FrancophonIA/ELRC3.0 huggingface dataset:
English: Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Maltese: Nivolumab isaħħaħ ir-risponsi taċ-ċelloli-T, li jinkludu risponsi kontra t-tumur, permezz ta' imblokk ta' PD-1 li jeħel ma' ligandi PD-L1 u PD-L2.
English: Of the 497 patients who were treated with nivolumab 3 mg/kg every 2 weeks and evaluable for the presence of anti-product-antibodies, 51 (10.3%) patients tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Maltese: Mill-497 pazjent li ġew ikkurati b'nivolumab 3 mg/kg kull ġimagħtejn, u evalwabbli għall-preżenza ta' antikorpi kontra l-prodott, 51 (10.3% tal-pazjenti) li rriżultaw pożittivi għal antikorpi kontra lprodott li seħħew minħabba l-kura, permezz ta' assaġġ elettrokemiluminexxenti (ECL, electrochemiluminescent). 4 (0.8%) biss mill-pazjenti kienu pożittivi b'mod persistenti.
English: Grade 2 cases were reported in 0.4% (1/248) of patients.
Maltese: Każijiet ta' Grad 2 ġew irrappurtati f'0.4% (1/248) tal-pazjenti.
English: Withhold Nivolumab BMS until creatinine returns to baseline and management with corticosteroids is complete
Maltese: Nivolumab BMS sakemm il-kreatinina tirritorna għal-linja bażi u jitlesta l-kontroll akut bil-kortikosterojdi
English: 4 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a dark blue flip-off seal (aluminium).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih 4 mL konċentrat f'kunjett tal-10 mL (ħġieġ tat-Tip I) b'tapp (lasktu tal-butyl miksi) u siġill blu skur li jinqala' mis-seba' (aluminju).
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
Maltese: Jekk minkejja l-użu tal-kortikosterojdi jkun hemm aggravar jew ma jsir ebda titjib, għandha tiżdied terapija immunosuppressiva mhux bil-kortikosterojdi.
English: Nivolumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Maltese: Nivolumab mhuwiex irrakkomandat matul it-tqala u f'nisa li jista' jkollhom it-tfal li ma jkunux qed jużaw kontraċezzjoni effettiva sakemm il-benefiċċju kliniku ma jisboqx ir-riskju potenzjali.
English: For Grade 2 diarrhoea or colitis, nivolumab should be withheld.
Maltese: Għal dijarea jew kolite tal-Grad 2, nivolumab għandu jitwaqqaf.
English: Table 2: Adverse reactions in patients with squamous NSCLC treated with nivolumab 3 mg/kg (CA209017 and CA209063)
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti b'NSCLC skawmużi ikkurati b'nivolumab 3 mg/kg
English: The effect of hepatic impairment on the CL of nivolumab was evaluated in patients with mild hepatic impairment (total bilirubin 1.0 × to 1.5 × ULN or AST > ULN as defined using the National Cancer Institute criteria of hepatic dysfunction; n = 92) compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN; n = 804) in the population PK analyses.
Maltese: L-effett tal-indeboliment tal-fwied fuq is-CL ta' nivolumab ġie evalwat f'pazjenti b'indeboliment ħafif tal-fwied (bilirubina totali ta' 1.0 × sa 1.5 × ULN jew AST > ULN kif iddefinit bl-użu tal-kriterji ta' disfunzjoni tal-fwied minn National Cancer Institute;
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42-0
Maltese: Slovenská republika Bristol-Myers Squibb spol. s r.o. Tel: + 421 2 59298411
English: Fertility
Maltese: Anzjani
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nivolumab BMS 10 mg/mL sterile concentrate nivolumab
Maltese: Is-sustanza(i) attiva(i) hi (huma) nivolumab Kull mL tal-konċentrat għal soluzzjoni għal infużjoni fih 10 mg nivolumab.
English: Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
Maltese: Kundizzjonijiet tal-ħażna u żmien kemm idum tajjeb il-prodott
English: Laboratory abnormalities
Maltese: IL-PRODOTT MEDIĊINALI
English: Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Maltese: Linji gwida għal twaqqif permanenti jew interruzzjoni tad-dożi huma deskritti f'Tabella 1.
English: Based on the population pharmacokinetic (PK) results, no dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Maltese: Fuq il-bażi tar-riżultati farmakokinetiċi (pharmacokinetic, PK) tal-popolazzjoni, ma hemm bżonn ta' ebda aġġustament fid-doża f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209017).
Maltese: Is-sigurtà u l-effikaċja ta' nivolumab 3 mg/kg bħala aġent waħdieni għall-kura ta' NSCLC skwamuż metastatiku jew avvanzat ġew evalwati fi studju ta' fażi 3, b'tikketta mikxufa, randomizzat (CA209017).
English: What Nivolumab BMS looks like and contents of the pack Nivolumab BMS concentrate for solution for infusion (sterile concentrate) is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Maltese: Kif jidher Nivolumab BMS u l-kontenut tal-pakkett Nivolumab BMS konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili) huwa likwidu trasparenti sa opalexxenti, bla kulur sa isfar mitfi li jista' jkun fih ftit partikoli ħfief.
English: NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 10 mg/mL concentrate for solution for infusion.
Maltese: Nivolumab BMS 10 mg/mL konċentrat għal soluzzjoni għal infużjoni.
English: The full EPAR and risk management plan summary for Akynzeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Akynzeo netupitant / palonosetron hydrochloride
Maltese: Sommarju tal-EPAR għall-pubbliku netupitant / palonosetron hydrochloride
English: This is a summary of the European public assessment report (EPAR) for Akynzeo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Akynzeo.
English: The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%).
Maltese: L-effetti sekondarji l-aktar komuni rrapportati b'Akynzeo huma uġigħ ta' ras (li deher f'3.6% talpazjenti), stitikezza (3.0%) u għeja (1.2%).
English: Netupitant works by blocking neurokinin-1 (NK1)
Maltese: Netupitant jaħdem billi jimblokka r-riċetturi ta' neurokinin-1
English: In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136).
Maltese: Fi studju ewlieni li qabbel Akynzeo ma' palonosetron waħdu, 90% tal-pazjenti li kienu qegħdin jieħdu Akynzeo (121 minn 135) ma esperjenzaw ebda rimettar fi żmien 5 ijiem minn meta bdew kimoterapija emetoġenika ħafna meta mqabbel ma' 77% tal-pazjenti li kienu qegħdin jieħdu palonestron waħdu (104 minn 136).
English: Other information about Akynzeo
Maltese: Informazzjoni oħra dwar Akynzeo
English: Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron.
Maltese: Akynzeo jiġi bħala kapsuli li fihom 300 mg ta' netupitant u 0.5 mg ta' palonestron.
English: Why is Akynzeo approved?
Maltese: Għaliex ġie approvat Akynzeo?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Akynzeo fis-27 ta' Mejju 2015.
English: This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.
Maltese: Dan l-istudju involva 1,455 pazjent u l-pazjenti ħadu dexamethasone, mediċina oħra użata biex tipprevjeni r-rimettar, bħala kura addizzjonali.
English: Akynzeo contains the active substances netupitant and palonosetron.
Maltese: Akynzeo fih is-sustanzi attivi netupitant u palonosetron.
English: The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group.
Maltese: Iċ-ċifri għat-tieni jum sal-ħames jum kienu 77% għal pazjenti fil-grupp ta' Akynzeo u 70% għal dawk fil-grupp ta' palonosetron.
English: One of the active substances, palonosetron, has been authorised on its own in the EU since 2005.
Maltese: Waħda mis-sustanzi attivi, palonosetron, ilha awtorizzata waħedha fl-UE sa mill-2005.
English: Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron.
Maltese: Madwar 88% tal-pazjenti li kienu qegħdin jieħdu Aknyzeo ma esperjenzaw l-ebda rimettar fl-ewwel jum wara l-ewwel ċiklu ta' kimoterapija, meta mqabbel ma' 85% tal-pazjenti li kienu qegħdin jieħdu palonosetron.
English: Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy based on the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.
Maltese: Xi kimoterapija hija magħrufa li tinduċi nawsja severa u rimettar, u Akynzeo jintuża f'pazjenti li jirċievu kimoterapija emetoġenika ħafna (li twassal għal rimettar) bbażata fuq il-mediċina kontra l-kanċer cisplatin, jew kimoterapiji oħrajn li huma moderatament emetoġeniċi.
English: receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours); palonosetron, on the other hand, blocks 5HT3 receptors in the gut, which are responsible for the immediate phase (that occurs within the first 24 hours).
Maltese: (NK1), li jinstabu fis-sistema nervuża u huma responsabbli għal fażi mdewma ta' nawsja u rimettar (li sseħħ wara l-ewwel 24 siegħa); palonosetron, min-naħa l-oħra, jimblokka r-riċetturi 5HT3 fl-intestini, li huma responsabbli għall-fażi immedjata (li sseħħ fl-ewwel 24 siegħa).
English: Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer).
Maltese: Akynzeo huwa mediċina li tintuża biex tipprevjeni nawsja (tħossok ma tiflaħx) u rimettar f'pazjenti adulti bil-kanċer li jkunu qegħdin jirċievu kimoterapija (mediċini għall-kura tal-kanċer).
English: How is Akynzeo used?
Maltese: Kif jintuża Akynzeo?
English: The two active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy.
Maltese: Iż-żewġ sustanzi attivi f'Akynzeo jaħdmu billi jimblokkaw żewġ mekkaniżmi differenti li jwasslu għal nawsja u rimettar matul il-kimoterapija.
English: What are the risks associated with Akynzeo?
Maltese: X'inhuma r-riskji assoċjati ma' Akynzeo?
English: How does Akynzeo work?
Maltese: Kif jaħdem Akynzeo?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija nnota li Akynzeo kien effikaċi kemm biex jipprevjeni l-fażi immedjata kif ukoll dik imdewma ta' nawsja u rimettar wara lkimoterapija, u li l-mediċina għandha profil tas-sigurtà favoveroli.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administra
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: Kruczkowskiego 8 00-380 Warzawa Poland
Maltese: Kruczkowskiego 8 00-380 Warszawa Poland
English: Piazzale dell'Industria, 20 00144 Roma
Maltese: Piazzale dell'Industria, 20 00144
English: Czech Republic Baxter Czech spol.
Maltese: Baxter Czech spol.
English: Baxter Deutschland GmbH Edisonstr.
Maltese: Il-Ġermanja Baxter Deutschland GmbH Edisonstr.
English: A- 1221 Vienna Austria
Maltese: 1221 Vienna
English: Aprotinin 15000 KIU;
Maltese: Aprotinin 15000
English: 1138 Budapest Hungary
Maltese: IX. em. 1138 Budapest Hungary
English: Baxter A/S Gydevang 43
Maltese: Id-Danimarka Baxter A/S Gydevang 43
English: Syringe THROMBIN-CALCIUM
Maltese: THROMBIN-CALCIUM
English: Baxter Polska Sp. z o.o.
Maltese: Baxter Polska Sp. z o.o. ul.
English: ARTISS soluciones para adhesivo tisular
Maltese: ARTISS soluciones para adhesivo tisular Ultracongeladas
English: BERIPLAST P 0.5 ml, 1 ml, 3 ml, powders and solvents for sealant Combi-Set
Maltese: BERIPLAST P 0.5 ml, 1 ml, 3 ml, powders and solvents for sealant
English: Baxter SA Boulevard René Branquart 80 7860 Lessines Belgium
Maltese: Boulevard René Branquart 80 7860 Lessines
English: BAXTER HELLAS LTD 3 Metsovou str, 14121-N Irakleio, Athens
Maltese: BAXTER HELLAS LTD 3 Metsovou str, 14121-N
English: Norfork IP24 3SE,
Maltese: Norfolk IP24
English: CSL BEHRING 5 Hadjiyianni Mexi str, 11528-Athens Greece
Maltese: Hadjiyianni Mexi str, 11528-Athens Greece
English: Baxter AS, Gjerdrumsvei 11, 0484 Oslo, Norway
Maltese: In-Norveġja Baxter AS, Gjerdrumsvei 11, 0484
English: The Netherlands Baxter AG Industriestraße 67
Maltese: Il-Finlandja Baxter AG Industriestraße 67
English: Beriplast P CombiSet 1 ml prašek in vehikel za lepilo za tkiva
Maltese: Combi-Set 1 ml prašek in vehikel za lepilo za tkiva
English: TISSEEL Lyo, TwoComponent Fibrin Sealant
Maltese: TISSEEL Lyo, Two-Component Fibrin Sealant
English: Beriplast P CombiSet 3 ml prašek in vehikel za lepilo za tkiva
Maltese: Combi-Set 3 ml prašek in vehikel za lepilo za tkiva
English: Baxter Hungary Kft. Népfürdő u. 22.
Maltese: Népfürdő u. 22.
English: Karla Engliše 3201/6
Maltese: s r.o. Karla Engliše 3201/6 150 00 Praha 5
English: Baxter Medical AB, Isafjordstgatan 30B P.O.
Maltese: Baxter Medical AB, Isafjordsgatan 30B P.O. Box 63
English: Component Fibrin Sealant
Maltese: Two-component Fibrin Sealant
English: BAXTER SAS 6 Avenue Louis Pasteur 78310 MAUREPAS FRANCE
Maltese: Avenue Louis Pasteur 78310
English: Tisseel - Lösungen für einen
Maltese: Tisseel - Lösungen für einen Gewebekleber
English: Combi-Set 2: thrombin: 500 IU/ml
Maltese: Combi-Set 2: thrombin: 500
English: Tisseel Lyo - Pulver und Lösungsmittel für einen
Maltese: Tisseel Lyo - Pulver und Lösungsmittel für einen Gewebekleber
English: Component 1
Maltese: Komponent 1
English: Plasminogen 0.04-0.12 mg; Aprotinin 3000 KIU;
Maltese: 04-0.12 mg; Aprotinin 3000 KIU;
English: Component 2
Maltese: Komponent 2
English: Plasminogen 0.08-0.24 mg; Aprotinin 6000 KIU;
Maltese: Plasminogen 0.08-0.24 mg; Aprotinin 6000
English: The Netherlands Baxter B.V. Kobaltweg 49, Utrecht 3542 CE
Maltese: Kobaltweg 49, 3542 CE Utrecht The Netherlands
English: ARTISS - Lösungen für einen
Maltese: ARTISS - Lösungen für einen Gewebekleber
English: Norfork
Maltese: Norfolk
English: 1st Component:
Maltese: 1el Komponent:
English: 2nd Component:
Maltese: 2ni Komponent:
English: Component 1:
Maltese: Komponent 1:
English: Artiss and associated names; Tisseel and associated names; Tissucol and associated names Member State (in EEA)
Maltese: Artiss u ismijiet assoċjati; Tisseel u ismijiet assoċjati; Tissucol u ismijiet assoċjati Stat Membru (fiż-ŻEE)
English: Component 2:
Maltese: Komponent 2:
English: Baxter Oy, PL 119, 00181 Helsinki Finland
Maltese: Il-Finlandja Baxter Oy, PL 119,
English: IP24 3SE,
Maltese: IP24
English: Beriplast P CombiSet 0,5 ml, Beriplast P CombiSet 1 ml,
Maltese: Beriplast P Combi-Set 0,5 ml, Beriplast P Combi-Set 1 ml, Beriplast P Combi-Set 3 ml
English: Fibronectin 5,5 mg
Maltese: Fibrinogen 350-550 mg;
English: Fibrinogen 72-110 mg/ml Factor XIII coagulationis humanus 10 IU/ml
Maltese: Fibrinogen 72-110 mg/ml Fattur ta' Koagulazzjoni XIII uman 10 IU/ml
English: TISSUCOL Kit 1,0 kétkomponensű fibrinragasztó
Maltese: Kit 1,0 kétkomponensű fibrinragasztó
English: Zelezna cesta 18 1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana
English: IX.
Maltese: UI
English: TISSUCOL Kit 2,0 kétkomponensű fibrinragasztó
Maltese: Kit 2,0 kétkomponensű fibrinragasztó
English: TISSUCOL Kit 5,0 kétkomponensű fibrinragasztó
Maltese: Kit 5,0 kétkomponensű fibrinragasztó
English: UI/ml; Plasminogen 0.04-0.12 mg/ml;
Maltese: IU/ml; Plasminogen 0.040.12 mg/ml; Aprotinin 3000
English: Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml
Maltese: KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5.9 mg/ml
English: Calcium chloride: 40 µmol/ml Factor XIII: 30 IU/ml
Maltese: 40 µmol/ml Fattur XIII: 10 IU/ml
English: ARTISS LYOPulver und Lösungsmittel für einen
Maltese: ARTISS LYO - Pulver und Lösungsmittel für einen Gewebekleber
English: Norfork IP24 3SE, United Kingdom
Maltese: 3SE, United Kingdom
English: Proteins 50mg/ml; Bottle 4: Human Thrombin 4 UI/ml; Proteins 50mg/ml;
Maltese: IU/ml; Proteini 50 mg/ml; Flixkun 4: Thrombin Uman 4 IU/ml;
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
Maltese: Fibrinogen: 90 mg/ml Fattur ta' koagulazzjoni XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
English: Thrombin 1000 IU or Thrombin 8 UI; Calcium Chlorid Dihydrate 11.76 mg
Maltese: Calcium Chloride Dihydrate 11.76 mg
English: Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg; Plasma Fibronectin 4-18 mg; Factor XIII 20-100 UI;
Maltese: Plasma Fibronectin 4-18 mg; Fattur XIII 20-100
English: CHLORIDE: Proteins 50mg/ml; Thrombin 500 UI/ml; calcium chloride 40 µmol/ml
Maltese: Proteini 50 mg/ml; Flixkun 5: calcium chloride 40 µmol/ml
English: Fibrinogen: 90 mg/ml Aprotinin (bovine): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Factor XIII: 60 U/ml
Maltese: Fibrinogen: 90 mg/ml Aprotinin (talbaqar): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Fattur ta' koagulazzjoni XIII: 60 U/ml
English: Baxter d.o.o.
Maltese: Baxter B.V.
English: Total Protein 100-130 mg; Clottable protein: 75-115 mg, thereof Fibrinogen 70-110 mg; Plasma Fibronectin 2-9 mg; Factor XIII 10-50 UI;
Maltese: Proteini totali 100-130 mg/ml; proteina li tista' tagħqad 75-115 mg/ml, li minnhom fibrinogen 70110 mg/ml u fibronectin plażmatiku 2-9 mg/ml; Fattur XIII 10-50
English: Total Protein 200-260 mg;
Maltese: Fibrinogen 140-220 mg;
English: Fibrinogene humain (proteines coagulables) 72-110 mg/ml Facteur XIII ≤ 10 UI/ml Aprotinine 3000 UIK/ml Thrombine humaine 500 UI/ml Chlorure de calcium 40 μmol/ml
Maltese: Fibrinogen uman (proteini talkoagulazzjoni): 72-110 mg/ml Fattur XIII ≤ 10 IU/ml Aprotinin 3000 KIU/ml Thrombin uman 500
English: Bottle 5: calcium chloride 40 µmol/ml
Maltese: IU/ml; calcium chloride 40 µmol/ml
English: Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 μmol/ml
Maltese: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride:
English: Plasminogen: 0,08 mg/ml Fibronectin: 5,5 mg/ml
Maltese: 40 µmol/ml Fattur XIII: 30 IU/ml Plasminogen: 0,08 mg/ml Fibronectin: 5,5 mg/ml
English: Beriplast P CombiSet Pulver und Lösungsmittel für einen
Maltese: Beriplast P Combi-Set Pulver und
English: Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Maltese: KIU/ml Fibrinogen Uman 4 IU/ml Calcium Chloride 40 µmol/ml
English: Calcium chloride: 40 µmol/ml
Maltese: 40 µmol/ml
English: Aprotinin 3000 UIK/ml (1.67 UPE/ml);
Maltese: KIU/ml (1.67 EPU/ml); Siringa
English: Thrombin (human) 500 I.E./ml Calcium chloride: 5,88 mg/ml
Maltese: 4 IU/ml Calcium chloride: 5,88 mg/ml
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Maltese: Fibrinogen: 90 mg/ml Fattur ta' koagulazzjoni XIII: 60 U/ml Aprotinin: 1000
English: Slovak Republic CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Maltese: Is-Slovenja CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
English: Aprotinin 1,67 Ph.Eur.U./ml
Maltese: Aprotinin 1,67 Ph.Eur.U./ml Fattur ta' Koagulazzjoni XIII 30 IU/ml
English: Fibrinogen: 70-110mg/ml Plasmafibronectin (CIG): 2-9mg/ml Factor XIII: 10-50 U/ml Plasminogen: 0.04 - 0.12mg/ml
Maltese: Fibrinogen: 70-110 mg/ml Plasmafibronectin (CIG): 2-9 mg/ml
English: Thrombin 500 IU or Thrombin 4 UI; Calcium Chlorid Dihydrate 5.88 mg
Maltese: Calcium Chloride Dihydrate 5.88 mg
English: Thrombin 2500 IU or Thrombin 20 UI; Calcium Chlorid Dihydrate 29.4 mg
Maltese: Calcium Chloride Dihydrate 29.4 mg
English: Tisseel duo quick Plasmaproteinum humanum 100-130 mg/ml: Fibrinogen 90mg/ml
Maltese: Proteina tal-Plażma umana 100130 mg/ml: Fibrinogen 90 mg/ml Plasma Fibronectin 5,5 mg/ml Fattur ta' Koagulazzjoni XIII uman 30
English: Fibrinogen: 75mg Human thrombin: 500 IU Aprotinin: 3000KIU Calcium chloride: 40 mcmol/ml
Maltese: Fibrinogen: 75 mg/ml Thrombin uman: 500
English: Total Protein 500-650 mg;
Maltese: 375-575 mg,
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml
Maltese: 91 mg/ml Aprotinin (sintetiku): 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride:
English: Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg; Plasma Fibronectin 10-45 mg; Factor XIII 50-250 UI;
Maltese: Plasma Fibronectin 10-45 mg; Fattur XIII 50-250
English: CSL Behring GmbH Emil-von-Behring-Straße 76 D-35041 Marburg Germany
Maltese: L-Ungerija CSL Behring GmbH Emil-von-Behring-Straße 76 D-35041 Marburg
English: Human fibrinogen (clottable protein): 72-110 mg/ml
Maltese: Fibrinogen 70-110 mg;
English: Thrombin human 500 IE/ml plasmaproteinum humanum 50mg/ml Calcium Chloride Dihydrate 40 μg/ml
Maltese: IU/ml Calcium Chloride Dihydrate 40 μg/ml
English: Bottle 1: Total Proteins 100-130 mg/ml; dont clottable protein 75-115 mg/ml, Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Bottle 2: Aprotinin bovine 3000 UIK/ml (1.67 UPE/ml);
Maltese: Flixkun 1: Proteini Totali 100-130 mg/ml; proteina li tista' tagħqad 75-115 mg/ml; Fattur XIII 10-50
English: Aprotinin (bovel) 3000 KIU Plasminogen 80 microgram Thrombin solution per ml Human thrombin 500 ae Calcium chloridum 40 micromol
Maltese: Soluzzjoni ta' Tisseel kull mlFibrinogen 90 mg Fibronectin 5,5 mg Fattur XIII 30 IU Aprotinin (tal-baqar) 3000 KIU Plasminogen 80 microgram Soluzzjoni ta' thrombin per ml Thrombin uman 500
English: Human Fibrinogen 91 mg/ml Aprotinum INN 3000 KIU/ml (bovine) Human Thrombin 4 ae^3/ml Calcium Chloride 40 micromol/ml
Maltese: KIU/ml (tal-baqar) Thrombin Uman 4 IU^3/ml Calcium Chloride 40 micromol/ml
English: Sealant
Maltese: Siġillant
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10 IU/ml
Maltese: 2 - 9 mg/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Fattur XIII: 10-50
English: Fibrinogen: 70 - 110 mg/ml Plasmafibronectin: 2 - 9 mg/ml Coagulation factor XIII: 10 - 50 I.E/ml Aprotininsolution: 3000 KIE/ml
Maltese: Fibrinogen: 70-110 mg/ml Fattur ta' koagulazzjoni XIII: 10-50
English: Plasmafibrinonectinum 5,5mg/ml Factor XIII coagulationis humanus 30
Maltese: Plasminogen 80 μg/ml Fibrinogen uman 500
English: Bottle 3: Human Thrombin 500 IU/ml;
Maltese: KIU/ml Thrombin uman: 500
English: em.
Maltese: IU;
English: Human fibrinogen: 72-110 mg/ml Factor xiii: ≤10 UI Aprotinin: 3000 KU12/ml Human thrombin: 500 UI3/ml Calcium chloride: 40 micromol/ml
Maltese: Fibrinogen uman (proteina li tista' tagħqad): 72-110 mg/ml Fattur XIII ≤ 10 IU/ml Aprotinin: 3000 KIU/ml Thrombin Uman: 500
English: Tissucol-Kit Immuno
Maltese: Ir-Renju Unit
English: Factor XIII ≤ 10 UI/ml Aprotinin: 3000 UIK/ml Human Thrombin: 500 UI/ml Calcium chloride: 40 μmol/ml
Maltese: KIU2/ml) Thrombin uman (500 IU3/ml) Calcium chloride (40 micromol/ml)
English: Tisseel Duo Quick Fibrinogen 90mg/ml Fibronectin 6mg/ml
Maltese: Fibrinogen 90 mg/ml Fibronectin 6 mg/ml Aprotinin 3000 KIU/ml Fattur ta' Koagulazzjoni XIII 30 IU/ml
English: Dulaglutide - Gastrointestinal stenosis and obstruction (EPITT no 18931)
Maltese: Dulaglutide - Stenożi u ostruzzjoni gastrointestinali (EPITT nru 18931)
English: Adopted at the 8-11 January 2018 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-8-11 ta' Jannar 2018