FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder provided written explanations on 2 June 2008.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta spjegazzjonijiet bil-miktub fit-2 ta' Ġunju 2008.
English: Gedeon Richter Plc submitted a Marketing Authorisation Application (MAA) via mutual recognition procedure for Lisonorm on the basis of the marketing authorisation granted by Hungary on 30 April 2004.
Maltese: Gedeon Richter Plc ippreżentat Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAA) permezz ta' proċedura ta' rikonoxximent reċiproku għal Lisonorm fuq il-bażi tal-awtorizzazzjoni għattqegħid fis-suq mogħtija mill-Ungerija fit-30 ta' April 2004.
English: During their July 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lisonorm, that the objections raised by Czech Republic and Latvia should not prevent the granting of a Marketing Authorisation.
Maltese: Matul il-laqgħa tiegħu ta' Lulju 2008, is-CHMP, fid-dawl tad-dejta ġenerali ppreżentata u taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proporzjon benefiċċju/riskju kien wieħed favorevoli għal Lisonorm, li l-oġġezzjonijiet imqajma mir-Repubblika Ċeka u mil-Latvja ma għandhomx jimpedixxu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: The arbitration procedure started on 21 February 2008 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fil-21 ta' Frar 2008 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: The Mutual Recognition Procedure started on 3 August 2007.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku bdiet fit-3 ta' Awwissu 2007.
English: The Czech Republic and Latvia referred the reasons for disagreement to the EMEA on 1 February 2008.
Maltese: Ir-Repubblika Ċeka u l-Latvja irriferew ir-raġunijiet għan-nuqqas ta' qbil lill-EMEA fl-1 ta' Frar 2008.
English: 27 July 2010
Maltese: 27 Lulju 2010
English: Background information
Maltese: Informazzjoni ġenerali
English: 1 Article 34 of Directive 2001/82/EC
Maltese: 1 L-Artikolu 34 tad-Direttiva 2001/82/KE
English: Written explanations were provided by the marketing authorisation holders on 20 April 2009 and 16 November 2009.
Maltese: Ġew ipprovduti spjegazzjonijiet bilmiktub mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-20 ta' April 2009 u fis16 ta' Novembru 2009.
English: Opinion following an Article 34
Maltese: Opinjoni wara referenza skont l-Artikolu 34
English: Premixes containing tiamulin are marketed across the European Union under a variety of invented names and the authorised premix formulations are based on tiamulin hydrogen fumarate in a variety of concentrations: 0.8%, 2%, 10% and 80%.
Maltese: It-taħlitiet minn qabel li jkun fihom tiamulin huma kkummerċjalizzati madwar l-Unjoni Ewropea taħt varjetà ta' ismijiet ivvintati u l-formulazzjonijiet tat-taħlita minn qabel awtorizzati huma bbażati fuq tiamulin hydrogen fumarate f'varjetà ta' konċentrazzjonijiet: 0.8%, 2%, 10% u 80%.
English: Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and it is used only in veterinary medicine.
Maltese: Tiamulin huwa antibijotiku semi-sintetiku li jappartjeni għall-grupp ta' antibijotiċi pleuromutilin u jintuża biss fil-mediċina veterinarja.
English: The referral procedure started on 15 October 2008.
Maltese: Il-proċedura ta' referenza bdiet fil-15 ta' Ottubru 2008.
English: The rapporteur and co-rapporteur appointed were: Prof. Stane Srčič and Dr Karolina Törneke respectively.
Maltese: Ir-rapporteur u l-ko-rapporteur maħtura kienu: il-Professur Stane Srčič u t-tabiba Karolina
English: Tiamulin is used for the treatment and prevention of gastrointestinal and respiratory infections caused by different bacterial pathogens in pigs, poultry and rabbits.
Maltese: Tiamulin jintuża għat-trattament u l-prevenzjoni ta' infezzjonijiet gastrointestinali u respiratorji kkawżati minn patoġeni batterjali differenti fil-ħnieżer, it-tjur u l-fniek.
English: The final opinion was converted into a Decision by the European Commission on 27 July 2010.
Maltese: L-opinjoni finali ġiet mibdula f'Deċiżjoni mill-Kummissjoni Ewropea fi 27 Lulju 2010.
English: Due to differences among the nationally authorised summaries of product characteristics for Tiamutin premix and associated names across the European Union, especially as regards indications for use, amount to be administered and administration route and withdrawal periods, on 18 September 2008 Ireland and Belgium referred the matter to the European Medicines Agency under Article 34 of Directive 2001/82/EC.
Maltese: Minħabba differenzi fost is-sommarji awtorizzati fuq livell nazzjonali tal-karatteristiċi tal-prodott għattaħlita minn qabel ta' Tiamutin u l-ismijiet assoċjati madwar l-Unjoni Ewropea, b'mod speċjali firrigward tal-indikazzjonijiet għall-użu, l-ammont li għandu jingħata u mnejn jingħata u l-perjodi ta' rtirar, fit-18 ta' Settembru 2008, l-Irlanda u l-Belġju rreferew l-kwistjoni lill-Aġenzija Ewropea għallMediċini skont l-Artikolu 34 tad-Direttiva 2001/82/KE.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 10 March 2010, an opinion recommending the amendment of the marketing authorisations in terms of the summary of the product characteristics and labelling in order to harmonise the indications for use, amount to be administered and administration route and withdrawal periods.
Maltese: Fuq il-bażi tal-valutazzjoni tar-rapporteurs tad-dejta disponibbli bħalissa, fl-10 ta' Marzu 2010 is-CVMP adotta opinjoni li tirrakkomanda l-emenda tal-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward tassommarju tal-karatteristiċi tal-prodott u t-tikketta sabiex jiġu armonizzati l-indikazzjonijiet għall-użu, lammont li għandu jingħata u mnejn jingħata u l-perjodi ta' tiżmim.
English: Oral explanations were given on 10 February 2010.
Maltese: Spjegazzjonijiet verbali ingħataw fl-10 ta' Frar 2010.
English: referral for Tiamutin premix and associated names
Maltese: Il-konklużjonijiet xjentifiċi huma pprovduti fl-Anness
English: The target species are: pigs, chickens, turkeys and rabbits.
Maltese: L-ispeċi mmirati huma: il-ħnieżer, it-tiġieġ, id-dundjani u l-fniek.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20
English: Advanced melanoma
Maltese: Melanoma avvanzata
English: Further information on Yervoy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Yervoy.
Maltese: ema.europa.eu/medicines/human/EPAR/Yervoy.
English: This overview was last updated in 12-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'12-2018.
English: Other information about Yervoy
Maltese: Informazzjoni oħra dwar Yervoy
English: The active substance in Yervoy, ipilimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Yervoy, l-ipilimumab, hija antikorp monoklonali.
English: After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Maltese: Wara 24 xahar, 66.5 % tal-pazjenti li ngħataw il-kombinazzjoni kienu ħajjin meta mqabbla ma' 52.9 % fil-grupp ta' sunitinib.
English: In addition, 41.6% of patients (177 out of 423) responded to the treatment with the combination compared with 26.5% (112 out of 416) of those receiving sunitinib.
Maltese: Barra minn hekk, 41.6 % tal-pazjenti (177 minn 423) irrispondew għall-kura bil-kombinazzjoni meta mqabbla ma' 26.5 % (112 minn 416) ta' dawk li rċevew sinutinib.
English: In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, overall survival with Yervoy combined with an experimental medicine called ‘gp100' was 10 months, compared with 6 months in patients receiving gp100 alone.
Maltese: Fi studju li fih ħadu sehem 676 adult li fuqhom kura preċedenti għal melanoma avvanzata ma kinitx ħadmet jew waqfet taħdem, is-sopravivenza ġenerali b'Yervoy flimkien ma' mediċina esperimentali msejħa “gp100” kienet 10 xhur, meta mqabbla ma' 6 xhur f'pazjenti li rċevew gp100 waħidha.
English: Yervoy received a marketing authorisation valid throughout the EU on 13 July 2011.
Maltese: Yervoy rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-13 ta' Lulju 2011.
English: What are the risks associated with Yervoy?
Maltese: X'inhuma r-riskji assoċjati ma' Yervoy?
English: In two small studies involving a total of 30 adolescents aged 12 to 18 years with advanced melanoma, treatment with Yervoy produced similar levels of medicine in blood as in adults.
Maltese: F'żewġ studji żgħar li fihom ħadu sehem total ta' 30 adolexxent li kellhom minn 12 sa 18-il sena b'melanoma avvanzata, il-kura b'Yervoy ipproduċiet livelli simili ta' mediċina fid-demm għal dawk fladulti.
English: Yervoy is a cancer medicine used in adults and adolescents from 12 years of age with advanced melanoma (a type of skin cancer) and in adults with advanced renal cell carcinoma (a kidney cancer).
Maltese: Yervoy huwa mediċina kontra l-kanċer li tintuża fl-adulti u fl-adolexxenti minn 12-il sena ‘l fuq b'melanoma avvanzata (tip ta' kanċer tal-ġilda) u fl-adulti b'karċinoma avvanzata taċ-ċelloli renali (kanċer tal-kliewi).
English: Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation.
Maltese: Yervoy huwa spiss assoċjat ma' effetti sekondarji li jirriżultaw minn attività eċċessiva tas-sistema immunitarja, li jinkludu reazzjonijiet severi u infjammazzjoni.
English: In the first of these studies involving 945 adults, patients treated with Yervoy and nivolumab lived for 11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone.
Maltese: Fl-ewwel studju li fih ħadu sehem 945 adult, il-pazjenti kkurati b'Yervoy u nivolumab għexu medja ta' 11.7 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 6.9 xhur għal dawk ikkurati b'nivolumab waħdu u ma' 2.9 xhur għal dawk ikkurati b'Yervoy waħdu.
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Yervoy and nivolumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Maltese: Studju ewlieni li fih ħadu sehem 1,096 adult b'karċinoma avvanzata taċ-ċelloli renali li ma kinitx ġiet ikkurata qabel qabbel il-kura b'Yervoy u nivolumab mal-kura b'mediċina oħra kontra l-kanċer għallkarċinoma taċ-ċelloli renali, sunitinib.
English: Finally, two studies found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1.
Maltese: Finalment, żewġ studji sabu li l-kombinazzjoni ta' Yervoy u nivolumab hija effettiva biex tikkura melanoma avvanzata f'adulti li ma kinux ġew ikkurati qabel, u li l-kanċer tagħhom ipproduċa proteina msejħa PD-L1.
English: In the second study involving 142 adults, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone.
Maltese: Fittieni studju li fih ħadu sehem 142 adult, il-marda kienet ikkontrollata f'56 % tal-pazjenti li kienu qed jirċievu Yervoy u nivolumab meta mqabbla ma' 9 % tal-pazjenti li kienu qed jirċievu Yervoy waħdu.
English: The most frequent side effects of the medicine are mild to moderate in severity.
Maltese: L-effetti sekondarji l-aktar frekwenti tal-mediċina huma ħfief sa moderati fis-severità.
English: It acts on T cells by attaching to and blocking the activity of CTLA-4, a protein that controls the activity of T cells.
Maltese: Din taġixxi fuq iċ-ċelloli T billi teħel ma' u timblokka l-attività ta' CTLA-4, proteina li tikkontrolla l-attività taċ-ċelloli T.
English: Yervoy is usually used in combination with another medicine, nivolumab, but can also be used on its own for melanoma.
Maltese: Yervoy normalment jintuża flimkien ma' mediċina oħra, nivolumab, iżda jista' wkoll jintuża waħdu għall-melanoma.
English: Additional common side effects when Yervoy is used with nivolumab include fever, reduced or increased levels of thyroid hormones, colitis (inflammation of the lower gut), joint pain, headache and breathing difficulty.
Maltese: Effetti sekondarji komuni addizzjonali meta Yervoy jintuża ma' nivolumab jinkludu deni, livelli mnaqqsa jew miżjuda ta' ormoni tat-tirojde, kolite (infjammazzjoni tal-musrana t'isfel), uġigħ fil-ġogi, uġigħ ta' ras u diffikultà biex tieħu n-nifs.
English: Advanced renal cell carcinoma
Maltese: Karċinoma avvanzata taċ-ċelloli renali
English: Yervoy contains the active substance ipilimumab.
Maltese: Yervoy fih is-sustanza attiva ipilimumab.
English: The effects of Yervoy in adolescents are expected to be similar to those in adults.
Maltese: L-effetti ta' Yervoy fl-adolexxenti huma mistennija li jkunu simili għal dawk fl-adulti.
English: Yervoy is given by infusion (drip) into a vein over 90 minutes and the dose depends on the patient's body weight.
Maltese: Yervoy jingħata b'infużjoni (dripp) fil-vina matul 90 minuta u d-doża tiddependi mill-piż tal-ġisem talpazjent.
English: Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.
Maltese: Diversi studji oħra li fihom ħadu sehem adulti li ma kinux ikkurati qabel sabu li pazjenti kkurati b'Yervoy bi 3 mg għal kull kg għexu medja ta' 13.5 xhur.
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Maltese: Iż-żmien li l-pazjenti għexu qabel ma l-marda tagħhom marret għall-agħar kien 11.6 xhur bil-kombinazzjoni meta mqabbel ma' 8.4 b'sunitinib.
English: The most common side effects (which may affect more than 1 in 10 people) are diarrhoea, rash, itching, tiredness, nausea (feeling sick), vomiting, decreased appetite and abdominal pain (belly ache).
Maltese: L-effetti sekondarji l-aktar komuni (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma dijarea, raxx, ħakk, għeja, nawżja (tħossok ma tiflaħx), rimettar, nuqqas ta' aptit u wġigħ addominali (uġigħ ta' żaqq).
English: In a study involving 502 adults whose advanced melanoma had not been treated previously, patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine.
Maltese: Fi studju li fih ħadu sehem 502 adulti li l-melanoma avvanzata tagħhom ma kinitx ġiet ikkurata qabel, il-pazjenti kkurati b'doża għolja ta' Yervoy u dacarbazine għexu medja ta' 11-il xahar, meta mqabbla ma' 9 xhur għal dawk li ngħataw plaċebo (kura finta) flimkien ma' dacarbazine.
English: How does Yervoy work?
Maltese: Kif jaħdem Yervoy?
English: As for all medicines, data on the use of Yervoy are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Yervoy hija ssorveljata kontinwament.
English: Several studies have shown that Yervoy is effective in prolonging the lives of patients with advanced melanoma.
Maltese: Diversi studji wrew li Yervoy huwa effettiv biex itawwal il-ħajjiet ta' pazjenti b'melanoma avvanzata.
English: The company that markets Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are given a brochure with safety information on the medicine including the side effects resulting from excessive activity of the immune system.
Maltese: Il-kumpanija li tqiegħed Yervoy fis-suq għandha tiżgura li l-professjonisti kollha fil-qasam tal-kura tassaħħa li mistennija jordnaw il-mediċina kif ukoll il-pazjenti jingħataw fuljett b'informazzjoni dwar issigurtà tal-mediċina, inklużi l-effetti sekondarji li jirriżultaw mill-attività eċċessiva tas-sistema immunitarja.
English: In a study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg.
Maltese: Fi studju li fih ħadu sehem 727 adult b'melanoma avvanzata, pazjenti kkurati b'Yervoy 3 mg għal kull kg għexu medja ta' madwar 12-il xahar meta mqabbla ma' 16-il xahar għal dawk ikkurati b'10 mg għal kull kg. Madankollu, il-pazjenti kkurati bid-doża ogħla kellhom aktar effetti sekondarji u kellhom probabbiltà inqas li jtemmu l-kura bħala riżultat ta' dan.
English: Therefore, all adolescents treated with Yervoy will be monitored closely.
Maltese: Għalhekk, l-adolexxenti kollha li jiġu kkurati b'Yervoy se jiġu mmonitorjati mill-qrib.
English: For the full list of side effects and restrictions with Yervoy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Yervoy, ara l-fuljett ta' tagħrif.
English: This summary was last updated in April 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'April 2017.
English: The full EPAR for Suvaxyn Circo+MH RTU can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Suvaxyn Circo+MH RTU also contains adjuvants (ingredients that strengthen the immune response) called squalene, poloxamer 401 and polysorbate 80.
Maltese: Suvaxyn Circo+MH RTU fih ukoll aġġuvanti (ingredjenti li jsaħħu r-rispons immunitarju) imsejħa skwalena, polossamer 401 and polisorbat 80.
English: Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
Maltese: Il-protezzjoni damet għal 23 ġimgħa wara t-tilqima għal PCV2 u Mycoplasma hyopneumonia.
English: The most common side effect with Suvaxyn Circo+MH RTU (which may affect more than 1 in 10 pigs) are an increase in body temperature (on average 1 °C) in the first 24 hours after vaccination which resolves within 48 hours without treatment.
Maltese: RTU (li jista' jaffettwa aktar minn ħanżir 1 minn kull 10) huwa żieda fit-temperatura tal-ġisem (medja ta' 1°C) fl-ewwel 24 siegħa wara t-tilqim iżda tinżel fi żmien 48 siegħa mingħajr kura.
English: Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Maltese: Suvaxyn Circo+MH RTU fih sustanzi attivi inattivati (maqtula) derivati miċ-ċirkovirus tal-ħnieżer tat-tip 2 u mill-batterji Mycoplasma hyopneumoniae
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Suvaxyn Circo+MH RTU.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo+MH RTU on 6 November 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Suvaxyn Circo+MH RTU valida fl-UE kollha fis-6 ta' Novembru 2015.
English: Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Maltese: L-infezzjonjiet taċ-cirkovirus tal-ħnieżer tat-tip 2 (PCV2) jistgħu jipproduċu sinjali kliniċi bħal telf fil-piż jew nuqqas ta' żvilupp, tkabbir fl-għoqod limfatiċi, diffikultà fit-teħid tan-nifs, ġilda pallida u suffejra (ġilda safranija).
English: Suvaxyn Circo+MH RTU is a veterinary vaccine used to protect pigs over the age of 3 weeks against infections with porcine circovirus and the bacteria Mycoplasma hyopneumoniae.
Maltese: Suvaxyn Circo+MH RTU huwa vaċċin veterinarju użat sabiex jipproteġi lill-ħnieżer li għandhom iktar minn 3 ġimgħat kontra infezzjonijiet biċ-cirkovirus tal-ħnieżer u l-batterji Mycoplasma hyopneumoniae.
English: Suvaxyn Circo+MH RTU is a vaccine.
Maltese: Suvaxyn Circo+MH RTU huwa vaċċin.
English: Swelling, less than 2 cm in diameter, heat, redness at the injection site and pain to the touch which may last up to 2 days were also seen.
Maltese: Dehru wkoll nefħa, inqas minn 2 cm f'dijametru, sħana, ħmura fis-sit tal-injezzjoni u wġigħ hekk kif jintmiss, li jistgħu jdumu sa jumejn.
English: Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination.
Maltese: Il-protezzjoni tibda fi tliet ġimgħat wara t-tilqima u tibqa' sa 23 ġimgħa wara t-tilqima.
English: porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Maltese: Vaċċin taċ-cirkovirus tal-ħnieżer u pnewmonja enżootika tal-ħnieżer (inattivat)
English: Why is Suvaxyn Circo+MH RTU approved?
Maltese: Għaliex ġie approvat Suvaxyn Circo+MH RTU?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo+MH RTU's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Suvaxyn Circo+MH RTU huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Other information about Suvaxyn Circo+MH RTU?
Maltese: Kif jintuża Suvaxyn Circo+MH RTU?
English: For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Suvaxyn Circo+MH RTU, ara l-fuljett ta' tagħrif.
English: The vaccine contains small amounts of a protein from PCV2 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease.
Maltese: Il-vaċċin fih ammonti żgħar ta' proteina minn PCV2 u batterji sħaħ Mycoplasma hyopneumoniae li ġew maqtula (inattivati) sabiex ma jikkawżawx mard.
English: Benefit -risk balance
Maltese: Bilanċ tal-benefiċċju-riskju
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom kontraċettivi ormonali kkombinati.
English: There was no evidence for differences between these medicinal products in terms of beneficial effects.
Maltese: Ma kien hemm ebda evidenza ta' differenzi bejn dawn il-prodotti mediċinali f'termini ta' effetti benefiċċjali.
English: Having assessed all the available data, the PRAC concluded that:
Maltese: Wara li vvaluta ddejta kollha disponibbli, il-PRAC ikkonkluda li:
English: Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases.
Maltese: B'mod ġenerali, avvenimenti tromboemboliċi venużi (VTE) jistgħu jkunu fatali f'1-2% tal-każijiet.
English: These are combined with varying doses of ethinylestradiol (EE) or with estradiol (E2).
Maltese: Dawn jiġu kkombinati ma' dożi li jvarjaw ta' ethinylestradiol (EE) jew ma' estradiol (E2).
English: Also there are certain hereditary thrombophilic defects that increase the risk.
Maltese: Hemm ukoll ċerti difetti trombofiliċi ereditarji li jżidu r-riskju.
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis, DVT).
Maltese: Avvenimenti tromboemboliċi huma avvenimenti avversi li normalment iseħħu f'vina tar-riġel (trombożi tal-vini fil-fond, DVT).
English: Scientific conclusions and grounds for the conclusions
Maltese: Konklużjonijiet xjentifiċi u raġunijiet għall-konklużjonijiet
English: • The estimated incidence of risk is lowest with the CHCs containing the progestogens levonorgestrel, norgestimate and norethisterone: it is estimated that each year there will be between 5 and 7 cases of VTE per 10,000 women who use these medicines.
Maltese: • L-inċidenza stmata tar-riskju hija l-aktar baxxa bis-CHCs li fihom il-proġestoġeni levonorgestrel, norgestimate u norethisterone: huwa stmat li kull sena ikun hemm bejn 5 u 7 każijiet ta' VTE għal kull 10,000 mara li jużaw dawn il-mediċini.