natgillin/translations-raw huggingface dataset:
This particularly includes the following situations with increased bleeding risk: – Recent puncture of large vessels or organ biopsy – Anomaly of vessels or organs – Recent cerebrovascular accident, stroke, or intracerebral surgery – Severe uncontrolled hypertension – Bacterial endocarditis – Advanced renal impairment – Haemorrhagic diathesis – Recent major surgery – Recent bleeding (e. g. intracranial, gastrointestinal, intraocular, pulmonary) – Overt signs of bleeding – Recent active peptic ulcer – Age > 65 years.
To velja še zlasti za naslednja stanja s povečanim tveganjem krvavitve: – nedavna punkcija večjih žil ali biopsija organov – nepravilnosti ožilja ali organov – nedavni cerebrovaskularni insult, kap ali možganska operacija – huda neobvladana hipertenzija – bakterijski enodkarditis – napredovala okvara ledvic – hemoragična diateza – nedavni večji operativni poseg – nedavna krvavitev (npr. intrakranialna, gastrointestinalna, intraokularna, pljučna) – prikriti znaki krvavitve – nedavno aktivna želodčna razjeda – starost > 65 let.
– Anaphylaxis:
– Anafilaksa:
Refludan may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Refludan lahko povzroči alergijske reakcije, vključno z anafilakso in šokom (glejte poglavje 4. 8).
Treatment initiation with Refludan should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions. – Patients should be informed that they have received Refludan. – In case of renal impairment relative overdose may occur even under a standard dosage regimen.
Zdravljenje z Refludanom se mora začeti v ustanovi, kjer je v vsakem trenutku na voljo zdravniška pomoč in kjer je dostopno vse potrebno za zdravljenje anafilaktičnih reakcij. – Bolniki morajo biti obveščeni, da so dobili Refludan. – V primeru ledvične okvare lahko pride do relativnega prevelikega odmerka tudi ob standardni shemi odmerjanja.
The rate of infusion must be reduced in case of known or suspected renal insufficiency (see sections 4.2, and 5.2). – There is no experience with lepirudin in patients with significant liver impairment.
V primeru potrjene ledvične insuficience ali suma na okvaro ledvic je treba zmanjšati hitrost infundiranja (glejte poglavji 4. 2 in 5. 2). – Ni poročil o izkušnjah z lepirudinom pri bolnikih s pomembno okvaro jeter.
Serious liver injury (e. g. liver cirrhosis) may enhance the anticoagulant effect of lepirudin due to coagulation defects secondary to reduced generation of vitamin K-dependent coagulation factors. – Formation of anti-hirudin antibodies was observed in about 40% of HIT type II patients and have been reported especially with a treatment period exceeding five days.
Resna okvara jeter (npr. jetrna ciroza) lahko poveča antikoagulacijski učinek lepirudina zaradi koagulacijskih defektov, ki so posledica zmanjšane tvorbe od vitamina K odvisnih koagulacijskih faktorjev. – Pri 40% bolnikov s HIT tipa II so opazili tvorbo protiteles proti hirudinu, poročila pa jih omenjajo zlasti v povezavi z zdravljenjem, ki je trajalo dlje kot 5 dni.
This may result in an enhanced anticoagulant effect of lepirudin, possibly due to delayed renal elimination of active lepirudin-antihirudin complexes.
To lahko privede do povečanega antikoagulacijskega učinka lepirudina, verjetno zaradi podaljšanega izločanja aktivnih kompleksov lepirudin- antihirudin.
No evidence of a neutralisation of lepirudin or of an allergic reaction associated with the positive antibody test results was found. – Experience of combined therapy with thrombolytic agents in patients with HIT type II is very limited.
Ni dokazov za nevtralizacijo lepirudina ali za alergijsko reakcijo, povezano s pozitivnimi rezultati testiranja na protitelesa. – Izkušenj s kombinirano terapijo s trombolitičnimi zdravili pri bolnikih s HIT tipa II je zelo malo.
The optimal dose regimen of Refludan in these circumstances is not known. – Paediatric Use:
Optimalen način odmerjanja Refludana v teh okoliščinah ni znan. – Uporaba v pediatriji:
Safety and effectiveness in paediatric patients have not been established. – Elderly:
Varnosti in učinkovitosti uporabe pri pediatričnih bolnikih niso ugotavljali. – Starostniki:
Patients of advanced age have an increased risk of bleeding complications with anticoagulation.
Pri starejših bolnikih je tveganje zapletov s krvavitvami zaradi antikoagulacijske terapije večje.
With respect to lepirudin dosage the potential of renal impairment in elderly
Pri odmerjanju lepirudina je treba pri starejših bolnikih upoštevati možnost
5 patients is to be taken into account.
5 morebitne okvare ledvic.
Dosing adjustments are based on renal function, weight, and aPTT (see section 4.2).
Odmerjanje se prilagaja glede na delovanje ledvic, telesno maso in aPTT (glejte poglavje 4. 2).
Concomitant treatment with thrombolytics (e. g. rt-PA or streptokinase) may – increase the risk of bleeding complications – considerably enhance the effect of Refludan on aPTT prolongation.
Sočasno zdravljenje s trombolitiki (npr. rt- PA ali streptokinazo) lahko: – poveča tveganje zapletov s krvavitvami – značilno poveča učinek Refludana na podaljšanje aPTT.
Concomitant treatment with coumarin derivatives (vitamin K antagonists) and drugs that affect platelet function may also increase the risk of bleeding.
- zaviralci agregacije trombocitov (razen acetilsalicilne kisline), kot so tiklopidin ali klopidogrel,
Concomitant use with – antiplatelet agents other than acetylsalicylic acid, such as ticlopidine or clopidogrel, – GpIIb/ IIIa receptor antagonists such as eptifibatide, tirofiban, or abciximab, – other thrombin inhibitors such as low molecular weight heparins has not been assessed.
- antagonisti receptorjev GpIIb/ IIIa, kot so eptifibatid, tirofiban ali abciksimab,
4.6 Pregnancy and lactation
- drugimi zaviralci trombina, kot so nizkomolekularni heparini,
The majority of undesirable effects experienced by patients treated with Refuldan were generally related to bleeding (> 1/ 10).
Večina neželenih učinkov, ki so se pojavili pri bolnikih, zdravljenih z Refludanom, je bila večinoma povezana s krvavitvami (> 1/ 10).
Life-threatening bleeding events (including intracranial bleeding) were uncommonly reported (≥ 1/ 1,000 to < 1/ 100) in patients with acute coronary syndrome included in clinical studies.
O življenjsko nevarnih krvavitvah (vključno z intrakranialnimi krvavitvami) so poročali občasno (> 1/ 1. 000 do < 1/ 100) pri bolnikih z akutnim koronarnim sindromom, ki so bili vključeni v klinične študije.
In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1% and intracranial bleeding in 0.2% of patients
V intenzivnem postmarketinškem spremljanju bolnikov s HIT tipa II so poročali o pojavu krvavitev s smrtnim izidom pri 1% bolnikov, o pojavu intrakranialnih krvavitev pa pri 0, 2% bolnikov.
Adverse events reported on Refuldan are shown in the table below:
Neželeni učinki Refludana, o katerih so poročali, so prikazani v spodnji tabeli:
6 Very common (> 1/ 10); Common (> 1/ 100 ,< 1/10); Uncommon (> 1/1 ,000 < 1/100); Rare (> 1/10,000 < 1/ 1,000); Very Rare (< 1/10,000)
6 Zelo pogosti (> 1/ 10); Pogosti (> 1/ 100, < 1/ 10); Občasni (> 1/ 1. 000 < 1/ 100); Redki (> 1/ 10. 000 < 1/ 1. 000); Zelo redki (< 1/ 10. 000)
System Organ Class Immune System Disorders
Organski sistem Bolezni imunskega sistema
Rare Anaphylactic/ oid reactions
Redki Anafilaktične/ anafilaktoidne reakcije
Vascular Disorders
Alergijske
Anemia or drop in the haemoglobin value without obvious source of bleeding Haematoma Bleeding from puncture sites Epistaxis Haematuria Gastrointestinal bleeding Vaginal bleeding Rectal bleeding Pulmonary haemorrhage Postoperative haemothorax Haemopericardium Intracranial bleeding
(vključno z izpuščajem) Pruritus Urtikarija Angioedem (vključno z edemom obraza, edemom jezika, edemom grla) Zvišana telesna temperatura Splošne
Hot flushes Shock including fatal shock
težave
Respiratory, thoracic and mediastinal disorders
in
Cough Stridor Dyspnea
Mrzlica
Skin and Subcutaneous Tissue Disorders
spremembe aplikacije
Allergic Skin Reactions (including rash) Pruritus Urticaria Angio-oedema (including: face oedema, tongue oedema, larynx oedema)
na
General Disorders and Administration Site Conditions
mestu
Fever Chills Injection site reactions including pain.
Reakcije na mestu injiciranja, vključno z bolečino.
If life-threatening bleeding occurs and excessive plasma levels of lepirudin are suspected, the following recommendations should be followed: – Immediately STOP Refludan administration – Determine aPTT and other coagulation parameters as appropriate – Determine haemoglobin and prepare for blood transfusion – Follow the current guidelines for shock-therapy.
Ob pojavu življenjsko nevarne krvavitve in sumu na prevelike koncentracije lepirudina v plazmi je treba ukrepati v skladu z naslednjimi priporočili: – takoj PREKINITE z dajanjem Refludana; – določite aPTT in druge ustrezne koagulacijske parametre; – določite hemoglobin in pripravite vse potrebno za transfuzijo krvi; – upoštevajte navodila za terapijo šoka.
Additionally, individual case reports and in-vitro data suggest that either haemofiltration or haemodialysis (using high flux dialysis membranes with a cut-off point of 50,000 Dalton) may be useful in this situation.
Nadalje je iz posameznih prikazov primerov in in vitro podatkov razvidno, da je lahko v tem primeru koristna hemofiltracija ali hemodializa (ob uporabi visokopretočnih membran z mejno vrednostjo 50. 000 daltonov).
7 Results from studies in pigs showed that the application of von Willebrand Factor (vWF, 66 I. U. / kg body weight) markedly reduced the bleeding time.
Rezultati študij na prašičih so pokazali, da je uporaba von Willebrandovega faktorja (vWF, 66 i. e. / kg telesne mase) opazno skrajšala čas krvavitve.
Antithrombotic agent - direct thrombin inhibitor, ATC Code:
Antitrombotiki - direktni zaviralci trombina, oznaka ATC:
B01AE02
B01AEO2
Lepirudin ([Leu1, Thr2]-63-desulfohirudin) is a recombinant hirudin derived from yeast cells.
Lepirudin ([Leu1, Thr2] - 63- desulfohirudin) je rekombinantni hirudin, pridobljen iz celic kvasovk).
The polypeptide composed of 65 amino acids has a molecular weight of 6979.5 Dalton.
Polipeptid, ki ga sestavlja 65 aminokislin, ima molekulsko maso 6979, 5 daltonov.
Natural hirudin is produced in trace amounts as a family of highly homologous iso-polypeptides by the leech Hirudo medicinalis.
Naravni hirudin iz družine visoko homolognih izo- polipeptidov se v sledeh izloča v slini pijavke Hirudo medicinalis.
One anti-thrombin unit (ATU) is the amount of hirudin that neutralises one unit of WHO preparation 89/ 588 of thrombin.
Ena antitrombinska enota (ATe) je količina hirudina, ki nevtralizira eno enoto WHO preparata trombina 89/ 588.
The specific activity of lepirudin is approximately 16,000 ATU/ mg.
Specifična aktivnost lepirudina je približno 16. 000 ATe/ mg.
As a result all thrombin dependent coagulation assays are affected, e. g. the aPTT values increase in a dose-dependent fashion.
To vpliva na vse od trombina odvisne koagulacijske teste; vrednosti aPTT se npr. povečajo sorazmerno z odmerkom.
In the indication HIT type II with thromboembolic disease (125 patients) the overall mortality during the study period was approximately 9% while amputations and new thromboembolic complications were recorded in 6% and 10%, respectively.
Pri indikaciji HIT tipa II s tromboembolijo (125 bolnikov) je skupna umrljivost v času raziskave znašala približno 9%, medtem ko so amputacije zabeležili pri 6%, nove tromboembolične zaplete pa pri 10% bolnikov.
Elimination follows a first order process and is characterised by a terminal half-life of about 1.3 hours in young healthy volunteers.
Izločanje poteka po kinetiki prvega reda; končna razpolovna doba pri zdravih mladih prostovoljcih je približno 1, 3 ure.
About 35% of the dose is excreted as unchanged compound.
Tako izločanje kot presnova potekata v ledvicah in približno 45% apliciranega odmerka prehaja v urin. približno 35% odmerka se izloči v nespremenjeni obliki.
In female patients the systemic clearance is about 25% lower as compared to male patients.
Pri ženskih bolnicah je sistemski očistek za približno 25% nižji kot pri moških.
In elderly patients the systemic clearance of lepirudin is about 25% lower as compared to younger patients.
Pri starejših bolnikih je sistemski očistek lepirudina približno 25% nižji kot pri mlajših bolnikih.
Age alone causes a 7% reduction in clearance from the age of 30 to 70 years.
Sam dejavnik starosti vpliva na 7% zmanjšanje očistka v starosti med 30 do 70 let.
General toxicity Single and repeat-dose toxicity studies in mice, rats and monkeys showed the adverse responses that could be expected from an exaggerated pharmacodynamic impact of lepirudin.
Splošna toksičnost Študije toksičnosti po enkratnem in večkratnem odmerku pri miših, podganah in opicah so pokazale neželene odzive, ki bi jih lahko pričakovali ob pretiranem farmakodinamičnem učinku lepirudina.
Moreover, in rats slight to moderate sinushistiocytosis of the regional lymph
Poleg tega so pri podganah opazili blago do zmerno histiocitozo regionalnih bezgavk in zmanjšane zaloge hemosiderina v vranici.
– Mannitol – Sodium hydroxide for adjustment to pH 7
– manitol – natrijev hidroksid za prilagoditev vrednosti pH na 7
Presentations: – Pack with 1 vial – Pack with 10 vials
Oprema: – škatla z 1 vialo – škatla z 10 vialami
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution, sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 0.4 ml of diluent into the vacuum vial and shake it gently.
Splošna priporočila – Rekonstituiranje in nadaljnje redčenje je treba izvajati v sterilnih pogojih. – Za rekonstitucijo se uporablja voda za injekcije ali raztopina natrijevega klorida 9 mg/ mL( 0, 9%). – Za nadaljnje redčenje je primerna raztopina natrijevega klorida 9 mg/ mL( 0, 9%) ali raztopina 5% glukoze. – Za hitro in popolno rekonstitucijo vbrizgajte 0, 4 mL vehikla v vakuumsko vialo in rahlo pretresite.
On reconstitution a clear, colourless solution is usually obtained within less than 3 minutes. – Do not use solutions which are cloudy or contain particles. – The reconstituted solution is to be used immediately. – The preparation should be warmed to room temperature before administration.
Ob rekonstituciji dobite prozorno, brezbarvno raztopino običajno v manj kot 3 minutah. – Ne uporabljajte raztopine, če je kalna ali če vsebuje delce. – Rekonstituirano raztopino je treba takoj uporabiti. – Pred uporabo je treba zdravilo ogreti do sobne temperature. – Vso neuporabljeno raztopino je treba ustrezno zavreči. – Za injiciranje se smejo uporabljati le polipropilenske brizge.
9 – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Priprava raztopine Refludana v koncentraciji 5 mg/ ml Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/ ml: – Eno vialo (20 mg lepirudina) rekonstituirajte z 0, 4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%).
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion (see section 4.2).
9 – Končno koncentracijo 5 mg/ mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 5 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 4 ml. – Končno raztopino moramo aplicirati v skladu s telesno maso bolnika (glejte poglavje 4. 2).
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion (see section 4.2). – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Priprava raztopine Refludana v koncentraciji 2 mg/ ml Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ ml: – Uporabite dve viali s po 20 mg lepirudina; vsako od njih rekonstituirajte z 0, 4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%). – Končno koncentracijo 2 mg/ mL dobimo s prenosom obeh raztopin v eno sterilno perfuzorsko brizgo za enkratno uporabo (s prostornino 50 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 20 ml. – Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika (glejte poglavje 4. 2). – Brizgo perfuzorja je treba zamenjati najmanj vsakih 12 ur po nastavitvi infuzije.
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, Velika Britanija
EU/ 1/ 97/ 035/ 003 EU/ 1/ 97/ 035/ 004
EU/ 1/ 97/ 035/ 003 EU/ 1/ 97/ 035/ 004
REFLUDAN - 20 mg - Powder for solution for injection or infusion - 1 vial REFLUDAN - 20 mg - Powder for solution for injection or infusion - 10 vials
REFLUDAN - 20 mg - prašek za raztopino za injiciranje ali infundiranje – 1 viala REFLUDAN - 20 mg - prašek za raztopino za injiciranje ali infundiranje – 10 vial
13-03-1997 Date of last renewal:
13- 03- 1997 Datum zadnjega podaljšanja:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem proizvodu najdete na spletni strani Evropske agencije za zdravila (European Medicines Agency - EMEA): http: // www. emea. europa. eu
Powder for solution for injection or infusion.
Prašek za raztopino za injiciranje ali infundiranje
Monitoring: – In general, the dosage (infusion rate) should be adjusted to the activated partial thromboplastin time, aPTT. – The first aPTT determination should be done 4 hours after start of Refludan therapy.
Spremljanje: – Na splošno mora biti odmerjanje (hitrost indundiranja) prilagojena aktiviranemu parcialnemu tromboplastinskemu času (aPTT). – Prvo določanje vrednosti aPTT se mora opraviti 4 ure po začetku zdravljenja z Refludanom. – aPTT je potrebno preverjati vsaj enkrat dnevno.
11 – The aPTT should be monitored at least once daily.
11 – Ciljno območje (terapevtsko okno) za aPTT:
be calibrated by spiking standardised human plasma with 0.15 μ g/ ml lepirudin (lower limit) and 1.5 μ g/ ml lepirudin (upper limit).
uporabljeni testni reagent kalibrira tako, da se standardizirano humano plazmo obdela z 0, 15 μg/ mL lepirudina (spodnja meja) in 1, 5 μg/ mL lepirudina (zgornja meja).
12 Table 1:
12 Preglednica 1:
13 4.3 Contraindications
13
14 patients is to be taken into account.
14 morebitne okvare ledvic.
15 Very common (> 1/ 10); Common (> 1/ 100 ,< 1/10); Uncommon (> 1/1 ,000 < 1/100); Rare (> 1/10,000 < 1/ 1,000); Very Rare (< 1/10,000)
15 Zelo pogosti (> 1/ 10); Pogosti (> 1/ 100, < 1/ 10); Občasni (> 1/ 1. 000 < 1/ 100); Redki (> 1/ 10. 000 < 1/ 1. 000); Zelo redki (< 1/ 10. 000)
Vascular Disorders
Pljučna
Anemia or drop in the haemoglobin value without obvious source of bleeding Haematoma Bleeding from puncture sites Epistaxis Haematuria Gastrointestinal bleeding Vaginal bleeding Rectal bleeding Pulmonary haemorrhage Postoperative haemothorax Haemopericardium Intracranial bleeding
hemoragija
Hot flushes Shock including fatal shock
Pooperativni hemotoraks Hemoperikardij Krvavitev v osrčnik
Respiratory, thoracic and mediastinal disorders
Kašelj Bolezni dihal, prsnega koža Stridor in mediastinalnega prostora Dispneja Bolezni kože in podkožja
Cough Stridor Dyspnea
Alergijske
Skin and Subcutaneous Tissue Disorders
reakcije
Allergic Skin Reactions (including rash) Pruritus Urticaria Angio-oedema (including: face oedema, tongue oedema, larynx oedema)
(vključno z izpuščajem) Pruritus Urtikarija Angioedem (vključno z: edemom obraza, edemom jezika, edemom grla) Zvišana telesna temperatura Splošne
General Disorders and Administration Site Conditions
spremembe aplikacije
16 Results from studies in pigs showed that the application of von Willebrand Factor (vWF, 66 I. U. / kg body weight) markedly reduced the bleeding time.
Rezultati študij na prašičih so pokazali, da je uporaba von Willebrandovega faktorja (vWF, 66 i. e. / kg telesne mase) opazno skrajšala čas krvavitve.
Antithrombotic agent – direct thrombin inhibitor, ATC Code:
Antitrombotiki - direktni zaviralci trombina, oznaka ATC:
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution, sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently.
Splošna priporočila – Rekonstituiranje in nadaljnje redčenje je treba izvajati v sterilnih pogojih. – Za rekonstitucijo se uporablja voda za injekcije ali raztopina natrijevega klorida 9 mg/ mL (0, 9%). – Za nadaljnje redčenje je primerna raztopina natrijevega klorida 9 mg/ mL (0, 9%) ali raztopina 5% glukoze. – Za hitro in popolno rekonstitucijo vbrizgajte 0, 4 mL vehikla v vakuumsko vialo in rahlo pretresite.
18 – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Priprava raztopine Refludana v koncentraciji 5 mg/ ml Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/ ml: – Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%).
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion (see section 4.2).
18 – Končno koncentracijo 5 mg/ mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 10 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 10 ml. – Končno raztopino moramo aplicirati v skladu s telesno maso bolnika (glejte poglavje 4. 2).