FrancophonIA/ELRC3.0 huggingface dataset:
English: No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies.
Icelandic: Í rannsóknunum var hvorki greint frá 4. né 5. stigs nýrnabólgu eða nýrnabilun.
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
Icelandic: MARKAÐSLEYFISHAFI Bristol-Myers Squibb Pharma EEIG
English: Grade 2 and Grade 3 cases were reported in 1.6% (4/248) and 0.8% (2/248) of patients, respectively.
Icelandic: Greint var frá 2. stigs tilvikum hjá 1,6% (4/248) og 3. stigs tilvikum hjá 0,8% (2/248) sjúklinga.
English: For symptomatic hyperthyroidism, nivolumab should be withheld and methimazole should be initiated as needed.
Icelandic: Við einkenni skjaldkirtilsofstarfsemi á að fresta gjöf nivolumabs og gefa methimazol eftir þörfum.
English: Permanently discontinue Nivolumab BMS
Icelandic: Nivolumab BMS fyrir fullt og allt
English: Monitoring of pituitary function and hormone levels should continue to ensure appropriate hormone replacement is utilised.
Icelandic: Fylgjast skal áfram með starfsemi heiladinguls og hormónaþéttni til að tryggja viðeigandi
English: Grade 2 and Grade 3 cases were reported in 2% (5/248) and 1.6% (4/248) of patients, respectively.
Icelandic: Greint var frá 2. stigs tilvikum hjá 2% (5/248) og 3. stigs tilvikum hjá 1,6% (4/248) sjúklinga.
English: In CA209017 and CA209063, the incidence of thyroid disorders, including hypothyroidism or thyroiditis, was 4.4% (11/248).
Icelandic: Í rannsóknum CA209017 og CA209063 var tíðni skjaldkirtilsraskana, þ. á m. vanstarfsemi skjaldkirtils eða bólga í skjaldkirtli, 4,4% (11/248).
English: Baseline characteristics were generally balanced between the two groups.
Icelandic: Jafnvægi var á einkennum hjá hópunum við upphaf.
English: These reactions are presented by system organ class and by frequency.
Icelandic: Aukaverkanirnar eru flokkaðar eftir líffærum og tíðni.
English: NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 10 mg/mL concentrate for solution for infusion.
Icelandic: HEITI LYFS Nivolumab BMS 10 mg/ml innrennslisþykkni, lausn.
English: Underactive thyroid gland which can cause tiredness or weight gain Inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs, headache, dizziness
Icelandic: Bólga í taugum sem veldur dofa, máttleysi, náladofa eða sviðaverk í hand- og fótleggjum, höfuðverkur, sundl
English: The infusion must be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 µm.
Icelandic: Innrennslið skal vera í gegnum sæfða síu í innrennslissetti sem er án sótthitavalda og með litla próteinbindandi eiginleika (gatastærð 0,2-1,2 μm).
English: One vial of 10 mL contains 100 mg of nivolumab.
Icelandic: Í 10 ml hettuglasi eru 100 mg nivolumab.
English: Immune-related nephritis or renal dysfunction present with asymptomatic increases in serum creatinine.
Icelandic: Kreatínínúthreinsum nivolumabs jókst með aukinni líkamsþyngd.
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Icelandic: Við viðvarandi niðurgangi eða ristilbólgu skal nota 0,5 til 1 mg/kg/sólarhring af jafngildi metýlprednisólons.
English: Upon improvement, nivolumab may be resumed after corticosteroid taper, if needed.
Icelandic: Þegar einkenni hafa hjaðnað má hefja meðferð með nivolumabi aftur þegar meðferð með barksterum hefur verið hætt smátt og smátt, ef þarf.
English: Grade 2 or 3 diarrhoea or colitis
Icelandic: Lungnavandamálum t.d. öndunarerfiðleikum eða hósta.
English: In CA209017 and CA209063, the incidence of hypersensitivity/infusion reactions was 1.6% (4/248).
Icelandic: Í rannsóknum CA209066 og CA209037 var tíðni ofnæmis/viðbragða við innrennsli 1,6% (4/248).
English: Upon improvement, nivolumab may be resumed after corticosteroid taper.
Icelandic: Þegar einkenni hafa hjaðnað má hefja meðferð með nivolumabi aftur þegar meðferð með barksterum hefur verið hætt smátt og smátt.
English: For symptomatic hypothyroidism, nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Icelandic: Við einkenni skjaldkirtilsvanstarfsemi á að fresta á gjöf nivolumabs og hefja uppbótarmeðferð með skjaldkirtilshormónum ef þarf.
English: Respiratory, thoracic and mediastinal disorders Common
Icelandic: Sýkingar af völdum sýkla og sníkjudýra
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Icelandic: Í lok nivolumabs innrennslisins á að skola slönguna með natríumklóríð 9 mg/ml (0,9%) stungulyfi, lausn eða 50 mg/ml (5%) glúkósa stungulyfi, lausn.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Icelandic: Einkenni innkirtlakvilla á að líta á sem ónæmistengd nema aðrar ástæður hafi verið staðfestar.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
Icelandic: Ef einkenni versna eða hjaðna ekki þrátt fyrir notkun barkstera á að auka skammtinn í 1 til 2 mg/kg/sólarhring af jafngildi metýlprednisólons og hætta notkun nivolumabs fyrir fullt og allt.
English: For symptomatic adrenal insufficiency, nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Icelandic: Við nýrnahettubilun með einkennum á að fresta gjöf nivolumabs og hefja viðeigandi lífeðlisfræðilega uppbótarmeðferð með barksterum eftir þörfum.
English: Disposal
Icelandic: Tenging
English: Intravenous use.
Icelandic: Halda á meðferð Nivolumab
English: To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066.
Icelandic: Að rannsaka frekar greiningu á tengslum PDL-1 og PDL-2 tjáningar í
English: Other forms of interaction
Icelandic: Aðrar gerðir milliverkana
English: NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 10 mg/mL concentrate for solution for infusion nivolumab
Icelandic: HEITI LYFS Nivolumab BMS 10 mg/ml innrennslisþykkni, lausn
English: Teл.
Icelandic: S.A.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
Icelandic: Ef einkenni versna eða hjaðna ekki þrátt fyrir notkun barkstera á að auka skammt barkstera í 2 til 4 mg/kg/sólarhring af jafngildi metýlprednisólons og hætta verður notkun nivolumabs fyrir fullt
English: Bristol-Myers Squibb AB Tel: + 46 8 704 71 00
Icelandic: Tel: + 46 8 704 71 00
English: Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day prednisone equivalents.
Icelandic: Til að ráða bót á verulegum útbrotum á að nota stóra skammta af barksterum, 1 til 2 mg/kg/sólarhring af jafngildi prednisóns.
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.
Icelandic: Nivolumab BMS innrennslisþykkni, lausn (sæft þykkni) er tær/ópallýsandi, litlaus/fölgulur vökvi sem
English: Patients with mild or moderate infusion reaction may receive nivolumab with close monitoring.
Icelandic: Sjúklingar sem fá væg til í meðallagi mikil viðbrögð við innrennsli mega fá nivolumab undir
English: BRISTOL-MYERS SQUIBB, S.A.
Icelandic: Bristol-Myers Squibb B.V.
English: Be aware of important symptoms of inflammation.
Icelandic: Gerðu þér grein fyrir þýðingarmiklum einkennum bólgu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Icelandic: Niðurstöður verkunar eru sýndar í töflu
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Icelandic: Innrennslið skal vera í gegnum sæfða síu í innrennslissetti, sem er án sótthitavalda og með litla próteinbindandi eiginleika (gatastærð 0,2-1,2 μm).
English: Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Icelandic: Nivolumab BMS er ætlað til meðferðar hjá fullorðnum á lungnakrabbameini af flöguþekjugerð sem er ekki af smáfrumugerð og erlangt gengið frá upptökum eða með meinvörpum, eftir undangengna
English: One patient required permanent discontinuation of nivolumab due to Grade 3 diarrhoea.
Icelandic: Einn sjúklingur með 3. stigs niðurgang þurfti að hætta alfarið meðferð með nivolumabi.
English: For Grade 3 or 4 pneumonitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Icelandic: á að hætta meðferð með nivolumabi fyrir fullt og allt og hefja meðferð með barksterum í skömmtunum 2 til 4 mg/kg/sólarhring af jafngildi metýlprednisólons.
English: Polyolefin containers
Icelandic: YTRI UMBÚÐUM ASKJA
English: IV use
Icelandic: Nivolumab
English: If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Icelandic: Í lok innrennslisins á að skola slönguna með natríumklóríð 9 mg/ml (0,9%) stungulyfi, lausn eða 50 mg/ml (5%) glúkósa stungulyfi, lausn.
English: Nivolumab is associated with immune-related adverse reactions.
Icelandic: Nivolumab tengist ónæmistengdum aukaverkunum.
English: The Grade 3 case required permanent discontinuation of nivolumab.
Icelandic: Sjúklingurinn með 3. stigs tilvikið þurfti að hætta alfarið meðferð með nivolumabi.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Icelandic: OG SKILYRÐI MARKAÐSLEYFIS D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN
English: EU/1/15/1026/001-002 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR
English: Based on this prescribed dose, calculate the total dose to be given.
Icelandic: Heildarskammtur sjúklings er reiknaður út samkvæmt þessum ávísaða skammti.
English: Common diarrhoea, stomatitis, vomiting, abdominal pain, constipation, dry mouth
Icelandic: Ónæmiskerfi bráðaofnæmisviðbrögð, ofnæmi, viðbrögð við innrennsli vöðvaslensheilkenni, fjöltaugataugakvilli niðurgangur, munnbólga, uppköst, kviðverkur, hægðatregða,
English: Grade 3 or 4 elevation in AST, ALT, or
Icelandic: Fresta á notkun nivolumabs við 2. stigs niðurgang eða ristilbólgu.
English: Disease-related aetiologies should be ruled out.
Icelandic: Útiloka þarf sjúkdómstengdar orsakir.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Icelandic: Ef skil á samantekt um öryggi lyfsins og uppfærsla á áætlun um áhættustjórnun er áætluð á svipuðum
English: Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.
Icelandic: Læknirinn getur hugsanlega gefið þér önnur lyf til þess að koma í veg fyrir fylgikvilla og draga úr einkennum frestað næsta skammti af Nivolumab BMS hætt alfarið meðferð með Nivolumab BMS Athugið að einkennin geta stundum verið síðbúin og komið fram vikum eða mánuðum eftir síðasta skammt.
English: • Risk Management Plan (RMP)
Icelandic: 1.Verkunarrannsókn eftir veitingu markaðsleyfis (PAES):
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Icelandic: Óeðlileg lifrarpróf (aukning lifrarensímanna aspartat amínótransferasa, alanín amínótransferasa eða alkalísks fosfatasa í blóði, aukin gildi bilirúbíns)
English: For symptomatic diabetes, nivolumab should be withheld, and insulin replacement should be initiated as needed.
Icelandic: Við sykursýki með einkennum á að fresta gjöf nivolumabs og hefja uppbótarmeðferð með insúlíni eftir þörfum.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administra
Icelandic: (Sér) heiti Styrkleiki Lyfjaform
English: 1138 Budapest Hungary
Icelandic: 1138 Budapest
English: Polígono Industrial Sector 14 Pouet de Camilo, 2
Icelandic: Industrial Sector 14 Pouet de Camilo, 2
English: A- 1221 Vienna Austria
Icelandic: 1221 Vienna
English: Czech Republic Baxter Czech spol.
Icelandic: Baxter Czech spol.
English: Baxter Oy, PL 119, 00181 Helsinki Finland
Icelandic: Oy, PL 119, 00181 Helsinki Finland
English: Aprotinin 15000 KIU;
Icelandic: Aprótínín 15000 KIU;
English: Artiss and associated names; Tisseel and associated names; Tissucol and associated names Member State (in EEA)
Icelandic: Artiss og tengd heiti; Tisseel og tengd heiti; Tissucol og tengd heiti Aðildarríki (í EES)
English: The Netherlands Baxter AG Industriestraße 67
Icelandic: Ungverjaland Baxter AG Industriestraße 67
English: Norfork IP24 3SE, United Kingdom
Icelandic: IP24 3SE, United Kingdom
English: Factor XIII 30 a.e
Icelandic: Þáttur XIII 30 a.e.
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park
Icelandic: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal
English: BAXTER HELLAS LTD 3 Metsovou str, 14121-N Irakleio, Athens
Icelandic: BAXTER HELLAS LTD 3 Metsovou str, 14121-N
English: Kruczkowskiego 8 00-380 Warzawa Poland
Icelandic: Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 00-380 Warszawa Poland
English: Beriplast P CombiSet, weefsellijm
Icelandic: P Combi-Set, weefsellijm
English: Baxter SA Boulevard René Branquart 80 7860 Lessines Belgium
Icelandic: Boulevard René Branquart 80 7860
English: Karla Engliše 3201/6
Icelandic: s r.o. Karla Engliše 3201/6 150 00 Praha 5
English: Total Protein 500-650 mg;
Icelandic: Heildarprótín 500-650 mg;
English: Fibronectin 5,5 mg
Icelandic: Fíbrónektín 5,5 mg
English: Total Protein 200-260 mg;
Icelandic: Heildarprótín 200-260 mg;
English: Baxter Medical AB, Isafjordstgatan 30B P.O.
Icelandic: Baxter Medical AB, Isafjordsgatan 30B P.O. Box 63
English: Tisseel Duo Quick Tisseel solution Per mlFibrinogen 90 mg
Icelandic: Tisseel Duo Quick Tisseel-lausn á mlFíbrínógen 90 mg
English: Beriplast and associated names Member State (in EEA)
Icelandic: Beriplast og tengd heiti Aðildarríki (í EES)
English: Beriplast P CombiSet 3 ml prašek in vehikel za lepilo za tkiva
Icelandic: 3 ml prašek in vehikel za lepilo za tkiva
English: Beriplast P CombiSet 1 ml prašek in vehikel za lepilo za tkiva
Icelandic: 1 ml prašek in vehikel za lepilo za tkiva
English: TISSEEL Lyo, TwoComponent Fibrin Sealant
Icelandic: TISSEEL Lyo, Two-Component Fibrin Sealant
English: Intralesional use
Icelandic: Staðbundin notkun
English: Tisseel Duo Quick Fibrinogen 90mg/ml Fibronectin 6mg/ml
Icelandic: Tisseel Duo Quick Fíbrínógen 90 mg/ml Fíbrónektín 6 mg/ml
English: TISSEEL KIT 2.0 ml, Two
Icelandic: TISSEEL KIT 2.0 ml,
English: Beriplast P CombiSet 0,5ml/1ml/3ml
Icelandic: P Combi-Set 0,5ml/1ml/3ml
English: Component Fibrin Sealant
Icelandic: Two-Component Fibrin Sealant
English: The Netherlands Baxter B.V. Kobaltweg 49, Utrecht 3542 CE
Icelandic: Kobaltweg 49, 3542 CE Utrecht The Netherlands
English: Plasminogen 0.2-0.6 mg;
Icelandic: Plasmínógen 0,2-0,6 mg;
English: Tisseel Lyo Twocomponent Fibrin Sealant
Icelandic: Tisseel Lyo Two-component Fibrin Sealant
English: D-85716 Unterschleißheim Germany
Icelandic: Unterschleißheim Germany
English: Norway
Icelandic: Norfolk
English: Thrombin 1000 IU or Thrombin 8 UI; Calcium Chlorid Dihydrate 11.76 mg
Icelandic: Þrombín 1000 a.e. eða þrombín 8 a.e.; Kalsíumklóríðtvíhýdrat 11,76 mg
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Icelandic: VIÐAUKI I LISTI YFIR HEITI, LYFJAFORM, STYRKLEIKA LYFJANNA, ÍKOMULEIÐIR
English: Aprotinin 3000 UIK/ml (1.67 UPE/ml);
Icelandic: Aprótínín úr nautgripum 3000 KIU/ml (1,67 EPU/ml); flaska 3:
English: Thrombin 2500 IU or Thrombin 20 UI; Calcium Chlorid Dihydrate 29.4 mg
Icelandic: Þrombín 2500 a.e. eða þrombín 20 a.e.; Kalsíumklóríðtvíhýdrat 29,4 mg
English: 1st Component:
Icelandic: Fyrsti efnisþáttur:
English: Component 1
Icelandic: Efnisþáttur 1
English: 150 00 Praha 5
Icelandic: 1000 KIU = 0,56
English: Component 2:
Icelandic: Efnisþáttur 2:
English: Component 2
Icelandic: Efnisþáttur 2
English: Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg; Plasma Fibronectin 10-45 mg; Factor XIII 50-250 UI;
Icelandic: 375-575 mg, þar af fíbrínógen 350-550 mg;
English: Baxter Hungary Kft. Népfürdő u. 22.
Icelandic: Ungverjaland Baxter Hungary Kft.
English: Component 1:
Icelandic: Efnisþáttur 1:
English: TISSUCOL Kit 1,0 kétkomponensű fibrinragasztó
Icelandic: Kit 1,0 kétkomponensű fibrinragasztó
English: Thrombin 500 IU or Thrombin 4 UI; Calcium Chlorid Dihydrate 5.88 mg
Icelandic: Þrombín 500 a.e. eða þrombín 4 a.e.; Kalsíumklóríðtvíhýdrat 5,88 mg
English: Beriplast P CombiSet Pulver und Lösungsmittel für einen
Icelandic: - Pulver und Lösungsmittel für einen
English: Norfork
Icelandic: Noregur
English: TISSUCOL Kit 2,0 kétkomponensű fibrinragasztó
Icelandic: Kit 2,0 kétkomponensű fibrinragasztó
English: Human fibrinogen (clottable protein): 72-110 mg/ml
Icelandic: Fíbrínógen úr mönnum 72-110 mg/ml
English: TISSUCOL Kit 5,0 kétkomponensű fibrinragasztó
Icelandic: Kit 5,0 kétkomponensű fibrinragasztó
English: Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg; Plasma Fibronectin 4-18 mg; Factor XIII 20-100 UI;
Icelandic: 150-230 mg, þar af fíbrínógen 140-220 mg;
English: IU/ml
Icelandic: 10 a.e./ml
English: Human fibrinogen (72-110 mg/ml) Factor xiii (≤10 UI) Aprotinin (3000 KUI2/ml) Human thrombin (500 UI3/ml) Calcium chloride (40micromol/ml)
Icelandic: Fíbrínógen úr mönnum (72-110 mg/ml) Þáttur xiii (≤10 a.e.) Aprótínín (3000 KIU2/ml) Þrombín úr mönnum (500 a.e.3/ml) Kalsíumklóríð (40 míkrómól/ml)
English: Plasminogen: 0,08 mg/ml Fibronectin: 5,5 mg/ml
Icelandic: 5,50 mg/ml Plasmínógen: 0,08 mg/ml
English: Solvent for sealant
Icelandic: Leysir fyrir vefjalím
English: UI/ml; Plasminogen 0.04-0.12 mg/ml;
Icelandic: Plasmínógen: 0,04-0,12 mg/ml
English: Sealant
Icelandic: Vefjalím
English: Syringe TISSUCOL-APROTININ: Total Proteins 100-130 mg/ml; clottable protein 75-115 mg/ml, of which fibrinogen 70-110 mg/ml and plasmatic fibronectin 2-9 mg/ml: Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Aprotinin 3000 UIK/ml (1.67 UPE/ml); Syringe THROMBIN-CALCIUM CHLORIDE: Proteins 50mg/ml; Thrombin 500 UI/ml; calcium chloride 40 µmol/ml
Icelandic: Heildarprótín 100-130 mg/ml; prótín með storkuþáttum 75-115 mg/ml, þar af fíbrínógen 70-110 mg/ml og plasma fíbrónektín 2-9 mg/ml; þáttur XIII 10-50 a.e./ml; plasmínógen 0,040,12 mg/ml; aprótínín 3000 KIU/ml (1,67 EPU/ml); sprauta ÞROMBÍNKALSÍUMKLÓRÍÐ:
English: Calcium chloride: 40 µmol/ml Factor XIII: 30 IU/ml
Icelandic: 40 μmól/ml Þáttur XIII ≤ 10 a.e./ml
English: CHLORIDE: Proteins 50mg/ml; Thrombin 500 UI/ml; calcium chloride 40 µmol/ml
Icelandic: Prótín 50 mg/ml; þrombín 500 a.e./ml; kalsíumklóríð 40 µmól/ml
English: Calcium chloride: 40 µmol/ml
Icelandic: 40 μmól/ml
English: Syringe THROMBIN-CALCIUM
Icelandic: EPU Þrombín :
English: Plasminogen 0.08-0.24 mg; Aprotinin 6000 KIU;
Icelandic: Plasmínógen 0,08-0,24 mg;
English: Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml
Icelandic: Plasmínógen 80 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);
Icelandic: Heildarprótín 100-130 mg/ml; prótín með storkuþáttum 75-115 mg/ml; þáttur XIII 10-50 a.e./ml; plasmínógen 0,04-0,12 mg/ml; flaska 2:
English: Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Icelandic: Fíbrínógen úr mönnum 91 mg/ml Aprótínín 3000 KIU/ml (úr nautgripum) Þrombín úr mönnum 4 a.e.^3/ml Kalsíumklóríð 40 míkrómól/ml
English: Proteins 50mg/ml; Bottle 4: Human Thrombin 4 UI/ml; Proteins 50mg/ml;
Icelandic: Þrombín úr mönnum 500 a.e./ml; prótín 50 mg/ml; flaska 4:
English: Fibrinogen 72-110 mg/ml Factor XIII coagulationis humanus 10 IU/ml
Icelandic: 72-110 mg/ml Þáttur XIII ≤ 10 a.e./ml Aprótínín:
English: 2nd Component: Thrombin 500 UI/ml
Icelandic: Þrombín 500 a.e./ml
English: Plasmafibrinonectinum 5,5mg/ml Factor XIII coagulationis humanus 30
Icelandic: 5,9 mg/ml Storkuþáttur XIII:
English: 2nd Component:
Icelandic: Annar efnisþáttur:
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
Icelandic: Fíbrínógen úr mönnum (prótín með storkuþætti) 72-110 mg/ml Þáttur XIII ≤ 10 a.e./ml Aprótínín 3000 KIU/ml Þrombín úr mönnum 500 a.e./ml Kalsíumklóríð 40 µmól/ml
English: Powder for sealant and Solution for sealant
Icelandic: Vefjalímsstofn og lausn fyrir vefjalím
English: Tisseel duo quick Plasmaproteinum humanum 100-130 mg/ml: Fibrinogen 90mg/ml
Icelandic: Plasmaprótín úr mönnum 100-130 mg/ml:
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Icelandic: 1000 KIU/ml=0.56 PEU/ml
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;
Icelandic: 75-115 mg, þar af fíbrínógen 70-110 mg;
English: Human Fibrinogen 91 gm/ml Human Factor XIII 10 IU/ml Bovine Aprotinin 3000 IU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 micromol/ml
Icelandic: Fíbrínógen úr mönnum 91 mg/ml Þáttur XIII úr mönnum 10 a.e./ml Aprótínín úr nautgripum 3000 KIU/ml Þrombín úr mönnum 500 a.e./ml Kalsíumklóríð 40 míkrómól/ml
English: Plasminogen 0.04-0.12 mg; Aprotinin 3000 KIU;
Icelandic: Plasmínógen 0,04-0,12 mg;
English: Aprotinin 3000KIE/ml Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml Thrombin human 500 IE/ml Calcium Chloride Dihydrate 40 μg/ml
Icelandic: Fíbrínógen 90 mg/ml Plasma fíbrónektín 5,5 mg/ml Storkuþáttur XIII úr mönnum 30 a.e./ml Aprótínín 1,67 Ph.Eur.einingar/ml Storkuþáttur XIII 30 a.e./ml Plasmínógen 80 μg/ml
English: Aprotinin 1,67 Ph.Eur.U./ml
Icelandic: ≤ 10 a.e./ml
English: Thrombin human 500 IE/ml plasmaproteinum humanum 50mg/ml Calcium Chloride Dihydrate 40 μg/ml
Icelandic: Þrombín úr mönnum 500 a.e./ml Kalsíumklóríðtvíhýdrat 40 μg/ml
English: Aprotinin (bovel) 3000 KIU Plasminogen 80 microgram Thrombin solution per ml Human thrombin 500 ae Calcium chloridum 40 micromol
Icelandic: Aprótínín (úr nautgripum) 3000 KIU Plasmínógen 80 míkrógrömm Þrombínlausn á ml
English: Powder, solution and solvent for sealant
Icelandic: Vefjalímsstofn, lausn og leysir
English: The following side effects have also been reported:
Icelandic: Einnig hefur verið tilkynnt um eftirfarandi aukaverkanir:
English: Adopted at the 8-11 January 2018 PRAC
Icelandic: Samþykkt á fundi PRAC 8.-11. janúar 2018
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 January 2018
Icelandic: 30 Churchill Place ● Canary Wharf ● London E14 5EU ●
English: Frequency ‘not known'
Icelandic: Tíðni ‘ekki þekkt'
English: Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Icelandic: Spyrja á sjúklinginn út í mögulega lungnavanstarfsemi, prófa á lungnastarfsemi ef þörf krefur.
English: Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
Icelandic: - Lungnablöðrublæðing (EPITT nr. 18850)
English: If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.
Icelandic: Ef þú finnur fyrir einkennunum blóðugum uppgangi eða blóðhósta skaltu hafa samband við lækninn án tafar.
English: Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Icelandic: Veita á sjúklingum upplýsingar um hættuna á lungnabólgu og ráðleggja þeim að hafa samband við lækninn án tafar ef þeir fá þrálátan hósta og mæði.
English: Not known: frequency cannot be estimated from the available data Increased urine output
Icelandic: Tíðni ekki þekkt: ekki hægt að meta tíðni út frá fyrirliggjandi gögnum Aukið þvagmagn