FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Erleada 60 mg
Danish: Erleada 60 mg
English: No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP2C8 (e.g., gemfibrozil, clopidogrel) however, a reduction of the Erleada dose based on tolerability should be considered (see section 4.2).
Danish: Initial dosisjustering er ikke nødvendig, når Erleada administreres sammen med en stærk CYP2C8-hæmmer (f.eks. gemfibrozil, clopidogrel), men det bør overvejes at reducere dosen af Erleada på baggrund af tolerabilitet (se pkt.
English: Medicinal products which prolong the QT interval Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g., quinidine, disopyramide) or class III (e.g., amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics (e.g. haloperidol), etc. should be carefully evaluated (see section 4.4).
Danish: Da androgen deprivationsbehandling kan forlænge QT-intervallet, skal samtidig brug af Erleada og lægemidler, der forlænger QT-intervallet, eller lægemidler, der kan inducere torsades de pointes, såsom klasse IA-antiarytmika (f.eks. quinidin, disopyramid) eller klasse III-antiarytmika (f.eks. amiodaron, sotalol, dofetilid, ibutilid), methadon, moxifloxacin, antipsykotika (f.eks. haloperidol) osv. evalueres nøje (se pkt.
English: Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5), physicians should assess the benefit-risk ratio including the potential for Torsade de pointes prior to initiating Erleada.
Danish: Androgen deprivationsbehandling kan forlænge QT-intervallet Hos patienter med QT-forlængelse i anamnesen eller med risikofaktorer for QT-forlængelse og hos patienter, der samtidigt får lægemidler, som kan forlænge QT-intervallet (se pkt.
English: • treat fungal infections (e.g. itraconazole, ketoconazole)
Danish: • behandling af svampeinfektioner (f.eks. itraconazol, ketoconazol)
English: Potential for other medicinal products to affect apalutamide exposures
Danish: Andre lægemidler, der kan påvirke apalutamideksponeringen
English: A major metabolite, N-desmethyl apalutamide, exhibited one-third the in vitro activity of apalutamide.
Danish: Hovedmetabolitten N-desmethylapalutamid kunne tilskrives en tredjedel af apalutamids in vitro-aktivitet.
English: 24 film-coated tablets each.
Danish: 24 filmovertrukne tabletter hver.
English: Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted (see section 4.5).
Danish: Thyreoidea-substitutionsbehandling bør iværksættes eller dosisjusteres, hvor det er klinisk relevant (se pkt.
English: In a drug-drug interaction study using a cocktail approach, co-administration of Erleada with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (CYP3A4 substrate), 85% decrease in the AUC of omeprazole (CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (CYP2C9 substrate).
Danish: I et interaktionsstudie, hvor der blev anvendt flere forskellige lægemidler, resulterede samtidig administration af Erleada og enkelte orale doser af følsomme CYP-substrater i en reduktion på 92 % i AUC af midazolam (CYP3A4-substrat), en reduktion på 85 % i AUC af omeprazol (CYP2C19substrat) og en reduktion på 46 % i AUC af S-warfarin (CYP2C9-substrat).
English: A dedicated hepatic impairment study compared the systemic exposure of apalutamide and N- desmethyl apalutamide in subjects with baseline mild hepatic impairment (N=8, Child-Pugh Class A, mean score = 5.3) or moderate hepatic impairment (N=8, Child-Pugh Class B, mean score = 7.6)
Danish: I et specifikt studie af nedsat leverfunktion blev den systemiske eksponering for apalutamid og N-desmethylapalutamid sammenlignet hos forsøgsdeltagere med let nedsat leverfunktion (N = 8, Child-Pugh-klasse A, gennemsnitsscore = 5,3) eller moderat nedsat leverfunktion (N = 8, Child-Pughklasse B, gennemsnitsscore = 7,6) ved baseline i forhold til raske kontrolpersoner med normal leverfunktion (N = 8).
English: Falls were reported for 15.6% of patients treated with Erleada versus 9.0% of patients treated with placebo (see section 4.4).
Danish: Fald blev indberettet hos 15,6 % af de patienter, der blev behandlet med Erleada, og hos 9,0 % af de patienter, der blev behandlet med placebo (se pkt.
English: Erleada 60 mg film-coated tablets apalutamide
Danish: Erleada 60 mg filmovertrukne tabletter apalutamid
English: For the most common adverse reactions, see section 4.8.
Danish: For de mest almindelige bivirkninger, se pkt.
English: Each film-coated tablet contains 60 mg of apalutamide.
Danish: Hver filmovertrukket tablet indeholder 60 mg apalutamid.
English: 28 film-coated tablets each.
Danish: 28 filmovertrukne tabletter hver.
English: • treat cancer (e.g. lapatinib, methotrexate)
Danish: • behandling af kræft (f.eks. lapatinib, methotrexat)
English: Skin rash led to Erleada treatment discontinuation in 9% of patients who experienced skin rash.
Danish: Hududslæt førte til seponering af behandlingen med Erleada hos 9 % af de patienter, der oplevede hududslæt.
English: In a drug-drug interaction study, the Cmax of apalutamide decreased by 21% while AUC increased by 68% following co-administration of apalutamide 240 mg single dose with gemfibrozil (strong CYP2C8 inhibitor).
Danish: I et lægemiddelinteraktionsstudie faldt Cmax af apalutamid med 21 %, mens AUC steg med 68 % efter samtidig administration af apalutamid 240 mg som enkeltdosis sammen med gemfibrozil (stærk CYP2C8-hæmmer).
English: • you have ever had fits or seizures
Danish: • du nogensinde har haft krampeanfald.
English: Mild or moderate inhibitors of CYP3A4 are not expected to affect the exposure of apalutamide.
Danish: Lette eller moderate CYP3A4-hæmmere forventes ikke at påvirke eksponeringen for apalutamid.
English: • treat epilepsy (e.g. phenytoin, valproic acid)
Danish: • behandling af epilepsi (f.eks. phenytoin, valproinsyre)
English: • treat opioid addiction or pain (e.g. methadone)
Danish: • behandling af opioidafhængighed eller smerter (f.eks. methadon)
English: In a drug-drug interaction study, the Cmax of apalutamide decreased by 22% while AUC was similar following co-administration of Erleada as a 240 mg single dose with itraconazole (strong CYP3A4 inhibitor).
Danish: I et lægemiddelinteraktionsstudie faldt Cmax af apalutamid med 22 %, mens AUC var uforandret efter samtidig administration af Erleada som en enkeltdosis på 240 mg sammen med itraconazol (stærk CYP3A4-hæmmer).
English: What Erleada looks like and contents of the pack Erleada film-coated tablets are slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), with “AR 60” written on one side.
Danish: Erleada filmovertrukne tabletter er let gullige til grågrønne, aflange, filmovertrukne tabletter (16,7 mm lange x 8,7 mm brede), der er præget med ”AR 60” på den ene side.
English: Colloidal anhydrous silica Croscarmellose sodium Hypromellose acetate succinate Magnesium stearate Microcrystalline cellulose Microcrystalline cellulose (silicified)
Danish: Kolloid, vandfri silica Croscarmellosenatrium hypromelloseacetatsuccinat Magnesiumstearat
English: Other medicines and Erleada
Danish: Brug af anden medicin sammen med Erleada
English: Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre patienter (se pkt.
English: • treat anxiety (e.g. midazolam, diazepam)
Danish: • behandling af angst (f.eks. midazolam, diazepam)
English: Nervous system disorders uncommon: seizure (see section 4.4)
Danish: Nervesystemet ikke almindelig: krampeanfald (se pkt.
English: When substrates of CYP2B6 (e.g., efavirenz) are administered with Erleada, monitoring for an adverse reaction and evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Danish: Når substrater for CYP2B6 (f.eks. efavirenz) administreres sammen med Erleada, bør der gennemføres monitorering for bivirkninger og evaluering for manglende virkning af substratet, og det kan være nødvendigt at justere dosen af substratet for at opretholde optimale plasmakoncentrationer.
English: Falls and fractures occurred in patients receiving Erleada (see section 4.8).
Danish: Fald og frakturer forekom hos patienter, der fik Erleada (se pkt.
English: Median time to reach tmax was delayed about 2 hours with food (see section 4.2).
Danish: Ved indtagelse sammen med mad var mediantiden til opnåelse af tmax cirka 2 timer længere (se pkt.
English: Musculoskeletal and connective tissue disorders very common: fracture+ very common: arthralgia
Danish: Knogler, led, muskler og bindevæv meget almindelig: fraktur meget almindelig: artralgi
English: • treat gastroesophageal reflux disease (conditions where there is too much acid in the stomach)
Danish: • behandling af gastroøsofageal reflukssygdom (tilstand med for meget mavesyre) (f.eks.
English: When substrates of UGT are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Danish: Når substrater for UGT administreres sammen med Erleada, bør der gennemføres evaluering for manglende virkning af substratet, og det kan være nødvendigt at justere dosen af substratet for at opretholde optimale plasmakoncentrationer.
English: Iron oxide black (E172) Iron oxide yellow (E172) Macrogol
Danish: Jernoxid, sort (E 172) Jernoxid, gul (E 172) Macrogol
English: P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Danish: Når substrater for P-gp, BCRP eller OATP1B1 administreres sammen med Erleada, bør der gennemføres evaluering for manglende virkning af substratet, og det kan være nødvendigt at justere dosen af substratet for at opretholde optimale plasmakoncentrationer.
English: Mild or moderate inhibitors of CYP2C8 are not expected to affect the exposure of apalutamide.
Danish: Lette eller moderate CYP2C8-hæmmere forventes ikke at påvirke eksponeringen for apalutamid.
English: • lower blood glucose (e.g. repaglinide)
Danish: • sænkning af blodsukkeret (f.eks. repaglinid)
English: Each bottle contains 120 tablets and a total of 6 g of desiccant.
Danish: Hver beholder indeholder 120 tabletter og i alt 6 g tørremidde.
English: Broken bones have been observed in patients taking Erleada.
Danish: Der er set brækkede knogler hos patienter, der tog Erleada.
English: A dedicated renal impairment study for apalutamide has not been conducted.
Danish: Der er ikke udført specifikke studier af nedsat nyrefunktion med apalutamid.
English: Concomitant use of apalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters (see section 4.5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations.
Danish: 4.5), bør generelt undgås, hvis disse lægemidlers terapeutiske virkning er af stor betydning for patienten, og hvis der ikke let kan udføres dosisjusteringer baseret på monitorering af virkning eller plasmakoncentrationer.
English: At steady-state, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms).
Danish: Ved steady state var den maksimale middelændring i QTcF i forhold til baseline 12,4 msek.
English: Each 28-day carton contains 112 film-coated tablets in 4 cardboard wallet packs of 28 film-coated tablets each.
Danish: Hver 28-dages karton indeholder 112 filmovertrukne tabletter i 4 pap-etuier med 28 filmovertrukne tabletter hver.
English: Τηλ: +357 22 207 700
Danish: CY-2234 Λευκωσία Τηλ: +357 22 207 700
English: PHARMACEUTICAL FORM AND CONTENTS 120 tablets
Danish: 120 tabletter
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets
Danish: 112 filmovertrukne tabletter
English: Erleada is co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) however, a reduction of the Erleada dose based on tolerability should be considered (see section 4.2).
Danish: Initial dosisjustering er ikke nødvendig, når Erleada administreres sammen med en stærk CYP3A4-hæmmer (f.eks. ketoconazol, ritonavir, clarithromycin), men det bør overvejes at reducere dosen af Erleada på baggrund af tolerabilitet (se pkt.
English: Each 30-day carton contains 120 film-coated tablets in 5 cardboard wallet packs of 24 film-coated tablets each.
Danish: Hver 30-dages karton indeholder 120 filmovertrukne tabletter i 5 pap-etuier med 24 filmovertrukne tabletter hver.
English: Erleada decreased the relative risk of distant metastasis or death by 70% compared to placebo (HR = 0.30;
Danish: Erleada reducerede den relative risiko for fjernmetastaser eller død med 70 % i forhold til placebo (HR = 0,30; 95 % CI: 0,24; 0,36; p < 0,0001).
English: Each bottle contains 120 film-coated tablets and a total of 6 g of silica gel desiccant.
Danish: Hver beholder indeholder 120 filmovertrukne tabletter og i alt 6 g silicageltørremiddel.
English: (1) Press and hold
Danish: Tryk og hold
English: It is metabolised primarily by CYP2C8 and CYP3A4 to form N-desmethyl apalutamide.
Danish: Det metaboliseres primært til N-desmethylapalutamid via CYP2C8 og CYP3A4.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 60 mg (12 count) (Blister sealed in inner wallet)
Danish: BLISTER 60 mg (12 stk.) (Blister i indre etui)
English: How to store Erleada
Danish: Indtagelse af Erleada
English: • Each 30-day carton contains 120 film coated tablets in 5 cardboard wallet packs of
Danish: • Hver 30-dages karton indeholder 120 filmovertrukne tabletter i 5 pap-etuier med
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 60 mg (16 count) (Blister sealed in inner wallet)
Danish: BLISTER 60 mg (16 stk.) (Blister i indre etui)
English: • treat hayfever and allergies (e.g. fexofenadine)
Danish: • behandling af høfeber og allergi (f.eks. fexofenadin)
English: Skin rash included rash, rash maculo-papular, rash generalised, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, and rash vesicular.
Danish: Hududslæt omfatter udslæt, makulopapuløst udslæt, generaliseret udslæt, urticaria, kløende udslæt, makulært udslæt, konjunktivitis, erythema multiforme, papuløst udslæt, hudeksfoliation, genitalt udslæt, erytematøst udslæt, stomatitis, lægemiddeludslæt, mundsår, pustuløst udslæt, blærer, papler, pemfigoid, huderosion og vesikulært udslæt.
English: • Each 28-day carton contains 112 film coated tablets in 4 cardboard wallet packs of
Danish: • Hver 28-dages karton indeholder 112 filmovertrukne tabletter i 4 pap-etuier med
English: If you stop taking Erleada
Danish: Hvis du har taget for meget Erleada
English: Based on the population pharmacokinetic analysis using data from clinical studies in subjects with castration-resistant prostate cancer (CRPC) and healthy subjects, no significant difference in systemic exposure was observed in subjects with pre-existing mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] between 30 to 89 mL/min/1.73 m2; N=585) compared to subjects with baseline normal renal function (eGFR ≥ 90 mL/min/1.73 m2; N=372).
Danish: Baseret på den farmakokinetiske populationsanalyse af data fra kliniske studier med forsøgsdeltagere med kastrationsresistent prostatacancer (CRPC) og raske forsøgsdeltagere blev der ikke set nogen signifikant forskel i den systemiske eksponering hos forsøgsdeltagere med præeksisterende mild til moderat nyreinsufficiens (estimeret glomerulær filtrationshastighed [eGFR] fra 30 til
English: Hypothyroidism was reported for 8.1% of patients treated with Erleada and 2.0% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months.
Danish: Hypothyreoidisme blev indberettet hos 8,1 % af de patienter, der blev behandlet med Erleada, og hos 2,0 % af de patienter, der blev behandlet med placebo.
English: This medicine is not likely to affect you being able to drive and use any tools or machines.
Danish: Dette lægemiddel påvirker sandsynligvis ikke arbejdssikkerheden eller evnen til at færdes i trafikken.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Erleada.
Danish: Tal med din læge eller apotekspersonalet, inden du tager Erleada, hvis noget af ovenstående gør sig gældende for dig (eller hvis du er i tvivl).
English: How to take Erleada
Danish: Sådan skal du tage Erleada
English: • you are taking any medicines to prevent blood clots (e.g., warfarin, acenocoumarol) • you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia)
Danish: • du tager medicin til forebyggelse af blodpropper (f.eks. warfarin eller acenocoumarol).
English: • falls
Danish: • fald
English: • treat thyroid conditions (e.g. levothyroxine)
Danish: • behandling af skjoldbruskkirtelsygdomme (f.eks. levothyroxin)
English: Metabolism is the main route of elimination of apalutamide.
Danish: Apalutamid elimineres primært via metabolisering.
English: (2) Pull out
Danish: Træk ud
English: Fill in your weekdays Start date:
Danish: Udfyld dine ugedage
English: Falls have been observed in patients taking Erleada.
Danish: Der er set fald hos patienter, der tog Erleada.
English: What you need to know before you take Erleada 3.
Danish: Det skal du vide, før du begynder at tage Erleada Sådan skal du tage Erleada Bivirkninger
English: Bottle
Danish: Placebo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 60 mg (BOTTLE)
Danish: KARTON 60 mg (BEHOLDER)
English: PHARMACEUTICAL FORM AND CONTENTS 24 film-coated tablets per wallet pack
Danish: 24 filmovertrukne tabletter pr. etui
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 60 mg
Danish: ETIKET TIL BEHOLDER 60 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 60 mg (28 days)
Danish: KARTON 60 mg (28 dage)
English: NAME OF THE MEDICINAL PRODUCT Erleada 60 mg film-coated tablets
Danish: Erleada 60 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 60 mg (30 days)
Danish: KARTON 60 mg (30 dage)
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets per wallet pack
Danish: 28 filmovertrukne tabletter pr. etui
English: • treat gout (e.g. colchicine)
Danish: • behandling af urinsyregigt (f.eks. colchicin)
English: Seizure
Danish: Hududslæt
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INNER WALLET 60 mg (28 days)
Danish: INDRE ETUI 60 mg (28 dage)
English: Do not swallow or discard the desiccant.
Danish: Tørremidlet må ikke indtages eller fjernes.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg apalutamide.
Danish: Hver tablet indeholder 60 mg apalutamid.
English: • broken bones
Danish: • knoglebrud
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INNER WALLET 60 mg (30 days)
Danish: INDRE ETUI 60 mg (30 dage)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING OUTER WALLET 60 mg (28 days)
Danish: YDRE ETUI 60 mg (28 dage)
English: 95% CI: 0.24, 0.36; p < 0.0001).
Danish: (2-sidet 90 % øvre CI: 16,0 msek.).
English: If treatment is started, patients should be monitored for the adverse reactions listed in section 4.8 and dose reduce as per section 4.2 Posology and method of administration.
Danish: 4.8, og dosen skal reduceres i henhold til pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING OUTER WALLET 60 mg (30 days)
Danish: YDRE ETUI 60 mg (30 dage)
English: When substrates of
Danish: Måneder fra randomisering
English: These combinations are not covered in this summary.
Danish: Disse kombinationer er ikke indeholdt i dette sammendrag.
English: These medicines should only be used in adult women.
Danish: Disse lægemidler bør kun anvendes til voksne kvinder.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018 EMA/181295/2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: Bearberry leaf preparations should only be used after serious conditions have been excluded by a doctor.
Danish: Tilberedninger med melbærrisblad bør kun anvendes, når en læge har udelukket mere alvorlige tilstande.
English: Bearberry leaf is the common name for the leaves of the plant Arctostaphylos uva-ursi (L.) Spreng.
Danish: Melbærrisblad er fællesnavnet for blade af planten Arctostaphylos uva-ursi (L.) Spreng.
English: The HMPC conclusions on the use of these bearberry leaf medicines for lower urinary tract infections are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med melbærrisblade til at behandle infektioner i de nedre urinveje er baseret på lægemidlernes "traditionelle anvendelse".
English: Any applications for the licensing of medicines containing bearberry leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder melbærrisblad, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of bearberry leaf medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder melbærrisblad, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: In its assessment, the HMPC considered laboratory studies which showed bearberry leaf preparations to have antibacterial action.
Danish: HMPC har i sin vurdering lagt vægt på laboratorieundersøgelser, der har vist, at tilberedninger med melbærrisblad har antibakteriel effekt.
English: Women with kidney disorders must not take bearberry leaf medicines.
Danish: Kvinder med nyreproblemer må ikke tage lægemidler med melbærrisblad.
English: Further information on the risks associated with these bearberry leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder melbærrisblad, herunder passende forholdsregler, der skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: "ema.europa.eu/Find medicine/Herbal medicines for human use".
English: Bearberry leaf preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af melbærrisblade findes desuden kombineret med andre droger i visse plantelægemidler.
English: Detailed instructions on how to take bearberry leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med melbærrisblad bør tages, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: They should not be taken for longer than one week and if symptoms last for more than four days or worsen during the use of the medicine a
Danish: end 1 uge, og hvis symptomerne varer længere end fire dage eller forværres under brug af lægemidlet, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.