FrancophonIA/ELRC3.0 huggingface dataset:
English: Netarsudil belongs to a group of medicines called “Rho kinase inhibitors”, which work to reduce the amount of fluid inside the eye and so lower its pressure.
Danish: Netarsudil tilhører en gruppe lægemidler, der kaldes "Rho-kinase-hæmmere", og de reducerer mængden af væske i øjet og får derved trykket til at falde.
English: Netarsudil dosed twice daily provided slightly larger IOP reductions, but had a less favorable safety profile as reflected in a higher rate and increased severity of ocular adverse reactions.
Danish: Netarsudil administreret to gange om dagen medførte lidt større reduktion af det intraokulære tryk, men havde en mindre gunstig sikkerhedsprofil, idet der sås flere og alvorligere okulære bivirkninger.
English: Efficacy was also investigated in patients with baseline IOP ≥25 mmHg and <30 mmHg.
Danish: Virkningen blev også undersøgt hos patienter med et intraokulært tryk ved baseline på ≥ 25 mmHg og < 30 mmHg.
English: If topical overdose of netarsudil should occur, the eye(s) may be flushed with tap water.
Danish: Hvis en topisk overdosering af netarsudil skulle forekomme, kan øjet/øjnene skylles med postevand.
English: The following adverse reactions have been reported with netarsudil, dosed once daily.
Danish: Følgende bivirkninger er rapporteret ved administration af netarsudil én gang dagligt.
English: PHARMACEUTICAL FORM Eye drops, solution (eye drops).
Danish: LÆGEMIDDELFORM Øjendråber, opløsning (øjendråber).
English: Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface and is known to discolour soft contact lenses.
Danish: Benzalkoniumchlorid er rapporteret at medføre øjenirritation og symptomer på tørre øjne, og det kan påvirke tårefilmen og hornhindens overflade; det kan også misfarve bløde kontaktlinser.
English: Discontinuation rates due to adverse reactions were 19.3% for the netarsudil treatment group versus 1.7% for the timolol maleate group.
Danish: Forekomsten af seponering som følge af bivirkninger var 19,3 % for netarsudil-grupperne vs. 1,7 % for timololmaleat-grupperne.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE
English: • Twist off the bottle cap, and lie the cap on a clean surface on its side.
Danish: • Drej låget af flasken, og læg det på siden på en ren overflade.
English: A randomised, double-blind, multicentre Phase 3 clinical trial compared the efficacy and safety of netarsudil once daily with that of timolol maleate 0.5% twice daily in reducing IOP in a total of 708 patients with open-angle glaucoma or ocular hypertension.
Danish: I et randomiseret, dobbeltblindet, klinisk fase 3-studie på flere centre blev virkningen og sikkerheden ved netarsudil én gang dagligt sammenholdt med virkningen og sikkerheden ved timololmaleat 0,5 % to gange dagligt til reduktion af det intraokulære tryk hos i alt 708 patienter med åbenvinklet glaukom eller okulær hypertension.
English: If you stop using Rhokiinsa
Danish: Hvis du holder op med at bruge Rhokiinsa
English: Other ocular adverse reactions reported are: cornea verticillata (17%), instillation site pain (17%), and conjunctival haemorrhage (8%).
Danish: Andre okulære bivirkninger er: cornea verticillata (17 %), smerter ved instillationsstedet (17 %) og konjunktival blødning (8 %).
English: Completion rates in Phase 3 studies were lower in the netarsudil treatment group when compared with the timolol maleate group.
Danish: Gennemførelsesraten i fase 3-studierne var lavere i netarsudil-grupperne end i timololmaleatgrupperne.
English: In pregnant rats, 0.3 mg/kg/day (1000 times the recommended ophthalmic dose) and higher showed increased postimplantation loss and reduced foetal viability.
Danish: Hos drægtige rotter medførte doser på 0,3 mg/kg/dag (1.000 gange den anbefalede oftalmologiske dosis) og derover øget postimplantationstab og reduceret fosterlevedygtighed.
English: If you forget to use Rhokiinsa
Danish: Hvis du har glemt at bruge Rhokiinsa
English: The tip of the dispensing container should avoid contacting the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution.
Danish: For at undgå kontaminering af opløsningen bør spidsen af dryppeanordningen ikke komme i kontakt med øjnene, de omkringliggende strukturer, fingre eller andre overflader.
English: The incidences of hyperemia and vision blurred were sporadic in nature.
Danish: Forekomsten af hyperæmi og sløret syn var sporadisk.
English: If you get any side effects, talk to your doctor, or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apotekspersonalet.
English: Netarsudil demonstrated clinically relevant reductions in IOP at all timepoints, however non-inferiority to timolol was not demonstrated in this population with baseline IOP ≥25 mmHg and <30 mmHg (Table 2).
Danish: Det er påvist, at netarsudil medfører klinisk relevante reduktioner af det intraokulære tryk ved alle tidspunkter, idet der dog ikke er påvist non-inferioritet over for timolol i denne population med et intraokulært tryk på ≥ 25 mmHg og < 30 mmHg (se tabel 2).
English: For ocular use.
Danish: Til okulær anvendelse.
English: However, while no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding women to netarsudil is expected to be negligible, no relevant clinical data are available (see section 5.2).
Danish: Der forventes ikke nogen indvirkning på diende nyfødte/spædbørn, da den ammende kvindes systemiske eksponering for netarsudil formodes at være ubetydelig; der foreligger dog ingen relevante kliniske data (se pkt.
English: Common headache Uncommon dizziness,
Danish: Almindelig hovedpine Ikke almindelig svimmelhed, synsfeltsdefekt
English: Rhokiinsa is used to lower pressure in the eyes in adults who have an eye condition known as glaucoma or who have raised pressure in their eyes.
Danish: Rhokiinsa anvendes til at sænke trykket i øjet hos voksne, der har en øjensygdom, som hedder glaukom (grøn stær), eller som har et øget tryk i øjnene.
English: PHARMACEUTICAL FORM AND CONTENTS Eye drops, solution
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Øjendråber, opløsning
English: In pregnant rabbits, 3 mg/kg/day (10000 times the recommended ophthalmic dose) and higher showed an increase in post-implantation loss and a decrease in foetal weight.
Danish: Hos drægtige kaniner medførte doser på 3 mg/kg/dag (10.000 gange den anbefalede oftalmologiske dosis) og derover øget postimplantationstab og reduceret fostervægt.
English: What Rhokiinsa looks like and contents of the pack Rhokiinsa is a clear, liquid eye drop solution in a plastic bottle.
Danish: Rhokiinsa er en klar opløsning (øjendråber) i en plastikflaske.
English: Do not use more than one drop in the affected eye(s) once a day.
Danish: Anvend ikke mere end 1 dråbe i det eller de berørte øjne én gang dagligt.
English: - The other excipients are benzalkonium chloride (see section 2 under ‘Rhokiinsa contains benzalkonium chloride'), mannitol, boric acid, sodium hydroxide and water for injections.
Danish: 2 under "Rhokiinsa indeholder benzalkoniumchlorid"), mannitol, borsyre, natriumhydroxid og vand til injektionsvæsker.
English: The study was designed to show non-inferiority of netarsudil when dosed once daily in the evening to timolol maleate 0.5% dosed twice daily in patients with a baseline IOP of >20 mmHg and <25 mmHg.
Danish: Studiet var designet til at vise netarsudils non-inferioritet ved dosering én gang dagligt om aftenen i forhold til timololmaleat 0,5 % givet to gange dagligt hos patienter med et intraokulært tryk ved baseline på > 20 mmHg og < 25 mmHg.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
English: However, no effects are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Danish: Der forventes dog ingen indvirkning, da den systemiske eksponering for netarsudil er ubetydelig (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 200 micrograms netarsudil (as mesylate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml opløsning indeholder 200 mikrogram netarsudil (som mesylat).
English: No effects during pregnancy are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Danish: Der forventes ingen indvirkning på graviditet, da den systemiske eksponering for netarsudil er ubetydelig (se pkt.
English: The IOP reduction with netarsudil dosed once daily was non-inferior to the effect of timolol 0.5% dosed twice daily in patients with baseline IOP of <25 mmHg (Table 1).
Danish: Faldet i det intraokulære tryk ved anvendelse af netarsudil én gang dagligt var non-inferiort i forhold til effekten af timolol 0,5 % givet to gange dagligt hos patienter med et intraokulært tryk ved baseline på < 25 mmHg (tabel 1).
English: Rhokiinsa is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.
Danish: Rhokiinsa er indiceret til reduktion af forhøjet intraokulært tryk hos voksne patienter med primært åbenvinklet glaukom eller okulær hypertension.
English: Netarsudil, a Rho kinase inhibitor, is believed to reduce IOP by increasing outflow of aqueous humor.
Danish: Netarsudil, der er en Rho-kinase-hæmmer, menes at reducere det intraokulære tryk ved at øge afløbet af kammervand.
English: Table 2: Mean IOP by visit: PP population with baseline IOP ≥25 and <30 mmHg Study Visit and Time Point
Danish: Tabel 2: Gennemsnitligt intraokulært tryk pr. besøg: PP-population med et intraokulært tryk ved baseline på ≥ 25 mmHg og < 30 mmHg Studiebesøg og tidspunkt
English: The cornea verticillata seen in netarsudil-treated patients were first noted at 4 weeks of daily dosing.
Danish: Hos netarsudil-behandlede patienter sås det først efter fire ugers daglig dosering.
English: Frequency Adverse reactions
Danish: Hyppighed Bivirkninger
English: What Rhokiinsa contains - The active substance is netarsudil.
Danish: Rhokiinsa indeholder: - Aktivt stof: netarsudil.
English: Each ml of solution contains 200 micrograms netarsudil (as mesylate).
Danish: En ml opløsning indeholder 200 mikrogram netarsudil (som mesylat).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rhokiinsa 200 micrograms/ml eye drops netarsudil
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Rhokiinsa 200 mikrogram/ml øjendråber netarsudil
English: Once opened, do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: Table 1: Mean IOP by visit: PP population with baseline IOP <25 mmHg Study Visit and Time Point
Danish: Tabel 1: Gennemsnitligt intraokulært tryk pr. besøg: PP-population med et intraokulært tryk ved baseline på < 25 mmHg Studiebesøg og tidspunkt
English: Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Danish: Brug af kontaminerede opløsninger kan medføre alvorlig skade på øjet og efterfølgende synstab.
English: Uncommon ocular hyperaemia, blepharitis, corneal disorder, eyelid margin crusting, eye allergy, conjunctival follicles, ocular discomfort, eye swelling, corneal deposits, eyelid disorder, meibomian gland dysfuntion, corneal pigmentation, diplopia, ectropion, lenticular opacities, noninfective conjunctivitis, abnormal sensation in the eye, asthenopia, episcleral hyperaemia, halo vision, keratitis, refraction disorder, anterior chamber flare, anterior chamber inflammation, blindness, conjunctival irritation, conjunctivochalasis, diabetic retinopathy, eczema eyelids, eyelid skin dryness, glaucoma, growth of eyelashes, iris adhesions, iris bombe, iritis, ocular hypertension, visual impairment, corneal dystrophy, instillation site foreign body sensation, instillation site irritation, glassy eyes, fatigue, instillation site dryness, instillation site oedema, instillation site paraesthesia, conjunctival staining, optic nerve cup/disc ratio increased, madarosis
Danish: Ikke almindelig okulær hyperæmi, blefaritis, hornhindeforstyrrelse, skorpedannelse på øjenlågsranden, øjenallergi, konjunktivale follikler, okulært ubehag, øjenhævelse, aflejringer i hornhinden, øjenlågsforstyrrelse, dysfunktion i de meibomske kirtler, hornhindepigmentering, dobbeltsyn, ectropion, uklarheder i øjets linse, ikke-infektiøs konjunktivitis, unormal fornemmelse i øjet, astenopi, episkleral hyperæmi, lysringe i synsfeltet, keratitis, refraktionsforstyrrelse, opblussen i øjets forreste kammer, inflammation i øjets forreste kammer, blindhed, konjunktival irritation, conjunctivochalasis, diabetisk retinopati, øjenlågseksem, tørre øjenlåg, glaukom, øjenvippevækst, iris adherancer, iris bombé, iritis, okulær hypertension, synsnedsættelse, hornhinde-dystrofi, fornemmelse af fremmedlegeme ved instillationsstedet, irritation ved instillationsstedet, spejlblanke øjne, træthed, tørhed ved instillationsstedet, ødem ved instillationsstedet, paræstesi ved instillationsstedet, farvning af bindehinden, øget cup/disc-ratio for synsnerven, madarose
English: Rinse your eye with warm water.
Danish: Hvis du har brugt for meget Rhokiinsa Skyl dit øje med varmt vand.
English: • General side effects: Increased allergic symptoms; dizziness; blurred vision; nasal discomfort and pain; redness or itching of the skin; rash on skin; inflammation of the cartilage; picking of the skin
Danish: • Andre bivirkninger: Øgede allergiske symptomer, svimmelhed, sløret syn, ubehag og smerter i næsen, rødme eller hudkløe, hududslæt, bindevævsbetændelse, kradsen
English: • Effects in the eye: Infection or inflammation of the eye; dryness of the eye or small breaks in the film of liquid on the surface of the eye; eye discharge; itchy eyelids; clouding of the eye and vision may decrease somewhat; eye pain; feeling of grittiness or having something in the eye; general eye redness shortly after drops are put in; spots or patches of eye redness; eye inflammation caused by an allergic reaction or prominent blood vessels; eyes can become watery, sensitive to light; swelling around the eye; blurred vision
Danish: • Reaktioner i øjet: Infektion eller betændelse i øjet, tørhed i øjet eller små revner i tårefilmen, sekret fra øjet, kløe i øjenlågene, uklarhed i øjet og let forringet syn, øjensmerter, følelse af sandkorn eller fremmedlegeme i øjet, røde øjne kort efter drypning af øjet, røde prikker eller pletter i øjnene, øjenbetændelse forårsaget af en allergisk reaktion eller synlige blodkar, øjnene kan løbe i vand eller blive lysfølsomme, hævelse omkring øjnene, sløret syn.
English: What Rhokiinsa is and what it is used for What you need to know before you use Rhokiinsa How to use Rhokiinsa
Danish: Det skal du vide, før du begynder at bruge Rhokiinsa Sådan skal du bruge Rhokiinsa Bivirkninger
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of solution contains 200 micrograms netarsudil (as mesylate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml opløsning indeholder 200 mikrogram netarsudil (som mesylat).
English: How to use Rhokiinsa
Danish: Sådan skal du bruge Rhokiinsa
English: • Effects in the eye: Increased fluid pressure inside the eye; inflammation of the coloured part of the eye (the iris); bulging of iris; growth of eyelashes; eyelid dryness; eye disease related to diabetes; excess folds of the conjunctiva; blindness; blurred, double and halo vision; cataracts; abnormal turning outward of the lower eyelid; small colored spots on the eye surface; eye dryness caused by inflammation of the glands of the eyelids; eye allergy; eyelid crusting; glassy eyes; loss of eyelashes; tiredness
Danish: • Reaktioner i øjet: Øget væsketryk i øjet, betændelse i den farvede del af øjet (iris), iris buler frem, øjenvippevækst, tørre øjenlåg, øjensygdom relateret til diabetes, mange folder i bindehinden, blindhed, sløret syn, dobbeltsyn, lysringe i synsfeltet, grå stær, unormal udaddrejning af det nedre øjenlåg, små farvede prikker på øjenoverfladen, tørre øjne forårsaget af betændelse i kirtlerne i øjenlåget, øjenallergi, skorpedannelse på øjenlåget, spejlblanke øjne, tab af øjenvipper, træthed
English: Benzalkonium chloride content
Danish: Benzalkoniumchlorid-indhold
English: NAME OF THE MEDICINAL PRODUCT Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
Danish: LÆGEMIDLETS NAVN Rhokiinsa 200 mikrogram/ml øjendråber, opløsning netarsudil
English: Netarsudil and its active metabolite AR-13503 was found to have a possible phototoxic potential in a modified 3T3 NRU-PT in vitro assay, where the wavelength was extended to include UVB light.
Danish: I en modificeret 3T3 NRU-PT-in vitro-test, hvor bølgelængden var udvidet til at omfatte UVB-lys, blev det påvist, at netarsudil og dets metabolit, AR-13503, har et muligt fototoksisk potentiale.
English: Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
Danish: Rhokiinsa 200 mikrogram/ml øjendråber, opløsning netarsudil
English: Boric acid
Danish: Vand til injektionsvæsker
English: Common conjunctival haemorrhage, vision blurred, lacrimation increased, erythema of eyelid, eye pruritis, eye irritation, visual acuity reduced, eyelid oedema, punctate keratitis, conjunctival oedema, foreign body sensation in eyes, conjunctivitis, conjunctivitis allergic, photophobia, eyelid pruritus, eye pain, corneal opacity, dry eye, eye discharge,
Danish: Meget almindelig konjunktival hyperæmi cornea verticillata smerter ved instillationsstedet Almindelig konjunktival blødning, sløret syn, øget tåreflåd, erytem i øjenlåget, øjenpruritus, øjenirritation, nedsat synsskarphed, ødem i øjenlåget, punktatkeratitis, konjunktivalt ødem, følelse af fremmedlegeme i øjet, konjunktivitis, allergisk konjunktivitis, fotofobi, øjenlågspruritus, øjensmerter, uklarheder i hornhinden, tørre øjne, sekret fra øjet, erytem ved instillationsstedet, ubehag ved instillationsstedet, pruritus ved instillationsstedet, farvning af hornhinden,
English: Each ml of solution contains 150 micrograms benzalkonium chloride.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: En ml opløsning indeholder 150 mikrogram benzalkoniumchlorid.
English: Uncommon dermatitis allergic, dermatitis contact, lichenification, petechiae Musculoskeletal and connective tissue disorders Uncommon polychondritis Injury, poisoning and procedural complications Uncommon excoriation 1 See Description of selected adverse reactions for further information
Danish: Ikke almindelig allergisk dermatitis, kontaktdermatitis, likenisering, petekkier
English: NAME OF THE MEDICINAL PRODUCT Rhokiinsa 200 micrograms/ml eye drops, solution.
Danish: Rhokiinsa 200 mikrogram/ml øjendråber, opløsning.
English: • Effects in the eye: Eye redness; fine deposits on the front of the eye and pain where the drops have been put in
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) • Reaktioner i øjet: Røde øjne, små aflejringer forrest i øjet og smerter ved inddrypningsstedet
English: Respiratory, thoracic and mediastinal disorders Uncommon nasal discomfort, rhinalgia
Danish: Luftveje, thorax og mediastinum
English: Posology
Danish: Administration
English: Your doctor will decide which strength is best for you.
Danish: Lægen vil afgøre hvilken styrke, der er bedst for dig.
English: Therefore it should not be used in this age group.
Danish: Derfor bør den ikke anvendes til denne aldersgruppe.
English: The primary response to vaccination was not affected.
Danish: Det primære respons på vaccination påvirkedes ikke.
English: County Kerry Ireland
Danish: County Kerry Irland
English: Date of first authorisation: 28 February 2002 Date of latest renewal: 20 November 2006
Danish: Dato for første markedsføringstilladelse: 28. februar 2002 Dato for seneste fornyelse: 20. november 2006
English: Not known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke vurderes ud fra forhåndenværende data)
English: Data from six major trials are presented here.
Danish: Data fra seks større afprøvninger bliver vist her.
English: Treatment duration was for up to three weeks.
Danish: Behandlingens varighed var i indtil 3 uger.
English: Treatment should not be continuous on a long-term basis.
Danish: Behandlingen bør ikke være kontinuerlig i en længerevarende periode.
English: In addition, ask your doctor for advice on other appropriate sun protection methods.
Danish: Spørg desuden lægen til råds om andre passende solbeskyttelsesmetoder.
English: The average total body clearance is approximately 2.25 l/h.
Danish: Den gennemsnitlige totale clearance fra kroppen er omkring 2,25 l/time.
English: The results in the control group were similar.
Danish: Kontrolgruppen viste lignende resultater.
English: • increased skin sensitivity (especially to hot and cold)
Danish: • øget hudfølsomhed (særlig over for varme og kulde)
English: Specific studies have not been conducted in older people.
Danish: Der er ikke foretaget specifikke studier med ældre personer.
English: Eczema herpeticum, Folliculitis,
Danish: Eczema herpeticum, Follikulitis,
English: Systemic exposure increases with increasing treatment areas.
Danish: Den systemiske eksponering stiger med øgede behandlingsområder.
English: Table 4: Efficacy (moderate to severe subpopulation)
Danish: Tabel 4: Virkning (moderat til alvorlig subpopulation)
English: Thereafter, patients are considered suitable for maintenance treatment (see below).
Danish: Herefter betragtes patienterne som egnet til vedligeholdelsesbehandling (se nedenfor).
English: Fertility There are no fertility data available.
Danish: Fertilitet Der foreligger ingen fertilitetsdata.
English: Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Danish: Pakningsstørrelser: 10 g, 30 g og 60 g. Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: • The safety of using Protopic for a long time is not known.
Danish: • Sikkerheden ved langtidsbrug af Protopic er ukendt.
English: Thereafter, patients entered a double-blind disease control period (DCP) for up to 12 months.
Danish: Derefter indgik patienterne i en dobbelt-blindet sygdomskontrolperiode (DCP) i op til 12 måneder.
English: Adults, ≥16 years
Danish: Voksne, ≥ 16 år
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
Danish: Hyppigheden er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: Repeated dose toxicity and local tolerance
Danish: Kronisk toksicitet og lokal tolerabilitet
English: • Wash your hands after applying Protopic unless your hands are also being treated.
Danish: • Vask hænder efter påsmøring af Protopic, medmindre hænderne også skal behandles.
English: • Avoid using the ointment inside your nose or mouth or in your eyes.
Danish: • Undgå at smøre salven i næsen, munden eller i øjnene.
English: 4.6 Fertility, Pregnancy and lactation
Danish: 4.6 Fertilitet, graviditet og amning
English: However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.
Danish: De kliniske erfaringer, som er tilgængelige for denne patientpopulation, tyder imidlertid ikke på, at dosisjustering er nødvendig.
English: LEO Pharma A/S Industriparken 55 2750 Ballerup Denmark
Danish: LEO Pharma A/S Industriparken 55 2750 Ballerup Danmark
English: Children, 2-15 years
Danish: Børn, 2 -15 år
English: There are no adequate data from the use of tacrolimus ointment in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af tacrolimus til gravide kvinder.
English: The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of tacrolimus ointment is unknown.
Danish: Risikoen for mennesker kan ikke fuldstændig udelukkes da potentialet for lokal immunsuppression ved langtidsbrug af tacrolimussalve er ukendt.
English: The response rates at month 6 were comparable to the 3-month results.
Danish: Responsraten ved måned 6 svarede til resultaterne ved måned 3.
English: (immuno-compromised) whatever the cause.
Danish: (er immunkompromitteret) uanset årsagen.