FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: constipation, dyspepsia Uncommon: anorexia, increased appetite, taste disturbances Rare: abdominal discomfort, diarrhoea, vomiting
Danish: Almindelig: Konstipation, dyspepsi Usædvanlig: Anorexi, øget appetit, smagsforstyrrelser Sjælden: Abdominalt ubehag, diaré, opkastning
English: 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.
Danish: 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.
English: Common: accomodation disturbances Uncommon: lacrimation, photophobia Rare: blurred vision
Danish: Almindelig: Akkomoderingsforstyrrelser Usædvanlig: Tåreflåd, fotofobi Sjælden: Sløret syn
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular pain, arthralgia, muscle weakness
Danish: Sygdomme i bevægeapparatet og bindevæv: Usædvanlig: Muskelsmerter, arthralgi, muskelsvaghed
English: Doxagamma 4 mg prolonged release tablets and associated names can be taken with or without food.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne kan tages med eller uden mad.
English: 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.
Danish: 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.
English: Silica, colloidal anhydrous Sodium stearyl fumarate
Danish: Kolloidalt vandfrit silica Natriumstearylfumarat
English: 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
Danish: LÆGEMIDLETS NAVN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] Doxazosin NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt] UDLØBSDATO Udløbsdato: BATCHNUMMER
English: Doxazosin therapy in patients with hepatic impairment should be performed with caution (see section 4.4).
Danish: Behandling med doxazosin hos patienter med nedsat leverfunktion bør udføres med forsigtighed (se pkt.
English: 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.
Danish: 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.
English: Common: giddiness, dizziness, oedema, orthostatic dysregulation Uncommon: postural hypotension, peripheral ischaemia, syncope Rare: cerebrovascular disturbances
Danish: Almindelig: Svimmelhed, ødem, ortostatisk fejlregulering Usædvanlig: Postural hypotension, perifer iskæmi, synkope Sjælden: Cerebrovaskulære forstyrrelser
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxagamma 4 mg prolonged release tablets and associated names (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF Doxagamma 4 mg depottabletter og de tilknyttede navne ( se bilag I)
English: 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.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne er kontraindicerede under amning, da lægemidlet akkumuleres i mælken hos ammende rotter (se pkt.
English: Pack sizes: 100, 250 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Særlige forholdsregler ved bortskaffelse Ingen særlige forholdsregler.
English: • Do not chew, break or crush the tablets.
Danish: • Tabletterne må ikke tygges, brækkes over eller knuses
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Doxagamma 4 mg prolonged release tablets and associated names [See Annex I] (Doxazosin)
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] (Doxazosin)
English: 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).
Danish: 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).
English: Do not use Doxagamma 4 mg prolonged release tablets and associated names after the expiry date which is stated on the blister and carton.
Danish: Anvend Doxagamma 4 mg depottabletter og de dermed forbundne navne ikke efter udløbsdato, som er angivet på blisterpakningen.
English: (E321), alpha-tocopherol, anhydrous colloidal silica, sodium stearyl fumarate, methacrylic acid copolymer and titanium dioxide (E171)
Danish: butylhydroxytoluen (E321), α-Tocopherol, kolloidalt vandfrit silica, natriumstearyl fumarat,
English: Common: frequent desire to micturate, increased micturation, delayed ejaculation Uncommon: incontinence, micturation disturbances, dysuria Rare: impotence, priapism
Danish: Almindelig: Hyppigt ønske om at lade vandet, øget vandladning, sen ejakulation Usædvanlig: Inkontinens, vandladningsforstyrrelser, dysuri Sjælden: impotens, priapisme
English: 1 WHAT DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES IS AND WHAT IT IS USED FOR
Danish: 1 HVAD DOXAGAMMA 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE NAVNE ER, OG HVAD DE ANVENDES TIL
English: Patients with hepatic impairment: Doxazosin should be given with particular caution to patients with evidence of impaired liver function.
Danish: Doxazosin bør gives med særlig forsigtighed til patienter med tegn på nedsat leverfunktion.
English: 1 NAME OF THE MEDICINAL PRODUCT Doxagamma 4 mg prolonged release tablets and associated names [See Annex I]
Danish: 1 LÆGEMIDLETS NAVN Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I]
English: 8 MARKETING AUTHORISATION NUMBER [To be completed nationally]
Danish: 8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes national]
English: Doxagamma 4 mg prolonged release tablets and associated names {See Annex I] doxazosin
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] Doxazosin
English: The prolonged-release tablets should not be chewed, divided or crushed.
Danish: Depottabletterne bør ikke tygge, dele eller knuse tabletten.
English: - Lactation
Danish: Depottablet
English: Uncommon: epistaxis, broncho spasms, cough, pharyngitis Rare: oedema of larynx
Danish: Usædvanlig: Epistaxi, bronkospasmer, hoste, faryngit Sjælden: Larynxødem
English: Oral use
Danish: Depottabletter oral anvendelse
English: 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.
Danish: 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.
English: Hepato-biliary disorders: Rare: icterus, increased liver values
Danish: Sygdomme i lever og galdeveje: Sjælden: Ikterus, forhøjede levertal
English: 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).
Danish: anbefaler CPMP, at der udstedes markedsføringstilladelse(r) for Doxagamma 4 mg depottabletter og de tilknyttede navne (se bilag I).
English: General disorders and administration site conditions: Common: asthenia
Danish: Almene lidelser og reaktioner på indgivelsesstedet: Almindelig: Astheni
English: 3 HOW TO TAKE DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Danish: 3 HVORDAN DE TAGER DOXAGAMMA 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
English: Do not take Doxagamma 4 mg prolonged release tablets and associated names
Danish: De bør ikke tage Doxagamma 4 mg depottabletter og dermed forbundne navne
English: Metabolism and nutrition disorders: Uncommon: thirst, hypokalaemia, gout Rare: hypoglycaemia Very rare: increase in serum urea.
Danish: Stofskiftesygdomme og ernæringsbetingede sygdoomme: Usædvanlig: Tørst, hypokaliæmi, podegra Sjælden: Hypoglycæmi
English: Patients with hepatic impairment:
Danish: Patienter med nedsat nyrefunktion:
English: Take special care with Doxagamma 4 mg prolonged release tablets and associated names
Danish: Vær særlig forsigtig med at anvende Doxagamma 4 mg depottabletter og dermed forbundne navne
English: What Doxagamma 4 mg prolonged release tablets and associated names looks like and contents of the pack
Danish: Hvordan Doxagamma 4 mg depottabletter og dermed forbundne navne ser ud og pakningsstørrelsen
English: 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.
Danish: 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.
English: Taking other medicines
Danish: 10.1 Indtagelse af anden medicin
English: For a full list of excipients, see section 6.1.
Danish: For en komplet liste over hjælpestoffer er anført under pkt.
English: 2 BEFORE YOU TAKE DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Danish: 2 HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE DOXAGAMMA 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
English: 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.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne kan tages sammen med eller efter maden.
English: Rare: low body temperature in elderly
Danish: Usædvanlig: Rødmen, feber/kulderystelser, bleghed Sjælden: Lav legemstemperatur hos ældre
English: After 10 years, the marketing authorisation was renewed for a further five years.
Danish: Efter 10 år blev markedsføringstilladelsen forlænget i yderligere fem år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Regranex to Janssen-Cilag International NV on 29 March 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Regranex til Janssen-Cilag International NV den 29. marts 1999.
English: This document is a summary of the European Public Assessment Report (EPAR) for Regranex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Regranex.
English: 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.
Danish: 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.
English: The dressing should not be air- or watertight.
Danish: Gazen må ikke være luft- eller vandtæt.
English: In total, there were 922 ulcers in the studies.
Danish: Det samlede antal sår i undersøgelsen var 922.
English: Regranex is a gel that contains the active substance becaplermin.
Danish: Regranex er en gel, der indeholder det aktive stof becaplermin.
English: The full EPAR for Regranex can be found here.
Danish: Den fuldstændige EPAR for Regranex findes her.
English: 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.
Danish: 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.
English: The CHMP decided that Regranex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Regranex er større end risiciene, og anbefalede udstedelse af
English: 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.
Danish: 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
English: The main measure of effectiveness was the number of ulcers that had completely healed after 20 weeks.
Danish: Virkningen blev hovedsagelig bedømt på antallet af sår, som var fuldstændigt helet efter 20 uger.
English: Neuropathic ulcers are caused by a nerve problem, and not by a problem with the blood supply to the area affected.
Danish: Neuropatiske sår skyldes en nervelidelse og ikke svigt af blodforsyningen til det berørte
English: Each tube of Regranex should only be used on one patient.
Danish: En tube Regranex bør kun anvendes af én person.
English: 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).
Danish: 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).
English: Treatment with Regranex should be started and monitored by a doctor who has experience in the management of diabetic wounds.
Danish: Behandlingen med Regranex bør indledes og overvåges af en læge med erfaring i behandling af
English: Regranex should not be used in people who may be hypersensitive (allergic) to becaplermin or any of the other ingredients.
Danish: Regranex bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for becaplermin eller andre af indholdsstofferne.
English: Regranex should be used carefully to make sure that the gel does not become contaminated with bacteria.
Danish: Regranex skal anvendes med forsigtighed, så gelen ikke forurenes med bakterier.
English: Regranex is used on neuropathic ulcers up to 5 cm2 in size.
Danish: Regranex anvendes til neuropatiske sår på op til 5 cm2.
English: When the results of all four studies were looked at together, Regranex healed about 10% more ulcers than the placebo gel.
Danish: Det samlede resultatet af de fire undersøgelser viser, at Regranex heler ca. 10 % flere sår end placebogel.
English: For more information about treatment with Regranex, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med Regranex fremgår af indlægssedlen (også en del af denne EPAR).
English: Regranex should not be used for more than 20 weeks, and should always be used alongside other measures that help ulcers heal, such as keeping them clean and not applying any pressure onto them while they are healing.
Danish: 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.
English: The ulcer should be cleaned with water or saline (salt) solution before each application of Regranex.
Danish: Såret skal renses med vand eller en saltvandsopløsning inden hver påføring af Regranex.
English: Platelet-derived growth factors act on cells that are involved in repairing wounds.
Danish: Blodpladeafledte vækstfaktorer virker på celler, der medvirker til sårheling.
English: Regranex was compared with placebo (a dummy treatment) and with no treatment, but all of the patients received standard wound care.
Danish: Regranex blev sammenlignet med placebo (en virkningsløs behandling) og med ingen behandling.
English: In the patients who used Regranex, 47% of the ulcers that were less than 5 cm2
Danish: Regranex helede 47 % af de sår, som var under 5 cm2.
English: Regranex is used together with other wound care measures to help granulation (healing) of long-term skin ulcers in people with diabetes.
Danish: Regranex anvendes i kombination med andre sårplejeforanstaltninger til at fremme granuleringen (helingen) af kroniske hudsår hos sukkersygepatienter.
English: What benefit has Regranex shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Regranex?
English: How does Regranex work?
Danish: Hvordan virker Regranex?
English: The sites should then be covered by a moist saline gauze dressing to keep the area moist while the ulcers are healing.
Danish: Det behandlede område skal herefter dækkes med en fugtig saltvandsvædet forbindingsgaze, så området holdes fugtigt, mens såret heles.
English: For the full list of side effects reported with Regranex, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Regranex fremgår af indlægssedlen.
English: The active substance in Regranex, becaplermin, is a copy of a human protein called platelet-derived growth factor-BB. Growth factors are proteins that stimulate cells to multiply.
Danish: Det aktive stof i Regranex er becaplermin, som er en kopi af det humane protein Platelet Derived Growth Factor-BB (blodpladeafledt vækstfaktor).
English: The gel should then be applied as a layer to the entire surface of the ulcers once a day using a clean application aid, such as a cotton swab.
Danish: Der påføres et lag Regranex på hele sårarealet en gang dagligt ved hjælp af et rent påføringsmiddel, f.eks. en vatpind.
English: This compared to 35% in the patients using the placebo gel and 30% in the patients who were given only standard wound care.
Danish: Til sammenligning helede placebogelen 35 % af sårene, og den sårplejende standardbehandling som eneste behandling helede
English: See the Package Leaflet for further details.
Danish: Yderligere oplysninger herom fremgår af indlægssedlen.
English: It must not be used in people with any known cancer or who have ulcers that are infected.
Danish: Det må ikke påføres på eller i nærheden af et område med hudkræft
English: It is important that both men and women read the information.
Danish: Det er vigtigt, at både mænd og kvinder læser oplysningerne.
English: Date of first authorisation: 22 July 2016
Danish: Dato for første markedsføringstilladelse: 22. juli 2016
English: This means you and your partner must take special precautions in sexual activity if there is any chance you or your partner could become pregnant.
Danish: Derfor skal du og din partner tage særlige forholdsregler ved seksuel aktivitet, hvis der er mulighed for, at du eller din partner kan blive gravid.
English: • have diabetes.
Danish: • har diabetes.
English: This is so your doctor can:
Danish: Derved kan lægen:
English: Clinical and laboratory monitoring is recommended.
Danish: Klinisk overvågning og laboratorieovervågning anbefales.
English: For elbasvir, the absolute bioavailability is estimated to be 32%.
Danish: For elbasvir er den absolutte biotilgængelighed estimeret til at være 32%.
English: Weight/BMI
Danish: Vægt/BMI
English: • Do not take a double dose (two doses together) to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis (to tabletter samtidigt) som erstatning for den glemte dosis.
English: Take the medicine pack with you so that you can show the doctor what you have taken.
Danish: Tag medicinpakningen med, så du kan vise lægen, hvad du har taget.
English: It is very important that you complete the full course of treatment.
Danish: Det er meget vigtigt, at du gennemfører hele behandlingsprogrammet.
English: These late ALT elevations were typically asymptomatic.
Danish: Disse sene ALAT-forhøjelser var typisk asymptomatiske.
English: Number of isolates tested: a=5, b=4, c=14, d=10, e=9
Danish: Antal testede isolater: a=5, b=4, c=14, d=10, e=9
English: • check if your treatment has worked and you are free of hepatitis C
Danish: • kontrollere, om din behandling har virket, og om du er fri for hepatitis C-virus
English: This is because ZEPATIER has not been tested in this age group.
Danish: Det skyldes, at ZEPATIER ikke er undersøgt i denne aldersgruppe.
English: Persistence of resistance-associated substitutions
Danish: Persistens af resistens-associerede substitutioner
English: Changes in selected laboratory parameters are described in Table 4.
Danish: Ændringer i udvalgte laboratorieparametre er beskrevet i tabel 4.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning hos patienter på en kontrolleret natriumdiæt.
English: ZEPATIER is not recommended in patients infected with these genotypes.
Danish: ZEPATIER anbefales ikke til patienter, som er inficeret med disse genotyper.
English: • have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely
Danish: • har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere
English: Your doctor will test your blood before, during and after your treatment with ZEPATIER.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med ZEPATIER.
English: Patients should be instructed not to take a double dose.
Danish: Patienten skal informeres om ikke at tage en dobbeltdosis.