natgillin/translations-raw huggingface dataset:
Sanofi-aventis Letland SIA Kr. Valdemāra iela 33 - 8 LV - 1010 Riga Letland
Sanofi-aventis Latvia SIA Kr. Valdemāra iela 33 - 8 LV - 1010 Riga Latvia
Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgien
Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium
Valproinsäure-ratiopharm Lösung
Valproinsäure-ratiopharm Lösung oral solution
D-63741 Aschaffenburg Tyskland
D-63741 Aschaffenburg Germany
D-86156 Augsburg Tyskland
D-86156 Augsburg Germany
Arnethgasse 3, A-1160, Vienna, Østrig
Arnethgasse 3, A-1160, Vienna, Austria
8502 Lannach Østrig
8502 Lannach Austria
Remedica Ltd Aharnon street P.O.Box 51706 3508 Lemesos Cypern
Remedica Ltd Aharnon street P.O.Box 51706 3508 Lemesos Cyprus
Valpro TAD Lösung
Valpro TAD Lösung oral solution
Albert Basin, Royal Docks London E16 2QJ England
Albert Basin, Royal Docks London E16 2QJ United Kingdom
Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Østrig
Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria
D-89146 Laichingen Tyskland
D-89146 Laichingen Germany
Albert Basin, Royal Dock Canning Town London E16 2QJ England
Albert Basin, Royal Dock Canning Town London E16 2QJ United Kingdom
Limassol Industrial Estate Aharnon P.O Box 51706 3508 Limassol Cypern
Limassol Industrial Estate Aharnon P.O Box 51706 3508 Limassol Cyprus
Lundbeck GmbH Postfach 900662 D-21046 Hamburg Tyskland
Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany
D-79359 Riegel Tyskland
D-79359 Riegel Germany
Kapsel, hård
capsule, hard
A-8502 Lannach Østrig
A-8502 Lannach Austria
Weg Beim Jäger 214 22335 Hamburg Tyskland
Weg Beim Jäger 214 22335 Hamburg Germany
kapsel, blød
capsule, soft
Valproat-RPh Lösung
Valproat-RPh Lösung oral solution
49, avenue Georges Pompidou 92300 Levallois-Perret FRANKRIG
49, avenue Georges Pompidou 92300 Levallois-Perret France
49, avenue Georges Pompidou 92300 Levallois-Perret Frankrig
49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Oral opløsning esparma GmbH Seepark 7
Ergenyl Lösung oral solution esparma GmbH Seepark 7
Industriestrasse 25 D-83607 Holzkirchen Tyskland
Industriestrasse 25 D-83607 Holzkirchen Germany
D-39116 Magdeburg Tyskland espa-valept 600mg
D-39116 Magdeburg Germany espa-valept 600mg
SANDOZ GmbH Biochemiestrasse 10 A-6250 Kundl Østrig
SANDOZ GmbH Biochemiestrasse 10 A-6250 Kundl Austria
G.L.Pharma GmbH Schlossplatz 1, A-8502 Lannach, Østrig
G.L.Pharma GmbH Schlossplatz 1, A-8502 Lannach, Austria
ICN Polfa Rzeszów S.A. Przemysłowa 2 st. Rzeszów 35-959
ICN Polfa Rzeszów S.A. Przemysłowa 2 st.
G.L.Pharma GmbH Schlossplatz A-8502 Lannach Østrig
G.L.Pharma GmbH Schlossplatz A-8502 Lannach Austria
1 Onslow Street, Guildford Surrey, GU1 4YS England
1 Onslow Street, Guildford Surrey, GU1 4YS United Kingdom
Convulex kapsel, blød
Convulex capsule, soft
Sodium valproate Oral opløsning BP
Sodium valproate oral solution BP
Kapsler
capsule
Convulex Tropflösung
Convulex Tropflösung oral solution
30 g orale dråber, opløsning Oral anvendelse
30 g oral drops, solution
Kampenringweg 45 D-E NL-2803 PE Gouda Holland
The Netherlands sanofi-aventis Netherlands B.V. Kampenringweg 45 D-E NL-2803 PE Gouda The Netherlands
Valproat HEXAL 300mg/ml Lösung
Valproat HEXAL 300mg/ml Lösung oral solution
217.75mg/500.06mg Depotgranulat
217.75mg/500.06mg prolonged-release granules
72.61mg/166.76 mg Depotgranulat
72.61mg/166.76 mg prolonged-release granules
D-83602 Holzkirchen Tyskland
D-83602 Holzkirchen Germany
145.14mg/333.3 mg Depotgranulat
145.14mg/333.3 mg prolonged-release granules
Convulex 300 mg/mlLösung zum Einnehmen 300 mg/ml
Convulex 300 mg/mlLösung zum Einnehmen 300 mg/ml oral solution
Tablet med modificeret udløsning
modified release tablet
500,06 sodium valproate and 217,75 mg valproic acid per sachet
500,06 sodium valproate and 217,75 mg valproic acid per sachet modified-release granules
Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Tyskland
Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany
220 mg sodium valproate and 95,8 mg valproic acid per gram
220 mg sodium valproate and 95,8 mg valproic acid per gram modified-release granules
NATRIUMVALPROAATTI LONG DESITIN 1000 mg/ dose
NATRIUMVALPROAATTI LONG DESITIN 1000 mg/ dose prolonged-release granules
290.27mg/666.60mg Depotgranulat
290.27mg/666.60mg prolonged-release granules
166,76 sodium valproate and 72,61 mg valproic acid per sachet
166,76 sodium valproate and 72,61 mg valproic acid per sachet modified-release granules
Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Tyskland
Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany
VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFISYNTHELABO FRANKRIG L.P.
VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFISYNTHELABO FRANCE L.P.
SODIUM VALPROATE TABLETS BP 500MG EC 500mg
SODIUM VALPROATE TABLETS BP 500MG EC 500mg coated tablet
A-1160, Vienna Østrig
A-1160, Vienna Austria
Orfiril CR 150 mg modified-release Kapsler
Orfiril CR 150 mg modified-release capsule
Orfiril CR 300 mg modified-release Kapsler
Orfiril CR 300 mg modified-release capsule
Convulex 150 mg kapsuly 150 mg
Convulex 150 mg kapsuly 150 mg capsule
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Tyskland valprodura 150mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 150mg
RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Tyskland
RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany
29.03 mg/66.66 mg Depotgranulat
29.03 mg/66.66 mg prolonged-release granules
DEPAKINE CRONO 300 mg comprimidos recubiertos
DEPAKINE CRONO 300 mg comprimidos recubiertos coated tablet
Depakine Chronosphere 500-1000 mg/DosisRetardgranulat
Depakine Chronosphere 500-1000 mg/DosisRetardgranulat prolonged-release granules
Intravenøs anvendelse
Intravenous
D-22311 Hamburg Tyskland
D-22311 Hamburg Germany
33,33 sodium valproate and 14,51 mg valproic acid per sachet
33,33 sodium valproate and 14,51 mg valproic acid per sachet modified-release granules
NATRIUMVALPROAATTI LONG DESITIN 500 mg/ dose
NATRIUMVALPROAATTI LONG DESITIN 500 mg/ dose prolonged-release granules
A-1160 Wien, Østrig
A-1160 Wien, Austria
CONVULEX 300 mg / ml 300 mg / 1 ml of drops orale dråber, opløsning Oral anvendelse
CONVULEX 300 mg / ml 300 mg / 1 ml of drops oral drops, solution
500,06 mg + 217,75 mg
500,06 mg + 217,75 mg prolonged-release granules
66,66 sodium valproate and 29,03 mg valproic acid per sachet
66,66 sodium valproate and 29,03 mg valproic acid per sachet modified-release granules
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Tyskland valprodura 600 mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 600 mg
666,60 sodium valproate and 290,27 mg valproic acid per sachet
666,60 sodium valproate and 290,27 mg valproic acid per sachet modified-release granules
Valproinsäure Valeant 600 600 mg ratiopharm GmbH D-89070 Ulm Tyskland
Valproinsäure Valeant 600 600 mg ratiopharm GmbH D-89070 Ulm Germany
DEPAKINE CRONO 500 mg comprimidos recubiertos
DEPAKINE CRONO 500 mg comprimidos recubiertos coated tablet
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Tyskland valprodura 300 mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 300 mg
Filmovertrukken tablet Oral anvendelse
modified-release tablet Oral Use
166,76 mg + 72,61 mg
166,76 mg + 72,61 mg prolonged-release granules
Valproinsäure-ratiopharm ratiopharm GmbH D-89070 Ulm Tyskland
Valproinsäure-ratiopharm ratiopharm GmbH D-89070 Ulm Germany
EPISENTA 150 MG PROLONGED RELEASE CAPSULES
EPISENTA 150 MG PROLONGED-RELEASE CAPSULE
333,30 sodium valproate and 145,14 mg valproic acid per sachet
333,30 sodium valproate and 145,14 mg valproic acid per sachet modified-release granules
SODIUM VALPROATE TABLETS BP 200MG 200mg
SODIUM VALPROATE TABLETS BP 200MG 200mg coated tablet
Convulex 500 mg kapsuly 500 mg
Convulex 500 mg kapsuly 500 mg capsule
EPISENTA 300 MG PROLONGED RELEASE CAPSULES
EPISENTA 300 MG PROLONGED-RELEASE CAPSULE
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.