FrancophonIA/ELRC3.0 huggingface dataset:
English: • It is recommended that Fluenz is not given at the same time as influenza-specific antiviral medicines.
Maltese: • Hu rakkomandat li Fluenz ma jingħatax fl-istess ħin ma' mediċini antivirali speċifiċi għall-influwenza.
English: This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2013/2014 season.
Maltese: Din it-tilqima hi konformi mar-rakkomandazzjoni tal-WHO (Emisferu tat-Tramuntana) u d-deċiżjoni tal-UE għall-istaġun 2013/2014.
English: Non-clinical data with FLUENZ reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance, and neurovirulence.
Maltese: Tagħrif mhux kliniku bi FLUENZ, ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, tolleranza lokali, u newrovirulenza, ma juri l-ebda periklu speċjali għall-bnedmin.
English: FLUENZ should not be used in infants and toddlers below 24 months of age because of safety concerns (see section 4.4).
Maltese: FLUENZ m'għandiex jintuża fit-tfal żgħar u trabi ta' eta` ta' inqas minn 24 xahar minħabba tħassib dwar sigurtà (ara sezzjoni 4.4).
English: Fluenz will be given as a spray in each nostril.
Maltese: Fluenz mhuwiex rakkomandat għal nisa li huma tqal jew li jkunu qed ireddgħu.
English: M = months b Reduction in culture-confirmed influenza illness relative to placebo.
Maltese: X=xhur b Tnaqqis f'mard tal-influwenza kkonfermat permezz ta' koltura meta mqabbel mal-plaċebo.
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
Maltese: • jekk it-tabib tiegħek ikun qallek li għandek sistema immuni dgħajfa minħabba xi marda, mediċina, jew kura oħra.
English: • Do not give acetylsalicylic acid to children aged less than 18 years for 4 weeks after vaccination with Fluenz unless your doctor, nurse or pharmacist tells you otherwise.
Maltese: • Tagħtix acetylsalicylic acid lil tfal li għandhom inqas minn 18-il sena għal 4 ġimgħat wara t-tilqima bi Fluenz, ħlief jekk it-tabib, l-infermiera jew l-ispiżjar tiegħek jgħidulek tagħmel mod ieħor.
English: The adverse reactions reported were similar to those seen with the recommended single dose of FLUENZ.
Maltese: Ir-reazzjonijiet avversi rrappurtati kienu simili għal dawk li kienu osservati bid-doża waħda rakkomandata ta' FLUENZ.
English: Paediatric studies
Maltese: TAL-PRODOTT MEDIĊINALI
English: Study Number
Maltese: NUMRU(I)
English: Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure FLUENZ is delivered into the nose.
Maltese: Jekk mediċini antivirali kontra influwenza u FLUENZ jingħataw fl-istess ħin, għandu jiġi kkunsidrat tilqim mill-ġdid meta jkun meħtieġ.
English: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or FLUENZ have been observed.
Maltese: Ma kien osservat l-ebda tibdil klinikament sinifikanti fir-risponsi immuni għal ħosba, gattone, ġidri r-riħ, poliovirus li jingħata mill-ħalq jew FLUENZ.
English: Table 2 FLUENZ Relative Efficacy in Active-controlled Paediatric Studies with Injectable
Maltese: Tabella 2 Effikaċja Relattiva ta' FLUENZ fi Studji Pedjatriċi Kkontrollati b'Mod Attiv b'Tilqima Kontra l-Influwenza li Tista' Tiġi Injettata tal-Istudju Reġjun Medda
English: However, this alteration might not be of clinical relevance with the two dose immunisation schedule of the rubella vaccine.
Maltese: Madankollu, din il-bidla tista' ma tkunx ta' rilevanza klinika bl-iskeda ta' immunizzazzjoni b'żewġ dożi tat-tilqima kontra l-ħosba Ġermaniża.
English: EU number Invented name
Maltese: Numru ta' l-UE Isem kummerċjali
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure)
Maltese: • Kawtela fl-użu fl-anzjani fid-dawl tar-riskji relatati ma' l-età (b'mod partikolari l-kanċer tal bużżieqa, ksur u insuffiċjenza tal-qalb).
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Maltese: ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU MPLIMENTATI
English: ATCvet code: QM01AH90.
Maltese: QM01AH90.
English: 10 tablets 30 tablets 60 tablets 180 tablets
Maltese: 10 pilloli 30 pillola 60 pillola 180 pillola
English: Iron oxides (E172) Caramel (E150d)
Maltese: Iron oxides (E172) Karamell (E150d)
English: The elimination half-life (t½) is 7.59 (± 1.53) hours.
Maltese: L-eliminazzjoni half-life (t½) hija ta' 7.59 (± 1.53) siegħat.
English: Firocoxib is approximately 96 % bound to plasma proteins.
Maltese: Il-Firocoxib jeħel approssimattivament 96 % mal-proteini tal-plasma.
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 30 °C.
English: Manufacturer for the batch release: MERIAL, 4 Chemin du Calquet, 31000 Toulouse, France
Maltese: Manifattur li jħalli l-konsenja tmur fis-suq: MERIAL, 4 Chemin du Calquet, 31000 Toulouse, France
English: Lactose Monohydrate Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Caramel (E150d) Silica, colloidal anhydrous Iron Oxides (E172)
Maltese: Lattosju Monoidrat Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Karamell (E150d)
English: Osteoarthritis:
Maltese: Ostjoartrite:
English: 5 mg/kg once daily.
Maltese: 5 mg/kg darba kuljum.
English: EU/2/04/045/001-006 EU/2/04/045/008-009
Maltese: EU/2/04/045/008-009
English: EU/2/04/045/001 10 tablets EU/2/04/045/002 30 tablets EU/2/04/045/005 180 tablets EU/2/04/045/008 60 tablets
Maltese: EU/2/04/045/001 10 pilloli EU/2/04/045/002 30 pillola EU/2/04/045/005 180 pillola EU/2/04/045/ 008 60 pillola
English: EU/2/04/045/003 10 tablets EU/2/04/045/004 30 tablets EU/2/04/045/006 180 tablets EU/2/04/045/009 60 tablets
Maltese: EU/2/04/045/003 10 pilloli EU/2/04/045/004 30 pillola EU/2/04/045/006 180 pillola EU/2/04/045/009 60 pillola
English: The peak concentration (Cmax) is 0.52 (± 0.22) µg/ml (equivalent to approximately 1.5 µM), area under the curve (AUC 0-24) is 4.63 (±1.91) µg x hr/ml, and oral bioavailability is 36.9 (± 20.4) percent.
Maltese: L-għola konċentrazzjoni (Cmax) hija ta' 0.52 (± 0.22) µg/ml (ekwivalenti għal bejn wieħed u ieħor 1.5 µM), l-erja taħt il-kurva (AUC 0-24) hija 4.63 (± 1.91) µg xhr/ml u l-biodisponibilità orali hija ta' 36.9 (± 20.4) fil-mija.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
Maltese: Grupp Farmako-terapewtiku:Prodotti anti-infjammatorji u antirewmatiċi, mhux sterojdi.
English: Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties.
Maltese: Coxibs juru kwalitajiet analġesiċi, anti-infjammatorji, u antipiretiċi.
English: 4 Chemin de Calquet 31000 Toulouse France
Maltese: MERIAL S.A.S. 4 Chemin de Calquet 31000
English: Cyclooxygenase is responsible for generation of prostaglandins.
Maltese: Iccyclooxygenase huwa responsabbli biex jifformaw il-prostaglandin.
English: Date of first authorisation: 13/09/2004 Date of last renewal: 29/05/2009
Maltese: Data tal-aħħar tiġdid : 29.05.2009
English: Tan-brown, round, convex, engraved scored tablets.
Maltese: Pilloli kannella ċari, tondi, konvessi, inċiżi u b'talja fin-nofs.
English: MERIAL S.A.S.
Maltese: ANNESS II A.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Maltese: Il-Firocoxib hija mediċina anti-infjammatorja mhux sterojdi (NSAID) li taġixxi b'inibizzjoni selettiva ta' cyclooxygenase-2 (COX-2) - sintesi medjata tal-prostaglandin.
English: Elimination is principally in the bile and gastrointestinal tract.
Maltese: L-eliminazzjoni hija prinċipalment fil-bili u fl-apparat gastrointestinali.
English: Previcox tablets are supplied in blisters (transparent PVC /aluminium foil) or in 30 ml or 100 ml high density polyethylene bottles (with polypropylene closure).
Maltese: Il-pilloli Previcox jiġu forniti ġo folji (PVC trasparenti/fojl tal-aluminju) jew ġo fliexken tal-polietelin ta' densità għolja ta' 30 jew 100 ml (bl-għeluq tal-polipropilin)
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Maltese: Il-Firocoxib hija mediċina anti-infjammatorja mhux sterojdi (NSAID) li tappartjeni għall-grupp Coxib li taġixxi b'inibizzjoni selettiva ta' cyclooxygenase-2 (COX-2) - sintesi medjata tal-prostaglandin.
English: The concentration of firocoxib required to inhibit 50 % of the COX-2 enzyme (i.e., the IC50) is 0.16 (± 0.05) µM, whereas the IC50 for COX-1 is 56 (± 7) µM.
Maltese: (jiġifieri il IC50) hija ta' 0.16 (± 0.05) µM, mentri il IC50 għal COX-1 hija ta' 56 (± 7) µM.
English: Dogs.
Maltese: tijiem.
English: Previcox 227 mg chewable tablets for dogs
Maltese: VETERINARJU Previcox 227 mg pilloli lii tomgħodhom
English: COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception and cognitive function).
Maltese: huwa involut fl-ovulazzjoni, it-twaħħil ta' l-embriju, l-għeluq tad-ductus arteriosus, u l-funzjonijiet tas-sistema nervuza (induzzjoni tad-deni, perċezzjoni ta' l-uġigħ, u l-funzjoni konjittiva).
English: Store in the original package.
Maltese: Aħżen fil-pakkett oriġinali
English: Read the package leaflet before use.
Maltese: Taqbisx id-doża rakkomandata.
English: The chewable tablets (57 mg or 227 mg) are available in the following pack sizes:
Maltese: Il-pilloli li tomgħodhom (57 mg jew 227 mg) jinstabu fid-daqsijiet tal-pakketti li gejjin:
English: Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
Maltese: L-amministrazzjoni flimkien ma mediċina potenzialment nefrotossika għanda tiġi evitata għax jista' jkun hemm żieda fir-riskju ta' tossiċità fil-kliewi.
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 mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Previcox 57 mg chewable tablets for dogs
Maltese: VETERINARJU Previcox 57 mg pilloli lii tomgħodhom
English: At dose rates equal or greater to 15 mg/kg/day (3 times the recommended dose) for six months, similar clinical signs were observed, albeit that the severity and frequency were less and duodenal ulcers were absent.
Maltese: F'rati ta' dożi ugwali jew iktar għolja minn 15mg/kg/kuljum (3 darbiet iżjed mid-doża rakkomandata) għal 6 xhur, sinjali kliniċi similari ġew osservati, għalkemm is-severità u l-frekwenza kienu inqas u ma kienx hemm sinjali ta' ulċeri fid-duodenum.
English: Concomitant treatment with molecules displaying action on renal flow, e.g. diuretics or Angiotensin Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring.
Maltese: Angiotensin Converting Enzyme (ACE), għandu jsir taħt monitoraġġ kliniku.
English: In order to protect from moisture, store in the original package.
Maltese: Sabiex tipproteġi mill-umdità, aħżen fil-pakkett oriġinali.
English: Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver.
Maltese: Il-Firocoxib huwa metabolizzat l-aktar bil-dejalkilazzjoni u glukoronidazzjoni fil-fwied.
English: D. STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TA' L-MRLs
English: Chewable tablets.
Maltese: Pilloli li tomgħodhom.
English: - 1 cardboard box containing 10 tablets in one blister - 1 cardboard box containing 30 tablets in three blisters - 1 cardboard box containing 180 tablets in eighteen blisters - 1 cardboard box containing 60 tablets in one bottle
Maltese: - kaxxa tal-kardbord li fiha 30 pillola fi tliet folji - kaxxa tal-kardbord li fiha 180 pillola fi tmintax-il folja
English: PACKAGE LEAFLET Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Maltese: FIL-PAKKETT Previcox 57 mg pilloli li tgħomodhom għall-klieb Previcox 227 mg pilloli li tgħomodhom għall-klieb
English: In in-vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
Maltese: Fil-provi in-vitro tad-demm sħiħ tal-klieb, il-firocoxib juri bejn wieħed u ieħor selettivita' ta' 380 darba għal COX-2 fuq COX-1.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu f'annimali deidrati, hypovolaemic jew hypotensive, peress li hemm riskju potenzjali ta'
English: As anaesthetic drugs may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
Maltese: Peress li l-anestetiċi jistgħu jeffettwaw il-perfużjoni renali, l-użu ta' terapija parenterali ta' likwidi waqt il-kirurġija għandu jiġi kkunsidrat biex jitnaqqsu l komplikazzjonijiet potenzjali renali meta jiġu wżati l-NSAIDs waqt l-operazzjoni.
English: Very rare (affects less than 1 animal in 10,000)
Maltese: Rari (teffettwa 1 sa 10 annimali f'10,000) Rari ħafna (teffettwa inqas minn annimal f'10,000)
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Tużax flimkien ma kortikosterojdi jew mediċini oħra anti-infjammatorji mhux sterojdi (NSAIDs).
English: Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Maltese: VETERINARJU Previcox 57 mg pilloli lii tomgħodhom għall-klieb Previcox 227 mg pilloli lii tomgħodhom għall-klieb
English: If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm effetti mhux mixtieqa bħal rimettar, dijarea ripetuta, demm fil-purgar, nuqqas f'daqqa fil-piż, anoreksja, telqa, degradazzjoni tal-parametri biokimiċi tal-kliewi jew tal-fwied, l-użu tal-prodott għandu jitwaqqaf u jittieħed il-parir ta' tabib veterinarju.
English: The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
Maltese: Il-kura għandha titwaqqaf jekk xi wieħed minn dawn is-sinjali jiġu osservati: dijarea ripetuta, rimettar, demm fil-purgar, tnaqqis fil-piż f'daqqa, anoreksja, telqa, degradazzjoni tal-parametri biokimiċi tal kliewi u tal-fwied.
English: To be supplied only on veterinary prescription.
Maltese: Biss għandu jingħata biss bi preskrizzjoni veterinarja.
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Maltese: Il-perijodu mingħajr kura għandu jikkunsidra il-kwalitijiet farmakoloġiċi tal-prodotti li ġew użati qabel.
English: Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ippakkjat għall-bejgħ : 4 snin.
English: In dogs seven months of age at the start of treatment at dose rates greater than or equal to 25 mg/kg/day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i.e. vomiting were observed.
Maltese: Fi klieb ta' 7 xhur fil-bidu tal-kura f'rati ta' dożi ugwali jew iktar għoljin minn 25 mg/kg/kuljum (5 darbiet iżjed mid-doża rakkomandata) għal 6 xhur, effetti mhux mixtieqa gastrointestinali, jiġifieri rimettar, ġew osservati .
English: As field studies were limited to 90 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Maltese: kura iżjed fit-tul għanda tiġi ikkunsidrata b'attenzjoni u taħt il-monitoraġġ regolari tat-tabib veterinarju.
English: Following oral administration in dogs at the recommended dose of 5 mg per kg of bodyweight, firocoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 1.25 (± 0.85) hours.
Maltese: Wara l-amministrazzjoni mill-ħalq lill-klieb fid-doża rakkomandata ta' 5mg għal kull kg ta' piż, ilfirocoxib jiġi assorbit malajr u l-ħin għall-konċentrazzjonali massimali (Tmax) huwa ta' 1.25 (± 0.85) siegħat.
English: Concurrent use of other active substances that have a high degree of protein binding may compete with firocoxib for binding and thus lead to toxic effects.
Maltese: L-użu fl-istess waqt ta' sustanzi attivi oħra li għandhom kapacità għolja li jeħlu mal-proteini taddemm jista jikkompeti mal-firocoxib għal din l'azzjoni u għaldaqstant jirriżulta f'effetti tossiċi.
English: Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Maltese: Uża dan il-prodott taħt monitoraġġ strett veterinarju fejn hemm riskju ta' emorraġija gastrointestinali,
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Maltese: COX-2 hija l-isoforma tal-enżima li ġie muri li tiġi indotta minn stimoli pro-infjammatorji u huwa maħsub li hija primarjament responsabbli għas-sintesi tal-medjaturi prostanojdi ta' l-uġigħ, infjammazzjoni u d-deni.
English: Chewable tablet
Maltese: TWISSIJIET SPEĊJALI
English: Thromboembolic events, including interaction with oestrogens have been reported.
Maltese: Ġew irrapportati avvenimenti tromboemboliċi, inkluż interazzjoni mal-estroġeni.
English: Tranexamic acid is a lysine analogue authorised for several indication since 1969.
Maltese: Tranexamic acid huwa analogu ta' lysine awtorizzat għal diversi indikazzjonijiet sa mill-1963.
English: This document presents the conclusions on tranexamic acid.
Maltese: Dan id-dokument jippreżenta l-konklużjonijiet dwar tranexamic acid.
English: The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE, għal aprotinin, aminocaproic acid u tranexamic acid (ara Anness I).
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Maltese: Ir-riżultati preliminari ta' prova klinika kkontrollata randomizzata, l-istudju dwar il-‘Konservazzjoni tad-demm permezz tal-antifibrinolitiċi: prova randomizzata f'popolazzjoni ta' kirurġija tal-qalb' (BART), urew li minkejja li l-użu ta' aprotinin kien assoċjat ma' fsadiet inqas serji minn dawk li jirriżultaw millmediċini ta' tqabbil, ġiet osservata żieda fir-rata ta' mortalità fuq perjodu ta' 30 jum minħabba kwalunkwe kawża fost il-pazjenti li kienu qegħdin jirċievu aprotinin meta mqabbla ma' pazjenti li kienu qegħdin jieħdu mediċini oħra.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Tranexamic acid containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' riferiment dwar antifibrinolitiċi Prodotti mediċinali li fihom Tranexamic acid (ara Anness I)
English: This PK study had been requested by the CHMP in the article 31 referral on antifibrinolytics containing aprotinin, aminocaproic acid and tranexamic acid.
Maltese: Dan l-istudju farmakokinetiku kien intalab misCHMP fir-riferiment skont l-Artikolu 31 dwar antifibrinolitiċi li fihom aprotinin, aminocaproic acid u tranexamic acid.
English: Data available from randomised clinical trials and observational studies, including meta-analysis were considered.
Maltese: Ġiet ikkunsidrata d-dejta disponibbli minn provi kliniċi randomizzati u minn studji ta' osservazzjoni, inkluż minn meta-analiżi.
English: The safety profile of TXA has evolved since its authorisation, and safety data has accumulated over the years.
Maltese: Il-profil tas-sigurtà ta' TXA evolva mill-awtorizzazzjoni tiegħu, u d-dejta ta' sigurtà akkumulata matul is-snin.
English: The results of the BART trial did not have a negative impact on the benefit risk profile of TXA.
Maltese: Ir-riżultati tal-prova BART ma kellhomx impatt negattiv fuq il-profil tal-benefiċċju-riskju ta' TXA.
English: Figure: 3.
Maltese: III għall-opinjoni.
English: Dermatitis allergic, vascular disorders, such as malaise with hypotension, with or without loss of consciousness and arterial or venous thrombosis, and hypersensitivity reactions including anaphylaxis have been reported.
Maltese: Dermatite allerġika, disturbi vaskulari, bħal telqa flimkien ma' pressjoni baxxa, b'telf mis-sensi jew mingħajru u trombożi arterjali jew venuża, u reazzjonijiet ta' ipersensittività inkluż anafilassi kienu rrappurtati.
English: Tranexamic acid has also been associated with gastrointestinal adverse events, such as nausea, diarrhoea and vomiting.
Maltese: Tranexamic acid ġie assoċjat ukoll ma' avvenimenti gastrointestinali avversi, bħal dardir, dijarea u rimettar.
English: The marketing authorisations of EACA and TXA were not affected by the initial 2007 review.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq ta' EACA u TXA ma ġewx affettwati mir-reviżjoni inizjali tal-2007.
English: Tranexamic acid had not previously been associated with an increased risk of mortality and this has remained unchanged post-publication of the BART study.
Maltese: Tranexamic acid ma kienx ġie assoċjat qabel ma' riskju akbar ta' mortalità u dan baqa' ma nbidilx wara l-pubblikazzjoni talistudju BART.
English: Acute venous or arterial thrombosis should constitute a contraindication.
Maltese: Trombożi akuta arterjali jew venuża għandha tikkostitwixxi kontraindikazzjoni.
English: The MAH was not convinced that the fulfilment of a condition such as performing a pharmacokinetic study in children was an essential condition for the safe and effective use of tranexamic acid IV in adults.
Maltese: • Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ma kienx konvint li t-twettiq ta' kundizzjoni bħat-twettiq ta' studju farmakokinetiku fuq it-tfal kienet kundizzjoni essenzjali għallużu sigur u effettiv ta' tranexamic acid IV fl-adulti.
English: The CHMP identified that information on disseminated intravascular coagulation, visual disturbances including impaired colour vision, thromboembolism, haematuria and convulsions should be appropriately reflected through warnings and recommendations in the product information.
Maltese: Is-CHMP identifika li l-informazzjoni dwar il-koagulazzjoni intravaskulari mxerrda, iddisturbi viżwali inkluż l-indeboliment tal-viżjoni tal-kulur, it-tromboemboliżmu, l-ematurja u lkonvulżjonijiet, għandhom jiġu adegwatament riflessi permezz ta' twissijiet u rakkomandazzjonijiet fl-informazzjoni dwar il-prodott.
English: The ongoing studies could provide some relevant PK data in different age stratum and some pharmacodynamic data, which is considered of interest.
Maltese: L-istudji li għaddejjin jistgħu jipprovdu xi dejta farmakokinetika rilevanti fi gruppi differenti ta' età u xi dejta farmakodinamika, li hija meqjusa ta' interess.