrelser, lammelse af dele af kroppen (hemiparese) og anfald (kramper).
English: Children and adolescents The use of Metalyse in children and adolescents up to the age of 18 years is not recommended.
Danish: Børn og unge Metalyse anbefales ikke til børn og unge under 18 år.
English: As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:
Danish: Som med andre trombolytiske stoffer er følgende tilfælde blevet rapporteret som sequelae efter myokardieinfarkt og/eller trombolytisk administration:
English: Accordingly, there is no guidance for the adjustment to tenecteplase dose in patients with hepatic and severe renal insufficiency.
Danish: Der foreligger derfor ingen retningslinjer for dosisjustering af tenecteplase hos patienter med nedsat leverfunktion og svært nedsat nyrefunktion.
English: Recent gastrointestinal or genitourinary bleeding (within the past 10 days) High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation Any known recent (within the past 2 days) intramuscular injection Advanced age, i.e. over 75 years
Danish: Nylig gastrointestinal eller køns- eller urinvejsblødning (indenfor de sidste 10 dage) Høj sandsynlighed for venstre hjerteforkammerembolus, f.eks. mitralstenose med atrieflimren Enhver nylig kendt (indenfor de sidste 2 dage) intramuskulær injektion Høj alder dvs. over 75 år
English: A large scale mortality trial (ASSENT-2) in approx. 17,000 patients showed that tenecteplase is therapeutically equivalent to alteplase in reducing mortality (6.2% for both treatments, at 30 days, upper limit of the 95% CI for the relative risk ratio 1.124) and that the use of tenecteplase is associated with a significantly lower incidence of non-intracranial bleedings (26.4% vs. 28.9%, p=0.0003).
Danish: Et stort mortalitetsstudie (ASSENT-2) med ca. 17.000 patienter viste, at tenecteplase er terapeutisk ækvivalent med alteplase med hensyn til at nedsætte mortalitet (6,2 % for begge behandlinger, efter 30 dage, øverste grænse af 95 % konfidensinterval for den relative risikoratio 1,124) og at brugen af tenecteplase er associeret med en signifikant lavere forekomst af ikke-intrakraniale blødninger (26,4 % imod 28,9 %, p=0,0003).
English: After the dose reduction of tenecteplase by half in patients ≥ 75 years there was no further intracranial hemorrhage (0 of 97 patients) (95% CI: 0.0-3.7) versus 8.1% (3 of 37 patients) (95% CI: 1.7-21.9) prior to dose reduction.
Danish: Efter halvering af tenecteplasedosis hos patienter ≥ 75 år var der ingen yderligere intrakraniel blødning (0 ud af 97 patienter) (95 % KI: 0,0-3,7) versus 8,1 % (3 ud af 37 patienter) (95 % KI: 1,7-21,9) før dosisreduktion.
English: Patients who cannot undergo primary PCI within one hour as recommended by guidelines and receive tenecteplase as primary coronary recanalization treatment should be transferred without delay to a coronary intervention capable facility for angiography and timely adjunctive coronary intervention within 6-24 hours or earlier if medically indicated (see section 5.1 STREAM study).
Danish: Patienter, der ikke kan få foretaget primær PCI indenfor en time som anbefalet i vejledningen og få tenecteplase som primær koronar rekanalisering, bør straks overføres til kardiologisk specialafdeling med henblik på angiografi og rettidig supplerende koronar intervention indenfor 6-24 timer eller tidligere, hvis der er klinisk indikation herfor (se pkt.
English: Metalyse is incompatible with glucose infusion solutions.
Danish: Metalyse er uforligeligt med glucoseinfusionsvæsker.
English: The solvent is water for injections.
Danish: Solvens er vand til injektionsvæske.
English: What do you need to know before you receive Metalyse
Danish: Det skal du vide, før du begynder at få Metalyse
English: Metalyse is incompatible with glucose solution.
Danish: Metalyse er uforlignelig med glucoseopløsning.
English: Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months(this includes any trauma associated with the current AMI) Recent trauma to the head or cranium
Danish: Større operation, parenkymal organbiopsi, eller signifikant traume indenfor de sidste 2 måneder (dette inkluderer ethvert traume forbundet med det nuværende AMI) Nyligt hoved- eller kranietraume
English: The ASSENT-4 PCI study was designed to show if in 4000 patients with large myocardial infarctions pre-treatment with full dose tenecteplase and concomitant single bolus of up to 4,000 IU unfractionated heparin administered prior to primary PCI to be performed within 60 to 180 minutes leads to better outcomes than primary PCI alone.
Danish: Studiet blev udført med henblik på at vise, om forbehandling med fuld dosis tenecteplace og samtidig enkel bolus på op til 4.000 IU ufraktioneret heparin forud for primær PCI (udført i et tidsrum på mellem 60 til 180 minutter) er bedre end PCI alene.
English: Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.
Danish: Før brug tilsættes solvensen (vand til injektionsvæsker) til pulveret for at fremstille en opløsning.
English: Tenecteplase is a recombinant fibrin-specific plasminogen activator that is derived from native t-PA by modifications at three sites of the protein structure.
Danish: Tenecteplase er en rekombinant fibrinspecifikt plasminogen aktivator, som stammer fra t-PA ved hjælp af modifikationer på 3 steder af proteinstrukturen.
English: Rare (may affect up to 1 in 1,000 people): Blood clot in the lung (pulmonary embolism)
Danish: Sjælden (kan forekomme hos 1 ud af 1.000 patienter): blodprop i lungerne (lungeemboli)
English: Metalyse should be administered with caution in the elderly ( 75 years) due to a higher bleeding risk (see information on bleeding in section 4.4 and on the STREAM study in section 5.1).
Danish: Metalyse bør administreres med forsigtighed hos ældre (> 75 år) på grund af en højere blødningsrisiko (se pkt.
English: Haemorrhage is a very common undesirable effect associated with the use of tenecteplase.
Danish: Blødning er en meget almindelig bivirkning i forbindelse med brug af tenecteplase.
English: Anaphylactoid reaction (including rash, urticaria, bronchospasm, laryngeal oedema)
Danish: Anafylaktoide reaktioner (herunder udslæt, urticaria, bronkospasme, laryngealt ødem)
English: Blood pressure decreased
Danish: Blodtryksfald
English: NAME OF THE MEDICINAL PRODUCT Metalyse 8,000 U
Danish: LÆGEMIDLETS NAVN Metalyse 8.000 U
English: However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.
Danish: Lægen vil dog normalt bruge den fremstillede injektionsvæske med det samme af mikrobiologiske årsager.
English: The safety and efficacy of Metalyse in children (below 18 years) have not been established.
Danish: Metalyses sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Retroperitoneal haemorrhage (such as retroperitoneal haematoma)
Danish: Retroperitoneal blødning (såsom retroperitonealt hæmatom)
English: Any known history of haemorrhagic stroke or stroke of unknown origin Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months Dementia
Danish: Kendt anamnese af iskæmisk apopleksi (slagtilfælde) eller transitorisk iskæmisk attak i de foregående 6 måneder
English: NAME OF THE MEDICINAL PRODUCT Metalyse 10,000 U
Danish: LÆGEMIDLETS NAVN Metalyse 10.000 U
English: The primary endpoint, a composite of death or cardiogenic shock or congestive heart failure or re-infarction within 30 days, was observed in 12.4% (116/939) of the pharmaco-invasive arm versus 14.3% (135/943) in the primary PCI arm (relative risk 0.86 (0.68-1.09)).
Danish: Det primære endepunkt, sammensat af død, kardiogent shock, kongestivt hjertesvigt og reinfarkt indenfor 30 dage, blev observeret hos 12,4 % (116/939) i den farmako-invasive arm versus 14,3 % (135/943) i den primære PCI-arm (relativ risiko 0,86 (0,68-1,09)).
English: Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology.
Danish: Tenecteplase er en fibrinspecifik plasminogenaktivator produceret ved recombinant DNA-teknik i cellemateriale fra kinesiske hamstres æggestokke.
English: Your doctor will give Metalyse as soon as possible after your chest pain starts as a single dose.
Danish: Lægen vil give Metalyse som en enkelt dosis hurtigst muligt efter, dine brystsmerter er begyndt.
English: If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need;
Danish: Hvis behandling med Metalyse alligevel anses for at være nødvendig, skal der være genoplivningsudstyr inden for rækkevidde;
English: Remove the flip-off cap from the vial.
Danish: Fjern flip-offhætten fra hætteglasset.
English: Reconstitute by swirling gently.
Danish: Opløs ved at slynge forsigtigt rundt.
English: EXPIRY DATE
Danish: UDLØBSDATO EXP {MM/ÅÅÅÅ}>
English: For coronary intervention see section 4.4.
Danish: For koronar intervention se pkt.
English: Sterile vial adapter.
Danish: Steril adapter til hætteglasset.
English: Your doctor will take special care with Metalyse:
Danish: Din læge vil være ekstra forsigtig med at give dig Metalyse
English: Caution is needed when administering tenecteplase to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, or to gentamicin (a residue from the manufacturing process).
Danish: Der skal udvises forsigtighed, når tenecteplase gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof, et af hjælpestofferne eller gentamicin (sporrest fra fremstilingsprocessen).
English: The reconstituted preparation is a clear and colourless to slightly yellow solution.
Danish: Den rekonstituerede opløsning er klar, farveløs til svag gullig.
English: In patients ≥ 75 years the observed incidence of the primary efficacy composite end point for the pharmaco-invasive strategy and primary PCI were as follows: before dose reduction 11/37 (29.7%) (95% CI: 15.9- 47.0) versus 10/32 (31.3%) (95% CI: 16.1-50.0), after dose reduction: 25/97 (25.8%) (95% CI: 17.4-35.7) versus 25/88 (24.8%) (95% CI: 19.3-39.0).
Danish: Hos patienter ≥ 75 år var den observerede forekomst af det primære sammensatte endepunkt for den farmako-invasive strategi og primær PCI følgende: Før dosishalvering 11/37 (29,7 %) (95 % KI: 15,9-47,0) versus 10/32 (31,3 %) (95 % KI: 16,1-50,0), efter dosishalvering: 25/97 (25,8 %) (95 % KI: 17,4-35,7) versus 25/88 (24,8 %) (95 % KI: 19,3-39,0).
English: Your doctor will give you the medicinal product to prevent blood clotting in addition to Metalyse, as soon as possible after your chest pain starts.
Danish: Som supplement til Metalyse vil lægen give dig lægemidlet for at forebygge blodpropper så hurtigt som muligt efter, dine brystsmerter er begyndt.
English: a bleeding disorder or tendency to bleed (haemorrhage) stroke (cerebrovascular event) very high, uncontrolled blood pressure a head injury severe liver disease a stomach ulcer (peptic ulcer) varicose veins in the gullet (oesophageal varices) abnormality of the blood vessels (e.g. an aneurysm) certain tumours inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis) dementia;
Danish: meget højt, ukontrolleret blodtryk kvæstelse i hovedet alvorlig leversygdom mavesår (peptisk ulcus) åreknuder i spiserøret (øsofageale varicer) abnormitet i blodkarrene (f.eks. et aneurisme) visse tumorer betændelse omkring hjertesækken (pericarditis) eller betændelse eller infektion i hjerteklapperne (endocarditis) demens
English: All-cause mortality Cardiogenic shock Congestive heart failure Re-infarction Cardiac mortality
Danish: Sammensat: død, shock, kongestivt hjertesvigt, re-infarkt Alle typer af mortalitet Kardiogent shock Kongestivt hjertesvigt Re-infarkt
English: Uncommon (may affect up to 1 in 100 people): irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest.
Danish: Ikke almindelig (kan forekomme hos 1 ud af 100 patienter): uregelmæssige hjerteslag (reperfusionsarytmier), som kan føre til hjertestop.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 ml water for injections
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 10 ml vand til injektionsvæske
English: When reconstituted with 8 ml solvent each ml contains 1,000 U tenecteplase.
Danish: Efter rekonstitution med 8 ml solvens indeholder hver ml 1.000 U tenecteplase.
English: Add the water for injections into the vial by pushing the syringe plunger down slowly to avoid foaming.
Danish: Tilsæt vandet til injektionsvæske til hætteglasset ved at presse injektionssprøjtens stempel langsomt ned for at undgå, at det skummer.
English: if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of Metalyse.
Danish: Hvis du tidligere har haft en pludselig, livstruende overfølsomhedsreaktion (svær overfølsomhed) over for det aktive indholdsstof tenecteplase, gentamicin (en sporrest fra fremstillingsprocessen) eller et af de øvrige indholdsstoffer i Metalyse (angivet i afsnit 6).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 8 ml water for injections
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 8 ml vand til injektionsvæske
English: The reconstituted solution contains 1,000 units (5 mg) tenecteplase per ml.
Danish: Den rekonstituerede opløsning indeholder 1.000 enheder (5 mg) tenecteplase/ml.
English: When reconstituted with 10 ml solvent each ml contains 1,000 U tenecteplase.
Danish: Efter rekonstitution med 10 ml solvens indeholder hver ml 1.000 U tenecteplase.
English: Directly before the solution will be administered, invert the vial with the syringe still attached, so that the syringe is below the vial.
Danish: Umiddelbart før opløsningen skal bruges vendes hætteglasset med injektionssprøjten stadig påsat sådan at sprøjten er under hætteglasset.
English: Intracranial haemorrhage (such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage) including associated symptoms as somnolence, aphasia, hemiparesis, convulsion
Danish: Intrakraniel blødning (såsom cerebral blødning, cerebralt hæmatom, hæmoragisk apopleksi, hæmoragisk transformation af apopleksi, intrakranielt hæmatom, subaraknoidal blødning), herunder relaterede symptomer som døsighed, afasi, hemiparese, kramper
English: The observed incidence of major and of minor non-ICH bleeds were similar in both groups: Pharmaco-invasive (n=944)
Danish: Den observerede forekomst af større eller mindre ikke-kranielle blødninger var ens i begge grupper:
English: The occurrence of the primary endpoint, a composite of death or cardiogenic shock or congestive heart failure within 90 days, was significantly higher in the group receiving the exploratory regimen of tenecteplase followed by routine immediate PCI: 18.6% (151/810) compared to 13.4% (110/819) in the PCI only group, p=0.0045.
Danish: Forekomsten af det primære endepunkt, sammensat af dødsfald, kardiogent shock og højresidig hjerteinsufficiens i løbet af 90 dage, var signifikant højere i gruppen, der fik det undersøgte regime med tenecteplase efterfulgt af den rutinemæssige PCI behandling: 18,6 % (151/810) sammenlignet med 13,4 % (110/819) i gruppen, der kun fik PCI, p=0,0045.
English: Metalyse will not be prescribed and given by your doctor:
Danish: Din læge vil ikke give dig Metalyse:
English: Common (may affect up to 1 in 10 people): bleeding at the injection or puncture site nosebleeds genitourinary bleeding (you may notice blood in your urine) bruising gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)
Danish: Almindelig (kan forekomme hos 1 ud af 10 patienter): blødning ved injektions- eller indstikstedet næseblod blødning fra kønsorganer og urinveje (du kan se blod i urinen) blodudtrædninger under huden (blå mærker) blødning fra maven eller tarmen
English: Metalyse must not be administered to patients with a history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient) or gentamicin (a trace residue from the manufacturing process).
Danish: Metalyse er kontraindiceret til patienter, som tidligere har haft en anafylaktisk reaktion (dvs. livstruende) over for et eller flere af indholdsstofferne (dvs. tenecteplase eller nogen af hjælpestofferne) eller gentamicin (sporrest fra fremstillingsprocessen).
English: Very common(may affect more than 1 in 10 people): Low blood pressure (hypotension) Irregular heart beat
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter): lavt blodtryk (hypotension) uregelmæssig hjerterytme brystsmerter (angina pectoris)
English: Significant bleeding disorder either at present or within the past 6 months Patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (INR > 1.3) (see section 4.4, subsection “Bleeding”)
Danish: Patienter, der får effektiv oral antikoagulerende behandling, f.eks. warfarinnatrium (INR > 1,3) (se pkt.
English: For intravenous use after reconstitution with 10 ml solvent
Danish: Til intravenøs anvendelse efter opløsning med 10 ml solvens
English: Invert vial/syringe and transfer the appropriate volume of the solution into syringe according to the dosing instructions.
Danish: Vend hætteglas / injektionssprøjten og overfør den rette mængde injektionsvæske til injektionssprøjten I overensstemmelse med doseringsinstruktionerne.
English: Antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be administered according to the current relevant treatment guidelines for the management of patients with ST-elevation myocardial infarction.
Danish: Hos patienter med ST-elevations-AMI (myokardieinfarkt) bør adjuverende antitrombotisk behandling med trombocythæmmere og antikoagulantia administreres i henhold til gældende relevante behandlingsvejledninger.
English: Other medicinesand Metalyse
Danish: Brug af anden medicin sammen med Metalyse
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution with 8 ml solvent
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter opløsning med 8 ml solvens
English: Rare(may affect up to 1 in 1,000 people): low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), difficulty breathing (bronchospasm) bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism)and in the vessels of other organ systems (thrombotic embolisation)
Danish: Sjælden (kan forekomme hos 1 ud af 1.000 patienter): - lavt blodtryk (hypotension) blødning i lungerne (pulmonal hæmoragi) overfølsomhed (anafylaksilignende reaktion) f.eks. udslæt, nældefeber (urticaria), åndedrætsbesvær (bronkospasmer) blødning i området omkring hjertet (hæmopericardium) blodprop i lungerne (lungeemboli) og i blodkarrene i andre organer (trombotisk emboli)
English: Sterile needle for single use.
Danish: Steril kanyle til engangsbrug.
English: For details see section 6.6: Special precautions for disposal and other handling
Danish: 6.6: Regler for bortskaffelse og anden håndtering
English: Numerically all of the components of the clinical composite endpoint were in favour of the PCI only regimen: death: 6.7% vs. 4.9% p=0.14; cardiogenic shock: 6.3% vs. 4.8% p=0.19; congestive heart failure: 12.0% vs. 9.2% p=0.06 respectively.
Danish: Alle dele af de kliniske sammensatte endepunkter var til fordel for PCI behandling alene: Dødsfald: 6,7 % vs. 4,9 % p = 0,14; kardiogent shock: 6,3 % vs. 4,8 % p = 0,19; højresidig hjerteinsufficiens: 12,0 % vs. 9,2 % p = 0,06.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Metalyse 8,000 U
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Metalyse 8.000 U
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution with 10 ml solvent
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter opløsning med 10 ml solvens
English: For intravenous use after reconstitution with 8 ml solvent
Danish: Til intravenøs anvendelse efter opløsning med 8 ml solvens.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Metalyse 10,000 U
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Metalyse 10.000 U
English: one vial of 8,000 units Metalyse powder and one pre-filled syringe containing 8 ml water for injections
Danish: 1 hætteglas med 8.000 enheder Metalyse-pulver 1 fyldt injektionssprøjte indeholdende 8 ml vand til injektionsvæsker.
English: Open the top of the vial-adapter.
Danish: Åbn hætten på adapteren til hætteglasset.
English: less than 6060 to 7070 to 8080 to 90above 90
Danish:  60 til < 70  70 til < 80  80 til < 90
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65, 88397 Biberach/Riss Germany
Danish: KG Birkendorfer Strasse 65, 88397 Biberach/Riss Tyskland
English: The following adverse events occurred more frequently with tenecteplase prior to PCI: intracranial haemorrhage: 1% vs. 0% p=0.0037; stroke: 1.8% vs. 0% p<0.0001; major bleeds: 5.6% vs. 4.4% p=0.3118; minor bleeds: 25.3% vs. 19.0% p= 0.0021; blood transfusions: 6.2% vs. 4.2% p=0.0873; abrupt vessel closure: 1.9% vs. 0.1% p=0.0001.
Danish: De følgende bivirkninger opstod hyppigere ved behandling med tenecteplase inden PCIbehandling: Intrakraniel blødning: 1 % vs. 0 % p = 0,0037; apopleksi: 1,8 % vs 0 % p < 0,0001; større blødninger: 5,6 % vs. 4,4 % p = 0,3118; mindre blødninger: 25,3 vs.19,0 % p = 0,0021; blodtransfusioner: 6,2 % vs. 4,2 % p = 0,0873; pludselig kar-okklusion: 1,9 % vs. 0,1 % p = 0,0001.
English: Powder and solvent for solution for injection Tenecteplase
Danish: Pulver og solvens til injektionsvæske, opløsning tenecteplase
English: Metalyse is a powder and solvent for solution for injection.
Danish: Metalyse er pulver og solvens til injektionsvæske, opløsning.
English: Then immediately screw the pre-filled syringe on the vial adapter and penetrate the vial stopper in the middle with the spike of the vial adapter.
Danish: Skru dernæst straks den fyldte injektionssprøjte på adapteren til hætteglasset, og stik spidsen af adapteren til hætteglasset ned igennem midten af hætteglassets prop.
English: one vial of 10,000 units Metalyse powder and one pre-filled syringe containing 10 ml water for injections.
Danish: 1 hætteglas med 10.000 enheder Metalyse-pulver 1 fyldt injektionssprøjte indeholdende 10 ml vand til injektionsvæsker.
English: Remove the tip-cap from the syringe.
Danish: Fjern hætten fra injektionssprøjten.
English: The reconstituted preparation results in a colourless to pale yellow, clear solution.
Danish: Opløsningen resulterer i en farveløs til bleggul, klar væske.
English: 10 ml plastic pre-filled syringe with 8 ml of solvent.
Danish: 10 ml fyldt plastikinjektionssprøjte med 8 ml solvens.