natgillin/translations-raw huggingface dataset:
- Den rekonstituerede Refludan injektionsvæske kan fortyndes med natriunchlorid 9 mg/ ml
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.
- Uklare injektionsvæsker eller injektionsvæsker, der indeholder partikler, må ikke anvendes.
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.
- Ikke anvendt injektionsvæske bør kasseres på passende vis.
9 – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Fremstilling af Refludan injektionsvæske 5 mg/ ml Til intravenøs bolus injektion anvendes en opløsning med styrken 5 mg/ ml.
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).
Fremstilling af Refludan infusionsvæske 2 mg/ ml Til kontinuerlig intravenøs infusion anvendes en opløsning med styrken 2 mg/ ml.
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.
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, Storbritannien.
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom
EU/ 1/ 97/ 035/ 003 REFLUDAN – 20 mg - pulver til injektionsvæske eller infusionsvæske, opløsning – 1 hætteglas EU/ 1/ 97/ 035/ 004 REFLUDAN – 20 mg – pulver til infusionsvæske eller infusionsvæske, opløsning – 10 hætteglas
EU/ 1/ 97/ 035/ 003 EU/ 1/ 97/ 035/ 004
13- 03- 97 Dato for sidste fornyelse af tilladelsen:
13-03-1997 Date of last renewal:
05- 03- 07
05-03-2007
(Lepirudin er et DNA- rekombinantprodukt fremstillet i gærceller)
(Lepirudin is a recombinant DNA product derived from yeast cells)
tromboplastin- tid, APTT.
Standard recommendations
- Den første APTT- bestemmelse skal laves 4 timer efter Refludanbehandlingens start.
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.
11
11 – The aPTT should be monitored at least once daily.
- Målintervallet (det terapeutiske vindue) for APTT:
More frequent determinations may be necessary, for example, in patients with renal impairment or with an increased risk of bleeding. – Target range (therapeutic window) for the aPTT:
- Målintervallet for APTT er en 1, 5- 3 gange forlængelse af den normale kontrolværdi, når
- Using "Actin FS" or "Neothromtin" on automated coagulometers the target range for the
der til kontrollen bruges "Actin FS" eller "Neothromtin" i automatiserede koagulometre.
aPTT is 1.5 fold to 3 fold prolongation of the normal control value.
- Med andre reagenser skal den øvre grænse for det terapeutiske APTT- vindue reduceres
- With other reagents, the upper limit of the therapeutic aPTT window should be reduced to
til 2, 5 gange forlængelse af den normale kontrolværdi.
2.5 fold prolongation of the normal control value.
- For at få en specifik og præcis APTT- grænse skal det anvendte
- To obtain specific and exact aPTT limits, the laboratory equipment / test reagent used may
laboratorieudstyr/ testreagenser kalibreres med standardiseret humanplasma tilsat 0, 15 µg/ ml lepirudin (nedre grænse) og 1, 5 µg/ ml lepirudin (øvre grænse).
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).
12 Tabel 1:
12 Table 1:
* Hos hæmodialysepatienter eller ved akut nyresvigt (kreatininclearance under 15 ml/ min eller S - kreatinin over 6 mg/ l [530 μmol/ l)] bør infusion af Refludan undgås eller afbrydes.
* In haemodialysis patients or in case of acute renal failure (creatinine clearance below 15 ml/ min or creatinine value above 60 mg/ l [530 μ mol/ l]), infusion of Refludan is to be avoided or stopped.
13 4. 3 Kontraindikationer
13 4.3 Contraindications
- Åbenlyse tegn på blødning
– Anaphylaxis:
Refludans optimale dosering under disse omstændigheder kendes ikke.
The optimal dose regimen of Refludan in these circumstances is not known. – Paediatric Use:
Sikkerheden og effektiviteten til behandling af pædiatriske patienter er ikke
Safety and effectiveness in paediatric patients have not been established. – Elderly:
Patienter af en høj alder har en forøgede risiko for blødningskomplikationer med anti -
Patients of advanced age have an increased risk of bleeding complications with anticoagulation.
Med hensyn til lepirudin dosis, skal der tages højde for mulig nedsat nyrefunktion hos ældre patienter.
With respect to lepirudin dosage the potential of renal impairment in elderly
14 4. 5 Interaktion med andre lægemidler og andre former for interaktion
14 patients is to be taken into account.
Der er ikke udført formelle interaktionsundersøgelser.
No specific dosage adjustment is made for elderly patients.
Samtidig behandling med thrombolytika (fx rt- PA eller streptokinase) kan:
4.5 Interaction with other medicinal products and other forms of interaction
- øge risikoen for blødningskomplikationer.
No interaction studies have been performed.
Samtidig behandling med − anti- blodplade stoffer udover acetylsalicylsyre, så som ticlopidin eller clopidogrel, − GpIIb/ IIIa receptor antagonister, så som eptifibatid, irofiban eller abciximab, − Andre trombin inhibitorer, så som lav molekulær vægt hepariner − er ikke blevet vurderet.
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.
15 Tabellen nedenfor viser de bivirkninger, der er rapporteret for Refludan:
Adverse events reported on Refuldan are shown in the table below:
Meget almindelig (> 1/ 10); Almindelig (> 1/ 100, < 1/ 10); Ikke almindelig (> 1/ 1, 000 < 1/ 100); Sjælden (> 1/ 10, 000 < 1/ 1, 000); Meget sjælden (< 1/ 10, 000)
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)
16 Enkeltpatient- rapporter og in- vitro data tyder på, at enten hæmofiltration eller hæmodialyse (her anvendes high flux dialysemembraner med et “ cut- off point ” på 50. 000 Dalton) kan være nyttig i denne situation.
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.
Undersøgelser på grise viser, at applikation af von Willebrand Factor (WF, 66 IE/ kg legemsvægt.) tydeligt reducerer blødningstiden.
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.
Antithrombosemiddel - direkte thrombininhibitor (ATC- kode:
Antithrombotic agent – direct thrombin inhibitor, ATC Code:
Hos patienter med terminal nyreinsufficiens fandtes en forlænget terminal halveringstid på ca.
In patients with terminal renal insufficiency prolonged elimination half-lives of about 2 days were observed.
2 døgn.
In monkeys retinal haemorrhages occurred.
17 5. 3 Prækliniske sikkerhedsdata
17 nodes and decreased haemosiderin deposits in the spleen were observed.
- Refludan rekonstitueres med sterilt vand eller natriumchlorid 9 mg/ ml (0, 9%) opløsning.
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.
- Den rekonstituerede Refludan injektionsvæske kan fortyndes med natriunchlorid 9 mg/ ml
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.
18
18 – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Fremstilling af Refludan injektionsvæske 5 mg/ ml Til intravenøs bolus injektion anvendes en opløsning med styrken 5 mg/ ml.
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).
Fremstilling af Refludan infusionsvæske 2 mg/ ml Til kontinuerlig intravenøs infusion anvendes en opløsning med styrken 2 mg/ ml.
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 50 mg of lepirudin) with 1 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 50 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.
EU/ 1/ 97/ 035/ 001 REFLUDAN – 50 mg - pulver til injektionsvæske eller infusionsvæske, opløsning – 1 hætteglas EU/ 1/ 97/ 035/ 002 REFLUDAN – 50 mg – pulver til infusionsvæske eller infusionsvæske, opløsning – 10 hætteglas
EU/ 1/ 97/ 035/ 001 EU/ 1/ 97/ 035/ 002
CSL Behring GmbH Emil- von- Behring- Straße 76 35041 Marburg Tyskland
CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
23 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Ydre karton:
OUTER CARTON:
20 mg x 1 hætteglas
20 mg x 1 VIAL
Refludan 20 mg Pulver til injektionsvæske eller infusionsvæske, opløsning
Refludan 20 mg powder for solution for injection or infusion
lepirudin
lepirudin
1 hætteglas (20 mg lepirudin) rekonstitueres med enten 0, 4 ml vand til injektionsvæsker eller natriumchlorid 9 mg/ ml (0, 9%), opløsning.
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.
Må ikke opbevares over 25°C Må ikke nedfryses Opbevar hætteglasset i den originale yderpakning
Keep the vial in the outer carton.
25 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
20 mg x 10 hætteglas
20 mg x 10 vials
Refludan 20 mg Pulver til injektionsvæske eller infusionsvæske, opløsning lepirudin
Refludan 20 mg powder for solution for injection or infusion
27 MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Hætteglas etiket 20 mg
20 mg
Refludan 20 mg pulver til injektion eller infusion, opløsning Lepirudin Intravenøs anvendelse
Refludan 20 mg powder for solution for injection or infusion Lepirudin Intravenous use
Læs indlægssedlen inden brug
. Read the package leaflet before use
EXP
< EXP {MM/YYYY} >
28 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 mg x 1 hætteglas
50 mg x 1 VIAL
1 hætteglas (50 mg lepirudin) rekonstitueres med enten 1 ml vand til injektionsvæsker eller natriumchlorid 9 mg/ ml (0, 9%), opløsning.
Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution.
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA Storbritannien.
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom
30 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 mg x 10 hætteglas
50 mg x 10 vials
Hætteglas etiket 50 mg
50 mg
Refludan 50 mg pulver til injektion eller infusion, opløsning lepirudin Intravenøs anvendelse
Refludan 50 mg powder for solution for injection or infusion Lepirudin Intravenous use.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som
- If any of the side effects gets serious, or if you notice side effects not listed in this leaflet,
Refludans virkning og hvad De skal bruge det til 2.
What Refludan is and what it is used for 2.
Det skal De vide, før De begynder at tage Refludan 3.
Before you use Refludan 3.
Sådan skal De tage Refludan 4.
How to use Refludan 4.
Sådan opbevarer De Refludan 6.
Possible side effects 5 How to store Refludan 6.
Refludan anvendes til antikoagulation (hæmning af blodpropdannelse) hos voksne patienter med heparin- induceret trombocytopeni (blodplademangel) type II HIT samt tromboembolisk sygdom (blodpropper), som kræver injiceret antithrombotisk medicin.
Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines.
Type II HIT er en sygdom, der kan opstå efter behandling med heparin- holdige lægemidler.
HIT type II is an illness which can occur after you have received heparin containing medicines.
Sygdommen kan medføre for lavt antal blodplader og/ eller blodpropper i Deres blodkar (tromboser).
It may result in a too low number of blood platelets and/ or clots in your blood vessels (thrombosis).
Tag ikke Refludan:
Do not use Refludan
- hvis De er overfølsom (allergisk) over for lepirudin, over for hirudiner eller et af de øvrige
- if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of
indholdsstoffer
Refludan.
- hvis De er gravid eller ammer
- if you are pregnant or breast-feeding.
Hvis de har blødningstendens vil Deres læge nøje overveje risikoen ved Refludanbehandling i forhold til fordelen.
Take special care with Refludan If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit.
- Nylig slagtilfælde, ulykker eller operationer, som medinddrager hjernen
Thus, please tell your doctor if you have or have had: – Recent puncture of large vessels or organs – Anomaly of vessels or organs – Recent stroke, accident or surgery involving the brain – High blood pressure – Inflammation of the inner membrane of the heart – Advanced kidney disease – Advanced bleeding tendency
35
35 – Recent major surgery – Recent bleeding (e. g. in brain, stomach/ intestine, eye, lung) – Obvious signs of bleeding – Recent active peptic ulcer – Age > 65 years
Du bør også fortælle din læge, om du tidligere er blevet behandlet med Refludan, hirudin eller et hirudin- lignende produkt.
You should also inform your doctor if you have ever received Refludan, hirudin or a hirudin analogue.
Refludan må ikke anvendes ved graviditet og amning
Refludan should not be administered to pregnant women or nursing mothers.
Meget almindelige (mindst 1 ud af 10 patienter) − Blødning
Very common (at least 1 in 10 people) – Bleeding
Anæmi eller fald i hæmoglobin værdi uden umiddelbar blødningskilde, blå mærker, blødning fra punktur sted, næseblødning, blod i urinen, maveblødning, vaginal blødning, rektal blødning, lungeblødning, blødning i brystområdet efter en operation, blødning i hjernen.
Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain.
I et intensivt postmarketing undersøgelse i HIT type II, blev dødelig blødning rapporteret i 1% og blødning i hjernen i 0, 2% af patienterne.
In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1% and intracranial bleeding in 0.2% of patients.
Alvorlig blødning og specielt blødning i hjernen kan være dødeligt.
Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae.
Alvorlig blødning kan føre til mindre volumen af cirkulerende blod, lavt blodtryk, chok, og disses kliniske symptomer.
Rare (less than 1 in 1,000 people affected) – Allergic skin reactions (including rash), itching, hot flushes, fever, chills.
Sjældne (mindre end 1 ud af 1000 patienter påvirkes) − Allergiske hudreaktioner (inklusive udslæt), kløe, hedeture, feber, kuldegysninger. − Anafylaktiske reaktioner inklusive nældefeber, åndenød, med krampeagtige anfald, hoste, skarp åndelyd, vand i kroppen og i indervæggen af karrene (inklusive ansigtsødem, tungeødem, halsødem).
36 – Anaphylactic/ oid reactions including urticaria, difficulty in breathing (e. g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
I alvorlige tilfælde kan dette medføre chok og dødsfald. − Reaktioner på injektionsstedet, inklusive smerte.
In severe cases these may lead to shock and death. – Injection site reactions, including pain.
36 Hvis nogen af bivirkninger bliver alvorlige, eller De bemærker bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De oplyse Deres læge eller apotek herom.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Aktivt stof: lepirudin, et rekombinant DNA- produkt afledt ud fra gærceller.
What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells.
Det leveres i et hætteglas, der indeholder 20 mg lepirudin.
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 20 mg lepirudin.
Indehaver af markedsføringstilladelsen Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, Storbritannien.
Marketing Authorisation Holder Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.
Fremstiller CSL Behring GmbH, Emil- von- Behring- Straße 76, 35041 Marburg, Tyskland.
Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany.
De kan finde yderligere information om Refludan på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
37 < --------------------------------------------------------------------------------------------------------------------- Følgende oplysninger er kun tiltænkt læger og sundhedspersonale:
37 < ------------------------------------------------------------------------------------------------------------------------------
Instruktioner vedrørende anvendelse, håndtering samt bortskaffelse:
The following information is intended for medical or healthcare professionals only:
Almene anbefalinger
Instructions for use and handling:
- Den rekonstituerede Refludan injektionsvæske kan fortyndes med natriumchlorid 9 mg/ ml
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.
- Uklare injektionsvæsker eller injektionsvæsker, der indeholder partikler, må ikke anvendes.
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. – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Fremstilling af Refludan injektionsvæske 5 mg/ ml Til i. v. bolus injektion anvendes en opløsning med styrken 5 mg/ ml.
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.
ml sprøjte) og herefter yderligere fortynde med natriumchlorid 9 mg/ ml (0, 9%) opløsning eller 5% glukoseinfusionsvæske til et totalvolumen på 20 ml.
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. – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
INFORMATION TIL BRUGEREN Refludan, 50 mg pulver til injektion eller infusion Lepirudin
Refludan 50 mg powder for solution for injection or infusion Lepirudin