qanastek/EMEA-V3 huggingface dataset:
Because the extent to which ISENTRESS may be dialysable is unknown, dosing before a dialysis session should be avoided.
Minħabba li l- punt kemm ISENTRESS jista ’ jkun dijalizzabbli m’ huwiex magħruf, dożaġġ qabel sessjoni ta ’ dijaliżi għandu jiġi evitat.
12 Hepatic impairment Raltegravir is eliminated primarily by glucuronidation in the liver.
Indeboliment epatiku Raltegravir huwa eliminat primarjament fil- fwied.
There were no clinically important pharmacokinetic differences between patients with moderate hepatic insufficiency and healthy subjects.
Ma kien hemm l- ebda differenza farmakokinetika klinikament importanti bejn pazjenti b’ indeboliment epatiku serju u suġġetti f’ saħħithom.
The effect of severe hepatic insufficiency on the pharmacokinetics of raltegravir has not been studied (see sections 4.2 and 4.4).
L- effett ta ’ indeboliment epatiku serju fuq il- farmakokinetiċi ta ’ raltegravir ma ġiex studjat (ara sezzjoni 4. 2 u 4. 4).
Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, and developmental toxicity, have been conducted with raltegravir, in mice, rats, dogs and rabbits.
Saru studji tossikoloġiċi li mhumiex kliniċi inkluż studji konvenzjonali tal- farmakoloġija tas- sigurtà, tossiċità ta ’ doża ripetuta, ġenotossiċità u tossiċità ta ’ l- iżvilupp, fuq ġrieden, firien, klieb u fniek.
Effects at exposure levels sufficiently in excess of clinical exposure levels indicate no special hazard for humans.
13 Effetti fuq livelli ta ’ espożizzjoni li huma ferm f’ eċċess tal- livelli ta ’ espożizzjoni kliniċi ma jindikaw ebda periklu speċjali għall- bniedem.
Mutagenicity No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies.
Mutaġeniċità L- ebda evidenza ta ’ mutaġeniċità jew ġenotossiċità ma kienet osservata f’ testijiet (Ames) ta ’ mutaġenesi mikrobjali in vitro, assaġġi alkaline elution in vitro għat- tkissir tad- DNA u studji ta ’ aberrazzjoni tal- kromożoni in vitro u in vivo.
Carcinogenicity Long-term (2-year) carcinogenicity studies of raltegravir in rodents are ongoing but have not been completed.
Karċinoġeniċità Studji dwar il- karċinoġeniċità ta ’ raltegravir fuq tul ta ’ żmien (sentejn) f’ annimali gerriema għadhom għaddejjin iżda għadhom ma ntemmux.
Developmental Toxicity Raltegravir was not teratogenic in developmental toxicity studies in rats and rabbits.
Tossiċità ta ’ l- Iżvilupp Raltegravir ma kienx teratoġeniku fl- istudji dwar l- effett tossiku fuq l- iżvilupp fil- firien u l- fniek.
A slight increase in incidence of supernumerary ribs was observed in rat pups of dams exposed to raltegravir at approximately 4.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr.
Żieda żgħira fl- inċidenza ta ’ kustilji supernumerarji kienet osservata fi friegħ ta ’ firien nisa esposti għal raltegravir f’ madwar 4. 4 drabi l- espożizzjoni umana f’ 400 mg darbtejn kuljum fuq il- bażi ta ’ AUC0- 24 hr.
No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
L- ebda effett fuq l- iżvilupp ma deher fi 3. 4 drabi l- espożizzjoni umana b’ 400 mg darbtejn kuljum fuq il- bażi ta ’ l- AUC0- 24 hr (ara sezzjoni 4. 6).
Similar findings were not observed in rabbits.
Riżultati simili ma kinux osservati fil- fniek.
Tablet core
Qalba tal- pillola
- microcrystalline cellulose
- microcrystalline cellulose
- lactose monohydrate
- lactose monohydrate
- calcium phosphate dibasic anhydrous
- calcium phosphate dibasic anhydrous
- sodium stearyl fumarate
- sodium stearyl fumarate
Film-coating
Kisja- rita
- polyvinyl alcohol
- polyvinyl alcohol
- polyethylene glycol 3350
- polyethylene glycol 3350
- red iron oxide (E 172)
- red iron oxide (E 172)
- black iron oxide (E 172)
- black iron oxide (E 172)
13 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure.
Flixkun tal- polyethylene ta ’ densità għolja (HDPE) b’ tapp tal- polypropylene li ma jinfetaħx mit- tfal.
1 bottle with 60 tablets, and a multi-pack containing 3 bottles of 60 tablets.
Jeżistu żewġ daqsijiet tal- pakkett: flixkun b’ 60 pillola, u multi- pack li fih 3 fliexken ta ’ 60 pillola.
Not all pack sizes may be marketed.
14 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
20 December 2007
Data ta ’ l- ewwel awtorizzazzjoni: < JJ xahar SSSS >
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediċinali hija disponibbli fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
14 ANNEX II
15 ANNEX II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGI SPEĊIFIĊI LI GĦANDHOM JIĠU SODISFATTI MID- DETENTUR TA ’ L - - AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Waarderweg 39 P. O. Box 581 2003 PC Haarlem The Netherlands
Waarderweg 39 P. O. Box 581 2003 PC Haarlem L- Olanda
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata biss bir- riċetta tat- tabib (Ara Anness I:
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 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 għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qed taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Ġestjoni tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif isir qbil fuqhom fil- verżjoni 2. 1 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP li jkun sar qbil fuqu mill- CHMP.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGI SPEĊIFIĊI LI GĦANDHOM JIĠU SODISFATTI MID- DETENTUR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame.
Id- Detentur ta ’ l- Awtorizzazzjoni Għat- Tqegħid fis- Suq għandu jtemm programm ta ’ studji f’ perjodu ta ’ żmien speċifikat.
The results of which shall be taken into account in the risk benefit balance during the assessment of the application for a renewal.
Ir- riżultati tiegħu għandhom jitqiesu fil- bilanċ bejn il- benefiċċju u r- riskju matul il- valutazzjoni ta ’ l- applikazzjoni għal tiġdid.
16 Area Clinical
Qasam Kliniku
Description To further support the benefit risk assessment, the MAH has provided the CHMP with the 48-week safety and efficacy data from the ongoing Phase III Protocol 018 (A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV- Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) and Protocol 019 (A Multicenter, Double-Blind, Randomized, Placebo- Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) for review.
Deskrizzjoni Sabiex jappoġġja aktar il- valutazzjoni tal- benefiċċju: riskju, l- Applikant jimpenja ruħu li jipprovdi lill- CHMP bid- data ta ’ 48 ġimgħa dwar is - sigurtà mill- Protokoll 018 ta ’ Fażi III għaddej il- ħin kollu (Studju b’ Aktar minn Ċentru Wieħed, Double- blind, Randomizzat, Ikkontrollat bi Plaċebo sabiex jevalwa s- Sigurtà u l- Attività Antiretrovirali ta ’ MK - 0518 f’ Kombinazzjoni Ma ’ Terapija ta ’ Sfond Ottimizzata (OBT), Kontra Terapija ta ’ Sfond Ottimizzata Waħidha, f’ Pazjenti Infettati b’ HIV B’ Reżistenza Dokumentata għal mill- Inqas Mediċina 1 f’ Kull Waħda mit- 3 Klassijiet ta ’ Terapiji Antiretrovirali Orali Liċenzjati) u Protokoll 019 (Studju b’ Aktar minn Ċentru Wieħed, Double- blind, Randomizzat, Ikkontrollat bi Plaċebo sabiex jevalwa s- Sigurtà u l - Attività Antiretrovirali ta ’ MK- 0518 f’ Kombinazzjoni Ma ’ Terapija ta ’ Sfond Ottimizzata (OBT), Kontra Terapija ta ’ Sfond Ottimizzata Waħidha, f’ Pazjenti Infettati b’ HIV B’ Reżistenza Dokumentata għal mill- Inqas Mediċina 1 f’ Kull Waħda mit- 3 Klassijiet ta ’ Terapiji Antiretrovirali Orali Liċenzjati) għal reviżjoni.
Due date Under assessment
31- Mar- 2008
Clinical
Kliniku
The MAH commits to provide the CHMP with detailed specific plans for monitoring of resistance with frequent reporting intervals.
L- applikant jimpenja ruħu li jipprovdi lill- CHMP bi pjanijiet speċifiċi dettaljati għall- monitoraġġ tar- reżistenza b’ intervalli ta ’ rapportaġġ frekwenti.
31-Oct-2008
31- Diċ- 2007
17 ANNEX III
Kliniku
LABELLING AND PACKAGE LEAFLET
31- Mar- 2008
Carton for individual packs
Kartuna għal pakketti individwali
ISENTRESS 400 mg film-coated tablets raltegravir
ISENTRESS 400 mg pilloli miksijin b’ rita raltegravir
Each tablet contains 400 mg of raltegravir (as potassium).
Kull pillola fiha 400 mg ta ’ raltegravir (bħala potassju).
60 film-coated tablets
60 pilloli miksijin b’ rita
EU/ 1/ 07/ 436/ 001
EU/ 1/ 07/ XXX/ XXX
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton for multi-packs
Kartuna għal pakketti multipli
Multi-pack containing 180 (3 bottles of 60) film-coated tablets
Pakkett multipli li fih 180 (3 fliexken ta ’ 60) pillola miksijin b’ rita
EU/ 1/ 07/ 436/ 002
EU/ 1/ 07/ XXX/ XXX
23 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
ISENTRESS 400 mg – bottle labelling for individual packs
ISENTRESS 400 mg – tikketta tal- flixkun għal pakketti individwali
60 film-coated tablets
60 pillola miksijin b’ rita
25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
ISENTRESS 400 mg – bottle labelling for multi-packs
ISENTRESS 400 mg – tikketta tal- flixkun għall- multi- packs
Component of a multi-pack comprising 3 bottles, each containing 60 film-coated tablets.
Komponent ta ’ multi- pack li fih 3 fliexken, kull wieħed fih 60 pillola miksija b’ rita.
ISENTRESS 400 mg tablets raltegravir
ISENTRESS 400 mg pilloli raltegravir
What ISENTRESS is and what it is used for 2.
X’ inhu ISENTRESS u għalxiex jintuża 2.
Before you take ISENTRESS 3.
Qabel ma tieħu ISENTRESS 3.
How to take ISENTRESS 4.
Kif għandek tieħu ISENTRESS 4.
How to store ISENTRESS 6.
Kif taħżen ISENTRESS 6.
WHAT ISENTRESS IS AND WHAT IT IS USED FOR
X’ INHU ISENTRESS U GĦALXIEX JINTUŻA
What ISENTRESS is ISENTRESS works against the Human Immunodeficiency Virus (HIV).
X’ inhu ISENTRESS ISENTRESS jaħdem kontra l- Virus ta ’ Immunodefiċjenza Umana (HIV).
This is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Dan huwa l- virus li jikkawża l- Acquired Immune Deficiency Syndrome (AIDS).
How ISENTRESS works The virus produces an enzyme called HIV integrase.
Kif jaħdem ISENTRESS Il- virus tal- HIV jipproduċi enzima msejħa integrase tal- HIV.
This helps the virus to multiply in the cells in your body.
Din tgħin lill- virus jimmultiplika fiċ - ċelloli f’ ġismek.
ISENTRESS stops this enzyme working.
ISENTRESS iwaqqaf lil din l- enzima milli tkompli taħdem.
When used with other medicines, ISENTRESS may reduce the amount of HIV in your blood (this is called your "viral load") and increase your CD4- cell count (a type of white blood cells that plays an important role in maintaining a healthy immune system to help fight infection).
Meta użat ma ’ mediċini oħrajn, ISENTRESS jista ’ jnaqqas l- ammont ta ’ HIV f’ demmek (dan huwa msejjaħ it - “ tagħbija virali ” tiegħek) u jżid l- għadd ta ’ ċelloli CD4 (T) (tip ta ’ ċelloli tad- demm bojod li għandhom rwol importanti fiż- żamma ta ’ sistema immunitarja b’ saħħitha fil- ġlieda kontra infezzjoni).
Reducing the amount of HIV in the blood may improve the functioning of your immune system.
It- tnaqqis ta ’ l- ammont ta ’ HIV fid- demm jista ’ jtejjeb il- funzjoni tas- sistema immunitarja tiegħek.
This means your body may fight infection better.
Dan ifisser li ġismek jista ’ jiġġieled infezzjoni aħjar.
ISENTRESS may not have these effects in all patients.
ISENTRESS jista ’ ma jkollux dawn l- effetti fil- pazjenti kollha.
ISENTRESS is not a cure for HIV infection.
ISENTRESS mhuwiex kura għal infezzjoni bl- HIV.
When ISENTRESS should be used ISENTRESS is used to treat adults who are infected by HIV and who are not responding adequately to their current anti-retroviral medicines.
It- tabib tiegħek ippreskriva ISENTRESS sabiex jgħinek tikkontrolla l- infezzjoni tal- HIV tiegħek.
Your doctor has prescribed ISENTRESS to help control your HIV infection.
ISENTRESS m’ huwiex kura għal infezzjoni tal- HIV.
BEFORE YOU TAKE ISENTRESS
QABEL TIEĦU ISENTRESS
Do not take ISENTRESS • If you are allergic (hypersensitive) to raltegravir or to any of the other ingredients in the tablets (listed in 6.
Tiħux ISENTRESS • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal raltegravir jew għal xi sustanza fil - pilloli (elenkati f’ 6.
Further information).
Aktar tagħrif).
Take special care with ISENTRESS Remember that ISENTRESS is not a cure for HIV infection.
30 Oqgħod attent ħafna b’ ISENTRESS Ftakar li ISENTRESS m’ huwiex kura għal infezzjoni ta ’ l- HIV.
This means that you may keep getting infections or other illnesses associated with HIV.
Dan ifisser li inti tista ’ tibqa ’ tieħu infezzjonijiet jew mard ieħor assoċjat mal- HIV.
You should keep seeing your doctor regularly while taking ISENTRESS.
Inti għandek tibqa ’ tara lit- tabib tiegħek regolarment meta tieħu ISENTRESS.
ISENTRESS is not for use in children and adolescents.
ISENTRESS ma għandux jintuża minn tfal u adoloxxenti
29 Some patients taking combination anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Xi pazjenti li jkunu qegħdin jieħdu terapija antiretrovirali ta ’ kombinazzjoni jistgħu jiżviluppaw marda ta ’ l- għadam imsejħa osteonekrosi (mewt tat- tessut ta ’ l- għadam ikkawżata minn telf tal- provvista tad - demm lill- għadma).
The length of combination anti-retroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul ta ’ terapija antiretrovirali ta ’ kombinazzjoni, l- użu ta ’ kortikosterojdi, il - konsum ta ’ l- alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem aktar għoli, fost l- oħrajn, jistgħu jkunu xi wħud mill- ħafna fatturi ta ’ riskju sabiex tiġi żviluppata din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Is- sinjali ta ’ osteonekrosi huma ebusija fil- ġogi, uġigħ fil- ġogi (speċjalment tal- ġenb, ta ’ l- irkoppa u ta ’ l- ispalla) u diffikultà fil- moviment.
If you notice any of these symptoms please inform your doctor.
Jekk jogħġbok informa lit- tabib tiegħek jekk tinnota xi wieħed minn dawn is - sintomi.
Tell your doctor if you have had problems with your liver before, including hepatitis B or C.
Għid lit- tabib tiegħek jekk kellek problemi bil- fwied qabel, fosthom epatite B jew Ċ.
Your doctor may evaluate how severe your liver disease is before deciding if you can take ISENTRESS.
It- tabib tiegħek jista ’ jevalwa l- gravità tal- mard tal- fwied tiegħek qabel jiddeċiedi jekk tistax tieħu ISENTRESS.
HIV infection is spread by contact with blood or sexual contact with a person with HIV.
L- infezzjoni tal- HIV tittieħed b’ kuntatt mad- demm jew b’ kuntatt sesswali ma ’ persuna b’ HIV.
Taking ISENTRESS has not been shown to reduce the risk of giving HIV to others through sexual contact or contact with blood.
Ma ntweriex li t- teħid ta ’ ISENTRESS inaqqas ir- riskju li l- HIV tingħata lil ħaddieħor permezz ta ’ kuntatt sesswali jew b’ kuntatt mad- demm.
Tell your doctor immediately if you notice any symptoms of infection.
Avża lit- tabib tiegħek minnufih jekk tinnota xi sintomi ta ’ infezzjoni.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F’ xi pazjenti b’ infezzjoni tal - HIV avvanzata u bi storja ta ’ infezzjoni opportunistika, jistgħu jseħħu sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet preċedenti ftit ħin wara li jkun inbeda trattament kontra l- HIV.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa mifhum li dawn is- sintomi huma dovuti għal titjib fir- rispons ta ’ l- immunità tal- ġisem, u dan jippermetti lill- ġisem jiġġieled l- infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.
Ikkuntattja lit- tabib tiegħek minnufih jekk tesperjenza uġigħ muskolari, tenerezza jew dgħjufija bla raġuni meta tkun qed tieħu ISENTRESS.
Tell your doctor if you have cancer, if you have been told you are at risk of cancer, or if you have a suspicious growth on your body.
Għid lit- tabib tiegħek jekk għandek kanċer, jekk taf li inti f’ riskju ta ’ kanċer, jew jekk għandek growth suspettuża fuq ġismek.
See section 4 of this leaflet.
Ara sezzjoni 4 ta ’ dan il- fuljett.
Taking other medicines ISENTRESS might interact with other medicines.
Meta tieħu mediċini oħra ISENTRESS jista ’ jinteraġixxi ma ’ mediċini oħra.
Raltegravir is not known to have an important effect on blood levels of other agents used to treat HIV.
Raltegravir mhuwiex magħruf li għandu effett importanti fuq il- livelli tad- demm ta ’ sustanzi oħra użati biex jittrattaw l- HIV.
Also, blood levels of raltegravir are not known to be affected to an important extent by other agents used to treat HIV.
Barra minn hekk, il - livelli tad- demm ta ’ raltegravir mhumiex magħrufin li jiġu affettwati sa punt importanti minn sustanzi oħra użati biex jittrattaw l- HIV.
However, further information is expected to become available as experience with the use of raltegravir increases.
Madankollu, aktar informazzjoni hija mistennija li ssir disponibbli hekk kif l- esperjenza bl- użu ta ’ raltegravir tiżdied.
Please tell your doctor or pharmacist if you are now or have recently taken: • rifampicin (a medicine used to treat some infections such as tuberculosis) • medicines used to treat stomach ulcer or heartburn (e. g., omeprazole, cimetidine, ranitidine) • any other medicines with or without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk bħalissa qiegħed tieħu jew ħadt dan l- aħħar: • rifampicin (mediċina użata biex jiġu ttrattati xi infezzjonijiet bħat- tuberkulożi) • mediċini wżati biex jittrattaw ulċera fl- istonku jew aċidu fl- istonku (eż omeprazole, cimetidine, ranitidine) • xi mediċini oħra bi jew mingħajr riċetta tat- tabib.
Taking ISENTRESS with food and drink You can take ISENTRESS with or without food or drink.
Meta tieħu ISENTRESS ma ’ l- ikel u max- xorb Tista ’ tieħu ISENTRESS kemm ma ’ l- ikel jew max- xorb kif ukoll le.
Pregnancy and breast-feeding Talk to your doctor before taking ISENTRESS if you are pregnant, might become pregnant or are breastfeeding.
Tqala u Treddigħ Għid lit- tabib tiegħek qabel tieħu ISENTRESS jekk inti tqila, tista ’ toħroġ tqila jew qegħda tredda ’.
If you become pregnant, tell your doctor straight away.
Jekk toħroġ tqila, għid lit- tabib tiegħek minnufih.
• ISENTRESS is not recommended in pregnancy because it has not been studied in pregnant women. • Women with HIV should not breast-feed their infants because babies can be infected with HIV through their breast milk.
31 • Nisa b’ HIV ma għandhomx ireddgħu lit- trabi tagħhom minħabba li t- trabi jistgħu jiġu infettati bl- HIV permezz tal- ħalib tas- sider.
Talk with your doctor about the best way to feed your baby.
Iddiskuti mat- tabib tiegħek fuq kif inhu l- aħjar mod kif tredda ’ lit- tarbija tiegħek.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast- feeding.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina jekk inti tqila jew qegħda tredda ’.
Driving and using machines Do not operate machines or drive if you feel dizzy after taking ISENTRESS.
Sewqan u tħaddim ta ’ magni M’ għandekx tagħmel użu minn għodda jew tħaddem magni jekk tħossok stordut wara li tieħu ISENTRESS.
30 Important information about some of the ingredients of ISENTRESS ISENTRESS contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ISENTRESS ISENTRESS fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti għande intolleranza għal xi zokkor, kellem lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE ISENTRESS
KIF GĦANDEK TIEĦU ISENTRESS
Always take ISENTRESS exactly as your doctor has told you.
Dejjem għandek tieħu ISENTRESS skond il- parir tat- tabib.
ISENTRESS must be used in combination with other medicines for HIV.
ISENTRESS għandu jintuża f’ kombinazzjoni ma ’ mediċini oħra għall - HIV.
How much to take • The usual dose of ISENTRESS is 1 tablet (400 mg) by mouth twice a day. • It is recommended not to chew, crush or split the tablets. • You can take ISENTRESS with or without food or drink. • Do not change your dose or stop taking ISENTRESS without first talking with your doctor.
Kemm għandek tieħu • Id- doża normali ta ’ ISENTRESS hija pillola 1 (400 mg) mill- ħalq darbtejn kuljum. • Huwa rakkomandat li ma tomgħodx, ma tfarrakx u ma taqsamx il- pilloli. • Tista ’ tieħu ISENTRESS kemm ma ’ l- ikel jew max- xorb kif ukoll le. • Tibdilx id- doża tiegħek jew tieqafx tieħu ISENTRESS mingħajr ma l- ewwel tkellem lit- tabib tiegħek.
If you take more ISENTRESS than you should Do not take more tablets than the doctor recommends.
Jekk tieħu ISENTRESS aktar milli suppost Tiħux aktar pilloli milli jgħidlek it- tabib.
If you do take too many tablets, contact your doctor.
Jekk tieħu wisq pilloli, ikkuntattja lit- tabib tiegħek.
If you forget to take ISENTRESS • If you forget to take a dose, take it as soon as you remember it. • However, if it is time for your next dose, skip the missed dose and go back to your regular schedule. • Do not take a double dose of ISENTRESS to make up for a forgotten dose.
Jekk tinsa tieħu ISENTRESS • Jekk tinsa tieħu doża, ħudha malli tiftakar teħodha. • Madankollu, jekk ikun wasal il- ħin għad- doża li jmiss tiegħek, aqbeż id- doża li tkun insejt tieħu u mur lura għall- iskeda regolari tiegħek. • M’ għandekx tieħu doża doppja biex tpatti għal kull doża ta ’ ISENTRESS li tkun insejt tieħu.
If you stop taking ISENTRESS It is important that you take ISENTRESS exactly as your doctor has instructed.
Jekk tieqaf tieħu ISENTRESS Huwa importanti li tieħu ISENTRESS eżattament kif jgħidlek it- tabib tiegħek.
Do not stop taking it because: • It is very important to take all your HIV medicines as prescribed and at the right times of day.
• Huwa importanti ferm li tieħu l- mediċini kollha tiegħek kontra l- HIV kif jgħidlek it- tabib u fil - ħinijiet ix- xierqa tal- ġurnata.
This can help your medicines work better.
Dan jista ’ jgħin lill- mediċini tiegħek jaħdmu aħjar.
It also lowers the chance that your medicines will stop being able to fight HIV (also called "drug resistance"). • When your supply of ISENTRESS starts to run low, get more from your doctor or pharmacy.
• Meta l- provvista ta ’ ISENTRESS tiegħek tkun waslet biex tispiċċa, ġib aktar mingħand it- tabib jew l- ispiżerija tiegħek.
This is because it is very important not to be without the medicine, even for a short time.
Dan minħabba li huwa importanti ħafna li ma tispiċċax mingħajr mediċina, anki għal perjodu ta ’ żmien qasir.
During a short break in taking the medicine the amount of virus in your blood may increase.
Jekk ma tiħux il- mediċina għal perjodu ta ’ żmien qasir, l- ammont ta ’ virus f’ demmek jista ’ jiżdied.
This may mean that the HIV virus will develop resistance to ISENTRESS and become harder to treat.
Dan jista ’ jfisser li l- virus tal- HIV jibda jiżviluppa reżistenza għal ISENTRESS u b’ hekk isir iktar diffiċli biex jiġi ttrattat.
If you have any further questions on the use of ISENTRESS, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ ISENTRESS, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, ISENTRESS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ISENTRESS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (affects 1 to 10 users in 100): • trouble sleeping • feeling dizzy; headache • bloating; abdominal pain; constipation; diarrhoea; excessive gas in the stomach or bowel; feeling sick; vomiting • excessive sweating; night sweats; itching; certain kinds of rash • joint pain • tiredness, unusual tiredness or weakness • increased liver blood tests; increased fat levels in blood; increased muscle enzyme in blood; blood test showing damage of pancreas
Effetti sekondarji komuni (jaffettwaw 1 sa 10 minn kull 100 persuna): • problemi biex torqod • stordament; uġigħ ta ’ ras • nefħa; uġigħ addominali; stitikezza; dijarea, gass eċċessiv fl- istonku jew fl- imsaren; tħossok ma tiflaħx; remettar • togħriq eċċessiv; togħriq bil- lejl; ħakk; ċertu tip ta ’ raxx; • uġigħ fil- ġogi • għeja kbira, għeja jew dgħufija mhux normali • riżultati aktar għolja fir- riżultati tat- testijiet tad- demm dwar il- funzjonament tal- fwied; żieda fil- livelli ta ’ grass fid- demm; żieda tal- enżima tal- muskolu fid- demm; test tad- demm li juri ħsara fil- frixa
During post-marketing experience the following side effects have been reported (frequency not known): • Severe skin reactions • Suicidal thoughts and actions
33 Waqt l- esperjenza ta ’ wara t- tqegħid fis- suq, l- effett mhux mixtieq li ġej ġie rapportat (frekwenza mhix magħrufa)
There have been reports of muscle pain, tenderness, or weakness during treatment with ISENTRESS.
Kien hemm rapporti ta ’ uġigħ fil- muskoli, sensittività, jew dgħufija matul trattament b’ ISENTRESS.
Cancers were reported in patients taking ISENTRESS.
Ġew irrapportati kanċers f’ pazjenti li kienu qed jieħdu ISENTRESS.
It is not known if these cancers were caused by ISENTRESS.
Għadu mhux magħruf jekk dawn il- kanċers ġewx ikkawżati minn ISENTRESS.
HOW TO STORE ISENTRESS
KIF TAĦŻEN ISENTRESS
• Keep out of the reach and sight of children. • Do not take ISENTRESS after the expiry date which is stated on the bottle after EXP.
• Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal. • Tiħux ISENTRESS wara d- data ta ’ skadenza li tidher fuq il- flixkun wara JIS.
The expiry date refers to the last day of that month. • This product does not require any special storage conditions.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. • Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
32 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What ISENTRESS contains The active substance is raltegravir.
X’ fih ISENTRESS Is- sustanza attiva hija raltegravir.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, and magnesium stearate.
Is- sustanzi l- oħra huma: lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, u magnesium stearate.
In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 3350, talc, red iron oxide (E 172) and black iron oxide (E 172).
Barra minn hekk, il- kisja b’ rita fiha s- sustanza inattivi li ġejjin: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 3350, talc, red iron oxide (E 172) u black iron oxide (E 172).
What ISENTRESS looks like and contents of the pack The film-coated tablet is oval-shaped, pink, marked with "227" on one side.
Id- dehra ta ’ ISENTRESS u l- kontenuti tal- pakkett Il- pillola miksija b’ rita għandha għamla ovali, hija roża u mmarkata b ’ "227" fuq naħa waħda.
1 bottle with 60 tablets, and a multi-pack containing 3 bottles of 60 tablets.
Jeżistu żewġ daqsijiet tal- pakkett: flixkun b’ 60 pillola, u multi- pack li fih 3 fliexken ta ’ 60 pillola kull wieħed.
The Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq huwa:
Tel.: +420 233 010 111 msd_cr@merck. com
Česká republika Merck Sharp & Dohme, IDEA, Inc., org. sl Tel.: +420 233 010 111 msd_ cr@ merck. com
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck. com
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0) 1 29987700 medinfo_ ireland@ merck. com
34 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar fi:
This medicine has been given “ conditional approval”.
Din il- mediċina ingħatat “ approvazzjoni b’ kundizzjoni ”.
This means that there is more evidence to come about this medicine.
Dan ifisser li se jkun hemm iktar evidenza fuq din il- mediċina.
The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) se tirrevedi informazzjoni ġdida dwar il- mediċina kull sena u dan il- fuljett se jiġi aġġornat kif ikun xieraq.
What is IVEMEND?
X' inhu IVEMEND?
IVEMEND is a powder containing 115 mg of the active substance fosaprepitant.
IVEMEND huwa trab li fih 115mg tas- sustanza attiva fosaprepitant.
It is made up into a solution for infusion (drip into a vein).
Dan huwa magħmul f’ soluzzjoni għall- infużjoni (drip fil- vina).
What is IVEMEND used for?
Għal x' hiex jintuża IVEMEND?
IVEMEND is used with other medicines to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines used to treat cancer).
IVEMEND jintuża flimkien ma ’ mediċini oħra sabiex jipprevjeni n- nawżea (tħoss id- dardir) u r - rimettar li huma kkawżati mill- kemjoterapija (mediċina użata fit- trattament tal- kanċer).
IVEMEND works with chemotherapy that uses cisplatin and is a strong trigger for nausea and vomiting (‘ highly emetogenic ’) and with chemotherapy that is a moderate trigger (‘ moderately emetogenic’).
IVEMEND jaħdem mal- kemjoterapija li tuża cisplatin u hija kawża qawwija ta ’ nawżea u rimettar (‘ ferm emetoġenika ’) u ma ’ kemjoterapija li tikkawża dawn l- istess sintomi b’ mod moderat (‘ moderatament emetoġeniku ’).
How is IVEMEND used?
Kif jintuża IVEMEND?
IVEMEND is given as a 15-minute infusion 30 minutes before the start of chemotherapy on the first day of chemotherapy.
IVEMEND jingħata bħala infużjoni ta ’ 15 - il minuta, 30 minuta qabel il- bidu tal- kemjoterapija fl - ewwel jum tat- trattament.
It must always be given with other medicines that also prevent nausea and vomiting, including a corticosteroid and a 5HT3 antagonist (another type of medicine which prevents nausea and vomiting, such as ondansetron).
Irid dejjem jingħata ma ’ mediċini oħra li jipprevjenu huma wkoll in - nawżea u r- rimettar, inkluż kortikosterojd u antagonist 5HT3 (tip ieħor ta ’ mediċina li tipprevjeni n - nawżea u r- rimettar, bħal ondanestron).
The patient should continue receiving treatment by mouth for a further two to three days.
Il- pazjent għandu jkompli jirċievi t- trattament b’ mod orali (mill- ħalq) għal jumejn oħra jew tlieta.
How does IVEMEND work?
Kif jaħdem IVEMEND?
The active substance in IVEMEND, fosaprepitant, is a ‘ prodrug ’ of aprepitant.
Is- sustanza attiva f’ IVEMEND, fosaprepitant, hija ‘ promediċina ’ ta ’ aprepitant.
This means that it is converted to aprepitant in the body.
Dan ifisser li hija tiġi kkonvertita għal aprepitant fil- ġisem.
Aprepitant is a neurokinin 1 (NK1) receptor antagonist.
Aprepitant huwa antagonist tar- riċettur newrokinin 1 (NK1).
When substance P attaches to these receptors, it causes nausea and vomiting.
Meta sustanza P teħel ma ’ dawn ir- riċetturi, hija tikkawża nawżea u rimettar.
By blocking the receptors, IVEMEND can prevent nausea and vomiting, which often happens during and after chemotherapy.
Billi jimblokka r- riċevituri, IVEMEND jista ’ jipprevjeni nawżea u rimettar, li ħafna drabi jiġri matul u wara l- kemjoterapija.
Medicines containing aprepitant have been available in the European Union as EMEND since 2003.
Mediċini li fihom aprepitant jinsabu disponibbli fl- Unjoni Ewropea bħala EMEND sa mill- 2003.
How has IVEMEND been studied?
Kif ġie studjat IVEMEND?
The effects of IVEMEND were first tested in experimental models before being studied in humans.
L- effetti ta ’ IVEMEND għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The company presented data to show that an infusion of 115 mg IVEMEND produces the same amount of aprepitant in the body as one EMEND 125 mg capsule.
Il- kumpanija ppreżentat dejta sabiex turi li infużjoni ta ’ 115mg ta ’ IVEMEND tipproduċi l - istess ammont ta ’ aprepitant fil- ġisem daqs kapsula waħda ta ’ 125mg ta ’ EMEND.
The company also supplied data supporting the use of EMEND to support the use of IVEMEND, as in all EMEND studies, the 125-mg capsules were used on the day of chemotherapy.
Il- kumpanija ppreżentat ukoll dejta li tappoġġa l- użu ta ’ EMEND sabiex tappoġġa l- użu ta ’ IVEMEND; bħal ma sar fl- istudji kollha ta ’ EMEND, il- kapsuli ta ’ 125- mg intużaw fil- jum tal- kemjoterapija.
There were two studies in highly emetogenic chemotherapy, involving a total of 1,094 patients, where EMEND combined with dexamethasone (a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Kien hemm żewġ studji ta ’ kemjoterpaija li kienet ferm emetoġenika, li kienet tinkludi total ta ’ 1, 094 pazjent, fejn 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged corticosteroid) and ondansetron was compared with a standard treatment of only dexamethasone and ondansetron.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged EMEND flimkien ma ’ dexamethasone (kortikosterojdi) u ondansetron ġew ipparagunati ma ’ trattament standard b ’ dexamethasone u ondansetron biss.
One study in less emetogenic chemotherapy compared EMEND in the same way in 866 patients with breast cancer who were receiving cyclophosphamide with or without doxorubicin or epirubicin.
Studju ieħor ta ’ kemjoterapija inqas emetoġenika pparaguna EMEND bl- istess mod fi 866 pazjent b’ kanċer fis- sider li kienu qed jirċievu ċiklofosfamide bi jew mingħajr doxorubicin jew epirubicin.
The measure of effectiveness was the proportion of patients who had nausea and vomiting over the five days after receiving the chemotherapy.
Il- miżura ta ’ l- effikaċja kienet il - proporzjoni ta ’ pazjenti li kellhom nawżea jew rimettar fil- ħamest ijiem wara li kienu rċevew il - kemjoterapija.
What benefit has IVEMEND shown during the studies?
Liema benefiċċju wera IVEMEND waqt l- istudji mwettqa?
In the studies in highly emetogenic chemotherapy, the proportion of patients who had no nausea or vomiting over five days was 67.7% in the EMEND group and 47.8% in the comparator group.
Fl- istudji b’ kemjoterapija ferm emetoġenika, il- proporzjon ta ’ pazjenti li ma kellhomx nawżea jew rimettar fuq żmien ħamest ijiem kien ta ’ 67. 7% fil- grupp EMEND u 47. 8% fil- grupp ta ’ paragun.
This benefit shown by EMEND 125 mg capsules given on the first day of chemotherapy can be applied to IVEMEND as the two medicines were shown to produce equivalent levels of aprepitant in the body.
Fl - istudju fejn il- pazjenti rċevew kemjoterapija inqas emetoġenika, il- perċentwali kienu ta ’ 50. 8% (grupp EMEND) u 42. 5% (grupp ta ’ paragun) Dan il- benefiċċju li deher minn kapsuli EMEND ta ’ 125 mg mogħtija fl- ewwel jum tal- kemjoterapija huwa wkoll applikabbli għal IVEMEND minħabba li ż- żewġ mediċini wrew li jipproduċu livelli ekwivalenti ta ’ aprepitant fil- ġisem.
What is the risk associated with IVEMEND?
X’ inhu r- riskju assoċjat ma ’ IVEMEND?
The most common side effects with IVEMEND (seen in between 1 and 10 patients in 100) are increased liver enzymes, headache, dizziness, hiccups, constipation, diarrhoea, dyspepsia (indigestion), eructation (burping), anorexia (loss of appetite) and asthenia or fatigue (weakness or tiredness). For the full list of all side effects reported with IVEMEND, see the Package Leaflet.
Għal lista sħiħa ta ’ effetti sekondarji rrappurtati b’ IVEMEND, ara l- Fuljett ta ’ Tagħrif.
IVEMEND should not be used in people who may be hypersensitive (allergic) to aprepitant, to polysorbate 80 or any of the other ingredients.
IVEMEND m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għall- aprepitant, għal polysorbate 80 jew għal kwalunkwe wieħed mis- sustanzi l- oħra.
IVEMEND cannot be given at the same time as the following medicines: • pimozide (used to treat mental illness), • astemizole, terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription), • cisapride (used to relieve certain stomach problems).
IVEMEND ma jistax jingħata fl- istess ħin ma ’ dawn il- mediċini: • pimozide (użat għall- kura ta ’ mard mentali), • astemizole, terfenadine (sikwit użati fit- trattament ta 'sintomi ta' l- allerġiji - dawn il- mediċini jistgħu jinkisbu mingħajr riċetta medika), • cisapride (użat biex inaqqas ċerti problemi fl- istonku),
Why has IVEMEND been approved?
Għaliex ġie approvat IVEMEND?
The Committee for Medicinal products for Human Use (CHMP) decided that IVEMEND is effective in the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li IVEMEND huwa effikaċi fil- prevenzjoni ta ’ nawżea u rimettar akuti u li jfeġġu tard, assoċjati ma ’ kemjoterapija għal kanċer ibbażata fuq cisplatin li tkun ferm emetoġenika u għal dardir u rimettar assoċjat ma ’ kemjoterapija tal- kanċer li tkun moderatament emetoġenika.
The Committee decided that IVEMEND’ s benefits are greater than its risks and recommended that IVEMEND be given marketing authorisation.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ IVEMEND huma akbar mir- riskji tiegħu u irrakkomanda li IVEMEND jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about IVEMEND:
Tagħrif ieħor dwar IVEMEND:
The European Commission granted a marketing authorisation valid throughout the European Union for IVEMEND to Merck Sharp & Dohme Ltd on 11 January 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal IVEMEND valida fl- Unjoni Ewropea kollha lil Merck Sharp & Dohme Ltd fit- 11 ta 'Jannar 2008.
The full EPAR for IVEMEND can be found here.
L- EPAR sħiħ għal IVEMEND jista ’ jinstab hawnhekk
This summary was last updated in 12-2007.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Powder for solution for infusion
Trab għal soluzzjoni għal infużjoni
Intravenous use
Użu ġol- vini
IVEMEND 115 mg powder for solution for infusion.
IVEMEND 115 mg trab għal soluzzjoni għal infużjoni.
Each vial contains fosaprepitant dimeglumine equivalent to 115 mg fosaprepitant.
Kull kunjett fih fosaprepitant dimeglumine ekwivalenti għal 115 mg fosaprepitant.
After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (see section 6.6).
Wara rikostituzzjoni u dilwizzjoni, 1 ml tas- soluzzjoni fih 1 mg ta ’ fosaprepitant (ara sezzjoni 6. 6).
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta’ sustanzi attivi, ara sezzjoni 6. 1.
Powder for solution for infusion.
Trab għal soluzzjoni għal infużjoni.
White to off-white amorphous powder.
Trab abjad għal ofwajt amorfu.
Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy.
Prevenzjoni ta ’ nawsja u rimettar akuti jew ittardjati assoċjati ma ’ kimoterapija tal- kanċer emetoġenika ħafna ibbażata fuq cisplatin.
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Prevenzjoni ta ’ nawsja u rimettar assoċjati ma ’ kimoterapija tal- kanċer moderatament emetoġenika.
IVEMEND is given as part of a combination therapy (see section 4.2).
IVEMEND jingħata bħala parti minn terapija ta ’ kombinazzjoni (ara sezzjoni 4. 2).
IVEMEND is a lyophilized prodrug of aprepitant containing polysorbate 80 (PS80) for intravenous administration.
IVEMEND għal amministrazzjoni fil- vina huwa promediċina lijofilizzata ta ’ aprepitant li fiha polysorbate 80 (PS80).
Aprepitant is available as capsules for oral administration.
Aprepitant jiġi bħala kapsuli għal amministrazzjoni orali.
Posology IVEMEND (115 mg) may be substituted for aprepitant (125 mg) prior to chemotherapy, on Day 1 only of the chemotherapy induced nausea and vomiting (CINV) regimen as an infusion administered over 15 minutes (see section 6.6).
Pożoloġija IVEMEND (115 mg) jista ’ jiġi sostitwit b’ aprepitant (125 mg) qabel il- kimoterapija, f’ Jum 1 biss tan - nawsja u rimettar imqanqla mill- kimoterapija tar- reġimen CINV amministrat bħala infużjoni fuq 15- il minuta (ara sezzjoni 6. 6).
The 3-day CINV regimen includes IVEMEND (115 mg) 30 minutes prior to chemotherapy treatment or aprepitant (125 mg) one hour prior to chemotherapy treatment on Day 1; aprepitant (80 mg) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist.
Ir- reġimen CINV ta ’ 3 ijiem jinkludi IVEMEND (115 mg) 30 minuta qabel trattament bil- kimoterapija jew aprepitant (125 mg) siegħa qabel trattament bil- kimoterapija f’ Jum 1: aprepitant (80 mg) f’ Jiem 2 u 3; addizjonalment ma ’ kortikosterojde u antagonist 5- HT3.
2 The following regimen is recommended, based on clinical studies with aprepitant, for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.
2 Ir- reġimen li ġej huwa rrakkomandat abbażi ta ’ studji kliniċi b’ aprepitant, għall- prevenzjoni ta ’ nawsja u rimettar assoċjati ma ’ kimoterapija tal- kanċer emetoġenika:
Highly Emetogenic Chemotherapy Regimen
Reġimen ta ’ Kimoterapija Emetoġenika Ħafna
none
xejn xejn
8 mg orally 8 mg orally
8 mg oralment 8 mg oralment
8 mg orally
8 mg oralment
Ondansetron
Ondansetron kliniċi:
32 mg intravenously
32 mg IV
none none
xejn xejn
Aprepitant was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3.
Aprepitant kien amministrat oralment siegħa qabel il- kimoterapija f’ Jum 1 u filgħodu f’ Jiem 2 u 3.
Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4.
Dexamethasone kien amministrat 30 minuta qabel trattament bil- kimoterapija f’ Jum 1 u filgħodu f’ Jiem 2 sa 4.
The dose of dexamethasone was chosen to account for medicinal product interactions.
Id- doża ta ’ dexamethasone kienet magħżula filwaqt li tqiesu l - interazzjonijiet ta ’ prodotti mediċinali.
Ondansetron was administered intravenously 30 minutes prior to chemotherapy treatment on Day 1.
Ondansetron kien amministrat fil- vina 30 minuta qabel it- trattament bil- kimoterapija f’ Jum 1.
Moderately Emetogenic Chemotherapy Regimen
Reġimen ta ’ Kimoterapija Moderatament Emetoġenika
2 x 8 mg orally
2 x 8 mg oralment
In clinical studies:
kliniċi:
Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1.
Dexamethasone kien amministrat 30 minuta qabel trattament bil- kimoterapija f’ Jum 1.
The dose of dexamethasone was chosen to account for medicinal product interactions.
Id- doża ta ’ dexamethasone kienet magħżula filwaqt li tqiesu l- interazzjonijiet ta ’ prodotti mediċinali.
One 8 mg capsule of ondansetron was administered 30 to 60 minutes prior to chemotherapy treatment and one 8 mg capsule was administered 8 hours after first dose on Day 1.
Kapsula ta ’ ondansetron ta ’ 8 mg ngħatat 30 sa 60 minuta qabel trattament bil- kimoterapija u kapsula waħda ta ’ 8 mg ngħatat 8 sigħat wara l- ewwel doża f’ Jum 1.
General information
Tagħrif Ġenerali
Efficacy data on combination with other corticosteroids and 5-HT3 antagonists are limited.
Dejta ta ’ l- effikaċja dwar il- kombinazzjoni ma ’ kortikosterojdi u antagonisti 5- HT3 hija limitata.
For additional information on the co-administration with corticosteroids, see section 4.5.
Għal tagħrif addizjonali fuq l- amministrazzjoni ta ’ ma ’ kortikosterojdi, ara sezzjoni 4. 5.
Refer to the full product information of co-administered antiemetic agents.
Irreferi għat- tagħrif sħiħ tal- prodott għal mediċini antiemetiċi amministrati flimkien.
Elderly No dose adjustment is necessary for the elderly.
Anzjani L- ebda aġġustament fid- doża ma huwa meħtieġ għall- anzjani.
Renal Impairment No dose adjustment is necessary for patients with renal insufficiency or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Indeboliment renali L- ebda aġġustament fid- doża ma huwa meħtieġ għal pazjenti b’ indeboliment renali jew għal pazjenti b’ mard renali fi stadju ta ’ l- aħħar li tkun qed issirilhom emodijaliżi (ara sezzjoni 5. 2).
Hepatic Impairment No dose adjustment is necessary for patients with mild hepatic insufficiency.
Indeboliment epatiku L- ebda aġġustament fid- doża ma huwa meħtieġ għal pazjenti b’ indeboliment epatiku ħafif.
There are limited data in patients with moderate hepatic insufficiency and no data in patients with severe hepatic insufficiency (see sections 4.4 and 5.2).
Hemm dejta limitata f’ pazjenti b’ indeboliment epatiku moderat u l- ebda dejta f’ pazjenti b’ indeboliment epatiku sever (ara sezzjonijiet 4. 4 u 5. 2).
Children and adolescents IVEMEND is not recommended for use in children below the age of 18 years of age due to insufficient data on safety and efficacy (see section 5.2).
3 IVEMEND m’ huwiex irrikmandat sabiex jintuża fi tfal taħt l- età ta ’ 18- il sena minħabba li m’ hemmx biżżejjed tagħrif dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
Method of Administration
Metodu ta ’ kif jingħata IVEMEND għandu jingħata ġol- vini u ma għandux jingħata ġol- muskoli jew fil- ġilda.
3 IVEMEND should be administered intravenously and should not be given by the intramuscular or subcutaneous route.
4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substance, aprepitant, or to polysorbate 80 or any of the other excipients.
Sensittività eċċessiva għas- sustanza attiva, aprepitant, polysorbate 80 jew għal xi excipients.