qanastek/EMEA-V3 huggingface dataset:
Based on the results of these in vitro experiments and the known elimination pathways of emtricitabine, the potential for CYP450 mediated interactions involving emtricitabine with other medicinal products is low.
Ibbażat fuq dawn ir- riżultati ta ’ dawn l- esperimenti in vitro u r- rotta ta ’ l - eliminazzjoni magħrufa ta ’ emtricitabine, il- kapaċità għal interazzjonijiet medjati minn CYP450 li jinvolvu emtricitabine ma ’ prodotti mediċinali oħra, hija baxxa.
There are no clinically significant interactions when emtricitabine is co-administered with indinavir, zidovudine, stavudine, famciclovir or tenofovir disoproxil fumarate.
M’ hemmx interazzjonijiet kliniċi sinifikanti meta emtricitabine jingħata flimkien ma ’ indinavir, zidovudine, stavudine, famciclovir, jew tenofovir disoproxil fumarate.
Emtricitabine is primarily excreted via glomerular filtration and active tubular secretion.
Emtricitabine jitneħħa mill- ġisem, primarjament, permezz ta ’ filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
With the exception of famciclovir and tenofovir disoproxil fumarate, the effect of co-administration of emtricitabine with medicinal products that are excreted by the renal route, or other medicinal products known to affect renal function, has not been evaluated.
Ħlief għal famciclovir u tenofovir disoproxil fumarate, l- effett ta ’ l- għoti ta ’ emtricitabine flimkien ma ’ prodotti mediċinali li jitneħħew mill- ġisem permezz tar- rotta renali, jew prodotti mediċinali oħra magħrufa li jaffettwaw il- funzjoni renali, ma ġiex evalwat.
Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product due to competition for this elimination pathway.
L- għoti ta ’ emtricitabine flimkien ma ’ prodotti mediċinali li huma eliminati permezz ta ’ sekrezzjoni tubulari attiva tista ’ twassal għal żieda ta ’ konċentrazzjonijiet fis- serum ta ’ emtricitabine jew tal- prodott mediċinali li jkun qed jingħata miegħu minħabba kompetizzjoni għal din ir- rotta ta ’ l- eliminazzjoni.
There is no clinical experience as yet on the co-administration of cytidine analogues.
Għad m’ hemm l- ebda esperjenza klinika dwar l- għoti ta ’ analogi ta ’ cytidine.
Consequently, the use of emtricitabine in combination with lamivudine or zalcitabine for the treatment of HIV infection cannot be recommended at this time.
Konsegwentement l- użu ta ’ emtricitabine flimkien ma ’ lamivudine jew zalcitabine għat- trattament ta ’ infezzjoni bl- HIV ma ’ jistax jiġi rakkomandat bħalissa.
The safety of emtricitabine in human pregnancy has not been established.
Is- sigurtà ta ’ emtricitabine fit- tqala umana mhijiex stabbilita.
Animal studies do not indicate direct or indirect harmful effects of emtricitabine 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 ta ’ emtricitabine fuq it- tqala, fuq l- iżvilupp tal- fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
Emtricitabine should be used during pregnancy only if necessary.
Emtricitabine għandha tintuża waqt it- tqala biss jekk ikun meħtieġ.
Given that the potential risks to developing human foetuses are unknown, the use of emtricitabine in women of childbearing potential must be accompanied by the use of effective contraception.
Peress li r- riskji possibbli għal feti umani li qegħdin jiżviluppaw m’ humiex magħrufa, nisa li jistgħu joħorġu tqal għandom jużaw kontraċettiv effettiv waqt t- trattament waqt l- użu ta ’ emtricitabine.
It is not known if emtricitabine is excreted in human milk.
Mhux magħruf jekk emtricitabine joħroġx fil- ħalib tas- sider.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
6 Huwa rakkomandat li nisa infettati bl- HIV ma jreddgħux lit- trabi tagħhom taħt l- ebda ċirkustanza sabiex jevitaw it- trasmissjoni ta ’ l- HIV.
However, patients should be informed that dizziness has been reported during treatment with emtricitabine.
Madankollu il- pazjenti għandhom jiġu infurmati li l- isturdament kien irrappurtat waqt it- trattament b’ emtricitabine.
Assessment of adverse reactions is based on data from three studies in adults (n=1,479) and three paediatric studies (n=169).
L- istima ta ’ reazzjonijiet avversi hija bbażata fuq informazzjoni minn tliet studji fl- adulti (n=1, 479) u tliet studji pedjatriċi (n=169).
In the adult studies, 1,039 treatment-naïve and 440 treatment-experienced patients received emtricitabine (n=814) or comparator medicinal product (n=665) for 48 weeks in combination with other antiretroviral medicinal products.
Fl- istudji fl- adulti, 1, 039 pazjent li qatt ma kienu ħadu din it- terapija qabel u 440 pazjent esperjenzati bil- kura, irċivew emtricitabine (n=814) jew prodott mediċinali biex iqabbel (n=665) għal 48 ġimgħa flimkien ma ’ prodotti mediċinali antiretrovirali oħra.
In three paediatric studies, treatment-naïve (n=123) and treatment-experienced (n=46) paediatric patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
Fi tliet studji pedjatriċi, pazjenti pedjatriċi li kellhom minn 4 xhur sa 18- il sena, li qatt ma kienu ħadu din it- terapija qabel (n=123) u dawk esperjenzati bil- kura (n=46), kienu ttrattati b’ emtricitabine flimkien ma ’ mediċini antiretrovirali oħrajn.
6 The adverse reactions with suspected (at least possible) relationship to treatment in adults are listed below by body system organ class and absolute frequency.
Ir- reazzjonjiet avversi b’ rabta suspetta (almenu possibbli) mat- trattament fl- adulti huma elenkati hawn taħt skond il- klassi ta ’ sistema ta ’ l- organu fil- ġisem u skond il- frekwenza assoluta.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l - ewwel.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10) or uncommon (≥ 1/ 1,000, < 1/ 100).
Il- frekwenza hija deskritta bħala komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100, < 1/ 10) jew mhux komuni (≥ 1/ 1, 000, < 1/ 100).
Common: neutropenia Uncommon: anaemia
Komuni: newtropenja Mhux komuni: anemija
Common: hypertriglyceridaemia, hyperglycaemia
Komuni: ipertrigliċeridimija, ipergliċemija
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues (see section 4.4).
Aċidożi lattika, ġeneralment assoċjata ma ’ stejatożi epatika, ġiet irrappurtata bl- użu ta ’ analogi tan - nukleosidi (ara sezzjoni 4. 4).
Common: insomnia, abnormal dreams
Komuni: nuqqas ta ’ rqad, ħolm anormali
Very common: headache Common: dizziness
Komuni ħafna: uġigħ ta ’ ras Komuni: sturdament
Very common: diarrhoea, nausea Common: vomiting, abdominal pain, elevated amylase including elevated pancreatic amylase, elevated serum lipase, dyspepsia
Komuni ħafna: dijarrea, tqalligħ Komuni: rimettar, uġigħ addominali, amylase għoli li jinkludi amylase pankreatika għolja livell għoli tal- lipase fis- serum, dispepsja
Common: hyperbilirubinaemia, elevated serum aspartate aminotransferase (AST) and/ or elevated serum alanine aminotransferase (ALT)
Komuni: iperbilirubinimja, serum għoli ta ’ l- aspartate aminotransferase (AST) u/ jew serum għoli ta ’ l- alanine aminotransferase (ALT)
Common: allergic reaction, urticaria, vesiculobullous rash, pustular rash, maculopapular rash, pruritus, rash, and skin discolouration (hyper-pigmentation)
Komuni: reazzjoni allerġika, urtikarja, raxx vesikulobullożu, raxx bil- ponot, raxx makulari bl- imfafet, ħakk, raxx u tibdil fil- kulur tal- ġilda (iperpigmentazzjoni)
Musculoskeletal and connective tissue disorders:
7 Disturbi muskolu- skeltrali u tal- connective tissue:
Very common: elevated creatine kinase
Komuni ħafna: creatine kinase għolja
Common: asthenia, pain
Komuni: astenja, uġigħ
In addition to the adverse reactions reported in adults, anaemia was common and skin discolouration (hyper-pigmentation) was very common in paediatric patients.
Flimkien mar- reazzjonijiet avversi rrappurtati fl- adulti, l- anemija kienet komuni u t- tibdil fil- kulur tal - ġilda (iperpigmentazzjoni) kien komuni ħafna f’ pazjenti pedjatriċi.
The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients infected with HIV without co-infection with HBV.
Il- profil tar- reazzjoni avversa f’ pazjenti infettati wkoll bl- HBV jixbah lil dak osservat f’ pazjenti infettati bl- HIV biss mingħajr infezzjoni bl- HBV.
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Madankollu, bħalma jkun mistenni f’ dan il- grupp ta ’ pazjenti, żieda fl- AST u l- ALT seħħet iżjed ta ’ spiss milli fil- popolazzjoni ġenerali infettatata bl- HIV.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
It- terapija antiretrovirali kombinata ġiet assoċjata ma ’ anormalitajiet metaboliċi bħalma huma l- ipergliċeridimja, l- iperkolesterolimja, reżistenza għall- insulina, ipergliċemija u l- iperlaktejtimja (ara sezzjoni 4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal
It- terapija antiretrovirali kombinata ġiet assoċjata mar- ridistribuzzjoni tax- xaħam fil- ġisem (lipodistrofija) f’ pazjenti bl- HIV fosthom it- telf tax- xaħam ta ’ taħt il- ġilda tal- wiċċ u fil- partijiet periferali tal- ġisem, żieda fix- xaħam intra- addominali u vixxerali, ipertrofija tas- sider u akkumulazzjoni ta ’ xaħam dorsoċervikali (ħotba tal- buflu) (ara sezzjoni 4. 4).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
F’ pazjenti infettati bl- HIV b’ defiċjenza immuni severa fiż- żmien tal- bidu tat- terapija antiretrovirali kombinata (CART), tista ’ sseħħ reazzjoni infjammatorja għal infezzjonijiet opportunistiċi asintomatiċi jew residwali (ara sezzjoni 4. 4).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Kienu rrappurtati każijiet ta ’ osteonekrożi, partikularment f’ pazjenti li jkollhom fatturi ta ’ riskju li huma magħrufa b’ mod ġenerali, mard ta ’ l- HIV li jkun fi stadju avvanzat jew esponiment fit- tul għal terapija antiretrovirali kombinata (CART).
The frequency of this is unknown (see section 4.4).
Il- frekwenza ta ’ dan il- mard mhijiex magħrufa (ara sezzjoni 4. 4).
Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8).
(ara sezzjoni 4. 8).
If overdose occurs, the patient should be monitored for signs of toxicity and standard supportive treatment applied as necessary.
Jekk iseħħ każ ta ’ doża eċċessiva, il- pazjent għandu jiġi mmonitorjat għal sinjali ta ’ tossiċità u t - trattament ta ’ appoġġ regolari għandu jingħata kif meħtieġ.
Up to 30% of the emtricitabine dose can be removed by haemodialysis.
Sa 30% tad- doża ta ’ emtricitabine tista ’ titneħħa permezz ta ’ dijaliżi tad- demm.
It is not known whether emtricitabine can be removed by peritoneal dialysis.
Mhux magħruf jekk emtricitabine tistax titneħħa permezz ta ’ dijaliżi peritoneali.
Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code:
Impedituri ta ’ nucleoside u nucleotide reverse transcriptase, kodiċi ATC:
Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus (HBV).
Emtricitabine huwa analogu tan- nukleosidi ta ’ cytidine sintetika b’ attività li hija speċifika għall- virus ta ’ l- immunodefiċjenza uman (HIV- 1 u HIV- 2) u l- virus ta ’ l- epatitie B (HBV).
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination.
8 Emtricitabine huwa fosforilat permezz ta ’ enzimi ċellulari biex jifforma emtricitabine 5 ’ - trifosfat li tinibixxi kompetittivament ir- reverse transcriptase ta ’ l- HIV- 1 li jirriżulta fit- terminazzjoni tal- katina tad- DNA.
Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.
Emtricitabine hija impeditur dgħajjef tal- polimerat tad- DNA mammifera α, β u ε u polimerat mitokondrijali tad- DNA γ.
Emtricitabine did not exhibit cytotoxicity to peripheral blood mononuclear cells (PBMCs), established lymphocyte and monocyte-macrophage cell lines or bone marrow progenitor cells in vitro.
Emtricitabine ma jinibixxix ċitotossiċità f’ ċelluli mononukleari tad- demm periferali (peripheral blood mononuclear cells, PBMCs), f’ razza ta ’ ċelluli stabbiliti tal- limfoċiti u tal- makrofaġi monoċitiċi jew f’ ċelluli progenitriċi tal- mudullun in vitro.
There was no evidence of toxicity to mitochondria in vitro or in vivo.
Ma kienx hemm evidenza ta ’ tossiċità lill- mitokondrija in vitro jew in vivo.
The 50% inhibitory concentration (IC50) value for emtricitabine against laboratory and clinical isolates of HIV-1 was in the range of 0.0013 to 0.5 µmol/ l.
Il- valur tal- konċentrazzjoni inibitorja ta ’ 50% (IC50) ta ’ emtricitabine kontra isolates tal- laboratorju u kliniċi ta ’ l- HIV- 1 kienet fil- medda ta ’ 0. 0013 sa 0. 5 µmol/ l.
In combination studies of emtricitabine with protease inhibitors, nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
Fi studji kombinati ta ’ emtricitabine flimkien ma ’ impedituri tal- protease, impedituri ta ’ l- analogi tan - nukleosidi, nukleotidi u mhux nukleosidi tar- reverse transcriptase ta ’ l- HIV, żidiet ma ’ l- effetti sinerġistiċi ġew osservati.
Most of these combinations have not been studied in humans.
Il- biċċa l- kbira ta ’ dawn il- kumbinazzjonijiet ma ġewx studjati fil- bniedem.
When tested for activity against laboratory strains of HBV, the 50% inhibitory concentration (IC50) value for emtricitabine was in the range of 0.01 to 0.04 µmol/ l.
Meta ttestajta għall- attività kontra strejns tal- HBV tal- laboratorju, il- valur ta ’ konċentrazzjoni inibitorja ta ’ 50% (IC50) għal emtricitabine kien fil- medda ta ’ 0. 01 sa 0. 04 µmol/ l.
HIV-1 resistance to emtricitabine develops as the result of changes at codon 184 causing the methionine to be changed to a valine (an isoleucine intermediate has also been observed) of the HIV reverse transcriptase.
Ir- reżistenza ta ’ l- HIV- 1 għal emtricitabine tiżviluppa bħala riżultat ta ’ tibdil fil - kodon 184 li jikkawża li methionine tinbidel f’ valine (isoleucine intermedja ġiet osservata wkoll) ta ’ l- HIV reverse transcriptase.
This HIV-1 mutation was observed in vitro and in HIV-1 infected patients.
Din il- mutazzjoni tal- HIV- 1 ġiet osservata in vitro u f’ pazjenti infettati bl- HIV- 1.
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir,
Il- viri reżistenti għal emtricitabine kienu cross- resistant għal lamivudine, iżda żammew is- sensittività għall- impedituri ta ’ nucleoside reverse transcriptase oħra (NRTI) (zidovudine, stavudine, tenofovir, abacavir, didanosine u zalcitabine), l- impedituri ta ’ non- nucleoside reverse transcriptase kollha (NNRTI) u l- impedituri tal- protease kollha (PIs).
Viruses resistant to zidovudine, zalcitabine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50=0.002 µmol/ l to 0.08 µmol/ l).
Il- viri reżistenti għal zidovudine, zalcitabine, didanosine u l- NNRTIs żammew is- sensittività għal emtricitabine (IC50=0. 002 µmol/ l sa 0. 08 µmol/ l).
Clinical experience:
Esperjenza klinika:
Emtricitabine in combination with other antiretroviral agents, including nucleoside analogues, non-nucleoside analogues and protease inhibitors, has been shown to be effective in the treatment of HIV infection in treatment-naïve patients and treatment-experienced patients with stable virological control.
Emtricitabine kombinata ma ’ mediċini antiretrovirali oħra, fosthom analogi tan - nukleosidi, analogi mhux nukleosidi u impedituri tal- protease, uriet li hija effettiva fit- trattament ta ’ l- infezzjoni ta ’ l- HIV f’ pazjenti li qatt ma kienu ħadu din it- terapija qabel u pazjenti esperjenzati bil - kura b’ kontroll viroloġiku stabbli.
There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
M’ hemmx esperjenza ta ’ l- użu ta ’ emtricitabine f’ pazjenti li ma jkunux qed jirnexxu fil- kors kurrenti tagħhom jew li ma rnexxewx f’ diversi korsijiet.
There is no clinical experience of the use of emtricitabine in infants less than 4 months of age.
M’ hemmx esperjenza klinika ta ’ l- użu ta ’ emtricitabine fi trabi iżgħar minn 4 xhur.
In antiretroviral treatment-naïve adults, emtricitabine was significantly superior to stavudine when both medicinal products were taken in combination with didanosine and efavirenz through 48 weeks of treatment.
F’ adulti li qatt ma kienu ħadu din it- terapija antiretrovirali qabel, l- emtricitabine kienet aħjar b’ mod sinifikanti minn stavudine meta ż- żewġ prodotti kkombinati ngħataw ma ’ didanosine u efavirenz matul 48 ġimgħa ta ’ trattament.
Phenotypic analysis showed no significant changes in emtricitabine susceptibility unless the M184V/ I mutation had developed.
Analiżi fenotipika ma wriet l- ebda tibdil sinifikanti fis- suxxettibiltà għal emtricitabine sakemm ma kinetx żviluppat il- mutazzjoni M184V/ 1.
In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a protease inhibitor (PI) or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/ ml) through 48 weeks (77% emtricitabine, 82% lamivudine).
F’ adulti esperjenzati bil- kura, viroloġikament stabbli, emtricitabine kkombinata ma ’ NRTI (jew stavudine jew zidovudine) u impeditur tal- protease (PI) jew NNRTI wriet li mhijiex inferjuri għal lamivudine rigward il- proporzjon ta ’ responders (< 400 kopja/ ml) matul 48 ġimgħa (77% emtricitabine, 82% lamivudine).
Additionally, in a second study, treatment-experienced adults on a stable PI based highly active antiretroviral therapy (HAART) regimen were randomised to a once daily regimen containing emtricitabine or to continue with their PI-HAART regimen.
Ma ’ dan, fit- tieni studju, adulti esperjenzati bil- kura f’ kors ta ’ terapija antiretrovirali attiva ħafna, ibbażata fuq PI stabbli (HAART) kienu randomised għal kors ta ’ darba kuljum li fih emtricitabine, jew li jkomplu bil- kors bil- PI- HAART tagħhom.
At 48 weeks of treatment the emtricitabine-containing regimen demonstrated an equivalent proportion of patients with HIV RNA < 400 copies/ ml (94% emtricitabine versus 92%) and a greater proportion of patients with HIV RNA < 50 copies/ ml (95% emtricitabine versus 87%) compared with the patients continuing with their PI-HAART regimen.
Wara 48 ġimgħa ta ’ trattament il- kors li kien fih emtricitabine wera proporzjon ekwivalenti ta ’ pazjenti bl- RNA tal - HIV b ’ < 440 kopja/ ml (94% emtricitabine kontra 92%) u proporzjon akbar ta ’ pazjenti bl- RNA tal - HIV b ’ < 50 kopja/ ml (95% emtricitabine kontra 87%) meta mqabbel mal- pazjenti li komplew il- kors PI- HAART tagħhom.
In infants and children older than 4 months, the majority of patients achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/ ml and 77% achieved ≤ 50 copies/ ml).
Fit- trabi u fit- tfal li kellhom iktar minn 4 xhur, il- maġġoranza tal- pazjenti laħqu jew żammew soppressjoni kompleta tal- RNA tal- HIV- 1 tal- plażma matul 48 ġimgħa (89% laħqu ≤ 400 kopja/ ml u 77% laħqu ≤ 50 kopja/ ml).
5.2 Pharmacokinetic properties
9 5. 2 Tagħrif farmakokinetiku
Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Emtricitabine tiġi assorbita malajr u b’ mod estensiv wara li tittieħed mill- ħalq, bl- ogħla konċentrazzjonijiet ta ’ plażma li jintlaħqu siegħa jew sagħtejn wara d- dożaġġ.
In 20 HIV infected subjects receiving 200 mg emtricitabine daily as hard capsules, steady-state plasma emtricitabine peak concentrations (Cmax), trough concentrations (Cmin) and area under the plasma concentration time curve over a 24-hour dosing interval (AUC) were 1.8±0.7 µg/ ml, 0.09±0.07 µg/ ml and 10.0±3.1 µg·h/ ml, respectively.
F’ 20 individwu infettati bl- HIV li kienu qegħdin jieħdu 200 mg ta ’ emtricitabine kuljum f’ kapsuli iebsin, l- ogħla konċentrazzjonijiet ta ’ emtricitabine fil- plażma fissa (Cmax), konċentrazzjonijiet l- iżjed baxxi (Cmin), u l- erja taħt il- kurva tal- ħin tal- konċentrazzjonijiet tal- plażma matul interval ta ’ dożaġġ ta ’ 24 siegħa (AUC) kienu ta ’ 1. 8±0. 7 µg/ ml, 0. 09±0. 07 µg/ ml u 10. 0±3. 1 µg· h/ ml, rispettivament.
Steady-state trough plasma concentrations reached levels approximately 4-fold above the in vitro IC90 values for anti-HIV activity.
L- inqas livelli ta ’ konċentrazzjonijiet tal- plażma fissa laħqu livelli bejn wieħed u ieħor erba ’ darbiet ogħla mill - valuri IC50 in vitro għall- attività anti- HIV.
The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/ ml oral solution was estimated to be 75%.
Ir- rata tal- biodisponibiltà assoluta ta ’ emtricitabine mill- kapsuli iebsin Emtriva ta ’ 200 mg ġiet stmata li hi ta ’ 93%, u r- rata tal- biodisponibiltà mis- soluzzjoni orali Emtriva ta ’ 10 mg/ ml kienet stmata li hi ta ’ 75%.
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/ ml oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard capsules.
Fi studju pilota fit- tfal u fi studju definittiv ta ’ bijoekwivalenza fl- adulti, is- soluzzjoni orali Emtriva ta ’ 10 mg/ ml ntwera li għandha bejn wieħed u ieħor 80% tar- rata tal- biodisponibiltà tal- kapsuli iebsin Emtriva ta ’ 200 mg.
The reason for this difference is unknown.
Ir- raġuni għal din id- differenza mhijiex magħrufa.
Due to this difference in bioavailability, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule.
Minħabba din id- differenza fil - biodisponibiltà, 240 mg ta ’ emtricitabine mogħtija bħala soluzzjoni orali għandha tipprovdi livelli ta ’ plażma li jixbħu li dawk osservati wara li tingħata kapsula iebsa waħda ta ’ 200 mg.
Therefore, children who weigh at least 33 kg may take either one 200 mg hard capsule daily or the oral solution up to a maximum dose of 240 mg (24 ml), once daily.
Għalhekk, tfal li jiżnu mill- inqas 33 kg jistgħu jieħdu jew kapsula iebsa waħda ta ’ 200 mg kuljum, jew is- soluzzjoni orali, sa doża massima ta ’ 240 mg (24 ml) darba kuljum.
Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/ ml oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/ ml oral solution may be administered with or without food.
L- għoti ta ’ kapsuli iebsin ta ’ 200 mg ta ’ Emtriva flimkien ma ’ ikla b’ kontenut għoli ta ’ xaħam jew l - għoti tas- soluzzjoni orali Emtriva ta ’ 10 mg/ ml flimkien ma ’ ikla b’ kontenut baxx jew ikla b’ kontenut għoli ta ’ xaħam ma ’ kellhomx effett fuq l- esponiment sistemiku (AUC0- ∞) ta ’ emtricitabine; għalhekk il- kapsuli iebsin ta ’ Emtriva ta ’ 200 mg u soluzzjoni orali Emtriva ta ’ 10 mg/ ml jistgħu jingħataw ma ’ l- ikel jew mingħajr l- ikel.
9 Distribution:
Distribuzzjoni:
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/ ml.
It- twaħħil in vitro ta ’ emtricitabine ma ’ proteini tal- plażma umana kienet ta ’ < 4% u indipendenti mill- konċentrazzjoni fil- medda ta ’ 0. 02- 200 µg/ ml.
The mean plasma to blood concentration ratio was approximately 1.0 and the mean semen to plasma concentration ratio was approximately 4.0.
Il- konċentrazzjoni medja tar- ratio tad- demm mal- plażma kien ta ’ bejn wieħed u ieħor 1. 0 u l- medja tar- ratio fil- proporzjon ta ’ konċentrazzjoni tas- semen mal- plażma kien ta ’ bejn wieħed u ieħor 4. 0.
The apparent volume of distribution after intravenous administration of emtricitabine was 1.4±0.3 l/ kg, indicating that emtricitabine is widely distributed throughout the body to both intracellular and extracellular fluid spaces.
Il- volum apparenti ta ’ distribuzzjoni wara għoti ġol- vini ta ’ emtricitabine kien ta ’ 1. 4±0. 3 l/ kg, li jindika li emtricitabine tinfirex mal- ġisem kollu fl- ispazji fluwidi kemm dawk intraċellurlari u kemm ekstraċellulari.
Biotransformation:
Biotrasformazzjoni:
There is limited metabolism of emtricitabine.
Hemm metaboliżmu limitat ta ’ emtricitabine.
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Il- biotrasformazzjoni ta ’ emtricitabine tinkludi l- ossidazzjoni tat- thiol moiety biex tifforma 3 ’ - sulphoxide diastereomers (madwar 9% tad- doża) u l- konjugazzjoni ma ’ glucuronic acid biex tifforma 2 ’ - O- glucuronide (madwar 4% tad- doża).
Emtricitabine did not inhibit in vitro drug metabolism mediated by the following human CYP450 isoenzymes:
Emtricitabine ma impedixxix in vitro l- metaboliżmu tal- mediċina medjat bl- iżoenzimi CYP450 umani li ġejjin:
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Emtricitabine, ukoll, ma impedixxix lill- enzima uridine- 5 ’ - diphosphoglucuronyl transferase, li hija responsabbli għall- glukoronidazzjoni.
Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Emtricitabine jiġi eliminat prinċipalment mill- kliewi bl- irkupru komplet tad- doża fl- awrina (madwar 86%) u fl- ippurgar (madwar 14%).
Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Tlettax fil- mija tad- doża ta ’ emtricitabine ġiet irkuprata fl- awrina bħala liet metaboli.
The systemic clearance of emtricitabine averaged 307 ml/ min (4.03 ml/ min/ kg).
It- tneħħija sistemika ta ’ emtricitabine kienet medja ta ’ 307 ml/ min (4. 03 ml/ min/ kg).
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Wara l- għoti mill- ħalq, il- half- life ta ’ l- eliminazzjoni ta ’ emtricitabine hija ta ’ madwar ta ’ 10 sigħat.
Linearity/ non-linearity:
10 Linejarità/ non- linejarità:
The pharmacokinetics of emtricitabine are proportional to dose over the dose range of 25-200 mg following single or repeated administration.
Il- farmakokinetiċi ta ’ emtricitabine hum proporzjonali għad- doża fuq il - medda tad- dożaġġ ta ’ 25- 200 mg, wara l- għotja ta ’ darba jew ripetuta.
Intracellular pharmacokinetics:
Farmakokinetiċi intraċellulari:
In a clinical study, the intracellular half-life of emtricitabine-triphosphate in peripheral blood mononuclear cells was 39 hours.
Fi studju kliniku, il- half- life intraċellulari ta ’ emtricitabine- trifosfat f’ ċelluli mononukleari tad- demm periferali kienet ta ’ 39 siegħa.
Intracellular triphosphate levels increased with dose, but reached a plateau at doses of 200 mg or greater.
Il- livelli ta ’ trifosfat intraċellulari żdiedu mad- doża, iżda laħqu livell għoli u stabbli b’ dożi ta ’ 200 mg jew ogħla.
Adults with renal insufficiency:
Adulti b’ insuffiċjenza renali:
Pharmacokinetic parameters were determined following administration of a single dose of 200 mg emtricitabine hard capsules to 30 non-HIV infected subjects with varying degrees of renal insufficiency.
Il- parametri farmakokinetiċi kienu stabbiliti wara li ngħatat doża waħda ta ’ kapsuli iebsa ta ’ 200 mg ta ’ emtricitabine lil 30 individwu mhux infettati bl- HIV, b’ livelli varji ta ’ insuffiċjenza renali.
Subjects were grouped according to baseline creatinine clearance (> 80 ml/ min as normal function; 50-80 ml/ min as mild impairment; 30-49 ml/ min as moderate impairment; < 30 ml/ min as severe impairment; < 15 ml/ min as functionally anephric requiring haemodialysis).
L- individwi tqassmu skond il- linja bażi tat- tneħħija tal- krejatinina (> 80 ml/ min bħala funzjoni normali; 50- 80 ml/ min bħala indeboliment ħafif; 30- 49 ml/ min bħala indeboliment moderat; < 30 ml/ min bħala indeboliment sever; < 15 ml/ min bħala funzjonament anefriku li jeħtieġ l - dijaliżi tad- demm).
The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8±2.9 µg·h/ ml in subjects with normal renal function to 19.9±1.1, 25.0±5.7 and 34.0±2.1 µg·h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
L- esponiment sistemiku ta ’ emtricitabine (medja ± devjazzjoni standard) żdiedet minn 11. 8±2. 9 µg· h/ ml f’ individwi b’ funzjoni renali normali, għal 19. 9±1. 1, 25. 0±5. 7 u 34. 0±2. 1 µg· h/ ml, f’ pazjenti b’ indeboliment ħafif, moderat u sever rispettivament.
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine dosing (blood flow rate of 400 ml/ min and dialysate flow rate of approximately 600 ml/ min).
F’ pazjenti bl- ESRD fuq l- dijaliżi tad- demm, madwar 30% tad- doża ta ’ emtricitabine ġiet irkuprata fid- dijalizzat fuq 3 sigħat ta ’ dijaliżi li nbdiet sa siegħa u nofs mid- dożaġġ b’ emtricitabine (rata tat - tnixxija tad- demm ta ’ 400 ml/ min u rata tat- tnixxija ta ’ dijalizzat ta ’ madwar 600 ml/ min).
The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Il- farmakokinetiċi ta ’ emtricitabine ma ġewx studjati f’ individwi li m’ humiex infettati bl- HBV, bi gradi diversi ta ’ insuffiċjenza epatika.
In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected subjects.
B’ mod ġenerali il- farmakokinetiċi ta ’ emtricitabine f’ individwi infettati bl- HBV kienu simili għal dawk f’ individwi f’ saħħithom u f’ individwi infettati bl- HIV.
Age, gender and ethnicity:
Età, sess u etniċità:
In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
B’ mod ġenerali, il- farmakokinetiċi ta ’ emtricitabine fit- trabi, tfal u adolexxenti (età ta ’ bejn 4 xhur sa 18- il sena) huwa simili għal dawk osservati fl- adulti.
10 The mean AUC in 77 infants, children and adolescents receiving 6 mg/ kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/ ml in 20 adults receiving 200 mg hard capsules once daily.
L- AUC medja f’ 77 tarbija, tfal u adolexxenti li kienu jirċievu 6 mg/ kg ta ’ emtricitabine darba kuljum bħala soluzzjoni orali jew 200 mg ta ’ emtricitabine bħal kapsuli iebsin darba kuljum, kienet tixbah lill- medja ta ’ l- AUC ta ’ 10. 0 µg· h/ ml f’ 20 adult, li kienu jirċievu 200 mg kapsuli iebsin darba kuljum.
In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/ kg once daily.
Fi studju open- label, mhux komparattiv, tagħrif farmakokinetiku nkiseb minn 20 tarbija tat- twelid ta ’ ommijiet infettati bl- HIV li rċivew żewġ korsijiet ta ’ 4 ijiem ta ’ soluzzjoni orali emtricitabine bejn l - ewwel ġimgħa tal- ħajja u l- età ta ’ 3 xhur, f’ livell ta ’ doża ta ’ 3 mg/ kg darba kuljum.
This dose is half of that approved for infants aged 4 months and over (6 mg/ kg).
Din id- doża hi nofs ta ’ dik approvata għat- trabi li għandhom 4 xhur u iktar (6 mg/ kg).
The apparent total body clearance at steady state (CL/ F) increased with age over the 3-month period with a corresponding decrease in AUC.
It- tneħħija totali apparenti mill- ġisem fl- istat fiss (CL/ F) żdiedet ma ’ l- età fuq il- perijodu ta ’ dawn it- 3 xhur bi tnaqqis korrispondenti fl- AUC.
Plasma emtricitabine exposure (AUC) in infants up to 3 months of age who received 3 mg/ kg emtricitabine once daily was similar to that observed using 6 mg/ kg daily doses in HIV infected adults and children aged 4 months and over.
L- esponiment ta ’ emtricitabine fil- plażma (AUC) fi trabi li kellhom sa 3 xhur li rċivew 3 mg/ kg ta ’ emtricitabine darba kuljum kienet simili għal dik li kienet osservata bl- użu ta ’ dożi ta ’ 6 mg/ kg kuljum f’ adulti u tfal infettati bl- HIV li kellhom 4 xhur jew iktar.
Pharmacokinetic data are not available in the elderly.
M’ hemmx tagħrif farmakokinetiku disponibbli dwar l- anzjani.
Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.
Għalkemm il- medja ta ’ Cmax u ta ’ Cmin kienet ta ’ madwar 20% ogħla u l- medja ta ’ l- AUC kienet ta ’ 16% ogħla fin- nisa meta mqabbla ma ’ l- irġiel, din id- differenza ma kinetx ikkunsidrata li kienet klinikament sinifikanti.
No clinically important pharmacokinetic difference due to race has been identified.
L- ebda differenza farmakokinetika klinikament importanti minħabba r- razza ma ġiet identifikata.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and reproductive/ developmental toxicity.
Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, effett tossiku fuq is- sistema riproduttiva u tossiċità ta ’ l- iżvilupp, ma turi l- ebda periklu speċjali għall- bnedmin.
Emtricitabine did not show any carcinogenic potential in long-term oral carcinogenicity studies in mice and rats.
Emtricitabine ma wera l- ebda riskju ta ’ kanċer fi studji orali, fit- tul dwar il- karċinoġeniċità fil- ġrieden u fil- firien.
Capsule contents:
Kontenut tal- kapsula:
Cellulose, microcrystalline (E460) Crospovidone Magnesium stearate (E572) Povidone (E1201)
Cellulose, microcrystalline (E460) Crospovidone Magnesium stearate (E572) Povidone (E1201)
Capsule shell:
Qoxra tal- kapsula:
Gelatin Indigotine (E132) Titanium dioxide (E171)
Gelatin Indigotine (E132) Titanium dioxide (E171)
Printing ink containing:
Linka ta ’ l- istampar fiha:
Black iron oxide (E172) Shellac (E904)
Black iron oxide (E172) Shellac (E904)
11 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
White high-density polyethylene (HDPE) bottle fitted with a child-resistant closure, containing 30 hard capsules.
Flixken piknometri tal- polythene (HDPE) b’ għatu li ma jinfetaħx mit- tfal, li fihom 30 kapsula iebsin.
Blisters made of polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminium.
Folja ta ’ polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminju.
Each blister pack contains 30 hard capsules.
Kull folja fil- pakkett fiha 30 kapsula iebsin.
30 hard capsules.
30 kapsula iebsin.
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Gilead Sciences International Limited Cambridge CB21 6GT Ir- Renju Unit
24 October 2003 Date of last renewal:
24 t’ Ottubru 2003 Data ta ’ l- aħħar tiġdid ta ’ l- awtorizzazzjoni:
22 September 2008
22 ta ’ Settembru 2008
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
Emtriva 10 mg/ ml oral solution
Emtriva 10 mg/ ml soluzzjoni orali
Each ml of Emtriva oral solution contains 10 mg emtricitabine.
Kull ml ta ’ Emtriva soluzzjoni orali fih 10 mg ta ’ emtricitabine.
Each dose (24 ml) contains 36 mg methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg Sunset Yellow (E110) and has a sodium content of 254 mg.
Kull doża (24 ml) fiha 36 mg ta ’ methyl parahydroxybenzoate (E218), 3. 6 mg propyl parahydroxybenzoate (E216), 1. 2 mg Sunset yellow (E110) u għandha kontenut ta ’ sodium ta ’ 254 mg.
Oral solution.
Soluzzjoni orali.
The clear solution is orange to dark orange in colour.
Il- kulur tas- soluzzjoni orali trasparenti huwa oranġjo jagħti għal oranġjo skur.
Emtriva 10 mg/ ml oral solution may be taken with or without food.
Emtriva 10 mg/ ml soluzzjoni orali tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
A measuring cup is provided (see section 6.5).
Tazza tal- kejl hija pprovduta (ara sezzjoni 6. 5).
The recommended dose of Emtriva 10 mg/ ml oral solution is 240 mg (24 ml) once daily.
Id- doża rakkomandata ta ’ Emtriva 10 mg/ ml soluzzjoni orali hija ta ’ 240 mg (24 ml) darba kuljum.
Infants, children and adolescents up to 18 years of age:
Trabi, tfal u adolexxenti sa 18- il sena:
The recommended dose of Emtriva 10 mg/ ml oral solution is 6 mg/ kg up to a maximum of 240 mg (24 ml) once daily.
Id- doża rakkomandata ta ’ Emtriva 10 mg/ ml soluzzjoni orali hija ta ’ 6 mg/ kg sa massimu ta ’ 240 mg (24 ml) darba kuljum.
Children who weigh at least 33 kg may either take one 200 mg hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
Tfal li jiżnu mill- inqas 33 kg jistgħu jieħdu jew kapsula iebsa ta ’ 200 mg kuljum jew jieħdu emtricitabine bħala soluzzjoni orali sa massimu ta ’ 240 mg darba kuljum.
There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
14 M’ hemmx informazzjoni dwar l- effikaċja, u informazzjoni hija limitata ħafna dwar is- sigurtà ta ’ emtricitabine fi trabi ta ’ anqas minn 4 xhur.
Therefore Emtriva is not recommended for use in
Għalhekk Emtriva mhux rakkomandat għall- użu fi trabi ta ’ anqas minn 4 xhur.
Emtriva 200 mg hard capsules are available for adults, adolescents and children who weigh at least 33 kg and can swallow hard capsules.
Kapsuli iebsin ta ’ Emtriva ta ’ 200 mg huma disponibbli għall- adulti, adolexxenti u tfal li jiżnu mill - inqas 33 kg u li jistgħu jibilgħu kapsuli iebsin.
Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.
Jekk jogħġbok ara S- Sommarju tal- Karatteristiċi tal - Prodott ta ’ Emtriva 200 mg kapsuli iebsin.
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 ml) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Minħabba d- differenza fil- biodisponibiltà ta ’ emtricitabine bejn l- għamliet ta ’ kapsuli iebsin u s- soluzzjoni orali, 240 mg ta ’ emtricitabine mogħtija bħala soluzzjoni orali (24 ml), għandhom jagħtu livelli ta ’ plażma bħal dawk li jkunu osservati wara l- għoti ta ’ kapsula iebsa waħda ta ’ 200 mg ta ’ emtricitabine (ara sezzjoni 5. 2).
The table below provides daily doses of Emtriva 10 mg/ ml oral solution according to the degree of renal insufficiency.
It- tabella t’ hawn taħt tipprovdi d- dożi ta ’ kuljum ta ’ Emtriva 10 mg/ ml soluzzjoni orali skond il- grad ta ’ insuffiċjenza renali.
The safety and efficacy of these doses have not been clinically evaluated.
Is- sigurtà u l- effikaċja ta ’ dawn id- dożi ma ġewx evalwati b’ mod kliniku.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Għalhekk, ir- rispons kliniku għat- trattament u l- funzjoni renali għandhom ikunu mmonitorjati mill - qrib f’ dawn il- pazjenti (ara sezzjoni 4. 4).
Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Pazjenti b’ insuffiċjenza renali jistgħu jiġu mmaniġġjati wkoll bl- għoti ta ’ Emtriva 200 mg kapsuli iebsin f’ intervalli ta ’ dożaġġ modifikati.
Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.
Jekk jogħġbok ara S- Sommarju tal- Karatteristiċi tal- Prodott ta ’ Emtriva 200 mg kapsuli iebsin.
(functionally anephric, requiring intermittent haemodialysis)* Recommended dose of Emtriva 10 mg/ ml oral solution every 24 hours
rakkomandata ta ’ Emtriva 10 mg/ ml soluzzjoni orali kull 24 siegħa
If Emtriva is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
15 Jekk Emtriva jitwaqqaf f’ pazjenti infettati kemm bl- HIV kif ukoll bl- HBV, dawn il- pazjenti għandhom ikunu immonitorjati mill- qrib għal evidenza jekk l- epatite tmur għall- agħar (ara sezzjoni 4. 4).
14 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Is- sigurtà u l- effikaċja tad- dożi mnaqqsa pprovduti f’ sezzjoni 4. 2 huma bbażati fuq l- informazzjoni farmakokinetika u fuq l- immudellar ta ’ doża waħda, u ma ġewx evalwati klinikament.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with a reduced dose of emtricitabine (see sections 4.2 and 5.2).
Għalhekk, ir - rispons kliniku għat- trattament u l- funzjoni renali għandhom ikunu mmonitorjati mill- qrib f’ pazjenti ttrattati b’ doża mnaqqsa ta ’ emtricitabine (ara sezzjonijiet 4. 2 u 5. 2).
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
16 Għandha tingħata attenzjoni meta jingħataw analogi tan- nukleosidi lil kwalunkwe pazjent (partikularment nisa obeżi) li għandhom epatomegalija, epatite jew fatturi oħra ta ’ riskju magħrufa għall- mard tal- fwied u stejatożi epatika (fosthom ċerti prodotti mediċinali u l- alkoħol).
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Jista ’ jkun hemm riskju speċjali f’ pazjenti li għandhom ukoll l- epatite Ċ u li qed jingħataw terapija b’ alfa interferon u ribavirin.
15 Patients at increased risk should be followed closely.
Pazjenti f’ riskju ogħla għandhom ikunu segwiti mill- qrib.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- avvenimenti għandhom m’ humiex magħrufa.
Whether the neurological disorders are transient or permanent is currently unknown.
17 newroloġiċi jgħaddux maż- żmien jew humiex permanenti.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Kull tarbija esposta fl- utru għall- analogi tan- nukleosidi u tan- nukleotidi, anke trabi li huma negattivi għall- HIV, għandhom jiġu segwiti klinikament u b’ testijiet tal- laboratorju u jridu jiġu investigati kompletament għall- possibbiltà ta ’ disfunzjoni tal- mitokondrija f’ każ ta ’ sinjali jew sintomi rilevanti.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Dawn is- sejbiet m’ għandhomx jaffettwa r- rakkomandazzjonijiet nazzjonali kurrenti għall- użu tat- terapija antiretrovirali f’ nisa tqal għall- prevenzjoni tat- trasmissjoni vertikali ta ’ HIV.
Any inflammatory symptoms
Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/ jew fokali, u pulmonite tat- tip Pneumocystis carinii.
16 should be evaluated and treatment instituted when necessary.
Kwalunkwe sintomu ta ’ infjammazzjoni għandu jiġu evalwat u t- trattament jinbeda meta meħtieġ.
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Għalkemm l- etjoloġija hi kkunsidrata li tkun ġejja minn ħafna fatturi (li jinkludi l- użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa, indiċi ogħla tal- piż tal- ġisem), kienu rrappurtati każijiet ta ’ osteonekrożi partikularment f’ pazjenti li jkollhom mard tal- HIV li jkun fi stadju avvanzat u/ jew esponiment fit- tul għal terapija antiretrovirali kombinata (combination antiretroviral therapy, CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jingħataw parir biex jieħdu parir mediku jekk ikollhom uġigħ fil- ġogi, ebusija fil- ġogi jew jekk ikollhom diffikultà biex jitħarrku.
Emtriva oral solution contains Sunset Yellow (E110) which may cause allergic reactions, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Emtriva soluzzjoni orali fiha Sunset yellow (E110) li jista ’ jikkawża reazzjonijiet allerġiċi, methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) li jista ’ jikkawża reazzjonijiet allerġiċi (li jistgħu jittardjaw).
This medicinal product contains 254 mg of sodium per dose which should be taken into consideration by patients on a controlled sodium diet.
Dan il- prodott mediċinali fih 254 mg ta ’ sodium f’ kull doża u dan għandu jitqies f’ pazjenti li jikkontrollaw l- ammont ta ’ sodium li jieħdu fid- dieta.
Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to pregnancy, foetal development, parturition or postnatal development (see section 5.3).
18 Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti ta ’ emtricitabine fuq it- tqala, fuq l- iżvilupp tal- fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Huwa rakkomandat li nisa infettati bl- HIV ma jreddgħux lit- trabi tagħhom taħt l- ebda ċirkustanza sabiex jevitaw it- trasmissjoni ta ’ l- HIV.
However,
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
17 patients should be informed that dizziness has been reported during treatment with emtricitabine.
Madankollu il- pazjenti għandhom jiġu infurmati li l- isturdament kien irrappurtat waqt it- trattament b’ emtricitabine.
The adverse reactions with suspected (at least possible) relationship to treatment in adults are listed below by body system organ class and absolute frequency.
Ir- reazzjonjiet avversi b’ rabta suspetta (almenu possibbli) mat- trattament fl- adulti huma elenkati hawn taħt skond il- klassi ta ’ sistema ta ’ l- organu fil- ġisem u skond il- frekwenza assoluta.
Hepatobiliary disorders:
19 Disturbi fil- fwied u fil- marrara:
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeltrali u tal- connective tissue:
18 infected with HIV without co-infection with HBV.
Il- profil tar- reazzjoni avversa f’ pazjenti infettati wkoll bl- HBV jixbah lil dak osservat f’ pazjenti infettati bl- HIV biss mingħajr infezzjoni bl- HBV.