qanastek/EMEA-V3 huggingface dataset:
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Il- pazjenti rċevew clopidogrel (300 mg bħala d- doża qawwija inizjali segwita minn 75 mg / kuljum, n=1752) jew il - plaċebo (n=1739), it- tnejn ma ’ ASA (150 sa 325 mg bħala doża qawwija inizjali segwita minn 75 sa 162 mg/ kuljum), sustanza fibrinolitika u, fejn kien xieraq, heparin.
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favor of clopidogrel (95% CI:
21 Ħmistax fil- mija (15. 0%) tal- pazjenti fil- grupp tal- clopidogrel u 21. 7% tal- grupp bil- plaċebo laħqu l - punt primarju u aħħari, li jirrappreżentaw tnaqqis assolut ta ’ 6. 7% u 36% ta ’ tnaqqis probabbli favur clopidogrel (95% CI:
3mg/l after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
Il- livelli massimi fil- plażma ta ’ dan il- metabolit (bejn wieħed u ieħor 3 mg/ l wara dożi ripetuti ta ’ 75 mg) seħħew bejn wieħed u ieħor siegħa wara d- dożaġġ.
After repeated doses of 75 mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) compared to subjects with moderate renal disease (creatinine clearance from 30 to 60 ml/min) and to levels observed in other studies with healthy subjects.
Wara dożi ripetuti ta ’ 75 mg ta ’ clopidogrel kuljum, il- livelli fil- plażma tal- metabolit prinċipali ċirkolanti kienu iktar baxxi f’ persuni b’ mard sever tal- kliewi (tneħħija tal- kreatinina minn 5 sa 15 ml/ min) meta mqabbla ma ’ persuni b’ mard moderat tal- kliewi (tneħħija tal- kreatitina minn 30 sa
When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Meta clopidogrel ngħata lill- firien li kienu qed ireddgħu, dan ikkawża dewmienżgħir fl- iżvilupp tat- trabi.
6.2 Incompatibilities
23 6. 2 Inkompatibilitajiet
EU/1/98/070/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/ 1/ 98/ 070/ 008 – Pakketti ta ’ 4x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju EU/ 1/ 98/ 070/ 009 – Pakketti ta ’ 30x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju EU/ 1/ 98/ 070/ 010 – Pakketti ta ’ 100x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju
24 A.
24 ANNESS II
- Iscover 75 mg film-coated tablets
- Iscover 75 mg pilloli miksija b' rita
Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-335 65 Carbon Blanc cedex France
Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc cedex Franza
Sanofi Winthrop Industrie 6, Boulevard de l’Europe F-21800 Quétigny France
Sanofi Winthrop Industrie 6, Boulevard de l’ Europe F- 21800 Quétigny Franza
Sanofi Synthelabo Limited Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT – UK United Kingdom
Sanofi Synthelabo Limited Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT – UK Renju Unit
- Iscover 300 mg film-coated tablets
- Iscover 300 mg pilloli miksija b' rita
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 dated 25 September 2007 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.
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta' farmakoviġilanza, kif deskritta f' verżjoni 2. 0 ippreżentat f' Modulu 1. 8. 1. ta 'l- Applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq, tkun fis- seħħ u implimentata qabel u waqt li l- prodott ikun tqiegħed fis- suq.
26 A.
26 ANNESS III
Iscover 75 mg film-coated tablets clopidogrel
Iscover 75 mg pillola miksija b’ rita clopidogrel
28 film-coated tablets 30 film-coated tablets 50x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 14 film-coated tablets 7 film-coated tablets
28 pillola miksija b’ rita 30 pillola miksija b’ rita 50x1 pilloli miksijin b’ rita 84 pillola miksija b’ rita 90 pillola miksija b’ rita 100 pillola miksija b’ rita 14- il pillola miksija b’ rita 7 pilloli miksija b’ rita
Store below 30°C (for PVC/PVDC/aluminium blisters) Or No special storage conditions (for all aluminium blisters)
Jew M’ hemmx bżonn kundizzjonijiet speċjali ta ’ kif jinħażen (għall- folji kollha kemm huma ta ’ l - aluminju)
EU/1/98/070/001a 28 tablets EU/1/98/070/001b 28 tablets EU/1/98/070/002a 50x1 tablets EU/1/98/070/002b 50x1 tablets EU/1/98/070/003a 84 tablets EU/1/98/070/003b 84 tablets EU/1/98/070/004a 100 tablets EU/1/98/070/004b 100 tablets EU/1/98/070/005a 30 tablets EU/1/98/070/005b 30 tablets EU/1/98/070/006a 90 tablets EU/1/98/070/006b 90 tablets EU/1/98/070/007a 14 tablets EU/1/98/070/007b 14 tablets EU/1/98/070/011a 7 tablets EU/1/98/070/011b 7 tablets
EU/ 1/ 98/ 070/ 001a 28 pillola EU/ 1/ 98/ 070/ 001b 28 pillola EU/ 1/ 98/ 070/ 002a 50x1 pilloli EU/ 1/ 98/ 070/ 002b 50x1 pilloli EU/ 1/ 98/ 070/ 003a 84 pillola EU/ 1/ 98/ 070/ 003b 84 pillola EU/ 1/ 98/ 070/ 004a 100 pillola EU/ 1/ 98/ 070/ 004b 100 pillola EU/ 1/ 98/ 070/ 005a 30 pillola EU/ 1/ 98/ 070/ 005b 30 pillola EU/ 1/ 98/ 070/ 006a 90 pillola EU/ 1/ 98/ 070/ 006b 90 pillola EU/ 1/ 98/ 070/ 007a 14– il pillola EU/ 1/ 98/ 070/ 007b 14– il pillola EU/ 1/ 98/ 070/ 011a 7 pilloli EU/ 1/ 98/ 070/ 011b 7 pilloli
30 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
Iscover 75 mg 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta ’ 7, 14, 28 jew 84 pillola)
Iscover 75 mg film-coated tablets clopidogrel
Iscover 75 mg pilloli miksija b’ rita clopidogrel
Bristol Myers Squibb Pharma EEIG
Sanofi Pharma Bristol- Myers Squibb SNC
31 PARTICULARS TO APPEAR ON BLISTERS (boxes of 30, 50x1, 90 or 100 tablets)
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta’ 30, 50x1, 90 jew 100 pillola)
Iscover 75 mg film-coated tablets clopidogrel
Iscover 75 mg pilloli miksijin b’ rita clopidogrel
Iscover 300 mg film-coated tablets clopidogrel
Iscover 300 mg pilloli miksija b’ rita clopidogrel
EU/1/98/070/008 4x1 film-coated tablets EU/1/98/070/009 30x1 film-coated tablets EU/1/98/070/010 100x1 film-coated tablets
4x1 pilloli miksija b’ rita 30x1 pilloli miksija b’ rita 100x1 pilloli miksija b’ rita
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA/ kaxxa ta ’ 4x1, 30x1 jew 100x1 pilloli
Iscover 300 mg film-coated tablets clopidogrel
Iscover 300 mg pilloli miksijin b’ rita clopidogrel
36 PACKAGE LEAFLET:
36 FULJETT TA ’ TAGĦRIF:
What Iscover is and what it is used for 2.
X’ inhu Iscover u għalxiex jintuża 2.
Before you take Iscover 3.
Qabel ma tieħu Iscover 3.
How to take Iscover 4.
Kif għandek tieħu Iscover 4.
Possible side effects 5 How to store Iscover 6.
Effetti sekondarju li jista jkollu 5.
Further information
Kif taħżen Iscover 6.
WHAT ISCOVER IS AND WHAT IT IS USED FOR
X’ INHU ISCOVER U GĦALXIEX JINTUŻA
Iscover belongs to a group of medicines called antiplatelet medicinal products.
Iscover jifforma parti minn grupp ta ’ mediċini msejħa prodotti mediċinali ta ’ kontra l- plejtlets.
Iscover is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Iscover jittieħed biex inaqqas ir- riskju li ċapep tad- demm (trombi) jifformaw fl- arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
You have been prescribed Iscover to help prevent blood clots and reduce the risk of these severe events because:
Ingħatajt Iscover biex inaqqas ir- riskju ta ’ ċapep tad- demm u l- konsegwenzi severi tagħhom għaliex:
BEFORE YOU TAKE ISCOVER
QABEL MA TIEĦU ISCOVER
Do not take Iscover:
Tiħux Iscover:
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Iscover; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- clopidogrel jew sustanzi oħra ta ’ Iscover; • Jekk tbati minn kundizzjoni medika li fil- preżent qiegħda tikkawża fsada, bħal ulċera fl- istonku jew fsada ġewwa l- moħħ; • Jekk tbati minn mard sever tal- fwied.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Iscover.
Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu Iscover.
37 Take special care with Iscover:
37 Oqgħod attent ħafna b’ Iscover:
If any of the situations mentioned below apply to you, you should tell your doctor before taking Iscover: • if you have a risk of bleeding such as
Jekk xi sitwazzjoni msemmija hawn taħt tgħodd għalik, ħu parir tat- tabib tiegħek qabel tibda tieħu Iscover: • jekk tinsab f’ riskju ta ’ fsada bħal:
While you are taking Iscover: • You should tell your doctor if a surgery (including dental) is planned. • You should also tell your doctor immediately if you develop a medical condition that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see ‘POSSIBLE SIDE EFFECTS’). • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Waqt li qiegħed/ qiegħda tieħu Iscover: • Għandek tgħid lit- tabib tiegħek jekk għandek xi operazzjoni ppjanata (anki tas- snien). • Għandek ukoll tgħid lit- tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika li tinkludi deni u tbenġil taħt il- ġilda li jidher bħal tikek ħomor irqaq, flimkien ma 'jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal- ġilda jew ta' l- għajnejn (suffejra) (ara 'EFFETTI SEKONDARJI LI JISTA' JKOLLU '). • Jekk taqta' x' imkien jew tweġġa ', id- demm jista' jdum aktar mis- soltu biex jieqaf.
For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Għal qtugħ u feriti żgħar eż. meta taqta 'x' imkien, meta tqaxxar, normalment m' hemmx għax tinkwieta.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘POSSIBLE SIDE EFFECTS’). • Your doctor may order blood tests. • You should tell your doctor or pharmacist if you notice any side effect not listed in the ‘POSSIBLE SIDE EFFECTS’ section of this leaflet or if you notice that a side effect gets serious.
Madanakollu, jekk id- demm li ħiereġ jinkwetak, għandek tkellem lit- tabib tiegħek minnufih (ara 'EFFETTI SEKONDARJI LI JISTA' JKOLLU '). • It- tabib tiegħek jista' jordnalek testijiet tad- demm. • Għandek tgħid lit- tabib jew lill- ispiżjar tiegħek jekk tinnota xi effett sekondarji li mhux imniżżel fis- sezzjoni 'EFFETTI SEKONDARJI LI JISTA' JKOLLU 'ta' dan il- fuljett jew jekk tinnota effett sekondarji li qiegħed jiggrava.
Iscover is not intended for use in children or adolescents.
Iscover m’ għandux jingħata lit- tfal jew lill- adolexxenti.
Some other medicines may influence the use of Iscover or vice versa.
Xi mediċini oħra jistgħu jeffettwaw l- użu ta ’ Iscover u viċe- versa.
The use of oral anticoagulants (medicines used to reduce blood clotting) with Iscover is not recommended.
L- użu ta ’ sustanzi kontra l- koagulazzjoni tad- demm li jittieħdu mill- ħalq (mediċini li jraqqu d- demm) flimkien ma ’ Iscover mhux irrakkomandat.
You should specifically tell your doctor if you take a non-steroidal anti-inflammatory drug, usually used to treat painful and/or inflammatory conditions of muscle or joints, or if you take heparin or any other medicine used to reduce blood clotting.
Għandek speċifikament tgħid lit- tabib tiegħek jekk qiegħed tieħu xi prodott mediċinali li huwa anti - infjammatorju li mhux sterojde, normalment użat biex jiġi ittrattat l- uġigħ u/ jew kundizzjonijiet infjammatorji tal - muskoli jew tal- ġogi, jew jekk qed tieħu l- heparin jew xi mediċina oħra użata biex traqqaq id- demm.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Iscover in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Jekk ħassejt uġigħ qawwi f’ sidrek (anġina mhux stabbli jew attakk tal- qalb), jista ’ jingħatalek Iscover flimkien ma ’ acetylsalicylic acid, sustanza inkorporata f’ ħafna mediċini użati biex itaffu l- uġigħ u jnaqqsu d- deni.
Taking Iscover with food and drink Food/meals have no influence.
Meta tiehu Iscover ma ’ l- ikel jew ix- xorb Ikel/ ikliet m’ għandhomx effett.
Iscover may be taken with or without food.
Iscover jista ’ jittieħed ma ’ l- ikel jew mingħajru.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Iscover.
38 Qabel ma tibda tieħu Iscover, tinforma lit- tabib jew lill- ispiżjar/ a tiegħek jekk inti tqila jew taħseb li inti tqila.
If you become pregnant while taking Iscover, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Iscover, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tieħux clopidrogrel waqt it- tqala.
Ask your doctor or pharmacist for advice before taking any medicine.
Waqt li qiegħed tieħu Iscover, għandek tikkonsulta mat- tabib tiegħek dwar it- treddigħ tat- tarbija. Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Iscover is unlikely to affect your ability to drive or to use machines.
Sewqan u tħaddim ta ’ magni Iscover m’ għandux jaffettwa is- sewqan jew it- tħaddim ta ’ magni.
Iscover contains lactose and hydrogenated castor oil.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Iscover Iscover fih lactose u castor oil idroġenat.
HOW TO TAKE ISCOVER
KIF GĦANDEK TIEĦU ISCOVER
Always take Iscover exactly as your doctor has told you.
Dejjem għandek tieħu Iscover skond il- parir tat- tabib.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Iscover (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Jekk kellek uġigħ sever f’ sidrek (anġina instabbli jew attakk tal- qalb), it- tabib jista ’ jagħtik 300 mg ta ’ Iscover (pillola 1 ta '300 mg jew 4 pilloli ta ’ 75 mg) darba fil- bidu tal- kura.
Then, the usual dose is one 75-mg tablet of Iscover per day to be taken orally with or without food, and at the same time each day.
Wara, id- doża normali hija ta ’ pillola waħda ta ’ 75 mg Iscover kuljum li għandha tittieħed mill- ħalq ma ’ l- ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
You should take Iscover for as long as your doctor continues to prescribe it.
Għandek tieħu Iscover sakemm it- tabib jibqa ’ jagħmillek ir- riċetta.
If you take more Iscover than you should:
Jekk tieħu Iscover aktar milli suppost:
If you forget to take Iscover:
Jek tinsa tieħu Iscover:
If you forget to take a dose of Iscover, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Jekk tinsa tieħu xi doża ta ’ Iscover, iżda tiftakar fit- 12- il siegħa ta ’ wara, ħu l- pillola mill- ewwel, imbagħad ħu l- pillola li jkun imiss fil- ħin tas- soltu.
If you forget for more than 12 hours, simply take the next single dose at the usual time.
Jekk tinsa tieħu Iscover għal aktar minn 12- il siegħa, sempliċiment ħu d- doża waħda li jkun imiss fil - ħin tas- soltu.
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Iscover by referring to the calendar printed on the blister.
Għall- pakketti ta ’ 7, 14, 28 u 84 pilloli, tista ’ tiċċekkja l- ġurnata li fiha ħadt l- aħħar il- pillola ta ’ Iscover billi tirreferi għall- kalendarju stampat fuq il- folja.
If you stop taking Iscover:
Meta tieqaf tieħu Iscover:
Like all medicines, Iscover can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Iscover jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see ‘Take special care with Iscover’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Iscover').
The most common side effect (affects 1 to 10 patients in 100) reported with Iscover is bleeding.
L- iżjed effett komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) irrappurtat b’ Iscover hija l- fsada.
If you experience prolonged bleeding when taking Iscover If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu Iscover Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘Take special care with Iscover’).
Madanakollu, jekk id- demm li ħiereġ jinkwetak, għandek tkellem lit- tabib tiegħek minnufih (ara 'Oqgħod attent ħafna b' Iscover').
Other side effects reported with Iscover are:
Effetti oħra li ġew irrappurtati b’ Iscover huma:
HOW TO STORE ISCOVER
KIF TAĦŻEN ISCOVER
Do not use Iscover after the expiry date which is stated on the carton and on the blister.
Tużax Iscover wara d- data ta ’ skadenza li tidher fuq il - kaxxa few fuq il- folja.
If Iscover is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Jekk Plavix huwa fornut ġo folji tal- PVC/ PVDC/ Aluminju, aħżen f’ temperatura taħt 30°C.
Do not use Iscover if you notice any visible sign of deterioration.
Jekk Plavix huwa fornut ġo folji kollha kemm huma ta ’ l- aluminju, din il- mediċina m’ għandhiex bżonn ħażna speċjali.
40 Medicines should not be disposed of via wastewater or household waste.
40 Tużax Iscover jekk tinnota xi sinjali visibli ta ’ deterjorament.
What Iscover contains The active substance is clopidogrel.
X’ fih Iscover Is- sustanza attiva hi clopidogrel.
What Iscover looks like and contents of the pack
Id- dehra ta ’ Iscover u l- kontenuti tal- pakkett
Iscover 75-mg tablets are round, biconvex, pink, film-coated tablets engraved on one side with the number ‘75’ and on the other side with the number ‘1171’.
Il- pilloli ta ’ Iscover 75- mg huma tondi, konvessi miż- żewġ naħat, ta ’ kulur roża, bin- numru ‘ 75 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1171 ’ imnaqqax fuq in- naħa l- oħra.
They are supplied in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters, or 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters.
Huma fornuti f’ kaxex tal - kartun li fihom 7, 14, 28, 30, 84, 90 u 100 pilloli ġo folji tal- PVC/ PVDC/ Aluminju jew ġo folji magħmulin kollha mill- aluminju, jew 50x1 pilloli f' folji tal- PVC/ PVDC/ Aluminju jew f' folji mtaqqbin b’ doża waħda kollha kemm huma ta ’ l- aluminju.
Belgique/België/Belgien BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.
41 Belgique/ België/ Belgien BRISTOL- MYERS SQUIBB BELGIUM S. A. / N. V.
Deutschland BRISTOL-MYERS SQUIBB GMBH & CO.
Norge Deutschland BRISTOL- MYERS SQUIBB NORWAY LTD BRISTOL- MYERS SQUIBB GMBH & CO.
Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT Tel: +372 640 1301
GYÓGYSZERKERESKEDELMI KFT Tel: +372 640 1301
Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
42 Latvija BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Iscover 300 -mg film-coated tablets clopidogrel
Iscover 300 mg pilloli miksija b’ rita clopidogrel
Iscover is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Iscover jittieħed biex inaqqas ir- riskju li ċapep tad- demm (trombi) jifformaw fl- arterji mwebbsin, proċess imsejjaħ aterotrombosi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
- You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial
- Kellek uġigħ sever f’ sidrek magħruf bħala anġina mhux stabbli jew unfart mijokardijaku
If any of the situations mentioned below apply to you, you should tell your doctor before taking Iscover: • if you have a risk of bleeding such as
44 Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu Iscover.
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)
Jekk xi sitwazzjoni msemmija hawn taħt tgħodd għalik, ħu parir tat- tabib tiegħek qabel tibda tieħu Iscover: • jekk tinsab f’ riskju ta ’ fsada bħal:
45 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
45 Tqala u treddigħ Huwa preferibbli li ma tużax dan il- prodott waqt it- tqala u t- treddigħ.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Iscover.
Qabel ma tibda tieħu Iscover, għandek tinforma lit- tabib jew lill- ispiżjar/ a tiegħek jekk inti tqila jew taħseb li inti tqila.
If you become pregnant while taking Iscover, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Iscover, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tiħux clopidogrel fit- tqala.
While taking Iscover, consult your doctor about the breast-feeding of a baby.
Waqt li qiegħed tieħu Iscover, għandek tikkonsulta mat- tabib tiegħek dwar it- treddigħ tat- tarbija.
HOW TO TAKE ISCOVER
KIF GĦANDEK TIEĦU ISCOVER 3.
Then, the usual dose is one 75 mg tablet of Iscover per day to be taken orally with or without food, and at the same time each day.
Wara, id- doża normali hija ta ’ pillola waħda ta ’ 75 mg Iscover kuljum li għandha tittieħed mill- ħalq ma ’ l- ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see ‘Take special care with Iscover’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Iscover').
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or
F’ numru żgħir ta ’ każijiet oħra ġew irrappurtati fsada fl- għajn, fir- ras, fil- pulmun jew fil- ġogi.
In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
46 Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu Iscover Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
Do not use Iscover after the expiry date which is stated on the carton and on the blister.
Tużax Iscover wara d- data ta ’ skadenza li tidher fuq il - kaxxa jew fuq il- folja.
Do not use Iscover if you notice any visible sign of deterioration.
Tużax Iscover jekk tinnota xi sinjali visibli ta ’ deterjorament.
What Iscover looks like and contents of the pack
47 Id- dehra ta ’ Iscover u l- kontenuti tal- pakkett
They are supplied in cardboard cartons containing
Il- pilloli ta ’ Iscover 300 mg huma oblungi, ta ’ kulur roża, miksijin b’ rita u bin- numru ‘ 300 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1332 ’ imnaqqax fuq in- naħa l- oħra.
47 4x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Issibhom f’ kaxex tal- kartun li fihom 4x1, 30x1 u 100x1 pilloli ġo folji mtaqqbin ta ’ doża waħda magħmulin kollha kemm huma mill - aluminju.
Magyarország BRI STOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
GYÓGYSZERKERESKEDELMI KFT.
Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT Tel: +372 640 1 301
Eesti BRISTOL- MYERS SQUIBB
Österreich BRISTOL-MYERS SQUIBB GESMBH Tel: + 43 1 60 14 30
Österreich BRISTOL- MYERS SQUIBB GESMBH
España BRISTOL-MYERS SQUIBB, S.A.
48 España BRISTOL- MYERS SQUIBB, S. A.
Ireland BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD Tel: + 353 (1 800) 749 749
Ireland BRISTOL- MYERS SQUIBB PHARMACEUTICALS
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.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, biex jissodisfa r- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li huwa wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Isentress?
X' inhu Isentress?
Isentress is a medicine that contains the active substance raltegravir.
Isentress huwa mediċina li fiha s- sustanza attiva raltegravir.
It is available as pink, oval tablets (400 mg).
Jiġi bħala pilloli roża, ovali (tal- 400 mg).
What is Isentress used for?
Għal xiex jintuża Isentress?
Isentress is an antiviral medicine.
Isentress huwa mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma 'mediċini antivirali oħra fit- trattament ta' adulti infettati bil- virus tal- immunodefiċjenza umana (HIV- 1), il- virus li jikkawża s- sindromu tal - immunodefiċjenza akkwiżita (AIDS).
Isentress is only used in patients who are already being treated for their HIV infection, if tests show that the virus is multiplying in the blood despite treatment.
Isentress jintuża biss għal pazjenti li jkunu diġà qed jingħataw trattament għall- infezzjoni tal- HIV, jekk it- testijiet juru li l- virus ikun qed jitkattar fid- demm minkejja t- trattament.
How is Isentress used?
Kif jintuża Isentress?
Treatment with Isentress should be started by a doctor who has experience in the management of HIV infection.
It- trattament b' Isentress għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni tal- infezzjoni tal - HIV.
It is given as one tablet twice a day, with or without food.
Jingħata bħala pillola waħda darbtejn kuljum, ma 'l- ikel jew waħdu.
Care should be taken when it is given to elderly patients or patients with severe liver problems.
Wieħed għandu joqgħod attent meta jagħti din il- mediċina lil pazjenti anzjani jew bi problemi gravi fil- fwied.
How does Isentress work?
Kif jaħdem Isentress?
The active substance in Isentress, raltegravir, is an integrase inhibitor.
Is- sustanza attiva f' Isentress, raltegravir, hija inibitur tal- integrażi.
It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Timblokka enżim imsejjaħ integrażi li għandu x' jaqsam ma 'fażi mir- riproduzzjoni tal- HIV.
When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Meta l- enżim jiġi mblukkat, il- virus ma jkunx jista 'jirriproduċi ruħu b' mod normali, u dan inaqqas ir- rata li biha tinfirex l- infezzjoni.
Isentress, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Isentress, meħud flimkien ma 'mediċini antivirali oħra, inaqqas l- ammont ta' HIV fid- demm u jżommu f' livell baxx.
Isentress does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Isentress ma jfejjaqx l- infezzjoni tal- HIV jew tal- AIDS, iżda jista 'jdewwem il- ħsara lis- sistema immunitarja u l- iżvilupp ta' infezzjonijiet u mardiet assoċjati ma 'l- AIDS.
How has Isentress been studied?
Kif ġie studjat Isentress?
The effects of Isentress were first tested in experimental models before being studied in humans.
L- effetti ta 'Isentress għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fil - bnedmin.
The two main studies of Isentress, still ongoing and scheduled to last up to three years, have included a total of 699 HIV-infected patients.
Fiż- żewġ studji ewlenin ta 'Isentress, li għadhom għaddejjin u li mistennija jdumu sa tliet snin, b' kollox ħadu sehem 699 pazjent infettati bl- HIV.
All of the patients have been receiving ‘ optimised background therapy’ (a combination of other antiviral medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood) to which either Isentress or placebo (a dummy treatment) has been added.
Il- pazjenti kollha kienu qed jingħataw 'terapija ta' sfond ottimizzata '(kombinazzjoni ta' mediċini antivirali oħra magħżula għal kull pazjent billi kienet tagħti l- aqwa possibilità ta 'tnaqqis tal- livelli tal- HIV fid- demm) li magħhom żdied Isentress jew plaċebo (trattament finta).
The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 16 weeks.
Il- mezz ewlieni tal- kejl tal- effikaċja kien it- tnaqqis tal- livelli tal- HIV fid - demm (viral load) wara 16- il ġimgħa.
What benefit has Isentress shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu European Medicines Agency, 2008 Reproduction is authorised provided the source is acknowledged X' inhuma l- benefiċċji ta 'Isentress li ntwerew f' dawn l- istudji?
Isentress was more effective than placebo in reducing viral load.
Isentress kien iktar effikaċi mill- plaċebo fit- tnaqqis tal- viral load.
After 16 weeks, 77% of the patients who took Isentress in addition to optimised background therapy had viral loads below 400 copies per millilitre of blood, compared with 42% of the patients who received placebo plus optimised background therapy.
Wara 16- il ġimgħa, 77% tal- pazjenti li kienu ħadu Isentress flimkien mat- terapija ta 'sfond ottimizzata kellhom viral loads ta' inqas minn 400 kopja kull millilitru demm, meta mqabbla ma '42% tal- pazjenti li kienu ngħataw plaċebo flimkien ma' terapija ta 'sfond ottimizzata.
The CHMP also considered the results seen after 24 and 48 weeks, which showed that the response seen at 16 weeks was sustained for at least 48 weeks.
Is- CHMP ikkunsidra wkoll ir- riżultati li dehru wara 24 u 48 ġimgħa li wrew li r- rispons li deher wara 16- il ġimgħa inżammu għal minn ta ’ l- inqas 48 ġimgħa.
What is the risk associated with Isentress?
X' inhu r- riskju assoċjat ma 'Isentress?
The most common side effects with Isentress (seen in between 1 and 10 patients in 100) are insomnia (difficulty sleeping), dizziness, headache, abdominal distension (bloating), abdominal (tummy) pain, constipation, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, hyperhidrosis (excessive sweating), night sweats, pruritus (itching), rash, arthralgia (joint pain), asthenia (weakness), fatigue (tiredness) and increased blood levels of liver enzymes (alanine aminotransferase and aspartate aminotransferase), triglycerides (a type of fat), creatinine kinase (an enzyme found in muscles) and lipase (an enzyme found in the pancreas).
L- iktar effetti sekonarji komuni b’ Isentress (li dehru f' bejn pazjent 1 u 10 minn kull 100) huma l - insomnja (diffikultà fl- irqad), sturdamenti, uġigħ ta ’ ras, distensjoni addominali (nefħa), uġigħ addominali (fiż- żaqq), stitikezza, dijarrea, flatulenza (gass), nawżea (tħossok ma tiflaħx), rimettar, iperidrożi (għaraq eċċessiv), għaraq matul il- lejl, prurite (ħakk), raxx, artralġja (uġigħ fil- ġogi), astenja (dgħjufija), għejja u żieda fil- livelli ta ’ enżimi tal- fwied (aminotransferażi alanina u aminotransferażi aspartat), trigliċeridi (tip ta ’ xaħam), kinażi tal- kreatinina (enżim li jinsab fil- muskoli) u lipażi (enżim li jinsab fil- pankrea).
For the full list of all side effects reported with Isentress, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma 'Isentress, ara l- Fuljett ta' Tagħrif.
Isentress should not be used in people who may be hypersensitive (allergic) to raltegravir or to any of the other ingredients.
Isentress m' għandux jintuża minn persuni allerġiċi għal raltegravir jew għal kwalunkwe mill - ingredjenti l- oħra.
As with other anti-HIV medicines, patients taking Isentress may be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta 'mediċini oħra ta' kontra l- HIV, il- pazjenti li jkunu qed jieħdu Isentress jista 'jkollhom riskju ikbar ta' osteonekrożi (mewt tat- tessut tal- għadam) jew sindromu tar- rijattivazzjoni immunoloġika (sintomi ta 'infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
During the studies, patients receiving Isentress developed more cancers than patients receiving optimised background therapy.
Waqt l- istudji, il- pazjenti li jkunu qed jingħataw Isentress żviluppaw iktar kanċers minn pazjenti li kienu qed jingħataw it- terapija ta 'sfond ottimizzata.
It is not known if these cancers were due to Isentress.
Mhux magħruf jekk dawn il- kanċers kinux dovuti għal Isentress.
Why has Isentress been approved?
Għaliex ġie approvat Isentress?
The Committee for Medicinal Products for Human Use (CHMP) decided that Isentress’ s benefits, when taken in combination with other antiretroviral medicinal products, outweigh its risks for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Isentress, meta meħud flimkien ma' prodotti mediċinali antiretrovirali oħra, jegħlbu lir- riskji tiegħu għat- trattament ta 'infezzjoni tal- HIV- 1 f' pazjenti adulti li jkunu diġà ġew ittrattati u li fihom ikun hemm evidenza ta' tkattir tal- infezzjoni tal- HIV- 1 minkejja t- terepija antiretrovirali rikorrenti.
This indication is based on 48-week data from two studies comparing it with placebo.
Din l - indikazzjoni hija bbażata fuq dejta minn 48 ġimgħa minn żewġ studji li qabbluh ma 'plaċebo.
The Committee recommended that Isentress be given marketing authorisation.
Il - Kumitat irrakkomanda li Isentress jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Isentress has been given ‘ Conditional Approval’.
Isentress ingħata 'Approvazzjoni b' Kundizzjoni'.
This means that there is more evidence to come about the medicine.
Dan ifisser li għad iridu jaslu iktar provi dwar il - mediċina.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available, and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea tal- Mediċini (l- EMEA) se tanalizza kull tagħrif ġdid li jista 'joħroġ, u dan is- sommarju se jiġi aġġornat kif meħtieġ.
What information is still awaited for Isentress?
X' tagħrif għadu mistenni għal Isentress?
The company that makes Isentress will set up studies to monitor the development of resistance to raltegravir.
Il- kumpanija li tagħmel Isentress se tibda wkoll studji biex tissorvelja l- iżvilupp ta 'reżistenza għal raltegravir.
Other information about Isentress:
Tagħrif ieħor dwar Isentress:
The European Commission granted a marketing authorisation valid throughout the European Union for Isentress to Merck Sharp & Dohme Limited on 20 December 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Isentress lil Merck Sharp & Dohme Limited fl- 20 ta 'Diċembru 2007.
The full EPAR for Isentress can be found here.
L- EPAR sħiħ għal Isentress jista 'jiġi kkonsultat hawn.
EU Number EU/ 1/ 07/ 436/ 001 EU/ 1/ 07/ 436/ 002
Numru ta ’ l- EU EU/ 1/ 07/ 436/ 001 EU/ 1/ 07/ 436/ 002
Invented name ISENTRESS ISENTRESS
Isem inventat ISENTRESS ISENTRESS
Strength 400 mg 400 mg
Qawwa 400 mg 400 mg
Pharmaceutical Form Film-coated tablets Film-coated tablets
Għamla farmaċewtika Pilloli miksijin b’ rita Pilloli miksijin b’ rita
Route of Administration Oral use Oral use
Mnejn jingħata Użu orali Użu orali
Packaging Bottle (HDPE) Bottle (HDPE)
Il- pakkett Bottle (HDPE) Bottle (HDPE)
Package size 60 tablets 180 (3x60) tablets
Daqs tal- pakkett 60 pillola 180 (3x60) pillola
ISENTRESS 400 mg film-coated tablets
ISENTRESS 400 mg pilloli miksija b’ rita.
Each film-coated tablet contains 400 mg of raltegravir (as potassium).
Kull pillola miksija b’ rita fiha 400 mg ta ’ raltegravir (bħala potassju).
Each tablet contains 26.06 mg lactose monohydrate.
Kull pillola fiha 26. 06 mg lactose monohydrate.
Pink, oval tablet, marked with "227" on one side.
Pillola roża, ovali, immarkata b ’ "227" fuq naħa waħda.
ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing anti-retroviral therapy.
ISENTRESS huwa indikata f’ kumbinazzjoni ma ’ prodotti mediċinali anti- retrovirali oħra għat - - trattament ta ’ infezzjoni bil- virus ta ’ l- immunodefiċjenza tal- bniedem (HIV- 1) f’ pazjenti adulti li diġà rċevew it- trattament qabel b’ evidenza ta ’ replikazzjoni ta ’ HIV- 1 minkejja terapija antiretrovirali li tkun għadha għaddejja.
This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials of 48 weeks duration in treatment-experienced patients (see section 5.1).
Din l- indikazzjoni hija bbażata fuq informazzjoni dwar is- sigurtà u l- effikaċja minn żewġ provi double- blind ikkontrollati bil- plaċebo, ta ’ 48 ġimgħa f’ pazjent li diġà rċevew it- trattament qabel (ara sezzjoni 5. 1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib esperjenzat fil- maniġment ta ’ infezzjoni bl- HIV.
ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see sections 4.4 and 5.1).
ISENTRESS għandu jintuża flimkien ma ’ terapiji antiretrovirali (ARTs) attivi oħra (ara sezzjonijiet 4. 4 u 5. 1).
Posology Adults The recommended dosage of ISENTRESS is 400 mg administered twice daily with or without food.
Pożoloġija Adulti Id- doża rakkomandata ta ’ ISENTRESS hija 400 mg mogħtija darbtejn kuljum ma ’ l- ikel jew fuq stonku vojt.
The effect of food on absorption of raltegravir is uncertain (see section 5.2).
L- effett ta ’ l- ikel fuq l- assorbiment ta ’ raltegravir mhuwiex ċert (ara sezzjoni 5. 2).
It is not recommended to chew, crush or split the tablets.
Mhux rakkomandat li tomgħod, tfarrak jew taqsam il- pilloli.
Elderly There is limited information regarding the use of ISENTRESS in the elderly (see section 5.2).
Anzjani Hemm tagħrif limitat dwar l- użu ta ’ ISENTRESS fl- anzjani (ara sezzjoni 5. 2).
Therefore ISENTRESS should be used with caution in this population.
Għalhekk ISENTRESS għandu jintuża b’ kawtela f’ din il- popolazzjoni.
Children and adolescents Safety and efficacy have not been established in patients below 16 years of age (see sections 5.1 and 5.2).
Tfal u adoloxxenti Is- sigurtà u l- effikaċja ma ġewx stabbiliti f’ pazjenti ta ’ taħt is- 16- il sena (ara sezzjonijiet 5. 1 u 5. 2).
Renal impairment No dosage adjustment is required for patients with renal impairment (see section 5.2).
Indeboliment tal- kliewi L- ebda aġġustament fid- doża ma huwa meħtieġ f’ pazjenti b’ indeboliment renali (ara sezzjoni 5. 2).
2 Hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment.
2 Indeboliment tal- fwied L- ebda aġġustament fid- doża ma huwa meħtieġ għal pazjenti b’ indeboliment epatiku ħafif għal moderat.
The safety and efficacy of ISENTRESS have not been established in patients with severe underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ ISENTRESS ma ġewx stabbiliti f’ pazjenti b’ disturbi inerenti serji tal- fwied.
Therefore ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Għalhekk ISENTRESS għandu jintuża b’ kawtela f’ pazjenti li jkollhom indeboliment epatiku sever (ara sezzjoni 4. 4 u 5. 2).
Method of administration Oral
Metodu ta ’ kif għandu jingħata Għoti orali
Patients should be advised that current anti-retroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood or sexual contact.
Il- pazjenti għandhom ikunu avżati li terapija antiretrovirali kurrenti ma tikkurax l- HIV u ma ġietx ippruvata li timpedixxi t- trasmissjoni ta ’ l- HIV lil ħaddieħor permezz ta ’ kuntatt mad- demm jew permezz ta ’ kuntatt sesswali.
Appropriate precautions should continue to be employed.
Għandhom jibqgħu jittieħdu prekawzjonijiet xierqa.
Overall, considerable inter- and intra-subject variability was observed in the pharmacokinetics of raltegravir (see sections 4.5 and 5.2).
Kollox ma ’ kollox, ġiet osservata varjanza konsiderevoli inter - u intra- soġġetti fil- farmakokinetiċi ta ’ raltegravir (ara sezzjonijiet 4. 5 u 5. 2).
Higher response rates were observed in patients with Genotypic Sensitivity Score (GSS) > 0.
Kienu osservati rati ta ’ rispons ogħla f’ pazjenti b’ Punteġġ ta ’ Sensittività Ġenotipika (GSS) > 0.
Patients with GSS or Phenotypic Sensitivity Score (PSS) = 0 had a higher risk of developing resistance to raltegravir (see section 5.1).
Pazjenti b’ GSS jew Punteġġ ta ’ Sensittività Ġenotipika (PSS) =0 kellhom riskju ogħla li jiżviluppaw reżistenza għal raltegravir (ara sezzjoni 5. 1).
Raltegravir should be used in combination with at least one other active agent to enhance benefit and to reduce the risk of virologic failure and development of resistance to raltegravir.
Raltegravir għandu jintuża ma ’ talanqas sustanza attiva oħra sabiex jitkabbar il- benefiċċju u jitnaqqas ir- riskju ta ’ falliment viroloġiku u l- iżvilupp ta ’ reżistenza għal raltegravir.
Therefore ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Għalhekk ISENTRESS għandu jintuża b’ kawtela f’ pazjenti li jkollhom indeboliment epatiku sever (ara sezzjoni 4. 2 u 5. 2).
Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination anti-retroviral therapy and should be monitored according to standard practice.
Pazjenti li diġà jkollhom disfunzjoni tal- fwied fosthom epatite kronika għandhom frekwenza akbar ta ’ anormalitajiet fil- funzjoni tal- fwied waqt terapija antiretrovirali ta ’ kombinazzjoni u għandhom jiġu mmonitorjati skond metodi standard.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Jekk ikun hemm evidenza ta ’ mard tal- fwied li jmur għall- agħar f’ tali pazjenti, wieħed għandu jikkunsidra l- interruzzjoni jew it- twaqqif tat- trattament.
There are very limited data on the use of raltegravir in patients co-infected with HIV and hepatitis B virus (HBV) or hepatitis C virus (HCV).
Hemm informazzjoni limitata ħafna dwar l- użu ta ’ raltegravir f’ pazjenti infettati fl- istess ħin bl- HIV u bil- virus ta ’ l- epatite B (HBV) jew bil- virus ta ’ l- epatite Ċ (HCV).
Patients with chronic hepatitis B or C and treated with combination anti-retroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Pazjenti b’ epatite B jew Ċ kronika u ttrattati b’ terapija antiretrovirali ta ’ kombinazzjoni huma f’ riskju akbar għal episodji epatiċi avversi gravi u potenzjalment fatali.
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/ or long-term exposure to combination anti-retroviral therapy.
Osteonekrosi Għalkemm l- etjoloġija hija kkunsidrata bħala multifattorjali (fosthom l- użu ta ’ kortikosterojdi, il - - konsum ta ’ l- alkoħol, immunosuppressjoni severa, indiċi tal- massa tal- ġisem aktar għoli), każi ta ’ osteonekrosi ġew irrappurtati b’ mod partikolari f’ pazjenti b’ mard ta ’ l- HIV avanzat u/ jew esponiment fit- tul għal terapija antiretrovirali ta ’ kombinazzjoni.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jiġu avżati sabiex ifittxu parir mediku jekk iħossu wġigħ fil- ġogi, ebusija fil- ġogi jew diffikultà fil- moviment.
Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination anti- retroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindromu ta ’ attivazzjoni immunitarja mill- ġdid F’ pazjenti infettati bl- HIV b’ defiċjenza immunitarja serja fiż- żmien tal- bidu ta ’ terapija antiretrovirali ikkumbinata (CART), tista ’ sseħħ reazzjoni infjammatorja għal patoġeni opportunisti asintomatiċi jew residwali u din tista ’ tikkaġuna kondizzjonijiet kliniċi serji, jew aggravament ta ’ sintomi.
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Tipikament, reazzjonijiet bħal dawn ġew osservati fi żmien l- ewwel ftit ġimgħat jew xhur mill- bidu ta ’ CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Eżempji relevanti huma retinite b’ cytomegalovirus, infezzjonijiet ġeneralizzati u/ jew fokali b’ majkobatterji u pnewmonja ikkaġunata minn Pneumocystis jiroveci (qabel magħruf bħala
3 Caution should be used when co-administering ISENTRESS with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (e. g., rifampicin).
Kwalunkwe sintomu infjammatorju għandu jiġi evalwat u għandu jinbeda trattament meta jkun meħtieġ.
Rifampicin reduces plasma levels of raltegravir; the impact on the efficacy of raltegravir is unknown.
Rifampicin inaqqas il - livelli ta ’ raltegravir fil- plażma; l- impatt fuq l- effikaċja ta ’ raltegravir mhuwiex magħruf.
However, if co-administration with rifampicin is unavoidable, a doubling of the dose of ISENTRESS can be considered (see section 4.5).
Madankollu jekk l- għoti flimkien ma ’ rifampicin ikun inevitabbli, l- irduppjar tad- doża ta ’ ISENTRESS jista ’ jiġi kkunsidrat (ara sezzjoni 4. 5).
Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known.
Mijopatija u rabdomyolysis ġew irrapportati; madankollu, ir- relazzjoni ta ’ ISENTRESS ma ’ dawn l - episodji mhijiex magħrufa.
Use with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other medicinal products associated with these conditions (see section 4.8).
Uża b’ kawtela f’ pazjenti li kellhom mijopatija jew rhabdomyolysis fil - passat jew li jbatu minn sitwazzjonijiet predisposti inkluż mediċini oħra assoċjati ma ’ dawn il - kundizzjonijiet (ara sezzjoni 4. 8).
During the clinical studies in treatment-experienced HIV-infected patients there was a slightly higher rate of cancer in the raltegravir group compared to the group that received only optimised background therapy.
Matul l- istudji kliniċi f’ pazjenti infettati bl- HIV b’ esperjenza fit- trattament, kien hemm rata kemmxejn ogħla ta ’ kanċer fil- grupp ta ’ raltegravir meta mqabbel mal- grupp li rċieva terapija ta ’ sfond ottimizzata biss.