FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction via effects on transport proteins cannot be excluded.
Maltese: Ma tistax tiġi eskluża interazzjoni permezz ta' effetti fuq proteini tat-trasport.
English: Invirase comes as a 500 mg film-coated tablet.
Maltese: Kapsuli ta' Invirase 500 mg fihom lattosju.
English: The modified Invirase/ritonavir regimen reduced mean maximum ΔQTcFdense in the first week of treatment compared with the same value in healthy volunteers receiving the standard Invirase/ritonavir dosing regimen in the TQT study on Day 3, (Table 4) based on cross-study comparison in a different population.
Maltese: Dawn irriżultati jissuġġerixxu li r-responsabbiltà ta' QTc hija mnaqqsa b'kors ta' dożaġġ modifikat ta' Invirase/ritonavir, ibbażat fuq paragun bejn l-istudji f'popolazzjoni differenti (Tabella 4).
English: Table 7: Outcomes at Week 48 MaxCmin1 and MaxCmin2†
Maltese: Riżultati wara 48 Ġimgħa f'MaxCmin1 u MaxCmin2†
English: • congenital or documented acquired QT prolongation
Maltese: • titwil ta' QT miksub b'mod konġenitali jew dokumentat
English: Following intravenous administration 66 % of circulating saquinavir was present as unchanged compound and the remainder as metabolites, suggesting that saquinavir undergoes extensive first pass metabolism.
Maltese: Wara għotja ġol-vini, 66 % ta' saquinavir li kien jiċċirkola kien preżenti bħala mediċina mhux mibdula u l-bqija bħala metaboli, li jissuġġerixxi li saquinavir jgħaddi minn metaboliżmu first pass estensiv.
English: Monitoring of saquinavir plasma concentration might be indicated.
Maltese: Jista' jiġi ndikat monitoraġġ tal-konċentrazzjoni ta' saquinavir fil-plażma.
English: Interaction with tipranavir: Concomitant use of boosted saquinavir and tipranavir, co-administered with low dose ritonavir in a dual-boosted regimen, results in a significant decrease in saquinavir plasma concentrations (see section 4.5).
Maltese: Jekk kura b'inibitur ta' l-HMGCoA reductase hija ndikata, pravastatin jew fluvastatin huma rakkomandati b'monitoraġġ b'attenzjoni (ara sezzjoni 4.5).
English: The combination of saquinavir and ritonavir exhibited a superior virological activity compared with the indinavir and ritonavir arm when switch from the assigned treatment was counted as virological failure.
Maltese: It-taħlita ta' saquinavir u ritonavir uriet attività viraloġika superjuri meta mqabbla mal-kategorija ta' indinavir u ritonavir meta bdil mill-kura assenjata kienet meqjusa bħala falliment viroloġiku.
English: Pimozide is a CYP3A4 substrate and is associated with QT prolongation,
Maltese: Pimozide huwa sottostrat ta' CYP3A4 u hu assoċjat ma' titwil tal-QT.
English: Tyrosine kinase inhibitors All tyrosine kinase inhibitors with a risk of QT prolongation e.g. dasatinib, sunitinib
Maltese: kanċer bħal dasatinib u sunitinib.
English: Effective therapy in treatment experienced patients is associated with a Cmin of approximately 100 ng/ml and an AUC0-24 of about 20,000 ng·h/ml.
Maltese: It-terapija effettiva fil-kura ta' pazjenti b'esperjenza hija assoċjata ma' Cmin ta' bejn wieħed u ieħor 100 ng/ml u AUC0-24 ta' madwar 20,000 ng*h/ml.
English: Only 2/21 (9%) patients across all study days had maximum QTcF change from dense predose baseline ≥ 30 ms following administration of the modified Invirase/ritonavir regimen in the treatment-naïve HIV-1 infected patient population; and the maximum mean change from dense predose baseline in QTcF was < 10 ms across all study days.
Maltese: Il-kors modifikat ta' Invirase/ritonavir naqqas ΔQTcFdense massima medja fl-ewwel ġimgħa ta' kura meta mqabbel mal-istess valur f'voluntiera f'saħħithom li rċivew dożaġġ standard ta' Invirase/ritonavir fl-istudju TQT f'Jum 3, (Tabella 4) ibbażat fuq paragun bejn l-istudji f'popolazzjoni differenti. 2/21 (9%) pazjent biss tul il-ġranet kollha tal-istudju kellhom bidla massima f'QTcF millinja bażi densa ta' qabel id-doża ta' ≥ 30 ms wara l-għoti tal-kors modifikat ta' Invirase/ritonavir filpopolazzjoni ta' pazjenti infettati b'HIV-1 li qatt ma ħadu kura qabel; u l-bidla massima medja millinja bażi densa ta' qabel id-doża ta' QTcF kienet ta' < 10 ms tul il-ġranet kollha tal-istudju.
English: Corticosteroids - Dexamethasone
Maltese: - Dexamethasone (saquinavir/
English: Contraindicated in combination with Invirase/ritonavir due to the potential for life threatening cardiac arrhythmia (see sections 4.3 and 4.4).
Maltese: Invirase/ritonavir minħabba lpotenzjal ta' arritmija kardijaka ta' periklu għall-ħajja (ara sezzjonijiet 4.3 u 4.4).
English: 20 hours
Maltese: 20 siegħa
English: Hepatic impairment:
Maltese: Sigurtà farmakoloġika:
English: These medicinal products are contraindicated for use with Invirase/ritonavir (see section 4.3).
Maltese: Dawn il-prodotti mediċinali huma kontraindikati għall-użu flimkien ma' Invirase/ritonavir (ara sezzjoni 4.3).
English: Ritonavirboosted Invirase at a dose of 2000 mg once daily with ritonavir 100 mg once daily has not been studied with regard to the risk of QT prolongation and is not recommended.
Maltese: Invirase imsaħħaħ b'ritonavir b'doża ta' 2000 mg darba kuljum flimkien ma' 100 mg ritonavir darba kuljum ma ġiex studjat rigward ir-riskju ta' titwil ta' QT u mhux irrakkomandat.
English: Co-administration of fusidic acid and Invirase/ritonavir can cause increased plasma concentration of both fusidic acid and saquinavir/ritonavir.
Maltese: Għoti flimkien ta' fusidic acid u Invirase/ritonavir jista' jikkawża żjieda tal-konċentrazzjoni fil-plażma kemm ta' fusidic acid kif ukoll ta' saquinavir/ritonavir.
English: Infection: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after antiHIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni ta' l-HIV avvanzata (AIDS) u passat ta' infezzjonijiet opportunistiċi, sinjali u sintomi minn infezzjonijiet minn qabel jistgħu jseħħu hekk kif tinbeda kura kontra l-HIV.
English: Dyspnoea
Maltese: Bosentan
English: CYP3A4 Interactions: Saquinavir could interact and modify the pharmacokinetics of other drugs that are substrates for CYP3A4 and/or P-gp and should be used with caution.
Maltese: Saquinavir jista' jkollu interazzjoni ma' u jimmodifika l farmakokinetika ta' mediċini oħra li huma sottostrati ta' CYP3A4 u/jew P-gp u għandu jintuża b'attenzjoni.
English: John's wort must not be used concomitantly with Invirase.
Maltese: John's wort jista' jippersisti għal mill-inqas ġimagħtejn wara li titwaqqaf il kura.
English: (90% CI 146%-193%) Ketoconazole Cmax ↑ 45% (90% CI 32%-59%)
Maltese: Saquinavir AUC ↔ Saquinavir Cmax ↔ Ritonavir AUC ↔ Ritonavir Cmax ↔ Ketoconazole AUC ↑ 168 % (90 % CI 146 %-193 %) Ketoconazole Cmax ↑ 45 % (90 % CI 32 %-59 %)
English: - Indinavir 800 mg tid (saquinavir 600-1200 mg single dose)
Maltese: - Sildenafil 100 mg (doża waħda) (saquinavir mhux imsaħħaħ 1200 mg tid)
English: Psychiatric Disorders Common
Maltese: Disturbi Psikjatriċi
English: - Indinavir (saquinavir/ritonavir)
Maltese: - Indinavir (saquinavir/
English: Concentrations of bepridil, systemic lidocaine, quinidine or hydroquinidine may be increased when co-administered with Invirase/ritonavir.
Maltese: Konċentrazzjonijiet ta' bepridil, lidocaine sistemiku, quinidine jew hydroquinidine jistgħu jiżdiedu meta jingħataw flimkien ma' Invirase/ritonavir.
English: Monitoring of neutropenia and liver enzyme levels is recommended due to an expected increase in exposure to rifabutin.
Maltese: Huwa rrakkomandat monitoraġġ tan-newtropenija u tal-livelli tal enzimi tal-fwied.
English: Zidovudine
Maltese: Fosamprenavir
English: Antiretroviral naïve (%) PI naïve (%)
Maltese: Categorija C ta' CDC ( %) Bla esperjenza ta' Antiretrovirali
English: It is for the treatment of infection with the human immunodeficiency virus (HIV).
Maltese: Huwa użat għall-kura ta' infezzjoni bil-vajrus uman li jikkawża immunodefiċjenza (HIV).
English: Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Plasma concentrations highly dependent on CYP3A4 metabolism.
Maltese: Konċentrazzjonijiet fil-plażma huma dipendenti ħafna fuq metaboliżmu minn CYP3A4.
English: Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
Maltese: Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
English: b. Tabulated list of adverse reactions
Maltese: Lista f'tabellta ta' reazzjonijiet avversi
English: Rifabutin active moiety*
Maltese: Kontra-indikat flimkien ma'
English: Both drugs are CYP3A4 inhibitors and may increase the plasma concentration of saquinavir.
Maltese: Iż-żewġ mediċini huma inibituri ta' CYP3A4 u jistgħu jżidu l-konċentrazzjoni fil-plażma ta' saquinavir.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti nfettati bl-HIV b'defiċjenza immunitarja severa fiż-żmien li nbdiet il-kura antiretrovirali kombinata (CART), jista' jkun hemm reazzjoni infjammatorja għal infezzjonijiet opportunistiċi bla sintomi jew li għad hemm.
English: • Take one 500 mg film-coated tablet of Invirase twice a day.
Maltese: • Ħu żewġ pilloli miksija b'rita ta' Invirase 500 mg darbtejn kuljum.
English: Anticoagulant Warfarin (saquinavir/ritonavir)
Maltese: Warfarin (saquinavir/ritonavir)
English: MaxCmin2: any rise > 0.5 log at a specific visit; < 0.5 log reduction if VL > 200 copies/ml at week 4; < 1.0 log reduction from base line if VL > 200 copies/ml at week 12; and a VL > 200 copies/ml at week 24.
Maltese: Għal dawk li daħlu fl-istudju b'VL > 200 kopji/ml, VF iddefinit bħala kull żjieda > 0.5 logs u/jew VL > 50,000 kopji/ml wara 4 ġimgħat, > 5,000 kopji/ml wara 12-il ġimgħa, jew > 200 kopji/ml wara 24-il ġimgħa u il-quddiem. MaxCmin2: kull żjieda > 0.5 log f'vista speċifika; < 0.5 log tnaqqis jekkVL > 200 kopji/ml wara 4 ġimgħat; < 1.0 log tnaqqis mill-linja bażi jekk VL > 200 kopji/ml wara 12-il ġimgħa; u VL > 200 kopji/ml wara 24 ġimgħa.
English: The recommended dose of Invirase is 1000 mg (2 x 500 mg film-coated tablets) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
Maltese: Id-doża rakkomandata ta' Invirase hija ta' 1000 mg (2 x 500 mg pilloli miksija b'rita) mogħtija darbtejn kuljum flimkien ma' 100 mg ta' ritonavir mogħtija darbtejn kuljum, flimkien ma' sustanzi antitretrovirali oħrajn.
English: ΔQTcFdense ≥ 30 ms (%)
Maltese: ΔQTcFdense massima medja ms (SD) Pazjenti b'ΔQTcFdense massima ta' ≥ 30 ms
English: Antiarrhythmics Bepridil
Maltese: TAL-PRODOTT MEDIĊINALI
English: BATCH NUMBER Batch
Maltese: NUMRU TAL-LOTT
English: Four patients in the study experienced five adverse events that were considered related to trial treatment.
Maltese: F'dan l-istudju ma kienux osservati avvenimenti avversi mhux mistennija.
English: EU/2/05/054/017 Profender spot-on solution for cats
Maltese: EU/2/05/054/017 Profender - taħlita likwida għal użu lokalizzat fuq qtates.
English: Spot-on use Bottle (glass) 14 ml
Maltese: 14 ml Flixkun wieħed
English: Page 1/5
Maltese: Flixkun (ħġieġ)
English: EMEA/52482/2009
Maltese: Direttiva 2004/24/KE.
English: The focus for 2011 will include:
Maltese: L-enfasi għall-2011 sejra tinkludi:
English: Introduction by the Executive Director
Maltese: Introduzzjoni mid-Direttur Eżekuttiv
English: Effective monitoring of the balance of benefits and risks is an ongoing priority area for the Agency.
Maltese: Il-monitoraġġ effettiv tal-bilanċ tal-benefiċċji u tar-riskji huwa qasam ta' prijorità kontinwu għallAġenzija.
English: Globalisation of pharmaceutical research, development and manufacturing is a predominant theme.
Maltese: Il-globalizzazzjoni tar-riċerka, l-iżvilupp u l-manifattura tal-farmaċewtika hija tema predominanti.
English: In addition to the Agency's strong bilateral cooperation with a number of international regulatory authorities, the Agency is particularly involved in the areas of clinical trials, manufacturing of active pharmaceutical ingredients and medicinal products, and ongoing regulatory collaboration with its international partners.
Maltese: Barra mill-kooperazzjoni bilaterali b'saħħitha tal-Aġenzija ma' numru ta' awtoritajiet regolatorji nazzjonali, l-Aġenzija hija partikolarment involuta fl-oqsma tal-provi kliniċi, fil-manifattura ta' sustanzi farmaċewtiċi attivi u ta' prodotti mediċinali, u fil-kollaborazzjoni regolatorja kontinwa malimsieħba internazzjonali tagħha.
English: • ISO IDMP (identification of medicinal products) standard available Q4.
Maltese: • ir-rispons għall-ħtiġijiet tas-saħħa pubblika, inkluż id-disponibiltà tal-mediċini;
English: There is an increasing expectation for closer interaction and collaboration between regulators and health technology assessment bodies.
Maltese: Hemm aspettattiva li qiegħda tiżdied għal interazzjoni u kollaborazzjoni eqreb bejn ir-regolaturi u lkorpi ta' valutazzjoni għat-teknoloġija tas-saħħa.
English: Public statement on Echinaceae angustifoliae radix
Maltese: Programm ta' ħidma 2011 tal-Aġenzija Ewropea għallMediċini
English: Conduct gap analysis of outcome measures for paediatric clinical trials.
Maltese: Id-dibattitu dwar il-futur tadDirettiva dwar il-Provi Kliniċi sejjer ikompli.
English: Core SmPC for technetium (99mTc) nanocolloids Core PL for technetium (99mTc) nanocolloids
Maltese: Fil-qasam tas-saħħa pubblika, aħna sejrin inkomplu nsaħħu l-kontribut tal-Aġenzija fl-attivitajiet Ewropej fir-rigward tal-prodotti mediċinali għall-użu fil-popolazzjoni anzjana.
English: Addendum to the Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis” (CPMP/EWP/552/95 Rev. 2): Clinical investigation of medicinal products intended for treatment of glucocorticoid
Maltese: Il-perjodu tranżitorju għas-sottomissjoni ta' prodotti mediċinali ta' terapijatal-ġeni u taċ-ċelloli soġġetti għal-leġiżlazzjoni dwar il-prodotti mediċinali ta' terapija avvanzata sejjer jiskadi wkoll.
English: Agendas and minutes of scientific-committee and working-party meetings will be published, and work will be progressed to provide interested parties with access to certain information contained in clinical-trials and EudraVigilance databases.
Maltese: L-aġendi u l-minuti tal-laqgħat tal-kumitat xjentifiku u tal-grupp ta' ħidma sejrin jiġu ppubblikati, u l-ħidma sejra tiġi avvanzat biex jipprovdi lill-partijiet interessati b'aċċess għal ċerta informazzjoni li tinsab fil-provi kliniċi u fid-databases tal-EudraVigilance.
English: Core PL for gadopentetate dimeglumine
Maltese: Inizjattivi oħrajn imsemmija fil-pjan direzzjonali sejrin jiġu ppjanati.
English: Mock-up of Module 3 of CTD for herbal medicinal products, as a future development of the HMPC ‘Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products' (EMEA/HMPC/71049/2007)
Maltese: F'dan il-kuntest, fl-2011 l-Aġenzija sejra tkompli tiffoka l-isforzi fil-qasam tat-tnaqqis tar-riskju tarreżistenza antimikrobika li qamet bħala riżultat tal-użu tal-antibijotiċi fil-bnedmin u fl-annimali.
English: • EudraCT version 8.x: New CTA Paediatrics Protocol, EU Clinical Trials Register and delivering increased electronic communication between registries and other stakeholders by Q3.
Maltese: • il-kontribut għall-attivitajiet internazzjonali u r-rispons għall-globalizzazzjoni tar-riċerka, liżvilupp u l-manifattura tal-farmaċewtiċi;
English: We will work to extend international partnerships in the areas of goodmanufacturing-practice (GMP) and good-clinical-practice (GCP) inspections, will extend initiatives with the US Food and Drug Administration (FDA) on GCP and on GMP inspections of finished products, and will extend the active pharmaceutical ingredient inspection programme.
Maltese: Aħna sejrin naħdmu biex nestendu l-isħubiji internazzjonali floqsma tal-ispezzjonijiet tal-prattika ta' manifattura tajba (GMP) u tal-prattika klinika tajba (GCP), sejrin nestendu l-inizjattivi mal-Amministrazzjoni tal-Ikel u tal-Mediċini (FDA) tal-Istati Uniti dwar il-GCP u dwar l-ispezzjonijiet tal-GMP tal-prodotti lesti, u sejrin nestendu l-programm ta' spezzjoni tas-sustanza attiva farmaċewtika.
English: on Plantaginis lanceolatae folium
Maltese: Dan il-qasam għadu importanti fil-pjan direzzjonali l-ġdid.
English: With regard to emerging therapies and new technologies, the area is subject to gradual change, and the Agency will have to address new challenges in fields like nanotechnologies, personalised medicine, borderline products and other complex areas, such as the combination of medicines and medical devices as single integral products, leading to further reflection on the criteria to address borderline issues and develop the most appropriate guidelines and regulatory oversight.
Maltese: Fid-dawl tat-tmiem li qiegħed joqrob tal-perjodu tranżitorju għar-reġistrazzjoni ta' prodotti mediċinali erbali tradizzjonali, l-Aġenzija sejra tindirizza, skont ir-riżorsi umani disponibbli, l-isfidi speċifiċi fil-qasam, bħall-ħtieġa li jitjiebu l-kontributi tal-Kumitat dwar il-Prodotti Mediċinali Erbali f'termini ta' monografi u dħul fil-listi, u li tiġi indirizzata kwalunkwe azzjoni li tirriżulta mit-tmiem tal-perjodu tranżitorju li fih l-Istati Membri għandhom japplikaw id-dispożizzjonijiet tad
English: VICH Guideline on the detection of mycoplasma
Maltese: • it-trawwim tan-netwerk regolatorju Ewropew.
English: The Agency will pursue initiatives in the framework of a proactive conduct of pharmacovigilance by supporting the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) as a functional network of centres for the monitoring of targeted authorised medicines.
Maltese: Farmakoviġilanza (ENCePP) bħala n-netwerk funzjonali ta' ċentri għall-monitoraġġ ta' mediċiniawtorizzati immirati.
English: Annex 1 Establishment plan 2009-2011..................................................50 Annex 2 Revenue and expenditure overview 2009-2011.........................51 Annex 3 Working-party guidelines..........................................................52
Maltese: Billi tkopri l-mediċini kemm għall-bnedmin kif ukoll għall-annimali, lAġenzija hija f'pożizzjoni partikolarment tajba biex fil-prattika timplimenta l-kunċett ta' 'Dinja Waħda, Saħħa Waħda', fejn il-promozzjoni tas-saħħa fl-annimali tippromwovi s-saħħa fil-bnedmin.
English: Type-IA variations Type-IB variations Type-II variations Line extensions Note: 2010 and 2011 figures based on revised classification.
Maltese: Fl-2011, l-Aġenzija sejra tiffoka fuq il-preparamenti għallapplikazzjoni tal-miżuri l-ġodda fl-2012 billi tipprepara proċeduri ġodda u tippjana żviluppi importanti fl-IT.
English: EMEA/CVMP/VICH/463104/2 009-CONSULTATION EMEA/CVMP/VICH/463202/2 009-CONSULTATION EMEA/CVMP/VICH/463072/2 009-CONSULTATION EMEA/CVMP/VICH/463199/2 009-CONSULTATION
Maltese: L-Aġenzija sejra tkompli tibni fuq il-ħidma u l-kisbiet preċedenti tagħha fil-qasam, u sejra twessa' l-iskop tal-interazzjoni mar-rappreżentanti tas-soċjetà ċivili permezz talimplimentazzjoni ta' qafas ta' interazzjoni mal-pazjenti rivedut u l-implimentazzjoni gradwali talqafas ta' interazzjoni mal-professjonisti tal-kura tas-saħħa.
English: Community herbal monograph on Filipendulae ulmariae herba
Maltese: Fl-2011, numru ta' fatturi tal-ambjent kummerċjali eżistenti u ġodda sejrin isawwru l-prijoritajiet u l-objettivi tal-Aġenzija.
English: Community herbal monograph on Filipendulae ulmariae flos
Maltese: Kif magħruf fil-pjan direzzjonali, l-inizjattivi tal-UE fil-qasam tal-effikaċja relattiva tal-farmaċewtiċi sejrin ikollhom impatt huma wkoll fuq l-Aġenzija.
English: The CVMP, with the support of its Scientific Advisory Group on Antimicrobials, will continue its contribution to the work of the EU scientific committees and international organisations in the priority area of minimising the potential for the development of antimicrobial resistance through the use of antibiotics in animals.
Maltese: L-Aġenzija sejra tkompli trawwem kooperazzjoni produttiva mal-awtoritajiet u mal-esperti nazzjonali.
English: In the field of animal health, attention will remain focused on maintaining and improving the availability of veterinary medicines, particularly for minor species/minor uses (MUMS)/limited markets, and we will continue our contribution to the Community Animal Health Strategy where this relates to the use of medicines.
Maltese: Fil-qasam tas-saħħa tal-annimali, l-attenzjoni sejra tibqa' ffukata fuq iż-żamma u t-titjib tad-disponibiltà ta' mediċini veterinarji, b'mod partikolari għall-ispeċi minuri/l-użu minuri (MUMS)/swieq limitati, u aħna sejrin inkomplu bil-kontribut tagħna għall-Istrateġija dwar is-Saħħa tal-Annimali fil-Komunità fejn din tirrigwarda l-użu ta' mediċini.
English: Moreover, we will identify further opportunities for a strengthening of the interaction with our bilateral partners and international institutions such as the World Health Organization and the World Organisation for Animal Health (OIE).
Maltese: Barra minn hekk, sejrin nidentifikaw aktar opportunitajiet għattisħiħ tal-interazzjoni mal-imsieħba bilaterali tagħna u mal-istituzzjonijiet internazzjonali bħallOrganizzazzjoni Dinjija tas-Saħħa u l-Organizzazzjoni Dinjija għas-Saħħa tal-annimali (OIE).
English: ATC code: A10AC01.
Maltese: Kodiċi ATC A10AC01.
English: 5 units selected
Maltese: 5 unitajiet isselezzjonati
English: DK-4400 Kalundborg
Maltese: DK-4400
English: • Drink alcohol, see Protaphane with alcohol in section 2.
Maltese: • Tixrob l-alkoħol, ara Protaphane mal-alkoħol f'sezzjoni 2.
English: SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: SAS, 45 Avenue d'Orléans F-28000 Chartres, Franza.
English: Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Maltese: Hu rrappurtat li l-insulina umana tiġi degradata mill-protease insulinika jew mill-enzimi degradanti ta' l-insulina u possibbilment mill-proteina disulfide isomerase.
English: The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day.
Maltese: Normalment il-ħtieġa individwali għall-insulina hi ta' bejn 0.3 u 1.0 unitajiet internazzjonali/kg/kuljum.
English: 1 ml suspension contains 40 international units isophane (NPH) insulin human* (equivalent to 1.4 mg).
Maltese: Millilitru ta' suspensjoni fih 40 unità internazzjonali ta' insulina isophane (NPH) umana* (ekwivalenti għal 1.4 mg).
English: Zinc chloride
Maltese: Zinc chloride Glycerol Metacresol
English: 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg).
Maltese: Millilitru ta' suspensjoni fih 100 unità internazzjonali ta' insulina isophane (NPH) umana* (ekwivalenti għal 3.5 mg).
English: Protaphane vial (40 international units/ml)/Protaphane vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Maltese: Protaphane f'kunjett (40 unità internazzjonali/ml)/ Protaphane f'kunjett (100 unità internazzjonali/ml) Kunjett (tal-ħġieġ ta'tip 1) magħluq b'disk (gomma tal-bromobutyl/polyisoprene) u b'għatu protettiv tal-plastik li jingħalaq b'sikurezza u li fih suspensjoni ta' 10 ml.
English: Suspension for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: 1 x 3 ml skartoċċ 5 x 3 ml skartoċċi 10 x 3 ml skartoċċi
English: *Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: * L-insulina umana hija magħmula f'Saccharomyces cerevisiae permezz tat-teknoloġija tad-DNA rikombinanti
English: Protaphane contains sodium
Maltese: Protaphane fih sodium
English: Other medicines and Protaphane
Maltese: Mediċini oħra u Protaphane
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1).
English: - If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: Jekk it-tieni u t-tielet karattri huma H7 jew T6, il-manifattur huwa Novo Nordisk Production SAS, 45, Avenue d'Orléans, F-28000 Chartres, Franza.