FrancophonIA/ELRC3.0 huggingface dataset:
English: It was to be used in patients who had a specific genetic mutation (change) called NRAS Q61 mutation.
Maltese: Dan kellu jintuża f'pazjenti li kellhom mutazzjoni ġenetika speċifika (bidla) imsejħa mutazzjoni NRAS Q61.
English: What was Balimek expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Balimek?
English: Balimek is a medicine that contains the active substance binimetinib.
Maltese: Balimek huwa mediċina li fiha s-sustanza attiva binimetinib.
English: On 4 January 2018, Pierre Fabre Médicament officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Balimek, for the treatment of melanoma.
Maltese: Fl-4 ta' Jannar 2018, Pierre Fabre Médicament għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għattqegħid fis-suq għal Balimek, għall-kura ta' melanoma.
English: The study involved 402 patients with advanced melanoma with the NRAS Q61 mutation that had spread or could not be removed by surgery.
Maltese: L-istudju involva 402 pazjenti b'melanoma avvanzata bil-mutazzjoni NRAS Q61 li kienet infirxet jew li ma setgħetx titneħħa b'kirurġija.
English: Based on the data reviewed, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Balimek could not have been approved for the treatment of advanced melanoma in patients with the NRAS Q61 mutation.
Maltese: Il-Kumitat ikkunsidra wkoll li għalkemm ma ġiet approvata l-ebda mediċina speċifikament biex tikkura pazjenti bil-mutazzjoni NRAS Q61, hemm kuri effettivi għall-melanoma inġenerali.
English: By blocking the MEK proteins, Balimek is expected to slow down the growth of melanoma cells.
Maltese: Billi jimblokka l-proteini MEK, Balimek mistenni li jnaqqas ir-ritmu tat-tkabbir ta' ċelloli tal-melanoma.
English: Withdrawal of the marketing authorisation application for Balimek (binimetinib)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Balimek (binimetinib)
English: Moreover, the CHMP was concerned that Balimek was linked to worse side effects than dacarbazine.
Maltese: Barra minn hekk, is-CHMP kien imħasseb li Balimek kien marbut ma' effetti sekondarji agħar minn dacarbazine.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Balimek.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm l-ebda konsegwenza għall-pazjenti li bħalissa huma inklużi fi provi kliniċi b'Balimek.
English: 1 ml (100 mg/ml) 2 pre-filled syringes
Maltese: 1 mL (100 mg/mL) 2 siringi mimlijin għal-lest
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Maltese: 1 mL (100 mg/mL) 1 siringa mimlija għal-lest
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA
English: 10 mg/ml
Maltese: 19 ml (190mg/19 ml) 2 kunjetti
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (UE) Isem (ivvintat)
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Maltese: Numru tal-MA Isem (ivvintat)
English: Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
Maltese: Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444
English: Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A 1020 Wien
Maltese: Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A 1020
English: Novartis Pharmaceuticals UK, Frimley Business Park, Frimley, Camberley, Surrey Gu16 7SR United Kingdom Mailing address:
Maltese: UK, Frimley Business Park, Frimley, Camberley, Surrey Gu16 7SR United Kingdom Mailing address:
English: Novartis Norge AS Postboks 237 Okern 0510 Oslo Norway injection
Maltese: Novartis Norge AS Postboks 237 Okern 0510
English: Novartis Farma spa Largo Umberto Boccioni, 121040 Origgio- Varese Italy
Maltese: Novartis Farma spa Largo Umberto Boccioni, 121040
English: Bartók Béla út 43-47.
Maltese: Bartók Béla út 43-47. (Bartók-Ház, V. em.) 1114
English: NOVARTIS (HELLAS) A.E.B.E.
Maltese: A.E.B.E.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI, ID-DETENTURI TALAWTORIZZAZZJONI GĦAT-TQEGĦID
English: The full EPAR for Capecitabine SUN 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: 5-FU is an analogue of pyrimidine.
Maltese: 5-FU hu analogu tal-pirimidina (pyrimidine).
English: capecitabine
Maltese: kapesitabina
English: Capecitabine SUN is available as tablets (150 and 500 mg).
Maltese: Capecitabine SUN jiġi bħala pilloli (150 u 500 mg).
English: It is used to treat:
Maltese: Jintuża fittrattament ta':
English: This summary was last updated in 06-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 06-2013.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine SUN.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Capecitabine SUN.
English: Pyrimidine is part of the genetic material of cells (DNA and RNA).
Maltese: Il-pirimidina hija parti mill-materjal ġenetiku taċ-ċelloli (DNA u RNA).
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Maltese: Fil-ġisem, 5-FU jissostitwixxi l-pirimidina u jinterferixxi mal-enzimi involuti filproduzzjoni ta' DNA ġdid.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Maltese: Tittieħed bħala pilloli, filwaqt li 5-FU normalment tkun trid tiġi injettata.
English: Treatment is continued for six months after colon surgery.
Maltese: It-trattament jitkompla tul sitt xhur wara l-intervent kirurġiku fil-kolon.
English: Capecitabine SUN is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Capecitabine SUN jittieħed darbtejn kuljum b'dożi ta' bejn 625 u 1,250 mg għal kull metru kwadru tassuperfiċje tal-ġisem (li jiġi kkalkulat permezz tat-tul u l-piż tal-pazjent).
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, mainly in tumour cells.
Maltese: Il-kapeċitabina hija ‘promediċina' li fil-ġisem tinbidel għal 5-fluorouracil (5-FU), prinċipalment fiċ-ċelloli tat-tumur.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine SUN on 21 June 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Capecitabine SUN fil-21 ta' Ġunju 2013.
English: A risk management plan has been developed to ensure that Capecitabine SUN is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Capecitabine SUN jintuża bl-aktar mod sigur possibbli.
English: The active substance in Capecitabine SUN, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Maltese: Is-sustanza attiva f'Capecitabine SUN, il-kapesitabina, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qed jimmultiplikaw, bħaċ-ċelloli tal-kanċer) li tagħmel parti mill-grupp ta' ‘antimetaboliti'.
English: Capecitabine SUN is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Maltese: Capecitabine SUN jintuża flimkien ma' medicini oħra kontra l-kanċer, inklużi mediċina kontra l-kanċer li jkun fiha l-platinu bħaċ-ċisplatina;
English: Why has Capecitabine SUN been approved?
Maltese: Għaliex ġie approvat Capecitabine SUN?
English: Capecitabine SUN tablets should be swallowed with water within the 30 minutes after a meal.
Maltese: Il-pazjent għandu jibla' l-pilloli ta' Capecitabine SUN mal-ilma sa 30 minuta wara l-ikel.
English: Capecitabine SUN is an anticancer medicine that contains the active substance capecitabine.
Maltese: X'hinu Capecitabine SUN u għal xiex jintuża? Capecitabine SUN huwa mediċina kontra l-kanċer li fiha s-sustanza attiva kapesitabina.
English: How has Capecitabine SUN been studied?
Maltese: Kif ġie studjat Capecitabine SUN?
English: This means that Capecitabine SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Maltese: Capecitabine SUN huwa ‘mediċina ġenerika' Dan ifisser li Capecitabine SUN huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Xeloda.
English: Because Capecitabine SUN is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Capecitabine SUN huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Capecitabine SUN?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Capecitabine SUN?
English: The Committee recommended that Capecitabine SUN be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Capecitabine SUN ikun approvat għall-użu fl-UE.
English: Because Capecitabine SUN is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Maltese: Peress li Capecitabine SUN huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet biex jiġi stabbilit jekk din il-mediċina hijiex bijoekwivalenti għall-mediċina ta' referenza, Xeloda.
English: Capecitabine SUN is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Maltese: • kanċer tal-kolon (tal-musrana l-għamja). Capecitabine SUN jintuża waħdu jew ma' mediċini oħra kontra l-kanċer f'pazjenti li kienu sottoposti għal intervent kirurġiku għal kanċer tal-kolon tal-‘fażi III' jew ‘fażi C ta' ‘Dukes';
English: What measures are being taken to ensure the safe and effective use of Capecitabine SUN?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw l-użu sigur u effettiv ta' Capecitabine SUN?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Capecitabine SUN has been shown to have comparable quality and to be bioequivalent to Xeloda.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Capecitabine SUN għandu kwalità komparabbli u huwa bijoekwivalenti għal Xeloda.
English: Capecitabine SUN is a ‘generic medicine'.
Maltese: L-EPAR sħiħ għal Capecitabine SUN jinstab fis-sit elettroniku tal-Aġenzija:
English: Capecitabine SUN is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Maltese: • kanċer tas-sider lokalment avvanzat jew metastatiku (kanċer tas-sider li beda jinfirex ma' partijiet oħra tal-ġisem). Capecitabine SUN jintuża ma' docetaxel (mediċina oħra kontra l-kanċer) wara li jkun falla trattament bl-antraċiklini (tip ieħor ta' mediċini kontra l-kanċer).
English: 31 March 2016
Maltese: 31 ta' Marzu 2016
English: • report on venous thrombolic events (VTE) including deep venous thrombosis (VTE) and pulmonary embolism (PE) in a separate section in the next PSUR.
Maltese: • jirrapportaw fuq avvenimenti tromboemboliċi venużi (VTE - Venous Thrombolic Events) u emboliżu pulmonari (PE - Pulmonary Embolism) f'sezzjoni separata fil-PSUR li jmiss.
English: • monitor cardiovascular risk (including literature review, clinical trials data and all other relevant data) and discuss the finding in the next PSUR.
Maltese: • jimmonitorjaw riskju kardjovaskulari (inkluż reviżjoni tal-letteratura, dejta ta' provi kliniċi u kull dejta relevanti oħra) u jiddiskutu s-sejba filPSUR li jmiss.
English: • submit the PSUR within 90 days following the DLP of 31 December
Maltese: • jissottomettu l-PSUR fi żmien 90 jum wara d-DLP tal-31 ta' Diċembru
English: The spontaneous reports shall not be presented as a listing of the individual cases, but rather as a general discussion of the aggregated cases, and include all relevant information, e.g. time to onset (when available), haematocrit/haemoglobin level (when available), indication, age, confounding factors and other.
Maltese: Ir-rapporti spontanji mhux sejrin jiġu ppreżentati bħala lista tal-każijiet individwali, iżda bħala diskussjoni ġenerali tal-każijiet miġbura, u sejrin jinkludu kull informazzjoni relevanti, eż. żmien tal-bidu (meta disponibbli), livell talematokrit/emoglobina (meta disponibbli), indikazzjoni, età, fatturi ta' tgerfix u oħrajn.
English: This section should also include literature case reports and review.
Maltese: Din is-sezzjoni għandha tinkludi wkoll letteratura ta' rapporti ta' każijiet u reviżjoni.
English: • discuss a possible mechanism of VTE and the potential association between CV/VTE events and testosterone levels (whether low or high levels compared to eugonadal level may contribute to the risk), and discuss if the information should be included in the product information.
Maltese: • jiddiskutu mekkaniżmu possibbli tal-VTE u l-assoċjazzjoni potenzjali bejn avvenimenti CV/VTE u livelli ta' testosteron (jekk livelli baxxi jew għoljin meta mqabblin mal-livell ta' eugonadal jistgħux jikkontribwixxu għar-riskju), u jiddiskutu jekk l-informazzjoni għandhiex tiġi inkluża flinformazzjoni tal-prodott.
English: • discuss the usage in elderly, taking into account the naturally lower level of testosterone in this age group of patients.
Maltese: • jiddiskutu l-użu fl-anzjani, filwaqt li jitqiesu l-livelli aktar baxxi b'mod naturali f'dan il-grupp ta' età ta' pazjenti.
English: Furthermore the discussion on the adverse events in this group should be compared with the pattern of adverse events in other age groups.
Maltese: Barra minn hekk iddiskussjoni fuq l-avvenimenti avversi f'dan il-grupp għandha titqabbel max-xejra ta' avvennimenti avversi fi gruppi ta' età oħrajn.
English: The Marketing Authorisation Holders of testosterone-containing medicinal products should, with the next PSUR:
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' prodotti mediċinali li fihom it-testosteron għandhom, mar-rapport perjodiku ta' aġġornament dwar is-sikurezza (PSUR - Periodic Safety Update Report) li jmiss:
English: EMA/60227/2014 EMEA/H/C/002805
Maltese: EMEA/H/C/002805
English: This summary was last updated in 03-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 03-2014.
English: The full EPAR and risk management plan summary for Zoledronic acid Teva Generics 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: Zoledronic acid Teva Generics is given as an infusion lasting at least 15 minutes.
Maltese: Zoledronic acid Teva Generics jingħata bħala infużjoni li ddum tal-inqas 15-il minuta.
English: Zoledronic acid Teva Generics is a ‘generic medicine'.
Maltese: Zoledronic acid Teva Generics hija ‘mediċina ġenerika'.
English: Zoledronic acid Teva Generics is a medicine that contains zoledronic acid (5mg).
Maltese: Zoledronic acid Teva Generics hija mediċina li fiha zoledronic acid (5 mg).
English: The active substance in Zoledronic acid Teva Generics, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic acid Teva Generics, zoledronic acid, hija bisfosfonat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Generics on 27 March 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic acid Teva Generics fil-27 ta' Marzu 2014.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Generics.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zoledronic acid Teva Generics.
English: Zoledronic acid Teva Generics zoledronic acid
Maltese: Informazzjoni oħra dwar Zoledronic acid Teva Generics
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Generics is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Zoledronic acid Teva Generics jintuża bl-aktar mod sigur possibbli.
English: This can be repeated once a year in patients being treated for osteoporosis.
Maltese: Dan jista' jiġi ripetut darba f'sena f'pazjenti kkurati għal osteoporożi.
English: This means that Zoledronic acid Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Maltese: Dan ifisser li Zoledronic acid Teva Generics huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) imsejħa Aclasta.
English: Because Zoledronic acid Teva Generics is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Zoledronic acid Teva Generics huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Why is Zoledronic acid Teva Generics approved?
Maltese: Għal xiex ġie approvat Zoledronic acid Teva Generics?
English: Zoledronic acid Teva Generics is available as a solution for infusion (drip) into a vein; the medicine can only be obtained with a prescription.
Maltese: Zoledronic acid Teva Generics huwa disponibbli bħala soluzzjoni għall-infużjoni (dripp) ġol-vina; ilmediċina tista' tinkiseb biss b'riċetta ta' tabib.
English: No additional studies were needed as Zoledronic acid Teva Generics is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Zoledronic acid Teva Generics huwa mediċina ġenerika li tingħata b'infużjoni u fiha l-istess sustanza attiva bħall-mediċina ta' referenza, Aclasta.
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Maltese: Fin-nisa, losteoporożi hija aktar komuni wara l-menopawża, meta l-livelli ta' estroġenu fl-ormoni tan-nisa jaqgħu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Generics, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Zoledronic acid Teva Generics, fosthom ilprekawzjonijiet xierqa li jridu jiġu segwiti mill-professjonisti tas-saħħa u l-pazjenti.
English: It is used in patients who are at risk of fractures (broken bones) and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Maltese: Jintuża f'pazjenti li jkunu f'riskju ta' ksur (għadam miksur) u f'pazjenti li l-osteoporożi tagħhom hija marbuta ma' kura fit-tul b'glukokortikojdi (tip ta' sterojd).
English: How has Zoledronic acid Teva Generics been studied?
Maltese: Kif ġie studjat Zoledronic acid Teva Generics?
English: How is Zoledronic acid Teva Generics used?
Maltese: Kif jintuża Zoledronic acid Teva Generics?
English: Parameter n (%)
Maltese: Parametru n (%)
English: Difference (95% CI) p-value
Maltese: Differenza (95 % CI) valur-p †
English: 2220 Heist-op-den-Berg
Maltese: B-2220 Heist-op-den-Berg
English: NC=F, Non-Completer=Failure.
Maltese: NC=F, Ma Lestiex=Falliment.
English: Opioid agonists Examples: alfentanil, fentanyl
Maltese: Agonisti opjojde Eżempji: alfentanil, fentanyl
English: Manufacturer Schering-Plough Labo NV Industriepark 30 - Zone A B-2220 Heist-op-den-Berg Belgium
Maltese: Schering-Plough Labo NV Industriepark 30 - Zone A B-2220 Heist-op-den-Berg Il-Belġju
English: Inhibitors of P-gp/BCRP
Maltese: Inibituri ta' P-gp/BCRP
English: Plasticizers Diethylhexyl-phthalate (DEHP), tris (2-ethylhexyl) trimellitate (TOTM), butyl benzyl phthalate (BBP)
Maltese: Plastifikanti Diethylhexyl-phthalate (DEHP), tris (2-ethylhexyl) trimellitate (TOTM), butyl benzyl phthalate (BBP)
English: Table 2: Adverse reactions identified with PREVYMIS Frequency
Maltese: Tabella 2: Reazzjonijiet avversi identifikati bi PREVYMIS Frekwenza
English: Catheters Radiopaque polyurethane
Maltese: Katereri Radiopaque polyurethane
English: Expected: ↓ dabigatran
Maltese: Mistennija: ↓ dabigatran
English: The mutations map to UL56 and occur in amino acid residues between 231 and 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
Maltese: Ilmutazzjonijiet jimmarkaw għal UL56 u jseħħu f'residwi tal-amminoaċidi bejn 231 u 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
English: 31 May 2020 (PACMP Step 2)
Maltese: 31 ta' Mejju 202 (PACMP Stadju 2)
English: HIV antivirals (ritonavir, lopinavir)
Maltese: Antivirali kontra l-HIV (ritonavir, lopinavir)
English: # (see section 4.4).
Maltese: (ara sezzjoni 4.4).
English: The active substance is letermovir.
Maltese: Is-sustanza attiva hi letermovir.
English: Oral anticoagulants warfarin
Maltese: Antikoagulanti orali warfarin
English: Endothelin antagonists bosentan
Maltese: Antagonisti tal-endotelina bosentan
English: Expected: ↓ letermovir (P-gp/UGT induction)
Maltese: Mistennija: ↓ letermovir (Induzzjoni ta' P-gp/UGT)
English: However, Amphotericin B (liposomal) is incompatible (see section 6.2).
Maltese: Madankollu, Amphotericin B (liposomal) huwa inkompatibbli (ara sezzjoni 6.2).
English: Expected: ↑ quinidine
Maltese: Mistennija: ↑ quinidine
English: HIV medicinal products efavirenz
Maltese: Prodotti mediċinali tal-HIV efavirenz
English: Expected: ↓ warfarin
Maltese: Mistennija: ↓ warfarin
English: n (%) = Number (percent) of subjects in each sub-category.
Maltese: n (%) = Numru (perċentwal) ta' individwi f'kull sottokategorija.
English: o St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: Expected: ↓ pantoprazole
Maltese: Mistennija: ↓ pantoprazole
English: Median (90% Prediction Interval)*
Maltese: Medjan (Intervall ta' Tbassir ta' 90 %)*
English: PREVYMIS contains lactose monohydrate.
Maltese: PREVYMIS fih lactose monohydrate.
English: When letermovir is combined with cyclosporine:
Maltese: Meta letermovir jiġi kkombinat ma' cyclosporine:
English: Expected: ↔ valacyclovir
Maltese: Mistennija: ↔ valacyclovir
English: Titanium dioxide (E171) Triacetin (E1518)
Maltese: Titanium dioxide (E171)
English: Antimycobacterials rifabutin
Maltese: Antimikobatteriċi rifabutin
English: Expected; ↔ fluconazole ↔ letermovir
Maltese: Mistennija; ↔ fluconazole ↔ letermovir
English: • efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
Maltese: • efavirenz, etravirine, nevirapine, lopinavir, ritonavir - għall-HIV
English: Administration See section 4.2.
Maltese: Għoti Ara sezzjoni 4.2.
English: Expected: ↑ glyburide
Maltese: Mistennija: ↑ glyburide
English: Antidiabetic medicinal products repaglinide
Maltese: Prodotti mediċinali antidijabetiċi repaglinide
English: PREVYMIS contains cyclodextrin
Maltese: PREVYMIS fih cyclodextrin
English: Antipsychotics thioridazine
Maltese: Antipsikotiċi thioridazine
English: Letermovir is a moderate inhibitor of CYP3A in vivo.
Maltese: Letermovir huwa inibitur moderat ta' CYP3A in vivo.
English: Incompatible medicinal products
Maltese: Prodotti mediċinali inkompatibbli
English: Medicinal products metabolised by CYP3A
Maltese: Prodotti mediċinali metabolizzati minn CYP3A
English: Sodium hydroxide (E524) Water for injections
Maltese: Sodium hydroxide (E524)