qanastek/EMEA-V3 huggingface dataset:
Greater than 80% of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites.
Aktar minn 80% tar- radjuattività fl- awrina kienet magħmula minn metaboliti idrossilatati ikkonġugati ma 'glucuronide.
Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Għaldaqstant il- metaboliżmu ta 'ċitokroma P450, konġugazzjoni mal - glucuronide, u eliminazzjoni fl- awrina ta ’ dawn il- metaboliti ikkonġugati mal- glucuronide huma r - rotot ewlenin ta ’ kif nevirapine jiġi mibdul fil- ġisem tal- bniedem u jiġi eliminat.
Only a small fraction (< 5%) of the radioactivity in urine (representing < 3% of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Dan jindika li l- eliminazzjoni ta ’ nevirapine mill- kliewi hija baxxa ħafna.
The
Instab li nevirapine jistimula l- produzzjoni ta ’ enzimi metaboliċi tas- sistema P450 li tinsab fil- fwied.
19 pharmacokinetics of autoinduction are characterised by an approximately 1.5 to 2 fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg/ day.
Dan l- effett jikkaġuna farmakokinetiċi karaterizzati b' żjieda ta ’ minn madwar 1. 5 darbiet sa 2 fir- rata ta 'eliminazzjoni tad- doża orali ta ’ nevirapine hekk kif waqt it- trattament jissokta minn doża waħda ta ’ 200- 400 mg/ jum għal ġimagħtejn - erba ġimgħat.
Autoinduction also results in a corresponding decrease in the terminal phase half-life of nevirapine in plasma from approximately 45 hours (single dose) to approximately 25-30 hours following multiple dosing with 200-400 mg/ day.
Minħabba din l- eliminazzjoni jkun hemm tnaqqis bl - istess mod fl- aħħar fażi ta 'half- life ta' nevirapine fil- plażma, minn madwar 45 siegħa (doża waħda) sa madwar 25- 30 siegħa wara dożi multipli ta ’ 200- 400 mg/ jum.
Special populations:
Populazzjonijiet speċjali:
Renal dysfunction:
Problemi fil- kliewi:
The single-dose pharmacokinetics of nevirapine have been compared in 23 subjects with either mild (50 ≤ CLcr < 80 ml/ min), moderate (30 ≤ CLcr < 50 ml/ min) or severe renal dysfunction (CLcr< 30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 subjects with normal renal function (CLcr> 80 ml/ min).
Tmin suġġetti kellhom kliewi normali (CLcr > 80 ml/ min).
Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Indeboliment (ħafif, moderat, u qawwi) ma rriżulta fl - ebda bidla sinifikanti fil- farmakokinetika ta ’ nevirapine.
However, subjects with ESRD requiring dialysis exhibited a 43.5% reduction in nevirapine AUC over a one-week exposure period.
Madankollu, dawk li kienu morda bl- ESRD li kienu jinħtieġu dijaliżi, kellhom tnaqqis ta ’ 43. 5% fl- AUC ta ’ nevirapine, wara perijodu ta ’ ġimgħa fuq nevirapine.
There was also accumulation of nevirapine hydroxy-metabolites in plasma.
Kien hemm ukoll akkumulazzjoni ta 'metaboliti idrossilatati ta' nevirapine fil- plażma.
The results suggest that supplementing VIRAMUNE therapy with an additional 200 mg dose of VIRAMUNE following each dialysis treatment would help offset the effects of dialysis on nevirapine clearance.
Dawn ir- riżultati juru li għandha tiġi supplementata t- terapija b’ VIRAMUNE permezz ta ’ doża addizzjonali ta ’ 200 mg VIRAMUNE wara kull trattament ta 'dijaliżi, biex jagħmel tajjeb għall- iżbilanċ li jikkaġuna d- dijaliżi fir- rata ta' l- eliminazzjoni ta 'nevirapine mill- ġisem.
Otherwise patients with CLcr ≥ 20 ml/ min do not require an adjustment in VIRAMUNE dosing.
Pazjenti li għandhom rata ta ’ CLcr ta '≥ 20 ml/ min m’ għandhomx għalfejn jaġġustaw id - doża ta ’ VIRAMUNE.
Hepatic dysfunction: A steady state study comparing 46 patients with mild (n=17:
Sar studju ta ’ stadju fiss li qabbel 46 pazjent ma ’ fibrosi tal fwied ħafifa (n=17:
Ishak Score 1-2), moderate (n=20; Ishak Score 3-4), or severe (n=9; Ishak Score 5-6, Child-Pugh A in 8 pts., for 1 Child-Pugh score not applicable) liver fibrosis as a measure of hepatic impairment was conducted.
Punteġġ Ishak 1- 2), moderata (n=20; Punteġġ Ishak 3- 4), jew qawwija (n=9; Punteġġ Ishak 5- 6, Child- Pugh A fi 8 pti., mhux applikabbli għal punteġġ Child - Pugh 1) bħala kejl ta ’ indeboliment renali.
The patients studied were receiving antiretroviral therapy containing Viramune 200 mg twice daily for at least 6 weeks prior to pharmacokinetic sampling, with a median duration of therapy of 3.4 years.
Il- pazjenti studjati kienu qed jirċievu terapija antiretrovirali li fiha Viramune 200 mg darbtejn kuljum għal ta ’ lanqas 6 ġimgħat qabel ma ttieħdu l- kampjuni farmakokinetiċi, li damet sejra għal perijodu medjan ta ’ 3. 4 snin.
In this study, the multiple dose pharmacokinetic disposition of nevirapine and the five oxidative metabolites were not altered.
F’ dan l- istudju, id- dispożizzjoni farmakokinetika għal doża multipla ta ’ nevirapine u l- ħames metaboliti ossidattivi ma nbidlitx.
However, approximately 15% of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ ml (2 fold the usual mean trough).
Madankollu, madwar 15% ta ’ dawn il- pazjenti b’ fibrosi epatika kellhom konċentrazzjonijiet l- aktar baxxi ta ’ nevirapine ’ l fuq minn 9, 000 ng/ ml (darbtejn l- aktar livell medju baxx).
Patients with hepatic impairment should be monitored carefully for evidence of drug induced toxicity.
Pazjenti b’ indeboliment epatiku għandhom jiġu sorveljati b’ kawtela għal evidenza ta ’ tossiċità ikkaġunata mill- mediċina.
In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairment (Child-Pugh A, n=6; Child-Pugh B, n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
Fi studju farmakokinetiku b’ doża waħda ta ’ 200 mg nevirapine fuq pazjenti b’ riżultat negattiv ta ’ HIV b’ indeboliment epatiku ħafif u moderat (Child- Pugh A, n=6; Child- Pugh B, n=4) żieda sinifikanti fl - AUC ta ’ nevirapine kienet osservata f’ pazjent Child- Pugh B b’ axxite li jissuġerixxi li pazjenti b’ funzjoni epatika u axxite li sejrin għal agħar jistgħu jkunu f’ riskju li qed jakkumulaw nevirapine fis- sistema taċ- ċirkolazzjoni.
Because nevirapine induces its own metabolism with multiple dosing, this single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokinetics (see section 4.4).
Peress li nevirapine jinduċi l- metaboliżmu tiegħu stess b’ doża multipla, dan l- istudju b’ doża waħda jista ’ ma jirriflettiex l- impatt ta ’ indeboliment epatiku fuq il - farmakokinetika ta ’ doża multipla (ara sezzjoni 4. 4).
In the multinational 2NN study, a population pharmacokinetic substudy of 1077 patients was performed that included 391 females.
Fl- istudju multinazzjonali 2NN, sar sottostudju farmakokinetiku ta ’ popolazzjoni ta’ 1077 pazjent li kien jinkludi 391 mara.
Female patients showed a 13.8% lower clearance of nevirapine than did male patients.
Il- pazjenti nisa wrew rata ta ’ eliminazzjoni ta ’ nevirapine ta ’ 13. 8% inqas mill- irġiel.
This difference is not considered clinically relevant.
Din id- differenza mhix ikkonsidrata klinikament rilevanti.
Since neither body weight nor Body Mass Index (BMI) had influence on the clearance of nevirapine, the effect of gender cannot be explained by body size.
Peress li la l- piż tal- ġisem u lanqas il- Body Mass Index (BMI) ma kellhom influwenza fuq ir- rata ta ’ l- eliminazzjoni ta ’ nevirapine, 21 l- effett tal- ġens ma jistax jiġi spjegat bid- daqs tal- ġisem.
Nevirapine pharmacokinetics in HIV-1 infected adults do not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Il- farmakokinetika ta 'nevirapine f’ adulti b' HIV- 1 ma tinbidilx bl- età (fuq medda ta ’ 19- 68 snin) jew razza (Suwed, Ispaniċi, jew Kawkażi).
VIRAMUNE has not been specifically investigated in patients over the age of 65.
VIRAMUNE ma ġiex speċifikament studjat f’ pazjenti 'l fuq minn 65 sena.
Data concerning the pharmacokinetics of nevirapine has been derived from two major sources: a 48 week paediatric trial in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Dejta rigward il- farmakokinetika ta 'nevirapine kienet miksuba minn żewġ sorsi ewlenin: prova pedjatrika ta' 48 ġimgħa (BI 1100. 1368) li saret fl- Afrika t' Isfel li tinvolvi 123 HIV- 1 pazjenti pożittivi li huma inkonsapevoli li qed jieħdu mediċina antiretrovirali bejn l- etajiet ta '3 xhur u 16- il sena; u analiżi konsolidata ta' ħames protokolli tal- Paediatric AIDS Clinical Trials Group (PACTG) li kellhom 495 pazjent bejn l- etajiet ta '14- il jum u 19- il sena.
20 The results of the 48 week analysis of the South African study BI 1100.1368 confirmed that the 4/ 7 mg/ kg and 150 mg/ m2 nevirapine dose groups were well tolerated and effective in treating antiretroviral naïve paediatric patients.
Ir- riżultati ta 'din l- analiżi ta' 48 ġimgħa ta 'l- istudju BI 1100. 1368 ta' l- Afrika t' Isfel ikkonfermat li d - dożi ta 'nevirapine ta' 4/ 7 mg/ kg u 150 mg/ m2 kienu tollerati tajjeb u effettivament fit- trattament ta 'pazjenti pedjatri li ma jafux li qed jieħdu mediċina antiretrovirali.
A marked improvement in the CD4+ cell percent was observed through week 48 for both dose groups.
Titjib notevoli fil- perċentwali ta 'ċelluli CD4+ ġie osservat matul ġimgħa 48 għaż- żewġ gruppi dożati.
Also, both dosing regimens were effective in reducing the viral load.
Barra minn dan, iż- żewġ tipi ta ’ dożi kienu effettivi biex jonqos il- viral load.
In this 48 week study no unexpected safety findings were observed in either dosing group.
F' dan l- istudju ta '48 ġimgħa ma kienx hemm eżiti mhux mistennija dwar is- sigurtà osservati f' wieħed mill- gruppi.
Pharmacokinetic data on 33 patients (age range 0.77 – 13.7 years) in the intensive sampling group demonstrated that clearance of nevirapine increased with increasing age in a manner consistent with increasing body surface area.
Dejta farmakokinetika fuq 33 pazjent (età mifruxa bejn 0. 77 – 13. 7 sena) fil- grupp ta 'kampjuni intensivi wriet li r- rata ta' eliminazzjoni ta 'nevirapine żdiedet meta l- età żdidet b’ mod konsistenti ma ’ żjieda fl- erja superfiċjali korporali.
Dosing of nevirapine at 150 mg/ m2 BID (after a two-week lead in at 150 mg/ m2 QD) produced geometric mean or mean trough nevirapine concentrations between 4- 6 µg/ ml (as targeted from adult data).
Dożi ta 'nevirapine ta' 150 mg/ m2 BID (wara ġimagħtejn jingħataw b' 150 mg/ m2 QD) rriżultaw f' medja ġeometrika jew f' konċentrazzjonijiet minimi medji ta 'nevirapine ta' bejn 4- 6 µg/ ml (kif immirata minn dejta ta 'adulti).
In addition, the observed trough nevirapine concentrations were comparable between the two methods.
Barraminhekk, il- konċentrazzjonijiet minimi ta 'nevirapine osservati kienu komparabbli fiż- żewġ metodi.
The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
L- analiżi konsolidata ta 'protokolli 245, 356, 366, 377, u 403 tal- Paediatric AIDS Clinical Trials Group (PACTG) ippermettew għall- evalwazzjoni ta' pazjenti pedjatri li għandhom anqas minn 3 xhur (n=17) reklutati f' dawn l- istudji ta 'PACTG.
The plasma nevirapine concentrations observed were within the range observed in adults and the remainder of the paediatric population, but were more variable between patients, particularly in the second month of age.
Il- konċentrazzjonijiet ta 'nevirapine fil- plażma osservati kienu fi ħdan il- firxa osservata għal adulti u l- kumplament tal- popolazzjoni pedjatra, imma kienu aktar varjabbli bejn pazjenti, partikolarment fit- tieni xahar ta' età.
Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Tagħrif mhux kliniku żvela li m’ hemm l- ebda periklu speċjali għal bniedem, minbarra dawk osservati waqt l- istudji kliniċi msejsa fuq studji konvenzjonali dwar sigurtà, farmakoloġija, it- tossiċità ta ’ doża ripetitiva, u ġenotossiċità.
In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Studji fuq it- tossiċità waqt ir- riproduzzjoni żvelaw indeboliment tas - sistema riproduttiva fil- firien.
In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Fi studji dwar il- kanċeroġeniċità, instab li nevirapine jikkaġuna tumuri fil- fwied tal- firien u ġrieden.
These findings are most likely related to nevirapine being a strong inducer of liver enzymes, and not due to a genotoxic mode of action.
Dawn ir- riżultati x' aktarx huma aktar relatati mal- fatt li nevirapine huwa sensitizzatur qawwi ta 'l- enzini tal- fwied, u mhux minħabba mod t' azzjoni ġenotossika.
Microcrystalline cellulose Lactose monohydrate Povidone K25 Sodium starch glycolate Colloidal silicon dioxide Magnesium stearate
Microcrystalline cellulose, Lactose monohydrate, Povidone K25, Sodium starch glycolate, Colloidal silicon dioxide Magnesium stearate.
Polyvinyl chloride (PVC)/ aluminium foil push-through blister units (blister card of 7 tablets).
Pakkett tal- bidu tat- trattament Strixxa ta 'polyvinyl chloride (PVC) / aluminju magħmula minn bżieżaq singoli li timbotta (strixxa ta ’ 7 pilloli).
Cartons containing 2 blister cards (14 tablets).
Kartun li fihom 2 strixxi (14- il pillola).
Polyvinyl chloride (PVC)/ aluminium foil push-through blister units (blister card of 10 tablets).
Pakketti ta ’ manteniment Strixxa ta 'polyvinyl chloride (PVC) / aluminju magħmula minn bżieżaq singoli li timbotta (strixxa ta ’ 10 pilloli).
Cartons containing 6 or 12 blister cards (60 or 120 tablets).
Kartun li fihom 6 jew 12- il strixxa (60 jew 120 pillola).
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FS- SUQ
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Germany
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Il- Ġermanja
EU/ 1/ 97/ 055/ 001 (60 tablets) EU/ 1/ 97/ 055/ 003 (120 tablets) EU/ 1/ 97/ 055/ 004 (14 tablets)
EU/ 1/ 97/ 055/ 001 (60 pillola) EU/ 1/ 97/ 055/ 003 (120 pillola) EU/ 1/ 97/ 055/ 004 (14- il pillola)
5 February 1998 Date of latest renewal:
5 ta 'Frar 1998 Data ta' l- aħħar tiġdid:
10 January 2008
10 ta 'Jannar 2008
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
23 Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
VIRAMUNE 50 mg/ 5 ml oral suspension
VIRAMUNE 50 mg/ 5 ml suspensjoni orali
Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
Kull ml ta ’ suspensjoni orali fiha 10 mg/ ml ta 'nevirapine (bħala hemihydrate).
Each bottle contains 2.4 g of nevirapine.
Kull flixkun fih 2. 4 g ta ’ nevirapine
Excipient: each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
Sustanza mhix attiva: kull ml ta ’ suspensjoni orali fiha 150 mg sukkrosju, 162 mg sorbitol, 1. 8 mg ta ’ methyl parahydroxybenzoate u 0. 24 mg ta ’ propyl parahydroxybenzoate.
Oral suspension
Suspensjoni orali
White to off-white homogenous suspension.
Suspensjoni orali omoġenja ta 'lewn bajdani għal bajdani matt.
VIRAMUNE is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4).
VIRAMUNE huwa intiż biex jingħata flimkien ma ’ prodotti mediċinali anti- retrovirali oħra għat - trattament ta ’ adulti, adoloxxenti u tfal ta ’ kwalunkwe età infettati bl- HIV- 1 (ara sezzjoni 4. 4).
Most of the experience with VIRAMUNE is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
L- aktar esperjenza miksuba b’ VIRAMUNE hija meta jintuża ma ’ impedituri ta 'l- enzima nucleoside reverse transcriptase (NRTI’ s).
The total daily dose should not exceed 400 mg for any patient.
Id- doża globali ta 'kuljum m' għandhiex taqbeż aktar minn 400 mg għal kwalunkwe pazjent.
VIRAMUNE may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows:
VIRAMUNE għandu jiġi dożat f' pazjenti pedjatriċi jew skond l- erja superfiċjali korporali (BSA) jew permezz tal- piż korporali kif ġej:
By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/ m2 once daily for two weeks followed by 150 mg/ m2 twice daily thereafter.
B' BSA permezz tal- formula Mosteller id- doża orali rakkomandata għal pazjenti pedjatriċi ta 'kull età hi ta' 150 mg/ m2 darba kuljum għal ġimagħtejn segwita minn 150 mg/ m2 darbtejn kuljum wara dan.
23 Calculation of the volume of Viramune® oral suspension (50 mg/ 5 ml) required for paediatric dosing on a body surface basis of 150 mg/ m2:
Kalkulazzjoni tal- volum ta 'suspensjoni orali ta' Viramune® oral (50 mg/ 5 ml) meħtieġa għal doża pedjatrika fuq bażi ta 'erja superfiċjali korporali ta' 150 mg/ m2:
BSA range (m2) 0.08 – 0.25 0.25 – 0.42 0.42 – 0.58 0.58 – 0.75 0.75 – 0.92 0.92 – 1.08 1.08 – 1.25 1.25+
25
Volume (ml) 2.5 5 7.5 10 12.5 15 17.5 20
Firxa ta 'BSA (m2) 0. 08 – 0. 25 0. 25 – 0. 42 0. 42 – 0. 58 0. 58 – 0. 75 0. 75 – 0. 92 0. 92 – 1. 08 1. 08 – 1. 25 1. 25+
Mosteller Formula:
Volum (ml) 2. 5 5 7. 5 10 12. 5 15 17. 5 20
BSA (m2) =
BSA (m2) = Formula Mosteller:
(cm) x Wt (kg) 3600
Tul (cm) x Piz (kg) 3600
By weight the recommended oral dose for paediatric patients up to 8 years of age is 4 mg/ kg once daily for two weeks followed by 7 mg/ kg twice daily thereafter.
Id- doża orali rakkomandata skond il- piż għal pazjenti pedjatriċi sakemm ikollhom 8 snin hi ta '4 mg/ kg darba kuljum għal ġimagħtejn segwita b' 7 mg/ kg darbtejn kuljum wara.
For patients 8 years and older the recommended dose is 4 mg/ kg once daily for two weeks followed by 4 mg/ kg twice daily thereafter.
Għal pazjenti ta '8 snin jew aktar id- doża rakkomandata hi ta' 4 mg/ kg darba kuljum għal ġimagħtejn segwita b' 4 mg/ kg darbtejn kuljum wara dan.
Calculation of the volume of Viramune® oral suspension (50 mg/ 5 ml) required for paediatric dosing after the two weeks lead-in period.
Il- kalkulazzjoni tal- volum ta 'suspensjoni orali ta' Viramune® (50 mg/ 5 ml) meħtieġa għal doża pedjatrika wara ġimagħtejn ta 'perijodu tal- bidu.
Weight Range (kg) for Weight Range (kg) for
Il- Firxa tal- Piżijiet (kg) għal pazjenti < 8 snin
patients < 8 yrs of age on a body weight basis receiving 7 mg/ kg.
fuq bażi ta 'piż korporali li qed jirċievu 7 mg/ kg.
patients ≥ 8 years of age on a body weight basis receiving 4 mg/ kg.
bażi ta 'piż korporali li qed jirċievu 4 mg/ kg.
1.79 – 5.36 5.36 – 8.93 8.93 – 12.50 12.50 – 16.07 16.07 – 19.64 19.64 – 23.21 23.21 – 26.79 26.79+
1. 79 – 5. 36 5. 36 – 8. 93 8. 93 – 12. 50 12. 50 – 16. 07 16. 07 – 19. 64 19. 64 – 23. 21 23. 21 – 26. 79 26. 79+
3.13 – 9.38 9.38 – 15.63 15.63 – 21.88 21.88 – 28.12 28.12 – 34.37 34.37 – 40.62 40.62– 46.88 46.88+
3. 13 – 9. 38 9. 38 – 15. 63 15. 63 – 21. 88 21. 88 – 28. 12 28. 12 – 34. 37 34. 37 – 40. 62 40. 62 – 46. 88 46. 88+
2.5 5 7.5 10 12.5 15 17.5 20
2. 5 5 7. 5 10 12. 5 15 17. 5 20
All patients less than 16 years of age receiving VIRAMUNE oral suspension should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
Il- pazjenti kollha li għandhom anqas minn 16- il sena li jirċievu s- suspensjoni orali VIRAMUNE għandu jkollhom l- piż u l- BSA tagħhom iċċekkjata ta ’ spiss sabiex jiġi assessjat jekk aġġustamenti fid- doża hux meħtieġ.
The recommended dose for VIRAMUNE is 20 ml (200 mg) oral suspension once daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by 20 ml (200 mg) oral suspension twice daily, in combination with at least two additional antiretroviral agents.
Id- doża rakkomandata ta ’ VIRAMUNE hi ta ’ 20 ml (200 mg) suspensjoni orali darba kuljum għal 14 - il jum (dal- perijodu ta ’ introduzzjoni huwa meħtieġ għax instab li titnaqqas l- frekwenza li jitrabba raxx), segwit minn 20 ml (200 mg) suspensjoni orali darbtejn kuljum, flimkien ma ’ mill- anqas żewġ sustanzi anti- retrovirali.
It is important that the entire measured dose of VIRAMUNE oral suspension is administered.
Huwa importanti li tingħata d- doża miżurata kollha tas- suspensjoni orali ta 'VIRAMUNE.
This is assisted by the use of the supplied dispensing syringe.
Dan hu possibbli bl- użu ta 'siringa għat- teħid li hija fornuta.
If an alternative measuring device is used (e. g. a dispensing cup or teaspoon for larger doses) it is important that the device is rinsed to ensure complete removal of residual oral suspension.
Jekk jintuża xi mezz ta 'kejl ieħor (eż. kikkra għat- teħid, jew mgħarfa għal dożi akbar) huwa importanti li l- mezz jiġi mlaħlaħ sew biex jiġi żgurat li ma jkunx hemm fdal tas- suspensjoni orali.
24 particularly adolescents, weighing 50 kg or more or whose BSA is above 1.25 m2.
VIRAMUNE jiġi wkoll f' pilloli ta '200 mg għal pazjenti li għandhom 16- il sena jew aktar, jew għal tfal akbar, b' mod partikolari adoloxxenti, li jiżnu 50 kg jew aktar jew li għandhom BSA hu akbar minn 1. 25 m2.
VIRAMUNE may be taken with or without food.
26 VIRAMUNE jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Renal impairment For patients with renal dysfunction requiring dialysis an additional 200 mg dose of VIRAMUNE following each dialysis treatment is recommended.
Indeboliment fil- kliewi Huwa rakkomandat li għal pazjenti li għandhom problemi fil- kliewi li jinħtieġu d- dijaliżi, 200 mg addizzjonali ta ’ VIRAMUNE huma meħtieġa wara kull trattament ta ’ dijaliżi.
Hepatic impairment VIRAMUNE should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Indeboliment fil- fwied VIRAMUNE m’ għandux jingħata lil pazjenti li għandhom indeboliment epatiku sever (Child- Pugh C ara sezzjoni 4. 3).
Patients experiencing rash during the 14-day lead-in period of 200 mg/ day (4 mg/ kg/ day or 150 mg/ m2/ day for paediatric patients) should not have their VIRAMUNE dose increased until the rash has resolved.
Pazjenti li jiżviluppaw raxx fil- perijodu inizjali ta ’ 14- il jum b’ 200 mg/ jum (4 mg/ kg/ kuljum jew 150 mg/ m2/ kuljum għal pazjenti pedjatriċi) m’ għandhomx jingħataw żjieda fid- doża ta ’ VIRAMUNE qabel ma jitfejqu mir- raxx.
VIRAMUNE must not be used in patients with severe hepatic impairment (Child-Pugh C) or pre- treatment ASAT or ALAT > 5 ULN until baseline ASAT/ ALAT are stabilised < 5 ULN.
VIRAMUNE m’ għandux jingħata 'l pazjenti li għandhom indeboliment serju tal- fwied (Child- Pugh C) jew' l ASAT jew ALAT > 5 ULN ta ’ qabel it- trattament sakemm il- linja ta 'referenza bażi ASAT/ ALAT tkun stabbli f ’ < 5 ULN.
VIRAMUNE must not be readministered in patients who previously had ASAT or ALAT > 5 ULN during VIRAMUNE therapy and had recurrence of liver function abnormalities upon readministration of VIRAMUNE (see section 4.4).
VIRAMUNE m’ għandux jerġa ’ jingħata lill- pazjenti li kellhom ASAT jew ALAT > 5 ULN waqt terapija b’ VIRAMUNE, u li kellhom mill- ġdid abnormalitàjiet fil- funzjoni tal- fwied meta reġgħu ngħataw VIRAMUNE (ara sezzjoni 4. 4).
25 The first 18 weeks of therapy with VIRAMUNE are a critical period which requires close monitoring of patients to disclose the potential appearance of severe and life-threatening skin reactions (including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) or serious hepatitis/ hepatic failure.
27 L- ewwel 18- il ġimgħa ta 'trattament b’ VIRAMUNE huwa perijodu kritiku li jeħtieġ monitoraġġ mill- viċin biex jinkixfu sinjali li jistgħu jintwerew f’ każijiet ta ’ reazzjonijiet qawwija fil- ġilda li jistgħu jwasslu sal- mewt (li jinkludu każijiet ta' sindromu Stevens- Johnson (SJS) u nekroliżi tossika epidermali (TEN)) jew każijiet ta ’ epatite serja / insuffiċjenza tal- fwied.
The greatest risk of hepatic events and skin reactions occurs in the first 6 weeks of therapy.
L- ogħla riskju għal każijiet epatiċi u għal reazzjonijiet fil- ġilda jseħħu fl- ewwel 6 ġimgħat tat - terapija.
However, the risk of any hepatic event continues past this period and monitoring should continue at frequent intervals.
Madankollu, ir- riskju ta 'avveniment epatiku jkompli wara dan il- perijodu u l - monitoraġġ għandu jitkompla f' intervalli frekwenti.
Unless the benefit outweighs the risk VIRAMUNE should not be initiated in adult females with CD4 cell counts greater than 250 cells/ mm3 or in adult males with CD4 cell counts greater than 400 cells/ mm3.
Ħlief meta s - siwi huwa ogħla mir- riskju VIRAMUNE m' għandux jiġi mibdi f' nisa adulti meta l- għadd ta 'ċelluli CD4 tagħhom ikun ogħla minn 250 ċellula/ mm3 jew f' irġiel adulti b' għadd ta' ċelluli ogħla minn 400 ċellula/ mm3.
Viramune must not be restarted following severe hepatic, skin or hypersensitivity reactions (see section 4.3).
VIRAMUNE m' għandux jinbeda mill- ġdid wara reazzjonijiet epatiċi u tal- ġilda serji jew reazzjonijiet ta 'sensittività eċċessiva (ara sezzjoni 4. 3).
These have included cases of Stevens- Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Dawn kienu jinkludu każijiet tas- sindrome ta 'Stevens- Johnson, nekroliżi epidermali tossika, reazzjonijiet ta ’ ipersensittività kkaratterizzati b’ raxx, sinjali fuq il- ġisem u problemi vixxerali.
Patients should be intensively monitored during the first 18 weeks of treatment.
Il- pazjenti għandhom ikunu osservati mill- qrib ħafna b’ mod intensiv fl- ewwel 18- il ġimgħa tat- trattament.
VIRAMUNE must be permanently discontinued in any patient experiencing severe rash or a rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), including Stevens-Johnson syndrome, or toxic epidermal necrolysis.
VIRAMUNE għandu jiġi mwaqqaf b' mod permanenti kemm- il darba l- pazjenti jsofru minn raxx qawwi jew raxx flimkien ma ’ sintomi oħrajn fil- ġisem (bħalma huma deni, infafet, leżjonijiet fil- ħalq, konġjuntivite, edema fil- wiċċ, uġigħ fil- muskoli jew ġogi, jew telqa fil- ġisem kollu), li jinkludu wkoll is- sindromu ta 'Stevens- Johnson, jew nekroliżi epidermali tossika.
VIRAMUNE must be permanently discontinued in any patient experiencing hypersensitivity reaction (characterised by rash with constitutional symptoms, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction) see section 4.4.
VIRAMUNE għandu jitwaqqaf b' mod permanenti f’ kull pazjent li jiżviluppa reazzjoni ta 'sensittività eċċessiva (karatterizzata b’ raxx u sintomi oħrajn fil- ġisem, problemi vixxerali, bħal epatite, eosinofilja, granuloċitopenija, u disfunzjoni renali), ara sezzjoni 4. 4.
Concomitant prednisone use (40 mg/ day for the first 14 days of VIRAMUNE administration) has been shown not to decrease the incidence of VIRAMUNE-associated rash, and may be associated with an increase in incidence and severity of rash during the first 6 weeks of VIRAMUNE therapy.
Instab li meta jingħata wkoll prednisone (40 mg/ jum waqt l- ewwel 14- il jum li jingħata VIRAMUNE) mhux talli ma jkunx hemm tnaqqis fl- inċidenza ta 'raxx ikkaġunat minn VIRAMUNE iżda jista ’ jkun assoċjat ma ’ żjieda fl- inċidenza u l- ħruxija ta' raxx waqt l- ewwel 6 gimgħat ta 'terapija b’ VIRAMUNE.
Some risk factors for developing serious cutaneous reactions have been identified, they include failure to follow the initial dosing of 200 mg daily (4 mg/ kg or 150 mg/ m2 for paediatric patients) during the lead-in period and a long delay between the initial symptoms and medical consultation.
Dawn jinkludu meta d- dożaġġ inizjali ta ’ 200 mg kuljum (4 mg/ kg jew 150 mg/ m2 għall- pazjenti pedjatriċi) waqt l- ewwel perijodu tat- trattament ma jitkompliex, kif ukoll meta jkun hemm dewmien twil meta jiżvillupaw l - ewwel sintomi u jkun hemm konsulta medika.
Women appear to be at higher risk than men of developing rash, whether receiving VIRAMUNE or non- VIRAMUNE containing therapy.
In- nisa jidhru li huma f' riskju ogħla mill- irġiel li jiżviluppaw raxx, kemm jekk jieħdu VIRAMUNE kif ukoll jekk ikunu taħt terapija mingħajr VIRAMUNE.
Patients should be instructed that a major toxicity of VIRAMUNE is rash.
28 Pazjenti għandhom ikunu mgħarrfa li r- raxx huwa tossiċità ewlenija ta ’ VIRAMUNE.
Patients should be instructed that dose escalation is not to occur if any rash occurs
Il- pazjenti għandhom jingħataw parir li jekk jiżviluppalhom raxx waqt l- ewwel ġimagħtejn fil- perijodu inizjali, m’ għandhomx iżidu d- doża, sakemm ir- raxx jisparixxi.
Careful monitoring of paediatric patients is especially warranted, particularly in the first 18 weeks of treatment, since these patients may be less likely than adults to notice, or report, skin reactions.
Monitoraġġ b' reqqa f' pazjenti pedjatriċi huwa tassew essenzjali, b' mod partikolari fl- ewwel 18- il ġimgħa ta 'trattament, imbilli dawn il- pazjenti jafu ma jindunawx jew ma jirrapportawx bħal kbar li għandhom reazzjoni tal- ġilda.
Any patient experiencing severe rash or a rash accompanied by constitutional symptoms such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise should discontinue the medicinal product and immediately seek medical evaluation.
Kull pazjent li jiżviluppa raxx serju, jew kull raxx flimkien ma ’ sintomi oħrajn fil- ġisem bħal deni, infafet, feriti fil- ħalq, konġjuntivite, edema fil- wiċċ, uġigħ fil- muskoli jew ġogi, jew telqa fil- ġisem kollu, għandu jwaqqaf il- prodott mediċinali u minnufih jitlob għal evalwazzjoni medika.
Severe and life-threatening hepatoxicity, including fatal fulminant hepatitis, has occurred in patients treated with VIRAMUNE.
Tossiċità serja tal- fwied u li hija gravi tista 'tkun fatali, li tinkludi epatite fulminanti fatali ġrat f' pazjenti trattati b' VIRAMUNE.
However the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.
Madankollu r- riskju jissokta wara dan il- perijodu u l- monitoraġġ għandu jibqa ’ fuq frekwenza spissa waqt it- trattament.
Female gender and patients with higher CD4 counts are at increased risk of hepatic adverse events.
Il- ġens feminil u pazjenti li għandhom l- għadd ta 'CD4 ogħla huma f' riskju akbar ta' każijiet epatiċi avversi.
In a retrospective review, women with CD4 counts > 250 cells/ mm3 had a 12 fold higher risk of symptomatic hepatic adverse events compared to women with CD4 counts < 250 cells/ mm3 (11.0% versus 0.9%).
0. 9%).
An increased risk was observed in men with CD4 counts > 400 cells/ mm3 (6.3% versus 1,2% for men with CD4 counts < 400 cells/ mm3).
Riskju akbar kien osservat f' irġiel li kellhom l- għadd ta 'ċelluli CD4 > 400 ċelluli/ mm3 (6. 3% kontra 1. 2%) meta mqabbla ma ’ dawk l- irġiel li għandhom l - għadd ta ’ ċelluli CD4 < 400 ċelluli/ mm3.
Patients should be informed that hepatic reactions are a major toxicity of VIRAMUNE requiring a close monitoring during the first 18 weeks.
Il- pazjenti għandhom ikunu mgħarrfa li reazzjonijiet fil- fwied huma riżultat ta ’ tossiċità qawwija minn VIRAMUNE, li tinħtieġ osservazzjoni mill- qrib fl- ewwel 18- il ġimgħa.
They should be informed that occurrence of symptoms suggestive of hepatitis should lead them to discontinue VIRAMUNE and immediately seek medical evaluation, which should include liver function tests.
Għandhom ikunu wkoll infurmati li jekk jiżviluppaw sintomi ta ’ epatite, dan għandu jwassalhom biex iwaqqfu VIRAMUNE
Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a
Żjieda fil- livelli ta ’ l- enzimi tal- fwied mingħajr sintomi, ġew irrapportati kemm- il darba u mhux neċessarjament huma kontra- indikazzjoni għal użu ta ’ VIRAMUNE.
Asymptomatic GGT elevations are not a contraindication to continue therapy.
Żjieda fil- livell ta 'GGT mingħajr sintomi mhux kontra- indikazzjoni biex titkompla t- terapija.
Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3rd month and then regularly thereafter.
Monitoraġġ ta 'testijiet tal- fwied għandhom isiru kull ġimagħtejn fl- ewwel xahrejn ta' trattament, fit- 3 xahar u wara dan jibqgħu sejrin b’ mod regolari.
Liver test monitoring should be performed if the patient experiences signs or symptoms suggestive of hepatitis and/ or hypersensitivity.
Dawn jibqgħu jsiru kemm- il darba l- pazjent jiżviluppa sinjali jew sintomi li huma suuġestivi li hemm epatite jew/ u ipersensittività.
If ASAT or ALAT > 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
Jekk l- għadd ASAT jew ALAT > 2. 5 ULN qabel jew waqt it- trattament, it- testijiet ta 'fwied iridu jiġu ssorveljati aktar ta' spiss waqt il- visti regolari fil- klinika.
If ASAT and ALAT return to baseline values and if the patient had no clinical signs or symptoms of hepatitis, rash, constitutional symptoms or other findings suggestive of organ dysfunction, it may be possible to reintroduce VIRAMUNE, on a case by case basis, at the starting dosage regimen of 200 mg/ day for 14 days followed by 400 mg/ day.
Jekk l- għadd ASAT u ALAT imur lura għal linja bażi ta 'riferiment u jekk il- pazjent ma juri l- ebda sinjal kliniku jew sintomu kostituzzjonali ta ’ l- epatite, raxx, sintomi oħrajn fil- ġisem, jew riżultati oħrajn li jagħtu ħjiel ta ’ xi organu mhux jaħdem tajjeb, jista' jkun possibbli li jerġa 'jingħata VIRAMUNE, skond il- każ, fid- doża tal- bidu li hi ta ’ 200 mg/ jum għal 14- il jum u wara tiżdied għal 400 mg/ jum.
If liver function abnormalities recur, VIRAMUNE should be permanently discontinued.
Jekk jirriżulta li l- funzjoni tal- fwied tkun abnormali, VIRAMUNE għandu jitwaqqaf b' mod permanenti.
If clinical hepatitis occurs, characterised by anorexia, nausea, vomiting, icterus AND laboratory findings (such as moderate or severe liver function test abnormalities (excluding GGT), VIRAMUNE must be permanently stopped.
Jekk tiżviluppa epatite klinika li tkun ikkaratterizzata minn anoreksja, tqallih, rimettar, icterus FLIMKIEN MA ’ riżultati fil- laboratorju (bħal abnormalità moderata jew qawwija fil- funzjoni tal- fwied, eskluż il- GGT), VIRAMUNE għandu jitwaqqaf għal dejjem.
VIRAMUNE is contraindicated in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
VIRAMUNE huwa kontra- indikat f’ pazjenti li għandhom indeboliment qawwi fil- fwied (Child- Pugh C, ara sezzjoni 4. 3).
In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Jekk fl- istess waqt tkun qed tingħata terapija anti- virali kontra l- epatite B jew Ċ, jekk jogħġbok ara l- informazzjoni rilevanti ta ’ dawn il- mediċini.
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.
Dawn il- pazjenti għandhom ikunu sorveljati skond il- prattika standard.
Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of VIRAMUNE in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Profilassi ta 'wara l- espożizzjoni: epatotossiċità serja, li tinkludi insuffiċjenza tal- fwied li tkun teħtieġ trapjantar, ġiet rapportata f' individwi mhux infettati b' HIV li qed jirċievu dożi multipli ta' VIRAMUNE bħala profilassi ta 'wara l- espożizzjoni (PEP), f' użu mhux approvat.
Combination therapy with VIRAMUNE is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
Terapija kkombinata li fiha VIRAMUNE mhix trattament kurattiv fuq pazjenti infettati b' HIV- 1; il - pazjenti jistgħu jibqgħu jkomplu jimirdu b’ infezzjoni avvanzata ta 'HIV- 1, kif ukoll b’ infezzjonijiet opportunistiċi.
28 Combination therapy with VIRAMUNE has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or contaminated blood.
Terapija kkombinata b' VIRAMUNE ma tnaqqas ir- riskju biex l- HIV- 1 jgħaddi lil ħaddieħor b 'kuntatt sesswali jew permezz ta ’ demm infettat.
For this reason, and to reduce the risk of HIV transmission, barrier contraception (e. g. condoms) is recommended.
Għal din ir- raġuni, u biex jitnaqqas ir- riskju tal- firxa ta 'HIV, l- użu ta ’ kontraċettivi li jostakolaw fiżikament (eż. kondoms) huma rakkomandati.
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 ġie assoċjat ma ’ fatturi individwali bħal xjuħija, kif ukoll ma ’ fatturi konnessi ma 'mediċini bħal perijodu itwal ta ’ trattament anti- retrovirali u disturbi metaboliċi assoċjati.
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.
Sindromu ta 'Riattivazzjoni Immunitarja: F' pazjenti infettati b' HIV li għandhom defiċjenza immunitarja serja fiż- żmien li tibda tingħata t- terapija anti- retrovirali konġunta (CART), jista' jkun hemm reazzjoni infjammatorja għal patoġeni opportunisti asintomatiċi jew residwi li jistgħu jikkaġunaw kundizzjonijiet kliniċi serji, jew jaggravaw is- sintomi.
The available pharmacokinetic data suggest that the concomitant use of rifampicin and VIRAMUNE is not recommended (please also refer to section 4.5).
31 Id- dejta farmakokinetika disponibbli tissuġerixxi li l- użu ta ’ VIRAMUNE flimkien ma ’ rifampicin mhux rakkomandat (jekk jogħġbok irreferi wkoll għal sezzjoni 4. 5).
VIRAMUNE oral suspension contains 150 mg of sucrose per ml.
Is- sopensjoni orali VIRAMUNE fiha 150 mg ta ’ sukrożju kull ml.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fruttożju, assorbiment ħażin ta ’ glukozju- galattozju jew insuffiċjenza ta ’ sukrozju- isomaltase m’ għandhomx jieħdu din il- mediċina.
VIRAMUNE oral suspension contains 162 mg of sorbitol per ml.
Is- suspensjoni orali VIRAMUNE fiha 162 mg ta ’ sorbitol kull ml.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fruttożju, m’ għandhomx jieħdu din il- mediċina.
Methyl and propyl parahydroxybenzoates:
Methyl u propryl parahydroxybenzoates:
VIRAMUNE oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Is- suspensjoni orali VIRAMUNE fiha methyl parahydroxybenzoate u propyl parahydroxybenzoate, li jistgħu jikkawżaw reazzjonijiet allerġiċi serji (possibilment ittardjati),
Careful monitoring of the therapeutic effectiveness of P450
Komposti li jużaw dan il- passaġġ metaboliku jista ’ jkollhom konċentrazzjonijiet imnaqqsa fil- plażma meta jingħataw flimkien ma ’ VIRAMUNE.
29 metabolised medicinal products is recommended when taken in combination with VIRAMUNE.
Monitoraġġ kawt ta ’ l- effettività terapewtika ta ’ prodotti mediċinali metabolizzati minn P450 hu rakkomandat meta jingħataw flimkien ma ’ VIRAMUNE.
The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
Id- dejta dwar l- interazzjonijiet hu ppreżentat bħala valur ġeometriku medju b’ intervall ta ’ kunfidenza ta ’ 90% (90% CI) kull meta dawn il- valuri kienu disponibbli.
ND = Not Determined, ↑ = Increased, ↓ = Decreased, ↔ = No Effect
ND - Mhux Stabbilit, ↑ = Żdied, ↓ = Tbaxxa, ↔ = Ebda Effett
Lamivudine and VIRAMUNE can be co-administered without dose adjustments.
32 Stavudine AUC ↔ 0. 96 (0. 89- 1. 03) Stavudine:
Nevirapine plasma levels were not altered by co-administration of tenofovir.
Il- livelli ta ’ nevirapine fil- plażma ma nbiddlux bl- għoti fl- istess ħin ta ’ tenofovir.
Zidovudine and VIRAMUNE can be co-administered without dose adjustments
jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża
Zidovudine had no effect on its pharmacokinetics.
Zidovudine ma kellux effett fuq il- farmakokinetiċi tiegħu.
It is not recommended to co- administer efavirenz and VIRAMUNE, because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone.
VIRAMUNE jingħataw flimkien, minħabba tossiċità adittiva u ebda siwi f’ termini tal- effikaċja ta ’ ebda mill - NNRTI waħedhom.
30 PIs Atazanavir/ ritonavir 300/ 100 mg QD 400/ 100 mg QD
Atazanavir/ ritonavir
Atazanavir/ r 300/ 100mg:
Atazanavir/ r300/ 100mg:
Atazanavir/ r 400/ 100mg:
Atazanavir/ r Cmax ↓ 0. 72 (0. 60- 0. 86)
31 Lopinavir/ ritonavir (capsules) 400/ 100 mg BID
(kapsuli) 400/ 100 mg
An increase in the dose of lopinavir/ ritonavir to 533/ 133 mg (4 capsules) or 500/ 125 mg (5 tablets with 100/ 25 mg each) twice daily with food is recommended in combination with VIRAMUNE.
500/ 125 mg (5 pilloli b’ 100/ 25 kull waħda) darbtejn kuljum mal- ikel hi rakkomandata flimkien ma ’ VIRAMUNE.
Dose adjustment of VIRAMUNE is not required when co-administered with lopinavir.
Aġġustament fid- doża ta ’ VIRAMUNE mhux meħtieġ meta jingħata flimkien ma ’ lopinavir.
Lopinavir/ ritonavir (oral solution) 300/ 75 mg/ m2 BID
(soluzzjoni orali) 300/ 75 mg/ m2 BID
Nelfinavir and VIRAMUNE can be
Nelfinavir u VIRAMUNE jistgħu
750 mg TID
AUC ↔ 1. 06 (0. 78- 1. 14) 750 mg TID
AUC ↔ 1.06 (0.78-1.14) Cmin ↔ 0.68 (0.50-1.5) Cmax ↔ 1.06 (0.92-1.22)
Cmin ↔ 0. 68 (0. 50- 1. 5) Cmax ↔ 1. 06 (0. 92- 1. 22)
co-administered without dose adjustments.
jingħataw flimkien mingħajr aġġustamenti fid- doża.
32 Entry Inhibitors Enfuvirtide
Enfuvirtide
Integrase Inhibitors Raltegravir 400 mg BID
35 Impedituri ta ’ Integrase Raltegravir 400 mg BID Antibijotiċi
33 Rifabutin 150 or 300 mg QD
150 jew 300 mg QD
Physicians needing to treat patients
Tobba li jeħtieġu jittrattaw pazjenti
co-infected with tuberculosis and using a VIRAMUNE containing regimen may consider co- administration of rifabutin instead.
ko- infettati bit- tuberkolożi u li qed jużaw kors maħsub li fih VIRAMUNE jistgħu jikkunsidraw li jjagħtu rifabutin fl- istess ħin minfloku.
Antifungals Fluconazole 200 mg QD
Itraconazole AUC ↓ 0. 39
34 ANTACIDS Cimetidine
ANTAĊIDI Cimetidine
Cimetidine: no significant effect on cimetidine PK parameters is seen.
Cimentidine: ma deher l- ebda effett sinifikanti fuq il- parametri PK ta ’ cimetidine.
Cimetidine and VIRAMUNE can be co-administered without dose adjustments.
Cimetidine u VIRAMUNE jistgħu jingħataw flimkien mingħajr aġġustamenti fid- doża.
CONTRACEPTIVES
KONTRAĊETTIVI
Viramune co-administration did not
L- għoti flimkien ta ’ VIRAMUNE ma
medroxyprogesterone acetate (DMPA) 150 mg every 3
medroxyprogesterone
alter the ovulation suppression effects of DMPA.
bidilx l- effetti tat- trażżin tal -
Nevirapine AUC ↑ 1.20 Nevirapine Cmax ↑ 1.20
DMPA u VIRAMUNE jistgħu jintużaw mingħajr aġġustamenti fid- doża.
Norethindrone (NET) 1.0 mg QD
37 NET AUC ↓ 0. 81 (0. 70 - 0. 93) Norethindrone (NET)
Herbal preparations containing St.
Taħlitiet bi ħxejjex li jkun fihom St.
John‘ s Wort check nevirapine and if possible viral levels and stop St John‘ s Wort.
John’ s Wort, iċċekkja l - livell ta ’ nevirapine u jekk possibbli l - livelli virali u waqqaf St John’ s Wort.
Nevirapine levels may increase on stopping St John‘ s Wort.
Il- livelli ta ’ nevirapine jistgħu jiżdiedu malli St John’ s Wort jitwaqqaf.
35 Other information:
Tagħrif ieħor:
Nevirapine readily crosses the placenta and is found in breast milk.
38 Nevirapine faċilment jaqsam is- sekonda u jinsab fil- ħalib tas- sider.
It is recommended that HIV infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving VIRAMUNE.
Huwa rakkomandat li ommijiet infettati b' HIV ma jreddgħux lill- uliedhom biex jevitaw ir- riskju li jgħaddu l- HIV wara t- twelid u li l- ommijiet għandhom jieqfu jreddgħu jekk ikunu qed jieħdu VIRAMUNE.
The most frequently reported adverse reactions related to VIRAMUNE therapy, across all clinical trials, were rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache and myalgia.
L- aktar reazzjonijiet avversi rapportati ta ’ spiss waqt il- provi kliniċi kollha li saru bit- terapija ta 'VIRAMUNE, kienu: raxx, reazzjonijiet allerġiċi, epatite, testijiet abnormali tal- funzjonament tal - fwied, tqallih, rimettar, dijarea, uġigħ addominali, għeja, deni, uġigħ ta ’ ras u uġigħ fil- muskoli.
36 The postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome and toxic epidermal necrolysis and serious hepatitis/ hepatic failure and hypersensitivity reactions, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
L- esperjenza ta ’ wara li l- prodott tqiegħed fis- suq uriet li l- aktar effetti mhux mixtieqa serji huma: is - sindromu ta ’ Stevens- Johnson, nekroliżi tossika epidermali, epatite serja / insuffiċjenza tal- fwied, reazzjonijiet ta ’ sensittività eċċessiva li huma kkaratterizzati b’ raxx u sintomi avversi fil- ġisem bħad - deni, artalaġja, uġigħ fil- muskoli, u limfodenopatija, kif ukoll problemi vixxerali bħal epatite, eosinofilja, granuloċitopenija u disfunzjoni renali.
The frequencies estimated are based on pooled clinical trial data for events considered related to VIRAMUNE treatment.
Il- frekwenzi msemmija huma stmati fuq riżultati kollettivament miġbura minn provi kliniċi li għandhom x’ jaqsmu ma 'trattament b’ VIRAMUNE.
Nervous system disorders Common
Disturbi tas- sistema nervuża komuni
Musculoskeletal and connective tissue disorders Common Uncommon
Disturbi muskolo- skeletriċi u tat- tessut konnettiv Komuni
myalgia arthralgia
uġigħ tal- muskoli
General disorders and administration site conditions Common
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata Komuni
37 Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients including the loss of peripheral and facial subcutaneous fat, increased intra- abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Dan jinkludi telf ta ’ xaħam periferiku u minn taħt il- ġilda tal- wiċċ, żjieda fix- xaħam intra- addominali u vixxerali, u akkumulazzjoni ta ’ xaħam dorsoċervikali (ħotba tal- buflu).
These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however it is unlikely that these events are due to VIRAMUNE treatment.
Il- każijiet li ġejjin ġew rapportati wkoll meta VIRAMUNE intuża flimkien ma ’ sustanzi anti - retrovirali oħra: pankreatite, newropatija periferika u tromboċitopenija. Dawn il- każijiet huma komunament assoċjati ma ’ mediċini anti- retrovirali oħrajn u jista 'jkun li jseħħu meta VIRAMUNE jiġi użat flimkien ma' mediċini oħra; madankollu huwa x' aktarx improbabbli li dawn il- każijiet iseħħu minħabba trattament b' VIRAMUNE.
The most common clinical toxicity of VIRAMUNE is rash, with VIRAMUNE attributable rash occurring in 13.6% of patients in combination regimens in controlled studies.
Skond studji b’ kontrolli, ir- raxx jaqbad lil 13. 6% ta 'pazjenti li jużaw VIRAMUNE ma ’ mediċini oħrajn..