FrancophonIA/ELRC3.0 huggingface dataset:
English: Kalydeco 50 mg granules ivacaftor
Maltese: Kalydeco 50 mg granijiet f'qartas ivacaftor
English: Table 3: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Maltese: Tabella 3: L-effett ta' ivacaftor fuq punti aħħarin tal-effikaċja oħrajn fi studji 1 u 2
English: Secondary endpoints were evaluation of pharmacokinetics and the absolute change from baseline in sweat chloride through 24 weeks of treatment (see Pharmacodynamic effects).
Maltese: Il-punti aħħarin sekondarji kienu evalwazzjoni tal-farmakokinetika u l-bidla assoluta mil-linja bażi talchloride fl-għaraq fuq 24 ġimgħa ta' trattament (ara Effetti farmakodinamiċi).
English: The mean absolute change from baseline through week 24 in percent predicted FEV1 was -2.8 percentage points in the ivacaftor group and 3.5 percentage points in the placebo group.
Maltese: Il-bidla assoluta medja millinja bażi sa ġimgħa 24 f'perċentwali ta' FEV1 imbassar kienet ta' -2.8 punti perċentwali fil-grupp ta' ivacaftor u 3.5 punti perċentwali fil-grupp tal-plaċebo.
English: During the 24-week open-label Phase 3 clinical study of ivacaftor in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34).
Maltese: Matul l-istudju kliniku ta' ivacaftor ta' Fażi 3 li dam 24 ġimgħa li sar f'34 pazjent, li kellhom minn sentejn sa inqas minn 6 snin (studju 7), l-inċidenza ta' pazjenti li kellhom żidiet fil-livell ta' transaminases (ALT jew AST) >3 x ULN kienet ta' 14.7% (5/34).
English: Nipple disorder uncommon
Maltese: Batterji fl-isputum komuni ħafna
English: No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti li għandhom indeboliment ħafif tal-fwied (ChildPugh Klassi A).
English: 12 months to less than 24 months (7 kg to < 14 kg)
Maltese: (7 kg sa <14 kg)
English: The recommended dose is one tezacaftor 100 mg/ivacaftor 150 mg tablet taken in the morning and one Kalydeco 150 mg tablet taken in the evening, approximately 12 hours apart with fat-containing food (see Method of administration).
Maltese: Id-doża rakkomandata hija pillola waħda tezacaftor 100 mg/ivacaftor 150 mg filgħodu u pillola Kalydeco waħda ta' 150 mg filgħaxija, b'madwar 12-il siegħa bejniethom ma' ikel li jkun fih ixxaħam (ara Metodu ta' kif għandu jingħata).
English: Ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, has not been studied in patients with CF who have undergone organ transplantation.
Maltese: Ivacaftor, jew f'monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor, ma ġiex studjat f'pazjenti b'CF li kellhom trapjant tal-organi.
English: The dose of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) must be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see sections 4.2 and 4.5).
Maltese: Id-doża ta' Kalydeco trid tiġi aġġustata meta tintuża fl-istess ħin ma' inibituri qawwija u moderati ta' CYP3A (ara sezzjoni 4.2 u 4.5).
English: * Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Maltese: * Kompli d-dożaġġ ma' pilloli ta' tezacaftor 100 mg/ivacaftor 150 mg jew ivacaftor 150 mg ġurnata iva u ġurnata le.
English: The impact of severe hepatic impairment (Child Pugh Class C, score 10 to15) on the pharmacokinetics of ivacaftor monotherapy or in combination with tezacaftor/ivacaftor have not been studied.
Maltese: L-impatt ta' indeboliment sever tal-fwied (Child- Pugh Klassi Ċ, punteġġ 10 sa 15) fuq ilfarmakokinetika ta' monoterapija b'ivacaftor jew flimkien ma' tezacaftor/ivacaftor ma ġewx studjati.
English: Study 2 evaluated 52 patients who were 6 to 11 years of age at screening; mean (SD) body weight was 30.9 (8.63) kg; 42 (80.8%) patients had the F508del mutation in the second allele.
Maltese: Studju 2 evalwa 52 pazjent li kellhom minn 6 sa 11-il sena meta sar l-iscreening; medja (SD) tal-piż tal-ġisem kienet ta' 30.9 (8.63) kg; 42 (80.
English: Clinical studies of ivacaftor monotherapy did not include sufficient numbers of patients age 65 years and older to determine whether pharmacokinetic parameters are similar or not to those in younger adults.
Maltese: Provi kliniċi ta' monoterapija b'ivacaftor ma kinux jinkludu numri suffiċjenti ta' pazjenti li kellhom 65 sena jew iktar biex jiġi stabbilit jekk il-parametri farmakokinetiċi huma simili jew le għal dawk f'adulti iżgħar.
English: The mean absolute change from baseline through week 16 in percent predicted FEV1 (primary efficacy endpoint) was 1.5 percentage points in the ivacaftor group and -0.2 percentage points in the placebo group.
Maltese: Il-bidla assoluta medja mil-linja bażi sa ġimgħa 16 f'perċentwali tal-FEV1 imbassar (punt aħħari taleffikaċja primarja) kienet ta' 1.5 punti perċentwali fil-grupp ta' ivacaftor u -0.2 punti perċentwali filgrupp tal-plaċebo.
English: The major metabolites M1 and M6 accounted for approximately 65% of the total dose eliminated with 22% as M1 and 43% as M6.
Maltese: M1 u M6 kienu jammontaw għal madwar 65% tad-doża totali eliminata bi 22% bħala
English: Cases suggestive of positive rechallenge were observed.
Maltese: Każijiet suġġestivi ta' sfida mill-ġdid pożittiva ġew osservati.
English: Sucralose
Maltese: Mutazzjoni
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of the clinical status of the patient.
Maltese: Il-kura ta' doża eċċessiva tikkonsisti minn miżuri ta' appoġġ ġenerali li jinkludu monitoraġġ tas-sinjali vitali, testijiet tal-funzjoni tal-fwied u osservazzjoni tal-istat kliniku tal-pazjent.
English: No safety data are available in infants aged 6 to less than 12 months of age with moderate or severe hepatic impairment treated with ivacaftor.
Maltese: M'hemm l-ebda data disponibbli dwar is-sigurtà fi trabi ta' età ta' 6 xhur sa inqas minn 12-il xahar b'indeboliment moderat jew sever tal-fwied ikkurati b'ivacaftor.
English: Table 6: Effect of ivacaftor on growth parameters in patients aged 6 months to less than 24 months with baseline and week 24 values
Maltese: Tabella 6: Effett ta' ivacaftor fuq il-parametri tat-tkabbir f'pazjenti li kellhom 6 xhur sa inqas minn 24 xahar bil-valuri fil-linja bażi u f'ġimgħa 24
English: A reduction of the Kalydeco dose is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4).
Maltese: Tnaqqis fid-doża ta' Kalydeco hu rakkomandat għal pazjenti li jkunu qed jieħdu inibituri moderati ta' CYP3A fl-istess ħin, bħal fluconazole u erythromycin (ara sezzjonijiet 4.2 u 4.4).
English: Two patients, one on placebo and one on ivacaftor permanently discontinued treatment for elevated transaminases, each > 8 x ULN.
Maltese: Żewġ pazjenti, wieħed fuq plaċebo u wieħed fuq ivacaftor, waqqfu l-kura b'mod permanenti minħabba livelli għoljin ta' transaminases, kull wieħed >8 x ULN.
English: M1 has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Maltese: M1 għandu madwar wieħed minn sitta tal-potenza ta' ivacaftor u hu kkunsidrat li hu farmakoloġikament attiv.
English: Clinical efficacy in patients with the G970R mutation of the CFTR gene could not be established (see section 5.1).
Maltese: L-effikaċja klinika f'pazjenti bil-mutazzjoni G970R tal-ġene CFTR ma setgħetx tiġi stabbilita (ara sezzjoni 5.1).
English: No dose adjustment of CYP3A substrates, such as midazolam, alprazolam, diazepam or triazolam, is required when these are coadministered with ivacaftor.
Maltese: Lebda aġġustament fid-doża ta' substrati ta' CYP3A, bħal midazolam, alprazolam, diazepam jew triazolam, mhu meħtieġ meta dawn jingħataw flimkien ma' ivacaftor.
English: Kalydeco tablets are indicated for the treatment of adults, adolescents and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Maltese: Il-pilloli Kalydeco huma indikati għal kura f'adulti, adolexxenti u tfal li għandhom 6 snin u aktar u li jiżnu 25 kg jew aktar b'fibrożi ċistika (CF) li għandhom waħda mill-mutazzjonijiet gating li ġejjin fil ġene CFTR: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N jew S549R Il-pilloli Kalydeco huma indikati ukoll għall-kura ta' adulti li jkollhom 18-il sena u aktar b'CF, li jkollhom mutazzjoni R117H fil-ġene CFTR.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Administration of Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) may increase systemic exposure of medicinal products that are sensitive substrates of P-gp, which may increase or prolong their therapeutic effect and adverse reactions.
Maltese: L-għoti ta' Kalydeco (bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor) jista' jżid l-esponiment sistemiku ta' prodotti mediċinali li huma substrati sensittivi ta' P-gp, u dan jista' jżid jew itawwal leffett terapewtiku u r-reazzjonijiet avversi tagħhom.
English: Use all 7 days' doses before starting a new wallet.
Maltese: Uża d-dożi kollha ta' 7 ijiem qabel ma tibda kartiera ġdida.
English: In three of four patients the change in the sweat chloride test was < 5 mmol/L and this group did not demonstrate a clinically relevant improvement in FEV1 after 8 weeks of treatment.
Maltese: Fi tlieta minn erba' pazjenti, il-bidla filchloride test tal-għaraq kienet ta' <5 mmol/L u dan il-grupp ma weriex titjib klinikament rilevanti f'FEV1 wara 8 ġimgħat ta' kura.
English: Printing ink
Maltese: Mhux applikabbli
English: Each sachet contains 50 mg of ivacaftor.
Maltese: Kull qartas fih 50 mg ta' ivacaftor.
English: No dose adjustment of CYP3A substrates, such as midazolam, alprazolam, diazepam or triazolam, is required when these are co-administered with ivacaftor (as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Maltese: Lebda aġġustament fid-doża ta' substrati ta' CYP3A bħal midazolam, alprazolam, diazepam jew triazolam, mhu meħtieġ meta dawn jingħataw flimkien ma' ivacaftor (bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor).
English: Ivacaftor monotherapy
Maltese: Monoterapija b'ivacaftor
English: Patients received ivacaftor 25 mg, 50 mg or 75 mg according to their weight at each study visit (see section 4.2).
Maltese: Il-pazjenti rċevew ivacaftor 25 mg, 50 mg jew 75 mg skont il-piż tal-ġisem tagħhom f'kull viżta ta' studju (ara sezzjoni 4.2).
English: A reduction of the Kalydeco dose (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4).
Maltese: Tnaqqis fid-doża ta' Kalydeco (bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor) hu rakkomandat għal pazjenti li jkunu qed jieħdu inibituri moderati ta' CYP3A fl-istess ħin, bħal fluconazole u erythromycin (ara sezzjonijiet 4.2 u 4.4).
English: Each sachet contains 36.6 mg of lactose (as monohydrate) Kalydeco 50 mg granules in sachet Each sachet contains 50 mg of ivacaftor.
Maltese: Doża adattata għal tfal taħt is-6 snin u li jiżnu inqas minn 25 kg ma tistax tinkiseb bil-pilloli Kalydeco.
English: In a subgroup analysis in patients with a confirmed R117H-5T genetic variant, the difference in the mean absolute change from baseline through week 24 in percent predicted FEV1 between ivacaftor and placebo was 5.3% (95% CI 1.3, 9.3).
Maltese: F'analiżi ta' sottogrupp f'pazjenti b'varjant ġenetiku ta' R117H-5T ikkonfermat, id-differenza fil-bidla assoluta medja mil-linja bażi sa ġimgħa 24 f'perċentwali ta' FEV1 imbassar bejn ivacaftor u l-plaċebo kienet ta' 5.3% (95% CI 1.3, 9.3).
English: 6- to 11-year-olds † (≥ 14 kg to < 25 kg)
Maltese: 12-il xahar sa inqas minn 24 xahar (7 kg sa <14 kg)
English: Efficacy results from a Phase 2 study in patients with CF who are homozygous for the F508del mutation in the CFTR gene showed no statistically significant difference in FEV1 over 16 weeks of ivacaftor treatment compared to placebo (see section 5.1).
Maltese: 2 f'pazjenti b'CF li huma omożigotiċi għall-mutazzjoni F508del fil-ġene CFTR ma wrew l-ebda differenza statistikament sinifikanti f'FEV1 fuq perjodu ta' 16-il ġimgħa ta' kura b'ivacaftor meta mqabbel ma' plaċebo (ara sezzjoni 5.1).
English: Table 4: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Maltese: Tabella 4: L-effett ta' ivacaftor fuq punti aħħarin tal-effikaċja oħrajn fi studji 1 u 2 Studju 1
English: The mean absolute change from baseline through week 8 in percent predicted FEV1 (primary efficacy endpoint) was 7.5% in the ivacaftor period and -3.2% in the placebo period.
Maltese: Il-medja tal-bidla assoluta mil-linja bażi sa ġimgħa 8 f'perċentwali ta' FEV1 imbassar (punt aħħari tal-effikaċja primarja) kien ta' 7.5% fil-perjodu ta' ivacaftor u ta' -3.2% fil-perjodu tal-plaċebo.
English: Each sachet of granules contains 75 mg of ivacaftor.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull qartas ta' granijiet fih 75 mg ta' ivacaftor.
English: Use of ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Maltese: L-użu ta' ivacaftor, jew f'monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor, mhuwiex rakkomandat f'pazjenti b'indeboliment sever tal-fwied ħlief jekk il-benefiċċji jkunu mistennija li jiżbqu r-riskji (ara sezzjonijiet 4.2 u 5.2).
English: After steady-state dosing of ivacaftor in combination with tezacaftor in CF patients, the mean (SD) terminal half-life of ivacaftor was approximately 9.3 (1.7) hours.
Maltese: Wara dożaġġ fl-istat fiss ta' ivacaftor flimkien ma' tezacaftor f'pazjenti b'CF, ilhalf-life terminali medja (SD) ta' ivacaftor kienet bejn wieħed u ieħor ta' 9.3 (1.7) sigħat.
English: Each sachet of granules contains 25 mg of ivacaftor.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull qartas ta' granijiet fih 25 mg ta' ivacaftor.
English: The pharmacokinetic parameters of ivacaftor, either as monotherapy or in combination with tezacaftor, are similar in males and females.
Maltese: Il-parametri farmakokinetiċi ta' ivacaftor, jew bħala monoterapija jew flimkien ma' tezacaftor, huma simili fl-irġiel u n-nisa.
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Maltese: tezacaftor 100 mg/ivacaftor 150 mg darba kuljum.
English: Ivacaftor dosing was interrupted in most patients with transaminase elevations > 5 x ULN.
Maltese: Id-dożaġġ ta' ivacaftor ġie interrott fil-biċċa l-kbira tal-pazjenti b'żidiet fil-livelli ta' transaminases ta' >5 x ULN.
English: Study 1 evaluated 161 patients who were 12 years of age or older; 122 (75.8%) patients had the F508del mutation in the second allele.
Maltese: Studju 1 evalwa 161 pazjent li kellhom 12-il sena jew aktar: 122 (75.
English: Concomitant use of CYP3A inhibitors
Maltese: Inibituri ta' CYP3A
English: Package leaflet: Information for the patient Kalydeco 150 mg film-coated tablets ivacaftor
Maltese: Informazzjoni għall-pazjent Kalydeco 150 mg pilloli miksija b'rita ivacaftor
English: Therefore, monitoring of the international normalised ratio (INR) is recommended during co-administration of warfarin with Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Maltese: Għalhekk, hu rakkomandat li jsir monitoraġġ tal-proporzjon normalizzat internazzjonali (INR, international normalised ratio) waqt l-għoti flimkien ta' warfarin ma' Kalydeco (bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor).
English: • Cheese, whole milk, whole-milk dairy products, yogurt, breast milk, infant formula, chocolate
Maltese: • Ġobon, ħalib sħiħ, prodotti tal-ħalib magħmulin minn ħalib sħiħ, jogurt, ħalib tas-sider, formula tat-trabi, ċikkulata
English: Polyvinyl alcohol
Maltese: GĦAMLA FARMAĊEWTIKA
English: At the follow-up visit, 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -5.9% (9.4%).
Maltese: Fil-viżta follow-up, 4 ġimgħat wara li d-dożaġġ b'ivacaftor kien spiċċa, il-medja (SD) ta' bidla assoluta f'perċentwali ta' FEV1 imbassar minn parti 2 ġimgħa 16 kienet ta' -5.9% (9.4%).
English: The NOAEL for viability and growth in the offspring provides an exposure level of approximately 3 times the systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy in adult humans at the MRHD.
Maltese: In-NOAEL għall-vijabilità u l-iżvilupp fil-frieħ jipprovdi livell ta' esponiment ta' madwar 3 darbiet aktar mill-esponiment sistemiku ta' ivacaftor u l-metaboliti tiegħu meta mogħti bħala monoterapija b'ivacaftor fil-bnedmin adulti fl-MRHD.
English: This finding has not been observed in foetuses derived from rat dams treated with ivacaftor on gestation days 7 to 17, in rat pups exposed to ivacaftor through milk ingestion up to postnatal day 20, in 7-week old rats, nor in 3.5 to 5-month old dogs treated with ivacaftor.
Maltese: Din is-sejba ma ġietx osservata f'feti li twieldu minn firien nisa li ġew ikkurati b'ivacaftor f'jiem 7 sa 17 tat-tqala, fi frieħ tal-firien li ġew esposti għal ivacaftor permezz tal-ħalib li xorbu sa jum 20 wara t-twelid, f'firien li kellhom 7 ġimgħat, u lanqas fi klieb li kellhom minn 3.5 sa 5 xhur ikkurati b'ivacaftor.
English: At week 24 At week 48
Maltese: Jum 1 Jum 2 Jum 3 Jum 4*
English: When co-administered with strong inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg twice a week (see sections 4.4 and 4.5).
Maltese: Meta jingħata flimkien ma' inibituri qawwija ta' CYP3A, id-doża ta' Kalydeco għandha titnaqqas għal 150 mg darbtejn fil-ġimgħa (ara sezzjonijiet 4.4 u 4.5).
English: For patients who rolled over from study 2 the number of events was, overall, low.
Maltese: Għall-pazjenti li qalbu għal studju 2, in-numru tal-avvenimenti kien, globalment, baxx.
English: At the follow up visit, 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -7.4% (5.5%).
Maltese: Fil-viżta follow-up, 4 ġimgħat wara li d-dożaġġ b'ivacaftor kien intemm, il-medja (SD) ta' bidla assoluta f'perċentwali ta' FEV1 imbassar minn parti 2 ġimgħa 16 kienet ta' -7.4% (5.5%).
English: • Changes in the type of bacteria in mucus
Maltese: .8 Effetti mhux mixtieqa
English: After every 12-hour dosing, steady-state plasma concentrations of ivacaftor were reached by days 3 to 5, with an accumulation ratio ranging from 2.2 to 2.9.
Maltese: Wara dożaġġ kull 12-il siegħa, il-konċentrazzjonijiet ta' ivacaftor fil-plażma fl-istat fiss intlaħqu sa jiem 3 sa 5, bi proporzjon ta' akkumulazzjoni li jvarja minn 2.2 sa 2.9.
English: No ivacaftor-treated patients experienced a transaminase elevation > 3 x ULN associated with elevated total bilirubin > 1.5 x ULN.
Maltese: L-ebda pazjenti kkurati b'ivacaftor ma kellhom żieda fil-livell ta' transaminases ta' >3 x ULN assoċjat ma' livell għoli ta' bilirubina totali ta' >1.5 x ULN.
English: For patients in the placebo/ivacaftor group baseline percent predicted FEV1 is that of study 4 while for patients in the ivacaftor/ivacaftor group the baseline value is that of studies 1 and 2.
Maltese: Għal pazjenti fil-grupp tal-plaċebo/ivacaftor, il-linja bażi f'perċentwali tal-FEV1 imbassar hi dik ta' studju 4, filwaqt għal pazjenti fil-grupp ta' ivacaftor/ivacaftor, il-valur fil-linja bażi hu dak ta' studji 1 u 2.
English: Not applicable.
Maltese: rispettivament.
English: Caution is recommended when administering ivacaftor, either as monotherapy or in combination with tezacaftor, to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Maltese: Madankollu, il-kawtela hi rakkomandata meta ivacaftor jingħata lil pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina inqas minn jew ugwali għal 30 mL/min) jew b'mard tal-kliewi fl-aħħar stadju (ara sezzjonijiet 4.2 u 4.4).
English: ≥ 7 kg to < 14 kg 50 mg granules taken orally every 12 hours with fat-containing food
Maltese: ≥7 kg sa <14 kg Granijiet ta' 50 mg li jittieħdu mill-ħalq kull 12-il siegħa ma' ikel li jkun fih ix-xaħam
English: For patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be reduced (see Table 2).
Maltese: Għal pazjenti b'indeboliment moderat tal-fwied (Child-Pugh Klassi B), id-doża għandha tkun imnaqqsa (ara Tabella 2).
English: Kalydeco granules are indicated for the treatment of infants aged at least 6 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).
Maltese: Il-granijiet Kalydeco huma indikati għall-kura ta' trabi li għandhom mill-inqas 6 xhur, trabi li għadhom kemm telqu jimxu u tfal li jiżnu 5 kg sa inqas minn 25 kg b'fibrożi ċistika (CF) li għandhom waħda mill-mutazzjonijiet gating (klassi III) li ġejjin fil-ġene CFTR: G551D, G1244E, G1349D,
English: Concomitant use of CYP3A inhibitors Kalydeco monotherapy
Maltese: Kif jidher Kalydeco u l-kontenut tal-pakkett
English: Granules in sachet White to off-white granules approximately 2 mm in diameter.
Maltese: Granijiet ta' lewn abjad sa abjad jagħti fil-griż b'dijametru ta' madwar 2 mm.
English: 10 vials (powder) + 10 vials (suspension)
Maltese: 10 kunjetti (trab)+ 10 kunjetti (sospensjoni)
English: 2 AS01B Adjuvant System is composed of the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota (50 micrograms)
Maltese: --1 Wara r-rikostituzzjoni, doża waħda (0.5 ml) fiha 50 mikrogramma Antiġen1 tal-glikoproteina E ma l-adjuvantat b'AS01B2 1 Virus Varicella Zoster (VZV) glikoproteina E (gE) prodotta f'ċelluli Ovariċi tal-Ħamster Ċiniż (CHO, Chinese Hamster Ovarian) permezz ta' teknoloġija tad-DNA rikombinanti 2 adjuvantat b'AS01B li fih estratt tal-pjanta Quillaja saponaria Molina, frazzjoni 21 (QS-21) (50 mikrogramma) u 3-O-desacyl-4'-monophosphoryl lipidu A (MPL, monophosphoryl lipid) minn Salmonella minnesota (50 mikrogramma)
English: 1 vial (powder) + 1 vial (suspension)
Maltese: Daqs talpakkett trab: 50µg sospensjoni: 0.5 ml kunjett 1 (trab)+ kunjett 1 (sospensjoni)
English: 1 Varicella Zoster Virus (VZV) glycoprotein E (gE) produced by recombinant DNA technology in Chinese Hamster Ovarian (CHO) cells
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Strength Pharmaceutical Form
Maltese: Numru tal-proċedura talEMA
English: Further information on Alecensa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Alecensa received a marketing authorisation valid throughout the EU on 16 February 2017.
Maltese: Alecensa ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Frar 2017.
English: The medicine is available as capsules (150 mg).
Maltese: Il-mediċina tiġi bħala kapsuli (150 mg).
English: Alecensa contains the active substance alectinib.
Maltese: Alecensa fih is-sustanza attiva alectinib.