qanastek/EMEA-V3 huggingface dataset:
Pre- and post-natal developmental studies were performed in rats at doses up to 27-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Saru studji fuq il- firien dwar l- iżvilupp ta ’ qabel u wara t- twelid b’ dożi sa 27 darba l- AUC klinika libera stmata għal doża ta ’ 300 mg darbtejn kuljum.
A slight increase in motor activity in high-dose male rats at both weaning and as adults was noted, while no effects were seen in females.
Ġiet innotata żieda żgħira fl- attività motorili tal - firien irġiel b’ doża għolja kemm fil- ftim kif ukoll bħala adulti, filwaqt li ma dehru ebda effetti fin- nisa.
Other developmental parameters of these offspring, including fertility and reproductive performance, were not affected by the maternal administration of maraviroc.
Parametri oħra ta ’ l- iżvilupp ta ’ dawn il- frieħ, fosthom il- fertilità u l- kapaċità riproduttiva, ma kinux affettwati mill- għoti ta ’ maraviroc lill- omm.
6 PHARMACEUTICAL PARTICULARS
6 TAGĦRIF FARMAĊEWTIKU
Tablet core:
Qalba tal- pillola:
Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate
Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous
Film-coat:
Kisja tar- rita:
Poly (vinyl alcohol) Titanium dioxide Macrogol 3350 Talc Soya Lecithin Indigo carmine aluminium lake (E132)
Poly (vinyl alcohol) Titanium dioxide Macrogol 3350 Talc Soya Lecithin Indigo carmine aluminium lake (E132)
16 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years.
3 snin
This medicinal product does not require any special storage condition.
Dan il- prodott mediċinali ma jeħtieġx kondizzjonijiet speċjali għall- ħażna.
High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/ polyethylene heat induction seal containing 180 film-coated tablets.
Fliexken magħmulin minn politin ta ’ densità għolja (HDPE – high density polyethylene) b’ għeluq tal - polipropelin reżistenti għat- tfal (CR – child resistant) u siġill ta ’ folja ta ’ l- aluminju/ politin b’ induzzjoni termika li jesgħu 180 pillola miksija b’ rita.
Polyvinyl chloride (PVC) blisters with aluminium foil backing in a carton containing 30, 60, 90 film- coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Folji tal- polyvinyl chloride (PVC) b’ rinforz ta ’ folja ta ’ l- aluminju f’ kaxxa li tesa ’ 30, 60, 90 pilloli miksijin b’ rita u pakketti multipli li fihom 180 (2 pakketti ta ’ 90) pillola miksijin b’ rita.
7 MARKETING AUTHORISATION HOLDER
7 ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Ir- Renju Unit
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata fuq dan il- prodott mediċinali tinstab fuq is- sit elettroniku ta ’ l- Aġenzija Ewropeja tal- Mediċini (EMEA) http: // www. emea. europa. eu
CELSENTRI 300 mg film-coated tablets.
CELSENTRI 300 mg pilloli miksijin b’ rita
Each film-coated tablet contains 300 mg of maraviroc.
Kull pillola miksija b’ rita fiha 300 mg ta ’ maraviroc.
Excipients Each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Sustanzi mhux attivi Kull pillola miksija b’ rita ta ’ 300 mg fiha 1, 68 mg ta ’ leċitina tas- soja.
Blue, biconvex, oval film-coated tablets debossed with “ Pfizer” on one side and “ MVC 300” on the other.
Pilloli blu ġejjin għat- tond miż- żewġ naħat ta ’ forma ovali miksijin b’ rita bi “ Pfizer ” imnaqqax fuq naħa u “ MVC 300 ” fuq in- naħa l- oħra.
18 Elderly: there is limited experience in patients > 65 years of age (see section 5.2), therefore CELSENTRI should be used with caution in this population.
21 Anzjani: hemm esperjenza limitata f’ pazjenti ta ’ > 65 sena (ara sezzjoni 5. 2), għaldaqstant CELSENTRI għandu jintuża b’ kawtela f’ din il- popolazzjoni.
Dose adjustment: physicians should ensure that appropriate dose adjustment of CELSENTRI is made when CELSENTRI is co-administered with CYP3A4 inhibitors and/ or inducers since maraviroc concentrations and its therapeutic effects may be affected (see sections 4.2 and 4.5).
22 Aġġustament tad- doża: it- tobba għandhom jiżguraw li jsir aġġustament adegwat fid- doża ta ’ CELSENTRI meta CELSENTRI jingħata ma ’ inibituri u/ jew indutturi ta ’ CYP3A4 billi l - konċentrazzjonijiet ta ’ maraviroc u l- effetti terapewtiċi tiegħu jistgħu jiġu affettwati (ara sezzjoni 4. 2 u 4. 5).
19 Information for patients: patients should be advised that antiretroviral therapies including CELSENTRI have not been shown to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Tagħrif għall- pazjenti: il- pazjenti għandhom jiġu informati li t- terapiji antiretrovirali fosthom CELSENTRI ma ġewx murija li jevitaw ir- riskju ta ’ trasmissjoni ta ’ l- HIV lil ħaddieħor permezz ta ’ kuntatt sesswali jew kontaminazzjoni bid- demm.
In case of concomitant antiviral therapy for hepatitis B and/ or C, please refer also to the relevant product information for these medicinal products.
23 Twaqqif tat- trattament b’ CELSENTRI għandu jkun ikkunsidrat f’ kwalinkwe pazjent b’ sinjali jew sintomi ta ’ epatite akuta, partikolarment jekk tkun issuspettata ipersensitivita ’ relatata ma ’ xi prodott, jew ma żieda ta ’ transaminases tal- fwied flimkien ma ’ raxx jew sintomi sistemiċi oħra (eż. raxx, prurite, esinofila jew IgE elevat).
20 There is limited experience in patients with reduced hepatic function, therefore CELSENTRI should be used with caution in this population (see sections 4.2 and 5.2).
Hemm esperjenza limitata f’ pazjenti li għandhom funzjoni tal- fwied imnaqqsa, għalhekk CELSENTRI għandu jintuża b’ kawtela f’ din il- popolazzjoni (ara sezzjoni 4. 2 u 5. 2).
In vitro results indicate that maraviroc could inhibit P- glycoprotein in the gut and may thus affect bioavailability of certain drugs..
Barra minn hekk, l- amministrazzjoni ta ’ CELSENTRI ma ’ lamivudine/ zidovudine ma wriet ebda effett ta ’ maraviroc fuq il- farmakokinetiċi ta ’ lamivudine (imneħħi prinċipalment mill- kliewi) jew ta ’ zidovudine (metaboliżmu mhux P450 u tneħħija mill - kliewi). Riżultati in vitro jindikaw li maraviroc jista jinibixxi P- glycoprotein fl- imsaren u għalhekk jista jaffetwa il - bijodisponibilità ta ’ ċertu mediċini.
Table 2.
24 Tabella 2.
Interactions and dose recommendations with other medical products
Effetti ma ’ prodotti mediċinali oħra u rakkomandazzjonijiet dwar id- doża Prodott mediċinali skond il- klassi terapewtika (doża ta ’ CELSENTRI użata fl - istudju) KONTRA L - INFEZZJONIJIET Antiretrovirali NRTIs
Medicinal product by therapeutic areas (dose of CELSENTRI used in study) ANTI-INFECTIVES Antiretrovirals NRTIs
Effetti fuq livelli ta ’ Prodotti Mediċinali Proporzjon Ġeometriku medju (intervall) jekk mhux indikat mod ieħor
Effects on drug levels Geometric mean ratio (range) if not stated otherwise
Rakommandazzjonijiet dwar l - amministrazzjoni ma ’ mediċini oħra
Recommendations concerning co- administration
Lamivudine 150 mg BID (maraviroc 300 mg BID)
21
Lamivudine AUC12: ↔ 1. 13 (0. 82, 2. 09)
Lamivudine 150 mg BID (maraviroc 300 mg BID)
La kien hemm u mhux mistenni li jkun hemm effett sinifikanti. CELSENTRI
Comparison to exposure in historical controls suggests that CELSENTRI 300 mg twice daily and nevirapine can be co-administered without dose adjustment.
Maraviroc AUC12: ↔ mqabbla Meta tqabbel ma espożizzjoni ma kontrolli storiċi f’ kontrolli li saru fil- passat Maraviroc Cmax: mqabbla ma CELSENTRI 300 mg darbtejn kontrolli storiċi kulljum u nevirapine jistgħu jiġu Il- konċetrazzjonijiet ta ’ mgħotija flimkien mingħajr ebda Nevirapine ma kienux imkejjla, aġġustament fid- doża. l- ebda effett mhu mistenni
Maraviroc AUC12 ↑ 3.57 (2.55, 4.45) Maraviroc Cmax: ↑ 2.09 (1.31, 4.19) Atazanavir concentrations not measured, no effect is expected.
Maraviroc AUC12 ↑ 3. 57 (2. 55, Id- doża ta ’ CELSENTRI għandha 4. 45) tkun imnaqqsa għal 150mg darbtejn Maraviroc Cmax: ↑ 2. 09 (1. 31, kulljum meta jkun mgħoti flimkien 4. 19) ma PI; ħlief meta jkun mgħoti Il- konċetrazzjonijiet ta ’ flimkien ma ’ tipranavir/ ritonavir jew Atazanavir ma kienux imkejjla, fosamprenavir/ ritonavir, fejn id- doża l- ebda effett mhu mistenni għandha tkun 300mg BID.
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with a PI; except in combination with
25 Maraviroc ma jaffetwax sinfikattivament il- livelli tal- PI.
Limited data are available for co-
Hemm tgħarif limitat fuq l- użu ma ’ nelfinavir.
Tipranavir/ ritonavir 500 mg/ 200 mg BID (maraviroc 150 mg BID) NNRTI + PI
26 Tipranavir/ ritonavir 500 mg/ 200 mg BID (maraviroc 150 mg BID) NNRTI + PI
Maraviroc AUC12 ↔ 1.02 (0.65, 1.87) Maraviroc Cmax: ↔ 0.86 (0.37, 3.20) Tipranavir/ ritonavir concentrations were consistent with historical data.
Maraviroc AUC12 ↔ 1. 02 (0. 65, 1. 87) Maraviroc Cmax: ↔ 0. 86 (0. 37, 3. 20) Il- konċentrazzjonijiet ta; Tipranavir/ ritonavir kienu konsistenti mat- tgħarif li nġabar fil- passat
See also section 4.4.
Il - bdil fid- doża ma ġiex studjat f’ pazjenti b’ HIV Ara wkoll sezzjoni 4. 4.
Combination with two inducers has not been studied.
Li- kombinazzjoni ma ’ żewġt indutturi ma kienetx studjata.
There may be a risk of suboptimal levels with risk of loss of virologic response and resistance development.
Jista jkun hemm riskju ta ’ livelli anqas milli mixtieqa flimkien ma riskju ta ’ nuqqas ta ’ rispons viroloġiku u żviluppament ta ’
When combining rifabutin with protease inhibitors that are potent inhibitors of CYP3A4 a net inhibitory effect on maraviroc is expected.
Meta jingħata rifabutin ma inibitturi Protease li huma inibituri qawwija ta ’ CYP3A4, f’ laħħar hu mistenni li jkun hemm effett inibitorju fuq maraviroc.
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with rifabutin in the presence of a PI (except tipranavir/ ritonavir or fosamprenavir/ ritonavir where the dose should be 300 mg twice daily).
Id- doża ta ’ CELSENTRI għandha tkun imnaqqsa għal 150mg darbtejn kulljum meta dan ikun mgħoti ma rifabutin fil- preżenza ta PI (barra ma tipranavir/ ritonavir jew fosamprenavir/ ritonavir fejn id- doża għandha tkun ta ’ 300 mg darbtejn kulljum).
Cmax: ↔ 0.99 (0.61, 1.32) Maraviroc concentrations not measured, no interaction expected.
Cmax: ↔ 0. 99 (0. 61, 1. 32) Il- konċetrazzjonijiet ta ’ Maraviroc ma kienux imkejjla, l - ebda effett mhu mistenni
Levonorgestrel 150mcg QD (maraviroc 100 mg BID) SEDATIVES
Levonorgestrel 150mcg QD (maraviroc 100 mg BID) SEDATIVI Benzodiazepines
24 4.8 Undesirable effects
29 4. 8 Effetti mhux mixtieqa
The most frequently reported adverse reactions occurring in the Phase 3 studies at the recommended dose regardless of the incidence compared to OBT alone were diarrhoea, nausea and headache.
L- aktar reazzjonijiet avversi rrapportati ta ’ sikwit li seħħew fl- istudji ta ’ Fażi 3 bid- doża rakkomandata irrispittivament mill inċidenza meta mqabbla ma OBT waħdu kienu dijarea, dardir u wġigħ ta ’ ras.
Table 4.
30 Tabella 4.
25 ischaemia
mhux komuni
4.9 Overdose
31 4. 9 Doża eċċessiva
However, no clinically significant QT prolongation compared to OBT alone was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of CELSENTRI to prolong the QT interval.
Madankollu, ma deher l- ebda titwil klinikament sinifikanti fil- QT meta mqabbel ma ’ OBT waħedha fl- istudji kliniċi ta ’ Fażi 3 bl- użu tad- doża rakkomandata ta ’ maraviroc jew fi studju farmakokinetiku speċifku biex jiġi evalwat il- potenzjal ta ’ CELSENTRI li jtawwal l - intervall QT.
26 There is no specific antidote for overdose with CELSENTRI.
M’ hemmx antidotu speċifiku għal doża eċċessiva b’ CELSENTRI.
Phenotypic resistance: concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc.
Il- kurvi tar- rispons mal- konċentrazzjoni għall- virus reżistenti għal maraviroc kienu kkaratterizzati finotipikament minn kurvi li ma laħqux 100% inibizzjoni f’ analiżi tal- mediċina
Cross-resistance in vitro:
Cross- resistance in vitro:
Key mutations (V3-loop) can presently not be suggested due to the high variability of the V3-sequence, and the low number of samples analysed.
Mutazzjonijiet speċifiċi (V3- loop) bħalissa ma jistgħux ikunu suġġeriti minħabba varjabilita ’ għolja tas- sekwenza V3, u n- numru żgħir ta ’ ezemplari analizzati.
Clinical Results
. Riżultati kliniċi
The clinical efficacy of CELSENTRI (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal ongoing, randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
L- effikaċja klinika ta ’ CELSENTRI (flimkien ma ’ prodotti mediċinali antiretrovirali oħra) fuq il - livelli ta ’ HIV RNA fil- plasma u l- għadd taċ- ċelloli CD4+ ġew investigati f’ żewġ studji ewlenin, double blind, multicentre, kontinwi magħmula b’ għażla każwali (MOTIVATE 1 u MOTIVATE 2, n=1076) f’ pazjenti infettati bil- virus ta ’ l- HIV- 1 CCR5 tropiku kif stabbilit bil- Monogram Trofile Assay..
= 426 46.3
46. 3
N = 209 45.7
45. 7
(Range, years)
(Medda, snin)
Male Sex
Sess maskil
89.7%
89. 7%
Table 7.
34 Tabella 7.
OBT alone
waħedha
Treatment Difference1 (Confidence Interval2)
(Intervall ta ’ kunfidenza 2)
HIV-1 RNA
darbtejn kuljum + OBT HIV- 1 RNA
(log10 copies/ mL)
(log10 kopji/ mL) Perċentwali ta ’ pazjenti b’ HIV
Proportion of patients with HIV RNA < 400 copies/ ml
RNA < 400 kopji/ ml Perċentwali ta ’ pazjenti b’ HIV
Proportion of patients with HIV RNA < 50 copies/ ml CD4+ cell count
RNA < 50 kopji/ ml Bidla mil- linja bażi għall- għadd ta ’
Change from baseline (cells/ mm3) 1 p-values < 0.0001 2
ċelloli CD4+ (ċelloli/ mm3) 1 valur p < 0. 0001 2
For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline which was 97.5%
Għall- endpoints kollha ta ’ l- effikaċja l- intervalli ta ’ kunfidenza kienu 95%, ħlief għall- Bidla fl- HIV - 1 RNA mil- linja bażi li kienet 97. 5%
29 CELSENTRI 300 mg twice daily + OBT was superior to OBT alone across all subgroups of patients analysed (see Table 8).
CELSENTRI 300 mg darbtejn kuljum + OBT kien aqwa minn OBT waħidha fil- gruppi ta ’ pazjenti kollha analizzati (ara Tabella 8).
Patients with very low CD4+ count at baseline (i. e. < 50 cells/ uL) had a less favourable outcome.
Pazjenti b’ livell baxx ta ’ CD4 fil- linja bażi (i. e. < 50ċelluli/ uL) kellhom riżultat inqas favorevoli.
< 5.0 log10 copies/ ml ≥ 5.0 log10 copies/ ml
< 5. 0 log10 kopji/ ml ≥5. 0 log10 kopji/ ml CD4+ (ċelluli/ uL):
Studies in Non-CCR5-tropic Treatment-Experienced Patients:
35 Studji fuq Pazjenti Mhux CCR5- tropiċi Esperjenzati bil- Kura:
Median peak maraviroc plasma concentrations is attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.
L- ogħla konċentrazzjoni medja ta ’ maraviroc fil- plasma tintlaħaq sagħtejn (medda 0. 5- 4 sigħat) wara l - amministrazzoni ta ’ dożi waħdiena orali ta ’ 300 mg pillola kummerċjali mogħtija lil voluntiera b’ saħħithom.
Metabolism: studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system
Metaboliżmu: studji fil- bniedem u studji in vitro li użaw mikrosomi tal- fwied uman u enzimi espressi wrew li maraviroc jiġi metabolizzat prinċipalment mis- sistema taċ- ċitokromu P450 għal metaboliti li huma essenzjalment inattivi kontra l- HIV- 1.
Hepatic impairment: maraviroc is primarily metabolized and eliminated by the liver.
36 Indeboliment tal- fwied: maraviroc huwa metabolizzat primarjament u eliminat mill- fwied.
In vitro and in vivo studies showed that maraviroc has a potential to increase QTc interval at supratherapeutic doses with no evidence of arrhythmia.
Studji in vitro u in vivo studies urew li maraviroc għandu l- potenzjali li jżid l- intervall ta ’ QTc f’ dożi supraterapewtiċi mingħajr evidenza ta ’ arrhythmia.
31 Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, necrosis).
Studji ripetuti tal- ħsara tad- doża fil- firien, identifikaw il- fwied bħala l- organu fil- mira ewlieni li ssirlu l- aktar ħsara (żieda fit- transaminases,, iperplażja tal- bile duct, nekrożi).
6 PHARMACEUTICAL PARTICULARS
37 6 TAGĦRIF FARMAĊEWTIKU
Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate
Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate
32 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
EU/ 1/ 07/ 418/ 006 EU/ 1/ 07/ 418/ 007 EU/ 1/ 07/ 418/ 008 EU/ 1/ 07/ 418/ 009 EU/ 1/ 07/ 418/ 010
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 07/ 418/ 006 EU/ 1/ 07/ 418/ 007 EU/ 1/ 07/ 418/ 008 EU/ 1/ 07/ 418/ 009 EU/ 1/ 07/ 418/ 010
33 ANNEX II
39 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
Gödecke GmbH Mooswaldallee 1 79090 Freiburg Germany
Gödecke GmbH Mooswaldallee 1 79090 Freiburg Ġermanja
Pharmacovigilance system
Is sistema ta ’ Farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq irid jassigura li s- sistema ta ’ Farmakoviġilanza kif deskritta f’ versjoni 1. 1 ppreżentata f’ sezzjoni 1. 8. 1 ta ’ l- applikazzjoni għat- tqegħid fis- suq, taħdem sewwa qabel u waqt li l- prodott qiegħed fuq is- suq.
Risk Management plan
Pjan ta ’ mmaniġġjar tar- riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jobbliga ruħu li jorganizza studji u attivitajiet oħra ta ’ Farmakoviġilanza kif dettaljat fil pjan ta ’ Farmakoviġilanza, kif miftiehem f’ versjoni 1. 4 tal - Pjan ta ’ mmaniġġjar tar- riskju (RMP) kif preżentat f’ sezzjoni 1. 8. 2 ta ’ l- applikazzjoni għat- tqegħid fis- suq u kull tiġdid tal RMP miftiehem mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- gwida tas- CHMP fuq is- sistemi ta ’ l- immaniġġjar tar- riskju għal prodotti mediċinal għal użu uman, l- RMP imġedded irid ikun sottomess f’ l- istess żmien mal PSUR li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Ukoll, RMP imġedded irid jiġi sottomess • Meta jkun hemm informazzjoni ġdida li teffetwa l- speċifikazzjonijijiet ta ’ sigurta ’, pjan ta ’ Farmakoviġilanza, jew attivitajiet li jnaqqsu r- riskju. • Fi żmien 60 ġurnata ta ’ avveniment importanti (Farmakoviġilanza jew tnaqqis tar- riskju). • Fuq talba ta l- EMEA
35 ANNEX III
41 ANNESS III
37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Bottle label - 150 mg film-coated tablets
Tikketta tal- flixkun - 150 mg - pilloli miksijin b’ rita
CELSENTRI 150 mg film-coated tablets maraviroc
CELSENTRI 150 mg pilloli miksijin b’ rita maraviroc
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I)
Contains soya lecithin: see the package leaflet for further information.
Fih leċitina tas- soja: ara l- fuljett ta ’ tagħrif għal aktar tagħrif
180 film-coated tablets
180 pilloli miksijin b’ rita
Oral use.
Għal użu orali.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF REACH AND SITE OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EXP {MM-YYYY}
JIS {XX- SSSS}
SPECIAL STORAGE CONDITIONS
KONDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
Pfizer Limited Ramsgate Road Sandwich CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich CT13 9NJ Ir- Renju Unit
Lot:
Lott:
{number}
{numru}
39 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Bottle label - 300 mg film-coated tablets
Tikketta tal- flixkun - 300 mg - pilloli miksijin b’ rita
CELSENTRI 300 mg film-coated tablets maraviroc
CELSENTRI 300 mg pilloli miksijin b’ rita maraviroc
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton for blister pack containing 150 mg maraviroc film-coated tablets
Kaxxa għall- pakkett tal- folji li fiha 150 mg maraviroc pilloli miksijin b’ rita
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets Multipack containing 180 (2 packs of 90) film-coated tablets
30 pillola miksija b’ rita 60 pillola miksija b’ rita 90 pillola miksija b’ rita Pakkett multiplu li fih 180 (2 pakketti ta ’ 90) pillola miksija b’ rita
Sealed pack Do not use if box has been opened
Pakkett issiġillat Tużax jekk il- kaxxa tkun infetħet
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton for blister pack containing 300 mg maraviroc film-coated tablets
Kaxxa għall- pakkett tal- folji li fiha 300 mg maraviroc pilloli miksijin b’ rita
45 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Multipacks of 180 (2 packs of 90 film-coated tablets) - without blue box - 150 mg film-coated tablets
Pakketti multipli ta ’ 180 (2 pakketti ta ’ 90 pillola miksija b’ rita) – mingħajr kaxxa blu - 150 mg maraviroc pilloli miksijin b’ rita
Celsentri 150 mg film-coated tablets maraviroc
CELSENTRI 150 mg pilloli miksijin b’ rita maraviroc
Component of a multipack comprising 2 packs, each containing 90 film-coated tablets
Il- pakkett multiplu fih 2 pakketti li fihom 90 pillola miksijin b’ rita
Sealed pack Do not use if box has been opened
Pakkett issiġillat Tużax jekk il- kaxxa kienet miftuħa
47 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Multipacks of 180 (2 packs of 90 film-coated tablets) - without blue box - 300 mg film-coated tablets
Pakketti multipli ta ’ 180 (2 pakketti ta ’ 90 pillola miksija b’ rita) – mingħajr kaxxa blu - 300 mg maraviroc pilloli miksijin b’ rita
Celsentri 300 mg film-coated tablets maraviroc
CELSENTRI 300 mg pilloli miksijin b’ rita maraviroc
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
Tikketta tal- karta ta ’ barra ta ’ fuq pakketti multipli ta ’ 180 (2 pakketti ta ’ 90 pillola miksija b’ rita) imdawwra b ’ folja trasparenti – bil- kaxxa b’ kollox - 150 mg maraviroc pilloli miksijin b’ rita
Multipack comprising 2 packs, each containing 90 film-coated tablets
Pakkett multiplu li fih 2 pakketti ta ’ 90 pillola miksija b’ rita
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 mg film-coated tablets
Tikketta tal- karta ta ’ barra ta ’ fuq pakketti multipli ta ’ 180 (2 pakketti ta ’ 90 pillola miksija b’ rita) imdawwra b ’ folja trasparenti – bil- kaxxa blu b’ kollox - 300 mg maraviroc pilloli miksijin b’ rita
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister Pack of 10 x 150 mg maraviroc film-coated tablets
Pakkett tal- Folji ta ’ 10 x 150 mg maraviroc pilloli miksijin b’ rita
Pfizer (logo)
Pfizer (lowgo)
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister Pack of 10 x 300 mg maraviroc film-coated tablets
Pakkett tal- Folji ta ’ 10 x 300 mg maraviroc pilloli miksijin b’ rita
56 PACKAGE LEAFLET:
62 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN JAGĦMEL UŻU MINNHA
CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc
CELSENTRI 150 mg pilloli miksijin b’ rita CELSENTRI 300 mg pilloli miksijin b’ rita maraviroc
if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
please tell your doctor or your pharmacist.
imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What CELSENTRI is and what it is used for 2.
X’ inhu CELSENTRI u għalxiex jintuża 2.
Before you take CELSENTRI 3.
Qabel ma tieħu CELSENTRI 3.
How to take CELSENTRI 4.
Kif għandek tieħu CELSENTRI 4.
How to store CELSENTRI 6.
Kif taħżen CELSENTRI 6.
WHAT CELSENTRI IS AND WHAT IT IS USED FOR
X’ INHU CELSENTRI U GĦALXIEX JINTUŻA
CELSENTRI is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus type-1 (HIV-1) infection.
CELSENTRI hu mediċina antiretrovirali li tintuża fil- kura ta ’ infezzjoni bil- Virus ta ’ l - Immunodefiċjenza Uman ta ’ l- ewwel tip (HIV- 1).
Its active ingredient, maraviroc, belongs to a group of medicines called CCR5 antagonists.
Is- sustanza attiva tiegħu, maraviroc, tappartjeni għal grupp ta ’ mediċini msejħa antagonisti ta ’ CCR5.
CELSENTRI prevents the entry of HIV-1 into the cells in your blood that are attacked by HIV (called CD4 or T-cells).
CELSENTRI jimpedixxi d- dħul ta ’ HIV- 1 fiċ- ċelloli tad- demm tiegħek li jiġu attakkati mill- HIV (imsejħin CD4 jew ċelloli T).
CELSENTRI works by blocking a receptor called CCR5 that HIV use to gain entry into these cells.
CELSENTRI jaħdem billi jimblokka riċettur imsejjaħ CCR5 li l- HIV juża biex jidħol f’ dawn iċ- ċelloli.
CELSENTRI reduces the amount of HIV in your body and enhances your immune system.
CELSENTRI jnaqqas l- ammont ta ’ HIV fil- ġisem tiegħek u jtejjeb is- sistema immuni tiegħek.
CELSENTRI must be taken in combination with other medicines used to treat HIV.
CELSENTRI irid jittieħed flimkien ma ’ mediċini oħra użata għall- kura ta ’ l- HIV.
2 BEFORE YOU TAKE CELSENTRI
QABEL MA TIEĦU CELSENTRI
Do not take CELSENTRI if you are allergic (hypersensitive) to maraviroc or to peanut or soya or to any of the other ingredients of CELSENTRI (see section 2, Important information about some of the ingredients of CELSENTRI).
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal maraviroc jew għall- karawett jew għas - soja jew għal xi sustanzi oħra ta ’ CELSENTRI (ara sezzjoni 2, Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ CELSENTRI).
Take special care with CELSENTRI:
Oqgħod attent ħafna b’ CELSENTRI:
Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for you.
It- tabib tiegħek irid jeħodlok kampjuni tad- demm biex jittestja jekk CELSENTRI hux il- kura adattata għalik.
Before taking this medicine, make sure that your doctor knows if you:
Qabel tieħu din il- mediċina, kun żgur li t- tabib tiegħek ikun jaf jekk:
• have problems with your liver including chronic hepatitis B or C as there is only limited experience in patients with liver problems.
• għandek problemi fil- fwied inkluż epatite B jew Ċ kronika minħabba li hemm biss ftit esperjenza f’ pazjenti bi problemi fil- fwied.
Your liver function may need to be closely monitored.
Il- funzjoni tal- fwied tiegħek teħtieġ li tiġi mmonitorjata mill - qrib. Jekk tinnota xi sintomi ta ’ epatite, (bħal nuqqas ta ’ aptit, deni, tħossok jew tkun marid u/ jew
If you notice symptoms of hepatitis (loss of appetite, fever, feeling sick/ being sick and/ or yellowing of skin or eyes), rash and/ or itching, you should stop taking CELSENTRI and inform your doctor immediately.
63 tisfarlek il- ġilda jew l- abjad ta ’ għajnejk), raxx u/ jew ħakk, għandek tieqaf tieħu CELSENTRI u tinforma mill- ewwel lit- tabib tiegħek.
57 • have or previously had low blood pressure and/ or if you are taking any medicines to lower blood pressure
• għandek jew kellek storja ta ’ pressjoni tad- demm baxxa u/ jew jekk qed tieħu xi mediċini biex ibaxxu l- pressjoni tad- demm
• have tuberculosis or serious fungal infections as due to the way CELSENTRI works on certain immune cells, CELSENTRI could potentially increase the risk of developing infections.
• għandek it- tuberkulożi jew infezzjoni fungali serja minħabba il- mod kif jaħdem CELSENTRI fuq ċelloli immuni, CELSENTRI jista potenzjalment iżid ir- riskju ta ’ żviluppar ta ’ infezzjonijiet.
However, there has been no evidence of an increase in the occurrence of AIDS-related infections associated with the use of CELSENTRI in clinical studies
Madankollu, fi studji kliniċi, ma kien hemm l- ebda evidenza ta ’ żieda fl- infezzjonijiet relatati ma ’ l- AIDS, li kientet assoċjata ma l- użu ta ’ CELSENTRI.
• have or previously had any kidney problems particularly if you are taking certain antibiotics (clarithromycin, telithromycin, antifungal medicines (ketoconazole, itraconazole) and/ or protease inhibitors (except for tipranavir/ ritonavir)
• għandek jew kellek storja ta ’ xi problemi fil- kliewi b’ mod partikolari jekk qed tieħu ċerti antibijotiċi (clarithromycin, telithromycin, mediċini kontra fungi (ketoconazole, itraconazole) u/ jew inibituri ta ’ protease (għajr għal tipranavir/ ritonavir)
• have problems with your heart or circulatory system as there is only limited experience in patients with serious problems of this type.
• għandek problemi b’ qalbek jew bis- sistema taċ- ċirkolazzjoni minħabba li teżisti biss ftit esperjenza f’ pazjenti bi problemi serji ta ’ dan it- tip
Therefore CELSENTRI is not recommended for use in children.
Mhux mgħaruf jekk CELSENTRI jaħdimx fi tfal, għalekk CELSENTRI m’ huwiex irrikmandat sabiex jintuża fuq tfal.
CELSENTRI has only been used in limited numbers of patients 65 years or older.
CELSENTRI intuża biss f’ numru limitat ta ’ pazjenti ta ’ 65 sena u akbar.
If you belong to this age group please discuss with your doctor if you can use CELSENTRI.
Jekk inti tagħmel parti minn dan il- grupp t’ età jekk jogħġbok iddiskuti mat- tabib tiegħek jekk tistax tuża CELSENTRI.
CELSENTRI is not a cure for HIV infection or AIDS (advanced HIV infection).
CELSENTRI m’ huwiex kura għal infezzjoni ta ’ l- HIV jew AIDS (infezzjoni ta ’ l- HIV avvanzata).
CELSENTRI does not reduce the risk of passing HIV to others through sexual contact, sharing needles or exposure to your blood.
CELSENTRI ma jnaqqasx ir- riskju li tgħaddi l- HIV lil ħaddieħor permezz ta ’ kuntatt sesswali, użu ta ’ l- istess labar jew esponiment għad- demm tiegħek.
It is important to continue to take appropriate precautions to prevent passing HIV to others.
Huwa importanti li tkompli tieħu prekawzjonijiet xierqa biex tevita li tgħaddi l- HIV lil ħaddieħor.
In some patients with AIDS and a history of opportunistic infection (an infection that can occur when your immune system is impaired), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F’ xi pazjenti bl- AIDS u storja ta ’ infezzjoni opportunistika (infezzjoni li tista ’ sseħħ meta s- sistema immuni tiegħek tkun indebolita), sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet oħrajn jistgħu jseħħu fi żmien qasir wara li tinbeda l- kura 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 maħsub li dawn is- sintomi huma dovuti għal titjib fir- rispons immuni tal- ġisem, li jippermetti lill- ġisem jiġġieled infezzjonijiet li setgħu kienu preżenti mingħajr ebda sintomi evidenti.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinnota xi sintomi ta ’ infezzjoni, jekk jogħġbok informa lit- tabib tiegħek minnufih.
Some patients taking combination antiretroviral 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 fl- għadam imsejħa osteonekrożi (mewt tat- tessut ta ’ l- għadam ikkawżat minn telf tal- provvista tad - demm għall- għadam).
The length of combination antiretroviral 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 tat- terapija antiretrovirali ta ’ kombinazzjoni, l- użu ta ’ corticosteroid, il - konsum ta ’ alkoħol, immunosuppressjoni qawwija, indiċi ogħla tal- piż tal- ġisem, fost affarijiet oħra, jistgħu jkunu wħud mill- bosta fatturi ta ’ riskju għall- iżvilupp ta ’ din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma ebusija u uġigħ fil- ġogi (b’ mod speċjali l- ġogi tal- koxxa, l- irkoppa u l- ispalla) u diffikultà fil - movimenti.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi sintomi minn dawn jekk jogħġbok informa lit- tabib tiegħek.
Please tell your doctor and your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħrajn, inkluż dawk miksuba mingħajr riċetta.
Some medicines may affect the levels of CELSENTRI in the body when they are taken at the same time as CELSENTRI.
Xi mediċini, jistgħu jaffettwaw il- livelli ta ’ CELSENTRI fil- ġisem meta jittieħdu fl- istess ħin ma ’ CELSENTRI.
Therefore the dose of CELSENTRI may need to be adjusted.
Għalekk d- doża ta ’ CELSENTRI tista ’ teħtieġ li tiġi aġġustata.
Tell your doctor if you are taking any medicines including other medicines to treat HIV infection (e. g. efavirenz, lopinavir, saquinavir, darunavir, atazanavir, nelfinavir, indinavir), antibiotics (clarithromycin, telithromycin, rifampicin) and antifungal medicines (ketoconazole, itraconazole).
Għid lit- tabib tiegħek jekk inti qed tieħu xi mediċini inkluż mediċini oħra biex tittratta l- infezzjoni ta ’ l- HIV tiegħek (eż. efavirenz, lopinavir, saquinavir, darunavir, atazanavir, nelfinavir, indinavir), antibijotiċi (clarithromycin, telithromycin, rifampicin) u mediċini kontra fungi (ketoconazole, itraconazole).
This will allow your doctor to prescribe the most appropriate dose of CELSENTRI for you.
Dan jippermetti lit- tabib tiegħek jordnalek l- aktar doża ta ’ CELSENTRI adattata għalik.
Medicines containing St.
64 Mediċini li fihom St.
John’ s wort (Hypericum perforatum) are likely to prevent CELSENTRI from working properly and should not be taken together with CELSENTRI.
John’ s wort (Hypericum perforatum) mistennija li jtellfu CELSENTRI milli jaħdem kif kuppost u m’ għandhomx jittieħdu flimkien ma ’ CELSENTRI.
58 Taking CELSENTRI with food and drink
Meta tieħu CELSENTRI ma ’ l- ikel u max- xorb
Pregnancy
Tqala
Tell your doctor if you are pregnant, planning to become pregnant or become pregnant whilst taking this medicine.
Għid lit- tabib tiegħek jekk inti tqila, qed tippjana biex tinqabad tqila jew jekk tinqabad tqila waqt li tkun qiegħda tieħu din il- mediċina.
If you are pregnant, CELSENTRI should only be taken after careful discussion with your doctor.
Jekk inti tqila, CELSENTRI għandu jittieħed biss wara diskussjoni bir- reqqa mat- tabib tiegħek.
The safe use of CELSENTRI in pregnancy has not been established.
L- użu mingħajr periklu ta ’ CELSENTRI fit- tqala ma ġiex stabbilit.
Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar tiegħek qabel tieħu xi mediċina.
Breast-feeding
Treddigħ
It is not known whether the active ingredient in CELSENTRI can pass into your breast milk.
Mhux magħruf jekk is- sustanza attiva ta ’ CELSENTRI tistax tgħaddi fil- ħalib tas- sider tiegħek.
Therefore, mothers should not breast-feed during treatment with CELSENTRI.
Għalhekk, l- ommijiet m’ għandhomx ireddgħu waqt kura b’ CELSENTRI.
In general, women infected with HIV should not breast-feed because the virus may be transmitted through the breast milk.
B’ mod ġenerali, nisa infettati bl- HIV ma għandhomx ireddgħu minħabba li l- virus jista ’ jiġi trasmess mal- ħalib tas- sider.
If you experience dizziness while taking CELSENTRI do not drive and do not operate any tools or machines.
Jekk tesperjenza sturdament waqt lit kun qed tieħu CELSENTRI, issuqx u tħaddimx għodod jew magni.
Important information about some of the ingredients of CELSENTRI
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ CELSENTRI
CELSENTRI contains soya lecithin.
CELSENTRI fih leċitina tas- soja.
If you are allergic to peanut or soya do not use this medicinal product.
Jekk inti allerġiku/ allerġika għall- karawett jew għas- soja, tużax dan il- prodott mediċinali.
HOW TO TAKE CELSENTRI
KIF GĦANDEK TIEĦU CELSENTRI
Always take CELSENTRI exactly as your doctor has instructed.
Dejjem għandek tieħu CELSENTRI skond il- parir tat- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure how to take CELSENTRI.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju fuq kif tieħu CELSENTRI.
The usual dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that you are taking at the same time as CELSENTRI.
Id- doża li ssoltu tingħata ta ’ CELSENTRI hija 150 mg, 300 mg jew 600 mg darbtejn kuljum jiddependi fuq il- mediċini l- oħra li inti tkun qed tieħu fl- istess ħin ma ’ CELSENTRI.
Always take the dose recommended by your doctor.
Dejjem ħu d - doża rakkomandata mit- tabib tiegħek.
CELSENTRI can be taken with or without food.
CELSENTRI jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
CELSENTRI should always be taken by mouth.
CELSENTRI għandu dejjem jittieħed mill- ħalq.
You should continue to take CELSENTRI for as long as instructed by your doctor.
Inti għandek tkompli tieħu CELSENTRI għal kemm jgħidlek it- tabib tiegħek.
CELSENTRI must be taken in combination with other medicines used to treat HIV.
CELSENTRI irid jittieħed ma ’ mediċini oħra użati għall- kura ta ’ l- HIV.
Please refer to the Package Leaflets of these other medicines for guidance on how to take them.
Jekk jogħġbok irreferi għall - Fuljetti ta ’ Tagħrif ta ’ dawn il- mediċini għal gwida dwar kif tużahom.
If you take more CELSENTRI than you should
Jekk tieħu aktar CELSENTRI milli suppost
If you accidentally take more than the prescribed dose of CELSENTRI, contact your doctor or the nearest hospital right away.
Jekk aċċidentalment tieħu iżjed mid- doża ordnata ta ’ CELSENTRI, ikkuntattja lit- tabib tiegħek jew lill- eqreb sptar immedjatament.
You may feel dizzy or light-headed when you stand or sit up quickly.
Tista ’ tħossok sturdut jew ma tħossokx daqstant tajjeb/ tajba meta tqum jew tqum minn bilqiegħda f’ salt.
This is due to a sudden fall in your blood pressure.
Dan huwa minħabba waqa ’ f’ daqqa fil- pressjoni tad- demm tiegħek.
If this happens, lie down until you feel better.
Jekk jiġri dan, strieħ mimdud/ a sakemm tħossok aħjar.
When you get up, do so as slowly as possible.
Meta tqum, agħmel dan kemm jista ’ jkun bil- mod.
59 If you forget to take CELSENTRI
65 Jekk tinsa tieħu CELSENTRI
If you miss a dose of CELSENTRI, take the missed dose as soon as possible and then take your next scheduled dose at its regular time.
Jekk tinsa tieħu doża ta ’ CELSENTRI, ħu d- doża li jmiss mill- aktar fis u mbagħad ħu d- doża skedata tiegħek li jmiss fil- ħin regolari tagħha.
If it is almost time for your next dose, do not take the missed dose.
Jekk ikun wasal il- ħin għad- doża li jmiss, tiħux id- doża li tkun insejt.
Wait and take the next dose at its regular time.
Stenna u ħu d- doża li jmiss fil- ħin regolari tagħha.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
If you stop taking CELSENTRI
Jekk tieqaf tieħu CELSENTRI
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your antiretroviral medicines.
Ġie muri li t- teħid tad- dożi kollha fil- ħinijiet korretti jista ’ jżid mhux ftit l- effikaċja ta ’ mediċini antiretrovirali tiegħek.
Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.
Għalhekk, sakemm it- tabib tiegħek ma jordnalekx biex twaqqaf il- kura, huwa importanti li tkompli tieħu CELENTRI sewwa, kif deskritt hawn fuq.
If you have any further questions on the use of this product, ask your doctor or your pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, CELSENTRI can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CELSENTRI jista ’ ikollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always easy to identify what side effects are caused by CELSENTRI, by the other medicines you are taking, or by the HIV infection itself.
Fil- kura ta ’ infezzjoni bl- HIV, mhux dejjem huwa faċli tidentifika liema effetti sekondarji huma kkawżati minn CELSENTRI, mill- mediċini l- oħra li tkun qed tieħu, jew mill- infezzjoni ta ’ l - HIV innifisha.
Tell your doctor if you notice anything unusual about your health.
Għid lit- tabib tiegħek jekk tinnota xi ħaġa mhux tas- soltu dwar saħħtek.
A very common side-effect (likely to occur in more than 1 in 10 patients) is feeling sick.
Effett sekondarju komuni ħafna (li jista ’ jseħħ f’ aktar minn pazjent 1 minn kull 10) huwa li wieħed iħossu ma jiflaħx.
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Effetti sekondarji komuni (li jistgħu jseħħu f’ anqas minn pazjent 1 minn kull 10) jinkludu:
• diarrhoea, being sick (vomiting), stomach ache, feeling bloated, indigestion, constipation, weight loss • headache, dizziness, abnormal sense of taste, sleepiness, problems sleeping, abnormal sensations in the body such as pins and needles • rash, itching, muscle spasms, back pain, feeling weak, cough • increased levels of substances that measure the function of the liver and pancreas.
• dijarea, sensazzjoni ta ’ mard (rimettar), uġigħ ta ’ żaqq, wieħed iħossu mifquħ, indiġestjoni, stitikezza, telf tal- piż • uġigħ ta ’ ras, sens anormali tat- togħma, problemi ta ’ rqad, sensazzjonijiet mhux normali fil- ġisem bħal irqad ta ’ partijiet tal- ġisem • raxx, ħakk, spażmi fil- muskoli, uġigħ fid- dahar, dgħjufija, sogħla. • livelli ogħla ta ’ sustanzi li jkejlu l- funzjoni tal- fwied u frixa.
If you experience symptoms, such as loss of appetite, feeling sick/ being sick and/ or yellowing of skin or eyes, you should inform your doctor.
Dawn jistgħu jintwerew fir- riżultati tat- testijiet tad- demm u jistgħu ikunu sinjali ta ’ funzjoni ridotta jew ħsara f’ dawn l- organi. Jekk tesperjenza sintomi bħal nuqqas ta ’ aptit, tħossok marid/ tkun marid u/ jew sfurija tal- ġilda jew l - għajnejn, għanddek mill- ewwel tinforma lit- tabb tiegħek.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Effetti sekondarji mhux komuni (li jistgħu jseħħu f’ anqas minn pazjent 1 minn kull 100) jinkludu:
• reduction in number of white and red blood cells, enlarged lymph glands, heart attack, reduced blood flow to the heart • inflammation of the pancreas, rectal bleeding, liver disease, muscle aches and pains • fainting, epilepsy, fits, inability to move the muscles in the face, tingling or burning sensation in the hands or feet, loss of reflexes, hallucination • kidney failure, producing more urine than normal • pneumonia, breathing difficulties such as shortness of breath.
• tnaqqis fin- numru ta ’ ċelloli bojod u ħomor tad- demm, tkabbir tal- glandoli żgħar limfatiċi, attakk tal- qalb, tnaqqis fil- fluss tad- demm għall- qalb • infjammazzjoni tal- frixa, fsada mir- rektum, mard tal- fwied, uġigħ fil- muskoli • ħass ħażin, epilessija, attakki tal- qamar, inkapaċità biex iċċaqlaq il- muskoli tal- wiċċ, sensazzjoni ta ’ tnemnim jew ta ’ ħruq fl- idejn jew fis- saqajn, telf tar- riflessi, alluċinazzjoni • insuffiċjenza tal- kliewi, aktar awrina mis- soltu • pnewmonja, diffikultajiet fit- teħid tan- nifs bħal qtugħ ta ’ nifs
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CELSENTRI
KIF TAĦŻEN CELSENTRI
• Keep out of the reach and sight of children.
• Żommu fejn ma jintlaħaqx u ma jidhirx u mit- tfal.
• Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
• Tużax CELSENTRI wara d- data ta ’ skadenza li tidher fuq il- kaxxa, folja jew tikketta tal - fliexkun.
The expiry date refers to the last day of that month.
Id- data ta ’ meta jiskadi tirreferi għall- aħħar jum tax- xahar
60 • This medicine does not require any special storage conditions.
• Din il- mediċina ma teħtieġ ebda kondizzjonijiet speċjali għall- ħażna.
Medicines should not be disposed of via wastewater or household waste.
Id- data ta ’ skadenza tirreferi għall- aħħar jum ta ’ dak ix- xahar.
Ask your pharmacist how to dispose of medicines no longer required.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What CELSENTRI contains
X’ fih CELSENTRI
• The active ingredient in CELSENTRI is maraviroc.
• Is- sustanza attiva f’ CELSENTRI hi maraviroc.
Each film-coated tablet contains either 150 mg or 300 mg of maraviroc.
Kull pillola miksija b’ rita fiha jew 150 mg jew 300 mg ta ’ maraviroc.
• The other ingredients are:
• Is- sustanzi l- oħra huma:
Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Qalba tal- pillola: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Film-coat: poly (vinyl alcohol), titanium dioxide, macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
Kisja tar- rita: poly (vinyl alcohol), titanium dioxide, macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
What CELSENTRI looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
CELSENTRI film-coated tablets are blue coloured with “ Pfizer” on one side and “ MVC 150” or “ MVC 300” on the other.
CELSENTRI pilloli miksijin b’ rita huma ta ’ lewn blu bi “ Pfizer ” fuq naħa u “ MVC 150 ” jew “ MVC 300 ” fuq in- naħa l- oħra.
CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
CELSENTRI 150 mg u 300 mg pilloli miksijin b’ rita jiġu fi fliexken ta ’ 180 pillola jew f’ pakketti ta ’ folji ta ’ 30, 60, 90 pilloli miksijin b’ rita u pakketti multipli li fihom 180 (2 pakketti ta ’ 90) pillola miksija b’ rita.
Not all pack sizes may be marketed in all countries.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali f’ kull pajjiż.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
The Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq hu: