FrancophonIA/ELRC3.0 huggingface dataset:
English: The opinion was converted into a Decision by the European Commission on 5 December 2014.
Danish: Udtalelsen blev den 5. december 2014 omarbejdet til en beslutning truffet af Europa-Kommissionen.
English: The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Danish: Ændringsproceduren (FR/V/0167/01/II/017) blev indledt den 28. januar 2013.
English: International non-proprietary name (INN): florfenicol, flunixin
Danish: Internationalt fællesnavn (INN): florfenicol, flunixin
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis C. Ibrahim og M. Holzhauser-Alberti.
English: Oral explanations were given on 10 September 2014.
Danish: Mundtlige redegørelser blev afgivet den 10. september 2014.
English: Day 60 of the CMD(v) procedure was on 23 January 2014, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Danish: Dag 60 i proceduren i CMD(v) var den 23. januar 2014, og da de berørte medlemsstater ikke var i stand til at nå til enighed, blev proceduren indbragt for CVMP.
English: A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (2 mL/15 kg bw) is recommended.
Danish: Den anbefalede dosering er en enkelt subkutan injektion af 40 mg florfenicol og 2,2 mg flunixin/kg kropsvægt (2 ml/15 kg kropsvægt).
English: Written explanations were provided by the marketing authorisation holder on 12 May 2014 and 19 June 2014.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 12. maj 2014 og den 19. juni 2014.
English: The referral procedure started on 12 February 2014.
Danish: Indbringelsesproceduren blev indledt den 12. februar 2014.
English: The marketing authorisation holder Intervet International BV submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Danish: Indehaveren af markedsføringstilladelsen, Intervet International BV, indgav en ansøgning om en type II-ændring med henblik på tilføjelse af Mycoplasma bovis som målpatogen.
English: On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 25 November 2013.
Danish: På dag 90 var disse spørgsmål fortsat uafklarede, hvorfor sagen den 25. november 2013 i medfør af artikel 13, stk. 1, i Kommissionens forordning (EF) nr. 1234/2008 blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - veterinær (CMD(v)).
English: The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.
Danish: CVMP konkluderede, at den kliniske fordel ved Resflor til behandling af luftvejsinfektioner knyttet til M. bovis er godtgjort, og at der ikke er påvist nogen specifik risiko for antimikrobiel resistens ved anvendelse af produktet.
English: On 24 January 2014, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Danish: Den 24. januar 2014 underrettede referencemedlemsstaten, Frankrig, Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed, og indbragte sagen for CVMP i medfør af 13, stk. 2, i Kommissionens forordning (EF) nr. 1234/2008.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Based on the evaluation of the available data the CVMP adopted by majority, on 7 October 2014, an opinion recommending the granting of the variation of the marketing authorisations for Resflor solution injectable and its associated names.
Danish: På grundlag af vurderingen af de foreliggende data vedtog CVMP den 7. oktober 2014 ved en flertalsafgørelse en udtalelse, som anbefalede ændring af markedsføringstilladelserne for Resflor, injektionsvæske, opløsning, og relaterede navne.
English: Potential serious risks to animal health were identified during the decentralised procedure by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Danish: Ved den decentrale procedure påpegede Danmark og Tyskland potentielle alvorlige risici for dyrs sundhed vedrørende dokumentationen for virkning i de kliniske undersøgelser og begrundelsen for den anbefalede dosis af Resflor til behandling af luftvejsinfektioner forårsaget af Mycoplasma bovis, som kan være forbundet med øget risiko for udvikling af antimikrobiel resistens.
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Danish: Det indeholder florfenicol og flunixin som aktive indholdsstoffer og er indiceret til behandling af luftvejsinfektioner forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni forbundet med pyreksi.
English: Opinion following an Article 13 referral for Resflor solution injectable and associated names
Danish: Udtalelse efter en artikel 13 -indbringelse for Resflor, injektionsvæske, opløsning, og relaterede navne
English: Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients.
Danish: Resflor er en injektionsvæske, opløsning, til anvendelse hos kvæg.
English: referral for Resflor solution injectable and associated names
Danish: 1-indbringelse for Resflor, injektionsvæske, opløsning, og relaterede navne
English: It is used to treat the following conditions:
Danish: Det anvendes til behandling af følgende tilstande:
English: This overview was last updated in 03-2018.
Danish: Denne oversigt blev sidst ajourført i 03-2018.
English: IN addition, no infections occurred during the study period.
Danish: Desuden forekom der ingen infektioner i studieperioden.
English: Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.
Danish: Hizentra fik en markedsføringstilladelse med gyldighed i hele EU den 14. april 2011.
English: Further information on Hizentracan be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Hizentra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose may need to be adjusted depending on how well the medicine is working.
Danish: Det kan være nødvendigt at justere dosis afhængigt af, hvor godt lægemidlet virker.
English: Normal immunoglobulin has been used as a medicine since the 1980s.
Danish: Normalt immunglobulin er blevet anvendt som lægemiddel siden 1980'erne.
English: It may be given at home, while the side effects are manageable.
Danish: Det kan gives hjemme, så længe bivirkningerne er håndterbare.
English: Other information about Hizentra
Danish: Andre oplysninger om Hizentra
English: As for all medicines, data on the use of Hizentra is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Hizentra løbende overvåget.
English: • chronic inflammatory demyelinating polyneuropathy (CIDP).
Danish: • kronisk inflammatorisk demyelinerende polyneuropati (CIDP).
English: It can also help to control the immune system when it is working abnormally such as in CIDP.
Danish: Det kan også hjælpe med at styre immunsystemet, når dette ikke fungerer normalt, f.eks. ved CIDP.
English: As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies were needed to establish the effectiveness and safety of Hizentra in patients.
Danish: Da humant normalt immunglobulin er blevet anvendt til behandling af de pågældende sygdomme i mange år, var det i henhold til de gældende retningslinjer tilstrækkeligt med to små studier til at fastslå virkningen og sikkerheden af Hizentra hos patienterne.
English: What measures are being taken to ensure the safe and effective use of Hizentra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hizentra?
English: For more information about using Hizentra, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Hizentra, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Patients (or their carers) may inject Hizentra at home once they have been trained.
Danish: Patienten selv (eller dennes omsorgsperson) kan injicere Hizentra i hjemmet efter at have fået passende oplæring.
English: The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness.
Danish: De hyppigste bivirkninger ved Hizentra (som kan forekomme hos flere end 1 ud af 10 patienter) er hovedpine, udslæt, muskel- og ledsmerter (herunder muskelspasmer og svaghed), reaktioner på injektionsstedet (hævelse, ømhed, rødme, blæredannelse, varme, kløe, blå mærker og udslæt) og influenzalignende symptomer.
English: Hizentra was shown to prevent serious bacterial infections in PID patients and reduce the chance of CIDP coming back.
Danish: Det blev påvist, at Hizentra kan forebygge alvorlige bakterielle infektioner hos PID-patienter og reducere risikoen for, at CIDP vender tilbage.
English: It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection.
Danish: Det indeholder primært immunglobulin G (IgG), der består af en række antistoffer, som medvirker ved bekæmpelsen af organismer, der kan medføre infektion.
English: Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).
Danish: I sjældne tilfælde kan patienter opleve et pludseligt blodtryksfald eller et anafylaktisk chok (pludselig, alvorlig allergisk reaktion).
English: The European Medicines Agency decided that Hizentra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Hizentra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It is given by subcutaneous infusion (very slow injection under the skin) through a device that controls the speed of infusion.
Danish: Det gives ved subkutan infusion (meget langsom injektion under huden) gennem et apparat, der styrer infusionshastigheden.
English: An overview of Hizentra and why it is authorised in the EU
Danish: En oversigt over Hizentra, og hvorfor det er godkendt i EU
English: Side effects reported with Hizentra are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Hizentra vurderes omhyggeligt, og der tages om nødvendigt relevante forholdsregler for at beskytte patienterne.
English: Why is Hizentra authorised in the EU?
Danish: Hvorfor blev Hizentra godkendt i EU?
English: Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Danish: Hizentra anvendes til patienter, hvis blod ikke indeholder tilstrækkeligt med antistoffer (proteiner, der hjælper kroppen med at bekæmpe infektioner og andre sygdomme), også kendt som immunglobuliner.
English: What is Hizentra and what is it used for?
Danish: Hvad er Hizentra, og hvad anvendes det til?
English: In this rare disease, the immune system (the body's defence system) works abnormally and destroys the protective covering over the nerves.
Danish: Ved denne sjældne sygdom fungerer immunsystemet (kroppens forsvar) ikke normalt, men ødelægger det beskyttende lag over nerverne.
English: The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.
Danish: Patienterne fik Hizentra i 28 uger, og de laveste IgG-niveauer under behandlingen med Hizentra (gennemsnitligt niveau på 8,1 g/l) var af samme størrelsesorden som dem, der var observeret under den tidligere immunglobulinbehandling.
English: The dose and how often Hizentra infusion is given depend on the disease being treated.
Danish: Dosis og hyppighed af Hizentra-infusionerne afhænger af den sygdom, der behandles.
English: Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.
Danish: Hizentra udleveres kun efter recept, og behandlingen bør iværksættes af en læge eller sygeplejerske med erfaring i behandling af patienter med et svækket immunforsvar eller CIDP.
English: • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
Danish: • primære immundefektsyndromer (PID, hvor man fødes med en manglende evne til at danne tilstrækkeligt med antistoffer)
English: Patients received Hizentra or placebo (a dummy treatment) for 13 weeks and the study measured the proportion of patients in whom the disease came back within 13 weeks.
Danish: Patienterne fik Hizentra eller placebo (et uvirksomt stof) i 13 uger, og undersøgelsen målte andelen af patienter, hos hvem sygdommen kom tilbage inden for 13 uger.
English: Hizentra works by restoring abnormally low IgG levels to their normal range in the patient's blood.
Danish: Hizentra virker ved at bringe unormalt lave IgG-niveauer op på deres normale niveau i patientens blod.
English: What are the risks associated with Hizentra?
Danish: Hvilke risici er der forbundet med Hizentra?
English: • low levels of antibodies in the blood in patients before or after allogeneic haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);
Danish: • lave niveauer af antistoffer i blodet før eller efter allogen hæmatopoietisk stamcelletransplantation (en procedure, hvor patientens knoglemarv renses for celler og erstattes med stamceller fra en donor)
English: • low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections;
Danish: • lave niveauer af antistoffer i blodet hos patienter med kronisk lymfatisk leukæmi (kræft i en type hvide blodlegemer) eller myelom (kræft i en anden type hvide blodlegemer), og som har hyppige infektioner
English: The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from donated human blood.
Danish: Det aktive stof i Hizentra, humant normalt immunglobulin, er et højtoprenset protein, der er udvundet af humant donorblod.
English: Hizentra (human normal immunoglobulin)
Danish: Hizentra (humant normalt immunglobulin)
English: Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing hgh levels of the amino acid proline in the blood).
Danish: Hizentra må ikke anvendes hos patienter med hyperprolinæmi (en genetisk sygdom, der medfører høje niveauer af aminosyren prolin i blodet).
English: It is given in the abdomen (belly), thigh, upper arm or hip.
Danish: Det gives i maven, låret, overarmen eller hoften.
English: For the full list of side effects and restrictions with Hizentra, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Hizentra fremgår af indlægssedlen.
English: For patients on placebo, the disease came back in about 63% of patients, for patients on Hizentra, the disease came back in 33 and 39% of patients; depending on the dose used.
Danish: Sygdommen kom tilbage hos ca. 63 % af de patienter, der fik placebo, og hos 33 % og 39 % (afhængigt af dosen) af de patienter, der fik Hizentra.
English: In the second study Hizentra was studied in 172 patients with CIDP who had previously received human immunoglobulin treatment by injection into a vein.
Danish: I det andet studie blev Hizentra undersøgt hos 172 patienter med CIDP, som tidligere havde fået behandling med humant immunglobulin indsprøjtet i en blodåre.
English: Hizentra contains the active substance human normal immunoglobulin.
Danish: Hizentra indeholder det aktive stof humant normalt immunglobulin.
English: It must not be injected into a blood vessel.
Danish: Hizentra må ikke indgives i et blodkar.
English: Hizentra is available as a solution for injection.
Danish: Hizentra fås som injektionsvæske.
English: How is Hizentra used?
Danish: Hvordan anvendes Hizentra?
English: What benefits of Hizentra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Hizentra?
English: In the first study, Hizentra was investigated in 51 PID patients who had already received human immunoglobulin into a vein for at least six months.
Danish: I det første studie blev Hizentra undersøgt hos 51 patienter med PID, som allerede havde fået mindst seks måneders behandling med humant normalt immunglobulin indsprøjtet i en blodåre.
English: How does Hizentra work?
Danish: Hvordan virker Hizentra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hizentra 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 Hizentra.
English: 1 vial + 1 pre-filled syringe + 2 needles
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 2 kanyler
English: 1 vial + 1 pre-filled syringe without needle
Danish: 1 hætteglas + 1 fyldt injektionssprøjte uden kanyle
English: 1 vial + 1 pre-filled syringe + 1 needle
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 1kanyle
English: 10 vials + 10 prefilled syringes with attached needle
Danish: 10 fyldte injektionssprøjter med fastsiddende kanyle
English: 1 vial + 1 pre-filled syringe with attached needle
Danish: 1 fyldt injektionssprøjte med fastsiddende kanyle
English: This may happen:
Danish: Dette kan ske:
English: Bear in mind that you could endanger yourself or others.
Danish: Husk, at du kan bringe dig selv og andre i fare.
English: The exact mechanism of this interaction is not clear.
Danish: Den nøjagtige mekanisme af denne interaktion er ikke klar.
English: Contact a doctor immediately.
Danish: Kontakt straks en læge.
English: Please ask your doctor whether you can drive a car if you:
Danish: Spørg venligst din læge om du kan køre bil, hvis du:
English: Enyglid should be taken with caution.
Danish: Enyglid skal tages med forsigtighed.
English: Your diabetes may get worse.
Danish: Din diabetes kan forværres.
English: Your doctor will advise you.
Danish: Lægen vil rådgive dig.
English: Be aware that the desired effect is not achieved if you stop taking Enyglid.
Danish: Vær opmærksom på at den ønskede virkning ikke opnås, hvis du stopper med at tage Enyglid.
English: The advisability of driving should be considered in these circumstances.
Danish: Tilrådeligheden af at køre bør i sådanne tilfælde overvejes.
English: Date of first authorisation: 14/10/2009 Date of latest renewal: 22 August 2014
Danish: Dato for første markedsføringstilladelse: 14/10/2009 Dato for seneste fornyelse: 22. august 2014
English: If this happens, medical assistance is needed immediately.
Danish: Hvis dette sker, har du brug for øjeblikkelig lægehjælp.
English: Enyglid may not be suitable for you.
Danish: Enyglid er måske ikke den rigtige løsning for dig.
English: Debilitated or malnourished patients
Danish: Svækkede eller fejlernærede patienter
English: If you miss a dose, take the next dose as usual.
Danish: Hvis du glemmer at tage en dosis, skal du tage den næste dosis som sædvanligt.
English: Talk to your doctor if any of the above applies to you.
Danish: Fortæl det til din læge, hvis noget af ovennævnte gælder for dig.
English: The safety and efficacy of repaglinide in children below 18 years have not been established.
Danish: Sikkerheden og virkningen af repaglinid hos børn under 18 år er endnu ikke klarlagt.
English: The dosage should be determined by the physician, according to the patient's requirements.
Danish: Dosis fastlægges af lægen i henhold til patientens behov.
English: The warning signs of too high blood sugar appear gradually.
Danish: Advarselstegnene på for højt blodsukker optræder gradvist.
English: • if you have type 1 diabetes.
Danish: • Hvis du har type 1-diabetes.
English: The amount of Enyglid, food or exercise may need to be adjusted.
Danish: Mængden af Enyglid, mad eller motion skal muligvis justeres.
English: * see section Description of selected adverse reactions below
Danish: *se afsnittet Beskrivelse af udvalgte bivirkninger nedenfor
English: Elderly No clinical studies have been conducted in patients >75 years of age.
Danish: Ældre Der er ikke udført kliniske studier hos patienter >75 år.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: For yderligere information vedrørende denne medicin kan du kontakte den lokale repræsentant for markedsføringstilladelsen:
English: If any change of your treatment is necessary contact your doctor first.
Danish: Hvis det er nødvendigt at ændre din behandling er nødvendig, skal du først kontakte din læge.
English: • if you have an infection or a fever,
Danish: • Hvis du har en infektion eller feber
English: The plasma elimination half-life is approximately one hour.
Danish: Plasma halveringstid er cirka en time.
English: Repaglinide should be taken before main meals (i.e. preprandially).
Danish: Repaglinid bør indtages før hovedmåltiderne (dvs. præprandielt).
English: Repaglinide was detected in the milk of animals.
Danish: Repaglinid var fundet i mælken hos dyr.
English: In very rare cases, severe hepatic dysfunction has been reported.
Danish: I meget sjældne tilfælde har der været rapporteret om alvorlig hepatisk dysfunktion.
English: There is no reason to suspect cross-allergenicity with sulphonylurea due to the difference in chemical structure.
Danish: Der er ingen grund til at forvente krydsallergi med sulfonylurinstoffer på grund af forskellen i den kemiske struktur.
English: Your body's response to Enyglid may change if you take other medicines, especially these:
Danish: Din krops reaktion på Enyglid kan ændres, hvis du tager anden medicin, især følgende:
English: If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
Danish: • Hvis alvorlig hypoglykæmi ikke behandles, kan det forårsage hjerneskade (midlertidig eller permanent) og endog død.
English: Repaglinide should be avoided during pregnancy.
Danish: Repaglinid bør undgås under graviditet.
English: No interaction studies have been performed in children and adolescents.
Danish: Der er ikke udført interaktionsstudier hos børn og unge.
English: Repaglinide is eliminated rapidly within 4 - 6 hours from the blood.
Danish: Repaglinid elimineres hurtigt fra blodet indenfor 4-6 timer.
English: - Diabetic ketoacidosis, with or without coma.
Danish: - Diabetisk ketoacidose, med eller uden koma.
English: Combination with metformin
Danish: Kombination med metformin