FrancophonIA/ELRC3.0 huggingface dataset:
English: Daptomycin should not be administered as a 2-minute injection to paediatric patients.
Maltese: Daptomycin m'għandux jingħata bħala injezzjoni ta' 2 minuti lill-pazjenti pedjatriċi.
English: It is particularly important that you mention the following: - Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis).
Maltese: Hu partikularment importanti li ssemmi dan li ġej: - Mediċini msejħa statins jew fibrati (biex ibaxxu l-kolesterol) jew ciclosporin (prodott mediċinali użat fit-trapjanti biex jipprevjeni r-rifjut ta' organu jew għal kondizzjonijiet oħrajn, eż. artrite rewmatojde jew dermatite atopika).
English: Reproductive toxicity testing showed no evidence of effects on fertility, embryofoetal, or postnatal development.
Maltese: Ittestjar dwar tossiċità fuq is-sistema riproduttiva ma wera l-ebda evidenza ta' effetti fuq il-fertilità, fuq l-embriju/fetu, jew fuq l-iżvilupp wara t-twelid.
English: Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or non-evaluable) at the TOC Visit; and Microbiological response (success, failure, or non-evaluable) based on evaluation of Baseline infecting pathogen at TOC.
Maltese: L-iskopijiet sekondarji kienu jinkludu: riżultat Kliniku abbażi tal-istima tarrispons kliniku (suċċess [kura, titjib], falliment, jew ma jistax jiġi evalwat) mill-Evalwatur li ma kienx jaf liema sustanza qed tintuża fil-Vista tat-TOC; u rispons Mikrobijoloġiku (suċċess, falliment, jew ma jistax jiġi evalwat) abbażi tal-valutazzjoni tal-patoġenu li qed jinfetta fil-linja bażi f'TOC.
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion Powder for solution for injection/infusion.
Maltese: Daptomycin Hospira 500 mg trab għal soluzzjoni għall-injezzjoni/infużjoni Trab għal soluzzjoni għall-injezzjoni/infużjoni.
English: EU/1/99/122/002 Thyrogen
Maltese: Mnejn jingħata
English: EU Number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/99/122/001 Thyrogen
Maltese: Għamla farmaċewtika
English: [carton only] PC:
Maltese: [kartuna biss] PC:
English: Hypromellose Polysorbate 80
Maltese: Hypromellose Polisorbate 80
English: [carton only]
Maltese: [kartuna biss]
English: Each tablet contains 1.82 mg sucrose.
Maltese: Kull pillola fiha 1.82 mg sucrose.
English: General characteristics of the active substance
Maltese: Karatteristiċi ġenerali tas-sustanza attiva
English: CI95% 45 min, 1 h 56 Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Maltese: CI95% 45 min, siegħa u 56 min Studju II: Proporzjon ta' Ħin On kuljum (%) Entacapone (n=103) Plaċebo (n=102)
English: What Comtan contains - The active substance is entacapone.
Maltese: X'fih Comtan - Is-sustanza attiva hi entacapone.
English: Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Maltese: Iron oxide isfar (E172) Iron oxide aħmar (E172) Titanium Dioxide (E171) Magnesium stearate
English: EU/1/98/081/001 30 film-coated tablets (glass) EU/1/98/081/002 60 film-coated tablets (glass) EU/1/98/081/003
Maltese: EU/1/98/081/001 30 pillola miksija b'rita (tal-ħġieġ) EU/1/98/081/002 60 pillola miksija b'rita (tal-ħġieġ) EU/1/98/081/003
English: Comtan 200 mg [carton only]
Maltese: Comtan 200 mg [kartuna biss]
English: Date of first authorisation: 22 September 1998 Date of latest renewal: 03 September 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Settembru 1998 Data tal-aħħar tiġdid: 03 ta' Settembru 2008
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan.
Maltese: Id-doża massima rrakkomandata hija ta' 10 pilloli kuljum, i.e. 2,000 mg ta' Comtan.
English: Do not take Comtan
Maltese: Tiħux Comtan
English: Orion Pharma d.o.o.
Maltese: Orion Pharma d.o.o. Tel.
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium,
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, mannitol, croscarmellose sodium,
English: However, in an interaction study in healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Maltese: Madanakollu, fi studju dwar l-interazzjonijiet, li sar f'volontiera f'saħħithom, entacapone ma biddilx il-livelli fil-plażma ta' S-warfarin, waqt li l-AUC għal R-warfarin żdied b'medja ta' 18% [CI90 11-26%].
English: Table 2 Daily ON time (Mean ± SD)
Maltese: Tabella 2 Ħin ON kuljum (Medja ± SD)
English: Other medicines and Comtan
Maltese: Mediċini oħra u Comtan
English: - The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171), magnesium stearate.
Maltese: - Il-kisja b'rita fiha hypromellose, polysorbate 80, glycerol 85%, sucrose, iron oxide isfar (E172),
English: See Section 4 Possible side effects for the characteristics of NMS;
Maltese: Ara sezzjoni 4 Effetti sekondarji possibbli għall-karatteristiċi ta' NMS;
English: 100 film-coated tablets (glass) 30 film-coated tablets (HDPE) 100 film-coated tablets (HDPE) 60 film-coated tablets (HDPE)
Maltese: 100 pillola miksija b'rita (tal-ħġieġ) 30 pillola miksija b'rita (HDPE) 100 pillola miksija b'rita (HDPE) 60 pillola miksija b'rita (HDPE)
English: Comtan tablets contain sucrose.
Maltese: Pilloli Comtan fihom is-sucrose.
English: Table 1* Adverse drug reactions
Maltese: Tabella 1* Reazzjonijiet avversi tal-mediċina
English: It is characterised by stiffness, muscle twitching, shaking, agitation, confusion, coma, high body temperature, increased heart rate and unstable blood pressure;
Maltese: Il-karatteristiċi tiegħu huma riġidità, ġbid ta' muskoli, tregħid, aġitazzjoni, konfużjoni, koma, temperatura għolja tal-ġisem, żieda fir-rata tal-qalb u pressjoni tad-demm mhux stabbli;
English: 1 tablet contains 200 mg of entacapone.
Maltese: Pillola 1 fiha 200 mg ta' entacapone.
English: There are three different pack sizes (bottles containing 30, 60, or 100 tablets).
Maltese: Hemm tliet daqsijiet differenti tal-pakkett (fliexken li fihom 30, 60 jew 100 pillola).
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60 or 100 tablets.
Maltese: Fliexken bojod magħmulin minn polyethylene ta' densità għolja (HDPE - high-density polyethylene) b'tappijiet bojod tal-polypropylene (PP) reżistenti għat-tbagħbis li jkun fihom 30, 60 jew 100 pillola.
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtan and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Maltese: Is-Sindrome Newrolettiku Malinn (NMS) huwa reazzjoni serja imma rari għal ċerti mediċini, u jista' jseħħ speċjalment meta Comtan u mediċini oħrajn biex jikkuraw il-marda ta' Parkinson jitwaqqfu ħesrem jew id-doża titnaqqas f'daqqa.
English: Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Għalhekk, pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose, malassorbiment tal-glucose-galactose jew nuqqas ta' sucrase-isomaltase, m'għandhomx jieħdu din il-mediċina.
English: Comtan aids levodopa in relieving the symptoms of Parkinson's disease.
Maltese: Comtan jgħin lil levodopa fis-serħan tas-sintomi tal-marda ta' Parkinson.
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Maltese: 30 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita
English: Tel: +34 91 599 86 01
Maltese: Orion Pharma S.L. Tel: +34 91 599 86 01
English: maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Maltese: Madanakollu, l-esperjenza bl-użu kliniku ta' entacapone ma' diversi prodotti mediċinali, inklużi l-inibituri MAO-A, antidepressanti triċikliċi, inibituri li jinibixxu l-assorbiment mill-ġdid ta' noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li jiġu metabolizzati b'COMT (eż. sustanzi bl-istruttura ta' catechol: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamina, dobutamine, alpha-methyldopa, apomorphine u paroxetine), għadha limitata.
English: Usually side effects caused by Comtan are mild to moderate.
Maltese: Ġeneralment effetti sekondarji kkawżati b'Comtan ikunu minn ħfief għal moderati.
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtan);
Maltese: • jekk int qed tieħu ċerti mediċini kontra d-depressjoni (saqsi lit-tabib jew lill-ispiżjar tiegħek jekk il-mediċina tiegħek ta' kontra d-depressjoni tistax tittieħed flimkien ma' Comtan);
English: Comtan 200 mg film-coated tablets entacapone
Maltese: Comtan 200 mg pilloli miksija b'rita entacapone
English: What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “Comtan” engraved on one side.
Maltese: Comtan 200 mg pilloli miksija b'rita huma pilloli ovali ta' kulur oranġjo jagħti fil-kannella, b' “Comtan” imnaqqxa fuq naħa waħda.
English: Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets.
Maltese: III), b'tappijiet bojod talpolyethylene reżistenti għat-tbagħbis li jkun fihom 30, 60 jew 100 pillola.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa (see section 4.4).
Maltese: Jista' jkun hemm logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, ikel bl-addoċċ u b'mod kompulsiv f'pazjenti mogħtija agonisti ta' dopamine u/jew trattamenti dopaminerġiċi oħrajn bħal Comtan flimkien ma' levodopa (ara sezzjoni 4.4).
English: Urine discolouration
Maltese: Diskineżja
English: The metabolism of the medicinal product is slowed in patients with mild to moderate liver insufficiency (Child-Pugh Class A and B), which leads to an increased plasma concentration of entacapone in both the absorption and elimination phases (see section 4.3).
Maltese: Il-metaboliżmu tal-prodott mediċinali jonqos f'pazjenti li għandhom insuffiċjenza minn ħafifa għal moderata tal-fwied (Klassi Child-Pugh A u B), li jagħti lok għal żieda fil-konċentrazzjoni ta' entacapone fil-plażma kemm fil-fażijiet tal-assorbiment kif ukoll f'dawk taleliminazzjoni (ara sezzjoni 4.3).
English: • Excessive movements (hyperkinesias), worsening of symptoms of Parkinson's disease,
Maltese: • Moviment eċċessiv (iperkineżji), is-sintomi tal-marda ta' Parkinson imorru għall-agħar,
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1. - Indeboliment tal-fwied.
English: Comtan contains sucrose Comtan tablets contain a sugar called sucrose.
Maltese: L-esperjenza b'Comtan f'pazjenti taħt it-18-il sena hija limitata.
English: General disorders and administration site conditions Common:
Maltese: Bidla fil-kulur tal-awrina Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: Comtan 200 mg film-coated tablets
Maltese: Comtan 200 mg pilloli miksija b'rita
English: Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: • if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
Maltese: • jekk jiżdidulek in-nuqqas ta' aptit, id-dgħjufija, it-telqa u t-telf tal-piż f'perjodu relattivament qasir, għandha titqies evalwazzjoni medika ġenerali inkluż tal-funzjoni tal-fwied.
English: prolonged muscle cramps (dystonia);
Maltese: • tħossok imqalla' (dardir);
English: The full EPAR for Alprolix 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: Hypersensitivity (allergic) reactions are seen rarely with Alprolix and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi) rari jidhru b'Alprolix u jinkludu: nefħa, ħruq u tingiż fis-sit tal-injezzjoni, tertir, fwawar, raxx bil-ħakk, uġigħ ta' ras, ħorriqija, pressjoni tad-demm baxxa, letarġija, dardir u rimettar, nuqqas ta' sabar, taħbit tal-qalb mgħaġġel, għafis tas-sider, u tħarħir ta' nifs.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Alprolix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Alprolix jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Alprolix
Maltese: Informazzjoni oħra dwar Alprolix
English: This is a summary of the European public assessment report (EPAR) for Alprolix.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Alprolix.
English: It can be used in patients of all ages.
Maltese: Jista' jintuża f'pazjenti ta' kull età.
English: In the first study involving 123 adults and adolescents aged 12 years or above, patients given Alprolix as a weekly preventive treatment had around 3 bleeding episodes a year, patients given Alprolix as an every 10 days preventive treatment had around 2 bleeding episodes per year, and patients given Alprolix for treating bleedings on demand had around 18 bleeding episodes a year.
Maltese: Fl-ewwel studju li involva 123 adult u adolexxenti li kellhom 12-il sena jew aktar, pazjenti mogħtija Alprolix bħala kura preventiva ta' kull ġimgħa kellhom madwar 3 episodji ta' fsada kull sena, pazjenti mogħtija Alprolix bħala kura preventiva mogħtija kull 10 ijiem kellhom nadwar 2 episodji ta' fsada fissena, u pazjenti mogħtija Alprolix għall-kura ta' fsada meta kellhom bżonn kellhom madwar 18il episodju ta' fsada kull sena.
English: The active substance in Alprolix, eftrenonacog alfa, works in the body in the same way as human factor IX.
Maltese: Is-sustanza attiva f'Alprolix, eftrenonacog alfa, taħdem fil-ġisem bl-istess mod bħall-fattur IX uman.
English: In the second study in 30 children aged below 12 years, Alprolix was similarly effective: 2 bleeding episodes occurred per year on average and around 75% of bleeding episodes resolved with one injection.
Maltese: Fit-tieni studju bi 30 tifel u tifla li kellhom anqas minn 12-il sena, Alprolix kien effettiv b'mod simili: bħala medja seħħew 2 episodji ta' fsada fis-sena u madwar 75 % tal-episodji ta' fsada ġew riżolti b'injezzjoni waħda biss.
English: Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Alprolix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2007.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn emofilja B huwa baxx, il-marda hija kkunsidrata ‘rari', u Alprolix ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Ġunju 2007.
English: Why is Alprolix approved?
Maltese: Għaliex ġie approvat Alprolix?
English: What are the risks associated with Alprolix?
Maltese: X'inhuma r-riskji assoċjati ma' Alprolix?
English: In addition, when bleeding did occur, around 90% of bleeding episodes resolved with one injection of Alprolix.
Maltese: Barra minn hekk, meta seħħet il-fsada, madwar 90% ta' episodji ta' fsada ġew riżolti b'injezzjoni waħda ta' Alprolix.
English: A risk management plan has been developed to ensure that Alprolix is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Alprolix jintuża bl-aktar mod sigur possibbli.
English: Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Alprolix huwa disponibbli bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni ġol-vina.
English: For the full list of all side effects and restrictions with Alprolix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Alprolix, ara l-fuljett ta' tagħrif.
English: Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B.
Maltese: Alprolix intwera li hu effettiv kemm fil-prevenzjoni kif ukoll fil-kura ta' episodji ta' fsada f'2 studji ewlenin li jinvolvu pazjenti b'emofilja B.
English: What measures are being taken to ensure the safe and effective use of Alprolix?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Alprolix?
English: Studies show that Alprolix is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Maltese: L-istudji juru li Alprolix huwa effettiv għall-prevenzjoni u l-kura tal-episodji ta' fsada f'pazjenti blemofilja B u s-sigurtà tiegħu hija komparabbli ma' dik ta' prodotti tal-fattur IX oħrajn.
English: Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Maltese: Il-mediċini talfattur IX jistgħu potenzjalment jikkawżaw problemi minħabba l-formazzjoni ta' emboli tad-demm flarterji u l-vini.
English: EMA/431413/2018 EMEA/H/C/004736
Maltese: asparaginase) EMA/431413/2018
English: What is Graspa?
Maltese: X'inhu Graspa?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 June 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 ta' Ġunju 2018 EMA/431413/2018 EMEA/H/C/004736
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 October 2006 for ALL.
Maltese: Graspa kien ikklassifikat bħala “mediċina orfni” (mediċina li għandha tintuża f'mard rari) fis27 ta' Ottubru 2006 għall-ALL.
English: On 22 June 2018, Erytech Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia (ALL).
Maltese: Fit-22 ta' Ġunju 2018, Erytech Pharma S.A. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal Graspa, għall-kura ta' lewkimja limfoblastika akuta (ALL).
English: Graspa is a cancer medicine that contains the active substance L-asparaginase that has been enclosed in red blood cells.
Maltese: Graspa huwa mediċina kontra l-kanċer li fih is-sustanza attiva
English: What was Graspa expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Graspa?
English: Graspa was intended to be given by infusion (drip) into a vein.
Maltese: Graspa kien maħsub li jingħata permezz ta' infużjoni (dripp) ġol-vina.
English: Withdrawal of the marketing authorisation application for Graspa (L-asparaginase)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Graspa (L-asparaginase)
English: In Graspa, L-asparaginase is enclosed in red blood cells because it was expected that this would allow the enzyme to work while protecting it from being broken down in blood and from antibodies that may attach to it and stop it from working.
Maltese: Fi Graspa, L-asparaginase tiddaħħal fiċ-ċelloli ħomor tad-demm għaliex dan kien mistenni li jippermetti lill-enzima taħdem filwaqt li jipproteġiha milli tinqasam fid-demm u minn antikorpi li jistgħu jaqbdu magħha u jżommuha milli taħdem.
English: Graspa was expected to be used in combination with other cancer medicines to treat adults and children with ALL that was not related to a particular genetic change (known as ‘Philadelphia chromosome negative').
Maltese: Graspa kien mistenni li jintuża flimkien ma' mediċini oħrajn tal-kanċer biex jikkura lill-adulti u lit-tfal li jkollhom l-ALL li ma kinitx relatata ma' bidla ġenetika partikolari (magħrufa bħala “kromożoma Philadelphia negattiva”).
English: The company provided data from a main study which compared Graspa with asparaginase (not enclosed in blood cells) in 80 patients aged 1 to 55 years with Philadelphia chromosome negative ALL whose disease had not improved with other treatment or had come back.
Maltese: Il-kumpanija pprovdiet data minn studju prinċipali li qabbel Graspa mal-asparaġinażi (mhux imdaħħla fiċ-ċelloli tad-demm) fi 80 pazjent bl-età bejn 1 sa 55 sena bil-kromożoma Philadelphia negattiva
English: The CHMP was concerned that the medicine contains a different type of asparaginase to that used in clinical studies and that the data provided were not sufficient to show how the medicine behaved in the body or how well it worked compared with other asparaginase medicines.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura.
English: Also, data were too limited to show how much Graspa's effectiveness was reduced by antibodies or how safe it was in children or after repeated treatments.
Maltese: Barra minn hekk, id-data kienet wisq limitata biex turi kemm l-effikaċja ta' Graspa tnaqqset mill-antikorpi jew kemm kienet sigura fit-tfal jew wara kuri ripetuti.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Graspa did not outweigh its risks.
Maltese: Għalhekk, fiż-żmien tal-irtirar, is-CHMP kien tal-opinjoni li, minħabba n-nuqqas ta' effikaċja mixhuda, il-benefiċċji ta' Graspa ma kinux jegħlbu r-riskji tiegħu.
English: EMA/626078/2014 EMEA/V/C/003703
Maltese: EMEA/V/C/003703
English: Mucosal disease is usually fatal.
Maltese: Marda mukosali hija normalment fatali.
English: Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhoea (BVD) virus (BVDV-1 and BVDV-2).
Maltese: Bovela huwa vaċċin veterinarju li fih żewġ tipi ta' virus tad-dijarrea virali tal-bovini (BVD - bovine viral diarrhoea) ħaj modifikat (BVDV-1 u BVDV-2).
English: In the group vaccinated with Bovela five out of 1,216 (0.4%) newborn calves were persistently infected with the virus, whereas in the group given the dummy injection there were ten persistently infected newborn calves out of 1,183 born (0.8%).
Maltese: Fil-grupp imlaqqam b'Bovela, ħamsa minn 1,216-il (0.4%) għoġol tat-twelid ġew infettati b'mod persistenti bil-virus, filwaqt li fil-grupp li ngħata injezzjoni finta, kien hemm għaxar għoġġiela tat-twelid persistentament infettati minn 1,183 mwielda (0.8%).
English: Bovine viral diarrhoea vaccine (modified live)
Maltese: Vaċċin tad-Dijarrea Virali tal-Bovini (ħaj modifikat)
English: In the field study 98.5% of vaccinated cattle sampled (range 269-274 animals) developed antibodies to both BVD virus types.
Maltese: Fl-istudju fil-prattika, 98.5% tal-għoġġiela mlaqqma kkampjunati (medda 269-274 annimal) żviluppaw antikorpi għaż-żewġ tipi ta' virusijiet BVD.
English: Bovela is a vaccine.
Maltese: Bovela huwa vaċċin.