FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials involving SIMBRINZA dosed twice daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately 6-7% of patients, and dysgeusia (bitter or unusual taste in the mouth following instillation) occurring in approximately 3% of patients.
Danish: I kliniske forsøg med SIMBRINZA doseret to gange dagligt var de hyppigste bivirkninger okulær hyperæmi og okulære overfølsomhedsreaktioner, som optrådte hos ca. 6-7 % af patienterne, og dysgeusi (en bitter eller usædvanlig smag i munden efter inddrypning), som optrådte hos ca. 3 % af patienterne.
English: Brimonidine, an alpha-2 adrenergic agonist, inhibits the enzyme adenylate cyclase and suppresses the cAMP-dependent formation of aqueous humour.
Danish: Brimonidin, en alfa-2-adrenerg agonist, hæmmer enzymet adenylat-cyclase og undertrykker den cAMP-afhængige dannelse af kammervæske.
English: Do not use SIMBRINZA - if you are allergic to brinzolamide or brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to sulphonamides (examples include medicines used to treat diabetes and infections and also diuretics (water tablets)) - if you are taking a monoamine oxidase (MAO) inhibitors (examples include medicines to treat depression or Parkinson's disease) or certain antidepressants.
Danish: Brug ikke SIMBRINZA - hvis du er allergisk over for brinzolamid eller brimonidintartrat eller et af de øvrige indholdsstoffer i SIMBRINZA (angivet i punkt 6) - hvis du er allergisk over for lægemidler, der tilhører "sulfonamiderne" (eksempler omfatter lægemidler, der anvendes til behandling af sukkersyge og infektioner, samt vanddrivende lægemidler) - hvis du tager monoamin-oxidase-hæmmere (MAO) (eksempler omfatter lægemidler til at behandle depression eller Parkinsons sygdom) eller bestemt medicin mod depression.
English: Brinzolamide acts by inhibiting the enzyme carbonic anhydrase (CA-II) in the ciliary epithelium that reduces the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport across the ciliary epithelium, resulting in decreased aqueous humour formation.
Danish: Brinzolamid virker ved at hæmme enzymet karboanhydrase (CA-II) i det ciliære epitel, som nedsætter dannelsen af bikarbonat-ioner med en efterfølgende reduktion af natrium og væsketransport på tværs af det ciliære epitel, som derved nedsætter dannelsen af kammervæske.
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Spain
Danish: Alcon Cusí S A Camil Fabra 58 08320 El Masnou Barcelona Spanien
English: Mean IOP reductions from baseline at each time point at each visit were greater with SIMBRINZA (6 to 9 mmHg) than monotherapy with either brinzolamide (5 to 7 mmHg) or brimonidine (4 to 7 mmHg).
Danish: Gennemsnitlige IOP-reduktioner fra baseline ved hvert tidspunkt ved hvert besøg, var større med SIMBRINZA (6 til 9 mmHg) end for monoterapi med enten brinzolamid (5 til 7 mmHg) eller brimonidin (4 til 7 mmHg).
English: Use in adults, including the elderly The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily.
Danish: Anvendelse til voksne inklusive ældre personer Den anbefalede dosis er 1 dråbe SIMBRINZA appliceret i det/de pågældende øje/øjne 2 gange dagligt.
English: Uncommon: cardio-respiratory distress
Danish: Ikke almindelig: hjerte- og åndedrætsbesvær
English: SIMBRINZA can be affected by alcohol.
Danish: Alkohol kan påvirke SIMBRINZA.
English: 2, pain in extremity
Danish: 2, smerte i ekstremiteter
English: SIMBRINZA has a moderate influence on the ability to drive and use machines.
Danish: SIMBRINZA påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and topical brinzolamide.
Danish: Der er en mulig additiv effekt af den kendte systemiske effekt af karboanhydrasehæmmere hos patienter, som både behandles med en oral karboanhydrasehæmmer og brinzolamid administreret topikalt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with SIMBRINZA in all subsets of the paediatric population in the treatment of glaucoma and ocular hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med SIMBRINZA i alle undergrupper af den pædiatriske population ved behandling af glaukom og okulær hypertension (se pkt.
English: Serious side effects have been reported in children who accidently swallowed medicines containing brimonidine.
Danish: Der er indberettet alvorlige bivirkninger hos børn, som er kommet til at sluge lægemidler, der indeholdt brimonidin.
English: If you stop using SIMBRINZA
Danish: Hvis du holder op med at bruge SIMBRINZA
English: The effects of renal and hepatic impairment on the systemic pharmacokinetics of brimonidine have not been evaluated.
Danish: Indvirkningen fra nedsat nyre- og leverfunktion på systemisk farmakokinetik for brimonidin er ikke blevet evalueret.
English: What SIMBRINZA looks like and contents of the pack SIMBRINZA eye drops, suspension, is a liquid (white-to-off-white suspension) supplied in a pack containing one or three 5 ml plastic bottles with screw cap.
Danish: SIMBRINZA øjendråber, suspension, er en væske (hvid til råhvid suspension), der leveres i en pakning med en eller tre 5 ml plastflasker med skruelåg.
English: SIMBRINZA may cause dizziness, fatigue and/or drowsiness, which may impair the ability to drive or use machines.
Danish: SIMBRINZA kan forårsage svimmelhed, træthed og/eller døsighed, hvilket kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Brinzolamide + Brimonidine Mean a
Danish: Brinzolamid + Brimonidin Gennemsnit a
English: The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration.
Danish: Samme type bivirkninger, som tilskrives sulfonamider, kan optræde ved topikal administration.
English: Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA or in patients with severe or unstable and uncontrolled cardiovascular disease (see section 4.5).
Danish: Forsigtighed tilrådes, når der anvendes lægemidler som antihypertensiva og/eller hjerteglykosider samtidig med SIMBRINZA eller til patienter med alvorlig eller ustabil og ukontrolleret kardiovaskulær sygdom (se pkt.
English: Neonates and infants under the age of 2 years (see section 4.4).
Danish: Nyfødte og spædbørn under 2 år (se pkt.
English: Do not use more than one drop in the affected eye(s) two times a day.
Danish: Brug ikke mere end 1 dråbe i det/de pågældende øje/øjne 2 gange dagligt.
English: It should be used with caution in dry eye patients and in patients whose cornea may be compromised.
Danish: Det skal anvendes med forsigtighed hos patienter med tørre øjne og hos patienter, hvor hornhinden kan være beskadiget.
English: The following adverse reactions have been reported during clinical studies with SIMBRINZA twicedaily dosing and during clinical studies and post-marketing surveillance with the individual components brinzolamide and brimonidine.
Danish: Nedenstående bivirkninger blev rapporteret under kliniske studier med SIMBRINZA doseret to gange dagligt, samt i kliniske studier med og ved overvågning efter markedsføring af de enkelte komponenter brinzolamid og brimonidin.
English: If you forget to use SIMBRINZA
Danish: Hvis du har glemt at bruge SIMBRINZA
English: Mean IOP reductions from baseline at each time point at each visit with SIMBRINZA or the individual components administered concomitantly were similar (7 to 10 mmHg).
Danish: Gennemsnitlige IOP-reduktioner fra baseline ved hvert tidspunkt ved hvert besøg, hvor SIMBRINZA eller de enkelte komponenter blev administreret samtidig var tilsvarende (7 til 10 mmHg).
English: SIMBRINZA has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients.
Danish: SIMBRINZA er ikke undersøgt hos patienter med snævervinklet glaukom, og det bør ikke anvendes til disse patienter.
English: Brimonidine exhibits affinity for pigmented ocular tissues, particularly iris-ciliary body, due to its known melanin binding properties.
Danish: Brimonidin udviser affinitet for okulært pigmentvæv, især corpus ciliare, som er kendt for sine melaninbindende egenskaber.
English: • General side effects: decreased blood pressure, chest pain, irregular heartbeat, slow or fast heart rate, palpitations, difficulty sleeping (insomnia), nightmares, depression, generalised weakness, headache, dizziness, nervousness, irritability, general feeling of being unwell, memory loss, shortness of breath, asthma, nose bleeds, cold symptoms, dry nose or throat, sore throat, throat irritation, cough, runny nose, stuffy nose, sneezing, sinus infection, chest congestion, ringing in ear, indigestion, intestinal gas or stomach ache, nausea, diarrhoea, vomiting, abnormal sensation in mouth, increased allergic symptoms on skin, rash, abnormal skin sensation, hair loss, generalised itching, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test, pain, back pain, muscle pain or spasm, kidney pain such as lower back pain, decreased libido, male sexual difficulty.
Danish: • Generelle bivirkninger: nedsat blodtryk, brystsmerter, uregelmæssig hjerterytme, langsom eller hurtig puls, hjertebanken, søvnbesvær (søvnløshed), mareridt, depression, generel svaghed, hovedpine, svimmelhed, nervøsitet, irritabilitet, almen utilpashed, hukommelsestab, stakåndethed, astma, næseblod, forkølelsessymptomer, tørhed i næse eller hals, ondt i halsen, halsirritation, hoste, rindende næse, tilstoppet næse, nysen, bihulebetændelse, trykken for brystet, ringen for ørerne, fordøjelsesbesvær, luft i tarmen eller mavesmerter, kvalme, diarré, opkastning, unormal fornemmelse i munden, forøgelse af allergiske symptomer på huden, udslæt, unormal følelse i huden, hårtab, udbredt kløe, øget indhold af chlorid i blodet eller nedsat antal af røde blodlegemer påvist ved en blodprøve, smerte, rygsmerte, muskelsmerter eller -kramper, nyresmerter såsom lændesmerter, nedsat seksualdrift, nedsat potens hos mænd.
English: 2, subconjunctival cyst
Danish: 2, subkonjunktival cyste
English: Benzalkonium chloride, propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
Danish: Benzalkoniumchlorid, propylenglycol, carbomer 974P, borsyre, mannitol, natriumchlorid, tyloxapol, saltsyre og/eller natriumhydroxid (til justering af pH) og renset vand.
English: The safety profile of SIMBRINZA in adjunct therapy was similar to that observed with SIMBRINZA monotherapy.
Danish: Sikkerhedsprofilen observeret for SIMBRINZA i kombinationsbehandling var tilsvarende til det observerede for SIMBRINZA monoterapi.
English: Symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving brimonidine eye drops as part of medical treatment of congenital glaucoma.
Danish: Symptomer på brimonidin-overdosis (herunder bevidstløshed, hypotension, hypotoni, bradykardi, hypotermi, cyanose og apnø) er rapporteret hos nyfødte og spædbørn, der har fået brimonidinøjendråber, som en del af en medicinsk behandling for medfødt glaukom.
English: Benzalkonium chloride has been reported to cause eye irritation and symptoms of dry eyes and may affect the tear film and corneal surface.
Danish: Det er rapporteret, at benzalkoniumchloridkan medføre øjenirritation og give symptomer på tørre øjne og det kan påvirke tårefilmen og hornhindens overflade.
English: The use of SIMBRINZA is not recommended during pregnancy.
Danish: SIMBRINZA må ikke anvendes under graviditet.
English: If you regularly consume alcohol, ask your doctor, optometrist (optician) or pharmacist for advice before taking this medicine.
Danish: Hvis du jævnligt indtager alkohol, bedes du spørge din læge, øjenlæge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Likewise, the steady-state plasma pharmacokinetics of brimonidine from the combination were similar to those observed for brimonidine administered alone, with the exception of the twice daily SIMBRINZA treatment group, for which the mean AUC0-12 hours was about 25% lower than that for brimonidine alone administered twice daily.
Danish: Ligeledes svarede steady-state-farmakokinetikken i plasma for brimonidin fra denne kombination til den som blev observeret for brimonidin givet alene med undtagelse af SIMBRINZAbehandlingsgruppen for hvilken middel-AUC på 0-12 timer var omkring 25 % lavere end for brimonidin alene, når det blev givet to gange dagligt.
English: In humans, urinary brinzolamide and Ndesethylbrinzolamide accounted for about 60 and 6% of the dose, respectively.
Danish: Hos mennesker udgjorde brinzolamid og N-desethylbrinzolamid udskilt gennem urinen hhv. ca. 60 og 6 % af dosen.
English: 2, nervousness
Danish: 2, nervøsitet
English: Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Danish: Orale overdoser af andre alfa-2-agonister er rapporteret til at medføre symptomer som hypotension, asteni, opkastning, letargi, sedation, bradykardi, arytmi, miose, apnø, hypotoni, hypotermi, respirationsdepression og kramper.
English: Since the brinzolamide component of SIMBRINZA and its metabolite are excreted predominantly by the kidney, SIMBRINZA is contraindicated in such patients (see section 4.3).
Danish: Brinzolamid-komponenten i SIMBRINZA og dennes metabolit udskilles overvejende renalt, hvorfor SIMBRINZA er kontraindiceret hos denne patientgruppe (se pkt.
English: Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties.
Danish: Bivirkninger omfattede træthed, slaphed, lav kropstemperatur, bleghed og åndedrætsbesvær.
English: Clinical data on the use of SIMBRINZA adjunctive to prostaglandin analogues (PGA) also showed superior IOP-lowering efficacy of SIMBRINZA + PGA compared with the PGA alone.
Danish: Kliniske data for brugen af SIMBRINZA i kombination med prostaglandin analoger (PGA) viste også en bedre IOP-sænkende effekt for SIMBRINZA + PGA sammenlignet med PGA alene.
English: If signs of serious reactions or hypersensitivity occur, the use of this medicinal product should be discontinued.
Danish: Såfremt der opstår tegn på eller tilfælde af alvorlige bivirkninger eller overfølsomhedsreaktioner, bør behandlingen afbrydes.
English: When nasolacrimal occlusion is used and the eyelids are closed for 2 minutes, systemic absorption is reduced.
Danish: Systemisk absorption reduceres, når der anvendes nasolakrimal okklusion og øjet lukkes i 2 minutter.
English: SIMBRINZA should not be used by women who are breast-feeding.
Danish: SIMBRINZA bør ikke anvendes af ammende kvinder.
English: What you need to know before you use SIMBRINZA
Danish: Det skal du vide, før du begynder at bruge SIMBRINZA
English: Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.
Danish: Brinzolamid hæmmer ikke cytokrom P450-isozymer.
English: SIMBRINZA is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: SIMBRINZA bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Some patients who dosed with SIMBRINZA experienced decreases in blood pressure similar to those observed with the use of brimonidine as monotherapy.
Danish: Nogle patienter, som modtog en dosis SIMBRINZA, oplevede fald i blodtrykket, som svarede til det, der blev observeret for brimonidin givet som monoterapi.
English: Uncommon: hypotension Very rare: hypertension
Danish: Vaskulære sygdomme Ikke almindelig: hypotension Meget sjælden: hypertension3
English: The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2B6, CYP2C8 and CYP2C9.
Danish: De cytokrom P450-isozymer, der er ansvarlige for metaboliseringen af brinzolamid, omfatter CYP3A4 (hovedsagelig), CYP2A6, CYP2B6, CYP2C8 og CYP2C9.
English: The concomitant administration of SIMBRINZA and oral carbonic anhydrase inhibitors is not recommended.
Danish: Samtidig behandling med SIMBRINZA øjendråber og orale karboanhydrasehæmmere anbefales ikke.
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 patienter)
English: • Chest pain, irregular heart beat
Danish: • Brystsmerter, uregelmæssig hjerterytme
English: Patients should be instructed to keep the bottle tightly closed when not in use.
Danish: Patienterne skal instrueres i at lukke flasken tæt efter brug.
English: In a topical ocular clinical study comparing the systemic pharmacokinetics of SIMBRINZA administered two or three times daily to brinzolamide and brimonidine administered individually using the same two posologies, the steady-state whole blood brinzolamide and N-desethylbrinzolamide pharmacokinetics were similar between the combination product and brinzolamide administered alone.
Danish: I kliniske forsøg med topikal okulær administration, hvor den systemiske farmakokinetik for SIMBRINZA administreres to eller tre gange om dagen i forhold til brinzolamid og brimonidin, der administreres individuelt ved de samme to doser, steady-state i fuldblod for brinzolamid og Ndesethylbrinzolamid-farmakokinetik svarede til hinanden for kombinationsproduktet og brinzolamid givet alene.
English: Women who may become pregnant are advised to use effective contraception during SIMBRINZA treatment.
Danish: Kvinder i den fødedygtige alder skal anvende sikker prævention under behandlingen med SIMBRINZA.
English: The pharmacokinetic/pharmacodynamic relationship in humans for IOP-lowering has not been established.
Danish: Den farmakokinetiske/farmakodynamiske sammenhæng ved IOPsænkning hos mennesker er ikke klarlagt.
English: 2, paraesthesia oral
Danish: 2, oral paræstesi
English: Oral carbonic anhydrase inhibitors may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination (see section 4.4).
Danish: Hos ældre patienter kan orale karboanhydrasehæmmere forringe evnen til at udføre opgaver, der kræver mental årvågenhed og/eller fysisk koordination (se pkt.
English: , tachycardia
Danish: , takykardi
English: 2, memory impairment
Danish: 2, hukommelsestab nedsat hukommelse
English: SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension
Danish: SIMBRINZA 10 mg/ml + 2 mg/ml øjendråber, suspension
English: It is not necessary to close and shake the bottle before you apply the drop in your other eye. Close the bottle cap firmly immediately after use.
Danish: Det er ikke nødvendigt at lukke og omryste flasken igen, inden du drypper dråben i det andet øje.
English: 2, peripheral oedema adverse reaction observed with SIMBRINZA 2 additional adverse reaction observed with brinzolamide monotherapy additional adverse reaction observed with brimonidine monotherapy
Danish: 2, perifert ødem bivirkning observeret med SIMBRINZA yderligere bivirkning observeret med brinzolamid-monoterapi yderligere bivirkning observeret med brimonidin-monoterapi
English: At the +2 h time point (the time corresponding to the morning efficacy peak) for the primary efficacy visit at Month 3, the percentage of patients with an IOP less than 18 mmHg was 61.7% in the SIMBRINZA group, 40.1% in the Brinzolamide group, and 40.0% in the Brimonidine group.
Danish: Ved +2 timers tidspunktet (tiden, der svarer til morgen-peakværdien for effekt) for det primære effektbesøg i måned 3 var andelen af patienter med en IOP på mindre end 18 mmHg 61,7 % i SIMBRINZA-gruppen og 40,1 % i Brinzolamid-gruppen og 40,0 % i Brimonidin-gruppen.
English: SIMBRINZA is contraindicated in neonates and infants aged less than 2 years in the decrease of elevated intraocular pressure (IOP) with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction because of safety concerns (see section 4.3).
Danish: SIMBRINZA er kontraindiceret til nyfødte og spædbørn under 2 år ved nedsættelse af forhøjet intraokulært tryk (IOP) med åbenvinklet glaukom eller okulær hypertension, for hvem monoterapi giver utilstrækkelig reduktion af IOP, da der er sikkerhedsanliggender (se pkt.
English: SIMBRINZA is contraindicated in patients receiving monoamine oxidase inhibitors and in patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin), (see section 4.3).
Danish: SIMBRINZA er kontraindiceret hos patienter, der behandles med monoaminoxidasehæmmere og hos patienter på antidepressiva, som påvirker den noradrenerge transmission (f.eks. tricykliske antidepressiva og mianserin) (se pkt.
English: The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated.
Danish: Patienterne, oplevede symptomer på CNS-depression, typisk midlertidig koma eller lavt bevidsthedsniveau, letargi, somnolens, hypotoni, bradykardi, hypotermi, bleghed, respirationsdepression og apnø, og behov for indlæggelse på intensiv afdeling med eventuel intubation.
English: 2, skin tightness
Danish: 2, stramhed i huden
English: The same types of adverse reactions that are attributable to oral carbonic inhibitors (i.e. acid-base disturbances) may occur with topical administration (see section 4.5).
Danish: De samme typer bivirkninger, der kan skyldes orale karboanhydrasehæmmere (dvs. syrebaseforstyrrelser), kan opstå efter topikal administration (se pkt.
English: Least squares means derived from a statistical model that accounts for study site, 9 AM baseline IOP stratum, and correlated IOP measurements within patient
Danish: Mindste kvadraters metode udledt fra en statistisk model, som tager højde for forsøgsstedet, baseline-IOPstratum kl. 9.00 og korrelerede IOP-målinger inden for samme patient.
English: If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.
Danish: Hvis der bruges mere end ét topikalt øjenpræparat, skal der være mindst 5 minutters interval imellem instillation af de enkelte præparater.
English: Wash your hands before you start.
Danish: Sådan skal du bruge SIMBRINZA Vask dine hænder, inden du begynder.
English: Brinzolamide is primarily eliminated in urine unchanged.
Danish: Brinzolamid udskilles primært som uændret stof gennem urinen.
English: It is unknown whether topical SIMBRINZA is excreted in human milk.
Danish: Det er ukendt, om SIMBRINZA udskilles i human mælk efter topikal administration.
English: Brinzolamide is metabolised by hepatic cytochrome P450 isozymes, specifically CYP3A4, CYP2A6, CYP2B6, CYP2C8 and CYP2C9.
Danish: Brinzolamid metaboliseres af cytokrom P450 i leveren, især CYP3A4, CYP2A6, CYP2B6, CYP2C8 og CYP2C9.
English: 2, scleral pigmentation
Danish: 2, pigmentering af sclera