FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges læge, og pakningen, indlægssedlen eller etiketten vises til lægen.
English: • For the prevention of vomiting except that induced by motion sickness.
Danish: • Til forebyggelse af opkastning, undtagen opkastning forårsaget af transportsyge.
English: Incidents of pre-travel vomiting, usually within two hours post-dosing were commonly reported after administration of the 8 mg/kg dose.
Danish: Efter administration af en dosis på 8 mg/kg sås af og til tilfælde af opkastning inden rejsens begyndelse, som regel inden for to timer efter dosering.
English: • Remove tablet from blister and administer as instructed.
Danish: • Fjern tabletten fra pakningen og giv tabletten som anvist.
English: • For the prevention of vomiting induced by motion sickness.
Danish: • Til forebyggelse af opkastning forårsaget af transportsyge.
English: The safety of Cerenia has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches.
Danish: Det veterinærmedicinske lægemiddels sikkerhed er ikke undersøgt hos hunde yngre end 16 uger for dosen 8 mg/kg (transportsyge), hos hunde yngre end 8 uger for dosen 2 mg/kg (opkastning) eller hos drægtige eller diegivende tæver.
English: Prevention of nausea induced by chemotherapy Treatment and prevention of vomiting (except motion sickness) Dog body weight (kg)
Danish: Til forebyggelse af kvalme forårsaget af kemoterapi Behandling og forebyggelse af opkastning (undtagen transportsyge)
English: For prevention of vomiting induced by motion sickness, only for dogs 16 weeks of age or older
Danish: Til forebyggelse af opkastning, forårsaget af køre- og søsyge, kun til hunde, der er 16 uger eller ældre.
English: Cerenia 10 mg/ml injection for dogs and cats maropitant
Danish: Cerenia 10 mg/ml injektionsvæske, opløsning til hunde og katte maropitant
English: In vivo studies in dogs demonstrated the anti-emetic efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and syrup of ipecac.
Danish: En række forskellige in vitro tests har vist, at maropitant binder sig selektivt til NK1 receptoren med dosisafhængig funktionel antagonisme af aktiviteten af substans P. In vivo undersøgelser i hunde viste den antiemetiske effekt af maropitant mod centrale og perifere emetika inklusive apomorfin, cisplatin og syrupus ipecacuana.
English: It is therefore recommended to initiate the treatment of emesis with Cerenia solution for injection.
Danish: Det anbefales derfor at bruge Cerenia injektionsvæske, opløsning som indledende terapi.
English: The pharmacokinetic profile of maropitant when administered as a single oral dose of 2 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 81 ng/ml; this was achieved within 1.9 hours post-dosing (Tmax).
Danish: Ved en enkelt oral dosis på 2 mg/kg legemsvægt til hunde var den farmakokinetiske profil karakteriseret ved en maksimal koncentration (Cmax) i plasma på omkring 81 ng/ml.
English: To treat or prevent vomiting, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below.
Danish: For at behandle eller forebygge opkastning gives Cerenia tabletter en gang dagligt med en dosis på 2 mg pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel.
English: The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to cats was characterised by a maximum concentration (Cmax) in plasma of approximately 165 ng/ml; this was achieved on average 0.32 hours (19 min) post-dosing (Tmax).
Danish: Givet som en enkelt subkutan dosis på 1 mg/kg legemsvægt til katte var maropitants farmakokinetiske profil karakteriseret ved en maksimal koncentration (Cmax) i plasma på omkring 165 ng/ml.
English: To treat and/or prevent vomiting except motion sickness, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below.
Danish: For at behandle eller forebygge opkastning, som ikke skyldes køre- eller søsyge, gives Cerenia tabletter en gang daglig med en dosis på 2 mg pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel.
English: The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Danish: Givet som en enkelt subkutan dosis på 1 mg/kg legemsvægt til hunde var den farmakokinetiske profil karakteriseret ved en maksimal koncentration (Cmax) i plasma på omkring 92 ng/ml.
English: Cerenia 10 mg/ml solution for injection for dogs and cats maropitant
Danish: Cerenia 10 mg/ ml injektionsvæske, opløsning til hunde og katte maropitant
English: PACKAGE LEAFLET: Cerenia 10 mg/ml solution for injection for dogs and cats
Danish: INDLÆGSSEDDEL Cerenia 10 mg/ml injektionsvæske, opløsning til hunde og katte
English: Each tablet contains 24 mg maropitant as maropitant citrate monohydrate.
Danish: Hver tablet indeholder 24 mg maropitant som maropitant citrat monohydrat.
English: Each tablet contains 16 mg maropitant as maropitant citrate monohydrate.
Danish: Hver tablet indeholder 16 mg maropitant som maropitant citrat monohydrat.
English: Each tablet contains 160 mg maropitant as maropitant citrate monohydrate.
Danish: Hver tablet indeholder 160 mg maropitant som maropitant citrat monohydrat.
English: Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been administered at doses in excess of 20 mg/kg.
Danish: Efter overdosering højere end 20 mg/kg er set spredte kliniske symptomer som opkastning efter første indgift, forøget spytsekretion og vandig afføring.
English: Each tablet contains 60 mg maropitant as maropitant citrate monohydrate.
Danish: Hver tablet indeholder 60 mg maropitant som maropitant citrat monohydrat.
English: EU Number
Danish: MF (EE)-Nummer (Særnavn) Navn
English: It is given as an injection under the skin twice daily for cats and once daily for dogs either at the same time or immediately after a meal.
Danish: Det indgives som injektion under huden to gange dagligt for katte og én gang dagligt for hunde enten på samme tidspunkt eller umiddelbart efter et måltid.
English: For dogs, if there is insufficient response to treatment after 4 - 6 weeks, the dose and/or frequency can be changed.
Danish: Hvis hunde ikke reagerer tilstrækkeligt på behandlingen efter 4-6 uger, kan dosis og/eller hyppighed ændres.
English: The correct dose is determined individually for each animal depending on weight and needs to be adjusted depending on the response to treatment.
Danish: Korrekt dosis afgøres individuelt for hvert dyr afhængigt af vægt og justeres afhængigt af reaktionen på behandlingen.
English: ProZinc received a marketing authorisation valid throughout the EU on 12 July 2013.
Danish: ProZinc modtog en markedsføringstilladelse med gyldighed i hele EU den 12. juli 2013.
English: It contains the active substance human insulin.
Danish: Det indeholder det aktive stof human insulin.
English: Further information on ProZinc can be found on the Agency's website: ema.europe.eu/medicines/veterinary/EPAR/prozinc
Danish: Yderligere oplysninger om ProZinc findes på agenturets websted under: ema.europe.eu/medicines/veterinary/EPAR/prozinc
English: There is a low chance of an allergic reaction in sensitised people.
Danish: Der er en lille risiko for allergisk reaktion hos personer, som er overfølsomme.
English: These hypoglycaemic events are generally mild in nature.
Danish: Disse hypoglykæmiske hændelser er generelt af en let karakter.
English: These are absorbed more slowly after injection and take longer to reach their target in the body than naturally produced insulin.
Danish: Disse absorberes langsommere efter injektion og er længere tid om at nå deres mål i kroppen end naturligt produceret insulin.
English: After 12 weeks, 113 out of 134 ProZinc treated dogs (84%) were successfully treated, compared to 91 out of the 111 control dogs (82%).
Danish: Efter 12 uger havde 113 ud af 134 hunde behandlet med ProZinc (84 %) fået en vellykket behandling, sammenlignet med 91 ud af de 111 kontrolhunde (82 %).
English: Other information about ProZinc
Danish: Andre oplysninger om ProZinc
English: A glucose containing solution or gel and/or food is required to be given to the animal immediately.
Danish: En glukoseholdig opløsning eller gel og/eller mad skal straks gives til dyret.
English: Because of its prolonged action, it must also not be used for the short-term management of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Danish: På grund af den forlængede virkningstid må det heller ikke anvendes til kortvarig håndtering af diabetisk ketoacidose (en alvorlig komplikation ved diabetes med højt indhold af ketonstoffer i blodet).
English: ProZinc is a veterinary medicine used to treat cats and dogs with diabetes.
Danish: ProZinc er et lægemiddel til dyr, som anvendes til behandling af katte og hunde med diabetes.
English: The European Medicines Agency decided ProZinc's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved ProZinc opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Diabetes is a disease in which the pancreas does not make enough insulin to control the level of blood glucose (sugar) and/or when the body is unable to use insulin effectively.
Danish: Diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkelig insulin til at kontrollere blodsukkeret (blodglukosen), og/eller hvor kroppen ikke kan anvende insulin effektivt.
English: ProZinc must not be used in cats or dogs which are hypersensitive (allergic) to insulin or any of the other ingredients.
Danish: ProZinc må ikke anvendes til katte eller hunde, der er overfølsomme (allergiske) over for insulin eller andre af indholdsstofferne.
English: Accidental self-injection can result in clinical signs of low blood glucose levels which can be treated by taking sugar by mouth.
Danish: Utilsigtet selvinjektion kan medføre kliniske tegn på lavt blodsukker, som kan behandles ved at indtage sukker gennem munden.
English: For more information about using ProZinc, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af ProZinc, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: This results in increased blood glucose levels and associated clinical signs such as polyuria (increase in urine volume), polydipsia (increase in water intake) and weight loss.
Danish: Dette resulterer i forhøjet blodsukker og tilknyttede kliniske tegn, f.eks. polyuri (forøget urinvolumen), polydipsi (forøget vandindtag) og vægttab.
English: ProZinc can only be obtained with a prescription and is available as a suspension for injection (40 IU/ml).
Danish: ProZinc udleveres kun efter recept og fås som en injektionsvæske, suspension (40 IE/ml).
English: If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved utilsigtet selvinjektion bør der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: An overview of ProZinc and why it is authorised in the EU
Danish: En oversigt over ProZinc, og hvorfor det er godkendt i EU
English: In an EU field study involving diabetic dogs, ProZinc was as effective as an authorised veterinary insulin, with improvement of at least one blood sugar measurement and at least one of three clinical signs: bodyweight, polyuria and polydipsia.
Danish: I et EU-feltstudie med diabetiske hunde var ProZinc lige så effektivt som en godkendt veterinær insulin, med forbedring af mindst én blodsukkermåling og mindst et af de kliniske tegn kropsvægt, polyuri og polydipsi.
English: For a full list of the side effects and restrictions with ProZinc, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved ProZinc fremgår af indlægssedlen.
English: The most common side effect during treatment with ProZinc (which may affect more than 1 in 10 animals) is hypoglycaemia (low blood glucose levels) which may result in signs such as hunger, anxiety, unsteady movement, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Danish: Den hyppigste bivirkning ved ProZinc (som kan optræde hos mere end 1 ud af 10 dyr) er hypoglykæmi (lavt blodsukker), der kan give tegn som sult, angst, ukoordinerede bevægelser, muskeltrækninger, snublen eller nedsynkning af bagbenene og desorientering.
English: What is ProZinc and what is it used for?
Danish: Hvad er ProZinc, og hvad anvendes det til?
English: Why is ProZinc authorised in the EU?
Danish: Hvorfor blev ProZinc godkendt i EU?
English: ProZinc works in the same way as naturally produced insulin with a longer duration of action, and helps glucose enter cells from the blood.
Danish: ProZinc virker på samme måde som naturligt produceret insulin med en længere virkningstid og hjælper sukkeret med at trænge ind i cellerne fra blodet.
English: What are the risks associated with ProZinc?
Danish: Hvilke risici er der forbundet med ProZinc?
English: ProZinc is an insulin to which protamine and zinc have been added to create crystals.
Danish: ProZinc er insulin tilsat protamin og zink for at danne krystaller.
English: In a field study involving 139 diabetic cats of various ages and breeds, after 6 weeks of treatment with ProZinc average blood sugar levels decreased and clinical signs improved, for example average body weight increased; 116 out of 139 cats (84%) were considered to be treated successfully.
Danish: I et feltstudie, som omfattede 139 katte i forskellig alder og af forskellig race med diabetes, faldt de gennemsnitlige blodsukkerniveauer, og de kliniske tegn forbedredes, efter 6 ugers behandling med
English: How is ProZinc used?
Danish: Hvordan anvendes ProZinc?
English: How does ProZinc work?
Danish: Hvordan virker ProZinc?
English: What benefits of ProZinc have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved ProZinc?
English: The active ingredient of ProZinc, human insulin, is produced by a method known as ‘recombinant DNA technology': it is made by yeast cells into which a gene (segment of DNA) has been introduced that makes the yeast cells able to produce insulin.
Danish: Det vil sige, det fremstilles af gærceller, der har fået indsat et gen (DNA-segment), som gør gærcellerne i stand til at danne insulin.
English: If it is not, then it is likely to
Danish: Hvis ikke, er den sandsynligvis godartet.
English: The marketing authorisation holder is CIS bio international.
Danish: Indehaveren af markedsføringstilladelsen er CIS bio international.
English: The marketing authorisation was renewed on 29 November 2005.
Danish: Denne tilladelse blev fornyet den 29. november 2005.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEOSPECT
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NEOSPECT
English: The European Commission granted a marketing authorisation valid throughout the European Union for NeoSpect on 29 November 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for NeoSpect med gyldighed i hele Den Europæiske Union den 29. november 2000.
English: Medicinal product no longer authorise©EMEA 2007
Danish: ©EMEA 2007
English: How has NeoSpect been studied?
Danish: Hvordan blev NeoSpect undersøgt?
English: The radiolabelled medicine is for diagnostic use.
Danish: Det radiomærkede lægemiddel er til diagnostisk brug.
English: The Committee recommended that NeoSpect be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for NeoSpect.
English: NeoSpect is only handled and given by specialised personnel who have experience in the safe handling of radioactive material.
Danish: NeoSpect må kun håndteres og indgives af specialuddannet personale med erfaring i sikker håndtering af radioaktivt materiale.
English: This means that it acts like somatostatin, and binds to the same receptors as somatostatin in the body.
Danish: Det vil sige, at stoffet har samme virkning som somatostatin og bindes til de samme receptorer som somatostatin i kroppen.
English: The active substance in NeoSpect, depreotide, is a somatostatin analogue.
Danish: Det aktive stof i NeoSpect, depreotid, er en somatostatin-analog.
English: NeoSpect has been studied in two main trials involving 258 patients with suspected lung cancer.
Danish: NeoSpect var genstand for to hovedundersøgelser, hvori der deltog 258 patienter med formodet lungekræft.
English: These receptors are found in large numbers on some malignant tumours such as lung tumours.
Danish: Disse receptorer findes i stort antal i visse ondartede svulster som lungesvulster.
English: When NeoSpect is radiolabelled, the radioactive element technetium-99m (99mTc) is attached to depreotide.
Danish: Ved radiomærkning af NeoSpect bindes det radioaktive grundstof technetium-99m (99mTc) til depreotid.
English: NeoSpect should not be used in women who are pregnant
Danish: NeoSpect bør ikke anvendes hos patienter, der er
English: If the solitary pulmonary nodule is labelled with NeoSpect, it is likely to be malignant.
Danish: Hvis den isolerede knude i lungerne bliver mærket af NeoSpect, er den sandsynligvis ondartet.
English: Side effects with NeoSpect are uncommon, but the most common (seen in between 1 and 10 patients in 1000) are headache, nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, dizziness, flushing and fatigue (tiredness).
Danish: De almindeligste bivirkninger (der ses hos mellem 1 og 10 patienter ud af 1 000) er hovedpine, kvalme, opkastning, diarré, mavesmerter, svimmelhed,
English: NeoSpect should not be used in people who may be hypersensitive (allergic) to depreotide, sodium pertechnetate or any of the other ingredients.
Danish: NeoSpect bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for depreotid, natriumpertechnetat eller andre af indholdsstofferne.
English: NeoSpect is not used on its own, but it must be radiolabelled before use.
Danish: NeoSpect anvendes ikke i den leverede form, men skal radiomærkes før brug.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse den faglige
English: As depreotide binds to the receptors, it carries the radioactivity with it, and this can be detected using special imaging equipment, such as scintigraphy or single photon emission computed tomography (SPECT).
Danish: Når depreotid bindes til receptorerne, fører det radioaktiviteten med sig, og dette kan spores med særlige billeddannelsesteknikker som scintigrafi eller SPECT (enkeltfotonemissionstomografi).
English: The result of the NeoSpect scan was in agreement with the result obtained by histology in between 80 and 90% of the cases.
Danish: Resultatet af NeoSpect-scanningen passede i 80-90 % af tilfældene med resultatet af den mikroskopiske undersøgelse.
English: NeoSpect is a kit for preparing a radiolabelled medicine.
Danish: NeoSpect er et sæt til fremstilling af et radioaktivt mærket lægemiddel.
English: The Committee for Medicinal products for Human Use (CHMP) decided that NeoSpect's benefits are greater than its risks for the scintigraphic imaging of suspected malignant lung tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved NeoSpect opvejer risiciene til scintigrafisk afbildning af allerede fundne, formodet ondartede lungesvulster ved anvendelse i kombination med CT-scanning eller røntgen af brystkassen hos patienter med isolerede knuder i lungerne.
English: The main measure of effectiveness was the accuracy of diagnosing a malignant tumour (positive) or a benign tumour (negative).
Danish: Virkningen blev hovedsagelig bedømt på korrektheden af diagnosen ondartet (positiv) eller godartet (negativ).
English: What benefit has NeoSpect shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved NeoSpect?
English: NeoSpect includes a white powder for solution for injection, which contains the active substance depreotide.
Danish: NeoSpect består af et hvidt pulver, hvoraf der fremstilles en injektionsvæske (opløsning), der indeholder det aktive stof depreotid.
English: Adding a NeoSpect scan to a CT scan increased the specificity of the scan, making it easier for the doctor to identify a nodule as malignant.
Danish: Når NeoSpect-scanning blev brugt i tilslutning til CT-scanning, blev scanningen mere specifik, så lægen lettere kunne afgøre om knuden var ondartet.
English: Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Danish: Radiomærkning er en teknik til mærkning af et stof med et radioaktivt stof.
English: The outcome of the NeoSpect scan was compared to the actual diagnosis, based on the histology of the
Danish: Resultatet af scanningen med NeoSpect blev sammenholdt med den faktiske diagnose.
English: NeoSpect is used in patients who have a single pulmonary nodule (a small, round lesion in the lungs) detected by a chest X-ray or computerised tomography (CT) scan to see if the nodule is malignant (cancerous).
Danish: NeoSpect anvendes hos patienter, der har en isoleret knude (en lille rund forandring) i lungerne, som er fundet ved røntgen af brystkassen eller ved en CT-scanning (computertomografi).
English: The patients underwent a chest X-ray or a CT scan as well as a SPECT scan using radiolabelled NeoSpect.
Danish: Patienterne fik dels taget røntgen af brystkassen eller CT-scanning, dels en SPECT
English: Medicinal product no longer authorised
Danish: Normalt bør dette lægemiddel ikke
English: nodule (when the tissue of the nodule is analysed under the microscope after it has been removed in an operation).
Danish: Den faktiske diagnose blev stillet ved mikroskopisk undersøgelse af knuden, når denne var fjernet ved operation.
English: Once made up into a radiolabelled solution, NeoSpect is given by intravenous injection (into a vein), and a scan is taken two to four hours after the injection.
Danish: Når den radiomærkede opløsning af NeoSpect er fremstillet, gives den ved indsprøjtning i en vene.
English: The full EPAR for NeoSpect is available here.
Danish: Bivirkninger af NeoSpect forekommer ikke ofte.
English: Do not use this medicine in children and adolescents under 13 years of age.
Danish: Dette lægemiddel må ikke anvendes til børn og unge under 13 år.
English: CARTON FOR BOTTLE AND BOTTLE LABEL
Danish: KARTON TIL FLASKE OG FLASKEETIKET
English: Try to take Aripiprazole Accord at the same time each day.
Danish: Forsøg at tage Aripiprazole Accord på samme tidspunkt hver dag.
English: • Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Danish: Fortæl din læge, hvis du oplever et sådant adfærdsmønster; han/hun vil diskutere måder til at håndtere eller mindske symptomerne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2015
Danish: Dato for første markedsføringstilladelse: 16 november 2015
English: Consequently, the frequency of these adverse events is qualified as “not known”
Danish: Hyppigheden af sådanne bivirkninger er derfor angivet som "ikke kendt".