qanastek/EMEA-V3 huggingface dataset:
VIRAMUNE 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Tfal kbar, speċjalment adoloxxenti, li għandhom anqas minn 16- il sena, u piż korporali ta’ 50 kg jew li l- erja superfiċjali ta 'ġisimhom hija aktar minn 1. 25 m2 skond il- formula ta' Mosteller għandhom jingħataw pilloli VIRAMUNE ta ’ 200 mg kif spjegat hawn fuq.
An oral suspension dosage form, which can be dosed according to body weight or body surface area, is available for children in this age group weighing less than 50 kg or whose body surface area is below 1.25 m2 (please refer to the Summary of Product Characteristics of VIRAMUNE oral suspension).
Tfal kbar u adoloxxenti li għandhom piż korporali ta ’ anqas minn 50 kg jew li l- erja superfiċjali tal- ġisem hi inqas minn 1. 25 m2 jistgħu jingħataw dil- mediċina taħt forma ta ’ suspensjoni orali, li tista ’ tingħatalhom bħala doża aġġustata skond il- piż korporali tagħhom jew l- erja superfiċjali tal- ġisem, (jekk jogħġbok ara s- Sommarju tal - Karatteristiċi tal- Prodott ta 'VIRAMUNE suspensjoni orali).
VIRAMUNE may be taken with or without food.
VIRAMUNE jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
2 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.
Patients with CLcr ≥ 20 ml/ min do not require a dose adjustment, see section 5.2.
Pazjenti b’ CLcr ≥ 20 ml/ min ma jinħteġux aġġustament fid- doża, ara sezzjoni 5. 2.
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).
No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
L- ebda aġġustament mhu meħtieġ għal pazjenti li għandhom indeboliment epatiku minn ħafif għal moderat (ara sezzjonijiet 4. 4 u 5. 2)
VIRAMUNE has not been specifically investigated in patients over the age of 65.
VIRAMUNE ma ġiex mistħarreġ speċifikament fuq pazjenti li għandhom aktar minn 65 sena.
Dose management considerations
Konsiderazzjonijiet dwar il- Ġestjoni tad- Doża
Patients experiencing rash during the 14-day lead-in period of 200 mg/ day 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, m’ għandhomx jingħataw żjieda fid- doża ta ’ VIRAMUNE qabel ma jitfejqu mir- raxx.
The isolated rash should be closely monitored (please refer to section 4.4).
Raxx iżolat għandu jiġi osservat mill- qrib (jekk jogħġbok ara sezzjoni 4. 4).
Patients who interrupt VIRAMUNE dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period.
Pazjenti li jwaqqfu t- trattament ta ’ VIRAMUNE għal aktar minn 7 ijiem għandhom jerġgħu jibdew it - terapija mill- ġdid billi jsegwu d- doża skond ir- reġimen ta 'l- ewwel ġimagħtejn kif rakkomandata.
For toxicities that require interruption of VIRAMUNE therapy, see section 4.4.
Meta għandha titwaqqaf it- terapija b’ VIRAMUNE minħabba tossiċitajiet, ara sezzjoni 4. 4.
VIRAMUNE must not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
VIRAMUNE m’ għandux jerġa 'jingħata lil pazjenti li kien meħtieġ li jwaqqfuh b' mod permanenti minħabba raxx qawwi, raxx akkumpanjat b' sintomi oħrajn tal- ġisem, reazzjonijiet ipersensittivi, jew epatite klinika minħabba nevirapine.
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).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking VIRAMUNE due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
M’ għandomx jittieħdu taħlitiet ta 'ħxejjex li fihom St John’ s wort (Hypericum perforatum) waqt li jkun qed jittieħed VIRAMUNE minħabba r- riskju li jitnaqqsu l- livelli ta' konċentrazzjonijiet ta ’ plażma kif ukoll l- effetti kliniċi ta 'nevirapine (ara sezzjoni 4. 5).
VIRAMUNE should only be used with at least two other antiretroviral agents (see section 5.1).
VIRAMUNE għandu jintuża biss ma ’ mill- anqas żewġ sustanzi anti- retrovirali oħra (ara sezzjoni 5. 1).
VIRAMUNE should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
VIRAMUNE m’ għandux jintuża bħala l- uniku antiretrovirali attiv, peress li kull monoterapija ma ’ antiretrovirali wriet li tirriżulta f’ reżistenza virali.
3 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.
L- ewwel 18- il ġimgħa ta 'terapija 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.
Female gender and higher CD4 counts at the initiation of therapy place patients at greater risk of hepatic adverse events.
Nisa u pazjenti li għandhom il- livelli ta ’ ċelluli CD4+ għoljin jinsabu f' riskju akbar li jkollhom problemi avversi tal- fwied.
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.
This is based on the occurrence of serious and life threatening hepatotoxicity in controlled and uncontrolled studies.
Dan hu msejjes fuq każijiet epatotossiċi serji u ta 'periklu għal ħajja fi studji kontrollati u mhux ikkontrollati.
In some cases, hepatic injury has progressed despite discontinuation of treatment.
F' xi każijiet, il- ħsara epatika kompliet minkejja t- twaqqif tat- trattament.
Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must discontinue VIRAMUNE and seek medical evaluation immediately.
Pazjenti li jiżviluppaw sinjali jew sintomi ta 'epatite, reazzjoni tal- ġilda serja jew reazzjonijiet ta' sensittività eċċessiva għandhom iwaqqfu VIRAMUNE u jfittxu evalwazzjoni medika minnufih.
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).
The dosage must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Id- doża għandha tittieħed kif suppost, speċjalment fl- ewwel perijodu ta ’ 14- il jum tal- mediċina (ara sezzjoni 4. 2).
Cutaneous reactions
Reazzjonijiet tal- ġilda
Severe and life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE mainly during the first 6 weeks of therapy.
Reazzjonijiet tal- ġilda qawwija u perikolużi, li jinkludu każijiet li waslu għal mewt, seħħew f’ pazjenti li kienu trattati b’ VIRAMUNE, l- aktar fl- ewwel 6 ġimgħat ta 'terapija.
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 ta ’ sindrome 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 b’ mod intensiv fl- ewwel 18- il ġimgħa tat- trattament.
Patients should be closely monitored if an isolated rash occurs.
Huma għandhom ikunu osservati mill- qrib jekk jiżviluppaw raxx iżolat.
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- sindrome 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.
VIRAMUNE administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Meta VIRAMUNE jingħata f’ dożi ogħla minn dawk rakkomandati jista ’ jwassal għal żjieda fil - frekwenza u l- gravità tar- reazzjonijiet fuq il- ġilda, bħas- sindrome Stevens- Johnson u nekroliżi epidermali tossika.
Rhabdomyolysis has been observed in patients experiencing skin and/ or liver reactions associated with VIRAMUNE use.
Rabdomijolisi ġiet osservata f’ pazjenti li jkollhom reazzjonijiet tal- ġilda u/ jew tal- fwied assoċjati ma ’ l- użu ta ’ VIRAMUNE.
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
Some risk factors for developing serious cutaneous reactions have been identified, they include failure to follow the initial dosing of 200 mg daily 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 waqt l- ewwel perijodu tat- trattament ma jitkompliex, kif ukoll meta jkun hemm dewmien twil minn 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.
Pazjenti għandhom ikunu mgħarrfa li r- raxx huwa tossiċità ewlenija ta ’ VIRAMUNE.
They should be advised to promptly notify their physician of any rash and avoid delay between the initial symptoms and medical consultation.
Għandhom jingħataw parir biex jinfurmaw lit- tabib tagħhom minnufih meta jkollhom xi raxx u jevitaw dewmien minn meta jkollhom l- ewwel sintomi sakemm issirilhom il- konsulta medika.
The majority of rashes associated with VIRAMUNE occur within the first 6 weeks of initiation of therapy.
Il- biċċa l- kbira ta 'raxxijiet li huma marbuta ma ’ l- użu ta ’ VIRAMUNE jiżviluppaw fl- ewwel 6 gimgħat minn meta tinbeda t- terapija.
Therefore, patients should be monitored carefully for the appearance of rash during this period.
Għalhekk il- pazjenti għandhom ikunu sorveljati b 'reqqa għal kull żvilupp ta ’ raxx waqt dal- perijodu.
Patients should be instructed that dose escalation is not to occur if any rash occurs during the two-week lead-in dosing period, until the rash resolves.
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.
4 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 tal- 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.
In these patients VIRAMUNE must not be restarted.
VIRAMUNE m’ għandux jerġa jingħata mill- ġdid lil dawn il- pazjenti.
If patients present with a suspected VIRAMUNE-associated rash, liver function tests should be performed.
Jekk ikun hemm suspett li pazjenti żviluppaw raxx minħabba VIRAMUNE, għandu jsirilhom testijiet dwar il- funzjoni tal- fwied.
Patients with moderate to severe elevations (ASAT or ALAT > 5 ULN) should be permanently discontinued from VIRAMUNE.
Pazjenti li jkollhom riżultati minn moderati sa għoljin (ASAT jew ALAT > 5 ULN) għandhom jieqfu b' mod permanenti milli jieħdu VIRAMUNE.
If a hypersensitivity reaction occurs, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction, VIRAMUNE must be permanently stopped and not be re- introduced (see section 4.3).
VIRAMUNE għandu jitwaqqaf għal dejjem u m’ għandhux jerġa ’ jintuża jekk ikun hemm xi reazzjoni ta ’ sensittività eċċessiva, ikkaratterizzata minn raxx b’ sintomi mal- ġisem kollu bħal deni, artralġja, uġigħ fil- muskoli, limfadenopatija, jew problemi vixxerali, bħal epatite, eosinofilja, granuloċitopenija, u nuqqas fil- funzjoni tal- kliewi (ara sezzjoni 4. 3).
Hepatic reactions
Reazzjonijiet fil- fwied
Severe and life-threatening hepatoxicity, including fatal fulminant hepatitis, has occurred in patients treated with VIRAMUNE.
Tossiċità tal- fwied li hija gravi tista 'tkun fatali, li tinkludi epatite fulminanti fatali ġrat f' pazjenti trattati b' VIRAMUNE.
The first 18 weeks of treatment is a critical period which requires close monitoring.
L- ewwel 18- il ġimgħa ta 'trattament huwa perijodu kritiku li jeħtieġ monitoraġġ mill- qrib.
The risk of hepatic events is greatest in the first 6 weeks of therapy.
L- ogħla riskju għall- funzjonament tal- fwied huwa l- aktar fl- ewwel 6 ġimgħat ta 'terapija.
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 kollu.
Increased ASAT or ALAT levels > 2.5 ULN and/ or co-infection with hepatitis B and/ or C at the start of antiretroviral therapy is associated with greater risk of hepatic adverse reactions during antiretroviral therapy in general, including VIRAMUNE containing regimens.
Żjieda fil- livelli ASAT jew ALAT > 2. 5 ULN, u/ jew ko- infezzjoni b' epatite B u/ jew Ċ, fil- bidu ta ’ terapija anti- retrovirali huma kollha fatturi assoċjati ma ’ żjieda fir- risku ta ’ reazzjonijiet avversi fil - fwied, ġeneralment waqt kull terapija anti- retrovirali, inklużi dawk li jużaw VIRAMUNE.
Female gender and patients with higher CD4 counts are at increased risk of hepatic adverse events.
Il- ġens femminil u pazjenti li għandhom l- għadd ta 'CD4 ogħla huma f' riskju akbar ta' każijiet epatiċi avversi.
Women have a three fold higher risk than men for symptomatic, often rash-associated, hepatic events (5.8% versus 2.2%), and patients with higher CD4 counts at initiation of VIRAMUNE therapy are at higher risk for symptomatic hepatic events with VIRAMUNE.
In- nisa għandhom riskju tliet darbiet ogħla mill- irġiel li jiżviluppaw problemi sintomatiċi fil - fwied, u ta 'spiss assoċjati ma raxx (5. 8% kontra 2. 2%) u pazjenti li għandhom għadd akbar ta' CD4 mal- bidu tat- terapija b' VIRAMUNE huma f' riskju ogħla ta 'każijiet sintomatiċi epatiċi b' VIRAMUNE.
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%).
Minn analiżi retrospettiva, nisa b’ għadd ta 'ċelluli CD4 > 250 ċelluli/ mm3 kellhom riskju 12- il darba akbar li jkollhom każijiet sintomatiċi epatiċi avversi meta mqabbla ma ’ nisa b' livelli ta ’ ċelluli CD4 < 250 ċelluli/ mm3 (11. 0% kontra 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 '
Patients should be informed that hepatic reactions are a major toxicity of VIRAMUNE requiring 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 minnufih u ifittxu għal evalwazzjoni medika, li għandha tinkludi testijiet dwar il- funzjonament tal - fwied.
Liver monitoring
Monitoraġġ tal- fwied
Clinical chemistry tests, which include liver function tests, should be performed prior to initiating VIRAMUNE therapy and at appropriate intervals during therapy.
Għandhom jitwettqu testijiet kimiċi kliniċi li jinkludu testijiet dwar il- funzjonament tal- fwied qabel ma tinbeda t- terapija b’ VIRAMUNE u f’ intervalli xierqa matul it- terapija.
Abnormal liver function tests have been reported with VIRAMUNE, some in the first few weeks of therapy.
Ġew irrapportati każijiet fejn kien hemm riżultati abnormali f' testijiet tal- fwied meta ngħata VIRAMUNE.
Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a contraindication to use VIRAMUNE.
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 asintomatiku mhux kontra- indikazzjoni biex titkompla t- terapija.
5 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 'riżultati 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 suġġestivi 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 sorveljati aktar ta' spiss waqt il- visti regolari fil- klinika.
VIRAMUNE must not be administered to patients with pre- treatment ASAT or ALAT > 5 ULN until baseline ASAT/ ALAT are stabilised < 5 ULN (see section 4.3).
VIRAMUNE m’ għandux jingħata lil pazjenti li għandhom l- għadd ASAT jew ALAT > 5 ULN sakemm il- linja ta 'referenza bażi ASAT/ ALAT tiġi stabbli < 5 ULN (ara sezzjoni 4. 3).
Physicians and patients should be vigilant for prodromal signs or findings of hepatitis, such as anorexia, nausea, jaundice, bilirubinuria, acholic stools, hepatomegaly or liver tenderness.
Kemm it- tobba kif ukoll il- pazjenti għandhom ikunu attenti ħafna għal sinjali prodromali jew riżultati ta ’ epatite, bħal anoreksja, dardir, suffejra, bilirubinurja, purgar akoliku, epatomegalija jew sensittività fil- fwied.
Patients should be instructed to seek medical attention promptly if these occur.
Il- pazjenti għandhom jingħataw parir biex ifittxu attenzjoni medika minnufih kemm- il darba jkollhom dawn is- sinjali.
If ASAT or ALAT increase to > 5 ULN during treatment, VIRAMUNE should be immediately stopped.
Jekk waqt it- trattament l- għadd ASAT jew ALAT jiżdied għal > 5 ULN, VIRAMUNE irid jiġi mwaqqaf minnufih.
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.
Id- doża tal- bidu għandha tkun ta ’ 200 mg/ jum għal 14- il jum u wara tiżdied għal 400 mg/ jum.
In these cases, more frequent liver monitoring is required.
F’ dawn il- każijiet ikun meħtieġ li jkun hemm żjieda fil- frekwenza ta ’ monitoraġġ tal- fwied.
If liver function abnormalities recur, VIRAMUNE should be permanently discontinued.
Jekk jirriżulta li l- funzjoni tal- fwied terġa ’ 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, remettar, icterus FLIMKIEN MA ’ riżultati fil- laboratorju (bħal abnormalità moderata jew qawwija fil- funzjoni tal- fwied, minbarra fir- riżultat tal- GGT), VIRAMUNE għandu jitwaqqaf għal dejjem.
VIRAMUNE must not be readministered to patients who have required permanent discontinuation for clinical hepatitis due to nevirapine.
VIRAMUNE m’ għandux jerġa 'jingħata lil pazjenti li waqqfuh b' mod permanenti minħabba epatite klinika ikkaġunata b' nevirapine.
Liver Disease
Mard tal- fwied
The safety and efficacy of VIRAMUNE has not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ VIRAMUNE ma ġewx stabbiliti f’ pazjenti li għandhom problemi tal- fwied fl- isfond li huma sinifikanti.
VIRAMUNE is contraindicated in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
6 qawwi fil- fwied (Child- Pugh C, ara sezzjoni 4. 3).
Pharmacokinetic results suggest caution should be exercised when VIRAMUNE is administered to patients with moderate hepatic dysfunction (Child-Pugh B).
Riżultati farmakokinetiċi jissuġerixxu li kawtela għandha tiġi eżerċitata meta VIRAMUNE jingħata lil pazjenti li għandhom problemi moderati tal - fwied (Child- Pugh B).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Pazjenti li jsofru b' mod kroniku minn epatite B jew Ċ, u li jkunu qegħdin taħt terapija anti- retrovirali kombinata, huma aktar predisposti għal mard qawwi jew fatali tal- fwied.
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 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.
Pazjenti li diġà jsofru minn mard tal- fwied, bħal epatite attiva kronika, għandhom frekwenza akbar ta ’ abnormalitajiet fil- fwied meta jingħataw terapija anti- retrovirali kkombinata. Dawn il- pazjenti għandhom ikunu sorveljati skond il- prattika standard.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Għandu jiġi kkunsidrat li t- trattament jiġi interrot jew imwaqqaf kemm- il darba jkun hemm xhieda li l- fwied jkun qed jimrad aktar.
Other warnings
Twissijiet oħra
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.
The use of VIRAMUNE has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
L- użu ta 'VIRAMUNE ma ġiex evalwat fi ħdan grupp speċifiku ta' PEP, speċjalment f' terminu ta 'trattament fuq tul taż- żmien u għalhekk huwa skorraġit b' mod qawwi.
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 jkomplu jimirdu b’ infezzjoni avvanzata ta 'HIV- 1, kif ukoll b’ infezzjonijiet opportunistiċi.
Combination therapy with VIRAMUNE has not been shown to reduce the risk of transmission of
Terapija kkombinata b' VIRAMUNE ma tnaqqas ir- riskju biex l- HIV- 1 jgħaddi lil ħaddieħor b 'kuntatt sesswali jew permezz ta ’ demm infettat.
Hormonal methods of birth control other than DMPA should not be used as the sole method of contraception in women taking VIRAMUNE, since nevirapine might lower the plasma concentrations of these medications.
Metodi ta ’ kontroll ta 'twelid fejn jintużaw l- ormoni, li mhumiex DMPA m’ għandhomx jintużaw bħala l- metodu ewlieni ta ’ kontraċezzjoni minn nisa li jkunu fuq VIRAMUNE, peress li nevirapine jista ’ jbaxxi l- konċentrazzjonijiet tal- plażma ta ’ dawn il- farmaċewtiċi.
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.
Additionally, when postmenopausal hormone therapy is used during administration of VIRAMUNE, its therapeutic effect should be monitored.
Barra dan, għandu jkun osservat l- effett terapewtiku ta ’ dan meta jingħataw ormoni terapewtiċi ta ’ wara l- menopawża waqt li jingħata VIRAMUNE.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.
Terapija antiretrovirali kombinata kienet assoċjata mat- tqassim mill- ġdid tal- grass fil- ġisem (lipodistrofija) f' pazjenti infettati b' HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fuq tul ta ’ żmien ta 'dawn l- effetti għadhom mhumiex attwalment magħrufa.
Knowledge about the mechanism is incomplete.
Tagħrif dwar il- mekkaniżmu kif dan iseħħ mhux komplet.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
Gie ipotizzat li lipomatożi vixxerali, PIs, lipoatrofija u NRTI, għandhom x’ jaqsmu flimkien.
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.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżami kliniku għandu jinkludi evalwazzjoni għas- sinjali fiżiċi ta 'distribuzzjoni tal- grass.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandha tingħata konsiderazzjoni għal miżura waqt sawm ta 'lipidi fis- serum u l- glukowż fid- demm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi bil- lipidi għandhom jiġi ġestiti bl- aktar mod kliniku xieraq (ara sezzjoni 4. 8).
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Għalkemm l- etjoloġija hi kkonsidrata bħala multi- fattorjali (li tinkludi l- użu ta 'kortikostirojd, konsum ta' alkoħol, immunosoppressjoni serja, indiċi tal- piż korporali ogħla), każijiet ta 'osteonekrosi ġew rapportati partikolarment f' pazjenti li għandhom marda ta' HIV avvanzata u/ jew espożizzjoni fuq tul ta 'żmien għal terapija antiretrovirali konġunta (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jingħataw parir biex ifittxu l- għajnuna medika jekk ikollhom uġigħ fil- ġogi, il- ġogi jħossuhom iebsa jew diffikultà biex jiċċaqilqu.
Immune Reactivation Syndrome:
Sindromu ta 'Riattivazzjoni Immunitarja:
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 b' HIV li għandhom defiċjenza immunitarja serja fiż- żmien li tibda tingħata t- terapija anti- retrovirali konġunta (CART), jista 'jkun
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Ġeneralment, reazzjonijiet bħal dawn ġew osservati fl- ewwel ftit ġimgħat jew xhur mill- bidu ta 'CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Eżempji rilevanti huma cytomegalovajrus retinitis, infezzjonijiet mikobatterjoloġiċi ġenerali jew/ u iffokati u pnewmonja Pneumocystis jirocevi.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu infjammatorju għandu jiġi evalwat u t- trattament għandu jingħata kif meħtieġ.
The available pharmacokinetic data suggest that the concomitant use of rifampicin and VIRAMUNE is not recommended (please also refer to section 4.5).
Id- dejta farmakokinetika disponibbli tissuġerixxi li l- użu ta ’ VIRAMUNE flimkien ma ’ rifampicin mhux rakkomandat (jekk jogħġbok irreferi wkoll għal sezzjoni 4. 5).
Lactose:
Lattosju:
VIRAMUNE tablets contain 636 mg of lactose per maximum recommended daily dose.
Il- pilloli VIRAMUNE fihom 636 mg ta ’ lattosju għal kull doża massima rakkomandata ta ’ kuljum.
Patients with rare hereditary problems of galactose intolerance e. g. galactosaemia, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għal gallatosju e. g. gallatosemija, id- defiċjenza ta ’ Lapp lactase jew problemi bl- assorbiment ta ’ glukosju- gallatosju m’ għandux jieħdu din il- mediċina.
Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Nevirapine huwa induttur ta ’ CYP3A u potenzjalment ta ’ CYP2B6, b’ induzzjoni massima li sseħħ fi żmien 2- 4 ġimgħat mill- bidu ta ’ terapija b’ diversi dożi.
Compounds using this metabolic pathway may have decreased plasma concentrations when co- administered with VIRAMUNE.
Komposti li jużaw dan il- passaġġ metaboliku jista ’ jkollhom konċentrazzjonijiet imnaqqsa fil- plażma meta jingħataw flimkien ma ’ VIRAMUNE.
Careful monitoring of the therapeutic effectiveness of P450 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 absorption of nevirapine is not affected by food, antacids or medicinal products which are formulated with an alkaline buffering agent.
L- assorbiment ta ’ nevirapine mhuwiex affettwat bl- ikel, antaċidi jew prodotti mediċinali li huma fformulati b’ sustanza ta ’ bafer alkalina.
7 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 - MhuxStabbilit, ↑ = Żdied, ↓ = Tbaxxa, ↔ = Ebda Effett
Medicinal products by therapeutic areas ANTI-INFECTIVES Antiretrovirals NRTIs
Prodotti mediċinali Interazzjoni skont il- qasam terapewtiku MEDIĊINI KONTRA L- INFEZZJONIJIET Antiretrovirali NRTIs Didanosine AUC ↔ 1. 08 (0. 92- 1. 27)
Recommendations concerning co- administration
Rakkomandazzjonijiet rigward l- għoti fl- istess ħin
Didanosine AUC ↔ 1.08 (0.92-1.27) Didanosine Cmin ND Didanosine Cmax ↔ 0.98 (0.79-1.21)
Didanosine 100- 150 mg BID Didanosine Cmin ND Didanosine Cmax ↔ 0. 98 (0. 79- 1. 21)
Didanosine and VIRAMUNE can be co-administered without dose adjustments.
Didanosine u VIRAMUNE jistgħu jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża.
Lamivudine 150 mg BID
Lamivudine Ma dehru l- ebda bidliet fit- tneħħija 150 mg BID apparenti għal lamivudine u għall - volum tad- distribuzzjoni, li jissuġġerixxi li m’ hemmx effett ta ’ induzzjoni ta ’ nevirapine fuq it - tneħħija ta ’ lamivudine.
No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of nevirapine on lamivudine clearance.
Lamivudine u VIRAMUNE jistgħu jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża.
Lamivudine and VIRAMUNE can be co-administered without dose adjustments.
8 Stavudine AUC ↔ 0. 96 (0. 89- 1. 03) Stavudine:
Stavudine:
Stavudine u VIRAMUNE jistgħu
30/ 40 mg BID
30/ 40 mg BID
Stavudine AUC ↔ 0.96 (0.89-1.03) Stavudine Cmin ND Stavudine Cmax ↔ 0.94 (0.86-1.03)
Stavudine Cmin ND Stavudine Cmax ↔ 0. 94 (0. 86- 1. 03)
Stavudine and VIRAMUNE can be co-administered without dose adjustments.
jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża.
Nevirapine: compared to historical controls, levels appeared to be unchanged.
Nevirapine: meta tqabbel ma ’ kontrolli storiċi, il- livelli dehru li ma tbiddlux.
Tenofovir plasma levels remain unchanged when co-administered with Nevirapine.
Il- livelli ta ’ tenofovir fil- plażma baqgħu l- istess meta ngħataw flimkien ma ’ Nevirapine.
Tenofovir and VIRAMUNE can be co-administered without dose adjustments.
Tenofovir u VIRAMUNE jistgħu jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża.
Nevirapine plasma levels were not altered by co-administration of tenofovir.
Il- livelli ta ’ nevirapine fil- plażma ma nbiddlux bl- għoti fl- istess ħin ma ’ tenofovir.
Zidovudine 100-200 mg TID
100- 200 mg TID
Zidovudine AUC ↓ 0.72 (0.60-0.96) Zidovudine Cmin ND Zidovudine Cmax ↓ 0.70 (0.49-1.04)
Zidovudine Cmin ND Zidovudine Cmax ↓ 0. 70 (0. 49- 1. 04)
Zidovudine and VIRAMUNE can be co-administered without dose adjustments
jintużaw mingħajr l- ebda aġġustamenti fid- doża
Zidovudine had no effect on its pharmacokinetics.
Zidovudine ma kellux effett fuq il- farmakokinetiċi tiegħu
Efavirenz AUC ↓ 0.72 (0.66-0.86) Efavirenz Cmin ↓ 0.68 (0.65-0.81) Efavirenz Cmax ↓ 0.88 (0.77-1.01)
Efavirenz Cmax ↓ 0. 88 (0. 77- 1. 01)
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 addittiva u ebda siwi f’ termini tal- effikaċja ta ’ ebda mill- NNRTI waħedhom.
Atazanavir/ ritonavir 300/ 100 mg QD 400/ 100 mg QD
Atazanavir/ ritonavir
Atazanavir/ r AUC ↓ 0.58 (0.48-0.71) Atazanavir/ r Cmin ↓ 0.28 (0.20-0.40) Atazanavir/ r Cmax ↓ 0.72 (0.60-0.86)
Atazanavir/ r Cmin ↓ 0. 28 (0. 20- 0. 40)
It is not recommended to co- administer atazanavir/ ritonavir and VIRAMUNE.
atazanavir/ ritonavir jingħataw
8 Atazanavir/ r 400/ 100mg:
Atazanavir/ r Cmax ↓ 0. 72 (0. 60- 0. 86)
Atazanavir/ r AUC ↓ 0.81 (0.65-1.02) Atazanavir/ r Cmin ↓ 0.41 (0.27-0.60) Atazanavir/ r Cmax ↔ 1.02 (0.85– 1.24) (compared to 300/ 100mg without nevirapine)
Atazanavir/ r 400/ 100mg Atazanavir/ r AUC ↓ 0. 81 (0. 65- 1. 02) Atazanavir/ r Cmin ↓ 0. 41 (0. 27- 0. 60) Atazanavir/ r Cmax ↔ 1. 02 (0. 85– 1. 24) (meta mqabbel ma ’ 300/ 100mg mingħajr nevirapine)
Nevirapine AUC ↑ 1.25 (1.17-1.34) Nevirapine Cmin ↑ 1.32 (1.22– 1.43) Nevirapine Cmax ↑ 1.17 (1.09-1.25)
Nevirapine AUC ↑ 1. 25 (1. 17- 1. 34) Nevirapine Cmax ↑ 1. 32 (1. 22- 1. 43) Nevirapine Cmin ↑ 1. 17 (1. 09– 1. 25)
Darunavir AUC ↑ 1.24 (0.97-1.57) Darunavir Cmin ↔ 1.02 (0.79-1.32) Darunavir Cmax ↑ 1.40 (1.14-1.73)
Darunavir Cmax ↑ 1. 40 (1. 14- 1. 73)
Darunavir and VIRAMUNE can be co-administered without dose adjustments.
jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża.
Nevirapine AUC ↑ 1.27 (1.12-1.44) Nevirapine Cmin ↑ 1.47 (1.20-1.82) Nevirapine Cmax ↑ 1.18 (1.02-1.37)
Nevirapine AUC ↑ 1. 27 (1. 12- 1. 44) Nevirapine Cmin ↑ 1. 47 (1. 20- 1. 82) Nevirapine Cmax ↑ 1. 18 (1. 02- 1. 37)
Fosamprenavir 1400 mg BID,
1400 mg BID,
Amprenavir AUC ↓ 0.67 (0.55-0.80) Amprenavir Cmin ↓ 0.65 (0.49-0.85) Amprenavir Cmax ↓ 0.75 (0.63-0.89) Nevirapine AUC ↑ 1.29 (1.19-1.40) Nevirapine Cmin ↑ 1.34 (1.21-1.49) Nevirapine Cmax ↑ 1.25 (1.14-1.37)
Amprenavir Cmax ↓ 0. 75 (0. 63- 0. 89) Nevirapine AUC ↑ 1. 29 (1. 19- 1. 40) Nevirapine Cmin ↑ 1. 34 (1. 21- 1. 49) Nevirapine Cmax ↑ 1. 25 (1. 14- 1. 37)
It is not recommended to co- administer fosamprenavir and VIRAMUNE if fosamprenavir is not co-administered with ritonavir.
jingħata flimkien ma ’ VIRAMUNE jekk fosamprenavir ma jingħatax flimkien ma ’ ritonavir.
Fosamprenavir/ ritona vir 700/ 100 mg BID
Amprenavir AUC ↔ 0. 89 (0. 77- 1. 03) Fosamprenavir/ ritonavir u Fosamprenavir / Amprenavir Cmin ↓ 0. 81 (0. 69- 0. 96) ritonavir 700/ 100 mg BID
Amprenavir AUC ↔ 0.89 (0.77- 1.03) Amprenavir Cmin ↓ 0.81 (0.69-0.96) Amprenavir Cmax ↔ 0.97 (0.85-1.10)
Amprenavir Cmax ↔ 0. 97 (0. 85- 1. 10) Nevirapine AUC ↑ 1. 14 (1. 05- 1. 24) Nevirapine Cmin ↑ 1. 22 (1. 10- 1. 35) Nevirapine Cmax ↑ 1. 13 (1. 03- 1. 24)
Fosamprenavir/ ritonavir and VIRAMUNE can be co-administered without dose adjustments
VIRAMUNE jistgħu jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża
Nevirapine AUC ↑ 1.14 (1.05-1.24) Nevirapine Cmin ↑ 1.22 (1.10-1.35) Nevirapine Cmax ↑ 1.13 (1.03-1.24)
Lopinavir AUC ↓ 0. 73 (0. 53- 0. 98)
Lopinavir/ ritonavir (capsules) 400/ 100 mg BID
(kapsuli) 400/ 100 mg
patients:
BID
Lopinavir AUC ↓ 0.73 (0.53-0.98) Lopinavir Cmin ↓ 0.54 (0.28-0.74) Lopinavir Cmax ↓ 0.81 (0.62-0.95)
Lopinavir Cmax ↓ 0. 81 (0. 62- 0. 95)
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 mg kull darba) darbtejn kuljum mal- ikel hi rakkomandata flimkien ma ’ VIRAMUNE.
Dose adjustment of VIRAMUNE is not required when co-administered with lopinavir.
L- aġġustament fid- doża ta ’ VIRAMUNE mhux meħtieġ meta jingħata flimkien ma ’ lopinavir.
9 Lopinavir/ ritonavir (oral solution) 300/ 75 mg/ m2 BID
(soluzzjoni orali) 300/ 75 mg/ m2 BID
Paediatric patients:
d- doża ta ’ lopinavir/ ritonavir tiżdied għal 300/ 75 mg/ m2 darbtejn kuljum
Lopinavir AUC ↓ 0.78 (0.56-1.09) Lopinavir Cmin ↓ 0.45 (0.25-0.82) Lopinavir Cmax ↓ 0.86 (0.64-1.16)
Lopinavir Cmax ↓ 0. 86 (0. 64- 1. 16)
For children, increase of the dose of lopinavir/ ritonavir to 300/ 75 mg/ m2 twice daily with food should be considered when used in combination with VIRAMUNE, particularly for patients in whom reduced susceptibility to lopinavir/ ritonavir is suspected.
mal- ikel meta tingħata flimkien ma ’ VIRAMUNE, partikolarment f’ pazjenti li huma suspettati li għandhom suxxettibilità mnaqqsa għal lopinavir/ ritonavir.
Nelfinavir 750 mg TID
AUC ↔ 1. 06 (0. 78- 1. 14) 750 mg TID
Nelfinavir 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)
Nelfinavir and VIRAMUNE can be co-administered without dose adjustments.
jingħataw flimkien mingħajr aġġustamenti fid- doża.
Nelfinavir metabolite M8:
Metabolit M8 minn nelfinavir:
AUC ↓ 0.38 (0.30– 0.47) Cmin ↓ 0.34 (0.26– 0.45) Cmax ↓ 0.41 (0.32– 0.52)
AUC ↓ 0. 38 (0. 30– 0. 47) Cmin ↓ 0. 34 (0. 26– 0. 45) Cmax ↓ 0. 41 (0. 32– 0. 52)
Nevirapine: compared to historical controls, levels appeared to be unchanged.
Nevirapine: meta mqabbel ma ’ kontrolli storiċi, il- livelli dehru li ma tbiddlux.
Ritonavir AUC↔ 0.92 (0.79-1.07) Ritonavir Cmin ↔ 0.93 (0.76-1.14) Ritonavir Cmax ↔ 0.93 (0.78-1.07)
Ritonavir Cmax ↔ 0. 93 (0. 78- 1. 07)
Ritonavir and VIRAMUNE can be co-administered without dose adjustments.
jingħataw flimkien mingħajr aġġustamenti fid- doża.
Co-administration of ritonavir does not lead to any clinically relevant change in nevirapine plasma levels.
L- għoti flimkien ma ritonavir ma jwassal għal ebda bidla klinikament rilevanti fil- livelli ta ’ nevirapine fil- plażma.
The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and Nevirapine
Id- dejta limitata disponibbli b’ kapsula ta ’ ġell artab ta ’ saquinavir imsaħħaħ b’ ritonavir ma tindika l- ebda interazzjoni klinikament rilevanti bejn saquinavir imsaħħaħ b’ ritonavir u Nevirapine
Saquinavir/ ritonavir and VIRAMUNE can be co-administered without dose adjustments.
Saquinavir/ ritonavir u VIRAMUNE jistgħu jingħataw flimkien mingħajr aġġustamenti fid- doża.
No specific drug-drug interaction study has been performed.
Ma sar ebda studju dwar l - interazzjoni ta ’ din il- mediċina meta tingħata mal- oħra.
The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.
It- dejta limitata disponibbli minn studju ta ’ fażi IIa f’ pazjenti infettati bl- HIV wera tnaqqis mhux klinikament sinifikanti ta ’ 20% fis - Cmin ta ’ TPV.
Tipranavir and VIRAMUNE can be co-administered without dose adjustments.
Tipranavir u VIRAMUNE jistgħu jingħataw flimkien mingħajr aġġustamenti fid- doża.
Entry Inhibitors Enfuvirtide
Impedituri tad- Dħul Enfuvirtide
Due to the metabolic pathway no clinically significant pharmacokinetic interactions are expected between enfuvirtide and nevirapine.
Minħabba l- passaġġ metaboliku mhux mistenni li jkun interazzjonijiet farmakokinetiċi klinikament sinifikanti bejn enfuvirtide u nevirapine.
Enfuvirtide and VIRAMUNE can be co-administered without dose adjustments.
Enfuvirtide u VIRAMUNE jistgħu jingħataw flimkien mingħajr aġġustamenti fid- doża.
10 Maraviroc 300 mg QD
Maraviroc
Maraviroc AUC ↔ 1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Maraviroc Cmin ND Maraviroc Cmax ↔ 1. 54 (0. 94- 2. 52) meta mqabbla ma ’ kontrolli storiċi
Maraviroc and VIRAMUNE can be co-administered without dose adjustments.
jingħataw flimkien mingħajr aġġustamenti fid- doża.
Nevirapine concentrations not measured, no effect is expected.
Il- konċentrazzjonijiet ta ’ nevirapine ma tkejlux u mhux mistenni li jkun hemm xi effett.
Integrase Inhibitors Raltegravir 400 mg BID
11 Impedituri ta ’ Integrase Raltegravir 400 mg BID Antibijotiċi
No clinical data available.
L- ebda dejta klinika mhi disponibbli.
Due to the metabolic pathway of raltegravir no interaction is expected.
Minħabba l- passaġġ metaboliku ta ’ raltegravir mhux mistenni li jkun hemm interazzjonijiet.
Raltegravir and VIRAMUNE can be co-administered without dose adjustments.
Raltegravir u VIRAMUNE jistgħu jingħataw flimkien mingħajr l- ebda aġġustamenti fid- doża.
Antibiotics
Clarithromycin
Clarithromycin AUC ↓ 0.69 (0.62- 0.76) Clarithromycin Cmin ↓ 0.44 (0.30- 0.64) Clarithromycin Cmax ↓ 0.77 (0.69- 0.86)
0. 76) Clarithromycin Cmin ↓ 0. 44 (0. 30 - 0. 64) Clarithromycin Cmax ↓ 0. 77 (0. 69 - 0. 86)
Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
tnaqqset b’ mod sinifikanti, l- espożizzjoni għal metabolit 14- OH żdiedet.
Because the clarithromycin active metabolite has reduced activity against Mycobacterium avium- intracellulare complex overall activity against the pathogen may be
Peress li l- metabolit attiv ta ’ clarithromycin għandu attività mnaqqsa kontra l- kumpless intraċellulari ta ’ Mycobacterium avium, l- attività globali kontra
Metabolite 14-OH clarithromycin AUC ↑ 1.42 (1.16-1.73) Metabolite 14-OH clarithromycin Cmin ↔ 0 (0.68-1.49) Metabolite 14-OH clarithromycin Cmax ↑ 1.47 (1.21-1.80)
AUC ↑ 1. 42 (1. 16- 1. 73) għal metabolit 14- OH clarithromycin Cmin ↔ 0 (0. 68- 1. 49) għal metabolit 14- OH clarithromycin Cmax ↑ 1. 47 (1. 21- 1. 80) għal metabolit 14- OH clarithromycin
altered.
l- patoġenu tista ’ tinbidel.
Alternatives to clarithromycin, such as azithromycin should be considered.
Alternattivi għal clarithromycin, bħal azithromycin għandhom jiġu kkunsidrati.
Close monitoring for hepatic abnormalities is recommended
Monitoraġġ mill- qrib għal abnormalitajiet tal- fwied hu rakkomandat.
Nevirapine AUC ↑ 1.26 Nevirapine Cmin ↑ 1.28 Nevirapine Cmax ↑ 1.24 compared to historical controls.
Nevirapine AUC ↑ 1. 26 Nevirapine Cmin ↑ 1. 28 Nevirapine Cmax ↑ 1. 24 meta mqabbel ma ’ kontrolli storiċi.
Rifabutin 150 or 300 mg QD
150 jew 300 mg QD
Rifabutin AUC ↑ 1.17 (0.98-1.40) Rifabutin Cmin ↔ 1.07 (0.84-1.37) Rifabutin Cmax ↑ 1.28 (1.09-1.51)
Rifabutin Cmax ↑ 1. 28 (1. 09- 1. 51)
No significant effect on rifabutin and VIRAMUNE mean PK parameters is seen.
fil- parametri PK medji ta ’ rifabutin u VIRAMUNE.
Rifabutin and VIRAMUNE can be co-administered without dose
Rifabutin u VIRAMUNE jistgħu jingħataw