FrancophonIA/ELRC3.0 huggingface dataset:
English: The major concern of the CHMP was that the studies presented by the company did not support the requested change in the marketing authorisation, as the patients treated in the studies had not been treated with the highest permitted dose of either rosiglitazone or pioglitazone before entering the studies.
Danish: CHMP's største betænkelighed var, at undersøgelserne, hvis resultater virksomheden fremlagde, ikke underbyggede den ændring i markedsføringstilladelsen, hvorom der blev ansøgt, da de behandlede patienter i undersøgelserne ikke var blevet behandlet med den højeste tilladte dosis af hverken rosiglitazon eller pioglitazon, inden de deltog i undersøgelserne.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with NovoNorm/Prandin?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, som deltager i kliniske undersøgelser med NovoNorm/Prandin?
English: The withdrawal has no consequences for patients currently included in clinical trials with NovoNorm/Prandin.
Danish: Tilbagetrækningen har ingen konsekvenser for patienter, som nu deltager i kliniske undersøgelser med NovoNorm/Prandin.
English: On 12 October 2006, Novo Nordisk A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for NovoNorm/Prandin, to add the use of NovoNorm/Prandin in combination with a thiazolidinedione for the treatment of type 2 diabetes.
Danish: Den 12. oktober 2006 underrettede Novo Nordisk A/S Udvalget for Humanmedicinske Lægemidler (CHMP) om, at firmaet ønsker at trække sin ansøgning om ændring af markedsføringstilladelsen for NovoNorm/Prandin tilbage for at kunne tilføje anvendelse af NovoNorm/Prandin i kombination med et thiazolidindion til behandling af type 2-diabetes.
English: Based on the review of the data submitted for this variation and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that NovoNorm/Prandin in combination with a thiazolidinedione could not have been approved for the treatment of type 2 diabetes.
Danish: På baggrund af gennemgangen af de data, der var indgivet for denne ændring, og virksomhedens svar på CHMP's liste med spørgsmål på tidspunktet for tilbagetrækning af ansøgningen havde CHMP sine betænkeligheder og var af den foreløbige opfattelse, at NovoNorm/Prandin i kombination med et thiazolidindion ikke kunne være blevet godkendt til behandling af type 2-diabetes.
English: Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus or maturity onset diabetes.
Danish: Type 2- diabetes kaldes også ikke-insulinkrævende diabetes mellitus eller gammelmandssukkersyge.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of NovoNorm/Prandin in combination with a thiazolidinedione had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at der ikke i tilstrækkelig grad var blevet påvist en effekt af NovoNorm/Prandin i kombination med et thiazolidindion, og at eventuelle fordele ikke opvejede de påviste risici.
English: It can be used on its own to lower blood glucose (sugar) in patients whose hyperglycaemia (high blood glucose) cannot be controlled by diet, weight reduction and exercise.
Danish: Det kan anvendes alene til at sænke blodglykosen (sukkeret) hos patienter, hvis hyperglykæmi (højt blodglykoseniveau) ikke længere kan holdes under kontrol med diæt, vægttab og motion.
English: The studies compared the effects of NovoNorm/Prandin combined with either rosiglitazone or pioglitazone, compared to the medicines taken alone.
Danish: I undersøgelserne blev virkningerne af NovoNorm/Prandin i kombination med enten rosiglitazon eller pioglitazon sammenlignet med lægemidlerne taget alene.
English: What is happening with NovoNorm/Prandin used in its current indications?
Danish: Hvad sker der med NovoNorm/Prandin, når det anvendes til de nuværende indikationer?
English: What is NovoNorm/Prandin?
Danish: Hvad er NovoNorm/Prandin?
English: In addition, the CHMP was concerned that the studies did not compare NovoNorm/Prandin with a thiazolidinedione to a combination of a thiazolidinedione with sulphonylurea, which is an approved treatment for patients who have failed to respond to a thiazolidinedione taken alone.
Danish: CHMP var endvidere bekymret over, at man i undersøgelserne ikke sammenlignede NovoNorm/Prandin og et thiazolidindion med en kombination af thiazolidindion og et sulfonylurinstof, som er en godkendt behandling for patienter, der ikke reagerer på et thiazolidindion taget alene.
English: NovoNorm/Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Danish: NovoNorm/Prandin får bugspytkirtlen til at producere mere insulin i forbindelse med måltider og anvendes til at holde type 2- diabetes under kontrol.
English: NovoNorm/Prandin is authorised for use in patients who have non insulin-dependent diabetes (type 2 diabetes).
Danish: NovoNorm/Prandin er godkendt til anvendelse hos patienter, som lider af ikke-insulinkrævende diabetes (type 2- diabetes).
English: NovoNorm/Prandin was to be used for the treatment of type 2 diabetes in combination with a thiazolidinedione (another type of anti-diabetes medicine) such as rosiglitazone or pioglitazone, in patients whose blood sugar levels could not be controlled by a thiazolidinedione taken alone.
Danish: NovoNorm/Prandin skulle have været anvendt til behandling af type 2-diabetes i kombination med et thiazolidindion (et andet antidiabetisk lægemiddel) såsom rosiglitazon eller pioglitazon hos patienter, hvis blodsukkerniveauer ikke kunne holdes under kontrol med et thiazolidindion taget alene.
English: What was NovoNorm/Prandin expected to be used for?
Danish: Hvad forventedes NovoNorm/Prandin anvendt til?
English: NovoNorm/Prandin may also be used with metformin (another anti-diabetes medicine) in patients with type 2 diabetes who are not satisfactorily controlled on metformin alone.
Danish: NovoNorm/Prandin kan også anvendes med metformin (et andet antidiabetisk lægemiddel) til patienter med type 2-diabetes, som ikke er tilfredsstillende kontrolleret med metformin alene.
English: How does NovoNorm/Prandin work?
Danish: Hvordan virker NovoNorm/Prandin?
English: • Wash your hands
Danish: • Vask dine hænder.
English: Treatment should be symptomatic and supportive.
Danish: Behandling bør være symptomatisk og understøttende.
English: Date of first authorisation: 9 March 2000 Date of latest renewal: 29 January 2010
Danish: Dato for første markedsføringstilladelse: 9. marts 2000 Dato for seneste fornyelse: 29. januar 2010
English: For a pack containing a single bottle, write only one date.
Danish: Hvis pakningen kun indeholder én flaske, skrives kun én dato.
English: About 20% of the dose has been accounted for in urine as metabolite.
Danish: Ca. 20% af dosis genfindes i urinen som metaboliter.
English: If the pressure in the eye is too high, it can damage your sight.
Danish: Hvis trykket i øjet bliver for højt, kan det beskadige dit syn.
English: No dose adjustment in elderly patients is necessary.
Danish: Dosisjustering er ikke nødvendig for ældre patienter.
English: Eye ointments should be administered last.
Danish: Øjensalve skal administreres sidst.
English: AZOPT may cause the same allergy.
Danish: AZOPT kan forårsage samme type allergi.
English: Do not use this medicine after the expiry date which is stated on the bottle and box after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken og kartonen efter ”EXP”.
English: - if you have dry eyes or cornea problems.
Danish: - hvis du har tørre øjne eller hornhindeproblemer.
English: Do not use AZOPT - if you have severe kidney problems.
Danish: Brug ikke AZOPT - hvis du har alvorlige nyreproblemer.
English: Specific interaction studies with other medicinal products have not been performed with AZOPT.
Danish: Specifikke interaktionsstudier med andre lægemidler er ikke lavet med AZOPT.
English: The drop will go in here (picture 1)
Danish: Dråben skal placeres der (figur 1).
English: If a drop misses your eye, try again.
Danish: Hvis en dråbe rammer forbi øjet, forsøg på ny.
English: Only use AZOPT for your eyes.
Danish: Brug kun AZOPT i øjnene.
English: • Get the AZOPT bottle and a mirror
Danish: • Hent flasken med AZOPT og et spejl.
English: Electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur.
Danish: Elektrolyt ubalance, udvikling af en acidotisk tilstand og mulig påvirkning af nervesystemet kan forekomme.
English: Binding to plasma proteins is not extensive (about 60%).
Danish: Plasma-protein-bindingen er ikke udpræget (ca. 60%).
English: The following side effects have been seen with AZOPT.
Danish: Der er set følgende bivirkninger med AZOPT.
English: If you stop using AZOPT without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Danish: Hvis du holder op med at bruge AZOPT uden at informere din læge, vil trykket i øjet ikke blive kontrolleret, hvilket kan medføre synstab.
English: Some patients may have a better response with one drop three times a day.
Danish: Nogle patienter kan have større effekt af 1 dråbe 3 gange daglig.
English: This medicine contains 3.35 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Danish: Dette lægemiddel indeholder 3,35 µg benzalkoniumchlorid pr. dråbe (= 1 dosis) svarende til 0,01% eller 0,1 mg/ml.
English: Serum electrolyte levels (particularly potassium) and blood pH levels must be monitored.
Danish: Serum elektrolyt niveauet (specielt kalium) og blod pH niveauet skal monitoreres.
English: Potential rebound effects following cessation of treatment with AZOPT have not been studied; the IOP-lowering effect is expected to last for 5-7 days.
Danish: Potentiel rebound-effekt efter seponering af behandling med AZOPT er ikke studeret; den IOP sænkende effekt forventes at holde 5-7 dage.
English: 1 drop in the affected eye or eyes twice a day - morning and night.
Danish: 1 dråbe i det angrebne øje (øjne) 2 gange dagligt-morgen og aften.
English: Common: dysgeusia
Danish: Almindelig: dysgeusi
English: - General side effects: bad taste.
Danish: • Generelle bivirkninger: dårlig smag i munden.
English: It is likely caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal.
Danish: Forandringen forårsages sandsynligvis af passage af øjendråberne til naso-pharynx via den nasolacrimale kanal.
English: The adverse reactions were obtained from clinical trials and post-marketing spontaneous reports.
Danish: Bivirkningerne er indhentet fra kliniske forsøg og spontane indberetninger efter markedsføring.
English: It reduces pressure within the eye.
Danish: Det sænker trykket inde i øjet.
English: Animal studies with brinzolamide demonstrated no effect on fertility.
Danish: Dyrestudier med brinzolamid viste ingen påvirkning af fertiliteten.
English: AZOPT is not to be used by infants, children or adolescents under 18 years of age unless advised by your doctor.
Danish: AZOPT må ikke bruges af spædbørn, børn og unge, der er under 18 år gamle, medmindre lægen anbefaler det.
English: Only use AZOPT in both eyes if your doctor told you to. Take it for as long as your doctor told you to.
Danish: Anvend kun AZOPT i begge øjne, hvis din læge har ordineret det. Anvend AZOPT så længe som ordineret af din læge.
English: Carbonic anhydrase activity was approximately 40-70% of predose levels.
Danish: Karboanhydrase aktiviteten var ca. 40-70% af niveauet før medicinering.
English: • Hyperchloraemic acidosis.
Danish: • Hyperkloræmisk acidose.
English: The dose should not exceed one drop in the affected eye(s) three times daily.
Danish: Dosis bør ikke overstige 1 dråbe i de(t) afficerede øje/øjne 3 gange daglig.
English: Brinzolamide is eliminated primarily by renal excretion (approximately 60%).
Danish: Brinzolamid elimineres primært ved renal udskillelse (ca. 60%).
English: - if you are allergic to medicines called sulphonamides.
Danish: - hvis du er allergisk over for lægemidler, der tilhører ”sulfonamiderne”.
English: - if you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
Danish: - hvis du lider af for høj surhedsgrad i blodet (en tilstand kaldet ”hyperkloræmisk acidose”).
English: There was an overall higher incidence of non-serious ocular adverse reactions, mainly related to signs of local irritation, in the brinzolamide/travoprost groups.
Danish: Der var generelt en hyppigere forekomst af ikke-alvorlige okulære bivirkninger, hovedsageligt relateret til tegn på lokal irritation hos brinzolamid/travoprost-grupperne.
English: AZOPT has a minor influence on the ability to drive and use machines.
Danish: AZOPT påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • After using AZOPT, press a finger to the corner of your eye, by the nose (picture 3) for at least
Danish: • Når du har dryppet med AZOPT, trykkes en finger mod øjenkrogen ind mod næsen (se figur 3) i mindst 1 minut.
English: Caution should be used in treating these patients and close monitoring of intraocular pressure (IOP) is recommended.
Danish: Der skal udvises forsigtighed ved behandling af disse patienter, og tæt monitorering af det intraokulære tryk anbefales.
English: White to off-white suspension.
Danish: Hvid til råhvid suspension.
English: The following adverse reactions have been reported with brinzolamide 10mg/ml eye drops, suspension and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 1/10), almindelig (> 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Gently press on the base of the bottle to release one drop of AZOPT at a time.
Danish: • Tryk let på flaskens bund for at frigøre en dråbe AZOPT ad gangen.
English: There are no or limited amount of data from the use of ophthalmic brinzolamide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af oftalmologisk brinzolamid hos gravide kvinder.
English: Not Known: hypersensitivity
Danish: Ikke kendt: overfølsomhed
English: • Known hypersensitivity to sulphonamides (see also section 4.4).
Danish: • Overfølsomhed over for sulfonamider (se også pkt.
English: • ocular hypertension
Danish: • okulær hypertension
English: If you stop using AZOPT
Danish: Hvis du holder op med at bruge AZOPT
English: In subjects with the highest degree of renal impairment inhibition of total CA activity was greater although it was inferior to 90% at steady-state.
Danish: Ved patienter med den højeste grad af nedsat nyrefunktion var hæmningen af total CA aktivitet større, selvom den var mindre end 90% ved steady-state.
English: 5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer).
Danish: 5 og 10 ml uklar lav densitet polyethylen dråbeflasker med polypropylene skruelåg (droptainer).
English: An additional decrease in mean diurnal IOP of 3.2 to 3.4 mmHg for the brinzolamide group and 3.2 to 4.2 mmHg for the timolol group were observed.
Danish: Der blev observeret en yderligere reduktion i det gennemsnitlige diurnale intraokulære tryk på 3,2 til 3,4 mmHg for brinzolamid-gruppen og 3,2 til 4,2 mmHg for timolol-gruppen.
English: The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count).
Danish: Brinzolamids mulige påvirkning af den korneale endotelfunktion er ikke vurderet hos patienter med kompromitteret cornea (især hos patienter med lavt endotel celletal).
English: Since AZOPT contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Danish: Da AZOPT øjendråber indeholder benzalkoniumchlorid, er tæt opfølgning nødvendig ved hyppig eller langvarig brug for patienter med tørre øjne eller ved tilfælde, hvor cornea er kompromitteret.
English: The adverse reactions seen with the adjunctive therapy have been observed with each active substance alone.
Danish: Bivirkninger, der er påvist ved supplerende terapi, er observeret med hvert af de aktive stoffer brugt alene.
English: Studies have not been performed to evaluate the effect of topical ocular administration of brinzolamide on human fertility.
Danish: Der er ikke udført studier til evaluering af virkningen af topikal okulær administration af brinzolamid på fertiliteten hos mennesker.
English: If affected, take care when driving or using machines.
Danish: Hvis du bliver påvirket, skal du udvise forsigtighed, når du kører bil eller betjener maskiner.
English: Brinzolamide has not been studied in pre-term infants (less than 36 weeks gestational age) or those less than 1 week of age.
Danish: Brinzolamid er ikke undersøgt hos for tidlig fødte børn (med en gestationsalder på under 36 uger) eller hos børn, der er under 1 uge gamle.
English: Examples include medicines used to treat diabetes and infections and also diuretics (water tablets).
Danish: Eksempler omfatter lægemidler, der anvendes til behandling af sukkersyge eller infektioner, samt vanddrivende lægemidler.
English: AZOPT contains benzalkonium chloride
Danish: AZOPT indeholder benzalkoniumchlorid
English: Due to its high affinity for CA-II, brinzolamide distributes extensively into the red blood cells (RBCs) and exhibits a long half-life in whole blood (mean of approximately 24 weeks).
Danish: På grund af den høje affinitet for CA-II, distribueres brinzolamid udpræget ind i de røde blodlegemer (RBC) og frembyder en lang halveringstid i fuldblod (ca. 24 uger).
English: What AZOPT contains
Danish: AZOPT indeholder
English: You may find that your vision is blurred for a time just after using AZOPT.
Danish: Dit syn kan blive sløret umiddelbart efter anvendelse af AZOPT.
English: It is unknown whether brinzolamide/metabolites are excreted in human milk following topical ocular administration.
Danish: Det er ukendt, om brinzolamid/metabolitter udskilles i human mælk efter topikal okulær administration.
English: Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Danish: Saltsyre/natriumhydroxid (til at justere pH) Renset vand
English: This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.
Danish: Dette kan reducere den systemiske absorption af lægemidler administreret okulært og resultere i færre systemiske bivirkninger.
English: Do not swallow or inject.
Danish: Det må ikke indtages gennem munden eller indsprøjtes.
English: To prevent contamination of the dropper tip and suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Danish: For at undgå kontaminering af dråbespidsen og suspensionen skal man være opmærksom på ikke at berøre øjenlåg, øjenomgivelser og andre overflader med spidsen af flasken.
English: Following a 4 week run-in with travoprost, patients with an IOP ≥19 mmHg were randomized to receive added treatment with brinzolamide or timolol.
Danish: Efter en 4-ugers indkøringsperiode med travoprost, blev patienter med et intraokulært tryk på ≥ 19 mmHg randomiseret til at modtage tillægsbehandling med brinzolamid eller timolol.
English: These findings occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased foetal weights.
Danish: Disse fund viste sig ved doser, som forårsagede metabolsk acidose med nedsat kropsvægt øgning hos mødrene og faldende kropsvægt hos fostrene.
English: The inhibition of total RBC CA activity at steady state was approximately 70-75%.
Danish: Hæmningen af de RBCs CA aktivitet ved steady-state var ca. 70-75%.
English: Use this much unless your doctor told you to do something different.
Danish: Anvend denne dosering medmindre din læge har ordineret dig noget andet.
English: At steady-state, brinzolamide and its metabolite RBC concentrations ranged from 22.0 to 46.1 and 17.1 to 88.6 µM, respectively.
Danish: Ved steady-state var brinzolamid og dens metabolit, i koncentrationer på henholdsvis fra 22,0 til 46,1 og 17,1 til 88,6 M, respektivt.
English: B-2870 Puurs, Belgium.
Danish: B-2870, Puurs Belgien eller
English: Dysgeusia (bitter or unusual taste in the mouth following instillation) was the most frequently reported systemic adverse reaction associated with the use of AZOPT during clinical studies.
Danish: Dysgeusi (bitter eller unormal smag i munden efter drypning) var den hyppigst forekommende uønskede virkning forbundet med behandling med AZOPT under de kliniske undersøgelser.
English: N-desethylbrinzolamide RBC concentrations increased and total RBC CA activity decreased with decreasing creatinine clearance but brinzolamide RBC concentrations and CA-II activity remained unchanged.
Danish: N-desethyl-brinzolamid RBC-koncentrationerne voksede, og total RBC CA aktivitet aftog med faldende cratinin clearance, mens brinzolamid RBC koncentrationerne og CA-II forblev uforandrede.
English: Developmental toxicity studies in rabbits with oral doses of brinzolamide of up to 6 mg/kg/day (125 times the recommended human ophthalmic dose) revealed no effect on foetal development despite significant maternal toxicity.
Danish: Toksiske udviklingsstudier med kaniner med oral dosering af brinzolamid op til 6 mg/kg/dag (125 gange den anbefalede humane dosis i øjnene) viste ingen effect på foster-udvikling, trods significant maternal toksisitet.
English: Patients must be instructed to remove contact lenses prior to the application of AZOPT and wait at least 15 minutes after instillation of the dose before reinsertion.
Danish: Patienterne skal instrueres i at fjerne kontaktlinserne før applikation af AZOPT og vente mindst 15 minutter efter instillation af dosis, før linserne sættes i.
English: This helps to stop AZOPT getting into the rest of the body.
Danish: Det forhindrer, at AZOPT optages i kroppen.
English: Studies in animals have shown reproductive toxicity following systemic administration (see also section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet efter systemisk administration (se pkt.
English: You must throw away a bottle four weeks after you first opened it, to prevent infections.
Danish: Flasken skal kasseres 4 uger efter åbning for at forhindre, at indholdet bliver forurenet.
English: Patients with significant renal tubular immaturity or abnormalities should only receive brinzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.
Danish: Patienter med signifikant immature eller abnorme tubuli renalis bør kun få brinzolamid efter nøje afvejning af risici og fordele på grund af den mulige risiko for metabolisk acidose.
English: AZOPT contains a preservative (benzalkonium chloride) which may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: AZOPT indeholder et konserveringsmiddel (benzalkoniumchlorid), som kan absorberes af bløde kontaktlinser og kan ændre farven af kontaktlinserne.
English: Brinzolamide, an inhibitor of carbonic anhydrase II (CA-II), the predominant iso-enzyme in the eye, with an in vitro IC50 of 3.2 nM and a Ki of 0.13 nM against CA-II.
Danish: Brinzolamid er en hæmmer af karboanhydrase II (CA-II), det fremherskende isozym i øjet med et in vitro IC50 på 3,2 nM og et Ki på 0,13 nM imod CA-II.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.