qanastek/EMEA-V3 huggingface dataset:
LDH, increased alkaline phosphatase ALT increase, AST increase)
Żjieda fil- lipase, żjieda fl- amylase, żjieda fil- bilirubin fid- demm, żjieda fl- LDH, żjieda fl- alkaline phosphatase Takikardija
increased (with or without concomitant increase of ALT)
Żjieda fil - bilirubin konjugat (bi jew mingħajr żjieda fl- istess waqt ta ’ l- ALT)
Common Uncommon
Disturbi tad- demm u
Not known*
tas- sistema limfatika
Anaemia (incl. respective laboratory parameter)
Anemija (li tinkludi Tromboċitemija (li tinkludi żjieda fl- għadd l- parametru tal - laboratorju rispettiv)
Thrombocythaemia (incl. platelet count increased)
tal- plejtlits)
Nervous system disorders Syncope (incl. loss of consciousness), dizziness, headache Gastrointestinal disorders
Disturbi fis- sistema nervuża Sinkope (li tinkludi li tintilef minn sensik), sturdament, uġigħ ta ’ ras Disturbi gastro- intestinali Nawseja
Constipation, diarrhoea, abdominal and gastrointestinal pain (incl. upper abdominal pain, stomach discomfort), dyspepsia (incl. epigastric discomfort), dry mouth, vomiting
Stitikezza, dijarea, uġigħ addominali u gastro- intestinali (li jinkludi wġigħ fin - naħa ta 'fuq taż- żaqq, skomdu fl- istonku), dispepsja (li tinkludi skomdu epigastriku), ħalq xott, rimettar
Renal and urinary disorders Renal impairment (incl. blood creatinine increased, blood urea increased) Skin and subcutaneous tissue disorders Pruritus (incl. rare cases of generalised pruritus), rash, urticaria (incl. rare cases of generalised urticaria), contusion Musculoskeletal and connective tissue disorders Pain in extremity Injury, poisoning and procedural complications Wound secretion Vascular disorders
Disturbi fil- kliewi u fis- sistema urinarja Indeboliment renali (li jinkludi żjieda tal - krejatinina fid- demm, żjieda tal- urea fid - demm) Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Ħakk (li jinkludi każijiet rari ta ’ ħakk ġeneralizzat), raxx, urtikarja (li tinkludi każijiet rari ta ’ urtikarja ġeneralizzata), tbenġil Disturbi muskolu- skeltrali u tal- connective tissue Uġigħ fl- estremitajiet Korriment, avvelenament u komplikazzjonijiet ta 'xi proċedura Tnixxija mill- ferita Disturbi vaskulari Emorraġija wara l -
Haemorrhage (incl. haematoma and rare
Emorraġija (li tinkludi ematoma u każijiet
Bleeding into a
Fsada f’ organu
haemorrhage (incl. cases of muscle haemorrhage), post-operative gastrointestinal tract haemorrhage (incl. anaemia, and gingival bleeding, rectal haemorrhage, wound haememesis), haematuria (incl. blood haemorrhage) urine present), genital tract haemorrhage (incl. menorrhagia), hypotension (incl. blood pressure decreased, procedural hypotension), nose bleed General disorders and administration site conditions Localised oedema, peripheral oedema, feeling unwell (incl. fatigue, asthenia), fever Immune system disorders
proċedura (li tinkludi rari ta ’ emorraġija fil- muskoli), emorraġija anemija ta ’ wara l - fl- apparat gastro- intestinali (li tinkludi kirurġija, u fsada mill- ħanek, emorraġija mir- rektum, emorraġija mill - ememesi), ematurja (li tinkludi l- preżenza ferita) ta ’ demm fl- awrina), emorraġija fl- apparat ġenitali (li tinkludi mestrwazzjoni esaġerata), pressjoni baxxa (li tinkludi tnaqqis fil- pressjoni tad- demm, pressjoni baxxa minħabba l- proċedura), fsada mill - imnieħer
critical organ (e. g. brain), adrenal haemorrhage, conjunctival haemorrhage, haemoptysis
kritiku (e. ż. il - moħħ), emorraġija adrenali, emorraġija fil - konġuntiva, emoptisi
Overdose following administration of rivaroxaban may lead to haemorrhagic complications due to its pharmacodynamic properties.
Doża eċċessiva wara l- għoti ta 'rivaroxaban tista' twassal għal komplikazzjonijiet emorraġiċi minħabba l - kwalitajiet farmakodinamiċi tiegħu.
A specific antidote antagonising the pharmacodynamic effect of rivaroxaban is not available.
Mhux disponibbli antidotu speċifiku li jantagonizza l- effett farmakodinamiku ta ’ rivaroxaban.
The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered.
Jista 'jkun ikkunsidrat l- użu ta' faħam attivat biex inaqqas l- assorbiment f' każ ta 'doża eċċessiva ta' rivaroxaban.
Should bleeding occur, management of the haemorrhage may include the following steps: • delay of next rivaroxaban administration or discontinuation of treatment as appropriate.
Jekk ikun hemm fsada, l- immaniġġjar ta 'l- emorraġija jista' jinkludi l- passi li ġejjin: • l- ittardjar ta 'l- għoti ta' rivaroxaban li jmiss jew it- twaqqif tal- kura, skond kif ikun xieraq.
If life-threatening bleeding cannot be controlled by the above measures, administration of recombinant factor VIIa may be considered.
Rivaroxaban għandu half- lives terminali medji bejn 7 u 11- il siegħa (ara sezzjoni 5. 2). • kura sintomatika adattata, e. ż. għandhom ikunu kkunsidrati kompressjoni mekkanika, interventi kirurġiċi, sostituzzjoni tal- fluwidu u sapport emodinamiku, trasfużjoni ta 'prodotti jew komponenti tad- demm. • Jekk il- fsada ta ’ periklu għall- ħajja ma tkunx tista' tiġi kkontrollata bil- miżuri ta ’ fuq, jista 'jkun ikkunsidrat l- għoti ta' fattur VIIa rikombinanti.
However, there is currently no experience with the use of recombinant factor VIIa in individuals receiving rivaroxaban.
Madankollu, bħalissa m' hemm l- ebda esperjenza bl- użu ta 'fattur VIIa rikombinanti f' individwi li jkunu qed jirċievu rivaroxaban.
The recommendation is based on limited non-clinical data.
Ir- rakkomandazzjoni hija bbażati fuq tagħrif mhux kliniku limitat.
Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
Għoti mill- ġdid ta ’ fattur VIIa rikombinanti għandu jiġi kkunsidrat u ttitrat skond it- titjib tal- fsada.
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban.
Mhux mistenni li protamine sulfate u vitamina K jaffettwaw l- attività kontra l- koagulazzjoni ta 'rivaroxaban.
There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (e. g. desmopressin, aprotinin, tranexamic acid, aminocaproic acid) in individuals receiving rivaroxaban.
La hemm raġuni fundamentali xjentifika għall- benefiċċju, lanqas esperjenza bl- użu ta ’ emostatiċi sistemiċi (e. ż. desmopressin, aprotinin, tranexamic acid, aminocaproic acid) f' individwi li jkunu qed jirċievu rivaroxaban.
Due to the high plasma protein binding rivaroxaban is not expected to be dialysable.
Minħabba l- livell għoli ta 'twaħħil mal- proteini fil- plażma, rivaroxaban mhux mistenni li jitneħħa bid- dijalisi.
Other antithrombotic agents, ATC code:
Sustanzi antitrombotiċi oħra, Kodiċi ATC:
Mechanism of Action Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability.
Mekkaniżmu ta ’ l- Azzjoni Rivaroxaban huwa inibitur dirett selettiv ħafna tal- fattur Xa b' biodisponibiltà orali.
Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi.
Inibizzjoni tal- Fattur Xa jinterrompi r- rotta intrinsika u ekstrinsika tal- kaskata tal- koagulazzjoni tad- demm, u b’ hekk jinibixxi kemm il - formazzjoni ta ’ thrombin kif ukoll l- iżviluppi ta ’ trombi.
Rivaroxaban does not inhibit thrombin (activated Factor II) and no effects on platelets have been demonstrated.
Rivaroxaban ma jinibixxix thrombin (Fattur II attivat) u ma ġew dimostrati l- ebda effetti fuq il- plejtlits.
Pharmacodynamic effects Dose-dependent inhibition of Factor Xa activity was observed in humans.
Effetti farmakodinamiċi Inibizzjoni dipendenti mid- doża ta ’ l- attività tal- Fattur Xa kienet osservata fil- bnedmin.
Prothrombin time (PT) is influenced by rivaroxaban in a dose dependent way with a close correlation to plasma concentrations (r value equals 0.98) if Neoplastin is used for the assay.
Jekk Neoplastin jintuża għall- assay, il- ħin ta ’ protrombin (PT) huwa nfluwenzat minn rivaroxaban b' mod li jiddependi mid- doża, b' korrelazzjoni mill- qrib mal- konċentrazzjonijiet fil- plażma (valur r = 0. 98).
Other reagents would provide different results.
Reaġents oħrajn jagħtu riżultati differenti.
The readout for PT is to be done in seconds, because the INR (International Normalized Ratio) is only calibrated and validated for coumarins and cannot be used for any other anticoagulant.
Il- qari tar- riżultat għal PT għandha ssir fi ftit sekondi, għax l- INR (Proporzjon Normalizzat
In patients undergoing major orthopaedic surgery, the 5/ 95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i. e. at the time of maximum effect) ranged from 13 to 25 s (baseline values before surgery 12 to 15s).
F' pazjenti li jkollhom kirurġija ortopedika maġġuri, il- percentiles 5/ 95 għal PT (Neoplastin) 2 - 4 sigħat wara li tittieħed il- pillola (i. e. fil- ħin ta 'l- effett massimu) varjaw minn 13 sa 25 s (valuri fil- linja bażi qabel il- kirurġja ta ’ 12 sa 15- il sekonda).
The activated partial thomboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
Il- ħin parzjali ta ’ tromboplastin attivat (aPTT) u HepTest ukoll huma mtawwla b’ mod li jiddependi mid- doża; madankollu, dawn mhumiex irrakkomandati biex jevalwaw l- effett farmakodinamiku ta 'rivaroxaban.
Anti- Factor Xa activity is also influenced by rivaroxaban; however, no standard for calibration is available.
L- attività kontra l- fattur Xa ukoll hija nfluwenzata minn rivaroxaban; madankollu, l- ebda stàndard għall- kalibrazzjoni ma huwa disponibbli.
There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine.
M' hemmx bżonn ta 'monitoraġġ tal- parametri tal- koagulazzjoni waqt kura b' rivaroxaban f’ rutina klinika.
Clinical efficacy and safety The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i. e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
L- effikaċja u s- sigurtà klinika Il- programm kliniku b' rivaroxaban kien maħsub biex juri l- effikaċja ta 'rivaroxaban għall- prevenzjoni ta' VTE, i. e. trombożi fil- vini l- kbar (DVT) prossimali u distali u emboliżmu pulmonari (PE) f' pazjenti li jkollhom kirurġija ortopedika maġġuri fir- riġlejn.
Over 9,500 patients (7,050 in total hip replacement surgery and 2,531 in total knee replacement surgery) were studied in controlled randomised double-blind phase III clinical studies, the RECORD-programme.
Aktar minn 9, 500 pazjent (7, 050 li kellhom kirurġija ta ’ bdil totali tal- ġenbejn u 2, 531 pazjent li kellhom kirurġija ta ’ bdil totali ta 'l- irkoppa), kienu studjati fil- programm RECORD, studji kliniċi kkontrollati, randomised, double- blind, ta' fażi III.
8 Rivaroxaban 10 mg once daily (od) started no sooner than 6 hours post-operatively was compared with enoxaparin 40 mg once daily started 12 hours pre-operatively.
Rivaroxaban 10 mg darba kuljum (od) li nbeda mhux aktar kmieni minn 6 sigħat wara l- kirurġija, tqabbel ma 'enoxaparin 40 mg darba kuljum li nbeda 12- siegħa qabel l- kirurġija.
In all three phase III studies (see table 2), rivaroxaban significantly reduced the rate of total VTE (any venographically detected or symptomatic DVT, non fatal PE and death) and major VTE (proximal DVT, non fatal PE and VTE-related death), the pre-specified primary and major secondary efficacy endpoints.
Fl- istudji kollha ta 'fażi III (ara tabella 2), rivaroxaban naqqas b' mod sinifikanti ir- rata ta' VTE totali (kwalunkwe DVT osservata venografikament jew sintomatika, PE mhux fatali u mewt) u VTE maġġuri (DVT prossimali, PE mhux fatali u mewt assoċjata ma 'VTE), il- mira ta' l- effikaċja primarja speċifikata minn qabel u dik sekondarja maġġuri.
Furthermore, in all three studies the rate of symptomatic VTE (symptomatic DVT, non- fatal PE, VTE-related death) was lower in rivaroxaban treated patients compared to patients treated with enoxaparin.
Barra dan, fit- tliet studji kollha, ir- rata ta 'VTE sintomatika (DVT sintomatika, PE mhux fatali, mewt assoċjata ma' VTE) kienet aktar baxxa f' pazjenti kkurati b' rivaroxaban meta mqabbla ma 'pazjenti kkurati b' enoxaparin.
The main safety endpoint, major bleeding, showed comparable rates for patients treated with rivaroxaban 10 mg compared to enoxaparin 40 mg.
Il- mira ewlenija tas- sigurtà, fsada maġġuri, wriet rati komparabbli għal pazjenti li kienu kkurati b' rivaroxaban 10 mg meta mqabbla ma 'enoxaparin 40 mg.
RECORD 2
Tabella 2:
RECORD 3
REKORD 3
Study Population
Popolazzjon
4,541 patients undergoing total hip replacement surgery
4, 541 pazjent li kellhom
2,509 patients undergoing total hip replacement surgery
2, 509 pazjent li kellhom kirurġija
2,531 patients undergoing total replacement surgery
2, 531 pazjent li kellhom kirurġija ta ’
knee
kirurġija
Treatment dose and duration after surgery
ta 'żmien wara l - kirurġija
Rivaroxaban Enoxaparin p 10 mg od 40 mg od 35 ± 4 days 35 ± 4 days
10 mg od 35 ± 4 35 ± 4 ijiem ijiem
Rivaroxaban Enoxaparin p 10 mg od 40 mg od 35 ± 4 days 12 ± 2 days
35 ± 4 ijiem 12 ± 2 ijiem
Rivaroxaban Enoxaparin 10 mg od 40 mg od 12 ± 2 days 12 ± 2 days
12 ± 2 ijiem 12 ± 2 ijiem
Total VTE Major VTE
VTE totali
18 (1.1%) 4 (0.2%)
18 (1. 1%)
58 (3.7%) 33 (2.0%)
58 (3. 7%) < 0. 001 17 (2. 0%)
< 0.001 < 0.001
81 (9. 3%) < 0. 001 79 (9. 6%)
17 (2.0%) 6 (0.6%)
166 (18. 9%) < 0. 001
81 (9.3%) < 0.001 49 (5.1%) < 0.001
4 (0. 2%) 33 (2. 0%) < 0. 001 6 (0. 6%)
79 (9.6%) 9 (1.0%)
49 (5. 1%) < 0. 001 9 (1. 0%)
166 (18.9%) < 0.001 24 (2.6%) 0.01
24 (2. 6%)
Sympto- matic VTE
VTE sintomatika
6 (0.4%)
6 (0. 4%)
11 (0.7%)
11 (0. 7%)
3 (0.4%)
3 (0. 4%)
15 (1.7%)
15 (1. 7%)
8 (1.0%)
8 (1. 0%)
24 (2.7%)
24 (2. 7%)
Major bleedings
Fsada maġġuri
6 (0.3%)
6 (0. 3%)
2 (0.1%)
2 (0. 1%)
1 (0.1%)
1 (0. 1%)
7 (0.6%)
1 (0. 1%)
6 (0.5%)
7 (0. 6%)
The analysis of the pooled results of the phase III trials corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
L- analiżi tar- riżultati miġbura tal- provi ta 'fażi III, ikkonfermat l- informazzjoni miksuba fl- istudji individwali dwar it- tnaqqis ta' VTE totali, VTE maġġuri u VTE sintomatika, b' rivaroxaban 10 mg darba kuljum meta mqabbel ma 'enoxaparin 40 mg darba kuljum.
Absorption The absolute bioavailability of rivaroxaban is high (80% - 100%) for the 10 mg dose.
Assorbiment Il- biodisponibiltà assoluta ta 'rivaroxaban hija għolja (80% - 100%) għad- doża ta' 10 mg.
Rivaroxaban is rapidly absorbed with maximum concentrations (Cmax) appearing 2 - 4 hours after tablet intake.
Rivaroxaban huwa assorbit malajr b' konċentrazzjonijiet massimi (Cmax) osservati minn 2 - 4 sigħat wara li tittieħed il- pillola.
Intake with food does not affect rivaroxaban AUC or Cmax at the 10 mg dose.
Teħid ma ’ l- ikel ma jaffettwax l- AUC jew Cmax ta ’ rivaroxaban fid- doza ta ’ 10 mg.
Rivaroxaban 10 mg dose can be taken with or without food.
Id- doża ta 'Rivaroxaban 10 mg tista' tittieħed ma 'l- ikel jew mingħajr ikel.
Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily.
Il- farmakokinetika ta ’ Rivaroxaban hija kważi lineari sa madwar 15 mg
At higher doses rivaroxaban displays dissolution limited absorption with decreased bioavailability and decreased absorption rate with increased dose.
F’ dożi aktar għoljin rivaroxaban juri assorbiment limitat mid- dissoluzzjoni bi tnaqqis fil - bijodisonibiltà u rata ta ’ assorbiment imnaqqsa b’ żjieda fid- doża.
This is more marked in fasting state than in fed state.
Dan jidher aktar fi stat sajjem milli wara l- ikel.
Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%, apart from the day of surgery and the following day when variability in exposure is high (70%).
Il- varjabilità fil- farmakokinetika ta 'rivaroxaban hija moderata b’ varjabilità bejn l- individwi (CV%) li tvarja minn 30% sa 40%, minbarra l- ġurnata tal- kirurġija u l- ġurnata ta ’ wara meta l- varjabilità fl- esponiment hija għolja (70%).
Distribution Plasma protein binding in humans is high at approximately 92% to 95%, with serum albumin being the main binding component.
Distribuzzjoni It- twaħħil mal- proteini fil- plażma fil- bnedmin huwa għoli, ta ’ madwar 92% sa 95%, bl- albumina fis- serum li hija l- komponent ta ’ twaħħil ewlieni.
The volume of distribution is moderate with Vss being approximately 50 litres.
Il- volum ta ’ distribuzzjoni huwa moderat b’ Vss ta ’ madwar 50 litru.
Metabolism and Elimination Of the administered rivaroxaban dose, approximately 2/ 3 undergoes metabolic degradation, with half then being eliminated renally and the other half eliminated by the faecal route.
Metaboliżmu u Eliminazzjoni Mid- doża mogħtija ta ’ rivaroxaban, madwar 2/ 3 tgħaddi minn degradazzjoni metabolika, li wara nofs tiġi eliminata mill- kliewi u n- nofs l- ieħor tiġi eliminata mir- rotta tal- purgar.
The final 1/ 3 of the administered dose undergoes direct renal excretion as unchanged active substance in the urine, mainly via active renal secretion.
L- aħħar 1/ 3 tad- doża mogħtija tgħaddi minn tneħħija renali diretta bħala s- sustanza attiva mhux mibdula fl- awrina, l- aktar permezz ta ’ sekrezzjoni renali attiva.
9 Rivaroxaban is metabolised via CYP3A4, CYP2J2 and CYP-independent mechanisms.
Rivaroxaban huwa metabolizzat permezz ta 'mekkaniżmi li huma indipendenti minn CYP3A4, CYP2J2 u CYP.
Oxidative degradation of the morpholinone moiety and hydrolysis of the amide bonds are the major sites of biotransformation.
Id- degradazzjoni ossidattiva tal- morpholinone moiety u l- idrolisi tal- amide bonds huma s- siti maġġuri ta 'biotrasformazzjoni.
Based on in vitro investigations rivaroxaban is a substrate of the transporter proteins P-gp (P-glycoprotein) and Bcrp (breast cancer resistance protein).
Ibbażat fuq investigazzjonijiet in vitro, rivaroxaban huwa substrat tal- proteini trasportaturi P - gp (P- glycoprotein) u Bcrp (proteina tar- reżistenza għall- kanċer tas- sider).
Unchanged rivaroxaban is the most important compound in human plasma, with no major or active circulating metabolites being present.
Rivaroxaban mhux mibdul huwa l- aktar kompost importanti fil- plażma umana, mingħajr il- preżenza ta ’ l- ebda metaboliti maġġuri jew attivi fiċ- ċirkulazzjoni.
With a systemic clearance of about 10 l/ h, rivaroxaban can be classified as a low-clearance drug.
Bi tneħħija sistemika ta 'madwar 10 l/ siegħa, rivaroxaban jista' jiġi kklassifikat bħala mediċina li titneħħa mill- ġisem bil- mod.
After intravenous administration of a 1 mg dose the elimination half-life is about 4.5 hours.
Wara għoti fil- vini ta ’ doża ta ’ 1 mg il- half- life ta ’ l - eliminazzjoni hija madwar 4. 5 sigħat.
After oral administration of a 10 mg dose the elimination becomes absorption rate limited with mean terminal half-lives of 7 to 11 hours.
Wara għoti orali ta ’ doża ta ’ 10 mg l- eliminazzjoni ssir limitata mir- rata ta ’ assorbiment b’ half- lives terminali medji ta ’ 7 sa 11- il siegħa.
Special populations Gender/ Elderly (above 65 years) Elderly patients exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 1.5 fold higher, mainly due to reduced (apparent) total and renal clearance.
Popolazzjonijiet speċjali Sess/ Anzjani (ta 'iktar minn 65 sena) Il- pazjenti anzjani wrew konċentrazzjonijiet ogħla fil- plażma minn pazjenti iżgħar, b' valuri medji ta' l- AUC madwar 1. 5 darbiet ogħla, primarjament minħabba tneħħija totali u renali mnaqqsa (apparenti).
No dose adjustment is necessary.
L- ebda aġġustament fid- doża ma huwa meħtieġ.
There were no clinically relevant differences in pharmacokinetics and pharmacodynamics between male and female patients.
Ma kien hemm l- ebda differenzi klinikament rilevanti fil- farmakokinetika u l- farmakodinamika bejn pazjenti rġiel u pazjenti nisa.
Different weight categories Extremes in body weight (< 50 kg or > 120 kg) had only a small influence on rivaroxaban plasma concentrations (less than 25%).
Kategoriji ta 'piż differenti Estremitajiet fil- piż tal- ġisem (< 50 kg jew > 120 kg) kellhom biss influwenza żgħira fuq il- konċentrazzjonijiet ta' rivaroxaban fil- plażma (inqas minn 25%).
No dose adjustment is necessary.
L- ebda aġġustament fid- doża ma huwa meħtieġ
Inter-ethnic differences No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding rivaroxaban pharmacokinetics and pharmacodynamics.
Differenzi bejn ir- razzez Ma kienet osservata l- ebda differenza bejn ir- razzez ta ’ rilevanza klinika fost pazjenti Kawkasi, Afrikani - Amerikani, Ispaniċi, Ġappuniżi jew Ċiniżi, rigward il- farmakokinetika u l- farmakodinamika ta 'rivaroxaban.
Hepatic impairment Cirrhotic patients with mild hepatic impairment (classified as Child Pugh A) exhibited only minor changes in rivaroxaban pharmacokinetics (1.2 fold increase in rivaroxaban AUC on average), nearly comparable to their matched healthy control group.
Indeboliment epatiku Pazjenti b’ ċirrożi, b' indeboliment epatiku ħafif (ikklassifikat bħala Child Pugh A), urew biss tibdil minuri fil - farmakokinetika ta 'rivaroxaban (żjieda medja ta' 1. 2 darbiet fl- AUC ta 'rivaroxaban), kważi komparabbli mal - grupp ta ’ kontroll korrispondenti magħmul minn persuni b' saħħithom.
In cirrhotic patients with moderate hepatic impairment (classified as Child Pugh B), rivaroxaban mean AUC was significantly increased by 2.3 fold compared to healthy volunteers.
F' pazjenti b’ ċirrożi, b' indeboliment epatiku moderat (ikklassifikat bħala Child Pugh B), l- AUC medja ta 'rivaroxaban żdiedet b' mod sinifikanti bi 2. 3 darbiet meta mqabbla ma' voluntiera b' saħħithom.
Unbound AUC was increased 2.6 fold.
AUC mhux imwaħħal żdied b’ 2. 6 darbiet.
These patients also had reduced renal elimination of rivaroxaban, similar to patients with moderate renal impairment.
Dawn il- pazjenti kellhom ukoll eliminazzjoni ta ’ rivaroxaban mill- kliewi mnaqqsa, simili għall- pazjenti b’ indeboliment renali moderat.
There are no data in patients with severe hepatic impairment.
M’ hemmx tagħrif f’ pazjenti b’ indeboliment sever tal- fwied.
The inhibition of Factor Xa activity was increased by a factor of 2.6 in patients with moderate hepatic impairment as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 2.1.
L- inibizzjoni ta 'l- attività ta' Fattur Xa żdiedet b' fattur ta '2. 6 f’ pazjenti b’ indeboliment moderat tal- fwied meta mqabbla ma' voluntiera b' saħħithom; it- titwil ta ’ PT żdied b’ mod simili b' fattur ta '2. 1.
Patients with moderate hepatic impairment were more sensitive to rivaroxaban resulting in a steeper PK/ PD relationship between concentration and PT.
Pazjenti b’ indeboliment moderat tal- fwied kienu aktar sensittivi għal rivaroxaban u wasslu għal relazzjoni ta ’ PK/ PD aktar wieqfa bejn il - konċentrazzjoni u PT.
Xarelto may be used with caution in cirrhotic patients with moderate hepatic impairment (Child Pugh B) if it is not associated with coagulopathy (see sections 4.3 and 4.4).
Xarelto jista ’ jintuża b’ attenzjoni f’ pazjenti b’ ċirrożi, b’ indeboliment epatiku moderat (Child Pugh B) jekk dan ma jkunx assoċjat ma ’ koagulopatija (ara sezzjonijiet 4. 3 u 4. 4)
Renal impairment There was an increase in rivaroxaban exposure correlated to decrease in renal function, as assessed via creatinine clearance measurements.
10 Indeboliment renali Kien hemm żjieda fl- espożizzjoni ta 'rivaroxaban li kienet korrelata ma ’ tnaqqis fil- funzjoni renali, kif stmata permezz tal- kejl tat- tneħħija tal- krejatinina.
In individuals with mild (creatinine clearance 50 - 80 ml/ min), moderate (creatinine clearance 30 - 49 ml/ min) and severe (creatinine clearance 15 - 29 ml/ min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4, 1.5 and 1.6 fold respectively.
F' individwi b' indeboliment renali ħafif (tneħħija tal- krejatinina ta '50 - 80 ml/ min), moderat (tneħħija tal- krejatinina ta' 30 - 49 ml/ min) u sever (tneħħija tal- krejatinina ta '15 - 29 ml/ min), il- konċentrazzjonijiet ta' rivaroxaban fil- plażma (AUC) kienu miżjuda b' 1. 4, 1. 5 u 1. 6 darbiet rispettivament.
Corresponding increases in pharmacodynamic effects were more pronounced.
Żidiet korrispondenti fl- effetti farmakodinamiċi kienu aktar prominenti.
In individuals with mild, moderate and severe renal impairment the overall inhibition of factor Xa activity was increased by a factor of 1.5, 1.9 and 2.0 respectively as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4 respectively.
F' individwi b' indeboliment renali ħafif, moderat u sever, l- inibizzjoni totali ta 'l- attività ta' fattur Xa żdiedet b' fattur ta '1. 5, 1. 9 u 2. 0 rispettivament, meta mqabbla ma' voluntiera b' saħħithom; t- titwil ta ’ PT żdied b’ mod simili b' fattur ta '1. 3, 2. 2 u 2. 4 rispettivament.
There are no data in patients with creatinine clearance < 15 ml/ min.
M’ hemm l- ebda tagħrif f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 15 ml/ min.
Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/ min (see section 4.4).
Xarelto għandu jintuża b’ attenzjoni f’ pazjenti bi tneħħija tal- krejatinina ta ’ 15 - 29 ml/ min (ara sezzjoni 4. 4).
10 Pharmacokinetic/ pharmacodynamic relationship The Pharmacokinetic/ pharmacodynamic (PK/ PD) relationship between rivaroxaban plasma concentration and several PD endpoints (Factor Xa inhibition, PT, aPTT, Heptest) has been evaluated after administration of a wide range of doses (5 - 30 mg bid).
Relazzjoni farmakokinetika/ farmakodinamika Ir- relazzjoni farmakokinetika/ farmakodinamika (PK/ PD) bejn il- konċentrazzjoni ta ’ rivaroxaban fil- plażma u diversi miri ta ’ PD (inibizzjoni tal- Fattur Xa, PT, aPTT, Heptest) kienet evalwata wara l- għoti ta ’ firxa wiesgħa ta ’ dożi (5 - 30 mg bid).
Rivaroxaban 10 mg od results in a steady state Cmax of about 125 µg/ l.
Rivaroxaban 10 mg od jirriżulta f’ Cmax fi stat fiss ta ’ madwar 125 µg/ l.
The relationship between rivaroxaban concentration and Factor Xa activity was best described by an Emax model.
Ir- relazzjoni bejn il - konċentrazzjoni ta ’ rivaroxaban u l- attività tal- Fattur Xa kienet deskritta l- aħjar permezz ta ’ mudell ta ’ Emax.
For PT, the linear intercept model generally described the data better.
Għal PT, il- mudell ta ’ interċett lineari ġeneralment iddeskriva t- tagħrif aħjar.
Depending on the different PT reagents used, the slope differed considerably.
Skond ir- reaġents differenti ta ’ PT li ntużaw, is- slope varjat b’ mod konsiderevoli.
When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/ (100 µg/ l).
Meta ntuża Neoplastin PT, PT fil- linja bażi kien madwar 13 s u s - slope kienet madwar 3 sa 4 s / (100 µg/ l).
The results of the PK/ PD analyses in Phase II were consistent with the data established in healthy subjects.
Ir- riżultati ta ’ l- analiżi PK/ PD f’ Fażi II kienu konsistenti mat- tagħrif stabbilit f’ individwi b’ saħħithom.
In patients, baseline Factor Xa and PT were influenced by the surgery resulting in a difference in the concentration-PT slope between the day post-surgery and steady state.
Fil- pazjenti, l- Fattur Xa u PT fil- linja bażi kienu nfluwenzati mill- kirurġija u rriżultaw f’ differenza bejn is- slope tal- konċentrazzjoni- PT fil- ġurnata wara l- kirurġija u dik fi stat fiss.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity and genotoxicity.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn doża waħda, fototossiċità u effett tossiku fuq il- ġeni ma turi l- ebda periklu speċjali għall- bnedmin.
Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of rivaroxaban.
L- effetti osservati fi studji dwar tossiċità minn dożi ripetuti fil- biċċa l- kbira kienu kkawżati mill- attività farmakodinamika esaġerata ta ’ rivaroxaban.
In rats, increased IgG and IgA plasma levels were seen at clinically relevant exposure levels.
Fil- firien, livelli miżjuda ta ’ IgG u IgA fil- plażma kienu osservati f’ livelli ta ’ esponiment ta ’ rilevanza klinika.
Animal studies have shown reproductive toxicity related to the pharmacological mode of action of rivaroxaban (e. g. haemorrhagic complications).
Studji fuq il- bhejjem urew tossiċità riproduttiva relatata mal- mod ta ’ azzjoni farmakoloġika ta ’ rivaroxaban (e. ż. komplikazzjonijiet emorraġiċi).
Embryo-foetal toxicity (post-implantation loss, retarded/ progressed ossification, hepatic multiple light coloured spots) and an increased incidence of common malformations as well as placental changes were observed at clinically relevant plasma concentrations.
F’ konċentrazzjonijiet fil- plażma ta ’ rilevanza klinika kienu osservati tossiċità għall- embriju- fetu (telf wara l- implantazzjoni, ossifikazzjoni ritardata/ avvanzata, dbabar multipli ta ’ kulur ċar fil - fwied) u żjieda fl- inċidenza ta ’ deformazzjonijiet komuni, kif ukoll bidliet fis- sekonda.
In the pre- and post-natal study in rats, reduced viability of the offspring was observed at doses that were toxic to the dams.
Fi studji qabel u wara t- twelid fil- firien, kienet osservata vijabilità mnaqqsa tal- wild f’ dożi li kienu tossiċi għall - ommijiet.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Hypromellose Sodium laurilsulfate Magnesium stearate
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Hypromellose Sodium laurilsulfate Magnesium stearate
Film-coat:
Kisja b’ rita:
Macrogol 3350 Hypromellose Titanium dioxide (E171) Iron oxide red (E172)
Macrogol 3350 Hypromellose Titanium dioxide (E171) Iron oxide aħmar (E172)
11 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
PP/ Aluminium foil blisters or PVC/ PVDC/ Aluminium foil blisters in cartons of 5, 10, 30 and 100 tablets.
Folji tal- fojl tal- PP/ Aluminju jew folji tal- fojl tal- PVC/ PVDC/ Aluminju f' kaxxi tal- kartun ta '5, 10, 30 u 100 pillola.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - ĦRUĠ TAL- LOTT Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 9.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ Farmokoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq, kif deskritt f’ versjoni 9. 2 ippreżentata f ’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP
Pjan għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 1. 4 tal- Pjan għall - Immaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għal- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida ta ’ CHMP dwar is- Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil - bniedem, l- RMP mġedded għandu jiġi pprovdut fl- istess żmien mar- Rapport Perjodiku ta ’ Aġġornament dwar is - Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjoni ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 ġurnata wara li jintlaħaq għan ewlieni (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
Outer Carton
Kartuna ta 'Barra
Xarelto 10 mg film-coated tablets Rivaroxaban
Xarelto 10 mg pilloli miksija b’ rita Rivaroxaban
5 film-coated tablets 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets
5 pilloli miksija b' rita 10 pilloli miksija b' rita 30 pillola miksija b' rita 100 pillola miksija b' rita
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister
Folja
Xarelto 10 mg tablets Rivaroxaban
Xarelto 10 mg pilloli Rivaroxaban
What Xarelto is and what it is used for 2.
X’ inhu Xarelto u għalxiex jintuża 2.
Before you take Xarelto 3.
Qabel ma tieħu Xarelto 3.
How to take Xarelto 4.
Kif għandek tieħu Xarelto 4.
How to store Xarelto 6.
Kif taħżen Xarelto 6.
WHAT XARELTO IS AND WHAT IT IS USED FOR
X’ INHU XARELTO U GĦALXIEX JINTUŻA
Xarelto is used to prevent blood clots in your veins after a hip or knee replacement operation.
Xarelto jintuża biex jiġu evitati emboli tad- demm fil- vini wara kirurġija ta ’ sostituzzjoni tal- ġembejn jew l - irkoppa.
Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.
It- tabib tiegħek tak riċetta għal din il- mediċina għax wara kirurġija tkun f' riskju miżjud li jkollok emboli tad- demm.
Xarelto belongs to a group of medicines called antithrombotic agents.
Xarelto jappartjeni għall- grupp ta ’ mediċini msejħa sustanzi antitrombotiċi.
It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.
Jaħdem billi jimblokka fattur tat - tagħqid tad- demm (fattur Xa) u b’ hekk inaqqas it- tendenza li d- demm jifforma emboli.
BEFORE YOU TAKE XARELTO
QABEL MA TIEĦU XARELTO
Do not take Xarelto
Tieħux Xarelto
- if you are allergic (hypersensitive) to rivaroxaban or any of the other ingredients of Xarelto.
Is -
The ingredients are listed at the end of this leaflet
sustanzi huma elenkati fit- tmiem ta 'dan il- fuljett
- if you are bleeding excessively
- jekk għandek fsada (ħruġ ta 'demm) eċċessiva
- if you have a liver disease which leads to an increased risk of bleeding
- jekk għandek marda tal- fwied li twassal għal żjieda fir- riskju ta 'fsada
- if you are pregnant or breast-feeding
- jekk inti tqila jew qed tredda '
Do not take Xarelto and tell your doctor if any of these apply to you.
Tieħux Xarelto u għid lit- tabib tiegħek jekk xi wieħed minn dawn japplika għalik.
Take special care with Xarelto
Oqgħod attent ħafna b' Xarelto
- if you have moderate or severe kidney disease
- jekk għandek mard moderat jew sever tal- kliewi
- if you have moderate liver disease
- jekk għandek mard moderat tal- fwied
- if you have an increased risk of bleeding such as:
- jekk għandek riskju miżjud ta 'fsada, bħal:
bleeding disorders very high blood pressure, not controlled by medical treatment active ulcer or a recent ulcer of your stomach or bowel a problem with the blood vessels in the back of your eyes (retinopathy) recent bleeding in your brain (intracranial or intracerebral bleeding) problems with the blood vessels in your brain or spinal column a recent operation on your brain, spinal column or eye
disturbi ta 'fsada pressjoni tad- demm għolja ħafna, li ma tkunx ikkontrollata minn kura medika ulċera attiva jew ulċera riċenti fl- istonku jew fl- imsaren problema fil- vini jew l- arterji fin- naħa ta' wara t' għajnejk (retinopatija) fsada riċenti f' moħħok (ħruġ ta 'demm fil- kranju jew intraċerebrali) problemi fil- kanali tad- demm f’ moħħok jew fil- kolonna vertibrali kirurġija riċenti f' moħħok, fis- sinsla tad- dahar jew fl- għajnejn
Tell your doctor before you take Xarelto, if any of these apply to you.
Għid lit- tabib tiegħek qabel ma tieħu Xarelto, jekk xi wieħed minn dawn li ġejjin japplika għalik.
Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.
It- tabib tiegħek se jiddeċiedi jekk għandekx tiġi kkurat b’ Xarelto u jekk għandekx tinżamm taħt osservazzjoni aktar mill- qrib.
- Xarelto is not recommended after an operation of a hip fracture.
- Xarelto mhux irrakkomandat wara kirurġija ta ’ ksur tal- ġembejn.
- in children and adolescents, Xarelto is not recommended for people under 18 years of age.
M’ hemmx
There is not enough information on its use in children and adolescents.
biżżejjed tagħrif dwar l- użu tiegħu fit- tfal u l- adoloxxenti.
- if your operation involves a catheter or injection into your spinal column (e.g. for epidural
Għall- anestesija
or spinal anaesthesia or pain reduction):
epidurali jew fis- sinsla tad- dahar jew għat- tnaqqis ta 'l- uġigħ):
it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor
huwa mportanti li tieħu Xarelto qabel u wara l- injezzjoni jew it- tneħħija tal- kateter eżattament fil - ħinijiet li jkun qallek it- tabib tiegħek
tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.
għid lit- tabib tiegħek immedjatament jekk ikollok tmewwit jew dgħjufija f' riġlejk, jew problemi fl - imsaren jew fil- bużżieqa ta 'l- awrina, wara li tgħaddi l- anestesija, għax tkun meħtieġa kura urġenti.
Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
- If you are taking:
- Jekk qed tieħu:
some medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), unless they are only applied to the skin
Ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), ħlief jekk tapplikahom fuq il- ġilda biss
some anti-viral medicines for HIV / AIDS (e.g. ritonavir) other medicines to reduce blood clotting (e.g. enoxaparin or clopidogrel) anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid)
xi mediċini kontra l- virus għall- HIV/ AIDS (e. ż. ritonavir) mediċini oħrajn biex inaqqsu t- tagħqid tad- demm (e. ż. enoxaparin jew clopidogrel) mediċini kontra l- infjammazzjoni u li jtaffu l- uġigħ (e. ż. naproxen jew acetylsalicylic acid)
Tell your doctor before taking Xarelto, because its effect may be increased.
Għid lit- tabib tiegħek qabel ma tieħu Xarelto, għax l- effett tiegħu jista 'jiġi miżjud.
some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital), St Johns Wort, a herbal product used for depression, rifampicin, an antibiotic.
xi mediċini għall- kura ta ’ l- epilessija (phenytoin, carbamazepine, phenobarbital), St Johns Wort, prodott mill- ħxejjex użat għad- depressjoni, rifampicin, antibijotiku.
Tell your doctor before taking Xarelto, because its effect may be reduced.
Għid lit- tabib tiegħek qabel tieħu Xarelto, għax l- effett tiegħu jista ’ jkun imnaqqas.
Taking Xarelto with food and drink Xarelto can be taken with or without food.
Meta tieħu Xarelto ma ’ l- ikel u max- xorb Xarelto jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto.
Tqala u treddigħ Jekk inti tqila jew qed tredda ’, tieħux Xarelto Jekk hemm ċans li tista 'toħroġ tqila, użu kontraċettiv affidabbli waqt li tkun qed tieħu Xarelto.
If you become pregnant while you are taking Xarelto, immediately tell your doctor, who will decide how you should be treated.
Jekk toħroġ tqila waqt li tkun qed tieħu Xarelto, għid lit- tabib tiegħek immedjatament, li mbagħad jiddeċiedi kif għandek tkun ikkurata.
Driving and using machines No studies on the effects of Xarelto on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti ta ’ Xarelto fuq il- ħila biex issuq u tħaddem magni.
However, Xarelto may cause side effects such as dizziness or fainting.
Madankollu, Xarelto jista ’ jikkawża effetti sekondarji bħal sturdament u ħass ħażin.
You should not drive or use machines if you are affected by these symptoms.
M’ għandekx issuq jew tħaddem magni jekk int affetwat minn dawn is- sintomi.
For Xarelto, these side effects are uncommon (see section 4 “Possible side effects”).
Għal Xarelto, dawn l- effetti sekondarji mhumiex komuni (ara sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu ”).
Important information about some of the ingredients of Xarelto Xarelto contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Xarelto Xarelto fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xarelto.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu Xarelto.
HOW TO TAKE XARELTO
KIF GĦANDEK TIEĦU XARELTO
Always take Xarelto exactly as your doctor has told you.
Dejjem għandek tieħu Xarelto skond il- parir eżatt tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma 'l - ispiżjar jekk ikollok xi dubju.
How much to take The usual dose is one tablet (10 mg) once a day.
Kemm għandek tieħu Id- doża tas- soltu hija pillola waħda (10 mg) darba kuljum.
Swallow the tablet preferably with water.
Ibla 'l- pillola preferibbilment ma' l- ilma.
Xarelto can be taken with or without food.
Xarelto jista ’ jittieħed ma 'l- ikel jew mingħajr l- ikel.
22 When to take Xarelto Take the first tablet 6 - 10 hours after your operation.
22 Meta għandek tieħu Xarelto Ħu l- ewwel pillola 6 - 10 sigħat wara l- kirurġija Imbagħad ħu pillola kuljum sakemm it- tabib tiegħek jgħidlek biex tieqaf.
Then take a tablet every day until your doctor tells you to stop.
Ipprova ħu l- pillola fl- istess ħin kuljum.
Try to take the tablet at the same time every day to help you to remember it.
Dan jgħinek biex tiftakar.
If you have had a major hip operation you will usually take the tablets for 5 weeks.
Jekk kellek operazzjoni maġġuri fil- ġenbejn, normalment ser tieħu l- pilloli għal 5 ġimgħat.
If you have had a major knee operation you will usually take the tablets for 2 weeks.
Jekk kellek operazzjoni maġġuri fl- irkoppa, normalment ser tieħu l- pilloli għal ġimagħtejn.
If you take more Xarelto than you should Contact your doctor immediately if you have taken too m any Xarelto tablets.
Jekk tieħu Xarelto aktar milli suppost Ikkuntattja t- tabib tiegħek immedjatament jekk tkun ħadt pilloli Xarelto żejda.
Taking too much Xarelto increases the risk of bleeding.
Li tieħu Xarelto żejjed iżid ir - riskju ta 'fsada.
If you forget to take Xarelto If you have missed a dose, take it as soon as you remember.
Jekk tinsa tieħu Xarelto Jekk tinsa tieħu doża, ħudha hekk kif tiftakar.
Take the next tablet on the following day and then carry on taking a tablet once a day as normal.
Ħu l- pillola li jmiss fil- jum ta 'wara u mbagħad kompli ħu pillola darba kuljum bħas- soltu.
If you stop taking Xarelto Don’t stop taking Xarelto without talking to your doctor first, because Xarelto prevents the development of a serious condition.
Jekk tieqaf tieħu Xarelto Tiqafx tieħu Xarelto mingħajr ma tkellem lit- tabib tiegħek l- ewwel, minħabba li Xarelto jimpedixxi l- iżvilupp ta 'kundizzjoni serja.
Like all medicines, Xarelto can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xarelto jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Like other similar medicines (antithrombotic agents), Xarelto may cause bleedings which may potentially be life threatening.
Bħal mediċini oħra simili (sustanzi antitrombotiċi), Xarelto jista 'jikkawża fsada li tista ’ tkun ta ’ periklu għall - ħajja.
In some cases these bleedings may not be obvious.
F' xi każijiet, din il- fsada tista 'ma tkunx ovvja.
Tell your doctor, if you experience any of the following side effects:
Għid it- tabib tiegħek, jekk ikollok xi wieħed minn dawn l- effetti sekondarji:
- long or excessive bleeding
- fsada twila jew eċċessiva
- exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling.
- dgħjufija eċċezzjonali, għeja, sfurija fil- ġilda, sturdament, uġigħ ta ’ ras jew nefħa mhux spjegata.
Your doctor may decide to keep you under closer observation or change how you should be treated.
It- tabib tiegħek jista 'jiddeċiedi li josservak aktar mill- qrib jew jibdel il- mod li bih tkun ikkurat.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza ta ’ l- effetti sekondarji possibli mniżżla taħt hija definita bl- użu tal- konvenzjoni li ġejja: komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10 li qed jużawh) komuni (jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh) mhux komuni (jaffettwaw minn persuna waħda sa 10 minn kull 1, 000 li qed jużawh) rari (jaffettwaw minn persuna waħda sa 10 minn kull 10, 000 li qed jużawh) rari ħafna (jaffettwaw inqas minn persuna waħda minn kull 10, 000 li qed jużawh) mhux magħruf (il- frekwenza ma tistax tiġi stmata mid- data disponibbli).
- bleeding following your operation
- fsada wara l- kirurġija tiegħek
- reduction in red blood cells which can make your sk in pale and cause weakness or breathlessness
- tnaqqis fiċ- ċelluli ħomor tad- demm li jista ’ jagħmel il- ġilda tiegħek pallida jew jikkawża dgħjufija jew nuqqas
- blood tests may show an increase in some liver enzymes
- it- testijiet tad- demm jistgħu juru żjieda f' xi enżimi tal- fwied
- bleeding in your stomach or bowel, genital bleeding, nose bleed
- fsada fl- istonku jew fl- imsaren, fsada fil- partijiet ġenitali, fsada mill- imnieħer
- bleeding into tissue or a cavity of your body (haematoma, bruising)
- fsada f’ tessut jew f’ xi spazju fil- ġisem tiegħek (ematoma, tbenġil)
- blood in your urine
- demm fl- awrina
- oozing of blood or fluid from surgical wound
- ħruġ ta 'demm jew fluwidu minn ferita kirurġika
- raised heartbeat
- żjieda fir- rata ta 'taħbit tal- qalb
- low blood pressure
- pressjoni tad- demm baxxa
- feeling unwell (weakness, tiredness), headache, dizziness, fainting
- ma tħossokx tajjeb (dgħjufija, għeja), uġigħ ta ’ ras, sturdament, ħass ħażin
- dry mouth
- ħalq xott
- localised swelling, swelling in your limbs
- nefħa lokalizzata, nefħa fid- dirgħajn/ riġlejn
- pain in your limbs
- uġigħ fid- dirgħajn/ riġlejn
- rash, itchy skin, hives
- raxx, ħakk fil- ġilda, urtikarja
- impaired function of your kidneys
- indeboliment fil- funzjoni tal- kliewi
- blood tests may show an increase in bilirubin, some pancreatic enzymes or in the number of platelets
- it- testijiet tad- demm jistgħu juru żjieda fil- bilirubina, f' xi enżimi pankreatiċi jew fin- numru ta 'plejtlits
Rare side effects
Effetti sekondarji rari
- impaired function of your liver
- indeboliment fil- funzjoni tal- fwied
- allergic skin reactions
- reazzjonijiet allerġiċi tal- ġilda
Side effects where frequency is not known
Effetti sekondarji fejn il- frekwenza mhux magħrufa
- bleeding into a critical organ (e.g. your brain)
- fsada f’ organu kritiku (e. ż. moħħok)
- adrenal bleeding
- fsada adrenali
- bleeding from the whites of your eyes
- fsada mill- abjad ta 'għajnejk
- coughing up blood
- tisgħol id- demm