natgillin/translations-raw huggingface dataset:
500,06 sodium valproate and 217,75 mg valproic acid per sachet modified-release granules
500,06 sodium valproate and 217,75 mg valproic acid per sachet
EPISENTA 1000 MG PROLONGED-RELEASE GRANULES
EPISENTA 1000 MG PROLONGEDRELEASE GRANULES
Rua Tierno Galvan - Amoreiras - Torre 3 - 12º
Rua Tierno GalvanAmoreiras - Torre 3 - 12º 1099-036 Lisboa Portugal
220 mg sodium valproate and 95,8 mg valproic acid per gram modified-release granules
220 mg sodium valproate and 95,8 mg valproic acid per gram
Ergenyl Lösung oral solution esparma GmbH Seepark 7
Suukaudne lahus esparma GmbH Seepark 7
1800 Vilvoorde Belgium
Telecom Gardens Medialaan 40 1800 Vilvoorde Belgia
166,76 sodium valproate and 72,61 mg valproic acid per sachet modified-release granules
166,76 sodium valproate and 72,61 mg valproic acid per sachet
powder and solvent for solution for infusion/injection
Infusiooni/süstelahuse pulber ja lahusti
EPISENTA 300 MG PROLONGED-RELEASE CAPSULE
EPISENTA 300 MG PROLONGEDRELEASE CAPSULE
Natriumvalproat 'ratiopharm' retard 300 mgFilmtabletten
Natriumvalproat 'ratiopharm' retard 300 mg - Filmtabletten
EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou
LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
modified release tablet
Toimeainet modifitseeritult vabastav tablett
Valpro TAD chrono 300 mg 300 mg
Valpro TAD chrono 300 mg
gastro-resistant capsule, hard
Gastro-resistentne kapsel
5,764 /100 ml syrup
5,764 /100 ml
NATRIUMVALPROAATTI LONG DESITIN 1000 mg/ dose prolonged-release granules
NATRIUMVALPROAATTI LONG DESITIN 1000 mg/ dose
Valpro beta chrono 300 mg Retardtabletten betapharm Arzneimittel GmbH Kobelweg 95
Valpro beta chrono 300 mg Retardtabletten betapharm Arzneimittel GmbH
Valpro TAD chrono 500 mg 500 mg
Valpro TAD chrono 500 mg
CONTROLLED RELEASE TABLETS 200MG
EPILIM CHRONO 200 CONTROLLED RELEASE TABLETS 200MG
500,06 mg + 217,75 mg prolonged-release granules
500,06 mg + 217,75 mg
Depakine 57,64 mg/ml syrup
Depakine 57,64 mg/ml
DEPAKINE CRONO 300 mg comprimidos recubiertos coated tablet
DEPAKINE CRONO 300 mg comprimidos recubiertos
CONTROLLED RELEASE TABLETS 500MG
EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS 500MG
CONVULEX CAPSULES 150MG
CONVULEX CAPSULES 150MG 150mg
NATRIUMVALPROAATTI LONG DESITIN 500 mg/ dose prolonged-release granules
NATRIUMVALPROAATTI LONG DESITIN 500 mg/ dose
Natriumvalproat 'ratiopharm' retard 500 mgFilmtabletten
Natriumvalproat 'ratiopharm' retard 500 mg - Filmtabletten
02200 Espoo Finland
02200 Espoo Soome
Valpro AL 500 mg Retardtabletten betapharm Arzneimittel GmbH Kobelweg 95
Valpro AL 500 mg Retardtabletten betapharm Arzneimittel GmbH
Convulex 150 mg kapsuly 150 mg capsule
Convulex 150 mg kapsuly 150 mg
166,76 mg + 72,61 mg prolonged-release granules
166,76 mg + 72,61 mg
RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany
RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Saksamaa
prolonged-release capsule
Toimeainet prolongeeritult vabastav kapsel
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 150mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Saksamaa valprodura 150mg
5.764 g/100 ml syrup
5.764 g/100 ml
D-22311 Hamburg Germany
D-22311 Hamburg Saksamaa
UAB ,,Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2
UAB ,,Sanofi Aventis“ Lietuva
EPISENTA 500 MG PROLONGED-RELEASE GRANULES
EPISENTA 500 MG PROLONGEDRELEASE GRANULES
33,33 sodium valproate and 14,51 mg valproic acid per sachet modified-release granules
33,33 sodium valproate and 14,51 mg valproic acid per sachet
MEDA Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co.
66,66 sodium valproate and 29,03 mg valproic acid per sachet modified-release granules
66,66 sodium valproate and 29,03 mg valproic acid per sachet
CONVULEX CAPSULES 300MG
CONVULEX CAPSULES 300MG 300mg
Depakine Chronosphere 500-1000 mg/DosisRetardgranulat prolonged-release granules
Depakine Chronosphere 500-1000 mg/DosisRetardgranulat
666,60 sodium valproate and 290,27 mg valproic acid per sachet modified-release granules
666,60 sodium valproate and 290,27 mg valproic acid per sachet
Convulex 300 mg kapsuly 300 mg capsule
Convulex 300 mg kapsuly 300 mg
DEPAKINE CRONO 500 mg comprimidos recubiertos coated tablet
DEPAKINE CRONO 500 mg comprimidos recubiertos
VALPROATE RETARD MYLAN 300 MG
VALPROATE RETARD MYLAN 300 MG 300 mg
CONVULEX CAPSULES 500MG
CONVULEX CAPSULES 500MG 500mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 600 mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Saksamaa valprodura 600 mg
66,66 mg + 29,03 mg prolonged-release granules
66,66 mg + 29,03 mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 300 mg
Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Saksamaa valprodura 300 mg
VALPROATE RETARD MYLAN 500 MG
VALPROATE RETARD MYLAN 500 MG 500 mg
333,30 sodium valproate and 145,14 mg valproic acid per sachet modified-release granules
333,30 sodium valproate and 145,14 mg valproic acid per sachet
SODIUM VALPROATE TABLETS BP 500MG EC 500mg coated tablet
SODIUM VALPROATE TABLETS BP 500MG EC
290.27mg/666.60mg prolonged-release granules
290.27mg/666.60mg
SODIUM VALPROATE TABLETS BP 200MG 200mg coated tablet
SODIUM VALPROATE TABLETS BP 200MG 200mg
ACIDO VALPROICO E SODIO VALPROATO EG 300 mg
ACIDO VALPROICO E SODIO VALPROATO EG
Ergenyl chrono 300 mg
Ergenyl chrono 300 mg 300 mg
Convulex 500 mg kapsuly 500 mg capsule
Convulex 500 mg kapsuly 500 mg
CHRONOSPHERE 1000 MG Granulado de liberación modificada modified-release granules
CHRONOSPHERE 1000 MG Granulado de liberación modificada
DEPAKINE 300 MG/5 ML 300 mg/5 ml syrup
DEPAKINE 300 MG/5 ML
NYCOMED BELGIUM N.V. Gentsesteenweg 615
Gentsesteenweg 615
217.75mg/500.06mg prolonged-release granules
217.75mg/500.06mg
Ergenyl chrono 500 mg
Ergenyl chrono 500 mg 500 mg
220.00 mg/g / 96.00 mg/g prolonged-release granules
220.00 mg/g / 96.00 mg/g
syrup
Siirup
SODIUM VALPROATE LIQUID 200MG/5ML 200mg oral solution
SODIUM VALPROATE LIQUID 200MG/5ML 200mg
666,60 mg + 290,27 mg prolonged-release granules
666,60 mg + 290,27 mg
Valproinsäure-ratiopharm 300 Filmtabletten ratiopharm GmbH D-89070 Ulm Germany
Valproinsäure-ratiopharm 300 Filmtabletten ratiopharm GmbH D-89070 Ulm Saksamaa
Valproat chrono Desitin 500mg Retardtabletten
Valproat chrono Desitin 500mg Retardtabletten 500 mg
Valproat chrono Desitin 300 mg Retardtabletten
Valproat chrono Desitin 300 mg Retardtabletten 300 mg
pharma GmbH & Co. KG
pharma GmbH & Co.
D-39116 Magdeburg Germany espa-valept 500 mg retard 500 mg esparma GmbH Seepark 7
D-39116 Magdeburg Saksamaa espa-valept 500 mg retard 500 mg esparma GmbH Seepark 7
Ratiopharm GmbH Arzneimittel Postfach 3380
Ratiopharm GmbH Arzneimittel Postfach 3380 D-89070 Ulm
15, boulevard Charles de Gaulle 92700 Colombes France
BIOGARAN 15, boulevard Charles de Gaulle
29.03 mg/66.66 mg prolonged-release granules
29.03 mg/66.66 mg
1000 MG/ SACHET modified-release granules
1000 MG/ SACHET
57,64 mg/ml syrup
57,64 mg/ml
223 35 Hamburg Germany
223 35 Hamburg Saksamaa
Valproinsäure-ratiopharm ratiopharm GmbH D-89070 Ulm Germany
Valproinsäure-ratiopharm ratiopharm GmbH D-89070 Ulm Saksamaa
72.61mg/166.76 mg prolonged-release granules
72.61mg/166.76 mg
250mg/5ml syrup
250mg/5ml
D-22335 Hamburg, Germany
D-22335 Hamburg, Saksamaa
50mg/1ml syrup
50mg/1ml
750 MG/ SACHET modified-release granules
750 MG/ SACHET
Convulex 300 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Convulex 300 mg gastroresistant capsules, soft
D-39116 Magdeburg Germany espa-valept 150mg esparma GmbH Seepark 7
D-39116 Magdeburg Saksamaa espa-valept 150mg esparma GmbH Seepark 7
Valproat HEXAL chrono 300 mg Retardtabletten
Valproat HEXAL chrono 300 mg Retardtabletten 300 mg
Ergenyl Chronosphere 1000 mg Retardgranulat prolonged-release granules
Ergenyl Chronosphere 1000 mg Retardgranulat
Convulex 300 mgFilmtabletten film-coated tablet
Convulex 300 mgFilmtabletten
prolonged -release granules
Toimeainet prolongeeritult vabastavad graanulid
D-39116 Magdeburg Germany espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
D-39116 Magdeburg Saksamaa espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
D-22335, Hamburg Germany
D-22335, Hamburg Saksamaa
EPILIM 500 ENTERIC COATED TABLETS
EPILIM 500 ENTERIC COATED TABLETS 500mg
500 MG/ SACHET modified-release granules
500 MG/ SACHET
250 MG/ SACHET modified-release granules
250 MG/ SACHET
Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
22335 Hamburg Germany
22335 Hamburg Saksamaa
AWD.pharma GmbH & Co. KG Wasastr.
AWD.pharma GmbH & Co.
Convulex 150 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Convulex 150 mg gastroresistant capsules, soft
300 mg/ml oral drops
300 mg / 1 ml of drops
betapharm Arzneimittel GmbH Kobelweg 95
betapharm Arzneimittel GmbH
57.64 mg/ml syrup
57.64 mg/ml
Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
Poola ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
Valproat HEXAL chrono 500 mg Retardtabletten
Valproat HEXAL chrono 500 mg Retardtabletten 500 mg
Convulex 500 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Convulex 500 mg gastroresistant capsules, soft
Depakine 300 mgFilmtabletten film-coated tablet
Depakine 300 mgFilmtabletten
D-39116 Magdeburg Germany espa-valept 300mg esparma GmbH Seepark 7
D-39116 Magdeburg Saksamaa espa-valept 300mg esparma GmbH Seepark 7
Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
Poola ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
Depakine Chronosphere 100 mg modified-release granules
DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada
300 mg/5 ml syrup
300 mg/5 ml
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Saksamaa
Depakine Chronosphere 250 mg modified-release granules
DEPAKINE CHRONOSPHERE 250 mg granulado de liberación modificada
Czech Republic ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Tsehhi ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Saksamaa
Depakine Chronosphere 50350 mg/DosisRetardgranulat prolonged-release granules
Depakine Chronosphere 50-350 mg/DosisRetardgranulat
Depakine Chronosphere 750 mg modified-release granules
DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada
Ergenyl Chronosphere 750 mg Retardgranulat prolonged-release granules
Ergenyl Chronosphere 750 mg Retardgranulat
Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Saksamaa
Valproic Acid ER-APC 300 300 mg
Valproic Acid ER-APC
Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln
DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada modified-release granules
DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada
D-22335 Hamburg Germany
D-22335 Hamburg Saksamaa
Ergenyl Chronosphere 100 mg Retardgranulat prolonged-release granules
Ergenyl Chronosphere 100 mg Retardgranulat
gastro-resistant capsule Oral Use
Gastro-resistentne pehmekapsel
Depakine Chronosphere 50200 mg/DosisRetardgranulat prolonged-release granules
Depakine Chronosphere 50-200 mg/DosisRetardgranulat
200 mg/5 ml syrup
200 mg/5 ml
Depakine Chronosphere 750 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 750 mg - Retardgranulat in Beuteln
Ergenyl Chronosphere 250 mg Retardgranulat prolonged-release granules
Ergenyl Chronosphere 250 mg Retardgranulat
Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Saksamaa
200 mg/ml oral solution
DEPAKINE solución oral 200 mg/ml
50 MG/ SACHET modified-release granules
50 MG/ SACHET
AT-1160 Wien
AT-1160 Wien AUSTRIA
Depakine Chronosphere 100 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 100 mg - Retardgranulat in Beuteln
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln
200mg/5ml syrup
200mg/5ml
Valproinsäure Valeant 600 600 mg ratiopharm GmbH D-89070 Ulm Germany
Valproinsäure Valeant ratiopharm GmbH D-89070 Ulm Saksamaa
Empreendimento Lagoas Park, Edifício 7 - 3º
Empreendimento Lagoas Park, Edifício 7 - 3º 2740-299 Porto Salvo Portugal
Ergenyl Chronosphere 50 mg Retardgranulat prolonged-release granules
Ergenyl Chronosphere 50 mg Retardgranulat
VALPROATE SODIUM SANDOZ 500MG
VALPROATE SODIUM SANDOZ 500MG 500mg
VALPROATE SODIUM SANDOZ 300MG
VALPROATE SODIUM SANDOZ 300MG 300mg
Ergenyl Chronosphere 500 mg Retardgranulat prolonged-release granules
Ergenyl Chronosphere 500 mg Retardgranulat
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln prolonged-release granules
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln
DEPAKINE CHRONO 300mg tablet
DEPAKINE CHRONO 300mg
333,30 mg + 145,14 mg prolonged-release granules
333,30 mg + 145,14 mg
100 MG/ SACHET modified-release granules
100 MG/ SACHET
MICROPAKINE LP
MICROPAKINE LP 100 mg
100 mg/ml syrup
100 mg/ml
Convulsofin Tabletten tablet
Õhukese polümeerikattega tablett Suukaudne
Depakine tablet
Depakine Zuur
ORFIRIL LONG 150 mg 150 mg prolonged-release capsule
ORFIRIL LONG 150 mg 150 mg
Valproinsäure Valeant 300 300 mg
Ácido Valpróico Generis 300 mg
Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Valproat-neuraxpharm neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Saksamaa
250 mg/dose prolonged-release granules
250 mg/dose
DEPAKINE CHRONO 500mg tablet
DEPAKINE CHRONO 500mg
Natriumvalproat Desitin retard 150 mg prolonged-release capsule
Natriumvalproat Desitin retard 150 mg
VALPROATE DE SODIUM RATIOPHARM L.P.
RATIOPHARM L.P.
DEPAKINE solución oral
Depakine suikervrije stroop
Czech Republic
Tsehhi
1000 mg/dose prolonged-release granules
1000 mg/dose
300 mg (199,8 mg/ 87 mg) modified-release tablet Oral Use
300 mg (199,8 mg/ 87 mg)
Orfiril CR 1000 mg modified-release granules
Orfiril CR 1000 mg
SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland
1-13, boulevard Romain Rolland
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside taotlejate loetelu liikmesriikides
Content (concentration)
Ravimvorm Manustamisviis Pakendi sisu (kontsentratsioon)
3.5 hours
3,5 tundi
• if you are a child (less than 18 years of age), this medicine is not appropriate for you.
• Kui te olete laps (alla 18aastane) ei ole see ravim teile sobiv.
Currently available data are described in sections 5.1 and 5.2.
Antud hetkel teadaolevad andmed on esitatud lõikudes 5.1 ja 5.2.
*Superiority p-value.
*Ülekaalukas p-value.
Compartment syndrome a, b
Kompartmendi sündroom a, b
Mortality among these patients was nil.
Suremus nende patsientide hulgas oli null.
INR increased d
INR tõus d
The majority of these cases were non-fatal.
Enamik nendest juhtudest ei olnud letaalsed.
30 day Composite MACE
30 päeva komposiit MACE
• before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction.
• enne süstimise või infusiooni algust informeerib arst teid allergilise reaktsiooni nähtudest.
This may, rarely, result in a stroke or be fatal.
See võib harvadel juhtudel põhjustada insulti või olla isegi surmav.
• Brief information on preparation and administration instructions.
• Lühike teave lahuse valmistamise ja manustamise kohta.
Ischaemic Components All cause death
Isheemilised komponendid Kõik surmapõhjused
Date of first authorisation: 20.09.2004 Date of latest renewal: 23.06.2014
Müügiloa esmase väljastamise kuupäev: 20.09.2004 Müügiloa viimase uuendamise kuupäev: 23.06.2014
Relative Risk [95% CI]
Suhteline risk [95% CI]
Comparison of the single and repeated dose studies revealed that toxicity was related primarily to duration of exposure.
Ühekordse ja korduva manustamisega uuringute tulemuste võrdlemisest ilmnes, et toksilisus oli eelkõige seotud ekspositsiooni kestvusega.
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.
Praegu puudub Angiox'i kasutus lastel vanuses alla 18 aasta ja soovitusi annustamise kohta ei ole võimalik anda.
All the undesirable effects, primary and secondary, resulting from excessive pharmacological activity were reversible.
Kõik kõrvaltoimed - nii primaarsed kui ka sekundaarsed -, mis tulenesid ülemäärasest farmakoloogilisest toimest, olid pöörduvad.
Justification for not including Braille accepted.
Põhjendus Braille' kirja (punktkirja) mitte lisamiseks on aktsepteeritav.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kasutamata ravimpreparaat või jäätmematerjal tuleb hävitada vastavalt kohalikele nõuetele
Do not use Angiox
Ärge kasutage Angiox'i
Clearance (ml/min/kg)
Kliirens (ml/min/kg)
• Bleeding and bruising at the puncture site (after PCI treatment) may be painful.
• Verejooks ja verevalum punktsiooni kohal (pärast PKI-ravi) võib olla valulik.
• Do not use bivalirudin without first diluting it.
• Ärge kasutage bivalirudiini enne selle lahjendamist.
OUTER CARTON (pack of 10 vials)
VÄLISKARP (10-viaaline pakend)
• if bleeding occurs (if this happens, treatment with Angiox will be stopped).
• kui esineb verejooks (kui see juhtub, katkestatakse Angiox'i manustamine).
If you get any of the following, potentially serious, side effects:
Kui teil tekib mis tahes järgmine potentsiaalselt tõsine kõrvaltoime:
• 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
• kui muudetakse riskijuhtimissüsteemi, eriti kui saadakse uut teavet, mis võib oluliselt mõjutada riski/kasu suhet, või kui saavutatakse oluline (ravimiohutuse või riski
If you cannot get access to your doctor go immediately to the Emergency Department of your nearest hospital
Kui te ei saa arstiga ühendust, pöörduge koheselt lähima haigla erakorralise meditsiini osakonda
This dosing regimen is required to achieve and maintain the plasma concentration required for effective ischaemic protection during PCI.
Selline annustamisskeem on vajalik plasmakontsentratsiooni saavutamiseks ja säilitamiseks, mis tagab tõhusa isheemiavastase kaitse PKI ajal.
The clinical utility of ACT in neonates and children should be considered with caution considering their developmental haematological state.
ACT kasutamise kliinilisse kasulikkusse vastsündinute ja laste puhul tuleb suhtuda ettevaatusega, arvestades nende hematoloogilist arengut.
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).
ACT vs kontsentratsiooni andmed näitavad täiskasvanutel kontsentratsiooni ja ravivastuse kõvera väiksemat suundumust võrreldes vanemate (6 aastat kuni < 16 aastat) ja nooremate lastega (2 aastat kuni < 6 aastat) ning vanematel lastel võrreldes imikutega (31 päeva kuni < 24 kuud) ja vastsündinutega (sünnist kuni 30 päevani).
Angiox should not be used during pregnancy unless the clinical condition of the woman requires treatment with bivalirudin.
Angiox'i ei tohi kasutada raseduse ajal, väljaarvatud juhul, kui naise kliiniline seisund vajab ravi bivalirudiiniga.
The bioavailability of bivalirudin for intravenous use is complete and immediate.
Bivalirudiini biosaadavus intravenoossel manustamisel on täielik ja kohene.
Hypersensitivity, including anaphylactic reaction and shock, including reports with fatal outcome
Ülitundlikkus, sh anafülaktiline reaktsioon ja šokk, sh teated fataalsest lõpptulemusest
• if you have been treated before with medicines similar to Angiox (e.g. lepirudin).
• kui teid on varem ravitud Angiox'iga sarnaste ravimitega (nt lepirudiin).
The most frequent event was a haematoma <5 cm at puncture site.
Kõige sagedasem oli hematoom <5 cm raadiuses punktsioonikohast.
• Allergic reactions,- are uncommon (may affect up to 1 in 100 people) and usually not serious but can become severe under some circumstances, and in rare cases may be fatal due to low blood pressure (shock).
• Allergilisi reaktsioone esineb aeg-ajalt (võib esineda kuni 1 inimesel 100-st) ja need ei ole tavaliselt rasked, kuid võivad teatud tingimustel muutuda raskeks ja olla harvadel juhtudel fataalsed madala vererõhu (šoki) tõttu.
In all clinical studies bleeding data were collected separately from adverse reactions and are summarised in Table 6 together with the bleeding definitions used for each study.
Kõikides kliinilistes uuringutes koguti andmeid verejooksu kohta eraldi andmetest ravimi kõrvaltoimete kohta ning nende kokkuvõte on esitatud Tabelis 6 koos iga uuringu raames kasutatud verejooksu definitsioonidega.
What Angiox contains
Mida Angiox sisaldab
The doctor will decide how much Angiox you receive, and will prepare the medicine.
Arst otsustab kui palju Angiox'i teile manustatakse ja valmistab ravimi ette.
Approximately 66% of patients were pre-treated with unfractionated heparin.
Ligikaudu 66% patsientidest said eelnevalt fraktsioneerimata hepariini ravi.
Angiox has no or negligible influence on the ability to drive and use machines.
Angiox ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
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.
Hariduslikku materjali kasutatakse kõigis liikmesriikides nii esialgseks koolituseks kui ka korduvate koolituste läbiviimiseks, kui saadakse teateid ainult boolusannuse kasutamise kohta sellele järgneva infusioonita.
In the case of shock, the current medical standards for shock treatment should be applied.
Šoki korral tuleb rakendada tänapäeva meditsiinilistele standarditele vastavat šokiravi.
Haematoma, Hypotension
Hematoom, hüpotensioon
Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Ärge kasutage seda ravimit pärast kõlblikkusaega, mis märgitud sildil ja karbil pärast „Kõlblik kuni”.
The corresponding clearance is about 3.4  0.5 ml/min/kg.
Sellele vastav kliirens on umbes 3,4 ±0,5 ml/min/kg.
No dose adjustment is needed.
Annuse kohandamine ei ole vajalik.
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).
Statistiliselt olulisi erinevusi stendi tromboosi näitajate osas uuringuharude vahel vahemikus 30 päeva (p=0,3257) ja 1 aasta (p=0,7754) ei esinenud.
About 20% of bivalirudin is excreted unchanged in the urine.
Umbes 20% bivalirudiinist eritub muutumatul kujul uriiniga.
Bleeding Definitions
Verejooksu definitsioonid
Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Loomkatsete põhjal ei saa välistada toimet rasedusele, embrüo/loote arengule, sünnitusele või postnataalsele arengule (vt lõik 5.3).
Caution should be exercised in patients previously treated with lepirudin who had developed lepirudin antibodies.
Ettevaatlik tuleb olla patsientide puhul, kes on varasemalt saanud lepirudiini ja kellel on tekkinud lepirudiini antikehad.
Your doctor will decide whether or not this treatment is appropriate for you.
Selle üle, kas antud ravim on teile sobiv või mitte otsustab teie arst.