FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is 1 drop in the affected eye every 2 hours, 6 times per day.
Danish: Anbefalet dosis er 1 dråbe i det berørte øje for hver 2 timer, 6 gange dagligt.
English: This is a summary of the European public assessment report (EPAR) for Oxervate.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Oxervate.
English: Other information about Oxervate
Danish: Andre oplysninger om Oxervate
English: What is Oxervate and what is it used for?
Danish: Hvad er Oxervate, og hvad anvendes det til?
English: The European Medicines Agency therefore decided that Oxervate's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Oxervate opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Why is Oxervate approved?
Danish: Hvorfor blev Oxervate godkendt?
English: Oxervate contains the active substance cenegermin.
Danish: Oxervate indeholder det aktive stof cenegermin.
English: What measures are being taken to ensure the safe and effective use of Oxervate?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Oxervate?
English: Oxervate can only be obtained with a prescription and treatment should be started and supervised by an eye specialist.
Danish: Oxervate udleveres kun efter recept, og behandlingen bør påbegyndes og overvåges af en øjenspecialist.
English: In the second study, figures were 70% (16 out of 23) with Oxervate and 29% (7 out of 24) with the dummy treatment.
Danish: I den anden undersøgelse var tallene 70 % (16 ud af 23) med Oxervate-behandling og 29 % (7 ud af 24) med den virkningsløse behandling.
English: Because the number of patients with neurotrophic keratitis is low, the disease is considered ‘rare', and Oxervate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 December
Danish: Da antallet af patienter med neurotrofisk keratitis er lavt, betragtes sygdommen som "sjælden", og Oxervate blev udpeget som "lægemiddel til sjældne sygdomme" den 14. december 2015.
English: It is not intended to provide practical advice on how to use Oxervate.
Danish: Det er ikke en praktisk vejledning i, hvordan Oxervate bør anvendes.
English: The full EPAR for Oxervate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Oxervate findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Oxervate (which may affect more than 1 in 100 people) are eye pain and inflammation, increased lacrimation (watery eyes), pain in the eyelid and sensation of a foreign body in the eye.
Danish: De mest almindelige bivirkninger med Oxervate (der kan berøre mere end 1 ud af 100 personer) er øjensmerter og betændelse, øget tåreproduktion (våde øjne), smerter i øjenlåget og en fornemmelse af at have et fremmedlegeme i øjet.
English: What are the risks associated with Oxervate?
Danish: Hvilke risici er der forbundet med Oxervate?
English: In the first study, 74% (37 out of 50) of patients treated with Oxervate for 8 weeks achieved complete healing of the eye's surface compared with 43% (22 out of 51) of patients treated with a dummy treatment containing the same eye drop formula but no active substance.
Danish: I den første undersøgelse opnåede 74 % (37 ud af 50) af de patienter, der blev behandlet med Oxervate i 8 uger, fuld helbredelse af øjets overflade til sammenligning med 43 % (22 ud af 51) af de patienter, der blev behandlet med en virkningsløs behandling, der indeholdt den samme øjendråbeformel, men intet aktivt stof.
English: The active substance in Oxervate, cenegermin, is a copy of a human growth factor called nerve growth factor.
Danish: Det aktive stof i Oxervate er cenegermin, som er en kopi af den humane vækstfaktor, der kaldes for nervevækstfaktor.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Oxervate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Oxervate findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Side effects with Oxervate are mainly related to the eye, are mild or moderate in severity and resolve over time.
Danish: Bivirkningerne, der er forbundet med Oxervate, vedrører hovedsageligt øjet, er milde eller moderate i alvorsgraden og forsvinder over tid.
English: For more information about treatment with Oxervate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Oxervate, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients with neurotrophic keratitis have lower than normal levels of substances including growth factors that are normally supplied by the trigeminal nerve and which play an important role in the growth and survival of the cells of the eye's surface.
Danish: Patienter med neurotrofisk keratitis har lavere stofniveauer end normalt, herunder vækstfaktorer, der normalt tilføres af nervus trigeminus, og som spiller en væsentlig rolle med hensyn til cellernes vækst og overlevelse i øjets overflade.
English: Oxervate has been shown to increase by around 30-40% the number of patients who achieve complete healing of the eye's surface when compared with eye drops containing no active substance.
Danish: Det er dokumenteret, at Oxervate øger antallet af patienter, der opnår fuld helbredelse af øjets overflade, med 30-40 %, når der sammenlignes med øjendråber, der ikke indeholder noget aktivt stof.
English: For the full list of all side effects and restrictions with Oxervate, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger forbundet med Oxervate fremgår af indlægssedlen.
English: Oxervate is a medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally.
Danish: Oxervate er et lægemiddel, der anvendes til at behandle neurotrofisk keratitis, en øjentilstand, hvor beskadigelse af nervus trigeminus, der forbinder til øjets overflade, forårsager tab af sanseindtryk og fejl, der ikke læger af sig selv.
English: For practical information about using Oxervate, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Oxervate, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: When given as eye drops to patients with neurotrophic keratitis, cenegermin helps restore some of the normal healing processes in the eye and repair damage to the eye's surface associated with the condition.
Danish: Når cenegermin gives som øjendråber til patienter med neurotrofisk keratitis, bidrager det til at restituere nogle af de normale helingsprocesser i øjet og reparere de beskadigelser i øjets overflade, der er forbundet med tilstanden.
English: How is Oxervate used?
Danish: Hvordan anvendes Oxervate?
English: What benefits of Oxervate have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Oxervate?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oxervate have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Oxervate.
English: How does Oxervate work?
Danish: Hvordan virker Oxervate?
English: Oxervate is available as eye drops.
Danish: Oxervate fås som øjendråber.
English: Oxervate has been shown to help heal damage to the eye's surface in 2 main studies involving a total of 204 adults with moderate or severe neurotrophic keratitis.
Danish: Det er i 2 hovedundersøgelser, der omfattede et samlet antal på 204 voksne med moderat eller alvorlig neurotrofisk keratitis, dokumenteret, at Oxervate bidrager til at helbrede beskadigelser i øjets overflade.
English: These symptoms may vary from person to person.
Danish: Disse symptomer kan variere fra person til person.
English: Just take the next dose at the scheduled time and continue as normal.
Danish: Tag blot den næste dosis på det planlagte tidspunkt og fortsæt på normal vis.
English: Total exposure in the clinical development plan exceeded 1,500 patient-years.
Danish: Den samlede eksponering i den kliniske udviklingsplan oversteg 1.500 patient-år.
English: CSBM/week
Danish: CSBM/uge
English: The active metabolite was not detected in any of the 162 patients at any time point.
Danish: Den aktive metabolit blev ikke detekteret hos nogen af de 162 patienter på noget tidspunkt.
English: Physicians should periodically assess the need for continued treatment.
Danish: Læger bør med jævne mellemrum vurdere behovet for fortsat behandling.
English: - The other ingredients are :
Danish: - Øvrige indholdsstoffer:
English: The most likely effect of taking too much Constella is diarrhoea.
Danish: Den mest sandsynlige virkning af at tage for meget Constella er diarré.
English: Component of a multipack, can't be sold separately.
Danish: Del af en multipakning, sælges ikke separat.
English: 28 capsules.
Danish: 28 kapsler.
English: Bloating (11-point NRS)
Danish: Oppustethed (11-punkts NRS)
English: However, treatment with Constella can be safely stopped at any time.
Danish: Behandling med Constella kan imidlertid stoppes helt risikofrit når som helst.
English: Side effects with frequency not known (frequency cannot be estimated from the available data):
Danish: Bivirkninger med hyppigheden ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: Patients with known or suspected mechanical gastrointestinal obstruction.
Danish: Patienter med kendt eller formodet mekanisk gastrointestinal obstruktion.
English: Take special care if you are older than 65 years, as there is a higher risk you experience diarrhoea.
Danish: Du skal være ekstra forsigtig, hvis du er over 65 år, da der så er en højere risiko for at få diarré.
English: The main symptoms of IBS with constipation include:
Danish: Hovedsymptomerne på IBS med forstoppelse inkluderer:
English: - if you or your doctor know that you have a blockage in your stomach or bowels.
Danish: - hvis du eller din læge ved, at du har en blokering i din mave eller tarm.
English: In cases of severe or prolonged diarrhoea, absorption of other oral medicinal products may be affected.
Danish: I tilfælde af svær eller langvarig diarré kan absorption af andre orale lægemidler blive påvirket.
English: Because these other diseases may have the same symptoms as IBS, it is important that you report any change or irregularity in symptoms to your doctor promptly.
Danish: Da symptomerne på disse andre sygdomme kan være de samme som for IBS, er det vigtigt, at du straks fortæller lægen om eventuelle ændringer eller uregelmæssigheder i dine symptomer.
English: Fertility Animal studies indicate that there is no effect on male or female fertility.
Danish: Fertilitet Dyreforsøg indikerer, at der ingen effekt er på den mandlige og kvindelige fertilitet.
English: LS: Least Square CSBM: Complete Spontaneous Bowel Movement
Danish: LS: Least Square (mindste kvadrat) CSBM: Complete Spontaneous Bowel Movement (spontan afføring med komplet tømning af rectum)
English: Unopened bottle for 10 capsules: 2 years.
Danish: Uåbnet beholder med 10 kapsler: 2 år.
English: Constella should not be used in children and adolescents as it has not been studied in this population.
Danish: Constella bør ikke anvendes til børn og unge, da det ikke er undersøgt i denne population.
English: It is unknown whether linaclotide is excreted in human milk.
Danish: Det er ukendt, om linaclotid udskilles i human mælk.
English: Do not use this medicine if you notice any signs of damage to the bottle or any change in the appearance of the capsules.
Danish: Brug ikke lægemidlet, hvis du ser nogen tegn på beskadigelse af beholderen eller nogen ændring i kapslernes udseende.
English: Linaclotide (N =805)
Danish: Linaclotid (N =805)
English: After first opening: 18 weeks.
Danish: Efter anbrud: 18 uger.
English: Other common adverse reactions (>1%) were abdominal pain, abdominal distension and flatulence.
Danish: Andre almindelige bivirkninger (>1 %) var abdominale smerter, abdominal udspiling og flatulens.
English: • feeling lightheaded after standing up quickly
Danish: • Svimmelhed, hvis du rejser dig hurtigt op
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after ¨EXP¨.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og beholderen efter ¨EXP¨.
English: In the second clinical study (study 2), 800 patients were treated for 12 weeks, and then re-randomised for an additional 4 weeks treatment period.
Danish: I det andet kliniske studie (studie 2) blev 800 patienter behandlet i 12 uger og derpå genrandomiseret til en supplerende 4 ugers behandlingsperiode.
English: Gender is not expected to have any impact on dosing.
Danish: Køn forventes ikke at have nogen indvirkning på dosering.
English: These effects were reached at 1 week and sustained over the entire treatment periods.
Danish: Disse virkninger blev opnået efter 1 uge og opretholdt i de fulde behandlingsperioder.
English: Contact your doctor or pharmacist if you have taken too much of this medicine.
Danish: Kontakt lægen eller apoteket, hvis du har taget for meget af medicinen.
English: As GC-C receptor is known to be overexpressed at early ages, children younger than 2 years may be particularly sensitive to linaclotide effects.
Danish: Da GC-C (guanylatcyclase C) receptor vides at være overudtrykt i en tidlig alder, kan børn under 2 år være særligt følsomme over for virkninger af linaclotid.
English: Date of first authorisation: 26 November 2012 Date of latest renewal: 28 August 2017
Danish: Dato for seneste fornyelse: 28. august 2017
English: There is limited amount of data from the use of linaclotide in pregnant women.
Danish: Der foreligger kun begrænsede data for brugen af linaclotid hos gravide kvinder.
English: - Medicines to treat pain and inflammation called NSAIDs.
Danish: - Lægemidler til behandling af smerte og betændelse, kaldet NSAID.
English: IBS is a common gut disorder.
Danish: IBS er en almindelig tarmsygdom.
English: • stomach flu (viral gastroenteritis)
Danish: • Maveinfluenza (viral gastroenteritis)
English: Approximately half of the diarrhoea episodes started within the first week of treatment.
Danish: Cirka halvdelen af episoderne med diarré startede i den første behandlingsuge.
English: Hypokalaemia Dehydration Decreased appetite
Danish: Hypokaliæmi Dehydrering Nedsat appetit
English: The efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Danish: Virkningen af orale præventionsmidler kan nedsættes, og det anbefales at anvende en ekstra præventionsform for at forebygge mulig svigt af oral prævention (se informationen for den orale prævention).
English: As a precautionary measure, it is preferable to avoid the use of Constella during pregnancy.
Danish: Som en sikkerhedsforanstaltning bør anvendelse af Constella undlades under graviditet.
English: In rare and more severe cases, this may - as a consequence - lead to the occurrence of dehydration, hypokalaemia, blood bicarbonate decrease, dizziness, and orthostatic hypotension.
Danish: I sjældne og mere alvorlige tilfælde kan det - som en følgevirkning - føre til dehydrering, hypokaliæmi, reduceret bicarbonat i blodet, svimmelhed og ortostatisk hypotension.
English: Your doctor has given this medicine to you after excluding other diseases, especially of your bowels and concluding that you suffer from IBS with constipation.
Danish: Din læge har givet dig denne medicin, efter han/hun har udelukket andre sygdomme, særligt i tarmene og konkluderet, at du har IBS med forstoppelse.
English: Very common Common Uncommon
Danish: Meget almindelig Almindelig
English: Of these patients, 892 patients received linaclotide at the recommended dose of 290 micrograms per day.
Danish: Af disse patienter modtog 892 patienter linaclotid med den anbefalede dosis på 290 mikrogram pr. dag.
English: If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
Danish: Hvis du har meget svær diaré, virker p-pillen muligvis ikke korrekt, og det anbefales at bruge en ekstra præventionsmetode.
English: Elderly (>65 years), hypertensive and diabetic patients reported diarrhoea more frequently as compared to the overall IBS-C population included in the clinical trials.
Danish: Ældre (>65 år), hypertensive og diabetiske patienter rapporterede hyppigere forekomst af diarré i forhold til den samlede IBS-C-population, som er inkluderet i de kliniske studier.
English: If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.
Danish: Hvis patienten ikke har oplevet forbedring af symptomer efter 4 ugers behandling, skal patienten undersøges på ny, og fordele og risici ved at fortsætte behandlingen bør overvejes igen.
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Constella in this age group has not been established.
Danish: Giv ikke dette lægemiddel til børn under 18 år, da sikkerheden og effekten ved Constella endnu ikke er klarlagt i denne aldersgruppe.
English: Linaclotide has been given orally to 1,166 patients with IBS-C in controlled clinical studies.
Danish: Linaclotid er givet oralt til 1.166 patienter med IBS-C i kontrollerede kliniske studier.
English: Once the bottle is opened, the capsules should be used within 18-weeks.
Danish: Når beholderen er åbnet, skal kapslerne anvendes inden for 18 uger.
English: Additional caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with cardiovascular (CV) diseases, diabetes, hypertension), and electrolyte control should be considered.
Danish: Der skal udvises yderligere forsigtighed hos patienter med særlig risiko for forstyrrelse af vand- eller elektrolytbalancen (f.eks. ældre, patienter med kardiovaskulære sygdomme, diabetes, hypertension), og elektrolytkontrol bør overvejes.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Caution should be used when co-administering Constella with such medications.
Danish: Der bør udvises forsigtighed, når Constella administreres sammen med denne type lægemidler.
English: The safety and efficacy of Constella in children aged 0 to18 years have not yet been established.
Danish: Constellas sikkerhed og virkning hos børn og teenagere fra 0 til 18 år er endnu ikke klarlagt.
English: The characteristics of the patient population included in Phase 3 clinical trials were as follows: mean age of 43.9 years [range 18 - 87 years with 5.3% ≥ 65 years of age], 90.1% female.
Danish: Karakteristika for den patientpopulation, der blev inkluderet i de kliniske fase 3-studier, var som følger: middelalder på 43,9 år [interval 18-87 år med 5,3 % ≥ 65 år], 90,1 % kvinder.
English: The diarrhoea resolved within seven days in about one third of patients, however 80 patients (50%) experienced diarrhoea with a duration of more than 28 days (representing 9.9% of all patients treated with linaclotide).
Danish: Diarréen gik over inden for syv dage hos cirka en tredjedel af patienterne, men 80 patienter (50 %) oplevede diarré i mere end 28 dage (hvilket udgør 9,9 % af alle patienter behandlet med linaclotid).
English: Some medicines may increase the risk of diarrhoea when taken with Constella, such as: - Medicines to treat stomach ulcers or excessive production of stomach acid called Proton Pump Inhibitors.
Danish: Nogle lægemidler kan øge risikoen for diarré, når de tages sammen med Constella, såsom: - Lægemidler til behandling af mavesår eller overdreven produktion af mavesyre, kaldet protonpumpeinhibitorer.
English: The efficacy of linaclotide has been established in double-blind placebo-controlled studies for up to 6 months.
Danish: Virkningen af linaclotid er klarlagt i placebokontrollerede dobbeltblinde studier i op til 6 måneder.
English: The capsule should be taken at least 30 minutes before a meal.
Danish: Kapslen skal tages mindst 30 minutter før et måltid.
English: Make sure you drink plenty of fluids to replace the water and electrolytes like potassium lost from the diarrhoea.
Danish: Sørg for at drikke rigeligt med væske for at erstatte vand og elektrolytter som kalium, som du mistede ved diarréen.
English: Linaclotide has been shown not to cause rebound effect when the treatment was stopped after 3 months continuous treatment.
Danish: Linaclotid udviste ikke rebound-effekt ved behandlingens ophør efter en 3måneders fortsat behandling.
English: There are limited data in elderly patients (see section 5.1).
Danish: Der foreligger begrænsede data om ældre patienter (se pkt.
English: An overdose may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product, mainly diarrhoea.
Danish: Overdosering kan medføre symptomer, der er resultat af en forstærkning af midlets kendte farmakodynamiske virkninger, primært diarré.
English: The following adverse reactions were reported in controlled clinical studies at the recommended dose of 290 micrograms per day with frequencies corresponding to: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to < 1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Følgende bivirkninger blev rapporteret i kontrollerede kliniske studier ved den anbefalede dosis på 290 mikrogram pr. dag med hyppigheder svarende til: 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) og meget sjælden (<1/10.000) ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: INFORMATION IN BRAILLE constella 290 mcg
Danish: INFORMATION I BRAILLESKRIFT constella 290 mcg
English: Pharmacotherapeutic group: Drugs for constipation, other drugs for constipation, ATC Code: A06AX04
Danish: Farmakoterapeutisk klassifikation: Midler mod obstipatio, andre midler mod obstipatio, ATC-kode: A06AX04
English: Constella with food
Danish: Brug af Constella sammen med mad
English: Talk to your doctor if you experience bleeding from the bowel or rectum.
Danish: Tal med din læge, hvis du oplever blødning fra tarmen eller endetarmen.
English: Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels.
Danish: Constella virker lokalt i din tarm og hjælper dig til at føle mindre smerte, mindre oppustet og med at genoprette tarmens normale funktion.