qanastek/EMEA-V3 huggingface dataset:
Fat redistribution and metabolic disorders Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
51 Terapija antiretrovirali b’ għadd ta ’ mediċini kienet assoċjata ma ’ ridistribuzzjoni tax- xaħam fil- ġisem (lipodistrofija) fil- pazjenti infettati bl- HIV.
Consideration should be given to measurement of
Eżami kliniku għandu jinkludi evalwazzjoni għas- sinjali fiżiċi ta ’ ridistribuzzjoni tax- xaħam.
47 fasting serum lipids and blood glucose.
Għandha tingħata konsiderazzjoni lit- tiqjis ta ’ xaħmijiet fis- serum u zokkor fid- demm waqt is- sawm.
PREZISTA co-administered with 100 mg ritonavir must not be combined with medicinal products that are highly dependent on CYP3A4 for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index).
PREZISTA amministrat flimkien ma ’ 100 mg ritonavir m’ għandhomx jingħataw flimkien ma ’ prodotti mediċinali li jiddependu ħafna minn CYP3A4 għat- tneħħija tagħhom u li liema żieda fl - esponiment sistemiku tagħhom huwa assoċjat ma ’ ġrajjiet serji u/ jew huwa ta ’ periklu għall- ħajja (indiċi terapewtiku strett).
These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, terfenadine, midazolam administered orally, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin and the ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (see section 4.3).
Dawn il- mediċini jinkludu amiodarone, bepridil, quinidine, lidocaine sistemiku, astemizole, terfenadine, midazolam mogħti mill- ħalq, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin u l- alkalojdi ergot (e. ż. ergotamine, dihydroergotamine, ergonovine u methylergonovine) (ara sezzjoni 4. 3).
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg b.i.d.
Għalhekk PREZISTA għandu jintuża
Therefore, PREZISTA must only be used in combination with 100 mg of ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
52 biss flimkien ma ’ 100 mg ritonavir biex jintensifika l- effett farmakokinetiku (ara sezzjonijiet 4. 4 u 5. 2).
A clinical study utilising a cocktail of drugs that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of PREZISTA/rtv, which may be attributed to the presence of low dose ritonavir.
Studju kliniku bl- użu ta ’ taħlita ta ’ mediċini li jiġu mmetabolizzati miċ- ċitokromi CYP2C9, CYP2C19 u CYP2D6 urew żieda fl- attività ta ’ CYP2C9 u CYP2C19 u impediment fl- attività ta ’ CYP2D6 fil - preżenza ta ’ PREZISTA/ rtv, li tista ’ tkun attribwita għall- preżenza ta ’ doża baxxa ta ’ ritonavir.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in
L- amministrazzjoni ta ’ darunavir flimkien ma ’ ritonavir u ma ’ prodotti mediċinali primarjament immetabolizzati minn CYP2C9 (bħal warfarin) u CYP2C19 (bħal methadone) tista ’ twassal għal esponiment sistemiku mnaqqas għal dawn il- prodotti mediċinali, li jista ’ jnaqqas jew iqassar l- effett terapewtiku tagħhom.
The study with boosted saquinavir showed no significant effect of darunavir on saquinavir.
53 L- istudju b’ saquinavir imsaħħaħ ma wera l- ebda effett sinifikanti ta ’ darunavir fuq saquinavir.
49 Co-administered
Doża tal- Prodott
Medicinal Product
Mediċinali
Co-administered Medicinal Product (mg)
Mediċinali
darunavir/ritonavir (mg)
Flimkien Miegħu
Product Assessed
Eżaminat
Based on the different elimination pathways of the other NRTIs zidovudine, zalcitabine, emtricitabine, stavudine, lamivudine, that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP450, no interactions are expected for these medicinal compounds and PREZISTA co-administered with 100 mg ritonavir.
Meta bbazati fuq il- passaġġi differenti ta ’ eliminazzjoni ta ’ l- NRTI l- oħra zidovudine, zalcitabine, emtricitabine, stavudine, lamivudine, li huma primarjament imneħħija permezz tal- kliewi, u abacavir li l- metaboliżmu tagħhom mhux medjat b’ CYP450, ma huma mistennija l- ebda interazzjonijiet bejn dawn il- prodotti mediċinali u PREZISTA amministrata flimkien ma ’ 100 mg ritonavir.
Didanosine ↔ NA Darunavir ↔ ↔ Didanosine was administered on an empty stomach 2 hours prior to administration of darunavir/ritonavir.
54 Didanosine kien amministrat fuq stonku vojt sagħtejn qabel l- amministrazzjoni ta ’ darunavir/ ritonavir.
The combination of PREZISTA co-administered with 100 mg ritonavir and didanosine can be used without dose adjustments.
L- użu flimkien ta ’ PREZISTA u 100 mg ritonavir flimkien ma ’ didanosine jista ’ jsir mingħajr aġġustamenti tad- doża. ↑ 305% Maraviroc
Maraviroc
150 b. i. d.
150 b.i.d.
Maraviroc 150 b. i. d.
Maraviroc ↑ 305% ND Darunavir ↔ ND The maraviroc dose should be 150 mg twice daily when co-administered with PREZISTA with low dose ritonavir.
Id- doża ta ’ maraviroc għandha tkun ta ’ 150 mg darbtejn kuljum meta tkun mogħtija flimkien ma ’ PREZISTA mogħti flimkien ma ’ doża baxxa ta ’ ritonvir.
Digoxin 0.4 mg single dose 600/100 b.i.d.
Digoxin doża waħda ta ’ 600/ 100 b. i. d.
50 Darunavir/ritonavir increases the plasma concentrations of digoxin.
0. 4 mg Darunavir/ ritonavir iżidu l- konċentrazzjonijiet ta ’ digoxin fil- plażma.
Voriconazole
55 Voriconazole
Ketoconazole 200 b.i.d.
Ketoconazole
Itraconazole, like ketoconazole, is a potent inhibitor as well as substrate of CYP3 A4.
Itraconazole, bħal ketoconazole, huwa impeditur potenti kif ukoll sustrat ta ’ CYP3A4.
51 Felodipine Nifedipine Nicardipine
Mediċini blokkaturi tal- kanali tal- kalċju Felodipine Nifedipine Nicardipine
600/100 b
600/ 100 b. i.
Ethinylestradiol Norethindrone
Ethinylestradiol
↓ 44% ↓ 14%
Norethindrone
PDE-5 inhibitors
Għalhekk monitoraġġ kliniku huwa rrakomandat minħabba li l- kura ta ’ manteniment jista ’ jkollha bżonn tkun aġġustata f’ xi pazjenti.
52 Sildenafil Vardenafil Tadalafil Rifamycines
Impedituri PDE- 5 Sildenafil Vardenafil Tadalafil Rifamycines
* sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day [i.e. rifabutin 150 mg q.o.d.
57 * l- għadd tan- nofsijiet attivi ta ’ rifabutin (mediċina oriġinali + metabolit 25- O- desacetyl) Tnaqqis fid- doża ta ’ rifabutin b’ 75% mid- doża tas- soltu ta ’ 300 mg/ kuljum [i. e. rifabutin 150 mg q. o. d.
No drug interaction study has been performed for the co-administration of PREZIST A/ritonavir with benzodiazepines.
Ma sar l- ebda studju dwar l- amministrazzjoni ta ’ PREZISTA/ ritonavir mal- benzodiazepines.
53 If SSRIs are co-administered with PREZISTA and ritonavir, the recommended approach is a dose titration of the SSRI based on a clinical assessment of antidepressant response.
Jekk l- SSRIs jiġu amministrati flimkien ma ’ PREZISTA u ritonavir, ir - rakkomandazzjoni hija li jsir ddożar tad- doża ta’ l- SSRI ibbażat fuq stima klinika tar - rispons antidepressiv.
Steroids Fluticasone propionate Budesonide
58 Fluticasone propionate Budesonide
However, dizziness has been reported in some patients during
Madanakollu, kien irrappurtat sturdament f’ xi wħud mill- pazjenti waqt trattament
54 treatment with regimens containing PREZISTA co-administered with 100 mg ritonavir and should be borne in mind when considering a patient’s ability to drive or operate machinery (see section 4.8).
59 b’ kors ta ’ mediċini li kien fihom PREZISTA flimkien ma ’ 100 mg ritonavir u dan għandu jinżamm fil - moħħ meta jiġi kkunsidrat jekk pazjent għandux ħila jsuq jew iħaddem magni (ara sezzjoni 4. 8).
55 uncommon Eye disorders
mhux komuni Disturbi fl- għajnejn
uncommon
61 mhux komuni
56 Musculoskeletal and connective tissue disorders uncommon
Disturbi muskolu- skeltrali u tal- connective tissue mhux komuni
Uncommon: hyperlipidaemia, vomiting, abdominal pain, increased aspartate aminotransferase, rash (including maculopapular rash), allergic dermatitis, pruritus.
62 Mhux komuni: iperlipidimja, rimettar, uġigħ fl- addome, żieda fl- aspartate aminotransferase, raxx (inkluż raxx makulopapulari), dermatite allerġika, ħakk.
57 Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
Terapija b’ taħlita ta ’ għadd ta ’ mediċini antiretrovirali kienet assoċjata ma ’ ridistribuzzjoni tax- xaħam tal- ġisem (lipodistrofija) fil- pazjent ta ’ l- HIV, inkluż telf ta ’ xaħam ta ’ taħt il- ġilda, periferali u fil - wiċċ, żieda fix- xaħam intra- addominali u tal- vixxri, ipertrofija tas- sider u akkumulazzjoni ta ’ xaħam dorsoċervikali (ħotba tal- buflu) (ara sezzjoni 4. 4).
Antiviral activity in vitro Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and
Attività antivirali in vitro Darunavir juri attività kontra razez tal- laboratorju u ċelluli puri ta ’ virusis iżolati klinikament ta ’ HIV- 1 u razez tal- laboratorju ta ’ HIV- 2 f’ linji ta ’ ċelluli T infettati b’ mod akut, ċelluli mononukleari periferali tad- demm umani u makrofaġi/ monoċiti umani b’ medjan ta ’ valuri EC50 minn 1. 2 sa 8. 5 nM (0. 7 sa 5. 0 ng/ ml).
Of the viruses isolated from patients experiencing virologic failure by rebound from the PREZISTA/rtv 600/100 mg b.i.d. group of the POWER and DUET trials, 85% of those susceptible to darunavir at baseline developed decreased susceptibility to darunavir during treatment.
Mill- virusis iżolati minn pazjenti li kienu qed jesperjenzaw falliment viroloġiku permezz ta ’ rebound mill- grupp PREZISTA/ rtv 600/ 100 mg b. i. d. tal- provi POWER u DUET, 85% ta ’ dawk suxxettibbli għal darunavir fil- linja bażi żviluppaw suxxettibilità mnaqqsa għal darunavir waqt il- kura.
Cross-resistance Darunavir has a < 10-fold decreased susceptibility against 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
64 saquinavir u/ jew tipranavir li juri li l- virusis reżistenti għall- maġġoranza tal- PIs jibqgħu suxxettibbli għal darunavir.
59 The mean baseline plasma HIV-1 RNA was 4.33 log10 copies/ml and the median baseline CD4+ cell count was 235 x 106 cells/l (range 3 – 831 x 106 cells/l) in the PREZISTA/ritonavir arm.
Il- linja bażi medja ta ’ RNA HIV- 1 fil- plażma kienet 4. 33 log10 kopja/ ml u l- linja bażi medjana tal- għadd ta ’ ċelluli CD4+ kienet 235 x 106 ċelluli/ l (medda minn 3 – 831 x 106 ċelluli/ l) fil- fergħa ta ’ PREZISTA/ ritonavir.
TITAN Outcomes
TITAN Effetti
60 HIV-1 RNA log10 mean change from baseline (log10 copies/ml)a
HIV- 1 RNA log10 medja tal- bidla mil- linja bażi (log10 kopji/ ml) a
1.32 (1.58; 1.05)d
- 1. 69 - 0. 37 1. 32 (1. 58; 1. 05) d
20 (16.1%)
81 (61. 8%) 20 (16. 1%) 45. 7% (35. 0%; 56. 4%) d
HIV RNA < 400 copies/mlc
HIV RNA < 400 kopja/ mlc
18 (14.5%)
72 (55. 0%) 18 (14. 5%) 40. 4% (29. 8%; 51. 1%) d
61 Baseline darunavir phenotype (shift in susceptibility relative to reference) was shown to be a predictive factor of virologic outcome.
Il- fenotip tal- linja bażi ta ’ darunavir (bidla żgħira fis- suxxettibbilità fejn għandha x’ taqsam mar - riferenza) intwera li kienet fattur li juri l- effett viroloġiku minn qabel.
Baseline darunavir phenotype
Il- fenotip tal- linja bażi ta ’ darunavir
Darunavir is primarily metabolised by CYP3A.
67 Darunavir huwa mmetabolizzat primarjament mis- CYP3A.
At least 3 oxidative metabolites of darunavir have been identified in
Ta ’ lanqas 3 sustanzi ossidattivi iffurmati mill - metaboliżmu ta ’ darunavir kienu identifikati fil- bnedmin; kollha wrew attività li kienet ta ’ lanqas 10 darbiet anqas mill- attività ta ’ darunavir kontra l- HIV li jinstab fin- natura.
Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
L- ammont ta ’ darunavir mhux mibdul kien ta ’ bejn wieħed u ieħor 41. 2% u 7. 7% tad- doża amministrata fl - ippurgar u fl- awrina rispettivament.
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
68 Għalkemm darunavir ma ġiex studjat fil- pazjenti b’ indeboliment renali, analiżi farmakokinetika ta ’ popolazzjoni wriet li l- farmakokinetika ta ’ darunavir m’ hijiex affettwata sinifikament fil- pazjenti infettati bl- HIV u li għandhom indeboliment renali moderat (CrCl bejn 30 - 60 ml/ min, n=20) (ara sezzjonijiet 4. 2 u 4. 4).
In the dog, no major toxicity
Fil- far, it- taħlita ta ’ darunavir ma ’ ritonavir wasslet għal żieda żgħira fl- effett fuq il- parametri taċ- ċelluli ħomor, tal- fwied, u tat- tirojde u żieda fl- inċidenza ta ’ fibrożi fl - iżoli tal- frixa (fil- firien irġiel biss) meta mqabbla ma ’ trattament b’ darunavir waħdu.
63 findings or target organs were identified up to exposures equivalent to clinical exposure at the recommended dose.
Fil- kelb, l- ebda sejbiet ta ’ tossiċità maġġuri jew organi mimsusa ma ’ kienu identifikati sa esponimenti ekwivalenti għal esponiment kliniku fid- doża rrakkomandata.
The exposure levels were lower than those with the recommended clinical dose in humans.
Il- livelli ta ’ esponiment kienu anqas minn dawk bid- doża klinikament rakkomandata fil- bnedmin.
Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
69 Darunavir ġie evalwat għal potenzjal kanċeroġeniku permezz ta ’ amministrazzjoni b’ tubu mill- ħalq lill- ġrieden u l- firien sa 104 ġimgħat.
Tablet film-coat Poly(vinyl alcohol) – partially hydrolyzed Macrogol 3350
Rita ta ’ barra tal- pillola Poly( vinyl alkoħol) – parzjalment idrolizzat Macrogol 3350 Titanium dioxide (E171) Terra Sunset yellow FCF (E110)
No special requirements.
70 L- ebda ħtiġijiet speċjali.
65 ANNEX II
71 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJNIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The MAH must ensure that the system of pharmacovigilance, as described in version 3 (dated 28 June 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni 3 (bid- data tat- 28 ta ’ Ġunju 2007) ippreżentata f’ Module 1. 8. 1 tal- Applikazzjoni tal- Awtorizzazzjoni għat- tqegħid fis- Suq, qegħda fis- seħħ u tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
Risk Management plan
Pjan ta ’ l- immaniggjar tar- riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 7 (dated 31 July 2008) 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 jintrabat li jagħmel l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali kif ddettaljat fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 7 (bid- data tal- 31 ta ’ Lulju 2008) tal- Pjan għall- Immaniġġar tar- Riskju (RMP) ippreżentat f’ Module 1. 8. 2 tal- Applikazzjoni għall- Awtorizzazzjoni għat- tqegħid fis- Suq u kull aġġornamenti sussegwenti tal- RMP miftiehem mas- CHMP.
In addition, an updated RMP should be submitted
Flimkien ma ’ dan, pjan ta ’ l- immaniġġar tar- riskju għandu jiġi sottomess
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Meta informazzjoni ġdida tinkiseb illi jkollha mpatt fuq l- ispeċifikazzjonijiet tas- sigurta ’ kurrenti, fuq il- pjan ta ’ farmakoviġilanza jew f ’ l- attivitajiet ta ’ minimizzazzjoni tar- riskji
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Fi żmien 60 ġurnata minn meta tintlaħaq ġrajja importanti (ta ’ farmakoviġilanza jew minimizzazzjoni tar- riskji)
At the request of the EMEA.
Fuq rikjesta ta ’ l- EMEA
67 ANNEX III
73 ANNESS III
69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
75 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON / BOTTLE LABEL
KARTUNA TA ’ BARRA/ TIKKETTA TAL- FLIXKUN
PREZISTA 300 mg film-coated tablets darunavir
PREZISTA 300 mg pilloli miksijin b’ rita darunavir
Each film-coated tablet contains 300 mg darunavir (as ethanolate).
Kull pillola miksija b’ rita fiha 300 mg darunavir (bħala ethanolate).
LIST OF EXCIPIENTS
LIST TA ’ SUSTANZI MHUX ATTIVI
Contains sunset yellow FCF (E110).
Fih sunset yellow FCF (E110).
120 film-coated tablets
120 pilloli miksijin b’ rita
INFORMATION IN BRAILLE (this is only applicable to the outer pack)
INFORMAZZJONI BIL- BRAILLE (Din tapplika biss għall- pakkett ta ’ barra)
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
PREZISTA 400 mg film-coated tablets darunavir
PREZISTA 400 mg pilloli miksijin b’ rita darunavir
Each film-coated tablet contains 400 mg darunavir (as ethanolate).
Kull pillola miksija b’ rita fiha 400 mg darunavir (bħala ethanolate).
Also contains sunset yellow FCF (E110).
Fih ukoll sunset yellow FCF (E110).
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
79 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
PREZISTA 600 mg film-coated tablets darunavir
PREZISTA 600 mg pilloli miksijin b’ rita darunavir
Each film-coated tablet contains 600 mg darunavir (as ethanolate).
Kull pillola miksija b’ rita fiha 600 mg darunavir (bħala ethanolate).
76 PACKAGE LEAFLET:
82 FULJETT TA ’ TAGĦRIF:
PREZISTA 300 mg film -coated tablets darunavir
PREZISTA 300 mg pilloli miksijin b’ rita darunavir
- This medicine has been prescribed for you.
M’ għandekx tgħaddiha lil persuni oħra.
- If a side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What PREZISTA is and what it is used for 2.
X’ inhu PREZISTA u għalxiex jintuża 2.
Before you take PREZISTA 3.
Qabel ma tieħu PREZISTA 3.
How to take PREZISTA 4.
Kif għandek tieħu PREZISTA 4.
How to store PREZISTA 6.
Kif taħżen PREZISTA 6.
WHAT PREZISTA IS AND WHAT IT IS USED FOR
X’ INHU PREZISTA U GĦALXIEX JINTUŻA
What is PREZISTA?
X’ inhu PREZISTA?
PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
PREZISTA huwa mediċina antiretrovirali użat għat- trattament ta ’ infezzjoni bil- Virus Uman ta ’ l - Immunodefiċjenza (HIV).
It belongs to a group of medicines called protease inhibitors.
Huwa jagħmel parti minn grupp ta ’ mediċini imsejħa Impedituri ta ’ Protease.
PREZISTA works by reducing the amount of HIV in your body.
PREZISTA jaħdem billi jnaqqas l- ammont ta ’ HIV f’ ġismek.
This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Dan itejjeb is- sistema immuni tiegħek u jnaqqas ir- riskju li tiżviluppa mard li għandu x’ jaqsam ma ’ infezzjoni bl- HIV.
What it is used for?
Għalxiex jintuża?
PREZISTA is used to treat adults who are infected by HIV and who have already used other antiretroviral medicines.
PREZISTA jintuża għat- trattament ta ’ adulti li huma infettati bl- HIV u li diġà wżaw mediċini antiretrovirali oħra.
PREZISTA must be taken in combination with a low dose of ritonavir and other anti-HIV medicines.
PREZISTA għandu jittieħed flimkien ma ’ doża baxxa ta ’ ritonavir u mediċini oħra kontra l- HIV.
Your doctor will discuss with you which combination of medicines is best for you.
It - tabib jiddiskuti miegħek liema taħlita ta ’ mediċini tkun l- aħjar għalik.
BEFORE YOU TAKE PREZISTA
QABEL MA TIEĦU PREZISTA
PREZISTA is to be taken in combination with a low dose of ritonavir and other antiretroviral medicines.
PREZISTA għandu jittieħed flimkien ma doża baxxa ta ’ ritonavir u mediċini antiretrovirali oħra.
It is therefore important that you carefully read the package leaflet that is provided with these medicines.
Għalhekk huwa importanti li inti taqra b’ attenzjoni il- fuljett ta ’ tagħrif li hawn ma ’ dawn il- mediċini.
If you have any further questions about the medicines prescribed, please ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar il- mediċini preskritti jekk jogħġbok staqsi lit- tabib jew lill - ispiżjar tiegħek.
Do not take PREZISTA:
Tieħux PREZISTA:
- if you are allergic (hypersensitive) to darunavir, other ingredients of PREZISTA or to ritonavir.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal darunavir, għal sustanzi oħra ta ’
- if you have severe liver problems.
PREZISTA jew għal ritonavir. jekk inti għandek problemi serji fil- fwied.
Ask your doctor if you are unsure about the severity of your
Staqsi lit- tabib jekk inti m’ intix ċert/ ċerta dwar
liver disease.
kemm huwa serju l- mard tal- fwied li għandek.
Some additional tests might be necessary.
Jista ’ jkun hemm bżonn ta ’ xi testijiet addizjonali.
Do not combine PREZISTA with any of the following medicines:
Tieħux PREZISTA ma ’ kwalunkwe wieħed minn dawn il- mediċini li ġejjin:
- astemizole or terfenadine (to treat allergy symptoms)
- astemizole jew terfenadine (biex tikkura s- sintomi ta ’ l- allerġija)
- triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety)
- triazolam u midazolam li jittieħed mill- ħalq (biex jgħinek torqod u/ jew tnaqqas l- ansjetà)
- cisapride (to treat some stomach conditions)
- cisapride (biex tikkura xi kundizzjonijiet ta ’ l- istonku)
- pimozide or sertindole (to treat psychiatric conditions)
- pimozide jew sertindole (biex tikkura kundizzjonijiet psikjatriċi)
- ergot alkaloids (like ergotamine, dihydroergotamine, ergonovine and methylergonovine used to
- alkalojdi ergot (bħal ergotamine, dihydroergotamine, ergonovine u methylergonovine użati biex
treat migraine and headaches)
jikkuraw l- emigranja u l- uġigħijiet ta ’ ras) amiodarone, bepridil, quinidine u lidocaine sistemiku (biex tikkura ċerti disturbi tal- qalb e. ż.
abnormal heart beat)
taħbit tal- qalb abnormali)
- lovastatin and simvastatin (medicines to lower cholesterol levels)
- lovastatin u simvastatin (mediċini biex ibaxxu l- livell tal- kolesterol)
- rifampicin (medicines to treat some infections such as tuberculosis)
- rifampicin (mediċini biex jikkuraw xi infezzjonijiet bħat- tuberkulożi)
- the combination product lopinavir/ritonavir (an anti-HIV medicine belonging to the same class
- il- prodott li fih lopinavir u ritonavir flimkien (mediċina kontra l- HIV li tagħmel parti mill- istess
as PREZISTA)
klassi ta ’ PREZISTA)
- products that contain St John’s wort (Hypericum perforatum)
- prodotti li fihom St John’ s wort (Hypericum perforatum).
If you are taking any of these, ask your doctor about switching to another medicine.
Jekk qed tieħu xi wieħed minn dawn, staqsi lit- tabib dwar il- bidla għal mediċina oħra.
Take special care with PREZISTA PREZISTA is not a cure for HIV infection.
Oqoghod attent ħafna bi PREZISTA PREZISTA mhux kura għall- infezzjoni ta ’ l- HIV.
PREZISTA does not reduce the risk of passing HIV to others through sexual contact or blood contamination.
PREZISTA ma jnaqqasx ir- riskju li tgħaddi l- HIV lill- oħrajn permezz ta ’ kuntatt sesswali jew kontaminazzjoni tad- demm.
Therefore, you must continue to use appropriate precautions.
Għalhekk, inti għandek tkompli tuża l- prekawzjonijiet xierqa.
People taking PREZISTA may still develop infections or other illnesses associated with HIV infection.
Persuni li qed jieħdu PREZISTA xorta jistgħu jiżviluppaw infezzjonijiet jew mard ieħor assoċjat ma ’ infezzjoni bl- HIV.
You must keep in regular contact with your doctor.
Inti għandek iżżomm kuntatt regolari mat- tabib tiegħek.
PREZISTA has only been used in limited numbers of patients 65 years or older.
PREZISTA kien użat biss f’ numru limitat ta ’ pazjenti ta ’ 65 sena jew aktar.
If you belong to this age group, please discuss with your doctor if you can use PREZISTA.
Jekk inti tagħmel parti minn dan il- grupp ta ’ età, jekk jogħġbok iddiskuti mat- tabib tiegħek jekk tistax tuża PREZISTA.
Tell your doctor about your situation Make sure that you check the following seven points and tell your doctor if any of these apply to you.
Għid lit- tabib dwar is- sitwazzjoni tiegħek Kun żgur/ a li tiċċekkja is- sebgħa punti li ġejjin u għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik.
- Tell your doctor if you have had problems with your liver before, including hepatitis B or C.
It -
Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.
tabib tiegħek jevalwa kemm hu serju il- mard tal- fwied li għandek qabel jiddeċiedi jekk inti tistax tieħu PREZISTA.
- Tell your doctor if you have diabetes.
- Għid lit- tabib tiegħek jekk għandek id- dijabete.
PREZISTA might increase sugar levels in the blood.
PREZISTA jista ’ jżid il- livelli ta ’ zokkor fid -
- Tell your doctor immediately if you notice any symptoms of infection.
- Għid lit- tabib tiegħek immedjatament jekk tinnota kwalunkwe sintomi ta ’ infezzjoni.
In some patients with
F’ xi
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.
pazjenti b’ infezzjoni avvanzata ta ’ l- HIV u storja ta ’ infezzjonjiet opportunistiċi, sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet ta ’ qabel tista ’ sseħħ ftit wara li jinbeda 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.
Hemm il- fehma li dawn is- sintomi jiġru minħabba titjib fir- rispons immuni tal- ġisem, li jgħin lill- ġisem jiġġieled infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
- Tell your doctor if you notice changes in body fat.
- Għid lit- tabib jekk tinnota tibdil fix- xaħam tal- ġisem.
Redistribution, accumulation or loss of
Ridistribuzzjoni, akkumulazzjoni jew
body fat may occur in patients receiving a combination of antiretroviral medicines.
telf ta ’ xaħam tal- ġisem tista ’ sseħħ f’ pazjenti li qed jirċievu taħlita ta’ għadd ta ’ mediċini antiretrovirali.
- Tell your doct or if you have haemophilia.
Għid lit- tabib tiegħek jekkk għandek l- emofilja.
PREZISTA, might increase the risk of bleeding.
PREZISTA jista ’ żżid ir- riskju tal- fsada.
- Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).
- Għid lit- tabib tiegħek jekk inti allerġika/ u għas- sulphonamides (e. ż. jintużaw għall- kura ta ’
- Tell your doctor if you notice any musculoskeletal problems.
- Għid lit- tabib tiegħek jekk tinnota xi problemi muskolu- skeletrali.
Some patients taking
Xi pazjenti li jieħdu
combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
terapija b’ taħlita ta ’ għadd ta ’ mediċini antiretrovirali jistgħu jiżviluppaw marda ta ’ l- għadam imsejħa osteonekrożi (it- tessuti ta ’ l- għadam imutu minħabba telf ta ’ provvista tad- demm lejn l - 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 ta ’ żmien ta ’ terapija antiretrovirali, l- użu tal- kortikosterojdi, il- konsum ta ’ l - alkoħol, immunosuppressjoni serja, indiċi tal– massa tal- ġisem ogħla, fost l- oħrajn, jistgħu jkunu xi wħud mill- ħafna 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 fil- ġogi, uġigħ (speċjalment tal- ġenbejn, l- irkoppa u l- ispalla) u diffikultà biex tiċċaqlaq.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
There are some medicines that you must not combine with PREZISTA.
Hemm xi mediċini li m’ għandekx tieħu ma ’ PREZISTA.
These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following:’
Dawn qegħdin imsemmijin aktar ’ il fuq taħt it- titlu ‘ Tieħux PREZISTA ma ’ kwalunkwe wieħed minn dawn li ġejjin: ’
In most cases, PREZISTA can be combined with anti -HIV medicines belonging to another class (e.g.
84 F’ ħafna mill- każi PREZISTA jista ’ jittiehed flimkien ma ’ mediċini li jagħmlu parti minn klassi oħra (e. ż.
NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non -nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)).
NRTI’ s (impedituri tan- nucleoside reverse transcriptase), NNRTI’ s (mhumiex impedituri tan - nucleoside reverse transcriptase), antagonisti ta ’ CCR5 u FIs (impedituri ta ’ fużjoni)).
PREZISTA with ritonavir has not been tested with all PIs (protease inhibitors) and should not be used with some PIs.
PREZISTA ma ’ ritonavir ma ’ ġiex ittestjat mal- PI’ s (Impedituri ta ’ Protease) kollha u ma jistax jintuża ma xi wħud mill- PIs.
Therefore always tell your doctor if you take other anti -HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.
Għalhekk jekk jogħġbok dejjem għid lit- tabib tiegħek jekk tieħu mediċini oħra kontra l- HIV u segwi sewwa l- istruzzjonijiet dwar liema mediċini jistgħu jittieħdu flimkien.
78 The effects of PREZISTA might be reduced if you take any of the following products.
L- effetti ta ’ PREZISTA jistgħu jitnaqqsu jekk tieħu xi wieħed minn dawn il- prodotti.
Tell your doctor if you take:
Għid lit- tabib tiegħek jekk tieħu:
- phenobarbital, phenytoin (medicines to prevent seizures)
- phenobarbital, phenytoin( mediċini biex jilqgħu kontra attakki ta ’ epilessija)
- dexamethasone (steroid).
- dexamethasone (sterojd).
The effects of other medicines might be influenced if you take PREZISTA.
L- effetti ta ’ mediċini oħra tista ’ tiġi influwenzata jekk inti tieħu PREZISTA.
Tell your doctor if you take:
Għid lit- tabib tiegħek jekk inti tieħu:
- felodipine, nifedipine, nicardipine (medicines for heart disease) as the therapeutic effect or
- felodipine, nifedipine, nicardipine (mediċini għall- mard tal- qalb) minħabba li l- effett
unwanted side effects of these medicines may be increased.
terapewtiku jew l- effetti sekondarji ta ’ dawn il- mediċini jistgħu jiżdiedu.
- warfarin (medicine used to reduce clotting of the blood) as their therapeutic effect or unwanted
- warfarin (mediċina li tintużaw biex tnaqqsu t- tgħaqqid tad- demm) minħabba li l- effett
side effects may be altered; your doctor may have to check your blood.
terapewtiku jew l- effetti sekondarji jistgħu jinbidlu; it- tabib tiegħek jista ’ jkun ikollu jiċċekkjalek id- demm.
- hormonal contraceptives and hormonal replacement therapy.
- kontraċettivi ormonali jew terapija ta ’ sostituzzjoni ta ’ l- ormoni.
PREZISTA might reduce its
PREZISTA jista ’ jnaqqas l -
effectiveness.
effikaċja tagħhom.
When used for birth control, you must combine hormonal contraceptives with other birth control methods such as a condom.
Meta użati għall- kontroll tat- twelid, inti għandek tuża l- kontraċettivi ormonali flimkien ma ’ metodi oħra ta ’ kontroll tat- twelid bħal ma huwa l- kondom.
- pravastatin, atorvastatin (medicines to lower cholesterol levels).
- pravastatin, atorvastatin (mediċini li jnaqqsu l- livelli ta ’ kolesterol fid- demm).
The risk of muscle tissue
Ir- riskju ta ’
disorder might be increased.
mard tat- tessuti tal- muskoli jista ’ jiżdied.
Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
It- tabib tiegħek jevalwa liema dożi ta ’ mediċini li jbaxxu l- kolesterol huma l- aħjar fis- sitwazzjoni speċifika tiegħek.
- cyclosporin, tacrolimus, sirolimus (medicines for your immune system) as the therapeutic effect
- cyclosporin, tacrolimus, sirolimus (mediċini għas- sistema immuni tiegħek) minħabba li l- effett
or unwanted side effects of these medicines might be increased.
terapewtiku jew l- effetti sekondarji jistgħu jiżdiedu.
Your doctor might want to do some additional tests.
It- tabib tiegħek jista ’ jkun irid jagħmel xi testijiet addizzjonali.
- fluticasone propionate, budesonide (medicines to control asthma).
- fluticasone propionate, budesonide (mediċini li jikkontrollaw l- ażma).
Its use should only take place
Għandu jintuża biss wara
after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
evalwazzjoni medika u b’ monitoraġġ mill- qrib mit- tabib tiegħek għal effetti sekondarji tal - kortikosterojdi.
The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or unwanted side effects may be influenced when combined.
Id- dożi ta ’ mediċini oħra jista ’ jkollhom bżonn jinbidlu minħabba li kemm l- effett terapewtiku jew l - effetti sekondarji tagħhom kif ukoll dak ta ’ PREZISTA jistgħu jiġu influwenzati meta meħuda flimkien.
Tell your doctor if you take:
Għid lit- tabib tiegħek jekk tieħu: digoxin (mediċina li tikkuraw ċertu mard tal- qalb)
- ketoconazole, itraconazole, clotrimazole (medicines against fungal infections).
- ketoconazole, itraconazole, clotrimazole (mediċini kontra infezzjonijiet fungali).
should only be taken after medical evaluation.
għandu jittieħed biss wara evalwazzjoni medika.
- rifabutin (medicine against bacterial infections)
- rifabutin (mediċina kontra infezzjonijiet batterjali)
- sildenafil, vardenafil, tadalafil (medicines for erectile dysfunction)
- sildenafil, vardenafil, tadalafil (mediċini għal anormalità erettili)
- clarithromycin (antibiotic)
- clarithromycin (antibijotiku)
- paroxetine, sertraline (medicines to treat depression and anxiety)
- paroxetine, sertraline (mediċini li jikkuraw depressjoni u ansjetà)
- methadone
- methadone
- sedative agents (e.g. midazolam administered by injection)
- aġenti sedattivi (e. ż. midazolam mogħti b‘ injezzjoni)
- carbamazepine (medicine to prevent seizures or to treat certain types of nerve pain).
carbamazepine (mediċina biex tippreveni l- aċċessjonijiet jew għal trattament ta ’ ċerti tipi ta ’
Taking PREZISTA with food and drink See section 3 ‘How to take PREZISTA with food and drink.’
Meta tieħu PREZISTA ma ’ l- ikel u max- xorb Ara sezzjoni 3 ‘ Kif għandek tieħu PREZISTA ma ’ l- ikel u max- xorb. ’
Pregnancy and breast-feeding Tell your doctor immediately if you are pregnant or if you are breast-feeding.
Tqala u treddigħ Għid lit- tabib tiegħek immedjatament jekk inti tqila jew qed tredda ’.
Pregnant or breast-feeding mothers should not take PREZISTA unless specifically directed by the doctor.
Ommijiet tqal jew li qed ireddgħu m’ għandhomx jieħdu PREZISTA sakemm ma jordnalikx speċifikament it- tabib.
It is recommended that HIV infected women should not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.
85 tiegħek tiġi nfettata bl- HIV li jgħaddi mill- ħalib tiegħek kif ukoll minħabba l- effetti mhux maghrufa tal- mediċina fuq it- tarbija tiegħek.
Driving and using machines Do not operate machines or drive if you feel dizzy after taking PREZISTA.
Sewqan u tħaddim ta ’ magni Tħaddimx magni jew issuqx jekk tħossok sturdut wara li tieħu PREZISTA.
Important information about some of the ingredients of PREZISTA PREZISTA tablets contain sunset yellow FCF (E110) which may cause allergic reactions.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ PREZISTA Il- pilloli PREZISTA fihom sunset yellow FCF (E110) li jista ’ jikkawża reazzjonijiet allerġiċi.
HOW TO TAKE PREZISTA
KIF GĦANDEK TIEĦU PREZISTA
79 Always use PREZISTA exactly as your doctor has told you.
Dejjem għandek tieħu PREZISTA skond il- parir eżatt tat- tabib.
You must check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib tiegħek jekk ikollok xi dubju.
Even if you feel better, do not stop taking PREZISTA without talking to your doctor.
Anke jekk tħossok aħjar, tieqafx tieħu PREZISTA mingħajr ma tkellem lit- tabib tiegħek.
PREZISTA is not for use in children and adolescents, as it has not been studied in patients under 18 years.
PREZISTA mhux qiegħed għall- użu fit- tfal u l- adoloxxenti minħabba li ma kienx studjat f’ pazjenti taħt it- 18- il sena.
- The usual dose of PREZISTA is two tablets twice daily.
Struzzjonijiet Id- doża ta ’ PREZISTA li s- soltu tingħata hija ta ’ żewġ pilloli kuljum.
- Take PREZISTA always together with ritonavir.
Dejjem ħu PREZISTA flimkien ma ’ ritonavir.
PREZISTA cannot work properly without
PREZISTA ma jistax jaħdem tajjeb mingħajr
- In the morning, take two 300 milligram PREZISTA tablets together with 100 milligram
Filgħodu, ħu żewġ pilloli ta ’ 300 mg PREZISTA flimkien ma ’ 100 mg ritonavir.
ritonavir.
-
- In the evening, take two 300 milligram PREZIST A tablets together with 100 milligram
Filgħaxija, ħu żewġ pilloli ta ’ 300 mg PREZISTA flimkien ma ’ 100 mg ritonavir.
riton avir.
-
- Take PREZISTA with food.
Ħu PREZISTA ma ’ l- ikel.
PREZISTA cannot work properly without food.
PREZISTA ma jistax jaħdem tajjeb mingħajr ikel.
The type of food is
It- tip ta ’ ikel
- Swallow the tablets with a drink such as water or milk.
Ibla ’ l- pilloli ma ’ xi ħaġa tax- xorb bħal ilma jew ħalib.
Removing the child resistant cap
Kif tneħħi l- għatu li ma jinfetaħx mit- tfal
The plastic bottle comes with a child resistant cap and should be opened as follows:
Il- flixkun tal- plastik jiġi b’ għatu li ma jinfetaħx mit- tfal u għandu jinfetaħ kif ġej:
Push the plastic screw cap down while turning it counter clockwise.
Agħfas l- għatu tal- plastik u bil- kamin l- isfel waqt li ddawwru n- naħa tax - xellug.
Remove the unscrewed cap.
Neħħi l- għatu miftuħ.
If you take more PREZISTA than you should Contact your doctor or pharmacist immediately.
Jekk tieħu PREZISTA aktar milli suppost Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek immedjatament.
If you forget to take PREZISTA If you notice within 6 hours, you must take the tablets immediately.
Jekk tinsa tieħu PREZISTA Jekk tinduna fi żmien 6 sigħat, inti għandek tieħu l- pilloli immedjatament.
Always take with ritonavir and food.
Dejjem ħudhom ma ’ ritonavir u ma ’ l- ikel.
If you notice after 6 hours, then skip the intake and take the next doses as usual.
Jekk tinduna wara 6 sigħat, aqbeż id- doża li tkun suppost ħadt u ħu d- dożi li jkun imiss bħas- soltu.
Do not stop using PREZISTA without talking to your doctor first HIV therapy may increase your sense of well -being.
Tieqafx tieħu PREZISTA mingħajr ma ’ l- ewwel tkellem lit- tabib tiegħek Terapija ta ’ l- HIV tista ’ ġġgħalek tħossok aktar tajjeb.
Even when you feel better, do not stop taking PREZISTA.
Anke meta tħossok aħjar, tieqafx tieħu PREZISTA.
Like all medicines, PREZISTA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, PREZISTA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always easy to identify what side effects are caused by PREZISTA, which are caused by other medicines you are taking, or which are caused by the HIV infection itself.
86 Fit- trattament ta ’ infezzjoni ta ’ l- HIV, m’ huwiex dejjem faċli li tiddentifika liema effetti sekondarji huma kkawżati minn PREZISTA, liema huma kkawżati minn mediċini oħra li qed tieħu, jew liema huma kkawżati mill- infezzjoni ta ’ l- HIV innifisha.
Very common side effects (these may affect more than 1 in 10 people)
Effetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw aktar minn pesuna waħda minn kull 10)
- diarrhoea.
- dijarea.
Common side effects (these may affect up to 1 in 10 people)
Effetti sekondarji komuni (dawn jistgħu jaffettwaw sa pesuna waħda minn kull 10)
- vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence
- rimettar, dardir, uġigħ jew nefħa fl- addome, dispepsja, gass
- headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of
- uġigħ ta ’ ras, għejja, sturdament, ngħas, titrix, tnemnim jew uġigħ fl- idejn jew fis- saqajn, telf ta ’
strength, difficulty falling asleep
saħħa, diffikultà biex torqod
- body changes associated with fat redistribution, changes in your blood tests such as cholesterol,
- tibdil fil- ġisem assoċjat ma ridistribuzzjoni tax- xaħam, tibdil fir- riżultati tiegħek tad- demm bħal
decreased appetite
kolesterol, tnaqqis fl- aptit raxx fil- ġilda, ħakk.
The rash is usually mild to moderate.
Ir- raxx ġeneralment ikun ħafif jew moderat.
A skin rash might also be a symptom of
Raxx fil- ġilda jista ’ jkun ukoll
a rare severe situation.
sintomu ta ’ sitwazzjoni serja rari.
It is therefore important to contact your doctor if you develop a rash.
Huwa għalhekk importanti li tikkuntattja lit- tabib tiegħek jekk tizviluppa raxx.
Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.
It- tabib jgħatik parir dwar kif tieħu ħsieb is- sintomi jew jekk PREZISTA għandux jitwaqqaf.
Uncommon side effects (these may affect up to 1 in 100 people)
Effetti sekondarji mhux komuni (dawn jistgħu jaffettwaw sa pesuna waħda minn kull 100)
- heart attack, chest pain, changes in electrocardiogram, rapid or slow heart beating, palpitations
- attakk tal- qalb, uġigħ fis- sider, tibdil fl- elettrokardjogram, qalb tħabbat mgħaġġel jew bil- mod,
- fainting, epileptic fits, decreased or abnormal skin sensibility, pins and needles, changes or loss
palpitazzjonijiet ħass ħażin, aċċessjonijiet tal- epilessija, sensibbilità fil- ġilda mnaqqsa jew mhux normali, tingiż
of taste, attention disturbance, loss of memory, problems with your balance
-
- difficulty breathing, cough, nosebleed, running nose, throat irritation
fil- partijiet tal- ġisem minħabba li jorqdu, tibdil jew telf tat- togħma, disturb fl- attenzjoni, telf tal - memorja, problemi bil- bilanċ
- inflammation of the pancreas, stomach, lips or mouth, mouth sores, heartburn, retching,
- diffikultà biex tieħu n- nifs, sogħla, tifġir tal- imnieħer, imnieħer inixxi, irritazzjoni fil- gerżuma
vomiting blood, dry mouth or lips, discomfort of the abdomen, constipation, belching, coated tongue
infjammazzjoni tal- frixa, l- istonku, ix- xufftejn jew il- ħalq, selħiet fil- ħalq, ħruq ta ’ stonku,
- kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of
taqligħ, rimettar ta ’ demm, ħalq jew xufftejn xotti, skonfort tal- addome, stitikezza, tifwieq, ilsien miksi falliment tal- kliewi, ġebel fil- kliewi, diffikultà biex tgħaddi l- awrina, tgħaddi l- awrina b’ mod
urine, sometimes at night
frekwenti jew eċċessiv, xi kultant bil- lejl
- urticaria, swelling of the face, eczema, excessive sweating, night sweats, hair loss, acne, dry or
- urtikarja, nefħa tal- wiċċ, ekżema, tgħereq iż- żejjed, ixoqq l- għaraq bil- lejl, jaqa ’ x- xagħar, akne,
scaly skin, coloration of nails, skin lesions
ġilda xotta jew taqa ’ qxur qxur, tbajja ’ fid- dwiefer, feriti fil- ġilda
- muscle pain, muscle cramps or weakness, stiffness of muscles or joints, joint pain with or
- uġigħ fil- muskoli, bugħawwieġ jew dgħjufija fil- muskoli, ebusija tal- muskoli jew tal- ġogi,
without inflammation, pain in extremity, osteoporosis
uġigħ fil- ġogi bl- infjammazzjoni jew mingħajrha, uġigħ fl- idejn u s- saqajn, osteoporożi
- slowing down of the thyroid gland function.
- glandola tat- tirojde taħdem aktar bil- mod.
This can be seen in a blood test.
Din tista ’ tidher f’ test tad- demm.
- diabetes, increased or decreased weight, increased appetite, increased thirst
dijabete, żieda jew telf ta ’ piż, żieda fl- aptit, żieda fl- għatx
- high blood pressure, flushing
- pressjoni għolja, fwawar
- visual disturbance, red or dry eyes
disturb fil- vista, għajnejn ħomor jew xotti
- fever, swelling of lower limbs due to fluids, malaise, chills, feeling abnormal, irritability, pain
- deni, nefħa fir- riġlejn minħabba fluwidi, telqa mingħajr sinjal ta ’ mard, tkexkix ta ’ bard, ma
- symptoms of infection, herpes simplex
- sintomi ta ’ infezzjoni, herpes simplex
- erectile dysfunction, enlargement of breasts
- abnormalità erettili, tkabbir tas- sider
- sleeping problems, sleepiness, depression, a feeling of confusion or disorientation, anxiety,
- problemi bl- irqad, xejra ta ’ ngħas, depressjoni, tħoss konfużjoni jew diżorjentament, ansjetà,
altered mood, abnormal dreams, decrease in sexual drive, restlessness
bidla fil- burdata, ħolm mhux normali, tnaqqis fil- ġibda sesswali, nuqqas ta ’ kwiet
- changes in some values of your blood cells or chemistry.
- bidla fl- istima jew fil- kimika taċ- ċelluli tad- demm tiegħek.
These can be seen in the results of
Dawn jistgħu jidhru fir- riżultati tat -
blood tests.
testijiet tad- demm.
Your doctor will explain these to you.
It- tabib jispjegalek dawn x’ hinuma.
Examples are: low white or red blood cell count, low blood platelet count, high sugar levels, high levels of insulin.
Eżempji huma: għadd baxx ta ’ ċelluli bojod jew ħomor, għadd baxx ta ’ plejtlits, livelli għolja ta’ zokkor, livelli għolja ta ’ insulina.
Some side effects are typical for anti-HIV medicines in the same family as PREZISTA.
Xi effetti sekondarji huma tipiċi għall- mediċini kontra l- HIV li jagħmlu parti mill- familja ta ’ PREZISTA.
These are:
Dawn huma: żieda taz- zokkor fid- demm u dijabete li tmur għall- agħar.
- muscle pain, tenderness or weakness.
- uġigħ, sensittività jew debulizza fil- muskoli.
On rare occasions, these muscle disorders have been
F’ okkazzjonijiet rari, dawn id- disturbi fil- muskoli
serious.
kienu serji.
- changes in body shape due to fat redistribution.
- bidla fil- forma tal- ġisem minħabba ridistribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms
Dawn jistgħu jinkludu telf
and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (buffalo hump).
ta’ xaħam mir- riġlejn, mid- dirgħajn u mill- wiċċ, żieda fix- xaħam ta ’ l- addome (taż- żaqq) u organi interni oħra, tkabbir tas- sider u ċapep ta ’ xaħam fuq wara ta ’ l- għonq (ħotba tal- buflu).
The cause and long-term health effects of these conditions are not known at this time.
87 Il- kawża ta ’ dawn il- kundizzjonijiet u l- effetti tagħhom fit- tul fuq is- saħħa m’ humiex magħrufa f’ dan iż- żmien.
HOW TO STORE PREZISTA
KIF TAĦŻEN PREZISTA
Do not use PREZISTA after the expiry date which is stated on the box and on the bottle after the letters EXP.
Tużax PREZISTA wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- flixkun wara l- ittri JIS.
PREZISTA does not require any special storage conditions.
PREZISTA m’ għandux bżonn kundizzjonijiet ta ’ ħażna speċjali.
81 Medicines should not be disposed of via waste water or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.