FrancophonIA/ELRC3.0 huggingface dataset:
English: Lopinavir/ritonavir tablets/ Efavirenz
Maltese: Lopinavir/ritonavir/efavirenz Pilloli ta'
English: - a history of symptomatic cardiac arrythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Maltese: - storja ta' arritmiji kardijaċi sintomatiċi jew bi bradikardija klinikament relevanti jew b'insuffiċjenza kardijaka konġestiva akkumpanjata minn frazzjoni mnaqqsa tal-ħruġ tal ventriklu tax-xellug.
English: If available, 90 % or 95 % confidence intervals are shown in parentheses.
Maltese: Jekk ikunu disponibbli, l-intervalli ta' kunfidenza ta' 90% jew 95% jintwerew fil-parentesi.
English: • Each Stocrin film-coated tablet contains 50 mg of the active substance efavirenz.
Maltese: • Kull pillola miksija b'rita ta' Stocrin fiha 50 mg tas-sustanza attiva efavirenz.
English: AUC: ↓ 36 % (↓ 32 to ↓ 40) Cmax: ↓ 21 % (↓ 15 to ↓ 26) Cmin: ↓ 47 % (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction) The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Maltese: ↓ 36% (↓ 32 għal ↓ 40) Cmax: ↓ 21% (↓ 15 għal ↓ 26) Cmin: ↓ 47% (↓ 41 għal ↓ 53) (tnaqqis fil-konċentrazzjonijiet ta' carbamazepine: induzzjoni ta' CYP3A4; tnaqqis filkonċentrazzjonijiet ta' efavirenz: induzzjoni ta' CYP3A4 u ta' CYP2B6)
English: (400/100 mg twice daily/600 mg once daily)
Maltese: (200 mg q12h/600 mg darba kuljum)
English: AUC: ↑ 20 % (↑ 8 to ↑ 34) Cmax: ↑ 21 % (↑ 10 to ↑ 33) The combination was generally well tolerated.
Maltese: AUC: ↑ 20% (↑ 8 għal ↑ 34) Cmax: ↑ 21% (↑ 10 għal ↑ 33) It-taħlita ġeneralment kienet ittollerata sewwa.
English: Medicinesused to lower blood fats (also called statins):atorvastatin, pravastatin, simvastatin.
Maltese: Mediċini użati biex ibaxxu l-ammont ta' xaħam fid-demm (magħrufin ukoll bħala statini): atorvastatin, pravastatin, simvastatin.
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg daily.
Maltese: Tnaqqis simili fl-espożizzjonijiet għal indinavir ġew osservati meta indinavir 1.000 mg q8h ingħata flimkien ma' efavirenz
English: Cmin: ↓ 10% (↑ 1 to ↓ 19)%
Maltese: Cmin: ↓ 8 % (↑ 14 għal ↓ 25)
English: (500/125 mg twice daily/600 mg once daily)
Maltese: (1,125 mg q8h/600 mg darba kuljum)
English: • Each Stocrin film-coated tablet contains 200 mg of the active substance efavirenz.
Maltese: • Kull pillola miksija b'rita ta' Stocrin fiha 200 mg tas-sustanza attiva efavirenz.
English: AUC: ↓ 83 % (↓ 79 to ↓ 87) Cmax: ↓ 80 % (↓ 77 to ↓ 83) Cmin: ↓ 86 % (↓ 80 to ↓ 90) (induction of metabolism) Efavirenz: no clinically significant interaction.
Maltese: AUC: ↓ 83 % (↓ 79 għal ↓ 87) Cmax: ↓ 80 % (↓ 77 għal ↓ 83) Cmin: ↓ 86 % (↓ 80 għal ↓ 90)
English: Rash was reported more frequently in children (in a clinical study including 57 children who received efavirenz during a 48-week period, rash was reported in 46 %) and was more often of higher grade than in adults (severe rash was reported in 5.3 % of children).
Maltese: Ir-raxx kien iktar irrapportat fit-tfal (fi studju kliniku li kien jinkludi 75 tifel u tifla li ngħataw efavirenz waqt perjodu ta' 48 ġimgħa, ir-raxx kien irrapportat f'46 %) u kien ta' grad ogħla iktar ta' spiss milli fl adulti (raxx sever kien irrapportat f'5.3 % mit-tfal).
English: The durability of the response was similar to that seen in adult patients.
Maltese: It-tul tar-rispons kien simili għal dak li ġie osservat f'pazjenti adulti.
English: - severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Maltese: - mġiba aggressiva - reazzjonijiet paranojdi
English: • if you are currently taking any of the following medicines (see also “Other medicines and Stocrin”): - astemizole or terfenadine (used to treat allergy symptoms) - bepridil (used to treat heart disease) - cisapride (used to treat heartburn) - ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) - midazolam or triazolam (used to help you sleep) - pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) - St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) - flecainide, metoprolol (used to treat irregular heart beat) - certain antibiotics (macrolides, fluoroquinolones, imidazole) - triazole antifungal agents - certain antimalarial treatments - methadone (used to treat opiate addiction) - elbasvir/grazoprevir
Maltese: • jekk bħalissa qed tieħu xi waħda minn dawn il-mediċini (ara wkoll “Mediċini oħra u Stocrin”): - astemizole jew terfenadine (użata biex tikkura sintomi allerġiċi) - bepridil (użata biex tikkura ħruq fl-istonku) - cisapride (użata biex tikkura ħruq fl-istonku) - ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (użati biex jikkuraw l-emikranji u uġigħ ta' ras regolari) - midazolam jew triazolam (użati biex jgħinuk torqod) - pimozide, imipramine, amitriptyline jew clomipramine (użati biex jikkuraw ċerti kundizzjonijiet mentali) - St.
English: In clinical controlled trials, frequently reported adverse reactions included, but were not limited to: dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
Maltese: Fi provi kliniċi kkontrollati, ir-reazzjonijiet avversi li ġew irrapportati b'mod frekwenti, kienu jinkludu, imma ma kinux limitati għal: sturdament, nuqqas ta' rqad, ngħas, nuqqas ta' konċentrazzjoni u ħolm mhux normali.
English: The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms (see section 4.4).
Maltese: Ir-reazzjonijiet avversi marbuta ma' efavirenz li kienu l-iktar prominenti kienu raxx u sintomi tas-sistema nervuża (ara sezzjoni 4.4).
English: Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Maltese: Efavirenz m'għandux jingħata flimkien ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (ngħidu aħna, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) billi l-inibizzjoni tal-metaboliżmu tagħhom tista' twassal għal avvenimenti serji u ta' riskju għall-ħajja (ara sezzjoni 4.3).
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with a fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Maltese: Ġew irrapportati żewġ każijiet addizzjonali (1 prospettiv u 1 retrospettiv) inkluż episodji konsistenti ma' difetti fit-tubu newrali b'pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz, emtricitabine, u tenofovir disoproxil.Ma setax jiġi stabbilit jekk dawn il-każijiet kinux ikkawżati bl-użu ta' efavirenz, u ddenominatur mhux magħruf.
English: - bepridil (used to treat heart disease) - cisapride (used to treat heartburn) - ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) - midazolam or triazolam (used to help you sleep) - pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) - St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) - flecainide, metoprolol (used to treat irregular heart beat) - certain antibiotics (macrolides, fluoroquinolones, imidazole) - triazole antifungal agents - certain antimalarial treatments - methadone (used to treat opiate addiction) - elbasvir/grazoprevir
Maltese: John's wort (Hypericum perforatum) (rimedju erbali użat biex jikkura dipressjoni u ansjetà - flecainide, metoprolol (użati biex jikkuraw taħbit tal-qalb irregolari) - ċerti antibijotiċi (makrolidi, fluworokinoloni, imidazole) - aġenti antifungali ta' triazole - ċerti kuri kontra l-malarja - methadone (jintuża biex jikkura dipendenza fuq l-opjati) - elbasvir/grazoprevir
English: AUC: ↓ 39 % (↓ 30 to ↓ 46) Cmax: ↓ 26 % (↓ 15 to ↓ 35) Clarithromycin
Maltese: ↓ 39% (↓ 30 għal ↓ 46) Cmax: ↓ 26% (↓ 15 għal ↓ 35) Clarithromycin 14-hydroxymetabolite:
English: • Each Stocrin film-coated tablet contains 600 mg of the active substance efavirenz.
Maltese: • Kull pillola miksija b'rita ta' Stocrin fiha 600 mg tas-sustanza attiva efavirenz.
English: Date of first authorisation: 28 May 1999.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 28 ta' Mejju 1999.
English: Grazoprevir: AUC: ↓83% Cmax: ↓87%
Maltese: ↓83% Cmax: ↓87%
English: The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 24 ml orally, once daily.
Maltese: Id-doża rakkomandata ta' efavirenz flimkien ma' nucleoside analogue reverse transcriptase inhibitors (NRTIs) flimkien ma' PIs jew mingħajrhom (ara sezzjoni 4.5) hija ta' 24 ml mill-ħalq, darba kuljum.
English: STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Maltese: STOCRIN huwa indikat għall-kura kombinata antiretrovirali tal-adulti, l-adoloxxenti u t-tfal ta' tliet snin jew ikbar li huma nfettati bil-virus tal-immunodefiċjenza umana-1 (HIV-1).
English: Responder rates (NC = F Plasma HIV-RNA
Maltese: Plażma HIV-RNA
English: If you could get pregnant while receiving Stocrin, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Maltese: Jekk tista' tinqabad tqila waqt li tkun qed tieħu Stocrin, inti trid tuża forma affidabbli ta' kontraċezzjoni barriera (per eżempju, kondom) ma' metodi oħra ta' kontraċezzjoni fosthom kontraċettivi orali (pillola) jew kontraċettivi oħra ormonali, (per eżempju impjanti, injezzjoni).
English: 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40  Stocrin 50 mg, 200 mg and 600 mg film-coated tablets are available.
Maltese: 32.5 sa < 40 ∗ hemm disponibbli pilloli miksijin b'rita ta' Stocrin 50 mg, 200 mg u 600 mg.
English: Information regarding post-marketing surveillance These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Maltese: madankollu l-frekwenzi kienu stabbiliti bl-użu ta' dejta minn 16-il prova klinika (n=3,969).
English: STOCRIN 600 mg film-coated tablets STOCRIN 50 mg film-coated tablets STOCRIN 200 mg film-coated tablets
Maltese: Kif jidher Stocrin u l-kontenut tal-pakkett Stocrin 600 mg pilloli miksija b'rita huma disponibbli fi fliexken ta' 30 pillola
English: 5 years or more
Maltese: 13 sa < 15
English: Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
Maltese: Għalhekk, teoretikament, efavirenz jista' inizjalment jżid l-espożizzjoni għas-sottostrati ta' CYP3A4 u hija meħtieġa kawtela għas sottostrati ta' CYP3A4 b'indiċi terapewtiku dejjaq (ara sezzjoni 4.3).
English: Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies of each of the above events ranging from 0.3 % for manic reactions to 2.0 % for both severe depression and suicidal ideation.
Maltese: Pazjenti bi storja medika ta' mard psikjatriku jidher li għandhom riskju ikbar għal dawn irreazzjonijiet psikjatriċi avversi serji bi frekwenzi ta' kull waħda minn dawn il-każijiet t'hawn fuq f'medda bejn 0.3 % għal reazzjonijiet manijaċi sa 2.0 % kemm għal dipressjoni severa kif ukoll għal ideat suwiċidali.
English: How to store Stocrin
Maltese: X'fih Stocrin
English: When taken with rifampicin in patients weighing 50 kg or greater, increasing efavirenz daily dose to 800 mg may provide exposure similar to a daily dose of 600 mg, when taken without rifampicin.
Maltese: Meta jittieħed ma' rifampicin f'pazjenti li jiżnu 50 kg jew aktar, iż-żieda fid-doża ta' kuljum ta' efavirenz għal 800 mg tista' tipprovdi esponiment simili għal doża ta' 600 mg, meta jittieħed mingħajr rifampicin.
English: Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Maltese: Reazzjonijiet avversi ta' severità moderata jew akbar b'għallinqas relazzjoni possibbli għar-reġimen tat-trattament (abbażi tal-attribuzzjoni tal-investigatur) irrapportati fi provi kliniċi ta' efavirenz fid-doża rakkomandata f'terapija ta' kombinazzjoni (n = 1,008) huma elenkati hawn taħt.
English: Norbuprenorphine:
Maltese: AUC: ↓ 50% Norbuprenorphine:
English: Cmax: ↑ 50% (↑ 20 to ↑ 80)
Maltese: Cmax: ↑ 50% (↑ 20 sa ↑ 80) (Induzzjoni ta' CYP2B6)
English: AUC: ↓ 27 % (↓ 20 to ↓ 33) Cmax: ↓ 20 % (↓ 15 to ↓ 24) Cmin: ↓ 35 % (↓ 24 to ↓ 44) Efavirenz:
Maltese: AUC: ↓ 18% (↓ 8 sa ↓ 27) Cmax: ↓ 14% (↓ 3 sa ↓ 24) Cmin: ↓ 25% (↓ 14 sa ↓ 34)% Efavirenz:
English: If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50 %, i.e., to 300 mg once daily.
Maltese: Jekk efavirenz jingħata flimkien ma' voriconazole, id-doża ta' manteniment ta' voriconazole għandha tiżidied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz għandha titnaqqas b'50 %, i.e., għal 300 mg darba kuljum.
English: ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg once daily/600 mg once daily)
Maltese: Carbamazepine/Efavirenz (400 mg darba kuljum/600 mg darba kuljum)
English: In 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 M, steady state Cmin was 5.6 M, and AUC was 216 M·h.
Maltese: F'49 pazjent pedjatriku li kienu qed jirċievu l-ekwivalenti ta' doża ta' 600 mg ta' efavirenz (doża aġġustata mill-kalkolu tad-daqs tal-ġisem ibbażat fuq il-piż), Cmax fl-istat fiss kienet ta' 14.1 µM, Cmin fl-istat fiss kienet ta' 5.6 µM, u l-AUC kienet ta' 216 µM·siegħa.
English: STOCRIN oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the film-coated tablets.
Maltese: STOCRIN soluzzjoni orali huwa indikat għall-kura kombinata antiretrovirali tal-adulti, l-adoloxxenti u t-tfal ta' tliet snin jew ikbar li huma nfettati bil-virus tal-immunodefiċjenza umana-1 (HIV-1), li ma jistgħux jibilgħu pilloli miksija b'rita.
English: Common (affects 1 to 10 users in 100) - abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness,
Maltese: Komuni (jaffettwaw utent wieħed sa 10 minn kull 100) - ħolm mhux normali, diffikultà fil-konċentrazzjoni, sturdament, uġigħ ta' ras, diffikultà fl-irqad,
English: Uncommon (affects 1 to 10 users in 1,000) - nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts - blurred vision - a feeling of spinning or tilting (vertigo) - pain in the abdomen (stomach) caused by inflammation of the pancreas - allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme,
Maltese: Mhux komuni (jaffettwaw utent wieħed sa 10 minn kull 1,000) - nervożiżmu, tinsa l-affarijiet, konfużjoni, attakki (aċċessjonijiet), ħsibijiet mhux normali - viżta mċajpra - sensazzjoni ta' tidwir jew għelib (vertiġni)
English: Rash was more common in children than in adults treated with Stocrin.
Maltese: Ir-raxx kien iktar komuni fit-tfal milli f'adulti kkurati bi Stocrin.
English: STOCRIN 600 mg film-coated tablets efavirenz
Maltese: STOCRIN 600 mg pilloli miksija b'rita efavirenz
English: Substantial decrease in lopinavir exposure.
Maltese: Minħabba l-metaboliżmu estensiv ta'
English: Pharmacotherapeutic group: Antivirals for systemic use.
Maltese: Antivirali għal użu sistemiku.
English: AUC: ↓ 75 % (↓ 59 to ↓ 84) Cmax: ↓ 64 % (↓ 57 to ↓ 69) Cmin: ↓ 62 % (↓ 44 to ↓ 75) N-monodesmethyl diltiazem: AUC: ↓ 37 % (↓ 17 to ↓ 52) Cmax: ↓ 28 % (↓ 7 to ↓ 44) Cmin: ↓ 37 % (↓ 17 to ↓ 52) Efavirenz:
Maltese: AUC: ↓ 75% (↓ 59 għal ↓ 84) Cmax: ↓ 64% (↓ 57 għal ↓ 69) Cmin: ↓ 62% (↓ 44 għal ↓ 75)
English: STOCRIN 600 mg film-coated tablets Each film-coated tablet contains 600 mg of efavirenz.
Maltese: 300 mg/ritonavir 100 mg darba kuljum filgħaxija mingħajr efavirenz.
English: Patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
Maltese: Pazjenti bi: - storja fil-familja ta' mewt f'daqqa jew ta' titwil konġenitali tal-intervall QTc fuq l elettrokardjogrammi, jew bi kwalunkwe kondizzjoni klinika oħra magħrufa li ttawwal l-intervall
English: AUC: ↓ 36 % C12: ↓ 21 % Cmax: ↓ 36 % (UGT1A1 induction)
Maltese: AUC: ↓ 50% Cmax: ↓ 45% (induzzjoni ta' UDP-G)
English: Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Maltese: M'hemmx biżżejjed informazzjoni dwar it tollerabilità ta' efavirenz ma' doża baxxa ta' ritonavir (100 mg, darba jew darbtejn kuljum).
English: The recommended dose of efavirenz in combination with a PI and/or NRTIs for patients between 3 and 17 years of age is described in Table 1.
Maltese: Id-doża rakkomandata ta' efavirenz flimkien ma' PI u/jew NRTIs għal pazjenti bejn it-3 u s-17-il sena hija deskritta fit-Tabella 1.
English: STOCRIN 200 mg film-coated tablets efavirenz
Maltese: STOCRIN 200 mg pillola miksija b'rita efavirenz
English: • The dose for children weighing 40 kg or more is 600 mg once daily.
Maltese: • Id-doża għat-tfal li jiżnu 40 kg jew aktar hija ta' 600 mg darba kuljum.
English: When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored.
Maltese: Meta jitwaqqaf it-trattament b'voriconazole, għandha terġa' tiddaħħal id-doża inizjali ta' efavirenz.
English: - if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
Maltese: - jekk għandek storja ta' konvulżjonijiet (attakki jew aċċessjonijiet) jew jekk tkun qed tiġi kkurat/a b'terapija antikonvulsanti bħal carbamazepine, phenobarbital u phenytoin.
English: When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50 %, i.e., to 300 mg once daily.
Maltese: manteniment ta' voriconazole għandha tiżdied għal 400 mg darbtejn kuljum u d-doża ta' efavirenz għandha titnaqqas b'50%, jiġifieri għal 300 mg darba kuljum.
English: STOCRIN 50 mg film-coated tablets efavirenz
Maltese: STOCRIN 50 mg pilloli miksija b'rita efavirenz
English: Grapefruit juice should be avoided when taking Stocrin.
Maltese: Il-meraq tal-grejpfrut għandu jiġi evitat meta tieħu Stocrin.
English: Dose adjustments of calcium channel blockers should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Maltese: L-aġġustamenti fid-doża talimblokkaturi tal-kanali tal-kalċju għandhom ikunu ggwidati mirrispons kliniku (irreferi għasSommarju tal-Karatteristiċi talProdott għall-imblokkatur tal kanali tal-kalċju).
English: Stocrin contains efavirenz andmay cause dizziness,impaired concentration, and drowsiness.
Maltese: Dawn l immunosuppressanti mhumiex mistennija li jkollhom effett fuq l-espożizzjoni ta' efavirenz.
English: (CYP2B6 induction)
Maltese: (induzzjoni tas-CYP3A
English: The administration of efavirenz with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Maltese: jwassal għal żieda fil-frekwenza tar-reazzjonijiet avversi (ara sezzjoni 4.8).
English: Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65)
Maltese: AUC: ↓ 43% (↓ 7 sa ↓ 65) Cmax: ↔
English: These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
Maltese: Dawn il-mediċini jinkludu: - antiarritmiċi ta' klassijiet IA u III, - newrolettiċi, aġenti antidipressivi, - ċerti antibijotiċi li jinkludu xi aġenti tal-klassijiet li ġejjin: makrolidi, fluworokinoloni,
English: ANTIHISTAMINES Cetirizine/Efavirenz (10 mg single dose/600 mg once daily)
Maltese: Atorvastatin/Efavirenz (10 mg darba kuljum/600 mg darba kuljum)
English: After use, soak the syringe in warm soapy water for at least a minute.
Maltese: Wara l-użu, ħalli s-siringa fl-ilma fietel bis-sapun għal mill-inqas minuta.
English: If you have severe liver disease, do not take Stocrin (see Section 2, Do not take Stocrin).
Maltese: Stocrin (ara Sezzjoni 2, Tiħux Stocrin).
English: Stocrin 600 mg film-coated tablets efavirenz
Maltese: Informazzjoni għall-utent Stocrin 600 mg pilloli miksija b'rita efavirenz
English: When efavirenz is co-administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
Maltese: Meta efavirenz jingħata fl-istess ħin ma' antikonvulsiv li jkun substrat ta' isoenzimi CYP450, għandu jsir monitoraġġ perjodiku tal-livelli tal-antikonvulsiv.
English: Dose adjustments of the immunosuppressant may be required.
Maltese: Jista' jkun hemm bżonn ta' aġġustamenti fid-doża tal immunosuppressant.
English: In a single-dose study, half life was doubled in the single patient with severe hepatic impairment (Child-Pugh Class C), indicating a potential for a much greater degree of accumulation.
Maltese: Fi studju ta' doża singola, il-half-life irduppjat f'pazjent wieħed b'indeboliment qawwi tal-fwied (Child-Pugh Klassi Ċ), li jindika possibbiltà ta' akkumulazzjoni sa grad ferm ogħla.
English: Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking another NNRTI.
Maltese: - reazzjoni allerġika (sensittività eċċessiva) li tista' tikkawża reazzjonijiet severi tal-ġilda (ertema multiforme, is-sindromu ta' Stevens-Johnson)
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism which may be clinically relevant in some patients.
Maltese: Efavirenz intwera li jinduċi CYP3A4 u CYP2B6, bir-riżultat li induċa l-metaboliżmu tiegħu stess u dan jista' jkun rilevanti b'mod kliniku f'xi pazjenti.
English: • Stocrin must be taken with other medicines that act against the HIV virus.
Maltese: • Stocrin irid jittieħed ma' mediċini oħra li jaħdmu kontra l-virus tal-HIV.
English: Ethinyloestradiol+Norgestimate/ Efavirenz (0.035 mg+0.25 mg once daily/600 mg once daily)
Maltese: (0.035 mg+0.25 mg darba kuljum/600 mg darba kuljum)
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1 % of patients treated with efavirenz.
Maltese: Ġie rrapportat raxx qawwi marbut ma' nfafet, tqaxxir umdu tal-ġilda u ulċeri f'inqas minn 1 % mill-pazjenti kkurati b'efavirenz.
English: Each film-coated tablet contains: efavirenz 200 mg
Maltese: Kull pillola miksija b'rita fiha: 200 mg ta' efavirenz
English: Malformations were observed in 3 of 20 foetuses/newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Maltese: Ġew osservati malformazzjonijiet fi 3 minn 20 fetu mwieled frisk minn xadini cynomolgus ikkurati b'efavirenz li ngħataw dożi li rriżultaw f'konċentrazzjonijiet ta' efavirenz fil-plażma li kienu simili għal dawk li ġew osservati fil-bnedmin.