qanastek/EMEA-V3 huggingface dataset:
Some patients have experienced the following side effects while taking metformin alone:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu metformin waħdu:
Very common: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite Common: a metallic taste Very rare: decreased vitamin B12 levels, hepatitis (a problem with your liver), redness of the skin (rash) or itching, lactic acidosis (excess of lactic acid in your blood) particularly in patients whose kidneys are not working properly.
Komuni ħafna: dardir, remettar, dijarea, uġigħ ta ’ żaqq u telf fl- aptit Komuni: togħma metallika Rari ħafna: tnaqqis fil- livelli ta ’ vitamina B12, epatite (problema tal- fwied), ħmura tal- ġilda (raxx) jew ħakk, aċidożi lattika (eċċess ta ’ aċidu lattiku fid- demm) partikolarment f’ pazjenti li l- kliewi tagħhom m’ humiex qegħdin jaħdmu kif suppost.
The symptoms include feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, or rapid breathing
Is- sintomi jinkludu bard jew skumdità, dardir jew remettar severi, uġigħ ta ’ żaqq, telf fil- piż mhux spjegabbli, jew nifs mgħaġġel.
HOW TO STORE EFFICIB
KIF TAĦŻEN EFFICIB
Do not use Efficib after the expiry date which is stated on the blister and the carton.
Tużax Efficib wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
What Efficib contains
X’ fih Efficib
- The active substances are sitagliptin and metformin.
- Is- sustanzi attivi huma sitagliptin u metformin.
Each film-coated tablet contains 50 mg of
Kull pillola miksija b’ rita fiha 50 mg ta ’
sitagliptin (as phosphate monohydrate) and 850 mg of metformin hydrochloride.
sitagliptin (bħala phosphate monohydrate) u 850 mg ta ’ metformin hydrochloride.
- The other ingredients are: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium
- Is- sustanzi l- oħra huma: microcrystalline cellulose (E460), povidone K 29/ 32 (E1201), sodium
lauril sulfate, and sodium stearyl fumarate.
lauril sulfate, u sodium stearyl fumarate.
In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Barra minn hekk, il- kisja tar- rita fiha s- sustanzi mhux attivi li ġejjin: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), u iron oxide black (E172).
What Efficib looks like and contents of the pack
Id- dehra ta ’ Efficib u l- kontenut tal- pakkett:
Capsule-shaped, pink film-coated tablet with “515” debossed on one side.
Pillola roża miksija b’ rita, forma ta ’ kapsula, b ’ “ 515 ” imnaqqxa fuq naħa waħda.
Opaque blisters (PVC/PE/PVDC and aluminum).
Folji opaki (PVC/ PE/ PVDC u aluminju).
Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets.
Pakketti ta ’ 14, 28, 56, 112, 168, 196 pillola miksija b’ rita, pakketti multipli li fihom 196 (2 pakketti ta ’ 98) jew 196 pillolia miksijin miksija b’ rita.
Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakkett ta ’ 50 x 1 pilloli miksijin b’ rita f’ folji ipperforati b’ dożi singoli.
Not all pack sizes may be marketed.
Manifattur Frosst Iberica S. A.
Via Compultense 140 28805 Alcala de Henares Spain
Via Compultense 140 28805 Alcala de Henares Spanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
53 PACKAGE LEAFLET:
55 FULJETT TA ’ TAGĦRIF:
Efficib 50 mg/1000 mg film-coated tablets sitagliptin/metformin hydrochloride
Efficib 50 mg/ 1000 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
They work together to control blood sugar levels in patients with a form of diabetes called ‘type 2 diabetes mellitus’.
Huma jaħdmu flimkien biex jikkontrollaw livelli ta ’ zokkor fid- demm f’ pazjenti b’ forma ta ’ dijabete msejħa ‘ dijabete mellitus tip 2 ’.
- if you are going to have an X-ray where you will be injected with a dye.
- jekk sejjer tieħu raġġi- X fejn ikun hemm bżonn tkun injettat bi speċi ta’ kulur għal kuntrast.
You will need to stop
Trid
taking Efficib at the time of the X -ray and for a few days after
tieqaf tieħu Efficib fil- ħin tar- raġġi- X u għal ftit jiem wara
- if you have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or
- jekk riċentement kellek attakk tal- qalb jew għandek problemi severi taċ- ċirkulazzjoni, bħalma
This is sometimes called insulin -dependent diabetes
- jekk għandek dijabete tip 1, jiġifieri jkun hemm bżonn l- insulina.
The following medicines are particularly important: • medicines used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids) • specific medicines for the treatment of high blood pressure (ACE inhibitors) • medicines which increase urine production (diuretics) • specific medicines for the treatment of bronchial asthma (β-sympathomimetics) • iodinated contrast agents or alcohol-containing medicines.
Il- mediċini li ġejjin huma partikolarment importanti: • mediċini wżati biex jikkuraw mard li jinvolvi infjammazzjoni, bħal ażma u artrite (kortikosterojdi) • mediċini speċifiċi għall- kura ta ’ pressjoni għolja tad- demm (impedituri ACE) • mediċini li jżidu l- produzzjoni ta ’ l- awrina (dijuretiċi) • mediċini speċifiċi għall- kura ta ’ ażma fil- bronki (simpatomimetiċi- β) • mediċini ta ’ kuntrast li fihom il- jodju jew mediċini li fihom l- alkoħol.
55 Metformin passes into human milk in small amounts.
Metformin jgħaddi fil- ħalib tal- omm f’ ammonti żgħar.
Driving and using machines No studies on the effects of Efficib on the ability to drive or to use machines have been performed.
57 Sewqan u tħaddim ta ’ magni Ma sar ebda studju fuq l- effetti ta ’ Efficib fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Very rarely patients taking metformin (one of the active substances of Efficib) have experienced a serious condition called lactic acidosis (too much lactic acid in your blood).
Din hija iktar komuni
This is more common in people whose kidneys are not working properly.
58 fin- nies li l- kliewi tagħhom ma jkunux qegħdin jaħdmu sew.
Common: low blood sugar, headache Uncommon: dizziness, constipation
Komuni: zokkor fid- demm baxx, uġigħ ta ’ ras Mhux komuni: sturdament, stitikezza Xi pazjenti kellhom ukoll l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu sitagliptin:
Do not store above 30°C.
59 Taħżinx f’ temperatura ogħla minn 30°C.
Each film -coated tablet contains 50 mg of
Kull pillola miksija b’ rita fiha 50 mg ta ’
sitagliptin (as phosphate monohydrate) and 1000 mg of metformin hydrochloride.
sitagliptin (bħala phosphate monohydrate) u 1000 mg ta ’ metformin hydrochloride.
Capsule-shaped, red film-coated tablet with “577” debossed on one side.
Pillola ħamra miksija b’ rita, forma ta ’ kapsula, b ’ “ 577 ” imnaqqxa fuq naħa waħda.
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@merck.com
60 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 Efficib@ msd. dk
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDU JIĠI IMPLIMENTAT MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDU JIĠI IMPLIMENTAT MILL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jassiguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- rigward tal- użu mingħajr periklu u effettiv tal- prodott mediċinali msemmi hawn taħt jiġu implimentati:
The MAH provides educational material to all physicians who may be involved in treating patients with prasugrel.
L- MAH għandu jipprovdi materjal edukattiv lill- ispeċjalisti kollha li jistgħu jkunu involuti fil- kura ta ’ pazjenti b’ prasugrel.
The format and means of dissemination, of this material should be discussed by the MAH with the appropriate learned societies.
Il- mod u manjiera ta ’ kif għandu jitqassam dan il- materjal għandu jiġi diskuss mal- awtoritajiet involuti fil- kura tas- saħħa.
The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state.
Ir- riżultati tad- diskussjoni, kif ukoll jekk ikun hemm bżonn il- materjal, għandhom jiġu miftiehma mal- awtorità kompetenti nazzjonali u jkunu disponibbli qabel il- ħruġ tal - prodott fis- suq f’ kull stat membru.
The educational material should include: • A copy of the SPC • Emphasis that: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age. o If, after a careful individual benefit/ risk evaluation by the prescribing physician, treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed. o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg o The evidence for a 5mg dose is based only on PK/ PD analyses and no clinical data currently exist on the safety of this dose in the at risk sub groups.
Normalment kura b’ prasugrel mhux rakkomandat f’ pazjenti ≥ 75 sena Jekk, wara valutazzjoni individwali bir- reqqa mill- ispeċjalista li qed jippreskrivih il- kura f’ dan il- grupp ta ’ età ta ’ pazjenti ≥ 75 sena tidher li tkun neċċessarja, mela mbagħad, wara d- doża ta ’ kkargar ta ’ 60 mg għandha tinkiteb riċetta ta ’ doża mnaqqsa ta ’ manteniment ta ’ 5 mg.
EPAR summary for the public
EFIENT Sommarju tal- EPAR għall- pubbliku
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is Efient?
X’ inhu Efient?
Efient is a medicine that contains the active substance prasugrel.
Efient huwa mediċina li fiha s- sustanza attiva prasugrel.
It is available as double-arrow- shaped tablets (yellow:
Jiġi bħala pilloli f’ forma ta ’ vleġġa doppja (sofor:
5 mg; beige:
5 mg; bex:
What is Efient used for?
Għal xiex jintuża Efient?
Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Efient jittieħed flimkien mal- aspirina għall- prevenzjoni ta ’ episodji aterotrombotiċi (problemi kkawżati minn tgħaqid tad- demm u twebbis tal- arterji) f’ pazjenti b’ sindromu koronarju akut li jkunu qegħdin jagħmlu intervent koronarju minn ġol- ġilda.
Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack.
Is- sindromu koronarju akut huwa grupp ta ’ kundizzjonijiet li jinkludi anġina mhux stabbli (tip serju ta ’ uġigħ fis- sider) u attakk tal- qalb.
Percutaneous coronary intervention is an operation used to unblock narrowed coronary arteries (blood vessels in the heart).
L - intervent koronarju minn ġol- ġilda huwa operazzjoni użata biex tiftaħ arterji koronarji (vini tad- demm fil- qalb) li djiequ.
How is Efient used?
Kif jintuża Efient?
Efient treatment starts with one 60-mg dose.
Il- kura b’ Efient għandha tinbeda b’ doża waħda ta ’ 60 mg.
This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Imbagħad din tiġi segwita b’ doża ta ’ 10 mg meħuda darba kuljum, ħlief f’ pazjenti li jiżnu inqas minn 60 kg, li għandhom jieħdu 5 mg darba kuljum.
The medicine can be taken with or without food.
Il- mediċina tista ’ tittieħed mal- ikel jew fuq stonku vojt.
Patients taking Efient should also take aspirin at a dose prescribed by their doctors.
Il- pazjenti li jieħdu Efient għandhom jieħdu wkoll aspirina f’ doża preskritta mit- tobba tagħhom.
It is recommended that treatment with Efient and aspirin continue for up to a year.
Huwa rrakkomandat li l- kura b’ Efient u l - aspirina tibqa ’ sejra sa sena.
The use of Efient in patients below 18 years of age is not recommended because of a lack of information on safety and effectiveness in this age group.
L- użu ta ’ Efient f’ pazjenti taħt it- 18- il sena mhuwiex rakkomandat minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din il- mediċina f’ dan il- grupp ta ’ età.
Its use is also not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary.
L- użu tiegħu mhux irrakkomandat ukoll f’ pazjenti li għandhom aktar minn 75 sena, sakemm it- tabib ma jkunx ikkunsidra sew il- benefiċċji u r- riskji tiegħu, u jqis li l- kura b’ Efient hija meħtieġa.
In this case, the 5-mg daily dose should be used following a 60-mg starting dose.
F’ dan il- każ, għandha tintuża d- doża ta ’ 5 mg kuljum wara d- doża tal- bidu ta ’ 60 mg.
How does Efient work?
Kif jaħdem Efient?
The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation.
Is- sustanza attiva f’ Efient, prasugrel, hija inibitur tal- aggregazzjoni tal- plejtlits.
This means that it helps to prevent blood clots from forming.
Dan ifisser li tgħin sabiex tipprevjeni l- formazzjoni ta ’ tagħqid tad- demm.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Meta d- demm jagħqad, dan iseħħ minħabba li ċelloli speċjali fid- demm, il- plejtlits, jeħlu ma ’ xulxin (aggregazzjoni).
Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface.
Prasugrel iwaqqaf il- plejtlits milli jeħlu ma ’ xulxin billi jimblokka sustanza msejħa ADP milli teħel ma ’ riċettur fuq il- wiċċ
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tagħhom.
How has Efient been studied?
Kif ġie studjat Efient?
The effects of Efient were first tested in experimental models before being studied in humans.
L- effetti ta ’ Efient għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘ maintenance’ doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin.
Fi studju ewlieni Efient, mogħti bħala doża tal- bidu ta ’ 60 mg segwita minn dożi ta ’ ‘ manteniment ’ ta ’ 10 mg, tqabbel ma ’ clopidogrel (inibitur ieħor tal- aggregazzjoni tal- plejtlits), biż - żewġ mediċini jittieħdu flimkien mal- aspirina.
The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention.
L- istudju kien jinvolvi kważi 14, 000 adult b’ sindromu koronarju akut li kien ser ikollhom intervent koronarju minn ġol- ġilda.
The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes.
Il- miżura ewlenija tal- effikaċja kienet it- tnaqqis fl- għadd totali ta ’ mwiet kardjovaskulari (imwiet ikkawżati minn problemi fil- qalb jew fl- arterji tad- demm), attakki tal- qalb jew puplesiji.
The patients were followed up for an average of 14.5 months.
Il- pazjenti ġew segwiti sa medja ta ’ 14. 5 xhur.
What benefit has Efient shown during the studies?
Liema benefiċċju wera Efient waqt l- istudji mwettqa?
Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes.
Efient kien aktar effettiv minn clopidogrel fit- tnaqqis tan- numru totali ta ’ mwiet għal raġunijiet kardjovaskulari, attakki tal- qalb u puplesiji.
At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).
Fl- aħħar tal- istudju, 9% tal- pazjenti li kienu ħadu Efient mietu minħabba kawżi kardjovaskulari jew kellhom attakk tal- qalb jew puplesija (643 minn 6, 813) meta mqabbla ma ’ 11% tal- pazjenti li kienu ħadu clopidogrel (781 minn 6, 795).
What is the risk associated with Efient?
X’ inhu r- riskju assoċjat ma’ Efient?
The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising.
L- iktar effetti sekondarji komuni b’ Efient (li dehru f’ bejn pazjent 1 u 10 minn kull 100) huma anemija (għadd baxx ta ’ ċelloli tad- demm ħomor), ematoma (ġbir ta ’ demm taħt il- ġilda jew f’ muskolu), epistassi (fsada mill- imnieħer), emorraġija gastrointestinali (fsada fl- istonku jew fl- intestini), raxx, ematurja (demm fl- awrina), fsada mill- partijiet fejn ikun sar xi titqib, ematoma u tbenġil fil- postijiet fejn ikun sar xi titqib.
For the full list of all side effects reported with Efient, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Efient, ara l- Fuljett ta ’ Tagħrif.
Efient should not be used in people who may be hypersensitive (allergic) to prasugrel or any of the other ingredients.
Efient m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal prasugrel jew għal xi sustanza oħra tiegħu.
It must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.
M’ għandux jintuża f’ pazjenti li għandhom kundizzjoni li tikkawża fsada eċċessiva, li kellhom puplesija jew attakk iskemiku temporanju (tnaqqis temporanju fil- provvista ta ’ demm f’ parti mill- moħħ), jew li għandhom problemi serji tal- fwied.
Why has Efient been approved?
Għaliex ġie approvat Efient?
The Committee for Medicinal Products for Human Use (CHMP) decided that Efient’ s benefits are greater than its risks, when co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Efient huma ikbar mir- riskji tiegħu, meta jingħata mal- aspirina, għall- prevenzjoni ta ’ episodji aterotrombotiċi f’ pazjenti b’ sindromu koronarju akut li għaddejjin minn intervent koronarju minn ġol - ġilda primarju jew ittardjat.
The Committee recommended that Efient be given marketing authorisation.
Il- Kumitat irrakkomanda li Efient jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Efient?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Efient?
The company that makes Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine.
Il- kumpanija li tipproduċi Efient sejra tiżgura li fl- Istati Membri kollha jkun hemm disponibbli materjal edukattiv għat- tobba li jkunu sejrin jikkuraw pazjenti b’ din il- mediċina.
The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years.
Il- materjal sejjer jinkludi tagħrif dwar kif il- mediċina tingħata b’ riċetta b’ mod sigur u jfakkar lit- tobba li l- mediċina mhijiex irrakkomandata għal pazjenti li għandhom aktar minn 75 sena.
Other information about Efient:
Informazzjoni oħra dwar Efient:
The European Commission granted a marketing authorisation valid throughout the European Union for Efient to Eli Lilly Nederland BV on 25 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Efient lil Eli Lilly Nederland BV fi 25 Frar 2009.
The full EPAR for Efient can be found here.
L- EPAR sħiħ għal Efient jista ’ jiġi kkonsultat hawn.
This summary was last updated in 01-2009.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU number
Numru ta ’ l- EU
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
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 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 Oral use Oral use Oral use Oral use Oral use Oral use
Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali
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14 tablets 28 tablets 30 x 1 tablet 56 tablets 84 tablets 90 x 1 tablet 98 tablets 14 tablets 28 tablets 30 x 1 tablet 56 tablets 84 tablets 90 x 1 tablet 98 tablets
14- il pillola 28 pillola 30 x 1 pillola 56 pillola 84 pillola 90 x 1 pillola 98 pillola 14- il pillola 28 pillola 30 x 1 pillola 56 pillola 84 pillola 90 x 1 pillola 98 pillola
NAME OF THE MEDICINAL PRODUCT
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Efient 5 mg film-coated tablets.
ISEM TAL- PRODOTT MEDIĊINALI
Each tablet contains 5 mg prasugrel (as hydrochloride).
Kull pillola fiha 5 mg prasugrel (bħala hydrochloride).
Each tablet contains 2.7 mg lactose.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Film-coated tablet (tablet).
Pillola miksija b' rita (pillola).
Yellow and double-arrow-shaped tablets, debossed with “ 5 mg” on one side and “ 4760” on the other.
Pilloli sofor f' forma ta 'vleġġa doppja, b' “ 5 mg ” imnaqqxa fuq naħa waħda u “ 4760 ” imnaqqxa fuq in - naħa l- oħra.
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i. e. unstable angina, non-ST segment elevation myocardial infarction [UA/ NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Efient, mogħti ma 'acetylsalicylic acid (ASA), huwa indikat għall- prevenzjoni ta' avvenimenti aterotrombotiċi f' pazjenti b' sindromu koronarju akut (jiġifieri anġina mhux stabbli, infart mijokardijaku mingħajr elevazzjoni tas- segment ST [UA/ NSTEMI] jew infart mijokardijaku b' elevazzjoni tas- segment ST [STEMI]) li għaddejjin minn intervent koronarju minn ġol- ġilda (PCI) primarju jew ittardjat.
For further information please refer to section 5.1.
Għal aktar tagħrif jekk jogħġbok irreferi għal sezzjoni 5. 1.
Adults Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Adulti Efient għandu jinbeda b' doża waħda ta ’ kkargar ta '60 mg u mbagħad jitkompla b' doża ta' 10 mg darba kuljum.
Patients taking Efient should also take ASA daily (75 mg to 325 mg).
Pazjenti li jieħdu Efient għandhom jieħdu wkoll ASA kuljum (75 mg sa 325 mg).
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’ s underlying disease.
F' pazjenti b' sindromu koronarju akut (ACS) li huma ttrattati b' PCI, it- twaqqif prematur ta 'kull sustanza kontra l- plejtlits, fosthom Efient, jista' jirriżulta, minħabba l- marda li għaddej minnha l- pazjent, f' riskju akbar ta 'trombożi, infart mijokardijaku jew mewt.
A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Huwa rrakkomandat li l- kura ddum sa 12- il xahar, għajr meta t- twaqqif ta 'Efient huwa klinikament indikat (ara sezzjonijiet 4. 4 u 5. 1).
Patients ≥ 75 years old The use of Efient in patients ≥ 75 years of age is generally not recommended.
Pazjenti ≥ 75 sena Normalment l- użu ta ’ Efient f’ pazjenti ≥ 75 sena mhux rakkomandat..
If, after a careful individual benefit/ risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
Jekk, wara valutazzjoni individwali bir- reqqa mill- ispeċjalista li qed jippreskrivih (ara sezzjoni 4. 4), il- kura f’ dan il- grupp ta ’ età ta ’ pazjenti ≥ 75 sena tidher li tkun neċċessarja, mela mbagħad, wara d- doża ta ’ kkargar ta ’ 60 mg għandha tinkiteb riċetta ta ’ doża mnaqqsa ta ’ manteniment ta ’ 5 mg.
Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Pazjenti ≥ 75 sena għandhom tendenza ogħla ta ’ fsada u espożizzjoni akbar għal metabolit attiv ta ’ prasugrel (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
The evidence for the 5 mg dose is based only on pharmacodynamic/ pharmacokinetic analyses and no clinical data currently exist on the safety of this dose in the patients age group ≥ 75 years.
L- evidenza għad- doża ta ’ 5 mg hija bbażata biss fuq l- analiżi farmakodinamika/ farmakokinetika u f’ dan il- mument ma jeżisti ebda tagħrif kliniku dwar is- sigurtà ta ’ din id- doża fil- grupp ta età ta ’ pazjenti ≥ 75 sena.
Patients weighing < 60 kg Efient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
2 Pazjenti li jiżnu < 60 kg Efient għandu jingħata bħala doża waħda ta ’ kkargar ta '60 mg u mbagħad jitkompla b' doża ta' 5 mg darba kuljum.
2 The 10 mg maintenance dose is not recommended.
Id- doża ta '10 mg mhix irrakkomandata.
This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg.
Dan minħabba espożizzjoni ogħla għall- metabolit attiv ta 'prasugrel, u riskju akbar ta' fsada f' pazjenti b' piż tal- ġisem < 60 kg meta jingħataw doża ta '10 mg darba kuljum meta mqabbel ma' pazjenti ≥60 kg.
Efficacy and safety of the 5 mg dose have not been prospectively assessed (see sections 4.4, 4.8 and 5.2).
L- effikaċja u s- sigurtà tad- doża ta '5 mg ma ġewx assessjati b' mod prospettiv (ara sezzjonijiet 4. 4, 4. 8 u 5. 2).
Renal impairment No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Indeboliment tal- kliewi Mhux meħtieġ aġġustament fid- doża għal pazjenti b' indeboliment tal- kliewi, fosthom pazjenti b' mard tal - kliewi fl- aħħar stadju (ara sezzjoni 5. 2).
There is limited therapeutic experience in patients with renal impairment (see section 4.4).
L- esperjenza terapewtika f' pazjenti b' indeboliment tal- kliewi hija limitata (ara sezzjoni 4. 4).
Hepatic impairment No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Indeboliment tal- fwied Mhux meħtieġ aġġustament fid- doża għal pazjenti b' indeboliment tal- fwied ħafif jew moderat (Child Pugh klassi A u B) (ara sezzjoni 5. 2).
There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
L- esperjenza terapewtika f' pazjenti b' disfunzjoni tal- fwied ħafifa u moderata hija limitata (ara sezzjoni 4. 4).
Children and adolescents Efient is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Tfal u adolexxenti Efient mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
Method of administration For oral use.
Kif jingħata Għall- użu mill- ħalq.
Efient may be administered with or without food.
Efient jista 'jingħata ma' l- ikel jew fuq stonku vojt.
Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
L- għoti fuq stonku vojt tad- doża ta ’ kkargar ta ’ 60 mg prasugrel jista ’ jipprovdi l- aktar mod mgħaġġel biex jibda jaħdem (ara sezzjoni 5. 2).
Do not crush or break the tablet.
Tfarrakx u taqsamx il- pillola.
Active pathological bleeding.
Fsada patoloġika attiva.
History of stroke or transient ischaemic attack (TIA).
Passat ta 'puplesija jew attakk iskemiku temporanju (TIA).
Severe hepatic impairment (Child Pugh class C).
Indeboliment qawwi tal- fwied (Child Pugh klassi Ċ).
Bleeding risk In the phase 3 clinical trial key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Riskju ta 'fsada F’ studju kliniku ta ’ fażi 3, il- kriterji ta' esklużjoni l- aktar importanti kienu jinkludu riskju akbar ta 'fsada; anemija; tromboċitopenija; passat ta' sejbiet patoloġiċi fil- kranju.
Patients with acute coronary syndromes undergoing PCI treated with Efient and ASA showed an increased risk of major and minor bleeding according to the TIMI classification system.
Pazjenti b' sindromi koronarji akuti ttratati b' PCI u kkurati b' Efient u ASA wrew riskju akbar ta 'fsada maġġuri u minuri skont is- sistema ta' klassifikazzjoni TIMI.
Therefore, the use of Efient in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings.
Għaldaqstant, l- użu ta 'Efient f' pazjenti b' riskju akbar ta' fsada għandhom jiġu kkunsidrati biss meta l- benefiċċji fis- sens tal- prevenzjoni ta 'avvenimenti iskemiċi huma maħsuba li jkunu akbar mir- riskju ta' fsadat serji.
This concern applies especially to patients: • ≥ 75 years of age (see below). • with a propensity to bleed (e. g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease) • with body weight < 60 kg (see sections 4.2 and 4.8).
Dan it- tħassib japplika speċjalment għal pazjenti: • ≥75 sena (ara hawn taħt). • b' tendenza li jkollhom xi fsada (eż. minħabba trawma reċenti, kirurġija reċenti, fsada gastro- intestinali reċenti jew rikorrenti, jew mard attiv ta 'ulċera peptika) • b' piż tal- ġisem < 60 kg (ara sezzjonijiet 4. 2 u 4. 8).
In these patients the 10 mg maintenance dose is not recommended.
F' dawn il- pazjenti d- doża ta 'manteniment ta' 10 mg mhix irrakkomandata.
A 5 mg maintenance dose should be used. • with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Għandha tintuża doża ta 'manteniment ta' 5 mg. • li fl- istess waqt jingħataw prodotti mediċinali li jistgħu jkabbru r- riskju ta 'fsada, fosthom sustanzi kontra l- koagulazzjoni tad- demm li jittieħdu mill- ħalq, clopidogrel, mediċini anti- infjammatorji mhux sterojdi (NSAIDs), u fibrinolitiċi.
For patients with active bleeding for whom reversal of the pharmacological effects of Efient is required, platelet transfusion may be appropriate.
F’ pazjenti b’ fsada attiva li jkollhom bżonn il- maqlub tal- effetti farmakoloġiċi ta ’ Efient, tista ’ tkun xierqa
The use of Efient in patients ≥ 75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/ risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
L- użu ta 'Efient f' pazjenti ta' ≥75 sena ġeneralment mhux irrakkomandat u għandu jingħata biss b' kawtela wara li valutazzjoni individwali bir- reqqa tal- benefiċċju/ riskju mill- ispeċjalista li jippreskrivih tindika li l - benefiċċji fis- sens tal- prevenzjoni ta 'avvenimenti iskemici jkunu akbar bil- qabda mir- riskju ta' fsadat serji.
In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal 3 bleeding, compared to patients < 75 years of age.
Fl- istudju kliniku ta 'fażi 3 dawn il- pazjenti kienu f' riskju akbar ta' fsada, inkluża fsada fatali, meta mqabbel ma 'pazjenti < 75 sena.
If prescribed, a lower maintenance dose of 5 mg should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8).
Jekk jiġi preskritt, għandha tintuża doża ta 'manteniment aktar baxxa ta' 5 mg; id- doża ta 'manteniment ta' 10 mg mhix irrakkomandata (ara sezzjonijiet 4. 2 u 4. 8).
Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
L- esperjenza terapewtika b' prasugrel f' pazjenti b' indeboliment tal- kliewi (inkluż ESRD) u f' pazjenti b' indeboliment moderat tal- fwied hija limitata.
These patients may have an increased bleeding risk.
Dawn il- pazjenti jistgħu jkollhom riskju akbar ta 'fsada.
Therefore, prasugrel should be used with caution in these patients.
Għaldaqstant, prasugrel għandu jintuża b' kawtela f' dawn il- pazjenti.
Therapeutic experience with prasugrel is limited in Asian patients.
L- esperjenza terapewtika b' prasugrel f' pazjenti Asjatiċi hija limitata.
Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Il- pazjenti għandhom jiġu infurmati li meta jieħdu prasugrel (flimkien ma 'ASA) jista' jkun li t- twaqqif ta 'fsada ddum aktar mis- soltu, u li għandhom jirrapportaw kull fsada mhux tas- soltu (sit jew tul ta' fsada) lill- ispeċjalista tagħhom.
Surgery Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
Kirurġija Il- pazjenti għandhom jiġu avżati biex jinfurmaw lill- ispeċjalisti u lid- dentisti li huma qegħdin jieħdu prasugrel qabel ma tiġi ppjanata xi kirurġija u qabel ma jittieħed xi prodott mediċinali ġdid.
If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Efient should be discontinued at least 7 days prior to surgery.
Jekk pazjent se ssirlu kirurġija mhux urġenti, u mhux mixtieq effett kontra l- plejtlits, Efient għandu jitwaqqaf mill - anqas 7 ijiem qabel il- kirurġija.
Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see 4.8).
F' pazjenti li ssirilhom kirurġija ta 'CABG fi żmien 7 ijiem li jitwaqqaf prasugrel tista' sseħħ fsada b' severità u frekwenza akbar (ara 4. 8).
The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Il- benefiċċji u r- riskji ta 'prasugrel għandhom jiġu kkunsidrati sewwa f' pazjenti li l- anatomija koronarja tagħhom ma ġietx definita u hemm possibiltà ta' CABG urġenti.
Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of other thienopyridines.
Purpura Trombotika Tromboċitopenika (TTP) Ġiet irrapportata TTP bl- użu ta 'thienopyridines oħra.
TTP is a serious condition and requires prompt treatment.
TTP hija kundizzjoni serja u tirrikjedi kura fil - pront.
Efient was not associated with TTP in clinical trials supporting registration.
Efient ma ġiex assoċjat ma 'TTP fil- provi kliniċi li jsostnu r- reġistrazzjoni.
Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take Efient.
Lactose Pazjenti bi problemi ereditarji rari ta 'intolleranza għal galactose, b' nuqqas ta' Lapp lactase jew b' assorbiment ħażin ta 'glucose- galactose m' għandhomx jieħdu Efient.
Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied.
It- teħid ta 'Efient flimkien ma' derivattivi ta 'coumarin minbarra warfarin ma ġiex studjat.
Because of the potential for increased risk of bleeding, warfarin (or other coumarin derivatives) and prasugrel should be co-administered with caution (see section 4.4).
Minħabba l- potenzjal ta 'riskju akbar ta' fsada, warfarin (jew derivattivi oħra ta 'coumarin) u prasugrel għandhom jingħataw flimkien b' kawtela (ara sezzjoni 4. 4).
Non-steroidal anti-inflammatory drugs (NSAIDs):
Mediċini anti- infjammatorji mhux sterojdi (NSAIDs):
Concomitant administration with chronic NSAIDs has not been studied.
It- teħid flimkien ma 'NSAIDs kroniċi ma ġiex studjat.
Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be co-administered with caution (see section 4.4).
Minħabba l- potenzjal ta 'riskju akbar ta' fsada, NSAIDs kroniċi (fosthom inibituri ta 'COX- 2) u Efient għandhom jingħataw flimkien b' kawtela (ara sezzjoni 4. 4).
Efient can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
4 Efient jista 'jingħata flimkien ma' prodotti mediċinali li jiġu mmetabolizzati minn enzimi ta 'ċitokromu P450 (fosthom statins), jew prodotti mediċinali li huma stimulanti jew inibituri ta' l- enzimi ta 'ċitokromu P450.
Efient can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Efient jista 'jingħata wkoll flimkien ma' ASA, eparina, digoxin, u prodotti mediċinali li jgħollu l- pH ta 'l- istonku, fosthom inibituri tal- pompa tal- proton u mblokkaturi ta' H2.
Although not studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/ IIIa inhibitors (no information available regarding the type of GP IIb/ IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Għalkemm ma ġiex studjat fi studji speċifiċi ta 'interazzjonijiet, fl- istudju kliniku ta' fażi 3 Efient ġie mogħti flimkien ma 'eparina b' piż molekulari baxx, bivalirudin, u inibituri ta' GP IIb/ IIIa (m' hemmx tagħrif dwar liema tip ta 'inibitur ta' GP IIb/ IIIa ġie użat) mingħajr evidenza ta 'interazzjonijiet avversi klinikament sinifikanti.
Effects of other medicinal products on Efient:
Effetti ta 'prodotti mediċinali oħra fuq Efient:
Acetylsalicylic acid:
Acetylsalicylic acid:
Efient is to be administered concomitantly with acetylsalicylic acid (ASA).
Efient għandu jingħata flimkien ma 'acetylsalicylic acid (ASA).
Although a pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible, the demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with ASA.
Għalkemm hemm possibiltà ta 'interazzjoni farmakodinamika ma' ASA li twassal għal riskju akbar ta 'fsada, it- turija ta' l - effikaċja u s- sigurtà ta 'prasugrel ġejja minn pazjenti li jeħduh flimkien ma' ASA.
A single intravenous bolus dose of unfractionated heparin (100 U/ kg) did not significantly alter the prasugrel-mediated inhibition of platelet aggregation.
Doża waħda sħiha ġol- vini ta 'eparina mhux maqsuma fi frazzjonijiet (100 U/ kg) ma bidlitx l - inibizzjoni ta' l- aggregazzjoni ta 'plejtlits permezz ta' prasugrel b' mod sinifikanti.
Likewise, prasugrel did not significantly alter the effect of heparin on measures of coagulation.
Bl- istess mod, prasugrel ma bidilx l- effett ta 'eparina fuq il- miżuri ta' koagulazzjoni b' mod sinifikanti.
Therefore, both medicinal products can be administered concomitantly.
Għaldaqstant, iż- żewġ prodotti mediċinali jistgħu jittieħdu flimkien.
An increased risk of bleeding is possible when Efient is co- administered with heparin.
Huwa possibbli li jkun hemm riskju akbar ta 'fsada meta Efient jingħata flimkien ma' eparina.
Statins:
Statins:
Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation.
Atorvastatin (80 mg kuljum) ma bidilx il- farmakokinetika u l- inibizzjoni ta 'l- aggregazzjoni ta' plejtlets ta 'prasugrel.
Therefore, statins that are substrates of CYP3A are not anticipated to have an effect on the pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Għaldaqstant, statins li huma substrati ta 'CYP3A mhumiex mistennija li jkollhom effett fuq il- farmakokinetika ta ’ prasugrel jew l- inibizzjoni ta' l- aggregazzjoni ta 'plejtlets permezz ta' prasugrel.
Medicinal products that elevate gastric pH:
Prodotti mediċinali li jgħollu l- pH ta 'l- istonku:
Daily co-administration of ranitidine (an H2 blocker) or lansoprazole (a proton pump inhibitor) did not change the prasugrel active metabolite’ s AUC and Tmax, but decreased the Cmax by 14% and 29%, respectively.
It- teħid kuljum flimkien ma 'ranitidine (imblokkatur ta' H2) jew lansoprazole (inibitur tal- pompa tal- proton) ma bidilx l- AUC u Tmax tal- metabolit attiv ta 'prasugrel, iżda naqqas is- Cmax b' 14% u 29%, rispettivament.
In the phase 3 clinical trial, Efient was administered without regard to co-administration of a proton pump inhibitor or H2 blocker.
Fl- istudju kliniku ta 'fażi 3, Efient ingħata mingħajr rigward għat- teħid flimkien ma' inibitur tal- pompa tal- proton jew imblokkatur ta 'H2.
Administration of the 60 mg prasugrel loading dose without concomitant use of proton pump inhibitors may provide most rapid onset of action.
It- teħid tad- doża ta ’ kkargar ta ’ 60 mg prasugrel mingħajr l- użu fl- istess ħin ta 'inibituri tal- pompa tal- proton jista ’ jipprovdi l- aktar mod mgħaġġel biex jibda jaħdem.
Inhibitors of CYP3A:
Inibituri ta 'CYP3A:
Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite’ s AUC and Tmax, but decreased the Cmax by 34% to 46%.
Ketoconazole (400 mg kuljum), inibitur selettiv u qawwi ta 'CYP3A4 u CYP3A5, ma affettwax l- inibizzjoni ta' l- aggregazzjoni ta 'plejtlits permezz ta' prasugrel jew l- AUC u Tmax tal- metabolit attiv ta 'prasugrel, iżda naqqas is- Cmax b’ 34% sa 46%.
Therefore, CYP3A inhibitors such as azol antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Għaldaqstant, inibituri ta 'CYP3A bħal sustanzi azol kontra l- fungi, inibituri ta' HIV protease, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, u meraq tal- grejpfrut mhumiex mistennija li jkollhom effett sinifikanti fuq il - farmakokinetika tal- metabolit attiv.
Inducers of cytochromes P450:
Stimulanti ta 'ċitokromi P450:
Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6, and an inducer of CYP2C9, CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of prasugrel.
Rifampicin (600 mg kuljum), stimulant qawwi ta 'CYP3A u CYP2B6, u stimulant ta' CYP2C9, CYP2C19, u CYP2C8, ma bidilx il- farmokokinetika ta 'prasugrel b' mod sinifikanti.
Therefore, known CYP3A inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 are not anticipated to have significant effect on the pharmacokinetics of the active metabolite.
Għaldaqstant, stimulanti magħrufa ta 'CYP3A bħal rifampicin, carbamazepine, u stimulanti oħra ta' ċitokromi P450 mhumiex mistennija li jkollhom effett sinifikanti fuq il- farmakokinetika tal - metabolit attiv.
Effects of Efient on other medicinal products:
Effett ta 'Efient fuq prodotti mediċinali oħra:
Digoxin: prasugrel has no clinically significant effect on the pharmacokinetics of digoxin.
Digoxin: prasugrel m' għandu l- ebda effett klinikament sinifikanti fuq il- farmakokinetika ta 'digoxin.
Medicinal products metabolised by CYP2C9: prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Prodotti mediċinali mmetabolizzati minn CYP2C9: prasugrel ma inibixxix CYP2C9, u ma affettwax il - farmakokinetika ta 'S- warfarin.
Because of the potential for increased risk of bleeding, warfarin and Efient should be co-administered with caution (see section 4.4).
Minħabba l- potenzjal ta 'riskju akbar ta' fsada, warfarin u Efient għandhom jingħataw flimkien b' kawtela (ara sezzjoni 4. 4).
Medicinal products metabolised by CYP2B6: prasugrel is a weak inhibitor of CYP2B6.
5 Prodotti mediċinali mmetabolizzati minn CYP2B6: prasugrel huwa inibitur dgħajjef ta 'CYP2B6.
In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%.
F' suġġetti b' saħħithom, prasugrel naqqas l- espożizzjoni għal hydroxybupropion, metabolit ta 'bupropion permezz ta' CYP2B6, b' 23%.
This effect is likely to be of clinical concern only when prasugrel is co- administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e. g. cyclophosphamide, efavirenz).
Dan l- effett jista 'jkun ta' interess kliniku biss meta prasugrel jingħata flimkien ma 'prodotti mediċinali għal liema CYP2B6 hija l- unika katalista għas- sensiela ta' reazzjonijiet metaboliċi u għandhom skala terapewtika dejqa (eż. cyclophosphamide, efavirenz).
No clinical study has been conducted in pregnant or lactating women.
Ma sarux studji kliniċi f' nisa tqal jew li qegħdin ireddgħu.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti fuq it- tqala, fuq l- iżvilupp ta 'l- embriju/ fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
Because animal reproduction studies are not always predictive of a human response, Efient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Billi studji tar- riproduzzjoni fil- bhejjem mhux dejjem jagħtu pronostku tar- rispons fl- umani, Efient għandu jintuża fit- tqala biss jekk il- benefiċċju potenzjali għall - omm jiġġustifika r- riskju potenzjali għall- fetu.
It is unknown whether prasugrel is excreted in human breast milk.
Mhux magħruf jekk prasugrel joħroġx fil- ħalib tas- sider uman.
Animal studies have shown excretion of prasugrel in breast milk.
Studji fuq il- bhejjem urew li prasugrel joħroġ fil- ħalib tas- sider.
The use of prasugrel during breastfeeding is not recommended.
L- użu ta 'prasugrel waqt it- treddigħ mhux irrakkomandat.
5 Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/ m2).
Prasugrel ma kellu l- ebda effett fuq il- fertilità ta 'firien maskili u femminili b' dożi mill- ħalq sa espożizzjoni ta' 240 darba aktar mid- doża ta 'manteniment irrakkomandata għall- umani li tittieħed kuljum (ibbażata fuq mg/ m2).