FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Ivabradine Anpharm (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Maltese: L-effett sekondarju l-aktar komuni b'Ivabradine Anpharm (li jista' jaffettwa aktar minn persuna 1 minn kull 10) huwa fenomeni mdawla jew "fosfeni" (dawl qawwi temporanju fil-vista).
English: In a fourth study in 889 patients, Ivabradine Anpharm was more effective than placebo when both were added to atenolol.
Maltese: Fir-raba' studju fi 889 pazjent, Ivabradine Anpharm kien aktar effettiv mill-plaċebo meta t-tnejn ġew miżjuda ma' atenolol.
English: Ivabradine Anpharm must not be taken with a number of other medicines.
Maltese: Ivabradine Anpharm m'għandux jittieħed ma' għadd ta' mediċini oħrajn.
English: For the full list of restrictions with Ivabradine Anpharm, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Ivabradine Anpharm, ara l-fuljett ta' tagħrif.
English: Ivabradine Anpharm was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Maltese: Ivabradine Anpharm kien imqabbel ma' plaċebo (kura finta) u kuri oħrajn f'ħames studji ewlenin li kienu jinvolvu aktar minn 4,000 adult b'anġina stabbli fit-tul.
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Maltese: Jintuża flimkien ma' terapija standard li tinkludi limblokkaturi tar-riċetturi beta, jew f'pazjenti li ma jistgħux jiġu kkurati b'imblokkaturi tar-riċetturi beta.
English: Ivabradine Anpharm is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Maltese: Ivabradine Anpharm jintuża wkoll f'pazjenti b'insuffiċjenza kardijaka fit-tul (meta l-qalb ma tkunx tista' tippompja biżżejjed demm lill-bqija tal-ġisem) li għandhom ritmu tal-qalb normali u li r-rata tal-qalb tagħhom hija tal-inqas 75 taħbita fil-minuta.
English: ATCvet code: QI01AD07.
Maltese: QI01ADO7.
English: Live IBV, 4-91
Maltese: IBV ħaj,4-91
English: Date of last renewal: 21/05/2008.
Maltese: Data tal-aħħar tiġdid: 21/05/2008.
English: ≥3.6 log10 EID50 IBV per dose
Maltese: > 3.6 log10 EID50 IBV kull doża
English: 1x 500 doses 1x 1,000 doses 1x 2,500 doses 1x 5,000 doses 1x 10,000 doses 10x 500 doses 10x 1,000 doses 10x 2,500 doses 10x 5,000 doses 10x 10,000 doses
Maltese: 1 x 500 doża 1 x 1,000 doża 1 x 2,500 doża 1 x 5,000 doża 1 x 10,000 doża 10 x 500 doża 10 x 1,000 doża 10 x 2,500 doża 10 x 5,000 doża 10 x 10,000 doża
English: Cups: off-white, predominantly sphere shaped.
Maltese: Tazzi: offwajt predominantament forma sferika.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Korverstraat 35 5831 AN Boxmeer
English: 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-100 spheres)
Maltese: 1,000 doża (3 - 100 sfera) 2,500 doża (3 - 100 sfera)
English: EU/2/98/006/001 (1,000 doses, vial) EU/2/98/006/002 (2,500 doses, vial) EU/2/98/006/003 (5,000 doses, vial) EU/2/98/006/004 (10,000 doses, vial) EU/2/98/006/005 (10x 1,000 doses, vials) EU/2/98/006/006 (10x 2,500 doses, vials) EU/2/98/006/007 (10x 5,000 doses, vials) EU/2/98/006/008 (10x 10,000 doses, vials) EU/2/98/006/009 (1x 500 doses, vial)
Maltese: EU/2/98/006/006(10 x 2,500 doża, kunjett) EU/2/98/006/007(10 x 5,000 doża, kunjett) EU/2/98/006/008(10 x 10,000 doża, kunjett) EU/2/98/006/009(1 x 500 doża, kunjett) EU/2/98/006/010(10 x 500 doża, kunjett) EU/2/98/006/011(10 x 1,000 doża, tazzi) EU/2/98/006/012(10 x 5,000 doża, tazzi) EU/2/98/006/013(10 x 10,000 doża, tazzi) EU/2/98/006/014(10 x 2,500 doża, tazzi)
English: Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Maltese: It-tazza tal-aluminjum laminata siġillata (tazza) ta' polypropylene u (għatu) wiċċ ta' kuntatt polypropylene/polyethylene li fiha 1,000, 2,500 5,000 jew 10,000 doża.
English: Guideline when the product is used with Nobilis IB Ma5
Maltese: Linja gwida meta l-prodott jintuża man-Nobilis IB Ma5
English: Name and address of the manufacturer of the biological active substance Intervet International B.V.
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva Intervet International B.V.
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Effetti fuq prodotti mediċinali oħra u forom oħra ta' interazzjonijiet:
English: 500 doses 1,000 doses 2,500 doses 5,000 doses 10,000 doses
Maltese: 1,000 doża 2,500 doża 5,000 doża 10,000 doża
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ f'temperatura ta' 2°Ċ - 8°Ċ.
English: Pharmacotherapeutic group: Immunologicals for Aves, domestic fowl, live viral vaccine, avian infectious bronchitis virus.
Maltese: Immunoloġiċi għal Tjur, tajr domestiku, vaċċin virali ħaj, virus talbronkite infettiva tat-tjur.
English: EU/2/98/006/010 (10x 500 doses, vials) EU/2/98/006/011 (10x 1,000 doses, cups) EU/2/98/006/012 (10x 5,000 doses, cups) EU/2/98/006/013 (10x 10,000 doses, cups EU/2/98/006/014 (10x 2,500 doses, cups)
Maltese: EU/2/98/006/004(10,000 doża, kunjett) EU/2/98/006/005(10 x 1,000 doża, kunjett)
English: Date of first authorisation: 09/06/1998.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09/06/1998.
English: Pancreatic digest of casein Disodium phosphate Water for injections
Maltese: Id-diġest pankrejatiku tal-kasejn Fosfat tad-disodju Ilma għall-injezzjoni
English: QUANTITY OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) ATTIVA(I)
English: Live attenuated infectious bronchitis virus strain 4-91 ≥ 3.6 log10 EID50* per dose *EID50: 50% embryo infective dose
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Virus ħaj attenwat tal-Bronkite Infettiva strejn 4-91 > 3.6 log10 EID50* kull doża * EID50: 50% tad-doża infettiva għal embrijun
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi mhux attivi, ara sezzjoni 6.1
English: Lyophilisate
Maltese: Ippakjar
English: By adding approximately 2 grams of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its activity longer.
Maltese: Jekk wieħed iżid 2 grammi ta' trab tal-ħalib xkumat, jew 20 ml ħalib likwidu xkumat għal kull litru ta' ilma, il-virus idum attiv għal aktar ħin.
English: Read the product information of Nobilis IB Ma5 before use.
Maltese: Aqra l-fuljett talinformazzjoni tan-Nobilis IB Ma5 qabel l-użu.
English: To be supplied only on veterinary prescription.
Maltese: - Għandu jingħata biss fuq preskrizzjoni ta' veterinarju.
English: Dissolve the vaccine in physiological saline solution or sterile distilled water (usually 30 ml per 1,000 doses, 75 ml per 2,500 doses) and administer by means of a standardized dropper.
Maltese: Dewweb il- vaċċin f'salina fiżjoloġika jew ilma distillat (ġeneralment 30 ml / 1000 doża jew 75 ml /2500 doża) u amministra permezz ta' qattara tajba.
English: Active immunisation against avian infectious bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Maltese: Immunità attiva kontra l-virus tat-tjur tal-Bronkite Infettiva strain IB 4-91 li jikkawża bronkite infettiva fit-tiġieġ.
English: Packaging:
Maltese: Gwida:
English: The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Maltese: Il-parametri tas-sigurtà tal-vaċċini mħallta mhumiex differenti minn dawk deskritti għall-vaċċini amministrati separatament.
English: Intranasal/ocular administration
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 .
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma sustanzi ammissibbli kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jindika li m'hemmx bżonn ta` MRLs jew huma kkunsidrati li ma jaqgħux fi ħdan liskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 recommended for use with the veterinary medicinal product.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor ħlief man-Nobilis IB Ma5 rakkomandat għallużu mal-prodott mediċinali veterinarju.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
Maltese: Nobilis IB 4-91 huwa intenzjonat li jipproteġi l-flieles kontra sinjali respiratorji tal-marda kkawżata minn IBV variant strain 4-91 biss u għaldaqstant m'għandux jintuża minflok tilqim ieħor tal-IBV.
English: Cardboard box with 10 cups of 1,000 doses.
Maltese: Kaxxa tal-kartun b` 10 tazzi ta' 1,000 doża.
English: Cardboard box with 10 cups of 2,500 doses.
Maltese: Kaxxa tal-kartun b` 10 tazzi ta' 2,500 doża.
English: Cardboard box with 10 cups of 5,000 doses.
Maltese: Kaxxa tal-kartun b` 10 tazzi ta' 5,000 doża.
English: Cardboard box with 10 cups of 10,000 doses.
Maltese: Kaxxa tal-kartun b` 10 tazzi ta' 10,000 doża.
English: Guideline
Maltese: MANIFATTURA
English: BATCH NUMBER.
Maltese: NUMRU/I
English: Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Maltese: Immunità attiva lit-tiġieġ sabiex jitnaqqsu sinjali respiratorji tal-bronkite infettiva kkawżata mill variant strain IB 4-91.
English: Vials: off-white/cream-coloured pellet.
Maltese: Kull doża rikostitwita tal-vaċċin fiha:
English: Shelf life of the veterinary medicinal product in aluminium laminate cups as packaged for sale: 24 months.
Maltese: Żmien li l-prodott mediċinali veterinarju f'tazzi laminati tal-aluminju kif ippakkjati għall-bejgħ: 24 xahar.
English: For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 6 weeks for the claimed protection against the Massachusetts strains and the variant strain 4-91 of IBV.
Maltese: Għall-prodotti mħallta, il-bidu tal-immunità hija 3 ġimġħat u l-immunità ddum 6 ġimgħat għall-protezzjoni ddikjarata kontra l-istrejn tal- l-Massachusetts u l-istrejn varjanti tal-4-91 tal-IBV.
English: EXP
Maltese: IB.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of spray administration, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Maltese: F`kas ta`amministrazzjoni bi sprej, apparat prottetiv personali li jikkonsisti f`maskra bi protezzjoni għall-għajnejn għandha tintlibes meta tuża dan il-prodott veterinarju mediċinali.
English: Cardboard box with 1 or 10 vials of 2,500 doses.
Maltese: Kaxxa tal-kartun b`1 jew 10 kunjetti ta' 2,500 doża.
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Maltese: IBV serotipi oħra (e.ż. Massachusetts) skont il-programm lokali ta' vaċċinazzjoni kontra
English: Spray method
Maltese: TAL-PRODOTT MEDIĊINALI
English: Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens
Maltese: VETERINARJU Nobilis IB 4-91, lijofiliżat għal suspensjoni għal amministrazzjoni fl-imnieħer/għajnejn għal użu flilma tax-xorb
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or intranasal/ocular administration to commercial chicks from one day of age onwards.
Maltese: Data fuq is-sigurtà u l-effikaċja huma disponibbli li juru li dan il-vaċċin jista' jitħallat u amministrat ma' Nobilis IB Ma5 għall-sprej jew amministrazzjoni fl-imnieħer/fl-għajnejn lill-flieles kummerċjali minn età ta' ġurnata 'l fuq.
English: Safety and efficacy data are available which demonstrate that Nobilis IB 4-91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD.
Maltese: Informazzjoni dwar is-sigurtà u l-effiċjenza huma disponibbli li juru li Nobilis IB 4-91jista' jingħata lil flieles ta`ġurnata li huma vaċċinati jew taħt il-ġilda jew in ovo bl-Innovax-ND-IBD.
English: PACKAGE LEAFLET: Nobilis IB4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens
Maltese: Nobilis IB4-91, lijofiliżat għal suspensjoni għal amministrazzjoni fl-imnieħer/għajnejn għal użu fl-ilma tax-xorb għat-tiġieġ
English: Cardboard box with 1 or 10 vials of 1,000 doses.
Maltese: Kaxxa tal-kartun b`1 jew 10 kunjetti ta' 1,000 doża.
English: DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX with 1 vial, 10 vials or 10 cups of lyophilisate
Maltese: KAXXA TAL_KARTUN b`kunjett 1, 10 kunjetti jew 10 tazzi tal-lijofilizat
English: At least 3.6 log10 EID50 (1 dose) per animal by coarse spray, drinking water or intranasal/ocular administration.
Maltese: Tal-inqas 3.6 log10 EID50 (doża waħda) kull annimal jew permezz ta' bexx, ilma tax-xorb jew amministrazzjoni fl-imnifsejn jew fl-għajnejn.
English: Packaging
Maltese: FARMAĊEWTIKU
English: Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water
Maltese: VETERINARJU Nobilis IB 4-91 lijofiliżat għal suspensjoni għal amministrazzjoni fl-imnieħer/għajnejn għal użu flilma tax-xorb
English: Cardboard box with 1 or 10 vials of 500 doses.
Maltese: Kaxxa tal-kartun b`1 jew 10 kunjetti ta' 500 doża.
English: Since the stability of IBV in suspension may be low due to sensitivity to high temperatures and impurities, water used for dissolving the freeze-dried vaccine should be cool and of good quality.
Maltese: Assigura li s-suspensjoni tal-vaċċin ġiet ikkunsmata kollha fi żmien sagħtejn.
English: Cardboard box with 1 or 10 vials of 5,000 doses.
Maltese: Kaxxa tal-kartun b`1 jew 10 kunjetti ta' 5,000 doża.
English: See package leaflet.
Maltese: kwalunkwe prodott ieħor.
English: In laboratory studies and field trials:
Maltese: Fi studji fil-laboratorju u provi fuq il-post:
English: Vials: off-white/cream-coloured pellet Cups: off-white, predominantly sphere shaped
Maltese: Lijofiliżat għal amministrazzjoni fl-imnieħer/għajnejn għal użu fl-ilma tax-xorb Kunjetti: pelit kulur offwajt/krema.
English: The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
Maltese: Il-prodott għandu jintuża biss wara li kien stabbilit li Nobilis variant strain IB 4-91 huwa epidjemjoloġikament relevanti fl-akkwata.
English: Broiler: The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by intranasal/ocular administration.
Maltese: Id-deċiżjoni li tuża dan il-vaċċin qabel jew wara kwalunkwe prodott mediċinali veterinarju għandha tittieħet kull każ għalih.
English: 14 December 2018 EMA/865778/2018 EMEA/H/C/004754
Maltese: EMA/865778/2018 EMEA/H/C/004754
English: EMA/865778/2018
Maltese: Novartis (kanakinumab) EMA/865778/2018
English: Canakinumab Novartis is a medicine that contains the active substance canakinumab.
Maltese: Canakinumab Novartis huwa mediċina li fiha s-sustanza attiva kanakinumab.
English: IL-1 beta is part of the immune system (the body's natural defences) and is involved in the inflammatory processes associated with heart and blood vessels problems.
Maltese: IL-1 beta hija parti mis-sistema immunitarja (id-difiżi naturali tal-ġisem) u hija involuta fil-proċessi infjammatorji assoċjati ma' problemi tal-qalb u tal-vini.
English: Patients were given canakinumab Novartis at different doses (50, 150 or 300 mg) or placebo (a dummy treatment) once every three months for up to six years.
Maltese: Il-pazjenti ngħataw canakinumab Novartis f'dożi differenti (50, 150 jew 300 mg) jew plaċebo (trattament finta) darba kull tliet xhur sa massimu ta' sitt snin.
English: The active substance in canakinumab Novartis, canakinumab, is a monoclonal antibody (a type of protein) which has been designed to recognise and attach to interleukin 1 (IL-1) beta.
Maltese: Is-sustanza attiva f'canakinumab Novartis, il-kanakinumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' interleukin 1 (IL-1) beta.
English: What is canakinumab Novartis?
Maltese: Kif jaħdem canakinumab Novartis?
English: On 4 December 2018, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for canakinumab Novartis, for the prevention of serious events such as stroke, heart attack or death in patients who have had a heart attack.
Maltese: Fl-4 ta' Diċembru 2018, Novartis Europharm Ltd. uffiċjalment innotifikat lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal canakinumab Novartis, għall-prevenzjoni ta' avvenimenti serji bħal puplesija, attakk tal-qalb jew mewt f'pazjenti li kellhom attakk tal-qalb.
English: The beneficial effects seen were considered modest, particularly in patients who also took statins, and were not considered to outweigh the increased risks of serious infections in patients treated with the medicine.
Maltese: L-effetti ta' benefiċċju li dehru tqiesu modesti, b'mod partikolari f'pazjenti li ħadu wkoll statins, u ma ġewx ikkunsidrati li jegħlbu r-riskji miżjuda ta' infezzjonijiet serji f'pazjenti kkurati bil-mediċina.
English: commonly used to prevent heart problems, such as statins.
Maltese: oħra użati b'mod komuni biex jipprevjenu problemi tal-qalb, bħal statins.
English: By attaching to IL-1 beta, canakinumab blocks its activity and reduces inflammation.
Maltese: Billi teħel mal-IL-1 beta, il-kanakinumab timblokka l-attività tiegħu u tnaqqas l-infjammazzjoni.
English: Canakinumab Novartis was expected to be used to prevent serious events such as stroke, heart attack or death in patients who have already had a heart attack.
Maltese: Canakinumab Novartis kien mistenni li jintuża biex jipprevjeni avvenimenti serji bħal puplesija, attakk tal-qalb jew mewt f'pazjenti li diġà kellhom attakk tal-qalb.
English: What was canakinumab Novartis expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża canakinumab Novartis?
English: The company provided the results of one study involving over 10,000 patients who had had a heart attack.
Maltese: Il-kumpanija pprovdiet ir-riżultati ta' studju wieħed li kien jinvolvi aktar minn 10 000 pazjent li kellhom attakk tal-qalb.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had remaining concerns and was of the provisional opinion that canakinumab Novartis could not have been approved for the prevention of serious heart problems in patients who have already had a heart attack.
Maltese: Fuq il-bażi tar-rieżami tad-data u t-tweġibiet tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma provviżorja li canakinumab Novartis ma setax jiġi approvat għall-prevenzjoni ta' problemi tal-qalb serji f'pazjenti li diġà kellhom attakk tal-qalb.
English: cefovecin
Maltese: Convenia cefovecin
English: What is the risk associated with Convenia?
Maltese: X'inhuma r-riskji assoċċjati ma' Convenia?
English: What is Convenia?
Maltese: X'inhu Convenia?
English: Convenia contains cefovecin, an antibiotic which is given by injection (under the skin).
Maltese: Convenia fih cefovecin, antibijotiku li jingħata bħala injezzjoni (taħt il-ġilda).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia on 19 June 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Convenia valida fl-Unjoni Ewropea kollha fid-19 ta' Ġunju 2006.
English: No side-effects have been reported with Convenia to date.
Maltese: S'issa, l-ebda effetti sekondarji ma ġew rapportati b'Convenia.
English: How has Convenia been studied?
Maltese: Kif ġie studjat Convenia?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: One injection lasts for up to 14 days.
Maltese: Injezzjoni waħda ddum sa 14-il ġurnata.
English: Other information about Convenia:
Maltese: Tagħrif ieħor dwar Convenia:
English: Cefovecin differs from other similar cephalosporin antibiotics as it stays in the dog's or cat's body for a very long time after it has been injected.
Maltese: Cefovecin huwa differenti mill-antibijotiċi cephalosporins l-oħra għax jibqa' fil-ġisem tal-kelb jew qattus għal żmien twil ħafna wara li jiġi injettat.
English: Data from laboratory studies with different bacteria showed that cefovecin was effective against the bacteria specified in the product information (SPC and package leaflet).
Maltese: Tagħrif minn studji fil-laboratorju b'batterji differenti wera li cefovecin huwa effettiv kontra lbatterji speċifikati fit-tagħrif dwar il-prodott (SPC u fuljett ta' tagħrif).
English: Like other antibiotics, cefovecin is not effective against all types of bacteria.
Maltese: Bħal antibijotiċi oħra, cefovecin m'huwiex effettiv kontra t-tipi ta' batterji kollha.
English: Convenia has been studied in dogs with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid) and in dogs with urinary tract infections (where it was compared to another cephalosporin antibiotic, cefalexin).
Maltese: Convenia ġie studjat fi klieb u qtates b'infezzjonijiet tal-ġilda u tessut artab (fejn tqabbel ma' antibijotiċi oħra li fihom amoxicillin u aċidu clavulanic) u fi klieb b'infezzjonijiet fil-pajp ta' l-awrina (fejn tqabbel ma' antibijotiku cephalosporin ieħor bl-isem ta' cefalexin).
English: Why has Convenia been approved?
Maltese: Għaliex ġie approvat Convenia?