FrancophonIA/ELRC3.0 huggingface dataset:
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Valdoxan could be a valuable treatment for some patients as long as their liver function is tested frequently.
Maltese: Madankollu, minħabba li l-mediċina għandha mod differenti ta' azzjoni, ftit effetti sekondarji u profil ta' sigurtà differenti minn antidipressivi eżistenti, il-Kumitat ikkonkluda li Valdoxan jista' jkun kura siewja għal xi pazjenti diment li l-funzjoni tal-fwied tagħhom tiġi ttestjata spiss.
English: Valdoxan is a medicine used to treat major depression in adults.
Maltese: Valdoxan huwa mediċina li tintuża fil-kura ta' dipressjoni qawwija fl-adulti.
English: The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant), which showed that Valdoxan was more effective than sertraline, with a reduction in HAM D scores after six weeks..
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studju ieħor li qabbel Valdoxan ma' sertralina (antidipressiv ieħor), li wera li Valdoxan kien aktar effettiv minn sertalina, bi tnaqqis fil-punteġġi ta' HAM D wara sitt ġimgħat.
English: A patient booklet will also be distributed to all patients who are prescribed Valdoxan so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Maltese: Ser jitqassam ukoll ktejjeb għall-pazjent lill-pazjenti kollha li jiġu preskritti b'Valdoxan sabiex ikunu konxji mir-riskju għall-fwied, l-importanza ta' sorveljanza tal-funzjoni tal-fwied u s-sinjali ta' problemi fil-fwied li għandhom joqogħdu attenti għalihom.
English: The most common side effects with Valdoxan (seen in more than 1 patients in 100) are headache, nausea (feeling sick) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Valdoxan (li dehru f'aktar minn pazjent 1 minn 100) huma wġigħ ta' ras, nawżja (dardir) u sturdament.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Valdoxan on 19 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Valdoxan fid-19 ta' Frar 2009.
English: In the first study, there was no difference between Valdoxan and placebo in preventing symptoms from returning during 26 weeks of treatment.
Maltese: Fl-ewwel studju, ma kien hemm l-ebda differenza bejn Valdoxan u l-plaċebo fil-prevenzjoni tas-sintomi milli jirritornaw matul 26 ġimgħa ta' kura.
English: Valdoxan must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Maltese: Valdoxan m'għandux jintuża f'pazjenti li jkollhom problemi fil-fwied, bħal ċirrożi (tbajja fil-fwied) jew mard attiv tal-fwied, u lanqas f'pazjenti li l-livell tagħhom ta' tranżaminażi (enzimi tal-fwied) fid-demm ikun aktar minn tliet darbiet tal-livell normali.
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Maltese: Ilkura m'għandhiex tinbeda jew għandha titwaqqaf f'pazjenti b'livelli anormali ta' enzimi tal-fwied fiddemm (aktar minn tliet darbiet mil-livell normali).
English: Other information about Valdoxan
Maltese: Tagħrif ieħor dwar Valdoxan
English: Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.
Maltese: Il-kura għandha titwaqqaf minnufih jekk il-pazjent jiżviluppa sintomi jew sinjali ta' ħsara potenzjali fil-fwied.
English: In the two studies where no active comparator was used Valdoxan was seen to be more effective than placebo.
Maltese: Fiż-żewġ studji fejn ma ntuża l-ebda komparatur attiv Valdoxan deher li kien aktar effettiv minn plaċebo.
English: The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li s-sintomi tagħhom irritornaw matul 24 sa 26 ġimgħa ta' kura.
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Maltese: Dipressjoni qawwija hija kundizzjoni li fiha l-pazjenti jkollhom disturbi fil-burdati li jinterferixxu mal-ħajja tagħhom ta' kuljum.
English: Communication and transparency
Maltese: Komunikazzjoni u trasparenza
English: Guido Rasi
Maltese: Mid-Direttur Eżekuttiv, Guido Rasi
English: EMA/MB/945561/2011 Executive Director
Maltese: 11 March 2013 EMA/154455/2013 Direttorat
English: Notifications of change
Maltese: Attivitajiet ta' valutazzjoni xjentifika
English: Revision of the veterinary-medicines legislation
Maltese: Reviżjoni tal-leġiżlazzjoni dwar il-mediċini veterinarji
English: It builds on existing processes and structures for pharmacovigilance, such as the EudraVigilance system for monitoring suspected side effects.
Maltese: Din tibni fuq proċessi u strutturi eżistenti għall-farmakoviġilanza, bħas-sistema EudraVigilance għall-monitoraġġ ta' effetti sekondarji suspettati.
English: • Continuing to ensure that assessment activities are conducted to the highest levels of quality and of regulatory and scientific consistency.
Maltese: • Inkomplu niżguraw li l-attivitajiet ta' valutazzjoni jitwettqu sal-ogħla livelli ta' kwalità u ta' konsistenza regolatorja u xjentifika.
English: • Further developing the communication and transparency activities of the Agency.
Maltese: • Niżviluppaw aktar l-attivitajiet ta' komunikazzjoni u trasparenza tal-Aġenzija.
English: Q42013 Initiate a pilot joint-inspection programme.
Maltese: Dawn qegħdin miġburin flimkien fil-programm dwar l-Eċċellenza Operazzjonali.
English: Numerous detailed aspects will be discussed and agreed with national authorities to facilitate a harmonised implementation.
Maltese: Ħafna aspetti dettaljati ser jiġu diskussi u maqbula mal-awtoritajiet nazzjonali biex tiġi faċilitata implimentazzjoni armonizzata.
English: As a parallel and related activity, we will implement a new ICT strategy, the key elements of which include reviewing the data architecture, streamlining the ICT-application portfolio, and assuring the best use of ICT to support the optimised processes of the Agency.
Maltese: Bħala attività parallela u relatata, ser nimplimentaw strateġija tal-ICT ġdida, li l-elementi ewlenin tagħha jinkludu reviżjoni tal-arkitettura tad-data, is-simplifikazzjoni tal-portafoll tal-applikazzjoni ICT, u l-iżgurar tal-aħjar użu tal-ICT għallappoġġ tal-proċessi ottimizzati tal-Aġenzija.
English: Revenue 1+5 Fees and charges 200 General EU contribution 200 Surplus from previous year 201 Special EU contribution for orphan medicinal products 300 Contribution from EEA 600 Community programmes 5+9 Other TOTAL REVENUE Expenditure Staff 11 Staff in active employment 13 Mission expenses 14 Socio-medical infrastructure 15 Exchange of civil servants and experts 2,274 1.1 2,405 1.1 2,428 1.0 16 Social welfare 17 Entertainment and representation expenses 18 Staff insurances Total title 1 Building/equipment 20 Investment in immovable property, renting of building and associated costs 20,069 9.9 21,491 9.7 20,997 9.1 21 Expenditure on admin. data processing 8,659 4.3 7,536 3.4 8,490 3.7 22 Movable property 23 Other admin. expenditure 24 Postage and communications 25 Expenditure on other meetings Total title 2 Operational expenditure 300 Meetings 301 Evaluation of medicines 302 Translations 303 Studies and consultants 304 Publications 305 Community programmes 31 Expenditure on business-related ICT projects Total title 3 TOTAL EXPENDITURE
Maltese: Għal dan l-għan, ser nintegraw aktar metodoloġiji ġodda bejn il-benefiċċju u r-riskju fil-ħidma tagħna ta' valutazzjoni fil-qasam tal-mediċini għall-użu millbniedem, u ser nużaw id-data biex nikkomunikaw mal-pubbliku dwar il-benefiċċji u r-riskji tal-mediċini, u dwar ir-raġuni fundamentali għall-opinjonijiet li nadottaw.
English: MRL extrapolations
Maltese: Inżidu l-effiċjenza tal-operazzjonijiet
English: Q4 2015 Revised structure for EPAR summaries, focusing on the benefit/risk balance of medicines in lay language.
Maltese: Aħna analizzajna l-ambjent tan-negozju fl-2012 u kkonkludejna li l-fatturi identifikati fl-istrateġija jibqgħu validi.
English: The budget for 2013 does show an increase compared to 2012, but this is mainly due to fees being increased in line with inflation.
Maltese: Il-baġit għall-2013 fil-fatt juri żieda meta mqabbel mal-2012, iżda dan huwa prinċipalment minħabba li t-tariffi żdiedu f'konformità mal-inflazzjoni.
English: This sharing of information and knowledge will benefit the scientific community and various bodies working in the field of medicines (e.g. health-technology-assessment bodies).
Maltese: Din il-kondiviżjoni ta' informazzjoni u għarfien ser tibbenefika l-komunità xjentifika u diversi korpi li jaħdmu fil-qasam tal-mediċini (eż. korpi tal-valutazzjoni tat-teknoloġiji tas-saħħa).
English: Started after 22 July 2012, PhV referrals
Maltese: Fid-dokument ta' strateġija tagħha ‘Pjan direzzjonali għall-2015'
English: Q4 2013 Improved search and reporting functionality of the EU Clinical Trials Register, including the use of thesaurus-enabled searching.
Maltese: Riskji oħra huma relatati mal-fatt li provi ta' manifattura u kliniċi jitwettqu barra l-Unjoni Ewropea (UE).
English: Q4 2013 Deliver:
Maltese: 'Pjan direzzjonali għall-2015:
English: The intention is ambitious, with the major drivers being to reduce the administrative burden for marketing-authorisation holders, to promote a genuine single market in veterinary medicines across the EU, thereby increasing availability, and to provide a more robust set of tools for managing risks associated with the use of veterinary antimicrobials.
Maltese: L-intenzjoni hija ambizzjuża, bl-iffokar maġġuri jkun fuq ittnaqqis tal-piż amministrattiv għad-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, il-promozzjoni ta' suq uniku ġenwin fil-mediċini veterinarji tul l-UE kollha, b'hekk tiżdied id-disponibbiltà, u li jiġi pprovdut sett aktar robust ta' għodda għall-ġestjoni tar-riskji assoċjati mal-użu ta' antimikrobiċi veterinarji.
English: GMP (including PMF)
Maltese: 1, l-Aġenzija Ewropea għall-Mediċini (l
English: We will continue our review of how committee activities are coordinated, making certain that this results in effective interactions and a smooth, timely and complete flow of information.
Maltese: Ser inkomplu r-reviżjoni tagħna dwar kif l-attivitajiet tal-kumitat ikunu kkoordinati, filwaqt li jkun aċċertat li dan jirriżulta f'interazzjonijiet effettivi u fluss ta' informazzjoni mingħajr xkiel, f'waqtu u komplut.
English: Resource consumption by activity; expenditure (forecast 2013)
Maltese: L-ambjent tan-negozju u l-prijoritajiet għall-2013
English: Streamline ICT application portfolio.
Maltese: disponibbiltà ta' kompetenza xjentifika u l-kwalità ta' data li tirċievi l-Aġenzija.
English: Activity statement: ENCePP studies Budget: €319,000 Financial year: 2013 Description of action: Ensuring best evidence is available to support Agency committees' assessments of the benefits and risks of authorised medicines (studies of risks and benefit risk) Type of contract: Call for expressions of interest; specific contract per study Number of contracts: 3 Indicative timeframe for contracts: Three procurements of approximately €106,000 each, one in each of the first three quarters of 2013 Indicative timeframe for procurement: Each of the first three quarters of 2013 Indicative budget for procurement: €319,000 Legal basis: Regulation 726/2004 and Directive 2001/83, notably Articles 31 and 107i - k Budget line: B3030 Activity statement: EudraVigilance data management Budget: €1.6 million per year, over 4 years (total: €6.5 million) Financial year: 2014-2018 Description of action: Data management and cleaning to ensure individual case reports are accurate, retrievable and analysable for safetysignal detection and evaluation Type of contract: Framework contract: operational consultancy; specific contracts Number of contracts: 5 Indicative timeframe for contracts: Commencing in 2013 Indicative timeframe for procurement: 2nd quarter of 2013 Indicative budget for procurement: €6,500,000 Legal basis: Article 24 of Regulation 726/2004 as amended by Regulation (EU) No 1235/2010 Budget line: B3030 Activity statement: Audit services Budget: €120,000 + €40,000 per year, over 4 years (total: €640,000) Financial year: 2013-2017/8 Description of action: Provision of audit and consultancy services Type of contract: Framework contract: audit and consultancy services; specific contracts: audit advisory committee Number of contracts: 8-10 Indicative timeframe for contract: Commencing in 2013 Indicative timeframe for procurement: 2nd quarter of 2013 Indicative budget for procurement: €640,000 Legal basis: Agency's financial regulation, Article 71 Budget line: B3030
Maltese: Wara l-workshop b'suċċess tagħna f'Novembru 2012, ser inklomplu bil-proċedura ppjanata tagħna għal konsultazzjoni mal-partijiet interessati, sabiex inkunu f'pożizzjoni li tiġi ppubblikata l-politika talAġenzija dwar ir-rilaxx ta' data minn provi kliniċi fl-aħħar parti tas-sena.
English: Art. 20 procedures (HUM), Art. 45 referrals (VET) Herbal medicinal products Administrative services Referrals, non-centrally authorised products Orphan medicinal product activities Non-IT projects Paediatric medicinal product activities Transparency, information and communication Public health activities Inspections CHMP, CVMP and working parties meetings IT projects Scientific advice and certification Initial applications for marketing authorisation Maintenance activities & pharmacovigilance Post-authorisation activities
Maltese: Ser inkomplu inrawmu l-approċċ tagħna għall-komunikazzjoni u t-trasparenza, sabiex tissaħħaħ ilfiduċja pubblika fl-Aġenzija u fis-sistema tal-UE għall-evalwazzjoni u s-superviżjoni tal-mediċini.
English: Q4 2013 Submit proposals for call topics for IMI.
Maltese: Il-ħidma ta' implimentazzjoni ser titkompla fl-2013.
English: • Organise an international workshop on good-clinical-practice inspections.
Maltese: • Inkomplu nħejju għall-implimentazzjoni tal-leġiżlazzjoni dwar medicini ffalsifikati.
English: Target 2013 Actual 2011
Maltese: Introduzzjoni għall-programm ta' ħidma 2013
English: Efficient telematics systems that are fit for purpose; subject to availability of resources, further development of EudraVigilance Vet v3.0 is planned that will deliver modules of the system such as integration with the medicinal products dictionary, improved data input and changes to assure compliance with international guidelines and enhanced processes.
Maltese: Aġenzija) identifikat għadd ta' xprunaturi tan-negozju li għandhom impatt fuq l-għażla tal-prijoritajiet u l-objettivi tagħna, inklużi l-avvanzi fix-xjenza, il-globalizzazzjoni, id-domanda għal komunikazzjoni aħjar u aktar onestà.
English: Collaborating on international standardisation, including ICSRs, IDMPs, risk-management, electronic PSURS and formats for clinical trials.
Maltese: Għad iridu jiġu implimentati għadd ta' dispożizzjonijiet, f'kooperazzjoni mal-awtoritajiet nazzjonali, u jiddependi jekk ir-riżorsi jistgħux isiru disponibbli.
English: ICT Service Desk: Performance indicators for meeting of SLAs per system/priority level Severity rating
Maltese: Kull sena, ser inwettqu wkoll reviżjoni strateġika dwar il-ġestjoni tar-riskju.
English: • Preparing for the outcome of the European Commission's impact assessment on revision of the veterinary-medicines legislation.
Maltese: • Inħejju għall-eżitu tal-valutazzjoni tal-impatt tal-Kummissjoni Ewropea dwar ir-reviżjoni talleġiżlazzjoni dwar il-mediċini veterinarji.
English: Implementing the new pharmacovigilance legislation.
Maltese: Il-leġiżlazzjoni dwar mediċini ffalsifikati.
English: • further development of ENCePP databases, considering interface with new pharmacovigilance legislation, HTA and the Enpr-EMA network.
Maltese: • Inkomplu nħejju għall-implimentazzjoni tal-leġiżlazzjoni dwar il-farmakoviġilanza, skont ir-riżorsi.
English: Started prior to 22 July 2012
Maltese: Il-leġiżlazzjoni tidħol fis-seħħ f'Jannar 2013.
English: 60 minutes.
Maltese: 60 minuta
English: Rates (95% CI)
Maltese: Rati (95% CI)
English: See sections 4.4, 4.8 and 5.3.
Maltese: Ara sezzjonijiet 4.4, 4.8 u 5.3.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL
Maltese: Belgique/België/Belgien MSD Belgium BVBA/SPRL
English: Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Maltese: Microbiologically modified intent-to-treat)
English: Uncommon: Supraventricular tachycardia, extrasystole
Maltese: Takikardija supraventrikolari, extrasystole
English: In vitro studies with human hepatocytes indicate that daptomycin does not inhibit or induce the activities of the following human cytochrome P450 isoforms: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4.
Maltese: Studji in vitro b'epatoċiti umani juru li daptomycin ma jinibixxix jew ma jinduċix l-attivitajiet taliżoformi taċ-ċitokromu uman P450 li ġejjin: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 u 3A4.
English: Peptostreptococcus spp
Maltese: Clostridium perfringens Peptostreptococcus spp
English: PP (per protocol) Population RIE
Maltese: Popolazzjoni PP (skont il-protokol) RIE
English: The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Maltese: L-aktar tip komuni ta' infezzjoni li kienet ikkurata kienet infezzjoni ta' ferita (38% tal-pazjenti), filwaqt li 21% kellhom axxess serju.
English: In clinical studies, 2,011 adult subjects received Cubicin.
Maltese: Fi studji kliniċi, aktar minn 2,011-il individwu adult irċevew Cubicin.
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg)
Maltese: AUC0-24siegħa (µg×siegħa/ml) Cmax (µg/ml) t1/2 apparenti (siegħa) CL/wt (ml/siegħa/kg)
English: Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Maltese: Indeboliment renali, inkluż insuffiċjenza renali, żieda tal-kreatinina fis-serum
English: Suomi/Finland MSD Finland Oy
Maltese: Suomi/Finland MSD Finland Oy Puh/Tel:
English: Interaction studies for Cubicin were performed with aztreonam, tobramycin, warfarin and probenecid.
Maltese: Saru studji dwar l-interazzjoni bejn Cubicin u aztreonam, tobramycin, warfarin u probenecid.
English: Date of first authorisation: 19 January 2006 Date of latest renewal: 29 November 2010
Maltese: Data tal-aħħar tiġdid: 29 Novembru 2010
English: The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Maltese: Dawn li ġejjin intwerew li kienu kompatibbli meta miżjuda ma' soluzzjonijiet tal-infużjoni li kien fihom Cubicin: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin u lidocaine.
English: What Cubicin contains - The active substance is daptomycin.
Maltese: X'fih Cubicin - Is-sustanza attiva hi daptomycin.
English: Group G streptococci
Maltese: Streptococci grupp G
English: Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with Cubicin, 9/53 (16.7%) patients treated with vancomycin and 2/62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
Maltese: Falliment tal-kura minħabba infezzjonijiet bi Staphylococcus aureus persistenti jew li jerġgħu joħorġu kienu osservati f'19/120 (15.8%) pazjent ikkurati bi Cubicin, 9/53 (16.7%) pazjent ikkurati b'vancomycin u 2/62 (3.2%) pazjent ikkurati b'penicillin semi-sintetiku kontra l-istaphylococci.
English: The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to very common ( 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data):
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati waqt it-terapija u waqt il-follow-up bi frekwenzi li jikkorrispondu għal komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli):
English: Clostridium difficile-associated diarrhoea (CDAD) has been reported with Cubicin (see section 4.8).
Maltese: Kienet irrappurtata dijarea assoċjata ma' clostridium difficile (CDAD) bi Cubicin (ara sezzjoni 4.8).
English: Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism.
Maltese: Daptomycin ikollu ftit li xejn jew l-ebda metaboliżmu permezz ta' cytochrome P450 (CYP450).
English: Prothrombin time (PT) prolonged Thrombocytopaenia
Maltese: Ħin ta' prothrombin (PT) imtawwal Tromboċitopenija
English: A total of 389 subjects were treated in the study, including 256 subjects who received daptomycin and 133 subjects who received standard-of-care.
Maltese: 389 individwu fl-istudju, inklużi 256 individwu li ngħataw daptomycin u 133 individwu li ngħataw standard ta' kura.
English: Streptococcus dysgalactiae subsp equisimilis*
Maltese: Streptococcus agalactiae* Streptococcus dysgalactiae sottospeċi equisimilis* Streptococcus pyogenes*
English: 2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
Maltese: Testijiet tal-funzjoni tal-fwied mhux normali2 (żieda fl-alanine aminotransferase (ALT), fl-aspartate aminotransferase (AST) jew fl-alkaline phosphatase (ALP))
English: Puh/Tel: +358 (0) 9 804650 info@msd.fi
Maltese: +358 (0) 9 804650 info@msd.fi
English: Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for Cubicin and comparator regimens.
Maltese: Reazzjonijiet avversi (ie. dawk meqjusa mill-investigatur bħala possibiliment, probabbilment jew bla ebda dubju relatati mal-prodott mediċinali) kienu rappurtati bi frekwenzi simili għal Cubicin u l-korsijet li ngħataw għat-tqabbil.
English: Tabulated list of adverse reactions
Maltese: Lista ttabbulata ta' reazzjonijiet avversi
English: Cubicin given as 2 -minute intravenous injection (adult patients only)
Maltese: Cubicin mogħti bħala injezzjoni ta' 2 minuti fil-vina (pazjenti adulti biss)
English: There were no differences in Cmax.
Maltese: Ma kienx hemm differenzi fis-Cmax.
English: If unexplained abnormalities of PT/INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test.
Maltese: Jekk ikun hemm anormalitajiet bla spjegazzjoni fil-PT/INR ta' pazjenti fuq daptomycin, għandha tkun ikkunsidrata interazzjoni in vitro mat-test tal-laboratorju.
English: - Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
Maltese: - Mediċini kontra l-uġigħ magħrufin bħala mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs) jew inibituri tal-COX-2 (eż.celecoxib).
English: Cubicin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Maltese: Cubicin huwa indikat għall-kura ta' infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1).
English: Of these 19 patients 11 were infected with methicillin-susceptible and 8 with methicillin-resistant Staphylococcus aureus.
Maltese: Minn dawn id-19-il pazjent 11 kienu infettati bi Staphylococcus aureus suxxettibbli u 8 bi Staphylococcus aureus reżistenti għall-methicillin.
English: The most frequently reported adverse reactions (frequency common (≥ 1/100 to < 1/10)) are:
Maltese: L-aktar reazzjonijiet avversi rrappurtati (frekwenza komuni (≥1/100 sa <1/10)) huma:
English: Limb pain, serum creatine phosphokinase (CPK) increased
Maltese: Uġigħ fir-riġel, żieda tal-creatine phosphokinase fisserum (CPK)2
English: Staphylococcus haemolyticus
Maltese: Staphylococcus aureus * Staphylococcus haemolyticus
English: Eosinophilic pneumonia
Maltese: Pulmonite eosinofilika