FrancophonIA/ELRC3.0 huggingface dataset:
English: In a controlled study involving 147 patients undergoing vascular grafting procedures (75 treated with EVICEL and 72 controls), a total of 16 subjects were reported to have had a graft thrombosis/occlusion adverse event during the study period.
Maltese: Fi studju kontrollat fuq 147 pazjent sottoposti għal proċeduri ta' trapjant (grafting) vaskulari (75 ittrattati b'EVICEL u 72 kontroll), ġew irrappurtati total ta' 16-il pazjent b'episodju avvers ta' trombożi/okklużjoni tat-trapjant (graft) matul l-istudju.
English: Spray pressure
Maltese: Pressjoni talisprej
English: How to store EVICEL
Maltese: Tużax EVICEL
English: However, 3 serious adverse events (SAE) (one abdominal abscess in the EVICEL group and one abdominal and one pelvic abscess in the control group) were considered by the Sponsor to be possibly related to study treatment.
Maltese: Madankollu, l-isponsor qies 3 episodji avversi gravi (axxess addominali fil-grupp b'EVICEL u axxess addominali u ieħor pelviku fil-grupp ta' kontroll) possibbilment marbutin mat-trattament ta' studju.
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/haemostatics.
Maltese: Reazzjonijiet ta' sensittività eċċessiva jew allerġiċi (li jinkludu anġjoedema, ħruq u tingiż fil-punt ta' applikazzjoni, bronkospażmi, tertir, ħmura fil-wiċċ, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, ipotensjoni, letarġija, nawżea, nuqqas ta' sabar, takikardija, għafis tas-sider, tnemnim, remettar, nifs bit-tħarħir) jistgħu jseħħu f'każijiet rari f'pazjenti b'siġillanti tal-fibrina/emostatiċi.
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 b'parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni fetali) u għal individwi li s-sistema immunitarja tagħhom hija batuta jew li għandhom xi tipi ta' anemija (ngħidu aħna, marda ta' ċelloli minġel (sickle cell disease) jew anemija emolitika).
English: Side effects which were uncommon during clinical trials with EVICEL (i.e., may affect up to 1 in 100 people) included infection, blood accumulation (haematoma), swelling, decreased haemoglobin, and post-operative wound complications (including bleeding or infection).
Maltese: Effetti sekondarji li kienu mhux komuni matul il-provi kliniċi b'EVICEL (i.e., jistgħu jaffettwaw sa 1 minn kull 100 persuna) kienu jinkludu infezzjoni, akkumulazzjoni ta' demm (ematoma), nefħa, tnaqqis flemoglobina, u kumplikazzjonijiet tal-ferita wara l-operazzjoni (li jinkludu ħruġ ta' demm jew infezzjoni).
English: Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL and 68 controls), no adverse events were considered to be causally related to the study treatment according to the investigator assessments.
Maltese: Fost il-135 pazjent sottoposti għal intervent kirurġiku retroperitoneali u intraddominali (67 pazjent ittrattati b'EVICEL u 68 kontroll), fuq il-bażi ta' valutazzjonijiet tal-investigatur, l-ebda episodju avvers ma ntqiesx marbut kawżalment mat-trattament ta' studju.
English: • The Healthcare professionals training material shall inform about the o risk of life-threatening gas embolism if the product is sprayed incorrectly o use of pressurized CO2 only o Restriction to open and laparoscopic surgeries, minimum spray distances must be observed:
Maltese: • Il-Materjal ta' taħriġ għall-professjonisti tal-kura tas-saħħa għandu jinforma dwar o ir-riskju ta' emboliżmu tal-gass li jista' jkun ta' theddida għall-ħajja, jekk il-prodott jiġi sprejjat b'mod inkorrettl-użu ta' CO2 taħt pressjoni o Restrizzjoni għal kirurġiji miftuħa (open surgery) u laporoskopiċi, għandhom jiġu osservati ddistanzi minimi tal-isprej:
English: However, since EVICEL is used during a surgical operation, if you are pregnant or breast-feeding, you should discuss the overall risks of the operation with your doctor.
Maltese: Madankollu, peress li EVICEL jintuża waqt operazzjoni kirurġika, jekk inti tqila jew qegħda tredda' għandek tiddiskuti r-riskji totali tal-operazzjoni mat-tabib tiegħek.
English: EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml of solution (Human Fibrinogen and Human Thrombin respectively).
Maltese: EVICEL huwa Siġillant li fih il-Fibrina Umana li huwa fornut bħala pakkett li fih żewġ kunjetti separati, kull wieħed fih 1 ml, 2 ml jew 5 ml ta' soluzzjoni (Fibrinoġen uman u Trombina umana, rispettivament).
English: EVICEL is supplied as a package containing two separate vials (glass type I) with rubber stoppers (type I), each containing 1 ml, 2 ml, or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
Maltese: EVICEL huwa fornut bħala pakkett li fih żewġ kunjetti separati (ħġieġ tip I) b'tappijiet tal-lastku (tip I), li kull wieħed fih 1 ml, 2 ml, jew 5 ml soluzzjoni ta' Fibrinoġen u Trombina rispettivament.
English: Intracranial hypotension (CSF leakage)
Maltese: Pressjoni baxxa intrakranjali (tnixxija ta' CSF)
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for lipid coated viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and the non-enveloped virus, hepatitis A. The measures taken may be of limited value against parvovirus B19.
Maltese: Il-miżuri meħudin fil-manifattura ta' fibrinoġen u trombina huma kkunsidrati effettivi għal virusijiet miksijin bil-lipidu bħalma huma l-virus mill-immunodefiċjenza umana (HIV), il-virus tal-epatite B u l-virus talepatite Ċ u l-virus mhux enveloppat, epatite A.
English: Studies performed in bacteria to determine mutagenicity were negative for thrombin alone, Biological Active Component (containing fibrinogen, citrate, glycine, tranexamic acid, and arginine hydrochloride), TnBP alone, and Triton X-100 alone at all concentrations tested.
Maltese: Studji magħmulin fil-batterji biex jiddeterminaw il-mutaġeniċità kienu negattivi għat-trombina waħedha, Komponent Bijoloġikament Attiv (li fih fibrinoġen, ċitrat, gliċina, aċidu traneksamiku, u arġinina-kloridrat), TnBP waħdu, u Triton
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g., haemolytic anaemia).
Maltese: Infezzjoni b'Parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni fetali) u għal individwi b'immunodefiċjenza jew b'żieda fl-eritropojeżi (eż., anemija emolitika).
English: For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tip.
Maltese: Għal applikazzjoni bl-isprej ara sezzjonijiet 4.4 u 6.6 għal rakkomandazzjonijiet speċifiċi dwar il-pressjoni u d-distanza mit-tessut meħtieġa għal kull proċedura kirurġika u t-tul tal-ponta tal-applikatur.
English: EVICEL is indicated in adults as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1).
Maltese: EVICEL huwa indikat f'adulti bħala kura ta' appoġġ fil-kirurġija, għal titjib tal-emostażi, fejn tekniċi kirurġiċi standard mhumiex biżżejjed (ara sezzjoni 5.1).
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Maltese: Hekk kif il-fejqan tal-ferita javvanza, żieda fl-attività fibrinolitika hija indotta mill-plażmina u tinbeda d-dekompożizzjoni ta' fibrina fi prodotti ta' degradazzjoni tal-fibrina.
English: 45 cm Flexible Tip
Maltese: 45 ċm Tarf Flessibbli
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: EVICEL is also indicated in adults as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure.
Maltese: EVICEL huwa applikat f'adulti waqt operazzjonijiet kirurġiċi biex inaqqas il-fsada u tnixxija waqt u wara loperazzjoni.
English: Store in a freezer at or below -18C.
Maltese: Aħżen fil-friżer f'temperatura ta' -18
English: I-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: I-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: Component 1: Human clottable protein containing mainly fibrinogen and fibronectin (50 - 90 mg/ml) Component 2: Human thrombin (800 - 1,200 IU/ml)
Maltese: Komponent 1: Proteina umana li tagħqad li prinċipalment fiha fibrinoġen u fibronektina (50 - 90 mg/ml) Komponent 2: Trombina umana (800 - 1,200 IU/ml)
English: 6 cm Flexible Tip
Maltese: 6 ċm Tarf Flessibbli
English: 6 cm flexible tip
Maltese: 6 ċm tarf flessibbli
English: Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce.
Maltese: Fibrinoġen huwa konċentrat ta' proteina li tgħaqqad u t-trombina hija enzima li tikkawża l-fużjoni tal-proteina li tgħaqqad.
English: Store in a freezer at -18°C or colder.
Maltese: Aħżen fil-friża f'temperatura ta' jew taħt -18°C.
English: If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting, or wheezing.
Maltese: Jekk tesperjenza reazzjoni allerġika jista' jkollok wieħed jew iktar mis-sintomi li ġejjin: raxx fil-ġilda, ħorriqija jew urtikarja, għafis fis-sider, tertir, fwawar, uġigħ ta' ras, pressjoni tad-demm baxxa, letarġija, nawżea, nuqqas ta' sabar, żieda fir-rata tal-qalb, tnemmil, remettar jew tħarħir.
English: Headache Hydrocephalus Subdural hygroma
Maltese: Igroma subdurali
English: • As with any product containing proteins, allergic-type hypersensitivity reactions are possible.
Maltese: • Bħal kwalunwe prodott li fih il-proteini, jista' jkun hemm reazzjonijiet minn ipersensittività tat-tip allerġiku.
English: The incidence of CSF leakage and the incidence of Surgical Site Infections were monitored as safety endpoints in the study.
Maltese: L-inċidenza ta' tnixxija ta' CSF u l-inċidenza ta' Infezzjonijiet fis-Sit Kirurġiku ġew immonitorjati bħala punti aħħarin tas-sigurtà fl-istudju.
English: Store in the outer carton at -18°C or colder, to protect from light.
Maltese: Aħżen fil-kartuna ta' barra f'temperatura ta' -18°C jew inqas, biex tilqa' mid-dawl.
English: • To avoid the risk of potentially fatal air or gas embolism EVICEL should be sprayed using pressurised CO2 gas only.
Maltese: • Biex tevita r-riskju ta' emboliżmu tal-arja jew il-gass li jista' jkun fatali EVICEL għandu jiġi sprejjat biss permezz ta' gass CO2 taħt pressjoni.
English: Omrix Biopharmaceuticals Ltd. Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B.
Maltese: Is-sinjali ta' dawn ir-reazzjonijiet jinkludu ħorriqijia, raxx, għafis tas-sider, tħarħir, tnaqqis filpressjoni tad-demm u anafilassi.
English: • controlling bleeding in the stomach or intestines by applying the product through an endoscope (tube)
Maltese: • fil-kontroll tal-emorraġija fl-istonku jew fl-imsaren bl-applikazzjoni tal-prodott permezz ta' endoskopju (tubu);
English: These included intracranial hypotension (CSF leakage), CSF rhinorrhea, meningitis, headache, hydrocephalus, subdural hygroma, and haematoma.
Maltese: Sinjali ta' reazzjonijiet ta' ipersensittività jinkludu ħorriqija, urtikarja ġeneralizzata, għafis tassider, tħarħir, pressjoni baxxa, u anafilassi.
English: The efficacy of EVICEL for suture line sealing in dura mater closure was demonstrated in 139 patients (89 treated with EVICEL and 50 controls) undergoing craniotomy/craniectomy procedures.
Maltese: L-effikaċja ta' EVICEL għall-issiġillar ta' linja ta' suturi fl-għeluq tad-dura mater intweriet f'139 pazjent (89 ikkurati b'EVICEL u 50 bħala kontrolli) li kienu qed isirulhom proċeduri ta' kranjotomija/kranjektomija.
English: EVICEL must not be applied intravascularly.
Maltese: EVICEL m'għandux jiġi applikat intravaskularment.
English: Meningitis
Maltese: Manifattur
English: In a controlled study involving 139 patients undergoing elective neurosurgical procedures (89 treated with EVICEL and 50 controls), a total of 7 subjects treated with EVICEL experienced nine AEs that were considered to be possibly related to the study product.
Maltese: Fi studju kkontrollat li kien jinvolvi 139 pazjent li kien qed ikollhom proċeduri newrokirurġiċi elettivi (89 ikkurati b'EVICEL u 50 bħala kontroll), total ta' 7 individwi kkurati b'EVICEL kellhom disa' AEs li kienu kkunsidrati li kienu possibbilment relatati mal-prodott tal-istudju.
English: Within the 2 years shelf life, after thawing, unopened vials can be stored at 2C - 8C and protected from light, for up to 30 days.
Maltese: Fi żmien is-sentejn kemm idum tajjeb il-prodott mediċinali, wara li jinħall, kunjetti mhux miftuħin jistgħu jinħażnu f'temperatura ta' 2C - 8C u protetti mid-dawl għal 30 jum.
English: The Marketing Authorisation 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: The vials can be stored at room temperature for up to 24 hours.
Maltese: Il-kunjetti jistgħu jinħażnu f'temperatura ambjentali tal-kamra sa 24 siegħa.
English: Other side effects which were reported to be common during clinical trials with EVICEL (i.e., may affect up to 1 in 10 people) included meningitis, and accumulation of CSF fluid in the brain cavities (hydrocephalus).
Maltese: Effetti sekondarji oħrajn li ġew irrappurtati li kienu komuni fil-provi kliniċi b'EVICEL (i.e., jistgħu jaffetwaw sa 1 minn kull 10 persuni) kienu jinkludu meninġite, u akkumulazzjoni ta' fluwidu CSF filkavitajiet tal-moħħ (idroċefalu).
English: Discard unused product after 24 hours at room temperature.
Maltese: Armi kwalunkwe prodott mhux użat wara 24 siegħa fit-temperatura ambjentali.
English: Spray distance from tissue and pressure should be within the ranges recommended by the manufacturer (see table in section Instructions for Use).
Maltese: Id-distanza tal-isprej mittessut u l-pressjoni għandhom ikunu fil-firxa rakkomandata mill-manifattur (ara t-tabella fis-sezzjoni Istruzzjonijiet għall-Użu).
English: • It is not known whether radiation therapy could affect the effectiveness of fibrin sealant when used for suture line sealing during neurosurgery.
Maltese: • Mhuwiex magħruf jekk terapija bir-radjazzjoni tistax taffettwa l-effikaċja ta' siġillant ta' fibrin meta tintuża għall-issiġillar ta' linja ta' suturi fin-newrokirurġija.
English: * Total quantity of protein is 80 - 120 mg/ml
Maltese: * Il-kwantità totali ta' proteina hija 80 - 120 mg/ml Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: EVICEL comes in sterile packages and therefore it is important to use only undamaged packages which have not been opened (post-sterilisation is not possible).
Maltese: EVICEL jiġi f'pakketti sterili u għaldaqstant huwa importanti li tuża biss pakketti li ma jkunx fihom ħsara, li ma jkunux infetħu (sterilizzazzjoni wara mhijiex possibbli).
English: - Laparoscopic surgery - minimum 4 cm if the spray distance can be accurately judged o correct pressure and distance from tissue depending on kind of surgery (open or laparoscopic)
Maltese: - Kirurġija miftuħa - minimu ta' 10 ċm Kirurġija laparoskopika- minimu ta' 4 ċm jekk id-distanza minima tal-isprej tkun tista' tiġi mkejla b'mod preċiż o pressjoni u distanza korretta mit-tessut skont it-tip ta' kirurġija (miftuħa jew laparoskopija) o il-ħtieġa li l-ġerħa tiġi xxuttata permezz ta' teknika standard (eż., applikazzjoni intermittenti ta' għafsiet , msieħ l-użu ta' tagħmir li jiġbed l-arja) qabel l-użu tal-prodott.
English: The MAH shall ensure that all users of the spray application of this product are provided with: - labels for the pressure regulator that inform about the correct pressures and distances in open and laparoscopic procedures - a warning card that informs about the correct pressures and distances for the spray application for open and laparoscopic procedures - a tag, to be placed on the device air hose, which provides instructions for use.
Maltese: Fuljetti li jagħtu struzzjonijiet iddettaljati għall-użu ta' EVICEL flimkien mal-apparat ta' applikazzjoni u truf aċċessorji mhux obbligatorji huma pprovduti mal-pakkett tal-apparat tal-applikazzjoni u tat-truf aċċessorji.
English: Before use, the product must reach 20-30°C.
Maltese: Qabel l-użu, il-prodott jeħtieġ jilħaq 20-30°C.
English: Do not use after the expiry date stated on the carton and label.
Maltese: Tużax wara d data ta' meta jiskadi li tidher fuqil-kartuna.
English: Component 1: 1 vial containing 5 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 5 ml of human thrombin (800 - 1200 IU/ml).
Maltese: Komponent 1: kunjett 1 li fih 5 ml proteina umana li tgħaqqad (50 - 90 mg/ml) Komponent 2: kunjett 1 li fih 5 ml trombina umana (800 - 1200
English: Factor XIIIa, which is activated from Factor XIII by thrombin, crosslinks fibrin.
Maltese: Il-Fattur XIIIa, li huwa attivat minn Fattur XIII minn trombina, jagħmel tinsiġ inkroċjat ma' fibrina.
English: Spray application of EVICEL should not be used in endoscopic procedures.
Maltese: L-ebda reazzjoni allerġika ma ġiet irrapportata s'issa f'pazjenti ttrattati b'EVICEL.
English: CARTON BOX
Maltese: Mhux komuni
English: The frequency of all of these effects was common.
Maltese: Il-frekwenza ta' dawn l-effetti kollha kienet komuni.
English: Component 1: 1 vial containing 1 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 1 ml of human thrombin (800 - 1200 IU/ml).
Maltese: Komponent 1: kunjett 1 li fih 1 ml proteina umana li tgħaqqad (50 - 90 mg/ml) Komponent 2: kunjett 1 li fih 1 ml trombina umana (800 - 1200
English: Component 1: 1 vial containing 2 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 2 ml of human thrombin (800 - 1200 IU/ml).
Maltese: Komponent 1: kunjett 1 li fih 2 ml proteina umana li tgħaqqad (50 - 90 mg/ml) Komponent 2: kunjett 1 li fih 2 ml trombina umana (800 - 1200
English: It will be dripped onto the tissue in very small amounts or sprayed in short bursts (0.1-0.2 ml), to produce a thin, even layer.
Maltese: Tintefa' f'forma ta' qtar fuq it-tessut fi kwantitajiet żgħar ħafna jew tiġi sprejjata fi kwantitajiet żgħar (0.1-0.2 ml) bil-għan li jiġi prodott saff irqiq u uniformi.
English: An application device and appropriate accessory tips are supplied separately.
Maltese: Apparat ta' applikazzjoni u truf aċċessorji adattati huma fornuti separatament.
English: Keep upright.
Maltese: Żomm wieqaf.
English: Connect the female luer-lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Maltese: Ikkonettja il-lokk tal-luwer feminil tat-tubu tal-gass (mal-filtru batterjostatiku ta' 0.2 μm) mar-regolatur tal-pressjoni.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: 35 cm rigid tip
Maltese: 35 ċm tarf riġidu
English: The vials should be thawed in one of the following ways:
Maltese: EVICEL jiġi fid-daqsijiet ta' pakketti li ġejjin:
English: The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL.
Maltese: L-użu ta' EVICEL huwa ristrett għall-kirurgi esperti li ġew imħarrġa fl-użu ta' EVICEL.
English: Graft infection, Staphylococcal infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: EVICEL must be sprayed using pressurised CO2 only.
Maltese: EVICEL għandu jiġi sprejjat bl-użu ta' CO2 taħt pressjoni biss.
English: Using
Maltese: JIS
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard biex jimpedixxu infezzjonijiet li jirriżultaw minn prodotti mediċinali ppreparati minn demm jew plażma umani jinkludu l-għażla ta' donaturi, eżamijiet ta' donazzjonijiet individwali u pools tal-plażma għal markaturi speċifiċi ta' infezzjonijiet, u l-inklużjoni ta' passi effikaċi ta' manifattura għallinattivazzjoni/tneħħija ta' virusijiet.
English: Adequate data are not available to support the use of this product in tissue gluing, application through a flexible endoscope for treatment of bleeding, or in gastrointestinal anastomoses.
Maltese: L-applikazzjoni bl-isprej ta' EVICEL m'għandhiex tintuża għal proċeduri endoskopiċi.
English: 1 ml vial
Maltese: IU/ml).
English: - EVICEL is not sprayed via an endoscope when the recommended minimum safe distance from the tissue cannot be observed.
Maltese: - EVICEL ma jiġix sprejjat permezz ta' endoskopju meta d-distanza sigura minima rakkomandata mittessut ma tkunx tista' tiġi osservata.
English: The measures taken are considered effective for enveloped viruses such as HIV, hepatitis C virus, and hepatitis B virus, and for the non-enveloped hepatitis A virus.
Maltese: HIV, virus tal-epatite Ċ u virus tal-epatite B u għall-virus mhux enveloppat tal-epatite A.
English: • gluing tissues together
Maltese: • biex tinkolla t-tessuti flimkien;
English: As a consequence, intravascular pharmacokinetic studies were not performed in man.
Maltese: Bħala konsegwenza, studji farmakokinetiċi intravaskulari ma sarux fil-bniedem.
English: Neurobehavioral observations for 14±1 days showed no abnormal findings.
Maltese: Osservazzjonijiet ta' mġiba newroloġika għal 14±1 jum ma wrew l-ebda anomalija.
English: Number (Age groups)
Maltese: Numru (gruppi skond l-età)
English: (2-65 years)
Maltese: (2-65 sena)
English: Immunogenicity
Maltese: Immunogenicità
English: 31.25x109 bacteria*
Maltese: 31,25x109 batterji*
English: Peru, military
Maltese: Peru, militari 1994
English: See Section 3.
Maltese: Ara Sezzjoni 3.
English: infodukoral@valneva.com
Maltese: L-Iżvezja infodukoral@valneva.com
English: Valneva Sweden AB, Sweden
Maltese: Valneva Sweden AB
English: Cholera Bangladesh 1985-88 3 doses at 6 week intervals
Maltese: Bangladexx 1985-88 3 dożi b'intervalli ta' 6 ġimgħat
English: EU/1/03/263/001 1 dose EU/1/03/263/002 2x1 dose EU/1/03/263/003 20x1 dose
Maltese: EU/1/03/263/002 2 x doża 1 EU/1/03/263/003 20 x doża 1
English: 1 dose (3 ml)
Maltese: Doża waħda (3 ml)
English: Date of first authorisation: 28 April 2004 Date of latest renewal: 25 March 2009
Maltese: Data tal-aħħar tiġdid: 25 ta' Marzu 2009
English: (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħrufa (ma tistax tiġi stmata mid-dejta disponibbli).