natgillin/translations-raw huggingface dataset:
Refludans virkning, og hvad De skal bruge det til 2.
What Refludan is and what it is used for 2.
Tag ikke Refludan
Do not use Refludan
- hvis De er overfølsom (allergisk) over for lepirudin, til hirudiner eller et af de øvrige
- if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of
39
39 – Recent major surgery – Recent bleeding (e. g. in brain, stomach/ intestine, eye, lung) – Obvious signs of bleeding – Recent active peptic ulcer – Age > 65 years
Meget almindelige (mindst 1 ud af 10 patienter)
Very common (at least 1 in 10 people) – Bleeding
Alvorlig blødning og specielt blødning i hjernen kan være dødligt.
Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae.
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).
40 – 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).
40 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.
Refludan indeholder Aktivt stof: et rekombinant DNA- produkt afledt ud fra gærceller.
What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells.
Refludans udseende og pakningstørrelse Refludan er et hvidt pulver, der skal opløses til injektion eller infusion.
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 50 mg lepirudin.
Det leveres i et hætteglas, der indeholder 20 mg lepirudin.
Refludan is available in packs of 1 or 10 vials.
Refludan fås i pakker på 1 eller 10 hætteglas.
Not all pack sizes may be marketed.
Fremstiller CSL Behring GmbH, Emil- von- Behring- Straße 76, 35041 Marburg, Tyskland
Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany.
41 < ---------------------------------------------------------------------------------------------------------------------
41 < ------------------------------------------------------------------------------------------------------------------------------
- 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 1 ml of diluent into the vacuum vial and shake it gently.
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 (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.
ml sprøjte) og herefter yderligere fortynde med natriumchlorid 9 mg/ ml (0, 9%) opløsning eller 5% glukoseinfusionsvæske til et totalvolumen på 50 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. – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Regranex er en klar, farveløs til strågul gel, der indeholder 0, 01% af det aktive stof, becaplermin.
Regranex is a clear colourless to straw-coloured gel, which contains 0.01% of the active substance becaplermin.
Regranex anvendes i kombination med andre sårplejeforanstaltninger til at fremme granuleringen (opheling af hudvæv) af kroniske, diabetiske sår på op til 5 cm2 (sukkersygepatienter har forhøjet risiko for at få hudsår).
Regranex is used together with other wound care measures to help granulation (healing of skin tissue) of long term, diabetic ulcers less than or equal to 5 cm2 (people with diabetes have a higher risk of developing skin ulcers).
Regranex anvendes ved neuropatiske sår, dvs. sår, der skyldes en nervelidelse og ikke svigt af blodforsyningen til det berørte område.
Regranex is used in neuropathic ulcers: these are ulcers due to a nerve problem, and not to a problem with the blood supply to the area affected.
Behandling med Regranex bør igangsættes og monitoreres af en læge med erfaring i behandling af diabetiske sår.
Treatment with Regranex should be started and monitored by a doctor who has experience in the management of diabetic wounds.
Regranex påføres som et lag på hele sårarealet en gang dagligt ved hjælp af et rent appliceringshjælpemiddel, f. eks. en bomuldsserviet.
Regranex should be applied as a layer to the entire ulcer(s) once daily using a clean application aid, such as a cotton swab.
Det behandlede område skal derefter dækkes med en fugtig saltvandsvædet forbindingsgaze (ikke gaze, som indelukker såret).
The site(s) should then be covered by a moist saline gauze dressing (not an occlusive dressing).
Regranex bør højst anvendes i 20 uger og altid sideløbende med anden sårhelende pleje som f. eks. renholdelse af såret og ikke at udsætte det for tryk, mens det heler.
Regranex should not be used for more than 20 weeks, and should always be used alongside other measures that promote the healing of ulcers, such as keeping the ulcer clean and not applying any pressure onto it while it is healing.
Regranex indeholder becaplermin, der er en rekombinant human Platelet Derived Growth Factor- BB (rhPDGF- BB) (blodpladeafledt vækstfaktor).
Regranex contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB (rhPDGF- BB).
Vækstfaktorer er proteiner, der kan stimulere celler til at dele sig.
Growth Factors are proteins that can stimulate cells to make them multiply.
Blodpladeafledte vækstfaktorer virker på celler, der medvirker til sårheling.
Platelet-Derived Growth Factors act on cells that are involved in wound repair.
Det aktive stof i Regranex, becaplermin, fremstilles ved en såkaldt ” rekombinant DNA- teknik ”.
The active ingredient of Regranex, becaplermin, is produced by a method known as ‘ recombinant DNA technology’.
Becaplermin produceres af gærceller, der har fået indsat et gen (DNA), som sætter dem i stand til at producere human Platelet Derived Growth Factor- BB.
The becaplermin is made by a yeast that has received a gene (DNA), which makes it able to produce human Platelet Derived Growth Factor-BB.
Becaplermin virker ligesom den naturlige vækstfaktor, idet det stimulerer cellevæksten og fremmer dannelsen af normalt væv til heling af sår.
Becaplermin acts like the natural growth factor, it stimulates cell growth and helps the growth of normal tissue for healing.
Hvordan er Regranex blevet undersøgt?
How has Regranex been studied?
Regranex er blevet undersøgt i fire kliniske undersøgelser af 20 ugers varighed hos voksne sukkersygepatienter, der har haft mindst ét diabetisk sår i mindst 8 uger (samlet antal sår:
Regranex has been studied in 4 clinical trials, lasting 20 weeks, in diabetic adults who had been suffering from at least one diabetic ulcer for at least 8 weeks (total number of ulcers:
922).
922).
Regranex blev sammenlignet med placebo (virkningsløs behandling, gelen uden aktivt indholdsstof).
Regranex was compared with a placebo (dummy treatment, the gel without any active substance added).
Hovedmålet for behandlingens virkning var fuldstændig opheling af sårene.
The main measure of effectiveness was complete healing of the ulcers.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 14 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvilken fordel viser undersøgelserne, at der er ved Regranex?
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 14 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Regranex shown during the studies?
10% flere sår efter 20 uger end en placebo- gel.
When the results of all four studies were analysed together, Regranex was showed to heal about 10% more ulcers after 20 weeks than a placebo gel.
Regranex helede 47% af sår under 5 cm2, mens 35% af sårene helede med placebo- gelen og 30% uden behandling
Regranex healed 47% of the ulcers that were less than 5 cm2, when the percentage healed using either a placebo gel, or no treatment, were 35 and 30%, respectively.
Følgende bivirkninger er indberettet i de kliniske undersøgelser: infektioner, hudsår, erytem (rødme af huden) og smerte.
The following side effects have been reported in clinical trials: infection, skin ulceration, erythema (redness of the skin) and pain.
Disse bivirkninger kan ikke med sikkerhed relateres til behandlingen med Regranex.
These are not clearly related to treatment with Regranex.
Behandling med Regranex er i sjældne tilfælde blevet kædet sammen med bulløst udslæt (blærer), ødem (hævelse) og hypertrofisk granulation (dannelse af for meget arvæv under helingen).
Rarely, treatment with Regranex has been associated with bullous eruption (blisters), oedema (swelling) and hypertrophic granulation (excessive production of tissue during healing).
Regranex bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for becaplermin eller andre af indholdsstofferne, og det bør ikke påføres på eller i nærheden af et område med hudkræft.
Regranex should not be used in people who may be hypersensitive (allergic) to becaplermin or to any of the other ingredients, and it should not be applied on or near skin cancers.
Hvorfor er Regranex blevet godkendt?
Why has Regranex been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Regranex er større end risiciene ved anvendelse til fremme af granulering og dermed opheling af kroniske, neuropatiske, diabetiske sår i fuld hudtykkelse mindre end eller lig med 5 cm2.
The Committee for Medicinal Products for Human Use (CHMP) decided that Regranex’ s benefits are greater than its risks to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers ≤ 5 cm2.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Regranex.
They recommended that Regranex be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Regranex til Janssen- Cilag International N. V den 29. marts 1999.
The European Commission granted a marketing authorisation valid throughout the European Union, for Regranex to Janssen-Cilag International N. V on 29 March 1999.
Denne tilladelse blev fornyet den 29. marts 2004.
The marketing authorisation was renewed on 29 March 2004.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Regranex kan ses i sin helhed her.
The full EPAR for Regranex is available here.
REGRANEX indeholder 100 μg becaplermin pr. gram gel.
REGRANEX contains100 µg of becaplermin per gram of gel.
Becaplermin er recombinant BB homodimer af human Platelet Derived Growth Factor (rhPDGF- BB).
Becaplermin is a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
24. 500 daltons.
It is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae. rhPDGF-BB is a dimeric protein with a molecular weight of approximately 24,500 daltons.
Gel.
Gel
REGRANEX er en klar farveløs til strågul konserveret gel.
REGRANEX is a clear colourless to straw-coloured preserved gel.
REGRANEX anvendes i kombination med andre gode sårpleje- foranstaltninger til at fremme granuleringen og dermed opheling af kroniske, neuropatiske, diabetiske sår i fuld hudtykkelse mindre end eller lig med 5 cm2.
REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Behandling med REGRANEX skal igangsættes og monitoreres af læger (speciallæge eller ikke - speciallæge), som har erfaring med behandling af diabetiske sår.
Treatment with REGRANEX should be initiated and monitored by physicians (specialists or non- specialists) who are experienced in the management of diabetic wounds.
REGRANEX bør altid anvendes sammen med god sårpleje bestående af initial debridering (fjernelse af alt det nekrotiske og/ eller inficerede væv), yderligere debridering om nødvendigt og et “ ikke tryk regimen ” for at afbøde tryk på såret.
REGRANEX should always be used in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/ or infected tissue), additional debridement as necessary and a non-weight-bearing regimen to alleviate pressure on the ulcer.
Infektioner relateret til såret bør identificeres og behandles med relevant antibiotikabehandling, før behandling med REGRANEX påbegyndes.
Wound-related infection should be identified and treated with appropriate antimicrobial therapy prior to the use of REGRANEX.
Før REGRANEX anvendes, bør underliggende tilstande så som osteomylitis og perifer arteriopati udelukkes eller behandles, hvis de forekommer.
Prior to the use of REGRANEX, related underlying conditions such as osteomyelitis and peripheral arteriopathy should be excluded or treated if present.
Osteomylitis bør vurderes ved en røntgenundersøgelse.
Osteomyelitis should be assessed by X-ray examination.
Perifer arteriopati bør udelukkes ved måling af fodpulsen eller anden lignende teknik.
Peripheral arteriopathy should be excluded by assessment of the pedal pulses or other techniques.
Der bør tages biopsier af sår med suspekt udseende for at udelukke maligne tilstande.
Ulcers with a suspicious appearance should be biopsied to exclude malignancy.
REGRANEX må ikke anvendes i mere end 20 uger for den enkelte patient.
REGRANEX should not be used for more than 20 weeks in any individual patient.
Såfremt der ikke ses tegn på en betydningsfuld helingsproces efter de første 10 ugers kontunuerlig behandling med REGRANEX, bør behandlingen re- evalueres og faktorer som kan umuliggøre heling (så som osteomyelitis, ischaemia, infektion) bør re- vurderes.
If during treatment with REGRANEX no meaningful healing progress is evident after the first ten weeks of continuous therapy, treatment should be re-evaluated, and factors known to compromise healing (such as osteomyelitis, ischaemia, infection) should be re-assessed.
2 REGRANEX skal normalt ikke anvendes gentagne gange.
2 REGRANEX is not intended for repeated use.
REGRANEX er ikke undersøgt hos børn.
REGRANEX has not been studied in children.
- Kendt overfølsomhed over for det aktive lægemiddelstof eller et af de øvrige indholdsstoffer i
- Known hypersensitivity to the active substance or to any of the excipients of this product.
REGRANEX.
- Known neoplasm(s) at or near the site(s) of application.
- Kendt neoplasma i nærheden af eller på selve applikationstedet.
- In patients with clinically infected ulcers.
- Patienter med klinisk inficerede sår (jf. afsnit 4. 4).
(See section 4.4).
Grundet mangel på data bør REGRANEX anvendes med forsigtighed til patienter med kendte maligne tilstande.
In view of the lack of data, REGRANEX should be used with caution in patients with known malignancies.
REGRANEX bør ikke anvendes til patienter med sår, der ikke er af primært neuropatisk oprindelse, som f. eks. sår der skyldes arteriopati eller andre faktorer.
REGRANEX should not be used in patients with ulcers that are not of primarily neuropathic origin, such as those due to arteriopathy or other factors.
Infektionen bør behandles, før REGRANEX anvendes.
Infection should be treated prior to the use of REGRANEX.
Hvis et sår bliver inficeret, mens patienten behandles med REGRANEX, skal behandlingen seponeres, indtil infektionen er forsvundet.
If a wound becomes infected during REGRANEX therapy, the product should be discontinued until the infection has cleared.
Der er utilstrækkelige data, der kan understøtte sikker anvendelse af produktet i mere 20 uger (se 5. 1 farmakodynamiske egenskaber).
There are insufficient data to support safe use of the product for more than 20 weeks (see 5.1 Pharmacodynamic properties).
Effekt er ikke blevet vist for sår med et overfladeareal > 5 cm2.
Efficacy has not been demonstrated for ulcers of baseline surface area > 5 cm2.
Det vides ikke om REGRANEX har interaktioner med andre topikale medikamenter, der appliceres på sårfladen.
It is not known whether REGRANEX interacts with other topical medications applied to the ulcer site.
Det anbefales derfor, REGRANEX ikke bør appliceres på såret samtidig med andre topikale medikamenter.
Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.
Der er ikke udført studier med gravide kvinder.
No studies in pregnant women have been conducted.
Derfor bør REGRANEX ikke anvendes til gravide.
Therefore, REGRANEX should not be used in pregnant women.
Amning
Nursing mothers
Det er ikke kendt om becaplermin bliver udskilt i modermælk.
It is not known whether becaplermin is excreted in human milk.
Derfor bør REGRANEX ikke anvendes til ammende kvinder.
Therefore, REGRANEX should not be used in nursing mothers.
Følgende bivirkningsreaktioner stammer fra kliniske forsøg og erfaring efter markedsføringstidspunktet.
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.
3 Bivirkningsreaktioner vises ud fra hyppighed (det antal patienter, der kan forventes at få reaktionen) i følgende kategorier: meget almindelig (> 1/ 10); almindelig (> 1/ 100, < 1/ 10); usædvanlig (> 1/ 1. 000, < 1/ 100); sjælden (> 1/ 10. 000, < 1/ 1. 000), meget sjælden (< 1/ 10. 000).
3 Adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000).
Alvorlige bivirkningsreaktioner fra kliniske forsøg.
Serious adverse reactions reported in clinical trials.
Følgende bivirkningsreaktioner blev rapporteret under de randomiserede kliniske undersøgelser med REGRANEX:
The following adverse reactions were reported in the randomised clinical trials of REGRANEX therapy:
Infektion (meget almindelig), osteomyelitis (almindelig), cellulitis (meget almindelig), sårdannelse (meget almindelig), påvirkning af huden (inklusive erytem) (almindelig) og smerte (almindelig).
Infection (very common), osteomyelitis (common), cellulitis (very common), skin ulceration (very common), skin disorder (including erythema) (common), and pain (common).
Bulløst udslæt og ødem blev sjældent rapporteret.
Bullous eruption and oedema were reported rarely.
Sjældne tilfælde af hypertrofisk granulation er blevet rapporteret.
Rare cases of hypertrophic granulation have been reported.
Da absorption fra applikationsstedet er ubetydelig, forventes der ingen uheldige systemiske bivirkninger.
Since absorption is insignificant from the site of topical application, no untoward systemic events are expected.
Præparat til behandling af sår og ulcus, ATC kode:
Preparation for treatment of wounds and ulcers, ATC code:
REGRANEX indeholder becaplermin, en recombinant human Platelet Derived Growth Factor- BB (rhPDGF- BB).
REGRANEX contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
Becaplermin dannes ved indsætning af genet for B- kæden af human Platelet Derived Growth Factor til gær Saccharomyces cerevisiae.
Becaplermin is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae.
I dyresår- modeller er becaplermins predominerende effekt at forøge dannelsen af fuldstændig sårheling.
In animal wound models, the predominant effect of becaplermin is to enhance the formation of granulation tissue.
Data samlet fra 4 kliniske undersøgelser udført over en 20 ugers behandlingsperiode for sår med et overfladeareal mindre end eller lig med 5 cm2, blev 47% af sårene behandlet med becaplermin 100 μg/ g fuldstændig helet, sammenlignet med 35% for de der kun fik placebo gel.
From data combined from 4 clinical trials conducted over a 20 week treatment phase for ulcers of baseline surface area less than or equal to 5 cm2, 47% of ulcers treated with becaplermin 100 µg/ g gel completely healed, compared to 35% which were treated with placebo gel alone.
Da becaplermin er en vækstfaktor, som stimulerer proliferationen af celler, skal det gives med forsigtighed til patienter med maligne tilstande.
Since becaplermin is a growth factor, which stimulates the proliferation of cells, it must be cautiously used in patients with malignancies.
Kliniske absorptionsstudier blev udført med patienter med et gennemsnitligt sår- areal på 10, 5 cm2 (område 2, 3- 43, 5 cm2).
Clinical absorption studies were conducted in patients with a mean diabetic ulcer area of 10.5 cm² (range 2.3 - 43.5 cm²).
Efter 14 på hinanden daglige applikationer med REGRANEX forekom der kun en ubetydelig systemisk absorption af becaplermin.
Following 14 consecutive daily topical applications of REGRANEX, only insignificant systemic absorption of becaplermin occurred.
5. 3 Prækliniske sikkerhedsdata
4 5.3 Preclinical safety data
Da absorption er ubetydelig fra det topikale applikationssted, er der ikke blevet udført carcinogenicitets - og reproduktionsstudier med REGRANEX.
Since absorption is insignificant from the site of topical application in man, carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX.
Der er dog ikke blevet rapporteret hudtumorer i de kliniske undersøgelser på
However, skin tumours have not been reported in the clinical trials at the site of application or in close proximity.
I en præklinisk undersøgelse med henblik på at bestemme virkningen af PDGF på eksponeret ben udviste rotter injiceret med becaplermin i mellemfoden med 3 eller 10 μg/ sted (koncentration 30 eller 100 μg/ ml/ sted) hver anden dag i 13 dage histologiske forandringer, som antydede accelereret benforandring bestående af periosteal hyperplasia og subperiosteal ben resorption og eksostose.
In a preclinical study designed to determine the effects of PDGF on exposed bone, rats injected at the metatarsals with 3 or 10 µg/ site (concentration of 30 or 100 µg/ ml/ site) of becaplermin every other day for 13 days displayed histological changes indicative of accelerated bone remodelling consisting of periosteal hyperplasia and subperiosteal bone resorption and exostosis.