natgillin/translations-raw huggingface dataset:
Doxazosin er blevet administreret sammen med thiaziddiuretika, furosemid, beta-blokerende midler, antibiotika, orale hypoglykæmiske midler, urikosuriske midler eller antikoagulantia uden bivirkningersreaktioner.
Doxazosin has been administered together with thiazide diuretics, furosemide, beta-blocking agents, antibiotics, oral hypoglycaemic agents, uricosuric agents, or anticoagulants without adverse drug interactions.
Til behandling af hypertension kan Deres læge give Dem anden medicin, der skal tages sammen med Doxagamma 4 mg depottabletter og dermed forbundne navne.
To treat hypertension, your doctor may give you another medicine to take along with Doxagamma 4 mg prolonged release tablets and associated names .
Doxagamma 4 mg depottabletter og dermed forbundne navne bør ikke anvendes under graviditet, medmindre der er et klart behov.
Doxagamma 4 mg prolonged release tablets and associated names should not be used during pregnancy unless clearly needed.
Hvis De glemmer at tage Doxagamma 4 mg depottabletter og dermed forbundne navne Tag den, så snart De kommer i tanke om den.
If you forget to take Doxagamma 4 mg prolonged release tablets and associated names Take it as soon as you remember.
Doxagamma 4 mg depottabletter og dermed forbundne navne kan også gives til mænd, der lider af en forstørret prostatakirtel, da det kan afslappe musklerne og dermed tillade urinen at passerer lettere
Doxagamma 4 mg prolonged release tablets and associated names can also be given to men suffering from an enlarged prostate gland, as it can relax the muscles allowing urine to be passed more easily.
Doxagamma 4 mg depottabletter og dermed forbundne navne kan behandle forhøjet blodtryk (hypertension) ved at afslappe blodkarrene i kroppen og sænke blodtrykket.
Doxagamma 4 mg prolonged release tablets and associated names can treat high blood pressure (hypertension) by relaxing the blood vessels in the body and lowering blood pressure.
De farmakokinetiske egenskaber ved doxazosin i Doxagamma 4 mg depottabletter og dermed forbundne navne leder til en mindre variation i plasmaniveauer.
The pharmacokinetic properties of doxazosin in Doxagamma 4 mg prolonged release tablets and associated names lead to a minor variation in plasma levels.
Usædvanlig: Mareridt, hukommelsestab, følelsesmæssig ustabilitet Sjælden: Depression, agitation
Uncommon: nightmares, amnesia, emotional instability Rare: depression, agitation
Doxagamma 4 mg depottabletter og dermed forbundne navne tabletter er hvide, runde, bikonvekse tabletter med “DL” påtrykt.
Doxagamma 4 mg prolonged release tablets and associated names tablets are white, round, biconvex tablets with bossing “DL”.
Sygdomme i det ydre og indre øre: Usædvanlig: Tinnitus
Ear and labyrinth disorders: Uncommon: tinnitus
Administration af Doxagamma 4 mg depottabletter og dermed forbundne navne til patienter med prostatahyperplasi resulterer i en signifikant forbedring af urodynamikken og symptomer som et resultat af en selektiv blokade af alfa-adrenoreceptorer lokaliseret prostatas muskelstroma, kapsel og hals.
Administration of Doxagamma 4 mg prolonged release tablets and associated names to patients with prostatic hyperplasia results in a significant improvement in urodynamics and symptoms as a result of a selective blockade of alpha-adrenoceptors located in the prostatic muscular stroma, capsule and bladder neck.
Doxagamma 4 mg depottabletter og dermed forbundne navne vil sandsynligvis ikke påvirke Deres blodtryk, medmindre De lider af hypertension.
Doxagamma 4 mg prolonged release tablets and associated names is unlikely to affect your blood pressure unless you suffer from hypertension.
Peak/bølgedalsratio for Doxagamma 4 mg depottabletter og dermed forbundne navne er mindre end halvdelen af den for doxazosin tabletter med umiddelbar frigivelse.
Peak/trough ratio of Doxagamma 4 mg prolonged release tablets and associated names is less than half that of immediate release doxazosin tablets.
Henover det anbefalede doseringsområde har Doxagamma 4 mg depottabletterne og dermed forbundne navne kun lille eller ingen virkning på blodtrykket hos normotensive patienter med benign prostatahyperplasi (BPH).
Throughout the recommended dosage range, Doxagamma 4 mg prolonged release tablets and associated names has only a minor or no effect on blood pressure in normotensive benign prostatic hyperplasia (BPH) patients.
10 depottabletter 20 depottabletter 28 depottabletter 30 depottabletter 50 depottabletter 56 depottabletter 60 depottabletter 90 depottabletter 98 depottabletter 100 depottabletter 140 depottabletter
10 prolonged-release tablets 20 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 56 prolonged-release tablets 60 prolonged-release tablets 90 prolonged-release tablets 98 prolonged-release tablets 100 prolonged-release tablets 140 prolonged-release tablets
2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én depottablet indeholder 4 mg doxazosin (som mesilat).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 4 mg doxazosin (as mesilate).
Sædvanligvis 4 mg doxazosin én gang daglig.
Adults: Usually 4 mg doxazosin once daily.
Doxagamma 4 mg depottabletter og dermed forbundne navne kan anvendes til ved benign prostatahyperplasi (BPH) patienter, der er enten hypertensive eller normotensive, da ændringer i blodtrykket hos normotensive patienter er klinisk usignifikant.
Doxagamma 4 mg prolonged release tablets and associated names may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
Sygdomme i åndedrætsorganer, brysthule og mediastinum: Almindelig: Dyspnøe, rhinit
Respiratory, thoracic and mediastinal disorders: Common: dyspnoea, rhinitis
Doxagamma 4 mg depottabletter og dermed forbundne navne anbefales ikke til patienter under 18 år gamle.
Children and adolescents: Doxagamma 4 mg prolonged release tablets and associated names are not recommended for patients under the age of 18 years.
Doxagamma 4 mg depottabletter og dermed forbundne navne kan anvendes som monoterapi eller i kombination med andre lægemidler, f.eks. et thiaziddiuretikum, et beta-adrenoreceptorblokerende middel, en calciumantagonist eller en ACE-hæmmer.
Doxagamma 4 mg prolonged release tablets and associated names can be used as sole agent or in combination with another medicinal product e.g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Almindelig: Palpitationer, brystsmerter Usædvanlig: Arytmi, angina pectoris, bradykardi, takykardi, myokardieinfarkt
Uncommon: arrhythmia, angina pectoris, bradycardia, tachycardia, myocardial infarction
Administration af Doxagamma 4 mg depottabletter og dermed forbundne navne hos hypertensive patienter medfører en klinisk signifikant reduktion af blodtrykket som et resultat af en reduktion i den systemiske vaskulære modstand.
Administration of Doxagamma 4 mg prolonged release tablets and associated names in hypertensive patients causes a clinically significant reduction in blood pressure as a result of a reduction in systemic vascular resistance.
Symptomatisk behandling af benign prostatahyperplasi.
- Essential hypertension - Symptomatic treatment of benign prostatic hyperplasia.
5 HVORDAN DE OPBEVARER DOXAGAMMA 4 MG DEPOTTABLETTER OG
5 HOW TO STORE DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND
Doxazosin bør gives med forsigtighed til patienter med tegn på lettere til moderat nedsat leverfunktion (se pkt.
Doxazosin should be administered with caution in patients with signs of mild to moderate hepatic impairment (see section 5.2).
Usædvanlig: Alopecia, ødem i ansigtet/generelt ødem Sjælden: Udslæt, pruritus, purpura
Uncommon: alopecia, oedema of the face/general oedema Rare: rash, pruritus, purpura
Hvad Doxagamma 4 mg depottabletter og dermed forbundne navne indeholder - Det aktive stof er 4 mg doxazosin som doxazosinmesilat).
What Doxagamma 4 mg prolonged release tablets and associated names contains - The active substance is 4 mg of doxazosin as doxazosin mesilate.
Doxazosin bliver omfattende metaboliseret med <5% udskilt som uændret produkt Doxazosin bliver primært metaboliseret ved O-demethylering og hydroxylering.
Doxazosin is extensively metabolised with <5% excreted as unchanged product.
Almindelig: Muskelkramper, træthed, malaise, hovedpine, somnolens Usædvanlig: Tremor, muskelstivhed Sjælden: Paræstesi
Common: muscle cramps, fatigue, malaise, headache, somnolence Uncommon: tremor, muscular stiffness Rare: paraesthesia
Hver depottablet indeholder 4 mg doxazosin (som mesilat).
Each prolonged-release tablet contains 4 mg of doxazosin (as mesylate).
De må ikke tage Doxagamma 4 mg depottabletter og dermed forbundne navne, hvis De er gravid eller ammer.
Do not take Doxagamma 4 mg prolonged release tablets and associated names if you are pregnant or breast-feeding.
Almindelig: Konstipation, dyspepsi Usædvanlig: Anorexi, øget appetit, smagsforstyrrelser Sjælden: Abdominalt ubehag, diaré, opkastning
Common: constipation, dyspepsia Uncommon: anorexia, increased appetite, taste disturbances Rare: abdominal discomfort, diarrhoea, vomiting
Undersøgelse af gravide kaniner og rotter ved daglige doseringer, der resulterede i plasmakoncentrationer på henholdsvis 4 og 10 gange den humane eksponering (Cmax og AUC), afslørede ikke bevis for skade på føtus.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity Studies in pregnant rabbits and rats at daily doses resulting in plasma concentrations 4 and 10 times the human exposure (Cmax and AUC), respectively, revealed no evidence of harm to the foetus.
Almindelig: Akkomoderingsforstyrrelser Usædvanlig: Tåreflåd, fotofobi Sjælden: Sløret syn
Common: accomodation disturbances Uncommon: lacrimation, photophobia Rare: blurred vision
Sygdomme i bevægeapparatet og bindevæv: Usædvanlig: Muskelsmerter, arthralgi, muskelsvaghed
Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular pain, arthralgia, muscle weakness
Doxagamma 4 mg depottabletter og dermed forbundne navne kan tages med eller uden mad.
Doxagamma 4 mg prolonged release tablets and associated names can be taken with or without food.
Usædvanlige bivirkninger,der ses hos færre end 1 patient ud af 1.000, men hos færre end 1 ud af 100 patienter, omfatter: Opsvulmen af of ansigt og krop, følelse af svaghed, kolde fingre og tær, svimmelhed ved at stå op, en hurtig eller uregelmæssig hjerterytme, en langsom hjerterytme, angina, kraftige brystsmerter, besvær med vejrtrækningen, tremor, muskelstivhed, svaghed eller smerter, smertende eller opsvulmede led, ændring i appetitten, hårtab, næseblod, hoste, ondt i opsvulmet hals, lave kaliunniveauer, følelse af tørst, podagra, mareridt, hukommelsestab, humørskift, tab af blærekontrol, eller mindre hyppig trang til at lade vandet, ringen for ørerne og smagsændringer.
Uncommon effects, seen in more than 1 out of 1,000 patients but less than 1 in 100 patients, include swelling of the face and body, feeling faint, cold fingers and toes,, dizziness on standing, a racing or irregular heart beat, a slow heart beat, angina, severe chest pain, difficulty breathing, tremor, muscle stiffness, weakness or pain, pain or swelling of joints, change in appetite, hair loss, nose bleeds, cough, sore swollen throat, low blood potassium levels, feeling thirsty, gout, nightmares, loss of memory, mood changes, loss of bladder control or less frequent urge to pass urine, ringing in the ears and changes in taste.
Kolloidalt vandfrit silica Natriumstearylfumarat
Silica, colloidal anhydrous Sodium stearyl fumarate
LÆGEMIDLETS NAVN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] Doxazosin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt] UDLØBSDATO Udløbsdato: BATCHNUMMER
NAME OF THE MEDICINAL PRODUCT Doxagamma 4 mg prolonged release tablets and associated names [See Annex I] doxazosin NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] EXPIRY DATE
Behandling med doxazosin hos patienter med nedsat leverfunktion bør udføres med forsigtighed (se pkt.
Doxazosin therapy in patients with hepatic impairment should be performed with caution (see section 4.4).
Sjældne bivirkninger, der ses hos flere end 1 patient ud af 10.000. menn færre end 1 ud af 1.000, omfatter depression, følelse af rastløshed, stikken og prikken, et allergisk udslæt, kløende rød hud, mavesmerter, diaré, værende syg, en hæs stemme, besvimelse, tab af bevidsthed, gulsot, leverforandringer, lavt blodsukker, impotens, vedvarende erektion.
Rare side effects, seen in more than 1 in 10,000 patients but less than 1 out of 1,000, include depression, feeling restless, pins and needles, an allergic rash, itchy red skin, stomach pain, diarrhoea, being sick, a hoarse voice, fainting, loss of consciousness, jaundice, liver changes, low blood sugar, impotence, persistent erection.
Almindelig: Svimmelhed, ødem, ortostatisk fejlregulering Usædvanlig: Postural hypotension, perifer iskæmi, synkope Sjælden: Cerebrovaskulære forstyrrelser
Common: giddiness, dizziness, oedema, orthostatic dysregulation Uncommon: postural hypotension, peripheral ischaemia, syncope Rare: cerebrovascular disturbances
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF Doxagamma 4 mg depottabletter og de tilknyttede navne ( se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxagamma 4 mg prolonged release tablets and associated names (see Annex I)
Doxagamma 4 mg depottabletter og dermed forbundne navne er kontraindicerede under amning, da lægemidlet akkumuleres i mælken hos ammende rotter (se pkt.
Doxagamma 4 mg prolonged release tablets and associated names is contraindicated during lactation as the medicinal product accumulates in the milk of lactating rats (see section 5.3) and there is no information about the excretion of the medicinal product into human breast milk.
6.6 Særlige forholdsregler ved bortskaffelse Ingen særlige forholdsregler.
Pack sizes: 100, 250 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal No special requirements.
• Tabletterne må ikke tygges, brækkes over eller knuses
• Do not chew, break or crush the tablets.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] (Doxazosin)
PACKAGE LEAFLET: INFORMATION FOR THE USER Doxagamma 4 mg prolonged release tablets and associated names [See Annex I] (Doxazosin)
LÆGEMIDLETS NAVN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] doxazosin ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 4 mg doxazosin (som mesilat).
NAME OF THE MEDICINAL PRODUCT Doxagamma 4 mg prolonged release tablets and associated names doxazosin STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 4 mg of doxazosin (as mesylate).
Anvend Doxagamma 4 mg depottabletter og de dermed forbundne navne ikke efter udløbsdato, som er angivet på blisterpakningen.
Do not use Doxagamma 4 mg prolonged release tablets and associated names after the expiry date which is stated on the blister and carton.
butylhydroxytoluen (E321), α-Tocopherol, kolloidalt vandfrit silica, natriumstearyl fumarat,
(E321), alpha-tocopherol, anhydrous colloidal silica, sodium stearyl fumarate, methacrylic acid copolymer and titanium dioxide (E171)
Almindelig: Hyppigt ønske om at lade vandet, øget vandladning, sen ejakulation Usædvanlig: Inkontinens, vandladningsforstyrrelser, dysuri Sjælden: impotens, priapisme
Common: frequent desire to micturate, increased micturation, delayed ejaculation Uncommon: incontinence, micturation disturbances, dysuria Rare: impotence, priapism
1 HVAD DOXAGAMMA 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE NAVNE ER, OG HVAD DE ANVENDES TIL
1 WHAT DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES IS AND WHAT IT IS USED FOR
Doxazosin bør gives med særlig forsigtighed til patienter med tegn på nedsat leverfunktion.
Patients with hepatic impairment: Doxazosin should be given with particular caution to patients with evidence of impaired liver function.
1 LÆGEMIDLETS NAVN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I]
1 NAME OF THE MEDICINAL PRODUCT Doxagamma 4 mg prolonged release tablets and associated names [See Annex I]
8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes national]
8 MARKETING AUTHORISATION NUMBER [To be completed nationally]
Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] Doxazosin
Doxagamma 4 mg prolonged release tablets and associated names {See Annex I] doxazosin
Depottabletterne bør ikke tygge, dele eller knuse tabletten.
The prolonged-release tablets should not be chewed, divided or crushed.
Depottablet
- Lactation
Usædvanlig: Epistaxi, bronkospasmer, hoste, faryngit Sjælden: Larynxødem
Uncommon: epistaxis, broncho spasms, cough, pharyngitis Rare: oedema of larynx
Depottabletter oral anvendelse
Oral use
Almindelige bivirkninger, der ses hos mere end 1 patient ud af 100, omfatter: Svimmelhed, følelse af usædvanlig træthed eller alem utilpashed, opsvulmen af anklerne, palpitationer, hoved pine, brystsmerter, søvninghed, muskelkramper, konstipation, fordøjelsesbesvær, åndenød, løbende næse, forsinket ejakulation, hyppig trang til at lade vandet og sløret syn.
Common side effects, seen in more than 1 in 100 patients but less than 1in 10, include dizziness, giddiness, feeling unusually tired or generally unwell, swelling of the ankles, palpitations, headache, chest pain, sleepiness, muscle cramp, constipation, indigestion, breathlessness, runny nose, delayed ejaculation, frequent urge to pass urine and blurred vision.
Sygdomme i lever og galdeveje: Sjælden: Ikterus, forhøjede levertal
Hepato-biliary disorders: Rare: icterus, increased liver values
anbefaler CPMP, at der udstedes markedsføringstilladelse(r) for Doxagamma 4 mg depottabletter og de tilknyttede navne (se bilag I).
the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxagamma 4 mg prolonged release tablets and associated names (see Annex I).
Almene lidelser og reaktioner på indgivelsesstedet: Almindelig: Astheni
General disorders and administration site conditions: Common: asthenia
3 HVORDAN DE TAGER DOXAGAMMA 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
3 HOW TO TAKE DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
De bør ikke tage Doxagamma 4 mg depottabletter og dermed forbundne navne
Do not take Doxagamma 4 mg prolonged release tablets and associated names
Stofskiftesygdomme og ernæringsbetingede sygdoomme: Usædvanlig: Tørst, hypokaliæmi, podegra Sjælden: Hypoglycæmi
Metabolism and nutrition disorders: Uncommon: thirst, hypokalaemia, gout Rare: hypoglycaemia Very rare: increase in serum urea.
Patienter med nedsat nyrefunktion:
Patients with hepatic impairment:
Vær særlig forsigtig med at anvende Doxagamma 4 mg depottabletter og dermed forbundne navne
Take special care with Doxagamma 4 mg prolonged release tablets and associated names
Hvordan Doxagamma 4 mg depottabletter og dermed forbundne navne ser ud og pakningsstørrelsen
What Doxagamma 4 mg prolonged release tablets and associated names looks like and contents of the pack
Hovedparten af patienterne kontrolleres med den indledende dosis på Doxagamma 4 mg depottabletter og dermed forbundne navne, Hos patienter med hypertension var faldet i blodtrykket under behandling med Doxagamma 4 mg depottabletter og dermed forbundne navne det samme i både siddende og stående stilling.
In patients with hypertension, the decrease in blood pressure during treatment with Doxagamma 4 mg prolonged release tablets and associated names was similar in both the sitting and standing position.
10.1 Indtagelse af anden medicin
Taking other medicines
For en komplet liste over hjælpestoffer er anført under pkt.
For a full list of excipients, see section 6.1.
2 HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE DOXAGAMMA 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
2 BEFORE YOU TAKE DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Doxagamma 4 mg depottabletter og dermed forbundne navne kan tages sammen med eller efter maden.
Taking Doxagamma 4 mg prolonged release tablets and associated names with food and drink Doxagamma 4 mg prolonged release tablets and associated names tablets can be taken with or after food.
Usædvanlig: Rødmen, feber/kulderystelser, bleghed Sjælden: Lav legemstemperatur hos ældre
Rare: low body temperature in elderly
Efter 10 år blev markedsføringstilladelsen forlænget i yderligere fem år.
After 10 years, the marketing authorisation was renewed for a further five years.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Regranex til Janssen-Cilag International NV den 29. marts 1999.
The European Commission granted a marketing authorisation valid throughout the European Union for Regranex to Janssen-Cilag International NV on 29 March 1999.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Regranex.
This document is a summary of the European Public Assessment Report (EPAR) for Regranex.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Regranex.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Regranex.
Gazen må ikke være luft- eller vandtæt.
The dressing should not be air- or watertight.
Det samlede antal sår i undersøgelsen var 922.
In total, there were 922 ulcers in the studies.
Regranex er en gel, der indeholder det aktive stof becaplermin.
Regranex is a gel that contains the active substance becaplermin.
Den fuldstændige EPAR for Regranex findes her.
The full EPAR for Regranex can be found here.
Regranex er blevet undersøgt i en hovedundersøgelse og tre yderligere undersøgelser med voksne sukkersygepatienter, der har haft mindst ét diabetisk sår i mindst otte uger.
Regranex has been studied in one main study and three additional studies involving diabetic adults who had had at least one diabetic ulcer for at least eight weeks.
CHMP besluttede, at fordelene ved Regranex er større end risiciene, og anbefalede udstedelse af
The CHMP decided that Regranex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Becaplermin produceres via en metode, der er kendt som ”rekombinant DNA-teknologi”: det produceres af gærceller, der har fået indsat et gen (DNA) og derved sættes i stand til at producere det humane protein Platelet Derived Growth Factor-BB. Becaplermin virker på samme måde som naturligt produceret vækstfaktor, idet det stimulerer cellevæksten og fremmer dannelsen af normalt væv til
Becaplermin 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 human platelet-derived growth factor-BB. Becaplermin acts in the same way as the naturally produced growth factor by stimulating cell growth and helping the growth of normal tissue for healing.
Virkningen blev hovedsagelig bedømt på antallet af sår, som var fuldstændigt helet efter 20 uger.
The main measure of effectiveness was the number of ulcers that had completely healed after 20 weeks.
Neuropatiske sår skyldes en nervelidelse og ikke svigt af blodforsyningen til det berørte
Neuropathic ulcers are caused by a nerve problem, and not by a problem with the blood supply to the area affected.
En tube Regranex bør kun anvendes af én person.
Each tube of Regranex should only be used on one patient.
De mest almindelige bivirkninger ved Regranex (som ses hos flere end 1 ud af 10 patienter) er sårinfektion og cellulitis (betændelse i de dybereliggende væv under huden).
The most common side effects with Regranex (seen in more than 1 patient in 10) are infected skin ulcers and cellulitis (inflammation of the deep skin tissue).