FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: antihaemorrhagics, local haemostatics, ATC code: B02BC30
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, emostatiċi lokali, Kodiċi ATC:
English: The surgeon will apply EVARREST during your operation.
Maltese: Il-kirurgu ser japplika EVARREST waqt l-operazzjoni tiegħek.
English: Clinical studies demonstrating haemostasis in mild or moderate soft tissue bleeding were conducted in a total of 141 subjects (111 treated with EVARREST and 30 with control) undergoing abdominal, retroperitoneal, pelvic, and (non-cardiac) thoracic surgery.
Maltese: Saru studji kliniċi li juru emostażi fi tnixxija dgħajfa jew moderata tat-tessut morbidu f'total ta' 141 individwu (111 ittrattati b'EVARREST u 30 bil-kontroll) sottoposti għal kirurġija addominali, retroperitoneali, pelvika, u toraċika (mhux kardijaka).
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji li ġejjin jintużaw biex jikklassifikaw ir-reazzjonijiet avversi skont il-frekwenza talokkorrenzi: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 to <1/1,000); u rari ħafna (<1/10,000), mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: Of the enrolled subjects, 4.7% of EVARREST treated subjects (18 subjects out of 381) and 2.6% of control subjects (7 subjects out of 272) experienced one or more adverse reactions.
Maltese: Mill-individwi rreġistrati, 4.7 % tal-individwi kkurati b'EVARREST (18-il individwu minn 381) u 2.6 % individwi tal-kontroll (7 individwi minn 272) kellhom reazzjoni avversa waħda jew aktar.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Maltese: Il-miżuri meħuda jistgħu jkunu ta' valur ristrett kontra viruses mhux inveloppjati bħal parvovirus B19.
English: Human Fibrinogen
Maltese: Fibrinoġen Uman
English: Fibrinogen is a protein extracted from the blood that forms a fibrin clot when acted upon by the enzyme thrombin.
Maltese: Fibrinoġen huwa proteina estratta mid-demm li tifforma għoqda tal-fibrina meta taġixxi fuqha lenzima trombin.
English: One (1/75) adverse reaction of deep vein thrombosis was reported in the EVARREST group.
Maltese: Reazzjoni avversa waħda (1/75) ta' trombożi tal-vini profondi ġiet irrappurtata fil-grupp ta' EVARREST.
English: A further trial in 91 patients undergoing abdominal, retroperitoneal, pelvic, and (non-cardiac) thoracic surgery (59 treated with EVARREST and 32 with control) demonstrated haemostasis in severe soft tissue bleeding.
Maltese: Saret prova oħra f'91 pazjent sottoposti għal kirurġija addominali, retroperitoneali, pelvika, u toraċika (mhux kardijaka) (59 ittrattati b'EVARREST u 32 bil-kontroll) li wriet emostażi fi tnixxija severa tat-tessut morbidu.
English: Human Thrombin
Maltese: Trombina Umana
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped virus hepatitis A virus (HAV).
Maltese: Il-miżuri li jittieħdu huma kkonsidrati effettivi għal viruses inveloppjati bħal virus talimmunodefiċjenza umana (HIV), virus tal-epatite B (HBV) u l-virus tal-epatite Ċ (HCV) u l-virus mhux inveloppjat, tal-epatite A (HAV).
English: 45075 Jerusalem 9777605
Maltese: St., Ramot Meir Building Har-Hotzvim P.O.B. 45075 Jerusalem 9777605
English: At the Cmax, the plasma concentration represented only 1 to 2% of the applied dose.
Maltese: Fis-Cmax, il-konċentrazzjoni tal-plażma rrappreżentat biss 1 sa 2 % tad-doża applikata.
English: Two subjects out of 145 (~1%) in the group treated with EVARREST showed a transient increase in fibrinogen antibody titres, with titre levels back at background levels at the 8 to 10 week time point.
Maltese: Żewġ individwi minn 145 (~1 %) fil-grupp ikkurat b'EVARREST urew żieda temporanja fit-titres ta' antikorpi ta' fibrinogen, bil-livelli tat-titres li reġgħu lura fil-livelli tal-isfond fil-punt ta' żmien ta' 8 sa 10 ġimgħat.
English: Other medicines and EVARREST
Maltese: Mediċini oħra u EVARREST
English: This will allow quick identification of new safety information.
Maltese: Dan jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida tas-sigurtà.
English: Non-clinical data on the Matrix component reveal no special hazard for humans based on studies of cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility.
Maltese: Tagħrif mhux kliniku dwar il-komponent tal-Matriċi ma jiżvela ebda periklu speċjali għall-bnedmin ibbażat fuq studji ta' ċitotossiċità, sensitizzazzjoni, reazzjoni intrakutanea, tossiċità sistematika akuta, piroġeniċità permezz tal-materjal, tossiċità sottokronika, ġenotossiċità, impjant, u emokompatibbiltà.
English: EVARREST contains up to 3.0 mmol (68.8 mg) sodium per sealant matrix.
Maltese: EVARREST fih sa 3.0 mmol (68.8 g) ta' sodju għal kull matriċi siġillanti.
English: Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Maltese: Is-siġillanti/l-emostatiċi abbażi tal-fibrina huma metabolizzati fl-istess mod ta' fibrina endoġena, permezz ta' fibrinoliżi u fagoċitożi.
English: Name and address of the manufacturer(s) responsible for batch release Omrix Biopharmaceuticals N.V.
Maltese: Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott Omrix Biopharmaceuticals N.V.
English: Three subjects out of 145 (~2%) in a clinical trial group treated with EVARREST showed an increase in the titre of anti-thrombin antibodies after treatment.
Maltese: Tliet individwi minn 145 (~2 %) fi grupp ta' prova klinika ikkurati b'EVARREST, urew żieda fit-titre ta' antikorpi anti-thrombin wara l-kura.
English: See the end of section 4 for how to report side effects.
Maltese: Ara l-aħħar ta' sezzjoni 4 dwar kif tista' tirrapporta effetti sekondarji.
English: The foil sachet protects EVARREST from moisture and from microbiological contamination.
Maltese: Il-qartas tal-fojl jipproteġi EVARREST mill-umdità u minn kontaminazzjoni mikrobijoloġika
English: Pack size of 2, 5.1 cm x 10.2 cm sealant matrices.
Maltese: Daqs ta' pakkett ta' 2, 5.1 cm x 10.2 cm matriċi siġillanti.
English: Omrix Biopharmaceuticals Ltd. Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B.
Maltese: EVARREST m'għandux jintuża biex isewwi l-ġrieħi fil-ħajt ta' arterji jew vini kbar fejn il-prodott huwa espost għall-fluss u l-pressjoni kostanti tad-demm.
English: Application of EVARREST
Maltese: L-Applikazzjoni ta' EVARREST
English: EVARREST is applied during surgical operations in adult subjects, to stop bleeding and oozing during the operation.
Maltese: EVARREST jiġi applikat matul operazzjonijiet kirurġiċi f'suġġetti adulti, biex titwaqqaf it-tnixxija u l-fluss tad-demm matul l-operazzjoni.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIOLOĠIĊI ATTIVI U MANIFATTUR(I) RESPONSABBLI
English: Sealant Matrix
Maltese: Matriċi Siġillanti.
English: EVARREST is to be applied with approximately 3 minutes of firm manual compression.
Maltese: EVARREST għandu jiġi applikat b'madwar 3 minuti ta' kompressjoni soda bl-idejn.
English: Two clinical studies in 206 patients undergoing hepatic surgery (110 treated with EVARREST and 96 with control) demonstrated haemostatic efficacy in persistent parenchymal bleeding.
Maltese: Żewġ studji kliniċi f'206 pazjenti li kellhom operazzjoni tal-fwied (110 ikkurati b'EVARREST u 96 bil-kontroll), urew effikaċja emostatika fi ħruġ ta' demm parenkimali persistenti.
English: EVARREST is a combination product made from an absorbable material (Matrix) coated with human fibrinogen and human thrombin.
Maltese: EVARREST hu prodott ta' kombinazzjoni magħmul minn _materjal (matriċi) assorbenti miksi b'fibrinoġen uman u trombina umana.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or abnormal erythropoiesis (e.g., haemolytic anaemia).
Maltese: Infezzjoni bil-Parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni fetali) u għal individwi b'immunodefiċjenza jew eritropojeżi abnormali (eż anemija emolitika)
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Maltese: INFORMAZZJONI BIL-BRAILLE Ġiet aċċettata l-ġustifikazzjoni għaliex il-Braille mhux inkluż.
English: None of the patients in any treatment group had a significant change in antibody titre to thrombin or fibrinogen.
Maltese: Ħadd mill-pazjenti fi kwalunkwe grupp ta' kura ma kellu bidla sinifikanti fit-titre tal-antikorpi għal thrombin jew fibrinogen.
English: (tube) - sealing surgical repairs to the intestines.
Maltese: Trażmissjoni ta' aġenti infettivi
English: Three subjects out of 145 (~2%) in the group treated with EVARREST showed an increase in the titre of anti-thrombin antibodies after treatment.
Maltese: Tliet individwi minn 145 (~2 %) fil-grupp ikkurat b'EVARREST urew żieda fit-titre ta' antikorpi antithrombin wara l-kura.
English: Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Maltese: Is-siġillanti ta' fibrin jistgħu, f'ċirkostanzi rari (sa persuna waħda f'1000), jikkaġunaw reazzjoni allerġika.
English: EVARREST is a white-to-yellow bio-absorbable combination product made from a flexible composite Matrix, coated with Human Fibrinogen and Human Thrombin.
Maltese: EVARREST huwa prodott imħallat ta' lewn bajdani għall-isfar bijoassorbenti magħmul minn Matriċi komposta flessibbli, miksija b'fibrinoġen uman u trombina umana.
English: Discard damaged packages as re-sterilisation is not possible.
Maltese: Armi pakketti li huma bil-ħsara peress li sterilizzazzjoni mill-ġdid mhix possibbli.
English: Blood clot (thromboembolism)
Maltese: Għoqda tad-demm (tromboemboliżmu)
English: Using 125I-thrombin it was shown that a slow absorption of biologically inactive peptides resulting from the breakdown of thrombin occurred, reaching a Cmax in the plasma after 6-8 hours.
Maltese: Permezz tal-użu ta' 125I-trombina ntwera li seħħ assorbiment bil-mod ta' peptidi bijoloġikament innattivi li jirriżultaw minn tkissir ta' trombina, li laħaq Cmax fil-plażma wara 6-8 sigħat.
English: A 90-day study in rats to evaluate subchronic systemic toxicity and immunogenicity of EVARREST after subcutaneous implantation found no signs of toxic effects and no evidence of increased immunogenicity relative to fibrin sealant products.
Maltese: Studju ta' 90 jum fil-farijiet biex jiġu evalwati t-tossiċità sistematika sottokronika u l-immunoġeniċità tal-EVARREST wara impjant taħt il-ġilda ma sab ebda evidenza ta' aktar immuniġeniċità relattiva għall-prodotti tas-siġillant tal-fibrina.
English: EVARREST contains Human Fibrinogen and Human Thrombin as a dried coating on the surface of an absorbable composite Matrix.
Maltese: EVARREST fih fibrinoġen uman u trombina umana bħala kisja mnixxfa fuq is-superfiċje ta' Matriċi komposta li tiġi assorbita.
English: EVARREST is intended for epilesional use only.
Maltese: EVARREST huwa intenzjonat għal użu epileżjonali biss.
English: 2 years.
Maltese: 2 cm.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Maltese: Rarament jistgħu jiġu żviluppati antikorpi kontra l-komponenti tal-prodotti li fihom siġillant abbażi tal-fibrina/emostatiċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) EVARREST contains per cm2
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: 5.1 cm x 10.2 cm sealant matrix in a tray (polyester).
Maltese: 2 cm fi trej (poliester).
English: Uncommon Uncommon
Maltese: Mhux komuni
English: This medicine contains up to 3.0 mmol (68.8 mg) sodium in each EVARREST sealant matrix.
Maltese: Din il-mediċina fiha sa 3.0 mmol (68.8 mg) ta' sodju għal kull matriċi siġillanti EVARREST.
English: The composite Matrix is composed of polyglactin 910 and oxidized regenerated cellulose, a commonly used haemostat.
Maltese: Il-Matriċi komposta hija magħmula minn poliglactin 910 u ċelluloża riġenerata ossidizzata, emostatiku użat komunement.
English: Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.4).
Maltese: Jistgħu jseħħu komplikazzjonijiet ta' emboli tad-demm jekk il-preparazzjoni tiġi applikata ġol-vażi b'mod mhux intenzjonat (ara Sezzjoni 4.4).
English: Contains one sealant matrix (10.2 cm x 10.2 cm)
Maltese: Fih matriċi siġillanti waħda (10.2 cm x 10.
English: NAME OF THE MEDICINAL PRODUCT EVARREST Sealant Matrix
Maltese: TAL-PRODOTT MEDIĊINALI EVARREST Matriċi Siġillanti
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura ogħla minn 25°C.
English: Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol, iodine, or heavy metals (e.g., antiseptic solutions).
Maltese: Simili għall-prodotti komparabbli jew soluzzjonijiet ta' trombina, il-prodott jista' jkun denaturat wara esponiment għal soluzzjonijiet li fihom l-alkoħol, jodju jew metalli tqal (eż. soluzzjonijiet antisettiċi).
English: Human Fibrinogen / Human Thrombin
Maltese: Fibrinoġen Uman Trombina Umana
English: Data from eight clinical trials with EVARREST have been pooled into an integrated dataset and the frequencies of occurrence described in the table below originate from this integrated dataset.
Maltese: Id-dejta minn tmien provi kliniċi b'EVARREST inġabret f'dataset integrat u l-frekwenzi talokkorrenzi spjegata fit-tabella t'hawn taħt joriġinaw minn dan id-dataset integrat.
English: The fibrin is then cross-linked by endogenous Factor XIII, creating a firm, mechanically stable fibrin network with good adhesive properties.
Maltese: Imbagħad ikun hemm cross-linkages tal-fibrina bil-Factor XIII endoġenu, li joħloq netwerk mekkanikament stabbli u sod tal-fibrina bi propjetajiet ta' adeżjoni tajba.
English: It was a prospective, randomised, controlled single-centre study observing the clinical utility of EVARREST against Standard of Care (SoC) in soft tissue bleeding during intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery.
Maltese: Kien studju prospettiv, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat u b'ċentru wieħed, li osserva l-utilità klinika ta' EVARREST kontra l-Istandard ta' Kura (SoC, Standard of Care) fi ħruġ ta' demm fit-tessut artab waqt operazzjoni intraaddominali, retroperitoneali, pelvika u operazzjoni toraċika mhux tal-qalb.
English: During surgery (operative haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Maltese: - Waqt l-operazzjoni (emorraġija operattiva); il-frekwenza kienet mhux komuni (tista' taffettwa sa 1 minn kull 100 persuna).
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g., sickle cell disease or haemolytic anaemia).
Maltese: Infezzjoni bil-parovirus B19 tista' tkun serja għal nisa tqal (infezzjoni fetali) u għal individwi li s-sistema immuni tagħhom hija batuta jew għandhom xi tip t'anemija (eż mard ta' ċellula f'għamla ta' minġel (sickle cell) jew anemija emolitika).
English: When the dry powder coating of EVARREST is wetted, the thrombin acts on the fibrinogen to rapidly form a clot.
Maltese: Meta t-trab xott li jiksi 'l EVARREST jixxarrab, it-trombina taġixxi fuq il-fibrinoġen biex malajr tifforma għoqda tad-demm.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/haemostatic products.
Maltese: Reazzjonijiet ta' sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq u tingiż fis-sit tal-applikazzjoni, bronkospażmu, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet f'ġismek, takikardija, tagħfis fissider, tnemnim, rimettar, tħarħir) jistgħu jseħħu f'każijiet rari f'pazjenti kkurati b'siġillanti talfibrin/prodotti emostatiċi.
English: • Risk Management Plan (RMP) The Marketing Authorization Holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: EVARREST Sealant Matrix
Maltese: IL-PRODOTT MEDIĊINALI EVARREST Matriċi Siġillanti
English: A prospective randomised controlled clinical study was conducted enrolling 156 subjects (76 EVARREST, 80 haemostatic fleece) demonstrating the safety and haemostatic effectiveness of EVARREST as an adjunct to controlling bleeding during cardiovascular surgery.
Maltese: Twettaq studju kliniku prospettiv u kkontrollat, li fih il-parteċipanti ntgħażlu b'mod każwali, li fih kienu rreġistrati 156 individwu (76 EVARREST, 80 fleece emostatiku).
English: From the stomach (intra-abdominal haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Maltese: - Mill-istonku (emorraġija intraaddominali); il-frekwenza kienet mhux komuni (tista' taffettwa sa 1 minn kull 100 persuna).
English: The overall incidence of deep vein thrombosis observed during clinical trials was consistent with published data and does not suggest an increased risk for thrombotic events in EVARREST-treated subjects, although from the available data, this risk cannot be completely ruled out.
Maltese: L-inċidenza globali ta' trombożi tal-vini profondi osservata matul il-provi kliniċi kienet konsistenti mad-dejta ppubblikata, u ma tissuġġerixxix riskju miżjud għal avvenimenti trombotiċi f'individwi kkurati b'EVARREST, għalkemm mid-dejta disponibbli, dan ir-riskju ma jistax jiġi eskluż kompletament.
English: Immunogenicity was evaluated in soft tissue clinical studies by testing blood samples collected at baseline, 4 to 6 weeks, and 8 to 10 weeks post-surgery for antibodies to human thrombin and fibrinogen by enzyme-linked immunosorbent assays.
Maltese: L-immunoġeniċità ġiet evalwata fi studji kliniċi dwar it-tessut artab permezz ta' ttestjar ta' kampjuni tad-demm miġbura fil-linja bażi, 4 sa 6 ġimgħat, u 8 sa 10 ġimgħat wara l-operazzjoni għal antikorpi għal thrombin u fibrinogen uman permezz ta' assaġġi immunosorbenti assoċjati mal-enzimi.
English: All adverse reactions reported during the clinical trials occurred at a frequency of less than 1% (uncommon).
Maltese: Ir-reazzjonijiet avversi kollha rrappurtati matul il-provi kliniċi seħħew fi frekwenza ta' inqas minn 1 % (mhux komuni).
English: 40 IU Contains one sealant matrix (5.1 cm x 10.2 cm)
Maltese: IU Fih matriċi siġillanti waħda (5.1 cm x 10.
English: How to store EVARREST
Maltese: L-Applikazzjoni ta' EVARREST™
English: Excipient(s) with known effect: Contains up to 3.0 mmol (68.8 mg) sodium per sealant matrix.
Maltese: Fih sa 3.0 mmol (68.8 g) ta' sodju għal kull matriċi siġillanti.
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped virus, hepatitis A. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Maltese: Il-miżuri li jittieħdu fil-manifattura ta' fibrinoġen u trombin huma kkonsidrati effettivi għal viruses inveloppjati bħal virus tal-immunodefiċjenza umana (HIV), virus tal-epatite B u l-virus tal-epatite Ċ u l-virus mhux inveloppjat, tal-epatite A.
English: Discard damaged packages.
Maltese: Daqs ta' pakkett ta' 2.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta l-pjan tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju/riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: ● Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: ● Ipersensittività għal sustanzi attivi jew għal xi wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: ● EVARREST must not be applied intravascularly.
Maltese: titneħħa u tiġi applikata oħra ġdida.
English: Allergic-type hypersensitivity reactions are possible.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku huma possibbli.
English: If not satisfied with the placement, remove EVARREST and use a new EVARREST sealant matrix.
Maltese: Jekk m'intix sodisfatt bit-tqegħid, neħħi l-EVARREST u qiegħed matriċi EVARREST ġdida.
English: A post-marketing safety study enrolling 150 subjects was conducted using EVARREST.
Maltese: Twettaq studju dwar is-sigurtà wara t-tqegħid fis-suq li rreġistra 150 individwu bl-użu ta' EVARREST.
English: ● Remove the white sterile tray from the pouch and place onto the sterile field.
Maltese: ● Neħħi t-trej sterili abjad minn ġol-pawċ u qiegħdu ġol-kamp sterili.
English: After the biologic components have been absorbed, the Matrix components (polyglactin 910 and oxidized regenerated cellulose) absorb completely.
Maltese: Wara li l-komponenti bijoloġiċi jkunu ġew assorbiti, il-komponenti tal-Matriċi (poliglactin 910 u ċelluloża riġenerata ossidizzata) jassorbu kompletament.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Omrix Biopharmaceuticals N.V.
Maltese: FIS-SUQ Omrix Biopharmaceuticals NV
English: Fibrinogen is converted into fibrin monomers which spontaneously polymerise to form a fibrin clot that holds the Matrix firmly to the wound surface.
Maltese: Il-fibrinoġen jiġi kkonvertit f'monomeri ta' fibrina li spontanjament jifformaw fibrina magħquda li żżomm il-Matriċi soda mas-superfiċje tal-ferita.
English: The incidence of thromboembolic events, the incidence of post-operative bleeding events specifically related to the target bleeding site and the incidence of increased blood fibrinogen levels were assessed and recorded up to the 30 days follow-up period.
Maltese: L-inċidenza ta' avvenimenti tromboemboliċi, l-inċidenza ta' avvenimenti ta' ħruġ ta' demm wara l-operazzjoni speċifikament relatati mas-sit tal-ħruġ ta' demm filmira, u l-inċidenza ta' żieda fil-livelli ta' fibrinogen fid-demm, ġew evalwati u rreġistrati għallperjodu ta' follow-up ta' 30 jum.
English: Remove the white sterile tray from the pouch and place onto the sterile field.
Maltese: Neħħi t-trej sterili abjad minn ġol-pawċ u qiegħdu ġol-kamp sterili.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Maltese: Sinjali ta' ipersensittività jinkludu ħorriqija, urtikarja ġeneralizzata, għafis tas-sider, tħarħir, ipotensjoni u anafilassi.
English: Multiple bleeding sites may be treated simultaneously.
Maltese: Jistgħu jiġu kkurati simultanjament bosta siti ta' tnixxija.
English: Do not apply intravascularly
Maltese: Twissijiet u prekawzjonijiet
English: Accumulation of fluid in the stomach, swelling of the stomach; the frequency was uncommon (may affect up to 1 in 100 people).
Maltese: Akkumulazzjoni ta' fluwidu fil-frixa; il-frekwenza kienet mhux komuni (tista' taffettwa sa 1 minn kull 100 persuna).