FrancophonIA/ELRC3.0 huggingface dataset:
English: There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Maltese: Kien hemm ukoll tħassib dwar nuqqasijiet fit-testijiet tal-laboratorju użati sabiex ikun ikkonfermat jekk il-pazjenti kellhomx l-influwenza jew le.
English: What was Fluad Paediatric expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Fluad Paediatric?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its withdrawal was based on the fact that it was unable to address the concerns of the CHMP within the required timelines.
Maltese: Fl-ittra mill-kumpanija li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjoni, il-kumpanija ddikjarat li lirtirar tagħha kien ibbażat fuq il-fatt li ma setgħetx tindirizza t-tħassib tas-CHMP fl-iskadenzi mogħtija.
English: The CHMP was particularly concerned by shortcomings in good clinical practice (GCP) that came to light following an inspection of the sites of the main study.
Maltese: Is-CHMP kien imħasseb b'mod partikolari b'xi nuqqasijiet ta' prattika klinika tajba (GCP) li ħarġu wara spezzjoni tal-bini fejn sar l-istudju ewlieni.
English: It has been made using a ‘recombinant DNA technique' (when genes are inserted into an organism) to carry the H5 (haemagglutinin 5) and N3 (neuraminidase 3) antigens.
Maltese: Sar bl-użu ta' ‘teknika ta' DNA rikombinanti' (meta ġeni jiddaħħlu f'organiżmu) biex ikollu l-antiġeni H5 (emagglutinina 5) u N3 (newraminidażi 3).
English: Inactivated recombinant avian influenza virus
Maltese: Virus rikombinant inattivat ta' l-influwenza avjana
English: • If the circulating avian influenza field virus has a different N component to the N3 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect specific Neuraminidase antibodies.
Maltese: • Jekk il-vajrus ta' l-influwenza avjarja li jinxtered għandu komponent N differenti mill-N3 li jinsab fil-vaċċin, jista' jkun possibbli li wieħed jagħmel differenza bejn tjur li ngħataw il-vaċċin u dawk infettati permezz ta' test dijanjostiku sabiex jinsabu antikorpi newraminidażi speċifiċi.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: Vaccinated birds can be differentiated from infected birds by looking for antibodies against the N3 component.
Maltese: It-tjur vaċċinati jistgħu jintgħarfu mit-tjur infettati mill-preżenza ta' antikorpi kontra l-kompost N3.
English: This summary was last updated on 26/10/2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 26/10/2011.
English: This strain has been chosen because it protects birds against the virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Maltese: Din l-istrain intgħażlet minħabba li tipproteġi t-tjur kontra d-damma tal-istrain H5N1 virulenti (cross protection), filwaqt li tippermetti ddifferenzjazzjoni bejn tjur ta' vaċċinati u tjur infettati.
English: The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated
Maltese: Il-vaċċin ma fihx sustanzi li jistgħu jkunu ta' riskju għall-konsumaturi ta' tjur vaċċinati.
English: This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.
Maltese: Dan huwa għaliex il-kontroll ta' l-influwenza avjarja huwa r-responsabbiltà ta' l-awtoritajiet veterinarji nazzjonali f'konsultazzjoni mal-Kummissjoni Ewropea.
English: • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks.
Maltese: • Il-vaċċin wera li jnaqqas is-sinjali kliniċi u l-mortalità u jnaqqas it-tixrid tal-vajrus f'tiġieġ u papri infettati.
English: Poulvac FluFend H5N3 RG is a vaccine used in chickens and ducks to protect against avian influenza.
Maltese: Poulvac FluFend H5N3 RG huwa vaċċin użat fit-tiġieġ u l-papri sabiex jiġu protetti kontra l-influwenza avjarja.
English: Poulvac FluFend H5N3 RG is a vaccine.
Maltese: Poulvac FluFend H5N3 RG huwa vaċċin.
English: Birds vaccinated with this vaccine make antibodies against these two chosen antigens.
Maltese: It-tjur li jingħataw dan ilvaċċin jipproduċu antikorpi kontra dawn iż-żewġ antiġeni.
English: • The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus.
Maltese: • L-istudji wrew li t-tjur li ngħataw il-vaċċin żviluppaw antikorpi kontra s-sottotip H5 tal-vajrus talinfluwenza avjarja.
English: Poulvac FluFend H5N3 RG is a vaccine containing an inactivated avian influenza virus H5N3 (inactivated means that the virus has been killed so that it cannot cause the disease anymore).
Maltese: Poulvac FluFend H5N3 RG huwa vaċċin li fih il-vajrus avjarju inattivat tal-influwenza H5N3 (inattivat jiġifieri li l-vajrus inqatel sabiex ma jkunx jista' jikkawża l-marda).
English: Other information about Poulvac FluFend H5N3 RG:
Maltese: Tagħrif ieħor dwar Poulvac FluFend H5N3 RG:
English: A field trial
Maltese: Twettqet ukoll prova fil-post.
English: The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds.
Maltese: Il-vaċċin inaqqas is-sinjali ta' l-influwenza u tal-eskrezzjoni (twaqqigħ tar-rix) tal-vajrus mittjur infettat.
English: The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be safe and to be effective in preventing disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Maltese: Il-Kumitat għall-Użu ta' Prodotti Mediċinali għall-Użu Veterinarju kkonkluda li l-vaċċin wera li huwa sikur u effikaċi fit-tnaqqis ta' mard fit-tjur u jista' jkun għodda utli fil-kontroll ta' tifqigħa ta' infezzjoni ta' l-influwenza avjarja.
English: In the future, if the birds are exposed to the avian flu virus, their immune systems will be able to make those antibodies quicker and this will help them fight the disease.
Maltese: Fil-futur, jekk it-tjur huma esposti għall-vajrus ta' l-influwenza avjarja, is-sistema immunitarja tagħhom tkun kapaċi tipproduċi antikorpi b'ritmu aktar mgħaġġel u dan jgħinhom jiġġieldu l-marda.
English: The vaccine was assessed in the context of an emergency situation which means that further studies with Poulvac FluFend H5N3 RG are still ongoing and will be assessed.
Maltese: Il-vaċċin kien valutat fil-kuntest ta' sitwazzjoni ta' emerġenza li jfisser li għadhom għaddejin studji fuq Poulvac FluFend H5N3 RG u dawn ser jiġu valutati.
English: Poulvac FluFend H5N3 RG has been authorised under “Exceptional Circumstances”.
Maltese: Poulvac FluFend H5N3 RG ġie awtorizzat taħt “Ċirkostanzi Eċċezzjonali”.
English: How does Poulvac FluFend H5N3 RG work?
Maltese: Għal xiex jintuża Poulvac FluFend H5N3 RG?
English: What is the risk associated with Poulvac FluFend H5N3 RG?
Maltese: X'inhu r-riskju assoċjat ma' Poulvac FluFend H5N3 RG?
English: Why has Poulvac FluFend H5N3 RG been approved?
Maltese: Għaliex ġie approvat Poulvac FluFend H5N3 RG?
English: How has Poulvac FluFend H5N3 RG been studied?
Maltese: Kif ġie studjat Poulvac FluFend H5N3 RG?
English: Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen.
Maltese: Twettqu studji fil-laboratorju li eżaminaw is-sigurtà tal-vaċċin wara doża waħda, wara doża eċċessiva u f'reġimwara sistema ta' dożaġġ ripetut.
English: The vaccine will only be used as part of an approved national disease control programme.
Maltese: Il-vaċċin ser jintuża biss bħala parti minn programm nazzjonali approvat għall-kontroll tal-mard.
English: EMA/CHMP/906885/2011
Maltese: EMA/CHMP/906885/2011 EMEA/H/C/002068
English: Ioa is a contraceptive pill.
Maltese: Ioa hija pillola kontraċettiva.
English: The full EPAR for Ioa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Ioa is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not
Maltese: Ioa huwa mediċina li tiġi f'24 pillola bajda ‘attiva' u tikkuntieni s-sustanzi attivi aċetat tannomegestrolu (2.5 mg) u estradijolu (1.5 mg), u erba' pilloli bojod ‘inattivi' li ma jikkontienu l-ebda sustanza attiva.
English: Ioa
Maltese: X'inhu Ioa?
English: This is a summary of the European public assessment report (EPAR) for Ioa.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ioa.
English: Ioa comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Maltese: Ioa jiġi f'folji ta' 28 pillola (24 pillola bajda u 4 pilloli sofor), li għandhom jittieħdu f'sekwenza partikulari bl-għajnuna ta' stikers li jindikaw il-jiem tal-ġimgħa għal kull pillola.
English: Ioa was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Maltese: Ioa ġie mistħarreġ f'żewġ studji ewlenin li b'kollox fihom ħadu sehem 4,433 mara ta' bejn it-18 u l-50 sena.
English: Ioa is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Maltese: Ioa hija pillola kontraċettiva kkumbinata li tikkuntieni żewġ sustanzi attivi, l-aċetat tan-nomegestrolu (proġestoġenu) u l-estradijolu (estroġenu).
English: In women aged 18 to 35, the Pearl Index was around 0.4 with Ioa and 0.8 with the comparator medicine in the first study, and around 1.2 with Ioa and 1.9 with the comparator medicine in the
Maltese: F'nisa ta' bejn it-18 u l-35 sena, fl-ewwel sudju ġie rreġistrat Indiċi Perla ta' madwar 0.4 b'Ioa u Indiċi Perla ta' madwar 0.8 bil-mediċina ta' referenza, mentri fit-tieni studju ġie rreġistrat Indiċi Perla ta' madwar 1.2 b'Ioa u Indiċi Perla ta' 1.9 bil-mediċina ta' referenza.
English: No clinical study data on Ioa are available in adolescents under 18 years old.
Maltese: Ma sar l-ebda studju kliniku fuq adoloxxenti ta' taħt it-18-il sena.
English: The effects of Ioa were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Ioa qabelxejn ġew ittestjati f'mudelli sperimentali qabel ma mbagħad ġew studjati fuq ilbnedmin.
English: What is the risk associated with Ioa?
Maltese: X'inhu r-riskju assoċjat ma' Ioa?
English: A lower Pearl Index represents a lower
Maltese: Indiċi Perla baxx jirrappreżenta riskju baxx ta' tqala.
English: The CHMP decided that the benefits of Ioa are greater than its risks and recommended that it be given
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Ioa huma akbar mir-riskji tiegħu u għaldaqstant irrikkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: It should not be used in women who have a disorder affecting blood clotting (such as protein C deficiency), migraine with aura (visual or other symptoms), severe liver problems with the liver still not functioning normally, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Maltese: Ma għandux jintuża lanqas minn nisa li jkollhom xi diżordni li tista' tikkaġuna t-tagħqid tad-demm (bħal nuqqas ta' proteina Ċ), migranja bl-awra (sintomi viżivi jew oħrajn), problemi gravi fil-fwied tant li l-fwied ma jkunx qed jaħdem kif suppost, ċerti tipi ta' kanċer jew tidmim vaġinali mhux normali b'kawża mhux magħrufa.
English: How has Ioa been studied?
Maltese: Kif ġie studjat Ioa?
English: The participants were given either Ioa or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Maltese: Il-parteċipanti ngħataw Ioa jew pillola kontraċettiva oħra li kienet tikkuntieni d-drospirenonu u letinilestradijolu tul sena sħiħa (13-il ċiklu mestrwali).
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Maltese: L-Indiċi Perla huwa mod standard kif titkejjel l-effikaċja talkontraċettivi, li jirreġistra l-għadd ta' każi ta' tqala mhux mixtieqa f'100 mara li jkunu qed jużaw kontraċettiv tul sena sħiħa (li jikkorrispondi ma' 1,300 ċiklu mestrwali).
English: The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-għadd ta' nisa ta' bejn it-18 u l-35 sena li nqabdu tqal matul jew ftit wara t-trattament, espress f'termini ta' rata ta' tqala permezz ta‘ ‘Indiċi Pearl'.
English: Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle.
Maltese: L-estradijolu hija identika għall-ormonu prodott b'mod naturali mill-ovarji matul iċ-ċiklu mestrwali.
English: It must not be used when a woman has, or has had, venous or arterial thrombosis (blood clots in the veins or arteries) including a stroke or a heart attack or when a woman has some of the risk factors for thrombosis (severe high blood pressure, diabetes with damage to the blood vessels or high cholesterol levels).
Maltese: Ma għandux jintuża minn nisa li jkollhom jew kellhom trombożi fil-vini jew fl-arterji (emboli tad-demm fil-vini jew fl-arterji) inklużi puplesija jew attakk tal-qalb, jew minn nisa li jkollhom uħud mill-fatturi tar-riskju tat-trombożi (pressjoni tad-demm għolja ħafna, dijabete bi ħsara fil-vini jew livelli għoljin ta' kolesterol.
English: The most frequent side effects with Ioa (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Maltese: L-effetti sekondarji l-iżjed komuni b'Ioa (li dehru f'iżjed minn pazjent 1 minn kull 10) huma raxx u bidliet fil-perjodi mestrwali (pereżempju, assenza jew irregolarità).
English: What benefit has Ioa shown during the studies?
Maltese: Għaliex ġie approvat Ioa?
English: Ioa works by changing the body's hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Maltese: Ioa jaħdem billi jibdel il-bilanċ ormonali tal-ġisem biex jimpedixxi l-ovulazzjoni, billi jibdel il-mukus ċervikali u billi jraqqaq lendometriju (ir-rita tal-ġuf).
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-MA (EU)
English: EU/1/16/1095/002IDELVION 500 IU Powder and solvent for solution for injection
Maltese: Il-pakkett li jmiss mal-prodott
English: Intravenous use
Maltese: Isem (ivvintat)
English: The full EPAR for Mysildecard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Mysildecard, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Maltese: Issustanza attiva f'Mysildecard, is-sildenafil, tappartjeni lil grupp ta' mediċini msejħa “inibituri talfosfodjesterażi tat-tip-5 (PDE5)”, li jfisser li timblokka l-enzima PDE5.
English: Mysildecard is available as tablets (20 mg).
Maltese: Mysildecard jiġi bħala pilloli (20 mg).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Mysildecard can only be used when a 20 mg dose is to be given.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Mysildecard contains the active substance sildenafil.
Maltese: Mysildecard fih is-sustanza attiva s-sildenafil.
English: This is a summary of the European public assessment report (EPAR) for Mysildecard.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mysildecard.
English: In this case Mysildecard was not compared with the reference product Revatio, but with Viagra.
Maltese: F'dan il-każ Mysildecard ma tqabbilx mal-prodott ta' referenza Revatio, imma mal-Viagra.
English: In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Maltese: II (limitazzjoni parzjali fl-attività fiżika) jew talklassi III (limitazzjoni notevoli fl-attività fiżika).
English: Other information about Mysildecard
Maltese: Informazzjoni oħra dwar Mysildecard
English: Mysildecard is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Maltese: Mysildecard huwa mediċina li tintuża fil-kura tal-adulti u tfal minn sena 'l fuq li jbatu minn ipertensjoni pulmonari arterjali (PAH, pressjoni tad-demm għolja mhux normali fl-arterji tal-pulmun).
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Maltese: Il-PAH hija marda debilitanti u jkun hemm restrizzjoni (tidjiq) gravi fil-vażijiet tal-pulmuni.
English: This means that Mysildecard is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio.
Maltese: Dan ifisser li Mysildecard huwa simili għall-"mediċina ta' referenza" diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Revatio.
English: Why is Mysildecard approved?
Maltese: Għaliex ġie approvat Mysildecard?
English: In adults, Mysildecard is taken at a dose of 20 mg three times a day.
Maltese: Fl-adulti, Mysildecard jittieħed f'doża ta' 20 mg tliet darbiet kuljum.
English: Because Mysildecard is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Mysildecard huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Mysildecard?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Mysildecard?
English: In children aged one to 17, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Maltese: Fi tfal li għandhom bejn sena u 17-il sena, id-doża rakkomandata hija 20 mg tliet darbiet kuljum f'dawk li jiżnu aktar minn 20 kg.
English: The Committee recommended that Mysildecard be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Mysildecard ikun approvat għall-użu fl-UE.
English: How has Mysildecard been studied?
Maltese: Kif ġie studjat Mysildecard?
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva filġisem.
English: What measures are being taken to ensure the safe and effective use of Mysildecard?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mysildecard?
English: Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Maltese: Peress li l-effikaċja u s-sigurtà tas-sildenafil f'PAH huma diġà stabbiliti sew, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw li hija bijoekwivalenti għal pillola awtorizzata oħra li fiha ssildenafil.
English: It is not intended to provide practical advice on how to use Mysildecard.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Mysildecard.
English: This was considered acceptable since Revatio and Viagra have the same qualitative composition and are made in the same way by the same manufacturer.
Maltese: Dan kien ikkunsidrat aċċettabbli peress li Revatio u Viagra għandhom l-istess kompożizzjoni qualitativa u huma magħmula bl-istess mod mill-istess manifattur.
English: Birkendorfer Strasse 65
Maltese: KG Birkendorfer Strasse 65
English: • The risk of opportunistic infections and tuberculosis (TB)
Maltese: • Ir-riskju ta' infezzjonijiet opportunistiċi u tuberkolożi (TB)
English: D-88397 Biberach an der Riss
Maltese: D-88397 Biberach an der Riss Il-Ġermanja
English: Clinical efficacy and safety
Maltese: Effettività u sigurtà klinika
English: a. p = 0.0001.
Maltese: p = 0.0001.
English: PASI 75, n (%)
Maltese: PASI 75, n (%) PASI 50, n (%)
English: TSS Erosions JSN
Maltese: TSS Erozjoni JSN
English: Introduction b.
Maltese: Introduzzjoni b.
English: Enbrel N=103 to 105*
Maltese: Enbrel N=103 sa 105*
English: This is normal.)
Maltese: Dan hu normali.)
English: Пфайзер Люксембург САРЛ, Клон България
Maltese: Пфайзер Люксембург САРЛ, Клон България Teл:
English: Double-Blind Clinical Responses at Week 12
Maltese: Risponsi kliniċi double-blind filĠimgħa 12
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Maltese: L-attività speċifika ta' etanercept hi 1.7 x 106 unitajiet/mg.
English: ACR Responsesa ACR 20
Maltese: Risponsi ACR ACR 20 ACR 50
English: Hampshire, PO9 2NG United Kingdom
Maltese: Hampshire, PO9 2NG Ir-Renju Unit
English: Placebo N=106 to 109*
Maltese: Plaċebo N=106 sa 109*
English: Malignant melanoma (see section 4.4), lymphoma, leukaemia
Maltese: Melanoma malinna (ara sezzjoni 4.4), limfoma, lewkimja
English: Placebo N = 139
Maltese: Plaċebo N = 139
English: Name and address of the manufacturers of the biological active substance Boehringer Ingelheim Pharma KG
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Boehringer Ingelheim Pharma
English: c: Remission is defined as DAS <1.6
Maltese: ċ: Tnaqqis fil-mard hu definita bħala DAS <1.6
English: Abbreviation: sPGA-static Physician Global Assessment.
Maltese: b. Dermatologist Static Global Assessment.
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
Maltese: F'sett ta' dejta miġbura ta' provi kliniċi, l-inċidenza totali ta' infezzjonijiet opportunistiċi kienet ta' 0.09% għal 15,402 persuna li rċivew Enbrel.
English: ---------------Study 3-----------
Maltese: --------------------Studju 2----------------- ----------------Studju 3--------
English: Enbrela
Maltese: Enbrel
English: Pfizer Luxembourg SARL filiāle Latvijā
Maltese: Pfizer Luxembourg SARL filiāle Latvijā Tel.
English: Placebo b: p = 0.002, Enbrel vs. placebo
Maltese: Plaċebo b: p = 0.002, Enbrel vs. Plaċebo
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Maltese: Lupus erythematosus tal-ġilda, lupus erythematosus sottoakut tal-ġilda, sindrome simili għall-lupus
English: Serious allergic/anaphylactic react ions (including angioedema, bronchospasm), sarcoidosis
Maltese: Reazzjonijiet allerġiċi/anafilattiċi serji (inklużi anġjoedema, bronkospażmu), sarkojdożi
English: Pancytopenia*
Maltese: Panċitopenja*
English: Hepat it is B reactivation, listeria
Maltese: Riattivazzjoni tal-epatite B, listeria,
English: This appearance is normal for Enbrel.
Maltese: Din id-dehra hi normali għal Enbrel.
English: ASAS** 40
Maltese: ASAS** 40 ASAS 20
English: T hrombocyt openia, anaemia, leukopenia, neutropenia
Maltese: Tromboċitopenja, anemija, lewkopenja, newtropenja
English: Pancytopenia and aplastic anaemia
Maltese: Panċitopenja u anemija aplastika
English: Linearity
Maltese: Linearjetà
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Maltese: Sindrome ta' Stevens-Johnson, vaskulite tal-ġilda (li tinkludi vaskulite b'sensittività eċċessiva), eritema multiforme, reazzjonijiet liċenojdi
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Maltese: Infezzjonijiet serji (inkluż pnewmonja, ċellulite, artrite batterjali, sepsis u infezzjoni parasitika)*
English: The active substance in Enbrel is etanercept.
Maltese: Is-sustanza attiva f'Enbrel hi etanercept.