FrancophonIA/ELRC3.0 huggingface dataset:
English: <Medicinal product subject to medical prescription.> <Medicinal product not subject to medical prescription.> <Medicinal product subject to special medical prescription.> <Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).> <Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Maltese: <Prodott mediċinali li jingħata bir-riċetta tat-tabib.> <Prodott mediċinali li jista' jingħata mingħajr riċetta tat-tabib.> <Prodott mediċinali li jingħata b'riċetta speċjali tat-tabib.> <Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).> <Prodott mediċinali li jingћata b'riċetta speċjali u ristretta tat-tabib (ara Anness I: Sommarju talKaratteristiċi tal-Prodott, sezzjoni 4.2).>
English: <This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:>
Maltese: <Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:>
English: QUALITATIVE AND QUANTITATIVE COMPOSITION <2.1 General description> [For advanced therapy products only] <2.2 Qualitative and quantitative composition> [For advanced therapy products only] <Excipient(s) with known effect> <For the full list of excipients, see section 6.1.>
Maltese: <2.2.2 Għamla kwalitattiva u kwantitattiva> [Għal prodott/i ta' terapija avvanzata biss]
English: <{X} is contraindicated in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...> (see section 4.3).> Method of administration <Precautions to be taken before handling or administering the medicinal product> <For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.>
Maltese: <M'hemm l-ebda użu rilevanti ta'{X} <fil-popolazzjoni pedjatrika> <fit-tfal minn età {x sa y} <snin>, <xhur> [jew xi kategoriji rilevanti oħra eż. piż, età tal-pubertà, sess] <għal indikazzjoni ta'...>.> <{X} huwa kontraindikat fit-tfal minn età {x sa y} <snin> <xhur> [jew xi kategoriji rilevanti oħra eż. piż, età tal-pubertà, sess] <għal-indikazzjoni ta'…> (ara sezzjoni 4.3).> Metodu ta' kif għandu jingħata <Prekawzjonijiet li għandhom jittieħdu qabel tmiss il-prodott mediċinali jew qabel tagћti l-prodott mediċinali> <Għal istruzzjonijiet fuq <ir-rikostituzzjoni> <dilwizzjoni> tal-prodott mediċinali qabel jingħata, ara sezzjoni <6.6><u><> <12>.
English: Warnings and precautions Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Maltese: X ma' <ikel><u> <,> <xorb> <u> <alkoħol>
English: <Post-authorisation efficacy study (PAES):> <Non-interventional post-authorisation safety study (PASS):>>
Maltese: [titlu jew deskrizzjoni ta' l-istudju] > <Studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni (PASS):
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of Member StateMS Agency (link)}>.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu ˂ u fuq is-sit elettroniku ta' {isem ta' l-Istat Membru/ Aġenzija (link)}>.
English: <{Netfang }>
Maltese: BISS]
English: Deutschland {Name} <{Anschrift} D-00000 {Stadt}> Tel: + {Telefonnummer} <{e-mail}>
Maltese: D-00000 {Stadt}> Tel: + {Telefonnummer} <{e-mail}>
English: X with <food> <and> <,> <drink> <and> <alcohol> Pregnancy <and> <,> breast-feeding <and fertility> <If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> <or> <pharmacist> for advice before taking this medicine.> Driving and using machines <X contains {name the excipient(s)}>
Maltese: Tqala <u> <,> treddigħ <u fertilità> <Jekk inti tqila jew qed tredda', taħseb li tista tkun tqila jew qed tippjana li jkollok tarbija, itlob il-parir tat-<tabib> <jew> tal- <ispiżjar> tiegħek qabel tieħu din il-mediċina.> Sewqan u tħaddim ta' magni <X fih {isem tas-sustanza(i) mhux attiva(i)}>
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name strength pharmaceutical form} {Aactive substance(s)} {Route of administration}
Maltese: IL-PRODOTT MEDIĊINALI {Isem (ivvintat) qawwa għamla farmaċewtika} {Sustanza(i) attiva(i)
English: < This medicine is subject to additional monitoring.
Maltese: < Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: <Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name strength pharmaceutical form} {Aactive substance(s)}
Maltese: TAL-PRODOTT MEDIĊINALI {Isem (ivvintat) qawwa għamla farmaċewtika} {Sustanza(i) attiva(i)
English: 4.5 Interaction with other medicinal products and other forms of interaction <No interaction studies have been performed.> <Paediatric population> <Interaction studies have only been performed in adults.> 4.6 Fertility, pregnancy and lactation <Pregnancy> <Breast-feeding> <Fertility>
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma twettaq l-ebda studju ta' interazzjoni.> <Popolazzjoni pedjatrika> <Studji ta' interazzjoni twettqu biss f'adulti.>
English: {(Invented) name strength pharmaceutical form} {Aactive substance(s)}
Maltese: {Isem (ivvintat) qawwa għamla farmaċewtika} {Sustanza(i) attiva(i)}
English: <{Адрес} {Град} {Пощенски код}> Teл.
Maltese: <{Адрес} {Град} {Пощенски код}> Teл.: + {Телефонен номер}
English: 6.2 Incompatibilities <Not applicable.> <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.> <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Maltese: .2 Inkompatibbiltajiet <Mhux applikabbli.> <Fin-nuqqas ta' studji ta' kompatibbiltà, dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn.> <Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn ħlief dawk imsemmija f'sezzjoni <6.6> <u> <12>.>
English: Österreich {Name} <{Anschrift} A-0000 {Stadt}> Tel: + {Telefonnummer} <{e-mail}>
Maltese: A-0000 {Stadt}> Tel: + {Telefonnummer} <{e-mail}>
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: <Non-interventional post-authorisation safety study (PASS):>>
Maltese: <Studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni (PASS):> [titlu jew deskrizzjoni ta' l-istudju] >>
English: 28 April 2016
Maltese: 28 ta' April 2016
English: March 2016 CMDh meeting
Maltese: Laqgħa tas-CMDh Marzu 2016
English: 28 May 2016
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri: 28 ta' Mejju 2016
English: 7 tablets
Maltese: 7 pillola
English: NA 1.4 (-1.0, 3.9)
Maltese: MA 1.4 (-1.0, 3.9)
English: NA 2.1 (1.2, 2.9)
Maltese: MA 2.1 (1.2, 2.9)
English: AUC0-24h or AUC0-12h
Maltese: AUC0-24h jew AUC0-12h
English: Moderate (Child-Pugh Class B)
Maltese: Moderat (Child-Pugh Klassi B)
English: These include St. John's wort (Hypericum perforatum).
Maltese: John's wort (Hypericum perforatum).
English: tacrolimus, sirolimus and everolimus.
Maltese: sirolimus u everolimus.
English: t½ (h)
Maltese: T TL E Ħ G S Ħ
English: clarithromycin, erythromycin, rifampicin and rifabutin.
Maltese: clarithromycin, erythromycin, rifampicin u rifabutin.
English: This is stamped with “V100”.
Maltese: Din hija stampata b'“V100”.
English: • telithromycin and clarithromycin
Maltese: • telithromycin u clarithromycin
English: • ketoconazole, itraconazole, posaconazole, and voriconazole
Maltese: • ketoconazole, itraconazole, posaconazole u voriconazole
English: Pulmonary exacerbations
Maltese: Aggravamenti pulmonari
English: itraconazole, posaconazole, voriconazole and fluconazole.
Maltese: itraconazole, posaconazole, voriconazole u fluconazole.
English: • Avocados, hummus, soy-based products (tofu)
Maltese: • Avocados, hummus, prodotti bbażati fuq is-sojja (tofu)
English: OATP1B1 substrates
Maltese: Substrati ta' OATP1B1
English: #P value not statistically significant.
Maltese: #valur-P ma kienx statistikament sinifikanti.
English: • Immunosuppressants (used after an organ transplantation).
Maltese: • Immunosoppressanti (użati wara trapjant tal-organi).
English: CYP3A, digoxin and other P-gp Substrates
Maltese: CYP3A, digoxin u Substrati oħra ta' P-gp
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: INFORMAZZJONI BIL-BRAILLE IDENTIFIKATUR UNIKU - BARCODE 2D
English: Paediatric population The safety profile is generally consistent among adolescents and adult patients.
Maltese: Il-profil tas-sigurtà hu ġeneralment konsistenti fost pazjenti adolexxenti u adulti.
English: Placebo N=161
Maltese: N=161
English: Tezacaftor and ivacaftor are substrates of CYP3A (ivacaftor is a sensitive substrate of CYP3A).
Maltese: Tezacaftor u ivacaftor huma substrati ta' CYP3A (ivacaftor huwa substrat sensittiv ta' CYP3A).
English: Mean (SD) tezacaftor and ivacaftor exposure by age group Age group
Maltese: Medja (SD) tal-esponiment ta' tezacaftor u ivacaftor skont il-grupp ta' età Grupp ta' età
English: Blister consisting of PCTFE (polychlorotrifluoroethylene)/PVC (polyvinyl chloride) with a paper-backed aluminum foil lidding.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja li tikkonsisti minn PCTFE (polychlorotrifluoroethylene)/PVC (polyvinyl chloride) b'paper-backed foil lidding tal-aluminju.
English: S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
Maltese: S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, u 3849+10kbC→T
English: The mean ppFEV1 at baseline was 62.3% (range: 34.6% to 93.5%).
Maltese: Il-ppFEV1 medju fil-linja bażi kien 62.3% (medda: 34.6% sa 93.5%).
English: The mean ppFEV1 at baseline was 60.0% (range: 27.8% to 96.2%).
Maltese: Il-ppFEV1 medju fil-linja bażi kien 60.0% (medda: 27.8% sa 96.2%).
English: • rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum)
Maltese: • rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, u St.
English: AUCτ,ss (mcg∙h/mL)
Maltese: Medja ta' Tezacaftor (SD) AUCτ,ss (mcg∙h/mL)
English: Potential for tezacaftor/ivacaftor to interact with transporters In vitro studies showed that tezacaftor is a substrate for the uptake transporter OATP1B1, and efflux transporters P-gp and Breast Cancer Resistance Protein (BCRP).
Maltese: Potenzjal għal tezacaftor/ivacaftor li jinteraġixxi ma' trasportaturi Studji in vitro wrew li tezacaftor huwa substrat għat-trasportatur uptake OATP1B1 (organic-aniontransporting polypepti), u t-trasportaturi efflux P-gp u l-Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP, Breast Cancer Resistance Protein).
English: Placebo N=256
Maltese: N=256
English: The rate ratio versus placebo was 0.53 (95% CI: 0.34, 0.82; nominal P= 0.0042).
Maltese: Il-proporzjon ta' rata kontra plaċebo kien 0.53 (95% CI: 0.34, 0.82; P nominali= 0.0042).
English: Medicinal products affected by tezacaftor and ivacaftor CYP2C9 substrates
Maltese: Prodotti mediċinali affettwati minn tezacaftor u ivacaftor Substrati ta' CYP2C9
English: See 4.2 for information on paediatric use.
Maltese: Ara 4.2 għal informazzjoni dwar l-użu pedjatriku.
English: Similar trends were observed for CFQ-R respiratory domain score, pulmonary exacerbation rate and BMI.
Maltese: Kienu osservati tendenzi simili għall-punteġġ ta' dominju respiratorju CFQ-R, għar-rata ta' aggravament pulmonari u għall-BMI.
English: Pack size of 28 tablets (4 blister cards of 7 tablets each).
Maltese: Daqs ta' pakkett ta' 28 pillola (4 folji ta' 7 pilloli kull waħda).
English: CFTR activity were represented: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L,
Maltese: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L,
English: Ivacaftor N=156
Maltese: N=156
English: The pharmacokinetics of tezacaftor and ivacaftor are similar between healthy adult volunteers and patients with CF.
Maltese: Il-farmakokinetika ta' tezacaftor u ivacaftor hi simili bejn voluntiera adulti f'saħħithom u pazjenti b'CF.
English: The mean (SD) elimination half-lives for M1-TEZ, M2-TEZ and M5-TEZ were similar to that of the parent compound.
Maltese: Il-half-lives tal-eliminazzjoni medji (SD) għal M1-TEZ, M2-TEZ u M5-TEZ kienu simili għal dik tal-kompost oriġinarju.
English: The mean (SD) elimination half-lives for M1-IVA and M6-IVA were 11.3 (2.12) h and 14.4 (6.14) h, respectively.
Maltese: Il-half-lives tal-eliminazzjoni medji (SD) għal M1-IVA u M6-IVA kienu 11.3 (2.12) sigħat u 14.4
English: Adolescents TEZ 100 mg qd/IVA 150 mg q12h Adults
Maltese: Adolexxenti TEZ 100 mg qd/IVA 150 mg q12h Adulti
English: Date of first authorisation: 31 October 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Ottubru 2018
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Maltese: Ivacaftor jeħel b'madwar 99% mal-proteini tal-plażma, primarjament ma' alpha 1-acid glikoproteina u mal-albumina.
English: Important information about the contents of Symkevi
Maltese: Informazzjoni importanti dwar il-kontenut ta' Symkevi
English: Very limited PK data indicate comparable exposure to tezacaftor in white (n=652) and non-white (n=8) patients.
Maltese: Dejta PK limitata ħafna tindika esponiment komparabbli ma' tezacaftor f'pazjenti bojod (n=652) u pazjenti mhux bojod (n=8).
English: These include ketoconazole,
Maltese: Dawn jinkludu ketoconazole,
English: − Tablet core: Hypromellose acetate succinate, sodium laurilsulfate (E487), hypromellose (E464), microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), and magnesium stearate (E470b).
Maltese: Hypromellose acetate succinate, sodium laurilsulfate (E487), hypromellose (E464), microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), u magnesium stearate (E470b).
English: In vitro and in vivo data indicate that ivacaftor is metabolized primarily by CYP3A4 and CYP3A5.
Maltese: Dejta in vitro u in vivo tindika li ivacaftor jiġi metabolizzat primarjament minn CYP3A4 u CYP3A5.
English: The recommended dose:
Maltese: Id-doża rakkomandata:
English: − Tablet film coating: Hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), and iron oxide yellow (E172).
Maltese: Hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), u ossidu tal-ħadid isfar (E172).
English: In a human pharmacokinetic study with ivacaftor alone, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Maltese: Fi studju farmakokinetiku fil-bnedmin b'ivacaftor waħdu, kien hemm eliminazzjoni minima ta' ivacaftor u l-metaboliti tiegħu fl-awrina (6.6% biss tar-radjuattività totali ġiet irkuprata fl-awrina).
English: Tezacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Maltese: Tezacaftor jeħel b'madwar 99% mal-proteini tal-plażma, primarjament mal-albumina.
English: Ear pain, Ear discomfort, Tinnitus, Tympanic membrane hyperaemia, Vestibular disorder common
Maltese: Uġigħ fil-widnejn, Skonfort filwidnejn, Tinnitus, Iperimija filmembrana timpanika, Disturb vestibulari komuni
English: The safety profile of Symkevi in combination with ivacaftor, including respiratory events (e.g., chest discomfort, dyspnea, and respiration abnormal), was generally similar across all subgroups of patients, including analysis by age, gender, and baseline percent predicted FEV1 (ppFEV1).
Maltese: Il-profil tas-sigurtà ta' Symkevi flimkien ma' ivacaftor, inklużi avvenimenti respiratorji (eż., skonfort fis-sider, qtugħ ta' nifs, u respirazzjoni anormali), kien ġeneralment simili fis-sottogruppi kollha talpazjenti, inkluż analiżi bl-età, sess tal-persuna, u l-linja bażi f'perċentwali tal-FEV1 imbassar (ppFEV1).
English: Symkevi is normally taken with ivacaftor, another medicine.
Maltese: Symkevi normalment jittieħed ma' ivacaftor, mediċina oħra.
English: Medicinal products affecting the pharmacokinetics of tezacaftor and ivacaftor CYP3A inducers
Maltese: Prodotti mediċinali li jaffettwaw il-farmakokinetika ta' tezacaftor u ivacaftor Indutturi ta' CYP3A
English: Following oral administration of a single dose of 100 mg 14C-tezacaftor to healthy male subjects, M1-TEZ, M2-TEZ, and M5-TEZ were the three major circulating metabolites of tezacaftor in humans, contributing to 15%, 31%, and 33% of total radioactivity, respectively.
Maltese: Wara l-għoti orali ta' doża waħda ta' 100 mg 14C-tezacaftor lil individwi rġiel f'saħħithom, M1-TEZ, M2-TEZ, u M5-TEZ kienu t-tliet metaboliti li jiċċirkolaw maġġuri ta' tezacaftor fil-bnedmin, u kkontribwew għal 15%, 31%, u 33% tar-radjuattività totali, rispettivament.
English: Another minor circulating metabolite, M3-TEZ, is formed by direct glucuronidation of tezacaftor.
Maltese: Metabolit li jiċċirkola minuri ieħor, M3-TEZ, huwa ffurmat bilglukuronidazzjoni diretta ta' tezacaftor.
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
English: When co-administered with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin), the dose should be adjusted to one Symkevi tablet twice a week, taken approximately 3 to 4 days apart.
Maltese: Meta jingħata flimkien ma' inibituri qawwija ta' CYP3A (eż. ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, u clarithromycin), id-doża għandha tiġi aġġustata għal pillola Symkevi waħda darbtejn fil-ġimgħa li tittieħed bejn wieħed u ieħor kull 3 jew 4 ijiem.
English: Pulmonary exacerbations requiring hospitalizations were similar between treatment groups (RR: 0.78 [95% CI: 0.44, 1.36]; P=0.3801).
Maltese: L-aggravamenti pulmonari li kienu jeħtieġu t-teħid l-isptar kienu simili bejn il-gruppi ta' trattament (RR: 0.78 [95% CI: 0.44, 1.36]; P=0.3801).
English: One patient (0.2%) on therapy and two patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Maltese: Pazjent wieħed (0.2%) fuq terapija u żewġ pazjenti (0.4%) fuq plaċebo, waqqfu l-kura b'mod permanenti minħabba livelli għoljin ta' transaminases.
English: Absolute change from baseline at Week 24 (kg/m2)**
Maltese: Bidla assoluta mil-linja bażi f'Ġimgħa 24 (kg/m2)**
English: Table 4 reflects adverse reactions observed in clinical studies in patients treated with ivacaftor monotherapy.
Maltese: Tabella 4 tirrifletti reazzjonijiet avversi osservati fi studji kliniċi f'pazjenti ttrattati b'monoterapija ta' ivacaftor.
English: These include phenobarbital, carbamazepine and phenytoin.
Maltese: Dawn jinkludu phenobarbital, carbamazepine u phenytoin.
English: In Study 2 (patients heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity), the treatment difference in mean absolute change from baseline in sweat chloride through Week 8 was -9.5 mmol/L (95% CI: -11.7, -7.3; nominal P<0.0001*) between Symkevi in combination with ivacaftor and placebo, and -4.5 mmol/L (95% CI: -6.7, -2.3; nominal P<0.0001*) between ivacaftor and placebo.
Maltese: Fi Studju 2 (pazjenti eterożigotiċi għall-mutazzjoni F508del u mutazzjoni oħra assoċjata ma' attività ta' CFTR residwa), id-differenza fil-kura fil-bidla assoluta medja mil-linja bażi fil-chloride tal-għaraq sa Ġimgħa 8 kienet -9.5 mmol/L (95% CI: -11.7, -7.3; nominali P<0.0001*) bejn Symkevi flimkien ma' ivacaftor u plaċebo, u -4.5 mmol/L (95% CI: -6.7, -2.3; nominali P<0.0001*) bejn ivacaftor u plaċebo.
English: CFQ-R respiratory domain score
Maltese: Punteġġ ta' dominju respiratorju CFQ-R Valur fil-linja bażi
English: M6-IVA is not considered pharmacologically active.
Maltese: M6-IVA mhuwiex ikkunsidrat farmakoloġikament attiv.
English: These include digoxin.
Maltese: Dawn jinkludu digoxin.
English: Tezacaftor is not a substrate for OATP1B3.
Maltese: Tezacaftor mhuwiex substrat għal OATP1B3.
English: • Antifungal medicines (used for the treatment of fungal infections).
Maltese: • Mediċini antifungali (użati għall-kura ta' infezzjonijiet fungali).
English: Ivacaftor was associated with slight decreases of the seminal vesicle weights, a decrease of overall fertility index and number of pregnancies in females mated with treated males and significant reductions in number of corpora lutea and implantation sites with subsequent reductions in the average litter size and average number of viable embryos per litter in treated females.
Maltese: Ivacaftor kien assoċjat ma' tnaqqis żgħir fil-piżijiet tal-vexxikuli seminali, ma' tnaqqis fl-indiċi globali tal-fertilità u fin-numru ta' tqaliet f'nisa mgħammra ma' irġiel ittrattati u ma' tnaqqis sinifikanti finnumru ta' corpora lutea u siti ta' impjantazzjoni bi tnaqqis sussegwenti fid-daqs medju tal-boton u nnumru medju ta' embrijuni vijabbli f'kull boton f'nisa ttrattati.
English: Tezacaftor Mean (SD)
Maltese: n/N Medja (SD)
English: Tezacaftor is metabolized extensively in humans.
Maltese: Tezacaftor jiġi metabolizzat b'mod estensiv fil-bnedmin.
English: The efficacy of Symkevi in combination with ivacaftor 150 mg tablet in patients with CF was demonstrated in two Phase 3, double-blind, controlled studies (Study 1 and Study 2), and one Phase 3, open-label extension study (Study 3).
Maltese: L-effikaċja ta' Symkevi flimkien ma' pillola ivacaftor ta' 150 mg f'pazjenti b'CF intweriet f'żewġ studji ta' Fażi 3, double-blind u kkontrollati (Studju 1 u Studju 2), u studju open-label ta' estensjoni ta' Fażi 3 (Studju 3).
English: See the end of section 2 for important information about the contents of Symkevi.
Maltese: Ara t-tmiem ta' sezzjoni 2 għal informazzjoni importanti dwar il-kontenut ta' Symkevi.
English: In vitro studies showed that ivacaftor is not a substrate for OATP1B1, OATP1B3, or P-gp.
Maltese: Studji in vitro wrew li ivacaftor mhuwiex substrat għal OATP1B1, OATP1B3, jew P-gp.
English: Symkevi in combination with ivacaftor has been studied with pitavastatin, an OATP1B1 substrate, and was found to have no clinically relevant effect on the exposure of pitavastatin (1.24 fold increased exposure based on AUC).
Maltese: Symkevi flimkien ma' ivacaftor ġie studjat ma' pitavastatin, substrat ta' OATP1B1 u nstab li ma kellu lebda effett klinikament sinifikanti fuq l-esponiment ta' pitavastatin (żieda ta' 1.24 darbiet fl-esponiment ibbażata fuq l-AUC).
English: Table 6: Primary and key secondary efficacy analyses, full analysis set (Study 2) Analysis
Maltese: Tabella 6: Analiżijiet ta' effikaċja primarji u sekondarji ewlenin, sett sħiħ ta' analiżi (Studju 2) Analizi
English: Key Secondary ppFEV1 Baseline value
Maltese: Sekondarju Ewlieni ppFEV1
English: The mean absolute change (SE) from baseline in BMI z-value was 0.24 (0.07) kg/m2 in the Symkevi in combination with ivacaftor group, 0.20 (0.07) kg/m2 in the ivacaftor group and 0.04 (0.07) kg/m2 in the placebo group in Study 2.
Maltese: Il-bidla assoluta medja (SE) mil-linja bażi fil-valur z tal-BMI kienet 0.24 (0.07) kg/m2 fil-grupp ta' Symkevi flimkien ma' ivacaftor, 0.20 (0.07) kg/m2 fil-grupp ta' ivacaftor, u 0.04 (0.07) kg/m2 fil-grupp tal-plaċebo fi Studju 2.
English: BMI increased in both treatment groups (Symkevi in combination with ivacaftor: 0.18 kg/m2, placebo: 0.12 kg/m2).
Maltese: Il-BMI żdied fiż-żewġ gruppi ta' kura (Symkevi flimkien ma' ivacaftor: 0.18 kg/m2, plaċebo 0.