qanastek/EMEA-V3 huggingface dataset:
17 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).
The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/ NSTEMI and All ACS populations.
L- inċidenza ta 'fsada maġġuri skont TIMI relatata ma' non- CABG, fosthom dik ta 'theddid għall- ħajja u fatali, kif ukoll fsada minuri skont TIMI, kienet ogħla b' mod statistikament sinifikanti f' suġġetti kkurati b' prasugrel meta mqabbel ma' clopidogrel f' UA/ NSTEMI u l- popolazzjonijiet tal - Pazjenti Kollha b' ACS.
a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria. b Other standard therapies were used as appropriate. c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥ 5 g/ dL.
2. 6
18 d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below.
a Avvenimenti ġġudikati ċentrali mfissra mill- kriterji tal- Grupp ta 'Studju ta' Trombolisi f' Infart Mijokardijaku (TIMI). b Terapiji standard oħra ġew użati kif xieraq. c Kull emorraġija fir- ras jew kull fsada li tidher klinikament u assoċjata ma 'waqa' ta 'emoglobina ta' ≥5 g/ dL. d Fsada ta 'theddid għall- ħajja hija set sekondarju mis- set ta' fsada maġġuri skont TIMI u tinkludi t- tipi mdaħħlin aktar 'il ġewwa ta' hawn taħt.
For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group.
Għall- pazjenti li rċevew thienopyridine fi żmien 3 ijiem qabel CABG, il- frekwenzi ta 'fsada maġġuri jew minuri skont TIMI kienu ta' 26. 7% (12
19 Gingival bleeding Skin and subcutaneous tissue disorders Renal and urinary disorders
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda Disturbi fil- kliewi u fis - sistema urinarja
Patients randomised to receive prasugrel (60 mg loading dose followed by 10 mg once daily) or clopidogrel (300 mg loading dose followed by 75 mg once daily) were treated for a median of 14.5 months (maximum of 15 months with a minimum of 6 months follow-up).
23 Pazjenti magħżulin b' mod arbitrarju biex jirċievu prasugrel (b' doża ta 'kkargar ta ’ 60 mg segwita b' 10 mg darba kuljum) jew clopidogrel (b' doża ta ’ kkargar ta' 300 mg segwita b' 75 mg darba kuljum) ġew ikkurati għal medjan ta '14. 5 xhur (massimu ta' 15- il xahar u segwiti wara l- kura għal minimu ta '6 xhur).
21 The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients < 75 years.
Il- benefiċċju ta 'prasugrel li ġie osservat f' pazjenti ≥ 75 sena kien anqas minn dak osservat f' pazjenti < 75 sena.
Table 3:
24 Tabella 3:
Outcome Events
Avvenimenti li Seħħew Pazjenti Kollha b' ACS
+ ASA
Prasugrel + ASA (N=6813)%
+ASA
Clopidogrel +ASA (N=6795)%
All ACS
valur p
22 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Pharmacokinetics of prasugrel and its inhibition of platelet aggregation are similar in patients with moderate renal impairment (GFR 30- < 50 ml/ min/ 1.73m2) and healthy subjects.
26 kliewi, inklużi pazjenti b' mard tal- kliewi fl- aħħar stadju (ESRD).
23 similar in patients with ESRD who required haemodialysis compared to healthy subjects, although Cmax and AUC of the active metabolite decreased 51% and 42%, respectively, in ESRD patients.
L- inibizzjoni ta 'aggregazzjoni ta' plejtlits permezz ta 'prasugrel kienet simili wkoll f' pazjenti b' ESRD li kellhom bżonn dijaliżi tad- demm meta mqabbel ma' suġġetti b' saħħithom, għalkemm Cmax u AUC tal- metabolit attiv naqsu 51% u 42%, rispettivament, f' pazjenti b' ESRD.
24 Film-Coat:
Kisja tal- pillola:
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide red (E172) Iron oxide yellow (E172) Talc
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide aħmar (E172) Iron oxide isfar (E172) Talc
< {DD month YYYY} >
{JJ xahar SSSS}
25 ANNEX II
29 ANNESS II
Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Avda de la Industria 30 E- 28108 Alcobendas (Madrid) Spanja
The MAH should provide 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 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.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version v2.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni v2. 1 ippreżentat fit- Taqsima 1. 8. 1 tal- Applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq, qiegħda preżenti u qiegħda taħdem qabel ma jpoġġi l- prodott fuq is- suq u waqt li l - prodott qiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Revision 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
31 Pjan dwar l- Immaniġġar tar- Riskju L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fir- Reviżjoni 1. 4 tal- Pjan dwar l- Immaniġġar tar- Riskju (RMP) ippreżentat fit- Taqsima 1. 8. 2 tal- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ kull aġġornament ta ’ l- RMP li jkun qabel miegħu is- CHMP.
27 As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kif hemm fil- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien mar- Rapport ta ’ Aġġornament Perjodiku dwar is- Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Fi żmien 60 ġurnata minn meta jkun deċiż xi avveniment importanti (ta ’ farmakoviġilanza jew tat- tnaqqis tar- riskju)
28 ANNEX III
32 ANNESS III
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF 5mg FILM-COATED TABLETS
KAXXA TA ’ 5 mg PILLOLI MIKSIJA B’ RITA
Efient 5 mg film-coated tablets prasugrel
ISEM TAL- PRODOTT MEDIĊINALI
Each tablet contains 5 mg prasugrel (as hydrochloride)
Kull pillola fiha 5 mg prasugrel (bħala hydrochloride)
Contains lactose.
Fih lactose.
See leaflet for further information.
Ara l- fuljett għal aktar informazzjoni
14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 56 film-coated tablets 84 film-coated tablets 90x1 film-coated tablet 98 film-coated tablets
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 x 1 pillola miksija b’ rita 56 pillola miksija b’ rita 84 pillola miksija b’ rita 90 x 1 pillola miksija b’ rita 98 pillola miksija b’ rita
Oral use
Għall- użu orali
EXP
JIS 9.
Store in the original package to protect from air and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- arja u mill- umdità
EU/ X/ XX/ XXX/ XXX 14 film-coated tablets EU/ X/ XX/ XXX/ XXX 28 film-coated tablets EU/ X/ XX/ XXX/ XXX 30x1 film-coated tablet EU/ X/ XX/ XXX/ XXX 56 film-coated tablets EU/ X/ XX/ XXX/ XXX 84 film-coated tablets EU/ X/ XX/ XXX/ XXX 90x1 film-coated tablet EU/ X/ XX/ XXX/ XXX 98 film-coated tablets
EU/ X/ XX/ XXX/ XXX 14- il pillola miksija b’ rita EU/ X/ XX/ XXX/ XXX 28 pillola miksija b’ rita EU/ X/ XX/ XXX/ XXX 30 x 1 pillola miksija b’ rita EU/ X/ XX/ XXX/ XXX 56 pillola miksija b’ rita EU/ X/ XX/ XXX/ XXX 84 pillola miksija b’ rita EU/ X/ XX/ XXX/ XXX 90 x 1 pillola miksija b’ rita EU/ X/ XX/ XXX/ XXX 98 pillola miksija b’ rita
Efient 5 mg
Efient 5 mg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER OF 5 mg FILM-COATED TABLETS
FOLJA TA ’ 5 mg PILLOLI MIKSIJA B’ RITA
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
< TNE, TLIE, ERB, ĦAM, ĠIM, SIB, ĦAD > TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF 10 mg FILM-COATED TABLETS
KAXXA TA ’ 10 mg PILLOLI MIKSIJA B’ RITA
Efient 10 mg film-coated tablets prasugrel
ISEM TAL- PRODOTT MEDIĊINALI
Each tablet contains 10 mg prasugrel (as hydrochloride)
Kull pillola fiha 10 mg prasugrel (bħala hydrochloride)
EXPIRY DATE
DATA TA ’ META JISKADI JIS
Efient 10 mg
Efient 10 mg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER OF 10 mg FILM-COATED TABLETS
FOLJA TA ’ 10 mg PILLOLI MIKSIJA B’ RITA
Lot:
Lott
< MON, TUE, WED, THU, FRI, SAT, SUN, >
< TNE, TLIE, ERB, ĦAM, ĠIM, SIB, ĦAD > B.
37 PACKAGE LEAFLET:
41 FULJETT TA ’ TAGĦRIF:
Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Efient 10 mg pilloli miksija b’ rita Efient 5 mg pilloli miksija b’ rita Prasugrel
if their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Efient is and what it is used for 2.
X’ inhu Efient u għalxiex jintuża 2.
Before you take Efient 3.
Qabel ma tieħu Efient 3.
How to take Efient 4.
Kif għandek tieħu Efient 4.
Possible side effects 5.
Effetti sekondarju li jista jkollu 5.
How to store Efient 6.
Kif taħżen Efient 6.
WHAT EFIENT IS AND WHAT IT IS USED FOR
X’ INHU EFIENT U GĦALXIEX JINTUŻA
Efient, belongs to a group of medicines called anti-platelet agents.
Efient, jifforma parti minn grupp ta ’ mediċini msejħa sustanzi ta ’ kontra l- plejtlets.
Platelets are very small cell particles that circulate in the blood.
Il- plejtlits huma partiċelli ċellulari żgħar ħafna li jiċċirkolaw fid- demm.
When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus).
Jekk ikun hemm xi ħsara f’ xi arterja jew vina per eżempju minħabba xi qtugħ, il- plejtlits jingħaqdu flimkien biex jgħinu biex jifforma koagulu tad- demm (trombu).
Therefore, platelets are essential to help stop bleeding.
Għalhekk, il- plejtlits huma essenzjali biex jgħinu jwaqqafu fsada.
If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death.
Jekk jifformaw xi ċapep tad - demm f’ xi parti mis- sistema ċirkolatorja bħal xi arterja li tkun ibbieset dawn jistgħu jkunu perikolużi ħafna għax jistgħu jwaqqfu l- forniment tad- demm u jikkawżaw attakk tal- qalb (infart mijokardiku), attakk ta ’ puplesija jew mewt.
Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain).
Ċapep tad- demm fl- arterji li jagħtu d- demm lill- qalb jistgħu wkoll inaqqsu l - ammont ta ’ demm li jasal fil- qalb li jwassal għal anġina instabbli (uġigħ qawwi fis- sider).
Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
Effient ma jħallix il- plejtlits jingħaqdu flimkien u għalhekk inaqqas il- possibbiltà li tifforma xi ċappa demm.
You have been prescribed Efient because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart.
Ingħatajt Efient għax inti diġà kellek attakk ta ’ qalb jew anġina instabbli u għaddejt minn proċedura biex jinfetħulek xi arterji mblokkati fil- qalb.
You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart.
Jista ’ jkun ukoll li poġġewlek xi ‘ stent ’ jew iżjed minn waħda sabiex arterja li tagħti d- demm lill- qalb li kienet imblokkata jew djieqet tibqa ’ miftuħa.
Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events.
Effient inaqqas il - possibbiltà li jkollok attakk ieħor ta ’ qalb jew xi attakk ta ’ puplesija jew li tmut minħabba xi wieħed minn dawn l- avvenimenti aterotrombotiċi.
Your doctor will also give you acetylsalicylic acid (e. g. aspirin), another anti- platelet agent.
It- tabib tiegħek se jagħtik ukoll acetylsalicylic acid (eż. aspirina), sustanza oħra kontra l- plejtlits.
BEFORE YOU TAKE EFIENT
QABEL MA TIEĦU EFIENT
Do not take Efient
Tieħux Efient:
An
– Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal prasugrel jew sustanzi oħra ta ’ Efient.
allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Tinduna li għandek reazzjoni allerġika għax ikollok raxx, ħakk, wiċċ minfuħ, xufftejn minfuħa u qtugħ ta ’ nifs.
If this has happened to you, tell your doctor.
Jekk ġralek hekk, għid lit- tabib tiegħek.
- If you have a medical condition that is currently causing bleeding, such as bleeding from your
42 – Jekk tbati minn kundizzjoni medika li fil- preżent qiegħda tikkawża xi fsada, bħal fsada mill- istonku jew mill- imsaren. – Jekk qatt kellek xi attakk ta ’ puplesija jew xi attakk iskemiku momentanju (TIA) – Jekk tbati minn mard sever tal- fwied;
38 Take special care with Efient You should tell your doctor before taking Efient if any of the situations mentioned below apply to you:
Oqgħod attent ħafna b’ Efient Jekk xi sitwazzjoni msemmija hawn taħt tgħodd għalik, għid lit- tabib tiegħek qabel tibda tieħu Efient:
age of 75 years or older.
– Jekk għandek riskju ogħla ta ’ fsada bħal: – età ta ’ 75 sena jew iżjed.
Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years
It- tabib għandu jagħmillek riċetta għal 5 mg kuljum għax ir - riskju ta ’ fsada hija ogħla f’ pazjenti li għandhom iżjed minn 75 sena – ferita gravi reċenti – operazzjoni reċenti (inklużi xi proċeduri li għandhom x’ jaqsmu mas- snien) – fsada reċenti jew rikorrenti mill- istonku jew mill- imsaren (eż. xi ulċera fl- istonku, polipi tal- kolon) – tiżen inqas minn 60 kg.
Your doctor should prescribe a daily dose of 5 mg of Efient if you weigh less than 60 kg
It- tabib għandu jagħmillek riċetta għal 5 mg ta ’ Efient kuljum jekk tiżen inqas minn 60 kg – mard renali (tal- kliewi) jew problemi moderati fil- fwied – tieħu xi ċerti tipi ta ’ mediċini (ara ‘ Meta tieħu mediċini oħra ’ aktar ’ l isfel) – operazzjoni li ser issirlek (inklużi xi proċeduri li għandhom x’ jaqsmu mas- snien) fis - sebat ijiem li ġejjin.
Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding
Jista ’ jkun li t- tabib ikun jixtieq iwaqqaf temporjanamet it- teħid ta ’ Efient minħabba r- riskju ogħla ta ’ fsada.
- Although no cases have been seen with Efient, with certain other antiplatelet agents a very rare
– Jekk inti Asjatiku/ a – l- esperjenza tal- użu ta ’ Efient fl- Asjatiċi hija limitata – Għalkemm ma dehrux każijiet b’ Efient, b’ ċerti sustanzi oħra kontra l- plejtlits seħħet kundizzjoni rari ħafna msejħa Purpura Tromboċitopenika Trombotika (PTT).
TTP is associated with fever, tiny round pin-point purplish-red bruises, small to medium-sized bruises, confusion, headaches and a decrease in the number of platelets.
PTT hija assoċjata ma ’, deni, tbenġil b’ forma ta ’ ponot żgħar ħafna ta ’ kulur aħmar fil- vjola, tbenġil ta ’ daqs medju għal żgħir, konfużjoni, uġigħ ta ’ ras u tnaqqis fin- numru ta ’ plejtlits.
If you notice tiny round pin-point purplish-red bruises, please contact your doctor immediately.
Jekk tinduna b’ xi ponot żgħar tondi ta ’ tbenġil ta ’ kulur aħmar fil- vjola, jekk jogħġbok għamel kuntatt mat- tabib tiegħek immedjatament.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, vitamini u prodotti magħmulin mill- ħxejjex.
It is particularly important to tell your doctor if you are being treated with clopidogrel (an anti-platelet agent), warfarin (an anti-coagulant), or “ non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).
B’ mod partikulari huwa importanti li tgħid lit- tabib tiegħek jekk qed/ a tiġi kkurat/ a b’ clopidogrel (sustanza kontra l- plejtlits), warfarin (antikoagulant), jew “ mediċini antinfjammatorji li mhumiex sterojdi ” għall- uġigħ u d- deni (bħal ibuprofen, naproxen, etoricoxib).
If given together with Efient these medicines may increase the risk of bleeding
Jekk jingħataw flimkien ma ’ Efient dawn il- mediċini jistgħu jżidu r - riskju ta ’ fsada.
Only take other medicines while you are on Efient if your doctor tells you that you can.
Waqt li qed/ a tieħu Efient, ħu biss mediċini oħra jekk it- tabib tiegħek jgħidlek li tista ’ teħodhom.
Taking Efient with food and drink Efient may be taken with or without food.
Efient jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Pregnancy and breast-feeding Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient.
Tqala u treddigħ Għid lit- tabib tiegħek jekk waqt li qeda tieħu Efient toħroġ tqila jew qeda tipprova toħroġ tqila.
You should use Efient only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Għandek tieħu Efient biss wara li ddiskutejt mat- tabib tiegħek il- benfiċċji li tista ’ tieħu u r- riskji li jista ’ jkun hemm għat- tarbija li għada ma twelditx.
If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.
Jekk qeda tredda ’, itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Driving and using machines No studies on the effects of Efient on the ability to drive and use machines have been performed.
43 Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti ta ’ Efient fuq il- kapaċità ta ’ sewqan u tħaddim ta ’ magni.
Efient is unlikely to affect your ability to drive or use machines.
Efient m’ għandux jaffettwa l- kapaċità tiegħek li ssuq jew tuża magni.
Important information about some of the ingredients of Efient Efient contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Efient Efient fih lactose.
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk xi tabib qallek li għandek xi intolleranza għal ċerti tipi ta ’ zokkor, ikkuntatja lit - tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE EFIENT
KIF GĦANDEK TIEĦU EFIENT
Always take Efient exactly as your doctor has told you.
Dejjem għandek tieħu Efient skont il- parir eżatt tat- tabib.
Your doctor will tell you how many Efient tablets to take.
It- tabib tiegħek se jgħidlek kemm għandek tieħu pilloli ta ’ Efient.
The usual dose of Efient is 10 mg per day.
Normalment, id- doża ta ’ Efient hi ta ’ 10 mg kuljum.
You will start the treatment with a single dose of 60 mg.
Tibda l- kura b’ doża waħda ta ’ 60 mg.
If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day.
Jekk tiżen inqas minn 60 kg jew għandek iżjed minn 75 sena, id- doża hi ta ’ 5 mg ta ’ Efient kuljum.
Your doctor will also tell you to take acetylsalicylic acid- (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
It- tabib tiegħek se jgħidlek ukoll biex tieħu acetylsalicylic acid – hu jew hi se tgħidlek id- doża eżatta li għandek tieħu (is- soltu bejn 75 mg u 325 mg kuljum).
You may take Efient with or without food.
Tista tieħu Efient ma ’ jew mingħajr l- ikel.
Take your dose at around the same time every day.
Ħu d- doża tiegħek bejn wieħed u ieħor fl- istess ħin kuljum.
Do not break or crush the tablet.
Tkissirx jew tfarrakx il- pillola.
It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient.
Huwa importanti li tgħid lit- tabib, dentista u spiżjar tiegħek li qed tieħu Efient.
Efient should not be used in children and adolescents below 18 years of age.
Efient ma għandux jingħata lit- tfal u adoloxxenti taħt 18 il- sena.
If you take more Efient than you should Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
B’ mod immedjat, ikkuntattja lit- tabib jew l- isptar tiegħek għax tista ’ tkun f’ riskju li titlef ħafna demm.
You should show the doctor your pack of Efient.
Għandek turi lit- tabib il- pakkett tiegħek ta ’ Efient.
If you forget to take Efient If you miss your scheduled daily dose, take Efient when you remember.
Jekk tinsa tieħu d- doża tiegħek normali ta ’ kuljum, ħu Efient meta tiftakar.
If you forget your dose for an entire day, just resume taking Efient at its usual dose the next day.
Jekk tinsa tieħu d- doża tiegħek għal ġurnata sħiħa, kull m’ għandek tagħmel hu li tieħu Efient skont id- doża tas- soltu, l- ġurnata li jmiss.
Do not take two doses in one day.
Tieħux żewġ dożi f’ ġurnata waħda.
For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Għall- pakketti ta ’ 14, 28 56, 84 u 96 pillola, tista ’ tiċċekkja l- ġurnata li fiha ħadt l- aħħar il- pillola ta ’ Efient billi tirreferi għall- kalendarju stampat fuq il- folja.
If you stop taking Efient Do not stop taking Efient without consulting your doctor.
Jekk tieqaf tieħu Efient:
It is especially important to discuss with your doctor before stopping Efient because both the risks and the benefits are based on regular use.
Tieqafx tieħu Efient mingħajr ma tkun tkellimt mat- tabib tiegħek. Huwa speċjalment importanti li qabel twaqqaf Efient tiddiskuti mat- tabib tiegħek għax kemm ir- riskji kif ukoll il- benefiċċji huma bbażati fuq l - użu regolari.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Efient can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Efient jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
• Frequencies of the observed side effects are defined as: • very common: affects more than 1 user in 10 • common: affects 1 to 10 users in 100 • uncommon: affects 1 to 10 users in 1,000 • rare: affects 1 to 10 users in 10,000 • very rare: affects less than 1 user in 10,000 • not known: frequency cannot be estimated from the available data
• Il- frekwenzi tal- effetti sekondarji osservati huma mfissra hekk: • komuni ħafna: jolqtu iżjed minn pazjent 1 minn kull 10 • komuni: jolqtu minn 1 sa 10 pazjenti minn kull 100 • mhux komuni: jolqtu minn 1 sa 10 pazjenti minn kull 1, 000
Contact your doctor immediately if you notice any of the following:
44 • rari: jolqtu minn 1 sa 10 pazjenti minn kull 10, 000 • rari ħafna: jolqtu inqas minn pazjent 1 minn kull 10, 000 • mhux magħruf: ma tistax tittieħed stima tal- frekwenza mid- dejta disponibbli
sudden confusion, difficulty speaking or understanding others sudden difficulty in walking or loss of balance or co-ordination sudden dizziness or sudden severe headache with no known cause
B’ mod immedjat ikkuntattja lit- tabib tiegħek jekk tinduna b’ xi wieħed minn dawn: • Tmewwit jew debbulizza f’ daqqa fid- driegħ, fis- sieq jew fil- wiċċ speċjalment jekk fuq naħa waħda biss • f’ daqqa waħda tħossok konfuż, ikollok diffikultà biex titkellem jew biex tifhem lil oħrjan • diffikultà f’ daqqa waħda biex timxi jew titlef il- bilanċ jew il- koordinazzjoni • sturdament f’ daqqa jew uġigħ ta ’ ras gravi f’ daqqa mingħajr ma taf il- kawża Dawn t’ hawn fuq jistgħu jkunu kollha sinjali ta ’ xi attakk ta ’ puplesija.
Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischaemic attack (TIA).
L- attakk ta ’ puplesija huwa effett sekondarju mhux komuni ta ’ Efient f’ pazjenti li qatt ma kellhom attakk ta ’ puplesija jew attakk iskemiku momentanju (TIA).
40 Tell your doctor promptly if you notice any of the following:
Għid lit- tabib tiegħek minnufih jekk tinduna b’ xi wieħed minn dawn:
Blood in your urine Bleeding from your rectum, blood in your stools or black stools Uncontrollable bleeding, for example from a cut
Demm fl- awrina tiegħek Fsada mir- rektum, demm fl- ippurgar tiegħek jew l- ippurgar ikun iswed Fsada bla kontroll, per eżempju minn xi ferita
All of the above may be signs of bleeding, the most common side effect with Efient.
Dawn t’ hawn fuq jistgħu jkunu kollha sinjali ta ’ fsada, l- aktar effett sekondarju komuni b’ Efient.
Although uncommon, severe bleeding can be life-threatening.
Għalkemm mhux komuni, fsada severa tista ’ tpoġġi l- ħajja tal- pazjent fil- periklu.
Side effects seen in clinical trials with Efient include:
Effetti sekondarji li dehru f’ studji kliniċi b’ Efient jinkludu:
Common side effects Bleeding in the stomach or bowels Bleeding from a needle puncture site Nose bleeds Skin rash Small red bruises on the skin (ecchymoses) Blood in urine Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling) Low haemoglobin or red blood cell count (anaemia) Bruising
Effetti sekondarji komuni Fsada fl- istonku jew fl- imsaren Fsada minn sit ta ’ injezzjoni Tinfaġar Raxx tal- ġilda Tbenġil żgħar ħomor fuq il- ġilda (ekkimożi) Demm fl- awrina Ematoma (fsada taħt il- ġilda fis- sit tal- injezzjoni jew ġo muskolu li tikkawża nefħa) Għadd baxx tal- emoglobina jew taċ- ċelloli ħomor tad- demm (anemija) Tbenġil
Uncommon side effects Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs Bleeding after surgery Coughing up blood Blood in stools
Effetti sekondarji mhux komuni Fsada f’ daqqa mill- għajn, rektum, ħanek jew fiż- żaqq madwar l- organi interni Fsada wara operazzjoni Ittella ’ d- demm wara li tisgħol Demm mal- ippurgar
Rare side effects Subcutaneous haematoma (bleeding under the skin causing a swelling)
Effetti sekondarji rari Ematoma taħt il- ġilda (demm taħt il- ġilda li tikkawża nefħa)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE EFIENT
KIF TAĦŻEN EFIENT
Do not use Efient after the expiry date, which is stated on the blister and carton after EXP.
45 Tużax Efient wara d- data ta ’ skadenza li tidher fuq il- folja u fuq il - kaxxa wara EXP.
What Efient contains
X’ fih Efient
Efient 10 mg:
– Is- sustanza attiva hi prasugrel. – Efient 10 mg:
Each tablet contains 10 mg of prasugrel (as hydrochloride).
Kull pillola fiha 10 mg ta ’ prasugrel (bħala hydrochloride) – Efient 5 mg:
Each tablet contains 5 mg of prasugrel (as hydrochloride).
Kull pillola fiha 5 mg ta ’ prasugrel (bħala hydrochloride)
hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
– Is- sustanzi l- oħra huma microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide aħmar (pilloli ta ’ 10 mg biss) (E172), iron oxide isfar (E172) u talc.
What Efient looks like and contents of the pack Efient 10 mg :The tablets are beige and double-arrow shaped, with ”10 mg” debossed on one side and “4759” on the other.
Il- pilloli huma ta ’ kulur kanella jagħti fl- isfar b’ forma ta ’ vleġġa doppja, imnaqqxa b ’ “ 10 mg ” fuq naħa waħda u b ’ “ 4759 ” fuq in- naħa l- oħra.
The tablets are yellow and double-arrow-shaped, with “5 mg” debossed on one side and “4760” on the other.
Il- pilloli huma sofor b’ forma ta ’ vleġġa doppja, imnaqqxa b ’ “ 5 mg ” fuq naħa waħda u b ’ “ 4760 ” fuq in- naħa l- oħra.
Efient is available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets.
Efient issibu f’ pakketti ta ’ 14, 28, 30, 56, 84, 90 u 98 pillola.
Marketing Authorisation Holder Eli Lilly Nederland BV Grootslag 1 – 5 NL-3991 RA, Houten The Netherlands.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Eli Lilly Nederland BV Grootslag 1 – 5 NL- 3991 RA, Houten L- Olanda
Avda. de la Industria 30 28108 Alcobendas Madrid Spain.
Avda. de la Industria 30 28108 Alcobendas Madrid Spanja.
Belgique/België/Belgien Daiichi Sankyo Belgium N.V.-S.A Tél/ Tel: +32 (0) 10 48 95 95 България ТП "Ели Лили Недерланд" Б.В. - България тел. +359 2 491 41 40 Česká republika ELI LILLY ČR, s.r.o.
46 Belgique/ België/ Belgien Daiichi Sankyo Belgium N. V. - S. A Tél/ Tel: +32 (0) 10 48 95 95 България ТП "Ели Лили Недерланд" Б. В. - България тел. +359 2 491 41 40 Česká republika ELI LILLY ČR, s. r. o.
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 Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
Elaprase 2 mg/ ml concentrate for solution for infusion.
Elaprase 2 mg/ ml konċentrat għal soluzzjoni għal infużjoni.
Each vial of 3 ml contains 6 mg of idursulfase.
Kull kunjett ta ’ 3 ml fih 6 mg ta ’ idursulfase.
Each ml contains 2 mg of idursulfase.
Kull ml fih 2 mg ta ’ idursulfase.
Idursulfase is produced by recombinant DNA technology in a continuous human cell line.
Idursulfase huwa magħmul permezz ta ’ teknoloġija tad- DNA rekombinanti fl- linja ta ’ ċelloli umani kontinwa.
Concentrate for solution for infusion.
Konċentrat għal soluzzjoni għal infużjoni.
A clear to slightly opalescent, colourless solution.
Soluzzjoni bla kulur, ċara għal ftit opalexxenti.
Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Elaprase huwa indikat għat- trattament fuq tul ta ’ żmien ta ’ pazjenti bis- sindromu ta ’ Hunter (Mucopolysaccharidosis II, MPS II).
Heterozygous females were not studied in the clinical trials.
Nisa eterożiġotiċi ma ġewx studjati fi provi kliniċi.
Elaprase treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders.
Trattament b’ Elaprase għandu jiġi segwit mill- qrib minn tabib jew minn professjonista tal- kura tas - saħħa ieħor li jkollu esperjenza fil- kura ta ’ pazjenti bil- marda tal- MPS II jew fuq mard metaboliku ieħor li jintiret.
Elaprase is administered at a dose of 0.5 mg/ kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4).
Elaprase jingħata f’ doża ta ’ 0. 5 mg/ kg piż tal- ġisem kull ġimgħa permezz ta ’ infużjoni ġol- vina fuq perjodu ta ’ 3 sigħat, li jista ’ jitnaqqas gradwalment għal siegħa jekk ma jkunux osservati reazzjonijiet assoċjati ma ’ l- infużjoni (ara sezzjoni 4. 4)
For preparation and administration instructions see section 6.6.
Għal struzzjonijiet dwar il- preparazzjoni u l- amministrazzjoni ara sezzjoni 6. 6.
Patients with renal or hepatic impairment There is no clinical experience in patients with renal or hepatic insufficiency.
Pazjenti b’ insuffiċjenza tal- kliewi jew tal- fwied Ma hemm l- ebda esperjenza klinika f’ pazjenti b’ insuffiċjenza tal- kliewi jew tal- fwied.
See section 5.2.
Ara sezzjoni 5. 2.
Elderly patients There is no clinical experience in patients over 65 years of age.
Pazjenti anzjani Ma hemm l- ebda esperjenza klinika f’ pazjenti li għandhom aktar minn 65 sena.
Paediatric patients The dose for children and adolescents is 0.5 mg/ kg body weight weekly.
Pazjenti pedjatriċi Id- doża fit- tfal u l- adolexxenti hija 0. 5 mg/ kg piż tal- ġisem kull ġimgħa.
There is no clinical experience in children under the age of 5.
Ma hemm l- ebda esperjenza klinika fi tfal taħt il- 5 snin.
2 4.4 Special warnings and precautions for use
2 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Patients treated with idursulfase may develop infusion-related reactions (see section 4.8).
Pazjenti ittrattati b’ idursulfase jistgħu jiżviluppaw reazzjonijiet assoċjati ma ’ l- infużjoni (ara sezzjoni 4. 8).
During clinical trials, the most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, and flushing.
Waqt provi kliniċi, l- aktar reazzjonijiet komuni relatati ma ’ l- infużjoni inkludew reazzjonijiet fil - ġilda (raxx, prurite, urtikarja), deni, uġigħ ta ’ ras, pressjoni għolja, u fwawar.
Infusion-related reactions were treated or ameliorated by slowing the infusion rate, interrupting the infusion, or by administration of medicines, such as antihistamines, antipyretics, low-dose corticosteroids (prednisone and methylprednisolone), or beta-agonist nebulization.
Reazzjonijiet relatati ma ’ l- infużjoni kienu ittrattati jew imtejjba billi tnaqqset ir- rata ta ’ l- infużjoni, twaqqif ta ’ l- infużjoni, jew permezz ta ’ amministrazzjoni ta ’ mediċini, bħalma huma mediċini kontra l- ħistamina, kontra d- deni, kortikosterojdi f’ doża baxxa (prednisone u methylprednisolone), jew nebulizzazzjoni b’ agonist- beta.
No patient discontinued treatment due to an infusion reaction during clinical studies.
Waqt l- istudji kliniċi l- ebda pazjent ma waqqaf it- trattament minħabba reazzjoni mill- infużjoni.
Special care should be taken when administering an infusion in patients with severe underlying airway disease.
Għandha tingħata attenzjoni speċjali meta tiġi amministrata infużjoni f’ pazjenti b’ mard serju diġà eżistenti tal- passaġġi ta ’ l- arja.
These patients should be closely monitored and infused in an appropriate clinical setting.
Dawn il- pazjenti għandhom jiġu sorveljati mill- qrib u mogħtija l - infużjoni f’ sitwazzjoni klinika addattata.
Caution must be exercised in the management and treatment of such patients by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Fil- ġestjoni u t- trattament ta ’ pazjenti bħal dawn għandha tiġi eżerċitata l- kawtela permezz ta ’ limitazzjoni jew sorveljanza bir- reqqa ta ’ l- użu ta ’ prodotti mediċinali kontra l- ħistamina jew sedattivi oħra.
Institution of positive-airway pressure may be necessary in some cases.
L- użu ta ’ pressjoni pożittiva fil- passaġġi ta ’ l- arja tista ’ tkun neċessarja f’ xi każijiet.
Consider delaying the infusion in patients who present with an acute febrile respiratory illness.
F’ pazjenti li jkollhom mard respiratorju akut bid- deni ikkunsidra li tipposponi l- infużjoni.
Patients using supplemental oxygen should have this treatment readily available during infusion in the event of an infusion-related reaction.
Pazjenti li jużaw ossiġnu supplimentali għandu jkollhom dan it- trattament bil- lest waqt l- infużjoni fil- każ ta ’ reazzjoni relatata ma ’ l- infużjoni.
Patients who develop IgM or IgG antibodies are at a higher risk of infusion reactions and other adverse reactions, however, IgE antibodies have not been observed.
Pazjenti li jiżviluppaw antikorpi IgM jew IgG huma f’ riskju aktar għoli ta ’ reazzjonijiet għal infużjoni u reazzjonijiet avversi oħra, madankollu, ma ġewx osservati antikorpi IgE.
Anaphylactoid reactions, which have the potential to be life threatening, have been observed in some patients treated with Elaprase, as with any intravenous protein product.
Reazzjonijiet anafilaktojdi, li għandhom il- potenzjal li jkunu ta ’ theddida għall- ħajja, ġew osservati f’ xi pazjenti ttrattati b’ Elaprase, bħal bi kwalunkwe prodott tal- proteini li jingħata ġol- vina.
Late emergent symptoms and signs of anaphylactoid reactions have been observed as long as 24 hours after an initial reaction.
Sintomi li joħorġu tard u sinjali ta ’ reazzjonijiet anafilaktojdi ġew osservati għal 24 siegħa wara r- reazzjoni inizjali.
If an anaphylactoid reaction occurs the infusion should be immediately suspended and appropriate treatment and observation initiated.
Jekk isseħħ reazzjoni anafilaktojdi, l- infużjoni għandha tiġi sospiża minnufih u għandu jingħata trattament xieraq u l- pazjent għandu jinżamm taħt osservazzjoni.
The current medical standards for emergency treatment are to be observed.
Għandhom jiġu segwiti l - istandardis mediċi attwali għal trattament ta ’ emerġenza.
Patients experiencing severe or refractory anaphylactoid reactions may require prolonged clinical monitoring.
Pazjenti li jesperjenzaw reazzjonijiet anafilaktojdi severi jew refrattorji jistgħu jeħtieġu monitoraġġ kliniku fit- tul.
Patients who have experienced anaphylactoid reactions should be treated with caution when re-administering Elaprase.
Pazjenti li jkunu esperjenzaw reazzjonijiet anafilaktodji għandhom jiġu ttrattati b’ kawtela meta Elaprase jingħatalhom mill- ġdid.
No formal drug interaction studies have been conducted with Elaprase.
Ma sar l- ebda studju formali ta ’ interazzjoni tal- mediċina b’ Elaprase.
Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Idursulfase m’ huwiex kandidat għal interazzjonijiet medjati minn ċitokroma P450, fuq il- bażi tal - metaboliżmu tagħha f’ liżożomi ċellulari.
Elaprase is not indicated for use in women of child-bearing potential.
Elaprase m’ huwiex indikat għal użu fuq nisa li jistgħu joħorġu tqal.
No reproductive studies in female animals have been performed.
Ma sar l- ebda studju riproduttiv f’ annimali nisa.
No effects on male fertility were seen in reproductive studies in male rats.
Fi studji riproduttivi fil- firien irġiel, ma ntwera l- ebda effett fuq il- fertilità fl- irġiel.
Excretion of idursulfase in milk has not been studied.
L- eliminazzjoni ta ’ idursulfase fil- ħalib ma ġietx studjata.
Adverse drug reactions that were reported for the 32 patients treated with 0.5 mg/ kg Elaprase weekly in the Phase II/ III 52-week placebo-controlled study were almost all mild to moderate in severity.
3 Ir- reazzjonijiet avversi tal- mediċina li ġew irrapportati għat- 32 pazjent ittrattati b’ 0. 5 mg/ kg Elaprase fil- ġimgħa fl- istudju Fażi II/ III ikkontrollat bi plaċebo ta ’ 52 ġimgħa kienu kważi kollha ħfief għal moderati fis- serjetà tagħhom.
The most common were infusion-related reactions, 202 of which were reported in 22 out of 32 patients
L- aktar komuni kienu reazzjonijiet relatati ma ’ l- infużjoni, li 202 minnhom ġew rapportati fi 22 minn 32 pazjent wara l- amministrazzjoni ta ’ total ta ’ 1580 infużjoni.
In the placebo treatment group 128 infusion- related reactions were reported in 21 out of 32 patients following administration of a total of 1612 infusions.
Fil- grupp ta ’ trattament bil- plaċebo, ġew irrapportati 128 reazzjoni relatata ma ’ l- infużjoni f’ 21 minn 32 pazjent wara l- amministrazzjoni ta ’ total ta ’ 1612- il infużjoni.
Since more than one infusion-related reaction may have occurred during any single infusion, the above numbers are likely to over estimate the true incidence of infusion reactions.
Minħabba li aktar minn reazzjoni relatata ma ’ l- infużjoni waħda setgħet seħħet waqt kwalunkwe infużjoni waħda, in- numri ta ’ hawn fuq x’ aktarx jagħtu stima aktar għolja ta ’ l- inċidenza ta ’ reazzjonijiet ta ’ l- infużjoni.
Related reactions in the placebo group were similar in nature and severity to those in the treated group.
Reazzjonijiet relatati fil- grupp tal- plaċebo kienu simili fin- natura u s- serjetà għal dawk fil- grupp ta ’ trattament.
The most common of these infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, and hypertension.
L- aktar komuni fost dawn ir- reazzjonijiet relatati ma ’ l- infużjoni kien hemm reazzjonijiet tal- ġilda (raxx, prurite, urtikarja), deni, uġigħ ta ’ ras, u pressjoni għolja.
The frequency of infusion-related reactions decreased over time with continued treatment.
Il- frekwenza ta ’ reazzjonijiet relatati ma ’ l - infużjoni naqsu matul iż- żmien bi trattament kontinwu.
Adverse drug reactions are listed in the table below with information presented by system organ class and frequency.
Ir- reazzjonijiet avversi tal- mediċina huma elenkati fit- tabella hawn taħt b’ tagħrif ippreżentat permezz ta ’ sistema tal- klassifika tal- organi u frekwenza.
Frequency is given as very common (> 1/ 10) or common (> 1/ 100, < 1/ 10).
Il- frekwenza tingħata bħala komuni ħafna (> 1/ 10) jew komuni (> 1/ 100, < 1/ 10).
The occurrence of an event in a single patient is defined as common in view of the number of patients treated.
Is- seħħ ta ’ episodju f’ pazjent huwa definit bħala komuni minħabba n- numru ta ’ pazjenti ittrattati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
Adverse drug reactions were defined as treatment-emergent events with suspected causality and excluded non-serious events that were reported only once in a single patient; treatment emergent events with an excess incidence of at least 9% compared with placebo were also considered as adverse drug reactions.
Ir- reazzjonijiet avversi tal- mediċina ġew definiti bħala episodji li ħarġu mit- trattament b’ suspett ta ’ kawżalità u eskludew episodji mhux serji li kienu irrapportati darba biss f’ pazjent; episodji li ħarġu mit- trattament b’ inċidenza żejda ta ’ mill- inqas 9% meta mqabbla ma ’ plaċebo ġew ikkunsidrati wkoll bħala reazzjonijiet avversi tal- mediċina.
Adverse Drug Reaction System Organ Class (Preferred Term) Nervous system disorders Eye disorders
Reazzjoni Avversa tal- Mediċina Klassi tas- Sistema ta ’ l- Organi (Terminu Ippreferut) Disturbi fis- sistema nervuża Disturbi fl- għajnejn
Very common:
ħafna:
headache dizziness, tremor
uġigħ ta ’ ras sturdament, rogħda
lacrimation increased
żieda fil- lakrimazzjoni
arrhythmia*, cyanosis
arritmija *, ċjanożi
Respiratory, thoracic mediastinal disorders
Komuni
Common: and
Komuni:
hypertension hypotension, flushing
pressjoni għolja pressjoni baxxa, fwawar
bronchospasm, pulmonary embolism*, cough, wheezing, tachypnoea, dyspnoea
bronkospażmu, emboliżmu pulmonari *, sogħla, tħarħir, takipneja, dispneja
Very
ħafna:
common Common:
Komuni:
dyspepsia abdominal pain, nausea, diarrhoea, swollen tongue
dispepsja, uġigħ addominali, dardir, dijarea, nefħa fl- ilsien
urticaria, rash, pruritus face oedema, erythema, eczema
urtikarja, raxx, prurite nefħa fil- wiċċ, eritima, ekżema
Musculoskeletal and connective tissue disorders General disorders and
Disturbi muskolu- skeltrali u tal - connective tissue
pyrexia, infusion site swelling oedema peripheral
uġigħ ta ’ ras artralġja
* see serious adverse reactions below
4 Reazzjoni Avversa tal- Mediċina Klassi tas- Sistema ta ’ l- Organi (Terminu Ippreferut) Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna: deni, nefħa fis- sit ta ’ l- infużjoni Komuni: edima periferali * ara reazzjonijiet avversi serji oħra
Four patients experienced a hypoxic episode during one or several
Tul l- istudji, reazzjonijiet avversi serji ġew irrapportati f’ total ta ’ 5 pazjenti li rċievew 0. 5 mg/ kg fil - ġimgħa jew ġimgħa iva u ġimgħa le.
4 infusions, which necessitated oxygen therapy in 3 patients with severe underlying obstructive airway disease (2 with a pre-existing tracheostomy).
Erba ’ pazjenti esperjenzaw episodju ipoxiku (nuqqas ta ’ ossiġnu) waqt waħda jew xi uħud mill- infużjonijiet, li kien jeħtieġ terapija bl- ossiġnu fi 3 pazjenti b’ mard ta ’ mblukkar tal- passaġġi ta ’ l- arja diġà eżistenti (2 bi trakeostomija diġà eżistenti).
The most severe episode, which was associated with a short seizure, occurred in a patient who received his infusion while he had a febrile respiratory exacerbation.
L- aktar episodju serju, li kien assoċjat ma ’ aċċessjoni qasira, seħħ f’ pazjent li rċieva l- infużjoni waqt li kellu taħrix respiratorju bid- deni.
In the fourth patient, who had less severe underlying disease, spontaneous resolution occurred shortly after the infusion was interrupted.
Fir- raba ’ pazjent, li kellu mard diġà eżistenti inqas serju, ritorn spontanju għan - normal seħħ ftit wara li twaqfet l- infużjoni.
These events did not recur with subsequent infusions using a slower infusion rate and administration of pre-infusion medicinal products, usually low-dose steroids, antihistamine, and beta-agonist nebulization.
Dawn l- episodji ma reġgħux seħħew b’ infużjonijiet sussegwenti bl- użu ta ’ rata ta ’ infużjoni aktar bil- mod u amministrazzjoni ta ’ prodotti mediċinali qabel l- infużjoni, ġeneralment sterojdi f’ dożi baxxi, mediċini kontra l- ħistamina u nebulizzazzjoni b’ agonist - beta.
The fifth patient, who had pre- existing cardiopathy, was diagnosed with ventricular premature complexes and pulmonary embolism during the study.
Il- ħames pazjent, li kellu kardjomajopatija diġà eżistenti, ġie dijanjożizzat li kellu kumplessi ventrikulari prematuri u emboliżmu pulmonari waqt l- istudju.
There have been post-marketing reports of anaphylactoid reactions.
Kien hemm rapporti ta ’ wara t- tqegħid fis- suq ta ’ reazzjonijiet anafilaktojdi.
Please see section 4.4 for further information.
Jekk jogħġbok ara sezzjoni 4. 4 għal aktar informazzjoni.
Across all studies, 53/ 108 patients (49%) developed anti-idursulfase IgG antibodies at some point.
Fil- medda ta ’ l- istudji, 53/ 108 pazjenti (49%) f’ ċertu punt żviluppaw antikorpi IgG kontra idursulfase.
Six of the IgG positive patients also tested positive for IgM antibodies, and 1 patient tested positive for IgA antibodies.
Sitta mill- pazjenti pożittivi għall- IgG ittestjaw pożittivi ukoll għal antikorpi IgM, u pazjent ittestja pożittiv għal antikorpi IgA.
No patient developed IgE antibodies during any study.
L- ebda pazjent ma żviluppa antikorpi IgE waqt xi studju.
The overall neutralizing antibody rate was 11/ 108 patients (10%).
Ir- rata totali ta ’ antikorpi newtralizzanti kienet 11/ 108- il pazjent (10%).
In the 52-week study, rates of seropositivity peaked by Weeks 18 to 27 and steadily declined thereafter for the remainder of this study.
Fl- istudju ta ’ 52 ġimgħa, ir- rati ta ’ seropożittività laħqu l- quċċata sa Ġimgħat 18 sa 27 u naqsu b’ mod stabbli minn hemm ’ il quddiem għall- kumplament ta ’ l- istudju.
In general, patients who tested positive for IgG antibodies were more likely to have infusion-related events than those who did not test positive.
B’ mod ġenerali, pazjenti li ttestjaw pożittivi għal antikorpi IgG kienu aktar probabbli li jkollhom episodji relatati ma ’ l- infużjoni milli dawk li ma ttestjawx pożittivi.
However, overall rates of infusion-related adverse events declined over time, regardless of antibody status.
Madankollu, ir- rati totali ta ’ reazzjonijiet avversi relatati ma ’ l- infużjoni naqsu maż- żmien, kien x’ kien l- istatus ta ’ l- antikorpi.
The reduction of urinary GAG excretion was somewhat less in patients for whom circulating anti-idursulfase antibodies were detected.
It- tnaqqis fl- eliminazzjoni awrinarja ta ’ GAG kien xi daqsxejn inqas f’ pazjenti li nstabulhom antikorpi kontra- idursulfase jiċċirkulaw.