FrancophonIA/ELRC3.0 huggingface dataset:
English: The administration of a proton-pump inhibitor (PPI) can be considered to prevent GI bleeding.
Slovenian: Za preprečevanje krvavitev iz prebavil je smotrno presoditi o uporabi zaviralca protonske črpalke.
English: Table 3: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Slovenian: Preglednica 3: Najnižje mejne vrednosti koagulacijskih testov, ki lahko kažejo na zvečano tveganje za krvavitev
English: Table 4: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Slovenian: Preglednica 4: Najnižje mejne vrednosti koagulacijskih testov, ki lahko kažejo na zvečano tveganje za krvavitev
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 150 mg hard capsules dabigatran etexilate
Slovenian: IME ZDRAVILA PRADAXA 150 mg trde kapsule dabigatran eteksilat
English: Table 6: Discontinuation rules before invasive or surgical procedures
Slovenian: Preglednica 6: Postopek ukinjanja zdravila pred invazivnimi ali kirurškimi posegi
English: Primary Prevention of Venous Thromboembolism in Orthopaedic Surgery Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25th-75th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25th-75th percentile range).
Slovenian: Primarno preprečevanje venske trombembolije pri ortopedski operaciji Geometrična sredina največje koncentracije dabigatrana v plazmi v ravnotežnem stanju (po 3. dnevu), izmerjene 2 uri po dajanju 220 mg dabigatran eteksilata, je bila 70,8 ng/ml, njen razpon pa je bil 35,2 do 162 ng/ml (25. do 75. percentil).
English: FOLDING BOX AND LABEL FOR BOTTLE for 75 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/ZUNANJA IN NALEPKA ZA PLASTENKO po 75 mg
English: • One individual blister should be teared off from the blister card along the perforated line.
Slovenian: • Po perforaciji odtrgajte eno enoto s pretisnega omota.
English: FOLDING BOX AND LABEL FOR BOTTLE for 150 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT po 150 mg
English: th th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25
Slovenian: Geometrična sredina najmanjše koncentracije dabigatrana, izmerjene ob koncu odmernega intervala (tj. 24 ur po odmerku 220 mg dabigatrana), je bila povprečno 22,0 ng/ml, njen razpon pa je bil 13,0 do 35,7 ng/ml (od 25. do 75. percentile) (glejte poglavje 4.4).
English: Table 16: Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.
Slovenian: Preglednica 16.: Analiza prvega pojava ishemične ali hemoragične možganske kapi v študiji RELY
English: VTE-related deaths 95 % confidence interval
Slovenian: Nepričakovane smrti 95-odstotni interval zaupanja
English: Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily.
Slovenian: Enkratni peroralni odmerek ketokonazola po 400 mg je za 2,38-krat povečal skupni dabigatranov AUC0-∞ in za 2,35-krat Cmax.
English: Prevention of blood clot formation after knee or hip replacement surgery
Slovenian: Preprečevanje nastanja krvnih strdkov po operativni vstavitvi umetnega kolena ali kolka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 110 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT po 110 mg
English: th percentile of dabigatran trough levels or a coagulation assay such as aPTT measured at trough (for aPTT thresholds see section 4.4, table 3) is considered to be associated with an increased risk of bleeding.
Slovenian: Pri tem sicer velja, da je preseganje 90. percentila najnižjih ravni dabigatrana ali vrednosti preskusa koagulacije, kot je aPTČ, takrat ko so najnižje (za mejne vrednosti aPTČ glejte poglavje 4.4, preglednica 3), povezano s povečanim tveganjem krvavitve.
English: Table 21: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-MEDY study
Slovenian: Preglednica 21: Analiza primarnih in sekundarnih učinkovitostnih opazovanih dogodkov (VTE je sestavljena iz GVT in/ali PE) za obdobje do konca obdobja po zdravljenju v študiji RE-MEDY
English: The duration of use of Pradaxa in the indications SPAF, DVT and PE are shown in table 2.
Slovenian: Trajanje uporabe zdravila Pradaxa pri indikacijah za SPAF, GVT in PE je navedeno v preglednici 2.
English: The International Normalised Ratio (INR) test is unreliable in patients on Pradaxa and false positive INR elevations have been reported.
Slovenian: Poročali so o lažno pozitivnem povečanju INR, zato tega preskusa ni priporočljivo izvajati.
English: Table 4: Discontinuation rules before invasive or surgical procedures
Slovenian: Preglednica 4: Postopek ukinjanja zdravila pred invazivnimi ali kirurškimi posegi
English: Dose of Pradaxa
Slovenian: Zdravilo Pradaxa
English: The Boehringer Ingelheim logo is printed on the cap and “R75” on the body of the capsule.
Slovenian: Na pokrovčku je vtisnjen logo podjetja Boehringer Ingelheim, na telesu kapsule pa oznaka »R75«.
English: th percentile of dabigatran trough levels or a coagulation assay such as aPTT measured at trough (for aPTT thresholds see section 4.4, table 4) is considered to be associated with an increased risk of bleeding.
Slovenian: Pri tem sicer velja, da je preseganje 90. percentila najnižjih ravni dabigatrana ali vrednosti preskusa koagulacije, kot je aPTČ, takrat ko so najnižje (za mejne vrednosti aPTČ glejte poglavje 4.4, preglednica 4), povezano s povečanim tveganjem krvavitve.
English: Table 21: Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.
Slovenian: Preglednica 21: Analiza prvega pojava ishemične ali hemoragične možganske kapi v študiji RELY
English: There were 5897 patients enrolled, representing 49 % of patients originally randomly assigned to receive dabigatran etexilate in RE-LY and 86 % of RELY-ABLE-eligible patients.
Slovenian: Bolniki, ki so jih vključili v 43-mesečno obdobje sledenja po končani študiji RE-LY (skupni srednji čas sledenja v študijah RE-LY in RELY-ABLE, 4,5 leta), so nadalje jemali enak, dvojno prikriti odmerek dabigatran eteksilata, za katerega so bili naključno razvrščeni v študiji RE-LY. Podaljšek je zajel 5897 (49 %) bolnikov iz študije RE-LY, ki so bili že v njej naključno razvrščeni v skupino dabigatran eteksilata, oziroma 86 % bolnikov, ki so izpolnjevali merila za vključitev v študijo RELYABLE.
English: The duration of use of Pradaxa in the indications SPAF, DVT and PE are shown in table 3.
Slovenian: Trajanje uporabe zdravila Pradaxa pri indikacijah za SPAF, GVT in PE je navedeno v preglednici 3.
English: Uncommon (may affect up to 1 in 100 people): - Bleeding - Bleeding may happen into a joint or from an injury - Bleeding may happen from piles - A fall in the number of red cells in the blood - Haematoma formation - Coughing of blood or blood stained sputum - Allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Feeling sick - Vomiting - Belly ache or stomach ache - Frequent loose or liquid bowel movements - Unusual laboratory test results on liver function - Liver enzymes increased
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - krvavitev, - krvavitev v sklep ali iz rane, - krvavitev hemoroidov, - zmanjšanje števila rdečih krvničk v krvi, - hematom, - izkašljevanje krvi ali krvav izpljunek, - alergijska reakcija, - nenadna sprememba na koži, ki spremeni njeno barvo in videz; - srbenje, - razjeda v želodcu ali črevesu, - vnetje požiralnika in želodca, - vračanje želodčnega soka v požiralnik, - slabo počutje, - bruhanje, - bolečina v trebuhu ali želodcu, - pogosto mehko ali tekoče blato, - neobičajen laboratorijski izvid preiskave jeter, - povečanje jetrnih encimov.
English: Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25
Slovenian: Geometrična sredina največje koncentracije dabigatrana v plazmi v ravnotežnem stanju (po 3. dnevu), izmerjene 2 uri po dajanju 220 mg dabigatran eteksilata, je bila 70,8 ng/ml, njen razpon pa je bil 35,2 do 162 ng/ml (25. do 75. percentil).
English: Trial
Slovenian: Študija
English: Table 12: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies
Slovenian: Večji dogodki s krvavitvijo pri zdravljenju v študijah RE-MODEL in RENOVATE
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R75”.
Slovenian: Na pokrovčku kapsule je vtisnjen znak podjetja Boehringer Ingelheim, na njenem telesu pa oznaka »R75«.
English: Table 6 summarises discontinuation rules before invasive or surgical procedures.
Slovenian: V preglednici 6 so zbrana navodila o ukinitvi zdravila pred invazivnimi ali kirurškimi posegi.
English: Nervous system disorders Intracranial haemorrhage
Slovenian: Bolezni živčevja znotrajlobanjska krvavitev redki
English: Subjects randomized Stroke
Slovenian: Sistemski embolični dogodki
English: dTT [ng/mL] ECT [x-fold upper limit of normal]
Slovenian: EKT [x-kratna zgornja meja normalne vrednosti]
English: Hypromellose Dimeticone 350
Slovenian: Vsebina kapsule vinska kislina arabski gumi hipromeloza dimetikon 350 smukec hidroksipropilceluloza
English: Table 27: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-SONATE study.
Slovenian: Preglednica 27: Analiza podatkov o primarnih in sekundarnih opazovanih dogodkov učinkovitosti (VTE je sestavljena iz GVT in/ali PE) do konca obdobja po zdravljenju v študiji RE-SONATE
English: Pradaxa is dialyzable.
Slovenian: ® se med dializo izloča.
English: Common (may affect up to 1 in 10 people): - Bleeding may happen from the nose, into the stomach or bowel, from the rectum, from penis/vagina or urinary tract (incl.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - krvavitev iz nosu, v želodec ali črevo, iz zadnjika, iz penisa oziroma vagine ali sečevoda (tudi kri v seču, ki ga obarva rožnato ali rdeče), ali pod kožo; - prebavne motnje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 180 (3 PACKS OF 60 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 110 mg HARD CAPSULES
Slovenian: ZUNANJA NALEPKA NA VEČKRATNIH PAKIRANJIH PO 180 (3 ENOTE S 60 TRDIMI KAPSULAMI), ZAVITE V PROZORNO FOLIJO - S PODATKI ZA 'BLUE BOX' - TRDE KAPSULE PO 110 mg
English: Skin and subcutaneous tissue disorder Skin haemorrhage
Slovenian: Bolezni kože in podkožja kožna krvavitev občasni alopecija neznana pogostnost
English: PC:
Slovenian: Plastenka:
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
Slovenian: Zdravljenje globoke venske tromboze (GVT) in pljučne embolije (PE) ter preprečevanje ponovitve GVT in PE pri odraslih.
English: Never skip a dose or stop the intake of Pradaxa
Slovenian: Nikoli ne izpustite odmerka oziroma ne prenehajte jemati tega zdravila, ne da bi se o tem pogovorili z zdravnikom.
English: Table 18: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies.
Slovenian: Preglednica 18.: Analiza skupne pogostnosti venskih trombemboličnih dogodkov in umrljivosti iz vseh vzrokov med zdravljenjem v študijah na področju ortopedske kirurgije RE-NOVATE in RE-MODEL
English: Rare (may affect up to 1 in 1,000 people): - Bleeding may happen into a joint, from a surgical incision, from an injury, from the site of entry of an injection or from the site of entry of a catheter into a vein - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - A decrease in the proportion of red cells in the blood - Liver enzymes increased - Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - krvavitev se lahko pojavi v sklepu, na mestu kirurškega reza, na mestu poškodbe, iz mesta vboda injekcijske igle, iz mesta vstavitve venskega katetra; - resna alergijska reakcija, ki povzroča težave z dihanjem ali omotico; - resna alergijska reakcija, ki povzroča otekanje obraza ali grla; - kožni izpuščaj s temno rdečimi, dvignjenimi, srbečimi izpuščaji, ki jih povzroča alergijska reakcija; - zmanjšanje deleža rdečih krvničk v krvi, - povečanje jetrnih encimov, - porumenelost kože ali beločnic zaradi motenj jeter ali krvi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 180 (3 PACKS OF 60 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 150 mg HARD CAPSULES
Slovenian: ZUNANJA NALEPKA NA VEČKRATNIH PAKIRANJIH PO 180 (3 ENOTE S 60 TRDIMI KAPSULAMI), ZAVITE V PROZORNO FOLIJO - S PODATKI ZA 'BLUE BOX' - TRDE KAPSULE PO 150 mg
English: Use of proton-pump inhibitors
Slovenian: Uporaba zaviralcev protonske črpalke
English: Rare (may affect up to 1 in 1,000 people): - Bleeding - Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein - Blood-stained discharge from the site of entry of a catheter into a vein - Coughing of blood or blood stained sputum - A fall in the number of platelets in the blood - A fall in the number of red cells in the blood after an operation - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel (incl.
Slovenian: Redki (pojavijo se lahko pri največ od 1.000 bolnikov): - krvavitev, - krvavitev se lahko pojavi v možganih, pri kirurškem rezu, na mestu vboda pri injiciranju ali na mestu vstavitve katetra v veno; - krvavi izloček iz mesta vstavitve katetra (cevke) v veno, - izkašljevanje krvi ali kri v izpljunku (sputumu), - zmanjšanje števila trombocitov v krvi, - zmanjšanje števila rdečih krvničk po operaciji, - resna alergijska reakcija, ki povzroča težave z dihanjem ali omotico, - resna alergijska reakcija, ki povzroča zatekanje obraza ali grla, - kožni izpuščaj s temno rdečimi, srbečimi izboklinami, ki ga povzroča alergijska reakcija; - nenadna sprememba barve in videza kože, - srbenje, - razjeda v želodcu ali črevesju (vključno z razjedo v požiralniku), - vnetje požiralnika in želodca, - vračanje želodčnega soka v požiralnik, - bolečina v trebuhu ali želodcu, - prebavne motnje, - težave s požiranjem, - izcedek iz rane, - izcedek tekočine iz operacijske rane.
English: Table 22: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-SONATE study.
Slovenian: Preglednica 22: Analiza podatkov o primarnih in sekundarnih učinkovitostnih opazovanih dogodkov (VTE je sestavljena iz GVT in/ali PE) do konca obdobja po zdravljenju v študiji RE-SONATE
English: Therefore surgical interventions may require the temporary discontinuation of Pradaxa.
Slovenian: Zato je treba jemanje zdravila Pradaxa včasih zaradi kirurških posegov začasno prekiniti.
English: RE-NOVATE (hip) Treated patients N Number of MBE N(%)
Slovenian: RE-NOVATE (kolk) zdravljeni bolniki N Število večjih dogodkov s krvavitvijo N (%)
English: When to seek medical advice
Slovenian: Poiščite nujno medicinsko pomoč.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 180 (3 PACKS OF 60 HARD-CAPSULES) - WITHOUT BLUE BOX150 mg HARD CAPSULES
Slovenian: VEČKRATNO PAKIRANJE PO 180 (3 ENOTE S 60 TRDIMI KAPSULAMI) - BREZ PODATKOV ZA 'BLUE BOX' - TRDE KAPSULE PO 150 mg
English: Table 4 summarises discontinuation rules before invasive or surgical procedures.
Slovenian: V preglednici 4 so navodila o ukinitvi zdravila pred invazivnimi ali kirurškimi posegi.
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 110 mg hard capsules dabigatran etexilate
Slovenian: IME ZDRAVILA Pradaxa 110 mg trde kapsule dabigatran eteksilat
English: FOLDING BOX AND LABEL FOR BOTTLE for 110 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/ZUNANJA IN NALEPKA ZA PLASTENKO po 110 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 100 (2 PACKS OF 50 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 150 mg HARD CAPSULES
Slovenian: ZUNANJA NALEPKA NA VEČKRATNIH PAKIRANJIH PO 100 (2 ENOTI S 50 TRDIMI KAPSULAMI), ZAVITE V PROZORNO FOLIJO - S PODATKI ZA 'BLUE BOX' - TRDE KAPSULE PO 150 mg
English: Renal and urinary disorders Genitourological haemorrhage, including haematuria
Slovenian: Bolezni sečil urogenitalna krvavitev, tudi hematurija občasni
English: The Boehringer Ingelheim logo is printed on the cap and “R150” on the body of the capsule.
Slovenian: Na pokrovčku je vtisnjen logo podjetja Boehringer Ingelheim, na telesu kapsule pa oznaka »R150«.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 100 (2 PACKS OF 50 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 110 mg HARD CAPSULES
Slovenian: ZUNANJA NALEPKA NA VEČKRATNIH PAKIRANJIH PO 100 (2 ENOTI S 50 TRDIMI KAPSULAMI), ZAVITE V PROZORNO FOLIJO - S PODATKI ZA 'BLUE BOX' - TRDE KAPSULE PO 110 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 180 (3 PACKS OF 60 HARD-CAPSULES) - WITHOUT BLUE BOX110 mg HARD CAPSULES
Slovenian: VEČKRATNO PAKIRANJE PO 180 (3 ENOTE S 60 TRDIMI KAPSULAMI) - BREZ PODATKOV ZA 'BLUE BOX' - TRDE KAPSULE PO 110 mg
English: Composite of major VTE (including PE and proximal DVT, whatever symptomatic or asymptomatic detected by routine venography) and VTE-related mortality constituted a secondary end-point and is considered of better clinical relevance.
Slovenian: Sekundarni opazovani dogodek, ki velja za klinično pomembnejšega, je bil sestavljeni opazovani dogodek, in sicer večji venski trombembolični dogodki (tudi pljučna embolija in proksimalna globoka venska tromboza, simptomatska ali nesimptomatska, odkrita med rutinsko venografijo) in umrljivost povezana z venskim trombemboličnim dogodkom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/008
English: Table 25: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the pooled studies RECOVER and RE-COVER II
Slovenian: Preglednica 25: Analiza pojavnosti primarnega in sekundarnega opazovanega dogodka (VTE je sestavljeni dogodek iz GVT in/ali PE) do konca obdobja po zdravljenju v združenih študijah RE-COVER in RE-COVER II
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”.
Slovenian: Na pokrovčku kapsule je vtisnjen znak podjetja Boehringer Ingelheim, na njenem telesu pa oznaka »R110«.
English: Table 20: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the pooled studies RECOVER and RE-COVER II
Slovenian: Preglednica 20: Analiza pojavnosti primarnega in sekundarnega opazovanega dogodka (VTE je sestavljeni dogodek iz GVT in/ali PE) do konca obdobja po zdravljenju v združenih študijah RE-COVER in RE-COVER II
English: Thereafter two capsules once a day should be taken for a total of 28-35 days.
Slovenian: Zdravljenje z zdravilom Pradaxa je treba začeti 1 do 4 ure po končani operaciji, in sicer z eno kapsulo in ga nadaljevati z dvema kapsulama 1-krat na dan 28 do 35 dni.
English: The Boehringer Ingelheim logo is printed on the cap and “R110” on the body of the capsule.
Slovenian: Na pokrovčku je vtisnjen logo podjetja Boehringer Ingelheim, na telesu kapsule pa oznaka »R110«.
English: Pradaxa 110 mg twice daily vs. warfarin
Slovenian: Zdravilo Pradaxa po 110 mg dvakrat na dan v primerjavi z varfarinom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/004
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R150”.
Slovenian: Na pokrovčku kapsule je vtisnjen znak podjetja Boehringer Ingelheim, na njenem telesu pa oznaka »R150«.
English: Table 16 shows bleeding events in pivotal study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Slovenian: V preglednici 16 so podatki o krvavitvah v ključni študiji RE-SONATE, študiji o preprečevanju globoke venske tromboze (GVT) in pljučne embolije (PE).
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa občasni hemoptiza redki
English: (maintenance dose) with 110 mg dabigatran etexilate increased the adjusted dabigatran AUCτ,ss and Cmax,ss 1.26-fold and 1.29-fold, respectively, compared with dabigatran etexilate given alone.
Slovenian: Pri sočasnem dajanju odmerka tikagrelorja po 90 mg dvakrat na dan (vzdrževalni odmerek) in odmerka dabigatran eteksilata po 110 mg sta se prilagojeni AUCτ,ss in Cmax,ss v primerjavi z dajanjem samega dabigatrana povečali za 1,26-krat in 1,29-krat.
English: The capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach.
Slovenian: Zdravilo Pradaxa lahko jemljete ob jedi ali ne. Celo kapsulo je treba pogoltniti s kozarcem vode, da se zagotovi prehod v želodec.
English: Table 14: Bleeding events in the studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) Pradaxa 150 mg twice daily
Slovenian: Preglednica 14: Dogodki krvavitev v študiji RE-SONATE, v kateri so proučevali preprečevanje globoke venske tromboze (GVT) in pljučne embolije (PE) Zdravilo Pradaxa 150 mg dvakrat na dan
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (DVT/PE treatment)
Slovenian: Zdravljenje globoke venske tromboze (GVT) in pljučne embolije (PE) ter preprečevanje ponovitev GVT in PE pri odraslih (zdravljenje GVT/PE)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 100 (2 PACKS OF 50 HARD-CAPSULES) - WITHOUT BLUE BOX150 mg HARD CAPSULES
Slovenian: VEČKRATNO PAKIRANJE PO 100 (2 ENOTI S 50 TRDIMI KAPSULAMI) - BREZ PODATKOV ZA 'BLUE BOX' - TRDE KAPSULE PO 150 mg
English: Table 15 shows bleeding events in pivotal study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Slovenian: V preglednici 15 so podatki o krvavitvah v ključni študiji RE-MEDY, študiji o preprečevanju globoke venske tromboze (GVT) in pljučne embolije (PE).
English: In the clinical studies mucosal bleedings (e.g. gastrointestinal, genitourinary) were seen more frequently during long term Pradaxa treatment compared with VKA treatment.
Slovenian: V kliničnih preskušanjih so pogosteje opazili sluznične krvavitve (npr. iz prebavil, urogenitalnega sistema) med dolgotrajnim zdravljenjem z zdravilom Pradaxa kot pri zdravljenju z antagonisti vitamina K. Zato je poleg ustreznega kliničnega nadzora koristno tudi laboratorijsko preverjanje ravni hemoglobina/hematokrita, da se zazna morebitne prikrite krvavitve.