natgillin/translations-raw huggingface dataset:
In the studied patient population of RE-MODEL and RE-NOVATE (5539 patients treated), 51% suffered from concomitant hypertension, 9% from concomitant diabetes, 9% from concomitant coronary artery disease and 20% had a history of venous insufficiency.
V populaciji bolnikov v raziskavah RE- MODEL in RE- NOVATE (5539 zdravljenih bolnikov) je 51% bolnikov imelo sočasno hipertenzijo, 9% sladkorno bolezen, 9% koronarno arterijsko bolezen in 20% vensko insufucienco v anamnezi.
Data for the major VTE and VTE-related mortality endpoint were homogeneous with regards to the primary efficacy endpoint and are shown in table 4.
Navedeni so v preglednici 4.
Data for the total VTE and all cause mortality endpoint are shown in table 5.
Podatki o opazovanem dogodku skupna pogostnost venskih trombemboličnih dogodkov in umrljivost iz vseh vzrokov so navedeni v preglednici 5.
Data for adjudicated major bleeding endpoints are shown in tables 6 below.
Podatki o opazovanem dogodku večje krvavitve so v preglednici 6.
Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopeadic surgery studies
Analiza hujše VTE in z VTE povezane umrljivosti med zdravljenjem v študijah na področju ortopedske kirurgije RE- NOVATE in RE- MODEL
Trial RE-NOVATE (hip)
Raziskava RE- NOVATE (kolk)
Dabigatran etexilate 220 mg
Dabigatran eteksilat Dabigatran eteksilat 220 mg 150 mg
Incidences (%) Risk ratio over
N Pojavnost (%) Razmerje tveganja
38 (4.3)
909 888 28 (3, 1) 38 (4, 3) 1, 09
95% CI RE-MODEL (knee)
glede na enoksaparin 95% CI RE- MODEL (koleno)
0.70, 1.70
0, 78 0, 48, 1, 27 0, 70, 1, 70
Incidences (%) Risk ratio over
N Pojavnost (%) Razmerje tveganja glede na enoksaparin
Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies
Analiza skupne pogostnosti venskih trombemboličnih dogodkov in umrljivosti iz vseh vzrokov med zdravljenjem v študijah na področju ortopedske kirurgije RE- NOVATE in RE- MODEL
Trial RE-NOVATE (hip)
Raziskava RE_ NOVATE (kolk)
Dabigatran 220 mg
Dabigatran eteksilat 220 mg
N
N Pojavnost (%) Razlike v tveganju glede ne enoksaparin (%)
880
880 53 (6, 0) - 0, 7
874
874 75 (8, 6) 1, 9
897
897 60 (6, 7)
Incidences (%) Risk ratio over enoxaparin
95% Cl Razmerje tveganja glede ne enoksaparin
53 (6.0) 0.9
(- 2, 9, 1, 6) 0, 9
75 (8.6) 1.28
(- 0, 6, 4, 4) 1, 28
95% CI RE-MODEL (knee)
95% Cl RE- MODEL (koleno)
N
N Pojavnost (%) Razlike v tveganju glede ne enoksaparin
503
503 183 (36, 4) - 1, 3
526
526 213 (40, 5) 2, 8
512
512 193 (37, 7)
Incidences (%) Risk ratio over enoxaparin
10
183 (36.4) 0.97
95% Cl Razmerje tveganja glede ne enoksaparin
213 (40.5) 1.07
(- 7, 3, 4, 6) 0, 97
193 (37.7)
(- 3, 1, 8, 7) 1, 07
95% CI
95% Cl
Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies
Večji dogodki s krvavitvijo pri zdravljenju v študijah RE- MODEL in RE- NOVATE
Dabigatran etexilate 150 mg
Dabigatran eteksilat Dabigatran eteksilat 220 mg 150 mg
Treated patients N Number of MBE N(%) RE-MODEL (knee)
zdravljeni bolniki N število večjih dogodkov s krvavitvijo N (%) RE- MODEL (koleno)
Treated patients N Number of MBE N(%)
zdravljeni bolniki N število večjih dogodkov s krvavitvijo N (%)
The absolute bioavailability of dabigatran following oral administration of Pradaxa was approximately 6.5%.
Absolutna biološka uporabnost dabigatrana je bila po peroralni aplikaciji zdravila Pradaxa približno 6, 5%.
After oral administration of Pradaxa in healthy volunteers, the pharmacokinetic profile of dabigatran in plasma is characterized by a rapid increase in plasma concentrations with Cmax attained within 0.5 and 2.0 hours post administration.
Po peroralni aplikaciji zdravila Pradaxa pri zdravih prostovoljcih je za farmakokinetiko dabigatrana v plazmi značilno hitro povečanje njegove koncentracije v plazmi – Cmax doseže v 0, 5 in 2, 0 ure po aplikaciji.
A study evaluating post-operative absorption of dabigatran etexilate, 1-3 hours following surgery, demonstrated relatively slow absorption compared with that in healthy volunteers, showing a smooth plasma concentration-time profile without high peak plasma concentrations.
Študija, v kateri so ocenjevali pooperativno absorpcijo dabigatran eteksilata, je 1 do 3 ure po operaciji pokazalo razmeroma počasno absorpcijo v primerjavi s podatki za zdrave prostovoljce; profil koncentracije v plazmi v odvisnosti od časa pa je bil enakomeren in brez vrhov koncentracij v plazmi.
Peak plasma concentrations are reached at 6 hours following administration in a postoperative period due to contributing factors such as anesthesia, gastrointestinal paresis, and surgical effects independent of the oral medicinal product formulation.
Koncentracije v plazmi so največje 6 ur po aplikaciji v pooperativnem obdobju, kar je posledica pridruženih dejavnikov, kot so anestezija, pareza prebavil in kirurški učinki in ni povezano s peroralno obliko zdravila.
Low (34-35%) concentration independent binding of dabigatran to human plasma proteins was observed.
Opazili so, da je pri človeku vezava dabigatrana na beljakovine v plazmi majhna (34 do 35%) in neodvisna od koncentracije.
The volume of distribution of dabigtran of 60 – 70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran.
Volumen porazdelitve dabigatrana, ki je 60 do 70 l, je bil večji od volumna skupne vode v telesu, kar kaže na zmerno porazdelitev dabigatrana v tkivih.
Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 12 - 14 hours in healthy volunteers and 14 – 17 hours in patients undergoing major orthopaedic surgery.
Plazemska koncentracija dabigatrana se manjša dvoeksponentno s srednjo končno razpolovno dobo 12 do 14 ur pri zdravih prostovoljcih in 14 do 17 ur pri bolnikih po večji ortopedski operaciji.
Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.
Presnavljanje in izločanje dabigatrana so raziskovali po enkratnem intravenskem odmerku
After an intravenous dose, the dabigatran-derived radioactivity was eliminated primarily in the urine (85%).
Po intravenskem odmerku se je radioaktivno označen dabigatran pretežno izločal s sečem (85%).
Faecal excretion accounted for 6% of the administered dose.
Z blatom se je izločilo 6% odmerka.
Recovery of the total radioactivity ranged from 88 - 94% of the administered dose by 168 hours post dose.
Skupno se je 88 do 94% radioaktivnega odmerka izločilo v 168 urah po odmerku.
Four positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide exist, each accounts for less than 10% of total dabigatran in plasma.
1- O -, 2- O -, 3- O - in 4- O- acilglukuronid, od katerih je delež vsakega manjši od 10% skupnega dabigatrana v plazmi.
Dabigatran is eliminated primarily in the unchanged form in the urine, at a rate of approximately 100 ml/ min corresponding to the glomerular filtration rate.
Dabigatran se pretežno izloča v nespremenjeni obliki s sečem, in sicer s hitrostjo približno 100 ml/ min, kar ustreza hitrosti glomerulne filtracije.
The exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7 fold higher in volunteers with moderate renal insufficiency (CrCL between 30 – 50 ml/ min) than in those without renal insufficiency.
Ledvična insuficienca Izpostavljenost (AUC) dabigatranu je po peroralni aplikaciji zdravila Pradaxa pri prostovoljcih z zmerno ledvično insuficienco (CrCl 30 do 50 ml/ min) približno 2 krat večja kot pri osebah brez ledvične insuficience.
In a small number of volunteers with severe renal insufficiency (CrCL 10 - 30 ml/ min), the exposure (AUC) to dabigatran was approximately 6 times higher and the half-life approximately 2 times longer than that observed in a population without renal insufficiency (see sections 4.2, 4.3 and 4.4).
Pri majhnem številu prostovoljcev s hudo ledvično insuficienco (CrCl 10 do 30 ml/ min) je bila izpostavljenost (AUC) dabigatranu približno 6- krat večja in njegova razpolovna doba približno 2- krat daljša kot v populaciji brez ledvične insuficience (glejte poglavja 4. 2, 4. 3 in 4. 4).
Specific pharmacokinetic studies with elderly subjects showed an increase of 40 to 60% in the AUC and of more than 25% in Cmax compared to young subjects.
Starejši bolniki Specifične farmakokinetične študije pri starejših osebah so pokazale 40 - do 60- odstotno povečanje AUC in več kot 25- odstotno povečanje Cmax v primerjavi z mladimi osebami.
Population-based pharmacokinetic studies have evaluated the pharmacokinetics of dabigatran after repeated doses in patients (up to 88 years).
V populacijskih farmakokinetičnih študijah so ocenjevali farmakokinetiko dabigatrana po ponovljenih odmerkih pri bolnikih (do 88 let).
The observed increase of dabigatran exposure correlated with the age-related reduction in creatinine clearance (see sections 4.2 and 4.4).
Povečanje izpostavljenosti dabigatranu je bilo sorazmerno s starostno zmanjšanim kreatininskim očistkom (glejte poglavje 4. 2 in 4. 4).
No change in dabigatran exposure was seen in 12 subjects with moderate hepatic insufficiency (Child Pugh B) compared to 12 controls (see sections 4.2 and 4.4).
Jetrna insuficienca Pri 12 osebah z zmerno jetrno insuficienco (Child- Pugh B) niso zasledili spremembe pri izpostavljenosti dabigatranu v primerjavi z 12 kontrolnimi osebami (glejte poglavji 4. 2 in 4. 4).
Population pharmacokinetic studies have evaluated the pharmacokinetics of dabigatran in patients of 48 to 120 kg body weight.
Telesna masa V populacijskih farmakokinetičnih študijah so farmakokinetiko dabigatrana ocenjevali pri bolnikih s telesno maso 48 do 120 kg.
Body weight had a minor effect on the plasma clearance of dabigatran resulting in higher exposure in patients with low body weight (see section 4.2 and 4.4).
Telesna masa je nekoliko vplivala na plazemski očistek dabigatrana, zaradi česar je bila izpostavljenost večja pri bolnikih z manjšo telesno maso (glejte poglavje 4. 2 in 4. 4).
Active substance exposure in female patients is about 40% to 50% higher than in male patients and no dose adjustment is recommended.
Spol Izpostavljenost zdravilni učinkovini je pri bolnicah približno 40 do 50% večja kot pri bolnikih, prilagajanja odmerka pa ne priporočajo.
The pharmacokinetics of dabigatran was investigated in Caucasian and Japanese volunteers after single and multiple doses.
Etnični izvor Farmakokinetika dabigatrana so raziskovali pri prostovoljcih belcih in Japoncih, in sicer po enkratnem odmerku in po večkratnih odmerkih.
Ethnic origin does not affect the pharmacokinetics of dabigatran in a clinically relevant manner.
Etnična pripadnost ne vpliva klinično pomembno na farmakokinetiko dabigatrana.
No pharmacokinetic data in black patients are available.
Farmakokinetični podatki za temnopolte bolnike niso na voljo.
In vitro interaction studies did not show any inhibition or induction of the principal isoenzymes of cytochrome P450.
Farmakokinetične interakcije Raziskave interakcij in vitro niso pokazale zaviranja ali indukcije glavnih izoencimov citokroma P450.
This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P- glycoprotein transporter interaction) and diclofenac (CYP2C9).
To so potrdile študije in vivo pri zdravih prostovoljcih, pri katerih ni bilo nikakršnih interakcij zdravila z naslednjimi zdravilnimi učinkovinami: atorvastatinom (CYP3A4), digoksinom (interakcija s prenosnim P- glikoprotein) in diklofenakom (CYP2C9).
Dabigatran exposure in healthy subjects was increased by 60% in the presence of amiodarone.
Izpostavljenost dabigatranu se je pri zdravih prostovoljcih v prisotnosti amiodarona povečala za 60%.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih 12 odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
An effect on female fertility was observed in the form of a decrease in implantations and an increase in pre- implantation loss at 70 mg/ kg (5-fold the plasma exposure level in patients).
Učinek na žensko plodnost se je pokazal v obliki manjšega števila implantacij in večje predimplantacijske izgube po odmerku 70 mg/ kg (5- krat več, kot je pri bolnikih izpostavljenost zdravilu v plazmi).
At doses that were toxic to the mothers (5 to 10-fold the plasma exposure level in patients), a decrease in foetal body weight and viability along with an increase in foetal variations were observed in rats and rabbits.
Pri odmerkih, ki so bili toksični za samice (5 - do 10- krat več, kot je pri bolnikih izpostavljenost zdravilu v plazmi), so pri podganah in kuncih zasledili manjšo telesno maso zarodkov in manjšo viabilnost ter pogostejše spremembe plodov.
In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
Raziskava o obdobju pred porodom in po njem je odkrila povečano umrljivost plodov po odmerkih, ki so bili toksični za samice (odmerkih, pri katerih je izpostavljenost zdravilu v plazmi 4- krat večja kot pri bolnikih).
Carcinogenicity studies have not yet been completed with dabigatran.
Raziskave o kancerogenosti dabigatrana še niso zaključene.
Capsule fill • Tartaric acid • Acacia • Hypromellose • Dimeticone 350 • Talc • Hydroxypropylcellulose
Vsebina kapsule • vinska kislina • akacija • hipromeloza • dimetikon 350 • smukec • hidroksipropilceluloza
Capsule shell • Carrageenan • Potassium Chloride • Titanium Dioxide • Indigo Carmine (E132) • Sunset Yellow (E110) • Hypromellose • Water purified
Kapsula • karagen • kalijev klorid • titanov dioksid • indigotin (E132) • oranžno FCF (E172) • hipromeloza • prečiščena voda
13 Black printing ink • Shellac • N-Butyl alcohol • Isopropyl alcohol • Industrial methylated spirit • Iron oxide black (E172) • Purified water • Propylene glycol
Črno tiskarsko črnilo • šelak • N- butil alkohol • izopropil alkohol • industrijski metilalkohol • črni železov oksid (E172) • prečiščena voda • propilenglikol
Blister and bottle:
Pretisni omot in plastenka:
Once the bottle is opened, the product must be used within 30 days
Po odprtju plastenke morate zdravilo porabiti v 30 dneh.
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje 13 Pretisni omot
Bottle:
Plastenka
Cartons containing 1, 3, or 6 blister strips (10 x 1, 30 x 1, 60 x 1) in perforated aluminium unit dose blisters.
Škatle po 1, 3 ali 6 pretisnih trakov (10 x 1, 30 x 1, 60 x 1) v perforiranih pretisnih omotih za enkratni odmerek iz aluminija.
The blister consists of an aluminium lidding foil coated with polyvinylchloride-polyvinylacetate copolymer- acrylate (PVCAC acrylate) in contact with the product and an aluminium bottom foil with polyvinylchloride (PVC) in contact with the product.
Pretisni omot je iz aluminijaste prekrivne folije, obložene s polivinilklorid polivinilacetat kopolimer akrilatom (PVCAC akrilat), ki je v stiku z zdravilom in aluminijaste folije s polivinilkloridom (PVC) na spodnji strani, ki je v stiku z zdravilom.
Polypropylene bottle with a screw cap containing 60 hard capsules.
Plastenka iz propilena z navojno zaporko s 60 trdimi kapsulami
• The hard capsules should be taken out of the blister card by peeling off the backing foil. • The hard capsules should not be pushed through the blister foil. • The blister foil should only be peeled off, when a hard capsule is required.
• Trde kapsule vzemite iz pretisnega omota tako, da odlepite spodnjo folijo. • Trdih kapsul ne smete potiskati skozi folijo na pretisnem omotu. • Folijo na pretisniem omotu odlepite šele, ko boste potrebovali trdo kapsulo.
When taking a hard capsule out of the bottle, please observe the following instructions:
Ko boste jemali trde kapsule iz stekleničke, upoštevajte naslednja navodila:
• The cap opens by pushing and turning.
Zaporko odprete tako, da jo potisnete navzdol in zavrtite.
18 March 2008
18 marec 2008
Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate) Excipients:
Ena trda kapsula vsebuje 110 mg dabigatran eteksilata (v obliki mesilata).
Each hard capsule contains 3 micrograms sunset yellow (E110)
Pomožne snovi: ena trda kapsula vsebuje 3 mikrograma barvila oranžno FCF (E110)
Imprinted capsules with light blue, opaque cap and cream-coloured, opaque body of size 1 filled with yellowish pellets.
Potiskane kapsule s svetlo modrim, neprozornim pokrovčkom in telesom kremne barve, velikosti 1, napolnjene z rumenkastimi peletami.
The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “ R110”.
Na pokrovčku kapsule je vtisnjen znak podjetja Boehringer Ingelheim, na njenem telesu pa oznaka » R110 «.
16 In patients with moderate renal impairment (creatinine clearance 30-50 ml/ min), there is limited clinical experience.
Z uporabo pri bolnikih z zmerno ledvično okvaro (kreatininski očistek 30- 50 ml/ min) je malo kliničnih izkušenj.
After knee replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
16 Po operativni vstavitvi umetnega kolena je treba zdravljenje začeti peroralno z eno kapsulo 1 do 4 ure po koncu operacije in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 10 dni.
17 Switching from parenteral anticoagulants treatment to Pradaxa:
Zamenjava parenteralnega antikoagulanta z zdravilom Pradaxa
No data are available, therefore it is not recommended to start the administration of Pradaxa before the next scheduled dose of the parenteral anticoagulant would have been due (see section 4.5).
17 O taki zamenjavi ni podatkov, zato ne priporočamo začetka dajanja zdravila Pradaxa pred naslednjim običajnim odmerkom parenteralnega antikoagulanta (glejte poglavje 4. 5).
Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout the treatment period, especially in the following situations that may increase the hemorrhagic risk: diseases associated with an increased risk of bleeding, such as congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease, recent biopsy or major trauma, recent intracranial haemorrhage or brain, spinal or ophthalmic surgery, bacterial endocarditis.
Natančen klinični nadzor (da bi odkrili znake krvavitve ali anemije) priporočamo ves čas zdravljenja, zlasti pa v naslednjih okoliščinah, ki lahko povečajo tveganje krvavitve: pri boleznih, ki so povezane s povečanim tveganjem za krvavitve, na primer prirojene ali pridobljene motnje strjevanja krvi, trombocitopenija ali okvara delovanja trombocitov, aktivna razjeda v prebavilih, nedavna biopsija ali večja poškodba, nedavna krvavitev v možganih ali operacija na možganih, hrbtenici ali na očeh ter bakterijski endokarditis.
In these situations, Pradaxa should be used with caution and a close clinical surveillance (looking for signs of bleeding or anemia) is required throughout the treatment period (see section 4.2).
V takih primerih moramo zdravilo Pradax dajati previdno in bolnike skrbno klinično nadzorovati (pozorni motamo biti na klinične znake krvavitve ali anemije) skozi vse obdobje zdravljenja (glejte poglavje 4. 2).
18 Spinal anaesthesia/ epidural anaesthesia/ lumbar puncture:
Spinalna anestezija/ epiduralna anestezija/ lumbalna punkcija
Therefore the use of Pradaxa is not recommended in patients undergoing anaesthesia with post-operative indwelling epidural catheters.
18 Uporabe zdravila Pradaxa zato ne priporočamo pri bolnikih, ki prejmejo anestezijo s pooperativnimi stalnimi epiduralnimi katetri.
The dabigatran AUC and Cmax were increased by about 60% and 50%, respectively.
AUC dabigatrana se je povečala za približno 60%, Cmax pa za približno 50%.
19 Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.2).
Bolnikom, ki so hkrati prejemali dabigatran eteksilat in amiodaron, je treba odmerek zdravila Pradaxa zmanjšati na 150 mg na dan (glejte poglavje 4. 2).
P- glycoprotein inducers:
19 Induktorji P- glikoproteina:
20 The table 1 shows the number (%) of patients experiencing bleeding events during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
V preglednici 1 je navedeno število (%) bolnikov, ki so imeli v dveh ključnih kliničnih raziskavah preprečevanja VTE med zdravljenjem dogodke s krvavitvijo.
Treated Major Bleeding Any bleeding
20 Večja krvavitev
Renal and urinary disorders Common
21 Bolezni sečil pogosto
Post procedural discharge
anemija po operaciji hematom po postopku krvavitev po postopku izcedek po postopku
Post procedural drainage Wound drainage
Kirurški in drugi medicinski posegi občasno drenaža po postopku drenaža rane
22 4.9 Overdose
4. 9 Preveliko odmerjanje
Pharmacotherapeutic group: direct thrombine inhibitors, ATC code:
22 Farmakoterapevtska skupina: direktni zaviralci trombina, oznaka ATC:
23 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.
Sekundarni opazovani dogodek, ki velja za klinično pomembnejšega, je bil sestavljeni opazovani dogodek, in sicer venski trombembolični dogodek (tudi pljučna embolija in proksimalna globoka venska tromboza, simptomatska ali nesimptomatska, odkrita med rutinsko venografijo) in umrljivost povezana z venskim trombemboličnim dogodkom.
The point estimate for incidence of Major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 4).
Točkovna ocena pogostnosti večjih trombemboličnih dogodkov in umrljivosti v povezavi s trombemboličnm dogodkom je bila za odmerek 150 mg nekoliko slabša kot pri enoksaparinu (preglednica 4).
There were no differences in the phase 3 clinical studies for efficacy and safety data between men and women.
23 V kliničnih raziskavah 3. faze se podatki o učinkovitosti in varnosti pri moških in ženskah niso razlikovali.
Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopeadic surgery studies
Analiza hujše VTE in z VTE povezane umrljivosti med zdravljenjem v študijah na področju ortopedske kirurgije RE- MODEL in RE- NOVATE
N Incidences (%) Risk ratio over
N Pojavnost (%) Razmerje tveganja
888 38 (4.3)
909 888 28 (3, 1) 38 (4, 3) 1, 09
N Incidences (%) Risk ratio over
N Pojavnost (%) Razmerje tveganja glede na enoksaparin
24 Table 5:
Preglednica 5.
Incidences (%) Risk ratio over enoxaparin
24
25 Distribution:
Porazdelitev:
The exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7 fold higher in volunteers with moderate renal insufficiency (CrCL between 30 – 50 ml/ min) than in those without renal insufficiency.
Ledvična insuficienca Izpostavljenost (AUC) dabigatranu je po peroralni aplikaciji zdravila Pradaxa pri prostovoljcih z zmerno ledvično insuficienco (CrCl 30 do 50 ml/ min) približno 2, 7- krat večja kot pri osebah brez ledvične insuficience.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih 26 odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
27 Black printing ink • Shellac • N-Butyl alcohol • Isopropyl alcohol • Industrial methylated spirit • Iron oxide black (E172) • Purified water • Propylene glycol
Črno tiskarsko črnilo • šelak • N- butil alkohol • izopropil alkohol • industrijski metilalkohol • črni železov oksid (E172) • prečiščena voda • propilenglikol
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje 27 Pretisni omot