FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir disoproxil Zentiva is an antiviral medicine used to treat patients aged 12 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Tenofovir disoproxil Zentiva huwa mediċina antivirali li tintuża għall-kura ta' pazjenti ta' 12-il sena u akbar infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV 1), virus li jikkawża s-sindromu minn immunodefiċjenza akkwiżita (AIDS).
English: Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil.
Maltese: Tenofovir disoproxil Zentiva fih is-sustanza attiva tenofovir disoproxil.
English: The active substance in Tenofovir disoproxil Zentiva, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Maltese: Is-sustanza attiva f'Tenofovir disoproxil Zentiva, tenofovir disoproxil, hija "prodroga" li fil-ġisem tiġi konvertita f'tenofovir.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Maltese: Tenofovir jinterferixxi wkoll mal-azzjoni ta' enzima prodotta mill-virus tal-epatite B li tissejjaħ "polimerażi tad-DNA", li hija involuta fil-formazzjoni ta' DNA virali.
English: Tenofovir disoproxil Zentiva is available as tablets (245 mg) to be taken by mouth.
Maltese: Tenofovir disoproxil Zentiva huwa disponibbli bħala pilloli (245 mg) li għandhom jittieħdu mill-ħalq.
English: This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Zentiva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tenofovir disoproxil Zentiva.
English: In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI).
Maltese: Fl-adolexxenti (minn 12 sa 18 il sena) l-użu tiegħu huwa biss għal dawk li ma jistgħux jingħataw kura b'inibituri nukleotidiċi oħra tat-traskriptażi inversa (NRTIs) tal-ewwel linja.
English: Other information about Tenofovir disoproxil Zentiva
Maltese: Informazzjoni oħra dwar Tenofovir disoproxil Zentiva
English: Tenofovir disoproxil Zentiva is used in combination with other HIV medicines.
Maltese: Tenofovir disoproxil Zentiva jintuża f'kombinazzjoni ma' mediċini oħra kontra l-HIV.
English: Tenofovir disoproxil Zentiva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Tenofovir disoproxil Zentiva, meta jittieħed flimkien ma' mediċini antivirali oħra, inaqqas lammont tal-HIV fid-demm u jżommu f'livell baxx.
English: Because Tenofovir disoproxil Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Maltese: Minħabba li Tenofovir disoproxil Zentiva huwa mediċina ġenerika, l-istudji fil-pazjenti ġew limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Viread.
English: The company that markets Tenofovir disoproxil Zentiva will ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Maltese: Il-kumpanija li tqiegħed Tenofovir disoproxil Zentiva fis-suq ser tiżgura li t-tobba kollha li huma mistennija jippreskrivu jew jużaw il-mediċina jingħataw materjal edukattiv li jkun fih informazzjoni importanti dwar is-sigurtà, partikolarment dwar ir-riskji u l-prekawzjonijiet relatati mal-funzjoni talkliewi u tal-għadam.
English: Tenofovir disoproxil Zentiva is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents aged 12 years and above with liver damage whose liver is still able to work (compensated liver disease).
Maltese: Tenofovir disoproxil Zentiva jintuża wkoll għall-kura ta' infezzjoni kronika (fit-tul) tal-virus tal-epatite B fl-adulti u fl-adolexxenti ta' 12-il sena u akbar li għandhom ħsara fil-fwied iżda li l-fwied tagħhom għadu jiffunzjona (mard tal-fwied ikkumpensat).
English: Why is Tenofovir disoproxil Zentiva approved?
Maltese: Għaliex ġie approvat Tenofovir disoproxil Zentiva?
English: Because Tenofovir disoproxil Zentiva 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: Minħabba li Tenofovir disoproxil Zentiva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: How is Tenofovir disoproxil Zentiva used?
Maltese: Kif jintuża Tenofovir disoproxil Zentiva?
English: Tenofovir disoproxil Zentiva stops the virus making DNA and prevents it from multiplying and spreading.
Maltese: Tenofovir disoproxil Zentiva jwaqqaf lill-virus milli jipproduċi DNA u ma jħallihx jimmultiplika u jinfirex.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Zentiva has been shown to have comparable quality and to be bioequivalent to Viread.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Tenofovir disoproxil Zentiva wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Viread.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument ta' mistoqsijiet u tweġibiet hawnhekk
English: Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Maltese: Tenofovir disoproxil Zentiva ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u jevita l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Zentiva once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Maltese: Għal pazjenti li qabel ikunu ħadu mediċini għall-kura tal-infezzjoni tal-HIV, it-tobba għandhom jippreskrivu Tenofovir disoproxil Zentiva biss wara li jkunu eżaminaw il-mediċini antivirali li l-pazjent ikun ħa qabel jew wara li jkunu eżaminaw il-probabbiltà li l-virus jirrispondi għal mediċini antivirali.
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Maltese: Fl-infezzjoni tal-HIV, jimblokka lattività tat-transkriptażi inversa, enzima prodotta mill-HIV li tħallih jinfetta ċ-ċelluli u jipproduċi aktar virusijiet.
English: For more information on how the medicine is taken including doses for adults and adolescents, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar il-mod kif tittieħed il-mediċina inklużi d-dożi għall-adulti u għall-adolexxenti, ara s-sommarju talkaratteristiċi tal-prodott (parti wkoll mill-EPAR).
English: This means that Tenofovir disoproxil Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viread.
Maltese: Dan ifisser li Tenofovir disoproxil Zentiva huwa simili għal "mediċina ta' referenza" diġà awtorizzata fl
English: Co. Tipperary E91 D768
Maltese: Tipperary E91 D768
English: Novogesic 500mg/150mg film coated tablets
Maltese: 500 mg/150 mg film coated tablets
English: 25 June 2015
Maltese: 25 ta' Ġunju 2015
English: Outcome of procedures under Article 29(4) of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE
English: What are the conclusions of the CHMP?
Maltese: X'inhuma il-konklużjonijiet tas-CHMP?
English: Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets)
Maltese: Mistoqsijiet u tweġibiet fuq Merisone u Myoson (tolperisone, pilloli ta' 50 u 150 mg)
English: Meditop Pharmaceutical Co. Ltd. submitted Merisone and Myoson for mutual recognition on the basis of their initial authorisation granted by Hungary on 18 March 2010.
Maltese: Meditop Pharmaceutical Co. Ltd. issottomettiet Merisone u Myoson għal rikonoxximent reċiproku abbażi tal-awtorizzazzjoni inizjali tagħhom li ngħatat mill-Ungerija fit-18 ta' Marzu 2010.
English: What are Merisone and Myoson?
Maltese: X'inhuma Merisone u Myoson?
English: On 23 April 2015, the European Medicines Agency completed two arbitration procedures following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Merisone and Myoson (tolperisone).
Maltese: Fit-23 ta' April 2015, l-Aġenzija Ewropea għall-Mediċini temmet żewġ proċeduri ta' arbitraġġ wara nuqqas ta' qbil bejn l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċini Merisone u Myoson (tolperisone).
English: Why were Merisone and Myoson reviewed?
Maltese: Għalxiex ġew riveduti Merisone u Myoson?
English: Merisone and Myoson are identical medicines that are used to treat muscle spasms (involuntary contractions) and spasticity.
Maltese: Merisone u Myoson huma mediċini identiċi li jintużaw fil-kura ta' spażmi tal-muskoli (kontrazzjonijiet involuntarji) u spastiċità.
English: Merisone and Myoson are generic medicines based on a ‘reference medicine', Mydeton, which is already authorised in the EU.
Maltese: Merisone u Myoson huma mediċini ġeneriċi bbażati fuq il-‘mediċina ta' referenza', Mydeton, li hija diġà awtorizzata fl-UE.
English: By reducing these impulses, tolperisone is believed to reduce muscle contraction and spacticity.
Maltese: Billi jnaqqas dawn l-impulsi, tolperisone huwa mifhum li jnaqqas il-kontrazzjoni u l-ispastiċità tal-muskoli.
English: The active substance in Merisone and Myoson, tolperisone, is a centrally acting muscle relaxant.
Maltese: Is-sustanza attiva f'Myderison, tolperisone, hija rilassant tal-muskolu li jaħdem b'mod ċentrali.
English: Because Merisone and Myoson are generic medicines, studies have been limited to tests to determine that they are bioequivalent to the reference medicine, Mydeton.
Maltese: Billi Merisone u Myoson huma mediċini ġeneriċi, l-istudji ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tagħhom mal-mediċina ta' referenza, Mydeton.
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Maltese: Il-mod eżatt ta' kif jaħdem tolperisone mhuwiex magħruf, iżda huwa maħsub li jaġixxi fuq il-moħħ u fuq issinsla tad-dahar sabiex inaqqas l-impulsi tan-nervituri li jġiegħlu lill-muskoli jinġibdu u jsiru riġidi.
English: The CHMP therefore concluded that in the case of Merisone and Myoson the bioequivalence study in the fasting state is sufficient to conclude on the bioequivalence in both the fasting and fed states and that the benefits and risks of Merisone and Myoson can be taken to be the same as the reference medicine's.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Merisone u Myoson huma akbar mir-riskji tagħhom, u li lawtorizzazzjoni għat-tqegħid fis-suq li ngħatat fl-Ungerija tista' tiġi rikonoxxuta fi Stati Membri oħrajn tal-UE.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that because of the characteristics of the active substance of Merisone and Myoson food will affect the absorption of the active substance in the same way as for Mydeton and no further studies are required.
Maltese: Abbażi tal-evalwazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fil-Kumitat, is-CHMP ikkonkluda li minħabba l-karatteristiċi tas-sustanza attiva ta' Merisone u Myoson l-ikel sejjer jaffettwa l-assorbiment tas-sustanza attiva bl-istess mod ta' Mydeton u m'hemm bżonn ta' ebda studji oħrajn.
English: However, the Member States were not able to reach an agreement and the German and Dutch medicines regulatory agencies referred the matter to the CHMP for arbitration on 24 December 2014.
Maltese: Madankollu, l-Istati Membri ma rnexxilhomx jilħqu qbil u fl-24 ta' Diċembru 2014 l-aġenziji regolatorji tal-mediċini tal-Ġermanja u tal-Pajjiżi l-Baxxi rreferew il-kwistjoni lis-CHMP għall-arbitraġġ.
English: Rates (95% CI)
Maltese: Rati (95 % CI)
English: UNIQUE IDENTIFIER -2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: 2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
Maltese: 2 (żieda f'alanine aminotransferase (ALT), aspartate aminotransferase (AST) jew alkaline phosphatase (ALP))
English: Anxiety, insomnia
Maltese: Ansjetà, insomnja
English: 7 to 11 years
Maltese: 7 sa 11-il sena
English: 12 to 17 years
Maltese: 12 sa 17-il sena
English: Uncommon: Supraventricular tachycardia, extrasystole
Maltese: Mhux komuni: 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 jindikaw li daptomycin ma jinibixxix jew jinduċi l-attivitajiet tal-iżoformi li ġejjin ta' ċitokrom P450 tal-bniedem: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 u 3A4.
English: The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Maltese: L-aktar tip ta' infezzjoni komuni li ġiet ikkurata kienet infezzjoni ta' ferita (38 % tal-pazjenti), filwaqt li 21 % kellhom axxessi maġġuri.
English: Up to 14 Days
Maltese: Sa 14-il Jum
English: Comparator
Maltese: Komparatur
English: Interaction studies for daptomycin were performed with aztreonam, tobramycin, warfarin and probenecid.
Maltese: Studji ta' interazzjoni għal daptomycin twettqu b'aztreonam, tobramycin, warfarin u probenecid.
English: Daptomycin Comparator
Maltese: Daptomycin Komparatur
English: Uncommon: Urticaria
Maltese: Mhux komuni: Urtikarja
English: Adults (18 years of age and above)
Maltese: Adulti (18-il sena u aktar)
English: Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Maltese: Intenzjoni li tiġi ttrattata modifikata b'mod mikrobijoloġiku (mMITT, Microbiologically modified intent-to-treat)
English: In clinical studies, 2,011 adult subjects received daptomycin.
Maltese: Fl-istudji kliniċi, aktar minn 2,011-il individwu adult irċivew daptomycin.
English: Pfizer Pharma PFE GmbH Tel:+ 49 (0)800 8535555
Maltese: PFE GmbH Tel:+ 49 (0)800 8535555
English: Sodium hydroxide (for pH adjustment) Citric acid (solubiliser/stabiliser)
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Citric acid (solubilizzant/stabilizzant)
English: Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with daptomycin, 9/53 (16.7%) patients treated with vancomycin and 2/62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
Maltese: Kura li ma tirnexxix minħabba infezzjonijiet bi Staphylococcus aureus persistenti jew li jirkadu, ġew osservati f'19/120 (15.8 %) tal-pazjenti kkurati b'daptomycin, 9/53 (16.7 %) tal-pazjenti kkurati b'vancomycin, u 2/62 (3.2 %) tal-pazjenti kkurati b'peniċillina semisintetiku kontra l-istafilokokki.
English: <Date of first authorisation: 22-March-2017> <Date of latest renewal: {DD month YYYY}>
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Marzu 2017 <Data tal-aħħar tiġdid: {JJ xahar SSSS}>
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 daptomycin and comparator regimens.
Maltese: Reazzjonijiet avversi (i.e. ikkunsidrati millinvestigatur bħala li huma possibbiliment, probabbilment jew definittivament relatati mal-prodott mediċinali) ġew irrappurtati bi frekwenzi simili għal daptomycin u l-korsijet tal-komparatur.
English: Uncommon: Thrombocythaemia, eosinophilia, international normalised ratio (INR) increased, leukocytosis
Maltese: Mhux komuni: Tromboċitemija, eosinofilija, żieda fil-proporzjon normalizzat internazzjonali (INR, international normalised ratio), lewkoċitożi
English: Uncommon: Vertigo
Maltese: Mhux komuni: Vertiġni
English: - That Daptomycin Hospira can interfere with coagulation tests (PT/INR) and this might lead to false results.
Maltese: - Li Daptomycin Hospira jista' jinterferixxi mat-testijiet tal-koagulazzjoni (PT/INR), u dan jista' jwassal għal riżultati foloz.
English: 12-17 years (N=13)
Maltese: 12-17-il sena (N=13)
English: The most frequently reported adverse reactions (frequency common (≥ 1/100 to < 1/10)) are:
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti (frekwenza komuni (≥ 1/100 sa < 1/10)) huma:
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 ġew irrappurtati matul it-terapija u matul is-segwitu, 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 daptomycin (see section 4.8).
Maltese: Ġiet irrappurtata dijarea assoċjata ma'Clostridium difficile (CDAD, Clostridium difficile-associated diarrhoea) b'daptomycin (ara sezzjoni 4.8).
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: Tital ta' 389 individwu fl-istudju, inklużi 256 individwu li ngħataw daptomycin u 133 individwu li ngħataw standard ta' kura.
English: 1 to 6 years (N=19)*
Maltese: Sena sa <6 snin (N=19)*
English: The key efficacy endpoint was the sponsor-defined clinical outcome at test-of-cure (TOC), which was defined by a blinded medical director.
Maltese: L-endpoint tal-effikaċja prinċipali kien leżitu kliniku definit mill-isponsor f'test tal-kura (TOC), li kien definit minn direttur mediku mgħammad.
English: Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism.
Maltese: Daptomycin ikollu ftit jew xejn metaboliżmu medjat minn Ċitokrom P450 (CYP450).
English: In in vitro studies, daptomycin was not metabolised by human liver microsomes.
Maltese: Fi studji in vitro, daptomycin ma ġiex metabolizzat mill-mikrożomi tal-fwied uman.
English: The following have been shown to be compatible when added to Daptomycin Hospira containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Maltese: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin u lidocaine.
English: Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Maltese: Daptomycin mogħti bħala injezzjoni ġol-vini ta' 2 minuti wera wkoll farmakokinetika proporzjonali għad-doża fil-medda tad-doża terapewtika approvata ta' 4 sa 6 mg/kg.
English: Differences in Success n/N (%)
Maltese: Differenzi fisSuċċess n/N (%)
English: The primary objective of Study DAP-PEDBAC-11-02 was to assess the safety of intravenous daptomycin versus SOC antibiotics.
Maltese: L-iskop primarju tal-Istudju DAP-PEDBAC-11-02 kien li jistma s-sigurtà ta' daptomycin mill-vini versus antibijotiċi SOC.
English: Fungal infections, urinary tract infection, candida infection, anaemia, anxiety, insomnia, dizziness, headache, hypertension, hypotension, gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension, liver function tests abnormal (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)), rash, pruritus, limb pain, serum creatine phosphokinase (CPK) increased, infusion site reactions, pyrexia, asthenia.
Maltese: Infezzjonijiet fungali, infezzjoni fil-passaġġ urinarju, infezzjoni minn candida, anemija, ansjetà, insomnja, sturdament, uġigħ ta' ras, ipertensjoni, ipotensjoni, uġigħ gastrointestinali u addominali, dardir, remettar, stitikezza, dijarea, gass, nefħa u distensjoni, testijiet tal-funzjoni tal-fwied b'riżultat anormali (żieda f'alanine aminotransferase (ALT), aspartate aminotransferase (AST) jew alkaline phosphatase (ALP)), raxx, ħakk, uġigħ fir-riġlejn/dirgħajn, żieda fil-creatine phosphokinase (CPK) fisserum, reazzjonijiet fis-sit tal-infużjoni, deni, astenija.
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Maltese: Mhuwiex probabbli li daptomycin se jinibixxi jew jinduċi l-metaboliżmu ta' prodotti mediċinali metabolizzati mis-sistema ta' P450.
English: Limb pain, serum creatine phosphokinase (CPK) increased
Maltese: Uġigħ fir-riġlejn/dirgħajn, żieda tal-creatine phosphokinase fis-serum (CPK)
English: Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers.
Maltese: F'dawn il-provi, 1,221 individwu rċivew doża ta' kuljum ta' 4 mg/kg, li minnhom 1,108 kienu pazjenti u 113 kienu voluntiera b'saħħithom; 460 individwu rċivew doża ta' kuljum ta' 6 mg/kg, li minnhom 304 kienu pazjenti u 156 kienu voluntiera b'saħħithom.
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 antinfjammatorji nonsterojdali (NSAIDs, nonsteroidal anti-inflammatory drug) jew inibituri ta' COX-2 (eż. celecoxib).
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 jiġu osservati anormalitajiet inspjegabbli ta' PT/INR f'pazjenti li jkunu qed jieħdu daptomycin, għandha tiġi kkunsidrata interazzjoni in vitro possibbli mat-test tal-laboratorju.
English: Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
Maltese: Ġew osservati metaboliti inattivi flawrina, kif determinat mid-differenza fil-konċentrazzjonijiet radjuattivi totali u l-konċentrazzjonijiet mikrobijoloġikament attivi.
English: Table 3 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age) in Study DAP-PEDBAC-11-02
Maltese: Tabella 3 Medja (Devjazzjoni Standard) tal-Farmakokinetika ta' Daptomycin f'Pazjenti Pedjatriċi b'SAB (Età minn sena sa 17-il Sena) fl-Istudju DAP-PEDBAC-11-02
English: What Daptomycin Hospira contains - The active substance is daptomycin.
Maltese: X'fih Daptomycin Hospira - Is-sustanza attiva hi daptomycin.
English: Table 2 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age) in Study DAP-PEDS-07-03
Maltese: Tabella 2 Medja (Devjazzjoni Standard) tal-Farmakokinetika ta' Daptomycin f'Pazjenti Pedjatriċi b'cSSTI (Età minn sena sa 17-il Sena) fl-Istudju DAP-PEDS-07-03