FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimester of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Danish: 6.1, eller over for andre sulfonamidderivater (hydrochlorthiazid er et sulfonamidderivat)
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Light pink to pink, film-coated capsule shaped tablet.
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter Lys pink til pink, filmovertrukne kapselformede tabletter.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets.
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter er lyse pink til pink, filmovertrukne kapselformede tabletter.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets.
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter er lyse pink til pink, filmovertrukne kapselformede tabletter.
English: Conversely, due to the irbesartan component of Irbesartan/Hydrochlorothiazide Teva hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Danish: Omvendt kan der opstå hyperkaliæmi på grund af irbesartankomponenten i Irbesartan/Hydrochlorthiazid Teva.
English: Psychiatric disorders:
Danish: Oversigt over indlægssedlen:
English: Digitalis glycosides
Danish: Gul jernoxid
English: Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Danish: Irbesartan forebygger at angiotensin-II binder sig til disse receptorer.
English: Each Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Danish: • Aktive stoffer: Irbesartan og hydrochlorthiazid Hver Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukket tablet indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid.
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Irbesartan/Hydrochlorothiazide Teva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: • Samtidig brug af Irbesartan/Hydrochlorthiazid Teva og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR
English: if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan/Hydrochlorothiazide Teva.
Danish: • hvis du oplever øget følsomhed af huden for sol med solskoldningssymptomer (såsom rødme, kløe, hævelse, blæredannelse), som forekommer hurtigere end normalt
English: Each Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Danish: • Aktive stoffer: Irbesartan og hydrochlorthiazid Hver Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukket tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Each Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Danish: • Aktive stoffer: Irbesartan og hydrochlorthiazid Hver Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukket tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: PC: SN: NN:
Danish: PC:
English: If you take more Irbesartan/Hydrochlorothiazide Teva than you should
Danish: Hvis du har taget for mange Irbesartan/Hydrochlorthiazid Teva tabletter
English: Marketing Authorisation Holder
Danish: Betingelser for markedsføringstilladelse
English: - Put yourself in a comfortable and stable position.
Danish: - Find en bekvem og stabil position.
English: - if you have diabetes.
Danish: - Hvis du har diabetes.
English: After first opening: 4 weeks.
Danish: Efter første åbning: 4 uger.
English: Treatment effect was evaluated up to 29 days.
Danish: Behandlingseffekten blev evalueret i op til 29 dage.
English: Povidone (K30)
Danish: Povidon (K30)
English: Use in adults, including the elderly
Danish: Brug hos voksne, inklusive ældre patienter
English: In vitro, the 99.8% were bound to proteins in human plasma.
Danish: In vitro var 99,8 % bundet til proteiner i humant plasma.
English: Pack of 1 bottle.
Danish: Pakken indeholder 1 flaske.
English: No interaction studies have been performed.
Danish: Der er ikke udført interaktionsundersøgelser.
English: Date of first authorisation: 18.05.2011 Date of latest renewal: 11.01.2016
Danish: Dato for første markedsføringstilladelse:18.05.2011 Dato for seneste fornyelse:11.01.2016
English: - Wash your hands before using the eye drops.
Danish: - Vask hænderne inden du bruger øjendråberne.
English: Rinse out your eye with warm water.
Danish: Skyl øjet med varmt vand.
English: By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Do not use Yellox longer than 2weeks.
Danish: Brug ikke Yellox længere end 2 uger.
English: Use a single dose as soon as you remember.
Danish: Brug en enkelt dosis, så snart du kommer i tanke om det.
English: - if you had repeated eye surgery within a short period of time.
Danish: - Hvis du har fået gentagne øjenoperationer inden for et kort tidsrum.
English: - if you have rheumatoid arthritis.
Danish: - Hvis du har rheumatoid arthritis (leddegigt).
English: Asthma*
Danish: Astma*
English: *Serious reports from post-marketing experience of more than 20 million patients ** Observed with four times daily dose
Danish: *Alvorlige rapporter fra erfaring efter markedsføring med flere end 20 millioner patienter ** Observeret ved dosering fire gange daglig
English: The treatment should not exceed 2 weeks as safety data beyond this is not available.
Danish: Behandlingen bør ikke overstige 2 uger, da der ikke foreligger sikkerhedsdata for behandling ud over dette tidsrum.
English: These events may be sight threatening.
Danish: Disse hændelser kan true synet.
English: Continue with the next regularly scheduled dose.
Danish: Fortsæt med den næste sædvanlige planlagte dosis.
English: Cyclooxygenase 1 (COX-1) is only inhibited to a small extent.
Danish: Cyclooxygenase 1 (COX-1) hæmmes kun i ringe omfang.
English: Your vision may be blurred for a short time after using this eye drops.
Danish: Dit syn kan blive sløret i et kort tidsrum efter brug af disse øjendråber.
English: Clear yellow solution.
Danish: Klar gul opløsning.
English: Based on clinical data available, a total of 3.4% of patients experienced one or more adverse reactions.
Danish: På grundlag af tilgængelige kliniske data fik i alt 3,4 % af patienterne én eller flere bivirkninger.
English: Contact with soft contact lenses must be avoided.
Danish: Kontakt med bløde kontaktlinser skal undgås.
English: Do not put in any more drops until it is time for your next regular dose.
Danish: Anvend ikke flere dråber, før det er tid for den næste sædvanlige dosis.
English: Yellox should not be used during the last three months of pregnancy.
Danish: Yellox bør ikke bruges i de sidste tre måneder af graviditeten.
English: It works by blocking certain substances involved in causing inflammation.
Danish: Det virker ved at blokere visse stoffer, der er involveret i udviklingen af betændelsen.
English: Therefore, treating individuals who have previously exhibited sensitivities to these medicinal products has to be avoided (see section 4.3).
Danish: Behandling af individer, som tidligere har udvist overfølsomhed over for disse lægemidler skal derfor undgås (se pkt.
English: There is practically no risk of adverse effects due to accidental oral ingestion.
Danish: Der er praktisk taget ingen risiko for bivirkninger som følge af utilsigtet oral indtagelse.
English: Topical NSAIDs should be used with caution in these patients.
Danish: Topikal NSAID skal bruges med forsigtighed hos disse patienter.
English: - Twist off the bottle cap. - Hold the bottle, pointing down, between your thumb and fingers.
Danish: - Drej flaskehætten og åbn den. - Vend flasken nedad og hold den mellem tommelfingeren og fingrene.
English: - Pull down your lower eyelid with a clean finger.
Danish: - Træk ned i det nederste øjenlåg med en ren finger.
English: The use of Yellox is in general not recommended during pregnancy unless the benefit outweighs the potential risk.
Danish: Brug af Yellox anbefales generelt ikke under graviditet, medmindre fordelen opvejer den potentielle risiko.
English: It is unknown whether bromfenac or its metabolites are excreted in human milk.
Danish: Det er ukendt, om bromfenac eller dets metabolitter udskilles i human mælk.
English: Discard the bottle 4 weeks after first opening to prevent infection even if there is solution remaining.
Danish: Kasser flasken 4 uger efter første åbning for at forebygge infektion, også selvom opløsningen ikke er opbrugt.
English: Do not stop using Yellox without speaking to your doctor.
Danish: Du må ikke holde op med at bruge Yellox uden at tale med din læge.
English: Do not use a double dose to make up for a forgotten dose.
Danish: Du må ikke bruge en dobbeltdosis som erstatning for den glemte dosis.
English: Accidental administration of more than one drop should not result in increased topical exposure as excessive volume would rinse out of the eye due to limited conjunctival sac capacity.
Danish: Utilsigtet administration af mere end én dråbe bør ikke resultere i øget topikal eksponering, da det overskydende volumen vil løbe ud af øjet som følge af begrænset kapacitet i konjunktivalsækken.
English: Yellox should not be used in children and adolescents.
Danish: Yellox bør ikke anvendes til børn og unge.
English: Bromfenac shows high binding to plasma proteins.
Danish: Bromfenac viser høj plasmaproteinbinding.
English: Write the date of opening on the carton label in the space provided.
Danish: Skriv datoen for åbning af kartonetiketten i det dertil beregnede område.
English: Since Yellox contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Danish: Da Yellox indeholder benzalkoniumchlorid, er nøje overvågning påkrævet ved hyppig eller længerevarig brug.
English: pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg
Danish: pH: 8,1-8,5; osmolalitet: 270-330 mOsmol/kg
English: In these studies, study substance was administered approximately 24 hours after cataract surgery and continued for up to 14 days.
Danish: I disse studier blev stoffet administreret ca. 24 timer efter kataraktkirurgi og behandlingen fortsatte i op til 14 dage.
English: Following twice daily dosing with bromfenac eye drops plasma concentrations were not quantifiable.
Danish: Efter dosering to gange daglig med bromfenac øjendråber var plasmakoncentrationerne ikke kvantificerbare.
English: Summary of the safety profile
Danish: Oversigt over sikkerhedsprofil
English: Do not use this medicine after the expiry date which is stated on the bottle and outer carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Duration of treatment
Danish: Behandlingsvarighed
English: In orally treated humans unchanged parent compound is the major component in plasma.
Danish: Hos mennesker behandlet oralt er det uændrede lægemiddelstof hovedkomponenten i plasma.
English: The doctor may prescribe this medicine during pregnancy if expected benefit to mother outweigh possible risk to baby.
Danish: Lægen kan dog ordinere dette lægemiddel til en gravid kvinde, hvis den forventede fordel for moderen opvejer den mulige risiko for barnet.
English: Therefore, patients should be advised not to wear contact lenses during treatment with Yellox.
Danish: Patienter skal derfor tilrådes ikke at bruge kontaktlinser under behandlingen med Yellox.
English: Since the systemic exposure in non-pregnant women is negligible after treatment with Yellox, the risk during pregnancy could be considered low.
Danish: Da den systemiske eksposition hos kvinder, der ikke er gravide er ubetydelig efter behandling med Yellox, kan risikoen under graviditet anses for at være lav.
English: - if you have experienced asthma, skin allergy or intense inflammation in your nose when using other NSAIDs.
Danish: - Hvis du haft astma, hudallergi eller intens betændelse i næsen ved brug af andre NSAID'er.
English: If it is almost time for the next dose, leave out the missed dose.
Danish: Hvis det næsten er tid til den næste dosis, skal du springe den glemte dosis over.
English: The table below describes adverse reactions by system organ class and frequency.
Danish: Nedenstående tabel beskriver bivirkninger i henhold til organklasser og frekvens.
English: Concentrations were maintained for 12 hours in aqueous humour with measurable levels up to 24 hours in major ocular tissues including the retina.
Danish: Koncentrationerne blev opretholdt i 12 timer i kammervæsken med målelige niveauer op til 24 timer i størstedelen af okulært væv, inklusive retina.
English: Yellox has minor influence on the ability to drive and use machines.
Danish: Yellox påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: No biological relevant melanin binding was observed in vitro.
Danish: Der blev ikke observeret nogen biologisk relevant melaninbinding in vitro.
English: Warning and precautions
Danish: Advarsler og forsigtighedsregler
English: Use of contact lenses
Danish: Brug af kontaktlinser
English: In a large, well-controlled study that was conducted in Japan, Yellox was shown to be as effective as pranoprofen ophthalmic solution.
Danish: I et stort velkontrolleret studie, der blev foretaget i Japan, viste Yellox sig at være lige så effektiv som pranoprofen okulær opløsning.
English: After oral administration of 14C-bromfenac to healthy volunteers, urinary excretion was found to be the major route of radioactive excretions, accounting for approximately 82% while faecal excretion represented approximately 13% of the dose.
Danish: Efter oral administration af 14C-bromfenac til raske frivillige fandtes urinudskillelse at være den vigtigste rute for radioaktive udskillelser, idet den udgjorde ca. 82 %, mens fækal udskillelse repræsenterede ca. 13 % af dosen.
English: Talk to your doctor or pharmacist before using this medicine - if you are using topical steroids (e.g. cortisone), as this may cause unwanted side effects.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger dette lægemiddel - Hvis du bruger topiske steroider (f.eks. kortison), da det kan medføre uønskede bivirkninger.
English: No interactions with antibiotic eye drops used in conjunction with surgery have been reported.
Danish: Der er ikke rapporteret interaktioner med antibiotiske øjendråber brugt i forbindelse med kirurgi.
English: - if you have eye problems (e.g. dry eye syndrome, corneal problems).
Danish: - Hvis du har øjenproblemer (f.eks. tørre øjne, problemer med hornhinden).
English: Water for injections Sodium hydroxide (for pH adjustment)
Danish: Vand til injektioner Natriumhydroxid (til pH-justering)
English: In vitro studies indicate that bromfenac is mainly metabolised by CYP2C9, which is absent in both iris-ciliary body and retina/choroid and the level of this enzyme in the cornea is less than 1% compared to the corresponding hepatic level.
Danish: In vitro studier indikerer, at bromfenac hovedsageligt metaboliseres af CYP2C9, der er fraværende i både corpus ciliare i iris og i retina/choroidea, og at niveauet af dette enzym i cornea er mindre end 1 % sammenlignet med det tilsvarende leverniveau.
English: Damage of the eye surface, redness of the eye, asthma.
Danish: Skade på øjets overflade, rødme i øjet, astma.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use Yellox.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel..
English: Yellox contains bromfenac and belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Yellox indeholder bromfenac og tilhører en gruppe lægemidler, der kaldes non-steroide antiinflammatoriske lægemidler (NSAID'er).
English: Several conjugated and unconjugated metabolites have been identified with the cyclic amide being the major urinary metabolite.
Danish: Flere konjugerede og ukonjugerede metabolitter er blevet identificeret med det cykliske amid som værende den vigtigste urinmetabolit.
English: Continue the drops through the first 2 weeks after your surgery.
Danish: Fortsæt med øjendråberne i de første 2 uger efter operationen.
English: However, 0.9 mg/kg/day in rats at oral doses (900 times the recommended ophthalmic dose) caused embryofoetal lethality, increased neonatal mortality, and reduced postnatal growth.
Danish: 0,9 mg/kg/dag hos rotter ved orale doser (900 gange den anbefalede okulærealmiske dosis) forårsagede imidlertid embryo-føtal letalitet, øget neonatal mortalitet og reduceret postnatal vækst.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, ‘repeated-dose' toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: There are no adequate data from the use of bromfenac in pregnant women.
Danish: Der er ingen eller utilstrækkelige data for anvendelse af bromfenac til gravide kvinder.
English: Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity which is thought to be due to its ability to block prostaglandin synthesis by inhibiting primarily cyclooxygenase 2 (COX-2).
Danish: Bromfenac er et non-steroidt antiinflammatorisk middel (NSAID), som har antiinflammatorisk aktivitet, der anses for at skyldes dets evne til at blokere prostaglandinsyntese gennem primært at hæmme cyclooxygenase 2 (COX-2).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHTAND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE BOTTLE 5 ML
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ENKELT FLASKE 5 ML
English: Pharmacotherapeutic group: Ophtalmologicals, Antiinflammatory agents, non-steroids, ATC code: S01BC11.
Danish: Farmakoterapeutisk klassifikation: Oftalmologiske midler, anti-inflammatoriske midler, non-steroider, ATC-kode: S01BC11
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: - The active substance is bromfenac.
Danish: - Aktivt stof: bromfenac.
English: Bromfenac efficiently permeates the cornea of cataract patients: A single dose resulted in a mean peak aqueous humour concentrations of 79±68 ng/ml at 150-180 minutes after dosing.
Danish: Bromfenac trænger effektivt igennem kornea på kataraktpatienter: En enkelt dosis resulterede i middel peak-koncentrationer i kammervæske på 79±68 ng/ml ved 150-180 minutter efter dosering.
English: Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.
Danish: Eksempler på NSAID'er er: acetylsalicylsyre, ibuprofen, ketoprofen, diclofenac.
English: If more than one topical ophtalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
Danish: Hvis der bruges flere end et lokalt virkende oftalmologiske lægemidler, skal hvert enkelt lægemiddel indgives med et mellemrum på mindst 5 minutter.
English: No abnormal findings or adverse reactions of clinical concern were noted upon administration of two drops 2mg/ml solution four times a day for the period of up to 28 days.
Danish: Der blev ikke noteret abnorme fund eller bivirkninger af klinisk relevans ved adminsitration af to dråber 2 mg/ml opløsning fire gange om dagen i en periode på op til 28 dage.
English: Yellox may be prescribed to breast-feeding woman and have no important influence on fertility.
Danish: Yellox kan ordineres til kvinder, der ammer, og det har ingen vigtig indflydelse på frugtbarheden.
English: Pregnant rabbits treated orally with 7.5 mg/kg/day (7500 times the recommended ophthalmic dose) caused increased postimplantation loss (see section 4.6).
Danish: Gravide kaniner, der blev behandlet oralt med 7,5 mg/kg/dag (7500 gange den anbefalede oftalmiske dosis), forårsagede øget postimplantationstab (se pkt.
English: After ocular administration the half-life of bromfenac in aqueous humour is 1.4 h indicating rapid elimination.
Danish: Efter okulær administration er bromfenacs halveringstid i kammervandet 1,4 timer, hvilket indikerer hurtig eliminering.
English: Yellox is a clear yellow liquid (solution) supplied in a pack containing one 5 ml plastic bottle with a screw cap.
Danish: Yellox er en klar gul væske (opløsning), der leveres i en pakning med én 5 ml plasticflaske med skruelåg.
English: Corneal adverse reactions were only observed in the Japanese population.
Danish: Bivirkninger i kornea blev kun observeret i den japanske population.
English: Two Phase II multicentre, randomised, double-masked, parallel group studies were conducted in Japan, and two Phase III multicentre, randomised (2:1), double-masked, parallel group, placebocontrolled studies were conducted in the US to assess the clinical safety and efficacy of Yellox dosed twice daily in the treatment of post-operative inflammation in patients undergoing cataract surgery.
Danish: Der blev foretaget to randomiserede, dobbeltblinde, multicenter, parallelgruppe, fase II-studier i Japan og to randomiserede (2:1), dobbeltblinde, placebokontrollerede multicenter, parallelgruppe, fase IIIstudier i USA for at vurdere den kliniske sikkerhed og effektivitet af Yellox doseret to gange daglig i behandlingen af postoperativ inflammation hos patienter, der gennemgik kataraktkirurgi.
English: Start using the drops the next day after your cataract surgery.
Danish: Begynd med at bruge dråberne dagen efter din kataraktoperation.
English: Conjunctival hyperaemia Abnormal sensation in eye Ocular discomfort
Danish: Konjunktival hyperæmi Unormal følelse i øjet Okulært ubehag
English: Ingestion of the 5 ml bottle content corresponds to an oral dose of less than 5 mg bromfenac, which is 30 times lower than daily dose of bromfenac oral formulation formerly used.
Danish: Indtagelse af indholdet i en flaske med 5 ml svarer til en oral dosis på under 5 mg bromfenac, hvilket er 30 gange lavere end den daglige dosis bromfenac i oral formulering, som blev anvendt tidligere.
English: A significantly greater proportion of patients in the Yellox group 64.0% vs. 43.3% in the placebo group (p<0.0001) experienced complete clearance of ocular inflammation at study day 15.
Danish: En signifikant større andel af patienter i Yellox gruppen 64,0 % vs. 43,3 % i placebogruppen (p<0,0001) opnåede komplet svind af okulær inflammation ved studiedag 15.