qanastek/EMEA-V3 huggingface dataset:
• Keep out of the reach and sight of children. • Keep the blister packs in the outer carton in order to protect from light. • Do not use after the expiry date which is stated on the carton. • Do not use if the pack is damaged or shows signs of tampering.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Aħżen il- folji fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl. • Tużahx wara d- data ta ’ skadenza li tidher fuq il- kartuna. • Tużahx jekk il- pakkett tkun saritlu xi ħsara jew juri sinjali ta ’ tbabis.
What Emselex contains
X’ fih Emselex
- The active substance is darifenacin (as hydrobromide).
- Is- sustanza attiva ta ’ Emselex hi darifenacin (bħala hydrobromide).
Each tablet contains 7.5 mg darifenacin.
Kull pillola fiha 7. 5 mg
- The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium
- Is- sustanzi l- oħra huma calcium hydrogen phosphate (anhydrous), hypromellose, magnesium
stearate, polyethylene glycol, titanium dioxide (E171) and talc.
stearate, polyethylene glycol, titanium dioxide (E171) u talc.
What Emselex looks like and contents of the pack Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with “ DF” on one side and “ 7.5” on the other.
Id- Dehra ta ’ Emselex u l- kontenuti tal- pakkett Emselex 7. 5 mg pilloli li jerħu l- mediċina bil- mod huma tondi, bojod, konvessi, imnaqqxa b ’ “ DF ” fuq naħa u “ 7. 5 ” fuq l- oħra.
The tablets are available in blister packs containing 7, 14, 28, 49, 56 or 98 tablets or in multipacks comprising 10 packs, each pack containing 14 tablets.
Il- pilloli jiġu f’ pakketti b’ folji li jkun fihom 7, 14, 28, 49, 56 jew 98 pillola jew f’ pakketti b’ ħafna li jkollhom 10 pakketti, kull pakkett ikun fih 14- il pillola.
Not all pack sizes may be available in your country.
Jista ’ jkun li ma jiġux il- pakketti tad- daqsijiet kollha f’ pajjiiżek.
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
44 Manifattur Novartis Pharma GmbH Roonstraße 25 D- 90429 Nuremberg Il- Ġermanja
If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Magyarország Bayer Hungária Kft.
Magyarország Novartis Hungária Kft.
Tel.: +36 1 487 41 00
Pharma Tel.: +36 1 457 65 00
44 PACKAGE LEAFLET:
46 FULJETT TA ’ TAGĦRIF:
Emselex 15 mg prolonged-release tablets Darifenacin
Emselex 15 mg pilloli li jerħu l- mediċina bil- mod Darifenacin
- This medicine has been prescribed only for you.
- Din il- mediċina ġiet mogħtija b’ riċetta għalik biss.
It may harm them,
Tista ’
even if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
45 Take special care with Emselex: • if you have autonomic neuropathy - your doctor will have told you if you have this. • if you have heartburn and belching. • if you have difficulties in passing urine and a weak stream of urine. • if you have severe constipation (less than or equal to 2 bowel movements per week). • if you have an obstructive gastrointestinal disorder - your doctor will have told you if you have this. • if you are receiving treatment for narrow-angle glaucoma. • if you have liver problems. • if you have kidney problems.
47 Oqgħod attent ħafna b’ Emselex: • jekk għandek newropatija awtonomika – it- tabib tiegħek ikun qallek jekk għandekx din il - marda. • jkk għandek ħruq ta ’ stonku jew qed titfewwaq. • jekk tbati biex tgħaddi l- awrina jew tgħaddi fluss ta ’ awrina dgħajjef ħafna. • jekk għandek stitikezza qawwija (tipporga darbtejn f’ ġimgħa jew anqas). • jekk għandek xi disturbi li qed jikkawżaw imblokk fis- sistema gastro- intestinali - it- tabib tiegħek ikun qallek jekk għandekx din. • jekk qed tirċievi kura għall- glawkoma tat- tip narrow angle. • jekk għandek problemi tal- fwied. • jekk għandek problemi tal- kliewi.
46 For adults and older people, the recommended starting dose is 7.5 mg daily.
48 Għall- adulti u persuni anzjani, id- doża tal- bidu rakkomandata hija 7. 5 mg kuljum.
Other side effects Very common side effects (affecting 10 or more in every 100 patients) Dry mouth, constipation.
49 Effetti sekondarji oħrajn Effetti sekondarji komuni ħafna (jeffettwaw 10 jew aktar minn kull 100 pazjent) Ħalq xott, stitikezza.
47 Common side effects (affecting less than 10 in every 100 patients) Headache, abdominal pain, indigestion, feeling sick, dry eyes.
Effetti sekondarji komuni (jeffettwaw anqas minn 10 minn kull 100 pazjent) Uġigħ ta ’ ras, uġigħ fl- addome, indiġestjoni, tħossok marid, għajnejn xotti.
Each tablet contains 15 mg darifenacin.
Kull pillola fiha 15 mg
- The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium
- Is - sustanzi l- oħra huma calcium hydrogen phosphate (anhydrous), hypromellose, magnesium
stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) u yellow iron oxide (E172).
What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “ DF” on one side and “ 15” on the other.
Id- Dehra ta ’ Emselex u l- kontenuti tal- pakkett Emselex 15 mg pilloli li jerħu l- mediċina bil- mod huma pilloli tondi, konvessi lewn il- ħawħ, imnaqqxa b ’ ” DF ” fuq naħa u “ 15 ” fuq l- oħra.
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
50 Manifattur Novartis Pharma GmbH Roonstraße 25 D- 90429 Nuremberg Il- Ġermanja
48 If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Emtriva?
X’ inhu Emtriva?
Emtriva is a medicine containing the active substance emtricitabine.
Emtriva huwa mediċina li fiha s- sustanza attiva emtricitabine.
It is available as white and light blue capsules (200 mg) and as an oral solution (10 mg/ ml).
Huwa disponibbli bħala kapsuli bojod u blu ċar (200 mg) u bħala soluzzjoni orali (10 mg/ ml).
What is Emtriva used for?
Għal xiex jintuża Emtriva?
Emtriva is an antiviral medicine.
Emtriva huwa mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma ’ mediċini antivirali oħra fit- trattament ta ’ adulti u tfal infettati mill- vajrus tal- immunodefiċjenza umana tat- tip 1 (HIV- 1), vajrus li jikkawża s - sindromu minn immunodefiċjenza akkwiżita (AIDS).
For patients who have taken medicines to treat their HIV infection before and failed to respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus ’ s response to any new antiviral medicines that might be prescribed.
Fil- każ tal- pazjenti li jkunu ħadu mediċini għat- trattament ta ’ infezzjoni bl- HIV qabel u ma jkunux irrispondew għal dak it- trattament, it- tobba għandhom jippreskrivu Emtriva wara li jkunu eżaminaw il- mediċini antivirali jkun diġà ħa l- pazjent u wara li jkunu vvalutaw l- possibbiltà li l- vajrus jirrispondi għal kwalunkwe mediċina antivirali ġdida eventwalment preskritta.
How is Emtriva used?
Kif jintuża Emtriva?
Treatment with Emtriva should be initiated by a doctor who has experience in the treatment of HIV infection.
It- trattament b’ Emtriva għandu jinbeda minn tabib li jkollu esperjenza fit- trattament tal- infezzjoni tal - HIV.
The recommended dose of Emtriva is one capsule once a day for patients who weigh 33 kg or more.
Id- doża rakkomandata ta ’ Emtriva għal pazjenti li jiżnu mill- inqas 33 kg hija kapsula waħda darba kuljum.
The oral solution should be used by patients who weigh less than 33 kg, and by patients who cannot swallow the capsules.
Is- soluzzjoni orali għandha tintuża minn pazjenti li jiżnu anqas minn 33 kg, u minn pazjenti li ma jkunux jistgħu jibilgħu l- kapsuli.
The dose of oral solution is 6 mg per kilogram body weight, up to a maximum of 240 mg (24 ml), taken once a day.
Id- doża tas- soluzzjoni orali hija 6 mg għal kull kilogramma tal- piż tal- ġisem, sa massimu ta ’ 240 mg (24 ml), meħuda darba kuljum.
The dose may need to be adjusted in patients who have problems with their kidneys.
Fil- pazjenti li jbatu minn problemi fil- kliewi, jista ’ jkun hemm bżonn li d- doża tiġi aġġustata.
Emtriva can be taken with or without food.
Emtriva tista ’ tittieħed fuq stonku vojt jew le.
Because of limited information on safety and effectiveness in infants below four months of age, Emtriva is not recommended for use in this age group.
Minħabba t- tagħrif limitat dwar is- sigurtà u l- effikaċja fi trabi ta ’ età inqas minn erba ’ xhur, Emtriva mhuwiex rakkomandat għall- użu f’ dan il- grupp.
For more information, see the Package Leaflet.
Għal aktar tagħrif, ara l - Fuljett ta ’ Tagħrif.
How does Emtriva work?
Kif jaħdem Emtriva?
The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Is- sustanza attiva f’ Emtriva, emtricitabine, hija inibitur nukleosidiku tat- transkrittażi inversa (nucleoside reverse transcriptase inhibitor, NRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Dan jimblokka l- attività tat- transkrittażi inversa, enzima prodotta mill- HIV li jippermetti lil dan tal- aħħar jinfetta ċ- ċelloli u jirriproduċi.
Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Emtriva, meta jittieħed ma ’ mediċini antivirali oħra, inaqqas il- kwantità ta ’ HIV fid- demm u jżommu f’ livell baxx.
Emtriva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Emtriva ma jfejjaqx infezzjoni mill- HIV jew tal- AIDS, iżda jista ’ jittardja l- ħsara prodotta lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard assoċjat mal- AIDS.
How has Emtriva been studied?
Kif ġie studjat Emtriva?
Emtriva has been studied in three main studies including 1,498 HIV-infected adults.
Emtriva ġie eżaminat fi tliet studji ewlenin li fihom ħadu sehem 1, 498 adult infettati mill- HIV.
The first study compared Emtriva with stavudine (another antiviral medicine) in 571 treatment-naïve adults (who had not received treatment for their HIV infection before).
L - ewwel studju qabbel Emtriva ma ’ stavudine (mediċina antivirali oħra) f’ 571 adult naïve għat - trattament (jiġifieri li ma kinux sottoposti qabel għal trattament għall- HIV).
Both medicines were taken in combination with didanosine and efavirenz (other antiviral medicines).
Iż- żewġ mediċini ttieħdu flimkien ma ’ didanosine u efavirenz (mediċini antivirali oħra).
The second study compared Emtriva with lamivudine (another antiviral medicine) in 468 treatment-naïve adults, in combination with stavudine and either efavirenz or nevirapine (other antiviral medicines).
It- tieni studju qabbel Emtriva ma ’ lamivudine (mediċina antivirali oħra) f’ 468 adult naïve għat- trattament, flimkien ma ’ stavudine kif ukoll efavirenz jew nevirapine (mediċini antivirali oħra).
The third study included 459 patients who had been taking three antiviral medicines (including lamivudine) for at least 12 weeks and had low levels of HIV in their blood.
Fit- tielet studju ħadu sehem 459 pazjent li kienu qed jieħdu tliet mediċini antivirali (fosthom lamivudine) għal tal- inqas 12- il ġimgħa u kellhom livelli baxxi ta ’ HIV fid- demm.
The study compared the effects of replacing lamivudine with Emtriva, or remaining on the existing antiviral medicine combination.
L- istudju qabbel l- effett tas- sostituzzjoni ta ’ lamivudine b’ Emtriva meta mqabbla maż- żamma tal- kombinazzjoni eżistenti ta ’ mediċini antivirali.
In all three studies, the main measure of effectiveness was the number of patients who had very low levels of HIV in their blood (viral load).
Fit- tliet studji, il- kejl ewlieni tal- effikaċja kien in- numru ta ’ pazjenti li kellhom livelli baxxi ħafna ta ’ HIV fid- demm (viral load).
The effectiveness of Emtriva, in combination with other antiviral medicines, was also assessed in two studies including 120 HIV-infected patients aged between four months and 18 years.
L- effikaċja ta ’ Emtriva, flimkien ma ’ mediċini antivirali oħra, ġiet valutata wkoll f’ żewġ studji li fihom ħadu sehem 120 pazjent infettati mill- HIV b’ età ta ’ bejn erba ’ xhur u 18- il sena.
What benefit has Emtriva shown during the studies?
X’ inhuma l- benefiċċji ta ’ Emtriva fl- istudji mwettqa?
Emtriva, in combination with other antiviral medicines, reduced viral loads in HIV-infected patients.
Emtriva, flimkien ma ’ mediċini antivirali oħra, naqas il- viral loads f’ pazjenti infettati mill- HIV.
In the first study of treatment-naïve adults, more patients taking Emtriva had viral loads below 50 copies/ ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
Fl - ewwel studju ta ’ adulti naïve għat- trattament, aktar pazjenti ttrattati b’ Emtriva b’ viral loads inqas minn 50 kopja/ ml wara trattament ta ’ 24 ġimgħa minn dawk ittrattati bi stavudine (81% u 70% rispettivament).
This difference was maintained after 48 weeks of treatment (73% and 56%).
Din id- differenza baqgħet tali wara trattament ta ’ 48 ġimgħa (73 u 56%).
In the second study, Emtriva was as effective as lamivudine: after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ ml, and slightly fewer had viral loads below 50 copies/ ml.
Fit- tieni studju, Emtriva kien effikaċi daqs lamivudine: wara 48 ġimgħa, madwar żewġ terzi tal- pazjenti rreġistraw viral loads inqas minn 400 kopja/ ml, filwaqt li numru ta ’ pazjenti kemxejn iktar baxx wera viral load inqas minn 50 kopja/ ml.
In treatment- experienced patients, the number of patients switching from lamivudine to Emtriva with viral loads below 400 copies/ ml was similar to the number who continued taking lamivudine after 48 weeks (73% and 82%, respectively).
Fil- pazjenti diġà sottoposti għal trattament, in- numru ta ’ individwi fost dawk li lamivudine ġiet sostitwita b’ Emtriva, li wera viral load inqas minn 400 kopja/ ml kien simili, wara 48 ġimgħa, għan- numru ta ’ individwi li kompla jieħu lamivudine (rispettivament 73% u 82%).
Similar results were seen in the two studies of children and adolescents taking Emtriva in combination with other antiviral medicines.
Riżultati analogi ġew osservati fiż- żewġ studji fuq tfal u adolexxenti ttrattati b’ Emtriva f’ kombinazzjoni ma ’ mediċini antivirali oħra.
What is the risk associated with Emtriva?
X’ riskji huma assoċjati ma ’ Emtriva?
The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles).
L- effetti sekondarji l- aktar komuni b’ Emtriva (li dehru f’ aktar minn pazjent 1 minn kull 10) huma wġigħ ta ’ ras, dijarrea, nawżea (dardir), u livelli għoljin ta ’ kreatina kinażi fid- demm (creatine kinase, enzima li tinsab fil- muskoli).
Skin discoloration was very common in children.
Fit- tfal, it- tibdil fil- kulur tal- ġilda hu komuni ħafna.
For the full list of all side effects reported with Emtriva, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati b’ Emtriva, ara l- Fuljett ta ’ Tagħrif.
Emtriva should not be used in people who may be hypersensitive (allergic) to emtricitabine or to any of the other ingredients.
Emtriva ma għandux jintuża minn persuni l jistgħu jkunu ipersensittivi (allerġiċi) għal emtricitabine jew għal kwalunkwe sustanza oħra tiegħu.
As with other anti-HIV medicines, patients taking Emtriva may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal għal mediċini oħra ta 'kontra l- HIV, il- pazjenti ttrattati b’ Emtriva jista' jkollhom riskju ta 'lipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fid- demm), osteonekrożi (mewt ta' tessut tal - għadam) jew sindromu tar- riattivazzjoni immunitarja (sintomi ta 'infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Emtriva.
Il- pazjenti li jkollhom problemi bil- fwied (inklużi infezzjonijiet tal - epatite B jew Ċ) jistgħu jkunu esposti aktar għar- riskju li jiżviluppaw ħsara fil- fwied jekk ittrattati b’ Emtriva.
As with all other NRTIs, Emtriva may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Emtriva during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal fil- każ tal- NRTIs l- oħra kollha, Emtriva jista ’ jikkawża wkoll aċidożi lattika (akkumulu ta ’ aċidu lattiku fil- ġisem) u, fit- trabi ta ’ ommijiet ittrattati b’ Emtriva waqt it- tqala, disfunzjoni mitokondrijali (ħsara fil- komponenti ċellulari li jipproduċi l- enerġija li tista ’ tikkawża problemi fid- demm).
Why has Emtriva been approved?
Għaliex ġie approvat Emtriva?
The Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva’ s benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Emtriva huma ogħla mir- riskji tiegħu fit- trattament tal- infezzjoni mill- HIV- 1 fl- adulti u fit- tfal f’ kombinazzjoni ma ’ aġenti antiretrovirali oħra.
The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working.
Il- Kumitat innota li din l- indikazzjoni hi bbażata fuq studji mwettqa fuq pazjenti li ma kinux irċevew trattament għall- HIV qabel, jew li l- HIV tagħhom kien diġà kkontrollat tajjeb b’ mediċini antivirali oħra, u li ma kien hemm ebda esperjenza rigward l - użu ta ’ Emtriva f’ pazjenti li t- trattamenti preċedenti tagħhom għall- HIV ma rriżultawx effikaċi.
The Committee recommended that Emtriva be given marketing authorisation.
Il - Kumitat irrakkomanda li Emtriva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Emtriva:
2/ 3 Aktar tagħrif dwar Emtriva:
The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva to Gilead Sciences International Limited on 24 October 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Emtriva lil Gilead Sciences International Limited fl- 24 ta ’ Ottubru 2003.
The marketing authorisation was renewed on 24 October 2008.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fl- 24 ta ’ Ottubru 2008.
2/ 3 The full EPAR for Emtriva can be found here.
L- EPAR sħiħ għal Emtriva jista ’ jiġi kkonsultat hawn.
Pharmaceutical form Capsule, hard Capsule, hard
Kapsula iebsa Kapsula iebsa
Route of administration Oral use Oral use
Jittieħed mill- ħalq Jittieħed mill- ħalq
Packaging Bottle (HDPE) Blister (Aclar/ polyethylene/ PVC)
Flixkun (HDPE) Folja (Aclar/ poly - ethylene/ PVC)
Package size 30 capsules 30 capsules
30 kapsula 30 kapsula
Oral solution
Soluzzjoni orali
Bottle (polyethylene terephthalate)
Jittieħed mill- ħalq
10 mg/ ml
Flixkun (polyethylene 10 mg/ ml terephthalate)
1 bottle
Flixkun wieħed
Emtriva 200 mg hard capsules
Emtriva 200 mg kapsuli iebsin
Each hard capsule contains 200 mg emtricitabine.
Kull kapsula iebsa fiha 200 mg ta ’ emtricitabine.
Each capsule has a white opaque body with a light blue opaque cap.
Kull kapsula hija bajda opaka b’ għatu ċelesti opak ċar.
Each capsule is printed with “ 200 mg” on the cap and “ GILEAD” and [Gilead logo] on the body in black ink.
Kull kapsula fiha “ 200 mg ” stampat fuq l - għatu u “ GILEAD ” u [logo ta ’ Gilead] fuq il- parti l- oħra b’ linka sewda.
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
4. 1 Indikazzjonijiet terapewtiċi
This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control.
Din l- indikazzjoni hija bbażata fuq studji f’ pazjenti li qatt ma kienu ħadu din it- terapija qabel u f’ pazjenti esperjenzati bil- kura b’ kontroll viroloġiku stabbli.
There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
M’ hemmx esperjenza ta ’ l- użu ta ’ Emtriva f’ pazjenti li ma kienux qegħdin jirnexxu fil- kors kurrenti tagħhom jew li ma kienux irnexxew f’ diversi korsijiet (ara sezzjoni 5. 1).
When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient.
Meta wieħed ikun qiegħed jagħżel kors ġdid għal pazjenti li jkunu fallew kors antiretrovirali, attenzjoni partikulari għandha tingħata lill- forom ta ’ mutazzjonijiet marbuta ma ’ prodotti mediċinali differenti u l- istorja tat- trattament tal- pazjent individwali.
Where available, resistance testing may be appropriate.
Fejn ikun possibbli, l- ittestjar tar- reżistenza jista ’ jkun adattat.
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib b’ esperjenza fl- immaniġġjar ta ’ infezzjoni HIV.
Emtriva 200 mg hard capsules may be taken with or without food.
Emtriva 200 mg kapsuli iebsin jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
Id- doża rakkomandata ta ’ Emtriva hija ta ’ kapsula iebsa waħda ta ’ 200 mg, li tittieħed mill - ħalq, darba kuljum.
Children and adolescents up to 18 years of age:
Tfal u adolexxenti sa 18- il sena:
The recommended dose of Emtriva for children and adolescents weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
Id- doża rakkomandata ta ’ Emtriva għat- tfal u adolexxenti li jiżnu mill- inqas 33 kg u li huma kapaċi jibilgħu kapsuli iebsin, hija ta ’ kapsula iebsa waħda ta ’ 200 mg, li tittieħed mill- ħalq, 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.
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 those aged less than 4 months.
Għalhekk Emtriva mhux rakkomandat għall- użu fi trabi ta ’ anqas minn 4 xhur.
(For pharmacokinetic data in this age group, see section 5.2).
(Għal tagħrif farmakokinetiku fil- grupp ta ’ din l- età, ara sezzjoni 5. 2.)
Emtriva is also available as a 10 mg/ ml oral solution for use in infants older than 4 months of age, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Jekk
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ ml oral solution.
2 jogħġbok ara S- Sommarju tal- Karatteristiċi tal- Prodott tas- soluzzjoni orali Emtriva ta ’ 10 mg/ ml.
2 presentations, 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 (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 mgħotija bħala soluzzjoni orali, 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).
There are no safety and efficacy data available in patients over the age of 65 years.
M’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja f’ pazjenti ta ’ ’ l fuq minn 65 sena.
However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
Madankollu l- ebda aġġustament fid- doża rakkomandata ta ’ kuljum għall- adulti ma jkun meħtieġ sakemm ma jkunx hemm indikazzjoni ta ’ insuffiċjenza renali.
Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2).
Emtricitabine hija eliminata permezz ta ’ tneħħija renali u l- esponiment għal emtricitabine jiżdied b’ mod sinifikanti f’ pazjenti b’ insuffiċjenza renali (ara sezzjoni 5. 2).
Dose or dose interval adjustment is required in all patients with creatinine clearance < 50 ml/ min (see section 4.4).
Aġġustament fid- doża jew fl- intervall tad- doża jkun meħtieġ fil- pazjenti kollha li għandhom tneħħija tal- krejatinina ta ’ < 50 ml/ min (ara sezzjoni 4. 4).
The table below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency.
It- tabella t’ hawn taħt tipprovdi l- linji gwida ta ’ l- aġġustament fl- intervall tad- doża għall- kapsuli iebsin ta ’ 200 mg skond il- grad ta ’ insuffiċjenza renali.
The safety and efficacy of these dose interval adjustment guidelines have not been clinically evaluated.
Is- sigurtà u l- effikaċja ta ’ dawn il- linji ta ’ gwida dwar it- tibdil fl- intervalli tad- doża 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 10 mg/ ml oral solution to provide a reduced daily dose of emtricitabine.
Pazjenti b’ insuffiċjenza renali jistgħu jiġu mmaniġġjati bl- għoti ta ’ soluzzjoni orali Emtriva ta ’ 10 mg/ ml biex tkun ipprovduta doża mnaqqsa ta ’ emtricitabine kuljum.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ ml oral solution.
Jekk jogħġbok ara S- Sommarju tal- Karatteristiċi tal- Prodott tas- soluzzjoni orali Emtriva ta ’ 10 mg/ ml.
Creatinine Clearance (CLcr) (ml/ min)
Tneħħija tal- Krejatinina (CLcr) (ml/ min)
(functionally anephric, requiring intermittent haemodialysis)* Recommended
(funzjonalità anefrika, teħtieġ dijaliżi tad - demm intermittenti) * Intervall tad -
One 200 mg hard One 200 mg hard One 200 mg hard One 200 mg hard
waħda ta ’ 200 mg waħda ta ’ 200 mg waħda ta ’ 200 mg
dose interval for 200 mg hard capsules
waħda ta ’ 200 mg
capsule every 48 hours
rakkomandat għall- kapsuli iebsin ta ’ 200 mg
capsule every 72 hours
kull 24 siegħa kull 48 siegħa kull 72 siegħa
capsule every 96 hours
kull 96 siegħa
* Assumes a 3 h haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.
* Tassumi seduta ta ’ 3 sigħat ta ’ dijaliżi tad- demm tliet darbiet fil- ġimgħa, li jibdew mill- inqas 12- il siegħa wara l- għoti ta ’ l- aħħar doża ta ’ emtricitabine.
Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
Pazjenti b’ mard renali fl- aħħar stadju (end- stage renal disease, ESRD) immaniġġjati b’ forom oħra ta ’ dijaliżi bħalma hi d- dijaliżi peritoneali ambulanti, ma ġewx studjati u l- ebda rakkomandazzjoni dwar id- doża ma ’ tista ’ tingħata.
No data are available on which to make a dosage recommendation in paediatric patients with renal insufficiency.
M’ hemmx informazzjoni disponibbli fuqhiex wieħed jista ’ jagħmel rakkomandazzjoni dwar id - dożaġġ f’ pazjenti pedjatriċi b’ insuffiċjenza renali.
Hepatic insufficiency:
Insuffiċjenza epatika:
No data are available on which to make a dose recommendation for patients with hepatic insufficiency.
M’ hemmx informazzjoni disponibbli fuqhiex wieħed jista ’ jagħmel rakkomandazzjoni għal pazjenti b’ insuffiċjenza epatika.
However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency (see section 5.2).
Madankollu, ibbażat fuq il- metaboliżmu minimu ta ’ emtricitabine u r- rotta ta ’ l- eliminazzjoni renali, huwa improbabbli li jkun meħtieġ aġġustament tad- doża f’ pazjenti b’ insuffiċjenza epatika (ara sezzjoni 5. 2).
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).
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).
4.3 Contraindications
3 4. 3 Kontra- indikazzjonijiet
3 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine.
Emtriva m’ għandux jittieħed flimkien ma ’ prodotti mediċinali oħrajn li fihom emtricitabine jew prodotti mediċinali li fihom lamivudine.
General:
Ġenerali:
Emtricitabine is not recommended as monotherapy for the treatment of HIV infection.
Emtricitabine mhijiex rakkomandata bħala monoterapija għat- trattament ta ’ l- infezzjoni bl- HIV.
It must be used in combination with other antiretrovirals.
Għandha tintuża flimkien ma ’ antiretrovirali oħra.
Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.
Jekk jogħġbok ara wkoll iS- Sommarju tal - Karatteristiċi tal- Prodott tal- prodotti mediċinali antiretrovirali l- oħra li jintużaw fil- kors ikkombinat.
Patients receiving emtricitabine or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Pazjenti li jieħdu emtricitabine jew terapija antiretrovirali oħra jistgħu jkomplu jiżviluppaw infezzjonijiet opportunistiċi u kumplikazzjonijiet oħra ta ’ l- infezzjoni ta ’ l- HIV u għalhekk għandhom jibqgħu taħt osservazzjoni klinika mill- qrib minn tobba b’ esperjenza fit- trattament ta ’ pazjenti b’ mard konness ma ’ l- HIV.
Patients should be advised that antiretroviral therapies, including emtricitabine, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Il- pazjenti għandhom jiġu avżati li t- terapiji antiretrovirali, fosthom emtricitabine, ma ġewx ippruvati li jeliminaw ir- riskju ta ’ trasmissjoni ta ’ HIV lil ħaddieħor minn kuntatt sesswali jew tniġġiż tad - demm.
Appropriate precautions should continue to be used.
Prekawzjonijiet adegwati għandhom jibqgħu jittieħdu.
Patients should also be informed that emtricitabine is not a cure for HIV infection.
Il- pazjenti għandhom ukoll ikunu infurmati li emtricitabine mhijiex xi kura għall- infezzjoni bl- HIV.
Renal function:
Funzjoni renali:
Emtricitabine is principally eliminated by the kidney via glomerular filtration and active tubular secretion.
Emtricitabine hija eliminata prinċipalment mill- kliewi permezz ta ’ filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
Emtricitabine exposure may be markedly increased in patients with moderate or severe renal insufficiency (creatinine clearance < 50 ml/ min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
L- esponiment għal emtricitabine jista ’ jiżdied b’ mod sinifikanti f’ pazjenti b’ insuffiċjenza renali moderata jew severa (tneħħija tal- krejatinina ta ’ < 50 ml/ min) li jirċievu dożi ta ’ 200 mg ta ’ emtricitabine bħala kapsuli iebsin, jew 240 mg ta ’ soluzzjoni orali kuljum.
Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/ ml oral solution) is required in all patients with creatinine clearance < 50 ml/ min.
Għalhekk, jew aġġustament ta ’ l- intervall tad- doża (permezz ta ’ kapsuli iebsin Emtriva ta ’ 200 mg) jew tnaqqis tad- doża ta ’ kuljum ta ’ emtricitabine (permezz ta ’ soluzzjoni orali Emtriva ta ’ 10 mg/ ml) ikun meħtieġ fil- pazjenti kollha bi tneħħija tal- krejatinina ta ’ < 50 ml/ min.
The safety and efficacy of the dose interval adjustment guidelines 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 tal- linji ta ’ gwida dwar it- tibdil fl- intervalli tad- doża pprovdut f’ sezzjoni 4. 2 huma bbażati fuq informazzjoni u mmudellar farmakokinetiku ta ’ doża waħda u ma ġewx evalwati klinikament.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (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’ emtricitabine għal intervalli ta ’ dożaġġ fit- tul (ara sezzjonijiet 4. 2 u 5. 2).
Caution should be exercised when emtricitabine is co-administered with medicinal products that are eliminated by active tubular secretion as such co-administration may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product, due to competition for this elimination pathway (see section 4.5).
Għandha tingħata attenzjoni partikulari meta emtricitabine tkun mgħotija ma ’ prodotti mediċinali oħra li huma eliminati permezz ta ’ sekrezzjoni tubulari attiva peress li dan l- għoti flimkien jista ’ jwassal għal żieda ta ’ konċentrazzjonijiet ta ’ serum ta ’ emtricitabine jew ta ’ prodott mediċinali li jkunu ttieħdu flimkien minħabba l- kompetizzjoni għal dan ir- rotta ta ’ l- eliminazzjoni (ara sezzjoni 4. 5).
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.
Aċidożi lattika, ġeneralment assoċjata ma ’ stejatożi epatika, kienet irrappurtata bl- użu ta ’ analogi tan- nukleosidi.
Early symptoms (symptomatic hyperlactataemia) 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 u/ 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 mortalità għolja u tista ’ tkun assoċjata ma ’ pankreatite, insuffiċjenza tal- fwied jew tal- kliewi.
Lactic acidosis generally occurred after a few or several months of treatment.
L- aċidożi lattika ġeneralment dehret wara ftit xhur jew wara diversi xhur ta ’ trattament.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactataemia 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.
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).
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 4 hemm riskju speċjali f’ pazjenti li għandhom ukoll l- epatite Ċ u li qed jingħataw terapija b’ alfa interferon u ribavirin.
Patients at increased risk should be followed closely.
Pazjenti f’ riskju ogħla għandhom ikunu segwiti mill- qrib.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
It- terapija antiretrovirali kombinata ġiet assoċjata mar- ridistribuzzjoni tax- xaħam fil - ġisem (lipodistrofija) f’ pazjenti b’ HIV.
The long-term consequences of these events are currently
Il- konsegwenzi fit- tul ta ’ dawn l- avvenimenti għandhom m’ humiex magħrufa.
Knowledge about the mechanism is incomplete.
It- tagħrif dwar dan il- proċess mhux magħruf.
A connection between visceral lipomatosis and protease inhibitors, and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Saret ipotesi dwar il- konnessjoni bjen lipomatożi vixxerali u impedituri ta ’ protease ma ’ lipoatrofija u impedituri ta ’ nucleoside reverse transcriptase.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju ogħla ta ’ lipodistrofija kien assoċjat ma ’ fatturi individwali bħalma huma età avvanzata u fatturi marbuta ma ’ mediċini bħal żmien itwal ta ’ trattament antiretrovirali u disturbi metaboliċi assoċjati mal- kura.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżaminazzjonijiet kliniċi għandhom jinkludu evalwazzjoni ta ’ sinjali fiżiċi li jindikaw ridistribuzzjoni tax- xaħam.
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.
Lipid disorders should be managed as clinically appropriate.
Disturbi fil- lipidi għandhom jiġu ttrattati kif ikun meħtieġ klinikament.
Liver function:
Funzjoni tal- fwied:
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 diġa jbatu minn disfunzjoni tal- fwied li tinkludi l- epatite kronika attiva, għandhom żdieda fil- frekwenza ta ’ anormalitajiet tal- funzjoni tal- fwied waqt it- terapija antiretrovirali kombinata u jeħtieġ li jiġu monitorjati skond il- prattika normali.
Patients with chronic hepatitis B or C infection treated with combination antiretroviral therapy are at increased risk of experiencing severe, and potentially fatal, hepatic adverse events.
Pazjenti b’ epatite kronika B jew Ċ ttrattati b’ terapija antiretrovirali kombinata huma f’ riskju akbar li jsofru minn avvenimenti avversi epatiċi severi jew potenzjalment fatali.
In case of concomitant antiviral therapy for hepatitis B or C, please also refer to the relevant Summary of Product Characteristics for these medicinal products.
Fil- każ ta ’ terapija antivirali konkomitanti għall- epatite B jew Ċ, jekk jogħġbok ara S- Sommarju tal- Karatteristiċi tal- Prodott rilevanti għal dawn il- prodotti mediċinali.
If there is evidence of exacerbations of liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk ikun hemm xi evidenza li l- mard tal- fwied imur għall- agħar fil- pazjenti, l- interruzzjoni jew it - twaqqif tat- trattament għandhom ikunu kkunsidrati.
Patients co-infected with hepatitis B virus (HBV):
Pazjenti infettati ukoll bil- virus ta ’ l- epatite B (HBV):
Emtricitabine is active in vitro against HBV.
Emtricitabine hija attiva in vitro kontra l- HBV.
However, limited data are available on the efficacy and safety of emtricitabine (as a 200 mg hard capsule once daily) in patients who are co-infected with HIV and HBV.
Madankollu, informazzjoni limitata hija disponibbli dwar is- sigurtà u l- effikaċja ta ’ emtricitabine (bħala kapsula iebsa ta ’ 200 mg darba kuljum) f’ pazjenti infettati wkoll bl- HIV u bl- HBV.
The use of emtricitabine in patient with chronic HBV induces the same mutation pattern in the YMDD motif observed with lamivudine therapy.
L- użu ta ’ emtricitabine f’ pazjenti b’ infezzjoni ta ’ l- HBV kronika jikkawża l- istess forma ta ’ mutazzjoni fil - motiv tal- YMDD bħal dak osservat bit- trattament b’ lamivudine.
The YMDD mutation confers resistance to both emtricitabine and lamivudine.
Il- mutazzjoni YMDD tikkawża reżistenza kemm għal emtricitabine u anke għal lamivudine.
Patients co-infected with HIV and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with emtricitabine for evidence of exacerbations of hepatitis.
Pazjenti infettati bl- HIV u bl- HBV għandhom jiġu mmonitorjati mill- qrib, b’ eżaminazzjonijiet kliniċi u tal- laboratorju, almenu għal diversi xhur wara li jitwaqqaf it- trattament b’ emtricitabine għal evidenza jekk l- epatite tmur għall- agħar.
Such exacerbations have been seen following discontinuation of emtricitabine treatment in HBV infected patients without concomitant HIV infection and have been detected primarily by serum alanine aminotransferase (ALT) elevations in addition to re-emergence of HBV DNA.
Aggravar bħal dan kien osservat wara li twaqqaf it- trattament b’ emtricitabine f’ pazjenti infettati bl- HBV mingħajr infezzjoni konkomitanti bl- HIV, u dan kien osservat primarjament permezz ta ’ żidiet fil- livell ta ’ alanine aminotransferase fis- serum (ALT) flimkien mad- dehra mill- ġdid tad- DNA tal- HBV.
In some of these patients, HBV reactivation was associated with more severe liver disease, including decompensation and liver failure.
F’ xi wħud minn dawn il- pazjenti, l- attivazzjoni mill - ġdid tal- HBV kienet assoċjata ma ’ mard tal- fwied iktar sever, li kien jinkludi d- dikumpens u l- kollass tal- fwied.
There is insufficient evidence to determine whether re-initiation of emtricitabine alters the course of post-treatment exacerbations of hepatitis.
M’ hemmx evidenza biżżejjed biex jiġi stabbilit jekk il- bidu mill- ġdid ta ’ emtricitabine jibdilx il- fatt li l- epatite tmur għall- agħar wara t- trattament.
Mitochondrial dysfunction:
Disfunzjoni mitokondrijali:
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Kemm in vivo, kif ukoll in vitro, deher li l- analogi tan- nukleosidi u tan - nukleotidi, jikkaġunaw gradi varjabbli ta ’ ħsara fil- mitokondrija.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/ or postnatally to nucleoside analogues.
Kien hemm rapporti ta ’ disfunzjoni tal- mitokondrija fi trabi li huma negattivi għal HIV li kienu esposti fl- utru u/ jew wara t- twelid għall - analogi tan- nukleosidi.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactataemia, hyperlipasaemia).
L- effetti avversi l- aktar komuni li kienu rrappurtati jinkludu disturbi ematoloġiċi (anemija, newrotropenja), u disturbi fil- metaboliżmu (iperlaktejtimja, iperlajpejżimja).
These events are often transitory.
Dawn l- effetti sikwit ikunu transitorji.
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Xi disturbi newroloġiċi li dehru iktar tard ġew irrappurtati (ipertonja, aċċessjoni, imġieba mhux normali).
Whether the neurological disorders are transient or permanent is currently unknown.
Bħalissa għadu mhux magħruf jekk dawn id- disturbi 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.
Dawn is- sejbiet m’ għandhomx
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
5 jaffettwa r- rakkomandazzjonijiet nazzjonali kurrenti għall- użu tat- terapija antiretrovirali f’ nisa tqal għall- prevenzjoni tat- trasmissjoni vertikali ta ’ HIV.
Immune Reactivation Syndrome:
Sindromu tar- Riattivazzjoni Immuni:
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.
F’ pazjenti infettati bl- HIV b’ defiċjenza immuni severa fiż- żmien tal- bidu tat- terapija antiretrovirali kombinata (combination antiretroviral therapy, CART), reazzjoni infjammatorja għal patoġeni opportunistiċi asintomatiċi jew residwali tista ’ sseħħ u tikkawża kundizzjonijiet kliniċi serji, jew tiggrava s- sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, reazzjonijiet bħal dawn kienu 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 carinii pneumonia.
Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/ jew fokali, u pulmonite tat- tip Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kwalunkwe sintomu ta ’ infjammazzjoni għandu jiġu evalwat u t- trattament jinbeda meta meħtieġ.
Osteonecrosis:
Osteonekrożi:
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
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.
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
In vitro, emtricitabine did not inhibit metabolism mediated by any of the following human CYP450 isoforms:
In vitro, emtricitabine ma impedixxix il- metaboliżmu medjat mill- iżoformi CYP450 umani li ġejjin:
1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4.
1A2, 2A6, 2B6, 2C9, 2C19, 2D6 u 3A4.
Emtricitabine did not inhibit the enzyme responsible for glucuronidation.
Emtricitabine ma impedixxix l- enzima responsabbli għall - glukoronidazzjoni.