FrancophonIA/ELRC3.0 huggingface dataset:
English: ORFIRIL LONG 300 mg 300 mg prolonged-release capsule
Slovenian: ORFIRIL LONG 300 mg 300 mg kapsula s podaljšanim sproščanjem
English: ORFIRIL LONG 1000 mg 1000 mg prolonged-release granules
Slovenian: ORFIRIL LONG 1000 mg 1000 mg zrnca s podaljšanim sproščanjem
English: Orfiril CR 150 mg modified-release capsule
Slovenian: Orfiril CR 150 mg kapsula s prirejenim sproščanjem
English: Convulex 200 mgKapseln gastro-resistant capsule, soft
Slovenian: Convulex 200 mgKapseln gastrorezistentna kapsula, mehka
English: Orfiril CR 300 mg modified-release capsule
Slovenian: Orfiril CR 300 mg kapsula s prirejenim sproščanjem
English: Convulex gastro-resistant capsule, soft
Slovenian: Convulex gastrorezistentna kapsula, mehka
English: 333 mg sodium valproate and 145 mg valproic acid modified-release tablet Oral Use
Slovenian: 333 mg sodium valproate and 145 mg valproic acid tableta s prirejenim sproščanjem
English: ORFIRIL LONG 150 mg 150 mg prolonged-release capsule
Slovenian: ORFIRIL LONG 150 mg 150 mg kapsula s podaljšanim sproščanjem
English: D-39116 Magdeburg Germany espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
Slovenian: D-39116 Magdeburg Nemčija espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
English: 1000 mg/dose prolonged-release granules
Slovenian: 1000 mg/dose zrnca s podaljšanim sproščanjem
English: gastro-resistant coated tablet
Slovenian: gastrorezistentna obložena tableta
English: DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada modified-release granules
Slovenian: DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada zrnca s prirejenim sproščanjem
English: ORFIRIL LONG 150 MG 150mg prolonged-release capsule, hard
Slovenian: ORFIRIL LONG 150 MG 150mg kapsula s podaljšanim sproščanjem, trda
English: Convulex 300 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Slovenian: Convulex 300 mg gastroresistant capsules , soft gastrorezistentna kapsula, mehka
English: CHRONOSPHERE 250 mg granulado de liberación modificada modified-release granules
Slovenian: CHRONOSPHERE 250 mg granulado de liberación modificada zrnca s prirejenim sproščanjem
English: 57,64 mg/ml syrup
Slovenian: 57,64 mg/ml sirup
English: Dipromal film-coated tablet
Slovenian: Dipromal filmsko obložena tableta Peroralna uporaba
English: ORFIRIL LONG 500 MG 500mg prolonged-release granules
Slovenian: ORFIRIL LONG 500 MG 500mg zrnca s podaljšanim sproščanjem
English: Czech Republic ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: Češka ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Nemčija
English: 300 mg/5 ml syrup
Slovenian: 300 mg/5 ml sirup
English: Orfiril long prolonged-release capsule, hard
Slovenian: Orfiril long kapsula s podaljšanim sproščanjem, trda
English: Convulex 300 mg - Kapseln 300 mg gastro-resistant capsule, soft
Slovenian: Convulex 300 mg - Kapseln 300 mg gastrorezistentna kapsula, mehka
English: DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada modified-release granules
Slovenian: DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada zrnca s prirejenim sproščanjem
English: Natriumvalproaat ratiopharm chrono 500 mg 500 mg modified-release tablet Oral Use
Slovenian: Natriumvalproaat ratiopharm chrono 500 mg 500 mg tableta s prirejenim sproščanjem
English: Ergenyl Chronosphere 750 mg Retardgranulat prolonged-release granules
Slovenian: Ergenyl Chronosphere 750 mg Retardgranulat zrnca s podaljšanim sproščanjem
English: ORFIRIL LONG 1000 MG 1000mg prolonged-release granules
Slovenian: ORFIRIL LONG 1000 MG 1000mg zrnca s podaljšanim sproščanjem
English: Natriumvalproat Desitin retard 300 mg prolonged-release capsule
Slovenian: Natriumvalproat Desitin retard 300 mg kapsula s podaljšanim sproščanjem
English: Propymal Enteric 300 mg 300 mg gastro-resistant capsule, soft
Slovenian: Propymal Enteric 300 mg 300 mg gastrorezistentna kapsula, mehka
English: D-22335, Hamburg Germany
Slovenian: D-22335, Hamburg Nemčija
English: Orfiri long prolonged-release capsule, hard
Slovenian: Orfiri long kapsula s podaljšanim sproščanjem, trda
English: 250 MG/ SACHET modified-release granules
Slovenian: 250 MG/ SACHET zrnca s prirejenim sproščanjem
English: Orfiril Long prolonged-release granules
Slovenian: Orfiril Long zrnca s podaljšanim sproščanjem
English: Natriumvalproaat ratiopharm chrono 300 mg 300 mg modified-release tablet Oral Use
Slovenian: Natriumvalproaat ratiopharm chrono 300 mg 300 mg tableta s prirejenim sproščanjem
English: Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
Slovenian: Poljska ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
English: Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Slovenian: Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Nemčija
English: Natriumvalproat Desitin retard 150 mg prolonged-release capsule
Slovenian: Natriumvalproat Desitin retard 150 mg kapsula s podaljšanim sproščanjem
English: ORFIRIL LONG 300 MG 300mg prolonged-release capsule, hard
Slovenian: ORFIRIL LONG 300 MG 300mg kapsula s podaljšanim sproščanjem, trda
English: DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada modified-release granules
Slovenian: DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada zrnca s prirejenim sproščanjem
English: 40 mg/ml syrup
Slovenian: 40 mg/ml sirup
English: prolonged-release capsule, hard
Slovenian: kapsula s podaljšanim sproščanjem, trda
English: 250 mg/dose prolonged-release granules
Slovenian: 250 mg/dose zrnca s podaljšanim sproščanjem
English: DEPAKINE CHRONO 500mg film-coated tablet
Slovenian: DEPAKINE CHRONO 500mg filmsko obložena tableta Peroralna uporaba
English: Convulex 150 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Slovenian: Convulex 150 mg gastroresistant capsules, soft gastrorezistentna kapsula, mehka
English: 100 mg/ml syrup
Slovenian: 100 mg/ml sirup
English: 100 MG/ SACHET modified-release granules
Slovenian: 100 MG/ SACHET zrnca s prirejenim sproščanjem
English: D-39116 Magdeburg Germany espa-valept 300mg esparma GmbH Seepark 7
Slovenian: D-39116 Magdeburg Nemčija espa-valept 300mg esparma GmbH Seepark 7
English: Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
Slovenian: Poljska ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
English: CONVULEX 150 MG 150mg gastro-resistant capsule, soft
Slovenian: CONVULEX 150 MG 150mg gastrorezistentna kapsula, mehka
English: 500 MG/ SACHET modified-release granules
Slovenian: 500 MG/ SACHET zrnca s prirejenim sproščanjem
English: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovenian: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Nemčija
English: pharma GmbH & Co. KG
Slovenian: pharma GmbH & Co.
English: Convulex 500 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Slovenian: Convulex 500 mg gastroresistant capsules , soft gastrorezistentna kapsula, mehka
English: Valproat-neuraxpharm 150 150 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Slovenian: Valproat-neuraxpharm 150 150 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
English: AWD.pharma GmbH & Co. KG Wasastr.
Slovenian: AWD.pharma GmbH & Co.
English: Ergenyl Chronosphere 1000 mg Retardgranulat prolonged-release granules
Slovenian: Ergenyl Chronosphere 1000 mg Retardgranulat zrnca s podaljšanim sproščanjem
English: DEPAKINE CHRONO 300mg film-coated tablet
Slovenian: DEPAKINE CHRONO 300mg filmsko obložena tableta Peroralna uporaba
English: film-coated tablet
Slovenian: filmsko obložena tableta Peroralna uporaba
English: 200mg/5ml syrup
Slovenian: 200mg/5ml sirup
English: gastro-resistant capsule Oral Use
Slovenian: gastrorezistentna kapsula
English: Depakine Chronosphere 750 mg - Retardgranulat in Beuteln prolonged-release granules
Slovenian: Depakine Chronosphere 750 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
English: Orfiril CR 1000 mg modified-release granules
Slovenian: Orfiril CR 1000 mg zrnca s prirejenim sproščanjem
English: Box 65 FIN-02101 ESPOO Finland
Slovenian: Orion Corporation Postfach P.O. Box 65 FIN-02101 ESPOO Finska
English: 50 MG/ SACHET modified-release granules
Slovenian: 50 MG/ SACHET zrnca s prirejenim sproščanjem
English: Depakine Chronosphere 100 mg - Retardgranulat in Beuteln prolonged-release granules
Slovenian: Depakine Chronosphere 100 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
English: D-22335 Hamburg Germany
Slovenian: D-22335 Hamburg Nemčija
English: 200 mg/5 ml syrup
Slovenian: 200 mg/5 ml sirup
English: 100 mg/dose prolonged-release granules
Slovenian: 100 mg/dose zrnca s podaljšanim sproščanjem
English: Ergenyl Chronosphere 100 mg Retardgranulat prolonged-release granules
Slovenian: Ergenyl Chronosphere 100 mg Retardgranulat zrnca s podaljšanim sproščanjem
English: 500 mg/dose prolonged-release granules
Slovenian: 500 mg/dose zrnca s podaljšanim sproščanjem
English: Convulex 500 mgKapseln gastro-resistant capsule, soft
Slovenian: Convulex 500 mgKapseln gastrorezistentna kapsula, mehka
English: coated tablet
Slovenian: obložena tableta
English: Convulex 150 mgKapseln gastro-resistant capsule, soft
Slovenian: Convulex 150 mgKapseln gastrorezistentna kapsula, mehka
English: 333 mg + 145 mg prolonged-release tablet Oral Use
Slovenian: 333 mg + 145 mg tableta s podaljšanim sproščanjem
English: Orfiril long 300 mg prolonged-release capsule, hard
Slovenian: Orfiril long 300 mg kapsula s podaljšanim sproščanjem, trda
English: Orfiril long 300 mg prolonged-release capsule
Slovenian: Orfiril long 300 mg kapsula s podaljšanim sproščanjem
English: Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Slovenian: Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
English: CONVULEX 300 MG 300mg gastro-resistant capsule, soft
Slovenian: CONVULEX 300 MG 300mg gastrorezistentna kapsula, mehka
English: Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln prolonged-release granules
Slovenian: Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
English: Orfiril long 150 mg prolonged-release capsule, hard
Slovenian: Orfiril long 150 mg kapsula s podaljšanim sproščanjem, trda
English: Depakine Chronosphere 50200 mg/DosisRetardgranulat prolonged-release granules
Slovenian: Depakine Chronosphere 50200 mg/DosisRetardgranulat zrnca s podaljšanim sproščanjem
English: 50mg/ml syrup
Slovenian: 50mg/ml sirup
English: Orfiril long 150 mg prolonged-release capsule
Slovenian: Orfiril long 150 mg kapsula s podaljšanim sproščanjem
English: Ergenyl Chronosphere 250 mg Retardgranulat prolonged-release granules
Slovenian: Ergenyl Chronosphere 250 mg Retardgranulat zrnca s podaljšanim sproščanjem
English: 50 mg/ml syrup
Slovenian: 50 mg/ml sirup
English: Depakine Chronosphere 250 mg - Retardgranulat in Beuteln prolonged-release granules
Slovenian: Depakine Chronosphere 250 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
English: Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Slovenian: Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
English: CONVULEX 150 mg gastro-resistant capsule, soft
Slovenian: CONVULEX 150 mg gastrorezistentna kapsula, mehka
English: Ergenyl Chronosphere 50 mg Retardgranulat prolonged-release granules
Slovenian: Ergenyl Chronosphere 50 mg Retardgranulat zrnca s podaljšanim sproščanjem
English: Depakine Chronosphere 50 mg - Retardgranulat in Beuteln prolonged-release granules
Slovenian: Depakine Chronosphere 50 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
English: CONVULEX 300 MG/ML 300mg/ml oral drops, solution
Slovenian: CONVULEX 300 MG/ML 300mg/ml peroralne kapljice, raztopina
English: CONVULEX 500 mg gastro-resistant capsule, soft
Slovenian: CONVULEX 500 mg gastrorezistentna kapsula, mehka
English: Ergenyl Chronosphere 500 mg Retardgranulat prolonged-release granules
Slovenian: Ergenyl Chronosphere 500 mg Retardgranulat zrnca s podaljšanim sproščanjem
English: Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Slovenian: Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
English: Depakine Chronosphere 500 mg - Retardgranulat in Beuteln prolonged-release granules
Slovenian: Depakine Chronosphere 500 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
English: CONVULEX 300 mg gastro-resistant capsule, soft
Slovenian: CONVULEX 300 mg gastrorezistentna kapsula, mehka
English: 200 mg/ml oral drops
Slovenian: 200 mg/ml peroralne kapljice
English: Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Slovenian: Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
English: 200 mg/ml oral drops, solution
Slovenian: 200 mg/ml peroralne kapljice, raztopina
English: Depakine Chronosphere modified-release granules
Slovenian: Depakine Chronosphere zrnca s prirejenim sproščanjem
English: Depakine Retard modified-release tablet Oral Use
Slovenian: Depakine Retard tableta s prirejenim sproščanjem
English: modified-release granules
Slovenian: zrnca s prirejenim sproščanjem
English: Depakine Chronosphere 50350 mg/DosisRetardgranulat prolonged-release granules
Slovenian: Depakine Chronosphere 50350 mg/DosisRetardgranulat zrnca s podaljšanim sproščanjem
English: Valproat-neuraxpharm 300 mg oral solution neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Slovenian: Valproat-neuraxpharm 300 mg peroralna raztopina neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, v državah članicah
English: Overall population (ITT)
Slovenian: Celotna populacija (ITT)
English: Currently available data are described in sections 5.1 and 5.2.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2
English: 3.5 hours
Slovenian: 3,5 ur
English: An updated RMP should be submitted:
Slovenian: Posodobljen RMP je treba predložiti :
English: • if you are a child (less than 18 years of age), this medicine is not appropriate for you.
Slovenian: • če ste otrok (mlajši od 18 let), ker to zdravilo ni primerno za vas.
English: Date of first authorisation: 20.09.2004 Date of latest renewal: 23.06.2014
Slovenian: Datum prve odobritve: 20.09.2004 Datum zadnjega podaljšanja: 23.06.2014
English: The majority of these cases were non-fatal.
Slovenian: V večini teh primerov ni prišlo do smrtnega izida.
English: • before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction.
Slovenian: • pred začetkom injiciranja ali infuzije vam bo zdravnik razložil znake alergijske reakcije.
English: All the undesirable effects, primary and secondary, resulting from excessive pharmacological activity were reversible.
Slovenian: Vsi neželeni učinki, primarni in sekundarni, ki so bili posledica pretirane farmakološke aktivnosti, so bili reverzibilni.
English: However, the maximal ACT values for all groups (adults and all paediatric groups) converge at a similar level near an ACT of 400 seconds.
Slovenian: Vendar pa se največje vrednosti ACT za vse skupine (odrasli in vse pediatrične skupine) približujejo na podobni ravni v bližini ACT 400 sekund.
English: In the case of shock, the current medical standards for shock treatment should be applied.
Slovenian: V primeru šoka uporabite trenutno veljavne medicinske standarde za zdravljenje šoka.
English: This leaflet was last revised in:
Slovenian: Navodilo je bilo nazadnje revidirano:
English: • if you are taking, or have recently taken or might take any other medicines.
Slovenian: • če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo
English: Your doctor will decide whether or not this treatment is appropriate for you.
Slovenian: Vaš zdravnik bo odločil, ali je ta način zdravljenja za vas primeren.
English: *Superiority p-value.
Slovenian: *p-vrednosti za superiornost.
English: About 20% of bivalirudin is excreted unchanged in the urine.
Slovenian: Približno 20 % bivalirudina se nespremenjenega izloči z urinom.
English: No dose adjustment is needed.
Slovenian: Prilagoditev odmerkov ni potrebna.
English: 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.
Slovenian: MAH se mora o kartici za odmerjanje skupaj z načrtom komunikacije dogovoriti s pristojnim nacionalnim organom vsake države članice pred distribucijo zdravila v državi članici.
English: The doctor will decide for how long you should be treated.
Slovenian: Zdravnik bo odločil, kako dolgo se morate zdraviti.
English: Comparison of the single and repeated dose studies revealed that toxicity was related primarily to duration of exposure.
Slovenian: Primerjave med študijami z enim in ponavljajočimi odmerki kažejo, da je bila toksičnost povezana predvsem s trajanjem izpostavljenosti.
English: Approximately 66% of patients were pre-treated with unfractionated heparin.
Slovenian: Približno 66 % bolnikov je bilo predhodno zdravljenih z nefrakcioniranim heparinom.
English: Clearance (ml/min/kg)
Slovenian: Očistek (ml/min/kg)
English: 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.
Slovenian: Trenutno ni indikacij za uporabo zdravila Angiox pri otrocih, mlajših od 18 let, priporočil o odmerjanju pa ni mogoče dati.
English: If you cannot get access to your doctor go immediately to the Emergency Department of your nearest hospital
Slovenian: Če do zdravnika ne morete doseči, takoj obiščite urgentni oddelek najbližje bolnišnice
English: The concentration-time profile following intravenous administration is well described by a twocompartment model.
Slovenian: Profil koncentracija-čas po intravenskem dajanju je dobro opisan z dvokomponentnim modelom.
English: Mortality among these patients was nil.
Slovenian: Smrtnosti med temi bolniki ni bilo.
English: The doctor will decide how much Angiox you receive, and will prepare the medicine.
Slovenian: Zdravnik bo odločil, koliko zdravila Angiox boste dobili, in bo zdravilo tudi pripravil.
English: • Brief information on preparation and administration instructions.
Slovenian: • Kratke informacije o pripravi in dajanju zdravila.
English: The results do not suggest pharmacodynamic interactions with these medicinal products.
Slovenian: Rezultati ne nakazujejo farmakodinamičnih interakcij s temi zdravili.
English: Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "EXP".
English: 30 day Composite MACE
Slovenian: 30 dnevna kompozita MACE
English: There is no known antidote to bivalirudin but its effect wears off quickly (T½ is 25 ± 12 minutes).
Slovenian: Antidota za bivalirudin ne poznamo, vendar njegovi učinki hitro popustijo (T½ je 25 ± 12 minut).
English: 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).
Slovenian: Podatki za ACT glede na koncentracijo kažejo trend nižje krivulje odziva na koncentracijo za odrasle v primerjavi s starejšimi otroki (6 let do < 16 let) in mlajšimi otroki (2 leti do < 6 let), in za starejše otroke v primerjavi z dojenčki (31 dni do < 24 mesecev) in novorojenčke (od rojstva do 30 dni).
English: The use of the Angiox dosing card is recommended as a quick reference guide.
Slovenian: Uporaba kartice za odmerjanje zdravila Angiox je priporočena kot hiter referenčni vodnik.
English: 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.
Slovenian: Izobraževalni material se uporablja v vseh državah članicah za začetno usposabljanje in ponovno učenje v primeru poročil o odmerjanju samo bolusnega odmerka brez infuzije v nadaljevanju.
English: • 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
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: • Do not use bivalirudin without first diluting it.
Slovenian: • Bivalirudina ne uporabljajte, ne da bi ga najprej redčili.
English: Half-life (minutes)
Slovenian: Razpolovna doba (minut)
English: Angiox is only given when a patient is in hospital.
Slovenian: Zdravilo Angiox se daje le, kadar je bolnik v bolnišnici.
English: The clinical utility of ACT in neonates and children should be considered with caution considering their developmental haematological state.
Slovenian: Glede klinične uporabnosti ACT pri novorojenčkih in otrocih je potrebna previdnost zaradi njihovega razvojnega hematološkega stanja.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih niso zadostne z obzirom na učinke na nosečnost, razvoj zarodka/ploda, porod ali razvoj po rojstvu (glejte poglavje 5.3).
English: Enoxaparin was used as comparator in ACUITY only.
Slovenian: Enoksaparin je bil uporabljen kot komparator samo pri študiji ACUITY.
English: Throughout your treatment, the doctor will check you for any signs of bleeding.
Slovenian: času celotnega zdravljenja bo vaš zdravnik preverjal kakršnekoli znake krvavenja.
English: Educational material includes a slide deck presentation, dosing cards as described in the risk minimization measures in the RMP, and a copy of the SmPC.
Slovenian: Izobraževalni material vključuje predstavitev z diapozotivi, kartice za odmerjanje, kot je opisano v ukrepih za zmanjšanje tveganj v RMP, in kopijo SmPC.
English: Undesirable effects that resulted from prolonged physiological stress in response to a non-homeostatic state of coagulation were not seen after short exposure comparable to that in clinical use, even at much higher doses.
Slovenian: Neželeni učinki zaradi daljšega fiziološkega stresa, kot odziv na nehomeostatsko stanje koagulacije niso bili opaženi po krajši izpostavljenosti, primerljivi s tisto pri klinični uporabi, tudi pri precej večjih odmerkih.
English: 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.
Slovenian: Po zdravljenju z zdravilom Angiox zaradi srčnega dogodka morate ostati v bolnišnici najmanj 24 ur in morajo vas nadzorovati glede simptomov ali znakov podobnih tistim, ki vas spominjajo na srčni dogodek, zaradi katerega ste bili hospitalizirani.