FrancophonIA/ELRC3.0 huggingface dataset:
English: Other proton pump inhibitors (saquinavir/ritonavir 1000/100 mg bid)
Maltese: Inibituri tal-proton pump oħra (saquinavir/ritonavir 1000/100 mg bid)
English: Maprotiline's metabolism appears to involve the cytochrome P450 isozymes CYP2D6 and CYP 1A2 Associated with a prolongation of QTc intervals.
Maltese: CYP2D6 u CYP 1A2 taċċitokromu P450
English: The plasma exposures (AUC values) in rats (maximum dose 1000 mg/kg/day) and in mice (maximum dose 2500 mg/kg/day) were lower than the expected plasma exposures obtained in humans at the recommended clinical dose of ritonavir boosted Invirase.
Maltese: L-espożizzjonijiet fil-plażma (valuri ta' l-AUC) fil-firien (doża massima ta' 1000 mg/kg/kuljum) u fil-ġrieden (doża massima ta' 2500 mg/kg/kuljum) kienu inqas mill-espożizzjonijiet mistennija fil-plażma miksuba fil-bniedem fid-doża klinika rakkomandata ta' Invirase imsaħħaħ b'ritonavir.
English: Increased concentrations of simvastatin and lovastatin have been associated with rhabdomyolysis.
Maltese: Konċentrazzjonijiet miżjuda ta' simvastatin u lovastatin ġew assoċjati ma' rabdomijolisi.
English: Therefore, when saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on other medicinal products (see the Summary of Product Characteristics for Norvir).
Maltese: Għalhekk, meta saquinavir jingħata flimkien ma' ritonavir, iridu jiġu kkunsidrati l-effetti potenzjali ta' ritonavir fuq prodotti mediċinali oħra (ara s-Sommarju ta' Karatteristiċi tal-Prodott għal Norvir).
English: 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.
Maltese: 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.
English: Alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.4).
Maltese: Miżuri ta' kontraċezzjoni alternattivi jew addizzjonali għandhom jiġu wżati meta kontraċettivi orali b'bażi ta' estroġenu jigħataw fl-istess waqt (ara sezzjoni 4.4).
English: Saquinavir AUC ↔ Saquinavir Cmax ↔ Ritonavir AUC ↔ Ritonavir Cmax ↔
Maltese: Użu ta' salmeterol flimkien ma' saquinavir/ritonavir huwa mistenni li jżid il-livelli fil-plażma ta'
English: Saquinavir does not induce chromosomal damage in vivo in the mouse micronucleus assay or in vitro in human peripheral blood lymphocytes and does not induce primary DNA damage in vitro in the unscheduled DNA synthesis test.
Maltese: Saquinavir ma jinduċix ħsara lill kromosomi in vivo fl-assay tal-mikronukleju tal-ġrieden jew in vitro fil-limfoċiti umani periferali tad demm u ma jinduċix ħsara primarja fid-DNA in vitro fit-test ta' sintesi mhux ipprogrammata tad-DNA.
English: The maximum mean PR interval changes relative to the pre-dose baseline value were 25 msec and 34 msec in the two ritonavir-boosted Invirase treatment groups, 1000/100 mg twice daily and 1500/100 mg twice daily, respectively (also see section 4.4).
Maltese: Il-bidliet massimi medji fl-intervall ta' PR relattiv għall-valur ta' qabel id-doża fil-linja bażi kienu ta' 25 msec u 34 msec fiż-żewġ ġruppi ta' kura ta' Invirase imsaħħaħ b'ritonavir, 1000/100 mg darbtejn kuljum u 1500/100 mg darbtejn kuljum, rispettivament (ara wkoll sezzjoni 4.4).
English: 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, see section 4.4).
Maltese: 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 filmuskoli, żjieda ta' creatinine kinase fil-plażma, ara sezzjoni 4.4).
English: One film-coated tablet of Invirase contains 500 mg of saquinavir as saquinavir mesilate.
Maltese: Kull pillola miksija b'rita fiha 500 mg ta' saquinavir bħala saquinavir mesilate.
English: Day 10 mg (n=21)
Maltese: Jum 10 mg (n=21)
English: Increased plasma concentrations of quetiapine may lead to coma (see sectin 4.3).
Maltese: Żieda filkonċentrazzjonijiet fil-plażma ta' quetiapine tista' twassal għal koma (ara sezzjoni 4.3).
English: • quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
Maltese: • quetiapine - użat biex jikkura l-iskiżofrenja, disturb bipolari u disturb depressiv maġġuri • lurasidone - użat biex jittratta l-iskiżofrenja
English: Pharmaco-therapeutic group: Antiviral agent, ATC code J05A E01
Maltese: Sustanza antiretrovirali, Kodiċi ATC:
English: • medicines used to treat high blood pressure in the arteries of the lungs (a disease known as pulmonary arterial hypertension) such as bosentan.
Maltese: • mediċini użati biex jikkuraw pressjoni għolja fl-arterji tal-pulmun (marda magħrufa bħala pressjoni arterjali pulmonari għolja) bħal bosentan.
English: Interaction with efavirenz: The combination of saquinavir and ritonavir with efavirenz has been shown to be associated with an increased risk of liver toxicity; liver function should be monitored when saquinavir and ritonavir are co-administered with efavirenz.
Maltese: Il-kombinazzjoni ta' saquinavir u ritonavir ma' efavirenz intweriet li hija assoċjata ma' riskju għola ta' tossiċità fil-fwied; funżjoni tal-fwied għandha tiġi sorveljata meta saquinavir u ritonavir jingħataw flimkien ma' efavirenz.
English: There were no clinically significant differences in the pharmacokinetic profile of ritonavir in fasting and fed conditions but the ritonavir Ctrough (geometric mean 245 vs. 348 ng/ml) was lower in the fasting state compared to the administration with a meal.
Maltese: Ma kienx hemm differenzi kliniċi sinifikanti fil-profil farmakokinetiku ta' ritonavir fi stat sajjem u wara l-ikel iżda Ctrough ta' ritanovir (medja ġejometrika 245 vs.
English: No pharmacokinetic interaction studies have been completed.
Maltese: - Ma ntemmewx studji dwar linterazzjoni farmakokinetika.
English: Absorption: In HIV-infected adult patients, Invirase in combination with ritonavir at doses of 1000/100 mg twice daily provides saquinavir systemic exposures over a 24-hour period similar to or greater than those achieved with saquinavir soft capsules 1200 mg tid (see Table 8).
Maltese: F'pazjenti adulti infettati bl-HIV, Invirase flimkien ma' ritonavir f'dożi ta' 1000/100 mg mogħtija darbtejn kuljum jipprovdu espożizzjonijiet sistemiċi ta' saquinavir fuq perijodu ta' 24 siegħa simili għal, jew akbar minn dawk miksuba b'1200 mg ta' kapsoli rotob ta' saquinavir tliet darbiet kuljum (ara Tabella 8).
English: Your doctor will prescribe Invirase in combination with ritonavir (Norvir) and other HIV medicines.
Maltese: It-tabib tiegħek se jippreskrivilek Invirase flimkien ma' ritonavir (Norvir) u mediċini għallHIV oħrajn.
English: • sedative agents - such as midazolam administered by injection
Maltese: • aġenti sedattivi - bħal midazolam mogħti permezz ta' injezzjoni
English: Invirase is indicated for the treatment of HIV-1 infected adult patients.
Maltese: Invirase huwa indikat għall-kura ta' adulti infettati bl-HIV-1 (ara sezzjoni 4.2).
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Każijiet ta' osteonekrożi kienu rrappurtati, speċjalment f'pazjenti b'fatturi ta' riskju ġeneralment magħrufa, marda ta' l-HIV avvanzata jew espożizzjoni fit-tul għal terapija antiretrovirali kombinata (CART).
English: Monitoring of saquinavir plasma concentration is recommended (see section 4.4)
Maltese: Huwa rakkomandat monitoraġġ talkonċentrazzjoni ta' saquinavir filplażma (ara sezzjoni 4.4)
English: Atorvastatin is less dependent on CYP3A4 for metabolism.
Maltese: Atorvastatin huwa inqas dipendenti minn CYP3A4 għall-metaboliżmu.
English: Contraindicated in combination with saquinavir/ritonavir due to potentially life threatening cardiac arrhythmia (see section 4.3).
Maltese: Kontra-indikat flimkien ma' saquinavir/ritonavir minħabba arritmija kardijaka b'potenzjal ta' periklu għal ħajja (ara sezzjoni 4.3).
English: Contraindicated in combination with saquinavir/ritonavir, due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Maltese: Kontra-indikat flimiken ma' saquinavir/ritonavir, minħabba rriskju potenzjali ta' titwil jew żjieda fis-sedazzjoni u depressjoni respiratorja (ara sezzjoni 4.3).
English: Alopecia, dry skin, eczema, lipoatrophy, pruritus, rash
Maltese: Alopeċja, ġilda xotta, ekżema, lipoatrofija, ħakk,
English: Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population (see sections 4.2 and 4.4).
Maltese: Sorveljanza b'attenzjoni tas-sigurtà (inkluż sinjali ta' arritmija kardijaka) u tar-rispons viroloġiku hija rrakkomandata minħabba varjabilità miżjuda ta' l-esponiment f'din il-popolazzjoni (ara sezzjonijiet 4.2 u 4.4).
English: HIV fusion inhibitor Enfuvirtide (saquinavir/ritonavir 1000/100 mg bid)
Maltese: Enfuvirtide (saquinavir/ritonavir 1000/100 mg bid)
English: On rare occasions these muscle disorders have been serious (rhabdomyolysis).
Maltese: F'okkażjonijiet rari dan il-mard tal-muskoli kien serju (rhabdomyolysis).
English: Acute and chronic toxicity: Saquinavir was well tolerated in oral acute and chronic toxicity studies in mice, rats, dogs and marmosets.
Maltese: Saquinavir kien ittolerat tajjeb fi studji dwar it-tossiċità akuta u kronika mill-ħalq, fi ġrieden, firien, klieb u marmoseti.
English: Tablet coat:
Maltese: Glukokortikojdi:
English: In vitro experiments have shown that the hepatic metabolism of saquinavir becomes saturable at concentrations above 2 µg/ml.
Maltese: Esperimenti in vitro wrew li l-metaboliżmu fil-fwied ta' saquinavir isir saturabbli f'konċentrazzjonijiet ta' 'l fuq minn 2 µg/ml.
English: Neutropenia
Maltese: Riżultat
English: Discontinued assigned treatment, n (%)
Maltese: Waqqfu il-kura assenjata, n
English: 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.
Maltese: 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 ukoll bla esperjenza) soġġett.
English: Clarithromycin
Maltese: Rapamycin
English: Saquinavir ↔ Efavirenz ↔
Maltese: Efavirenz ↔
English: It is not recommended to coadminister Invirase/ritonavir with cobicistat containing products (see section 4.4).
Maltese: Mhux rakkomandat li Invirase/ritonavir jingħataw flimkien ma' prodotti li fihom cobicistat (ara sezzjoni 4.4).
English: Patients switching immediately from treatment with another protease inhibitor taken with ritonavir or from a non-nucleoside reverse transcriptase inhibitor based regimen, except rilpivirine (see section 4.5), without a wash-out period, should however initiate and continue Invirase at the standard recommended dose of 1000 mg two times daily with ritonavir 100 mg two times daily.
Maltese: Pazjenti li jaqilbu immedjatament minn kura b'inibitur ta' protease ieħor meħud ma' ritonavir jew minn kors ibbażat fuq inibitur ta' non-nucleoside reverse transcriptase, għajr rilpivirine (ara sezzjoni 4.5), mingħajr perijodu ta' wash-out, madankollu għandhom jibdew u jkomplu Invirase fid-doża stàndard irrakkomandata ta' 1000 mg darbtejn kuljum flimkien ma' ritonavir 100 mg darbtejn kuljum.
English: Caution is warranted and clinical monitoring of patients is recommended.
Maltese: Hija rrakkomandata attenzjoni u sorveljanza klinika tal-pazjenti.
English: Decreased platelet count
Maltese: Indeboliment tal-kliewi
English: On Day 3, mean Cmax values were approximately 3-fold and 4-fold higher with the therapeutic and supra-therapeutic doses, respectively, relative to the mean Cmax observed at steady state with the therapeutic dose administered to HIV patients.
Maltese: F'Ġurnata 3, il-valuri medji ta' Cmax kienu madwar 3 darbiet u 4 darbiet ogħla b'dożi terapewtiċi u supra-terapewtiċi, rispettivament, relattiv għal Cmax medja osservata fi stat fiss bid-doża terapewtika mogħtija lill-pazjenti bl-HIV.
English: In vitro studies have shown that saquinavir is a substrate for P-glycoprotein (P-gp).
Maltese: Studji in vitro wrew li saquinavir huwa sottostrat għall-glikoproteina P (P-gp).
English: • certain medicines used to prevent rejection of new organs after a transplant operation such as tacrolimus
Maltese: • ċertu mediċini li jintużaw biex jipprevjenu rifjut ta' organi ġodda wara operazzjoni ta' trapjant bħal tacrolimus
English: # ITT/e = Intent-to-treat/exposed † Data from clinical study report ‡ Data from MaxCmin1 publication
Maltese: ITT/e = Ħsieb-biex-tikkura/espost Tagħrif miġbur mir-rapport ta' l-istudju kliniku Tagħrif mill-publikazzjoni ta' MaxCmin1
English: Effect of food: In a cross-over study in 22 HIV-infected patients treated with Invirase/ritonavir 1000 mg/100 mg twice daily and receiving three consecutive doses under fasting conditions or after a high-fat, high-calorie meal (46 g fat, 1,091 Kcal), the AUC0-12, Cmax and Ctrough values of saquinavir under fasting conditions were about 70 per cent lower than with a high-fat meal.
Maltese: Effett tal-ikel: Fi studju cross-over f'22 pazjenti infetti b'HIV kkurati b'Invirase/ritonavir 1000 mg/100 mg darbtejn kuljum u li rċevew tliet dożi konsekuttivi fi stat sajjem jew wara ikla b'ħafna xaħam u ħafna kaloriji (46 g xaħam, 1,091 Kcal), il-valuri ta' l-AUC0-12, Cmax u Ctrough ta' saquinavir fi stat sajjem kienu madwar 70 fil-mija inqas minn dawk ma' ikla b'ħafna xaħam.
English: Dexamethasone induces CYP3A4 and may decrease saquinavir concentrations.
Maltese: - Dexamethasone jinduċi lil CYP3A4 u jista' jnaqqas ilkonċentrazzjonijiet ta'
English: 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.
Maltese: 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.
English: Following the modified Invirase/ritonavir regimen, saquinavir exposure during the first week peaked on Day 3 and declined to the lowest exposure on Day 7 with ritonavir induction effects, while Day 14 saquinavir PK parameters (following full doses of Invirase/ritonavir in the second week) approached the range of historical mean values for saquinavir steady-state values in HIV-1 infected patients (Table 9).
Maltese: Wara l-kors modifikat ta' Invirase/ritonavir, l-esponiment għal saquinavir matul l-ewwel ġimgħa żdied għall-massimu f'Jum 3 u naqas għall-inqas esponiment f'Jum 7 b'effetti ta' induzzjoni ta' ritonavir, filwaqt li l-parametri PK ta' saquinavir f'Jum 14 ( wara dożi sħaħ ta' Invirase/ritonavir fit-tieni ġimgħa) avviċinaw il-firxa ta' valuri storiċi medji għall-valuri fi stat fiss ta' saquinavir f'pazjenti infettati b'HIV-1 (Tabella 9).
English: Additionally, in vitro studies have shown that saquinavir is a substrate and an inhibitor for P-glycoprotein (P-gp).
Maltese: Ukoll, studji in vitro wrew li saquinavir huwa sottostrat u inibitur għal glikoprotejina-P (P-gp).
English: Terfenadine AUC ↑, associated with a prolongation of QTc intervals.
Maltese: Terfenadine AUC ↑, assoċjata ma'
English: Effect of gender following treatment with Invirase/ritonavir: A gender difference was observed with females showing higher saquinavir exposure than males (AUC on average 56 % higher and Cmax on average 26 % higher) in the bioequivalence study comparing Invirase 500 mg film coated tablets with Invirase 200 mg hard capsules both in combination with ritonavir.
Maltese: Kienet osservata differenza fis-sess, bin-nisa juru espożizzjoni ta' saquinavir għola mill-irġiel (AUC b'medja ta' 56 % għola u Cmax b'medja ta' 26 % għola) fl-istudju ta' bijoekwivalenza li qabbel pilloli miksija b'rita ta' Invirase 500 mg ma' kapsoli iebsa ta' Invirase 200 mg, it-tnejn f'taħlita ma' ritonavir.
English: No clinical data available for the combination of saquinavir/ritonavir 1000/100 mg bid and atazanavir.
Maltese: M'hemmx tagħrif kliniku disponibbli għat-taħlita ta' saquinavir/ritonavir 1000/100 mg bid u atazanavir.
English: • a history of an irregular heart beat (arrhythmias)
Maltese: • passat ta' ritmi tal-qalb mhux normali (arritmija)
English: 2 to < 6 years
Maltese: sentejn sa < 6 snin
English: Effective therapy in treatment naïve patients is associated with a Cmin of approximately 50 ng/ml and an AUC0-24 of about 20,000 ng·h/ml.
Maltese: Terapija effettiva fil-kura ta' pażjenti bla esperjenza tal-kura hija assoċjata ma' Cmin ta' bejn wieħed u ieħor 50 ng/ml u AUC0-24 ta' madwar 20,000 ng*h/ml.
English: Whereas acute or chronic overdose of saquinavir alone did not result in major complications, in combination with other protease inhibitors, overdose symptoms and signs such as general weakness, fatigue, diarrhoea, nausea, vomiting, hair loss, dry mouth, hyponatraemia, weight loss and orthostatic hypotension have been observed.
Maltese: Filwaqt li doża eċċessiva akuta jew kronika ta' saquinavir waħdu ma rriżultatx f'kumplikazzjonijiet maġġuri, flimkien ma' inibituri ta' protease oħra ġew osservati sinjali u sintomi ta' doża eċċessiva bħal debbulizza ġenerali, għejja, dijarea, tqalligħ, rimettar, telf ta' xagħar, ħalq xott, iponatrimja, telf ta' piż u ipotensjoni ortostatika.
English: Erythromycin (saquinavir/ritonavir)
Maltese: Erythromycin (saquinavir/
English: • certain medicines commonly used for allergy symptoms such as terfenadine and astemizole
Maltese: • ċertu mediċini użati b'mod komuni għal sintomi ta' allerġija bħal terfenadine u astemizole
English: Interaction with Invirase/ritonavir not studied.
Maltese: Interazzjoni ma' Invirase/ritonavir ma ġietx studjata.
English: Carcinogenesis: There was no evidence of carcinogenic activity after the administration of saquinavir mesilate for 96 to 104 weeks to rats and mice.
Maltese: Ma kien hemm l-ebda evidenza ta' attività karċinoġenika wara l-għotja ta' saquinavir mesylate għal 96 sa 104 ġimgħa lill-firien u ġrieden.
English: After 7 days, the recommended dose of Invirase is 1000 mg two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
Maltese: Wara 7 ijiem, id-doża rrakkomandata ta' Invirase hija ta' 1000 mg darbtejn kuljum flimkien ma' 100 mg ritonavir darbtejn kuljum flimkien ma' sustanzi antiretrovirali oħra.
English: Gastrointestinal disorders Very common
Maltese: Disturbi gastro-intestinali
English: Invirase/ritonavir may increase ergot alkaloids exposure, and consequently, increase the potential for acute ergot toxicity.
Maltese: Invirase/ritonavir jista' jżid lespożizzjoni għall-alkalojdi ergot, u b'hekk iżid il-potenzjal għal tossiċità akuta ta' ergot.
English: Number of Saquinavir Associated Resistance Mutations at Baseline*
Maltese: Numru ta' Mutazzjonijiet ta' Reżistenza Assoċjati ma' Saquinavir filLinja Bażi*
English: Invirase (hard capsule) 600 mg tid saquinavir soft capsule 1200 mg tid Invirase (tablet) 1000 mg bid plus ritonavir 100 mg bid* (fasting condition) Invirase (tablet) 1000 mg bid plus ritonavir 100 mg bid* (high fat meal)
Maltese: Reazzjonijiet avversi minn żewġ studji pivitali dwar kapsula ratba ta' saquinavir (1000 mg darbtejn kuljum) użat flimkien ma' doża baxxa ta' ritonavir (100 mg darbtejn kuljum) għal mill-anqas 48 ġimgħa huma miġbura fil-qosor f'Tabella 2.
English: Limited data is available from two clinical 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.
Maltese: Hemm disponibbli dejta limitata minn żewġ studji kliniċi fejn is-sigurtà ta' kapsuli rotob ta' saquinavir (1000 mg darbtejn kuljum) użati flimkien ma' doża baxxa ta' ritonavir (100 mg darbtejn kuljum) għal mill-anqas 48 ġimgħa kienet studjata f'311-il pazjent.
English: Oral contraceptives: Because concentration of ethinyl estradiol may be decreased when coadministered with Invirase/ritonavir, alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.5).
Maltese: Minħabba li l-konċentrazzjoni ta' ethinyl estradiol tista' tonqos meta jingħata fimkien ma' Invirase/ritonavir, miżuri alternattivi jew addizzjonali ta' kontraċezzjoni iridu jintużaw meta kontraċettivi b'bażi ta' estroġenu jingħataw fl-istess ħin (ara sezzjoni 4.5).
English: Anti-gout preparation Colchicine
Maltese: Informazzjoni għall-utent
English: For patients with a QT interval < 450 msec, an on treatment ECG is recommended.
Maltese: Għall-pazjenti b'intervall QT ta' < 450 msec, huwa rrakkomandat ECG waqt il-kura.
English: Ritonavir Cmax ↑ 34% Atazanavir ↔
Maltese: Saquinavir AUC ↑ 60 % Saquinavir Cmax ↑ 42 % Ritonavir AUC ↑ 41 % Ritonavir Cmax ↑ 34 % Atazanavir ↔
English: If signs or symptoms suggesting cardiac arrhythmia occur, continuous monitoring of ECG should be performed.
Maltese: Jekk iseħħu sinjali jew sintomi li jissuġġerixxu arritmija kardijaka, għandu jsir monitoraġġ kontinwu tal-ECG.
English: Concomitant use of bosentan and saquinavir/ritonavir may increase plasma levels of bosentan and may decrease plasma levels of saquinavir/ritonavir.
Maltese: bosentan u jista' jnaqqas il-livelli fil-plażma ta' saquinavir/ritonavir.
English: Interaction with zalcitabine is unlikely due to different routes of metabolism and excretion.
Maltese: - Interazzjoni ma' zalcitabine mhux probabbli minħabba rotot differenti ta' metaboliżmu u tneħħija.
English: Nucleoside reverse transcriptase inhibitors (NRTIs) - Zalcitabine and/or
Maltese: Sustanzi antiretrovirali Inibituri ta' nucleoside reverse transcriptase (NRTIs)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 500 mg saquinavir bħala saquinavir mesylate.
English: Tablet core:
Maltese: Mutaġenesi:
English: Clinical experience in pregnant women is limited: Congenital malformations, birth defects and other disorders (without a congenital malformation) have been reported rarely in pregnant women who had received saquinavir in combination with other antiretroviral agents.
Maltese: Malformazzjonijiet konġenitali, difetti tat-twelid u mard ieħor (mingħajr xi malformazzjoni konġenitali) rarament kienu rappurtati f'nisa tqal li kienu rċevew saquinavir flimkien ma' sustanzi antiretrovirali oħrajn.
English: To prevent possible development of rifabutin resistance in TB and HIV co-infected patients, the recommended dose of rifabutin is 150 mg every other day or three times per week, with the dose of saquinavir/ritonavir unchanged (1000/100 mg bid).
Maltese: Biex jiġi evitat l-iżvilupp possibbli ta' reżistenza għal rifabutin f'pazjenti ko-infettati bit-TB u lHIV, id-doża rrakkomandata ta' rifabutin hija ta' 150 mg kull jumejn jew tliet darbiet fil-ġimgħa, biddoża ta' saquinavir/ritonavir mhux mibdula (1000/100 mg bid).
English: Contraindicated in combination with Invirase/ritonavir due to potentially life threatening cardiac arrhythmia (see sections 4.3 and 4.4).
Maltese: Kontra-indikat flimkien ma' Invirase/ritonavir minħabba arritmija kardijaka b'potenzjal ta' periklu għall-ħajja (ara sezzjonijiet 4.3 u 4.4).