FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no carcinogenic effects were recorded in studies conducted in mice and rats receiving up to 400 mg/kg/day maltol.
Danish: Der blev imidlertid ikke registreret karcinogen effekt i undersøgelser hos mus og rotter, der fik maltol op til 400 mg/kg/dag.
English: Do not store the capsules above 25°C.
Danish: Kapslerne må ikke opbevares ved temperaturer over 25º C.
English: Black discolouration of the stool is a well-known ADR of oral iron formulations.
Danish: Sort misfarvning af fæces er en velkendt bivirkning ved orale jernpræparater.
English: • Allura Red AC (E129) (see section 2)
Danish: • Allura Red AC (E129) (se afsnit 2)
English: Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the irondesferroxamine complex.
Danish: Hæmodialyse fjerner ikke jern effektivt, men bør overvejes som støttende behandling ved akut nyresvigt, da det fremmer fjernelsen af jern-deferoxaminkomplekset.
English: Iron overdosage is dangerous and can be life-threatening in young children, requiring immediate attention.
Danish: Overdosering med jern er farlig og kan hos små børn være livsfarlig og kræve behandling øjeblikkeligt.
English: Concomitant use of iron with methyldopa should be avoided as oral iron may antagonise the hypotensive effect of methyldopa.
Danish: Brug af jern sammen med methyldopa bør undgås, da oralt jern kan modvirke den hypotensive virkning af methyldopa.
English: Capsule shell:
Danish: Kapsel:
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 18.
English: Following completion of the 12-week placebo-controlled phase of the studies, all subjects were switched to Feraccru 30 mg twice daily open-label treatment for a further 52 weeks.
Danish: Efter gennemførelsen af den 12-ugers placebokontrollerede fase af undersøgelserne skiftede alle personerne til åben behandling med Feraccru, 30 mg to gange dagligt, i yderligere 52 uger.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.> 18.
English: No reproductive and developmental toxicity or carcinogenicity studies have been conducted with ferric maltol.
Danish: Der er ikke udført undersøgelser af reproduktions- og udviklingstoksicitet eller karcinogenicitet med ferrimaltol.
English: Feraccru is indicated in adults for the treatment of iron deficiency.
Danish: Feraccru er indiceret til behandling af jernmangel hos voksne.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Detaljeret information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Sunset Yellow (E110) and Allura Red (E129): may cause allergic reactions.
Danish: Sunset Yellow (E110) og Allura Red (E129): kan forårsage allergiske reaktioner.
English: • Colloidal anhydrous silica
Danish: • Kolloid vandfri silica
English: Ferritin continued to rise over long-term treatment with Feraccru (mean 68.9 μg/L [SD 96.24] at 64 weeks, a mean overall improvement of 60.3 μg/L).
Danish: Ferritin fortsatte med at stige i løbet af langtidsbehandlingen med Ferracru (gennemsnit 68,9 μg/l [SD 96,24] ved uge 64, hvilket er en samlet forbedring på 60,3 μg/l i gennemsnit).
English: Exposure to maltol glucuronide increased dose proportionally over the Feraccru 30 to 90 mg twice daily dosing range and there was no significant accumulation of either after 7 days treatment with Feraccru.
Danish: Eksponeringen for maltolglucuronid øgedes proportionalt med doseringen af Feraccru mellem 30 og 90 mg to gange dagligt, og der var ingen nævneværdig akkumulering af nogen af stofferne efter 7 dages behandling med Feraccru.
English: Based on an in vitro study maltol is glucuronised through UGT1A6 (see section 5.2).
Danish: Baseret på et in vitro-studie glukuronideres maltol via UGT1A6 (se pkt.
English: No clinical data on the need to adjust the dosage in patients with impaired hepatic or renal function are available (see section 4.4).
Danish: Der foreligger ingen kliniske data om, hvorvidt det er nødvendigt med en dosisjustering hos patienter med nedsat lever- eller nyrefunktion (se pkt.
English: If you forget to take your Feraccru
Danish: Hvis du har glemt at tage Feraccru
English: What Feraccru looks like and contents of the pack Feraccru is a red hard capsule containing a reddish-brown powder.
Danish: Feraccru er røde hårde kapsler, der indeholder et rødbrunt pulver.
English: Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis.
Danish: På dette trin ses tegn på hepatocellulær nekrose med ikterus, blødning, hypoglykæmi, encefalopati og metabolisk acidose med positivt anion forskel.
English: • Haemochromatosis and other iron overload syndromes.
Danish: • Hæmokromatose og andre syndromer med jernophobning.
English: Taking too much Feraccru can make the person feel sick or be sick and cause bellyache and diarrhoea.
Danish: Personer, der får for meget Feraccru, kan få kvalme, mavepine og diarré.
English: Store below 25°C.
Danish: Opbevares ved temperaturer under 25 C.
English: • Magnesium stearate
Danish: • Magnesiumstearat
English: • Lactose monohydrate (see section 2)
Danish: • Lactosemonohydrat (se afsnit 2)
English: This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Da dette lægemiddel indeholder lactose, bør det ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110).
Danish: En kapsel indeholder 91,5 mg lactose, 0,5 mg Allura Red AC (E129) og 0,3 mg Sunset Yellow FCF (E110).
English: An increase of ≥2 g/dL change in Hb at Week 12 was achieved in 62 % and 51 % of the ulcerative colitis and Crohn's Disease subgroups, respectively.
Danish: Der opnåedes en stigning på ≥2 g/dl i Hb ved uge 12 hos hhv. 62 % og 51 % af patienterne i undergrupperne med colitis ulcerosa og Crohns sygdom.
English: On the basis of the scientific conclusions for ferric maltol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ferric maltol is unchanged subject to the proposed changes to the product information
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne På baggrund af de videnskabelige konklusioner for ferrimaltol er CHMP af den opfattelse, at benefit/riskforholdet for det lægemiddel/de lægemidler, der indeholder ferrimaltol, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
English: Mean ferritin (μg/L) levels in subjects taking feraccru improved steadily from baseline (mean 8.6 μg/L [SD 6.77]) to Week 12 (mean 26.0 μg/L [SD 30.57]), a mean overall improvement of 17.4 μg/L.
Danish: Det gennemsnitlige ferritinniveau (μg/l) hos personer, der tog Feraccru, steg støt fra baseline (gennemsnit 8,6 μg/l [SD 6,77]) til uge 12 (gennemsnit 26,0 μg/l [SD 30,57]), hvilket er en samlet forbedring på 17,4 μg/l i gennemsnit.
English: • Sunset Yellow FCF (E110) (see section 2)
Danish: • Sunset yellow FCF (E110) (se afsnit 2)
English: Concomitant use of chloramphenicol with iron should be avoided as chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Danish: Brug af kloramfenikol samtidig med jern bør undgås, da kloramfenikol forsinker clearance af jern fra plasma og inkorporering af jern i erytrocytterne og griber ind i erytropoiesen.
English: Concomitant use of iron with dimercaprol should be avoided as the combination of dimercaprol and iron is nephrotoxic.
Danish: Brug af jern sammen med dimercaprol bør undgås, da kombinationen af dimercaprol og jern er nefrotoksisk.
English: An increase of ≥1 g/dL change in Hb at Week 12 was achieved in 90 % and 69 % of the ulcerative colitis (N=29) and Crohn's Disease (N=35) subgroups, respectively.
Danish: Der opnåedes en stigning på ≥1 g/dl i Hb ved uge 12 hos hhv. 90 % og 69 % af patienterne i undergrupperne med colitis ulcerosa (N=29) og Crohns sygdom (N=35).
English: Possible side effects.
Danish: Bivirkninger.
English: Maximum maltol and maltol glucuronide concentrations were reached approximately 1 hour after oral administration of Feraccru.
Danish: Den maksimale koncentration af maltol og maltolglucuronid blev nået ca. 1 time efter oral administration af Feraccru.
English: Maltol was transiently measured in plasma with a AUC0-t between 0.022 and 0.205 h.µg/mL across all dosing regimens and both study days.
Danish: AUC0-t var mellem 0,022 og 0,205 h.µg/ml for alle dosisregimer og begge undersøgelsesdage.
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules
Danish: LÆGEMIDLETS NAVN Feraccru, hårde kapsler, 30 mg
English: Contents of the pack and other information.
Danish: Pakningsstørrelser og yderligere oplysninger.
English: Feraccru contains iron (as ferric maltol).
Danish: Feraccru indeholder jern (som ferrimaltol).
English: As a precautionary measure, it is preferable to avoid the use of Feraccru during breast-feeding.
Danish: Som forsigtighedsforanstaltning må det foretrækkes at undgå at anvende Feraccru under amning.
English: Ferric maltol
Danish: Ferrimaltol
English: Maximum maltol and maltol glucuronide concentrations were reached 1 to 1.5 hours after oral administration of Feraccru.
Danish: Den maksimale koncentration af maltol og maltolglucuronid blev nået 1-1,5 timer efter oral administration af Feraccru.
English: Deposition of iron in the reticulo-endothelial system, liver and spleen was recorded in dogs administered 250 mg/kg/day ferric maltol.
Danish: Jernafsætningen i det retikuloendoteliale system, leveren og milten blev registreret hos hunde, der fik ferrimaltol 250 mg/kg/dag.
English: • Gelatin
Danish: • Gelatine
English: The pharmacokinetic properties of Feraccru was assessed through measurement of plasma and urine concentrations of maltol and maltol glucuronide, together with serum iron parameters after a single dose and at steady state (after 1 week) in 24 subjects with iron deficiency, randomised to receive 30 mg, 60 mg or 90 mg Feraccru twice daily.
Danish: De farmakokinetiske egenskaber af Feraccru blev undersøgt ved måling af plasma- og urinkoncentrationen af maltol og maltolglucuronid foruden serumjernparametre efter en enkeltdosis og i steady state (efter 1 uge) hos 24 personer med jernmangelanæmi, der var randomiseret til enten 30 mg, 60 mg eller 90 mg Feraccru to gange dagligt, Der foretoges bestemmelse af maltol og maltolglucuronid i prøver af blod og urin.
English: Special care should be taken if other dietary and/or iron salt supplementation are used concurrently.
Danish: Særlig forsigtighed bør udvises ved sideløbende anvendelse af andre jerntilskud i kosten og/eller tilskud af jernsalte.
English: • Flatulence (wind)
Danish: • tarmluft (flatulens)
English: Definitive animal studies are not available for maltol with respect to reproductive toxicity.
Danish: Der foreligger ingen definitive dyreundersøgelser af reproduktionstoxicitet af maltol.
English: Hb change (g/dL) from Baseline* at Week 4
Danish: Gennemsnitlig ændring i Hb (g/dL) fra baseline* ved uge 4 (SE)
English: Driving and using machines Feraccru is unlikely to have any effect on the ability to drive and use machines.
Danish: Feraccru forventes ikke at påvirke evnen til at føre motorkøretøj bil eller betjene maskiner.
English: Blood thyroid stimulating hormone increased Gamma-glutamyltransferase increased
Danish: Forhøjet TSH Forhøjet gammaglutamyltransferase
English: You should avoid taking Feraccru if you are experiencing a “flare” of your IBD.
Danish: Du skal undgå at tage Feraccru, hvis du har en forværring af din irritable tarmsygdom.
English: Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand.
Danish: Feraccru indeholder et kompleks af stabilt jern(III) og en trimaltol-ligand.
English: Proportion of subjects that achieved ≥2 g/dL change in Hb at Week
Danish: Andel personer, havde opnået en Hb-ændring på ≥2 g/dl ved uge
English: What you need to know before you take Feraccru.
Danish: Det skal du vide, før du begynder at tage Feraccru.
English: Serum samples were assayed for iron parameters.
Danish: Der foretoges bestemmelse af jernparametre i serumprøver.
English: What you need to know before you take Feraccru
Danish: Det skal du vide, før du begynder at tage Feraccru
English: Feraccru (N=64) 1.06 (0.08)*** 1.79 (0.11)*** 66 Placebo (N=64) 0.02 (0.08) * Hb at Baseline mean (SE): Feraccru 11.0 (1.027) g/dL, Placebo 11.1 (0.851) g/dL; ***p<0.0001 compared to placebo group;
Danish: * Gennemsnit for Hb ved baseline (SE): Feraccru 11,0 (1,027) g/dL, placebo 11,1 (0,851) g/dL; ***p<0,0001 sammenlignet med placebogruppen;
English: Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBDpatients with haemoglobin (Hb) <9.5 g/dl.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Feraccru bør ikke anvendes til patienter med eksacerbation af aktiv inflammatorisk tarmsygdom (IBD) eller IBD- patienter med niveauer af hæmoglobin (Hb) under 9,5 g/dl.
English: Faeces discolouration was observed in patients treated with ferric maltol in clinical trials.
Danish: I kliniske studier blev der observeret fæcesmisfarvning hos patienter behandlet med ferrimaltol.
English: MARKETING AUTHORISATION HOLDER Norgine B.V.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Norgine B.V.
English: Proportion of subjects that achieved ≥1 g/dL change in Hb at Week
Danish: Andel personer, der havde opnået en Hb-ændring på ≥1 g/dl ved uge 12 (%)
English: LIST OF EXCIPIENTS Contains lactose, Sunset Yellow (E110) and Allura Red (E129).
Danish: Feraccru-kapsler indeholder lactose, Sunset Yellow (E110) og Allura Red (E129).
English: Abdominal discomfort/ distension
Danish: Flatulens forstoppelse (konstipation) Abdominalt ubehag/abdominal udspiling
English: Haemosiderin was observed in Kupffer cells of dogs administered 250 mg/kg/day maltol.
Danish: Der blev iagttaget hæmosiderin i Kupffer-cellerne hos hunde, der fik maltol 250 mg/kg/dag.
English: HDPE bottles with a child-proof polypropylene push-lock.
Danish: 6.5 Emballagetype og pakningsstørrelser HDPE-flasker med børnesikret låg af polypropylen.
English: Proportion of subjects that achieved normalised Hb at Week
Danish: Andel personer, der havde opnået normalt Hb ved uge 12 (%)
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11.
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF 11.
English: SYSTEM ORGAN CLASS COMMON (≥ 1/100 to < 1/10)
Danish: Tabel 1: Bivirkninger iagttaget i kliniske studier til dato SYSTEMORGANKLASSE ALMINDELIG (≥ 1/100 til < 1/10)
English: What Feraccru contains The active substance is 30 mg of iron as ferric maltol.
Danish: Det aktive stof er 30 mg jern som ferrimaltol.
English: Discoloured faeces Nausea
Danish: Misfarvet fæces Kvalme
English: Hb change (g/dL) from Baseline* at Week 8
Danish: Gennemsnitlig ændring i Hb (g/dL) fra baseline ved uge 8 (SE)
English: The median time since last dose of OFP was 22 months in the experimental group and 17 months in the placebo arm. 52 % of the patients in AEGIS 1 and 33 % in AEGIS 2 had a disease flare in the previous 6 months.
Danish: 52 % af patienterne i AEGIS 1 og 33 % i AEGIS 2 havde haft en eksacerbation af sygdommen i de foregående seks måneder.
English: Crospovidone (Type A)
Danish: Kolloid vandfri silica Crospovidon (Type A)
English: Feraccru 30 mg
Danish: INFORMATION I BRAILLESKRIFT Feraccru 30 mg
English: Tell your doctor or pharmacist if you are taking any other medicines.
Danish: Tal med lægen eller apotekspersonalet, hvis der er mere, du vil vide om brugen af lægemidlet.
English: Musculoskeletal and connective tissue disorders
Danish: Muskler, knogler og bindevæv
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg iron (as ferric maltol).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En kapsel indeholder 30 mg jern (som ferrimaltol) Hjælpestof(fer), som behandleren skal være opmærksom på:
English: • Discomfort or bloating in the stomach
Danish: • maveubehag eller oppustethed
English: • Nausea (feeling sick)
Danish: • forstoppelse (konstipation)
English: How to take Feraccru.
Danish: Sådan skal du tage Feraccru.
English: Absorption of both iron and antibiotic may be reduced if oral iron is given with tetracycline.
Danish: Hvis oralt jern gives sammen med tetracyklin, kan det nedsætte absorptionen af både jern og antibiotikum.
English: Peak transferrin saturation (TSAT) and total serum iron values were reached 1.5 to 3 hours after oral administration of Feraccru.
Danish: Den maksimale transferrinmætning (TSAT) og totale serumjernværdier blev nået 1,5 til 3 timer efter oral administration af Feraccru Den totale jernkoncentration i serum og TSAT-værdien var generelt større ved stigende doser af Feraccru.
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules Iron (as ferric maltol) STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 30 mg iron (as ferric maltol).
Danish: LÆGEMIDLETS NAVN Feraccru, hårde kapsler, 30 mg Jern (som ferrimaltol) ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En kapsel indeholder 30 mg jern (som ferrimaltol) LISTE OVER HJÆLPESTOFFER Indeholder lactose, Sunset Yellow (E110) og Allura Red (E129).
English: Food has been shown to inhibit uptake of Feraccru: Feraccru should be taken on an empty stomach (see section 4.2)
Danish: Feraccru bør tages på tom mave (se pkt.
English: This medicinal product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110): these may cause allergic reactions.
Danish: Dette lægemiddel indeholder Allura Red AC (E129) og Sunset Yellow FCF (E110).
English: PHARMACEUTICAL PARTICULARS
Danish: ANVENDELSE AF LÆGEMIDLET
English: How to take Feraccru
Danish: Sådan skal du tage Feraccru
English: Joint stiffness Pain in extremity
Danish: Ledstivhed Ekstremitetssmerter
English: Package leaflet: Information for the patient Feraccru 30 mg hard capsules Iron (as ferric maltol)
Danish: Feraccru, hårde kapsler, 30 mg Jern (som ferrimaltol)
English: • Constipation
Danish: • kvalme
English: Fertility was unaffected following maltol treatment in animal studies.
Danish: I dyreundersøgelser har maltol ikke vist påvirkning af fertiliteten.
English: Norgine B.V. medinfo.benelux@norgine.com
Danish: medinfo.benelux@norgine.com
English: 6.5 Nature and contents of container
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Kapselindhold:
English: Gastrointestinal disorders
Danish: Magnesiumstearat
English: • If you get any side effects, talk to your doctor or pharmacist.
Danish: • Kontakt lægen eller apotekspersonalet hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: • Discoloured faeces
Danish: • misfarvet afføring
English: • Stomach pain
Danish: • mavesmerter
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: The starting dose depends on the patient's body weight.
Danish: Startdosen afhænger af patientens kropsvægt.
English: The full EPAR for Sialanar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Sialanar findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Sialanar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sialanar.
English: Other information about Sialanar
Danish: Andre oplysninger om Sialanar
English: Sialanar is available as a solution to be taken by mouth three times a day, one hour before or two hours after meals.
Danish: Sialanar fås som en opløsning, der tages gennem munden tre gange om dagen, én time før eller to timer efter måltider.
English: Why is Sialanar approved?
Danish: Hvorfor blev Sialanar godkendt?
English: What measures are being taken to ensure the safe and effective use of Sialanar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sialanar?
English: The dose is then adjusted according to how the patient responds to the medicine and its side effects.
Danish: Dosen tilpasses efterfølgende, ud fra hvordan patienten reagerer på medicinen og bivirkningerne ved den.
English: What is Sialanar and what is it used for?
Danish: Hvad er Sialanar, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Sialanar.
Danish: Det er ikke en praktisk vejledning i, hvordan Sialanar bør anvendes.
English: Sialanar glycopyrronium bromide
Danish: Sialanar glycopyrroniumbromid
English: What are the risks associated with Sialanar?
Danish: Hvilke risici er der forbundet med Sialanar?
English: With regard to its risks, the side effects that occur with glycopyrronium bromide can be managed by adequately monitoring patients and adjusting the dose.
Danish: Hvad angår risiciene, kan de bivirkninger, der forekommer med glycopyrroniumbromid, styres med tilstrækkelig monitorering af patienterne og tilpasning af dosis.
English: It must also not be used in patients who are pregnant or are taking potassium chloride tablets or capsules or medicines which have anticholinergic effect.
Danish: Lægemidlet må ikke anvendes til patienter, der er gravide, eller som tager kaliumchlorid-tabletter eller -kapsler eller lægemidler, der har antikolinergisk virkning.
English: These receptors trigger the production of saliva when activated by nerves from the brain.
Danish: Disse receptorer udløser produktionen af spyt, når de aktiveres af nerver, der udgår fra hjernen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that benefits of Sialanar outweigh its risks and recommended that it be granted marketing authorisation in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Sialanar opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: By blocking the receptors, the medicine is expected to help reduce the amount of saliva produced by the glands and so reduce drooling.
Danish: Ved at blokere receptorerne forventes medicinen at medvirke til at nedsætte spytproduktionen i kirtlerne og dermed reducere savlen.
English: Sialanar should be prescribed by a doctor with experience in treating children with nervous system conditions and it can only be obtained with a prescription.
Danish: Sialanar bør udskrives af en læge med erfaring i behandling af børn med sygdomme i nervesystemet, og det kan kun fås på recept.
English: To help prescribers and carers use the medicine as safely as possible, the company that markets Sialanar will provide them with educational material containing information on how to use the medicine properly and manage its side effects.
Danish: Med henblik på at hjælpe de ordinerende læger og plejepersoner med at bruge lægemidlet så sikkert som muligt skal virksomheden, der markedsfører Sialanar, forsyne dem med informationsmateriale, der indeholder oplysninger om, hvordan lægemidlet skal anvendes korrekt, og hvordan bivirkningerne ved det skal styres.
English: It contains the active substance glycopyrronium bromide.
Danish: Det indeholder det aktive stof glycopyrroniumbromid.