qanastek/EMEA-V3 huggingface dataset:
The committee noted that the benefit of Viread is based on one study of patients with high viral loads who had not received any antiviral treatment before, and studies in which Viread was added to existing HIV treatment that was not working.
Il- kumitat innota li l- benefiċċju ta ’ Viread huwa bbażat fuq studju wieħed ta ’ pazjenti b’ tagħbijiet virali għoljin li ma kienu rċevew ebda trattament anti- virali qabel, u studji li fihom Viread ġiet miżjuda mat- trattament kontra l- HIV eżistenti li ma kienx qed jaħdem.
The committee recommended that Viread be given marketing authorisation.
Il- kumitat irrikmanda li Viread tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Viread was originally authorised under “ Exceptional Circumstances”, because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament Viread kienet awtorizzata taħt “ Ċirkostanzi ta ’ Eċċezzjoni ”, minħabba li, għal raġunijiet xjentifiċi, fil- ħin ta ’ l- approvazzjoni kien hemm ftit tagħrif disponibbli.
As the company had supplied the additional information requested, the “ Exceptional Circumstances ” ended on 8 July 2005.
Minħabba li l - kumpanija tat it- tagħrif addizzjonali mitlub, iċ - “ Ċirkustanzi ta ’ Eċċezzjoni ” ntemmu fit- 8 ta ’ Lulju 2005.
Other information about Viread:
Aktar tagħrif dwar Viread:
The European Commission granted a marketing authorisation valid throughout the European Union for Viread to Gilead Sciences International Limited on 5 February 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Viread lil Gilead Sciences International Limited fil- 5 ta ’ Frar 2002.
The marketing authorisation was renewed on 5 February 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq iġġeddet fil- 5 ta ’ Frar 2007.
The full EPAR for Viread is available here.
L- EPAR sħiħ għal Viread jista ’ jinstab hawnhekk.
This summary was last updated in 03-2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ 03- 2007.
Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use
Jittieħed mill- ħalq Jittieħed mill- ħalq
bottle (HDPE) bottle (HDPE)
Flixkun (HDPE) Flixkun (HDPE)
Viread 245 mg film-coated tablets
Viread 245 mg pilloli miksija b’ rita
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate), equivalent to 300 mg of tenofovir disoproxil fumarate, or 136 mg of tenofovir.
Kull pillola miksija b’ rita fiha 245 mg ta ’ tenofovir disoproxil (bħala fumarate), ekwivalenti għal 300 mg ta ’ tenofovir disoproxil fumarate, jew 136 mg ta ’ tenofovir.
Each tablet contains 153.33 mg lactose monohydrate.
Kull pillola fiha 153. 33 mg ta ’ lactose monohydrate.
Film-coated tablet.
Pilloli miksija b’ rita.
Light blue, almond-shaped, film-coated tablets, debossed on one side with the markings “ GILEAD” and “ 4331” and on the other side with the marking “ 300”.
Pilloli miksija b’ rita, ċelesti, forma ta ’ lewża, imnaqqxa fuq naħa waħda bil- marki “ GILEAD ” u “ 4331 ” u fuq in- naħa l- oħra bil- marka “ 300 ”.
HIV-1 infection:
Infezzjoni bl- HIV- 1:
Viread is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age.
Viread huwa indikat flimkien ma ’ prodotti mediċinali oħra antiretrovirali għat - trattament ta ’ adulti li għandhom iktar minn 18- il sena infettati b’ HIV- 1.
The demonstration of benefit of Viread in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ ml, with the majority of patients having < 5,000 copies/ ml).
Id- dimostrazzjoni tal- benefiċċju ta ’ Viread f’ infezzjoni bl- HIV- 1 hija bbażata fuq riżultati ta ’ studju fuq pazjenti li qatt ma kienu ħadu din it- terapija qabel, li jinkludu pazjenti b’ ammont ta ’ viri għoli (> 100, 000 kopja/ ml) u studji li fihom Viread kien miżjud ma ’ sfond ta ’ terapija stabbli (fil- biċċa l - kbira terapija bi tliet mediċini) f’ pazjenti li kienu ttrattati qabel b’ antiretrovirali li ġarrbu ħsara viroloġika bikrija (< 10, 000 kopja/ ml, bil- maġġoranza tal- pazjenti jkollhom < 5, 000 kopja/ ml).
The choice of Viread to treat antiretroviral experienced patients with HIV-1 infection should be based on individual viral resistance testing and/ or treatment history of patients.
Id- deċiżjoni li wieħed jagħżel Viread għat- trattament ta ’ pazjenti b’ infezzjoni bl- HIV- 1 li mhux l - ewwel darba li ngħataw sustanzi antiretrovirali għandha tiġi bbażata fuq testijiet tar- reżistenza virali individwali u/ jew fuq il- passat mediku tat- trattament tal- pazjenti.
Hepatitis B infection:
Infezzjoni b’ epatite B:
Viread is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Viread hu indikat għat- trattament ta ’ epatite B kronika f’ adulti b’ mard tal- fwied kumpensat, b’ evidenza ta ’ replikazzjoni virali attiva, b’ livelli ta ’ alanine aminotransferase (ALT) fis - serum li jkunu għolja b’ mod persistenti, u b’ evidenza istoloġika ta ’ infjammazzjoni attiva u/ jew fibrożi.
This indication is based on histological, virological, biochemical and serological responses mainly in adult nucleoside-naïve patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver function.
Din l- indikazzjoni hi bbażata fuq risponsi istoloġiċi, viroloġiċi, bijokimiċi u serologiċi prinċipalment f’ pazjenti adulti, b’ epatite B kronika b’ HBeAg pożittiv u HBeAg negattiv b’ funzjoni tal- fwied kumpensata. li qatt ma ngħataw nukleosides.
Therapy should be initiated by a physician experienced in the management of HIV infection and/ or treatment of chronic hepatitis B.
It- terapija għandha tinbeda minn tabib b’ esperjenza fl- immaniġġjar ta ’ infezzjoni HIV u/ jew trattament ta ’ epatite B kronika.
In exceptional circumstances in patients having particular difficulty in swallowing, Viread can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
2 F’ ċirkostanzi eċċezzjonali f’ pazjenti li jkollhom diffikultà partikulari biex jibilgħu, Viread jista ’ jingħata wara d- disintegrazzjoni tal- pillola f’ ta ’ l- anqas 100 ml ta ’ ilma, meraq tal- larinġ jew meraq ta ’ l- għeneb.
The recommended dose for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Id- doża rakkomandata għat- trattament ta ’ l- HIV jew għat- trattament ta ’ l- epatite B kronika hija ta ’ 245 mg (pillola waħda) darba kuljum meħuda mill- ħalq ma ’ l- ikel.
The optimal duration of treatment is unknown.
L- aħjar tul tat- trattament mhux magħruf.
Treatment discontinuation may be considered as follows:
It- twaqqif tat- trattament jista ’ jkun ikkunsidrat kif ġej:
- In HBeAg positive patients without cirrhosis, treatment should be administered for at least
- F’ pazjenti b’ HBeAg pożittiv mingħajr ċirrożi, it- trattament għandu jingħata għal mill- inqas
6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
6- 12- il xahar wara li s- serokonverżjoni ta ’ HBe (tnaqqis ta ’ HBeAg u tnaqqis ta ’ DNA tal- HBV b’ osservazzjoni ta ’ anti- HBe) tkun ikkonfermata jew sakemm ikun hemm is- serokonverżjoni ta ’ HBs jew ikun hemm tnaqqis ta ’ l- effikaċja (ara sezzjoni 4. 4).
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Il- livelli ta ’ l- ALT u tad- DNA tal - HBV fis- serum għandhom ikunu evalwati regolarment wara t- twaqqif tat- trattament, biex tinstab kwalunkwe rikaduta viroloġika li sseħħ wara ċertu żmien.
- In HBeAg negative patients without cirrhosis, treatment should be administered at least until
- F’ pazjenti b’ HBeAg negattiv mingħajr ċirrożi, it- trattament għandu jingħata mill- inqas sakemm
HBs seroconversion or there is evidence of loss of efficacy.
ikun hemm serokonverżjoni tal- HBs jew ikun hemm evidenza ta ’ telf ta ’ l- effikaċja.
With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Bi trattament fit- tul għal iktar minn sentejn, hi rakkomandata evalwazzjoni mill- ġdid b’ mod regolari biex tikkonferma li t- tkomplija tat- terapija magħżula tibqa ’ tkun adattata għall- pazjent.
Viread is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.2).
Viread mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
M’ hemmx informazzjoni fuqhiex wieħed jista ’ jagħti rakkomandazzjoni għall- pazjenti ta ’ ’ l fuq minn 65 sena (ara sezzjoni 4. 4).
Tenofovir is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal dysfunction.
Tenofovir huwa eliminat permezz ta ’ tneħħija renali u l- esponimenti għal tenofovir tiżdied f’ pazjenti b’ disfunzjoni renali.
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in patients with moderate and severe renal impairment (creatinine clearance < 50 ml/ min) and long term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/ min).
Hemm dejta limitata dwar is- sigurtà u l- effikaċja ta ’ tenofovir disoproxil fumarate f’ pazjenti b’ indeboliment renali moderat u sever (tneħħija tal- krejatinina ta ’ < 50 ml/ min) u dejta dwar is- sigurtà fuq tul ta ’ żmien ma kinitx evalwata għal indeboliment renali ħafif (tneħħija tal- krejatinina ta ’ 50- 80 ml/ min).
Therefore, in patients with renal impairment tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Għalhekk, f’ pazjenti b’ indeboliment renali, tenofovir disoproxil fumarate għandu jintuża biss jekk il- benefiċċji potenzjali tat- trattament jkunu kkunsidrati li jiżbqu r- riskji potenzjali.
Dose interval adjustments are recommended for patients with creatinine clearance < 50 ml/ min.
Aġġustamenti ta ’ l- intervall tad- doża huma rakkomandati għal pazjenti bi tneħħija tal- krejatinina ta ’ < 50 ml/ min.
Limited data from clinical studies support once daily dosing of tenofovir disoproxil fumarate in patients with mild renal impairment.
Informazzjoni limitata minn studji kliniċi jissapportjaw dożaġġ ta ’ darba kuljum ta ’ tenofovir disoproxil fumarate f’ pazjenti b’ indeboliment renali ħafif.
Administration of 245 mg tenofovir disoproxil (as fumarate) every 48 hours is recommended based on modelling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
L- għoti ta ’ 245 mg ta ’ tenofovir disoproxil (bħala fumarate) kull 48 siegħa hu rakkomandat ibbażat fuq l- immudellar ta ’ tagħrif farmakokinetiku ta ’ doża waħda f’ individwi li ma kienux infettati bl- HIV u dawk li ma kienux infettati bl- HBV b’ livelli differenti ta ’ indeboliment renali, li jinkludu mard renali fl- aħħar stadju li jeħtieġu d- dijaliżi tad- demm, iżda ma kienx ikkonfermat fl- istudji kliniċi.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see sections 4.4 and 5.2).
Għalhekk, ir- rispons kliniku għat- trattament u l- funzjoni renali għandhom ikunu mmonitorjati, mill- qrib f’ dawn il- pazjenti (ara sezzjonijiet 4. 4 u 5. 2).
Severe renal impairment (creatinine clearance < 30 ml/ min) and haemodialysis patients:
Indeboliment renali sever (tneħħija tal- krejatinina ta ’ < 30 ml/ min) u pazjenti fuq id- dijaliżi tad- demm:
Adequate dose adjustments cannot be applied due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Aġġustamenti fid- doża adegwati ma jistgħux ikunu applikati minħabba nuqqas ta ’ qawwiet alternattivi tal- pilloli, u għalhekk l- użu f’ dan il- grupp ta ’ pazjenti mhuwiex rakkomandat.
If no alternative treatment is available, prolonged dose intervals may be used as follows:
Jekk l- ebda trattament alternattiv ma jkun disponibbli, intervalli mtawla tad- doża jistgħu jintużaw kif ġej:
Severe renal impairment:
Indeboliment renali sever:
245 mg tenofovir disoproxil (as fumarate) may be administered every 72-96 hours (dosing twice a week).
245 mg ta ’ tenofovir disoproxil (bħala fumarate) jistgħu jingħataw kull 72- 96 siegħa (dożaġġ darbtejn fil- ġimgħa).
Haemodialysis patients:
3 Pazjenti fuq id- dijaliżi tad- demm:
245 mg tenofovir disoproxil (as fumarate) may be administered every 7 days following completion of a haemodialysis session*.
245 mg ta ’ tenofovir disoproxil (bħala fumarate) jistgħu jingħataw kull 7 ijiem wara t- tlestija ta ’ sessjoni ta ’ dijaliżi tad- demm *.
These dose adjustments have not been confirmed in clinical studies.
Dawn l- aġġustamenti fid- doża ma kinux ikkonfermati fl- istudji kliniċi.
Simulations suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
Is- simulazzjonijiet jissuġġerixxu li intervall tad- doża mtawwal mhuwiex l- aħjar għażla, u jista ’ jirriżulta f’ żieda fit - tossiċità u possibbilment f’ rispons inadegwat.
Therefore clinical response to treatment and renal function should be closely monitored (see sections 4.4 and 5.2).
Għalhekk, ir- rispons kliniku għat- trattament u l- funzjoni renali għandhom ikunu mmonitorjati mill- qrib (ara sezzjonijiet 4. 4 u 5. 2).
3 * Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
* Ġeneralment, dożaġġ darba f’ ġimgħa jekk wieħed jassumi li qed jittieħdu tliet sessjonijiet ta ’ dijaliżi tad- demm kull ġimgħa, kull waħda ta ’ madwar 4 siegħat jew wara 12- il siegħa ta ’ dijaliżi tad- demm kumulattiva.
No dosing recommendations can be given for non-haemodialysis patients with creatinine clearance < 10 ml/ min.
L- ebda rakkomandazzjonijiet dwar id- dożaġġ ma jistgħu jingħataw għal pazjenti li ma kienux qegħdin fuq dijaliżi tad- demm bi tneħħija tal- krejatinina ta ’ < 10 ml/ min.
No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
L- ebda aġġustament fid- doża mhu meħtieġ f’ pazjenti b’ indeboliment tal- fwied (ara sezzjonijiet 4. 4 u 5. 2).
If Viread is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Jekk Viread jitwaqqaf f’ pazjenti b’ epatite B kronika infettati wkoll bl- HIV jew mingħajrha, dawn il - pazjenti għandhom ikunu immonitorjati mill- qrib għal evidenza jekk l- epatite tmur għall- agħar (ara sezzjoni 4. 4).
Tenofovir disoproxil fumarate has not been studied in patients under the age of 18 or in patients over the age of 65.
Tenofovir disoproxil fumarate ma ġiex studjat f’ pazjenti taħt it- 18- il sena jew f’ pazjenti li jkollhom iktar minn 65 sena.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with tenofovir disoproxil fumarate (see below).
Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal- funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it - trattament b’ tenofovir disoproxil fumarate (ara hawn taħt).
HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir disoproxil fumarate therapy (see below Co-infection with HIV-1 and hepatitis B).
L- ittestjar għall- antikorpi ta ’ l- HIV għandu jkun offrut lill- pazjenti kollha infettati bl- HBV qabel ma tinbeda t- terapija b’ tenofovir disoproxil fumarate (ara hawn taħt Ko- infezzjoni bl- HIV- 1 u epatite B).
Patients must be advised that tenofovir disoproxil fumarate has not been proven to prevent the risk of transmission of HIV or HBV to others through sexual contact or contamination with blood.
Il- pazjenti għandhom jiġu avżati li tenofovir disoproxil fumarate, ma kienx ippruvat li jelimina r- riskju ta ’ trasmissjoni ta ’ HIV jew HBV lil ħaddieħor minn kuntatt sesswali jew tniġġiż tad- demm.
Viread contains lactose monohydrate.
Viread fih lactose monohydrate.
Co-administration of other medicinal products:
L- għoti flimkien ma ’ prodotti mediċinali oħra:
- Viread should not be administered with any other medicinal products containing tenofovir
- Viread m’ għandux jingħata flimkien ma ’ prodotti mediċinali oħrajn li fihom tenofovir
disoproxil fumarate (Truvada or Atripla).
disoproxil fumarate (Truvada jew Atripla).
- Viread should also not be administered concurrently with adefovir dipivoxil.
- Viread ukoll m’ għandux jingħata fl- istess ħin ma ’ adefovir dipivoxil.
- Co-administration of tenofovir disoproxil fumarate and didanosine is not recommended.
L- għoti
Co-administration of tenofovir disoproxil fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse events (see section 4.5).
ta ’ tenofovir disoproxil fumarate flimkien ma ’ didanosine jirriżulta f’ żieda ta ’ 40- 60% fl - esponiment sistemiku għad- didanosine, li jista ’ jżid ir- riskju ta ’ effetti avversi relatati ma ’ didanosine (ara sezzjoni 4. 5).
Co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i. e. active) didanosine.
L- għoti flimkien ta ’ tenofovir disoproxil fumarate u didanosine f’ doża ta ’ 400 mg kuljum kien assoċjat ma ’ tnaqqis sinifikanti fl- għadd taċ- ċelluli CD4, possibbilment minħabba interazzjoni intraċellulari li żiedet didanosine fosforilat (jiġifieri attiv).
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Dożaġġ imnaqqas ta ’ 250 mg ta ’ didanosine mogħti flimkien ma ’ terapija b’ tenofovir disoproxil
Triple therapy with nucleosides/ nucleotides:
Terapija tripla ma ’ nukleosides/ nukleotides:
There have been reports of a high rate of virological failure and of emergence of resistance at early stage in HIV patients when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Kien hemm rapporti ta ’ rata għolja ta ’ ħsara viroloġika, u ta ’ reżistenza li titfaċċa, li seħħew it- tnejn li huma fi stadju bikri f’ pazjenti bl- HIV, meta tenofovir disoproxil fumarate ngħata flimkien ma ’ lamivudine u abacavir, kif ukoll ma ’ lamivudine u didanosine bħala kors ta ’ għoti ta ’ darba kuljum.
Tenofovir is principally eliminated via the kidney.
Tenofovir huwa eliminat prinċipalment mill- kliewi.
Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice (see section 4.8).
Kollass renali, indeboliment renali, krejatinina għolja, ipofosfatimja u tubulopatija prossimali (inkluż is- sindromu ta ’ Fanconi) kienu rrappurtati bl- użu ta ’ tenofovir disoproxil fumarate fl- użu kliniku (ara sezzjoni 4. 8).
4 Renal safety with tenofovir has only been studied to a very limited degree in patients with impaired renal function (CrCl < 80 ml/ min).
Is- sigurtà renali b’ tenofovir kienet studjata biss b’ mod limitat ħafna f’ pazjenti b’ indeboliment fil - funzjoni tal- kliewi (CrCl < 80 ml/ min).
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with tenofovir disoproxil fumarate and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year, and then every three months.
Hu rakkomandat li t- tneħħija tal- krejatinina tkun ikkalkulata fil- pazjenti kollha qabel ma tinbeda t - terapija b’ tenofovir disoproxil fumarate u l- funzjoni renali (tneħħija tal- krejatinina u phosphate fis - serum) tkun wkoll immonitorjata kull erba ’ ġimgħat matul l- ewwel sena, u mbagħad kull tliet xhur.
Patients with creatinine clearance < 50 ml/ min, including haemodialysis patients:
Pazjenti bi tneħħija tal- krejatinina ta ’ < 50 ml/ min, li jinkludu pazjenti fuq id- dijaliżi tad- demm:
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in patients with impaired renal function.
Hemm dejta limitata dwar is- sigurtà u l- effikaċja ta ’ tenofovir disoproxil fumarate f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi.
Therefore, tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Għalhekk, tenofovir disoproxil fumarate għandu jintuża biss jekk il- benefiċċji potenzjali tat- trattament ikunu kkunsidrati li jiżbqu r- riskji potenzjali.
In patients with severe renal impairment (creatinine clearance < 30 ml/ min) use of tenofovir is not recommended.
F’ pazjenti b’ indeboliment sever fil- funzjoni tal- kliewi (tneħħija tal- krejatinina ta ’ < 30 ml/ min), l- użu ta ’ tenofovir mhuwiex rakkomandat.
If no alternative treatment is available, the dosing interval must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
Jekk l- ebda trattament alternattiv ma jkun disponibbli, l- intervall tad- dożaġġ għandu jkun aġġustat u l- funzjoni renali għandha tkun immonitorjata mill- qrib (ara sezzjonijiet 4. 2 u 5. 2).
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving tenofovir disoproxil fumarate, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Jekk il- phosphate fis- serum huwa < 1. 5 mg/ dl (0. 48 mmol/ l) jew it- tneħħija tal- krejatinina tonqos għal < 50 ml/ min, fi kwalunkwe pazjent li qed jirċievi tenofovir disoproxil fumarate, il- funzjoni renali għandha tkun evalwata mill- ġdid fi żmien ġimgħa, inkluż il- kejl tal- konċentrazzjonijiet tal- glucose fid - demm, tal- potassium fid- demm u tal- glucose fl- awrina (ara sezzjoni 4. 8, tubulopatija prossimali).
Consideration should also be given to interrupting treatment with tenofovir disoproxil fumarate in patients with creatinine clearance decreased to < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
Konsiderazzjoni għandha tingħata wkoll għall- waqfien tat- trattament b’ tenofovir disoproxil fumarate f’ pazjenti bi tneħħija tal- krejatinina mnaqqsa għal < 50 ml/ min jew tnaqqis tal- phosphate fis- serum għal < 1. 0 mg/ dl (0. 32 mmol/ l).
Use of tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product (e. g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2).
L- użu ta ’ tenofovir disoproxil fumarate flimkien ma ’ jew fi żmien qasir minn meta jkun ittieħed prodott mediċinali nefrotossiku (eż. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir jew interleukin- 2) għandu jiġi evitat.
If concomitant use of tenofovir disoproxil fumarate and nephrotoxic agents is unavoidable, renal function should be monitored weekly.
Jekk l- użu konkomitanti ta ’ tenofovir disoproxil fumarate u ta ’ sustanzi nefrotossiċi ma jistax jkun evitat, il- funzjoni renali għandha tkun immonitorjata ta ’ kull ġimgħa.
Tenofovir disoproxil fumarate has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e. g. cidofovir, a known nephrotoxic medicinal product).
Tenofovir disoproxil fumarate ma ġiex klinikament evalwat f’ pazjenti li kienu qed jirċievu prodotti mediċinali li huma mnixxija mill- istess passaġġ renali, li jinkludi t- trasportatur enajoniku organiku uman (hOAT) tal- proteini tat- trasport 1 u 3 jew MRP 4 (eż. cidofovir, prodott mediċinali nefrotossiku magħruf).
These renal transport proteins may be responsible for tubular secretion and in part, renal elimination of tenofovir and cidofovir.
Dawn il- proteini tat- trasportatur renali jistgħu jkunu responsabbli għas- sekrezzjoni tubulari u parzjalment, għall- eliminazzjoni ta ’ tenofovir u cidofovir mill- kliewi.
Consequently, the pharmacokinetics of these medicinal products which are secreted by the same renal pathway including transport proteins hOAT 1 and 3 or MRP 4 might be modified if they are co-administered.
Għalhekk, il- farmakokinetiċi ta ’ dawn il- prodotti mediċinali li huma mnixxija mill- istess passaġġ renali, li jinkludu l- proteini tat - trasport hOAT 1 u 3 jew MRP 4, jistghu jkunu mibdula jekk ikunu mogħtija flimkien.
Unless clearly necessary, concomitant use of these medicinal products which are secreted by the same renal pathway is not recommended, but if such use is unavoidable, renal function should be monitored weekly (see section 4.5).
Sakemm ma jkunx neċessarju b’ mod ċar, l- użu konkomitanti ta ’ dawn il- prodotti mediċinali li huma mnixxija mill - istess passaġġ renali, mhux irrakkomandat, iżda jekk dan l- użu ma jistax ikun evitat, il- funzjoni renali għandha tkun immonitorjata kull ġimgħa (ara sezzjoni 4. 5).
Bone effects:
5 Effetti fuq l- għadam:
In HIV infected patients, in a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Fi pazjenti infettati bl- HIV, fi studju kliniku kkontrollat ta ’ 144 ġimgħa fejn tqabblu tenofovir disoproxil fumarate ma ’ stavudine mogħti flimkien ma ’ lamivudine u efavirenz f’ pazjenti li qatt ma ’ kienu ngħataw mediċini antiretrovirali qabel, tnaqqis żgħir fid- densità minerali ta ’ l- għadam tal- ġenbejn u tas- sinsla tad- dahar kienu osservati fiż- żewġ gruppi tat- trattament.
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
Tnaqqis fid- densità minerali ta ’ l- għadam tas- sinsla tad- dahar u tibdil fil- bijomarkaturi mil- linja bażi kienu ogħla b’ mod sinifikanti fil- grupp tat- trattament ta ’ tenofovir disoproxil fumarate fil- 144 ġimgħa.
However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Madankollu, ma kienx hemm riskju akbar ta ’ ksur jew evidenza ta ’ anormalitajiet fl - għadam klinikament rilevanti matul 144 ġimgħa.
The safety of tenofovir in patients with decompensated liver disease is being studied.
Is- sigurtà ta ’ tenofovir f’ pazjenti b’ mard tal- fwied mhux kumpensat qed tiġi studjata.
At present the safety in this patient population has not been thoroughly evaluated.
Bħalissa, is- sigurtà f’ din il- popolazzjoni ta ’ pazjenti għadha ma ġietx evalwata bir- reqqa.
No safety and efficacy data are available in liver transplant patients.
L- ebda dejta dwar is- sigurtà u l- effikaċja mhi disponibbli f’ pazjenti li kellhom trapjant tal- fwied.
5 Exacerbations of hepatitis:
Epatite li tmur għall- agħar:
Flares on treatment:
Għall- agħar waqt it- trattament:
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT.
Epatite B kronika li tmur għall- agħar spontanjament hija relattivament komuni u kkaratterizzata minn żidiet temporanji fl- ALT tas- serum.
After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Wara li tinbeda terapija antivirali, l- ALT tas- serum jista ’ jiżdied f’ xi pazjenti hekk kif il- livelli tad- DNA tal- HBV fis - serum jonqsu (ara sezzjoni 4. 8).
Among tenofovir-treated patients on-treatment exacerbations typically occurred after 4-8 weeks of therapy.
Fost il- pazjenti ttrattati b’ tenofovir, l- epatite marret għall- agħar waqt it- trattament tipikament wara 4- 8 ġimgħat ta ’ terapija.
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
F’ pazjenti b’ mard tal- fwied kumpensat, dawn iż- żidiet fl- ALT tas- serum ġeneralment ma jkunux akkompanjati minn żieda fil- konċentrazzjonijiet ta ’ bilirubina fis- serum jew dikumpensazzjoni epatika.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Pazjenti b’ ċirrożi jistgħu jkunu f’ riskju ogħla għal dikumpensazzjoni epatika wara li l- epatite tmur għall- agħar u għalhekk għandhom ikunu mmonitorjati mill- qrib waqt it- terapija.
Flares after treatment discontinuation:
Għall- agħar wara t- twaqqif tal- kura:
Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Epatite li tmur għall- agħar b’ mod akut kienet irrappurtata ukoll f’ pazjenti li kienu waqqfu t- terapija kontra epatite B.
Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Epatite li marret għall- agħar wara t- trattament normalment kienet assoċjata ma ’ żieda fid- DNA ta ’ l- HBV, u fil- maġġoranza tagħha dehret li hija limitata.
However, severe exacerbations, including fatalities, have been reported.
Madankollu, epatite li tmur għall- agħar b’ mod sever, li jinkludu fatalitajiet, kienet rrappurtata.
Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Il- funzjoni epatika għandha tiġi mmonitorjata mill- qrib, ripetutament, b’ eżaminazzjonijiet kliniċi u tal- laboratorju għal mill- inqas 6 xhur wara t- twaqqif tat- terapija kontra epatite B.
If appropriate, resumption of hepatitis B therapy may be warranted.
Jekk ikun xieraq, it- tkomplija mill- ġdid tat- terapija kontra epatite B tista ’ tkun meħtieġa.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
F’ pazjenti b’ mard avvanzat tal- fwied jew ċirrożi, it- twaqqif tat- trattament mhuwiex rakkomandat, għax li l- epatite tmur għall- agħar wara t- trattament jista ’ jwassal għal dikumpensazzjoni epatika.
Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Mard tal- fwied li jmur għall- agħar huwa serju b’ mod speċjali, u xi kultant ikunu fatali f’ pazjenti b’ mard tal- fwied mhux kumpensat.
Co-infection with hepatitis C or D:
Ko- infezzjoni bl- epatite Ċ jew D:
There are no data on the efficacy of tenofovir in patients co-infected with hepatitis C or D virus.
M’ hemm l- ebda dejta dwar l- effikaċja ta ’ tenofovir f’ pazjenti ko - infettati bil- virus ta ’ l- epatite Ċ jew D.
Co-infection with HIV-1 and hepatitis B:
Ko- infezzjoni bl- HIV- 1 u epatite B:
Due to the risk of development of HIV resistance, tenofovir disoproxil fumarate should only be used as part of an appropriate antiretroviral combination regimen in HIV/ HBV co-infected patients.
Minħabba r- riskju ta ’ żvilupp ta ’ reżistenza mill- HIV, tenofovir disoproxil fumarate għandu jintuża biss bħala parti minn kors ta ’ kumbinazzjoni antiretrovirali f’ pazjenti ko- infettati bl- HIV/ HBV.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti li diġà jbatu minn disfunzjoni tal- fwied li tinkludi epatite kronika attiva, għandhom żieda fil- frekwenza ta ’ anormalitajiet tal- fwied waqt it- terapija antiretrovirali kombinata u jeħtieġ li jiġu monitorjati skond il- prattika normali.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk ikun hemm xi evidenza li l- mard tal- fwied qed imur għall- agħar f’ pazjenti bħal dawn, l- interruzzjoni jew it- twaqqif tat- ttrattament għandhom ikunu kkunsidrati.
However, it should be noted that increases of ALT can be part of HBV clearance during therapy with tenofovir, see above Exacerbations of hepatitis.
Madankollu, wieħed għandu jinnota li żidiet fl- ALT jistgħu jkunu parti mit- tneħħija ta ’ l- HBV matul terapija b’ tenofovir, ara hawn fuq Epatite li tmur għall- agħar.
Lactic acidosis:
6 Aċidożi lattika:
The preclinical and clinical data suggest that the risk of occurrence of lactic acidosis, a class effect of nucleoside analogues, is low for tenofovir disoproxil fumarate.
L- informazzjoni preklinika u klinika tissuġġerixxi li r- riskju ta ’ l - okkorrenza ta ’ l- aċidożi lattika, effett klassiku ta ’ analogi tan- nukleosidi, huwa baxx għal tenofovir disoproxil fumarate.
However, as tenofovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Madankollu, peress li tenofovir huwa strutturalment konness ma ’ analogi tan - nukleosidi, dan ir- riskju ma jistax ikun eskluż.
Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Sintomi bikrija (l- iperlaktejtimja sintomatika) jinkludu sintomi diġestivi beninji (tqalligħ, rimettar u uġigħ addominali), ħass ħażin mhux speċifiku, nuqqas ta ’ aptit, tnaqqis fil- piż, sintomi respiratorji (nifs mgħaġġel jew qawwi) jew sintomi newroloġiċi (fosthom indeboliment fil- moviment).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
L- aċidożi lattika għandha mortalitá għolja u tista ’ tkun assoċjata ma ’ pankreatite, kollass tal- fwied jew tal- kliewi.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
It- trattament b’ analogi tan- nukleosidi għandu jitwaqqaf meta sseħħ l- iperlaktejtimja sintomatika u aċidożi lattika/ metabolika, epatomegalija progressiva jew meta l- livelli ta ’ aminotransferase jiżdiedu malajr.
Lipodystrophy (lipoatrophy/ lipomatosis):
Lipodistrofija (lipoatrofija/ lipomatożi):
In HIV infected patients, combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy).
F’ pazjenti infettati bl- HIV, it- terapija antiretrovirali kombinata ġiet assoċjata mar- ridistribuzzjoni tax- xaħam fil- ġisem (lipodistrofija).
The long-term consequences 6 of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- avvenimenti għandhom m’ humiex magħrufa.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Saret ipotesi dwar il- konnessjoni bejn lipomatożi vixxerali u impedituri ta ’ protease ma ’ lipoatrofija u impedituri ta ’ nukleoside reverse transcriptase.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jiġi kkunsidrat il- kejl tal - livell tal- lipidi fis- serum u glucose fid- demm fl- istat sajjem.
However, 144-week clinical data from antiretroviral-naïve HIV infected patients indicate that the risk of lipodystrophy was lower with tenofovir disoproxil fumarate than with stavudine when administered with lamivudine and efavirenz.
Madankollu, tagħrif kliniku ta ’ 144 ġimgħa minn pazjenti infettati bl- HIV li qatt ma kienu ngħataw mediċini antiretrovirali jindika li r- riskju ta ’ lipodistrofija kien inqas b’ tenofovir disoproxil fumarate milli bi stavudine meta jingħata ma ’ lamivudine u efavirenz.
In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Tipikament, reazzjonijiet bħal dawn kienu
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
7 osservati matul l- ewwel ftit ġimgħat jew xhur mill- bidu tat- terapija antiretrovirali kombinata.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis jiroveci pneumonia.
Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/ jew fokali, u pulmonite tat- tip Pneumocystis jiroveci.
Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450 mediated interactions involving tenofovir with other medicinal products is low.
Ibbażat fuq riżultati ta ’ esperimenti in vitro u r- rotta ta ’ l- eliminazzjoni magħrufa ta ’ tenofovir, il - potenzjal għall- interazzjoni medjata minn CYP450 li tinvolvi tenofovir ma ’ prodotti mediċiali oħra hija baxxa.
Concomitant use not recommended:
L- użu fl- istess ħin mhuwiex rakkomandat:
Viread should not be administered with any other medicinal products containing tenofovir disoproxil fumarate (Truvada or Atripla).
Viread m’ għandux jingħata ma ’ kwalunkwe prodotti mediċinali oħrajn li fihom tenofovir disoproxil fumarate (Truvada jew Atripla).
Viread should also not be administered concurrently with adefovir dipivoxil.
Viread ukoll m’ għandux jingħata fl- istess ħin ma ’ adefovir dipivoxil.
Co-administration of tenofovir disoproxil fumarate and didanosine is not recommended (see section 4.4 and Table 1).
L- għoti flimkien ta ’ tenofovir disoproxil fumarate u didanosine mhuwiex rakkomandat (ara sezzjoni 4. 4 u Tabella 1).
7 Renally eliminated medicinal products:
Prodotti mediċinali eliminati mill- kliewi:
Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil fumarate with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, hOAT 3 or MRP 4 (e. g. cidofovir) may increase serum concentrations of tenofovir and/ or the co-administered medicinal products.
Minħabba li tenofovir hu primarjament eliminat mill- kliewi, l- għoti flimkien ta ’ tenofovir disoproxil fumarate ma ’ prodotti mediċinali li jnaqqsu l- funzjoni tal - kliewi jew jikkompetu għas- sekrezzjoni tubulari permezz tal- proteini tat- trasport hOAT 1, hOAT 3 jew MRP 4 (eż. cidofovir) jistgħu jżidu l- konċentrazzjonijiet fis- serum ta ’ tenofovir u/ jew il- prodotti mediċinali li jingħataw flimkien.
Use of tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
L- użu ta ’ tenofovir disoproxil fumarate flimkien ma ’ jew fi żmien qasir minn meta jkun ittieħed prodott mediċinali nefrotossiku għandu jiġi evitat.
Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (see section 4.4).
Xi eżempji jinkludu, iżda mhumiex limitati għal, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir jew interleukin- 2 (ara sezzjoni 4. 4).
Given that tacrolimus can affect renal function, close monitoring is recommended when it is co-administered with tenofovir disoproxil fumarate.
Billi tacrolimus jista ’ jaffettwa l- funzjoni renali, monitoraġġ mill- qrib tad- doża hu rakkomandat meta jingħata flimkien ma ’ tenofovir disoproxil fumarate.
Other interactions:
Interazzjonijiet oħra:
Interactions between tenofovir disoproxil fumarate and protease inhibitors and antiretroviral agents other than protease inhibitors are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ b. i. d.”, and once daily as “ q. d.”).
Interazzjonijiet bejn tenofovir disoproxil fumarate u impedituri ta ’ protease u mediċini antiretrovirali għajr impedituri ta ’ protease huma elenkati fit- Tabella 1 hawn taħt (żieda hija indikata b ’ “ ↑ ”, tnaqqis b ’ “ ↓ ”, ebda bidla b ’ “ ↔ ”, darbtejn kuljum b ’ “ b. i. d. ” u darba kuljum bi “ q. d. ”).
Table 1:
8 Tabella 1:
Interactions between tenofovir disoproxil fumarate and other medicinal products
Interazzjonijiet bejn tenofovir disoproxil fumarate u prodotti mediċinali oħrajn
Medicinal product by
Prodott mediċinali skond l - oqsma terapewtiċi
therapeutic areas
Rakkomandazzjoni dwar l- għoti flimkien ma ’
Mean percent change in AUC, Cmax, Cmin
Bidla perċentwali medja fl- AUC, Cmax, tenofovir disoproxil
concerning
(doża f’ milligrammi)
co-administration with tenofovir disoproxil fumarate 300 mg
fumarate 300 mg)
Atazanavir:
AUC: ↓ 25% Cmax: ↓ 28%
AUC: ↓ 25% Cmax: ↓ 28% Cmin: ↓ 26% Tenofovir:
Cmin: ↓ 26% Tenofovir:
The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
tenofovir, li jinkludu disturbi renali.
Renal function should be closely monitored (see section 4.4).
Il- funzjoni renali għandha tkun immonitorjata mill- qrib (ara sezzjoni 4. 4).
Lopinavir/ Ritonavir (400 b. i. d. / 100 b. i. d. / 300 q. d.)
Lopinavir/ Ritonavir
No significant effect on lopinavir/ ritonavir PK parameters.
L- ebda effett sinifikanti fuq il- parametri PK ta ’ lopinavir/ ritonavir.
AUC: ↑ 32% Cmax: ↔ Cmin: ↑ 51%
AUC: ↑ 32% Cmax: ↔
No dose adjustment is recommended.
disturbi renali.
The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Il- funzjoni renali għandha tkun immonitorjata mill- qrib
Renal function should be closely monitored (see section 4.4).
(ara sezzjoni 4. 4).
Darunavir/ Ritonavir (300/ 100 b. i. d. / 300 q. d.) NRTIs
Darunavir/ Ritonavir
No significant effect on darunavir/ ritonavir PK parameters.
L- ebda effett sinifikanti fuq il- parametri PK ta ’ darunavir/ ritonavir.
fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse events.
L- għoti ta ’ tenofovir disoproxil fumarate flimkien ma ’ didanosine jirriżulta f’ żieda ta ’ 40- 60% fl- esponiment sistemiku għad - didanosine, li jista ’ jżid ir- riskju għal effetti avversi relatati ma ’ didanosine.
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Dożaġġ imnaqqas ta ’ 250 mg ta ’ didanosine mogħti flimkien ma ’ terapija b’ tenofovir disoproxil fumarate kien assoċjat ma ’
tenofovir disoproxil fumarate and didanosine is not recommended (see section 4.4).
Mhux rakkomandat li tenofovir disoproxil fumarate jingħata flimkien ma ’ didanosine (ara sezzjoni 4. 4).
Tenofovir disoproxil fumarate should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Tenofovir disoproxil fumarate m’ għandux jingħata fl- istess ħin ma ’ adefovir dipivoxil (ara sezzjoni 4. 4).
No clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with entecavir.
Ma kien hemm l- ebda interazzjonijiet farmakokinetiċi klinikament sinifikanti meta tenofovir disoproxil fumarate ingħata flimkien ma ’ entecavir.
Studies conducted with other medicinal products:
Studju li saru bi prodotti mediċinali oħra:
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ ethinyl oestradiol.
Ma kien hemm l- ebda interazzjonijiet farmakokinetiċi klinikament sinifikanti meta tenofovir disoproxil fumarate ingħata flimkien ma ’ emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (imsaħħaħ b’ ritonavir), methadone, ribavirin, rifampicin, tacrolimus, jew il - kontraċettiv ormonali norgestimate/ ethinyl oestradiol.
Tenofovir disoproxil fumarate must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Tenofovir disoproxil fumarate għandu jittieħed ma ’ l- ikel, għax dan isaħħaħ il- biodisponibiltà ta ’ tenofovir (ara sezzjoni 5. 2).
Pregnancy For tenofovir disoproxil fumarate limited clinical data on exposed pregnancies are available.
Tqala Għal tenofovir disoproxil fumarate hemm tagħrif kliniku limitat dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects of tenofovir disoproxil fumarate with respect to pregnancy, foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala minn tenofovir disoproxil fumarate, fuq l- iżvilupp tal- fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
Tenofovir disoproxil fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Tenofovir disoproxil fumarate għandu jintuża biss waqt it- tqala, jekk il- benefiċċju potenzjali jiġġustifika r- riskju possibbli għall- fetu uman.
Given that the potential risks to developing human foetuses are unknown, the use of tenofovir disoproxil fumarate in women of childbearing potential must be accompanied by the use of effective contraception.
Peress li r- riskji potenzjali għal feti umani li qegħdin jiżviluppaw m’ humiex magħrufa, nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt t- trattament waqt l- użu ta ’ tenofovir disoproxil fumarate.
Lactation In animal studies it has been shown that tenofovir is excreted into milk.
Treddigħ Fi studji fuq bhejjem sar magħruf li tenofovir huwa mneħħi fil- ħalib.
It is not known whether tenofovir is excreted in human milk.
Mhux magħruf jekk tenofovir joħroġx mal- ħalib tas- sider.
Therefore, it is recommended that mothers being treated with tenofovir disoproxil fumarate do not breast-feed their infants.
Għalhekk, huwa rakkomandat li ommijiet li qed jingħataw trattament b’ tenofovir disoproxil fumarate ma jreddgħux t- trabi taghħom.
9 As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Bħala regola ġenerali, huwa rakkomandat li nisa infettati bl- HIV u bl- HBV ma jreddgħux lit- trabi tagħhom sabiex jevitaw li jgħaddu HIV u HBV lit- tarbija.
However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil fumarate.
Madankollu, il- pazjenti għandhom jiġu infurmati li l- isturdament kien irrappurtat waqt it- trattament b’ tenofovir disoproxil fumarate.