FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving Mylotarg in combination with daunorubicin and cytarabine, it took an average of 17.3 months until the treatment failed, the cancer came back or the patient died, compared with 9.5 months in patients receiving a combination of only daunorubicin and cytarabine.
Maltese: Fil-każ tal-pazjenti li rċevew Mylotarg flimkien ma' daunorubicin u cytarabine, bħala medja l-kura damet 17.3 xhur sakemm falliet, reġa' feġġ il-kanċer jew miet il-pazjent, meta mqabbla ma' 9.5 xhur fil-każ ta' pazjenti li rċevew kombinazzjoni ta' daunorubicin u cytarabine biss.
English: Mylotarg is a medicine used to treat a blood cancer called acute myeloid leukaemia (AML) in patients aged 15 years and above who are newly diagnosed and have not tried other treatments.
Maltese: Mylotarg huwa mediċina li tintuża biex tikkura kanċer tad-demm imsejjaħ lewkimja tal-majelojde akuta (acute myeloid leukaemia, AML) f'pazjenti ta' 15-il sena u aktar li jkunu għadhom kemm ġew dijanjostikati u li ma ppruvawx kuri oħrajn.
English: Inside the cells, the cytotoxic substance, which is called calicheamicin, is released.
Maltese: Ġewwa ċ-ċelloli, tiġi rilaxxata s-sustanza ċitotossika, li hija msejħa calicheamicin.
English: The patient will also be given two other medicines: daunorubicin and cytarabine.
Maltese: Il-pazjent se jingħata wkoll żewġ mediċini oħrajn: daunorubicin u cytarabine
English: A main study in 271 patients with AML has shown that adding Mylotarg to daunorubicin and cytarabine can prolong the time patients live without their cancer coming back by around 8 months.
Maltese: L-effetti sekondarji rrappurtati b'Mylotarg huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa biex tipproteġi lill-pazjenti.
English: How does Mylotarg work?
Maltese: Mylotarg?
English: Mylotarg is used in patients with a protein called CD33 on their cancer cells (which is the case in most patients with AML).
Maltese: Mylotarg jintuża f'pazjenti bi proteina msejħa CD33 fuq iċ-ċelloli tal-kanċer tagħhom (li dan huwa l-każ fil-maġġoranza tal-pazjenti b'AML).
English: The European Medicines Agency decided that Mylotarg's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini iddeċidiet li l-benefiċċji ta' Mylotarg huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: Fatro Ibérica S.L.
Maltese: Ibérica S.L.
English: BN{number}
Maltese: Jiskadi {xahar/sena}
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Date of first authorisation: 21/06/2016
Maltese: Data tal-ewwel awtorizazzjoni: 21/06/2016.
English: PB 3
Maltese: Constitución 1. PB 3
English: Anaesthetic regimens that include opioid, alpha-2-agonist,
Maltese: Reġimi anestetiċi li jinkludi pre-medikazzjoni bl-opijojdi, alpha-2-agonist,
English: In dogs exposed to 4% sevoflurane for 3 hours, mean peak maximum serum fluoride concentrations of 20.0 ± 4.8 µmol/l have been observed after 3 hours of anaesthesia.
Maltese: Fi klieb esposti għal 3 sigħat b'4% sevoflurane, ġiet osservata medja ta' konċentrazzjonijiet massimi ta' florid fis-sirum ta' 20.0 ± 4.8 μmol/l wara 3 sigħat t'anesteżija.
English: 100% v/v sevoflurane.
Maltese: OĦRA 100% v/v sevoflurane.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Maltese: Informazzjoni dettaljata fuq dan il-prodott mediċinali veterinarju huwa disponibbli fil-websajt talAġenzija Ewropea tal-Mediċini http://www.ema.europa.eu/.
English: A minimal amount of sevoflurane is required to be dissolved in the blood before the alveolar partial pressure is in equilibrium with the arterial partial pressure because of the low solubility of sevoflurane in blood (blood/gas partition coefficient at 30 °C is 0.63 to 0.69).
Maltese: Ammont minimu ta' sevoflurane fid-demm hu meħtieġ biex il-pressjoni parzjali alveolari tkun f'ekwilibriju mal-pressjoni parzjali arterjali minħabba s-solubilità baxxa ta' sevoflurane fid-demm (koeffiċjenza diviżorja demm/gas f'temperatura ta' 30°C hi bejn 0.63 u 0.69).
English: In dogs, transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin and white blood cell counts may occur with sevoflurane, as with the use of other halogenated anaesthetic agents.
Maltese: Fil-klieb, elevazzjoni temporanja fl-aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin, u l-għadd ta' ċelloli bojod fid-demm jistgħu jiġru b'sevoflurane, kif ukoll bl-użu ta' aġenti anestetiċi ħaloġenati oħra.
English: EU/2/16/196/001-002
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/16/196/001-002
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperatura ogħla minn 25 ºC.
English: Република България Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Maltese: Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
English: Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other appropriate techniques.
Maltese: Dipressjoni karjovaskulari għandha tiġi ttrattata bi plasma expanders, b'agenti li jistimulaw ilpressjoni, aġenti kontra l-arritmiji u teknikalitajiet oħra xierqa.
English: Anaesthetic regimens that include opioid, alpha-2-agonist, benzodiazepine or phenothiazine premedication will allow the use of lower sevoflurane maintenance concentrations.
Maltese: Reġimi anestetiċi li jinkludi pre-medikazzjoni bl-opijojdi, alpha-2-agonist, benzodijażepini jew phenothiazine jippermettu l-użu ta' konċentrazzjonijiet aktar baxxi ta' sevoflurane sabiex tinżamm anesteżija.
English: Premedication:
Maltese: Sími:
English: Alpha-2-agonists cause bradycardia which may occur when they are used with sevoflurane.
Maltese: Meta alpha-2-agonisti jintużaw ma' sevoflurane jista' jkun hemm bradikardja.
English: For mask induction using sevoflurane, inspired concentrations of 5 to 7% sevoflurane with oxygen are employed to induce surgical anaesthesia in the healthy dog, and 6 to 8% sevoflurane with oxygen in the cat.
Maltese: L-użu ta' maskra għal induzzjoni minn sevoflurane, f'konċentrazzjoni ispirata ta' 5 sa 7% sevoflurane bl-ossiġnu għandu jingħata biex jinbeda l-illuppjar kirurġiku fuq kelb f'saħħtu.
English: Sevoflurane produces unconsciousness by its action on the central nervous system.
Maltese: Sevoflurane jraqqad permezz ta' l-effett tiegħu fuq is-sistema nervuża ċentrali.
English: Doses required for maintenance of anaesthesia may need to be reduced by approximately 0.5% in geriatric dogs (i.e. 2.8 to 3.1% in premedicated geriatric dogs and 3.2 to 3.3% in unpremedicated geriatric dogs).
Maltese: Id-dożi meħtieġa għaż-żamma ta' anesteżija jistgħu jkollhom jitnaqqsu b'xi 0.5% fil-klieb xjuħ (i.e. 2.8% sa 3.1% fil-klieb xjuħ li ngħatalhom trattament qabel u 3.2 sa 3.3% fi klieb xjuħ biss, li ma ngħatalhomx trattament qabel).
English: For induction and maintenance of anaesthesia.
Maltese: Għal induzzjoni u ż-żamma t'anesteżija
English: Sevoflurane has a variable effect on heart rate, which tends to increase from baseline at low MAC and fall back with increasing MAC. Sevoflurane causes systemic vasodilation and produces dose dependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Maltese: Sevoflurane jikkawża twessiegħ sistemiku tal-vini u arterji u jipproduċi tnaqqis: fil-medja tal-pressjoni arterjali, dipendentement fuq iddoża, fir-reżistenza periferali sħiħa, volum tad-demm li joħroġ mill-qalb u possibilment fis-saħħa talkontrazzjoni muskolari tal-qalb u l-veloċità ta' rilassament tal-muskoli tal-qalb.
English: For the full list of excipients, see section 6.1.
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Xejn.
English: Sevohale 100% v/v Inhalation vapour, liquid for dogs and cats.
Maltese: VETERINARJU Sevohale 100% v/v Fwar jittieħed man-nifs, likwidu għal klieb u l-qtates.
English: Limited data are available on the effects of the highly potent alpha-2agonists (medetomidine, romifidine and dexmedetomidine) as premedication.
Maltese: Hemm informazzjoni ristretta disponibbli fuq l-effetti qawwija talagonisti alpha-2, (medetomidine u romifidine) bħala trattament mediku ta' qabel.
English: Lithuania LT-54464 Tel: + 370 37 222053
Maltese: Tel: + 370 37 222053
English: Pharmacotherapeutic group: inhalation anaesthetic, ATCvet code: QN 01AB08
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju għadha ma ġietx stabbilita waqt it-tqala jew it-treddigħ.
English: Advice to doctors:
Maltese: Ħtiġijiet speċifiċi ta' farmakoviġilanza:
English: PACKAGE LEAFLET: Sevohale Inhalation vapour, liquid for dogs and cats, 100% v/v sevoflurane
Maltese: Sevohale Fwar jittieħed man-nifs, likwidu għal klieb u l-qtates, 100% v/v sevoflurane.
English: Inhalation vapour, liquid
Maltese: HUWA INDIKAT IL-PRODOTT Klieb u l-qtates
English: Inhalation vapour, liquid.
Maltese: Fwar jittiehed man-nifs, likwidu.
English: In the dog, sevoflurane may increase intracranial pressure at concentrations of 2.0 MAC and above under normal partial pressures of carbon dioxide (normocapnia), but intracranial pressure has been shown to remain within normal range at sevoflurane concentrations of up to 1.5 MAC if hypocapnia is induced by hyperventilation.
Maltese: MAC jew aktar, f'każi normali ta' pressjoni parzjali ta' dijossidu tal-karbonju, iżda l-pressjoni intrakranjali ntweriet li baqgħet fil-firxa normali, f'konċentrazzjonijiet ta' sevoflurane sa' 1.5
English: Cardboard box containing either 1 or 6 bottles.
Maltese: Kaxxa tal-kartun li fihom 1 jew 6 fliexken.
English: 250 ml Type III amber glass bottle with a yellow collar on the neck, sealed with a poly-seal cap, and secured with PET film.
Maltese: Tip flixkun tal-ħġieġ bil-kullar isfar fuq l-għonq, issiġillat b'għatu poli-siġill, u assigurat b'tertuqa tal-PET.
English: These concentrations can be expected to produce surgical anaesthesia within 3 to 14 minutes in dogs and within 2 to 3 minutes in cats.
Maltese: Dawn ilkonċentrazzjonijiet għandhom iwasslu għal anesteżija kirurġika fi żmien bejn 3 sa 14-il minuta, u jistgħu jiġu ssettjati mill-bidu, jew jiġu meħudin matul il-kors ta' 1 jew 2 minuti.
English: Limited clinical experience in administering sevoflurane to animals with renal, hepatic and cardiovascular insufficiency suggests that sevoflurane may be safely used in these conditions.
Maltese: Esperjenza klinika ristretta, fl-għoti tassevoflurane lill-klieb b'insuffiċenza fil-kliewi, fwied u s-sistema karjovaskolari turi li sevoflurane jista' jiġi amministrat f'dawn il-kondizzjonijiet.
English: The Minimum Alveolar Concentration (MAC) of sevoflurane in dogs is 2.36% and the MAC in cats 3.1%.
Maltese: Minima (MAC) ta' sevoflurane għal klieb hi 2.36%. Multiplikazzjonijiet tal-MAC jintużaw bħala gwida għal livelli kirurġiċi ta' loppju, li tipikament huma minn 1.3 sa 1.5 drabi tal-valur tal-MAC.
English: In common with other inhalational anaesthetics, the MAC of sevoflurane is reduced by the concurrent administration of benzodiazepines and opioids.
Maltese: Il-għoti tas-Sevoflurane huwa kompattibli mal-barbiturati u propofol li jingħataw fil-vina.
English: • Use a cuffed endotracheal tube when possible for the administration of Sevohale during maintenance anaesthesia.
Maltese: • Uża tubu endotrakeali mxammar fejn hu possibli għal għoti ta' Sevohale waqt iż-żamma ta' l anesteżija.
English: In order to preserve renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs and cats during sevoflurane anaesthesia.
Maltese: Sabiex jinżamm l-influss ta' demm fil-kliewi, perijodi fit-tul ta' pressjoni baxxa fl-arterji (inqas minn 60 mmHg) għandhom jiġu evitati fil-klieb matul loppju bis-sevoflurane.
English: Bottle label
Maltese: DAQS TAL-PAKKETT
English: Active substance: Sevoflurane
Maltese: U KWANTITATTIVA Sustanza attiva:
English: Long duration, low-flow sevoflurane anaesthesia should be avoided due to the risks of Compound A accumulation.
Maltese: Dewmien żejjed, u influss tal-loppju sevoflurane bil-mod għandu jiġi evitat minħabba r-riskju ta' żieda fil-Kompost A.
English: In common with other inhalational anaesthetics, the minimum alveolar concentration (MAC) of sevoflurane is reduced by the concurrent administration of benzodiazepines and opioids.
Maltese: Sevoflurane jista' jista' jqabbad episodji ta' ta' temperatura għolja malinna f'klieb u qtates suxxettibbli.
English: Further information on Ervebo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ervebo.
Maltese: ema.europa.eu/medicines/human/EPAR/Ervebo.
English: Other information about Ervebo
Maltese: Informazzjoni oħra dwar Ervebo
English: When a person receives the vaccine, it triggers an immune response against the virus protein.
Maltese: Meta persuna tirċievi ttilqima, din tattiva rispons immuni kontra l-proteina virus.
English: Amongst the 2,108 people who received immediate vaccination, none had Ebola virus disease between 10 days and 31 days after vaccination; amongst those whose vaccination was delayed (1429 people), 10 developed the disease within 31 days after vaccination.
Maltese: Fost l2,108 persuni li rċivew tilqim immedjat, l-ebda waħda ma kellha l-marda tal-virus tal-Ebola bejn 10 ijiem u 31 jum wara t-tilqim; fost dawk li t-tilqim tagħhom ġie ttardjat (1429 persuna), 10 żviluppaw il-marda fi żmien 31 jum wara t-tilqim.
English: Ervebo is a vaccine to protect adults aged 18 years and older against Ebola virus disease caused by the Zaire Ebola virus.
Maltese: Ervebo huwa tilqima li tipproteġi lill-adulti li għandhom 18-il sena u aktar kontra l-marda tal-virus talEbola kkawżata mill-virus ta' Zaire Ebola.
English: The effectiveness of the vaccine to protect against confirmed Ebola virus disease was measured by comparing the number of cases occurring 10 to 31 days after vaccination in the group of people vaccinated immediately, versus the number of cases in the group of people who were vaccinated later.
Maltese: L-effettività tat-tilqima għall-protezzjoni kontra l-marda tal-virus tal-Ebola kkonfermata ġiet imkejla permezz ta' tqabbil bejn lgħadd ta' każijiet li seħħew bejn 10 u 31 jum wara t-tilqim fil-grupp ta' persuni mlaqqma immedjatament, kontra l-għadd ta' każijiet fil-grupp ta' persuni li ġew imlaqqma aktar tard.
English: What information is still awaited for Ervebo?
Maltese: Liema informazzjoni għadha mistennija għal Ervebo?
English: The most common side effects with Ervebo (which may affect more than 1 in 10 people) are pain, swelling and redness at the injection site, headache, fever, muscle pain, tiredness and joint pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Ervebo (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma wġigħ, nefħa u ħmura fis-sit tal-injezzjoni, uġigħ ta' ras, deni, uġigħ fil-muskoli, għeja u uġigħ fil-ġogi.
English: As for all medicines, data on the use of Ervebo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ervebo hija ssorveljata kontinwament.
English: Ervebo contains a virus known as vesicular stomatitis virus which has been weakened and modified to contain a protein from the Zaire Ebola virus.
Maltese: Ervebo fih virus magħruf bħala l-virus tal-istomatite vesikulari li ġie mdgħajjef u modifikat biex jinkludi proteina mill-virus ta' Zaire Ebola.
English: A main study showed that Ervebo was effective in preventing Ebola virus disease in adults at risk of infection during an outbreak.
Maltese: Studju ewlieni wera li Ervebo kien effettiv fil-prevenzjoni tal-marda tal-virus tal-Ebola f'adulti f'riskju ta' infezzjoni matul tifqigħa.
English: Ervebo should be used in individuals at risk of infection with Ebola virus.
Maltese: Ervebo għandu jintuża f'individwi li huma f'riskju ta' infezzjoni bil-virus tal-Ebola.
English: Ervebo has been given ‘conditional authorisation'.
Maltese: Ervebo ngħata “awtorizzazzjoni kkundizzjonata”.
English: Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Maltese: Ħarsa ġenerali lejn Ervebo u għalfejn huwa awtorizzat fl-UE
English: The active substance in Ervebo contains a protein found on the Ebola Zaire virus.
Maltese: Is-sustanza attiva f'Ervebo fiha proteina li tinsab fuq il-virus tal-Ebola Zaire.
English: The study was conducted in Guinea during an Ebola outbreak and involved people who were either direct contacts or contacts of contacts of someone who had Ebola virus disease.
Maltese: L-istudju sar fil-Guinea waqt tifqigħa tal-Ebola u involva persuni li jew kienu f'kuntatti diretti jew f'kuntatti ma' kuntatti ta' xi ħadd li kellu l-marda tal-virus tal-Ebola.
English: For the full list of side effects and restrictions of Ervebo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Ervebo, ara l-fuljett ta' tagħrif.
English: How does Ervebo work?
Maltese: Kif jintuża Ervebo?
English: Healthcare workers and other carers who have been vaccinated with Ervebo should also continue to apply standard precautions for safe injection and hygiene and wear personal protective equipment when caring for patients with known or suspected Ebola virus disease.
Maltese: Il-ħaddiema tal-kura tas-saħħa u persuni oħrajn li jindukraw li tlaqqmu b'Ervebo għandhom ukoll ikomplu japplikaw prekawzjonijiet standard għal injezzjoni sikura u dwar l-iġjene u jilbsu tagħmir personali protettiv meta jieħdu ħsieb pazjenti b'mard magħruf jew suspettat tal-virus tal-Ebola.
English: Why is Ervebo authorised in the EU?
Maltese: Għaliex Ervebo ġie awtorizzat fl-UE?
English: Side effects with Ervebo were similar to those of most vaccines; they were mild to moderate in intensity and generally lasted less than a week.
Maltese: L-effetti sekondarji b'Ervebo kienu simili għal dawk talbiċċa l-kbira tat-tilqimiet; dawn kienu ħfief sa moderati fl-intensità u ġeneralment damu inqas minn ġimgħa.
English: What are the risks associated with Ervebo?
Maltese: Kif jaħdem Ervebo?
English: It is given as a single 1 ml injection into the muscle around the shoulder (the deltoid) or a muscle of the thigh.
Maltese: Dan jingħata bħala injezzjoni waħda ta' 1 ml fil-muskolu madwar l-ispalla (id-deltojd) jew muskolu tal-koxxa.
English: Ervebo is effective in protecting adults from Ebola virus disease; however, the duration of this protection is currently unknown.
Maltese: Ervebo huwa effettiv biex jipproteġi lill-adulti mill-marda tal-virus tal-Ebola; madankollu, id-durata ta' din il-protezzjoni bħalissa mhijiex magħrufa.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Ir-riproduzzjoni u/jew id-distribuzzjoni ta' dan id-dokument huma awtorizzati għal għanijiet mhux kummerċjali biss dejjem jekk EMEA tkun rikonoxxuta
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DARONRIX EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) DARONRIX Sommarju ta' l-EPAR għall-pubbliku
English: It contains a flu strain called A/Viet Nam/1194/2004 (H5N1).
Maltese: Fih razza ta' l-influwenza imsejħa A/Viet Nam/1194/2004
English: The European Commission granted a marketing authorisation valid throughout the EU for Daronrix to GlaxoSmithKline Biologicals s.a. on 21 March 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-UE kollha għal Daronrix lil GlaxoSmithKline Biologicals s.a. nhar il-21 ta' Marzu 2007.
English: Daronrix contains small amounts of a virus called H5N1.
Maltese: Daronrix fih ammonti żgħar ta' virus imsejjaħ H5N1.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Maltese: Il-vaċċin fih ukoll ‘adjuvant' (kompost li fih l-aluminju) sabiex jistimula rispons aħjar.
English: This summary was last updated in 03-2007.©EMEA 2007
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 03-2007.
English: The CHMP concluded that Daronrix's benefits outweighed its risks, and that it had shown its suitability as a mock-up vaccine in preparation for a pandemic flu outbreak.
Maltese: Il-CHMP ikkonkluda li l-benefiċċji ta' Daronrix jisbqu r-riskji tiegħu, u li Daronrix wera ladegwatezza tiegħu bħala vaċċin prova fi tħejjija għal tifqigħa ta' l-influwenza pandemika.
English: It is a suspension for injection that contains influenza (flu) viruses that have been inactivated (killed).
Maltese: Huwa suspensjoni għall-injezzjoni li fiha virusijiet ta' l-influwenza (flu) li ġew inattivati (maqtula).
English: What is Daronrix?
Maltese: X'inhu Daronrix?
English: Daronrix should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as eggs, chicken protein or gentamicin sulphate (an antibiotic).
Maltese: Daronrix ma għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika serja) għal kwalunkwe wieħed mill-komponenti tal-vaċċin, jew għal xi sustanza misjuba f'livelli ta' traċċa, bħal bajd, proteina tat-tiġieġ jew gentamicin sulphate (antibijotiku).
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the patients' blood before vaccination, on the day of the second injection (day 21), and 21 days later (day 42).
Maltese: Il-miżuri ewlenin ta' l-effettività kienu l-livelli ta' antikorpi kontra l-virus ta' l-influwenza fid-demm tal-pazjenti qabel il-vaċċinazzjoni, fil-jum tat-tieni injezzjoni (jum 21), u 21 jum wara (jum 42).
English: Daronrix is a ‘mock-up' vaccine.
Maltese: Daronrix huwa vaċċin.
English: According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Maltese: Skond il-kriterji stabbiliti mill-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), vaċċin prova jeħtieġ li jġib livelli ta' protezzjoni ta' antikorpi f'għallinqas 70% tan-nies sabiex jitqies li jkun xieraq.
English: The main study of Daronrix included 387 healthy adults and compared the ability of different doses of Daronrix, with or without the adjuvant, to trigger the production of antibodies (immunogenicity).
Maltese: L-istudju prinċipali ta' Daronrix kien jinkludi 387 adult b'saħħtu u qabbel l-abbiltà ta' dożi differenti ta' Daronrix, bi jew mingħajr adjuvant, sabiex jistimulaw il-produzzjoni ta' antikorpi (immunoġeniċità).
English: The participants received two injections of Daronrix, containing one of four different amounts of haemagglutinin (a protein found in flu viruses), with or without the adjuvant, 21 days apart.
Maltese: Il-parteċipanti rċevew żewġ injezzjonijiet ta' Daronrix, li kien fihom waħda minn erba' ammonti differenti ta' haemagglutinin (proteina li tinsab fil-virus ta' l-influwenza), bi jew mingħajr adjuvant, 21 jum minn xulxin.