natgillin/translations-raw huggingface dataset:
Svær leverinsufficiens' indflydelse på deferiprons og deferipron 3-O-glucuronids farmakokinetik er ikke evalueret.
The influence of severe hepatic impairment on the pharmacokinetics of deferiprone and deferiprone 3-O-glucuronide has not been evaluated.
Et randomiseret, placebokontrolleret, dobbeltblindt studie vurderede effekten af samtidig behandling med Ferriprox og deferoxamin hos talassæmi-patienter, der tidligere havde fået standard kelationsmonoterapi med sukutan deferoxamin og som havde mild til moderat jernophobning i hjertet (myokardial T2* fra 8 til 20 ms).
A randomized, placebo-controlled, double-blind trial evaluated the effect of concurrent therapy with Ferriprox and deferoxamine in patients with thalassaemia major, who previously received the standard chelation monotherapy with subcutaneous deferoxamine and had mild to moderate cardiac iron loading (myocardial T2* from 8 to 20 ms).
Hvis du har glemt at tage Ferriprox
If you forget to take Ferriprox
Ferriprox oral opløsning indeholder farvestoffet Sunset Yellow (E110), som kan forårsage allergiske reaktioner.
Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Sunset yellow (E110) Sucralose (E955)
Sucralose (E955)
De bivirkninger, der hyppigst er blevet rapporteret i løbet af behandling med deferipron i kliniske studier var kvalme, opkastning, mavesmerte og kromaturi, som blev rapporteret hos mere end 10 % af patienterne.
The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients.
LISTE OVER HJÆLPESTOFFER Indeholder Sunset Yellow (E110); se yderligere oplysninger i indlægssedlen.
LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
Kombinationsterapi med deferoxamin frarådes, når monoterapi med et af de kelerende stoffer er tilstrækkelig, eller når serumferritin falder under 500 µg/l.
Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
Der foreligger ingen tilgængelige informationer om anvendelsen af deferipron hos patienter med nyresygdom i slutstadiet eller svær leverinsufficiens (se pkt.
There are no data available on the use of deferiprone in patients with end stage renal disease or severe hepatic impairment (see section 5.2).
Skal anvendes inden 50 dage efter første åbning.
After first opening use within 50 days.
Skal anvendes inden 35 dage efter første åbning.
After first opening use within 35 days.
Hvis patienten udvikler en infektion under behandlingen med deferipron, skal behandlingen omgående seponeres, og det absolutte neutrofiltal skal kontrolleres hurtigst muligt.
If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay.
FLASKE MED 50 TABLETTER
BOTTLE OF 50 TABLETS
De mest alvorlige bivirkninger, der er rapporteret ved kliniske studier med deferipron, er agranulocytose (neutrofiltal < 0,5 x 109/l) med en forekomst på 1,1% (0,6 tilfælde pr. 100 patient-årsbehandling) (se pkt.
The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Studie LA16-0102 sammenlignede Ferriprox' virkning med deferoxamins virkning mht. reduktion af kardial jernophobning og forbedring af hjertefunktionen (som målt med LVEF) hos transfusionsafhængige talassæmi-patienter.
Study LA16-0102 compared the efficacy of Ferriprox with that of deferoxamine in decreasing cardiac iron overload and in improving cardiac function (as measured by LVEF) in transfusion-dependent thalassaemia patients.
Sikkerhedsprofilen for kombinationsterapi (med deferipron og deferoxamin), der er observeret i kliniske studier, erfaring efter markedsføring og publicerede data, stemmer overens med den sikkerhedsprofil, som er karakteristisk for monoterapi.
The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterized for monotherapy.
Ferriprox er pakket i glas med 50 tabletter.
Ferriprox is packaged in bottles of 50 tablets.
Ferriprox er pakket i glas med 100 tabletter.
Ferriprox is packaged in bottles of 100 tablets.
− hvis du er overfølsom over for deferipron eller et af de øvrige indholdsstoffer i denne medicin
− if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).
60-89 ml/min/1,73m2), moderat nyreinsufficiens (eGFR 30-59 ml/min/1,73m2) og svær nyreinsufficiens (eGFR 15-29 ml/min/1,73m2).
60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Tag ikke Ferriprox
Do not take Ferriprox
4.4) er indiceret til behandling af talassæmi-patienter, hvor monoterapi med et andet jernkelerende stof er utilstrækkelig eller hvor forebyggelse eller behandling af livstruende konsekvenser af jernophobning (hovedsagelig i hjertet) kræver hurtig eller intensiv korrektion (se pkt.
Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2).
Ud fra resultaterne af dette studie er der ikke behov for justering af Ferriprox-dosisregimet hos patienter med let eller moderat leverinsufficiens.
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with mildly or moderately impaired hepatic function.
Ferriprox 1000 mg filmovertrukne tabletter EU/1/99/108/004
Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har brugt det for nylig eller evt. tager anden medicin.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Hver 500 mg tablet indeholder 500 mg deferipron.
Each 500 mg tablet contains 500 mg deferiprone.
FLASKE MED 100 TABLETTER
BOTTLE OF 100 TABLETS
Hvor effektiv Ferriprox er til at reducere kroppens jernophobning påvirkes direkte af doseringen, og hvor stor jernophobningen er.
The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
Patienterne skal have besked på at henvende sig til deres læge, hvis de oplever symptomer, der kan tyde på infektion (såsom feber, ondt i halsen og influenzalignende symptomer).
Patients should be aware to contact their physician if they experience any symptoms indicative of infection (such as fever, sore throat and flu-like symptoms).
Forekomsten af bivirkninger i systemorganklassen “Knogler, led, muskler og bindevævs” og "Nyrer og urinveje" var lavere under kombinationsterapi end monoterapi, hvorimod forekomsten af bivirkninger i systemorganklassen “Hjerte" var højere under kombinationsterapi end monoterapi.
The incidences of “Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders" were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders" was higher during combination therapy than monotherapy.
Der blev også anvendt en MR-skanningsmetode, T2*, til at kvantificere myokardial jernophobning.
A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Tag ikke aluminiumbaserede syreneutraliserende midler, samtidig med at du tager Ferriprox.
Do not take aluminium-based antacids at the same time as taking Ferriprox.
Nerveforstyrrelser (såsom tremor, gangforstyrrelser, dobbeltsyn, ufrivillige muskelsammentrækninger, problemer med bevægelseskoordination) er rapporteret hos børn, som igennem flere år frivilligt har fået ordineret mere end 2 gange den maksimalt anbefalede dosis på 100 mg/kg/dag, og er også observeret hos børn ved standarddoser af deferipron.
Neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been observed in children with standard doses of deferiprone.
Hjælpestof, som behandleren skal være opmærksom på Hver ml oral opløsning indeholder 0,4 mg Sunset yellow (E110).
Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Deferipron-AUC'erne var de samme i de forskellige behandlingsgrupper, men Cmax var 20 % lavere hos forsøgsdeltagere med let eller moderat leverinsufficiens sammenlignet med raske frivillige.
Deferiprone AUCs did not differ between treatment groups, but Cmax was decreased by 20% in mildly or moderately hepatically impaired subjects compared with healthy volunteers.
“Anden medicin og Ferriprox”).
Other medicines and Ferriprox
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ferriprox 500 mg filmovertrukne tabletter Hver tablet indeholder 500 mg deferipron.
QUALITATIVE AND QUANTITATIVE COMPOSITION Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone.
Et åbent, ikke-randomiseret klinisk studie med parallelle grupper blev udført med henblik på at vurdere effekten af leverinsufficiens på sikkerhed, tolerabilitet og farmakokinetik for en enkelt oral dosis på 33 mg/kg Ferriprox.
An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Ferriprox.
Der skal udvises forsigtighed hos patienter med nyresygdom i slutstadiet eller svær nyreinsufficiens.
Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
− Sammen med denne folder finder du et informationskort til patient/plejer.
− Attached to this leaflet you will find a patient/carer reminder card. You should detach,
Maksimal serumkoncentration ses 45 til 60 minutter efter en enkeltdosis hos fastende patienter, men kan være forsinket til 2 timer hos patienter, der har indtaget føde.
Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients.
Se nedenstående skema for anbefalede doser for legemsvægt i 10 kg trin.
See table below for recommended doses for body weights at 10 kg increments.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
oplevet en signifikant større reduktion i serumferritin (1574 µg/l til 598 µg/l med samtidig terapi vs. 1379 µg/l til 1146 µg/l med deferoxamin monoterapi, p<0.001), signifikant større reduktion i myokardial jernophobning som vurderet ved en stigning i MRI T2* (11,7 ms til 17,7 ms med samtidig terapi vs. 12,4 ms til 15,7 ms med deferoxamin monoterapi, p=0,02) og signifikant større reduktion i jernkoncentrationen i leveren, også vurderet ved en stigning i MRI T2* (4,9 ms til 10,7 ms ved samtidig terapi vs. 4,2 ms til 5,0 ms med deferoxamin monoterapi, p<0,001).
After one year of study therapy, patients on concurrent chelation therapy had experienced a significantly greater reduction in serum ferritin (1574 µg/l to 598 µg/l with concurrent therapy vs. 1379 µg/l to 1146 µg/l with deferoxamine monotherapy, p<0.001), significantly greater reduction in myocardial iron overload, as assessed by an increase in MRI T2* (11.7 ms to 17.7 ms with concurrent therapy vs. 12.4 ms to 15.7 ms with deferoxamine monotherapy, p=0.02) and significantly greater reduction in liver iron concentration, also assessed by an increase in MRI T2* (4.9 ms to 10.7 ms with concurrent therapy vs. 4.2 ms to 5.0 ms with deferoxamine monotherapy, p< 0.001).
Neutropeni/agranulocytose
Neutropenia/Agranulocytosis
Det skal du vide, før du begynder at tage Ferriprox
What you need to know before you take Ferriprox
Eksempler på legemsvægt i 10 kg trin er anført.
Sample body weights at 10 kg increments are listed.
Se nedenstående skemaer for anbefalede doser for legemsvægt i 10 kg trin.
See tables below for recommended doses for body weights at 10 kg increments.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) Ferriprox 500 mg filmovertrukne tabletter EU/1/99/108/001
MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Indehaver af virksomhedsgodkendelse: Eurofins PROXY Laboratories B.V.
Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
ALMINDELIG
COMMON
Klar, rød-orange væske.
Clear, reddish orange-coloured liquid.
Kombineret brug sammen med andre jernkelerende stoffer Brugen af kombinationsterapi bør overvejes i hvert enkelt tilfælde.
The use of combination therapy should be considered on a case-by-case basis.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 August 1999
Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svær nyreinsufficiens (se pkt.
Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Hver 1000 mg tablet indeholder 1000 mg deferipron.
Each 1000 mg tablet contains 1000 mg deferiprone.
Tabletterne er forsynet med rille og kan brækkes over i to dele.
The tablets are scored and breakable in half.
Ferriprox oral opløsning er en klar, rød-orange væske.
What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Koncentreret saltsyre, til pH-regulering Kunstig kirsebærsmag Pebermynteolie
Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour
Tabletovertræk: Hypromellose, hydroxypropylcellulose, macrogol, titandioxid.
Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Øvrige indholdsstoffer: Tabletkerne: Mikrokrystallinsk cellulose, magnesiumstearat, kolloid silica.
The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Pakkninger med 50 tabletter.
Pack size of 50 tablets.
Tabletovertræk: Hypromellose, macrogol, titandioxid.
Coating: Hypromellose, Macrogol, Titanium dioxide.
Mikrokrystallinsk cellulose Magnesiumstearat
Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Da mekanismen for neutropeni fremkaldt af deferipron ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se pkt.
Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section
Hydroxyethylcellulose Glycerol (E422)
Glycerol (E422)
Ferriprox 1000 mg filmovertrukne tabletter Hver tablet indeholder 1000 mg deferipron.
Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone.
Ferriprox bruges til at behandle jernophobning som følge af hyppige blodtransfusioner hos talassæmipatienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Der er dog observeret neurologiske forstyrrelser (såsom cerebellare symptomer, diplopi, lateral nystagmus, nedsat psykomotorisk tempo, håndbevægelser og aksial hypotoni) hos børn, som igennem flere år frivilligt har fået ordineret mere end 2,5 gange den maksimalt anbefalede dosis på 100 mg/kg dagligt.
However, neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Forsøgsdeltagerne blev opdelt i 4 grupper ud fra estimeret glomerulær filtrationshastighed (eGFR): raske frivillige (eGFR) ≥ 90 ml/min/1,73m2), let nyreinsufficiens (eGFR 60-89 ml/min/1,73m2), moderat nyreinsufficiens (eGFR 30-59 ml/min/1,73m2) og svær nyreinsufficiens (eGFR 15-29 ml/min/1,73m2).
Subjects were categorized into 4 groups based on estimated glomerular filtration rate (eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR 60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Der er observeret neurologiske forstyrrelser (såsom cerebellare symptomer, diplopi, lateral nystagmus, nedsat psykomotorisk tempo, håndbevægelser og aksial hypotoni) hos børn, som igennem flere år frivilligt har fået ordineret mere end 2,5 gange den maksimalt anbefalede dosis på 100 mg/kg/dag.
Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Pakninger med 100 tabletter.
Pack size of 100 tablets.
Der sås en alvorlig bivirkning med akut lever- og nyreskade hos én forsøgsdeltager med moderat leverinsufficiens.
A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment.
Hver ml oral opløsning indeholder 100 mg deferipron.
Each ml of oral solution contains 100 mg deferiprone.
INFORMATION I BRAILLE-SKRIFT Ferriprox 1000 mg
INFORMATION IN BRAILLE Ferriprox 1000 mg
- Da mekanismen for neutropeni fremkaldt af deferipron ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se pkt.
- Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
Hver ml oral opløsning indeholder 100 mg deferipron (25 g deferipron i 250 ml og 50 g deferipron i 500 ml).
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
Brug ikke Ferriprox, hvis du ammer.
Do not use Ferriprox if you are breast-feeding.
Følgelig reducerer øget myokardial jern de myokardiale MRI T2*-værdier.
Iron overload causes concentration-dependent MRI T2* signal loss, thus, increased myocardial iron reduces myocardial MRI T2* values.
Øvrige indholdsstoffer: Tabletkerne: Methylcellulose, crospovidon, magnesiumstearat.
Tablet core: Methylcellulose, crospovidone, magnesium stearate.
INFORMATION I BRAILLE-SKRIFT Ferriprox 100 mg/ml
INFORMATION IN BRAILLE Ferriprox 100 mg/ml
Vis dette kort til lægen, hvis du udvikler symptomer på infektion, f.eks. feber, ondt i halsen eller influenzalignende symptomer.
Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.
Dosisjustering er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (se pkt.
Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Ferriprox monoterapi er indiceret til behandling af jernophobning hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
INFORMATION I BRAILLE-SKRIFT Ferriprox 500 mg
INFORMATION IN BRAILLE Ferriprox 500 mg
De neurologiske forstyrrelser svandt gradvist efter seponering af deferipron (se pkt.
The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Ferriprox 100 mg/ml oral opløsning deferipron
Ferriprox 100 mg/ml oral solution deferiprone
Deferipron har vist sig at forårsage neutropeni, herunder agranulocytose (se pkt.
Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Tag ikke Ferriprox, hvis du ammer.
Do not take Ferriprox if you are breast-feeding.
Doseringsskema for Ferriprox 1000 mg filmovertrukne tabletter Kropsvægt (kg)
Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 500 mg deferipron.
STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 500 mg deferiprone.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 1000 mg deferipron.
STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 1000 mg deferiprone.
FLASKER À 250 ML ELLER 500 ML
BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
HDPE-flaske med et børnesikret polypropylenlåg.
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Hver ml oral opløsning indeholder 100 mg deferipron (25 g deferipron i 250 ml).
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
LÆGEMIDLETS NAVN Ferriprox 500 mg filmovertrukne tabletter Ferriprox 1000 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Du må ikke tage medicin, der vides at forårsage neutropeni eller agranulocytose (se pkt.
Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”).
Tabletten har delekærv.
The tablet is scored.
Hver ml oral opløsning indeholder 100 mg deferipron (50 g deferipron i 500 ml).
Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
LÆGEMIDLETS NAVN Ferriprox 100 mg/ml oral opløsning
NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
Indehaveren af markedsføringstilladelsen skal sørge for, at der ligge et patientkort i hver pakning.
The MAH should provide a patient/carer reminder card in each pack, the text of which is included in the Package Leaflet.
HDPE-flaske med et børnesikret polypropylenlåg og et tørremiddel.
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Sådan skal du tage Ferriprox
How to take Ferriprox
Hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “1000” på den anden, uden påtryk på bagsiden.
White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “500” på den anden, uden påtryk på bagsiden.
White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
LÆGEMIDLETS NAVN Ferriprox 100 mg/ml oral opløsning deferipron
NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution deferiprone
Ferriprox 500 mg tabletter er hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “500” på den anden, uden påtryk på bagsiden.
What Ferriprox looks like and contents of the pack Ferriprox 500 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Ved doser på 100 mg/kg/dag eller derover hos ikke-jernbelastede dyr blev der rapporteret om atrofi i thymus, lymfoide væv og testis samt hypertrofi i binyrerne.
Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/kg/day or greater in non-iron-loaded animals.