FrancophonIA/ELRC3.0 huggingface dataset:
English: It has been designed to attach to a specific protein on the surface of the fungal cells, called Heat Shock Protein 90 (hsp90).
Maltese: Ġiet imfassla biex teħel ma' proteina speċifika fuq il-wiċċ taċ-ċelloli tal-fungi, imsejħa Heat Shock Protein 90 (hsp90).
English: The medicine is associated with ‘cytokine release syndrome', a condition that can cause nausea, vomiting, pain and also hypertension (high blood pressure), but the reason for this is not clear.
Maltese: Il-mediċina hija assoċjata ma' ‘sindromu ta' liberazzjoni ta' ċitokini', kondizzjoni li tista' tikkaġuna dardir, rimettar, uġigħ u anke pressjoni għolja, imma r-raġuni għal dan mhix ċara.
English: Because the number of patients with invasive fungal infections is low, Mycograb was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Maltese: Minħabba li n-numru ta' pazjenti b'infezzjonijiet invażivi bil-fungu huwa wieħed baxx, Mycograb ġie innominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-5 ta' Diċembru 2001.
English: The effectiveness was measured by looking at the percentage of patients responding to treatment, based on improvement of their symptoms (including fever) and elimination of the fungus from samples, as measured on day 10 (5 days after the end of Mycograb or placebo treatment).
Maltese: L-effikaċja ġiet imkejjla b'kunsiderazzjoni tal-perċentwali ta' pazjenti li rrispondew għattrattament, fuq il-bażi tat-titjib tas-sintomi tagħhom (inkluż deni) u eliminazzjoni tal-fungu millkampjuni, kif imkejla f'jum 10 (5 ijiem wara t-trattament b'Mycograb jew bi plaċebo).
English: By attaching to hsp90, efungumab blocks the protein's normal activities.
Maltese: Enfungumab jimblokka l-attivitajiet normali tal-proteina billi jeħel ma' hsp90.
English: It also had concerns about the safety of Mycograb.
Maltese: Kien imħasseb ukoll fuq issigurtà ta' Mycograb.
English: In March 2007, following the re-examination, the CHMP removed their concern regarding the cytokine release syndrome and hypertension, as these would be manageable in clinical practice.
Maltese: F'Marzu 2007, wara eżaminazzjoni mill-ġdid, is-CHMP neħħa t-tħassib tiegħu dwar is-sindromu ta' liberazzjoni taċ-ċitokini u l-pressjoni għolja, minħabba li dawn ikunu maniġġevoli fil-prattika klinika.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Maltese: X'kienu t-tħassib maġġuri li wasslu lis-CHMP biex jirrikmanda r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq?
English: Too few patients have received Mycograb for its safety to be sufficiently assessed.
Maltese: Ftit wisq pazjenti ngħataw Mycograb sabiex is-sigurtà tiegħu tkun evalwata biżżejjed.
English: In invasive candidiasis, the fungal infection spreads to the internal organs such as the liver, spleen and kidneys via the bloodstream.
Maltese: F'kandidjasi invażiva, l-infezzjoni mill-fungu tinfirex għall-organi interni bħal ma huma l-fwied, il-milsa u l-kliewi minn ġon-nixxija tad-demm fil-ġisem.
English: In November 2006, the CHMP was concerned about some aspects of the quality of the medicine (such as the way the molecules of efungumab may fold or aggregate in the solution for injection and the level of some substances that could stimulate an immune response in patients).
Maltese: F'Novembru 2006, is-CHMP kien imħasseb fuq xi aspetti tal-kwalità tal-mediċina (bħalma huwa lmod kif il-molekuli ta' Mycograb jistgħu jintlewew jew jaggregaw fis-soluzzjoni għall-injezzjoni u llivell ta' xi sustanzi li jistgħu jistimulaw reazzjoni immuni fil-pazjenti).
English: Mycograb is a white powder that contains the active substance efungumab.
Maltese: Mycograb huwa trab abjad li fih is-sustanza attiva efungumab.
English: The effects of Mycograb were first tested in experimental models before being studied in humans.
Maltese: Qabel ma ġew studjati fil-bnedmin, l-effetti ta' Mycograb ġew l-ewwel ittestjati f'mudelli esperimentali.
English: How is Mycograb expected to work?
Maltese: Kif huwa mistenni li jaħdem Mycograb?
English: The company informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Mycograb.
Maltese: Il-kumpanija informat lis-CHMP li ma hemm l-ebda konsegwenzi fuq pazjenti bħalissa inklużi fi provi kliniċi jew programmi ta' użu ta' kompassjoni b'Mycograb.
English: After having considered the grounds for this request, the CHMP reexamined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March
Maltese: Wara li kkunsidra r-raġuni għal din it-talba, is-CHMP eżamina mill-ġdid l-opinjoni tal-bidu, u kkonferma r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq fl-20 ta' Marzu 2007.
English: This disease is caused by infection with a common fungus (yeast) called Candida.
Maltese: Din il-marda hija kkaġunata minn infezzjoni b'fungu komuni (ħmira) msejħa Candida.
English: Immunogenicity:
Maltese: Immunoġeniċità:
English: CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg IlĠermanja
English: Intestinal obstruction (in abdominal surgeries)
Maltese: Sadd intestinali (f'kirurġiji addominali)
English: Date of first authorisation: 8 June 2004 Date of latest renewal: 30 April 2009
Maltese: Data tal-aħħar tiġdid: 30 April 2009
English: • Risk management plan(RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: EU/1/04/277/001 1 matrix of 9.5 cm x 4.8 cm EU/1/04/277/002 2 matrices of 4.8 cm x 4.8 cm EU/1/04/277/003 1 matrix of 3.0 cm x 2.5 cm EU/1/04/277/004 5 matrices of 3.0 cm x 2.5 cm EU/1/04/277/005 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Maltese: EU/1/04/277/001 matriċi waħda ta' 9.5 ċm x 4.8 ċm EU/1/04/277/002 2 matriċi ta' 4.8 ċm x 4.8 ċm EU/1/04/277/003 matriċi waħda ta' 3.0 ċm x 2.5 ċm EU/1/04/277/004 5 matriċi ta' 3.0 ċm x 2.5 ċm EU/1/04/277/005
English: Anaphylactic shock, Hypersensitivity
Maltese: Xokk anafilattiku, Sensittività eċċessiva
English: See section 6.6 for more detailed instructions.
Maltese: Ara sezzjoni 6.6 għal struzzjonijiet aktar dettaljati.
English: TachoSil sealant matrix.
Maltese: TachoSil matriċi siġillanti.
English: A-4020 Linz, Austria
Maltese: A-4020
English: Clinical studies demonstrating haemostasis were conducted in a total of 240 patients (119 TachoSil, 121 argon beamer) undergoing partial liver resection surgery and 185 patients (92 TachoSil, 93 standard surgical treatment) undergoing surgical resection of superficial renal tumour.
Maltese: Saru studji kliniċi li juru l-emostażi f'total ta' 240 pazjent (119 TachoSil, 121 radjatur tal-argon) sottoposti għal kirurġija ta' qtugħ parzjali tal-fwied u 185 pazjent (92 TachoSil, 93 trattament kirurġiku standard) sottoposti għal qtugħ kirurġiku ta' tumur fis-superfiċje ta' kilwa.
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 limitat kontra nonenveloped viruses bħall-parvovirus B19.
English: In clinical trials, the individual dosages have typically ranged from 1-3 units (9.5 cm x 4.8 cm); application of up to 10 units has been reported.
Maltese: Fil-provi kliniċi, id-dożi individwali normalment varjaw bejn 1-3 unitajiet (9.5 ċm x 4.8 ċm); ġiet irrappurtata applikazzjoni sa 10 unitajiet.
English: For viral safety see section 4.4.
Maltese: Għas-sigurtà virali ara sezzjoni 4.4
English: Intravascular administration is contraindicated.
Maltese: L-amministrazzjoni intravaskulari hija kontraindikata.
English: One patient developed antibodies to human fibrinogen.
Maltese: Pazjent wieħed żviluppa antikorpi għal fibrinoġen uman.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Maltese: Antikorpi kontra l-komponenti ta' siġillanti tal-fibrin /prodotti emostatiċi jistgħu jseħħu b'mod rari.
English: POLYETHYLENE TEREPHTHALATE BLISTER
Maltese: FOLJA TAL-POLYETHYLENE TEREPHTHALATE
English: The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jippreżenta PSURs għal dan ilprodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: The efficacy of TachoSil was tested in a randomised controlled study in 726 patients (362 treated with TachoSil and 364 controls) undergoing skull base surgery as an adjunct to suture for sealing the dura mater, in which the efficacy outcome was measured post-operatively as verified cerebrospinal fluid (CSF) leaks or pseudomeningocoele, or treatment failure during surgery.
Maltese: L-effikaċja ta' TachoSil ġiet ittestjata fi studju każwali b'kontrolli fuq 726 pazjent (362 trattati b'TachoSil u 364 bħala kontroll) li kellhom kirurġija fil-bażi tal-kranju bħala aġġunt għal punti għallgħeluq tad-dura mater, fejn l-eżitu ta' effikaċja kien imkejjel wara l-operazzjoni bħala tnixxija ta' fluwidu ċerebrospinali (CSF) kif verifikat, jew psewdomeningocoele, jew falliment ta' trattament waqt kirurġija.
English: Fibrin sealants/haemostatics are metabolized in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Maltese: Siġillanti tal-fibrin/emostatiċi huma metabolizzati bl-istess mod bħal fibrin endoġenu permezz ta' fibrinolisi u fagoċitosi.
English: In the integrated analyses, 997 patients were treated with TachoSil and 984 patients were treated with comparator treatment.
Maltese: Fl-analiżi integrata, 997 pazjent kienu trattati b'TachoSil u 984 pazjent kienu trattati b'trattament komparatur.
English: TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
Maltese: TachoSil hija indikata għal trattament ta' sostenn f'adulti fil-kirurġija għal titjib tal-emostasi, sabiex jiġi inkoraġġut l-għeluq ta' tessuti korporali, għal sostenn ta' punti f'kirurġija vaskulari meta l-metodi ta' teknika standard ma jkunux biżżejjed, u għall-għeluq t'appoġġ fid-dura mater sabiex tiġi evitata tnixxija ċerebrospinali wara kirurġija newroloġika (ara sezzjoni 5.1).
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 allerġika (li jistgħu jinkludu anġjodema, ħruq jew tingiż fis-sit tal-applikazzjoni, bronkospażmu, sirdat, ħmura, urtikarja ġenerali, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, tqalligħ, irrekwitezza, takikardja, sider magħfus, tnemnim, remettar, tħarħir) jistgħu jseħħu f'każijiet rari fil-pazjenti trattati b'siġillanti tal-fibrin/prodotti emostatiċi.
English: Equine collagen Human albumin Riboflavine (E101) Sodium chloride Sodium citrate (E331) L-arginine-hydrochloride.
Maltese: Equine collagen Human albumin Riboflavine (E 101) Sodium chloride Sodium citrate (E331)
English: • Periodic safety update reports(PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà(PSURs)
English: Each matrix contains per cm Human fibrinogen 5.5 mg Human thrombin 2.0 IU
Maltese: Fibrinoġen tal-bniedem 5.5 mg Trombin tal-bniedem 2.0
English: Pharmacotherapeutic group: Local haemostatics, ATC code: B02BC30
Maltese: Emostatiċi lokali, kodiċi ATC:
English: - Keep this leaflet.
Maltese: HAV li mhux enveloped.
English: The yellow side of TachoSil contains the active components: fibrinogen and thrombin.
Maltese: In-naħa s-safra ta' TachoSil fiha s-sustanzi attivi: fibrinoġen u trombin.
English: Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Austria
Maltese: Peter Strasse 25 A-4020
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Maltese: Il-miżuri meħuda jitqiesu li huma effettivi għal enveloped viruses bħall-virus tal-immunodefiċjenza umana (HIV), il-virus tal-epatite B u l-virus tal-epatite Ċ u għall-virus tal-epatite A li mhux enveloped.
English: Hold down TachoSil with a gentle pressure for 3-5 minutes.
Maltese: Żomm TachoSil 'l isfel bi pressjoni ħafifa għal 3-5 minuti.
English: Sealant matrix
Maltese: Matriċi siġillanti
English: TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs.
Maltese: TachoSil tintuża matul il-kirurġija sabiex twaqqaf fsada lokali (emostasi) u biex jissiġilla wċuħ ta' tessuti fuq organi interni.
English: However, the second study investigating tissue sealing in 299 patients (149 TachoSil, 150 standard surgical treatment) with demonstrated intraoperative air leakage showed the superiority of TachoSil compared to standard treatment.
Maltese: Madankollu, it-tieni studju li stħarreġ l-issiġillar tat-tessuti f'299 pazjent (149 TachoSil, 150 trattament kirurġiku standard) b'tnixxija tal-arja murija waqt l-operazzjoni wera superjorità għal TachoSil meta mqabbel mattrattament standard.
English: However, in a clinical trial with TachoSil in hepatic surgery, in which patients were investigated for the development of antibodies, 26% of the 96 patients tested and treated with TachoSil developed antibodies to equine collagen.
Maltese: Madanakollu, fi prova klinika b'TachoSil f'kirurġija epatika, li fiha pazjenti ġew mistħarrġa għalliżvilupp ta' antikorpi, 26% tas-96 pazjent ittestjat u ttrattat b'TachoSil żviluppaw antikorpi għal kollaġen ekwin.
English: Single dose toxicity studies in different species of animals have shown no signs of acute toxic effects.
Maltese: Studji ta' tossiċità b'doża waħda fi speċi differenti ta' annimali ma taw l-ebda sinjali ta' effetti tossiċi akuti.
English: During the following time TachoSil will dissolve and disappear.
Maltese: Aktar tard TachoSil iddub u tisparixxi.
English: TachoSil, sealant matrix human fibrinogen/human thrombin
Maltese: TachoSil, matriċi siġillanti fibrinoġen tal-bniedem/trombin tal-bniedem
English: Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq fuq it-tikketta, wara “EXP”.
English: For smaller wounds, e.g. in minimally invasive surgery, the smaller sizes (4.8 x 4.8 cm or 3.0 x 2.5 cm) or the pre-rolled TachoSil (4.8 cm x 4.8 cm) is recommended.
Maltese: Għal feriti iżgħar, eż f'kirurġija minimament invażiva, id-daqsijiet żgħar (4.8 x 4.8 ċm jew 3.0 x 2.5 ċm) jew TachoSil irrumblat bil-lest (4.8 ċm x 4.8 ċm) hu rakkomandat.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: 1 matrix of 3.0 cm x 2.5 cm
Maltese: Matriċi waħda ta' 3.0 ċm x 2.5 ċm
English: The size of the sealant matrix depends on the size of the wound.
Maltese: Id-daqs tal-matriċi siġillanti jiddependi mid-daqs tal-ferita.
English: Specific data have not been obtained on the use of this product in gastrointestinal anastomoses surgery.
Maltese: Ma ġietx miksuba informazzjoni speċifika dwar l-użu ta' dan il-prodott fil-kirurġija ta' anastomożi gastrointestinali.
English: Parvovirus B19 infection may be serious for pregnant woman (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 tal-parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni tal-fetu) u għal individwi li ssistema ta' immunità tagħhom tkun dgħajfa jew li jkollhom xi tipi ta' anemija (eż. marda tas-sickle cell jew anemija emolitika).
English: Thromboembolic complications may occur if the preparation is applied intravascularly (see section 4.4).
Maltese: Kumplikazzjonijiet tromboembolitiċi jistgħu jseħħu jekk il-preparazzjoni tiġi applikata ġolarterja/vina (ara sezzjoni 4.4).
English: A further controlled study in 119 patients (62 TachoSil, 57 haemostatic fleece) demonstrated sealing, haemostasis and suture support in patients undergoing cardiovascular surgery.
Maltese: Studju ieħor li sar bil-kontrolli fuq 119-il pazjent (62 TachoSil, 57 suf emostatiku) urew issiġillar, emostasi u sostenn għal punti f'pazjenti li jkunu għaddejjin minn kirurġija kardjovaskulari.
English: While unrolling the matrix the yellow, active side of the matrix is applied to the bleeding/leaking surface using e.g. a pair of cleansed forceps and held against it with a moist pad under gentle pressure for 3-5 minutes.
Maltese: Il-parti safra, attiva tal-matriċi tiġi applikata fuq il-wiċċ tal-ferita minn fejn ikun ħiereġ iddemm jew li jkun qed inixxi u għandha tinżamm fuqu bi pressjoni ħafifa għal 3-5 minuti.
English: The numbers of subjects experiencing an efficacy outcome event were 25 (6.9%) and 30 (8.2%) for TachoSil and current practice treated patients, respectively, providing an Odds Ratio of 0.82 (95% CI: 0.47, 1.43).
Maltese: In-numri ta' individwi li esperjenzaw każ ta' eżitu ta' effikaċja kienu 25 (6.9%) u 30 (8.2%) għal TachoSil u pazjenti trattati bil-prattika attwali, rispettivament, li pprovdew Odds Ratio ta' 0.
English: ALUMINIUM-BONDED FOIL SACHET
Maltese: OĦRA, JEKK MEĦTIEĠA
English: For epilesional use.
Maltese: Mhux applikabbli.
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: L-infezzjoni tal-parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni tal-fetu) u għal individwi b'immunodefiċjenza jew eritropojeżi miżjuda (eż. anemija emolitika).
English: 1 matrix of 9.5 cm x 4.8 cm 2 matrices of 4.8 cm x 4.8 cm 1 matrix of 3.0 cm x 2.5 cm 5 matrices of 3.0 cm x 2.5 cm 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Maltese: Matriċi waħda ta' 9.5 ċm x 4.8 ċm 2 matriċi ta' 4.8 ċm x 4.8 ċm Matriċi waħda ta' 3.0 ċm x 2.5 ċm 5 matriċi ta' 3.0 ċm x 2.5 ċm Matriċi waħda rumblata bil-lest ta' 4.8 ċm x 4.8 ċm
English: The first controlled clinical trial investigating tissue sealing in lung surgery failed to document superiority over standard treatment measured by air leakage due to the inclusion of a large group of patients (53%) without air leakage.
Maltese: L-ewwel prova klinika kkontrollata li saret biex tinvestiga s-siġill tat-tessut fil-kirurġija tal-pulmun naqset li tiddokumenta superjorità fuq it-trattament standard imkejjel bit-telf tal-arja minħabba l-inklużjoni ta' għadd kbir ta' pazjenti (53%) mingħajr tnixxija t'arja.
English: Pre-rolled TachoSil can be used for both open surgery and in minimally invasive surgery, and it can pass through a 10 mm or larger port or trocar.
Maltese: TachoSil irrumblat bil-lest jista' jintuża kemm għal kirurġija miftuħa kif ukoll f'kirurġija minimament invażiva, u tista' tgħaddi minn port jew trocar ta' 10 mm jew aktar.
English: Alternatively, e.g. in case of stronger bleeding, TachoSil may be applied without pre-moistening, while also pressing gently to the wound for 3-5 minutes.
Maltese: Inkella, ngħidu aħna fil-każ ta' fsada aktar b'saħħitha, TachoSil tista' tiġi applikata mingħajr ma tixxarrab, filwaqt li tintgħafas bil-mod fuq il-ferita għal 3-5 minuti.
English: TachoSil is made of protein-containing components.
Maltese: TachoSil hija magħmula minn komponenti li fihom il-proteina.
English: • to use TachoSil immediately after opening the inner sterile package.
Maltese: • sabiex t Uża TachoSil immedjatament wara li jinfetaħ il-pakkett sterili ta' ġewwa.
English: For minimally invasive surgery, the pre-rolled matrix can be un-rolled with instruments at the site of application.
Maltese: Għal kirurġija minimament invażiva, il-matriċi rumblata bil-lest tista' tinħall mal-istrumenti fuq is-sit t'applikazzjoni.
English: Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Maltese: Pakkett b'matriċi waħda ta' 9.5 ċm x 4.8 ċm Pakkett b'2 matriċi ta' 4.8 ċm x 4.8 ċm Pakkett b'matriċi waħda ta' 3.0 ċm x 2.5 ċm Pakkett b'5 matriċi ta' 3.0 ċm x 2.5 ċm Pakkett 1 ta' matriċirumblati bil-lest ta' 4.8 ċm x 4.8 ċm
English: How does TachoSil work?
Maltese: Kif taħdem TachoSil?
English: 1 matrix of 9.5 cm x 4.8 cm
Maltese: Matriċi waħda ta' 9.5 ċm x 4.8 ċm
English: The un-rolled TachoSil should then be moistened at the site of application with a moist pad and held in place under gentle pressure for 3-5 minutes.
Maltese: TachSil mhix mħollha għandha mbagħad tiġi mxarrba fis-sit t'applikazzjoni b'pad niedja u għandha tinżamm fil-post taħt pressjoni ħafifa għal 3-5 minuti.
English: TachoSil, sealant matrix human fibrinogen/human thrombin For epilesional use
Maltese: TachoSil, matriċi siġillanti fibrinoġen tal-bniedem/trombin tal-bniedem Għal użu epileżjonali
English: 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Maltese: Matriċi 1 rumblata bil-lest ta' 4.8 ċm x 4.8 ċm
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2)
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Maltese: Il-miżuri meħuda jitqiesu li huma effettivi għal enveloped viruses bħall-HIV, HBV u HCV u għallvirus
English: 1 matrix of 4.8 cm x 4.8 cm
Maltese: Matriċi waħda ta' 4.8 ċm x 4.8 ċm
English: How to store TachoSil
Maltese: X'fih TachoSil
English: TachoSil is an off-white sealant matrix.
Maltese: TachoSil hija matriċi siġillanti ta' kulur offwajt.
English: For smaller wounds, e.g. in minimally invasive surgery the smaller size matrices (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based on a matrix of 4.8 cm x 4.8 cm) is recommended.
Maltese: Għal feriti iżgħar, eż. f'kirurġija invażiva minima, huma rrakkomandati l-matriċi ta' daqs iżgħar (4.8 ċm x 4.8 ċm jew 3.0 ċm x 2.5 ċm) f'matriċi rrumblata bil-lest (bażata fuq matriċi ta' 4.8 ċm x 4.8 ċm).
English: Use a moistened glove or a moist pad to keep TachoSil in place.
Maltese: L-applikazzjoni ta' TachoSil fuq id-dura u l-applikazzjoni ta' TachoSil fuq iż-żewġ naħat tad-dura.
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 għall-prevenzjoni ta' infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali mħejjija mid-demm jew mill-plażma tal-bniedem jinkludu l-għażla tad-donaturi, eżaminazzjoni taddonazzjonijiet individwali u tal-ġabriet ta' plażma għal markers speċifiċi ta' infezzjoni u linklużjoni ta' fażijiet effettivi ta' manifattura għall-inattivazzjoni/tneħħija tal-viruses.
English: TachoSil contains fibrinogen and thrombin as a dried coating on the surface of a collagen matrix.
Maltese: TachoSil fiha l-fibrinoġen u t-trombin bħala kisja mnixxfa fuq il-wiċċ ta' matriċi tal-collagen.
English: • to have a sterile person open the inner sterile package
Maltese: • li persuna sterili tiftaħ il-pakkett sterili ta' ġewwa