FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Maltese: Fil-majjali, wara għoti ġol-muskoli, il-half-life ta' eliminazzjoni medja fil-plasma hija ta' madwar 2.5 sigħat.
English: Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Maltese: VETERINARJU Meloxidolor 20 mg/ml soluzzjoni għall-injezzjoni għal baqar, majjali u żwiemel. meloxicam
English: Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' NSAIDs bħal nuqqas ta' aptit, rimettar, dijarea, demm moħbi flippurgar, letarġija u insuffiċjenza tal-kliewi ġew irrappurtati rarament.
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days Not authorised for use in horses producing milk for human consumption.
Maltese: Baqar: laħam u ġewwieni tal-annimali: 15-il jum; ħalib: 5 ijiem Majjali, żwiemel: laħam u ġewwieni tal-annimali: 5 ijiem.
English: Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs meloxicam
Maltese: VETERINARJU Meloxidolor 5 mg/ml soluzzjoni għall-injezzjoni għal klieb, qtates, baqar u majjali. meloxicam
English: Comparatively low concentrations are detectable in skeletal muscle and fat.
Maltese: Konċentrazzjonijiet komparattivament baxxi jidhru fil-muskolu skeletali u fix-xaħam.
English: Active substance: Meloxicam 5 mg
Maltese: Meloxicam 5 mg
English: 3421 TV Oudewater The Netherlands tel: fax: e-mail:
Maltese: 3421 TV Oudewater The Netherlands Tel.
English: Carton for the 10 ml, 20 ml and 100 ml
Maltese: Kartuna għall-10 ml, 20 ml u 100 ml Tikketta għall-100 ml
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Maltese: Instabu ħames metaboliti prinċipali, u ntwera li kollha kienu farmakoloġikament inattivi. Meloxicam huwa metabolizzat għal alkoħol, derivat tal-aċidu u għal diversi metaboliti polari.
English: Colourless type I glass vials of 10 ml, 20 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Maltese: Kunjetti tal-ħġieġ ta' tip I bla kulur ta' 10 ml, 20 ml jew 100 ml, magħluqin b'tapp tal-lastiku u ssiġillati b'għatu tal-aluminju.
English: QUANITITY OF THE ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.
Maltese: Meloxicam għandu wkoll karatteristiċi antiendotossiċi minħabba li ntwera li jinibixxi l-produzzjoni ta' thromboxane B2 indotta mill-għoti tal-endotossin E. coli f'għoġġiela u majjali.
English: Interactions with other medicinal products and other forms of interaction:
Maltese: Interazzjonijiet ma' prodotti mediċinali oħrajn u forom oħrajn ta' interazzjoni:
English: If required, a second administration of meloxicam can be given after 24 hours.
Maltese: Jekk ikun hemm bżonn, tieni amministrazzjoni ta' meloxicam tista' tingħata wara 24 siegħa.
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm reazzjonijiet mhux mixtieqa, it-trattament għandu jitwaqqaf u għandu jittieħed ilparir ta' veterinarju.
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Maltese: Injezzjoni waħda ġol-vina b'dożaġġ ta' 0.6 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 3 ml/ 100 kg ta' piż tal-ġisem).
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/25 kg body weight).
Maltese: Injezzjoni intramuskolari waħdanija f'dożaġġ ta' 0.4 mg meloxicam/kg piż tal-ġisem (jiġifieri 2 ml/25 kg piż tal-ġisem).
English: Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) bħal nuqqas ta' aptit, rimettar, dijarea, demm moħbi fl-ippurgar, letarġija u insuffiċjenza tal-kliewi ġew irrappurtati b'mod rari.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: Only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Maltese: Nefħa temporanja ħafifa biss fis-sit tal-injezzjoni wara għoti taħt il-ġilda hija osservata f'inqas minn 10% tal-baqar ikkurati fi studji kliniċi.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Maltese: Injezzjoni intramuskolari waħdanija f'dożaġġ ta' 0.4 mg meloxicam/kg piż tal-ġisem (jiġifieri 0.4 ml/5 kg piż tal-ġisem) qabel kirurġija.
English: One ml contains:
Maltese: Puh/Tel:
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 μg/ml was reached within 1 hour in pigs.
Maltese: Wara dożi waħdanin ġol-muskoli ta' 0.4 mg meloxicam/kg, intlaħaq valur Cmax ta' 1.1 sa 1.5 μg/ml fi żmien siegħa fil-majjali.
English: Label for 10 ml and 20 ml
Maltese: Tikketta għall-10 ml u 20 ml
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Maltese: Meloxicam għandu wkoll proprjetajiet anti-endotossiċi għax intwera li jinibixxi l-produzzjoni ta' thromboxane B2 ikkaġunata mill-għoti ta' E. coli endotoxin fl-għoġġiela, baqar li jkunu qed ireddgħu u majjali.
English: Dechra Veterinary Products AB Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Tel. +46 8 325355
Maltese: Wäsby Orangeriet 3 194 37 Upplands Väsby Tel.
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: MANIFATTUR RESPONSABBLI
English: Do not use in cattle and pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Maltese: Tużax f'baqar u majjali li jsofru minn funzjoni epatika, kardijaka u renali indebolita u minn disturbi emorraġiċi, jew fejn hemm evidenza ta' leżjonijiet gastrointestinali ulċeroġeniċi.
English: The metabolism in horses has not been investigated.
Maltese: Ilmetaboliżmu fiż-żwiemel ma kienx investigat.
English: Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses
Maltese: VETERINARJU Meloxidolor 20 mg/ml soluzzjoni għall-injezzjoni għal baqar, majjali u żwiemel.
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs:
Maltese: laħam u ġewwieni tal-annimali: 15-il jum; ħalib: 5 ijiem
English: Dogs:
Maltese: Frat:
English: Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Maltese: Biex inaqqas l-uġigħ u l-infjammazzjoni wara operazzjoni ortopedika u tat-tessut artab.
English: Horses: meat and offal: 5 days.
Maltese: laħam u ġewwieni tal-annimali: 5 ijiem.
English: Treatment of calves with Meloxidolor 20 minutes before dehorning reduces post-operative pain.
Maltese: Trattament ta' għoġġiela b'Meloxidolor 20 minuta qabel it-tneħħija tal-qrun tnaqqas l-uġigħ ta' wara loperazzjoni.
English: Interactions with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Maltese: Interazzjonijiet ma' prodotti mediċinali oħrajn u forom oħrajn ta' interazzjoni M'għandux jingħata flimkien ma' glukokortikosterojdi, sustanzi oħrajn mhux sterojdiċi u antiinfjammatorji jew ma' mediċini antikoagulanti.
English: To obtain the best possible pain relieving effect post-surgery Meloxidolor should be administered 30 minutes before surgical intervention.
Maltese: Sabiex jinkiseb l-aqwa effett ta' serħan mill-uġigħ possibbli għall-majjali wara kirurġija, Meloxidolor għandu jingħata 30 minuta qabel intervent kirurġiku.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: 15 μg/kg Milk
Maltese: 15 μg/kg Ħalib
English: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Maltese: Injezzjoni waħda taħt il-ġilda b'dożaġġ ta' 0.2 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 0.4 ml/10 kg ta' piż tal-ġisem).
English: Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs
Maltese: VETERINARJU Meloxidolor 5 mg/ml soluzzjoni għall-injezzjoni għall-klieb, qtates, baqar u majjali.
English: Oral suspensions of meloxicam for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Maltese: Suspensjonijiet orali ta' meloxicam għall-klieb jistgħu jintużaw għat-tkomplija tat-trattament f'dożaġġ ta' 0.1 mg ta' meloxicam/kg ta' piż tal-ġisem, 24 siegħa wara l-għoti tal-injezzjoni.
English: Excipient: Ethanol
Maltese: INDIKAZZJONI(JIET)
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħdanija taħt il-ġilda jew ġol-vini f'dożaġġ ta' 0.5 mg meloxicam/kg piż tal-ġisem (jiġifieri 10 ml/100 kg piż tal-ġisem) f'kombinazzjoni ma' kura antibijotika jew ma' kura ta' reidratazzjoni orali, kif xieraq.
English: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Maltese: Għall-użu f'infezzjoni respiratorja akuta b'terapija antibijotika xierqa sabiex jitnaqqsu s-sinjali kliniċi fil-baqar.
English: Cattle: SC or IV Pigs:
Maltese: SC jew IV Majjali: IM Żwiemel:
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda jew ġol-vina, b'dożaġġ ta' 0.5 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 2.5 ml/100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, skont kif ikun xieraq.
English: PACKAGE LEAFLET:
Maltese: Klieb:
English: Antiinflammatory agents/Non steroidal antiinflammatory agents
Maltese: Mediċini kontra linfjammazzjoni/ Mediċini mhux sterojdi kontra l-infjammazzjoni
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidratat, ipovolemiku jew ipotensiv, għax hemm riskju potenzjali ta' tossiċità tal-kliewi.
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Maltese: Wara l-għoti ta' żewġ dożi fil-muskoli ta' 0.4 mg ta' meloxicam/kg, intlaħaq valur Cmax ta' 1.9 µg/ml fi żmien siegħa fil-majjali.
English: During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
Maltese: Waqt l-għoti tal-loppju, il-monitoraġġ u terapija bi fluwidu għandhom jiġu kkunsidrati bħala prattika standard.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
Maltese: Wara doża waħdanija taħt il-ġilda ta' 0.5 mg meloxicam/kg, il-valuri Cmax ta' 2.1 μg/ml intlaħqu wara 7.7 sigħat f'baqar żgħar.
English: Ref. EMEA/CHMP/150525/2009 rev.1 EMEA/H/A-29/1083
Maltese: EMEA/CHMP/150525/2009 rev.1 EMEA/H/A-29/1083
English: 23 October 2008
Maltese: 23 ta' Ottubru 2008
English: Dr. Broich (Germany)
Maltese: Dr. Broich (Il-Ġermanja)
English: London, 2 October 2009 Doc.
Maltese: Londra, 2 ta' Ottubru 2009 Dok. ta' Ref.
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni twettqet skont referenza tal-‘Artikolu 29'1.
English: Company responses provided on: 26 January 2009; 27 April 2009; 28 May 2009 Opinion date:
Maltese: 26 ta' Jannar 2009; 27 ta' April 2009; 28 ta' Mejju 2009
English: Dr. Hudson (United Kingdom)
Maltese: Dr. Hudson (Ir-Renju Unit)
English: Questions and answers on the referral for Octegra solution for infusion containing moxifloxacin 400 mg/250 ml
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Octegra soluzzjoni għal infużjoni li fiha moxifloxacin 400 mg/250 ml
English: 25 June 2009
Maltese: 25 ta' Ġunju 2009
English: The active substance in Octegra solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Maltese: Is-sustanza attiva f'Octegra soluzzjoni għal infużjoni, moxifloxacin, tappartjeni għall-grupp ta' ‘fluoroquinolones'.
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: L-Artikolu 29 tad-Direttiva 2001/83/KE kif emendata, referenza fuq il-bażi ta' riskju potenzjali serju għassaħħa pubblika
English: Octegra solution for infusion is an antibiotic given by infusion (drip into a vein).
Maltese: Octegra soluzzjoni għal infużjoni hija antibijotiku mogħti b'infużjoni (dripp fil-vina).
English: What is Octegra solution for infusion?
Maltese: X'inhi Octegra soluzzjoni għal infużjoni?
English: Bayer Vital GmbH submitted Octegra solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Maltese: Bayer Vital GmbH issottomettiet Octegra soluzzjoni għal infużjoni għal rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mill-Ġermanja nhar it-30 ta' April 2002.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Octegra solution for infusion.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Octegra soluzzjoni għal infużjoni.
English: Why was Octegra solution for infusion reviewed?
Maltese: Għaliex ġiet riveduta Octegra soluzzjoni għal infużjoni?
English: It can be used to treat the following bacterial infections: - community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); - complicated infections of the skin and the soft tissues below the skin.
Maltese: Tista' tintuża biex tikkura l-infezzjonijiet batterjali li ġejjin: - pnewmonja akkwsitata mill-komunità (infezzjoni tal-pulmuni li tinqabad barra minn sptar); - infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob taħt il-ġilda.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 10 October 2008.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini Ġermaniża rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fl-10 ta' Ottubru 2008.
English: The grounds for the referral were concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Maltese: Ir-raġunijiet għar-referenza kienu tħassib imfissra minn Franza fir-rigward tar-riskju tal-mediċina li tikkawża problemi relatati mar-rittmu tal-qalb (titwil tal-intervall QT).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Octegra solution for infusion outweigh its risks, and therefore the marketing authorisation for Octegra solution for infusion should be granted in all concerned Member States.
Maltese: Madankollu, l-informazzjoni ta' fuq ir-riċetta għal Octegra soluzzjoni għal infużjoni għandha tiġi emendata fl-Istati Membri kollha fejn din hija awtorizzata.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Octegra solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely France and Portugal.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Octegra soluzzjoni għal infużjoni jisbqu r-riskji tagħha, u li lawtorizzazzjoni għat-tqegħid fis-suq mogħtija fil-Ġermanja tista' tiġi rikonoxxuta fi Stati Membri oħrajn tal-UE, jiġifieri Franza u l-Portugall.
English: The amended information to healthcare professionals and patients is available here.
Maltese: L-informazzjoni emendata għall-professjonisti tal-kura tas-saħħa u għall-pazjenti hija disponibbli minn hawn.
English: The company wanted the authorisation to be recognised in France and Portugal (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fi Franza u fil-Portugall (l-‘Istati Membri konċernati').
English: It works by blocking enzymes that bacteria use to make more DNA.
Maltese: Taħdem billi timblokka enzimi li l-batterja jużaw sabiex jagħmlu iktar DNA.
English: Complicated means that the infection is difficult to treat because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Maltese: Ikkumplikati tfisser li l infezzjoni hija waħda diffiċli biex tiġi kkurata minħabba li tkun infirxet għat-tessuti fondi taħt il ġilda, jista' jkun hemm bżonn ta' kura b'kirurġija, jew il-pazjent ikollu kundizzjonijiet oħrajn li jista' jkollhom effett fuq ir-rispons għall-kura.
English: 20 February 2013
Maltese: 20 ta' Frar 2013
English: It was authorised in October 2008 and is available in 11 EU member states1.
Maltese: Kien awtorizzat f'Ottubru 2008 u huwa disponibbli fi 11-il Stat Membru tal-UE1.
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 31 of Directive 2001/83/EC
Maltese: Riżultat ta' proċeduri skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 u l-Artikolu 31 tad-Direttiva 2001/83/KE
English: 1 Austria, Denmark, Estonia, France, Finland, Germany, Ireland, Netherlands, Spain, Sweden and United Kingdom, as well as Norway.
Maltese: 1 L-Awstrija, id-Danimarka, l-Estonja, Franza, il-Finlandja, il-Ġermanja, l-Irlanda, il-Pajjiżi l-Baxxi, Spanja, l-Isvezja u rRenju Unit, kif ukoll in-Norveġja.
English: • Spraying Evicel or Quixil in endoscopic surgery is contraindicated.
Maltese: • L-isprejjar ta' Evicel jew Quixil f'kirurġija endoskopika huwa kontraindikat.
English: In addition, care should be taken during laparoscopy (another type of less invasive surgical procedure) to ensure that the minimum safe distance from the tissues is observed;
Maltese: proċedura kirurġika inqas invażiva) biex jiġi żgurat li tiġi osservata d-distanza minima sigura mit tessut;
English: On 15 November 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Evicel and Quixil given by spray application, following cases of gas embolisms reported with these medicines.
Maltese: Fil-15 ta' Novembru 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja tas-siġillanti tal-fibrina Evicel u Quixil li jingħataw b'applikazzjoni sprej, wara każijiet ta' emboliżmi talgass irrapportati b'dawn il-mediċini.
English: • Evicel and Quixil should be sprayed using CO2 only, instead of pressurised air, because the greater solubility of CO2 in blood reduces the risk of embolism;
Maltese: • Evicel u Quixil għandhom jiġu sprejjati bis-CO2 biss, minflok b'arja taħt pressjoni, minħabba li s solubbilità akbar ta' CO2 fid-demm tnaqqas ir-riskju ta' emboliżmu;
English: The Committee recommended that:
Maltese: Il-Kumitat irrakkomanda li:
English: Evicel is the only centrally authorised fibrin sealant.
Maltese: Evicel huwa l-uniku siġillant tal-fibrina awtorizzat ċentralment.
English: The European Commission issued a decision for Evicel on 13 February 2013 and for Quixil on 20 February 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għal Evicel fit-13 ta' Frar 2013 u għal Quixil fl20 ta' Frar 2013.
English: • Evicel and Quixil should be sprayed using CO2 only.
Maltese: • Evicel u Quixil għandhom jiġu sprejjati biss bis-CO2.
English: Other fibrin sealants in the EU are authorised nationally and these include Quixil, Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Maltese: Siġillanti oħra tal-fibrina fl-UE huma awtorizzati fuq livell nazzjonali u dawn jinkludu Quixil, Tisseel, Tissucol, Artiss u Beriplast P (u ismijiet assoċjati).
English: The CHMP reviewed available safety data on fibrin sealants from clinical studies, post-marketing use and the published literature, focusing on reported cases of confirmed or suspected gas embolism.
Maltese: Is-CHMP irreveda d-dejta disponibbli dwar is-sigurtà ta' siġillanti tal-fibrina minn studji kliniċi, l-użu wara t-tqegħid fis-suq u mil-letteratura ppubblikata, u ffoka fuq każijiet irrapportati ta' każijiet ikkonfermati jew suspettati ta' emboliżmu tal-gass.
English: • these medicines should not be sprayed in endoscopic surgery (a type of less invasive surgical procedure).
Maltese: • dawn il-mediċini ma għandhomx jiġu sprejjati f'kirurġija endoskopika (tip ta' proċedura kirurġika inqas invażiva).
English: The CHMP is still reviewing four other fibrin sealants: Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Maltese: Tisseel, Tissucol, Artiss u Beriplast P (u ismijiet assoċjati).
English: • the wording for the product information should be strengthened and educational materials updated to provide clear and consistent information to surgeons on the recommended pressure and distance during spray application;
Maltese: • it-test tal-informazzjoni dwar il-prodott għandu jissaħħaħ u l-materjal edukattiv għandu jiġi aġġornat biex tiġi pprovduta informazzjoni ċara u konsistenti lill-kirurgi dwar il-pressjoni u d distanza rakkomandata b'applikazzjoni sprej;
English: In August 2010, measures were taken to minimise the risk of gas embolism (presence of a gas bubble in the blood that affects the blood flow) following five reported cases involving Evicel or Quixil applied
Maltese: F'Awwissu 2010, ittieħdu miżuri biex jiġi minimizzat ir-riskju ta' emboliżmu tal-gass (preżenza ta' bużżieqa tal-gass fid-demm li taffettwa l-fluss tad-demm) wara li ġew irrapportati ħames każijiet li
English: They are composed of two solutions, one containing fibrinogen and the other containing thrombin, which are both proteins involved in the blood clotting process.
Maltese: Huma magħmulin minn żewġ soluzzjonijiet, waħda li fiha fibrinogen u l-oħra li fiha thrombin, it-tnejn proteini involuti fil-proċess tal-għaqid tad-demm.
English: • Surgeons should note the potential risk of gas embolism with improper spray application of Evicel and Quixil and take the necessary precautions detailed in the updated prescribing advice for these medicines.
Maltese: • Il-kirurgi għandhom jinnotaw ir-riskju potenzjali ta' emboliżmu tal-gass b'applikazzjoni ħażina ta' Evicel u Quixil bi sprej u għandhom jieħdu l-prekawzjonijiet neċessarji dettaljati fil-parir aġġornat dwar il-preskrizzjoni għal dawn il-mediċini.