qanastek/EMEA-V3 huggingface dataset:
Saquinavir Cmin ↓ 78% Dual-boosted protease inhibitor combination therapy in multiple- treatment experienced HIV-positive adults.
Inibitur tal- fużjoni ta ’ l- HIV Saquinavir ↔
Concomitant administration of tipranavir, co-administered with low dose ritonavir, with saquinavir/ritonavir, is not recommended.
L- għoti fl- istess waqt ta ’ tipranavir, l- għoti flimkien ma ’ doża baxxa ta ’ ritonavir, ma ’ saquinavir/ ritonavir, mhux irrakkomandat.
Saquinavir ↔ Enfuvirtide ↔ No clinically significant interaction was noted.
Enfuvirtide Enfuvirtide ↔
Bepridil Lidocaine (systemic) Quinidine (saquinavir/ritonavir) Amiodarone flecainide propafenone (saquinavir/ritonavir) Anticoagulant
(saquinavir/ ritonavir 1000/ 100 mg bid) Ma ġiet innutata l- ebda interazzjoni ta ’ sinifikanza klinika.
Concentrations of bepridil, systemic lidocaine or quinidine may be increased when co-administered with Invirase/ritonavir.
Prodotti mediċinali oħra Anti- arritmijaċi Konċentrazzjonijiet ta ’ bepridil, Bepridil lidocaine sistemiku jew quinidine Lidocaine (sistemiku) jistgħu jiżdiedu meta jingħataw Quinidine flimkien ma ’ Invirase/ ritonavir.
Concentrations of amiodarone, flecainide or propafenone may be increased when co-administered with Invirase/ritonavir.
(saquinavir/ ritonavir) Konċentrazzjonijiet ta ’ amiodarone, Amiodarone flecainide jew propafenone jistgħu flecainide jiżdiedu meta jingħataw flimkien ma ’ propafenone Invirase/ ritonavir.
Contraindicated in combination with saquinavir/ritonavir due to potentially life threatening cardiac arrhythmia (see section 4.3).
Kontra- indikat flimkien ma ’ saquinavir/ ritonavir minħabba arritmija kardijaka b’ potenzjal ta ’ periklu għal ħajja (ara sezzjoni 4. 3).
INR (international normalised ratio) monitoring recommended.
Huwa rrakkomandat li l- INR (il - proporzjon normalizzat internazzjonali) jiġi sorveljat.
- Carbamazepine Phenobarbital Phenytoin (saquinavir/ritonavir)
32
- Interaction with Invirase/ritonavir not studied.
Prodott mediċinali skond Interazzjoni is- settur terapewtiku (doża ta ’ Invirase użata fl- istudju) - L- interazzjoni ma ’ - Carbamazepine Invirase/ ritonavir ma ’ ġietx Phenobarbital studjata.
- These medicinal products will induce CYP3A4 and may therefore decrease saquinavir concentrations.
Phenytoin (saquinavir/ ritonavir) - Carbamazepine - Dawn il- prodotti mediċinali Phenobarbital jinduċu CYP3A4 u għalhekk Phenytoin jistgħu jnaqqsu l - (saquinavir mhux konċentrazzjonijiet ta ’ saquinavir. imsaħħaħ) Anti- depressanti Invirase/ ritonavir jista ’ jżid il - Anti- depressanti triċikliċi konċentrazzjonijiet ta ’ anti - (e. ż. amitriptyline, depressanti triċikliċi. imipramine) (saquinavir/ ritonavir) - Nefazodone - L- interazzjoni ma ’ (saquinavir/ ritonavir) saquinavir/ ritonavir ma ġietx stmata.
Therapeutic concentration monitoring recommended.
Rakkomandazzjonijiet li jikkonċernaw l- għoti fl- istess waqt Hija rrakkomandata sorveljanza tal - konċentrazzjoni terapewtika.
- Nefazodone (saquinavir/ritonavir)
- Nefazodone - Nefazodone jinibixxi lil CYP3A4.
- Interaction with saquinavir/ritonavir not evaluated.
(saquinavir mhux imsaħħaħ Il- konċentrazzjonijiet ta ’ saquinavir jistgħu jiżdiedu.
- Nefazodone inhibits CYP3A4.
Antistaminiċi
Terfenadine Astemizole (saquinavir/ritonavir) Anti-infectives
Terfenadine Terfenadine AUC ↑, assoċjata ma ’ Astemizole titwil ta ’ l- intervalli ta ’ QTc.
Terfenadine AUC ↑, associated with a prolongation of QTc intervals.
(saquinavir/ ritonavir) Interazzjoni simili ma ’ astemizole hija probabbli.
A similar interaction with astemizole is likely.
Anti- infettivi - Clarithromycin - L- interazzjoni ma ’ Invirase/ ritonavir (saquinavir/ ritonavir) ma ’ ġietx studjata. - Saquinavir AUC ↑ 177%
- Clarithromycin (saquinavir/ritonavir)
- Clarithromycin Saquinavir Cmax ↑ 187%
- Interaction with Invirase/ritonavir not studied.
- L- ebda aġġustament fid- doża ma
- Clarithromycin 500 mg bid (unboosted saquinavir 1200 mg tid) - Erythromycin (saquinavir/ritonavir)
500 mg bid (saquinavir mhux Clarithromycin AUC ↑ 40% imsaħħaħ 1200 mg tid) Clarithromycin Cmax ↑ 40% - Erythromycin - L- interazzjoni ma ’ Invirase/ ritonavir (saquinavir/ ritonavir) ma ’ ġietx studjata. - Saquinavir AUC ↑ 99%
- No dose adjustment is required when co-administered for a limited time at the doses studied.
huwa meħtieġ meta jingħataw flimikien għal żmien limitat fid - dożi studjati.
- Saquinavir AUC ↑ 99% Saquinavir Cmax ↑ 106%
- Erythromycin Saquinavir Cmax ↑ 106%
- Interaction with Invirase/ritonavir not studied.
250 mg qid (saquinavir mhux imsaħħaħ 1200 mg tid) - Anti- bijotiċi - L- interazzjoni ma ’ Invirase/ ritonavir streptogramin ma ’ ġietx studjata.
- Streptogramin antibiotics such as quinupristin/dalfopristin inhibit CYP3A4.
(saquinavir/ ritonavir) - Anti- bijotiċi streptogramin bħal - Anti- bijotiċi quinupristin/ dalfopristin jinibixxu streptogramin lil CYP3A4.
Saquinavir concentrations may be increased.
Il- konċentrazzjonijiet (saquinavir mhux ta ’ saquinavir jistgħu jiżjiedu. imsaħħaħ) Sustanzi kontra l- moffa Saquinavir AUC ↔
- Monitoring for saquinavir toxicity recommended.
fid- doża. - Sorveljanza għat- tossiċità ta ’ saquinavir hija rrakkomandata.
Ketoconazole 200 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Ketoconazole 200 mg qd (saquinavir/ ritonavir Saquinavir Cmax ↔
Saquinavir AUC ↔ Saquinavir Cmax ↔ Ritonavir AUC ↔ Ritonavir Cmax ↔ Ketoconazole AUC ↑ 168% (90% CI 146%-193%) Ketoconazole Cmax ↑ 45% (90% CI 32%-59%)
1000/ 100 mg bid) Ritonavir AUC ↔ Ritonavir Cmax ↔ Ketoconazole AUC ↑ 168% (90% CI 146% - 193%) Ketoconazole Cmax ↑ 45% (90% CI 32% - 59%) 33
No dose adjustment required when saquinavir/ritonavir combined with ≤ 200 mg/day ketoconazole.
jingħata flimkien ma ’ ketoconazole ≤ 200 mg/ kuljum.
High doses of ketoconazole (> 200 mg/day) are not recommended.
Dożi għolja ta ’ ketoconazole (> 200 mg/ kuljum) mhux irrakkomandati.
- Itraconazole (saquinavir/ritonavir)
Prodott mediċinali skond Interazzjoni is- settur terapewtiku (doża ta ’ Invirase użata fl- istudju) - Itraconazole - L- interazzjoni ma ’ Invirase/ ritonavir (saquinavir/ ritonavir) ma ’ ġietx studjata. - Itraconazole huwa inibitur qawwi
- Interaction with Invirase/ritonavir not studied.
Rakkomandazzjonijiet li jikkonċernaw l- għoti fl- istess waqt
- Itraconazole (unboosted saquinavir)
- Itraconazole b’ mod moderat ta ’ CYP3A4.
- Itraconazole is a moderately potent inhibitor of CYP3A4.
Sorveljanza għat- tossiċità ta ’
Monitoring for saquinavir toxicity recommended.
(saquinavir mhux Interazzjoni hija possibbli. imsaħħaħ) Fluconazole/ miconazole L- interazzjoni ma ’ Invirase/ ritonavir (saquinavir/ ritonavir) ma ’ ġietx studjata.
Fluconazole/miconazole (saquinavir/ritonavir) Antimycobacterials
Sustanzi kontra l- mycobacteria
Interaction with Invirase/ritonavir not studied.
saquinavir hija rrakkomandata.
Rifampicin 600 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Fi studju kliniku 11 minn 17- il Rifampicin 600 mg qd
Rifampicin is contraindicated in combination with Invirase/ritonavir (see section 4.3).
Rifampicin huwa kontra- indikat
32 Medicinal product by therapeutic area (dose of Invirase used in study)
voluntier b’ saħħithom (65%) (saquinavir/ ritonavir
Rifabutin (saquinavir/ritonavir 1000/100 mg bid) Benzodiazepines
L- interazzjoni ma ’ Rifabutin saquinavir/ ritonavir 1000/ 100 mg ma ’ (saquinavir/ ritonavir ġietx studjata.
Interaction with saquinavir/ritonavir 1000/100 mg not studied.
Konċentrazzjonijiet ta ’ dawn il -
Patients receiving rifabutin with Invirase/ritonavir should be closely monitored for liver function test elevations and emergence of adverse events associated with rifabutin therapy.
Pazjenti li qed jingħataw rifabutin ma ’ Invirase/ ritonavir għandhom jiġu sorveljati mill- viċin għal żjidiet fit - test tal- funzjoni tal- fwied u d- dehra ta ’ avvenimenti avversi assoċjati ma ’ terapija b’ rifabutin.
Further dosage reduction of rifabutin may be necessary.
Aktar tnaqqis fid- doża ta ’ rifabutin tista ’ tkun neċessarja.
Therapeutic concentration monitoring for saquinavir is recommended.
Sorveljanza tal - konċentrazzjoni terapewtika għal saquinavir hija rrakkomandata.
Co-administration of Invirase/ritonavir with orally administered midazolam is contraindicated (see section 4.3).
L- għoti ta ’ Invirase/ ritonavir flimkien ma ’ midazolam orali huwa kontra - indikat (ara sezzjoni 4. 3).
Caution should be used with co- administration of Invirase and parenteral midazolam.
Għandha tintuża kawtela meta Invirase jingħata flimkien ma ’ midazolam mogħti b’ mod parenterali.
If Invirase 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 Invirase jingħata flimkien ma ’ midazolam parenterali dan għandu jsir f’ sala ta ’ kura intensiva (ICU) jew post simili li jista ’ jassigura sorveljanza klinika mill- viċin u mmaniġġjar mediku xieraq f’ każ ta ’ depressjoni respiratorja u/ jew sedazzjoni mtawwla.
Alprazolam Clorazepate Diazepam Flurazepam (saquinavir/ritonavir)
Alprazolam prodotti mediċinali jistgħu jiżdiedu
Concentrations of these medicinal products may be increased when co- administered with Invirase/ritonavir.
Clorazepate meta jingħataw flimkien ma ’
Careful monitoring of patients with regard to sedative effects is warranted.
rigward l- effetti sedattivi hija
A decrease in the dose of the benzodiazepine may be required.
Tista ’ tkun meħtieġa
Triazolam (saquinavir/ritonavir) Calcium channel blockers
Flurazepam (saquinavir/ ritonavir) Triazolam Konċentrazzjonijiet ta ’ triazolam
Concentrations of triazolam may be increased when co-administered with Invirase/ritonavir.
Prodott mediċinali skond Interazzjoni is- settur terapewtiku (doża ta ’ Invirase użata fl- istudju) (saquinavir/ ritonavir) jistgħu jiżdiedu meta jingħata flimkien ma ’ Invirase/ ritonavir.
Contraindicated in combination with saquinavir/ritonavir, due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Rakkomandazzjonijiet li jikkonċernaw l- għoti fl- istess waqt saquinavir/ ritonavir, minħabba r - riskju potenzjali ta ’ titwil jew żjieda fis- sedazzjoni u depressjoni respiratorja (ara sezzjoni 4. 3).
Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
Imblokkaturi tal- kanali tal- kalċju Konċentrazzjonijiet ta ’ dawn il - Felodipine, nifedipine,
Concentrations of these medicinal products may be increased when co- administered with Invirase/ritonavir.
prodotti mediċinali jistgħu jiżdiedu
33 Medicinal product by therapeutic area (dose of Invirase used in study) Corticosteroids
nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ ritonavir) Kortikosterojdi
Recommendations concerning co - administration
sorveljanza klinika tal- pazjenti.
- Dexamethasone (saquinavir/ritonavir)
- Dexamethasone (saquinavir/ ritonavir)
- Interaction with Invirase/ritonavir not studied.
- L- interazzjoni ma ’ Invirase/ ritonavir ma ġietx studjata.
Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Effetti sistemiċi tal - kortikosterojdi inkluż is- sindrome ta ’ Cushing u soppressjoni adrenali kienu irrapportati f’ pazjenti li ngħataw ritonavir u fluticasone propionate mogħti man- nifs mill- ħalq jew mill - imnieħer; dan jista ’ jseħħ wkoll ma ’ kortikosterojdi oħra metabolizzati mir- rotta ta ’ P450 3A e. ż. budesonide.
Concomitant administration of boosted saquinavir and fluticasone propionate and other corticosteroids metabolised via the P450 3A pathway (e.g. budesonide) is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
L- effetti ta ’ esponiment sistemiku għoli ta ’ fluticasone fuq il- livelli fil - plażma ta ’ ritonavir għadhom mhux magħrufa.
Dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g.
Prodotti mediċinali li huma substrati ta ’ P- glycoprotein Glycosides ta ’ Digitalis Digoxin 0. 5 mg Digoxin AUC0- 72 ↑ 49% doża waħda Digoxin Cmax ↑ 27% (saquinavir/ ritonavir Livelli ta ’ digoxin jistgħu jkunu 1000/ 100 mg bid) differenti maż- żmien.
Medicinal products that are substrates of P-glycoprotein Digitalis glycosides Digoxin 0.5 mg single dose (saquinavir/ritonavir 1000/100 mg bid)
imsaħħaħ u fluticasone propionate u kortikosterojdi oħra metabolizzati permezz tar- rotta ta ’ P450 3A (e. ż. budesonide) mhux irrakkomandat sakemm il- benefiċċju potenzjali tal - kura ma jkunx akbar mir- riskju ta ’ effetti sistemiċi tal- kortikosterojdi (ara sezzjoni 4. 4).
Large increments of digoxin may be expected when saquinavir/ritonavir is introduced in patients already treated with digoxin.
F’ każ ta ’ rtirar tal- glukokortikojdi, jista ’ jkun hemm bżonn ta ’ tnaqqis gradwali fid- doża fuq perijodu ta ’ żmien itwal.
Caution should be exercised when Invirase/ritonavir and digoxin are co- administered.
Għandu jkun hemm kawtela meta Invirase/ ritonavir u digoxin jingħataw flimkien.
Histamine H2-receptor antagonist -
35
- Interaction with Invirase/ritonavir not studied.
Prodott mediċinali skond Interazzjoni is- settur terapewtiku (doża ta ’ Invirase użata fl- istudju)
Ranitidine (unboosted saquinavir)
Rakkomandazzjonijiet li jikkonċernaw l- għoti fl- istess waqt
- Saquinavir AUC ↑ 67%
- Saquinavir AUC ↑ 67% - Ranitidine (saquinavir mhux imsaħħaħ) Inibituri ta ’ HMG- CoA reductase L- interazzjoni ma ’ ġietx studjata.
HMG-CoA reductase inhibitors Pravastatin Fluvastatin (saquinavir/ritonavir)
Pravastatin metaboliżmu ta ’ pravastatin u
Metabolism of pravastatin and fluvastatin is not dependent on CYP3A4.
Fluvastatin fluvastatin mhux dipendenti fuq
If no alternative treatment is available, use with careful monitoring.
m’ hemmx kura alternattiva
Simvastatin Lovastatin (saquinavir/ritonavir)
(saquinavir/ ritonavir) CYP3A4.
Simvastatin ↑↑ Lovastatin ↑↑ Plasma concentrations highly dependent on CYP3A4 metabolism.
Simvastatin Simvastatin ↑↑ Lovastatin Lovastatin ↑↑ (saquinavir/ ritonavir) Konċentrazzjonijiet fil- plażma huma dipendenti ħafna fuq metaboliżmu minn CYP3A4.
Increased concentrations of simvastatin and lovastatin have been associated with rhabdomyolysis.
Atorvastatin Atorvastatin huwa inqas dipendenti (saquinavir/ ritonavir) minn CYP3A4 għall- metaboliżmu.
These medicinal products are contraindicated for use with Invirase/ritonavir (see section 4.3).
Immunosoppressanti Ciclosporin Konċentrazzjonijiet ta ’ dawn il - Tacrolimus prodotti mediċinali jiżdiedu b’ ħafna Rapamycin drabi meta jingħataw flimkien ma ’ (saquinavir/ ritonavir) Invirase/ ritonavir.
Medicinal product by therapeutic area (dose of Invirase used in study)
Analġeżiċi narkotiċi Methadone AUC ↓ 19%
Recommendations concerning co- administration
disponibbli, uża flimkien ma ’ sorveljanza b’ attenzjoni.
Atorvastatin (saquinavir/ritonavir) Immunosuppressants
Konċentrazzjonijiet miżjuda ta ’ simvastatin u lovastatin ġew assoċjati ma ’ rabdomijolisi.
Atorvastatin is less dependent on CYP3A4 for metabolism.
Dawn il - prodotti mediċinali huma kontra - indikati għall- użu flimkien ma ’ Invirase/ ritonavir (ara sezzjoni 4. 3).
When used with Invirase/ritonavir, the lowest possible dose of atorvastatin should be administered and the patient should be carefully monitored for signs/symptoms of myopathy (muscle weakness, muscle pain, rising plasma creatinine kinase).
Meta wżat ma ’ Invirase/ ritonavir, għandha tingħata l- inqas doża possibli ta ’ atorvastatin u l- pazjent għandu jiġi sorveljat b’ attenzjoni għal sinjali/ sintomi ta ’ mijopatija (dgħjufija tal- muskoli, uġigħ fil - muskoli, żjieda ta ’ creatinine kinase fil- plażma).
Careful therapeutic drug monitoring is necessary for immunosuppressants when co-administered with Invirase/ritonavir.
Sorveljanza terapewtika tal- mediċina b’ attenzjoni hija meħtieġa għall - immunosoppressanti meta jingħataw flimkien ma ’ Invirase/ ritonavir.
Methadone AUC ↓ 19% (90% CI 9% to 29%) None of the 12 patients experienced withdrawal symptoms.
Newroleptiċi
Concentrations of pimozide may be increased when co-administered with Invirase/ritonavir.
Pimozide Konċentrazzjonijiet ta ’ pimozide (saquinavir/ ritonavir) jistgħu jiżdiedu meta jingħata flimkien ma ’ Invirase/ ritonavir.
Concentration of ethinyl estradiol may be decreased when co- administered with Invirase/ritonavir.
Kontraċettivi orali Ethinyl estradiol Konċentrazzjoni ta ’ ethinyl estradiol (saquinavir/ ritonavir) tista ’ tonqos meta jingħata flimkien ma ’ Invirase/ ritonavir.
Sildenafil (saquinavir/ritonavir)
Miżuri ta ’ kontraċezzjoni alternattivi jew addizzjonali għandhom jiġu wżati meta kontraċettivi orali b’ bażi ta ’ estroġenu jigħataw fl- istess waqt.
Interaction with Invirase/ritonavir not studied.
- Sildenafil - L- interazzjoni ma ’ (saquinavir/ ritonavir) Invirase/ ritonavir ma ’ ġietx studjata. - Saquinavir ↔
Sildenafil 100 mg (single dose) (unboosted saquinavir
- Sildenafil 100 mg 36
- Use sildenafil with caution at reduced doses of no more than 25 mg every 48 hours with
- Uża sildenafil b’ kawtela f’ dożi
increased monitoring of adverse events when administered concomitantly with Invirase/ritonavir.
Prodott mediċinali skond Interazzjoni is- settur terapewtiku (doża ta ’ Invirase użata fl- istudju)
Vardenafil (saquinavir/ritonavir)
Rakkomandazzjonijiet li jikkonċernaw l- għoti fl- istess waqt
Concentrations of vardenafil may be increased when co-administered with Invirase/ritonavir.
Vardenafil Konċentrazzjonijiet ta ’ vardenafil (saquinavir/ ritonavir) jistgħu jiżdiedu meta jingħata flimkien ma ’ Invirase/ ritonavir.
Use vardenafil with caution at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring of adverse events when administered concomitantly with Invirase/ritonavir.
Tadalafil Konċentrazzjonijiet ta ’ tadalafil (saquinavir/ ritonavir) jistgħu jiżdiedu meta jingħata flimkien ma ’ Invirase/ ritonavir.
Tadalafil (saquinavir/ritonavir)
Inibituri tal- proton pump
Concentrations of tadalafil may be increased when co-administered with Invirase/ritonavir.
mnaqqsa ta ’ mhux aktar minn 25 mg kull 48 siegħa b’ sorveljanza miżjuda għall- effetti avversi meta dan jingħata flimkien ma ’ Invirase/ ritonavir Uża vardenafil b’ kawtela f’ dożi mnaqqsa ta ’ mhux aktar minn 2. 5 mg kull 72 siegħa b’ sorveljanza miżjuda għall- effetti avversi meta dan jingħata flimkien ma ’ Invirase/ ritonavir.
Use tadalafil with caution at reduced doses of no more than 10 mg every 72 hours with increased monitoring of adverse events when administered concomitantly with Invirase/ritonavir.
Uża tadalafil b’ kawtela f’ dożi mnaqqsa ta ’ mhux aktar minn 10 mg kull 72 siegħa b’ sorveljanza miżjuda għall- effetti avversi meta dan jingħata flimkien ma ’ Invirase/ ritonavir.
35 Medicinal product by therapeutic area (dose of Invirase used in study) Proton pump inhibitors
Omeprazole 40 mg qd Saquinavir AUC ↑ 82% (saquinavir/ ritonavir (90% CI 44- 131%) 1000/ 100 mg bid) Saquinavir Cmax ↑ 75% (90% CI 38- 123%) Ritonavir ↔ Inibituri tal- proton pump L- ebda tagħrif ma huwa disponibbli oħra dwar l- għoti ta ’ Invirase/ ritonavir (saquinavir/ ritonavir flimkien ma ’ inibituri oħra tal- proton 1000/ 100 mg bid) pump.
Recommendations concerning co- administration
Oħrajn Alkalojdi ergot (e. ż.
If omeprazole or other proton pump inhibitors are taken concomitantly with Invirase/ritonavir, monitoring for potential saquinavir toxicities is recommended.
Jekk omeprazole jew inibituri oħra tal- proton pump jittieħdu flimkien ma ’ Invirase/ ritonavir, hija rrakkomandata sorveljanza għal tossiċitajiet potenzjali ta ’ saquinavir.
The concomitant use of Invirase/ritonavir and ergot alkaloids is contra -indicated (see section 4.3).
L- użu ta ’ Invirase/ ritonavir flimkien ma ’ alkalojdi ergot huwa kontra - indikat (ara sezzjoni 4. 3). - Iż- żjieda mhix maħsuba li hija ta ’ rilevanza klinika.
- Grapefruit juice (saquinavir/ritonavir)
Mhux meħtieġ aġġustament fid- doża..
- Interaction with Invirase/ritonavir not studied.
- Kapsuli tat- tewm (doża ekwivalenti għal Saquinavir Ctrough ↓ 49% (8 sigħat
- Grapefruit juice (single dose) (unboosted saquinavir)
- Pazjenti fuq kura b’ saquinavir m’ għandhomx jieħdu kapsuli tat -
- Saquinavir ↑ 50% (normal strength grapefruit juice) - Saquinavir ↑ 100% (double strength grapefruit juice)
madwar żewġ sinniet wara d- doża)
- Increase not thought to be clinically relevant.
tewm minħabba r- riskju ta ’
- Garlic capsules (saquinavir/ritonavir)
tewm ta ’ 4 g kuljum) Saquinavir Cmax ↓ 54%.
- Interaction with Invirase/ritonavir not studied.
konċentrazzjonijiet fil- plażma
- Garlic capsules (dose approx. equivalent to two 4 g cloves of garlic daily) (unboosted saquinavir 1200 mg tid)
(saquinavir mhux imsaħħaħ 1200 mg tid)
- Saquinavir AUC ↓ 51% Saquinavir Ctrough ↓ 49% (8 hours post dose) Saquinavir Cmax ↓ 54%.
mnaqqsa u t- telf tar- rispons viroloġiku u l- possibiltà ta ’ reżistenza għal wieħed jew aktar mill- komponenti tal- kors
- Patients on saquinavir treatment must not take garlic capsules due to the risk of decreased plasma concentrations and loss of virological response and possible resistance to one or more components of the antiretroviral regimen.
37
36 Medicinal product by therapeutic area (dose of Invirase used in study)
Prodott mediċinali skond Interazzjoni is- settur terapewtiku (doża ta ’ Invirase użata fl- istudju) - St.
Recommendations concerning co - administration
John’ s wort - L- interazzjoni ma ’ (saquinavir/ ritonavir) Invirase/ ritonavir ma ’ ġietx studjata.
John’s wort (saquinavir/ritonavir)
Rakkomandazzjonijiet li jikkonċernaw l- għoti fl- istess waqt antiretrovirali. - Preparazzjonijiet tal- ħxejjex li
- Interaction with Invirase/ritonavir not studied.
- Il- livelli fil- plażma ta ’ saquinavir
John’s wort (unboosted saquinavir) Other potential interactions
John’ s wort
John’s wort (Hypericum perforatum).
John’ s wort (Hypericum digà qed jieħu St.
John’s wort.
John’ s wort, perforatum).
John’s wort, check viral levels and if possible saquinavir levels.
Il- livelli ta ’ proteini tat- trasport minn St. saquinavir jistgħu jiżdiedu kif John’ s wort. jitwaqqaf St.
John’s wort, and the dose of saquinavir may need adjusting.
John’ s wort, u d - doża ta ’ saquinavir jista ’ jkollha bżonn tiġi aġġustata.
John’s wort may persist for at least 2 weeks after cessation of treatment.
John’ s wort jista ’ jippersisti għal mill- inqas ġimagħtejn wara li titwaqqaf il - kura.
Medicinal products that are substrates of CYP3A4 e.g. dapsone, disopyramide, quinine, fentanyl, and alfentanyl (unboosted saquinavir)
Interazzjonijiet potenzjali oħra Prodotti mediċinali li huma substrati ta ’ CYP3A4 Għalkemm ma sarux studji speċifiċi, e. ż. dapsone,
Although specific studies have not been performed, co-administration of Invirase/ritonavir with medicinal products that are mainly metabolised by CYP3A4 pathway may result in elevated plasma concentrations of these medicinal products.
l- għoti ta ’ Invirase/ ritonavir flimkien
These combinations should be given with caution.
Dawn it- taħlitiet għandhom
Medicinal products reducing gastrointestinal transit time Metoclopramide
disopyramide, quinine, fentanyl, u alfentanyl (saquinavir mhux imsaħħaħ)
The re are no laboratory animal or human data available on secretion of saquinavir in breast milk.
Ma hemmx informazzjoni disponibbli minn annimali tal- laboratorju jew mill- bniedem dwar il- ħruġ ta ’ saquinavir fil- ħalib tas- sider.
4.7 Effects on ability to drive and use machines
38 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
37 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
The following adverse events with an at least possible relationship to ritonavir boosted saquinavir (i.e. adverse reactions) were reported most frequently: nausea, diarrhoea, fatigue, vomiting, flatulence, and abdominal pain.
L- effetti avversi li ġejjin li għandhom ta ’ l- inqas relazzjoni possibbli ma ’ saquinavir msaħħaħ b’ ritonavir (i. e. reazzjonijiet avversi) kienu rrappurtati l- aktar frekwenti: dardir, dijareja. għejja, remettar, gass u uġigħ ta ’ żaqq.
Limited data is available from two studies where the safety of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg twice daily) for at least 48 weeks was studied in 311 patients.
Tagħrif limitat huwa disponibbli minn żewġ studji fejn is- sikurtà ta ’ kapsoli rotob ta ’ saquinavir (1000 mg darbtejn kuljum) użat flimkien ma ’ doża baxxa ta ’ ritonavir (100 mg darbtejn kuljum) għal ta ’ l- inqas 48 ġimgħa kienet studjata f’ 311 pazjent.
38 Table 2:
39 Tabella 2:
Common Fatigue Investigations
Komuni Investigazzjonijiet
39 • Immune system disorders:
• Mard tas- sistema mmunitarja:
• Metabolism and nutrition disorders:
40 • Mard tal- metaboliżmu u nutrizzjoni:
body fat (lipodystrophy) in HIV infected patients including the loss of peripheral and facial subcutaneous fat, increased intra -abdominal and visceral fat, breast hypertrophy and dorsicervical fat accumulation (buffalo hump).
fil- ġisem (lipodistrofija) f’ pazjenti infettati bl- HIV inkluż telf tax- xaħam ta ’ taħt il- ġilda periferali u fil- wiċċ, żjieda fix- xaħam intra- addominali u fil- vixxri, ipertrofija tas- sider u akkumulazzjoni dorsiċervikali tax- xaħam (buffalo hump).
Increased CPK, myalgia, myositis and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
Żjieda f’ CPK, mijalġja, mijosite u rarament, rhabdomyolysis kienu rrappurtati b’ inibituri tal- protease, speċjalment f’ taħlita ma ’ analogy ta ’ nucleoside.
Treatment of overdose with saquinavir should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient’s clinical status.
Kura ta ’ doża eċċessiva b’ saquinavir għandha tikkonsisti minn miżuri ta ’ support ġenerali, inkluż sorveljanza tas- sinjali vitali u ECG, u osservazzjonijiet ta ’ l- istat kliniku tal- pazjent.
Saquinavir selectively inhibits the HIV protease, thereby preventing the creation of mature infectious virus particles.
Saquinavir jinibixxi b’ mod selettiv il- protease tal- HIV u b’ hekk jipprevjeni il- formazzjoni ta ’ partiċelli nfettivi tal- virus maturi.
40 Antiviral activity in vitro:
Attività antivirali in vitro:
Saquinavir demonstrates antiviral activity against a panel of laboratory strains and clinical isolates of HIV-1 with typical EC50 and EC90 values in the range 1-10 nM and 5-50 nM, respectively, with no apparent difference between subtype B and non-B clades.
Saquinavir juri attività antivirali kontra firxa ta ’ razez tal- laboratorju u iżolati kliniċi ta ’ HIV- 1 b’ valuri tipiċi ta ’ EC50 u EC90 fil- firxa ta ’ 1- 10 nM u 5- 50 nM rispettivament, bl- ebda differenza evidenti bejn il- gruppi tas- sottotip B u mhux B.
The corresponding serum (50% human serum) adjusted EC50 ranged from 25-250 nM.
L- EC50 korrispondenti aġġustat tas - serum (50% serum uman) varja minn 25- 250 nM.
Resistance
41 Reżistenza
Marcelin et al (2007) identified nine protease codons (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M) that were associated with decreased virological response to saquinavir/ritonavir (1000/100 mg twice daily) in 138 saquinavir naive patients.
Marcelin et al (2007) identifika disa ’ kodons tal- protease (L10F/ I/ M/ R/ V, I15A/ V, K20I/ M/ R/ T, L24I, I62V, G73S/ T, V82A/ F/ S/ T, I84V, L90M) li kienu assoċjati ma ’ tnaqqis fir- rispons viroloġiku għal saquinavir/ ritonavir (1000/ 100 mg darbtejn kuljum) f’ 138 pazjent li qatt ma ħadu saquinavir qabel.
The presence of 3 or more mutations was associated with reduced response to saquinavir/ritonavir.
Il - preżenza ta ’ 3 mutazzjonijiet jew aktar kienet assoċjata ma ’ rispons imnaqqas għal saquinavir/ ritonavir.
Virological response to saquinavir/ritonavir stratified by the number of baseline saquinavir- associated resistance mutations
Rispons viroloġiku għal saquinavir/ ritonavir stratifikat bin- numru ta ’ mutazzjonijiet ta ’ reżistenza assoċjati ma ’ saquinavir fil- linja bażi
SQV Naive/Experienced Population
Mutazzjonijiet Popolazzjoni li Qatt ma Ħadu SQV Popolazzjoni li Qatt ma Ħadu SQV ta ’ Reżistenza
Week s 12-20
fil- Linja Bażi N=114 f’ Ġimgħa 12- 20
- 2.24 -1.88 -1.43 -0.52 -0.18 -0.11 -0.30 -
- 1. 43 - 0. 52 - 0. 18 - 0. 11 - 0. 30 -
In the MaxCmin1 study, the safety and efficacy of saquinavir soft capsules/ritonavir 1000/100 mg twice daily plus 2 NRTIs/Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) was compared to indinavir/ritonavir 800/100 mg twice daily plus 2 NRTIs/NNRTIs in over 300 (both protease inhibitor treatment naïve and experienced) subjects.
Fl- istudju MaxCmin1, is- sikurtà u l- effikaċja ta ’ kapsoli rotob ta ’ saquinavir/ ritonavir 1000/ 100 mg darbtejn kuljum ma ’ 2 NRTIs/ Inibituri tar - Reverse Transcriptase Non- Nucleoside (NNRTIs) kienu mqabbla ma ’ indinavir/ ritonavir 800/ 100 mg darbtejn kuljum ma ’ 2 NRTIs/ NNRTIs f’ aktar minn 300 (kemm b’ esperjenza ta ’ kura b’ inibituri tal- protease kif ukoll bla esperjenza) soġġett.
The combination of saquinavir and ritonavir
It- taħlita ta ’ saquinavir u ritonavir uriet attività viraloġika superjuri meta mqabbla mal- kategorija ta ’ indinavir u ritonavir meta bdil mill- kura assenjata kienet meqjusa bħala falliment viroloġiku.
41 exhibited a superior virological activity compared with the indinavir and ritonavir arm when switch from the assigned treatment was counted as virological failure.
Fl- istudju MaxCmin2, is- sikurtà u l- effikaċja ta ’ kapsoli rotob ta ’ saquinavir/ ritonavir 1000/ 100 mg darbtejn kuljum flimkien ma ’ 2 NRTIs/ NNRTIs kienu mqabbla ma ’ lopinavir/ ritonavir 400/ 100 mg darbtejn kuljum ma ’ 2 NRTIs/ NNRTIs f’ 324 (kemm b’ esperjenza ta ’ kura b’ inibituri tal- protease kif
In the MaxCmin2 study, the safety and efficacy of saquinavir soft capsules/ritonavir 1000/100 mg twice daily plus 2 NRTIs/NNRTIs was compared with lopinavir/ritonavir 400/100 mg twice daily plus 2 NRTIs/NNRTIs in 324 (both protease inhibitor treatment naïve and experienced) subjects.
L- ebda wieħed mis- soġġetti fil- kategorija ta ’ lopinavir/ ritonavir ma kien espost għal lopinavir qabel ma saret l- għażla bl- addoċċ, filwaqt li 16- il soġġett fil- kategorija saquinavir/ ritonavir kienu esposti minn qabel għal saquinavir.
Table 4:
43 Tabella 4:
Subject Demographics MaxCmin1 and MaxCmin2†
Demografija tas- Suġġetti f’ MaxCmin1 u MaxCmin2 †
Sex
Sess Rġiel
†
41%
Male Race (White/Black/Asian)% Age, median, yrs CDC Category C (%) Antiretroviral naïve (%) PI naïve (%) Median Baseline HIV-1 RNA, log10 copies/ml (IQR) Median Baseline CD4+ Cell Count, cells/mm3 (IQR) data from clinical study report
log10 kopji/ ml (IQR) Linja bażi Medjana ta ’ l- Għadd taċ- ċelluli CD4+, ċelluli/ mm3 (IQR) †
76% 74/19/2 40 31% 34% 48% 4.6 (3.5-5.3) 239 (95-420)
(3. 5- 5. 3) 239 (95- 420)
42 Table 5:
44 Tabella 5:
Outcomes
Riżultat
Proportion with VL < 50 copies/ml at week 48, On Treatment
Proporzjon b’ VL < 50 kopji/ ml wara 48 ġimgħa, B’ Kura
Absorption and bioavailability in adults:
Assorbiment u biodisponibilità fl- adulti:
43 Table 6:
45 Tabella 6:
Cmin
Cmin (ng/ ml)
Invirase (tablet)
Invirase (pillola) 1000 mg bid ma ’ ritonavir 100 mg bid * (ikla b’ ħafna xaħam)
34,926
34, 926 (11, 826 - 105, 992)
(11,826-105,992)
5208 (1, 536- 14, 369)
(334-5,176) ††
1, 179 (334- 5, 176) ††
ritonavir 100 mg bid* (high fat meal) τ = dosing interval, i.e.
τ = interval tad- dożaġġ, i. e.
Cmin = the observed plasma concentration at the end of the dose interval. bid = twice daily tid = three times daily * results are geometric mean (min - max) † derived from tid or bid dosing schedule †† Ctrough values
8 siegħa għal tid u 12- il siegħa għal għotja tad- dożi bid Cmin = il- konċentrazzjoni fil- plażma osservata fl- aħħar ta ’ l- intervall tad- doża bid = darbtejn kuljum tid = tlett darbiet kuljum * riżultati huma l- medja ġejometrika (min - max) † derivati minn skeda ta ’ dożaġġ ta ’ tid jew bid †† valuri ta ’ Ctrough
Effect ive therapy in treatment experienced patients is associated with a Cmin of approximately 100 ng/ml and an AUC0-24 of about 20,000 ng·h/ml.
It- terapija effettiva fil- kura ta ’ pazjenti b’ esperjenza hija assoċjata ma ’ Cmin ta ’ bejn wieħed u ieħor 100 ng/ ml u AUC0- 24 ta ’ madwar 20, 000 ng* h/ ml.
In vitro studies h ave shown that saquinavir is a substrate for P-glycoprotein (P-gp).
Studji in vitro wrew li saquinavir huwa sottostrat għall- glikoproteina P (P- gp).
348 ng/ml) was lower in the fasting state compared to the administration with a meal.
348 ng/ ml) kienet inqas fi stat sajjem meta mqabbel ma ’ l- għotja ma ’ ikla.
In two patients receiving Invirase 600 mg three times daily, cerebrospinal fluid concentrations of saquinavir were negligible when compared to concentrations from matching plasma samples.
F’ żewġ pazjenti li kienu qed jirċievu 600 mg ta ’ Invirase tlett darbiet kuljum, il -
44 Metabolism and elimination in adults:
Metaboliżmu u eliminazzjoni fl- adulti:
In vitro studies using hum an liver microsomes have shown that the metabolism of saquinavir is cytochrome P450 mediated with the specific isoenzyme, CYP3A4, responsible for more than 90% of the hepatic metabolism.
Studji in vitro li użaw mikrosomi tal- fwied uman urew li l - metaboliżmu ta ’ saquinavir huwa medjat miċ- ċitokromju P450 permezz ta ’ l- iżosima speċifika, CYP3A4, responsabbli għal aktar minn 90% tal- metaboliżmu fil- fwied.
In a mass balance study using 600 mg 14C-saquinavir (n = 8), 88% and 1% of the orally administered radioactivity, was recovered in faeces and urine, respectively, within 4 days of dosing.
Fi studju mass balance bl- użu ta ’ 600 mg ta ’ 14C- saquinavir (n = 8), 88% u 1% tar- radjuattività mogħtija mill - ħalq, kienet irkuprata fl- ippurgar u fl- awrina, rispettivament, sa 4 ijiem mill- għotja tad- doża.
There was no evidence of carcinogenic activity after the administration of saquinavir mesilate for 96 to 104 weeks to rats and mice.
Ma kien hemm l- ebda evidenza ta ’ attività karċinoġenika wara l- għotja ta ’ saquinavir mesylate għal 96 sa 104 ġimgħa lill- firien u ġrieden.
Fertility, peri- and postnatal development were not affected, and embryotoxic / teratogenic effects were not observed in rats or rabbits at plasma exposures lower than those achieved in humans at the recommended clinical dose of ritonavir boosted Invirase.
effetti embrijotossiċi / teratoġeniċi ma kienux osservati fil- firien jew fniek f’ espożizzjonijiet fil - plażma inqas minn dawk li ntlaħqu fil- bnedmin bid- doża klinikament irrakkomandata ta ’ Invirase imsaħħaħ b’ ritonavir.
Distribution studies in these species showed that the placental transfer of saquinavir is low (less than 5% of maternal plasma concentrations).
Studji tad- distribuzzjoni f’ dawn l- ispeċi wera li t- trasferiment ta ’ saquinavir mill- plaċenta huwa baxx (inqas minn 5% tal- konċentrazzjonijiet fil- plażma matern).
Tablet core:
Mili tal- pillola:
45 Microcrystalline cellulose, Croscarmellose sodium, Povidone, Lactose (monohydrate), Magnesium stearate.
47 Microcrystalline cellulose, Croscarmellose sodium, Povidone, Lactose (monohydrate), Magnesium stearate.
Tablet coat:
Rita tal- pillola:
Hypromellose, Titanium dioxide (E 171), Talc, Glycerol triacetate, Iron oxide yellow and red (E172).
Hypromellose, Titanium dioxide (E 171), Talc, Glycerol triacetate, Iron oxide isfar u aħmar (E172).
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jinħtieġ l- ebda prekawzjonijiet speċjali għall- ħażna.
Plastic bottles (HDPE) containing 120 tablets.
Fliexken tal- plastika (HDPE) li fihom 120 pillola.
04 October 1996 Date of last renewal:
4 ta ’ Ottubru 1996 Data ta ’ l- aħħar tiġdid:
48 A.
48 ANESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
50 A.
50 ANNESS III
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
TEXT FOR THE BOTTLE LABEL AND THE OUTER CARTON
KLIEM GĦAL FUQ IT- TIKKETTA U L- PAKKETT TA ’ BARRA
Invirase 200 mg hard capsules Saquinavir
Invirase 200 mg kapsuli iebsa Saquinavir
Each capsule contains saquinavir mesilate corresponding to 200 mg saquinavir.
Kull kapsula fiha saquinavir mesilate li tikkorrespondi għal 200 mg saquinavir.
Also contains lactose (anhydrous) 63.3 mg, colourants (titanium dioxide E 171, iron oxide E 172, indigocarmine E 132) and other constituents.
Fih ukoll lactose (anhydrous) 63. 3 mg, koloranti (titanium dioxide E 171, iron oxide E 172, indigocarmine E 132) u sustanzi oħra.
270 hard capsules
270 kapsuli iebsa
Oral use The capsules should be swallowed whole Read the package leaflet before use
Għall- użu mll- ħalq Il- kapsuli iridu jinbelgħu sħaħ Aqra l- fuljett ta ’ tagħrif qabel l- użu
Store in the original container
Aħżen fil- kontenitur oriġinali
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 53 11.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Invirase 500 mg film-coated tablets Saquinavir
Invirase 500 mg pilloli miksija b’ rita Saquinavir
Each film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.
Kull pillola miksija b’ rita fiha 500mg ta ’ saquinavir bħala saquinavir mesilate.
Also contains lactose (monohydrate) 38.5 mg, colourants (titanium dioxide E 171, iron oxide E 172) and other constituents.
Fih ukoll lattosju (monohydrate) 38. 5 mg, kulur (titanium dioxide E 171, iron oxide E 172) u sustanzi oħra.
120 film-coated tablets
120 pillola miksija b’ rita
Oral use The film-coated tablets should be swallowed whole Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
56 PACKAGE LEAFLET:
56 B.
Invirase 200 mg hard capsules Saquinavir
Invirase 200 mg Kapsuli iebsa Saquinavir
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina. - Żomm dan il- fuljett.
It may harm them, even
Tista ’ tagħmlilhom il- ħsara, anki
if their symptoms are the same as yours.
- jekk ikollhom l- istess sintomi bħal tiegħek.
What Invirase is and what it is used for 2.
X’ inhu Invirase u għalxiex jintuża 2.
Before you take Invirase 3.
Qabel ma tieħu Invirase 3.
How to take Invirase 4.
Kif għandek tieħu Invirase 4.
How to store Invirase 6.
Kif taħżen Invirase 6.
WHAT INVIRASE IS AND WHAT IT IS USED FOR
X’ INHU INVIRASE U GĦALXIEX JINTUŻA
Invirase is an antiviral agent.
Invirase huwa sustanza antivirali.
It is a member of a class of medicines called protease inhibitors.
Huwa membru ta ’ klassi ta ’ prodotti mediċinali msejħin inibituri tal - protease.
It is for the treatment of infection with the human immunodeficiency virus (HIV).
Huwa użat għall- kura ta ’ infezzjoni bil- vajrus uman li jikkawża immunodefiċjenza (HIV).
Invirase is used by HIV-infected individuals over 16 years of age.
Invirase huwa użat minn individwi b’ età aktar minn 16- il sena infettati bl- HIV.
Invirase is prescribed for use in combination with ritonavir and other antiretroviral medicines.
Invirase huwa preskritt biex jintuża flimkien ma ’ ritonavir u mediċini antiretrovirali oħrajn.
BEFORE YOU TAKE INVIRASE
QABEL MA TIEĦU INVIRASE
Do not take Invirase • if you are allergic (hypersensitive) to saquinavir, ritonavir or any of the other ingredients (see section “Important information about an ingredient of Invirase” and section “What Invirase contains”). • if you have liver disease with severe disease symptoms (e.g. jaundice or hepatitis with ascites, mental confusion and/or bleeding from veins of the oesophagus). • if you are currently taking any of the following medicines:
Tieħux Invirase jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal saquinavir jew sustanzi oħra (ara sezzjoni “ Tagħrif importanti dwar sustanza ta ’ Invirase ” u sezzjoni “ X’ fih Invirase ”). • jekk għandek mard tal- fwied b’ sintomi severi tal- marda (e. ż. suffejra, jew epatite b’ axxite, konfużjoni mentali u/ jew fsad ta ’ demm mill- vini ta ’ l- esofagu. • jekk qed tieħu xi mediċini msemmija hawn taħt:
terfenadine and astemizole (commonly used to treat allergy symptoms), pimozide (for psychiatric problems), cisapride (for heart burn or problems with the digestive system), ergot alkaloids (used to treat migraine attacks), triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety),
terfenadine u astemizole (użati b’ mod komuni biex jikkuraw sintomi ta ’ allerġija), pimozide (għall- problemi psikjatriċi), cisapride (għall- ħruq ta ’ stonku jew problemi tas- sistema diġestiva), ergot alkaloids (użati biex jikkuraw attakki ta ’ emikranja), triazolam u midazolam orali (meħud mill- ħalq) (użati biex jgħinuk torqod u/ jew biex itaffu l- ansjetà), amiodarone (użat biex jikkura taħbit mhux normali tal- qalb), flecainide u propafenone (mediċini għall- qalb), rifampicin (użat biex jipprevjeni jew jikkura t- tuberkulożi), simvastatin u lovastatin (użati biex ibaxxu l- kolesterol fid- demm).
Take special care with Invirase You should know that Invirase/ritonavir is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease.
Oqgħod attent ħafna b’ Invirase Għandek tkun taf li Invirase/ ritonavir mhuwiex kura għall- infezzjoni ta ’ l- HIV u li int tista ’ tkompli tiżviluppa infezzjonijiet jew mard ieħor assoċjat mal- marda ta ’ l- HIV.
You should, therefore, remain under the care of your doctor while taking Invirase/ritonavir.
Għalhekk int għandek tibqa ’ taħt il- kura tat- tabib tiegħek waqt li qed tieħu Invirase/ ritonavir.
57 Treatment with Invirase/ritonavir has not been shown to reduce the risk of transmission of HIV to others through sexual contacts or contamination with blood.
Ma jidhirx li l- kura b’ Invirase/ ritonavir tnaqqas ir- riskju li l- HIV jgħaddi lil oħrajn b’ kuntatti sesswali jew b’ kontaminazzjoni bid- demm.
Therefore, you must continue to take appropriate precautions to avoid giving the virus to others.
Għalhekk, għandek tkompli tieħu prekawzjonijiet xierqa biex tevita li tgħaddi l- vajrus lil oħrajn.
At present, there is only limited information on the use of Invirase/ritonavir in children under the age of 16 years and in adults over 60 years.
58 Fil- preżent, hemm biss informazzjoni limitata dwar l- użu ta ’ Invirase/ ritonavir fi tfal taħt l- età ta ’ 16 - il sena u f’ adulti ta ’ aktar minn 60 sena.
Consult your doctor if you have a history of kidney disease.
Kellem lit- tabib tiegħek jekk għandek passat mediku ta ’ mard tal- kliewi.
Please speak with your doctor if you have a history of liver disease.
Jekk jogħġbok kellem lit- tabib tiegħek jekk għandek passat mediku ta ’ mard tal- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Pazjenti b’ epatite kronika B jew C u qed jiġu kkurati b’ sustanzi antiretrovirali huma f’ riskju akbar għal effetti avversi serji u potenzjalment fatali tal- fwied u jista ’ jkollhom bżonn testijiet tad- demm għall- kontroll tal- funzjoni tal- fwied.
There are certain conditions, which you may have, or have had, which require special care before or while taking Invirase/ritonavir.
Hemm ċerti kundizzjonijiet li jista ’ jkollok, jew li kellek, li jinħtieġu kura speċjali qabel jew waqt l - użu ta ’ Invirase/ ritonavir.
Therefore, before using this medicine, you should have told your doctor if you suffer from diabetes mellitus, diarrhoea, or if you have allergies (see section 4) or if you have an intolerance to some sugars (see section “Important information about an ingredient of Invirase”).
Għalhekk, qabel tuża din il- mediċina, għandek tgħid lit- tabib tiegħek jekk tbati minn dijabete mellitus, dijareja, jew jekk għandek allerġiji (ara sessjoni 4) jew jekk għandek intolleranza għal xi żokkrijiet (ara sezzjoni “ Tagħrif importanti dwar sustanza ta ’ Invirase ”).
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F’ xi pazjenti b’ infezzjoni ta ’ l- HIV avvanzata (AIDS) u passat ta ’ infezzjonijiet opportunistiċi, sinjali u sintomi minn infezzjonijiet minn qabel jistgħu jseħħu hekk kif tinbeda kura kontra l- HIV.
It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dawn is- sintomi jseħħu minħabba titjib fir- rispons immunitarju tal- ġisem, li jagħati possibiltà lill- ġisem li jiġġieled infezzjonijiet li setgħa kien hemm mingħajr sintomi ovvji.
If you notice any symptoms of infection, please inform your doctor immediately (see section 4).
Jekk tinnota xi sintomi ta ’ infezzjoni jekk jogħġbok għid lit- tabib tiegħek immedjetament (ara sessjoni 4).
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Ridistribuzzjoni, akkumulazzjoni jew telf ta ’ xaħam tal- ġisem jistgħu jseħħu f’ pazjenti li qed jirċievu terapija antiretrovirali kombinata.
Contact your doctor if you notice changes in body fat (see section 4).
Kellem lit- tabib tiegħek jekk tinnota tibdil fix- xaħam f’ ġismek (ara sessjoni 4).
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Xi pazjenti li qed jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam msejħa osteonekrożi (mewt tat- tessut ta ’ l- għadam ikkawżat minn telf tal - provvista tad- demm lill- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem għola, fost oħrajn, jistgħu jkunu wħud mill- ħafna fatturi ta ’ riskju għall- iżvilupp tal- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma egħbusijja tal- ġogi, weġgħat u uġigħ (speċjalment fil- ġenbejn, irkoppa u spalla) u diffikultà fil - moviment.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi wħud minn dawn is- sintomi jekk jogħġbok għid lit- tabib tiegħek.
Invirase/ritonavir may be taken with a number of other medications that are commonly used in HIV infection.
Invirase/ ritonavir jista ’ jittieħed ma ’ numru ta ’ mediċini oħrajn li huma użati ta ’ sikwit f’ infezzjoni ta ’ l- HIV.
There are some medications that must not be taken with Invirase/ritonavir (see section "Do not take Invirase") or that require dosage reduction of that medicine or Invirase or ritonavir.
Hemm xi mediċini oħrajn li ma għandhomx jittieħdu ma ’ Invirase/ ritonavir (ara sessjoni “ Tieħux Invirase ”) jew li għandhom bżonn tnaqqis fid- dożaġġ ta ’ dik il- mediċina jew ta ’ Invirase jew ritonavir.
Ask your doctor or pharmacist for more information about taking Invirase/ritonavir with other medicines.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għal aktar informazzjoni dwar it- teħid ta ’ Invirase/ ritonavir ma ’ mediċini oħrajn.