qanastek/EMEA-V3 huggingface dataset:
Post-marketing experience with nelfinavir Serious and non-serious adverse reactions from post-marketing spontaneous reports (where nelfinavir was taken as the sole protease inhibitor or in combination with other antiretroviral therapy), not mentioned previously in section 4.8, for which a causal relationship to nelfinavir cannot be excluded, are summarised below.
Esperjenza ta ’ wara t- tqegħid fis- suq b’ nelfinavir Reazzjonijiet avversi serji u mhux serji minn rapporti spontanji ta ’ wara t- tqegħid fis- suq (fejn nelfinavir ittieħed bħala l- uniku inibitur ta ’ protease jew flimkien ma ’ terapija antiretrovirali oħra), mhux imsemmija qabel f’ sezzjoni 4. 8, li għalihom relazzjoni kawżali għal nelfinavir ma tistax tiġi eskluża, huma miġbura isfel.
As these data come from the spontaneous reporting system, the frequency of the adverse reactions is not confirmed.
Minħabba li dan it- tagħrif ġej mis- sistema ta ’ rappurtaġġ spontanju, il - frekwenza tar- reazzjonijiet avversi mhijiex ikkonfermata.
27 Metabolism and nutrition disorders:
28 Disturbi fil- metaboliżmu u n- nutrizzjoni:
Uncommon - rare (≥ 0.01% - ≤ 1%):
Mhux komuni - rari (≥ 0. 01% - ≤ 1%):
Pharmacotherapeutic group: direct acting antivirals, ATC code:
Kategorija farmakoterapewtika: antivirali li jaħdmu b’ mod dirett, Kodiċi ATC:
HIV protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors to the individual proteins found in infectious HIV.
Il- protease ta ’ l- HIV hija enzima meħtieġa għall- qtugħ protejolitiku tal - prekursuri tal- poliprotejini virali (proteolytic cleavage of the viral polyprotein precursors) għall - proteini individwali li jinsabu f’ HIV infettiva.
The effects of nelfinavir (alone or combined with other antiretroviral agents) on biological markers of disease activity, CD4 cell count and viral RNA, were evaluated in several studies involving HIV-1 infected patients.
30 fuq il- markaturi bijoloġiċi ta ’ l- attività tal- marda, l- għadd taċ- ċelluli CD4 u l- RNA virali, kienu evalwati f’ diversi studji li kienu jinvolvu pazjenti infettati bl- HIV- 1.
29 The efficacy of the BID regimen has been evaluated versus the TID regimen with VIRACEPT 250 mg tablets primarily in patients naïve to PIs.
L- effikaċja tal- kors BID kien evalwat kontra l- kors TID b’ pilloli VIRACEPT 250 mg primarjament f’ pazjenti ġodda għal PIs.
Proportion of patients with HIV RNA below LOQ (sensitive and ultrasensitive assays) at Week 48 Assay
Proporzjon ta ’ pazjenti b’ RNA ta ’ - HIV taħt LOQ (analiżi sensittiva u ultrasensittiva) f’ Ġimgħa 48
Viracept TID (%) 146/169 (86%)
Viracept BID (%) Viracept TID (%)
Plasma levels of nelfinavir, which is metabolised predominantly by CYP2C19 and only partially by CYP3A4, are not greatly increased by co-administration with ritonavir, and therefore co-administration of nelfinavir with low-dose ritonavir does not appear to be beneficial.
Livelli fil- plażma ta ’ nelfinavir, li jiġi mmetabolizzat primarjament minn CYP2C19 u parzjalment biss minn CYP3A4, m’ humiex miżjuda ħafna bl- għotja flimkien ma ’ ritonavir, u għalhekk l- għotja flimkien ta ’ nelfinavir ma ’ doża baxxa ta ’ ritonavir ma
Two studies have compared the safety and efficacy of nelfinavir (unboosted) with ritonavir- boosted protease inhibitors, each in combination with other antiretroviral agents.
Żewġ studji kkumparaw is- sigurtà u l- effikaċja ta ’ nelfinavir (mhux imsaħħaħ) ma ’ inibituri ta ’ protease msaħħa b’ ritonavir, kull wieħed f’ taħlita ma ’ sustanzi antiretrovirali oħra.
Study M98-863 is a randomised, double blind trial of 653 antiretroviral-naïve patients investigating lopinavir/ritonavir (400/100 mg BID n=326) compared to nelfinavir (750 mg TID n=327), each in combination with lamivudine (150 mg twice daily) and stavudine (40 mg twice daily).
Studju M98- 863 huwa prova randomised, double blind b’ 653 pazjent ġodda għal terapija antiretrovirali li nvestiga lopinavir/ ritonavir (400/ 100 mg BID n=326) mqabbel ma ’ nelfinavir (750mg TID n=327), kull wieħed f’ taħlita ma ’ lamivudine (150 mg darbtejn kuljum) u stavudine (40 mg darbtejn kuljum).
Median baseline CD4+ cell count was 232 cells/mm3
Medjan ta ’ l- għadd ta ’ ċelluli CD4+ fil- linja bażi kien ta ’ 232 ċellula/ mm3 fiż- żewġ gruppi.
The mean increase from baseline in CD4+ cell count at week 48 was 195 cells/mm3 and 207 cells/mm3 in the nelfinavir and lopinavir/ritonavir groups respectively.
Iż- żjieda medja mill- linja bażi ta ’ l - għadd taċ- ċelluli CD4+ fit- 48 ġimgħa kienet ta ’ 195 ċellula/ mm3 u 207 ċellula/ mm3 fil- gruppi b’ nelfinavir u b’ lopinavir/ ritonavir rispettivament.
Through 48 weeks of therapy, a statistically significantly higher proportion of patients in the lopinavir/ritonavir arm had HIV-1 RN A< 50 copies/ml compared to the nelfinavir arm.
Matul it- 48 ġimgħa ta ’ terapija, proporzjoni statistikament sinifikanti għola ta ’ pazjenti fil- grupp b’ lopinavir/ ritonavir kellhom RNA ta ’ HIV- 1 ta ’ < 50 kopja/ ml meta mqabbel mal- grupp b’ nelfinavir.
Study APV30002 is a randomised, open-label trial of 649 antiretroviral treatment naïve patients with advanced HIV-disease, investigating fosamprenavir/ritonavir (1400 mg/200 mg QD n=322) compared to nelfinavir (1250 mg BID n=327), each in combination with lamivudine (150 mg twice daily) and abacavir (300 mg twice daily).
Studju APV30002 huwa prova randomised, open- label b’ 649 pazjent ġodda għal terapja antiretrovirali b’ marda ta ’ l- HIV avvanzata, li nvestiga fosamprenavir/ ritonavir (1400 mg/ 200 mg QD n=322) mqabbel ma ’ nelfinavir (1250mg BID n=327), kull wieħed f’ taħlita ma ’ lamivudine (150 mg darbtejn kuljum) u abacavir (300 mg darbtejn kuljum).
Patients receiving VIRACEPT BID (n=10) achieved nelfinavir Cmax of 4.0 ± 0.8 µg/ml and morning and evening trough concentrations of 2.2 ± 1.3 µg/ml and 0.7 ± 0.4 µg/ml, respectively.
Pazjenti li kienu qed jirċievu VIRACEPT BID (n=10) laħqu s- Cmax ta ’ nelfinavir ta ’ 4. 0 ± 0. 8 µg/ ml u konċentrazzjonijiet baxxi ta ’ filgħodu u ta ’ filgħaxija ta ’ 2. 2 ±1. 3 µg/ ml u ta ’ 0. 7 ± 0. 4 µg/ ml, rispettivament.
The difference between morning and afternoon or evening trough concentrations for the TID and BID regimens was also observed in healthy volunteers who were dosed at precise 8- or 12-hour intervals.
32 nofsinhar jew ta ’ filgħaxija għall- korsijiet BID u TID kienet osservata wkoll f’ voluntiera f’ saħħithom li ngħataw id- dożaġġ f’ intervalli preċiżi ta ’ 8 jew 12- il siegħa.
The increased plasma concentrations with food were independent of fat content of the
Il- konċentrazzjonijiet tal- plażma ogħla ma ’ l- ikel kienu indipendenti mill- kontenut tax- xaħam ta ’ l - ikel.
Steady state nelfinavir AUC and Cmax were respectively 15% and 20% higher when doses followed a 800 kcal/50% fat meal compared to those following a light meal (350 kcal/33% fat), suggesting that meal content has less effect on nelfinavir exposures during multiple dosing than would be anticipated based on data from single dose studies.
L- AUC u Cmax ta ’ nelfinavir fi stat stabbli kienu 15% u 20% rispettivament għola meta d- dożi ngħataw wara ikla ta ’ 800 kcal/ 50% xaħam meta mqabbla ma ’ dawk wara ikla ħafifa (350 kcal/ 33% xaħam), biex b’ hekk jissuġġerixxu li l- kontenut ta ’ ikla għandu inqas effett fuq l- espożizzjonijiet ta ’ nelfinavir waqt dożi multipli milli tista ’ tistenna bbażat fuq tagħrif minn studji b’ doża waħda.
Administration of VIRACEPT oral powder or film-coated tablets with food at a dose of approximately 25-30 mg/kg TID achieves steady-state plasma concentrations similar to adult patients receiving 750 mg TID.
L- għoti tat- trab ta ’ VIRACEPT li jittieħed mill- ħalq jew ta ’ pilloli ma ’ l- ikel f’ doża ta ’ madwar 25- 30 mg/ kg TID laħqet konċentrazzjonijiet tal- plażma f’ kondizzjoni ta ’ stat stabbli simili għall- pazjenti adulti li kienu qed jirċievu 750 mg TID.
The Cmin, Cmax and AUC0-24 were all significantly higher with the BID regimen compared with the TID regimen.
Is- Cmin, is- Cmax u l- AUC0- 24 kienu kollha ogħla b’ mod sinifikattiv fil- kors BID meta pparagunati mal - kors TID.
A 49 %-69% increase was observed in AUC of nelfinavir in the
Il- farmakokinetiċi ta’ nelfinavir wara doża waħda ta ’ 750 mg kienu studjati f’ pazjenti b’ mard tal- fwied u f’ voluntiera f’ saħħithom.
32 hepatically impaired groups with impairment (Child-Turcotte Classes A to C) compared to the healthy group.
Żjieda ta ’ 49% - 69% kienet osservata fl- AUC ta ’ nelfinavir fi gruppi b’ mard tal- fwied (Child- Turcotte Klassijiet A sa C) meta pparagunati mal- grupp b’ saħħtu.
Each tablet contains the following excipients:
Kull pillola fiha dawn is- sustanzi mhux attivi li ġejjin:
Calcium silicate, Crospovidone, Magnesium stearate, Indigo carmine (E132) as powder.
Calcium silicate, Crospovidone, Magnesium stearate, Indigo carmine (E132) bħala trab.
Tablet coat:
Ir- rita tal- pillola:
Hypromellose, Glycerol triacetate.
Hypromellose, Glycerol triacetate.
33 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
VIRACEPT film-coated tablets are provided in HDPE plastic bottles containing either 270 or 300 tablets, fitted with HDPE child resistant closures with polyethylene liners.
Il- pilloli miksija b’ rita ta ’ VIRACEPT huma pprovduti fi fliexken tal- plastik HDPE li fihom jew 270 jew 300 pillola, u għandhom tapp reżistenti għat- tfal li fihom inforor tal- polyethylene.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet tal- pakketti kollha jkunu għall- skop kummerċjali.
MARKETING AUTHORISATION HOLDER
7. - DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
34 ANNEX II
36 ANNESS II
VIRACEPT 50 mg/g oral powder
VIRACEPT 50 mg/ g trab orali
VIRACEPT 250 mg film-coated tablets:
VIRACEPT 250 mg pilloli miksija b’ rita:
Conditions Or Restrictions Regarding Supply And Use Imposed On The Marketing Authorisation Holder
Kundizzjonijiet jew restrizzjonijiet fuq il- forniment u l- użu imposti fuq id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Summary of Product Characteristics, 4.2.)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
Conditions Or Restrictions With Regard To The Safe And Effective Use Of The Medicinal Product
Kundizzjonijiet jew restrizzjonijiet fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali
Other Conditions
Kundizzjonijiet oħra
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1, dated 30 July 2007 of the Risk Management Plan (RMP) presented in Module 1.8. 2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immaniġġjar tar- Riskju L- MAH jikkommetti li jwettaq l- attivitajiet ta ’ farmakoviġilanza ddettaljati fil- Pjan ta 'Farmakoviġilanza kif miftiehem f’ verżjoni 1, datata 30 ta ’ Lulju 2007 tal- Pjan għall- Immaniġġjar tar - Riskju (RMP) ippreżentat f’ Module 1. 8. 2 ta ’ l- Applikazzjoni għat- Tqegħid fis- Suq u kull aġġornament ta ’ l- RMP kif miftiehem mas- CHMP.
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
Barra minn hekk, RMP aġġornat għandu jkun sottomess • Meta tkun irċevuta informazzjoni ġdida li tista ’ tagħmel impatt fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskju. • F’ 60 ġurnata sa meta jrid tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
The Marketing Authorisation Holder will continue to submit 6 monthly PSURs.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq se jkompli jissottometti PSURs kull 6 xhur.
36 ANNEX III
38 ANNESS III
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Outer carton text/Bottle label text
Kliem stampat fuq il- kartuna ta ’ barra/ Kliem stampat fuq it- tikketta tal- flixkun
Viracept 50 mg/g oral powder Nelfinavir
VIRACEPT 50 mg/ g trab orali Nelfinavir
The bottle contains 144 g of oral powder.
Il- flixkun fiħ 144 g ta ’ trab orali.
Also contains sweetener aspartame (E951), sucrose palmitate, potassium, natural and artificial flavourings and other constituents.
Fih ukoll aspartame (E951) bħala sustanza li tagħti togħma ħelwa, sucrose palmitate, potassium, benna naturali u artifiċjali u kostitwenti oħra.
See the Package Leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
144 g Oral powder
144 g ta ’ Trab Orali
Oral use Read the package leaflet before use
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu
Do not reconstitute in the bottle
Tirrikostitwixxix fil- flixkun
Do not store above 30°C Store in the original container
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- pakkett oriġinali
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Viracept 250 mg film-coated tablets Nelfinavir
VIRACEPT 250 mg pilloli miksija b’ rita Nelfinavir
Each film-coated tablet contains 292.25 mg of nelfinavir mesilate, equivalent to 250 mg nelfinavir as free base.
Kull pillola miksija b’ rita fiha 292. 25 mg ta ’ nelfinavir mesilate li jikkorrispondi għal 250 mg ta ’ nelfinavir bħala bażi libera.
Also contains colourant indigocarmine (E132) and other constituents.
Fih wkoll is- sustanza li tagħti l- kulur indigocarmine (E132) u kostitwenti oħra.
270 film-coated tablets
270 pillola miksija b’ rita
Store in the original container
Aħżen fil- pakkett oriġinali
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
300 film-coated tablets
300 pillola miksija b’ rita
45 PACKAGE LEAFLET:
47 FULJETT TA ’ TAGĦRIF:
VIRACEPT 50 mg/g oral powder Nelfinavir
VIRACEPT 50 mg/ g trab orali Nelfinavir
You may need to read it again.
Jista ’ jkollok bżonn terġa taqrah
What VIRACEPT is and what it is used for 2.
X’ inhu VIRACEPT u għalxhiex jintuża 2.
Before you take VIRACEPT 3.
Qabel ma tieħu VIRACEPT 3.
How to take VIRACEPT 4.
Kif għandek tieħu VIRACEPT 4.
How to store VIRACEPT 6.
Kif taħżen VIRACEPT 6.
WHAT VIRACEPT IS AND WHAT IT IS USED FOR
X’ INHU VIRACEPT U GĦALXHIEX JINTUŻA
VIRACEPT is an antiviral agent.
VIRACEPT huwa agent antivirali.
It is a member of a class of medicinal products called protease inhibitors.
Huwa membru ta ’ klassi ta ’ prodotti mediċinali msejħin inibituri tal- protease.
It is active against the Human Immunodeficiency Virus (HIV) helping to reduce the number of HIV particles in blood.
Huwa attiv kontra l- Vajrus ta ’ l- Immunodefiċjenza Uman (HIV) u jgħin biex inaqqas in - numru tal- partiċelli ta ’ HIV fid- demm.
Your doctor has prescribed VIRACEPT for you because you have HIV infection.
It- tabib tiegħek ippreskrivielek VIRACEPT għax għandek infezzjoni ta ’ HIV.
HIV infection is a disease spread by contact with blood that contains HIV particles or by sexual contact with an infected individual.
L- infezzjoni ta ’ HIV hija marda li tinxtered b’ kuntatt ma ’ demm li fih partiċelli ta ’ HIV jew permezz ta ’ kuntatt sesswali ma ’ individwu li hu infettat.
VIRACEPT should be taken in combination with other medicines that are active against HIV.
VIRACEPT għandu jittieħed flimkien ma ’ mediċini oħra li huma attivi kontra l- HIV.
These medicines, including VIRACEPT, are called antiretroviral agents.
Dawn il - mediċini, inkluż VIRACEPT, huma msejjħa mediċini antitretrovirali.
These combinations have been shown to reduce the number of HIV particles in the blood and to increase circulating CD4 cells (the type of white blood cell that is particularly reduced in numbers by HIV, leading to an increased risk of many types of infections).
Dawn il- kumbinazzjonijiet kienu murija li jnaqqsu n- numru ta ’ partiċelli ta ’ l- HIV fid- demm u jżidu ċ- ċelluli CD4 li jkunu jiċċirkolaw (it- tip ta ’ ċelluli bojod tad- demm li l- kwantità tagħhom hija mnaqqsa b’ mod partikolari minn HIV, u b’ hekk iwasslu għal żjieda fir- riskju ta ’ ħafna tipi ta ’ infezzjonijiet).
BEFORE YOU TAKE VIRACEPT
QABEL MA TIEĦU VIRACEPT
Do not take VIRACEPT:
Tieħux VIRACEPT:
- if you are allergic to nelfinavir or to any of the other ingredients.
- jekk inti allerġiku/ a għal nelfinavir jew għal xi wieħed mill- ingredjenti oħra.
- if you take a medicine that contains any of the following: terfenadine, astemizole, cisapride,
- jekk qed tieħu mediċina li fiha xi wieħed minn dawn: terfenadine, astemizole, cisapride,
amiodarone, quinidine, pimozide, triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety), ergot derivatives (sometimes used to treat migraine), rifampicin, omeprazole or herbal preparations containing St.
amiodarone, quinidine, pimozide, triazolam, midazolam orali (mogħti mill- ħalq) (użat biex jgħinek torqod u/ jew biex itaffi l- ansjetà), derivati ta ’ ergot (xi kultant użat biex jikkuraw l - emigranja), rifampicin, omeprazole, jew preparazzjonijiet mill- ħxejjex li fihom St.
John’s wort (Hypericum perforatum).
John’ s wort (Hypericum perforatum).
Take special care with VIRACEPT:
Oqgħod attent ħafna b’ VIRACEPT:
You should know that VIRACEPT is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease.
Għandek tkun taf li VIRACEPT mhuwiex xi kura għall- infezzjoni ta ’ HIV u li int tista ’ tkompli tiżviluppa infezzjonijiet jew mard ieħor assoċjat mal- mard ta ’ HIV.
You should, therefore, remain under the care of your doctor while taking VIRACEPT.
Għalhekk int għandek tibqa ’ taħt il- kura tat- tabib tiegħek waqt li qed tieħu VIRACEPT.
46 Treatment with VIRACEPT has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
48 It- trattament b’ VIRACEPT ma kienx muri li jnaqqas ir- riskju tat- trasmissjoni ta ’ HIV lil oħrajn b’ kuntatti sesswali jew b’ kontaminazzjoni tad- demm.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
It- tqassim mill- ġdid, akkumulazzjoni jew it- telf ta ’ xaħam tal- ġisem jistgħu jseħħu f’ pazjenti li qed jirċievu terapija mħallta antiretrovirali.
Contact your doctor if you notice changes in body fat.
Kellem lit- tabib tiegħek jekk tinnota tibdil fix- xaħam tal - ġisem.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F’ xi pazjenti b’ infezzjoni ta ’ l- HIV avvanzata u b’ passat ta ’ infezzjoni opportunistika, jistgħu jseħħu sinjali u sintomi ta ’ infjammazjoni minn infezzjonijiet ta ’ qabel ftit wara li tinbeda l- kura anti- 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 jseħħu minħabba titjib fir- respons immuni tal- ġisem, li jġiegħel lill - ġisem jiġġieled l- infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
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 mill- pazjenti li qed jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam li tissejjaħ osteonekrożi (l- mewt tat- tessut ta ’ l- għadam ikkawżat minn telf fil- provvista ta ’ demm lill - 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 kombinata, l- użu ta ’ kortikoserojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem ogħla, fost l- oħrajn, jistgħu jkunu uħud mill - 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 egħbusijja, weġgħat u uġigħ fil- ġogi (speċjalment tal- ġenbejn, irkoppa u spalla) u diffikultà fil- moviment.
Consult your doctor if you have diabetes because an increase in severity of existing diabetes has been rarely reported in patients receiving protease inhibitors (see also section 4 of this leaflet).
Kellem lit- tabib tiegħek jekk għandek id- dijabete minħabba li żjieda fis- severità tad- dijabete eżistenti kienet irrappurtata b’ mod rari f’ pazjenti li rċevew inibituri tal- protease (ara wkoll sezzjoni 4 ta ’ dan il - fuljett).
Consult your doctor if you have haemophilia because there have been r are reports of increased bleeding while taking this treatment or ano ther protease inhibitor (see also section 4 of this leaflet).
Kellem lit- tabib tiegħek jekk għandek emofilja minħabba li kien hemm rapporti rari ta ’ żjieda fil- fsada waqt li qed tieħu din il- kura jew inibitur tal- protease ieħor (ara wkoll sezzjoni 4 ta dan il- fuljett).
There are not sufficient data available on patients with this condition taking VIRACEPT.
M’ hemmx informazzjoni biżżejjed fuq pazjenti b’ din il- kondizzjoni li qed jieħdu l- VIRACEPT.
Consult your doctor if you have kidney disease.
Kellem lit- tabib tiegħek jekk għandek mard tal- kliewi.
Patients with liver disease:
Pazjenti b’ mard tal- fwied:
Please speak with your doctor if you have a history of liver disease.
Jekk jogħġbok kellem lit- tabib tiegħek jekk għandek storja ta ’ mard tal- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Pazjenti b’ epatite kronika B jew C u ttrattati b’ mediċini antiretrovirali huma f’ riskju miżjud għall- effetti mhux mixtieqa serji u potenzjalment fatali tal- fwied u jista ’ jkollhom bżonn ta ’ testijiet tad- demm għall- kontroll tal - funzjoni tal- fwied.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients taking VIRACEPT must not take products containing St.
Pazjenti li qed jieħdu VIRACEPT m’ għandhomx jieħdu prodotti li fihom St.
John's wort (Hypericum perforatum) as this may result in the loss of therapeutic effect and development of resistance.
John' s wort (Hypericum perforatum) minħabba li dan jista ’ jwassal għal telf ta ’ l- effett terapewtiku u żvilupp ta ’ reżistenza.
Other medicines that cannot be taken with VIRACEPT include rifampicin (used for treating bacterial infections), terfenadine or astemizole (commonly used to treat allergy symptoms), cisapride (for heart burn or problems with the digestive system), amiodarone or quinidine (used to treat an irregular heart beat), triazolam or oral midazolam (used to relieve anxiety and/or trouble with sleeping), omeprazole (used in the treatment of gastrointestinal ulcers), ergot derivatives (used to treat migraine), and pimozide (for psychiatric problems).
Mediċini oħra li ma jistgħux jittieħdu ma ’ VIRACEPT jinkludu rifampicin (użat għall- kura ta ’ infezzjonijiet mill- batterji), terfenadine jew astemizole (użati b’ mod komuni ħafna għall- kura ta ’ sintomi allerġiċi), cisapride (għall- ħruq ta ’ stonku jew problemi fis- sistema diġestiva), amiodarone jew quinidine (użat għall- kura ta ’ taħbit tal- qalb irregolari), triazolam jew midazolam orali (użat biex itaffi l- ansjetà u/ jew problemi fl- irqad), omeprazole (użat fil- kura ta ’ ulċeri gastro- intestinali), derivati ta ’ l - ergot (użati għall- kura ta ’ l- emigranja), u pimozide (għall- problemi psikjatriċi).
VIRACEPT can be taken with most medicines that are commonly used in HIV infection but special care is needed with some of these and also with some other medicines.
VIRACEPT jista ’ jittieħed ma ’ ħafna mill- mediċini li jintużaw b’ mod komuni f’ infezzjoni ta ’ l- HIV iżda tinħtieġ attenzjoni speċjali ma ’ wħud minn dawn u wkoll ma ’ xi mediċini oħra.
This is because the actions of VIRACEPT or the other medicines can be affected if they are taken together.
Dan minħabba li l- azzjonijiet ta ’ VIRACEPT jew tal- mediċini l- oħra jistgħu jiġu affettwati jekk jittieħdu flimkien.
Consult your doctor if you are taking the following medicines.
49 Kellem lit- tabib tiegħek jekk qed tieħu l- mediċini li ġejjin.
In some cases, their use with VIRACEPT is not usually recommended.
F’ xi każijiet, l- użu tagħhom ma ’ VIRACEPT ġeneralment mhux rakkomandat.
47 rifabutin (used for treating bacterial infections), birth control pills (may not prevent pregnancy when given with VIRACEPT so other birth control methods should be used), calcium channel blockers including bepridil (for the treatment of heart conditions), immunosuppressants including tacrolimus and ciclosporin, sildenafil (for male impotence), statins (used to lower lipid levels in the blood), phenobarbital, phenytoin or carbamazepine (used in the treatment of epilepsy), methadone (used in the treatment of opiate dependence), lansoprazole and other medicines which reduce stomach acid, sedative agents (i.e. midazolam administered by injection).
F’ każijiet oħra, jista ’ jkun hemm bżomm ta ’ żjieda fis - sorveljanza u/ jew bidla fid- doża ta ’ dawn il- mediċini jew ta ’ VIRACEPT: ritonavir, indinavir, saquinavir u delavirdine (użati fil- kura ta ’ infezzjoni ta ’ l- HIV), rifabutin (użat fil- kura ta ’ infezzjonijiet mill- batterji), pilloli għall- kontroll tat- twelid (jistgħu ma jwaqqfux it- tqala meta jingħataw ma ’ VIRACEPT għalhekk għandhom jintużaw metodi ta ’ kontroll tat- twelid oħra), blokkaturi tal- kanali tal- kalċju inkluż bepridil (għal- kura ta ’ kundizzjonijiet tal- qalb), immunosoppressanti inkluż tacrolimus u ciclosporin, sildenafil (għal impotenza ta ’ l- irġiel), statins (użati biex ibaxxu l- livelli tax- xaħam fid- demm), phenobarbital, phenytoin jew carbamazepine (użati fil- kura ta ’ l- epilessija), methadone (użat fil- kura tad- dipendenza mill- opojdi), sedattivi (jiġifieri midazolam mogħti b’ injezzjoni). lansoprazole u mediċini oħra li jnaqqsu l- aċtu tal- istonku.
Severe interactions with other medicines would not be expected with the following medicines but the possibility cannot be excluded: amprenavir, efavirenz and nevirapine (used in the treatment of HIV infection); ketoconazole, itraconazole and fluconazole (used for treating fungal infections); erythromycin and clarithromycin (used for treating bacterial infections); fluoxetine, paroxetine, imipramine and amitriptyline (used in the treatment of depression), diazepam (used to relieve anxiety and/or trouble with sleeping).
Interazzjonijiet severi ma ’ mediċini oħra mhux mistennija mal- mediċini li ġejjin iżda l- possibilità ma tistax tiġi eskluża: amprenavir, efavirenz u nevirapine (użati fil- kura ta ’ infezzjoni ta ’ l- HIV); ketoconazole, itraconazole u fluconazole (użati fil- kura ta ’ infezzjonijiet mill- moffa); erythromycin u clarithromycin (użati fil- kura ta ’ infezzjonijiet mill- betterji); fluoxetine, paroxetine, imipramine u amitriptyline (użati fil- kura tad- depressjoni), diazepam (użat biex itaffi l- ansjetà u/ jew problemi biex torqod).
Taking VIRACEPT with food and drink:
Meta tieħu VIRACEPT ma ’ l- ikel u max- xorb:
To obtain the full benefit of VIRACEPT, the powder form of VIRACEPT must be taken by mouth, with a meal.
Biex tieħu l- benefiċċju kollu ta ’ VIRACEPT, il- forma tat- trab ta ’ VIRACEPT għandha tittieħed mill - ħalq, ma ’ ikla.
VIRACEPT may be mixed with water, milk, formula, soy formula, soy milk, dietary supplements, or pudding.
VIRACEPT jista ’ jitħallat ma ’ ilma, ħalib, trab tal- ħalib, trab tal- ħalib tas- sojja, ħalib tas- sojja, supplimenti tad- dieta jew pudina.
It is recommended that VIRACEPT oral powder mixed in these media be used within 6 hours.
Huwa rakkomandat li trab orali ta ’ VIRACEPT mħallat ma ’ dawn l - affarijiet għandu jintuża fi żmien 6 sigħat.
VIRACEPT should not be mixed with orange juice, apple juice, apple sauce or other liquids or foods that are acidic due to taste.
VIRACEPT m’ għandux jitħallat ma ’ meraq tal- larinġ, meraq tat- tuffieħ jew likwidi oħra jew ikel li huma aċidużi minħabba t- togħma.
Do not add water to bottles of VIRACEPT powder.
Iżżidx ilma mal - fliexken tat- trab ta ’ VIRACEPT.
Inform your doctor if you are pregnant or planning to become pregnant.
Għarraf lit- tabib tiegħek jekk inti tqila jew qed tippjana li toħroġ tqila.
You should not breast-feed while taking VIRACEPT.
M’ għandekx tredda ’ waqt li qed tieħu VIRACEPT.
VIRACEPT has no or very little effect on the ability to drive and use machines.
VIRACEPT m’ għandux effett jew għandu effett żgħir ħafna fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of VIRACEPT:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ VIRACEPT:
VIRACEPT 50 mg/g oral powder contains aspartame as a sweetening agent.
VIRACEPT 50 mg/ g trab orali fiħ aspartame bħala sustanza li tagħti togħma ħelwa.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE VIRACEPT
KIF GĦANDEK TIEĦU VIRACEPT
Always take VIRACEPT exactly as your doctor has instructed you.
Dejjem ħu VIRACEPT eżattament kif jgħidlek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are unsure.
Għandek tiċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek jekk m’ intix ċert/ a.
The usual doses are described below.
Id- dożi tas- soltu huma deskritti hawn taħt.
Please observe these instructions for use, otherwise you will not fully benefit from VIRACEPT.
Jekk jogħġbok osserva dawn l- istruzzjonijiet għall- użu, għax inkella ma tibbenefikax kif suppost minn VIRACEPT.
There are two scoops provided in the box, a white 1 gram scoop and a blue 5 gram scoop.
50 Hemm żewġ kuċċarini pprovduti fil- kaxxa, kuċċarina bajda ta ’ ġramma waħda u kuċċarina blu ta ’ 5 grammi.
You should measure out a level scoop of powder by using the handle of the second scoop to scrape off the extra powder (see picture below).
Għandek tkejjel kuċċarina minsuħa ta ’ trab u tneħħi żżejjed billi tuża l- manku tat- tieni kuċċarina (ara l- istampa isfel).
48 For those patients who are unable to take tablets:
Għal dawk il- pazjenti li ma jistgħux jieħdu l- pilloli:
For adults and children older than 13 years, the recommended dose of VIRACEPT 50 mg/g oral powder can be taken either twice a day (BID) or three times a day (TID) with the following dosage:
Għal adulti u tfal li għandhom aktar minn 13- il sena, id- doża rakkomandata ta ’ VIRACEPT 50 mg/ g trab orali tista ’ tittieħed darbtejn kuljum (BID) jew tliet darbiet kuljum (TID) bid- dożaġġ li ġej:
Dose to be taken by adults and children older than 13 years
Doża li għandha tittieħed mill- adulti u tfal akbar minn 13- il sena
Dosage regimen
Programm ta ’ dożaġġ
Total grams of Powder per dose
Total ta ’ grammi ta ’ Trab kull doża
Twice daily or
Darbtejn kuljum jew
Three times daily
Tliet darbiet kuljum
For children, aged 3 to 13 years, the recommended dose of VIRACEPT oral powder is either 50-55 mg /kg if given twice daily (BID) or 25-30 mg per kg of body weight if given three times daily (TID).
Għat- tfal b’ età minn 3 snin sa 13- il sena, id- doża rakkomandata tat- trab ta ’ VIRACEPT trab orali hija ta ’ 50- 55 mg / kg jekk mogħtija darbtejn kuljum (BID) jew ta ’ 25- 30 mg kull kg jekk mogħtija tliet darbiet kuljum (TID).
The following table shows the dose that should be given to children, if giving VIRACEPT twice daily (BID).
Il- lista li jmiss turi d- doża li għandha tingħata lit- tfal, jekk VIRACEPT jingħata darbtejn kuljum (BID).
Dose to be given two times a day to children aged 3 to 13
Doża li għandha tingħata darbtejn kuljum lit- tfal b’ età minn 3 snin sa 13- il sena
10.5 to 12 kg 12 to 14 kg 14 to 16 kg 16 to 18 kg 18 to 22 kg over 22 kg
10. 5 sa 12 kg 12 sa 14 kg 14 sa 16 kg 16 sa 18 kg 18 sa 22 kg ‘ l fuq minn 22 kg
49 The following table shows the dose that should be given to children, if giving VIRACEPT three times daily (TID).
51 Il- lista li jmiss turi d- doża li għandha tingħata lit- tfal, jekk VIRACEPT jingħata tliet darbiet kuljum (TID).
Dose to be administered three times a day to children aged 3 to 13
Doża li għandha tingħata darbtejn kuljum lit- tfal b’ età minn 3 snin sa 13- il sena
Blue Scoop 5 gram
Kuċċarina Blu 5 gram
VIRACEPT 50 mg/g oral powder may be mixed with water, milk, formula, soy formula, soy milk, dietary supplements, or pudding.
VIRACEPT trab orali għandu jittieħed mill- ħalq ma ’ ikla: ` VIRACEPT 50 mg/ g trab orali jista ’ jitħallat ma ’ l- ilma, ħalib, trab tal- ħalib, trab tal- ħalib tas- sojja, ħalib tas- sojja, supplimenti tad- dieta, jew pudina.
It is recommended that VIRACEPT 50 mg/g oral powder mixed in these media be used within 6 hours.
Huwa rakkomandat li VIRACEPT 50 mg/ g trab orali imħallat f’ dawn l- affarijiet jintuża sa 6 siegħat.
VIRACEPT 50 mg/g oral powder should not be mixed with orange juice, apple juice, apple sauce or other liquids or foods that are acidic due to taste.
VIRACEPT 50mg/ g trab orali m’ għandux jitħallat ma ’ meraq tal- larinġ, meraq tat- tuffieħ, zalza tat- tuffieħ jew likwidi u ikel ieħor li huma aċidużi minħabba t- togħma.
Do not add water to bottles of VIRACEPT 50 mg/g oral powder.
Iżżidx ilma fil- fliexken ta ’ VIRACEPT 50 mg/ g trab orali.
VIRACEPT 250 mg tablets are generally recommended for adults and older children.
Il- pilloli ta ’ 250 mg ta ’ VIRACEPT huma ġeneralment rakkomandati għal adulti u tfal kbar.
For younger children able to take tablets, VIRACEPT tablets may be administered instead of the oral powder.
Għat- tfal iżgħar li jistgħu jieħdu l- pilloli, il- pilloli ta ’ VIRACEPT jistgħu jingħataw minflok it- trab orali.
See Package Leaflet for VIRACEPT tablets.
Ara l - Fuljett ta ’ Tagħrif għall- pilloli ta ’ VIRACEPT.
If you take more VIRACEPT than you should:
Jekk tieħu aktar VIRACEPT milli suppost:
If you realise you have taken more VIRACEPT than you should have, contact your doctor right away.
Jekk tinduna li ħadt aktar VIRACEPT minn dak li kellek tieħu, ikkuntattja lit- tabib tiegħek mill - ewwel.
If you cannot reach your doctor, go to the nearest emergency room and take your VIRACEPT powder with you.
Jekk ma tkunx tista ’ tikkuntattja lit- tabib tiegħek, mur fl- eqreb taqsima ta ’ l- emergenza ta ’ l - isptar u ħu t- trab ta ’ VIRACEPT miegħek.
Among other symptoms, very large doses of VIRACEPT might cause disturbances in the heart rhythm.
Fost sintomi oħrajn, dożijiet għolja ħafna ta ’ VIRACEPT jistgħu jwasslu għal disturbi fir- ritmu tal- qalb.
If you forget to take VIRACEPT:
Jekk tinsa tieħu VIRACEPT:
Take the next dose as soon as you remember and then carry on as before.
Hu d- doża li jmiss hekk kif tiftakar u wara kompli bħal qabel.
Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal kulldoża individwali li nsejt tieħu.
If you stop taking VIRACEPT:
Jekk tieqaf tieħu VIRACEPT:
Continue to take this medicine until your doctor tells you otherwise.
Kompli ħu din il- mediċina sakemm it- tabib tiegħek jgħidlek mod ieħor.
Like all medicines, VIRACEPT can have side effects, although not everybody gets them.
Bħal mediċini kollha, VIRACEPT jista ’ jkollu effetti sekondarji għalkemm ma jidhrux fuq kulħadd.
If you experience any side effects that are not in this leaflet, please tell your doctor or pharmacist.
Jekk ikollok esperjenza ta ’ xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Also, tell your doctor if you have any severe or unusual symptoms or if any side effect that you think you may have gets worse or persists.
Għarraf lit- tabib ukoll jekk ikollok xi sintomi severi jew mhux tas- soltu jew jekk xi wieħed mill- effetti sekondarji li taħseb li għandek jiggrava jew jippersisti.
In clinical trials with VIRACEPT 250 mg tablets, either taken as 1250 mg two times daily or 750 mg three times daily, diarrhoea was the most often reported side effect (likely to occur in more than 1 in 10 patients).
Fi provi kliniċi b’ pilloli VIRACEPT 250 mg, meħuda bħala 1250 mg darbtejn kuljum jew bħala 750 mg tliet darbiet kuljum, dijarea kienet l- aktar effett sekondarju rrapportat ta ’ spiss (x’ aktarx li sseħħ f’ aktar minn 1 kull 10 pazjenti).
The most commonly reported (likely to occur in less than 1 in 10 to fewer than 1 in 100 patients) moderate or severe side effects were:
L- effetti sekondarji moderati jew severi rrapportati b’ mod l - aktar komuni (x’ aktarx li jseħħu f’ inqas minn 1 kull 10 sa inqas minn 1 kull 100 pazjent) kienu:
- diarrhoea,
- dijarea,
- wind,
- ġass,
- feeling sick,
- tħossok ma tiflaħx,
- low numbers of a particular type of white blood cell that fights infections (neutrophils),
- kwantitajiet baxxi ta ’ tip partikolari ċelluli bojod tad- demm li jiġġieled l- infezzjonijiet
- abnormal results from blood tests that measure how the liver is working and
- riżultati anormali għat- testijiet tad- demm li jkejjlu kif qed jaħdem il- fwied u
- abnormal results from a blood test that measures how muscle tissue is working.
- riżultati anormali fit- testijiet tad- demm li jkejjlu kif qed jaħdem it- tessut tal- muskoli.
Other side effects that have been experienced with VIRACEPT are described below.
Effetti sekondarji oħra esperjenzati b’ VIRACEPT huma deskritti taħt.
Uncommon (in more than one in a thousand but less than one in a hundred persons):
Mhux komuni (f’ aktar minn wieħed kull elf iżda inqas minn wieħed kull mitt pazjent):
Allergic reactions including difficulty in breathing, fever, itching, swelling of the face and skin rashes that can sometimes form blisters, being sick, inflammation of the pancreas.
Reazzjonijiet allerġiċi inkluż diffikultà biex tieħu n- nifs, deni, ħakk, nefħa fil- wiċċ u raxx tal- ġilda li xi kultant jifforma l- infafet, tħossok ma tiflaħx, infjammazzjoni tal- frixa.
Sometimes there are no symptoms of this and the problem appears only in blood tests.
Xi kultant ma jkunx hemm sintomi ta ’ din u l- problema tidher biss mit- testijiet tad- demm.
Rare (in more than one in ten thousand but less than one in a thousand persons):
Rari (f’ aktar minn wieħed kull għaxart elef iżda inqas minn wieħed kull elf pazjent):
Inflammation of the liver, sometimes with jaundice (yellowing of the skin and eyes), swelling of the belly.
Infjammazzjoni tal- fwied, xi kultant b’ suffejra (ġilda u għajnejn jisfaru), nefħa fiż- żaqq.
New onset diabetes mellitus, high blood sugar or an increase in severity of existing diabetes mellitus has been rarely reported in patients receiving protease inhibitors.
Il- bidu ġdid ta ’ dijabete mellitus, zokkor tad- demm għoli jew żjieda fis- severità ta ’ dijabete mellitus eżistenti kien irrappurtat b’ mod rari f’ pazjenti li qed jirċievu l- PIs.
In some of these the high blood sugar was severe and in some cases also associated with ketoacidosis (change in metabolite levels in the blood).
F’ xi uħud minn dawn, iz- zokkor għoli fid- demm kien sever u f’ xi każijiet kien ukoll assoċjat ma ’ ketoċidosi (tibdil fil- livelli tal - metaboliti fid- demm).
Many of these patients had additional medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or high blood sugar.
Ħafna pazjenti kellhom kondizzjonijiet mediċi addizzjonali, li xi ftit minnhom kienu jeħtieġu terapija b’ mediċini li kienu assoċjati ma ’ l- iżvilupp tad- dijabete mellitus jew ta ’ zokkor tad- demm għoli.
In patients with haemophilia type A and B (patients who have blood clotting problems), there have been rare reports of increased bleeding while taking this treatment or another protease inhibitor.
F’ pazjenti b’ emofilja tat- tip A u B (pazjenti li għandhom problemi bl- emboli) kien hemm rapporti rari ta ’ żjieda fit- telf ta’ demm waqt li qed kienu qed jieħdu dan it- trattament jew xi inibitur ieħor tal - protease.
Should this happen to you, seek immediate advice from your doctor.
Jekk dan jiġri, int għandek tikseb parir immedjat mit- tabib tiegħek.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija mħallta antiretrovirali tista ’ tikkawża tibdil fil- forma tal- ġisem minħabba t- tibdil fid - distribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms 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’).
Din jista ’ jinkludi telf ta ’ xaħam mir- riġlejn, dirgħajn u l- wiċċ, żjieda fix - xaħam fl- addome (żaqq) u f’ organi interni oħra, tkabbir tas- sider u ħotob tax- xaħam fuq in- naħa ta ’ wara ta ’ l- għonq (‘ ħotba tal- buflu ’).
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kondizzjonijiet mhumiex magħrufa bħalissa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija mħallta antiretrovirali tista ’ wkoll tikkawża żjieda fl- aċidu lattiku u fiz- zokkor fid- demm, iperlipemija (żjieda fix- xaħmijiet tad- demm) u reżistenza għall - insulina.
There have been rare reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Kien hemm rapporti rari ta ’ uġigħ fil- muskoli, sensittività jew dgħjufija, partikularment b’ terapija mħallta antiretrovirali li tinkludi l- inibituri ta’ protease u analogi ta ’ nucleoside.
On rare occasions these muscle problems have been serious causing muscle degeneration (rhabdomyolysis).
F’ okkażjonijiet rari dawn il- problemi tal- muskoli kienu serji u kkawżaw deġenerazzjoni tal- muskolu (rabdomijolosi).
About 400 children and neonates (aged from 0 to 13 years) received VIRACEPT in clinical trials.
Madwar 400 tifel/ a u trabi (b’ età minn 0 sa 13- il sena) rċevew VIRACEPT fi provi kliniċi.
The side effects seen in children and neonates are similar to those seen in adults.
L- effetti sekondarji li dehru fit- tfal u trabi huma simili għal dawk li dehru fl- adulti.
The most commonly reported side effect in children is diarrhoea.
L- effett sekondarju rrapportat b’ mod l- aktar komuni fit- tfal huwa dijarea.
The side effects only rarely resulted into having to stop taking VIRACEPT.
L- effetti sekondarji wasslu għal twaqqif tat - teħid ta ’ VIRACEPT f’ każijiet rari biss.
HOW TO STORE VIRACEPT
KIF TAĦŻEN VIRACEPT
Do not use after the expiry date stated on the label and carton.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
Do not store above 30°C.
53 Taħżinx f’ temperatura ’ l fuq minn 30oC.
What VIRACEPT contains Each gram of oral powder contains nelfinavir mesilate corresponding to 50 mg of nelfinavir.
Kull gramma ta ’ trab orali fiha nelfinavir mesilate li jikkorrispondi għal 50 mg ta ’ nelfinavir.
The other ingredients are microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hydroxypropyl methylcellulose, aspartame (E951), sucrose palmitate, and natural and artificial flavour.
Is- sustanzi l- oħra huma microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hydroxypropyl methylcellulose, aspartame (E951), sucrose palmitate, u benna naturali u artifiċjali.
Important information about some of the ingredients:
Tagħrif importanti dwar xi wħud mis- sustanzi l- oħra:
Contains a source of phenylalanine.
Fiħ sorsi ta ’ phenylalanine.
May be harmful for people with phenylketonuria.
Jista ’ jkun ta ’ ħsara għal nies b’ phenylketonuria.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium- free’.
Din il- mediċina fiha potassium, inqas minn 1 mmol (39 mg) kull doża, i. e. essenzjalment ‘ mingħajr potassium ’.
This is to be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet
Dan għandu jittieħed f’ konsiderazzjoni minn pazjenti b’ funzjoni tal- kliewi mnaqqsa jew pazjenti fuq dieta ta ’ potassium ikkontrollat.
What VIRACEPT looks like and contents of the pack:
Id- Dehra ta ’ VIRACEPT u l- kontenuti tal- pakkett:
VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child resistant closures with a polyethylene liner.
VIRACEPT 50 mg/ g trab orali jiġi pprovdut fi fliexken tal- plastik HDPE magħluqa b’ għotjien ta ’ polypropylene reżistenti għat- tfal b’ kisja ta ’ polyethylene.
Each bottle contains 144 grams of oral powder and is supplied with a 1 gram (white) and a 5 gram (blue) polypropylene scoop.
Kull flixkun fiħ 144 gramma ta ’ trab orali u huwa pprovdut b’ kuċċarina tal- polypropylene ta ’ gramma waħda (bajda) u ta ’ 5 grammi (blu).
Danmark Roche a/s Tlf: +45 - 36 39 99 99
54 Danmark Roche a/ s Tlf: +45 - 36 39 99 99
Tel: +31 (0) 348 438050
Nederland Roche Nederland B. V Tel: +31 (0) 348 438050
This leaflet was last approved in
Din fuljett kien approvat l- aħħar f ’
VIRACEPT 250 mg film-coated tablets Nelfinavir
VIRACEPT 250 pilloli miksija b’ rita Nelfinavir
- If you have further questions, please ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek
It
M’ għandekx tgħaddiha lil persuni
may harm them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What VIRACEPT is and what it is used for 2.
X’ inhu VIRACEPT u għal xhiex jintuża 2.
WHAT VIRACEPT IS AND WHAT IT IS USED FOR
X’ INHU VIRACEPT U GĦAL XHIEX JINTUŻA
VIRACEPT is an antiviral agent.
Il- VIRACEPT huwa agent antivirali.
Your doctor has prescribed VIRACEPT for you because you have HIV infection.
It- tabib tiegħek ippreskrivielek il- VIRACEPT għax għandek infezzjoni ta ’ HIV.
These combinations have been shown to reduce the number of HIV particles in the blood and to increase circulating CD4 cells (the type of white blood cell that is particularly reduced in numbers by HIV, leading to an increased risk of many types of infections).
Dawn il- kumbinazzjonijiet kienu murija li jnaqqsu n- numru ta ’ partiċelli ta ’ l- HIV fid- demm u jżidu ċ- ċelluli CD4 li jkunu jiċċirkolaw( it- tip ta ’ ċelluli bojod tad- demm li l- kwantità tagħhom hija mnaqqsa b’ mod partikolari minn HIV, u b’ hekk iwasslu għal żjieda fir- riskju ta ’ ħafna tipi ta ’ infezzjonijiet).
amiodarone, quinidine, pimozide, triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety), ergot derivatives (sometimes used to treat migraine), rifampicin, omeprazole or herbal preparations containing St.
amiodarone, quinidine, pimozide, triazolam, midazolam orali, (mogħti mill- ħalq) (użat biex jgħinek torqod u/ jew biex itaffi l- ansjetà) derivati ta ’ ergot (xi kultant użat biex jikkuraw l - emigranja), rifampicin, omeprazole, jew preparazzjonijiet mill- ħxejjex li fihom St.
54 Treatment with VIRACEPT has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
56 It- trattament b’ VIRACEPT ma kienx muri li jnaqqas ir- riskju tat- trasmissjoni ta ’ HIV lil oħrajn b’ kuntatti sesswali jew b’ kontaminazzjoni tad- demm.
There are not sufficient data available on patients with this condition taking VIRACEPT.
M’ hemmx informazzjoni biżżejjed fuq pazjenti b’ din il- kondizzjoni li qed jieħdu VIRACEPT.