FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi ta 'aġġornament għal dan il-prodott mediċinali huma stabbiliti fil-lista ta' dati ta 'referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c (7)
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Teva);
Maltese: • jekk int qed tieħu ċerti mediċini kontra d-dipressjoni (saqsi lit-tabib jew lill-ispiżjar tiegħek jekk il-mediċina tiegħek ta' kontra d-dipressjoni tistax tittieħed flimkien ma' Entacapone Teva);
English: The safety and efficacy of Entacapone Teva in children below age 18 have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Entacapone Teva fit-tfal taħt it-18-il sena ma ġewx determinati s'issa.
English: blister (PVC/alu) 3 x 28 tablets (24 active + 4 placebo)
Maltese: folja (PVC/alu) 3 x 28 pillola (24 attivi + 4 plaċebo)
English: Package size blister (PVC/alu) 28 tablets (24 active + 4 placebo)
Maltese: Daqs talpakkett folja (PVC/alu) 28 pillola (24 attivi + 4 plaċebo)
English: o The need of pre-medication by a bronchodilator 5-15 minutes before the Bronchitol initiation dose assessment and before each therapeutic administration of Bronchitol.
Maltese: o Il-ħtieġa ta' premedikazzjoni permezz ta' bronkodilatur 5-15-il minuta qabel ilvalutazzjoni tad-doża inizjali ta' Bronchitol u qabel kull amministrazzjoni terapewtika ta' Bronchitol.
English: Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder.
Maltese: Qabel it-tnedija tal-prodott fl-Istat Membru, l-awtorità kompetenti nazzjonali għandha taqbel malkontenut u l-format tal-materjal edukattiv mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: The risk of bronchospasm during treatment o The need to perform the Bronchitol initiation dose assessment to identify patients who have bronchial hyperresponsiveness in response to inhaled mannitol by measuring the degree of bronchoconstriction that occurs following sequential administrations of mannitol.
Maltese: Ir-riskju ta' bronkospażmu matul it-trattament o Il-ħtieġa li ssir valutazzjoni tad-doża inizjali ta' Bronchitol sabiex jiġu identificati dawk ilpazjenti li jkollhom ipersensibilità bronkjali b'reazzjoni għall-inalazzjoni tal-mannitolu, billi jitkejjel il-grad tal-bronkokostrizzjoni li tirriżulta wara amministrazzjonijiet sekwenzjali tal-mannitolu.
English: The risk of haemoptysis during treatment o That Bronchitol has not been studied in patients with a history of significant haemoptysis (>60 ml) in the previous three months.
Maltese: Ir-riskju ta' emottiżi matul it-trattament o Bronchitol ma ġiex studjat f'pazjenti bi storja medika ta' emottiżi sinifikanti (>60 ml) matul it-tliet xhur preċedenti.
English: o The need for monitoring and when to withhold treatment.
Maltese: o Il-ħtieġa tas-sorveljanza u meta għandu jitwaqqaf it-trattament.
English: o How to interpret the results of the Bronchitol initiation dose assessment as Pass, Fail or Incomplete.
Maltese: o Kif għandhom jiġu interpretati r-riżultati tal-valutazzjoni tad-doża inizjali ta' Bronchitol, jiġifieri Pass, Negattiv jew Inkomplet.
English: Summary of Product Characteristics and Patient Information Leaflet Educational material for Healthcare Professionals
Maltese: Sommarju tal-Karatteristiċi tal-Prodott u Fuljett ta' Tagħrif għall-Pazjent Materjal edukattiv għall-Professjonisti tal-Qasam tas-Saħħa
English: The Marketing Authorisation Holder (MAH) should ensure that at launch all Healthcare Professionals who are expected to use and/or prescribe Bronchitol are provided with an educational pack.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jassigura li fi żmien it-tnedija l-professjonisti kollha tal-qasam tas-saħħa li huma mistennija jippreskrivu Bronchitol jingħataw pakkett edukattiv.
English: The potential risk of cough related sequelae during treatment o The need to train the patient to minimise cough during administration in using the correct inhalation technique.
Maltese: Ir-riskju potenzjali ta' konsegwenzi kkaġunati mis-sogħla matul it-trattament o Il-ħtieġa li l-pazjent jitħarreġ kif inaqqas is-sogħla kemm jista' jkun matul lamministrazzjoni billi jħaddem it-teknika korretta tal-inalazzjoni.
English: Commission decision date: 22/03/2017.
Maltese: Dati tad-deċiżjoni tal-Kummissjoni: 22/03/2017.
English: They have been authorised for up to 20 years as Valette and other trade names via national procedures in the following EU Member States: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Maltese: L-Awstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, l-Estonja, il-Ġermanja, l-Ungerija, il-Latvja, il-Litwanja, il-Lussemburgu, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja u Spanja.
English: • Your acne will usually improve after 3 to 6 months of treatment with dienogest/ethinylestradiol.
Maltese: • Normalment l-akne tiegħek titjieb wara 3 sa 6 xhur ta' kura b'dienogest/ethinylestradiol.
English: • Data from two phase III trials (study no. A07062 and A28501) in a total of around 2,400 women (mostly with moderate acne) showed that dienogest/ethinylestradiol was more effective than placebo and at least as effective as ethinylestradiol/norgestimate and ethinylestradiol/cyproterone at treating acne in terms of changes in inflammatory lesion count, total lesion count and improvement of facial acne according to IGA (Investigator's Global Assessment).
Maltese: A07062 u A28501) f'total ta' madwar 2,400 mara (laktar b'akne moderata) uriet li dienogest/ethinylestradiol kien aktar effettiv minn plaċebo u talanqas effettiv daqs ethinylestradiol/norgestimate u ethinylestradiol/cyproterone fil-kura ta' akne f'termini ta' tibdil fl-għadd ta' feriti infjammati, l-għadd totali ta' feriti u titjib fl-akne tal-wiċċ skont l-IGA (Valutazzjoni Globali tal-Investigatur).
English: Dienogest and ethinylestradiol are two types of hormones, a progestogen and an oestrogen.
Maltese: Dienogest u ethinylestradiol huma żewġ tipi ta' ormoni, proġestoġen u estroġenu.
English: Medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg are used as oral contraceptives and for the treatment of moderate acne.
Maltese: Mediċini li fihom dienogest 2 mg u ethinylestradiol 0.03 mg jintużaw bħala kontraċettivi orali u għallkura ta' akne moderata.
English: They work by blocking the effects of a class of hormones called androgens.
Maltese: Dawn il-mediċini jaħdmu billi jimblokkaw l-effetti ta' klassi ta' ormoni msejħa androġeni.
English: The review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne was initiated on 25 February 2016 at the request of the UK's medicines agency (the Medicines and Healthcare products Regulatory Agency, MHRA), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' mediċini li fihom dienogest 2 mg u ethinylestradiol 0.03 mg għall-akne nbdiet fil25 ta' Frar 2016 fuq talba tal-aġenzija tal-mediċini tar-Renju Unit (l-Aġenzija Regolatorja tal-Mediċini u l-Kura tas-Saħħa, l-MHRA), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Maltese: L-opinjoni finali tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE.
English: • When taking dienogest/ethinylestradiol, you should be alert to the signs and symptoms of blood clots in veins, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arms or legs.
Maltese: • Meta tkun qed tieħu dienogest/ethinylestradiol, għandek toqgħod attenta għas-sinjali u għassintomi ta' emboli tad-demm fil-vini, li jistgħu jinkludu uġigħ qawwi jew nefħa fir-riġlejn, qtugħ ta' nifs f'daqqa u mingħajr spjegazzjoni, nifs mgħaġġel jew sogħla, uġigħ fis-sider, u dgħjufija jew titrix tal-wiċċ, tad-dirgħajn jew tar-riġlejn.
English: The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low.
Maltese: Ir-riskju magħruf ta' tromboemboliżmu venuż (VTE jew emboli tad-demm fil-vini), li jista' jseħħ bil-kontraċettivi ormonali kkombinati kollha, huwa meqjus baxx.
English: However, to date, there are insufficient data to accurately determine the relative risk of venous thromboembolism (VTE) with respect to other combined hormonal contraceptives containing other progestogens.
Maltese: Madankollu, sal-lum, ma hemmx biżżejjed data sabiex jiġi determinat b'mod preċiż ir-riskju relattiv ta' tromboemboliżmu venuż (VTE) fir-rigward ta' kontraċettivi ormonali kkombinati oħra li fihom proġestoġeni oħra.
English: • It is not known how the efficacy of dienogest/ethinylestradiol compares with other acne treatments, i.e. topical treatments and systemic antibiotics.
Maltese: • Mhuwiex magħruf kif l-effikaċja ta' dienogest/ethinylestradiol tipparaguna ma' dik ta' kuri oħra talakne, jiġifieri kuri topiċi u antibijotiċi sistemiċi.
English: Considering the observed benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen.
Maltese: Meta wieħed iqis il-benefiċċji osservati ta' dienogest/ethinylestradiol fil-kura tal-akne, ir-riskju potenzjali ta' VTE u n-natura tal-marda, is-CHMP ikkonkluda li din il-kombinazzjoni għandha tintuża biss wara li ċertu kuri oħra jkunu fallew, u biss meta tintuża kontraċezzjoni orali.
English: • The combination dienogest/ethinylestradiol should be used for the treatment of moderate acne only after failure of suitable local therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Maltese: • Il-kombinazzjoni ta' dienogest/ethinylestradiol għandha tintuża għall-kura ta' akne moderata biss wara li terapiji lokali xierqa jew kura antibijotika orali f'nisa li jkunu għażlu li jużaw kontraċettiv orali jkunu fallew.
English: • Since improvement of acne usually requires at least 3 months of treatment with dienogest/ethinylestradiol and further improvement has been seen after 6 months, women should be assessed 3 to 6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Maltese: • Peress li normalment it-titjib tal-akne jieħu mill-inqas 3 xhur ta' kura b'dienogest/ethinylestradiol u titjib ulterjuri ġie osservat wara 6 xhur, in-nisa għandhom jiġu vvalutati wara 3 sa 6 xhur minn meta jkunu bdew il-kura u perjodikament wara dan biex tiġi riveduta l-ħtieġa għat-tkomplija talkura.
English: On 26 January 2016, the European Medicines Agency (EMA) recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when suitable treatments applied to the skin or antibiotics taken by mouth have not worked.
Maltese: Fis-26 ta' Jannar 2016, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat li l-mediċini li fihom kombinazzjoni ta' dienogest 2 mg u ethinylestradiol 0.03 mg jistgħu jkomplu jintużaw għall-kura ta' akne moderata meta kuri xierqa applikati fuq il-ġilda jew antibijotiċi orali ma jkunux ħadmu.
English: This alters the production of oils in the skin and also suppresses ovulation.
Maltese: Dan ibiddel il-produzzjoni ta' żjut fil-ġilda u jrażżan ukoll l-ovulazzjoni.
English: The CHMP also recommended that women should be assessed by their doctor 3 to 6 months after starting treatment and periodically thereafter to review the need for continuation of treatment.
Maltese: It-tabib tiegħek ser jivvaluta jekk għandekx tkompli l-kura b'din il-mediċina wara 3 sa 6 xhur minn meta tkun bdejt il-kura u regolarment wara dan.
English: • Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception.
Maltese: • Meta wieħed iqis l-evidenza disponibbli, u sabiex in-nisa ma jiġux esposti bla bżonn għal riskju potenzjali akbar ta' VTE, l-użu ta' dienogest/ethinylestradiol għandu jkun ristrett għat-tieni linja u għal nisa li jagħżlu wkoll kontraċezzjoni orali.
English: • You should be aware that, as with other hormonal contraceptives, there is a risk of blood clots associated with the use of dienogest/ethinylestradiol.
Maltese: • Għandek tkun taf li, bħal fil-każ ta' kontraċettivi ormonali oħrajn, hemm riskju ta' emboli taddemm assoċjat mal-użu ta' dienogest/ethinylestradiol.
English: It is available as tablets (20 mg).
Maltese: Jiġi bħala pilloli (20 mg).
English: The full EPAR for Conbriza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Conbriza jinstab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 06-2015.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'06-2015.
English: After three years, 2% of the patients receiving Conbriza (35 out of 1,724) had new fractures compared with 4% of those receiving placebo (59 out of 1,741).
Maltese: Wara tliet snin, 2% tal-pazjenti ttrattati b'Conbriza (35 minn 1,724) kellhom ksur ġdid meta mqabbla ma' 4% ta' dawk ittrattati bil-plaċebo (59 minn 1,741).
English: The active substance in Conbriza, bazedoxifene, is a selective oestrogen receptor modulator (SERM).
Maltese: Is-sustanza attiva f'Conbriza, il-bazedoxifene, hija modulatur selettiv tar-riċettur tal-estroġenu (SERM).
English: This is a summary of the European public assessment report (EPAR) for Conbriza.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Conbriza.
English: Conbriza is a medicine that contains the active substance bazedoxifene.
Maltese: Conbriza huwa mediċina li fiha s-sustanza attiva bazedoxifene.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Conbriza on 17 April 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Conbriza fis-17 ta' April 2009.
English: In both main studies the effects of Conbriza were similar to the effects of raloxifene.
Maltese: Fiż-żewġ studji prinċipali l-effetti ta' Conbriza kienu simili għall-effetti ta' raloxifene.
English: Conbriza has been compared with raloxifene (another medicine used to treat osteoporosis) and placebo (a dummy treatment) in one main study involving about 7,500 women with osteoporosis who had been through the menopause.
Maltese: Conbriza tqabbel mar-raloxifene (mediċina oħra użata fit-trattament tal-osteoporożi) u ma' plaċebo (trattament finta) fi studju ewlieni wieħed li involva 7,500 mara bl-osteoporożi li għaddew millmenopawża.
English: Conbriza must not be used in women who have had venous thromboembolism events (problems due to the formation of blood clots in the veins) including deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Maltese: Conbriza ma għandux jintuża f'nisa li kellhom episodji ta' tromboemboliżmu tal-vini (problemi minħabba l-formazzjoni ta' emboli fid-demm fil-vini) fosthom trombożi tal-vini fondi (embola taddemm f'vina fonda, ġeneralment fis-sieq), emboliżmu pulmonari (embola tad-demm fil-pulmuni) u trombożi tal-vini tar-retina (embola tad-demm fuq in-naħa ta' wara tal-għajn).
English: Conbriza was also compared with raloxifene and placebo in another main study involving 1,583 postmenopausal women who were considered to be at risk of osteoporosis.
Maltese: Conbriza tqabbel ukoll mar-raloxifene u ma' plaċebo fi studju ewlieni ieħor li involva 1,583 mara li għaddew mill-menopawża meqjusa f'riskju ta' osteoporożi.
English: The most common side effects with Conbriza (seen in more than 1 patient in 10) are hot flushes, muscle spasms and peripheral oedema (swelling, especially of the ankles and feet).
Maltese: L-aktar effetti sekondarji komuni b'Conbriza (li dehru f'aktar minn pazjent 1 minn kull 10) huma għadd ta' sħanat, spażmi fil-muskoli u edema periferali (nefħa, speċjalment fl-għekiesi u fis-saqajn).
English: What is the risk associated with Conbriza?
Maltese: X'inhu r-riskju assoċjat ma' Conbriza?
English: The difference was more relevant in the sub-group of women at higher risk of fractures before the study.
Maltese: Id-differenza kienet aktar rilevanti fissottogrupp ta' nisa f'riskju ogħla ta' ksur qabel l-istudju.
English: All of the women in the study were also given calcium and vitamin D supplements.
Maltese: In-nisa kollha involuti fl-istudju ngħataw ukoll supplimenti ta' kalċju u ta' vitamina D.
English: Why has Conbriza been approved?
Maltese: Għaliex ġie approvat Conbriza?
English: A risk management plan has been developed to ensure that Conbriza is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Conbriza jintuża bl-aktar mod sigur possibbli.
English: What is Conbriza?
Maltese: X'inhu Conbriza?
English: What benefit has Conbriza shown during the studies?
Maltese: Liema benefiċċju wera Conbriza matul l-istudji?
English: The CHMP decided that Conbriza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Conbriza huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Protection starts 21 days after vaccination and lasts for 105 days.
Maltese: Il-protezzjoni tibda 21 jum wara t-tilqima u ddum 105 ijiem.
English: Genetically modified recombinant Stx2e antigen
Maltese: Antiġen ġenetikament immodifikat rikombinanti ta' Stx2e
English: Ecoporc Shiga is a vaccine containing the modified toxin Stx2e.
Maltese: Ecoporc Shiga huwa vaċċin li fih it-tossin modifikat Stx2e.
English: The modified toxin in the vaccine is produced by a method known as ‘recombinant DNA technology': it is made by bacteria which have received a gene (DNA) that makes them produce the modified toxin.
Maltese: It-tossin modifikat fil-vaċċin ġie prodott b'metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA': jiġi magħmul minn batterji li jkunu rċevew ġene (DNA) li jġiegħlhom jipproduċu t-tossin modifikat.
English: Ecoporc Shiga contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Maltese: Ecoporc Shiga fih aġġuvant (aluminium hydroxide) biex itejjeb ir-rispons immuni.
English: The most common side effects after injection of Ecoporc Shiga (which may affect up to 1 in 10 animals) are mild swelling, lasting for up to 7 days, at the injection site and a slight rise in body temperature for up to two days after injection; both resolve without treatment.
Maltese: L-aktar effetti sekondarji komuni wara l-injezzjoni ta' Ecoporc Shiga (li jistgħu jaffettwaw sa annimal 1 minn kull 10) huma nefħa ħafifa, li ddum mhux aktar minn 7 ijiem, fis-sit tal-injezzjoni u żieda żgħira fit-temperatura tal-ġisem ta' mhux aktar minn jumejn wara l-injezzjoni; it-tnejn li huma jgħibu mingħajr kura.
English: Ecoporc Shiga is used in pigs from the age of 4 days for active immunisation against oedema disease, which leads to fluids accumulating in the tissues of the stomach and gut.
Maltese: Ecoporc Shiga jintuża fil-ħnieżer minn età ta' 4 ijiem għall-immunizzazzjoni attiva kontra l-marda taledema, li twassal biex jakkumulaw fluwidi fit-tessuti tal-istonku u tal-imsaren.
English: The vaccine is given as a single injection into a muscle, preferably the neck muscle behind the ear.
Maltese: Il-vaċċin jingħata bħala injezzjoni unika fil-muskolu, preferibbilment fil-muskolu tal-għonq wara lwidna.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ecoporc Shiga on 10 April 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Ecoporc Shiga fi 10/04/2013.
English: The purpose of the studies was to establish how long it took for piglets to be fully protected, the length of time protection lasts against oedema disease as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Maltese: L-għan talistudji kien li jistabbilixxu t-tul ta' żmien biex il-qżieqeż ikunu kompletament protetti, it-tul ta' żmien li l-protezzjoni kontra l-marda tal-edema ddum kif ukoll l-influwenza ta' antikorpi materni (trażmessi mill-omm) fuq l-effikaċja tal-vaċċin.
English: What is the risk associated with Ecoporc Shiga?
Maltese: X'riskji huma assoċjati ma' Ecoporc Shiga?
English: The laboratory studies showed that the injection had its full effect by 21 days, and that protection lasted for at least 105 days after injection; protection was not affected by antibodies transmitted from the mother.
Maltese: L-istudji fil-laboratorju urew li l-injezzjoni laħqet l-effett sħiħ tagħha wara 21 jum, u li l-protezzjoni damet għal mill-inqas 105 ijiem wara l-injezzjoni; il-protezzjoni ma ġietx affettwata minn antikorpi trażmessi mill-omm.
English: The field studies showed that the vaccine reduced the mortality and clinical signs of oedema disease compared with placebo: in all three studies no piglets receiving Ecoporc Shiga died, while up to 11% of piglets receiving placebo died.
Maltese: L-istudji fuq il-post urew li l-vaċċin naqqas il-mortalità u s-sinjali kliniċi tal-marda tal-edema meta mqabbla ma' plaċebo: fit-tliet studji kollha l-ebda qażquż li kien qed jirċievi Ecoporc Shiga ma miet, filwaqt li sa 11% tal-qżieqeż li rċevew plaċebo mietu.
English: What is Ecoporc Shiga?
Maltese: X'inhu Ecoporc Shiga?
English: Three field trials were also performed to assess the effect on mortality and clinical signs of oedema disease in a total of 518 piglets receiving Ecoporc Shiga compared with a similar number of piglets receiving placebo (a dummy injection).
Maltese: Saru wkoll tliet provi fuq il-post biex jevalwaw l-effett fuq il-mortalità u s-sinjali kliniċi tal-marda taledema f'total ta' 518-il qażquż li kienu qed jirċievu Ecoporc Shiga meta mqabbla ma' għadd simili ta' qżieqeż li kienu qed jirċievu plaċebo (injezzjoni finta).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ecoporc Shiga exceed the risks for the approved indications and recommended that Ecoporc Shiga be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Ecoporc Shiga jegħlbu r-riskji għall-indikazzjonijiet approvati u rrakkomanda li Ecoporc Shiga jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Ecoporc Shiga is a vaccine containing a form of Shiga toxin (Stx2e) that has been modified so that it can no longer cause disease.
Maltese: Ecoporc Shiga huwa vaċċin li fih forma tat-tossin Shiga (Stx2e) li ġie modifikat sabiex ma jkunx jista' jibqa' jikkawża mard.
English: Oedema disease is found worldwide and usually occurs in the first two weeks after weaning of the piglets, and is an acute (short-term) condition which can lead to death within 24 to 48 hours.
Maltese: Ilmarda tal-edema tinsab madwar id-dinja u ġeneralment isseħħ fl-ewwel ġimagħtejn wara l-ftim talqżieqeż, u hija kondizzjoni akuta (għal żmien qasir) li tista' twassal għall-mewt fi żmien 24 sa 48 siegħa.
English: Other information about Ecoporc Shiga:
Maltese: Tagħrif ieħor dwar Ecoporc Shiga: