qanastek/EMEA-V3 huggingface dataset:
Dizziness (rarely when standing up or getting out of bed), tiredness, palpitations (awareness of a forceful heartbeat which may be rapid or irregular), nausea, diarrhoea, stomach pain, indigestion and wind, vomiting, anaemia (a small reduction in red blood cell count and iron deficiency), fluid retention (including swelling of your ankles) or rash.
Sturdament (f’ każijiet rari meta tqum bil- wieqfa jew tqum mis- sodda), għeja, taħbit tal- qalb (konxji minn taħbit qawwi tal- qalb li jista 'jkun rapidu jew irregolari) dardir, dijarea, uġigħ fl- istonku, indiġestjoni u gass, rimettar, anemija (tnaqqis żgħir fl- għadd ta' ċelloli ħomor tad- demm u nuqqas ta 'ħadid), akkumulazzjoni ta' fluwidu (li jinkludi nefħa ta 'l- għakiesi) jew raxx.
Serious side effects.
Effetti sekondarji serji.
If you notice any of the following, contact your doctor immediately: severe chest pain, palpitations associated with dizziness or feeling faint, fainting, severe abdominal or gastro- intestinal pain, vomiting blood or passing bloody or black stools, breathing difficulties or shortness of breath, particularly if your lips or skin turn a bluish colour.
Jekk tinduna b ’ xi wieħed minn dawn li ġejjin ikkuntattja lit- tabib tiegħek minnufih: uġigħ fis- sider qawwi, taħbit tal- qalb assoċjat ma 'sturdament jew tħossok debboli, ħass ħażin, uġigħ addominali qawwi jew uġigħ gastro- intestinali, rimettar bid- demm jew jekk tagħmel l- ippurgar bid- demm jew iswed, diffikultajiet biex tieħu n- nifs jew qtugħ ta ’ nifs, partikolarment jekk xofftejk jew il- ġilda tiegħek isiru blu.
These have not occurred commonly but are serious conditions.
Dawn ma seħħewx b’ mod komuni, iżda huma kundizzjonijiet serji.
Uncommon side effects, (may occur in fewer than 1 in 100, but more than 1 in 1,000 patients):
Effetti sekondarji mhux komuni, (jistgħu jseħħu f’ inqas minn 1 minn kull 100 pazjent, iżda f’ iktar minn 1 minn kull 1, 000 pazjent):
A feeling of weakness or feeling unwell, high blood pressure, chills or fever, heartburn, anorexia, constipation, bruising, localised swelling with fluid (oedema), weight loss, muscle aches, painful joints, back pain, reduced feeling or tingling in toes or fingers, sleeplessness, depression, confusion, nervousness, dry mouth, loss of memory, allergic coughing, breathlessness, nosebleed, lung infection, hair loss, skin itching or discolouration, impotence.
Tħossok debboli jew ma tħossokx f' tiegħek, pressjoni għolja tad- demm, sried jew deni, ħruq ta ’ stonku, anoreksja, stitikezza, tbenġil, nefħa f' xi postijiet bil- fluwidu (edema), telf ta 'piż, uġigħ fil - muskoli, ġogi muġugħa, uġigħ fid- dahar, jonqos is- sens ta' ħass jew tnemmin fis- swaba tas- sieq jew ta 'l- id, ngħas, dipressjoni, konfużjoni, nervi, ħalq xott, telf ta' memorja, sogħla allerġika, nuqqas ta 'nifs, l- imnieħer jinfaraġ, infezzjoni fil- pulmun, telf ta' xagħar, ħakk fil- ġilda jew tibdil fil- kulur, impotenza.
Your doctor may do a blood test which may show an increase in your liver enzymes.
It- tabib tiegħek għandu mnejn jagħmel test tad- demm li jista ’ juri żieda fil- livelli ta 'l- enżimi tal- fwied tiegħek.
If any of these side effects cause you a problem, speak to your doctor.
Jekk xi wieħed minn dawn l- effetti joħolqulek problema, kellem lit- tabib tiegħek.
Rare side effects (may occur in fewer than 1 in 1,000 patients):
Effetti sekondarji rari (jistgħu jseħħu f’ inqas minn 1 minn kull 1, 000 pazjent):
Heart attack, bleeding gums, weight gain, heart muscle disease, loss of coordination, difficulty in speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, increased need to pass water at night, pain, ‘ flu-like’ symptoms.
Attakk tal- qalb, fsada fil- ħanek, żieda fil- piż, mard fil- muskolu tal- qalb, telf fil- koordinazzjoni, diffikultà meta wieħed jitkellem, ġilda xotta, emigranja, disturbi fil- vista jew vista doppja, ċenċil fil- widnejn, bżonn aktar ta 'spiss biex tagħmel l- awrina bil- lejl, uġigħ, sintomi bħal tar- riħ / l- influwenza.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinduna b' xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok informa lit- tabib jew lill- ispiżjar tiegħek
HOW TO STORE XAGRID
KIF TAĦŻEN XAGRID
Xagrid does not require any special storage conditions within European countries.
Xagrid m' għandux bżonn ta 'ħażna speċjali fil- pajjiżi Ewropej.
Do not use Xagrid after the expiry date which is stated on the carton.
Tużax Xagrid wara d- data ta ’ skadenza li tidher fuq il- kartuna.
If your doctor stops your medicine, do not keep any leftover capsules unless your doctor tells you to.
Jekk it- tabib tiegħek iwaqqaflek il- mediċina tiegħek, iżżomx il- kapsuli li jibqalek sakemm ma jkunx qallek biex iżżommhom it- tabib.
21 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Xagrid contains The active substance is anagrelide.
X’ fih Xagrid Is- sustanza attiva hi anagrelide.
Each capsule contains 0.5mg anagrelide (as hydrochloride).
Kull kapsula fiha 0. 5mg ta ’ anagrelide (bħala hydrochloride).
Povidone (E1201), crospovidone, anhydrous lactose, lactose monohydrate, microcrystalline cellulose (E460), magnesium stearate.
Povidone (E1201), crospovidone, anhydrous lactose, lactose monohydrate, microcrystalline cellulose (E460), magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E171) Printing ink: shellac, strong ammonium solution, potassium hydroxide (E525), black iron oxide (E172).
Qoxra tal- kapsula: gelatin u titanium dioxide (E171) Linka ta ’ l- istampar: shellac, strong ammonium solution, potassium hydroxide (E525), black iron oxide (E172).
What Xagrid looks like and contents of the pack Xagrid is supplied to you as opaque, white, hard capsules.
Id- dehra ta ’ Xagrid u l- kontenuti tal- pakkett Xagrid hu pprovdut lilek bħala kapsuli opaki, bojod u iebsin.
They are marked with ‘ S 063’.
Huma mmarkati b ’’ S 063 ’.
The capsules are provided in bottles containing 100 hard capsules.
Il- kapsuli huma pprovduti fi fliexken li fihom 100 kapsula iebsa.
Marketing Authorisation Holder Shire Pharmaceutical Contracts Limited Hampshire International Business Park Chineham, Basingstoke Hampshire RG24 8EP United Kingdom
Shire Pharmaceutical Contracts Limited Hampshire International Business Park Chineham, Basingstoke Hampshire RG24 8EP Ir- Renju Unit
Manufacturer Wasdell Packaging Limited Upper Mills Estate Bristol Road, Stonehouse Gloucestershire GL10 2BJ United Kingdom
Upper Mills Estate Bristol Road, Stonehouse Gloucestershire GL10 2BJ Ir- Renju Unit
Sverige Swedish Orphan AB Drottninggatan 98 S-111 60 Stockholm Tel: +46 8 412 9800
Drottninggatan 98 S- 111 60 Stockholm Tel: +46 8 412 9800
Ireland Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP United Kingdom Tel:
United Kingdom Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP
United Kingdom Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP Tel:
Tel:
This leaflet was last approved
Dan il- fuljett kien approvat l- aħħar fis -
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
There are also links to other websites about rare diseases and their treatments.
Hemm ukoll links għall- websites oħrajn dwar mard rari u l- kura.
What is Xarelto?
X' inhu Xarelto?
Xarelto is a medicine containing the active substance rivaroxaban.
Xarelto huwa mediċina li fiha s- sustanza attiva rivaroxaban.
It is available as red, round tablets (10 mg).
Huwa disponibbli f’ forma ta ’ pilloli tondi u ħomor (10 mg).
What is Xarelto used for?
Għal xiex jintuża Xarelto?
Xarelto is used to prevent the formation of clots in the veins (venous thromboembolism, VTE) in adults who are undergoing surgery to replace a hip or knee.
Xarelto jintuża għall- prevenzjoni tal- formazzjoni ta ’ għoqod fil- vini (tromboemboliżmu venuż, VTE) f’ adulti sottoposti għal intervent kirurġiku għas- sostituzzjoni ta ’ ġenb jew ta ’ rkoppa.
How is Xarelto used?
Kif jintuża Xarelto?
Treatment with Xarelto should start six to 10 hours after surgery, provided that the patient is no longer bleeding from the site of surgery.
It- trattament bi Xarelto għandu jibda bejn 6 u 10 sigħat wara l- intervent kirurġiku, bil- kundizzjoni li l - pazjent ma jibqax ikollu fsada fis- sit tal- intervent.
Xarelto is taken by mouth as one 10 mg tablet once a day, with or without food.
Xarelto jittieħed oralment fid- doża ta ’ pillola waħda ta ’ 10 mg darba kuljum, fuq stonku vojt jew le.
Treatment should continue for five weeks in patients who have had hip replacement surgery, and for two weeks in patients who have had knee replacement surgery.
It- trattament għandu jkompli għal ħames ġimgħat fil - pazjenti li kienu sottoposti għal intervent kirurġiku ta ’ sostituzzjoni ta ’ ġenb u għal ġimagħtejn fil - pazjenti li kienu sottoposti għal intervent kirurġiku ta ’ sostituzzjoni ta ’ rkoppa.
Xarelto should be used with caution in patients with severe kidney problems.
Xarelto għandu jintuża b’ kawtela fil- pazjenti li jbatu minn problemi renali (fil- kliewi) gravi.
How does Xarelto work?
Kif jaħdem Xarelto?
Patients undergoing hip or knee replacement surgery are at a high risk of forming blood clots in the veins.
Il- pazjenti li kienu sottoposti għal intervent kirurġiku ta ’ sostituzzjoni ta ’ ġenb jew ta ’ rkoppa huma f’ riskju għoli li jiffurmawlhom għoqod tad- demm fil- vini.
These clots can be dangerous if they move to another part of the body such as the lungs.
Dawn l- għoqod jistgħu jkunu perikolużi jekk jinxterdu ma ’ partijiet oħra tal- ġisem, pereżempju fil- pulmuni.
The active substance in Xarelto, rivaroxaban, is a ‘ factor Xa inhibitor’.
Is- sustanza attiva fi Xarelto, rivaroxaban, hija ‘ inibitur tal- fattur Xa ’ li jfisser li timbokka l- fattur Xa, enzima involuta fil - produzzjoni tat- trombina (thrombin).
This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin.
It- trombina hija fundamentali fil- proċess tat- tagħqid tad- demm.
By blocking factor Xa, the levels of thrombin decrease, which reduces the risk of blood clots forming in the veins.
Meta l- fattur Xa huwa mblukkat, jonqsu l- livelli tat- trombina u b’ hekk jitnaqqas ir- riskju ta ’ formazzjoni tal- għoqod tad- demm fil- vini.
How has Xarelto been studied?
Kif ġie studjat Xarelto?
The effects of Xarelto were first tested in experimental models before being studied in humans.
L- effetti ta ’ Xarelto ġew għall- ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil - bniedem.
The effectiveness of Xarelto was compared with that of enoxaparin (another medicine that prevents the blood from clotting) in three main studies, two with patients undergoing hip replacement surgery and one with patients undergoing knee replacement surgery.
L- effikaċja ta ’ Xarelto tqabblet ma ’ dik ta ’ enoxaparin (mediċina oħra li tipprevjeni t- tagħqid tad - demm) fi tliet studji ewlenin, tnejn minnhom involvew il- pazjenti sottoposti għal intervent kirurġiku
Reproduction is authorised provided the source is acknowledged. two weeks of enoxaparin in around 2,500 patients undergoing knee replacement surgery.
Reproduction is authorised provided the source is acknowledged. ta ’ sostituzzjoni ta ’ ġenb u wieħed involva l- pazjenti sottoposti għal intervent kirurġiku ta ’ sostituzzjoni ta ’ rkoppa.
In all of the studies, the effectiveness was measured by looking at the number of patients who either had blood clots in the veins or in the lungs, or who died of any cause during the treatment period.
Fl- istudji kollha, l- effikaċja tkejlet billi ġie osservat l- għadd ta ’ pazjenti li kellhom għoqod tad- demm fil- vini jew fil- pulmun, jew li mietu minħabba kwalunkwe kawża matul il- perjodu ta ’ trattament.
What benefit has Xarelto shown during the studies?
X’ benefiċċju wera Xarelto matul l- istudji mwettqa?
In all of the main studies, Xarelto was more effective than enoxaparin in preventing the formation of blood clots and death.
Fl- istudji ewlenin kollha, Xarelto rriżulta aktar effikaċi meta mqabbel ma ’ enoxaparin għall - prevenzjoni tal- mewt u tal- formazzjoni ta ’ għoqod tad- demm.
In the first study in hip replacement surgery, 1% of the patients who completed treatment with Xarelto either had blood clots or died (18 out of 1,595), compared with 4% of the patients receiving enoxaparin (58 out of 1,558).
Fl- ewwel studju tal- każijiet tal- intervent kirurġiku ta ’ sostituzzjoni ta ’ ġenb, 1% tal- pazjenti li lestew it- trattament bi Xarelto kellhom għoqod tad- demm jew mietu (18 minn 1, 595), meta mqabbla mal- 4% tal- pazjenti ttrattati b’ enoxaparin (58 minn 1, 558).
In the second study, 2% of the patients taking Xarelto had blood clots or died (17 out of 864), compared with 9% of the patients receiving enoxaparin (81 out of 869).
Fit- tieni studju, 2% tal- pazjenti ttrattati bi Xarelto kellhom għoqod tad- demm jew mietu (17 minn 864) meta mqabbla mad- 9% tal- pazjenti ttrattati b’ enoxaparin (81 minn 869).
After knee replacement surgery, 10% of the patients receiving Xarelto had blood clots or died (79 out of 824), compared with 19% of the patients receiving enoxaparin (166 out of 878).
Wara l- intervent kirurġiku ta ’ sostituzzjoni ta ’ rkoppa, 10% tal- pazjenti ttrattati bi Xarelto kellhom għoqod tad- demm jew mietu (79 minn 824) meta mqabbla mad- 19% tal- pazjenti ttrattati b’ enoxaparin (166 minn 878).
What is the risk associated with Xarelto?
X’ inhu r- riskju assoċjat ma ’ Xarelto?
The most common side effects with Xarelto (seen in between 1 and 10 patients in 100) are bleeding following an operation, nausea (feeling sick), anaemia (low red blood cell counts) and increased levels of some liver enzymes in the blood.
L- effetti sekondarji l- aktar komuni bi Xarelto (li dehru f’ bejn 1 u 10 pazjenti minn 100) kienu fsada wara l- operazzjoni, nawżea (dardir), anemija (għadd taċ- ċelloli ħomor tad- demm baxx) u żieda fil - livelli ta ’ xi enzimi epatiċi fid- demm.
For the full list of all side effects reported with Xarelto, see the Package Leaflet.
Għal lista sħiħa tal- effetti sekondarji kollha rrappurtati bi Xarelto, ara l- Fuljett ta ’ Tagħrif.
Xarelto should not be used in people who may be hypersensitive (allergic) to rivaroxaban or any of the other ingredients.
Xarelto ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal rivaroxaban jew għal xi sustanzi oħra tiegħu.
It must not be used in patients who are bleeding or in patients who have a liver disease that is associated with an increased risk of bleeding, although it may be used with caution in patients with moderate liver problems if they do not have an increased risk of bleeding.
Ma għandux jintuża f’ pazjenti bi fsada jew f’ pazjenti li għandhom marda epatika (tal- fwied) assoċjata ma ’ żieda fir- riskju ta ’ fsada, iżda huwa possibbli li jintuża b’ kawtela f’ pazjenti bi problemi epatiċi moderati f’ każ li ma għandhomx riskju ogħla ta ’ fsada.
Xarelto must not be used in women who are pregnant or breast-feeding.
Xarelto ma għandux jintuża waqt it- tqala jew it- treddigħ.
Why has Xarelto been approved?
Għaliex ġie approvat Xarelto?
The Committee for Medicinal Products for Human Use (CHMP) decided that Xarelto’ s benefits are greater than its risks for the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Xarelto huma ogħla mir- riskji tiegħu għall- prevenzjoni tal- VTE f’ pazjenti adulti sottoposti għal interventi kirurġiċi ta ’ sostituzzjoni elettiva ta ’ ġenb jew ta ’ rkoppa.
The Committee recommended that Xarelto be given marketing authorisation.
Il- Kumitat irrakkomanda li Xarelto jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Xarelto:
Aktar tagħrif dwar Xarelto:
The European Commission granted a marketing authorisation valid throughout the European Union for Xarelto to Bayer HealthCare AG on 30 September 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Xarelto lil Bayer HealthCare AG fit- 30 ta ’ Settembru 2008.
The full EPAR for Xarelto can be found here.
L- EPAR sħiħ għal Xarelto jista ’ jiġi kkonsultat hawn.
EU/ 1/ 08/ 472/ 001 EU/ 1/ 08/ 472/ 002 EU/ 1/ 08/ 472/ 003 EU/ 1/ 08/ 472/ 004 EU/ 1/ 08/ 472/ 005 EU/ 1/ 08/ 472/ 006 EU/ 1/ 08/ 472/ 007 EU/ 1/ 08/ 472/ 008
Numru ta ’ l- EU EU/ 1/ 08/ 472/ 001 EU/ 1/ 08/ 472/ 002 EU/ 1/ 08/ 472/ 003 EU/ 1/ 08/ 472/ 004 EU/ 1/ 08/ 472/ 005 EU/ 1/ 08/ 472/ 006 EU/ 1/ 08/ 472/ 007 EU/ 1/ 08/ 472/ 008
Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto
Isem inventat Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto
10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg
Qawwa 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla Farmaċewtika Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnjen jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PP / alu) blister (PP / alu) blister (PP / alu) blister (PP / alu)
Il- pakkett folja (PVC/ PVDC/ alu) folja (PVC/ PVDC/ alu) folja (PVC/ PVDC/ alu) folja (PVC/ PVDC/ alu) folja (PP / alu) folja (PP / alu) folja (PP / alu) folja (PP / alu)
5 tablets 10 tablets 30 tablets 100 tablets 5 tablets 10 tablets 30 tablets 100 tablets
Daqs tal- pakkett 5 pilloli 10 pilloli 30 pillola 100 pillola 5 pilloli 10 pilloli 30 pillola 100 pillola
Xarelto 10 mg film-coated tablets
Xarelto 10 mg pilloli miksija b’ rita
Each film-coated tablet contains 10 mg rivaroxaban.
Kull pillola miksija b' rita fiha 10 mg rivaroxaban.
Each film-coated tablet contains 27.9 mg lactose monohydrate, see section 4.4.
Kull pillola miksija b’ rita fiha 27. 9 mg ta ’ lactose monohydrate, ara sezzjoni 4. 4.
Light red, round tablets marked with the BAYER-cross on one side and "10" and a triangle on the other side.
Pilloli ta ’ kulur aħmar ċar, tondi, immarkati bis- salib tal- BAYER fuq naħa waħda, u b ’ “ 10 ” u trijangolu fuq in - naħa l- oħra.
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Għall- prevenzjoni ta 'trombo- emboliżmu fil- vini (VTE) f' pazjenti adulti li jkollhom kirurġija ippjanata ta ’ sostituzzjoni tal- ġenbejn jew ta ’ l- irkoppa.
The recommended dose is 10 mg rivaroxaban taken orally once daily.
Id- doża rrakkomandata hija 10 mg rivaroxaban li tittieħed darba kuljum mill- ħalq.
The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established.
Id- doża tal- bidu għandha tittieħed 6 sa 10 sigħat wara l- kirurġija, dejjem jekk l- emostasi tkun ġiet stabbilita.
The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery. • For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
It- tul tal- kura jiddependi fuq ir- riskju ndividwali tal- pazjent għal trombo- emboliżmu fil- vini li huwa stabbilit mit - tip ta 'kirurġija ortopedika. • Għall- pazjenti li jkollhom kirurġija maġġuri fil- ġenbejn, hija rrakkomandata kura li ddum 5 ġimgħat. • Għall- pazjenti li jkollhom kirurġija maġġuri fl- irkoppa, hija rrakkomandata kura li ddum ġimagħtejn.
If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before.
Jekk tintnesa doża, l- pazjent għandu jieħu Xarelto immedjatament u mbagħad il- ġurnata ta ’ wara għandu jkompli b’ doża ta ’ darba kuljum bħal qabel.
Xarelto can be taken with or without food.
Xarelto jista 'jittieħed ma' l- ikel jew mingħajr ikel.
Renal impairment No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/ min) or moderate renal impairment (creatinine clearance 30 - 49 ml/ min) (see section 5.2).
Indeboliment renali L- ebda aġġustament fid- doża ma huwa meħtieġ f' pazjenti b' indeboliment renali ħafif (tneħħija tal- krejatinina ta '50 - 80 ml/ min) jew b' indeboliment renali moderat (tneħħija tal- krejatinina ta' 30 - 49 ml/ min) (ara sezzjoni 5. 2).
Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/ min) indicate that rivaroxaban plasma concentrations are significantly increased in this patient population, therefore, Xarelto is to be used with caution in these patients.
Tagħrif kliniku limitat għal pazjenti b' indeboliment renali sever (tneħħija tal- krejatinina ta '15 - 29 ml/ min) jindika li konċentrazzjonijiet ta' rivaroxaban fil- plażma jiżdiedu b' mod sinifikanti f' din il- popolazzjoni ta 'pazjenti, għalhekk, Xarelto għandu jintuża b’ attenzjoni f' dawn il- pazjenti.
Use is not recommended in patients with creatinine clearance < 15 ml/ min (see sections 4.4 and 5.2).
L- użu mhux irrakkomandat f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 15 ml/ min (ara sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see sections 4.3 and 5.2).
Indeboliment epatiku Xarelto huwa kontra- indikat f' pazjenti b' mard epatiku assoċjat ma 'koagulopatija u riskju ta' fsada ta ’ rilevanza klinika (ara sezzjonijiet 4. 3 u 5. 2).
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 4.4 and 5.2).
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. 4 u 5. 2).
2 No dose adjustment is necessary in patients with other hepatic diseases.
L- ebda aġġustament fid- doża ma huwa meħtieġ f' pazjenti b' mard epatiku ieħor.
Patients above 65 years No dose adjustment.
2 Pazjenti ta 'aktar minn 65 sena L- ebda aġġustament fid- doża.
Body weight No dose adjustment.
Piż tal- ġisem L- ebda aġġustament fid- doża.
Gender No dose adjustment.
Sess L- ebda aġġustament fid- doża.
Children and adolescents Xarelto is not recommended for use in children or adolescents below 18 years of age due to a lack of data on safety and efficacy.
Tfal u adoloxxenti Xarelto mhux irrakkomandat għall- użu fit- tfal u l- adoloxxenti taħt it- 18- il sena, peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Clinically significant active bleeding.
Fsada attiva ta ’ sinifikanza klinika.
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 5.2).
Mard epatiku assoċjat ma 'koagulopatija u riskju ta' fsada ta ’ rilevanza klinika (ara sezzjoni 5. 2).
Haemorrhagic risk Several sub-groups of patients, as detailed below, are at increased risk of bleeding.
Riskju ta ’ emorraġija Bosta sotto gruppi ta ’ pazjenti, kif iddettaljat isfel, huma f’ riskju miżjud ta ’ fsada.
These patients are to be carefully monitored for signs of bleeding complications after initiation of treatment.
Dawn l- pazjenti għandhom jiġu sorveljati b’ attenzjoni għal sinjali ta ’ komplikazzjonijiet ta ’ fsada wara l- bidu tal- kura.
This may be done by regular physical examination of the patients, close observation of the surgical wound drainage and periodic measurements of haemoglobin.
Dan jista ’ jsir permezz ta ’ eżaminazzjoni fiżika regolari tal- pazjenti, osservazzjoni mill- qrib tal- ħruġ ta ’ likwidu mill- ferita kirurġika u kejl perjodiku ta ’ l- emoglobina.
Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site.
Kull tnaqqis mhux spjegat fl- emoglobina jew fil- pressjoni tad- demm, għandu jwassal għal tfittxija għall- post ta ’ fsada.
Renal impairment In patients with severe renal impairment (creatinine clearance < 30 ml/ min) rivaroxaban plasma levels may be significantly increased which may lead to an increased bleeding risk.
Indeboliment renali F' pazjenti b' indeboliment renali sever (tneħħija tal- krejatinina ta '< 30 ml/ min), il- livelli ta' rivaroxaban fil- plażma jistgħu jiżdiedu b' mod sinifikanti, u dan jista 'jwassal għal żjieda fir- riskju ta' fsada.
Use is not recommended in patients with creatinine clearance < 15 ml/ min.
L- użu mhux irrakkomandat 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 sections 4.2 and 5.2).
Xarelto għandu jintuża b’ attenzjoni f' pazjenti bi tneħħija tal - krejatinina ta ’ 15 - 29 ml/ min (ara sezzjonijiet 4. 2 u 5. 2).
Xarelto is to be used with caution in patients with moderate renal impairment (creatinine clearance 30 - 49 ml/ min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations (see section 4.5).
Xarelto għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment renali moderat (tneħħija tal- krejatinina ta ’ 30 - 49 ml/ min) li qed jirċievu prodotti mediċinali oħra fl- istess waqt li jżidu l- konċentrazzjonijiet fil- plażma ta ’ rivaroxaban (ara sezzjoni 4. 5).
Hepatic impairment In cirrhotic patients with moderate hepatic impairment (classified as Child Pugh B), rivaroxaban plasma levels may be significantly increased which may lead to an increased bleeding risk.
Indeboliment epatiku F’ pazjenti b’ ċirrożi b’ indeboliment epatiku moderat (ikklassifikat bħala Child Pugh B), il- livelli ta ’ rivaroxaban fil- plażma jistgħu jkunu miżjuda b’ mod sinifikanti u dan jista ’ jwassal għal żjieda fir- riskju ta ’ fsada.
Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
Xarelto huwa kontra- indikat f’ pazjenti b’ mard epatiku assoċjat ma ’ koagulopatija u riskju ta ’ fsada ta ’ rilevanza klinika.
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 4.2, 4.3 and 5.2).
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. 2, 4. 3 u 5. 2).
Interaction with other medicinal products The use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e. g. ritonavir).
Interazzjoni ma ’ prodotti mediċinali oħra L- użu ta ’ Xarelto mhux irrakkomandat f' pazjenti li jkunu qed jirċievu kura sistemika fl- istess waqt b' azole - antimycotics (bħal ketoconazole, itraconazole, voriconazole u posaconazole) jew b' inibituri tal- protease tal- HIV (e. ż. ritonavir).
These active substances are strong inhibitors of both CYP3A4 and P-gp and therefore may increase rivaroxaban plasma concentrations to a clinically relevant degree which may lead to an increased bleeding risk (see section 4.5).
Dawn is- sustanzi attivi huma inibituri qawwija kemm ta 'CYP3A4 kif ukoll ta' P- gp, u għalhekk jistgħu jżidu l- konċentrazzjonijiet ta 'rivaroxaban fil- plażma sa grad li jkun klinikament rilevanti li jista ’ jwassal għal żjieda fir- riskju ta ’ fsada (ara sezzjoni 4. 5).
3 Fluconazole is expected to have less effect on rivaroxaban exposure and can be co-administered with caution.
Fluconazole huwa mistenni li jkollu effett inqas fuq l- espożizzjoni ta ’ rivaroxaban u jista ’ jingħata fl- istess waqt b’ attenzjoni.
Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents (see section 4.5).
3 Għandu jkun hemm attenzjoni jekk il- pazjenti huma kkurati fl- istess waqt bi prodotti mediċinali li jaffettwaw l - emostasi bħal mediċini anti- infjammatorji mhux sterojdi (NSAIDs), acetylsalicylic acid, inibituri ta ’ l - aggregazzjoni tal- plejtlits, jew sustanzi antitrombotiċi oħra (ara sezzjoni 4. 5).
Other haemorrhagic risk factors Rivaroxaban, like other antithrombotic agents, is to be used with caution in patients with an increased bleeding risk such as: • congenital or acquired bleeding disorders • uncontrolled severe arterial hypertension • active ulcerative gastrointestinal disease • recent gastrointestinal ulcerations • vascular retinopathy • recent intracranial or intracerebral haemorrhage • intraspinal or intracerebral vascular abnormalities • recent brain, spinal or ophthalmological surgery.
Fatturi oħra ta ’ riskju ta ’ emorraġija Rivaroxaban, bħal sustanzi antitrombotiċi oħrajn, għandu jintuża b’ attenzjoni f' pazjenti b' riskju miżjud ta 'fsada bħal: • disturbi konġenitali jew miksuba ta' fsada • pressjoni għolja severa mhux ikkontrollata fl- arterji • mard gastro- intestinali ulċerattiv attiv • ulċerazzjonijiet gastro- intestinali riċenti • retinopatija vaskulari • emorraġija fil- kranju jew intraċerebrali riċenti • anormalitajiet vaskulari intraspinali jew intraċerebrali • kirurġija fil- moħħ, fis- sinsla tad- dahar jew fl- għajnejn riċenti.
Hip fracture surgery Rivaroxaban has not been studied in clinical trials in patients undergoing hip fracture surgery to evaluate efficacy and safety in these patients.
Kirurġija tal- ksur tal- ġenbejn Rivaroxaban ma kienx studjat fi provi kliniċi f’ pazjenti li għamlu kirurġija tal- ksur tal- ġenbejn biex jiġu stmati l - effikaċja u s- sigurtà f’ dawn il- pazjenti.
Therefore, rivaroxaban is not recommended in these patients.
Għalhekk rivaroxaban mhux irrakkomandat f’ dawn il- pazjenti.
Spinal/ epidural anaesthesia or puncture When neuraxial anaesthesia (spinal/ epidural anaesthesia) or spinal/ epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Anestesija jew titqib fis- sinsla tad- dahar/ epidurali Meta tintuża anestesija newro- assjali (asestesija fis- sinsla tad- dahar/ epidurali) jew titqiba fis- sinsla tad - dahar/ epidurali, pazjenti kkurati b' sustanzi antitrombotiċi għall- prevenzjoni ta 'komplikazzjonijiet tromboemboliċi, huma f' riskju li jiżviluppaw ematoma epidurali jew fis- sinsla tad- dahar li tista' tirriżulta f' paralisi fit- tul jew permanenti.
The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.
Ir- riskju ta 'dawn l- avvenimenti jista' jiżdied bl- użu ta 'kateters epidurali indwelling wara l- kirurġija, jew bl- użu fl- istess waqt ta' prodotti mediċinali li jaffettwaw l- emostasi.
The risk may also be increased by traumatic or repeated epidural or spinal puncture.
Ir- riskju jista 'jiżdied ukoll minn titqib trawmatiku jew minn titqib ripetut epidurali jew fis- sinsla tad- dahar.
Patients are to be frequently monitored for signs and symptoms of neurological impairment (e. g. numbness or weakness of the legs, bowel or bladder dysfunction).
Il- pazjenti għandhom ikunu mmonitorjati b' mod frekwenti għal sinjali u sintomi ta 'indeboliment newroloġiku (e. ż. tmewwit jew dgħjufija fir- riġlejn, funzjoni mhux normali tal- imsaren jew tal- bużżieqa ta' l- awrina).
If neurological compromise is noted, urgent diagnosis and treatment is necessary.
Jekk ikun osservat kompromess newroloġiku, tkun meħtieġa dijanjosi u kura urġenti.
Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
Qabel ma jsir intervent newro- assjali, it- tabib għandu jikkunsidra l - benefiċċju potenzjali kontra r- riskju f' pazjenti li jkunu ngħataw mediċina kontra l- koagulazzjoni tad- demm, jew f' pazjenti li jkunu ser jingħataw mediċina kontra l- koagulazzjoni tad- demm għal tromboprofilassi.
An epidural catheter is not to be removed earlier than 18 hours after the last administration of rivaroxaban.
Kateter epidurali m' għandux jitneħħa qabel 18- il siegħa wara l- aħħar għoti ta 'rivaroxaban.
The next rivaroxaban dose is to be administered not earlier than 6 hours after the removal of the catheter.
Id- doża ta ’ wara ta 'rivaroxaban m’ għandhiex tingħata qabel 6 sigħat wara t- tneħħija tal- kateter.
If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
Jekk iseħħ titqib trawmatiku, l- għoti ta 'rivaroxaban għandu jkun ittardjat għal 24 siegħa.
Interaction with CYP3A4 inducers The concomitant use of rivaroxaban with strong CYP3A4 inducers (e. g. rifampicin, phenytoin, carbamazepine, phenobarbital or St.
Interazzjoni ma ’ indutturi ta ’ CYP3A4 L- użu fl- istess waqt ta ’ rivaroxaban u indutturi qawwija ta ’ CYP3A4 (e. ż. rifampicin, phenytoin, carbamazepine, phenobarbital jew St.
John’ s Wort) may lead to reduced rivaroxaban plasma concentrations.
John’ s Wort) jista ’ jwassal għal konċentrazzjonijiet ta ’ rivaroxaban fil- plażma mnaqqsa.
Strong CYP3A4 inducers should be co-administered with caution (see section 4.5).
Indutturi qawwija ta ’ CYP3A4 għandhom jingħataw flimkien b’ attenzjoni (ara sezzjoni 4. 5).
Information about excipients Xarelto contains lactose.
4 Informazzjoni dwar sustanzi mhux attivi Xarelto fih lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, defiċjenza ta ’ Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose, m’ għandhomx jieħdu dan il- prodott mediċinali.
CYP3A4 and P-gp inhibitors Co-administration of rivaroxaban with ketoconazole (400 mg once a day [od]) or ritonavir (600 mg twice a day [bid]) led to a 2.6 fold / 2.5 fold increase in mean rivaroxaban AUC and a 1.7 fold / 1.6 fold increase in mean rivaroxaban Cmax, with significant increases in pharmacodynamic effects which may lead to an increased bleeding risk.
Inibituri ta ’ CYP3A4 u ta ’ P- gp L- għoti ta 'rivaroxaban flimkien ma' ketoconazole (400 mg darba kuljum [od]) jew ritonavir (600 mg darbtejn kuljum [bid]), wasslu għal żjieda ta '2. 6 darbiet / 2. 5 darbiet fil- medja ta' l- AUC ta 'rivaroxaban, u żjieda ta' 1. 7 darbiet / 1. 6 darbiet fil- medja ta ’ Cmax ta 'rivaroxaban, b' żidiet sinifikanti fl- effetti farmakodinamiċi li jistgħu jwasslu għal żjieda fir- riskju ta ’ fsada.
Therefore, the use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics such as ketoconazole, 4 itraconazole, voriconazole and posaconazole or HIV protease inhibitors.
Għalhekk, l- użu ta ’ Xarelto mhux irrakkomandat f' pazjenti li jkunu qed jirċievu kura sistemika fl- istess waqt b' azole- antimycotics bħal ketoconazole, itraconazole, voriconazole u posaconazole jew b' inibituri tal- protease tal- HIV.
These active substances are strong inhibitors of both CYP3A4 and P-gp (see section 4.4).
Dawn is- sustanzi attivi huma inibituri qawwija kemm ta 'CYP3A4 kif ukoll ta' P- gp (ara sezzjoni 4. 4).
Fluconazole is expected to have less effect on rivaroxaban exposure and can be co-administered with caution.
Fluconazole huwa mistenni li jkollu effett inqas fuq l- espożizzjoni ta ’ rivaroxaban u jista ’ jingħata flimkien b’ attenzjoni.
Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations to a lesser extent.
Sustanzi attivi li jinibixxu b’ mod qawwi wieħed biss mir- rotot ta ’ eliminazzjoni ta ’ rivaroxaban, CYP3A4 jew P - gp, huma mistennija li jżidu l- konċentrazzjonijiet fil- plażma ta ’ rivaroxaban fi kwantità inqas.
Clarithromycin (500 mg bid), for instance, considered as strong CYP3A4 inhibitor and moderate P-gp inhibitor, led to a 1.5 fold increase in mean rivaroxaban AUC and a 1.4 fold increase in Cmax.
Per eżempju, clarithromycin (500 mg bid), ikkunsidrat bħala inibitur qawwi ta ’ CYP3A4 u inibitur moderat ta ’ P- gp, wassal għal żjieda ta ’ 1. 5 darbiet fil- medja ta ’ l- AUC ta ’ rivaroxaban u żjieda ta ’ 1. 4 darbiet f’ Cmax.
This increase is not considered clinically relevant.
Din iż- żjieda mhux ikkunsidrata bħala klinikament rilevanti.
Erythromycin (500 mg three times a day [tid]), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Erythromycin (500 mg tliet darbiet kuljum [tid]), li jinibixxi CYP3A4 u P- gp b’ mod moderat, wassal għal żjieda ta '1. 3 darbiet fil- medja ta' l- AUC u Cmax ta 'rivaroxaban.
Anticoagulants After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose) an additive effect on anti-Factor Xa activity was observed without any additional effects on clotting tests (PT, aPTT).
Sustanzi kontra l- koagulazzjoni tad- demm Wara l- għoti ta 'enoxaparin (doża waħda ta' 40 mg) flimkien ma ’ rivaroxaban (doża waħda ta '10 mg), kien osservat effett addittiv fuq l- attività ta' kontra l- fattur Xa mingħajr l- ebda effetti oħrajn fuq it- testijiet tal - koagulazzjoni (PT, aPTT).
Enoxaparin did not affect the pharmacokinetics of rivaroxaban.
Enoxaparin ma kellux effett fuq il- farmakokinetika ta 'rivaroxaban.
Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants (see section 4.4).
Minħabba ż- żjieda fir- riskju ta 'fsada, għandha tingħata attenzjoni jekk il- pazjenti jkunu kkurati fl- istess ħin b' xi sustanzi kontra l- koagulazzjoni tad- demm oħrajn (ara sezzjoni 4. 4).
NSAIDs/ platelet aggregation inhibitors No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban and 500 mg naproxen.
NSAIDs/ inibituri ta 'l- aggregazzjoni tal- plejtlits Ma kienx osservat titwil ta' rilevanza klinika fil- ħin ta 'fsada wara l- għoti ta' rivaroxaban flimkien ma ’ naproxen 500 mg.
Nevertheless, there may be individuals with a more pronounced pharmacodynamic response.
Madankollu, jista 'jkun hemm individwi b' rispons farmakodinamiku iżjed prominenti.
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with 500 mg acetylsalicylic acid.
Ma kienu osservati l- ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi ta ’ sinifikanza klinika meta rivaroxaban ingħata flimkien ma '500 mg ta' acetylsalicylic acid.
Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/ IIIa receptor levels.
Clopidogrel (doża għolja tal- bidu ta '300 mg segwita minn doża ta ’ manteniment ta ’ 75 mg) ma weriex interazzjoni farmakokinetika, iżda kienet osservata żjieda rilevanti fil- ħin ta' fsada f' sotto- grupp ta 'pazjenti li ma kienitx ikkorrelata ma' l- aggregazzjoni tal- plejtlits, P- selectin, jew mal- livelli ta ’ riċetturi ta 'GPIIb/ IIIa.
Care is to be taken if patients are treated concomitantly with NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors because these medicinal products typically increase the bleeding risk (see section 4.4).
Għandha tingħata attenzjoni jekk il- pazjenti jkunu kkurati fl- istess waqt b’ NSAIDs inkluż acetylsalicylic acid u b' inibituri ta 'l- aggregazzjoni tal- plejtlits, għax dawn il- prodotti mediċinali tipikament iżidu r- riskju ta' fsada (ara sezzjoni 4. 4).
CYP3A4 inducers Co-administration of rivaroxaban with the strong CYP3A4 inducer rifampicin led to an approximate 50% decrease in mean rivaroxaban AUC, with parallel decreases in its pharmacodynamic effects.
Indotturi ta 'CYP3A4 L- għoti ta' rivaroxaban flimkien ma 'l- indottur qawwi ta ’ CYP3A4, rifampicin, wassal għal tnaqqis ta' madwar 50% fl- AUC medja ta 'rivaroxaban, bi tnaqqis parallel fl- effetti farmakodinamiċi tiegħu.
The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e. g. phenytoin, carbamazepine, phenobarbital or St.
L- użu ta 'rivaroxaban flimkien ma' indotturi qawwija oħrajn ta 'CYP3A4 (e. ż. phenytoin, carbamazepine, phenobarbital jew St.
John’ s Wort) may also lead to reduced rivaroxaban plasma concentrations.
John’ s Wort), jista 'jwassal ukoll għal tnaqqis fil- konċentrazzjonijiet ta' rivaroxaban fil- plażma.
Strong CYP3A4 inducers should be co-administered with caution.
Indutturi qawwija ta ’ CYP3A4 għandhom jingħataw flimkien b’ attenzjoni.
Other concomitant therapies No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp) or atorvastatin (substrate of CYP3A4 and P-gp).
Terapiji fl- istess waqt oħrajn Ma kienu osservati l- ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi ta ’ sinifikanza klinika meta rivaroxaban ingħata flimkien ma 'midazolam (substrat ta' CYP3A4), digoxin (substrat ta 'P- gp) jew atorvastatin (substrat ta' CYP3A4 u P- gp).
Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
Rivaroxaban la jinibixxi u lanqas jindotta isoformi maġġuri ta ’ CYP bħal CYP3A4.
No clinically relevant interaction with food was observed (see section 4.2).
5 Ma kienet osservata l- ebda interazzjoni ta ’ rilevanza klinika ma 'l- ikel (ara sezzjoni 4. 2).
Laboratory parameters Clotting parameters (e. g.
Parametri tal- laboratorju Il- parametri tat- tagħqid tad- demm (e. ż.
PT, aPTT, HepTest) are affected as expected by the mode of action of rivaroxaban (see section 5.1).
PT, aPTT, Hep Test) huma affettwati kif mistenni mill- mod ta 'azzjoni ta' rivaroxaban (ara sezzjoni 5. 1).
Pregnancy There are no adequate data from the use of rivaroxaban in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta 'rivaroxaban f' nisa tqal.
5 risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy (see section 4.3).
Minħabba l- potenzjal ta ’ tossiċità riproduttiva, r- riskju intrinsiku ta ’ fsada u l- evidenza li rivaroxaban jgħaddi mill- plaċenta, Xarelto huwa kontra- indikat waqt it- tqala (ara sezzjoni 4. 3).
Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Nisa li jista ’ jkollhom it- tfal għandhom jevitaw li joħorġu tqal waqt kura b’ rivaroxaban.
Lactation No data on the use of rivaroxaban in breast-feeding women are available.
Treddigħ M' hemm l- ebda tagħrif disponibbli dwar l- użu ta 'rivaroxaban f' nisa li jkunu qed ireddgħu.
Data from animals indicate that rivaroxaban is secreted into milk.
Tagħrif mill- annimali jindika li rivaroxaban jitneħħa fil- ħalib.
Therefore Xarelto is contraindicated during breast-feeding (see section 4.3).
Għalhekk, Xarelto huwa kontra- indikat waqt it- treddigħ (ara sezzjoni 4. 3).
A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from therapy.
Għandha tittieħed deċiżjoni jekk jitwaqqafx it- treddigħ jew jekk titwaqqafx/ tastjieni mit- terapija.
No studies of the effects on the ability to drive and use machines have been performed.
Sinkope u sturdament kienu rrapportati fl- isfond ta ’ wara kirurġija u jistgħu jaffettwaw il- ħila biex issuq u tħaddem magni.
Syncope and dizziness have been reported in the post-operative setting and may affect the ability to drive and use machines, these adverse reactions have been reported to be uncommon (see section 4.8).
Dawn ir- reazzjonijiet avversa kienu rrapportati bħala mhux komuni (ara sezzjoni 4. 8).
Patients experiencing these adverse reactions should not drive or use machines.
Pazjenti li jkollhom esperjenza ta ’ dawn ir- reazzjonijiet avversa m’ għandhomx isuqu jew iħaddmu magni.
The safety of rivaroxaban 10 mg has been evaluated in three phase III studies including 4,571 patients exposed to rivaroxaban undergoing major orthopaedic surgery of the lower limbs (total hip replacement or total knee replacement) treated for up to 39 days.
Is- sigurtà ta 'rivaroxaban 10 mg kienet stmata fi tliet studji ta' fażi III li kienu jinkludu 4571 pazjent esposti għal rivaroxaban li kellhom kirurġija ortopedika maġġuri fir- riġlejn (bdil totali tal- ġenbejn jew bdil totali ta 'l- irkoppa) li kienu kkurati sa 39 ġurnata.
In total, about 14% of the treated patients experienced adverse reactions.
Total ta ’ madwar 14% tal- pazjenti kkurati kellhom esperjenza ta ’ reazzjonijiet avversi.
Bleedings or anaemia occurred in approximately 3.3% and 1% of patients, respectively.
Fsada jew anemija seħħew f’ madwar 3. 3% u 1% tal- pazjenti, rispettivament.
Other common adverse reactions were nausea, increased GGT and an increase in transaminases.
Reazzjonijiet avversi komuni oħra kienu tqalligħ, żjieda f’ GGT u żjieda fit- transaminases.
The adverse reactions should be interpreted within the surgical setting.
Ir- reazzjonijiet avversi għandhom ikunu interpretati fi sfond kirurġiku.
Due to the pharmacological mode of action, the use of Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in posthaemorrhagic anaemia.
Minħabba l- mod ta 'azzjoni farmakoloġika, l- użu ta' Xarelto jista 'jkun assoċjat ma' żjieda fir- riskju ta 'fsada moħbija jew li tidher minn kull tessut jew organu, li tista' tirriżulta f' anemija wara l- emorraġija.
The signs, symptoms, and severity (including possibly fatal outcome) will vary according to the location and degree or extent of the bleeding.
Is- sinjali, sintomi, u s- severità (inkluż l- possibbiltà ta ’ riżultat fatali) ser ivarjaw skond il- post u l- grad, jew skond il- vastità tal- fsada.
The risk of bleedings may be increased in certain patient groups e. g. those patients with uncontrolled severe arterial hypertension and/ or on concomitant treatment with other medicinal products affecting haemostasis (see Haemorrhagic risk in section 4.4).
Ir- riskju ta ’ fsad jista ’ jiżdied f’ ċertu ġruppi ta ’ pazjenti e. ż. dawk il- pazjenti bi pressjoni arterjali għolja severa mhux ikkontrollata u/ jew kura fl- istess waqt bi prodotti mediċinali oħra li jaffettwaw l- emostasi (ara Riskju ta ’ emorraġija f’ sezzjoni 4. 4).
Haemorrhagic complications may present as weakness, asthenia, paleness, dizziness, headache or unexplained swelling.
Komplikazzjonijiet emorraġiċi jistgħu jidhru bħala dgħjufija, astenja, sfurija tal- ġilda, sturdament, uġigħ ta ’ ras jew nefħa mhux spjegata.
Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
Għalhekk, il- possibbiltà ta 'emorraġija għandha tkun ikkunsidrata fl- evalwazzjoni tal - kondizzjoni fi kull pazjent li jkun ingħata sustanza kontra l- koagulazzjoni tad- demm.
Adverse reactions in the three phase III studies are listed in table 1 below by system organ class (in MedDRA) and by frequency.
Reazzjonijiet avversi fit- tliet studji ta ’ fażi III huma elenkati f' Tabella 1 hawn taħt skond is- sistema tal- klassifika tal- organi (f’ MedDRA) u skond il- frekwenza.
Frequencies are defined as:
Mhux komuni:
Common: ≥ 1/ 100 to < 1/ 10 Uncommon: ≥ 1/ 1,000 to < 1/ 100 Rare: ≥ 1/ 10,000 to < 1/ 1,000 Very rare: < 1/ 10,000 Not known: cannot be estimated from the available data.
≥ 1/ 100 sa < 1/ 10 ≥ 1/ 1, 000 sa < 1/ 100
Treatment-emergent adverse reactions
Rari: ≥ 1/ 10, 000 sa < 1/ 1, 000 Rari ħafna: < 1/ 10, 000 Mhux magħruf:
Common
ma tistax tittieħed stima mid- data disponibbli.
Uncommon
6 Tabella 1:
Not known*
Mhux Komuni
Investigations
Rari
Increased GGT, increase in
Mhux magħruf *
Bilirubin conjugated
Investigazzjonijiet
transaminases (incl.
Żjieda fil- GGT, żjieda fit - transaminases (li tinkludi żjieda fl - ALT, żjieda fl- AST) Disturbi fil- qalb