FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral contraceptives and other steroidal agents Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Danish: In vitro-studier viser, at duloxetin ikke inducerer CYP3A's nedbrydende aktivitet.
English: Gastrointestinal haemorrhage7
Danish: Gastrointesti-nal blødning7
English: Weight decrease Weight increase Blood creatine phosphokinase increased
Danish: Vægtstigning Forhøjet kreatinfosfo-kinase i blodet
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/h (mean 101 l/h).
Danish: Efter en oral dosis ligger den tilsyneladende plasmaclearance for duloxetin på 33-261 l/t.
English: Orthostatic hypotension2
Danish: Hypertension3,7 Ortostatisk hypotension2
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Danish: Knogler, led, muskler og bindevæv Muskulo- skeletale smerter
English: Duloxetine Zentiva 30 mg is available in packs of 7, 28, 56, 84 and 98 capsules.
Danish: Duloxetine Zentiva 30 mg findes i pakninger med 7, 28, 56, 84 og 98 kapsler.
English: INFORMATION IN BRAILLE Duloxetine Zentiva 30 mg
Danish: INFORMATION I BRAILLESKRIFT Duloxetine Zentiva 30 mg
English: Tolerability of duloxetine 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Danish: Den procentvise del af de ældre patienter, som kunne tåle behandlingen med duloxetin 60 mg en gang daglig var sammenlignelig med den, der blev set hos yngre voksne.
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g., lack of coordination or involuntary movements of the muscles,
Danish: • pludselig, ufrivillig spjætten eller sitren i musklerne, følelse af rastløshed eller manglende evne til at sidde eller stå stille, nervøsitet, koncentrationsbesvær, ændret smagsoplevelse, problemer med at styre sine bevægelser f.eks. koordinationsbesvær eller ufrivillige muskelbevægelser, restless legs syndrom (stærk uro og krybende fornemmelse i underbenene), dårlig søvnkvalitet
English: Cutaneous vasculitis
Danish: kutan vasculit is
English: INFORMATION IN BRAILLE Duloxetine Zentiva 60 mg
Danish: INFORMATION I BRAILLESKRIFT Duloxetine Zentiva 60 mg
English: Duloxetine Zentiva must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Danish: Duloxetine Zentiva må ikke bruges til patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min, se pkt.
English: Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Danish: Der er blevet rapporteret tilfælde af selvmordstanker og -adfærd under duloxetin-behandling eller tidligt efter behandlingens ophør (se pkt.
English: • have liver disease;
Danish: • har en leversygdom.
English: What you need to know before you take Duloxetine Zentiva
Danish: Det skal du vide, før du begynder at tage Duloxetine Zentiva
English: Adverse reactions may be more common during concomitant use of Duloxetine Zentiva and herbal preparations containing St. John's wort (Hypericum perforatum).
Danish: Bivirkninger kan forekomme hyppigere ved samtidig brug af Duloxetine Zentiva og naturlægemidler samt kosttilskud indeholdende perikon (Hypericum perforatum).
English: Caution is advisable if duloxetine is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St. John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Danish: Det anbefales at udvise forsigtighed, hvis duloxetin anvendes sammen med serotonerge lægemidler som SSRI-præparater, SNRI-præparater, tricykliske antidepressiva f.eks. clomipramin eller amitriptylin, MAO-hæmmere som moclobemid eller linezolid, perikon (Hypericum perforatum) eller triptaner, tramadol, pethidin og tryptophan (se pkt.
English: Throat tightness Epistaxis
Danish: Sammensnøret hals Epistaxis
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan ske hos flere end 1 ud af 10 patienter)
English: The risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Danish: Bortset fra de her i afsnittet nævnte interaktioner, er risikoen ved brug af duloxetin i kombination med andre CNS-aktive lægemidler ikke blevet systematisk undersøgt.
English: The following are reasons why Duloxetine Zentiva may not be suitable for you.
Danish: I følgende situationer kan du muligvis ikke anvende Duloxetine Zentiva.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with duloxetine and 23% of patients taking placebo.
Danish: I kliniske studier er der observeret utilsigtede hændelser ved pludselig afbrydelse af behandlingen hos ca. 45 % og 23 % af patienterne behandlet med hhv. duloxetin og placebo.
English: Inducers of CYP1A2
Danish: CYP1A2-induktorer
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
Danish: Doseringer over 60 mg en gang daglig op til maksimaldosis på 120 mg daglig er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: If your doctor has prescribed Duloxetine Zentiva for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Du bedes henvende dig til din læge, hvis din læge har udskrevet Duloxetine Zentiva til en patient under 18 år, og du gerne vil diskutere dette.
English: Use in children and adolescents under 18 years of age Duloxetine should not be used in the treatment of children and adolescents under the age of 18 years.
Danish: Duloxetine Zentiva bør ikke bruges til behandling af børn og unge under 18 år.
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan ske hos op til 1 ud af 1.000 patienter)
English: • dizziness, tingling, feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Danish: • svimmelhed, prikkende følelse som når noget sover eller følelse af elektriske stød (især i hovedet), søvnforstyrrelser (livagtige drømme, mareridt, søvnløshed), træthed, søvnighed, rastløshed eller uro, angst, kvalme eller opkastning, rystelser (tremor), hovedpine, muskelsmerter, irritation, diaré, forøget tendens til at svede eller svimmelhed.
English: The use of Duloxetine Zentiva while breast-feeding is not recommended.
Danish: Det anbefales ikke at bruge Duloxetine Zentiva, mens du ammer.
English: The efficacy of duloxetine at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, doubleblind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Danish: Effekten af duloxetin er vist med den anbefalede faste dosis på 60 mg én gang daglig i tre ud af tre randomiserede dobbeltblinde, placebokontrollerede studier på voksne akutte ambulante patienter med moderate til svære depressioner.
English: • have kidney disease;
Danish: • har en nyresygdom
English: • dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin;
Danish: • svimmelhed, følelse af ugidelighed, rysten, følelsesløshed inklusive følelsesløshed eller prikken/snurren i huden
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: titanium dioxide (E171), gelatin
Danish: Kapseltop: Indigotin (E132), titandioxid (E171), gelatine Kapselbund: Titandioxid (E171), gelatine.
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Galactorrhoea Hyperprolactinaemia Postpartum haemorrhage6
Danish: Menopausale symptomer Galaktorré Hyperprolaktinæmi Postpartum blødning6
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind;
Danish: • forstoppelse, diarré, mavesmerter, opkastning, halsbrand eller fordøjelsesbesvær, luft i maven
English: Monoamine oxidase inhibitors (MAOIs)
Danish: Monoaminoxidasehæmmere (MAO-hæmmere)
English: Increased tendency to bruise
Danish: Øget tendens til at få blå mærker
English: • Monoamine oxidase inhibitors (MAOIs): You should not take Duloxetine Zentiva if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Danish: • Monoaminoxidasehæmmere (MAO-hæmmere): Du må ikke tage Duloxetine Zentiva sammen med en MAO- hæmmer eller inden for 14 dage efter afsluttet behandling med en MAO-hæmmer.
English: • increased sweating, (itchy) rash;
Danish: • øget tendens til at svede, (kløende) udslæt
English: 10Estimated frequency based on placebo-controlled clinical trials.
Danish: ikke observeret i placebokontrollerede kliniske studier.
English: 7 gastro-resistant hard capsules 28 gastro-resistant hard capsules 56 gastro-resistant hard capsules 84 gastro-resistant hard capsules 98 gastro-resistant hard capsules
Danish: 7 hårde enterokapsler 28 hårde enterokapsler 56 hårde enterokapsler 84 hårde enterokapsler 98 hårde enterokapsler
English: • are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Zentiva');
Danish: • tager anden medicin til behandling af depression (se ”Brug af anden medicin sammen med
English: How to take Duloxetine Zentiva
Danish: Sådan skal du tage Duloxetine Zentiva
English: Dermatitis contact Cold sweat Photo-sensitivity reactions
Danish: Kontakt-dermatitis Koldsved
English: Do not take more than the daily amount of Duloxetine Zentiva that has been prescribed for you in one day.
Danish: Du må ikke tage mere Duloxetine Zentiva pr. dag, end lægen har ordineret.
English: Sleep disorder Bruxism Disorientation Apathy
Danish: Søvnforstyr-relser Tænderskæren Desorientering Apati
English: Duloxetine Zentiva must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Danish: Duloxetine Zentiva må ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt.
English: restless legs syndrome, poor sleep quality;
Danish: Dyskinesi Uro i benene Dårlig søvnkvalitet
English: Duloxetine Zentiva gastro-resistant hard capsules contain sucrose.
Danish: Duloxetine Zentiva hårde enterokapsler indeholder saccharose.
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/h to 46 l/h (mean of 36 l/h).
Danish: Efter en intravenøs dosis ligger duloxetins plasmaclearance på 22-46 l/t.
English: Each capsule contains duloxetine hydrochloride equivalent to 30 or 60 mg duloxetine.
Danish: Hver kapsel indeholder 30 eller 60 mg duloxetin.
English: Urine flow decreased
Danish: Nedsat urinmængde
English: Duloxetine Zentiva contains sucrose
Danish: Duloxetine Zentiva indeholder saccharose
English: Concomitant use of Duloxetine Zentiva with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Danish: Duloxetine Zentiva må ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAO-hæmmere) (se pkt.
English: What Duloxetine Zentiva is and what it is used for What you need to know before you take Duloxetine Zentiva How to take Duloxetine Zentiva Possible side effects
Danish: Det skal du vide, før du begynder at tage Duloxetine Zentiva Sådan skal du tage Duloxetine Zentiva Bivirkninger
English: 28 gastro-resistant hard capsules 56 gastro-resistant hard capsules 84 gastro-resistant hard capsules 98 gastro-resistant hard capsules
Danish: 28 hårde enterokapsler 56 hårde enterokapsler 84 hårde enterokapsler 98 hårde enterokapsler
English: • are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine
Danish: • samtidig tager anden medicin med duloxetin (se ”Brug af anden medicin sammen med
English: • muscle pain, muscle spasm;
Danish: • muskelstivhed, muskelkramper
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder duloxetinhydroclorid svarende til 60 mg duloxetin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder duloxetinhydroclorid svarende til 30 mg duloxetin.
English: − Titanium dioxide (E171)
Danish: Kapselbund - Titandioxid (E171) - Gelatine
English: Do not stop taking Duloxetine Zentiva, or change your dose, without talking to your doctor.
Danish: Du må kun stoppe behandlingen eller ændre dosis efter aftale med lægen.
English: Gastroenteritis Eructation Gastritis Dysphagia
Danish: Gastroenteritis Opstød
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Danish: Urinretention Besværet vandladning Natlig vandladning Polyuri
English: Zentiva').
Danish: Duloxetine Zentiva").
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Danish: Duloxetine Zentiva 30 mg hårde enterokapsler Duloxetine Zentiva 60 mg hårde enterokapsler
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan ske hos op til 1 ud af 100 patienter)
English: NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 60 mg gastro-resistant hard capsules Duloxetine
Danish: LÆGEMIDLETS NAVN Duloxetine Zentiva 60 mg hårde enterokapsler Duloxetin
English: NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine
Danish: LÆGEMIDLETS NAVN Duloxetine Zentiva 30 mg hårde enterokapsler Duloxetin
English: • abnormal urine odour;
Danish: • unormal urinlugt
English: − Keep this leaflet.
Danish: • Gem indlægssedlen.
English: Ejaculation disorder
Danish: Obstipation Diarré
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing;
Danish: • opkastning af blod eller sort, tjærefarvet afføring (på grund af blod i afføringen), mave-tarmkatar, bøvsen, synkebesvær
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label duloxetine 60 mg once daily were randomised to either duloxetine 60 mg once daily or placebo for a further 6-months.
Danish: I et studie med forebyggelse af tilbagefald, hvor patienterne blev randomiserede til enten duloxetin 60 mg eller placebo, efter 12-ugers akut behandling med open-label duloxetin 60 mg én gang daglig viste duloxetin 60 mg én gang daglig sig statistisk signifikant bedre end placebo (p=0,004) på den primære parameter, som var forebyggelsen af depressive tilbagefald målt som tid til tilbagefald.
English: The effect of duloxetine 60 mg once a day in elderly depressed patients (≥ 65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Danish: I et studie med ældre depressive patienter (≥ 65 år), som viste en statistisk signifikant forskel i reduktionen i HAM-D17-scoren for duloxetinbehandlede patienter sammenlignet med placebo, blev effekten af duloxetin 60 mg en gang daglig særligt undersøgt.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan ske hos op til 1 ud af 10 patienter)
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: yellow iron oxide (E172), titanium dioxide (E171), gelatin
Danish: Kapselbund: Gul jernoxid (E172), titandioxid (E171), gelatine.
English: The 30 mg capsules are hard opaque gelatin capsules of length approx. 15.9 mm with white opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Danish: 30 mg kapslerne er hårde, uigennemsigtige gelatinekapsler, cirka 15,9 mm lange med hvid, uigennemsigtig kapseltop og lyseblå, uigennemsigtig kapselbund.
English: • increased yawning;
Danish: • øget tendens til at gabe
English: The active substance is duloxetine.
Danish: Duloxetine Zentiva indeholder Aktivt stof: Duloxetin.
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of duloxetine 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Danish: Hos de patienter, som responderede på 8-ugers akut behandling med 60 mg duloxetin en gang daglig i et open-label, langtids-, ukontrolleret studie, holdt smertereduktionen i yderligere 6 måneder.
English: 6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo controlled clinical trials.
Danish: 6 Estimeret hyppighed baseret på rapporterede bivirkninger under overvågning efter markedsføring;
English: • weight loss.
Danish: • har svært nedsat nyrefunktion.
English: The 60 mg capsules are hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Danish: 60 mg kapslerne er hårde, uigennemsigtige gelatinekapsler, cirka 19,4 mm lange med beige, uigennemsigtig kapseltop og lyseblå, uigennemsigtig kapselbund.
English: • weight gain;
Danish: • vægtøgning
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Capsule cap
Danish: Duloxetine Zentiva 60 mg hårde enterokapsler
English: Hypromellose
Danish: Hypromellose Talcum
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Capsule cap
Danish: Duloxetine Zentiva 30 mg hårde enterokapsler
English: Malaise
Danish: Urticaria
English: drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Danish: • Serotoninsyndrom (en sjælden bivirkning, der kan forårsage unormal opstemthed, døsighed, klodsethed, rastløshed, en følelse af at være beruset, feber, tendens til at svede eller muskelstivhed), krampeanfald
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Duloxetine Zentiva Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Duloxetine Zentiva 30 mg gastro-resistant hard capsules Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Duloxetine Zentiva 30 mg hårde enterokapsler
English: What Duloxetine Zentiva looks like and contents of the pack Duloxetine Zentiva is a gastro-resistant hard capsule.
Danish: Duloxetine Zentiva er en hård enterokapsel.
English: • feeling sick (nausea), dry mouth.
Danish: • sammensnørret hals, næseblod
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Danish: Hårde, uigennemsigtige gelatinekapsler, cirka 19,4 mm lange med beige, uigennemsigtig bund og lyseblå, uigennemsigtig top, som indeholder off-white til lysbrun-gullige, sfæriske pellets.
English: Generalised anxiety disorder
Danish: Nervøsitet Koncentrationsbesvær Dysgeusi
English: The usual dose of Duloxetine Zentiva is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den anbefalede dosis af Duloxetine Zentiva er 60 mg én gang daglig.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: 85033Episcopia (Potenza) Italy
Danish: 85033Episcopia (Potenza) Italien
English: 17674, Kallithea, Athens Greece
Danish: 17674, Kallithea, Athens Grækenland
English: Rua João Chagas, 53 Piso 3
Danish: Rua João Chagas, 53
English: 66020 San Giovanni Teatino (Chieti) Italy
Danish: 66020 San Giovanni Teatino (Chieti) Italien
English: Orodispersible tablet Oral use
Danish: Tablet med delekærv Oral anvendelse
English: Via Nocera Umbra, 75 00181 Rome Italy
Danish: Via Nocera Umbra, 75 00181 Rome Italien
English: Valle Slimbene (Pavia) I-27010 Italy
Danish: Valle Slimbene (Pavia) I-27010 Italien
English: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italy
Danish: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italien
English: 20143 Milan Italy
Danish: 20143 Milan Italien
English: Sanofi-Aventis AEBE Syngrou Av. 348
Danish: Grækenland Sanofi-Aventis AEBE Syngrou Av. 348
English: 160 00 Praha 6 - Vokovice Czech Republic
Danish: Evropská 846/176a 160 00 Praha 6 - Vokovice Czech Republic
English: Farmaceutici Caber S.P.A. Viale Citta' D'Europa, 681 Rome
Danish: Viale Citta' D'Europa, 681 Rome
English: Via Pavia, 6 20136 Milan Italy
Danish: Via Pavia, 6 20136 Milan Italien
English: Viale Luigi Bodio, 37/B 20158 Milan Italy
Danish: Viale Luigi Bodio, 37/B 20158 Milan Italien
English: 1499-040 Cruz QuebradaDafundo
Danish: 1499-040 Cruz Quebrada - Dafundo Portugal
English: Iasis Pharmaceuticals Hellas AEBE, 137 Fylis Av. 13451 Kamatero,Athens Greece
Danish: Grækenland Iasis Pharmaceuticals Hellas AEBE, 137 Fylis Av.
English: Via Manunzio, 7 20124 Milan Italy
Danish: Via Manunzio, 7 20124 Milan Italien
English: Via Vittor Pisani, 20 20124 Milan Italy
Danish: Via Vittor Pisani, 20 20124 Milan Italien
English: Viale Papiniano, 22/B 20123 Milan Italy
Danish: Viale Papiniano, 22/B 20123 Milan Italien
English: Triq Kan. K. Pirotta Birkirkara, BKR 1114, Malta
Danish: Sanofi-Aventis Malta Ltd Floor 3, Charles de Giorgio Buildings Triq Kan. K. Pirotta Birkirkara, BKR 1114, Malta
English: COLTRAMYL 4 mg, comprimé
Danish: COLTRAMYL 4 mg, comprimé 4mg
English: The overall treatment period should not be longer than 20 days.
Danish: Den samlede behandlingsperiode må ikke overstige 20 dage.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Removab to Fresenius Biotech GmbH on 20 April 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Removab til Fresenius Biotech GmbH den 20. april 2009.
English: It is usually given as four infusions in increasing doses from 10 to 150 micrograms over 11 days.
Danish: Det indgives som regel som fire infusioner med stigende doser fra 10 til 150 mikrogram i løbet af 11 dage.
English: Patients should be monitored after each infusion.
Danish: Patienten skal overvåges efter hver infusion.
English: There must be an interval of at least two days between infusions, but the interval can be increased if the patient has side effects.
Danish: Der skal være et interval på mindst to dage mellem hver infusion, men intervallet kan øges, hvis patienten får bivirkninger.
English: The Committee recommended that Removab be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Removab.
English: Around 90% of patients treated with Removab have side effects.
Danish: Cirka 90 % af de patienter, som får behandling med Removab, får bivirkninger.
English: Before treatment, it is recommended that patients are given medicines to reduce pain, fever and inflammation.
Danish: Før behandlingen påbegyndes, anbefales det at give patienten lægemidler, der mindsker smerte, feber og betændelse.
English: Other information about Removab:
Danish: Andre oplysninger om Removab: