FrancophonIA/ELRC3.0 huggingface dataset:
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: Three cases of acute oral overdose with zinc salts (sulphate or gluconate) have been reported in the literature.
Danish: Der er rapporteret tre tilfælde af akut, oral overdosering med zinksalte (sulfater eller gluconater) i litteraturen.
English: The non-ceruloplasmin plasma copper is calculated by subtracting the ceruloplasmin-bound copper from the total plasma copper, given that each milligram of ceruloplasmin contains 3 micrograms of copper.
Danish: Det nonceruloplasmin plasma kobber beregnes ved at trække det ceruloplasmine-bundne kobber fra det totale plasma kobber, under forudsætning af at hvert milligram af ceruplasmin indeholder 3 mikrogram kobber.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
English: POSSIBLE SIDE EFFECTS Like all medicines, Wilzin can cause side effects, although not everybody gets them..
Danish: Wilzin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: • Adults:
Danish: • Voksne:
English: However, they must be distinguished from haemolytic anaemia which commonly occurs where there is elevated serum free copper in uncontrolled Wilson's disease.
Danish: Men det skal adskilles fra hæmeolytiske anæmi, der hyppigt forekommer, når der er et forhøjet serum frit kobber i en ukontrolleret Wilson´s sygdom.
English: As with other anti-copper agents such as penicillamine, your symptoms may get worse after starting the treatment.
Danish: Som for andre anti-kobber præparater som f.eks. penicillamin, kan Deres symptomer bliver forværret efter behandlingsstart.
English: Five miscarriages and 2 birth defects (microcephaly and correctable heart defect) were reported in 42 pregnancies.
Danish: Der er rapporteret fire aborter og to misdannelser (mikrocephali og korrigerbar hjertefejl) ud af 42 graviditeter.
English: This is probably due to some extent of complexion of zinc by the chelator, thus reducing the effect of both active substances.
Danish: I et vist omfang skyldes det formentligt en kompleksbinding af zink til chelatet, og dermed en reduktion i effekt af begge aktive substanser.
English: A daily regimen of 150 mg of Wilzin in three administrations was shown to be effective in significantly reducing copper absorption and inducing a negative copper balance.
Danish: En daglig dosis på 150 mg Wilzin fordelt på tre administrationer viste at have en signifikant effekt på at reduktion af kobber absorptionen og induktion af en negativ kobberbalance.
English: Laboratory follow-up including haematological surveillance and lipoproteins determination should also be performed in order to detect early manifestations of copper deficiency, such as anaemia and/or leukopenia resulting from bone marrow depression, and decrease in HDL cholesterol and HDL/total cholesterol ratio.
Danish: Der bør også foretages laboratorieopfølgning herunder overvågning af hematologi og lidoproteinindhold for at følge tidlige en tidlig manifestation på kobbermangel, som f.eks. anæmi og/eller leukopeni, der er et resultat af knoglemarvsdepression, og et fald i HDL-kolesterol og HDL/total kolesterolforholdet.
English: In these patient groups, urinary copper levels should be kept a little above the upper limit of normal or in the high normal range (i.e. 40 - 50 microgram/24 h).
Danish: Hos disse patientgrupper skal kobber i urinen holdes på en lille smule over den øverste grænse af normalt eller i det høje normal område (dvs. 40-50 mikrogram/24 timer).
English: Treatment of overdose should be with gastric lavage or induced emesis as quickly as possible to remove unabsorbed zinc.
Danish: Behandlingen af en overdosering bør være en maveudskylning eller ved at inducere opkastning så hurtigt som muligt for derved at fjerne uabsorberet zink.
English: In the blood, about 80% of absorbed zinc is distributed to erythrocytes, with most of the remainder being bound to albumin and other plasma proteins.
Danish: I blodet er ca. 80% af det absorberede zink fordelt i erythrocytterne og med den det meste af det overskyde bundet til albumin eller andre plasmaproteiner.
English: The level of hepatic copper cannot be used to manage therapy since it does not differentiate between potentially toxic free copper and metallothionein bound copper.
Danish: Niveauet af kobber i leveren kan ikke bruges til at styre behandlingen, da det ikke skelner imellem potentielt toksisk frit kobber og metallothionein-bundet kobber.
English: The other ingredients are maize starch and magnesium stearate.
Danish: - Øvrige indholdsstoffer er majsstivelse, og magnesiumstearat.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: 4.6 Pregnancy and lactation
Danish: 4.6 Graviditet og amning
English: 4.1 Therapeutic indications
Danish: 4.1 Terapeutiske indikationer
English: As copper deficiency may also cause myeloneuropathy, physicians should be alert to sensory and motor symptoms and signs which may potentially indicate incipient neuropathy or myelopathy in patients treated with Wilzin.
Danish: Da kobbermangel også kan forårsage myeloneuropati, bør læger være agtpågivende over for sensoriske og motoriske symptoner og tegn, der potentielt kan indikere begyndende neuropati eller myelopati, hos patienter i behandling med Wilzin.
English: 4.4 Special warnings and special precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Bone marrow examination usually reveals characteristic "ringed sideroblasts" (i.e. developing red blood cells containing iron-engorged paranuclear mitochondria).
Danish: En undersøgelse af knoglemarven afslører sædvanligvis en karakteristisk ”ringet sideroblast” (dvs. udvikling af røde blodceller, der indeholder jernberigede paranukleare mitochondrier).
English: Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine.
Danish: Niveauet af kobber i urinen øges sædvanligvis i en chelatbehandling som penicillamin eller trientine.
English: 4.3 Contraindications
Danish: 4.3 Kontraindikationer
English: When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Danish: Når en patient skifter fra en chelatbehandling til Wilzin vedligeholdelsesbehandling, skal chelatbehandlingen forsættes som samtidig behandling i 2-3 uger, idet det er den tid det tager for at zinkbehandlingen at inducere en maksimal metallothionein induktion og en fuldstændig blokering af kobber absorptionen.
English: Wilzin should be taken on an empty stomach, separated from mealtimes.
Danish: Wilzin skal tages på en tom mave, adskilt fra måltiderne.
English: Dietary copper, which cannot be properly eliminated, accumulates first in the liver, then in other organs such as the eyes and the brain.
Danish: Kobber i føden, der ikke kan elimineres på ordentlig vis, akkumuleres først i leveren siden i andre organer som øjnene og hjernen.
English: Dietary fibres and some dairy products, in particular, delay the absorption of zinc salts.
Danish: Kostfibre og specielt visse mælkeprodukter kan forsinke absorptionen af zinksalte.
English: If you have been prescribed Wilzin with another anti-copper agent, such as penicillamine, keep an interval of at least 1 hour between the two medicines.
Danish: Hvis De har fået ordineret Wilzin sammen med et andet anti-kobber produkt, som f.eks. penicillamin, skal der være et interval på mindst 1 time imellem indtagelse af de to produkter.
English: 6.2 Incompatibilities
Danish: 6.2 Uforligeligheder
English: Whether this is related to mobilisation of copper stores or to natural history of the disease remains unclear.
Danish: Det er fortsat uklart om det er relateret til mobilisering af kobberdepoterne eller om det skyldes sygdommens natur.
English: No special requirements
Danish: Ingen særlige forholdsregler.
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: Elevations of serum alkaline phosphatase, amylase and lipase may occur after a few weeks of treatment, with levels usually returning to high normal within the first one or two years of treatment.
Danish: Der kan forekomme forhøjede værdier af basisk phosphatase, amylase og lipase efter få ugers behandling, men niveauerne normaliseres efter 1-2 års behandling.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: • Do not store above 25°C.
Danish: • Må ikke opbevares ved temperaturer over 25 °C.
English: It is extremely important that pregnant Wilson's disease patients continue their therapy during pregnancy.
Danish: Det er meget vigtigt at gravide med Wilsons´s sygdom fortsætter deres behandling under graviditeten.
English: Wilson's disease will persist during the entire lifetime of the patient and therefore the need for this treatment is life-long.
Danish: Wilson´s sygdom er en livsvarig lidelse, og derfor er behandlingsbehovet også livsvarigt.
English: Like with all anti-copper agents overtreatment carries the risk of copper deficiency, which is especially harmful for children and pregnant women since copper is required for proper growth and mental development.
Danish: Som med alle anti-kobber stoffer, kan en over-behandling medføre en risiko for kobbermangel, der især er skadeligt for børn og gravide kvinder, idet det er nødvendigt for vækst og mental udvikling.
English: In order to follow up your condition and treatment your doctor will check your blood and urine on a regular basis.
Danish: Deres læge vil regelmæssigt kontrollere Deres blod og urin for at følge Deres tilstand og behandling.
English: Other medicinal products
Danish: Andre lægemidler
English: This side effect may be reduced by postponing the first dose of the day until mid-morning (between breakfast and the midday meal).
Danish: Denne bivirkning kan reduceres ved at udsætte den første dosis på dagen til om formiddagen (mellem morgenmad og frokost).
English: The absorption of zinc may be reduced by iron and calcium supplements, tetracyclines and phosphorus-containing compounds, while zinc may reduce the absorption of iron, tetracyclines, fluoroquinolones.
Danish: Absorptionen af zink kan blive reduceret af jern og calcium tilskud, tetracycliner og forbindelser, der indeholder phosphor, mens zink kan reducere absorptionen af jern, tetracycliner og flouroquinoloner.
English: Another adolescent who ingested 4 g of zinc had serum zinc level of about 50 mg/l 5 hours later and only experienced severe nausea, vomiting and dizziness.
Danish: Andre yngre personer, der havde indtaget 4 g zink havde et serum zink niveau på ca. 50 mg/l efter 5 timer og oplevede kun alvorlig kvalme, opkastning og svimmelhed.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: The faecal excretion is in the greatest part due to the passage of unabsorbed zinc but it is also due to endogenous intestinal secretion.
Danish: Den fækale udskillelse skyldes overvejende passagen af uabsorberet zink, men skyldes også endogen intestinel sekretion.
English: Studies of the co-administration of zinc with food performed in healthy volunteers showed that the absorption of zinc was significantly delayed by many foods (including bread, hard boiled eggs, coffee and milk).
Danish: Undersøgelser, hvor mad er blevet givet samtidig med zink til raske forsøgspersoner, viser at absorptionen forsinkes signifikant af mange fødevarer (herunder brød, hårdkogte æg, kaffe og mælk).
English: The oral LD50 is approximately 300 mg zinc/kg body weight (about 100 to 150 times the human therapeutic dose).
Danish: Den orale LD50 er ca. 300 mg zink/kg kropsvægt (ca. 100 til 150 gange den menneskelige terapeutiske dosis).
English: Pharmacodynamic investigations of copper metabolism in patients with Wilson's disease included determinations of net copper balance and radiolabelled copper uptake.
Danish: De farmakodynamiske undersøgelser af kobbermetabolismen i patienter med Wilson´s sygdom, omfatter bestemmelse af netto balancen og radioaktivt mærket kobber optagelse.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: In children who are unable to swallow capsules, these should be opened and their content suspended in a little water (possibly sugar or syrup flavoured water).
Danish: Hos børn, der ikke kan sluge kapsler, kan disse åbnes, og indholdet kan suspenderes i lidt vand (kan være sukker- eller saftevand).
English: White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil).
Danish: Hvide HDPE beholdere, der har en polypropylen og HDPE lukning og indeholder fyld (bomuldstot).
English: The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/l (normal: 100-150 microgram/l) and the urinary copper excretion below 125 microgram/24 h (normal: < 50 microgram/24 h).
Danish: Formålet med denne behandling er at opnå plasma frit kobber (også kendt som non-ceruloplasmin plasma kobber) mindre end 250 mikrogram/l (normalt 100-150 mikrogram/l) og urin kobber ekskreationen under 125 mikrogram/24 timer (normalt: < 50 mikrogram/24 timer).
English: GENERAL CLASSIFICATION FOR SUPPLY
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: It is also possible to take Wilzin with a little protein, such as meat.
Danish: Det er også muligt at indtage Wilzin med en lidt protein, f.eks. kød.
English: They may be early manifestations of copper deficiency and may recover rapidly following reduction of zinc dosage.
Danish: Det kan være en tidlig manifestation af kobbermangel og normaliseres hurtigt efter en reduktion af zinkdosis.
English: Substances in food, especially phytates and fibres, bind zinc and prevent it from entering the intestinal cells.
Danish: Indholdsstoffer i mad, f.eks. fytater og fibre, binder zink og forhindre det i at trænge ind i de intestitielle celle.
English: It may also be minimised by taking the first dose of Wilzin with a small amount of protein-containing food, such as meat (but not milk).
Danish: Den kan også minimeres ved at tage den første dosis af Wilzin med en lille smule proteinholdigt mad, f.eks. kød (men ikke mælk).
English: They showed no significant overall effect on copper balance although mild interaction of zinc with chelators (penicillamine and trientine) could be detected with decreased faecal but increased urinary copper excretion as compared with zinc alone.
Danish: Der blev ikke set nogen signifikant overordnet effekt på kobberbalancen, selvom der var en mild interaktion mellem zink og chelaterne (penicillamin og trientin), der kunne ses som en mindre fækal men øget urinudskillelse af kobber sammenlignet med zink alene.
English: In treated patients, assays of urinary and/or plasma zinc may be a useful measure of treatment compliance.
Danish: Hos patienter i behandling er analyser af urin og/eller plasma zink et brugbart mål for medicinefterlevelsen.
English: - If you have any further questions, please ask your doctor or pharmacist.
Danish: - Hvis De har yderligere spørgsmål, bedes De kontakte Deres læge eller apotek.
English: Symptomatic patients must be initially treated with a chelating agent; once copper levels are below toxic thresholds and patients are clinically stable, maintenance treatment with Wilzin can be considered.
Danish: Symptomatiske patienter skal initialt i en chelatbehandling; når kobberniveauerne er over den toksiske grænse og patienten er klinisk stabil, kan en vedligeholdelsesbehandling med Wilzin overvejes.
English: It is available in packs of 250 hard capsules in a polyethylene bottle closed by a polypropylene and polyethylene closure.
Danish: Wilzin findes i pakker med 250 hårde kapsler i polyethylen-flasker lukket med en polypropylen- og polyethylen-lukning.
English: It ranges from 30 to 60% with usual dietary intake (7-15 mg/d) and decreases to 7% with pharmacological doses of 100 mg/d.
Danish: Med en normal kost, varierer det fra 30 - 60% (7-15 mg/dag) og falder til 7% med en farmakologisk dosis på 100 mg/dag.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Wilzin is indicated in the treatment of Wilson's disease, which is a rare inherited defect in copper excretion.
Danish: Wilzin er indiceret til behandling af Wilson´s sygdom, der er en sjælden, arvelig defekt i kobberudskillelsen.
English: 2D barcode carrying the unique identifier included.
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: In this case, you must inform your doctor.
Danish: I sådanne tilfælde skal De orientere Deres læge.
English: Two patients of a series of 16 died from hepatic decompensation and advanced portal hypertension after being changed from penicillamine to zinc therapy.
Danish: To patienter ud af 16 døde af levernedbrydning og fremskreden portal hypertension efter at have skiftet fra penicillamin til zinkbehandling.
English: Animal studies conducted with different zinc salts do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg med forskellige zinksalte viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Copper accumulation in the liver leads to hepatocellular injury and eventual cirrhosis.
Danish: Ophobning af kobber i leveren fører til en hepatocellulær skade og eventuelt til cirrose.
English: gastric irritation
Danish: Almindelige: Gastrisk irritation
English: Values of urinary zinc above 2 mg/24 h and of plasma zinc above 1250 microgram/l generally indicate adequate compliance.
Danish: Værdier af zink i urinen, der overstiger 2 mg/24 timer og på plasma zink over 1250 mikrogram/l indikere en tilstrækkelig efterlevelse.
English: Patients may present clinically with predominantly hepatic, neurologic, or psychiatric symptoms.
Danish: Klinisk udviser patienterne symptomer som overvejende er hepatiske, neurologisk og psykiatriske.
English: ANNEX I
Danish: BILAG I
English: Repeat-dose toxicity studies have established that the NOEL (No Observed Effect Level) is about 95 mg zinc/kg body weight (about 48 times the human therapeutic dose).
Danish: Gentagen-dosis toksicitets studier har vist at NOEL (Niveauet for Ingen Observeret Effekt) er ca. 95 mg zink/kg kropsvægt (ca. 48 gange den humane terapeutiske dosis).
English: If the morning dose is not well tolerated (see section 4) it is possible to delay it to mid-morning, between breakfast and lunch.
Danish: Hvis morgendosisen ikke tåles så godt (se afsnit 4), kan denne dosis skubbes til om formiddagen, mellem morgenmad og frokost.
English: ANNEX III
Danish: BILAG III
English: A dose of 25 mg 3 times daily is usually effective but the dose should be adjusted to copper levels (see section 4.4 and section 4.6).
Danish: En dosis på 25 mg tre gange dagligt er sædvanligvis effektiv, men dosis skal justeres til kobberniveauer (se pkt.
English: No conventional carcinogenicity study has been conducted with zinc acetate dihydrate.
Danish: Der er ikke lavet et traditionelt carciogenitetsstudie med zinkacetatdihydrat.
English: Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson's disease (see section 4.4).
Danish: Når en behandling med Wilzin skal startes, skal det ske under en overvågning af en læge, der er erfaren i behandling af Wilson´s sygdom (se pkt.
English: • Do not use Wilzin after the expiry date stated on the bottle and the carton, after EXP.
Danish: • Brug ikke Wilzin efter den udløbsdato, der står på pakningen.
English: 250 hard capsules.
Danish: 250 kapsler, hårde.
English: Wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile.
Danish: Wilsons´s sygdom (hepatolentikulær degeneration) er en autosomal resseciv metabolisk defekt i leverens udskillelse af kobber i galden.
English: Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: Reproduction toxicology studies performed with different zinc salts showed no clinically relevant evidence of embryotoxicity, foetotoxicity or teratogenicity.
Danish: Reproduktionsstudier, der er gennemført med forskellige zinksalte, viste ikke nogen klinisk relevante tegn på embryotoksicitet, foetaltoksicitet eller teratogenicitet.
English: Nevertheless, while awaiting zinc induced duodenal metallothionein production and consequential effective inhibition of copper absorption, zinc acetate dehydrate could be administered initially in symptomatic patients in combination with a chelating agent.
Danish: Imidlertid, mens der ventes på den zinkinducerede duodenal metallothioneinproduktion, og følgeligt en effektivt inhibering af kobberabsorptionen, så kan zinkacetatdihydrat initielt gives til symptomatiske patienter i kombination med et chelaterende produkt.
English: Pharmacological and toxicological data available showed large similarities between zinc salts and among animal species.
Danish: De farmakologiske og toksikologiske data, der er tilgængelige, viser en stor lighed imellem zinksaltene og imellem dyrespecies.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu/.
English: - Keep this leaflet.
Danish: - Gem indlægssedlen.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil eller betjene maskiner.
English: Conversely, the effectiveness of some medicines, such as iron, tetracyclines or fluoroquinolones (antibiotics), may be reduced by Wilzin.
Danish: Omvendt kan virkningen af andre lægemidler som jern, tetracycliner, flouroquinoloner (antibiotika) nedsættes på grund af Wilzin.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: ANNEX II
Danish: BILAG II
English: Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre France
Danish: Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre Frankrig
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstilles efter, hvor alvorlige de er.
English: NAME OF THE MEDICINAL PRODUCT
Danish: LÆGEMIDLETS NAVN
English: Wilzin blocks the absorption of copper from the intestine thereby preventing its transfer into the blood and its further accumulation in the body.
Danish: Wilzin blokerer for absorptionen af kobber fra tarmen og forhindrer derved overførsel til blodet og dermed videre ophobning i kroppen.
English: 5.3 Preclinical safety data
Danish: 5.3 Prækliniske sikkerhedsdata