natgillin/translations-raw huggingface dataset:
Check with your doctor or nurse before you are given Nivolumab BMS if: you have been told that your cancer has spread to your brain you have an autoimmune disease (a condition where the body attacks its own cells); you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system.
Preden boste prvič prejeli zdravilo Nivolumab BMS se posvetujte z zdravnikom ali medicinsko če vam je zdravnik povedal, da se je rak razširil v možgane.
Post-authorisation efficacy study (PAES): The MAH should submit an updated OS data for Study CA209017: a Phase 3, randomized study of nivolumab vs docetaxel in subjects with advanced or metastatic squamous NSCLC who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen.
Študija učinkovitosti po pridobitvi dovoljenja za promet (PAES): Imetnik dovoljenja za promet z zdravilom mora predložiti dopolnjene podatke o celokupnem preživetju za študijo CA209017: randomizirana študija faze 3
STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of concentrate contains 10 mg of nivolumab.
En ml koncentrata vsebuje 10 mg nivolumaba.
Upon improvement, nivolumab may be resumed after corticosteroid taper, if needed.
Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida, če je bilo takšno zdravljenje potrebno, se zdravljenje z nivolumabom lahko nadaljuje.
Monitoring of thyroid function should continue to ensure appropriate hormone replacement is utilised.
Za zagotovitev, da je hormonsko nadomestno zdravljenje ustrezno, je treba kontinuirano
Grade 3 or 4 pneumonitis
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Three patients, including the one patient with Grade 3 adrenal insufficiency, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-1.3) for 2.7 weeks (range: 0.6-4.6).
Trije bolniki, vključno z enim bolnikom z insuficienco nadledvičnih žlez stopnje 3, so prejemali visoke odmerke kortikosteroidov (odmerke, ki so ustrezali vsaj 40 mg prednizona) z medianim začetnim odmerkom
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Vrednotenje tumorja na osnovi različice 1.1 kriterijev za vrednotenje odziva pri solidnih tumorjih (RECIST v1.1, Response Evaluation Criteria in Solid
Immune-related adverse reaction
Imunsko pogojeni neželeni učinek
Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222
Tel: + 31 (0)30 300 2222
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
Common
Dogodki
More than one vial of Nivolumab BMS may be necessary to obtain the required dose.
Za potreben odmerek bo morda treba uporabiti več kot
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.
0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno (50 mg/ml)
No Grade 4 or 5 rash was reported in these studies.
izpuščaju stopnje 4 ali 5 v teh študijah niso poročali.
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00
Tel: + 40 (0)21 272 16 00
Nivolumab BMS should be continued in the presence of hormone replacement therapy a as long as no symptoms are present
Če med hormonskim nadomestnim zdravljenjem a simptomi niso prisotni, je treba zdravljenje z zdravilom Nivolumab BMS nadaljevati.
Gently mix the infusion by manual
Raztopino za infundiranje z vrtenjem v rokah nežno premešajte.
The patient takes one capsule one hour before starting each chemotherapy cycle.
Bolnik mora vzeti eno kapsulo eno uro pred začetkom vsakega cikla kemoterapije.
One of the active substances, palonosetron, has been authorised on its own in the EU since 2005.
Ena od zdravilnih učinkovin, palonosetron, je v EU samostojno odobrena od leta 2005.
The Committee therefore concluded that the medicine's benefits are greater than its risk and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015
Evropska komisija je dovoljenje za promet z zdravilom Akynzeo, veljavno po vsej Evropski uniji, izdala 27. maja 2015.
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.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Akynzeo sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Akynzeo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Akynzeo.
What measures are being taken to ensure the safe and effective use of Akynzeo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Akynzeo?
Other information about Akynzeo
Druge informacije o zdravilu Akynzeo
Akynzeo netupitant / palonosetron hydrochloride
Akynzeo netupitant/palonosetronijev klorid
This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.
V tej študiji je sodelovalo 1455 bolnikov, ki so kot dopolnilno zdravljenje prejemali tudi deksametazon, drugo zdravilo, ki se uporablja za preprečevanje bruhanja.
A risk management plan has been developed to ensure that Akynzeo is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Akynzeo je bil pripravljen načrt obvladovanja tveganj.
The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%).
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Akynzeo, so glavobol (ki so ga opazili pri 3,6 % bolnikov), zaprtost (3,0 %) in utrujenost (1,2 %).
Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron.
Zdravilo Akynzeo je na voljo v obliki kapsul, ki vsebujejo 300 mg netupitanta in 0,5 mg palonosetrona.
What benefits of Akynzeo have been shown in studies?
Kakšne koristi je zdravilo Akynzeo izkazalo v študijah?
For more information about treatment with Akynzeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Akynzeo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy.
V drugi glavni študiji so proučevali koristi zdravila Akynzeo pri bolnikih, ki prejemajo zmerno emetogeno kemoterapijo.
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).
V glavni študiji, v kateri so zdravilo Akynzeo primerjali s samim palonosetronom, se bruhanje v 5 dneh po začetku zdravljenja z zelo emetogeno kemoterapijo ni pojavilo pri 90 % bolnikov, ki so jemali Akynzeo (121 od 135), v primerjavi s 77 % bolnikov, ki so jemali samo palonosetron (104 od 136).
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).
Akynzeo je zdravilo, ki se uporablja za preprečevanje navzeje (slabosti) in bruhanja pri odraslih bolnikih z rakom, ki prejemajo kemoterapijo (zdravila za zdravljenje raka).
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je upošteval, da je zdravilo Akynzeo učinkovito preprečilo tako takojšnjo kot zapoznelo fazo slabosti in bruhanja po kemoterapiji in da ima ugoden varnostni profil.
What is Akynzeo and what is it used for?
Kaj je zdravilo Akynzeo in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Akynzeo, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the risks associated with Akynzeo?
Kakšna tveganja so povezana z zdravilom Akynzeo?
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.
Določene vrste kemoterapije dokazano povzročajo hudo slabost in bruhanje, zdravilo Akynzeo pa se uporablja pri bolnikih, ki prejemajo bodisi zelo emetogeno (takšno, ki povzroča bruhanje) kemoterapijo na osnovi zdravila proti raku cisplatina ali druge vrste kemoterapije, ki so zmerno emetogene.
For practical information about using Akynzeo, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Akynzeo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Why is Akynzeo approved?
Zakaj je bilo zdravilo Akynzeo odobreno?
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).
Netupitant deluje tako, da zavira receptorje za nevrokinin-1 (NK1) - receptorje, ki so prisotni v živčnem sistemu in so odgovorni za zapoznelo fazo slabosti in bruhanja (ki se pojavi po prvih 24 urah), palonosetron pa zavira receptorje 5HT3 v črevesju, ki so odgovorni za takojšnjo fazo (ki se pojavi v prvih 24 urah).
It is not intended to provide practical advice on how to use Akynzeo.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron.
Bruhanja prvi dan po prvem ciklusu kemoterapije niso opazili pri 88 % bolnikov, ki so jemali zdravilo Akynzeo, v primerjavi s 85 % bolnikov, ki so jemali palonosetron.
The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group.
Med drugim in petim dnem pa ga niso opazili pri 77 % bolnikov v skupini z zdravilom Akynzeo in pri 70 % bolnikov v skupini s palonosetronom.
The two active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy.
Zdravilni učinkovini v zdravilu Akynzeo delujeta tako, da zavirata dva različna mehanizma, ki sodelujeta pri povzročanju slabosti in bruhanja med kemoterapijo.
Akynzeo contains the active substances netupitant and palonosetron.
Zdravilo Akynzeo vsebuje zdravilni učinkovini netupitant in palonosetron.
How does Akynzeo work?
Kako zdravilo Akynzeo deluje?
How is Akynzeo used?
Kako se zdravilo Akynzeo uporablja?
By having both active substances together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.
Zdravilo Akynzeo, ki vsebuje obe zdravilni učinkovini, tako pomaga pri obvladovanju tako takojšnje kot zapoznele faze slabosti in bruhanja, ki se pojavita po kemoterapiji.
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administra
(Izmišljeno) ime Jakost
Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park
Abrunheira - Edifício 10 - Sintra Business Park
Kruczkowskiego 8 00-380 Warzawa Poland
Kruczkowskiego 8 00-380 Warszawa Poland
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Beriplast and associated names Member State (in EEA)
Beriplast in povezana imena Država članica (v EGP)
Artiss and associated names; Tisseel and associated names; Tissucol and associated names Member State (in EEA)
Artiss in povezana imena; Tisseel in povezana imena; Tissucol in povezana imena Država članica (v EGP)
Baxter Médico-Farmacêutica, Lda.
Portugalska Baxter Médico-Farmacêutica, Lda.
The Netherlands Baxter AG Industriestraße 67
Nizozemska Baxter AG Industriestraße 67
Combi-Set 2: thrombin: 500 IU/ml
Combi-Set 2: trombin : 500 IU/ml
ARTISS soluciones para adhesivo tisular
ARTISS soluciones para adhesivo tisular Ultracongeladas intralezijska uporaba
IU/ml
EIK2/ml
Intralesional use
Artiss intralezijska uporaba
Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml
Trombin : 500 IU/ml Kalcijev klorid: 5,9 mg/ml
Thrombin 1000 IU or Thrombin 8 UI; Calcium Chlorid Dihydrate 11.76 mg
2. komponenta: trombin 1000 i.e. ali trombin 8 i.e.; kalcijev klorid dihidrat 11,76 mg
Thrombin 2500 IU or Thrombin 20 UI; Calcium Chlorid Dihydrate 29.4 mg
2. komponenta: trombin 2500 i.e. ali trombin 20 i.e.; kalcijev klorid dihidrat 29,4 mg
Fibrinogen human 90,00 mg /ml Factor XIII : 10,00 UI/ml Fibronectin : 5,50 mg/ml Plasminogen : 0,08 mg/ml Aprotinin 3000,0 UIK*** /ml
1. komponenta: fibrinogen, humani 90,00 mg/ml faktor XIII: 10,00 i.e./ml fibronektin: 5,50 mg/ml plazminogen: 0,08 mg/ml aprotinin 3000,0 EIK***/ml
Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg; Plasma Fibronectin 10-45 mg; Factor XIII 50-250 UI;
1. komponenta: skupne beljakovine 500650 mg; koagulabilne beljakovine: 375575 mg, od tega fibrinogen 350-550 mg; plazemski fibronektin 10-45 mg; faktor XIII 50-250 i.e.; plazminogen: 0,2-0,6 mg; aprotinin 15000 EIK;
Thrombin (human) 500 I.E./ml Calcium chloride: 5,88 mg/ml
2. komponenta: trombin (humani) 500 i.e./ml kalcijev klorid: 5,88 mg/ml
Human fibrinogen: 90 mg Coagulation factor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Calcium chloride: 5,9 mg
Humani fibrinogen: 90 mg Koagulacijski faktor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Kalcijev klorid: 5,9 mg
Thrombin S lyophilized: 500 I.E/ml Thrombin L lyophilized: 4 I.E/ml Calcium chloride: 5,88 mg/ml
500 i.e./ml trombin L, liofiliziran: 4 i.e./ml kalcijev klorid: 5,88 mg/ml
Thrombin 500 IU or Thrombin 4 UI; Calcium Chlorid Dihydrate 5.88 mg
2. komponenta: trombin 500 i.e. ali trombin 4 i.e.; kalcijev klorid dihidrat 5,88 mg
Combi-Set 1: fibrinogen: 90 mg/ml coagulation factor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
Combi-Set 1: fibrinogen: 90 mg/ml koagulacijski faktor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
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
Brizga TISSUCOL-APROTININ: skupne beljakovine 100130 mg/ml; koagulabilne beljakovine 75115 mg/ml, od tega fibrinogen 70-110 mg/ml in plazemski fibronektin 2-9 mg/ml: faktor XIII 10-50 i.e./ml; plazminogen 0,04-0,12 mg/ml; aprotinin 3000 EIK/ml (1,67 EEP/ml); Brizga TROMBIN-KALCIJEV KLORID: beljakovine 50 mg/ml; trombin 500 i.e./ml; kalcijev klorid 40 µmol/ml
Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg; Plasma Fibronectin 4-18 mg; Factor XIII 20-100 UI;
1. komponenta: skupne beljakovine 200260 mg; koagulabilne beljakovine: 150230 mg, od tega fibrinogen 140-220 mg; plazemski fibronektin 4-18 mg; faktor XIII 20-100 i.e.; plazminogen: 0,08-0,24 mg; aprotinin 6000 EIK;
Fibrinogen: 90 mg/ml Aprotinin (bovine): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Factor XIII: 60 U/ml
Fibrinogen: 90 mg/ml Aprotinin (goveji): 1000 KIU/ml Trombin : 500 IU/ml Kalcijev klorid: 5,9 mg/ml Koagulacijski faktor XIII: 60 U/ml
Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
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;
1. komponenta: skupne beljakovine 100130 mg; koagulabilne beljakovine: 75115 mg, od tega fibrinogen 70-110 mg; plazemski fibronektin 2-9 mg; faktor XIII 10-50 i.e.; plazminogen: 0,04-0,12 mg; aprotinin 3000 EIK;
The Netherlands Baxter B.V. Kobaltweg 49, Utrecht 3542 CE
3542 CE Utrecht The Netherlands
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
humani fibrinogen 91 mg/ml humani faktor XIII 10 i.e./ml goveji aprotinin 3000 EIK/ml humani trombin 500 i.e./ml kalcijev klorid 40 mikromol/ml
Fibrinogen: 70 - 110 mg/ml Fibronectine 2 - 9 mg/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10-50 IU/ml Aprotinine (bovine): 3000 KIU/ml
fibrinogen: 70-110 mg/ml fibronektin: 2-9 mg/ml trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml faktor XIII: 10-50 i.e./ml aprotinin (goveji): 3000 EIK/ml
Human fibrinogen: 90 mg/ml Coagulation factor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Thrombin: 7,6 mg/ml Calcium chloride: 5,9 mg/ml
Humani fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Trombin : 7,6 mg/ml Kalcijev klorid: 5,9 mg/ml
Human fibrinogen (72-110 mg/ml) Factor xiii (≤10 UI) Aprotinin (3000 KUI2/ml) Human thrombin (500 UI3/ml) Calcium chloride (40micromol/ml)
Tisseellyo humani fibrinogen (72110 mg/ml) faktor XIII (≤10 i.e.) aprotinin (3000 EIK2/ml) humani trombin (500 i.e.3/ml) kalcijev klorid (40 mikromol/ml)
Human Fibrinogen 91 mg/ml Aprotinum INN 3000 KIU/ml (bovine) Human Thrombin 4 ae^3/ml Calcium Chloride 40 micromol/ml
Artiss humani fibrinogen 91 mg/ml aprotinin 3000 EIK/ml (goveji) humani trombin 4 i.e.^3/ml kalcijev klorid 40 mikromol/ml
The Netherlands CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Nizozemska CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Fibrinogen:70-110 mg/ml Coagulation factor XIII: 10-50 I.E./ml Plasmafibronectin: 2-9 mg/ml Aprotinin (bovin): 3000 KIE/ml
1. komponenta: fibrinogen: 70-110 mg/ml koagulacijski faktor XIII: 1050 i.e./ml plazemski fibronektin: 2-9 mg/ml aprotinin (goveji): 3000 EIK/ml
Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Thrombin: 500 IU /ml Calcium chloride (dihydrate): 5,9 mg/ml
Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Trombin : 500 IU /ml Kalcijev klorid dihidrat: 5,9 mg/ml
Fibrinogen: 70-110mg/ml Plasmafibronectin (CIG): 2-9mg/ml Factor XIII: 10-50 U/ml Plasminogen: 0.04 - 0.12mg/ml
TISSEEL KIT 2.0 ml, Two-Component Fibrin Sealant fibrinogen: 70-110 mg/ml plazemski fibronektin (CIG): 29 mg/ml faktor XIII: 10-50 e./ml plazminogen: 0,04-0,12 mg/ml dermalna uporaba
Human Fibrinogen: 91 mg1/ml Aprotinin: 3000 KIU2/ml Human Thrombin: 500 IU3/ml Calcium Chloride: 40 µmol/ml
Tisseel humani fibrinogen: 91 mg1/ml aprotinin: 3000 EIK2/ml humani trombin: 500 i.e.3/ml kalcijev klorid: 40 μmol/ml
Human fibrinogen: 72-110 mg/ml Factor xiii: ≤10 UI Aprotinin: 3000 KU12/ml Human thrombin: 500 UI3/ml Calcium chloride: 40 micromol/ml
Tisseel humani fibrinogen: 72-110 mg/ml faktor XIII: ≤10 i.e. aprotinin: 3000 EIK2/ml humani trombin: 500 i.e.3/ml kalcijev klorid: 40 mikromol/ml
Aprotinin 3000KIE/ml Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml Thrombin human 500 IE/ml Calcium Chloride Dihydrate 40 μg/ml
Tisseel Duo Quick fibrinogen 90 mg/ml fibronektin 6 mg/ml aprotinin 3000 EIK/ml koagulacijski faktor XIII 30 i.e./ml plazminogen 80 μg/ml trombin, humani 500 i.e./ml kalcijev klorid dihidrat 40 μg/ml intralezijska uporaba
Human fibrinogen 72-110 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 µmol/ml
Tisseel solutions for sealant humani fibrinogen 72110 mg/ml aprotinin 3000 EIK/ml humani trombin 500 i.e./ml kalcijev klorid 40 µmol/ml
Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Trombin : 500 UI/ml Kalcijev klorid dihidrat: 5,9 mg/ml
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10 IU/ml
Tisseel fibrinogen: 91 mg/ml aprotinin: 3000 EIK/ml trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml faktor XIII: 10 i.e./ml
Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5.9 mg/ml
Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Trombin : 500 IU/ml Kalcijev klorid: 5.9 mg/ml
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU Thrombin: 500 UI/ML Calcium Chloride: 40 MMO LI/L Factor XIII ≤ 10 UI/ml
fibrinogen: 91 mg/ml aprotinin: 3000 EIK trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml faktor XIII ≤10 i.e./ml
Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Artiss solution for sealant frozen humani fibrinogen 91 mg/ml aprotinin 3000 EIK/ml humani trombin 4 i.e./ml kalcijev klorid 40 µmol/ml
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);
Tissucol Kit steklenica 1: skupne beljakovine 100-130 mg/ml; koagulabilne beljakovine 75115 mg/ml, faktor XIII 1050 i.e./ml; plazminogen 0,040,12 mg/ml; steklenica 2: aprotinin, goveji 3000 EIK/ml (1,67 EEP/ml); steklenica 3: humani trombin 500 i.e./ml; beljakovine 50 mg/ml; steklenica 4: humani trombin 4 i.e./ml; beljakovine 50 mg/ml; steklenica 5: kalcijev klorid 40 µmol/ml
Aprotinin (bovel) 3000 KIU Plasminogen 80 microgram Thrombin solution per ml Human thrombin 500 ae Calcium chloridum 40 micromol
Tisseel raztopina na mlfibrinogen 90 mg fibronektin 5,5 mg faktor XIII 30 i.e. aprotinin (goveji) 3000 EIK plazminogen 80 mikrogramov Raztopina trombina na ml humani trombin 500 i.e. kalcijev klorid 40 mikromol
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
Tissucol S/D Kit humani fibrinogen (koagulacijske beljakovine) 72110 mg/ml faktor XIII ≤10 i.e./ml aprotinin 3000 EIK/ml humani trombin 500 i.e./ml kalcijev klorid 40 µmol/ml
Fibrinogen: 72-110mg/ml Aprotinin: 3000KIU/ml Thrombin: 500 IU/ml in 45-55mg total protein
TISSEEL Lyo, Two-Component Fibrin Sealant fibrinogen: 72-110 mg/ml aprotinin: 3000 EIK/ml trombin: 500 i.e./ml v 4555 mg skupnih beljakovin kalcijev klorid: 40 μmol/ml dermalna uporaba
Human fibrinogen: 91 mg/ml Aprotinin: 3000 KUI2/ml Human thrombin: 4 UI3/ml Calcium chloride: 40 mmol/ml
Artiss humani fibrinogen: 91 mg/ml aprotinin: 3000 EIK2/ml humani trombin: 4 i.e.3/ml kalcijev klorid: 40 mikromol/ml vehikel za lepilo za tkiva
Human Fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIU/ml Human Thrombin: 4 IU/ml Calcium Chloride: 40 μmol/ml
TISSEEL Lyo humani fibrinogen: 72-110 mg/ml aprotinin: 3000 EIK/ml humani trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml
Fibrinogen: 70 - 110 mg/ml Plasmafibronectin: 2 - 9 mg/ml Coagulation factor XIII: 10 - 50 I.E/ml Aprotininsolution: 3000 KIE/ml
1. komponenta: fibrinogen: 70-110 mg/ml plazemski fibronektin: 2-9 mg/ml koagulacijski faktor XIII: 10-50 i.e./ml raztopina aprotinina:
Aprotinin 3000 UIK/ml (1.67 UPE/ml);
3000 EIK/ml