FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, Tisseel/Tissucol and Artiss should only be sprayed using a pressure regulator that caps the maximum pressure at 2.0 bar in open wound surgery and using a pressure regulator device that deliver a maximum pressure of 1.5 bar and carbon dioxide gas only in minimally invasive/laparoscopic procedures.
Danish: Endelig skal spraypåføring af Tisseel/Tissucol og Artiss ved åbne kirurgiske indgreb udelukkende ske med en trykregulator, der begrænser det maksimale tryk til 2,0 bar. Ved minimalt invasive/laparoskopiske procedurer skal trykregulatorens maksimale tryk være 1,5 bar, og der må kun anvendes kuldioxid.
English: Having considered all the available data, including the MAH written responses and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefit-risk balance of Beriplast P as supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis (including endoscopic treatment of bleeding gastro-duodenal ulcer) and as a tissue to promote adhesion/sealing or as suture support, is positive under normal conditions of use, subject to the changes to the product information, (see Annex III).
Danish: Efter gennemgang af alle foreliggende data, herunder den skriftlige besvarelser fra indehaveren af markedsføringstilladelsen og konklusionerne fra mødet i ad hoc-ekspertgruppen, afgjorde CHMP, at benefit/risk-forholdet for Beriplast P under normale anvendelsesbetingelser er positivt til støttende behandling, hvor sædvanlige kirurgiske teknikker er utilstrækkelige til forbedring af hæmostase (herunder endoskopisk behandling af blødende gastroduodenalt ulcus) og til forbedring af sammenføjning eller som støtte ved sammensyninger, forudsat at produktinformationen ændres (jf. bilag III).
English: Therefore the CHMP recommended the variation to the terms of the Marketing Authorisations for the Beriplast P medicinal products (and associated names) referred to in Annex I, in accordance to the amendments to the Summary of Product Characteristics and Package Leaflet set out in Annex III.
Danish: anbefalede CHMP ændring af betingelserne for markedsføringstilladelserne for Beriplast P og de relaterede navne, der er anført i bilag I, i overensstemmelse med de ændringer af produktresuméet og indlægssedlen, der fremgår af bilag III.
English: Although there are instructions in the current product labelling for use regarding the pressure that must be set and the distance from the bleeding tissue that must be maintained during the spray application in order to avoid forcing gas into the vasculature and the risk of air embolism, there is a concern that these instructions are not always being adhered to, leading to a risk of air embolism.
Danish: Den gældende produktinformation giver anvisninger for det tryk, der skal indstilles, og den afstand til det blødende væv, der skal holdes under spraypåføringen for at undgå gasindtrængen i karrene og risiko for luftemboli.
English: Based on the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 21 May 2012, requesting the CHMP to assess the above concerns and their impact on the benefit-risk for Evicel, to give its opinion on measures necessary to ensure the safe and effective use of Evicel and on whether the marketing authorisation for this product should be maintained, varied, suspended or withdrawn.
Danish: Kommissionen anmodede herunder CHMP om at vurdere ovennævnte betænkeligheder og indvirkningen heraf på benefit/risk-forholdet for Evicel og at afgive en udtalelse om behovet for foranstaltninger, der kan garantere sikker og effektiv anvendelse af Evicel og om, hvorvidt markedsføringstilladelsen for produktet bør opretholdes, ændres, suspenderes eller inddrages.
English: Having considered all the available data, including the MAH responses provided in writing and during oral explanations and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefitrisk balance of Tisseel, Tissucol and Artiss in their approved indications, is positive under normal conditions of use, subject to the changes to the product information, (see Annex III), together with the agreed risk minimisation measures (see Annex IV) and the agreed Direct Healthcare Professional Communication.
Danish: Efter gennemgang af de foreliggende data, herunder besvarelserne fra indehaveren af markedsføringstilladelsen, dels skriftligt, dels ved den mundtlige fremlæggelse, og konklusionerne fra ad hoc-ekspertgruppens møde, afgjorde CHMP, at benefit/risk-forholdet for Tisseel, Tissucol og Artiss til de godkendte indikationer er positivt under normale anvendelsesbetingelser, forudsat produktinformationen ændres (jf. bilag III) og at der udsendes en direkte meddelelse til sundhedspersonale.
English: • The Committee, as a consequence, concluded that the benefit-risk balance of the spray application of fibrinogen-sealants is positive under normal conditions of use, subject to the agreed risk minimisation measures, including changes to the product information.
Danish: • udvalget konkluderede følgelig, at benefit/risk-forholdet for spraypåføring af fibrinklæbere er positivt under normale anvendelsesbetingelser, forudsat at de vedtagne risikominimeringsforanstaltninger gennemføres, herunder ændring af produktinformationen,
English: Beriplast P, Tisseel, Tissucol and Artiss contain aprotinin, whereas Quixil contains tranexamic acid.
Danish: De aktive indholdsstoffer i disse produkter er forskellige, idet hovedforskellen vedrører den antifibrinolytiske komponent: Beriplast P, Tisseel, Tissucol og Artiss indeholder aprotinin, mens Quixil indeholder tranexamsyre.
English: The analysis of the case reports showed that symptomatic air/gas embolism had occurred only when the instructions for use were not followed; in each of the other cases there was a failure to follow at least one of the current guidelines on administration of spray application of fibrin sealants using pressurised gas:
Danish: I alle de øvrige tilfælde var der tale om manglende overholdelse af mindst én af de gældende retningslinjer for spraypåføring af fibrinklæbere med gas under tryk:
English: With regard to the efficacy of sprayable fibrin sealants, the CHMP assessed the available information, including data submitted by the MAHs.
Danish: CHMP vurderede de foreliggende oplysninger om virkningen af fibrinklæbere til spraypåføring, herunder oplysninger fra indehaverne af markedsføringstilladelsen.
English: On 15 November 2012, the CHMP concluded the review of Quixil (for which four cases of lifethreatening air embolism were reported) and agreed that the benefit-risk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis is positive under normal conditions of use, subject to changes to the product information and implementation of risk minimisation measures, including educational materials and training to be provided to users of the product.
Danish: Udvalget afgjorde, at benefit/risk-forholdet for Quixil under normale anvendelsesbetingelser er positivt som støttende behandling til forbedring af hæmostase ved operationer, hvor sædvanlig kirurgisk teknik er utilstrækkelig, forudsat at produktinformationen ændres, og at der indføres risikominimeringsforanstaltninger, herunder kursusmateriale og oplæring af brugerne af produktet.
English: It employs manual pressure derived by the syringe applicator and therefore, no gas-assisted spray device is available for Beriplast.
Danish: Der findes derfor ingen gasassisteret sprayanordning til Beriplast.
English: However, technical requirements when limiting spray application to CO2 gas were considered to add uncertainties to the clinical use of those products, e.g. in minimally invasive/laparoscopic surgery where the maximal pressure to be applied is 1.5 bar, the pressure regulator intended for open wound surgery that allows a higher pressure, could be used by mistake, or the handling associated with CO2 cylinders and respective pressure reducing connectors in the operating theatre.
Danish: Dette gælder f.eks. ved minimalt invasive/laparoskopiske kirurgiske indgreb, hvor der maksimalt må anvendes et tryk på 1,5 bar, idet der her ville være risiko for fejlagtig anvendelse af den trykregulator, der er beregnet til åbne kirurgiske indgreb og tillader højere tryk.
English: Having considered all available data, the MAH's responses and the ad-hoc advisory group recommendations, the CHMP identified and agreed upon a number of risk minimisation measures to be implemented by the MAH to reduce the risk of air/gas embolism associated with the spray use of Tisseel, Tissucol and Artiss.
Danish: Udvalget udpegede og vedtog en række risikominimeringsforanstaltninger, som skal gennemføres af indehaveren af markedsføringstilladelsen for at mindske risikoen for luft-/gasemboli ved spraypåføring af Tisseel, Tissucol og Artiss.
English: Date of first authorisation: 16 January.2007 Date of latest renewal: 21 November 2011
Danish: Dato for første markedsføringstilladelse: 16. januar 2007 Dato for seneste fornyelse: 21. november 2011
English: See also information under the heading “Do not take Copalia”.
Danish: Se også information under overskriften ”Tag ikke Copalia”.
English: You should never take Copalia again.
Danish: Du bør aldrig tage Copalia igen.
English: In two long-term follow-up studies the effect of Copalia was maintained for over one year.
Danish: I to langtids-og opfølgningsstudier blev effekten af Copalia opretholdt i over et år.
English: It is recommended to take Copalia with some water.
Danish: Det anbefales at tage Copalia med lidt vand.
English: You can take Copalia with or without food.
Danish: - Du kan tage Copalia med eller uden mad.
English: Copalia is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Copalia frarådes i den tidlige periode af graviditeten (de første 3 måneder), og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten.
English: Copalia with food and drink
Danish: Copalia sammen med mad og drikke
English: Over 1,400 hypertensive patients received Copalia once daily in two placebo-controlled trials.
Danish: Mere end 1.400 hypertensive patienter har fået Copalia en gang daglig i to placebokontrollerede studier.
English: Copalia and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Danish: Copalia og ældre patienter (65 år og derover) Din læge bør udvise forsigtighed, når dosis øges.
English: Correction of this condition prior to administration of Copalia or close medical supervision at the start of treatment is recommended.
Danish: Det anbefales, at denne tilstand korrigeres før administration af Copalia, eller at der foretages tæt medicinsk overvågning ved behandlingens start.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Danish: Alder, køn, race eller body mass indeks (≥30 kg/m 2, <30 kg/m 2) havde ingen indflydelse på Copalias virkning.
English: If you have taken too many tablets of Copalia, or if someone else has taken your tablets, consult a doctor immediately.
Danish: Hvis du har taget for mange Copalia-tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Copalia.
Danish: Hvis der samtidig gives et diuretikum, kan risikoen for lithiumtoksicitet muligvis være yderligere øget med Copalia.
English: Copalia has not been studied in any patient population other than hypertension.
Danish: Copalia er ikke undersøgt i andre patientgrupper end hypertension.
English: Do not use any Copalia pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger med Copalia, som er beskadiget eller viser tegn på åbning.
English: Do not take Copalia with grapefruit or grapefruit juice.
Danish: Tag ikke Copalia sammen med grapefrugt eller grapefrugtjuice.
English: The usual dose of Copalia is one tablet per day.
Danish: Den sædvanlige dosis af Copalia er én tablet daglig.
English: Children and adolescents The use of Copalia in children and adolescents is not recommended (aged below 18 years old).
Danish: Børn og unge Brug af Copalia til børn og unge frarådes (under 18 år).
English: The safety of Copalia has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Danish: Copalias sikkerhed er blevet evalueret i fem kontrollerede kliniske studier med 5.175 patienter, hvoraf 2.613 modtog valsartan i kombination med amlodipin.
English: The recommended dose of Copalia is one tablet per day.
Danish: Den anbefalede dosis af Copalia er én tablet daglig.
English: If you get these symptoms, stop taking Copalia and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Copalia og kontakte din læge med det samme.
English: Copalia should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Copalia skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
English: Abrupt withdrawal of Copalia has not been associated with a rapid increase in blood pressure.
Danish: Pludselig seponering af Copalia er ikke blevet forbundet med hurtig blodtryksstigning.
English: Stopping your treatment with Copalia may cause your disease to get worse.
Danish: Hvis du holder op med at tage Copalia, kan det resultere i, at din sygdom bliver værre.
English: No drug-drug interaction studies have been performed with Copalia and other medicinal products.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med Copalia og andre lægemidler.
English: if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for valsartan eller et af de øvrige indholdsstoffer i Copalia (angivet i punkt 6).
English: There is no experience of overdose with Copalia.
Danish: Der er ingen erfaring med overdosering af Copalia.
English: Your doctor will normally advise you to stop taking Copalia before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Copalia.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Copalia, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: To date there is no experience of the safe use of Copalia in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Copalia til patienter, som kort tid forinden har modtaget nyretransplantation.
English: Copalia should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Danish: Copalia skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serum-kreatinin kan stige hos disse patienter.
English: If you think you may be allergic, talk to your doctor before taking Copalia.
Danish: Hvis du tror, du er allergisk, skal du tale med din læge, inden du tager Copalia.
English: Do not take Copalia if you are allergic to amlodipine or to any other calcium channel blockers.
Danish: Tag ikke Copalia - hvis du er allergisk over for amlodipin eller andre calciumantagonister.
English: Copalia tablets contain two substances called amlodipine and valsartan.
Danish: Copalia tabletter indeholder to stoffer, som kaldes amlodipin og valsartan.
English: The rate and extent of absorption of Copalia are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Danish: Hastigheden og graden af Copalia-absorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
English: If hypotension occurs with Copalia, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer hypotension med Copalia, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af isotonisk natriumchlorid.
English: Copalia was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Danish: Copalia er også undersøgt i et aktivt kontrolleret studie med 130 hypertensive patienter med middel siddende diastolisk blodtryk ≥110 mmHg og <120 mmHg.
English: Clinically significant hypotension due to Copalia overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering med Copalia kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Copalia combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Danish: Copalia kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister og valsartan tilhører klassen kaldet angiotensin II-antagonister.
English: Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Copalia as well, even if not observed in clinical trials or during the post-marketing period.
Danish: Bivirkninger, som tidligere er indrapporteret for hver enkelt af de individuelle komponenter (amlodipin eller valsartan), kan også være potentielle bivirkninger med Copalia, selv i de tilfælde, hvor de ikke er set i kliniske studier eller i perioden efter markedsføring.
English: No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion (GFR >30 ml/min/1,73 m2).
English: Following oral administration of Copalia, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Danish: Efter oral administration af Copalia opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6-8 timer.
English: If you stop taking Copalia
Danish: Hvis du holder op med at tage Copalia
English: If any of the above applies to you, do not take Copalia and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Copalia, og du skal kontakte din læge.
English: If you forget to take Copalia
Danish: Hvis du har glemt at tage Copalia
English: Patients taking Copalia and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Danish: Patienter, som fører motorkøretøj eller betjener maskiner under behandling med Copalia, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
English: Talk to your doctor before taking Copalia: if you have been sick (vomiting or diarrhoea).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Copalia: - hvis du har været syg (opkastning eller diarré).
English: What you need to know before you take Copalia
Danish: Det skal du vide, før du begynder at tage Copalia
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The safety and efficacy of Copalia in children aged below 18 years have not been established.
Danish: Pædiatrisk population Copalias sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Copalia is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Danish: Copalia er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter, eller 20 kartoner med hver 14 tabletter.
English: Slovenská republika Novartis Slovakia r.o.
Danish: Slovenská republika Novartis s.Slovakia r.o.
English: The amlodipine component of Copalia inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Copalia hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Copalia containing the same component doses.
Danish: Patienter, som får valsartan og amlodipin fra hver sin tablet/kapsel, kan for nemhedens skyld skifte til Copalia med den samme dosis af hver komponent.
English: If any of these apply to you, tell your doctor before taking Copalia.
Danish: Hvis dette gælder for dig, så tal med din læge inden du tager Copalia.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Copalia or observed with a higher frequency than with Copalia:
Danish: Bivirkninger, som er rapporteret ved behandling med valsartan og amlodipin alene, og som enten ikke er set ved behandling med Copalia, eller som er set hyppigere end ved behandling med Copalia:
English: Particular caution should be exercised when administering Copalia to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Danish: Der bør udvises særlig forsigtighed, når Copalia gives til patienter med let til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
English: Frequency Copalia Amlodipine Valsartan
Danish: Frekvens Copalia Amlodipin Valsartan
English: What Copalia contains
Danish: Copalia indeholder:
English: There are no clinical studies on fertility with Copalia.
Danish: Der er ikke udført fertilitetsstudier med Copalia.
English: • Concomitant use of Copalia with aliskiren-containing products 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 Copalia og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Other possible side effects of Copalia:
Danish: Andre bivirkninger ved brug af Copalia
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Copalia in placebo-controlled studies.
Danish: Under placebokontrollerede studier blev der set udtalt hypotension hos 0,4% af patienterne med ukompliceret hypertension, som blev behandlet med Copalia.
English: Other medicines and Copalia
Danish: Brug af anden medicin sammen med Copalia
English: Hepatic impairment Copalia is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Nedsat leverfunktion Copalia er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Copalia.
Danish: Du må ikke indtage grapefrugt og grapefrugtjuice, mens du tager Copalia.
English: Copalia is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Danish: Copalia er indiceret til voksne, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin eller valsartan monoterapi.