FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/569/016 56 film-coated tablets
Danish: EU/1/09/569/016 56 filmovertrukne tabletter
English: EU/1/09/569/054 98 film-coated tablets
Danish: EU/1/09/569/054 98 filmovertrukne tabletter
English: EU/1/09/569/053 90 film-coated tablets
Danish: EU/1/09/569/053 90 filmovertrukne tabletter
English: EU/1/09/569/025 14 film-coated tablets
Danish: EU/1/09/569/025 14 filmovertrukne tabletter
English: EU/1/09/569/052 56 film-coated tablets
Danish: EU/1/09/569/052 56 filmovertrukne tabletter
English: EU/1/09/569/040 56 film-coated tablets
Danish: EU/1/09/569/040 56 filmovertrukne tabletter
English: EU/1/09/569/038 28 film-coated tablets
Danish: EU/1/09/569/038 28 filmovertrukne tabletter
English: EU/1/09/569/029 90 film-coated tablets
Danish: EU/1/09/569/029 90 filmovertrukne tabletter
English: EU/1/09/569/002 28 film-coated tablets
Danish: EU/1/09/569/002 28 filmovertrukne tabletter
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Exforge HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: EU/1/09/569/049 14 film-coated tablets
Danish: EU/1/09/569/049 14 filmovertrukne tabletter
English: EU/1/09/569/051 30 film-coated tablets
Danish: EU/1/09/569/051 30 filmovertrukne tabletter
English: What Exforge HCT is and what it is used for What you need to know before you take Exforge HCT How to take Exforge HCT
Danish: Det skal du vide, før du begynder at tage Exforge HCT Sådan skal du tage Exforge HCT Bivirkninger
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Danish: Exforge HCT 10 mg/160 mg/25 mg filmovertrukne tabletter er brun-gule, ovale tabletter præget med ”NVR” på den ene side og ”VHL” på den anden side.
English: EU/1/09/569/026 28 film-coated tablets
Danish: EU/1/09/569/026 28 filmovertrukne tabletter
English: EU/1/09/569/017 90 film-coated tablets
Danish: EU/1/09/569/017 90 filmovertrukne tabletter
English: EU/1/09/569/037 14 film-coated tablets
Danish: EU/1/09/569/037 14 filmovertrukne tabletter
English: EU/1/09/569/039 30 film-coated tablets
Danish: EU/1/09/569/039 30 filmovertrukne tabletter
English: If you think you may be allergic, do not take Exforge HCT and talk to your doctor.
Danish: Hvis du tror, du er overfølsom, skal du tale med din læge, inden du tager Exforge HCT.
English: EU/1/09/569/013 14 film-coated tablets
Danish: EU/1/09/569/013 14 filmovertrukne tabletter
English: EU/1/09/569/014 28 film-coated tablets
Danish: EU/1/09/569/014 28 filmovertrukne tabletter
English: EU/1/09/569/028 56 film-coated tablets
Danish: EU/1/09/569/028 56 filmovertrukne tabletter
English: EU/1/09/569/044 56 x 1 film-coated tablet (unit dose) EU/1/09/569/045 98 x 1 film-coated tablet (unit dose) EU/1/09/569/046 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/569/044 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/045 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/046 280 x 1 filmovertrukket tablet (enhedsdosis)
English: EU/1/09/569/050 28 film-coated tablets
Danish: EU/1/09/569/050 28 filmovertrukne tabletter
English: EU/1/09/569/015 30 film-coated tablets
Danish: EU/1/09/569/015 30 filmovertrukne tabletter
English: EU/1/09/569/056 56 x 1 film-coated tablet (unit dose) EU/1/09/569/057 98 x 1 film-coated tablet (unit dose) EU/1/09/569/058 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/569/056 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/057 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/058 280 x 1 filmovertrukket tablet (enhedsdosis)
English: EU/1/09/569/032 56 x 1 film-coated tablet (unit dose) EU/1/09/569/033 98 x 1 film-coated tablet (unit dose) EU/1/09/569/034 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/569/032 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/033 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/034 280 x 1 filmovertrukket tablet (enhedsdosis)
English: EU/1/09/569/008 56 x 1 film-coated tablet (unit dose) EU/1/09/569/009 98 x 1 film-coated tablet (unit dose) EU/1/09/569/010 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/569/008 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/009 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/010 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Exforge HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Due to the valsartan component, Exforge HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Danish: På grund af indholdet af valsartan er Exforge HCT kontraindiceret til patienter med nedsat leverfunktion (se pkt.
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Exforge HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Exforge HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Exfoge HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: EU/1/09/569/020 56 x 1 film-coated tablet (unit dose) EU/1/09/569/021 98 x 1 film-coated tablet (unit dose) EU/1/09/569/022 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/569/020 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/021 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/569/022 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Exforge HCT 5 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Exforge HCT 10 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Exforge HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Exforge HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: EU/1/09/569/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/569/036 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/569/035 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: What Exforge HCT looks like and contents of the pack Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Danish: Exforge HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter er hvide, ovale tabletter præget med ”NVR” på den ene side og ”VCL” på den anden side.
English: EU/1/09/569/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/569/048 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/569/047 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: Due to the hydrochlorothiazide component, Exforge HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Danish: 4.3) og til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) <30 ml/min/1,73 m2) (se pkt.
English: EU/1/09/569/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/569/060 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/569/059 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: EU/1/09/569/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/569/012 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/569/011 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: EU/1/09/569/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/569/024 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/569/023 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: No formal interaction studies with other medicinal products have been conducted.
Danish: Der er ikke udført formelle interaktionsstudier med andre lægemidler.
English: The tablets may be taken with or without food.
Danish: Tabletterne kan tages sammen med eller uden mad.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1290/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1290/001
English: Contact your doctor immediately for an eye examination.
Danish: Kontakt straks Deres læge for en øjenundersøgelse.
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalised during the first week of treatment.
Danish: Tilgængelige data fra en klinisk studie indikerer, at hos mere end 90 % af patienterne blev succinylacetone i urinen normaliseret under den første uges behandling.
English: For patients who require additional strengths (i.e. between multiples of 10 mg or lower than 10 mg) other medicinal products with lower strengths are available.
Danish: Til patienter, som har brug for yderligere styrker (dvs. styrker liggende udenfor et multiplum af 10 mg eller styrker mindre end 10 mg), findes der andre lægemidler med lavere styrke.
English: The study demonstrated that Nityr can be administered with or without food without affecting its bioavailability.
Danish: Studiet viste, at Nityr kan administreres sammen med eller uden mad, uden at dets biotilgængelighed påvirkes.
English: Nityr should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Danish: Nityr bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med nitisinon.
English: For paediatric patients who have difficulties swallowing tablets, other pharmaceutical forms are available.
Danish: Til pædiatriske patienter, som har svært ved at synke tabletter, findes der andre lægemiddelformer.
English: Tablets are not suitable for breaking to make up additional strengths.
Danish: Tabletterne er ikke egnede til at dele for at danne yderligere styrker.
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarised in the table below.
Danish: Sandsynlighederne for overlevelse efter 2, 4 og 6 års behandling med nitisinon er opsummeret i nedenstående tabel.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2018
Danish: Dato for første markedsføringstilladelse: 26. juli 2018
English: Nityr blocks the breakdown of tyrosine and the harmful substances are not formed.
Danish: Nityr blokerer nedbrydningen af tyrosin og de skadelige stoffer dannes derfor ikke.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4mediated metabolism.
Danish: Baseret på in vitro-studier forventes nitisinon ikke at hæmme CYP 1A2, 2C9, 2C19, 2D6, 2E1 eller 3A4-medieret metabolisme.
English: < 2 months > 2-6 months > 6 months
Danish: < 2 måneder > 2-6 måneder > 6 måneder
English: SPECIAL STORAGE CONDITIONS Store in the original bottle in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale beholder for at beskytte mod lys.
English: Do not breast-feed while taking this medicine, see section “Do not take Nityr”.
Danish: Lad være med at amme, når De tager dette lægemiddel, se punktet ”Tag ikke Nityr”.
English: Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Once the bottle is opened, the medicine can be stored for a period of 2 months, after which it must be discarded.
Danish: Efter anbrud af beholderen kan lægemidlet opbevares i en periode på 2 måneder, hvorefter det skal kasseres.
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment.
Danish: Det anbefales, at en undersøgelse af øjnene med en spaltelampe udføres, inden der indledes behandling med nitisinon.
English: Each carton contains 1 bottle.
Danish: Hver karton indeholder 1 beholder.
English: Nityr with food Nityr can be taken with or without food throughout your course of treatment.
Danish: Brug af Nityr sammen med mad Nityr kan tages sammen med eller uden mad igennem hele behandlingsforløbet.
English: Elms Industrial Estate
Danish: Elms Industrial Estate Bedford
English: In 23 healthy volunteers, after administration of a single dose of Nityr tablets (10 mg) the terminal half-life (median) of nitisinone in plasma was 59 hours (ranging from 41 to 74 hours).
Danish: Efter administration af en enkelt dosis Nityr tabletter (10 mg) var den terminale halveringstid (median) af nitosan i plasma hos 23 raske frivillige 59 timer (spændende fra 41 til 74 timer).
English: Store in the original bottle to protect from light.
Danish: Opbevares i den originale beholder for at beskytte mod lys.
English: A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, then the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
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 maksimalt anbefalede dosis for mennesker med en tendens i retning af en negativ virkning på overlevelsen hos ungerne startende fra doseringen på 5 mg/kg/dag.
English: Each bottle contains 60 tablets.
Danish: Hver beholder indeholder 60 tabletter.
English: Each tablet contains less than 120 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder mindre end 120 mg lactose (som monohydrat).
English: ≤ 2 months ≤ 6 months > 6 months Overall
Danish: ≤ 2 måneder ≤ 6 måneder > 6 måneder Samlet
English: Nityr has minor influence on the ability to drive and use machines.
Danish: Nityr påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Fertility There are no data on nitisinone affecting fertility.
Danish: Der foreligger ingen data vedrørende nitisinons indvirkning på fertilitet.
English: Marketing Authorisation Holder Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
Danish: Indehaver af markedsføringstilladelsen Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX04.
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte, Diverse midler til fordøjelsesorganer og stofskifte, ATC-kode: A16A X04.
English: If you stop taking Nityr
Danish: Hvis De holder op med at tage Nityr
English: The active ingredient of Nityr is nitisinone.
Danish: Det aktive stof i Nityr er nitisinon.
English: White to beige, round (7 x 2.3 mm), flat tablets which may display light yellow to brown speckles, marked “10” on one side and “L” on the other side.
Danish: Hvide til beige, runde (7 x 2,3 mm), flade tabletter, som kan have små lysegule til brune prikker, mærket “10” på den ene side og “L” på den anden.
English: Patients who have problems swallowing Nityr tablets whole, are recommended to take alternative nitisinone formulations.
Danish: Til patienter, der har svært ved at synke Nityr-tabletter hele, anbefales det at tage andre formuleringer af nitisinon.
English: Breastfeeding (see sections 4.6 and 5.3).
Danish: 4.6 og 5.3).
English: PHARMACEUTICAL FORM AND CONTENTS 60 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 tabletter
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
Danish: Lægemidlet anvendes til behandling af en sjælden sygdom, der kaldes arvelig tyrosinæmi type 1 hos voksne, unge og børn (i alle aldersgrupper).
English: Treatment of adult and paediatric 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: A food effect study has been conducted with Nityr.
Danish: Der er gennemført et studie af virkningen af fødeindtagelse på Nityr.
English: Shelf life after first opening - 2 months Open date:
Danish: Holdbarhed efter anbrud - 2 måneder Anbrudsdato:
English: ‘Nityr contains lactose').
Danish: 2 under "Nityr indeholder lactose").
English: The recommended total daily dose is 1 mg/kg body administered orally weight.
Danish: Den anbefalede totale daglige dosis er 1 mg/kg legemsvægt taget oralt (gennem munden).
English: During the shelf life, the patient may store the bottle after first opening for a period of 2 months, after which the medicinal product must be discarded.
Danish: I løbet af holdbarhedstiden kan patienten efter anbrud opbevare beholderen i en periode på 2 måneder, hvorefter lægemidlet skal kasseres.
English: Age at onset of symptoms
Danish: Alder ved start af symptomer 1 år
English: If you forget to take Nityr
Danish: Hvis De har glemt at tage Nityr
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg nitisinone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 10 mg nitisinon.
English: All patients
Danish: Antal patienter
English: INFORMATION IN BRAILLE Nityr 10 mg
Danish: INFORMATION I BRAILLE-SKRIFT Nityr 10 mg
English: Nityr contains lactose
Danish: Nityr indeholder Lactose
English: - Each tablet contains 10 mg nitisinone.
Danish: Hver tablet indeholder 10 mg nitisinon.
English: Common eye related side effects (may affect more than 1 in 10 people) 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: The tablets are white to beige, round, flat which may display light yellow to brown speckles marked with “L” on one side and “10” on the other side.
Danish: Hvide til beige, runde, flade tabletter, som kan have små lysegule til brune prikker, mærket “10” på den ene side og “L” på den anden.
English: However, due to the limited data in patients with body weight <20kg, it is recommended to divide the total daily dose into two daily administrations in this patient population.
Danish: Da der imidlertid kun foreligger begrænsede data for patienter, der vejer under 20 kg, anbefales det at dele den totale daglige dosis på to daglige doser hos denne patientpopulation.
English: HDPE 75 mL square bottles with a tamper-evident child-resistant closure of polypropylene (PP).
Danish: Firkantet 75 ml HDPE-plasticbeholder med et forseglet og børnesikret låg af polypropylen (PP).
English: The recommended initial dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Danish: Den anbefalede startdosis til børn og voksne er 1 mg/kg legemsvægt givet oralt.
English: - The other ingredients are glycerol dibehenate, and lactose monohydrate (see section 2 under
Danish: Øvrige indholdsstoffer: glyceroldibehenat og lactosemonohydrat (se pkt.
English: What you need to know before you take Nityr
Danish: Det skal De vide, før De begynder at tage Nityr
English: Other medicines and Nityr
Danish: Brug af anden medicin sammen med Nityr
English: Name and address of the manufacturer(s) responsible for batch release Central Pharma (Contract Packing) Limited Caxton Road
Danish: Central Pharma (Contract Packing) Limited Caxton Road
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nityr 10 mg tablets nitisinone oral use
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Nityr 10 mg tabletter nitisinon oral anvendelse
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 tablets
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Glycerol dibehenate
Danish: Glyceroldibehenat
English: NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets
Danish: LÆGEMIDLETS NAVN Nityr 10 mg tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg nitisinone
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg nitisinon
English: Dublin 2
Danish: BILAG II
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ INDRE EMBALLAGER ETIKET TIL BEHOLDER
English: How to take Nityr
Danish: Sådan skal De tage Nityr
English: NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets nitisinone
Danish: LÆGEMIDLETS NAVN Nityr 10 mg tabletter nitisinon
English: LIST OF EXCIPIENTS Contains lactose, see leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English: Start age ≤ 24 months Start age > 24 months
Danish: Alder ved behandlingsstart 2 år 4 år