qanastek/EMEA-V3 huggingface dataset:
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Fil- każ ta ’ terapija antivirali kombinata għall- epatite B jew C wieħed għandu dejjem jikkonsulta mas- Sommarju tal- Karatteristiċi tal- Prodott ta ’ dawn il- prodotti mediċinali.
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
Jekk ikun hemm
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
4 evidenza li turi li l- mard tal- fwied mar għall- agħar, wieħed għandu jikkunsidra jwaqqafx it- terapija għal ftit taż- żmien jew anke għal kollox.
The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
L- użu ta ’ Telzir fl- istess ħin ma ’ halofantrine jew lidocaine (sistemiku) mhux rakkomandat (ara sezzjoni 4. 5).
The use of Telzir concomitantly with PDE5 inhibitors (e. g. sildenafil and vardenafil) is not recommended (see section 4.5).
L- użu ta ’ Telzir fl- istess ħin ma ’ impedituri PDE5 (e. g. sildenafil u vardenafil) mhux rakkomandat (ara sezzjoni 4. 5).
Concomitant use of Telzir with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis (see section 4.5).
L- użu fl- istess ħin ta ’ Telzir ma ’ simvastatin jew lovastatin mhux rakkomandat minħabba li jiżdied ir - riskju ta ’ mijopatija, inkluż rabdomajoliżi (ara sezzjoni 4. 5)
A reduction in the rifabutin dosage by at least 75% is recommended when administered with Telzir with ritonavir.
Tnaqqis ta ’ mill- anqas 75% tad- doża ta ’ rifabutin huwa rakkomandat meta jittieħed ma ’ Telzir flimkien ma ’ ritonavir.
Further dose reduction may be necessary (see section 4.5).
Jista ’ jkun hemm il- bżonn ta ’ aktar tnaqqis fid- doża (ara sezzjoni 4. 5).
Because there may be an increased risk of hepatic transaminase elevations and hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative non- hormonal methods of contraception are recommended for women of childbearing potential (see section 4.5).
Minħabba li jista jkun hemm riskju akbar li jogħlew il- livelli tat- transaminase fil- fwied u l- livelli ormonali jistgħu jinbidlu meta fosamprenavir, ritonavir u kontraċettivi li jittieħdu mill- ħalq jingħataw flimkien, metodi alternattivi ta ’ kontraċezzjoni mhux ormonali huma rakkomandati għal nisa li jistgħu joħorġu tqal (ara sezzjoni 4. 5).
No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/ or progestogens when used as hormonal replacement therapies.
Ma hemm l- ebda data fuq fosamprenavir u ritonavir meta jingħataw flimkien ma ’ estroġeni u/ jew proġestoġeni meta dawn jintużaw bħala terapija ta ’ sostituzzjoni ta ’ l- ormoni.
The efficacy and safety of these therapies with fosamprenavir and ritonavir has not been established.
Għada ma ġietx stabbilita l- effikaċja u s- sigurtà ta ’ dawn it- terapiji ma ’ fosamprenavir u ritonavir
Anticonvulsants (carbamazepine, phenobarbital) should be used with caution.
Mediċini anti- konvulsivi (carbamazepine, phenobarbital) għandhom jintużaw b’ prekawzjoni.
Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
Telzir jista ’ jkun inqas effettiv minħabba tnaqqis tal- konċentrazzjonijiet ta ’ amprenavir fil- plażma f’ pazjenti li jkunu qed jieħdu dawn il- mediċini fl- istess ħin (ara sezzjoni 4. 5).
Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Telzir (see section 4.5).
Monitoraġġ ta ’ konċentrazzjonijiet terapewtiċi hu rakkomandat għal meta prodotti mediċinali immunosuppressivi (cyclosporine, tacrolimus, rapamycin) jittieħdu flimkien ma ’ Telzir (ara sezzjoni 4. 5).
Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e. g. desipramine and nortriptyline) when coadministered with Telzir (see section 4.5).
Monitoraġġ ta ’ konċentrazzjonijiet terapewtiċi hu rakkomandat għal meta antidepressanti triċikliki (e. g desipramine u nortriptyline) jittieħdu flimkien ma ’ Telzir (ara sezzjoni 4. 5).
When warfarin or other oral anticoagulants are coadministered with Telzir a reinforced monitoring of INR (International Normalised Ratio) is recommended (see section 4.5).
Meta warfarin u antikoagulanti oħra li jittieħdu mill- ħalq jingħataw flimkien ma ’ Telzir hu rakkomandat monitoraġġ aktar strett ta ’ l- INR (Proporzjon Internazzjonali Normalizzat) (ara sezzjoni 4. 5).
Concomitant use of Telzir with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing’ s syndrome and adrenal suppression (see section 4.5).
L- użu ta ’ Telzir flimkien ma ’ ritonavir u fluticasone jew glukokortikojdi oħra li huma mmetaboliżżati minn CYP3A4 mhuhiex rakkomandat sakemm il- benefiċċju potenzjali tal- kura ma jkunx akbar mir - riskju ta ’ effetti tal- kortikojdi fiċ- ċirkulazzjoni, bħas- sindromu ta ’ Cushing u trażżin tal- glandola adrenali (ara sezzjoni 4. 5)
Rash / cutaneous reactions
Raxx/ reazzjonijiet fil- ġilda
Most patients with mild or moderate rash can continue Telzir.
Il- maġġoranza ta ’ pazjenti b’ raxx ħafif jew moderat jistgħu jibqgħu jieħdu Telzir.
Appropriate antihistamines (e. g. cetirizine dihydrochloride) may reduce pruritus and hasten the resolution of rash.
Anti- istamini indikati (eż. cetirizine dihydrochloride) jistgħu jnaqqsu l- prurite u jħaffu l- proċess biex jgħaddi r- raxx.
Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
Reazzjonijiet fil- ġilda severi u li jipperikolaw il- ħajja, inkluża s- sindromu Stevens- Johnson, ġew rappurtati f’ inqas minn 1% ta ’ pazjenti li ħadu sehem fil- programm ta ’ żvilupp kliniku.
Telzir should be permanently discontinued in case of severe rash, or in case of rash of moderate intensity with systemic or mucosal symptoms (see section 4.8).
Telzir għandu jitwaqqaf għal kollox f’ każ ta ’ raxx severi, jew f’ każ ta ’ raxx b’ intensità moderata b’ sintomi sistemiċi jew mukużi (ara sezzjoni 4. 8).
5 patients administration of factor VIII was necessary.
5 Pazjenti bl- emofilja
In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued.
Kien hemm xi rapporti ta ’ żieda fil- fsada inklużi ematomi spontanji u emartrożi fil- ġilda ta ’ pazjenti bl- emofilja tat- tipi A u B fuq kura ta ’ impedituri protease (PIs).
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Relazzjoni kawżali kienet suġġerita, għalkemm il - mekkaniżmu ta ’ l- azzjoni ma kienx iċċarat.
Haemophiliac patients should therefore be informed of the possibility of increased bleeding.
Pazjenti bl- emofilja għandhom għalhekk jiġu nfurmati bil- possibiltà ta ’ żieda fil- fsada.
New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Ħruġ mill- ġdid tad- dijabete mellitus, ipergliċemija jew aggravar tad- dijabete mellitus eżistenti ġew rappurtati f’ pazjenti fuq terapija antiretrovirali, inklużi impedituri protease.
In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
F’ xi ftit minn dawn, l - ipergliċemija kienet severi u f’ xi każi kienet assoċjata wkoll ma ’ ketoaċidożi.
Many of the patients had confounding medical conditions, some of which required therapy with medicinal products that have been associated with the development of diabetes mellitus or hyperglycaemia.
Ħafna mill- pazjenti kellhom kundizzjonijiet mediċi mħawwda, u ftit minnhom kienu jeħtieġu terapija bi prodotti mediċinali li ġew assoċjati ma ’ l- iżvilupp tad- dijabete mellitus jew ipergliċemija.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Terapija antiretrovirali kombinata ġiet assoċjata ma ’ tqassim mill- ġdid tax- xaħam fil- ġisem (lipodistrofija) f’ pazjenti bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- ġrajjiet għadhom mhumiex magħrufa.
Knowledge about the mechanism is incomplete.
Tagħrif dwar il- mekkaniżmu għadu mhux komplet.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Konnessjoni bejn il- lipomatożi vixxerali u impedituri protease u il- lipoatrofija u inibituri ta ’ nucleoside reverse transcriptase ġiet ipotizzata.
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 akbar ta ’ lipodistrofija ġie assoċjat ma ’ fatturi individwali bħal età kbira, u ma ’ fatturi relatati ma ’ mediċina għal kura antiretrovirali aktar fit- tul u taqlib fil- metaboliżmu assoċjat miegħu.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżami kliniku għandu jinkludi valutazzjoni għal sinjali fiżiċi ta ’ distribuzzjoni mill- ġdid ta ’ xaħam.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jingħata każ tal- kejl tal- livelli tal- lipidi fis- serum waqt is- sawm u glukożju fid- demm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi tal- lipidi għandhom jiġu maniġġjati skond kif klinikament suppost (ara sezzjoni 4. 8).
Immune Reactivation Syndrome
Sindromu tar- Reattivazzjoni 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 bl- HIV b’ deffiċjenza severa fl- immunità fiż- żmien li tkun bdiet it- terapija antiretrovirali konġunt (TARK), jista jkun hemm reazzjoni nfjammatorja għal mikrobi asintomatiċi jew mikrobi opportunistiċi residwali li jwasslu għal kundizzjonijiet kliniċi serji, jew sintomi li jmorru għall- agħar.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Dawn ir- reazzjonijiet tipikament ġew osservati fl- ewwel ftit ġimgħat jew xhur mill- bidu tat- TARK.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Eżempji relevanti jinkludu retinite minħabba cytomegalovirus, infezzjonijiet bil - mycobacterium mifruxa jew lokaliżżati u pulmonite bi Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu ta ’ infjammazzjoni għandu jiġi vvalutat u fejn neċessarju tinbeda l- kura.
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 il- kawża tista ’ tkun minħabba ħafna fatturi, (li jinkludu l- użu ta ’ kortikosterojdi, il- konsum ta ’ alkoħol, trażżin severi fl- immunità, indiċi tal- massa tal- ġisem għoli), każijiet ta ’ nekrożi fl- għadam partikolarment f’ pazjenti b’ HIVavvanzat u/ jew esponiment għal terapija antiretrovirali kombinata (CART) fit- tul.
When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
6 Meta fosamprenavir u ritonavir jingħataw flimkien, il- profil ta ’ interazzjoni metabolika tad- droga ta ’ ritonavir jista ’ jkun predominanti għaliex ritonavir hu impeditur CYP3A4 aktar potenti.
The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir.
L - informazzjoni kollha ta ’ preskrizzjoni għal ritonavir għandha għalhekk tinqara sew qabel tinbeda t - terapija ta ’ Telzir ma ’ ritonavir.
Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4.
Ritonavir jimpedixxi wkoll is- CYP2D6 imma mhux daqs is - CYP3A4.
Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Ritonavir jistimula CYP3A4, CYP1A2, CYP2C9 u glucuronosyl transferase.
Therefore, any medicinal products that either share this
Barra minn hekk, kemm amprenavir, il- metabolu attiv ta ’ fosamprenavir, u kemm ritonavir huma primarjament metabolizzati fil- fwied b’ CYP3A4.
6 metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir and ritonavir.
Għalhekk, kull prodott mediċinali li juża wkoll dan il - passaġġ metaboliku jew li jibdel l- attività ta ’ CYP3A4 jista ’ jibdel il- farmakokinetika ta ’ amprenavir u ritonavir.
Similarly administration of fosamprenavir with ritonavir may modify the pharmacokinetics of other active substances that share this metabolic pathway.
Hekk ukoll meta fosamprenavir jingħata ma ’ ritonavir dan jista ’ jġib tibdil fil- farmakokinetika ta ’ sustanzi attivi oħra li jużaw dan il- passaġġ metaboliku.
Interaction studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarjiet oħra fuq dan il- prodott saru biss fl- adulti.
• Associations contraindicated (see section 4.3)
• Assoċjazzjonijiet kontra- indikati (ara sezzjoni 4. 3).
CYP3A4 substrates with narrow therapeutic index Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows containing active substances that are substrates of cytochrome P450 3A4 (CYP3A4).
Substrati CYP3A4 b’ indiċi terapewtiku dejjaq Telzir m’ għandux jingħata flimkien ma ’ prodotti mediċinali b’ windows terapewtiċi dojoq li jkun fihom sustanzi attivi li huma substrati taċ- ċitokromju P450 3A4 (CYP3A4).
Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e. g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e. g. ergotamine, dihydroergotamine).
Meta jingħataw flimkien jistgħu jikkaġunaw impediment kompetittiv tal- metaboliżmu ta ’ dawn is- sustanzi attivi li jiżdidilhom il- livell fil- plażma u li jista ’ jwassal għal effetti serji u/ jew li jkunu ta ’ periklu għall- ħajja bħal arritmja kardijaka (e. g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) jew vażospażmu periferali jew iskemija (e. g ergotamine, dihydroergotamine).
CYP2D6 substrates with narrow therapeutic index Telzir with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions.
Substrati CYP2D6 b’ indiċi terapewtiku dejjaq Telzir ma ’ ritonavir m’ għandhomx jingħataw flimkien ma ’ prodotti mediċinali li jkun fihom sustanzi attivi li jiddependu ħafna mill- metaboliżmu CYP2D6 u li għalihom konċentrazzjonijiet għolja fil - plażma huma assoċjati ma ’ effetti serji u/ jew li huma ta ’ periklu għall- ħajja.
These active substances include flecainide and propafenone.
Dawn is- sustanzi attivi jinkludu flecainide u propafenone.
The combination of rifampicin and Telzir with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Il- kumbinazzjoni ta ’ rifampicin u Telzir flimkien ma ’ doża baxxa ta ’ ritonavir hija kontraindikata (ara sezzjoni 4. 3)
St John’ s wort (Hypericum perforatum) Serum levels of amprenavir and ritonavir can be reduced by concomitant use of the herbal preparation St John’ s wort (Hypericum perforatum).
St John’ s wort (Hypericum perforatum) Il- livelli ta ’ amprenavir u ritonavir fis- serum jistgħu jitnaqqsu meta magħhom tintuża il- preparazzjoni ta ’ ħxejjex St John’ s wort (Hypericum perforatum).
This is due to induction of drug metabolising enzymes by St John’ s wort.
Dan iseħħ minħabba l- induzzjoni minn St John’ s wort ta ’ enżimi li jimmetabolizzaw il- mediċina.
Herbal preparations containing St John’ s wort should therefore not be combined with Telzir with ritonavir.
John’ s wort m’ għandhomx jingħataw flimkien ma ’ Telzir b’ ritonavir.
If a patient is already taking St John’ s wort, check amprenavir, ritonavir and if possible viral levels and stop St John’ s wort.
John’ s wort.
Amprenavir and ritonavir levels may increase on stopping St John’ s wort.
Il- livelli ta ’ amprenavir u ritonavir jistgħu jiżdiedu malli jitwaqqaf St.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’ s wort.
John’ s wort.
• Other combinations
7 • Taħlitiet oħra
Antiretroviral medicinal products
Prodotti mediċinali antiretrovirali
Non-nucleoside reverse transcriptase inhibitors
Inibituri reverse transcriptase mhux nuklejosidi
Efavirenz: there was no clinically relevant interaction when fosamprenavir 700 mg twice daily and ritonavir 100 mg twice daily was used concurrently with efavirenz (600 mg once daily).
Ma rriżultat ebda interazzjoni klinikament rilevanti meta 700 mg fosamprenavir darbtejn kuljum u 100 mg ritonavir darbtejn kuljum ittieħdu flimkien ma ’ efavirenz (600 mg darba kuljum).
Nevirapine: there was no clinically relevant interaction when fosamprenavir 700 mg twice daily and ritonavir 100 mg twice daily was used concurrently with nevirapine (200 mg twice daily).
Nevirapine: ma kien hemm ebda interazzjoni klinikament rilevanti meta fosamprenavir 700mg darbtejn kuljum u ritonavir 100mg darbtejn kuljum intużaw flimkien ma ’ neviparine (200mg darbtejn kuljum)
Nucleoside / Nucleotide reverse transcriptase inhibitors
Impedituri reverse transcriptase nuklejosidi / nuklejotidi
Interaction studies with abacavir, lamivudine and zidovudine have been performed with amprenavir without ritonavir.
Studji dwar interazzjoni ma ’ abacavir, lamivudine u zidovudine twettqu b’ amprenavir mingħajr ritonavir.
Based on data derived from these studies and because ritonavir is not expected to 7 have a significant impact on the pharmacokinetics of NRTIs, the co-administration of fosamprenavir and ritonavir with these medicinal products is not expected to significantly alter the exposure of the co-administered active substances.
Fuq il- bażi ta ’ tagħrif miksub minn dawn l- istudji u minħabba li ritonavir mhux mistenni li jkollu xi impatt sinifikanti fuq il- farmakokinetiċi ta ’ NRTIs, it- teħid flimkien ta ’ fosamprenavir u ritonavir ma ’ dawn il- prodotti mediċinali mhux mistenni li jbiddel b’ mod sinifikanti l- esponiment tas - sustanzi attivi li jkunu ttieħdu flimkien.
Didanosine chewable tablet: no pharmacokinetic study has been performed with fosamprenavir in combination with didanosine.
Ma sar l- ebda studju farmakokinetiku fuq fosamprenavir meta jittieħed flimkien ma ’ didanosine.
Clinically significant interaction resulting from an increase in the stomach pH due to the didanosine antacid component is unlikely and no dose separation or adjustment is considered necessary when fosamprenavir and didanosine are administered concomitantly (see chapter, Antacids).
Aktarx li ma tirriżulta ebda interazzjoni klinikament sinifikanti minn żieda ta ’ pH fl- istonku minħabba l- komponent kontra l- aċidu didanosine u m’ hemmx bżonn ta ’ separazzjoni jew tibdil ta ’ doża meta fosamprenavir u didanosine jingħataw flimkien (ara l- kapitolu, Mediċini kontra l- aċidu fl- istonku).
No significant interaction is expected with didanosine gastro-resistant capsule.
Ebda interazzjoni sinifikanti m’ hi mistennija mill- kapsula gastro - reżistenti ta ’ didanosine.
Tenofovir: no recommendations can be drawn at this stage on the co-administration of fosamprenavir with ritonavir with tenofovir.
F’ dan l- istadju, għad ma ħarġux rakkomandazzjonijiet dwar it- teħid flimkien ta ’ fosamprenavir ma 'ritonavir ma ’ tenofovir.
Protease Inhibitors
Impedituri protease
Co-administration of standard doses of lopinavir/ ritonavir with fosamprenavir results in a significant reduction in amprenavir concentrations.
It- teħid flimkien ta ’ dożi fissi ta ’ lopinavir/ ritonavir ma ’ fosamprenavir jirriżulta fi tnaqqis sinifikanti fil- konċentrazzjonijiet ta ’ amprenavir.
Co-administration of increased doses of fosamprenavir 1400mg twice daily with lopinavir/ ritonavir 533/ 133mg twice daily to PI-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ ritonavir.
It- teħid flimkien ta ’ dożi akbar ta ’ fosamprenavir 1400mg darbtejn kuljum ma ’ lopinavir/ ritonavir 533/ 133mg darbtejn kuljum f’ pazjenti b’ esperjenza PI irriżulta f’ inċidenza għola ta ’ eventi avversi gastro- intestinali u żidiet fi trigliċeridi bis- sistema ta ’ kura kombinata mingħajr żidiet fl- effikaċja viroloġika, meta mqabbla ma ’ dożi fissi ta ’ fosamprenavir/ ritonavir.
Therefore, concomitant administration of these medicinal products is not recommended.
Għalhekk, m’ huwiex rakkomandat it- tehid flimkien ta ’ dawn il- prodotti mediċinali.
No interaction studies have been undertaken between fosamprenavir with ritonavir and the protease inhibitors: indinavir, saquinavir, nelfinavir and atazanavir.
Ma saru ebda studji dwar interazzjoni bejn fosamprenavir b’ ritonavir u l- impedituri protease: indinavir, saquinavir, nelfinavir u atazanavir.
Antibiotics / Antifungals
Antibijotiċi/ Antifungi
Clarithromycin: a reduction in the clarithromycin dose should be considered when co-administered with Telzir with ritonavir in patients with renal impairment as moderate increases in clarithromycin concentrations are expected when co-administered with Telzir with ritonavir.
Clarithromycin: tnaqqis tad- doża ta ’ clarithromycin għandu jitqies meta jingħata flimkien ma ’ Telzir b’ ritonavir f’ pazjenti b’ indeboliment tal- kliewi għaliex żidiet moderati ta ’ konċentrazzjonijiet ta ’ clarithromycin huma mistennija meta jingħata ma ’ Telzir b’ ritonavir.
Erythromycin: no pharmacokinetic study has been performed with fosamprenavir with ritonavir in combination with erythromycin, however, plasma levels of erythromycin may be increased when co-administered.
Ma sar ebda studju farmakokinetiku dwar fosamprenavir b’ ritonavir flimkien ma ’ erythromycin, madankollu, livelli ta ’ erythromycin fil- plażma jistgħu jiżdiedu meta mogħtija flimkien.
Ketoconazole / Itraconazole: co-administration of fosamprenavir 700 mg with ritonavir 100 mg twice daily and ketoconazole 200 mg once daily increased plasma ketoconazole Cmax by 25% and increased AUC(0-τ) to values 2.69-fold those observed on administration of ketoconazole 200 mg once daily without concurrent fosamprenavir with ritonavir.
Ketoconazole/ Itraconazole: fosamprenavir 700mg flimkien ma ’ ritonavir 100mg darbtejn kuljum u ketoconazole 200mg darba kuljum, żiedu il- livelli Cmax ta ’ ketoconazole fil- plażma b’ 25% u l- AUC( 0 - τ) b’ 2. 69- il darba dawk osservati b’ ketoconazole 200mg darba kuljum mingħajr fosamprenavir ma ’
The Cmax, AUC and Cmin of amprenavir were unchanged.
Cmax, AUC u Cmin ta ’ amprenavir baqgħu l- istess.
When used with Telzir with ritonavir, high doses (> 200 mg/ day) of ketoconazole or itraconazole are not recommended.
Dożi għolja ta ’ ketoconazole (> 200mg kuljum) jew itraconazole ma ’ Telzir flimkien ma ’ ritonavir m’ humiex rakkomandati.
Rifabutin: compared to rifabutin administered alone (300 mg once daily), plasma rifabutin AUC (0- 48) was unchanged and Cmax was decreased 14% following co-administration of reduced doses of rifabutin (150 mg every other day) with fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily.
Meta mqabbla ma ’ rifabutin (300mg darba kuljum) waħdu, l - AUC (0- 48) ta ’ rifabutin fil - plażma baqa ’ l- istess u Cmax naqas b’ 14% wara li dożi mnaqqsa ta ’ rifabutin (150mg darba iva u darba le) ingħataw ma ’ fosamprenavir 700mg darbtejn kuljum u ritonavir 100mg darbtejn kuljum.
However, 25-O-desacetylrifabutin AUC (0-48) and Cmax were increased 11-fold and 6- fold respectively, which could potentially lead to an increase of rifabutin related adverse events, notably uveitis.
It- 25- O - desacetylrifabutin AUC (0- 48) u Cmax iżda żdiedu bi 11- il darba u b’ 6 darbiet rispettivament, li tista ’ potenzjalment twassal għal żieda ta ’ eventi avversi relatati ma ’ rifabutin, l- aktar uvejite.
Based on historical comparison, rifabutin did not appear to reduce amprenavir exposure.
Meta tqabbel x’ ġara storikament, rifabutin ma jidhirx li jnaqqas l- espożizzjoni għal amprenavir.
On the basis of these data, a 75% reduction of the standard rifabutin dose (i. e. to 150 mg every other day) is recommended when administered with Telzir with ritonavir.
Fuq bażi ta ’ din l - informazzjoni, tnaqqis fid- dożaġġ normali ta ’ rifabutin ta ’ għallinqas 75% (jiġifieri għall- 150mg darba iva u darba le) hu rakkomandat meta jingħata flimkien ma ’ Telzir ma ’ ritonavir.
Further dose reduction may be necessary.
Jista ’ jkun hemm bżonn ta ’ aktar tnaqqis fid- doża.
8 Other medicinal products
Prodotti mediċinali oħra
Medicinal products that may reduce plasma amprenavir concentrations when co-administered with Telzir
Prodotti mediċinali li jistgħu inaqqsu l- konċentrazzjonijiet fil- plażma ta ’ amprenavir meta jingħataw ma ’ Telzir
Antacids, Histamine H2 receptor antagonist and Proton-Pump inhibitors: no dose adjustment for any of the respective medicinal products is considered necessary when antacids, proton-pump inhibitors or histamine H2 receptor antagonists are administered concomitantly with fosamprenavir.
Mediċini kontra l- aċidu fl- istonku, antagonist tar- riċettur ta ’ l- istamina H2 u impedituri proton- pump: l- ebda tibdil fid- doża għal kull prodott mediċinali rispettiv ma hu meqjus neċessarju meta mediċini kontra l- aċidu fl- istonku, impedituri proton- pump jew antagonisti tar- riċettur ta ’ l- istamina H2 jingħataw flimkien ma ’ fosamprenavir.
The AUC and Cmax of amprenavir were decreased by 18% and 35% respectively, whilst the Cmin (C12h) was comparable, when a single 1400 mg dose of fosamprenavir was co-administered with a single 30 ml dose of antacid suspension (equivalent to 3.6 grams aluminium hydroxide and 1.8 grams magnesium hydroxide).
L- AUC u Cmax ta ’ amprenavir tnaqqsu bi 18% u 35% rispettivament, waqt li Cmin (C12h) kien komparabbli, meta doża waħda ta ’ 1400 mg fosamprenavir ingħatat flimkien ma ’ doża waħda ta ’ 30 ml ta ’ sospensjoni kontra l- aċidu fl- istonku (ekwivalenti għal 3. 6 grammi aluminium hydroxide u 1. 8 grammi magnesium hydroxide).
Serum levels of amprenavir can be reduced by concomitant use of histamine H2 receptor antagonists (for example ranitidine and cimetidine).
Il- livelli ta ’ amprenavir fis- serum jistgħu jonqsu meta flimkien magħhom jingħataw antagonisti tar - riċettur ta ’ l- istamina H2 (per eżempju ranitidine u cimetidine).
Concurrent administration of ranitidine (300 mg single dose) with fosamprenavir (1400 mg single dose) decreased plasma amprenavir AUC by 30% and Cmax by 51%.
Meta ranitidine (doża waħda ta ’ 300 mg) ingħata flimkien ma ’ fosamprenavir (doża waħda ta ’ 1400 mg) dan naqqas l- AUC ta ’ amprenavir fil- plażma bi 30% u Cmax b’ 51%.
There was, however, no change observed in the amprenavir Cmin (C12h).
Biss, l- ebda bidla ma ġiet osservata f’ Cmin (C12h) ta ’ amprenavir.
Anticonvulsant active substances:
Sustanzi attivi anti- konvulżivi:
The AUC and Cmin of amprenavir were increased by 20% and 19% respectively, with Cmax unchanged when fosamprenavir (700 mg twice daily) plus ritonavir (100 mg twice daily) was given concomitantly with phenytoin (300 mg once daily).
L- AUC u Cmin ta ’ amprenavir żdiedu b’ 20% u 19% rispettivament, u Cmax baqa ’ l- istess meta fosamprenavir (700mg darbtejn kuljum) u ritonavir (100mg darbtejn kuljum) ingħataw flimkien ma 'phenytoin (300mg darba kuljum).
The AUC, Cmax and Cmin of phenytoin were decreased by 22%, 20% and 29% respectively.
L- AUC, Cmax u Cmin ta ’ phenytoin naqqsu bi 22%, 20% u 29% rispettivament.
Therefore, if fosamprenavir plus ritonavir is given in combination with phenytoin, no change to the fosamprenavir plus ritonavir dosage regimen is required.
Għalhekk jekk fosamprenavir ma ’ ritonavir jingħataw flimkien ma ’ phenytoin, ma jkun hemm bżonn l- ebda bidla fid- doża ta ’ fosamprenavir ma ’ ritonavir.
However, it is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate.
Madanakollu huwa rakkommandat li jiġu osservati l- konċentrazzjonijiet ta ’ phenytoin fil- plażma u d- doża ta ’ phenytoin miżjuda jekk ikun hemm bżonn.
Concomitant administration of other anticonvulsant agents known to be enzymatic inducers (e. g. phenobarbital, carbamazepine) has not been studied but may lead to a decrease in the plasma concentrations of amprenavir.
L- għoti flimkien ta ’ sustanzi attivi anti- konvulżivi oħra magħrufa bħala inductors enżimatiċi (e. ż. phenytoin, phenobarbital, carbamazepine) ma ġietx studjata imma tista ’ twassal għal tnaqqis fil - konċentrazzjonijiet fil- plażma ta ’ amprenavir.
These combinations should be used with caution.
Dawn it- taħlitiet għandhom jintużaw b’ prekawzjoni.
Medicinal products whose plasma levels may be increased when co-administered with Telzir
Prodotti mediċinali li l- livelli tagħhom fil- plażma jistgħu jiżdiedu meta jingħataw ma ’ Telzir
Other medicinal products with a narrow therapeutic window: some substances (e. g. lidocaine (by systemic route) and halofantrine) given with Telzir may cause serious adverse reactions.
Prodotti mediċinali oħra b’ window terapewtika dejqa: xi sustanzi (e. g. lidocaine (b’ rotot sistemiċi) u halofantrine) meta mogħtija ma ’ Telzir jistgħu jikkaġunaw reazzjonijiet avversi serji.
Concomitant use is not recommended.
L- użu ta ’ dawn il- mediċini fl- istess ħin mhux rakkomandat.
Erectile dysfunction medicinal products: concomitant use is not recommended.
Prodotti mediċinali għal meta l- pene ma jaħdimx normali: l- użu ta ’ dawn fl- istess ħin mhux rakkomandat.
Based on data for ritonavir and other protease inhibitors, plasma concentrations of PDE5 inhibitors (e. g. sildenafil and vardenafil) are expected to substantially increase when co-administered with Telzir with ritonavir and may result in an increase in PDE5 inhibitor associated adverse reactions, including hypotension, visual changes and priapism.
Fuq il- bażi ta ’ informazzjoni dwar ritonavir u impedituri protease oħra, il - konċentrazzjonijiet ta ’ impedituri PDE5 (e. g. sildenafil u vardenafil) fil- plażma jkunu mistennija li jiżdiedu sew meta jingħataw ma ’ Telzir b’ ritonavir u jistgħu jirriżultaw f’ żieda ta ’ reazzjonijiet avversi assoċjati ma ’ l- impeditur PDE5, inklużi ipotensjoni, bidliet fil- vista u prijapiżmu.
Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82-89%).
9 Fluticasone propionate (effett ma ’ ritonavir): fi studju kliniku fejn kapsuli ta ’ ritonavir 100mg darbtejn kuljum ingħataw ma ’ fluticasone propionate 50μg erba ’ darbiet kuljum fl- imnieħer għal 7 ijiem f’ suġġetti b’ saħħithom, il- livelli ta ’ fluticasone propionate fil- plażma żdiedu b’ mod sinifikanti, filwaqt li l- livelli intrinsiċi ta ’ cortisol naqqsu bejn wieħed u ieħor bi 86% (90% confidence interval 82- 89%).
Consequently, concomitant administration of Telzir with ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Għal din ir- raġuni, m’ huwiex rakkommandat li Telzir ma ’ ritonavir jingħata ma ’ dawn il - glukokortikojdi sakemm il- benefiċċji ta ’ dan it- trattament jkun akbar mir- riskju ta ’ l- effetti sistemiċi tal- kortikosterojdi (ara sezzjoni 4. 4).
Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be
Fil- każ li jitwaqqfu l - glukokortikojdi, hemm mnejn ikun hemm bzonn tnaqqis fid- doża bil- mod fuq perjodu itwal ta ’ żmien.
HMG-CoA reductase inhibitors: if treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended because their metabolism is not dependent on CYP 3A4 and interactions are not expected with protease inhibitors.
Meta tkun indikata kura b’ impeditur HMG- CoA reductase, pravastatin jew fluvastatin huma rakkomandati għaliex il- metaboliżmu tagħhom ma jiddependix minn CYP3A4 u mhumiex mistennija interazzjonijiet b’ impedituri protease.
HMG-CoA reductase inhibitors which are highly dependent on CYP3A4 for metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with Telzir with ritonavir.
Impedituri HMG- CoA reductase li huma dipendenti ħafna fuq CYP3A4 għal metaboliżmu, bħal lovastatin u simvastatin, huma mistennija li jkollhom żidiet sew fil- konċentrazzjonijiet fil- plażma meta jingħataw ma ’ Telzir b’ ritonavir.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of lovastatin or simvastatin with Telzir with ritonavir is not recommended.
Billi konċentrazzjonijiet ogħla ta ’ impedituri HMG- CoA reductase jistgħu jikkaġunaw mijopatija, inkluż rabdomajoliżi, it- taħlita ta ’ lovastatin jew simvastatin ma ’ Telzir b’ ritonavir mhix rakkomandata.
No adjustment of the fosamprenavir or ritonavir dose is required when co-administered with atovarstatin.
M’ hemmx bżonn ta ’ xi tibdil fid- doża ta ’ fosamprenavir jew ritonavir meta tingħata ma ’ atovarstatin.
The Cmax, AUC and Cmin of atorvastatin were increased by 184%, 153% and 73% respectively when atorvastatin (10 mg once daily for 4 days) was given with fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily for two weeks.
Cmax, AUC u Cmin ta ’ atorvastatin żdiedu b’ 184%, 153% u 73% rispettivament meta atorvastatin (10 mg darba kuljum għal erbat ijiem) ingħata ma ’ 700 mg fosamprenavir darbtejn kuljum ma ’ 100 mg ritonavir darbtejn kuljum għal ġimgħatejn.
The Cmax, AUC and Cmin of amprenavir were unchanged.
Cmax, AUC u Cmin ta ’ amprenavir baqgħu ma nbidlux.
When used with Telzir with ritonavir, doses of atorvastatin no greater than 20 mg / day should be administered, with careful monitoring for atorvastatin toxicity.
Meta użati ma ’ Telzir b’ ritonavir, għandhom jingħataw dożi ta ’ atorvastatin ta ’ mhux iktar minn 20 mg kuljum, b’ monitoraġġ tajjeb għal xi tossiċità ta ’ atorvastatin.
Immunosuppressants: frequent therapeutic concentration monitoring of immunosuppresant levels is recommended until levels have stabilised as plasma concentrations of cyclosporin, rapamycin and tacrolimus may be increased when co-administered with fosamprenavir with ritonavir.
Immunosuppressanti: monitoraġġ ta ’ spiss ta ’ konċentrazzjonijiet terapewtiċi ta ’ livelli ta ’ immunosuppressanti hu rakkomandat sakemm il- livelli jistabbilizzaw ruħhom għaliex konċentrazzjonijiet ta ’ cyclosporin, rapamycin u tacrolimus fil- plażma jistgħu jiżdiedu meta jingħataw flimkien ma ’ fosamprenavir b’ ritonavir.
Midazolam: midazolam is extensively metabolized by CYP3A4.
Midazolam: midazolam jiġi mmetaboliżżat b’ mod estensiv minn CYP3A4.
Coadministration with Telzir/ ritonavir may cause a large increase in the concentration of this benzodiazepine.
L- użu flimkien ma ’ Telzir/ ritonavir jista ’ jwassal għal żieda kbira fil- livell ta ’ dan il- benzodiazepine.
No drug interaction study has been performed for the co-administration of Telzir/ ritonavir with benzodiazepines.
Ma sar l- ebda studju dwar interazzjoni ta ’ mediċina għal għoti flimkien ta ’ Telzir/ ritonavir ma ’ benzodiazepines.
Therefore Telzir/ ritonavir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Telzir/ ritonavir and parenteral midazolam.
Għal dan il- għan Telzir/ ritonavir m’ għandux jingħata flimkien ma ’ midazolam meta dan jingħata mill- ħalq (ara sezzjoni 4. 3), u għandu jkun hemm kawtela meta Telzir/ ritonavir jingħataw flimkien ma ’ midazolam mill- vina.
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Informazzjoni mill- użu ta ’ midazolam mill- vina flimkien ma ’ inibituri oħra ta ’ protease juru possibilità ta ’ żieda ta ’ 3- 4 darbiet aktar fil- livelli ta ’ midazolam fil- plażma.
If Telzir/ ritonavir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/ or prolonged sedation.
Jekk Telzir/ ritonavir jingħata flimkien ma ’ midazolam fil- vina, dan għandu jsir taħt kura intensiva jew x’ imkien ieħor simili li jiżgura li jkun hemm osservazzjoni klinika mill- viċin u mmaniġġar mediku kif għandu jkun f' każ ta ’ dipressjoni respiratorja u/ jew sedazzjoni fit- tul.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Għandu jiġi kkunsidrat aġġustament fid- doża ta’ midazolam, speċjalment jekk tingħata aktar minn doża waħda.
Tricyclic antidepressants: careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they (for example desipramine and nortriptyline) are concomitantly administered with Telzir.
Monitoraġġ tajjeb ta ’ l- effetti terapewtiċi u l- effetti avversi ta ’ antidepressanti triċikliċi hu rakkomandat meta dawn (per eżempju desipramine u nortriptyline) jingħataw flimkien ma ’ Telzir.
Medicinal products whose plasma levels may be decreased when co-administered with Telzir
10 Prodotti mediċinali li l- livelli tagħhom fil- plażma jistgħu jonqsu meta jingħataw ma ’ Telzir
Methadone: co-administration of fosamprenavir 700 mg and ritonavir 100 mg twice daily with methadone once daily (≤ 200 mg) for 14 days decreased the active (R-) methadone enantiomer AUC(0- τ) and Cmax by 18% and 21% respectively.
Methadone:: l- għoti ta ’ fosamprenavir 700mg u ritonavir 100mg darbtejn kuljum flimkien ma ’ methadone darba kuljum (≤200mg) għal 14- il ġurnata naqqas l- AUC( 0- τ) u Cmax ta ’ l- enantiomer attiv ta ’ (R -) methadone b’ 18% u 21% rispettivament.
This limited impact is not expected to be clinically significant.
Dan l- impatt limitat mhuwiex mistenni li jkun klinikament sinifikanti.
However, as a precaution, patients should be monitored for withdrawal syndrome.
Madankollu, bħala prekawzjoni, il- pazjenti għandhom ikunu osservati għas - sindromu ta ’ meta l- mediċina titwaqqaf f’ daqqa.
Based on historical comparisons, methadone did not appear to alter plasma amprenavir pharmacokinetic parameters.
Ibbażat fuq paraguni storiċi, methadone ma deherx li biddel il- parametri farmakokinetiċi ta 'amprenavir fil- plażma.
Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Telzir with ritonavir with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect.
Anti- koagulanti orali: monitoraġġ rinfurzat tal- Proporzjon Internazzjonali Normalizzathu rakkomandat f’ każi ta ’ l- għoti ta ’ Telzir b’ ritonavir ma ’ warfarin jew xi anti- koagulanti oħra, minħabba l- possibiltà ta ’ xi tnaqqis jew żieda ta ’ l- effett anti- trombotiku tagħhom.
10 daily decreased plasma EE AUC(0- τ) and Cmax by 37% and 28%, respectively, and decreased plasma NE AUC(0-τ), Cmax, and Cτ by 34%, 38%, and 26%, respectively.
Sterojdi: fosamprenavir 700mg darbtejn kuljum + ritonavir 100mg darbtejn kuljum flimkien ma ’ kontraċettiv orali li fih ethinyl estradiol (EE) 0. 035mg/ norethisterone (NE) 0. 5mg darba kuljum naqqsu l- EE AUC (0- τ) u s- Cmax fil- plażma b’ 37% u bi 28% rispettivament, u naqqsu l- NE AUC (0- τ), Cmax u Cτ b’ 34%, 38% u 26% rispettivament.
Steady state plasma amprenavir pharmacokinetic (PK) parameters were not significantly affected by co-administration with this oral contraceptive; however, ritonavir AUC(0- τ) and Cmax were 45% and 63% higher, respectively, compared to historical data in female subjects dosed with fosamprenavir / ritonavir alone.
Il- parametri farmakokinetiċi (PK) ta ’ amprenavir fil - plażma fi stat fiss ma kienux daqshekk affettwati meta ingħataw flimkien ma ’ dan il- kontraċettiv orali; għalkemm l- AUC (0- τ) u s- Cmax ta ’ ritonavir kienu aktar għoljin b’ 45% u 65% rispettivament, meta mqabbla ma ’ data storika f’ suġġetti femminili li ngħataw fosamprenavir/ ritonavir waħidhom.
In addition to the decreased hormonal contraceptive exposures, co-administration of fosamprenavir with ritonavir and this oral contraceptive resulted in clinically significant hepatic transaminase elevations in some healthy subjects.
Barra minn livelli aktar baxxi ta ’ ormoni kontraċettivi, meta l- fosamprenavir u r- ritonavir ingħataw flimkien ma 'dan il- kontraċettiv orali, kien hemm ukoll żieda klinikament sinifikanti fil- livelli tat- transaminase fil- fwied f’ xi suġġetti b’ saħħithom.
Therefore alternative non-hormonal methods of contraception are recommended for women of childbearing potential (see section 4.4).
(ara sezzjoni 4. 4)
The Cmax and AUC of paroxetine were decreased by 51% and 55% respectively when paroxetine 20 mg once daily was given with fosamprenavir 700 mg and ritonavir 100 mg twice daily for 10 days in healthy volunteers.
Is- Cmax u l- AUC ta ’ paroxetine tnaqqsu b’ 51% u 55% rispettivament meta paroxetine 20mg darba kuljum ingħatat ma ’ fosamprenavir 700mg u ritonavir 100mg darbtejn kuljum għal għaxart ijiem lill- voluntiera b’ saħħithom.
The mechanism of this interaction remains unknown.
Il- mekkaniżmu ta ’ din l- interazzjoni jibqa ’ mhux magħruf.
Based on historical comparison, amprenavir pharmacokinetic parameters were not altered by paroxetine.
Skond paragun li sar fil- passat, il- parametri farmakokinetiċi ta ’ amprenavir ma nbiddlux b’ paroxetine.
Therefore, if paroxetine is co-administered with Telzir and ritonavir, the recommended approach is a dose titration of paroxetine based on a clinical assessment of antidepressant response.
Għalhekk, jekk paroxetine jingħata flimkien ma ’ Telzir u ritonavir, il- mod rakkomandat huwa titrazzjoni tad- doża ta ’ paroxetine ibbażata fuq assessjar kliniku ta ’ rispons anti- dipressiv.
In addition, patients on stable dose of paroxetine who start treatment with Telzir and ritonavir should be monitored for antidepressant response.
Barra minn dan, pazjenti fuq doża stabbli ta ’ paroxetine li jibdew kura b’ Telzir u ritonavir għandu ikunu osservati għal rispons anti- dipressiv.
There is no clinical experience with fosamprenavir in pregnant women.
Għad m’ hemmx esperjenza klinika dwar fosamprenavir f’ nisa tqal.
In animal studies at systemic plasma exposures (AUC) to amprenavir lower than therapeutic exposure in patients treated with Telzir, some developmental toxicity was observed (see section 5.3).
Fi studji fuq annimali b’ esponimenti sistemiċi ta ’ amprenavir fil- plażma (AUC) inqas minn esponimenti terapewtiċi f’ pazjenti li jkunu qed jieħdu Telzir, ġie osservat xi żvilupp ta ’ tossiċità (ara sezzjoni 5. 3).
In view of the low exposure in reproductive toxicity studies, the potential developmental toxicity of Telzir has not been fully determined.
Minħabba l- esponiment baxx fi studji dwar tossiċità fuq is- sistema riproduttiva, it- tossiċità potenzjali ta ’ Telzir fuq l- iżvilupp għada ma ġietx stabbilita għal kollox.
Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Telzir għandu jintuża waqt it- tqala biss jekk il- benefiċċju li jista ’ jkollu jiġġustifika r- riskju li jista ’ jkun hemm għall- fetu.
Amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
Sustanzi relatati ma ’ amprenavir instabu fil- ħalib tal- firien, iżda mhux magħruf jekk amprenavir joħroġx fil- ħalib tal- bnedmin.
Rat pups exposed pre and post-natally to amprenavir and fosamprenavir showed developmental toxicity (see section 5.3).
Firien tat- twelid li kienu esposti għal amprenavir u fosamprenavir qabel u wara t- twelid urew tossiċità ta ’ l- iżvilupp (ara sezzjoni 5. 3).
It is therefore recommended that mothers treated with Telzir do not breast-feed their infants.
Għalhekk hu rakkomandat li ommijiet li qed jieħdu Telzir m’ għandhomx ireddgħu lit- trabi tagħhom.
As a general rule, it is recommended that HIV-infected women must not breast-feed under any circumstances to avoid transmission of HIV.
Bħala regola ġenerali, hu rakkomandat li nisa infettati bl- HIV m’ għandhomx ireddgħu taħt l- ebda ċirkostanza biex ma jgħaddux il- marda ta ’ l- HIV.
No studies on the effects of Telzir in combination with ritonavir on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta ’ Telzir flimkien ma ’ ritonavir fuq il- ħila biex issuq jew tħaddem magni.
The adverse reaction profile of Telzir should be borne in mind when considering the patient’ s ability to drive or operate machinery (see section 4.8).
Il- profil tar- reazzjonijiet avversi ta ’ Telzir għandu jitqies meta tkun qed tiġi kkunsidrata l- ħila ta ’ pazjent biex isuq jew iħaddem magni (ara sezzjoni 4. 8).
The safety of fosamprenavir has been studied in 755 adult patients in Phase II and III controlled clinical trials.
Is- sigurtà ta ’ fosamprenavir ġiet studjata f’ 755 pazjent adult fil- Fażi II u III ta ’ provi kliniċi kontrollati.
The safety of the co-administration of fosamprenavir with low dose ritonavir was established in two pivotal Phase III trials:
Is- sigurtà ta ’ l- għoti flimkien ta ’ fosamprenavir ma ’ doża baxxa ta ’ ritonavir kienet stabbilita f’ żewġ provi pivitali ta ’ Fażi III:
APV30002 (n = 322) in antiretroviral naïve patients, fosamprenavir (1400 mg) given once daily in combination with ritonavir (200 mg) as part of a triple regimen including abacavir and lamivudine.
APV30002( n=322) f’ pazjenti li m’ għandhomx esperjenza ta ’ trattament antiretrovirali, fosamprenavir (1400 mg) darba kuljum ma ’ ritonavir (200 mg) bħala parti minn kura li tinkludi abacavir u lamivudine.
APV30003 in protease inhibitor experienced patients, fosamprenavir given in combination with low dose ritonavir either once daily (1400 mg / 200 mg) (n =
APV30003 f’ pazjenti b’ esperjenza ta ’ impedituri protease, fosamprenavir flimkien ma ’ doża baxxa ta ’ ritonavir jew darba kuljum (1400 mg/ 200 mg) (n=106) jew darbtejn kuljum (700 mg/ 100 mg) (n=106) flimkien ma ’ żewġ impedituri attivi ta ’ reverse transcriptase (RTIs).
The adverse reaction profile was similar across all the respective adult studies: antiretroviral naïve (APV30002) and protease inhibitor experienced (twice daily dosing, APV30003) patient populations.
Il- profil ta ’ reazzjonijiet avversi kien simili għall- istudji kollha rispettivi f’ adulti: gruppi ta ’ pazjenti li m’ għandhomx esperjenza ta ’ trattament antiretrovirali (APV30002) u oħrajn b’ esperjenza ta ’ impedituri protease (doża ta ’ darbtejn kuljum, APV30003).
Frequencies are defined as:
Ir- reazzjonijiet avversi huma elenkati skond is- sistema MedDRA, klassi ta ’ organi u frekwenza assoluta.
Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10), Uncommon (≥ 1/ 1,000, < 1/ 100), Rare (≥ 1/ 10,000, < 1/ 1,000) or Very rare (< 1/ 10,000), including isolated reports.
Il- frekwenzi huma definiti bħala Komuni ħafna (≥1/ 10), Komuni (≥1/ 100, < 1/ 10), Mhux komuni (≥1/ 1, 000, < 1/ 100), Rari (≥1/ 10, 000, < 1/ 1, 000) jew Rari ħafna (≤1/ 10, 000), inklużi rapporti iżolati.