natgillin/translations-raw huggingface dataset:
Valproinsäure-ratiopharm chrono 500 Retardtabletten 500 mg ratiopharm GmbH D-89070 Ulm Tyskland 
Valproinsäure-ratiopharm chrono 500 Retardtabletten 500 mg ratiopharm GmbH D-89070 Ulm Germany
Convulex 300 mg kapsuly 300 mg 
Convulex 300 mg kapsuly 300 mg capsule
CHRONOSPHERE 1000 MG Granulado de liberación modificada 
CHRONOSPHERE 1000 MG Granulado de liberación modificada modified-release granules
1000 MG/ SACHET Granulat med modificeret udløsning Oral anvendelse 
1000 MG/ SACHET modified-release granules
66,66 mg + 29,03 mg 
66,66 mg + 29,03 mg prolonged-release granules
Depakine Chronosphere 50350 mg/DosisRetardgranulat 
Depakine Chronosphere 50350 mg/DosisRetardgranulat prolonged-release granules
SODIUM VALPROATE LIQUID 200MG/5ML 200mg 
SODIUM VALPROATE LIQUID 200MG/5ML 200mg oral solution
CHRONOSPHERE 250 mg granulado de liberación modificada 
CHRONOSPHERE 250 mg granulado de liberación modificada modified-release granules
333 mg + 145 mg Filmovertrukken depottablet 
333 mg + 145 mg prolonged-release filmcoated tablet
Valproinsäure-ratiopharm 300 Filmtabletten ratiopharm GmbH D-89070 Ulm Tyskland 
Valproinsäure-ratiopharm 300 Filmtabletten ratiopharm GmbH D-89070 Ulm Germany
223 35 Hamburg Tyskland 
223 35 Hamburg Germany
199,8 mg + 87 mg Depottabletter 
199,8 mg + 87 mg prolonged-release tablet Oral Use
EPILIM CHRONO 300 CONTROLLED RELEASE 300mg 
EPILIM CHRONO 300 CONTROLLED RELEASE 300mg modified-release tablet Oral Use
Depakine Chronosphere 50200 mg/DosisRetardgranulat 
Depakine Chronosphere 50200 mg/DosisRetardgranulat prolonged-release granules
D-39116 Magdeburg Tyskland espa-valept 500 mg retard 500 mg esparma GmbH Seepark 7 
D-39116 Magdeburg Germany espa-valept 500 mg retard 500 mg esparma GmbH Seepark 7
Tjekkiet ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland 
Czech Republic ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
D-22335 Hamburg, Tyskland 
D-22335 Hamburg, Germany
Valproinsäure-ratiopharm chrono 300 Retardtabletten 300 mg ratiopharm GmbH D-89070 Ulm Tyskland 
Valproinsäure-ratiopharm chrono 300 Retardtabletten 300 mg ratiopharm GmbH D-89070 Ulm Germany
Romænien 
Romania
D-39116 Magdeburg Tyskland espa-valept 150mg esparma GmbH Seepark 7 
D-39116 Magdeburg Germany espa-valept 150mg esparma GmbH Seepark 7
666,60 mg + 290,27 mg 
666,60 mg + 290,27 mg prolonged-release granules
22335 Hamburg Tyskland 
22335 Hamburg Germany
220.00 mg/g / 96.00 mg/g 
220.00 mg/g / 96.00 mg/g prolonged-release granules
750 MG/ SACHET Granulat med modificeret udløsning Oral anvendelse 
750 MG/ SACHET modified-release granules
Ergenyl Chronosphere 1000 mg Retardgranulat 
Ergenyl Chronosphere 1000 mg Retardgranulat prolonged-release granules
DEPAKINE CHRONO 500 mg prolonged-release Filmovertrukken tablet Oral anvendelse 
DEPAKINE CHRONO 500 mg prolonged-release filmcoated tablet
D-22335, Hamburg Tyskland 
D-22335, Hamburg Germany
Convulex 300 mgFilmtabletten 
Convulex 300 mgFilmtabletten film-coated tablet
250 MG/ SACHET Granulat med modificeret udløsning Oral anvendelse 
250 MG/ SACHET modified-release granules
D-39116 Magdeburg Tyskland espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7 
D-39116 Magdeburg Germany espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
Oral opløsning betapharm Arzneimittel GmbH Kobelweg 95 
Valpro beta oral solution betapharm Arzneimittel GmbH Kobelweg 95
87 mg /199.8 mg Depottablet 
87 mg /199.8 mg prolonged - release tablet
Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Tyskland 
Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Polen ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079 
Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Tyskland 
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Polen ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079 
Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
Orion Corporation Postfach P.O. Box 65 FIN-02101 ESPOO Finland 
Box 65 FIN-02101 ESPOO Finland
100 MG/ SACHET Granulat med modificeret udløsning Oral anvendelse 
100 MG/ SACHET modified-release granules
CONVULEX 300 MG/ML 300mg/ml orale dråber, opløsning Oral anvendelse 
CONVULEX 300 MG/ML 300mg/ml oral drops, solution
Depakine 300 mgFilmtabletten 
Depakine 300 mgFilmtabletten film-coated tablet
D-39116 Magdeburg Tyskland espa-valept 300mg esparma GmbH Seepark 7 
D-39116 Magdeburg Germany espa-valept 300mg esparma GmbH Seepark 7
DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada 
Depakine Chronosphere 750 mg modified-release granules
DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada 
Depakine Chronosphere 100 mg modified-release granules
500 MG/ SACHET Granulat med modificeret udløsning Oral anvendelse 
500 MG/ SACHET modified-release granules
Valproat-neuraxpharm 150 150 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Tyskland 
Valproat-neuraxpharm 150 150 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Ergenyl Chronosphere 750 mg Retardgranulat 
Ergenyl Chronosphere 750 mg Retardgranulat prolonged-release granules
DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada 
DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada modified-release granules
D-22335 Hamburg Tyskland 
D-22335 Hamburg Germany
Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln 
Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln prolonged-release granules
200 mg/ml orale dråber, opløsning Oral anvendelse 
200 mg/ml oral drops, solution
Ergenyl Chronosphere 100 mg Retardgranulat 
Ergenyl Chronosphere 100 mg Retardgranulat prolonged-release granules
Convulex 150 mg gastroresistant capsules, soft 
CONVULEX 150 mg gastro-resistant capsule, soft
50 MG/ SACHET Granulat med modificeret udløsning Oral anvendelse 
50 MG/ SACHET modified-release granules
Depot Enterotabletter Oral anvendelse 
gastro-resistant capsule Oral Use
Convulex 500 mg gastroresistant capsules, soft 
CONVULEX 500 mg gastro-resistant capsule, soft
Valproate sodium Sandoz 300 mg gastro-resistant capsules, soft 
Propymal Enteric 300 mg 300 mg gastro-resistant capsule, soft
Depakine Chronosphere 750 mg - Retardgranulat in Beuteln 
Depakine Chronosphere 750 mg - Retardgranulat in Beuteln prolonged-release granules
Ergenyl Chronosphere 250 mg Retardgranulat 
Ergenyl Chronosphere 250 mg Retardgranulat prolonged-release granules
Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Tyskland 
Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Convulex 300 mg gastroresistant capsules, soft 
CONVULEX 300 mg gastro-resistant capsule, soft
Depakine Chronosphere 100 mg - Retardgranulat in Beuteln 
Depakine Chronosphere 100 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln 
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln prolonged-release granules
Ergenyl Chronosphere 50 mg Retardgranulat 
Ergenyl Chronosphere 50 mg Retardgranulat prolonged-release granules
300 mg/ml orale dråber, opløsning Oral anvendelse 
300 mg/ml oral drops, solution
Ergenyl Chronosphere 500 mg Retardgranulat 
Ergenyl Chronosphere 500 mg Retardgranulat prolonged-release granules
Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Tyskland 
Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln 
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln 
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln prolonged-release granules
Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Tyskland 
Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Tyskland 
Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
1000 mg/dose 
1000 mg/dose prolonged-release granules
ORFIRIL LONG 1000 mg 1000 mg 
ORFIRIL LONG 1000 mg 1000 mg prolonged-release granules
EPISENTA 1000 MG PROLONGED RELEASE CAPSULES 
EPISENTA 1000 MG PROLONGED-RELEASE GRANULES
Natriumvalproat Desitin retard 150 mg 
Natriumvalproat Desitin retard 150 mg prolonged-release capsule
ORFIRIL LONG 150 mg 150 mg 
ORFIRIL LONG 150 mg 150 mg prolonged-release capsule
Filmovertrukken depottablet 
film-coated tablet
250 mg/dose 
250 mg/dose prolonged-release granules
333,30 mg + 145,14 mg 
333,30 mg + 145,14 mg prolonged-release granules
Granulat med modificeret udløsning Oral anvendelse 
Absenor modified-release tablet Oral Use
ORFIRIL LONG 1000 MG 1000mg 
ORFIRIL LONG 1000 MG 1000mg prolonged-release granules
Indgivelsesvej Indhold (Koncentration) 
Content (concentration)
Størstedelen af disse tilfælde var ikke dødelige. 
The majority of these cases were non-fatal.
Samlede population (ITT) 
Overall population (ITT)
• hvis du er barn (under 18 år), vil denne medicin ikke være egnet til dig. 
• if you are a child (less than 18 years of age), this medicine is not appropriate for you.
3,5 timer 
3.5 hours
*Superioritet p-værdi. 
*Superiority p-value.
Der bør tages de nødvendige forholdsregler til håndtering af disse. 
Necessary preparations should be made to deal with this.
Produktet bør ud fra en mikrobiologisk synsvinkel anvendes straks. 
From a microbiological point of view, the product should be used immediately.
• Kortfattede oplysninger om klargøring og vejledning i administration. 
• Brief information on preparation and administration instructions.
Dato for første markedsføringstilladelse: 20.09.2004 Dato for seneste fornyelse: 23.06.2014 
Date of first authorisation: 20.09.2004 Date of latest renewal: 23.06.2014
Kompartmentsyndrom a, b 
Compartment syndrome a, b
• alvorlig ukontrolleret hypertension 
• severe uncontrolled hypertension
Dødeligheden blandt disse patienter var lig nul. 
Mortality among these patients was nil.
Opløsninger, der indeholder partikler, bør ikke anvendes. 
Solutions containing particulate matter should not be used.
Cirka 20 % af bivalirudin udskilles uforandret i urinen. 
About 20% of bivalirudin is excreted unchanged in the urine.
Biotilgængeligheden af bivalirudin ved intravenøst brug er fuldstændig og øjeblikkelig. 
The bioavailability of bivalirudin for intravenous use is complete and immediate.
De maksimale ACT-værdier for alle grupper (voksne og alle pædiatriske populationer) konvergerer dog mod det samme niveau i nærheden af en ACT på 400 sekunder. 
However, the maximal ACT values for all groups (adults and all paediatric groups) converge at a similar level near an ACT of 400 seconds.
Halveringstid (minutter) 
Half-life (minutes)
• inden du får injektionen eller infusionen, vil din læge fortælle dig om kendetegnene ved allergiske reaktioner. 
• before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction.
Anvendelse af Angiox-doseringskortet anbefales som en hurtig referenceguide. 
The use of the Angiox dosing card is recommended as a quick reference guide.
Din læge vil beslutte, om denne behandling er passende for dig. 
Your doctor will decide whether or not this treatment is appropriate for you.
I alt 92,9 % af de behandlede patienter gennemgik primær PCI som deres primære behandlingsstrategi. 
A total of 92.9% of patients treated underwent primary PCI as their primary management strategy.
Der er på nuværende tidspunkt ingen indikation for brug af Angiox til børn eller unge under 18 år, og der kan ikke gives nogen anbefalinger vedrørende dosering. 
There is currently no indication for the use of Angiox in children less than 18 years old and no recommendation on a posology can be made.
Koncentration/tids-profilen efter intravenøs administration er godt beskrevet ved en to-kompartment model. 
The concentration-time profile following intravenous administration is well described by a twocompartment model.
Resultaterne antyder ingen farmakodynamiske interaktioner med disse stoffer. 
The results do not suggest pharmacodynamic interactions with these medicinal products.
Behandlingen med Angiox vil blive overvåget af en læge. 
Your treatment with Angiox will be supervised by a doctor.
Blødning er observeret i nogle rapporter om overdosering. 
Bleeding has been observed in some reports of overdose.
Administrationsfejl kan medføre letal trombose. 
Administration errors may lead to fatal thrombosis.
Alle bivirkninger, primære og sekundære, forårsaget af ekstraordinær stor farmakologisk aktivitet, var reversible. 
All the undesirable effects, primary and secondary, resulting from excessive pharmacological activity were reversible.
Enoxaparin blev kun anvendt som komparator i ACUITY. 
Enoxaparin was used as comparator in ACUITY only.
Blødningsdefinitioner 
Bleeding Definitions
Dette dosisregime er påkrævet for at opnå og bevare den plasmakoncentration, der er nødvendig for en effektiv iskæmisk beskyttelse under PCI. 
This dosing regimen is required to achieve and maintain the plasma concentration required for effective ischaemic protection during PCI.
• hvis du bruger anden medicin eller har gjort det for nylig. 
• if you are taking, or have recently taken or might take any other medicines.
Hvis du får nogle af følgende, potentielt alvorlige bivirkninger: 
If you get any of the following, potentially serious, side effects:
Det kan i sjældne tilfælde medføre slagtilfælde eller døden. 
This may, rarely, result in a stroke or be fatal.
Disse typer medicin kan øge risikoen for bivirkninger som blødning, hvis den tages samtidig med Angiox. 
these medicines may increase the risk of side effects such as bleeding when given at the same time as Angiox.
Lægen vil fastlægge, hvor meget Angiox du skal have, samt tilberede medicinen. 
The doctor will decide how much Angiox you receive, and will prepare the medicine.
• når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået. 
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Sammensat, 30 dage MACE 
30 day Composite MACE
Informationsmaterialet vil blive benyttet i alle medlemslande til både indledende uddannelse og genuddannelse ved indberetninger om behandling med bolusdosis alene uden efterfølgende infusion. 
The educational materials will be used in all member states for both initial training and re-education in the event of reports of bolus only dosing without subsequent infusion.
Angiox bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med bivalirudin. 
Angiox should not be used during pregnancy unless the clinical condition of the woman requires treatment with bivalirudin.
I tilfælde af chok skal gældende standard for shockbehandling initieres. 
In the case of shock, the current medical standards for shock treatment should be applied.
Farmakodynamiske modeller indikerede, at denne virkning skyldes en højere ACT ved baseline hos nyfødte og spædbørn end hos større børn. 
Pharmacodynamic models indicated that this effect is due to a higher baseline ACT in neonates and infants than in older children.
Iskæmiske komponenter Alle dødsårsager 
Ischaemic Components All cause death
Dette doseringsmønster var forbundet med øgede iskæmiske episoder på hospitalet (MACE). 
This dosing pattern was associated with increased in-hospital ischaemic events (MACE).
Der er ingen eller utilstrækkelige data fra anvendelse af bivalirudin til gravide kvinder. 
There are no or limited data from the use of bivalirudin in pregnant women.
Omtrent 66 % af patienterne var tidligere blevet behandlet med ufraktioneret heparin. 
Approximately 66% of patients were pre-treated with unfractionated heparin.
Sammenligning af enkeltdosis- og flerdosisundersøgelser viste, at toksiciteten primært var relateret til varigheden af behandlingen. 
Comparison of the single and repeated dose studies revealed that toxicity was related primarily to duration of exposure.
HORIZONS 30-dages forsøgsresultater (intent-to-treat-population) 
HORIZONS 30-day study results (intent-to-treat population)
Eliminationen følger en 1. ordens- proces med en terminal halveringstid på 25 ± 12 minutter hos patienter med normal nyrefunktion. 
Elimination follows a first order process with a terminal half-life of 25  12 minutes in patients with normal renal function.
Steady state distributionsvolumen er 0,1 l/kg. 
The steady-state volume of distribution is 0.1 l/kg.
Den hyppigste hændelse var et hæmatom på <5 cm ved punkturstedet. 
The most frequent event was a haematoma <5 cm at puncture site.
Der var ingen statistisk signifikant forskel i hyppigheden af stenttrombose mellem behandlingsarmene efter 30 dage (p=0,3257) og 1 år (p=0,7754). 
There was no statistically significant difference in the rates of stent thrombosis between treatment arms at 30 days (p=0.3257) and 1 year (p=0.7754).
• Blødning eller blå mærker på punktursted (efter PCI-behandling) kan være smertefulde. 
• Bleeding and bruising at the puncture site (after PCI treatment) may be painful.
Kliniske studier med et lille antal patienter har givet begrænset viden om brug af Angiox hos patienter med HIT/HITTS. 
Clinical trials in a small number of patients have provided limited information about the use of Angiox in patients with HIT/HITTS.
Justering af dosis er ikke nødvendig. 
No dose adjustment is needed.
ACT versus koncentration tyder på en tendens til en lavere koncentration-responskurve for voksne sammenlignet med større børn (6 år til <16 år) og mindre børn (2 år til <6 år), og for større børn sammenlignet med spædbørn (31 dage til <24 måneder) og nyfødte (fødsel til 30 dage). 
The ACT vs concentration data suggest a trend for a lower concentration response curve for adults as compared to older children (6 years to < 16 years) and younger children (2 years to <6 years), and for older children compared to infants (31 days to <24 months) and neonates (birth to 30 days).
Cirka 77 % af patienterne havde tilbagevendende iskæmi, cirka 70 % havde dynamiske EKG-forandringer eller forhøjede kardiale biomarkører, cirka 28 % havde diabetes og cirka 99 % af alle patienter undergik en angiografi inden for 72 timer. 
Approximately 77% of patients had recurrent ischaemia, approximately 70% had dynamic ECG changes or elevated cardiac biomarkers, approximately 28% had diabetes and approximately 99% of patients underwent angiography within 72 hours.
Under behandlingen vil din læge undersøge dig for tegn på blødning. 
Throughout your treatment, the doctor will check you for any signs of bleeding.
Der er ingen kendt antidot til bivalirudin, men virkengen aftager hurtigt (T½ er 25 ± 12 minutter). 
There is no known antidote to bivalirudin but its effect wears off quickly (T½ is 25 ± 12 minutes).
Angiox er kontraindiceret hos patienter med: 
Angiox is contraindicated in patients with:
For at sikre korrekt anvendelse af Angiox og for at undgå medicineringsfejl skal indehaveren af markedsføringstilladelsen sikre, at alle, som forventes at ordinere/bruge Angiox, oplæres i dosering og administration. 
In order to ensure the correct use of Angiox and to avoid medication errors, the MAH shall ensure that all prescribers who are expected to prescribe/use Angiox are provided with training on dosing and administration.
3, hvilket udgjorde et fald på ≥50 % i trombocyttal i forhold til baseline. 
3, representing a ≥50% decrease in platelets from baseline.
Stigning i aktiveret koagulationstid (ACT) kan benyttes som tegn på, at en patient har fået bivalirudin. 
An increase in the activated clotting time (ACT) may be used as an indication that a patient has received bivalirudin.
Toksicitet hos dyr udsat for gentagen eller kontinuerlig eksponering (fra 1 dag til 4 ugers behandlingsniveau med op til 10 gange klinisk steady state plasmakoncentration) var begrænset til overdreven farmakologisk virkning. 
Toxicity in animals upon repeated or continuous exposure (1 day to 4 weeks at exposure levels of up to 10 times the clinical steady state plasma concentration) was limited to exaggerated pharmacological effects.
Den relaterede clearance er cirka 3,4 ± 0,5 ml/min/kg. 
The corresponding clearance is about 3.4  0.5 ml/min/kg.
Efter angiografi blev patienterne enten henvist til medicinsk behandling (33 %), PCI (56 %) eller CABG (11 %). 
Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%).
• I ImproveR-registeret blev bolusdosering (uden efterfølgende infusion) observeret i klinisk praksis i EU. 
• In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice.
• hvis du tidligere er blevet behandlet med medicin, der ligner Angiox (f.eks. lepirudin). 
• if you have been treated before with medicines similar to Angiox (e.g. lepirudin).
Relativ risiko [95 % CI] 
Relative Risk [95% CI]
• aktiv blødning eller øget blødningsrisiko på grund af hæmostaseforstyrrelser og/eller irreversible koagulationsforstyrrelser 
• active bleeding or increased risk of bleeding because of haemostasis disorders and/or irreversible coagulation disorders
Clearance er reduceret med cirka 20 % hos patienter med moderat eller svært nedsat nyrefunktion, og med 80 % hos dialyseafhængige patienter (Se Tabel 8). 
Clearance is reduced by approximately 20% in patients with moderate or severe renal impairment, and 80% in dialysis-dependent patients (Table 8).
Når du er blevet behandlet med Angiox efter en hjertehændelse, skal du blive på hospitalet i mindst 24 timer, og du skal overvåges for symptomer eller tegn, der ligner dem, du havde i forbindelse med din hjertehændelse, og som medførte, at du blev indlagt på hospitalet. 
After being treated with Angiox for a cardiac event, you should stay in the hospital for at least 24 hours and you should be monitored for any symptoms or signs similar to the ones that remind you of your cardiac event and resulted in your hospitalisation.
Indehaveren af markedsføringstilladelsen skal blive enig om doseringskortet samt en kommunikationsplan med medlemsstatens relevante myndighed, før det distribueres i medlemsstaten. 
The MAH shall agree on the dosing card together with a communication plan, with the National Competent Authority in each Member State prior to distribution in the Member State.
Hvis den rekonstituerede/fortyndede opløsning ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens eget ansvar og bør normalt ikke overskride 24 timer ved 2 til 8 °C, medmindre rekonstitution/fortynding er blevet foretaget under kontrollerede og validerede aseptiske forhold.. 
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Data fra dyreforsøg er utilstrækkelige hvad angår virkningen på graviditet, embryonal/føtal udvikling, fødsel og postnatal udvikling (se pkt. 
Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Resultatet af din warfarinblodprøve (INR-prøve) kan påvirkes af Angiox. 
Your warfarin blood test result (INR test) may be affected by Angiox.