natgillin/translations-raw huggingface dataset:
De øvrige indholdsstoffer er: dinatriumfosfatdihydrat, natriumdihydrogenfosfatdihydrat, natriumklorid, kalciumkloriddihydrat, polysorbat 20, glycin, leucin, isoleucin, treonin, glutaminsyre, fenylalanin, vand til injektionsvæsker, natriumhydroxid (til justering af pH- værdien), saltsyre (til justering af pH- værdien).
191 The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
De fyldt injektionssprøjte indeholder mellem 0, 3 og 1, 0 ml opløsning, afhængig af indholdet af epoetin zeta (se ” Retacrit indeholder ”).
The pre-filled syringes contain between 0.3 and 1.0 ml solution, depending on the content of epoetin zeta (see “What Retacrit contains”).
Én pakning indeholder 1 eller 4 eller 6 fyldt injektionssprøjter.
One pack contains 1, 4 or 6 pre-filled syringes
Danmark Hospira Nordic AB
Danmark Hospira Nordic AB Tlf: + 46 (0)8 672 85 00
Nederland Hospira Benelux BVBA
Nederland Hospira Benelux BVBA Tel: + 32 2 332 03 15
Eesti Österreich Berren Medical, c/ o Axellus OÜ Tel: + 372 662 3573
Tel: + 372 662 3573
De kan finde yderligere information om Retacrit 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/.
204
193
REVASC EPAR - sammendrag for offentligheden
EPAR summary for the public
Revasc anvendes til forebyggelse af blodpropper hos voksne patienter efter indoperation af et kunstigt hofte - eller knæled.
Revasc is used in adult patients to prevent blood clotting after hip or knee replacement surgery.
Hos patienter med lever - eller nyreproblemer skal lægen overvåge blodets koagulationsevne med henblik på en eventuel justering af doseringen.
In patients who have liver or kidney problems, the doctor will monitor blood clotting to see if the dosages may need to be adjusted.
Det produceres af en gærart, der har fået indsat et gen (DNA), som gør den i stand til at producere stoffet.
Desirudin is produced by a method known as ’ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce the substance.
Revasc anvendt under og efter hofte - og knæoperationer mindsker stærkt risikoen for blodpropper i benene (dyb venøs trombose).
By using Revasc during and after hip or knee surgery, the risk of a blood clot forming in the blood vessels of the legs (deep vein thrombosis) is greatly reduced.
Revasc blev sammenlignet med ufraktioneret heparin eller 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Hovedformålet med forsøgene var at undersøge den samlede forekomst af trombotiske hændelser (blodpropper, der gav problemer) og forekomsten af dyb venøs trombose (blodpropper i en dybtliggende vene, sædvanligvis i benene).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged problems) and the rate of deep vein thrombosis (the formation of a blood clot in one of the deep veins of the body, usually in the leg).
De hyppigste bivirkninger af Revasc (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er anæmi (lavt antal røde blodlegemer), kvalme, væskeudsivning fra sår, hypotension (lavt blodtryk), dyb tromboflebitis (betændelse i de dybe vener, som kan skyldes en blodprop), feber, hævelse på injektionsstedet, hæmatomer (blodansamlinger), ødem (hævelse af benene) og ikke- fatale allergiske reaktioner.
The most common side effects with Revasc (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), nausea (feeling sick), wound secretion (oozing of fluid from wounds), hypotension (low blood pressure), deep thrombophlebitis (inflammation of deep veins that can be caused by a blood clot), fever, injection site mass (lumps at the site of injection), haematomas (collections of blood), oedema (swelling) in legs, and non-fatal allergic reactions.
Revasc må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for desirudin eller andre af indholdsstofferne, eller af gravide patienter, patienter der for nyligt har haft blødninger, patienter med stærkt forhøjet blodtryk, med alvorlige lever - eller nyresygdomme eller med hjertesygdomme.
Revasc should not be used in people who may be hypersensitive (allergic) to desirudin or any of the other ingredients, who are pregnant, who have had recent bleeding, who have severe high blood pressure or severe liver or kidney problems, or who have a heart infection.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Revasc er større en risiciene til forebyggelse af dyb venøs trombose hos patienter, der får indopereret et kunstigt hofte - eller knæled.
The Committee for Medicinal products for Human Use (CHMP) decided that Revasc’ s benefits are greater than its risks to prevent deep vein thrombosis in patients undergoing hip or knee replacement.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Revasc til Canyon Pharmaceuticals Limited den 9. juli 1997.
The European Commission granted a marketing authorisation valid throughout the European Union for Revasc to Canyon Pharmaceuticals Limited on 9 July 1997.
Dette sammendrag blev sidst ajourført i 07- 2007
This summary was last updated in 07-2007.
15 mg Solvens:
15 mg Solvent:
Revasc 15 mg/ 0, 5 ml pulver og solvens til injektionsvæske, opløsning
Revasc 15mg/ 0.5ml powder and solvent for solution for injection
Efter rekonstitution indeholder 1 hætteglas 15 mg ** desirudin * per 0, 5ml
After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml
Desirudin består af et enkeltkædet polypeptid af 65 aminosyrerester og 3 disulfid- bindinger.
Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
270. 000 antithrombinenheder (ATU) eller 18. 000 ATU pr. mg desirudin i henhold til WHO Second International Standard for alpha- thrombin.
* produced by recombinant DNA technology in yeast cells. ** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin.
Forebyggelse af dyb venethrombose hos patienter, som gennemgår planlagte operationer med udskiftning af hofte og knæ.
Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.
6. 6.
Instructions for the preparation of Revasc are provided in section 6.6.
Den første injektion bør gives indenfor 5- 15 minutter før operation, men efter anlæggelse af lokalanæstesi, hvis dette anvendes.
The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.
Behandling med desirudin fortsættes herefter to gange daglig post- operativt i 9 dage, maksimalt 12 dage, eller indtil patienten er fuldt oppegående afhængig af, hvilken situation der først indfinder sig.
Treatment with desirudin is then continued twice daily post-operatively for 9 days up to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first.
Desirudin er kontraindiceret hos patienter med svært nedsat nyrefunktion (kreatininclearence mindre end 30 ml/ min., svarende til serumkreatinin > 2, 5 mg/ dl eller 221μmol/ l); se pkt.
Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/ min corresponding to a serum creatinine > 2.5mg/ dl or 221μ mol/ l; see section 4.3).
Aktiveret partiel thromboplastintid (aPTT) skal monitoreres hos patienter med mild til moderat nedsat nyrefunktion (kreatininclearance mellem 31 og 90 ml/ min; se pkt.
In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/ min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.
2 Patienter med nedsat leverfunktion
2 Patients with liver impairment
4. 4).
In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended.
- overfølsomhed over for det aktive eller over for et eller flere af hjælpestofferne,
- with hypersensitivity to the active substance or to any of the excipients
- aktiv blødning og/ eller irreversible koagulationsforstyrrelser,
- with active bleeding and/ or irreversible coagulation disorders
- svær nedsat lever - og nyrefunktion,
- with severe renal and hepatic impairment
4. 6),
- during pregnancy (see section 4.6)
- alvorlig ukontrolleret hypertension og ved subakut bakteriel endocarditis.
- with severe uncontrolled hypertension and subacute bacterial endocarditis.
Anafylaksi:
Anaphylaxis:
4. 8).
Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Livsfarlige anafylaktiske reaktioner er rapporteret hos patienter, der gentagne gange har fået behandling med hirudin- produkter i andet eller efterfølgende behandlingsforløb.
Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent treatment course.
Desirudin bør anvendes med forsigtighed under omstændigheder med øget risiko for blødninger, som ved store operationer, biopsi eller punktur af et ikke kompressibelt blodkar indenfor de seneste måneder; tidligere tilfælde af hjerneblødning, intrakraniel eller intraokulær blødning inkl. diabetisk (hæmorragisk) retinopati: anfald af iltmangel til hjernen indenfor de senste 6 måneder, en kendt forstyrrelse af hæmostasen (medfødt eller akkvisit f. eks. hæmofili, leversygdom) eller tidligere tilfælde af gastrointestinal eller pulmonal blødning indenfor de seneste 3 måneder.
Desirudin should be used with caution in conditions with increased risks of haemorrhage such as major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder (congenital or acquired, e. g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary bleeding within the past 3 months.
Når desirudin administreres til patienter med øget risiko for blødningskomplikationer, mild til moderat nedsat leverfunktion og/ eller mild til moderat nedsat nyrefunktion bør aPPT monitoreres og maksimum aPTT bør ikke overskride 2 gange kontrolværdien.
When desirudin is administered in patients with increased risk of bleeding complications, mild to moderate hepatic dysfunction and/ or mild to moderate renal impairment, aPTT should be monitored and peak aPTT should not exceed twice the control value.
Desirudin bør anvendes med forsigtighed til patienter, som får antikoagulantia, og/ eller thrombocyt - hæmmere, og/ eller non steroid antiinflammatoriske lægemidler.
Desirudin should be used with care in patients receiving anticoagulants, and/ or platelet inhibitors, and/ or non-steroidal anti-inflammatory medicinal products.
4. 5).
Monitoring for evidence of bleeding is advised (see section 4.5).
Laboratorieprøver:
Laboratory Tests:
Aktiveret partiel thromboplastintid (aPPT) bør monitorers hos patienter med øget risiko for blødningskomplikationer og/ eller nedsat nyre - eller leverfunktion.
Activated partial thromboplastin time (aPTT) should be monitored in patients with increased risk of bleeding and/ or renal or hepatic impairment.
Om nødvendigt bør behandlingen med desirudin afbrydes, indtil
If necessary, therapy with desirudin should be interrupted until aPTT falls to less than
4. 5).
3 twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also section 4.5).
4. 4).
If co-administration cannot be avoided, close clinical and laboratory monitoring should be conducted (see section 4.4).
Ved profylakse kan samtidig brug af lægemidler, der indeholder hepariner (ikke- fraktionerede og lavmolekylære hepariner) og dextraner ikke anbefales.
During prophylaxis, concomitant use of medicinal products containing heparins (unfractionated and low-molecular weight heparins) and dextrans is not recommended.
4. 4).
The effects of desirudin and unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4).
Disse lægemidler omfatter acetylsalicylsyre og NSAID præparater ticlopidin og clopidogrel, glycoprotein IIb/ IIIa- antagonister (abciximab, eptifibatid, tirofiban) og iloprost.
As with other anticoagulants desirudin should be used with caution in conjunction with medicinal products which affect platelet function these medicinal products include: acetylsalicylic acid and NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/ IIIa antagonists (abciximab, eptifibatide, tirofiban) and iloprost.
4. 2).
That activity should be taken into account in the evaluation of the overall coagulation status of the patient during the switch (see section 4.2).
4. 3).
Revasc is contraindicated in pregnancy (see section 4.3).
Almindelig (≥ 1/ 100 til < 1/ 10); ikke almindelig ≥ 1/ 1. 000 til < 1/ 100); sjælden (≥ 1/ 10. 000 til < 1/ 1. 000).
The following related adverse reactions were listed below by system organ class and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000).
Stigning i serumtransaminaser
Increase in serum transaminases
Blod - og lymfesystem Almindelig:
4 Blood and the lymphatic system disorders Common:
Ikke almindelig:
Nervous system disorders Uncommon:
Svimmelhed, søvnløshed, konfusion
Dizziness, insomnia, confusion
4 Mave- tarmkanalen Almindelig:
Gastrointestinal disorders Common:
Kvalme Hæmatemese, opkastning, obstipation
Nausea Haematemesis, vomiting, constipation
Hæmaturi, urinretention
Haematuria, urinary retention
Udslæt, urtikaria
Rash, urticaria
Urinvejsinfektion, cystitis
Urinary tract infection, cystitis
Traumer, forgiftninger og behandlingskomplikationer Almindelig:
Uncommon:
Sårsekretion
Wound secretion Impaired wound healing
Ikke almindelig:
Vascular disorders
Vaskulære sygdomme Almindelig:
Common:
Hypotension, dyb tromboflebitis Epistaxis, hypertension
Hypotension, deep thrombophlebitis Epistaxis, hypertension
Almene symptomer Almindelig:
General disorders and administration site conditions Common:
og reaktioner på administrationsstedet Feber, hævelse på injektionsstedet, hæmatom, ødem af benene, Smerter i benene, smerter, abdominal - og brystsmerter
Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
Allergiske reaktioner er i kliniske undersøgelser rapporteret hos samme mængde (1, 6%) patienter, der blev behandlet med desirudin (N=2. 367) eller ufraktioneret heparin (N=1. 134), uanset kausalitet.
Allergic reactions have been reported in the same proportion (1.6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.
Anti- hirudin antistoffer er fundet efter reeksponering for desirudin i kliniske forsøg.
Anti-hirudin antibodies have been detected upon re-exposure to desirudin in clinical trials.
Om nødvendigt kan der indgives plasmasubstitutter og/ eller foretages blodtransfusion.
If necessary, plasma expanders and/ or blood transfusion may be used.
ATC- kode:
Anticoagulant, ATC code:
Desirudin er en yderst potent og selektiv hæmmer af frit cirkulerende og koagelbundet thrombin.
Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin.
1, 4 gange basisværdien er observeret efter subkutan (s. c.) injektion af 15 mg desirudin 2 gange daglig.
A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b. i. d. injection of 15mg desirudin.
Der er ved terapeutiske serum - koncentrationer ingen effekt på de andre enzymer i det hæmostatiske system såsom faktorerne IXa, Xa, kallikrein, plasmin, tPA og aktiveret protein C.
At therapeutic serum concentrations it has no effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, or activated protein C.
Herudover er der ikke effekt på andre serin - proteaser, såsom fordøjelsesenzymerne trypsin og kymotrypsin eller på komplementaktivering ad klassiske eller alternative veje.
In addition, it does not display any effect on other serine proteases, such as the digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or alternative pathways.
I to kontrollerede dobbeltblinde kliniske undersøgelser var den totale hyppighed af tromboemboliske hændelser hos patienter behandlet med desirudin 15 mg s. c.
In two controlled double blind clinical trials, the overall rate of thromboembolic events in patients treated with desirudin 15mg s. c. b. i. d.
2 gange daglig (N=370) det halve i forhold til patienter behandlet med en standarddosis af ikke- fraktioneret heparin (N=396) (p < 0, 0001); hyppigheden af proksimal dyb venetrombose var kun en femtedel af den ved heparin (p < 0, 0001) observerede.
(N=370) was half that in patients treated with a standard dose of unfractionated heparin (N=396) (p < 0.0001); the rate of proximal deep venous thrombosis was only one fifth that observed with the heparin (p < 0.0001).
Desirudins antikoagulerende egenskaber skyldes dets evne til at forlænge koagulationstiden i menneske - eller rotteplasma, hvad enten det er en direkte effekt (TT) eller via det intrinsikke (aPTT) eller ekstrinsikke (PT) system.
The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human or rat plasma whether induced directly (thrombin time) or via the intrinsic (aPTT) or extrinsic (PT) pathways.
Den gennemsnitlige absorptionstid for subkutan (s. c.) desirudin er 4, 1, 4, 5 og 5, 4 timer ved henholdsvis 0, 1, 0, 3 og 0, 5 mg/ kg (total middelværdi = 4, 6 timer).
Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 and 0.5 mg/ kg, respectively (overall mean = 4.6 h).
Absorptionen er fuldstændig og vurderet på areal under kurve - (AUC) værdierne.
Absorption is complete based on mean area under the curve (AUC) values.
Efter administrationen af en s. c. enkeltdosis på 0, 1 - 0, 75 mg/ kg stiger plasmakoncentrationen af desirudin hurtigt til maksimumniveauer (Cmax) i løbet af 1- 3 timer.
Following administration of single SC doses of 0.1-0.75 mg/ kg, plasma concentrations of desirudin increased rapidly to maximum levels (Cmax) between 1 and 3 h.
Både Cmax og AUC- værdier er proportionale med dosis.
Both Cmax and AUC values are dose proportional.
Desirudin fordeles ekstracellulært med et fordelingsvolumen ved steady state på 0, 25 l/ kg, uafhængig af dosis.
Desirudin is distributed in the extracellular space with a distribution volume at steady state of 0.251/ kg independently of the dose.
Udskillelsen af desirudin fra plasma er hurtig, således udskilles ca.
The disappearance of desirudin from plasma is rapid in the first phase with approximately 90% of an intravenous (IV) bolus dose disappearing from the circulation within 2 hours of the injection.
90% af en intravenøs bolusinjektion i løbet af 2 timer.
A slower terminal elimination phase follows with a dose-independent mean terminal elimination half-life of 2 to 3 h.
Derefter følger en langsommere terminal elimineringsfase med en dosis- uafhængig middel halveringstid på 2 til 3 timer. « Mean residence time » er 1, 7 - 2 timer og 6- 7 timer efter henholdsvis i. v. og s. c. administration.
The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Af den administrerede dosis udskilles 40- 50% uforandret i urinen.
The total urinary excretion of unchanged desirudin amounts to 40-50% of the administered dose.
Metabolitter, som mangler 1 eller 2 C- terminale aminosyrer udgør en mindre del af det materiale, som genvindes af urinen (< 7%).
Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material recovered from urine (< 7%).
Hepatisk elimination af desirudin eller thrombin- desirudin komplekset synes ikke at være væsentlig.
Hepatic elimination of desirudin or the thrombin- desirudin complex does not appear to be significant.
1, 95- 2, 20 ml/ min/ kg) og var uafhængig af dosis.
6 Total clearance of desirudin has been found to be in the same range following either SC or IV administration (ca 1.95-2.20ml/ min/ kg) and was dose-independent.
De ikke- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og karcinogenicitet..
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
magnesiumklorid natriumhydroxid.
magnesium chloride sodium hydroxide
mannitol (E421) vand til injektionsvæske.
mannitol (E 421) water for injections
Må ikke opbevares over 25°C Hætteglas og ampul opbevares i den ydre karton for at beskytte mod lys.
Keep the vial and ampoule in the outer carton in order to protect from light.
15 mg pulver i et hætteglas (type I glas) med prop (butylgummi) dækket med en film (fluoropolymer) på produktsiden og 0, 5 ml solvens i en ampul (type I glas).
15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).
For at tilberede den færdige opløsning tilsættes 0, 5 ml af den medfølgende mannitol solvens under aseptiske forhold til hætteglasset med pulveret til injektionsvæske.
To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection.
6. 3 ovenfor).
The reconstituted solution should be used as soon as possible (see section 6.3 above).
Canyon Pharmaceuticals Limited 20- 22 Bedford Row London WC1R 4JS Storbritannien
Canyon Pharmaceuticals Limited 20-22 Bedford Row London WC1R 4JS United Kingdom
EU/ 1/ 97/ 043/ 001 2 hætteglas/ 2 ampuller med solvens EU/ 1/ 97/ 043/ 002 10 hætteglas/ 10 ampuller med solvens EU/ 1/ 97/ 043/ 003 1 hætteglas/ 1 ampul med solvens
EU/ l/ 97/ 043/ 001 EU/ 1/ 97/ 043/ 002 EU/ 1/ 97/ 043/ 003
9. juli 1997 Dato for seneste fornyelse:
9 July 1997 Date of latest renewal:
NOVARTIS Pharma AG Lichtstrasse 35 CH- 4056 Basel Schweiz
NOVARTIS Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland
Lægemidlet må kun udleveres efter begrænset recept (jfr. bilag I:
Medicinal product subject to restricted medical prescription (See Annex I:
YDRE KARTON:
OUTER CARTON:
2 HÆTTEGLAS (15 mg hætteglas) OG 2 AMPULLER
FOR 2 VIALS (15mg/ vial) AND 2 AMPOULES
Revasc 15/ 0, 5 mg pulver og solvens til injektionsvæske, opløsning Desirudin
Revasc 15mg/ 0.5ml powder and solvent for solution for injection Desirudin
Hvert hætteglas indeholder 15 mg desirudin med 18. 000 ATU/ mg svarende til omtrent 270. 000 ATU pr. hætteglas.
Each vial contains 15mg desirudin with 18,000 ATU/ mg corresponding to approximately 270,000 ATU per vial.
Pulver: magnesiumklorid, natriumhydroxid Solvens: mannitol, vand til injektionsvæske
Powder: magnesium chloride, sodium hydroxide Solvent: mannitol, water for injections
Pulver og solvens til injektionsvæske, opløsning 15 mg pulver i hætteglas og 0, 5 ml solvens i en ampul
Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
Pakningstørrelse med 2
Pack size of 2
Dog er stabilitet under anvendelse demonstreret i 24 timer mellem 2°C og 8 °C (i køleskab).
However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).
10 HÆTTEGLAS (15 mg/ hætteglas) OG 10 AMPULLER
FOR 10 VIALS (15mg/ vial) AND 10 AMPOULES