natgillin/translations-raw huggingface dataset:
nefrotisk syndrom blevet rapporteret indenfor 6 måneder,
4 Two cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
I det ene tilfælde viste histologien en membranøs glomerulonefritis af den renale allograft og i det andet tilfælde hypersensitiv interstitiel nefritis.
Histology showed a membranous glomerulonephritis of the renal allograft in one case and hypersensitivity interstitial nephritis in the other.
Der er rapporteret enkelte tilfælde der minder om Ehlers- Danlos syndrom på albuerne hos børn, der kronisk bliver behandlet med høje doser af forskellige cysteamin formuleringer (cysteamin klorhydrat, cysteamin eller cysteamin bitartrat), hovedsageligt over den maksimale dosis på 1, 95 g/ m2/ dag.
A few cases of Ehlers-Danlos like syndrome on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/ m2/ day.
Disse hudlæsioner har i enkelte tilfælde været associeret med hud striae og knoglelæsioner, der blev opdaget ved en røntgenundersøgelse.
In some cases, these skin lesions were associated with skin striae and bone lesions first seen during an X-ray examination.
I de få tilfælde, hvor histo - / patologiske undersøgelse af huden er blevet udført tydede resultaterne på angioendotheliomatose.
In the few cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
Hos nogle patienter forsvandt hud - og albuelæsionerne efter at CYSTAGON dosen blev reduceret.
In some patients, the skin lesions on elbows regressed after CYSTAGON dose reduction.
4. 4).
Cysteamine mechanism of action by interfering with the cross-linking of collagen fibers has been postulated (see section 4.4).
I tilfælde af overdosering bør åndedrætssystemet og hjerte- kar kredsløbet styrkes.
Should overdosage occur, the respiratory and cardiovascular systems should be supported appropriately.
Behandling af diagnosticeret nephropatisk cystinosis, ATC- kode:
Alimentary tract and metabolism product, ATC code:
Normale individer og personer, som er heterocygote for cystinosis har et cystinniveau i de hvide blodlegemer på henholdsvis < 0, 2 og sædvanligvis under 1 nmol hemicystin/ mg protein.
Normal individuals and heterozygous subjects for cystinosis have white cell cystine levels of < 0.2, and usually below 1 nmol hemicystine/ mg protein, respectively.
Personer med nephropatisk cystinose har stigninger i cystinindholdet i hvide blodlegemer på over 2 nmol hemicystin/ mg protein.
Individuals with nephropathic cystinosis have elevations of white cell cystine above 2 nmol hemicystine/ mg protein
Cysteamin reagerer med cystin og danner et sammensat disulfid mellem cysteamin og cystin, og cystin.
Cysteamine reacts with cystine to form the mixed disulfide of cysteamine and cysteine, and cysteine.
Leukocyt cystinniveauet når dets minimum (middelværdi (± SD):
The leucocyte cystine level reaches its minimum (mean (± sd) value:
1, 8 ± 0, 8 timer) en anelse senere end peak plasmacysteaminkoncentrationen (middelværdi (± SD):
1.8 ± 0.8 hours) slightly later than the peak plasma cysteamine concentration (mean (± sd) value:
1, 4 ± 0, 4 timer) og vender tilbage til basisniveauet som plasmacysteaminkoncentrationen falder 6 timer efter dosering.
1.4 ± 0.4 hours) and returns to its baseline level as the plasma cysteamine concentration decreases at 6 hours post-dose.
5 I et klinisk studie var cystin baseline i de hvide blodlegemer 3, 73 (fra 0, 13 til 19, 8) nmol hemicystin/ mg protein og blev vedligeholdt tæt ved 1 nmol hemicystin/ mg protein med en cysteamindosis på fra 1, 3 til 1, 95 g/ m2/ dag.
In one clinical study, baseline white cell cystine levels were 3.73 (range 0.13 to 19.8) nmol hemicystine/ mg protein and were maintained close to 1 nmol hemicystine/ mg protein with a cysteamine dose range of 1.3 to 1.95 g/ m2/ day.
Et tidligere studie behandlede 94 børn med nephropatisk cystinosis med stigende mængder af cysteamin for at holde cystinniveauet i de hvide blodlegemer under 2 nmol hemicystin/ mg protein 5 til 6 timer efter doseringen og sammenlignede deres resultat med en historisk gruppe på 17 børn behandlet med placebo.
An earlier study treated 94 children with nephropathic cystinosis with increasing doses of cysteamine to attain white cell cystine levels of less than 2 nmol hemicystine/ mg protein 5 to 6 hours post-dose, and compared their outcome with an historical control group of 17 children treated with placebo.
Middelværdien for cystinniveauet i de hvide blodlegemer opretholdt under behandlingen var 1, 7 ± 0, 2 nmol hemicystin/ mg protein.
The mean white cell cystine level attained during treatment was 1.7 + 0.2 nmol hemicystine/ mg protein.
Imidlertid steg væksthastigheden ikke nok til, at patienterne kunne nå op på normerne ifølge deres alder.
5 increase enough to allow patients to catch up the normal for their age.
Efter en enkelt oral dosis cysteaminbitartrat svarende til 1, 05 g cysteamin fri base hos raske forsøgspersoner, er middelværdierne (± SD) for tiden til peak og peak plasmakoncentration henholdsvis 1, 4 (± 0, 5) timer og 4, 0 (± 1, 0) μg/ ml.
Following a single oral dose of cysteamine bitartrate equivalent to 1.05 g of cysteamine free base in healthy volunteers, the mean (± sd) values for the time to peak and peak plasma concentration are 1.4 (± 0.5) hours and 4.0 (± 1.0) µg/ ml, respectively.
Hos patienter i steady state er disse værdier henholdsvis 1, 4 (± 0, 4) timer og 2, 6 (± 0, 9) μg/ ml, efter en dose ranging fra 225 til 550 mg.
In patients at steady state, these values are 1.4 (± 0.4) hours and 2.6 (± 0.9) µg/ ml, respectively, after a dose ranging from 225 to 550 mg.
Cysteamins in vitro plasmaproteinbinding, som overvejende er til albumin, er uafhængig af plasmalægemiddelkoncentrationen over det terapeutiske område, med en middelværdi (± SD) på 54, 1% (±) 1, 5).
The in vitro plasma protein binding of cysteamine, which is mostly to albumin, is independent of plasma drug concentration over the therapeutic range, with a mean (± sd) value of 54.1% (± 1.5).
Plasmaproteinbindingen hos patienter i steady state er magen til:
The plasma protein binding in patients at steady state is similar:
Henholdsvis 53, 1% (± 3, 6) og 51, 1% (± 4, 5) ved henholdsvis 1, 5 og 6 timer efter dosering.
53.1% (± 3.6) and 51.1% (± 4.5) at 1.5 and 6 hours post-dose, respectively.
I en farmakokinetisk undersøgelse udført med 24 raske frivillige i 24 timer, var middelestimatet (± SD) for den terminale halveringstid for udskillelse 4, 8 (± 1, 8) timer.
In a pharmacokinetic study performed in 24 healthy volunteers for 24 hours, the mean estimate (± sd) for the terminal half-life of elimination was 4.8 (± 1.8) hours.
Eliminationen af uændret cysteamin i urinen har vist sig at ligge i området mellem 0, 3% og 1, 7% af den totale daglige dosis hos fire patienter; hovedparten af cysteamin bliver udskilt som sulfat.
The elimination of unchanged cysteamine in the urine has been shown to range between 0.3% and 1.7% of the total daily dose in four patients; the bulk of cysteamine is excreted as sulphate.
Selvom der i publicerede studier med cysteamin er blevet rapporteret induktion af kromosom- forandringer i dyrkede eukaryote cellelinier, viste specifikke studier med cysteaminbitartrat hverken mutagene effekter ved Ames test eller clastogene effekter ved mikronucleus test hos mus.
Genotoxicity studies have been performed: although in published studies using cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported, specific studies with cysteamine bitartrate did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
Reproduktionsstudier viste embryoføtale toksiske effekter (resorptioner og post implantale tab) hos rotter ved et dosisniveau på 100 mg/ kg/ dag og hos kaniner der fik cysteamin doser på 50 mg/ kg/ dag.
Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/ kg/ day dose level and in rabbits receiving cysteamine 50 mg/ kg/ day.
Teratogene virkninger er blevet beskrevet hos rotter, når der gives cysteamin over organogeneseperioden ved en dosis på 100 mg/ kg/ dag.
Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/ kg/ day.
Dette svarer til 0, 6 g/ m2/ dag hos rotten, hvilket er mindre end halvdelen af den anbefalede kliniske vedligeholdelsesdosis af cysteamin, dvs.
This is equivalent to 0.6 g/ m2/ day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i. e.
1, 30 g/ m2/ dag.
1.30 g/ m2/ day.
En reduktion i fertilitet blev observeret hos rotter ved 375 mg/ kg/ dag, en dosis hvor øgning af legemsvægt blev forhalet.
A reduction of fertility was observed in rats at 375 mg/ kg/ day, a dose at which body weight gain was retarded.
Høje doser af cysteamin forringer ammende mødres evne til at ernære 6 deres hvalpe.
High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Cellulose mikrokrystallinsk, stivelse pregelatineret, magnesiumstearat/ natriumlaurilsulfat, silica, kolloid dioxid, natrium carboxymethylcellulose,
Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/ sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide,
Gelatine, titandioxid, sort blæk på den hårde kapsel indeholder E172.
black ink on hard capsules containing E172
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris La Défense Frankrig
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris La Défense France
EU/ 1/ 97/ 039/ 001 (100 hårde kapsler pr. flaske), EU/ 1/ 97/ 039/ 002 (500 hårde kapsler pr. flaske).
EU/ 1/ 97/ 039/ 001 (100 hard capsules per bottle), EU/ 1/ 97/ 039/ 002 (500 hard capsules per bottle).
23. juni 1997.
23 June 1997.
23. juni 2007.
23 June 2007.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside, http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Hver hård kapsel indeholder 150 mg cysteamin (som mercaptamin bitartrat)
Each hard capsule contains 150 mg of cysteamine (as mercaptamine bitartrate) For a full list of excipients, see section 6.1.
Cysteamin reducerer cystin akkumuleringen i visse celler (f. eks. leukocytter, muskelceller og leverceller) hos patienter med nephropatisk cystinosis, og hvor behandlingen iværksættes tidligt forsinker det udviklingen af nyresvigt.
Cysteamine reduces cystine accumulation in some cells (e. g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
• For børn i alderen op til 12 år bør CYSTAGON dosen være baseret på overfladearealet (g/ m2/ dag).
• For children up to age 12 years, CYSTAGON dosing should be on the basis of body surface area (g/ m2/ day).
9 Patienter i dialyse eller post- transplanterede patienter:
9 Patients on dialysis or post-transplantation:
Erfaring har sommetider vist, at andre former af cysteamin tolereres dårligere (dvs. fører til flere bivirkninger) af patienter i dialyse.
Experience has occasionally shown that some forms of cysteamine are less well tolerated (i. e. leading to more adverse events) when patients are on dialysis.
5. 3), da det er teratogent i dyr.
CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.6 and section 5.3), as it is teratogenic in animals.
4. 2)
Intact CYSTAGON hard capsules should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2).
Der er ikke udført interaktionsundersøgelser.
No interaction studies have been performed Interactions with other medicines have not been studied.
CYSTAGON kan gives sammen med de elektrolyt - og mineraltilskud, som er nødvendige til behandling af Fanconi syndrom, ligesåvel som det kan gives sammen med D- vitamin og thyroidhormoner.
CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
4. 6 Graviditet og amning
10 4.6 Pregnancy and lactation
5. 3), er amning imidlertid kontraindikeret hos kvinder, der får CYSTAGON.
However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), breast-feeding is contra-indicated in women taking CYSTAGON.
CYSTAGON påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
CYSTAGON has minor or moderate influence on the ability to drive ans use machines CYSTAGON may cause drowsiness.
11 Almene forstyrrelser og tilstande ved administrationsstedet Forstyrrelser i immunsystemet Psykiatriske forstyrrelser
General disorders and administration site conditions Immune system disorders Psychiatric disorders
nefrotisk syndrom blevet rapporteret indenfor 6 måneder,
11 Two cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
Der er rapporteret enkelte tilfælde, der minder om Ehlers- Danlos syndrom på albuerne hos børn, der kronisk bliver behandlet med høje doser af forskellige cysteamin formuleringer (cysteamin klorhydrat, cysteamin eller cysteamin bitartrat), hovedsageligt over den maksimale dosis på 1, 95 g/ m2/ dag.
A few cases of Ehlers-Danlos like syndrome on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/ m2/ day.
I de få tilfælde, hvor histo - / patologiske undersøgelse af huden er blevet udført tydede resultaterne på angioendotheliomatosis.
In the few cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
Hos nogle patienter forsvandt hud - og albuelæsionerne efter at CYSTAGON dosen blev reduceret.
In some the patients, the skin lesions on elbows regressed after CYSTAGON dose reduction.
12 I et klinisk studie var cystin baseline i de hvide blodlegemer 3, 73 (fra 0, 13 til 19, 8) nmol hemicystin/ mg protein og blev vedligeholdt tæt ved 1 nmol hemicystin/ mg protein med en cysteamindosis på fra 1, 3 til 1, 95 g/ m2/ dag.
In one clinical study, baseline white cell cystine levels were 3.73 (range 0.13 to 19.8) nmol hemicystine/ mg protein and were maintained close to 1 nmol hemicystine/ mg protein with a cysteamine dose range of 1.3 to 1.95 g/ m2/ day.
Imidlertid steg væksthastigheden ikke nok til, at patienterne kunne nå op på normerne ifølge deres alder.
12 increase enough to allow patients to catch up the normal for their age.
I en farmakokinetisk undersøgelse udført med 24 raske frivillige i 24 timer, var middelestimatet (± SD) for den terminale halveringstid for udskillelse 4, 8 (±1, 8) timer.
In a pharmacokinetic study performed in 24 healthy volunteers for 24 hours, the mean estimate (± sd) for the terminal half-life of elimination was 4.8 (± 1.8) hours.
Høje doser af cysteamin forringer ammende mødres evne til at ernære deres 13 hvalpe.
High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Cellulose mikrokrystallinsk, stivelse pregelatineret, magnesium stearat/ natrium lauril sulfat, silica, kolloid dioxid, natrium carboxymethylcellulose
Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/ sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide,
EU/ 1/ 97/ 039/ 003 (100 hårde kapsler pr. flaske), EU/ 1/ 97/ 039/ 004 (500 hårde kapsler pr. flaske).
EU/ 1/ 97/ 039/ 003 (100 hard capsules per bottle), EU/ 1/ 97/ 039/ 004 (500 hard capsules per bottle).
23. juni 2007
23 June 2007
Orphan Europe SARL, Immeuble “ Le Wilson ”, 70 avenue du Général de Gaulle, F- 92800 Puteaux, Frankrig
Orphan Europe SARL, Immeuble “ Le Wilson”, 70 avenue du Général de Gaulle, F-92800 Puteaux, France
Hver hård kapsel indeholder 50 mg cysteamin (som mercaptaminbitartrat).
Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate).
Udløbsdato {måned/ år}
EXP {month/ year}
Orphan Europe SARL Immeuble ” Le Wilson ” F- 92058 Paris La Défense Frankrig
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris La Défense France
EU/ 1/ 97/ 039/ 001 - 100 hårde kapsler EU/ 1/ 97/ 039/ 002 - 500 hårde kapsler
EU/ 1/ 97/ 039/ 001 – 100 hard capsules EU/ 1/ 97/ 039/ 002 – 500 hard capsules
21 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Hver hård kapsel indeholder 150 mg cysteamin (som mercaptaminbitartrat).
Each hard capsule contains 150 mg of cysteamine (as mercaptamine bitartrate).
ANVENDELSESMÅDE OG ADMINISTATIONSVEJ( E)
METHOD AND ROUTE(S) OF ADMINISTRATION
EU/ 1/ 97/ 039/ 003 - 100 hårde kapsler EU/ 1/ 97/ 039/ 004 - 500 hårde kapsler
EU/ 1/ 97/ 039/ 003 – 100 hard capsules EU/ 1/ 97/ 039/ 004 – 500 hard capsules
23 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
23 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
25 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
ANVENDELSESMÅDE OG ADMINISTRATIONS( E)
METHOD AND ROUTE(S) OF ADMINISTRATION
Læs denne indlægsseddel grundigt, inden De/ du begynder at tage medicinen.
Read all of this leaflet carefully before you start using this medicine.
De/ du kan få brug for at læse den igen.
You may need to read it again.
- Spørg lægen eller på apoteket, hvis der er mere, De/ du vil vide.
- If you have further questions, please ask your doctor or your pharmacist.
- Lægen har ordineret CYSTAGON til Dem/ dig personligt.
- This medicine has been prescribed for you.
Det kan være skadeligt for andre, selvom de har samme symptomer, som De/ du har.
if their symptoms are the same as yours.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De/ du får bivirkninger,
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
CYSTAGONs virkning, og hvad Du/ de skal bruge det til 2.
What CYSTAGON is and what it is used for 2.
Det skal De/ du vide, før De/ du begynder at tage CYSTAGON 3.
Before you use CYSTAGON 3.
Sådan skal De/ du tage CYSTAGON 4.
How to use CYSTAGON 4.
Sådan opbevarer De/ du CYSTAGON 6.
How to store CYSTAGON 6.
CYSTAGONS VIRKNING OG HVAD DE/ DU SKAL BRUGE DET TIL
WHAT CYSTAGON IS AND WHAT IT IS USED FOR
Cystinosis er en metabolisk sygdom, der hedder ” nephropatisk cystinosis ”, som karakteriseres ved en unormal ophobning af aminosyren cystein i visse organer f. eks. nyrer, øjne, bugspytkirtlen og hjernen.
Cystinosis is a metabolic disease called ‘ nephropathic cystinosis’ which is characterized by an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain.
CYSTAGON er et lægemiddel, der reagerer med cystin og reducerer dets indhold indeni cellerne.
CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.
DET SKAL DE/ DU VIDE, FØR DE/ DU BEGYNDER AT TAGE CYSTAGON
BEFORE YOU USE CYSTAGON
Tag ikke CYSTAGON:
Do not use CYSTAGON
- hvis De/ du eller Deres/ dit barn er overfølsom (allergisk) over for cysteaminbitartrat eller
- if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or
penicillamin eller et af de øvrige indholdsstoffer.
any of the other ingredients of Cystagon.
- hvis De/ du er gravid, især hvis De/ du er i første trimester
- If you are pregnant, this is particularly relevant during the first trimester
- hvis De/ du ammer.
- if you are breast-feeding.
Vær ekstra forsigtig med at tage CYSTAGON:
Take special care with CYSTAGON
- når Deres/ din eller Deres/ dit barns sygdom er blevet bekræftet ved leukocyt cystein målinger
- When your or your child’ s disorder has been confirmed by leucocyte cystine measurements, the
skal behandling med CYSTAGON begynde så hurtigt som muligt.
therapy with CYSTAGON must be started as soon as possible.
- Der har været tilfælde af hudlæsioner, som små, hårde klumper, på albuer hos børn der har
- A few cases of skin lesions on elbows like little hard lumps have been reported in children
været behandlet med høje doser af forskellige cysteamin formuleringer.
treated with high doses of different cysteamine preparations.
Deres/ din læge kan jævnligt have brug for undersøgelser og røntgenoptagelser af hud og knogler for at overvære effekten af behandlingen.
Your doctor could require a regular physical and X-ray examination for the skin and the bones to control the effects of the medicinal product.
Egenundersøgelse af Deres/ din eller Deres/ dit barns hud anbefales.
Self examination of your or your child’ s skin is recommended.
Hvis der er hud - eller knogleforandringer, bør De/ du straks informere Deres/ din læge.
If any skin or bone abnormalities appear, please inform your doctor immediately.
- Deres/ din læge kan jævnligt have brug for at kontrollere antallet af celler i blodet.
- Your doctor could require controlling the blood cell count on a regular basis.
- Det er ikke vist, at CYSTAGON kan forhindre ophobning af cystin- krystaller i øjet.
- CYSTAGON has not been shown to prevent cystine crystals accumulating in the eye.
Hvis der af
Where
den grund tidligere har været brugt cysteamin øjendråber, skal man fortsætte brugen heraf.
cysteamine ophthalmic solution has been used for that purpose, its usage should continue.
29
29 and the dose of these may need to be changed when CYSTAGON is substituted for phosphocysteamine.
- I modsætning til fosfocysteamin, et andet aktivt stof nært beslægtet til cysteaminbitartrat,
- To avoid any risk of aspiration in the lungs, the capsules should not be given to children under
indeholder CYSTAGON ikke fosfat.
the age of approximately 6 years.
Dette gælder også medicin, som ikke er købt på recept.
Using other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Hos børn under 6 år, kan de hårde kapsler åbnes og indholdet drysses på føden (f. eks. mælk, kartofler eller stivelsesbaserede fødevarer) eller blandes i føden.
Using CYSTAGON with food and drink For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e. g. milk, potatoes or starch based foods) or mixed in formula.
Bør ikke blandes i syrlige drikkevarer f. eks. orange juice.
Do not add to acidic drinks e. g. orange juice.
Graviditet og amning De bør ikke anvende CYSTAGON, hvis De er gravid.
Pregnancy You should not use CYSTAGON if you are pregnant.
De/ du må ikke køre bil, motorcykel eller cykle samt arbejde med værktøj eller maskiner, fordi CYSTAGON kan forårsage sløvhed.
Driving and using machines CYSTAGON may cause some drowsiness.
Når behandlingen påbegyndes bør De/ du eller Deres/ dit barn ikke deltage i potentielt farlige aktiviteter, før virkningen af lægemidlet er velkendt.
When starting therapy, you or your child should not engage in potentially hazardous activities until the effects of the drug are well known.
SÅDAN SKAL DE/ DU TAGE CYSTAGON
HOW TO USE CYSTAGON
Tag altid CYSTAGON nøjagtigt efter lægens anvisning.
Always use CYSTAGON exactly as your doctor or your child’ s doctor has told you.
Er De/ du i tvivl så spørg lægen eller apoteket.
You should check with your doctor if you are not sure.
Den anførte dosis af CYSTAGON udskrevet til Dem/ dig eller Deres/ dit barn afhænger af Deres/ din eller Deres/ dit barns alder og vægt.
The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.