FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and tube after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara 'JIS'.
English: Gel.
Maltese: JIS
English: Repeated critical assessment of burn depth and healing progression is needed.
Maltese: Valutazzjoni kritika ripetuta tal-profondità tal-ħruq u tal-progress tal-fejqan hija meħtieġa.
English: The target wound area of each patient was divided into two treatment areas of approximately the same size; the treatment allocation to the two halves of the wound (distal vs. proximal) was determined by randomization (in the burn trial, two similar wounds could be used).
Maltese: L-erja tal-ġerħa fil-mira ta' kull pazjent kienet maqsuma f'żewġ żoni ta' kura ta' madwar l-istess daqs, l-allokazzjoni tal-kura liżżewġ nofsijiet tal-ġerħa (distali vs. prossimali) ġiet iddeterminata permezz ta' randomizzazzjoni (fil-prova tal-ħruq, jistgħu jintużaw żewġt iġrieħi simili).
English: What is the withdrawal period?
Maltese: Kemm għandu jdum il-perjodu ta' rtirar?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B.V. on 16 November 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Porcilis AR-T DF lil Intervet International B.V. fis-6 ta' Novembru 2000.
English: Porcilis AR-T DF contains a non-toxic recombinant derivative (see later) of the Pasteurella multocida toxin and also inactivated Bordetella bronchiseptica bacterial cells.
Maltese: Porcilis AR-T DF fih derivattiv rikombinanti non-tossiku (ara iżjed ‘l isfel) tat-tosin Pasteurella multocida li fih derivattiv rikombinanti non-tossiku u ċelloli batteriki inattivi tal-Bordetella bronchiseptica.
English: Other side effects are reduced activity and lack of appetite in 10-20% of the pigs on the day of vaccination and/or a temporary swelling (maximum diameter: 10 cm) for up to two weeks at the injection site.
Maltese: Effetti sekondarji oħrajn irrapportati huma tnaqqis fl-attività u nuqqas ta' aptit f'10-20% tal-ħnieżer f'jum l-injezzjoni u/jew nefħa temporanja (dijametru massimu: 10 cm) li jdum sa ħmistax fis-sit tal-injezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF exceed the risks for the reduction of clinical signs of progressive atrophic rhinitis in piglets, by passive oral immunisation with colostrum from dams actively immunised with the vaccine, and recommended that Porcilis AR-T DF should be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) qabel li l-benefiċċji ta' Porcilis AR-T DF huma ikbar mir-riskji tiegħu għat-tnaqqis ta' sinjali kliniċi tar-rinite atrofika progressiva fil-qżieqeż, permezz ta' immunizzazjoni orali passiva bil-kolostru matern immunizzat b'mod attiv bil-vaċċin, u għaldaqstant irrakkomanda li Porcilis AR-T DF jingħata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: The trials showed good protection against the clinical signs of progressive atrophic rhinitis.
Maltese: It-testijiet urew protezzjoni tajba kontra sinjali kliniċi tar-rinite atrofika progressiva.
English: Why has Porcilis AR-T DF been approved?
Maltese: Għaliex ġie approvat Porcilis AR-T DF?
English: Progressive atrophic rhinitis is caused by toxins from the bacteria Pasteurella multocida.
Maltese: Ir-rinite atrofika progressiva tiġi kkawżata minn tossini mill-batterja Pasteurella multocida.
English: An active ingredient of Porcilis AR-T DF, Pasteurella multocida toxin, is produced by a method known as ‘recombinant technology'.
Maltese: Ingredjant attiv partikulari ta' AR-T DF, jiġifieri t-tossin Pasteurella multocida, jiġi prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti'.
English: Porcilis AR-T DF is used to reduce the clinical signs of progressive atrophic rhinitis (a disease where the nose tissues become infected and die) in piglets.
Maltese: Porcilis AR-T DF jintuża biex inaqqas is-sinjali kliniċi tar-rinite atrofika progressiva (marda li tinfetta u toqtol it-tessuti tal-imnieħer) fil-qżieqeż.
English: The Pasteurella multocida toxin is made by a bacterium cell that has received a gene (DNA), which makes it able to produce Pasteurella multocida toxoid, a genetically modified form of toxin which has adequate immunogenic activity and which is free from the toxic properties.
Maltese: It-tossin Pasteurella multocida jingħamel minn ċellola batterika li tkun irċeviet ġene (DNA), li jagħtiha l-ħila tipproduċi Pasteurella multocida, għamla ġenetikament immodifikata ta' tossin li jkollu attività immunoġenika adegwata u li ma jkollu l-ebda karatteristiċi tossiċi.
English: Porcilis AR-T DF is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs of 18 weeks of age and older.
Maltese: Porcilis AR-T DF jingħata bħala doża ta' 2 ml b'injezzjoni intramuskolari (fil-muskolu) lill-qżieqeż nisa ta' 18-il ġimgħa jew ikbar.
English: Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5°C, and in some pigs of up to 3°C on the day of vaccination or the following day.
Maltese: Porcilis AR-T DF jista' jikkawża żieda temporanja fit-temperatura tal-ġisem ta' 1.5°C, u f'xi ħnieżer din tista' titla' sa 3°C nhar l-għoti tal-injezzjoni jew l-għada.
English: In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.
Maltese: F'dan l-istudju ttieħed demm mill-qżieqeż minn kull bott ta' kull qażquż biex jiġi ttestjat jekk kienx hemm antikorpi għat-tossin Pasteurella multocida u għat-tossin Bordetella bronchiseptica.
English: Porcilis AR-T DF is a suspension for injection which contains a non-toxic recombinant derivative (see ‘How does Porcilis AR-T DF work?')
Maltese: Porcilis AR-T DF huwa sospensjoni għal injezzjoni li fih derivattiv rikombinanti non-tossiku (ara t-taqsima ‘Kif jaħdem Porcilis AR-T DF?') tat-tossina Pasteurella multocida u ċelloli inattivi talBordetella bronchiseptica.
English: Vaccine to reduce atrophic rhinitis in piglets
Maltese: Dan ilbatterju spiss ikun preżenti mal-Pasteurella multocida u jiggrava l-marda.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn ir-riskji u l-benefiċċji jinstab fil-modulu tad-diskussjoni xjentifika modulu ta' dan l-EPAR.
English: The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.
Maltese: Il-qżieqeż instabulhom livelli kumprabbli ta' antikorpi kontra r-rinite atrofika progressiva ma' dawk miksuba blużu ta' vaċċin approvat ieħor.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Heparesc can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/684158/2015 EMEA/H/C/003750
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Ottubru 2015
English: What is Heparesc?
Maltese: X'inhu Heparesc?
English: The specific urea cycle disorders for which Heparesc was intended to be used are called carbamoylphosphate synthetase 1 deficiency, ornithine transcarbamylase deficiency, argininosuccinate synthetase deficiency (citrullinaemia type 1), argininosuccinate lyase deficiency (argininosuccinic aciduria) and arginase deficiency (hyperargininaemia).
Maltese: Id-disturbi speċifiċi fiċ-ċiklu tal-urea li għalihom Heparesc kien maħsub li jintuża huma msejħin defiċjenza ta' carbamoylphosphate synthetase 1, defiċjenza ta' ornithine transcarbamylase, defiċjenza ta' argininosuccinate synthetase (citrullinaemia tip 1), defiċjenza ta' argininosuccinate lyase (argininosuccinic aciduria) u defiċjenza ta' arginase (hyperargininaemia).
English: The company that applied for authorisation is Cytonet GmbH & Ci KG.
Maltese: Il-kumpanija li applikat għallawtorizzazzjoni hija Cytonet GmbH & Ci
English: Heparesc was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for ornithine transcarbamylase deficiency, and 17 December 2010 for the other above conditions.
Maltese: Heparesc kien ikklassifikat bħala ‘mediċina orfni' (mediċina li għandha tintuża f'mard rari) fl14 ta' Settembru 2007 għal defiċjenza ta' ornithine transcarbamylase, u fis-17 ta' Diċembru 2010 għall-kundizzjonijiet l-oħrajn ta' hawn fuq.
English: What was Heparesc expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Heparesc?
English: Heparesc was developed as a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Maltese: Heparesc ġie żviluppat bħala tip ta' mediċina għal terapija avvanzata msejħa ‘prodott ta' terapija taċċelloli somatiċi'.
English: Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Maltese: Minħabba li Heparesc huwa mediċina terapewtika avvanzata, huwa ġie evalwat mill-Kumitat għatTerapiji Avvanzati (CAT).
English: The effects of Heparesc were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Heparesc ġew l-ewwel analizzati fuq mudelli sperimentali qabel ma ġew studjati filbniedem.
English: On 25 June 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Heparesc, intended for the treatment of urea cycle disorders.
Maltese: Fil-25 ta' Ġunju 2015, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Heparesc, maħsub għall-kura ta' disturbi fiċ-ċiklu tal-urea.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 22 October 2015.
Maltese: Wara li kkunsidra r-raġunijet għal din ittalba, is-CHMP reġa' eżamina l-opinjoni inizjali u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fit-22 ta' Ottubru 2015.
English: The medicine was to be given by slow injection through a tube inserted by a surgical procedure into the portal vein (a vein leading directly to the patient's liver).
Maltese: Il-mediċina kellha tingħata b'injezzjoni bil-mod permezz ta' tubu mdaħħal bi proċedura kirurġika ġol-vina portali (vina li twassal direttament għall-fwied tal-pazjent).
English: In addition, the CHMP had concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
Maltese: Barra minn hekk, is-CHMP kellu tħassib dwar irrilevanza klinika tar-riżultati tat-testijiet li kejlu l-kapaċità ta' produzzjoni tal-urea.
English: Refusal of the marketing authorisation for Heparesc (human heterologous liver cells)
Maltese: Heparesc (ċelloli tal-fwied eterologi tal-bniedem)
English: The main measures of effectiveness were the change in the levels of 13C-labelled urea production (a test intended to show the ability to produce urea) after treatment as compared to before, and the number, length and severity of any episodes of high ammonia in the blood during the studies.
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tibdil fil-livelli ta' produzzjoni ta' urea b'tikketta 13C (test maħsub biex juri l-kapaċità ta' produzzjoni ta' urea) wara kura kif imqabbel mal-istat preċedenti, u nnumru, it-tul u s-severità ta' kwalunkwe episodju ta' livell għoli ta' ammonja fid-demm matul l-istudji.
English: During the re-examination the CAT and CHMP looked again at the data from the company, and also consulted experts in the treatment of urea cycle disorders.
Maltese: Matul l-eżaminazzjoni mill-ġdid, is-CAT u s-CHMP reġgħu eżaminaw id-data mill-kumpanija, u kkonsultaw ukoll esperti fil-kura ta' disturbi fiċ-ċiklu tal-urea.
English: Heparesc is made of liver cells from an organ donor who can produce the enzyme that is missing in patients with urea cycle disorders.
Maltese: Heparesc huma magħmul minn ċelloli tal-fwied minn donatur ta' organi li jista' jipproduċi l-enzima li hija nieqsa fil-pazjenti b'disturbi fiċ-ċiklu tal-urea.
English: The company presented the results of two main studies involving a total of 20 children with urea cycle disorders in which the effects of Heparesc were compared with historical results in children who had not received Heparesc treatment.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' żewġ studji ewlenin li jinvolvu total ta' 20 tifel u tifla b'disturbi fiċ-ċiklu tal-urea fejn l-effetti ta' Heparesc tqabblu ma' riżultati storiċi fi tfal li ma kinux irċevew kura b'Heparesc.
English: When the medicine is injected into the portal vein leading to the liver, some of the liver cells it contains are expected to settle in the recipient's liver and start producing the missing liver enzyme, thus helping to reduce the symptoms of the disease.
Maltese: Meta l-mediċina tiġi injettata ġol-vina portali li twassal għall-fwied, xi wħud miċ-ċelloli tal-fwied li għandha, huma mistennija li jistabbilixxu ruħhom fil-fwied tar-riċevitur u jibdew jipproduċu l-enzima tal-fwied nieqsa, u b'hekk tgħin tnaqqas is-sintomi tal-marda.
English: Packaging Package size
Maltese: Daqs tal pakkett
English: What is Tazocin?
Maltese: X'inhu Tazocin?
English: • complicated urinary tract infections, including pyelonephritis (kidney infection)
Maltese: • infezzjonijiet ikkumplikati fl-apparat urinarju, li jinkludu l-pajolenefrite (infezzjoni fil-kliewi)
English: Tazocin is also available in the EU under other trade names: Tazobac, Tazocel, Tazocilline and Tazonam.
Maltese: Tazocin huwa disponibbli wkoll fl-UE b'ismijiet kummerċjali oħrajn: Tazobac, Tazocel, Tazocilline u Tazonam.
English: • complicated intra-abdominal infections (infections within the abdomen)
Maltese: • infezzjonijiet ikkumplikati inter-addominali (infezzjonijiet fl-addome)
English: Tazocin is a medicine that contains the active substances piperacillin and tazobactam.
Maltese: Tazocin huwa mediċina li fiha s-sustanzi attivi piperacillin u tazobactam.
English: Tazocin was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Tazocin kien identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċeduri Reċiproċi u Deċentralizzati - Umani (CMD(h)).
English: The dose for children is 80 mg piperacillin /10 mg tazobactam per kilogram body weight every six hours for neutropenic children and 100 mg piperacillin /12.5 mg tazobactam per kg body weight every eight hours for children with complicated intra-abdominal infections.
Maltese: Id-doża għat-tfal hija ta' 80 mg piperacillin /10 mg tazobactam għal kull kilogramm tal-piż tal-ġisem kull sitt sigħat għat-tfal b' newtropenija u 100 mg piperacillin /12.5 mg tazobactam għal kull kilogramm tal-piż tal-ġisem kull tmien sigħat għat-tfal b'infezzjonijiet ikkumplikati intra-addominali.
English: Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion) EMA/656918/2010
Maltese: Mistoqsijiet u tweġibiet dwar Tazocin u l-ismijiet assoċjati (piperacillin u tazobactam, 2/0.25 g u 4/0.5 g trab għal soluzzjoni għal infużjoni) EMA/656918/2010
English: Piperacillin is an antibiotic that belongs to the group ‘beta-lactams'.
Maltese: Piperacillin huwa antibijotiku li jagħmel parti mill-grupp ta' ‘beta-lactams'.
English: Tazobactam blocks the action of bacterial enzymes called beta-lactamases.
Maltese: Tazobactam jimblokka l-azzjoni ta' enzimi batterjali li jissejħu beta-lactamases.
English: Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion)
Maltese: Mistoqsijiet u tweġibiet dwar Tazocin u l-ismijiet assoċjati (piperacillin u tazobactam, 2/0.25 g u 4/0.5 g trab għal soluzzjoni għal infużjoni)
English: Beta-lactamases break down beta-lactam antibiotics such as piperacillin, making the bacteria resistant to these medicines.
Maltese: Beta-lactamases jkissru l-antibijotiċi beta-lactam bħal piperacillin, u jagħmlu l-batterji reżistenti għal dawn il-mediċini.
English: In adults and adolescents the usual dose is 4 g piperacillin /0.5 g tazobactam given every eight hours.
Maltese: Fl-adulti u fl-adoloxxenti, id-doża tas-soltu hija ta' 4 g piperacillin /0.5 g tazobactam li tingħata kull tmien sigħat.
English: Tazocin is authorised in the EU via national procedures.
Maltese: Tazocin huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Tazocin can be used to treat complicated intra-abdominal infections in children aged from two to 12 years.
Maltese: Tazocin jista' jintuża fil-kura ta' infezzjonijiet ikkumplikati intra-addominali fit-tfal li għandhom minn sentejn sa 12-il sena.
English: On 12 June 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tazocin in the EU.
Maltese: Fit-12 ta' Ġunju 2009, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Tazocin fl-UE.
English: For severe pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin /0.5 g tazobactam given every six hours.
Maltese: Għall-pnewmonja serja u għall-infezzjonijiet batteriċi fil-pazjenti b'newtropenija, id-doża rakkomandata hija ta' 4 g piperacillin /0.5 g tazobactam li tingħata kull sitt sigħat.
English: The company that markets these medicines is Pfizer.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Pfizer.
English: The European Medicines Agency has completed a review of Tazocin.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet ir-reviżjoni ta' Tazocin.
English: Why was Tazocin reviewed?
Maltese: Għaliex ġie rivedut Tazocin?
English: • severe pneumonia (infection of the lungs), including infections acquired in hospital or by patients on a mechanical ventilator
Maltese: • pnewmonja severa (infezzjoni fil-pulmuni), li tinkludi infezzjonijiet li ttieħdu minn ġo sptar jew minn pazjenti fuq ventilatur mekkaniku
English: Tazocin may also be used to manage children, adolescents and adults with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection.
Maltese: Tazocin jista' wkoll jintuża għall-ġestjoni ta' tfal, adoloxxenti u adulti b'newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola tad-demm bajda) li wkoll għandhom id-deni li huwa ssuspettat li huwa kkawżat minn infezzjoni batterika.
English: • complicated skin and soft tissue infections, including diabetic foot infections.
Maltese: • infezzjonijiet ikkumplikati fil-ġilda u fit-tessut artab, li jinkludu infezzjonijiet tas-sieq dijabetika.
English: By blocking the action of beta-lactamases, tazobactam stops bacteria from being resistant to piperacillin, thereby making piperacillin more effective at killing them.
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħra tal-SmPC inklużi s-sezzjonijiet dwar kontraindikazzjonijiet, twissijiet speċjali u t-tqala u t-treddiegħ.
English: NC= Failure 257/333
Maltese: NC= Falliment 257/333
English: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest France
Maltese: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest Franza
English: Stevens-Johnson syndrome, erythema multiforme
Maltese: Sindromu ta' Stevens-Johnson, erythema multiforme
English: Difference [95% CI]
Maltese: Differenza [95% CI]
English: * n = 18 for Cmax ** n = 16 for Cpredose
Maltese: * n = 18 għas-Cmax ** n = 16 għal Cpredose
English: Plasma concentrations ↑ Cortisol levels ↓ 86%
Maltese: Konċentrazzjoni fil-plażma ↑ Livelli ta'cortisol ↓ 86%
English: Beta2-adrenoceptor agonist (long acting) Salmeterol
Maltese: Beta2-adrenoceptor agonist (iħalli effett fit-tul) Salmeterol
English: Oral contraceptives Ethinyl Oestradiol
Maltese: Kontraċettivi orali Ethinyl Oestradiol
English: Antibiotics Clarithromycin
Maltese: Antibijotiċi Clarithromycin
English: Lopinavir: ↔ (relative to historical comparison)
Maltese: Lopinavir: ↔ (relattiv għal paragun storiku)
English: Lopinavir/ritonavir is an antiretroviral medicine.
Maltese: Lopinavir/ritonavir huwa mediċina antiretrovirali.
English: Dieselweg 25, 3752 Bunschoten The Netherlands
Maltese: Dieselweg 25, 3752 Bunschoten L-Olanda
English: Observed data
Maltese: Informazzjoni osservata
English: 1 See section 4.4: pancreatitis and lipids c.
Maltese: 1 ara sezzjoni 4.4: pankreatite u lipidi c.
English: Rifabutin, 150 mg QD Rifabutin (parent drug and active 25O-desacetyl metabolite):
Maltese: Rifabutin, 150 mg QD Rifabutin (mediċina prinċipali u metabolit attiv 25-O-desacetyl):
English: Indinavir, 600 mg BID Indinavir: AUC: ↔
Maltese: Indinavir, 600 mg BID Indinavir:
English: HMG Co-A Reductase Inhibitors
Maltese: Impeditur ta' Reductase HMG CoA
English: Cmax: ↓ (relative to indinavir 800 mg TID alone)
Maltese: Cmax: ↓ (relattiv għal indinavir 800 mg TID waħdu)
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
Maltese: F'dan il-kwadru, il-mutazzjonijiet fil-protejaż ta' l-HIV li ġejjin, kienu assoċjati ma' tnaqqis fis-suxxettibilità in vitro għal lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V u L90M.
English: Afatinib: AUC: ↑ Cmax: ↑
Maltese: AUC: ↑ Cmax: ↑
English: Phosphodiesterase (PDE5) inhibitors Avanafil (ritonavir 600 mg BID)
Maltese: Inibituri ta' Phosphodiesterase(PDE5) Avanafil (ritonavir 600 mg BID)
English: Mylan SAS
Maltese: FIS-SUQ Mylan SAS
English: Phosphodiesterase (PDE5) inhibitors
Maltese: Impeditur ta' phosphodiesterase (PDE5)
English: Antihistamines Astemizole Terfenadine
Maltese: Antiistamini Astemizole Terfenadine
English: Lopinavir is essentially completely metabolised by CYP3A.
Maltese: Essenzjalment, lopinavir huwa kompletament metabolizzat minn CYP3A.
English: Postpartum n = 17**
Maltese: 2ni Trimestru n = 17*
English: (inhibition of CYP3A enzymes)
Maltese: (inibizzjoni tal-enzimi CYP3A)
English: AUC:↑ 5.7-fold
Maltese: AUC: ↑ 5.7-darbiet
English: Ergot alkaloids Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Maltese: Alkalojdi tal-ergot Dihydroergotamine, ergonovine, ergotamine, methylergonovine
English: Increased risk of alanine transaminase (ALT) elevations (see section 4.5).
Maltese: Żieda fir-riskju ta' żidiet ta ' alanine transaminase (ALT) (ara sezzjoni 4.5).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 Jannar 2016.
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Maltese: Erja tas-superfiċje tal-ġisem (BSA) (m2) =  (Tul (cm) X Piż (kg) / 3600)
English: (inhibition of CYP3A/efflux transporters)
Maltese: (inibizzjoni ta ' CYP3A/trasportaturi tal-effluss)
English: Antiviral activity in vitro
Maltese: Selezzjoni ta' reżistenza in vitro
English: Tabulated list of adverse reactions
Maltese: Tabella ta'reazzjonijiet avversi
English: Antifungals Ketoconazole and Itraconazole
Maltese: Ketoconazole, Itraconazole:
English: Refer to colchicine prescribing information.
Maltese: Irreferi għallinformazzjoni tal-preskrizzjoni ta' colchicine.
English: Mutations L33F, I50V and V32I combined with I47V/A were also observed.
Maltese: Ġew ukoll osservati mutazzjonijiet L33F, I50V u V32I kkombinati ma' I47V/A.
English: In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b).
Maltese: Fit-tfal ta' sentejn u ikbar, in-natura tal-profil ta' sigurta' huwa simili għal dak fl-adulti (ara t-tabella f'sezzjoni b).