FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not breast-feed while taking this medicine, see section “Do not take Nitisinone MDK”.
Danish: Lad være med at amme, når De tager dette lægemiddel, se punktet ”Tag ikke Nitisinone MDK”.
English: Can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Danish: Kan opbevares i en enkelt periode på 2 måneder ved en temperatur på ikke over 25 °C, hvorefter det skal kasseres.
English: NTBC study (N=250) Age at start of treatment
Danish: NTBC-studiet (N=250) Alder ved behandlingsstart 2 år 4 år
English: Dose-adjustment of these co-administered medicinal products may be needed (see section 4.5).
Danish: Det kan være nødvendigt at justere dosis af disse samtidigt administrerede lægemidler (se pkt.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte, Diverse midler til fordøjelsesorganer og stofskifte, ATC-kode: A16A X04.
English: Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Danish: Behandling af voksne og pædiatriske (alle aldersgrupper) patienter med en bekræftet diagnose på arvelig tyrosinæmi type 1 (HT-1) i kombination med kostmæssige restriktioner af tyrosin og fenylalanin.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Nitisinone is not expected to inhibit P-gp, BCRP or OCT2-mediated transport.
Danish: Nitisinon forventes ikke at hæmme P-gp-, BCRP- eller OCT2-medieret transport.
English: This medicine has minor influence on the ability to drive and use machines.
Danish: Lægemidlet påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Treatment with nitisinone was also found to result in reduced risk for the development of hepatocellular carcinoma compared to historical data on treatment with dietary restriction alone.
Danish: Det sås også, at behandling med nitisinon resulterede i en nedsat risiko for udvikling af hepatocellulært karcinom (HCC), sammenlignet med historiske data for behandling med kostmæssige restriktioner alene.
English: Treatment with this medicine should be started and supervised by a doctor experienced in the treatment of the disease (hereditary tyrosinemia type 1).
Danish: Behandling med lægemidlet skal startes og overvåges af en læge, der har erfaring med behandling af sygdommen (arvelig tyrosinæmi type 1).
English: Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids.
Danish: Behandling med nitisinon leder til normaliseret porfyrinmetabolisme med normal erytrocyt porfobilinogen-syntaseaktivitet og urin 5-aminolevulinat, nedsat udskillelse af succinylacetone i urinen, øget plasmakoncentration af tyrosin og øget udskillelse af fenolsyrer i urinen.
English: Nitisinone is a moderate CYP2C9 inhibitor.
Danish: Nitisinon er en moderat CYP 2C9-hæmmer.
English: Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Danish: Mødre, der får nitisinon, må derfor ikke amme, da en risiko for det ammende barn ikke kan udelukkes (se pkt.
English: During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Danish: Under regelmæssig monitorering er det passende at følge succinylacetone i urinen, leverfunktionstests og alfa-føtoprotein (se pkt.
English: By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Danish: Ved at hæmme den normale katabolisme af tyrosin hos patienter med HT-1, forhindrer nitisinon akkumuleringen af de toksiske mellemprodukter maleylacetoacetat og fumarylacetoacetat.
English: Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Danish: De må ikke amme, mens De tager dette lægemiddel, se punktet ”Graviditet og amning”.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Treatment with nitisinone leads to higher levels of tyrosine in the blood which can cause eye related symptoms.
Danish: Behandling med nitisinon fører til forhøjede tyrosinniveauer i blodet, hvilket kan give anledning til symptomer i forbindelse med øjnene.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Number of patients at
Danish: Antal patienter
English: Nitisinone is metabolised in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Danish: Nitisinon metaboliseres in vitro af CYP 3A4, og dosisjustering kan derfor blive nødvendig, når nitisinon gives samtidig med stoffer som hæmmer eller fremmer dette enzym.
English: Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Danish: Konjunktivitis, corneal opacitet, keratitis, fotofobi, øjensmerter
English: Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1.
Danish: Nitisinon forårsagede en ca. 30 % reduktion i chlorzoxazon AUC∞, hvilket er indikativt for en svag induktion af CYP 2E1.
English: Eye-related adverse reactions, such as conjunctivitis, corneal opacity, keratitis, photophobia, and eye pain, related to elevated tyrosine levels are therefore common.
Danish: Øjenrelaterede bivirkninger som f.eks. konjunktivitis, corneal opacitet, keratitis, fotofobi og øjensmerter, der relaterer sig til forhøjede tyrosinniveauer, er derfor almindelige.
English: In the rabbit, nitisinone induced a dose-related increase in malformations (umbilical hernia and gastroschisis) from a dose level 2.5-fold higher than the maximum recommended human dose (2 mg/kg/day).
Danish: I kanin inducerede nitisinon en dosisrelateret øgning i misdannelser (umbilicalt hernie og gastroschise) fra et dosisniveau, der var 2,5 gange højere end den anbefalede humane dosis på 2 mg/kg/dag.
English: Common eye related side effects (may affect more than 1 in 10 people) caused by higher tyrosine levels are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain.
Danish: Almindelige bivirkninger med forbindelse til øjnene (kan ramme flere end 1 ud af 10 personer), og som skyldes forhøjede tyrosinniveauer, omfatter øjenbetændelse (bindehindebetændelsekonjunktivitis), uklarhed og betændelse i hornhinden (keratitis), lysfølsomhed (fotofobi) og øjensmerter.
English: Other common side effects - Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).
Danish: Andre almindelige bivirkninger - Nedsat antal blodplader (trombocytopeni) og hvide blodlegemer (leukopeni), mangel på visse hvide blodlegemer (granulocytopeni).
English: By its mode of action, nitisinone increases tyrosine levels in all nitisinone treated patients.
Danish: På grund af sin virkningsmåde øger nitisinon tyrosinniveauerne hos alle patienter, der bliver behandlet med nitisinon.
English: Age at onset of symptoms 1 year 2 years < 2 months
Danish: Alder ved start af symptomer 1 år
English: ≤ 2 months ≤ 6 months
Danish: ≤ 2 måneder ≤ 6 måneder > 6 måneder Samlet
English: Nitisinone plasma concentration reached in clinical setting is not expected to inhibit OATP1B1, OATP1B3 mediated transport.
Danish: Plasmakoncentrationen af nitisinon, der opnås i klinisk regi, forventes ikke at hæmme OATP1B1-, OATP1B3-medieret transport.
English: Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels.
Danish: Indtagelse ved et uheld af nitisinon af personer, der spiser normal kost uden restriktioner for tyrosin og fenylalanin, vil resultere i forhøjede niveauer af tyrosin.
English: Thrombocytopenia, leucopenia, granulocytopenia
Danish: Trombocytopeni, leukopeni, granulocytopeni
English: The active ingredient of Nitisinone MDK is nitisinone.
Danish: Det aktive stof i Nitisinone MDK er nitisinon.
English: In rats, exposure via milk resulted in reduced mean pup weight and corneal lesions.
Danish: Hos rotter resulterede eksponering via mælk i en nedsat middelvægt for ungerne og læsioner af cornea.
English: If you notice any side effects relating to the eyes, talk to your doctor immediately to have an eye examination.
Danish: Hvis De bemærker nogen form for bivirkninger med forbindelse til øjnene, skal De straks kontakte Deres læge med henblik på en øjenundersøgelse.
English: Nitisinone is a weak inducer of CYP2E1 (30% decrease in chlorzoxazone AUC) and a weak inhibitor of OAT1 and OAT3 (1.7-fold increase in AUC of furosemide), whereas nitisinone did not inhibit CYP2D6 (see section 5.2).
Danish: Nitisinon er en svag induktor af CYP 2E1 (30 % reduktion i chlorzoxazon AUC) og en svag hæmmer af OAT1 og OAT3 (1,7 gange stigning i AUC for furosemid), hvorimod nitisinon ikke hæmmede CYP 2D6 (se pkt.
English: Tabulated list of adverse reactions The adverse reactions listed below by MedDRA system organ class and absolute frequency, are based on data from a clinical trial and post-marketing use.
Danish: Bivirkningerne, der er anført nedenfor i henhold til MedDRA-systemorganklassen og absolut hyppighed, er baseret på data fra kliniske studier og anvendelsen efter markedsføringen.
English: The recommended total daily dose is 1 mg/kg body weight administered orally.
Danish: Den anbefalede totale daglige dosis er 1 mg/kg legemsvægt taget oralt (gennem munden).
English: The capsule may be opened and the content suspended in a small amount of water or formula diet immediately before intake.
Danish: Kapslen kan åbnes, og indholdet opslæmmes umiddelbart inden indtagelse i en smule vand eller modermælkserstatning.
English: Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Danish: Nitisinon er en kompetitiv hæmmer af 4-hydroxyfenylpyruvatdioxygenase, et enzym, der går forud for fumarylacetoacetathydrolase i tyrosinkatabolismens vej.
English: Eye problems could be a sign of inadequate dietary control (see section 4).
Danish: Problemer med øjnene, se punkt 4, kan være et tegn på utilstrækkelig kontrol med kosten.
English: Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment.
Danish: Bivirkninger, der påvirkede MedDRA-systemorganklassen blod og lymfesystem, blev svagere under fortsat behandling med nitisinon.
English: Nitisinone treatment leads to elevated tyrosine levels.
Danish: Behandling med nitisinon fører til forhøjede niveauer af tyrosin.
English: Restriction of tyrosine and phenylalanine in the diet should limit the toxicity associated with this type of tyrosinemia by lowering tyrosine levels (see section 4.4).
Danish: Begrænsning af tyrosin og fenylalanin i kosten bør begrænse toksiciteten forbundet med denne type tyrosinæmi ved at sænke tyrosinniveauerne (se pkt.
English: The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway.
Danish: Den biokemiske defekt ved arvelig tyrosinæmi type 1 (HT-1) er en mangel på fumarylacetoacetathydrolyase, der er det sidste enzym på tyrosinkatabolismens vej.
English: During the shelf life, the patient may store the capsules for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which the medicinal product must be discarded.
Danish: I løbet af holdbarhedstiden kan patienten opbevare kapslerne i en periode på 2 måneder, efter første åbning flasken, ved en temperatur på ikke over 25 °C, hvorefter produktet skal kasseres.
English: Other sources of information
Danish: Andre oplysninger
English: Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9.
Danish: Behandling med nitisinon kan derfor føre til forhøjede plasmakoncentrationer af lægemidler, der administreres samtidigt, og primært metaboliseres via CYP 2C9.
English: Therefore, it is recommended that if nitisinone treatment with Nitisinone MDK hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Danish: Det anbefales derfor, at hvis nitisinonbehandling med Nitisinone MDK, hårde kapsler, startes op sammen med mad, bør dette bibeholdes rutinemæssigt, se pkt.
English: Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with this type of tyrosinemia.
Danish: Restriktioner for tyrosin og fenylalanin i kosten skulle begrænse toksiciteten forbundet med denne type tyrosinæmi.
English: - The active substance is nitisinone.
Danish: Aktivt stof: nitisinon.
English: Elevated levels of tyrosine have been associated with eye-related adverse reactions, such as e.g. corneal opacities and hyperkeratotic lesions.
Danish: Forhøjede niveauer af tyrosin er blevet forbundet med øjenrelaterede bivirkninger som f.eks. corneal opacitet og hyperkeratotiske læsioner.
English: All patients Start age
Danish: Alle patienter Startalder måneder Startalder måneder
English: The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Danish: Den anbefalede daglige startdosis til børn og voksne er 1 mg/kg legemsvægt givet oralt.
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone caused a 2.3-fold increase in AUC∞ of the CYP2C9 substrate tolbutamide, which is indicative of a moderate inhibition of CYP2C9.
Danish: Baseret på data fra et klinisk interaktionsstudie med 80 mg nitisinon ved steady-state, forårsagede nitisinon en 2,3 gange stigning i AUC∞ for CYP 2C9-substratet tolbutamid, hvilket er indikativt for en moderat hæmning af CYP 2C9.
English: The medicine can be stored for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which it must be discarded.
Danish: Dette lægemiddel kan opbevares i periode på 2 måneder, efter første åbning flasken, ved en temperatur på ikke over 25 °C, hvorefter det skal kasseres.
English: Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
Danish: Andre ikke almindelige bivirkninger - øget antal hvide blodlegemer (leukocytose) - kløen (pruritus), betændelse i huden (eksfoliativ dermatitis), udslæt.
English: Capsule content: pregelatinised maize starch Capsule shell: gelatin, titanium dioxide (E171) Printing ink: black iron oxide (E172), shellac glaze
Danish: Prægelatiniseret majsstivelse Kapselskallen: gelatin titandioxid (E 171) Trykfarve: sort jernoxid (E 172), shellac-glasur
English: Imprint ˗ Black iron oxide (E172) ˗ Shellac
Danish: Sort jernoxid (E 172) Shellac
English: Nitisinone MDK capsules are 15.7 mm long, white, opaque, hard gelatin capsules, imprinted with “Nitisinone” and the strength “2 mg”, “5 mg” or “10 mg”, in black.
Danish: Nitisinone MDK-kapslerne er 15,7 mm lange, hvide, ugennemsigtige, hårde og lavet af gelatine, påtrykt ” Nitisinone” og styrken ”2 mg”, ”5 mg”eller ”10 mg” med sort farve.
English: Other common adverse reactions include thrombocytopenia, leucopenia, and granulocytopenia.
Danish: Andre almindelige bivirkninger omfatter trombocytopeni, leukopeni og granulocytopeni.
English: HDPE plastic bottle with LDPE plastic cap containing 60 capsules.
Danish: Plasticfalske af højdensitet polyethylen med plastichætte af lavdensitet polyethylen, som indeholder 60 kapsler.
English: Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Danish: 4.8), kan påvirke synet.
English: Exfoliative dermatitis, erythematous rash, pruritus
Danish: Eksfoliativ dermatitis, erythematøst udslæt, pruritus
English: A pre- and postnatal development study in the mouse showed statistically significant reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher,
Danish: En præ- og postnatal udviklingsstudie i mus viste statistisk signifikant nedsat overlevelse hos ungerne og nedsat vækst hos ungerne under afvænningsperioden ved dosisniveauer, der var henholdsvis 125 og 25 gange højere end den maksimale anbefalede dosis til mennesker, med en tendens i retning af en negativ virkning på overlevelsen hos ungerne startende fra doseringen på 5 mg/kg/dag.
English: Contents of the pack and other information What Nitisinone MDK contains
Danish: Pakningsstørrelser og yderligere oplysninger Nitisinone MDK indeholder:
English: A study to evaluate the PK, efficacy and safety of once daily dosing compared to twice daily dosing was performed in 19 patients with HT-1.
Danish: Der blev udført et studie med 19 patienter med HT-1 for at evaluere farmakokinetikken, virkningen og sikkerheden ved dosering én gang dagligt sammenlignet med dosering to gange dagligt.
English: Mothers receiving nitisinone must not breast-feed (see sections 4.6 and 5.3).
Danish: Mødre, der får nitisinon, må ikke amme (se pkt.
English: Furosemide AUC∞ was increased 1.7-fold, indicating a weak inhibition of OAT1/OAT3 (see sections 4.4 and 4.5).
Danish: 1,7 gange, hvilket indikerer en svag hæmning af OAT1/OAT3 (se pkt.
English: What you need to know before you take Nitisinone MDK Do not take Nitisinone MDK:
Danish: Det skal De vide, før De begynder at tage Nitisinone MDK Tag ikke Nitisinone MDK
English: Other medicines and Nitisinone MDK
Danish: Brug af anden medicin sammen med Nitisinone MDK
English: If you forget to take Nitisinone MDK
Danish: Hvis De har glemt at tage Nitisinone MDK
English: If you stop taking Nitisinone MDK
Danish: Hvis De holder op med at tage Nitisinone MDK
English: - Your eyes will be checked by an ophthalmologist before and regularly during nitisinone treatment.
Danish: Kontakt lægen eller apoteketspersonalet, før De tager Nitisinone MDK, - Deres øjne vil blive kontrolleret af en oftalmolog inden og med regelmæssige mellemrum under behandlingen med nitisinon.
English: It is recommended that if nitisinone treatment is initiated with food, this should be maintained on a routine basis, see section 4.5.
Danish: Hvis nitisinon startes op sammen med mad, anbefales det, at dette bibeholdes rutinemæssigt, se pkt.
English: Nitisinone MDK 10 mg: Each capsule contains 10 mg nitisinone.
Danish: Nitisinone MDK, 10 mg: Hver kapsel indeholder 10 mg nitisinon.
English: Nitisinone MDK 2 mg: Each capsule contains 2 mg nitisinone.
Danish: Nitisinone MDK, 2 mg: Hver kapsel indeholder 2 mg nitisinon.
English: Each capsule contains 5 mg nitisinone.
Danish: Hver kapsel indeholder 5 mg nitisinon.
English: Nitisinone MDK 5 mg: Each capsule contains 5 mg nitisinone.
Danish: Nitisinone MDK, 5 mg: Hver kapsel indeholder 5 mg nitisinon.
English: Package leaflet: Information for the user Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone
Danish: Indlægsseddel: Information til brugeren Nitisinone MDK, 2 mg, hårde kapsler Nitisinone MDK, 5 mg, hårde kapsler Nitisinone MDK, 10 mg, hårde kapsler nitisinon
English: Each capsule contains 10 mg nitisinone.
Danish: Hver kapsel indeholder 10 mg nitisinon.
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Danish: Baseret på data fra et klinisk interaktionsstudie med 80 mg nitisinon ved steady-state, er nitisinon en moderat hæmmer af CYP 2C9 (2,3 gange stigning i tolbutamid AUC).
English: Capsule shell ˗ Gelatin ˗ Titanium dioxide (E171)
Danish: Titandioxid (E 171)
English: Each capsule contains 2 mg nitisinone.
Danish: Hver kapsel indeholder 2 mg nitisinon.
English: Posology
Danish: Påtryk
English: How to take Nitisinone MDK
Danish: Sådan skal De tage Nitisinone MDK
English: White, opaque capsules of 15.7 mm imprinted with black ink “10 mg” on the cap and “Nitisinone” on the body.
Danish: Hvide, opale kapsler (15,7 mm) med ”10 mg” påtrykt med sort farve på hætten og “Nitisinone” på selve kapslen.
English: White, opaque capsules of 15.7 mm imprinted with black ink “5 mg” on the cap and “Nitisinone” on the body.
Danish: Hvide, opale kapsler (15,7 mm) med ”5 mg” påtrykt med sort farve på hætten og “Nitisinone” på selve kapslen.
English: White, opaque capsules of 15.7 mm imprinted with black ink “2 mg” on the cap and “Nitisinone” on the body.
Danish: Hvide, opale kapsler (15,7 mm) med ”2 mg” påtrykt med sort farve på hætten og “Nitisinone”på selve kapslen.
English: 2 years 4 years 6 years
Danish: ved start efter 2 år efter 4 år efter 6 år efter 2 år efter 4 år efter 6 år
English: Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone
Danish: Nitisinone MDK, 2 mg hårde kapsler Nitisinone MDK, 5 mg, hårde kapsler Nitisinone MDK, 10 mg, hårde kapsler Nitisinon
English: AUTHORISATION
Danish: Administration
English: Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules
Danish: Nitisinone MDK, 2 mg, hårde kapsler Nitisinone MDK, 5 mg, hårde kapsler Nitisinone MDK, 10 mg, hårde kapsler
English: Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8).
Danish: Patienten skal følges med monitorering af plasma-aminosyrer (se pkt.
English: Adverse reaction
Danish: Bivirkninger
English: It is therefore difficult to recommend an optimum method.
Danish: Det er derfor vanskeligt at anbefale en optimal metode.
English: Please use as follows:
Danish: Anvendes på følgende måde:
English: Very rare: Not known:
Danish: Meget sjælden: Ikke kendt:
English: - if you are suffering from any other illness, especially if you think you have an infection.
Danish: - Hvis De har nogen anden sygdom, især hvis De tror, De har en infektion.
English: Regular urinanalysis should be performed to monitor this event.
Danish: Der bør udføres regelmæssige urinanalyser for at monitorere denne hændelse.
English: Only clear solutions without particles should be used.
Danish: Kun klare opløsninger uden partikler bør anvendes.
English: You will hear a “click”, which confirms activation of the safety device.
Danish: Du vil høre et "klik", som bekræfter aktivering af sikkerhedsanordningen.
English: different types of leukaemia).
Danish: forskellige typer leukæmi).
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes med det samme.
English: Component of a multipack, cannot be sold separately.
Danish: Del af en multipakke, må ikke sælges separat.
English: Date of latest renewal: 25 July 2013.
Danish: Dato for seneste fornyelse: 25. juli 2013
English: European retrospective study (2004)
Danish: Europæisk retrospektivt studie (2004)