FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with dihydroergotamine, ergonovine, ergotamine or methylergonovine is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Maltese: L-użu fl-istess ħin ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, ma' dihydroergotamine, ergonovine, ergotamine jew methylergonovine hu kontraindikat minħabba avvenimenti potenzjalment serji u/jew ta' periklu għall-ħajja (ara sezzjoni 4.3).
English: The mechanisms and potential mechanisms contributing to the interaction profile of tipranavir are described (see section 4.5).
Maltese: Ilmekkaniżmi u l-mekkaniżmi potenzjali li jinkontribwixxu għal profil ta' interazzjonijiet ta' tipranavir huma deskritti (ara sezzjoni 4.5).
English: Interactions between Aptivus and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”,once daily as “QD”, twice daily as “BID”).
Maltese: Interazzjonijiet bejn Aptivus u prodotti mediċinali mogħtija flimkien huma elenkati fit-tabella hawn taħt (żieda hi indikat bħala “↑”, tnaqqis bħala “↓”, u l-ebda bidla bħala “↔”, darba kuljum bħala “QD”, darbtejn kuljum bħala “BID”).
English: In general, caution should be exercised in the administration and monitoring of Aptivus in older people reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy (see section 4.4).
Maltese: B'mod ġenerali, għandha tintuża kawtela fl-għoti u fil-monitoraġġ ta' Aptivus f'persuni aktar anzjani li tirrifletti frekwenza akbar ta' tnaqqis fil-funzjoni tal-fwied, tal-kliewi, jew dik kardijaka, u ta' mard ieħor jew ta' terapija oħra fl-istess ħin (ara sezzjoni 4.4).
English: The most abundant urinary metabolite, at 11.0% of urine radioactivity (0.5% of dose) was a glucuronide conjugate of tipranavir.
Maltese: L-aktar metabolit abbundanti fl-awrina kien glucuronide conjugate li kien jirrapreżenta 11.0% tar-radjuattività fl-awrina (0.5% tad-doża).
English: Muscle disorders
Maltese: Disturbi muskolari
English: In a study performed in antiretroviral naïve adult patients, tipranavir 500 mg with ritonavir 200 mg twice daily, as compared to lopinavir/ritonavir, was associated with an excess in the occurrence of significant (grade 3 and 4) transaminase elevations without any advantage in terms of efficacy (trend towards a lower efficacy).
Maltese: Fi studju mwettaq fuq pazjenti adulti li qatt ma rċevew dan it-trattament qabel, tipranavir 500 mg ma' ritonavir 200 mg darbtejn kuljum, meta mqabbel ma' lopinavir/ritonavir, kien assoċjat ma' eċċess f'każijiet ta' żidied sinifikanti (grad 3 u 4) ta' transaminase, mingħajr vantaġġ f'termini ta' effikaċja (xejra lejn anqas effikaċja).
English: Haemophilia
Maltese: Emofilja
English: In a pharmacokinetic study of healthy volunteers, boceprevir decreased the exposure of ritonavir, and some ritonavir-boosted protease inhibitors.
Maltese: Fi studju farmakokinetiku ta' voluntiera b'saħħithom, boceprevir naqqas l-esponiment ta' ritonavir, u xi inibituri tal-protease imsaħħin b'ritonavir.
English: Each capsule contains 250 mg tipranavir.
Maltese: Kull kapsula ratba fiha 250 mg tipranavir
English: Other medicines with which Aptivus may interact include: - oral contraceptives/hormone replacement therapy (HRT): If you are taking the contraceptive pill to prevent pregnancy you should use an additional or different type of contraception (e.g. barrier contraception like condoms).
Maltese: Mediċini oħra li magħhom Aptivus jista' jista' jkollu effetti jinkludu: - kontraċettivi orali/terapija ta' sostituzzjoni ormonali (HRT): Jekk qed tieħu l-pillola kontraċettiva sabiex tevita li tinqabad tqila inti għandek tuża tip addizzjonali jew differenti ta' kontraċezzjoni (eż. kontraċettivi barrierabħal kondoms).
English: Other HMG-CoA reductase inhibitors should be considered such as pravastatin, fluvastatin or rosuvastatin (See also section 4.4 and rosuvastatin and pravastatin recommendations).
Maltese: Impedituri oħrajn ta' HMG-CoA reductase għandhom jiġu kkunsidrati, bħal pravastatin, fluvastatin jew rosuvastatin (Ara wkoll sezzjoni 4.4 u rakkomandazzjonijiet dwar rosuvastatin u pravastatin).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg tipranavir.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni orali fih 100 mg ta' tipranavir.
English: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in all Phase II and III trials in adults treated with the 500 mg tipranavir with 200 mg ritonavir dose twice daily (n=1397) and are listed below by system organ class and frequency according to the following categories:
Maltese: II u III li saru fuq persuni adulti kkurati b'doża ta' 500 mg ta' tipranavir flimkien ma' 200 mg ta' ritonavir darbtejn kuljum (n=1397) u huma elenkati hawn taħt skont il-klassi tal-organi tas-sistema u l-frekwenza skont il-kategoriji li ġejjin:
English: This study was also conducted with Aptivus oral solution 500 mg with ritonavir 200 mg and showed the same CYP P450 and P-gp interactions as the Aptivus capsule 500 mg with ritonavir 200 mg. Based on the results from this study, Aptivus oral solution might be expected to have a similar interaction profile as the capsules.
Maltese: Dan l-istudju sar ukoll b'Aptivus soluzzjoni orali 500 mg ma' ritonavir 200 mg u wera l-istess interazzjonijiet għal CYP P450 u P-gp bħal kapsula ta' Aptivus 500 mg ma' ritonavir 200 mg.
English: The clinical impact of the observed data, especially regarding the tipranavir with ritonavir safety profile, remains unknown.
Maltese: L-impatt kliniku tad-dejta osservata, speċjalment dwar il-profil tas-sigurtà ta' tipranavir ma' ritonavir, jibqa' mhux magħruf.
English: Median change from baseline in log10 HIV-1 RNA (copies/ml) Median change from baseline in CD4+ cell count (cells/mm3) Median change from baseline in % CD4+ cells
Maltese: Bidla medjana mil-linja bażi f' log10 RNA ta' HIV-1 (kopji/ml) Bidla medjana mil-linja bażi fl-għadd ta' ċelluli ta' CD4+ (ċelluli/mm3) Bidla medjana mil-linja bażi fl-għadd ta' % ta' CD4+ ċelluli
English: C-tipranavir to subjects (n = 8) that received 500 mg tipranavir with 200 mg ritonavir; twice daily dosed to steady-state demonstrated that most radioactivity (median 82.3%) was excreted in faeces, while only a median of 4.4% of the radioactive dose administered was recovered in urine.
Maltese: C-tipranavir lis-suġġetti (n = 8) li ħadu 500 mg ta' tipranavir ma' 200 mg ta' ritonavir darbtejn kuljum, f'dożi biex jintlaħaq l-istat fiss, wera li r-radjuattività (medja ta' 82.3%) l-aktar għolja kienet eliminata fl-ippurgar, filwaqt li kien biss ammont medju ta' 4.4% tad-doża radjuattiva li kienet irkuprata mill-awrina.
English: The combined use of Aptivus, coadministered with low dose ritonavir, with proton pump inhibitors is not recommended (see section 4.4).
Maltese: L-użu kombinat ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, ma' impedituri tal-pompa tal-proton mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Higher doses of carbamazepine (> 200 mg) may result in even larger decreases in tipranavir plasma concentrations (see section 4.4).
Maltese: Dożi ogħla ta' carbamazepine (> 200 mg) jistgħu jirriżultaw fi tnaqqis akbar filkonċentrazzjonijiet ta' tipranavir filplażma (ara sezzjoni 4.4).
English: 500 mg Tipranavir co-administered with low dose ritonavir (200 mg; twice daily) was associated with a 29-fold increase in the geometric mean morning steady-state trough plasma concentrations compared to tipranavir 500 mg twice daily without ritonavir.
Maltese: Meta 500 mg ta' tipranavir jingħata flimkien ma' doża baxxa ta' ritonavir (200 mg; darbtejn kuljum), dan kien assoċjat ma' żieda ta' 29 darba fil-medja ġeometrika fissa tal-konċentrazzjoni ta' tipranavir fil-plażma ta' fil-għodu, meta mqabbel ma' doża ta' 500 mg mogħtija darbtejn kuljum mingħajr ritonavir.
English: Increasing baseline phenotypic fold change to tipranavir in isolates is correlated to decreasing virological response.
Maltese: Għalhekk, modifika talesponiment għal Aptivus ma tistax tiġi eskluża.
English: Inhibition of CYP 3A4 by tipranavir/r
Maltese: Inibizzjoni ta' CYP 3A4 minn tipranavir/ r
English: Depending on your child's liver function they may have to delay or stop Aptivus treatment - if your child is currently taking products containing: - rifampicin (used to treat tuberculosis) - cisapride (used to treat stomach problems) - pimozide or sertindole (used to treat schizophrenia) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder) - lurasidone (used to treat schizophrenia) - triazolam or oral midazolam (taken by mouth).
Maltese: Skont il-funzjoni tal-fwied tat-tifel/tifla tiegħek għandu mnejn ikollok tittardja t-teħid jew twaqqaf it-trattament b'Aptivus - jekk it-tifel/tifla tiegħek attwalment qed tieħu prodotti li fihom: rifampicin (użat biex jittratta t-tunerkolisi) cisapride (użat biex jikkura problemi ta' l-istonku) pimozide jew sertindole (użat biex jikkura l-iskiżofrenja) quetiapine (użat biex jikkura skiżofrenija, disturb bipolari u disturb dipressiv maġġuri) lurasidone (użat biex jikkura l-iskiżofrenja) triazolam jew midazolam orali (meħud mill-ħalq).
English: In the paediatric clinical trial, the frequency of rash (all grades, all causality) through 48 weeks of treatment was higher than in adult patients.
Maltese: Fil-prova klinika pedjatrika, il-frekwenza ta' raxx (il-gradi kollha, kull każwalità) għal 48 ġimgħa ta' trattament kienet ogħla milli għal pazjenti adulti.
English: Sertindole Quetiapine Lurasidone No interaction study performed
Maltese: Quetiapine Lurasidone Ma sarux studji dwar linterazzjonijiet
English: Co-administration of Aptivus, coadministered with low dose ritonavir, and rosuvastatin should be initiated with the lowest dose (5 mg/day) of rosuvastatin, titrated to treatment response, and accompanied with careful clinical monitoring for rosuvastatin associated symptoms as described in the label of rosuvastatin.
Maltese: L-għoti flimkien ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, u rosuvastatin, għandu jinbeda blinqas doża (5 mg/kuljum) ta' rosuvastatin, ittritat skont ir-rispons tal-kura, u akkumpanjat b'monitoraġġ kliniku bir-reqqa għal sintomi assoċjati ma' rosuvastatin kif deskritt fuq it-tikketta ta' rosuvastatin.
English: In a pharmacokinetic study performed in healthy volunteers, concomitant use of low dose ritonavir (200 mg twice daily) with a single dose of trazodone led to an increased plasma concentration of trazodone (AUC increased by 2.4 fold).
Maltese: Fi studju farmakokinetiku li sar f'voluntiera b'saħħithom, l-użu flistess ħin ta' doża baxxa ta' ritonavir (200 mg darbtejn kuljum) ma' doża waħda ta' trazodone, wassal għal żieda talkonċentrazzjoni fil-plażma ta' trazodone (l-AUC żdiedet bi 2.4 darbiet).
English: Gastrointestinal disorders very common diarrhoea, nausea common vomiting, flatulence, abdominal pain, abdominal distension, dyspepsia uncommon gastrooesophageal reflux disease, pancreatitis rare lipase increased
Maltese: Disturbi gastro-intestinali komuni ħafna dijarea, nawseja komuni rimettar, gass, uġigħ ta' żaqq, nefħa fiż-żaqq, dispepsja mhux komuni marda ta' rifluss gastroesofagali, pankreatite rari żieda fil-livell tal-lipase
English: This leaflet was last approved in {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Potent inhibition of CYP 2D6 and both hepatic and intestinal CYP 3A4 activities were observed.
Maltese: Kien osservat li kien hemm impediment qawwi ta' CYP 2D6 u ta' l-attivitajiet ta' CYP 3A4 kemm tal-fwied u ta' l-imsaren.
English: Tipranavir, co-administered with low dose ritonavir, is expected to decrease meperidine concentrations and increase normeperidine metabolite concentrations.
Maltese: Tipranavir, mogħti flimkien ma' doża baxxa ta' ritonavir, hu mistenni li jnaqqas ilkonċentrazzjonijiet ta' meperidine u jżid ilkonċentrazzjonijiet tal-metabolit normeperidine.
English: Examples include: - rifabutin and clarithromycin (antibiotics) - theophylline (used to treat asthma) - desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for smoking cessation) - midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help you sleep - rosuvastatin or pravastatin (used to lower blood cholesterol) - colchicine (used to treat gout flares with normal kidney and liver function).
Maltese: Eżempji jinkludu: - rifabutin u clarithromycin (antibijotiċi) - theophylline (użat għat-trattament tal-ażma) - desipramine, trazodone u bupropion (użat għat-trattament ta' dipressjoni;; bupropion jintuża wkoll biex jgħin iwaqqaf it-tipjip) - midazolam (meta jingħata b'injezzjoni); midazolam huwa sedattiv użat biex jittratta l-ansjetà u jgħinek biex torqod.
English: Aptivus oral solution is supplied in amber glass bottles containing 95 ml of oral solution.
Maltese: Aptivus soluzzjoni orali huwa fornut fi flixken tal-ħġieġ ambra li fihom 95 ml ta' soluzzjoni orali.
English: Compared to the capsules, tipranavir exposure is higher when administering the same dose as oral solution.
Maltese: Il-kapsuli Aptivus ma jistgħux jiġu skambjati mas-soluzzjoni orali.
English: These medicines are used to treat anxiety or sleep disorders - ergot derivatives (used to treat headaches) - astemizole or terfenadine (used to treat allergies or hay fever) - simvastatin or lovastatin (used to lower blood cholesterol) - amiodarone, bepridil, flecainide, propafenone or quinidine (used to treat heart disorders) - metoprolol (used to treat heart failure) - alfuzosin and sildenafil (when used to treat a rare blood vessel disorder characterized by increased pressure in the pulmonary artery) - colchicine (when used to treat gout flares in patients with kidney or liver disease).
Maltese: Dawn il-mediċini jintużaw biex jikkura l-ansjetà jew disturbi ta' l-irqad) - derivati ta' ergot (użati biex jikkuraw l-uġigħ ta' ras) - astemizole jew terfenadine (użati għat-trattament ta' l-allerġiji jew hay fever) - simvastatin jew lovastatin (użati biex ibaxxu l-kolesterol fid-demm) - amiodarone, bepridil, flecainide, propafenone jew quinidine (użati għat-trattament ta'disturbi tal-qalb) - metoprolol (użat biex jittratta falliment kardijaku) - alfuzosin u sildenafil (meta jintużaw għall-kura ta' disturb rari tal-vini/arterji kkaratterizzat minn żieda fil-pressjoni fl-arterja pulmonari)
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Coadministration of Aptivus with ritonavir, with St. John's wort is expected to substantially decrease tipranavir and ritonavir concentrations and may result in sub-optimal levels of tipranavir and lead to loss of virologic response and possible resistance to tipranavir.
Maltese: John's wort hu mistenni li jnaqqas b'mod sostanzjali lkonċentrazzjonijiet ta' tipranavir u ritonavir u jista' jirriżulta f'livelli ta' tipranavir li ma jkunux mill-aħjar, u dan jista' jwassal għal telf ta' rispons viroloġiku u reżistenza possibbli għal tipranavir.
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Maltese: Interazzjonijiet magħrufa u teoretiċi bi prodotti mediċinali antiretrovirali u non-antiretrovirali magħżula huma elenkati fit-tabella hawn taħt.
English: Moreover a study with TPV/r and another NNRTI (efavirenz) did not show any clinically relevant interaction (see above).
Maltese: Barra dan, studju b'TPV/r u NNRTI ieħor (efavirenz) ma wera l-ebda interazzjoni klinikament rilevanti (ara hawn fuq).
English: Rare: may affect up to 1 in 1,000 people - Liver failure (including fatal outcome) - Hepatitis - Fatty liver - Increased blood levels of bilirubin (a breakdown product of haemoglobin) - Dehydration (when the body does not have enough water) - Thinning of the face - Bleeding in the brain* (see above) - Increased blood levels of the pancreas enzyme lipase
Maltese: Rari: jistgħu jaffettwaw sa 1 persuna minn kull 1000 - Insuffiċjenza tal-fwied (li tinkludi mewt) - Epatite - Xaħam fil-fwied - Żieda fil-livelli ta' bilirubina fid-demm (prodott li jirriżulta mit-tkissir tal-emoglobina) - Deidrattazzjoni (meta l-ġisem ma jkollux biżżejjed ilma) - Il-wiċċ jirqaq - Emorraġija fil-moħħ* (ara hawn fuq) - Żieda fil-livelli tal-enzima tal-frixa lipase fid-demm
English: The mean steady-state trough concentration prior to the morning dose was 41.6 ± 24.3 µM for female patients and 35.6 ± 16.7 µM for male patients.
Maltese: Ilkonċentrazzjoni medja l-aktar baxxa ta' l-istat fiss qabel id-doża ta' filgħodu kienet ta' 41.6 ± 24.3 µM għal pazjenti nisa u 35.6 ± 16.7 µM għal pazjenti rġiel.
English: % with Category C 29.2% Treatment history % with any ARV 96.6% Median # previous
Maltese: % b' Kategorija Ċ 29.2%
English: Clinical data on fertility are not available for tipranavir.
Maltese: M'hemm l-ebda dejta klinika disponibbli dwar il-fertilità għal tipranavir.
English: H2-receptor antagonists No interaction study performed
Maltese: Antagonisti ta' riċettur H2 Ma sarux studji dwar linterazzjonijiet
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of Aptivus/r (i.e. 500/200 mg BID).
Maltese: Ħlief jekk mhux iddikjarat mod ieħor, l-istudji msemmija hawn taħt saru bid-dożaġġ rakkomandat ta' Aptivus/r (i.e. 500/200 mg BID).
English: In a study comparing 9 patients with mild (Child-Pugh A) hepatic impairment to 9 controls, the single and multiple dose exposure of tipranavir and ritonavir were increased in patients with hepatic impairment but still within the range observed in clinical studies.
Maltese: Waqt studju fejn 9 pazjenti li kellhom indeboliment ħafif tal-fwied (Child-Pugh A) ġew mqabbla ma' 9 kontrolli, instab li meta ntużat doża waħda jew dożi ripetuti, id-dispożizzjoni farmakokinetika għal tipranavir u ritonavir żdiedet, iżda xorta kienet fil-medda osservata waqt l-istudji kliniċi.
English: The co-administration of tipranavir with vitamin E in the form of TPGS (d-alphatocopherol polyethylene glycol 1000 succinate) from 2,322 IU/m² upwards in rats resulted in a significant increase in effects on coagulation parameters, bleeding events and death.
Maltese: L-għoti flimkien ta' tipranavir ma' vitamina E f'għamla ta' TPGS (d-alphatocopherol polyethylene glycol 1000 succinate) minn 2322 IU/m² 'il fuq fil-firien irriżultaw f'żieda sinifikanti fl-effetti tal-parametri ta' koagulazzjoni, każijiet ta' fsada u mwiet.
English: Number of TPV Score Mutations**
Maltese: Suxxetibilità**
English: Due to Aptivus containing small amounts of sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Minħabba li Aptivus fih ammonti żgħar ta' sorbitol, pazjenti li għandhom problemi ereditarji rari ta' intolleranza tal-fruttożju m'għandhomx jieħdu din il-mediċina.
English: Adults and adolescents (from 12 - 18 years of age) The recommended dose of Aptivus is 500 mg, co-administered with 200 mg ritonavir (low dose ritonavir), twice daily (see section 4.4 for precautionary measures in adolescents).
Maltese: Id-doża rakkomandata ta' Aptivus hi ta' 500 mg, mogħtija flimkien ma' 200 mg ta' ritonavir (doża baxxa ta' ritonavir), darbtejn kuljum (ara sezzjoni 4.4 għal miżuri prekawzjonarji fl-adolexxenti).
English: recommended when coadministered with Aptivus/ritonavir.
Maltese: L-għoti flimkien ta' etravirine u Aptivus/ritonavir mhuwiex rakkomandat.
English: Treatment-naïve patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: - sildenafil, vardenafil, tadalafil (medicines used to produce and maintain an erection).
Maltese: Dawn jistgħu nnaqqsu l-effettività ta' Aptivus. - sildenafil, vardenafil, tadalafil (mediċini użati biex jipproduċu jew jżommu t-twebbis).
English: The following clinical safety features (hepatotoxicity, hyperlipidaemia, bleeding events, rash) were seen at higher frequency among tipranavir with ritonavir treated patients when compared with the comparator arm treated patients in the RESIST trials, or have been observed with tipranavir with ritonavir administration.
Maltese: Il-karatteristiċi ta' sigurtà klinika li ġejjin (epatotossiċità, iperlipidimja, każijiet ta' fsada, raxx) dehru fi frekwenza ogħla fost pazjenti trattati b'tipranavir ma' ritonavir meta mqabbla mal-komparatur ta' pazjenti fil-provi ta' RESIST, jew li ġew osservati bl-għoti b'tipranavir ma' ritonavir.
English: Dosage reductions of rifabutin by at least 75% of the usual 300 mg/day are recommended (ie 150 mg on alternate days, or three times per week).
Maltese: Tnaqqis fid-dożaġġ ta' rifabutin b'mill-inqas 75% tas-soltu ta' 300 mg/kuljum hu rakkomandat (i.e. 150 mg kull jumejn, jew tliet darbiet kull ġimgħa).
English: In patients with renal or hepatic impairment, co-administration of colchicine in patients on Aptivus/ritonavir is contraindicated (see section 4.3).
Maltese: F'pazjenti b'indeboliment tal-kliewi jew tal-fwied, l-għoti flimkien ta' colchicine f'pazjenti fuq Aptivus/ritonavir hu kontraindikat (ara sezzjoni 4.3).
English: The predominant effects of repeated administration of tipranavir across all species toxicologically tested were on the gastrointestinal tract (emesis, soft stool, diarrhoea) and the liver (hypertrophy).
Maltese: L-effetti ewlenin ta' l-użu ripetut ta' tipranavir fuq l-ispeċi kollha li ġew studjati minħabba l-effetti tossiċi, kienu fuq l-apparat gastro-intestinali (emesi, ippurgar merħi u dijarrea) u l-fwied (ipertrofija).
English: In an open-label, dose-finding study of tipranavir plus ritonavir (Trial 1182.14), 62 children aged 2 to 12 years received Aptivus oral solution.
Maltese: Fi studju sabiex tinstab id-doża adattata bit-tikketta tidher ta' tipranavir li ngħata flimkien ma' ritonavir, (Prova 1182.14), 28 tifel u tifla li kienu bejn sentejn u 12-il sena ħadu soluzzjoni orali ta' Aptivus.
English: Your child must take Aptivus in combination with low dose ritonavir and other antiretroviral medicines.
Maltese: Inti għandek tieħu Aptivus flimkien ma' doża baxxa ta' ritonavir u mediċini antiretrovirali oħrajn.
English: Fluticasone propionate Interaction study performed only with ritonavir
Maltese: Fluticasone propionate Studju dwar l-interazzjonijiet twettaq biss b'ritonavir
English: NAME OF THE MEDICINAL PRODUCT Aptivus 100 mg/ml oral solution
Maltese: Aptivus 100 mg/ml soluzzjoni orali
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with flecainide, propafenone or metoprolol is contraindicated (see section 4.3)
Maltese: L-użu fl-istess ħin ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, ma' flecainide, propafenone jew metoprolol, hu kontraindikat (ara sezzjoni 4.3)
English: If a rash occurs, it is usually mild to moderate.
Maltese: Jekk ikun hemm raxx, dan ġeneralment ikun minn ħafif sa moderat.
English: Absorption of tipranavir, co-administered with low dose ritonavir, is reduced in the presence of antacids (see section 4.5).
Maltese: L-assorbiment ta' tipranavir, mogħti flimkien ma' doża baxxa ta' ritonavir, hu mnaqqas fil-preżenza ta' antaċidi (ara sezzjoni 4.5).
English: Isolates with baseline fold change of >0 to 3 are considered susceptible; isolates with >3 to 10 fold changes have decreased susceptibility; isolates with >10 fold changes are resistant.
Maltese: Kampjuni iżolati b'bidla fil-linja ta' riferiment ta' bejn >0 sa 3 huma kkonsidrati suxxetibbli: kampjuni iżolati b'bidla ta' bejn >3 sa 10 għandhom suxxetibilità mnaqqsa; Kampjuni iżolati b'bidliet ta' >10huma reżistenti.