FrancophonIA/ELRC3.0 huggingface dataset:
English: Two pre-filled syringes assembled in a syringe holder.
Danish: To fyldte sprøjter monteret i en sprøjteholder.
English: Calcium chloride Human albumin Sodium chloride Glycine
Danish: Calciumchlorid Humant albumin Natriumchlorid Glycin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1239/001-004
Danish: EU/1/17/1239/001-004
English: The instructions for use are also described in the healthcare professionals' package leaflet part.
Danish: Brugsanvisningen findes også i lægernes og sundhedspersonalets del af indlægssedlen.
English: Do not remove the syringe luer cap until thawing is complete and the Dual Applicator is ready to be attached.
Danish: Fjern ikke Luer-hætten fra sprøjten, før optøningen er fuldstændig, og dobbeltapplikatoren er klar til at blive tilsluttet.
English: - VeraSeal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin) - VeraSeal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin) - VeraSeal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin) - VeraSeal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin)
Danish: - VeraSeal 2 ml (indeholdende 1 ml humant fibrinogen og 1 ml humant trombin) - VeraSeal 4 ml (indeholdende 2 ml humant fibrinogen og 2 ml humant trombin) - VeraSeal 6 ml (indeholdende 3 ml humant fibrinogen og 3 ml humant trombin) - VeraSeal 10 ml (indeholdende 5 ml humant fibrinogen og 5 ml humant trombin)
English: How VeraSeal is used
Danish: Sådan bruges VeraSeal
English: To remove air bubbles from syringes, strike gently the side of the syringe holder one or two times while keeping the syringe holder in an upright position and lightly depress the plunger to eject air. See Figure 4.
Danish: Luftbobler fjernes fra sprøjterne ved at slå forsigtigt på siden af sprøjteholderen en eller to gange, mens sprøjteholderen holdes lodret, og trykke let på stemplet for at presse luften ud.
English: VeraSeal is supplied as a single-use kit containing two pre-filled syringes (glass type I) with rubber stoppers, each with a sterile frozen solution, assembled in a syringe holder.
Danish: VeraSeal fås som et engangssæt med to fyldte sprøjter (glas type I) med gummipropper, hver med en steril, frossen opløsning, monteret i en sprøjteholder.
English: Keep the sterilized blister in the outer carton in order to protect from light.
Danish: Opbevar den steriliserede blister i den ydre karton for at beskytte mod lys.
English: When using the provided Dual Applicator, follow the connection instructions described above.
Danish: Når den medfølgende dobbeltapplikator anvendes, skal de ovenfor beskrevne tilslutningsanvisninger følges.
English: It must not be used if the solutions are cloudy or have deposits.
Danish: Det må ikke bruges, hvis opløsningerne er uklare eller indeholder partikler.
English: During parenchymous tissue surgery study 325 subjects were enrolled and underwent liver resections.
Danish: I studiet med kirurgi i parenkymt væv indgik 325 personer, og de gennemgik leverresektioner.
English: VeraSeal must not be applied inside blood vessels.
Danish: VeraSeal må ikke påføres inden i blodkarrene.
English: - Anaemia (insufficiency of red blood cells) - Anxiety - Atrial fibrillation (irregular heartbeat) - Back pain - Bladder spasm - Chills
Danish: - Anæmi (utilstrækkeligt antal røde blodlegemer) - Angst - Atrieflimmer (uregelmæssigt hjerteslag) - Rygsmerter - Blærekrampe - Kulderystelser
English: VeraSeal solutions for sealant human fibrinogen/human thrombin
Danish: VeraSeal opløsninger til vævsklæber humant fibrinogen / humant trombin
English: The fibrin monomers aggregate and form a fibrin clot.
Danish: Fibrinmonomererne aggregerer og danner en fibrinkoagel.
English: - Abdominal abscess (swollen area in abdomen caused by infection) - Abdominal wound dehiscence (wound breakdown due to incomplete healing) - Leak of bile (a liquid produced by the liver) after the procedure - Cellulitis (infection of the skin) - Deep vein thrombosis (blood clots in the blood vessels) - Liver abscess (swollen area in the liver caused by infection) - Peritonitis (inflammation of the wall of the abdomen) - Positive parvovirus B19 test (laboratory result showing infection with the virus) - Postoperative wound infection - Pulmonary embolism (blood clots in blood vessels in the lungs) - Wound infection
Danish: - Byld i maven (hævet område i maven forårsaget af en infektion) - Dehiscens af såret i maven (såret nedbrydes som følge af ufuldstændig heling) - Udsivning af galde (en væske, der dannes af leveren) efter indgrebet - Cellulitis (hudinfektion) - Dyb venetrombose (Blodpropper i blodkarrene) - Byld i leveren (hævet område i leveren forårsaget af en infektion) - Peritonitis (betændelse i mavevæggen) - Positiv parvovirus B19-test (laboratorieresultat, der viser infektion med denne virus) - Sårinfektion efter operationen - Lungeemboli (blodpropper i lungeblodkarrene) - Sårinfektion
English: Plasma cell myeloma
Danish: Plasmacellemyelom
English: Open the blister and make the VeraSeal Dual Applicator and two additional Airless Spray Tips available to a second person for transfer to the sterile field.
Danish: Åbn blisteren, og gør VeraSeal dobbeltapplikatoren og de 2 ekstra luftfrie sprøjtespidser tilgængelige for en anden person, så de kan overføres til det sterile område.
English: Place the blister containing the Dual Applicator at room temperature until the fibrin sealant is ready to use.
Danish: Placer blisteren med dobbeltapplikatoren ved stuetemperatur, indtil fibrin-vævsklæberen er klar til brug.
English: Human fibrinogen 80 mg/ml Component 2:
Danish: Humant fibrinogen 80 mg/ml Komponent 2:
English: The most frequent surgery types were femoral-popliteal bypass grafting, upper extremity vascular access for hemodialysis, and ilio-femoral bypass grafting.
Danish: De hyppigste former for kirurgi var femoral-popliteal bypass-transplantation, hæmodialyse med vaskulær adgang i overekstremiteter og ilio-femoral bypass-transplantation.
English: Grasp and bend the Dual Applicator to the desired position.
Danish: Tag fat om dobbeltapplikatoren, og bøj den til den ønskede position.
English: Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Danish: Parvovirus B19-infektion kan være alvorlig for gravide kvinder (føtal infektion) og for personer med nedsat immunforsvar eller med visse former for anæmi (f.eks. seglcellesygdom eller hæmolytisk anæmi).
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealant/haemostatic products.
Danish: Overfølsomhed eller allergiske reaktioner (som kan omfatte angioødem, brændende eller sviende fornemmelse på applikationsstedet, bronkospasme, kulderystelser, rødme, generaliseret urticaria, hovedpine, nældefeber, hypotension, letargi, kvalme, rastløshed, takykardi, trykken for brystet, prikkende fornemmelse, opkastning, hvæsende vejrtrækning) kan forekomme i sjældne tilfælde hos patienter i behandling med fibrin-vævsklæber/hæmostatiske præparater.
English: Solutions for sealant 2 ml
Danish: Opløsninger til vævsklæber 2 ml
English: One Dual Applicator with two additional Airless Spray Tips is supplied with the product, for application by spraying or dripping.
Danish: En dobbeltapplikator med to ekstra luftfrie sprøjtespidser leveres med præparatet, til sprøjte- eller drypapplikation.
English: When using accessory tips, the instructions for use of the tips should be followed.
Danish: Når der anvendes spidser som tilbehør, skal anvisningerne for disse spidser følges.
English: If you experience an allergic reaction you might have one or more of the following symptoms: swelling under skin (angioedema), skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, heart rate increase, tingling, vomiting or wheezing.
Danish: Hvis du oplever en allergisk reaktion kan du have en eller flere af følgende symptomer: hævelse under huden (angioødem), hududslæt, nældefeber, trykken for brystet, kulderystelser, rødmen, hovedpine, lavt blodtryk, sløvhed, kvalme, rastløshed, hurtigere puls, prikkende fornemmelse, opkastning eller hvæsende vejrtrækning.
English: Randomized, single-blind clinical studies with VeraSeal were conducted in subjects undergoing vascular, parenchymous tissue and soft tissue surgery demonstrating haemostasis, and suture support in vascular surgery.
Danish: Randomiserede, enkeltblindede kliniske studier med VeraSeal blev udført hos personer, der gennemgik karkirurgi, kirurgi i parenkymt væv og bløddelskirurgi, til påvisning af hæmostase og suturstøtte ved karkirurgi.
English: To change the Airless Spray Tip, remove the device from the patient and unscrew the used Airless Spray Tip.
Danish: Den luftfrie sprøjtespids udskiftes ved at fjerne anordningen fra patienten, og skrue den brugte luftfrie sprøjtespids af.
English: Attach the Dual Applicator.
Danish: Tilslut dobbeltapplikatoren.
English: During the vascular surgery study 225 subjects were enrolled and underwent vascular surgical procedures utilizing polytetrafluoroethylene graft material on end-to-side arterial anastomosis or on upper extremity vascular access arterial anastomosis.
Danish: 225 personer indgik i karkirurgistudiet, og de gennemgik karkirurgi med transplantatmaterialer med polytetrafluorethylen til end-to-side arteriel anastomose eller til arteriel anastomose med vaskulær adgang i overekstremiteter.
English: Handling of VeraSeal
Danish: Håndtering af VeraSeal
English: Grasp and bend the drip tip to the desired position.
Danish: Tag fat om drypspidsen, og bøj den til den ønskede position.
English: It is supplied as a single-use kit containing two pre-filled syringes assembled in a syringe holder.
Danish: Det leveres som et engangssæt med to fyldte sprøjter monteret i en sprøjteholder.
English: When using other applicator tips, follow the instructions for use that are provided with the applicator tips.
Danish: Når der anvendes andre applikatorspidser, skal anvisningerne, som leveres sammen med applikatorspidserne, følges.
English: Wipe the end of the applicator using dry or moist sterile surgical gauze.
Danish: Tør enden af applikatoren af med tør eller fugtig, steril kirurgisk gaze.
English: VeraSeal was shown to be non-inferior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes.
Danish: VeraSeal viste sig at være non-inferiørt i forhold til kontrolgruppen (oxideret regenereret cellulose) til at opnå hæmostase efter 4 minutter.
English: VeraSeal must not be applied intravascularly.
Danish: VeraSeal må ikke appliceres intravaskulært.
English: The rate of hemostasis at the target bleeding site by 4 minutes was 92.8% in the VeraSeal treatment group and was 80.5% in the control group.
Danish: Hyppigheden af hæmostase efter 4 minutter på målblødningsstedet var 92,8 % i behandlingsgruppen med VeraSeal, og den var 80,5 % i kontrolgruppen.
English: During soft tissue surgery study 327 subjects were enrolled and underwent pelvic and retroperitoneal surgical procedures, and abdominoplasties and mastopexies.
Danish: I studiet med bløddelskirurgi indgik 327 personer, og de gennemgik kirurgi i bækkenet og retroperitonealt samt abdominalplastik og mastopeksi.
English: See Figure 8.
Danish: Se figur 8.
English: Hyperglycaemia, hyperkalaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesemia, hyponatraemia, hypoproteinaemia
Danish: Metabolisme og ernæring Hyperglykæmi, hyperkaliæmi, hypocalcæmi, hypoglykæmi, hypokaliæmi, hypomagnesæmi, hyponatriæmi, hypoproteinæmi
English: Do not apply intravascularly.
Danish: Må ikke appliceres intravaskulært.
English: Apply VeraSeal using the syringe holder and plunger supplied.
Danish: Applicer VeraSeal med den leverede sprøjteholder og stemplet.
English: Open the blister and make the VeraSeal syringe holder with pre-filled syringes available to a second person for transfer to the sterile field.
Danish: Åbn blisteren, og gør VeraSeal sprøjteholderen med fyldte sprøjter tilgængelig for en anden person, så den kan overføres til det sterile område.
English: After thawing, the kit containing the VeraSeal syringe holder with pre-filled syringes and Dual Applicator can be stored before use for not more than 48 hours in the refrigerator at 2 - 8 ºC or 24 hours at room temperature (20 - 25 °C) if it remains sealed in the original packaging.
Danish: Efter optøning kan sættet, der indeholder VeraSeal sprøjteholderen med fyldte sprøjter og dobbeltapplikatoren, opbevares højst 48 timer i køleskab ved 2 - 8 ºC eller 24 timer ved stuetemperatur (20 - 25 °C) før brug, hvis det forbliver forseglet i den originale emballage.
English: The rate of hemostasis at the target bleeding site by 4 minutes was 76.1% in the VeraSeal treatment group and was 22.8% in the control group.
Danish: Hyppigheden af hæmostase efter 4 minutter på det tilsigtede blødningssted var 76,1 % i behandlingsgruppen med VeraSeal, og den var 22,8 % i kontrolgruppen.
English: Human fibrinogen syringe
Danish: Sprøjte med humant fibrinogen
English: Special safety warning
Danish: Særlig sikkerhedsadvarsel
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Danish: Tegn på overfølsomhedsreaktioner omfatter nældefeber, generaliseret urticaria, trykken for brystet, hvæsende vejrtrækning, hypotension og anafylakse.
English: Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.8).
Danish: Livstruende tromboemboliske komplikationer kan opstå, hvis præparatet utilsigtet appliceres intravaskulært (se pkt.
English: The rate of hemostasis at the target bleeding site by 4 minutes was 82.8% in the VeraSeal treatment group and was 77.8% in the control group.
Danish: Hyppigheden af hæmostase efter 4 minutter på det tilsigtede blødningssted var 82,8 % i behandlingsgruppen med VeraSeal, og den var 77,8 % i kontrolgruppen.
English: Anaemia, haemorrhagic anaemia, leukocytosis, leukopenia
Danish: Anæmi, hæmoragisk anæmi, leukocytose, leukopeni
English: Other medicines and VeraSeal
Danish: Brug af anden medicin sammen med VeraSeal
English: After thawing, it can be maintained not more than 48 hours at 2 ºC - 8 ºC or 24 hours at room temperature (20 ºC - 25 ºC) before use.
Danish: Efter optøning kan det opbevares højst 48 timer ved 2 ºC - 8 ºC eller 24 timer ved stuetemperatur (20 ºC - 25 ºC) før brug.
English: Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure (e.g. light-headedness, fainting, blurred vision), and anaphylaxis (a severe reaction with a rapid onset).
Danish: Tegn på sådanne reaktioner omfatter nældefeber, udslæt, trykken for brystet, hvæsende vejrtrækning, blodtryksfald (f.eks. omtågethed, besvimelse, sløret syn) og anafylakse (en alvorlig reaktion, der starter hurtigt).
English: VeraSeal was shown to be superior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes.
Danish: VeraSeal viste sig at være bedre end kontrolgruppen (oxideret regenereret cellulose) til at opnå hæmostase efter 4 minutter.
English: Apply VeraSeal using the Dual Applicator provided with the product.
Danish: Applicer VeraSeal med dobbeltapplikatoren, der følger med præparatet.
English: Official batch release
Danish: • Officiel batchfrigivelse
English: Once the blisters are opened, use VeraSeal immediately and discard any unused contents.
Danish: Når blisterne er anbrudt, skal VeraSeal straks bruges, og eventuelt ubrugt indhold skal bortskaffes.
English: For safety information with respect to transmissible agents, see section 4.4.
Danish: 4.4 med hensyn til sikkerhedsoplysninger for midler, der kan overføres.
English: It must be stored in a freezer at -18 ºC or colder.
Danish: Det skal opbevares i dybfryser ved -18 ºC eller derunder.
English: Once the blister is opened, VeraSeal should be used immediately.
Danish: Når blisteren er anbrudt, skal VeraSeal straks bruges.
English: Periodic safety update reports (PSURs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON [2 ml, 4 ml, 6 ml and 10 ml]
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON [2 ml, 4 ml, 6 ml og 10 ml]
English: Figure 8
Danish: Figur 8
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VeraSeal solutions for sealant
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E)
English: Post-Thawing Storage
Danish: Opbevaring efter optøning
English: Use VeraSeal immediately and discard any unused contents.
Danish: VeraSeal skal bruges straks, og eventuelt ubrugt indhold skal bortskaffes.
English: Pulmonary embolism, dyspnoea, hypoxia, pleural effusion, pleurisy, pulmonary oedema, rhonchi, wheezing
Danish: Lungeemboli, dyspnø, hypoksi, pleuraeffusion, pleurisi, lungeødem, rhonchi, hvæsende vejrtrækning
English: Abdominal abscess, cellulitis, liver abscess, peritonitis, postoperative wound infection, wound infection incision site infection, post procedural infection.
Danish: Abdominal absces, cellulitis, leverabsces, peritonitis, postoperativ sårinfektion, sårinfektion, infektion på incisionsstedet, infektion efter indgreb
English: In use shelf life: Once the blister is opened, VeraSeal should be used immediately.
Danish: Opbevaringstid efter anbrud: Når blisteren er anbrudt, skal VeraSeal straks bruges.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL - HUMAN FIBRINOGEN (1 ml, 2 ml, 3 ml and 5 ml)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SPRØJTEETIKET - HUMANT FIBRINOGEN (1 ml, 2 ml, 3 ml og 5 ml)
English: After thawing, it can be maintained not more than 48 hours at 2ºC - 8ºC or 24 hours at room temperature (20ºC - 25ºC) before use if it remains sealed in the original packaging.
Danish: Efter optøning kan lægemidlet opbevares højst 48 timer ved 2 ºC - 8 ºC eller 24 timer ved stuetemperatur (20 ºC - 25 ºC) før brug, hvis det forbliver forseglet i den oprindelige emballage.
English: See Figure 5.
Danish: Se figur 5.
English: NOTE: Do not trim the Dual Applicator to avoid exposing internal wire.
Danish: BEMÆRK: Trim ikke dobbeltapplikatoren, da den indre metaltråd derved kan eksponeres.
English: VeraSeal is intended for epilesional use only.
Danish: VeraSeal er kun beregnet til anvendelse på læsioner.
English: What you need to know before you are treated with VeraSeal
Danish: Det skal du vide, før du bliver behandlet med VeraSeal Sådan bruges VeraSeal
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL - HUMAN THROMBIN (1 ml, 2 ml, 3 ml and 5 ml)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SPRØJTEETIKET - HUMANT TROMBIN (1 ml, 2 ml, 3 ml og 5 ml)
English: - Component 2: Calcium chloride, human albumin, sodium chloride, glycine, water for injections.
Danish: - Komponent 2: Calciumchlorid, humant albumin, natriumchlorid, glycin, vand til injektionsvæsker.
English: Sodium citrate dihydrated Sodium chloride Arginine
Danish: Natriumcitratdihydrat Natriumchlorid Arginin
English: human thrombin - Calcium chloride, human albumin, sodium chloride, glycine, water for injections.
Danish: humant trombin - calciumchlorid, humant albumin, natriumchlorid, glycin, vand til injektionsvæsker.
English: VeraSeal was shown to be superior to the control group (manual compression) in achieving hemostasis by 4 minutes.
Danish: VeraSeal viste sig at være bedre end kontrolgruppen (manuel kompression) til at opnå hæmostase efter 4 minutter.
English: Constipation, flatulence, ileus, retroperitoneal haematoma, vomiting
Danish: Obstipation, flatulens, ileus, retroperitonealt hæmatom, opkastning
English: DK/FI/IS/NO/SE Grifols Nordic AB Tel: +46 8 441 89 50
Danish: Grifols Nordic AB Tel: +46 8 441 89 50
English: Store and transport in a freezer (at - 18 ºC or colder).
Danish: Opbevares og transporteres nedfrosset (ved -18 ºC eller koldere).
English: After thawing, the solutions are clear or slightly opalescent and colourless or pale yellow.
Danish: Efter optøning er opløsningerne klare eller let uigennemsigtige og farveløse eller svagt gule.
English: Remove the Airless Spray Tip portion of the spray and drip tip by unscrewing the Airless Spray Tip.
Danish: Fjern den luftfrie sprøjtespidsdel på sprøjten og drypspidsen ved at skrue den luftfrie sprøjtespids af.
English: Human thrombin syringe
Danish: Sprøjte med humant trombin
English: Application of the product must be individualised by the treating physician.
Danish: Den behandlende læge skal tilpasse applikationen af præparatet til den enkelte patient.
English: Thaw blister with VeraSeal pre-filled syringes at room temperature using the following steps:
Danish: Optø blisteren med VeraSeal fyldte sprøjter ved stuetemperatur ved at følge disse trin:
English: See Figure 2.
Danish: Se figur 2.
English: Transmissible agents
Danish: Overføringsanvisninger
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER LABEL [2 ml, 4 ml, 6 ml and 10 ml]
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BLISTERETIKET [2 ml, 4 ml, 6 ml og 10 ml]
English: After thawing, the solutions must be clear to slightly opalescent and colorless to pale yellow.
Danish: Efter optøning skal opløsningerne være klare til let uigennemsigtige og farveløse til svagt gule.
English: SPECIAL STORAGE CONDITIONS Store in a freezer (-18 ºC or colder).
Danish: Opbevares i dybfryser (-18 ºC eller koldere).
English: See Figure 7.
Danish: Se figur 7.
English: See Figure 6.
Danish: Se figur 6.
English: Your surgeon must not treat you with VeraSeal
Danish: Det skal du vide, før du bliver behandlet med VeraSeal Din kirurg må ikke behandle dig med VeraSeal
English: NOTE: Once the VeraSeal blisters are opened, use the product immediately.
Danish: BEMÆRK: Når blisterne med VeraSeal er anbrudt, skal præparatet straks bruges.
English: Excipients: human fibrinogen - Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
Danish: Hjælpestoffer: humant fibrinogen - natriumcitratdihydrat, natriumchlorid, arginin, isoleucin, glutaminsyre mononatrium, vand til injektionsvæsker.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: VeraSeal is presented as solutions for sealant.
Danish: VeraSeal fås som opløsninger til vævsklæber.
English: Tighten luer locks and ensure the Dual Applicator is firmly attached.
Danish: Stram luer-låsene, og sørg for, at dobbeltapplikatoren sidder godt fast.
English: Hold the VeraSeal syringe holder with syringe luer caps pointed upward.
Danish: Hold sprøjteholderen med luer-låsene pegende opad.
English: The other ingredients are: - Component 1: Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
Danish: Øvrige indholdsstoffer: - Komponent 1: Natriumcitratdihydrat, natriumchlorid, arginin, isoleucin, glutaminsyre, vand til injektionsvæsker.
English: VeraSeal must be kept out of the sight and reach of children.
Danish: VeraSeal skal opbevares utilgængeligt for børn.