natgillin/translations-raw huggingface dataset:
Utilsigtet selvinjektion kan medføre kliniske tegn på lavt blodsukker, som kan behandles ved at indtage sukker gennem munden.
Accidental self-injection can result in clinical signs of low blood glucose levels which can be treated by taking sugar by mouth.
Hvis du ønsker flere oplysninger om anvendelsen af ProZinc, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
For more information about using ProZinc, see the package leaflet or contact your veterinarian or pharmacist.
Dette resulterer i forhøjet blodsukker og tilknyttede kliniske tegn, f.eks. polyuri (forøget urinvolumen), polydipsi (forøget vandindtag) og vægttab.
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.
ProZinc udleveres kun efter recept og fås som en injektionsvæske, suspension (40 IE/ml).
ProZinc can only be obtained with a prescription and is available as a suspension for injection (40 IU/ml).
Ved utilsigtet selvinjektion bør der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
En oversigt over ProZinc, og hvorfor det er godkendt i EU
An overview of ProZinc and why it is authorised in the EU
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.
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.
Den fuldstændige liste over bivirkninger og begrænsninger ved ProZinc fremgår af indlægssedlen.
For a full list of the side effects and restrictions with ProZinc, see the package leaflet.
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.
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.
Hvad er ProZinc, og hvad anvendes det til?
What is ProZinc and what is it used for?
Hvorfor blev ProZinc godkendt i EU?
Why is ProZinc authorised in the EU?
ProZinc virker på samme måde som naturligt produceret insulin med en længere virkningstid og hjælper sukkeret med at trænge ind i cellerne fra blodet.
ProZinc works in the same way as naturally produced insulin with a longer duration of action, and helps glucose enter cells from the blood.
Hvilke risici er der forbundet med ProZinc?
What are the risks associated with ProZinc?
ProZinc er insulin tilsat protamin og zink for at danne krystaller.
ProZinc is an insulin to which protamine and zinc have been added to create crystals.
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
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.
Hvordan anvendes ProZinc?
How is ProZinc used?
Hvordan virker ProZinc?
How does ProZinc work?
Hvilke fordele viser studierne, at der er ved ProZinc?
What benefits of ProZinc have been shown in studies?
Det vil sige, det fremstilles af gærceller, der har fået indsat et gen (DNA-segment), som gør gærcellerne i stand til at danne insulin.
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.
Hvis ikke, er den sandsynligvis godartet.
If it is not, then it is likely to
Indehaveren af markedsføringstilladelsen er CIS bio international.
The marketing authorisation holder is CIS bio international.
Denne tilladelse blev fornyet den 29. november 2005.
The marketing authorisation was renewed on 29 November 2005.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NEOSPECT
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEOSPECT
Europa-Kommissionen udstedte en markedsføringstilladelse for NeoSpect med gyldighed i hele Den Europæiske Union den 29. november 2000.
The European Commission granted a marketing authorisation valid throughout the European Union for NeoSpect on 29 November 2000.
Hvordan blev NeoSpect undersøgt?
How has NeoSpect been studied?
Det radiomærkede lægemiddel er til diagnostisk brug.
The radiolabelled medicine is for diagnostic use.
Udvalget anbefalede udstedelse af markedsføringstilladelse for NeoSpect.
The Committee recommended that NeoSpect be given marketing authorisation.
NeoSpect må kun håndteres og indgives af specialuddannet personale med erfaring i sikker håndtering af radioaktivt materiale.
NeoSpect is only handled and given by specialised personnel who have experience in the safe handling of radioactive material.
Det vil sige, at stoffet har samme virkning som somatostatin og bindes til de samme receptorer som somatostatin i kroppen.
This means that it acts like somatostatin, and binds to the same receptors as somatostatin in the body.
Det aktive stof i NeoSpect, depreotid, er en somatostatin-analog.
The active substance in NeoSpect, depreotide, is a somatostatin analogue.
NeoSpect var genstand for to hovedundersøgelser, hvori der deltog 258 patienter med formodet lungekræft.
NeoSpect has been studied in two main trials involving 258 patients with suspected lung cancer.
Disse receptorer findes i stort antal i visse ondartede svulster som lungesvulster.
These receptors are found in large numbers on some malignant tumours such as lung tumours.
Ved radiomærkning af NeoSpect bindes det radioaktive grundstof technetium-99m (99mTc) til depreotid.
When NeoSpect is radiolabelled, the radioactive element technetium-99m (99mTc) is attached to depreotide.
NeoSpect bør ikke anvendes hos patienter, der er
NeoSpect should not be used in women who are pregnant
Hvis den isolerede knude i lungerne bliver mærket af NeoSpect, er den sandsynligvis ondartet.
If the solitary pulmonary nodule is labelled with NeoSpect, it is likely to be malignant.
De almindeligste bivirkninger (der ses hos mellem 1 og 10 patienter ud af 1 000) er hovedpine, kvalme, opkastning, diarré, mavesmerter, svimmelhed,
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).
NeoSpect bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for depreotid, natriumpertechnetat eller andre af indholdsstofferne.
NeoSpect should not be used in people who may be hypersensitive (allergic) to depreotide, sodium pertechnetate or any of the other ingredients.
NeoSpect anvendes ikke i den leverede form, men skal radiomærkes før brug.
NeoSpect is not used on its own, but it must be radiolabelled before use.
Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse den faglige
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Når depreotid bindes til receptorerne, fører det radioaktiviteten med sig, og dette kan spores med særlige billeddannelsesteknikker som scintigrafi eller SPECT (enkeltfotonemissionstomografi).
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).
Resultatet af NeoSpect-scanningen passede i 80-90 % af tilfældene med resultatet af den mikroskopiske undersøgelse.
The result of the NeoSpect scan was in agreement with the result obtained by histology in between 80 and 90% of the cases.
NeoSpect er et sæt til fremstilling af et radioaktivt mærket lægemiddel.
NeoSpect is a kit for preparing a radiolabelled medicine.
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.
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.
Virkningen blev hovedsagelig bedømt på korrektheden af diagnosen ondartet (positiv) eller godartet (negativ).
The main measure of effectiveness was the accuracy of diagnosing a malignant tumour (positive) or a benign tumour (negative).
Hvilken fordel viser undersøgelserne, der er ved NeoSpect?
What benefit has NeoSpect shown during the studies?
NeoSpect består af et hvidt pulver, hvoraf der fremstilles en injektionsvæske (opløsning), der indeholder det aktive stof depreotid.
NeoSpect includes a white powder for solution for injection, which contains the active substance depreotide.
Når NeoSpect-scanning blev brugt i tilslutning til CT-scanning, blev scanningen mere specifik, så lægen lettere kunne afgøre om knuden var ondartet.
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.
Radiomærkning er en teknik til mærkning af et stof med et radioaktivt stof.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Resultatet af scanningen med NeoSpect blev sammenholdt med den faktiske diagnose.
The outcome of the NeoSpect scan was compared to the actual diagnosis, based on the histology of the
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).
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).
Patienterne fik dels taget røntgen af brystkassen eller CT-scanning, dels en SPECT
The patients underwent a chest X-ray or a CT scan as well as a SPECT scan using radiolabelled NeoSpect.
Normalt bør dette lægemiddel ikke
Medicinal product no longer authorised
Den faktiske diagnose blev stillet ved mikroskopisk undersøgelse af knuden, når denne var fjernet ved operation.
nodule (when the tissue of the nodule is analysed under the microscope after it has been removed in an operation).
Når den radiomærkede opløsning af NeoSpect er fremstillet, gives den ved indsprøjtning i en vene.
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.
Bivirkninger af NeoSpect forekommer ikke ofte.
The full EPAR for NeoSpect is available here.
Dette lægemiddel må ikke anvendes til børn og unge under 13 år.
Do not use this medicine in children and adolescents under 13 years of age.
KARTON TIL FLASKE OG FLASKEETIKET
CARTON FOR BOTTLE AND BOTTLE LABEL
Forsøg at tage Aripiprazole Accord på samme tidspunkt hver dag.
Try to take Aripiprazole Accord at the same time each day.
Fortæl din læge, hvis du oplever et sådant adfærdsmønster; han/hun vil diskutere måder til at håndtere eller mindske symptomerne.
• Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Dato for første markedsføringstilladelse: 16 november 2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2015
Hyppigheden af sådanne bivirkninger er derfor angivet som "ikke kendt".
Consequently, the frequency of these adverse events is qualified as “not known”
Selvom du føler du har det bedre, må du ikke ændre eller lade være med at tage den daglige dosis af dette lægemiddel uden først at have kontaktet lægen.
Even if you feel better, do not alter or discontinue the daily dose of this medicine without first consulting your doctor.
Hos voksne forebygger det også, at tilstanden vender tilbage hos patienter, der har haft god effekt af behandling med dette lægemiddel.
In adults it also prevents this condition from returning in patients who have responded to the treatment with this medicine.
Hyppigheden af bivirkninger, der er rapporteret efter markedsføringen, kan ikke fastslås, da der er tale om spontane indberetninger.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
- stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser,
• strong impulse to gamble excessively despite serious personal or family consequences
- ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift,
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- uhæmmet madindtagelse (spise store mængder mad i en kort periode) eller overdreven madindtagelse (spise mere mad end sædvanligt og mere end nødvendigt for at dække sulten),
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ALUMINIUM/ALUMINIUM-BLISTER
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTERS
Blodtrykssænkende medicin: Aripiprazole Accord kan forstærke virkningen af medicin, der bruges til at sænke blodtrykket.
Blood pressure-lowering medicines: Aripiprazole Accord may increase the effect of medicines used to lower the blood pressure.
Det er vigtigt, at du fortsætter med at tage Aripiprazole Accord i så lang tid, som lægen har sagt, at du skal have dem.
It is important that you carry on taking Aripiprazole Accord for as long as your doctor has told you to.
Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet eller etiketten og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the blister or label and on the carton after EXP.
Blandt patienterne, inkluderet i den primære effektanalyse, var 139 patienter diagnosticeret med ADHD som comorbiditet.
Among the patients included in the primary efficacy analysis, 139 patients had a current co-morbid diagnosis of ADHD.
Aripiprazole Accord indeholder det aktive stof aripiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
Aripiprazole Accord contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
14 x 1 tabletter 28 x 1 tabletter 49 x 1 tabletter 56 x 1 tabletter 98 x 1 tabletter
14 x 1 tablets 28 x 1 tablets 49 x 1 tablets 56 x 1 tablets 98 x 1 tablets
Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget dette lægemiddel i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, døsighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
The following symptoms may occur in newborn babies, of mothers that have used this medicine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Dette lægemiddel bruges til at behandle voksne og unge i alderen 13 år og ældre, som lider af en sygdom, der er forbundet med symptomer som fx at føle sig "høj", en overdreven mængde energi, behov for meget mindre søvn end sædvanligt, meget hurtigt tale med et væld af idéer og nogle gange voldsom irritabilitet.
This medicine is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Aripiprazole Accord er indiceret til behandling af skizofreni hos voksne og unge i alderen 15 år og opefter.
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Hvis du tager Aripiprazole Accord, vil din læge drøfte med dig, om du bør amme dit barn, ved at se på fordelen for dig ved behandling og fordelen ved amning for barnet.
If you are taking ARIPIPRAZOLE ACCORD, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
WESSLING Hungary, Anonymus u. 6., Budapest, 1045, Ungarn
Wessling Hungary, Anonymus u. 6., Budapest, 1045, Hungary
Administration Aripiprazole Accord er til oral anvendelse.
Aripiprazole Accord is for oral use.
Bivirkningerne er opstillet efter systemorganklasse og hyppighed: 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), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra de foreliggende data).
All ADRs are listed by system organ class and frequency; 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), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Accord Healthcare Limited Sage house, 319 Pinner Road, North Harrow, Middlesex HA1 4HF Storbritannien
Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom
Hvis du har taget for meget Aripiprazole Accord Hvis du tror, du har taget mere Aripiprazole Accord, end lægen har anbefalet (eller hvis en anden er kommet til at tage noget af din Aripiprazole Accord), skal du straks kontakte lægen.
If you realise you have taken more Aripiprazole Accord than your doctor has recommended (or if someone else has taken some of your Aripiprazole Accord), contact your doctor right away.
Patienterne var 6-18 år og havde en gennemsnitlig baseline-score på 29 på TTS-YGTSS-skalaen.
Patients were 6 - 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Punktestimatet for hazard ratioen i hele populationen var 0,461 (95 %-konfidensinterval, 0,242-0,879).
The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Hos de patienter, der fik aripiprazol, var den mediane tid til debut 30 dage, og den mediane varighed var 194 dage.
For patients receiving aripiprazole, the median time to onset was 30 days and median duration was 194 days.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Aripiprazole i en eller flere undergrupper af den pædiatriske population ved behandling af skizofreni og bipolær lidelse (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with aripiprazole in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
• Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, majsstivelse, hydroxypropylcellulose, magnesiumstearat og indigotin (E132) aluminium lake (5 mg tabletter) eller rød jernoxid (E172) (10 og 30 mg tabletter) eller gul jernoxid (E172) (15 mg tabletter).
• The other ingredients are lactose monohydrate, cellulose microcrystalline,maize starch, hydroxypropylcellulose , magnesium stearate, and indigo carmine aluminium lake (E132) (for 5 mg) or iron oxide red (E172) (for 10 mg and 30 mg) or iron oxide yellow (E172) (for 15 mg).
Hos de patienter, der fik aripiprazol, var den mediane tid til debut 42 dage, og den mediane varighed var 34 dage.
For patients receiving aripiprazole, the median time to onset was 42 days and median duration was 34 days.
De hyppigst rapporterede bivirkninger i placebokontrollerede forsøg er akatisi og kvalme, som hver forekom hos mere end 3 % af de patienter, der blev behandlet med oral aripiprazol.
The most commonly reported adverse reactions in placebo-controlled trials are akathisia and nausea each occurring in more than 3% of patients treated with oral aripiprazole.
Irritabilitet associeret med autisme: Aripiprazole Accords sikkerhed og virkning hos børn og unge under 18 år er endnu ikke blevet klarlagt.
Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents aged below 18 years have not yet been established.
HDPE-flaskepakning bør anvendes inden for 30 dage efter første åbning (flaske med 30 tabletter).
HDPE bottle pack should be used within 30 days after first opening.
Skizofreni: I et længerevarende, 52-ugers kontrolleret forsøg havde aripiprazol-behandlede patienter totalt set en lavere forekomst (25,8 %) af EPS, inklusive parkinsonisme, akatisi, dystoni og dyskinesi sammenlignet med patienter behandlet med haloperidol (57,3 %).
Schizophrenia: in a long term 52-week controlled trial, aripiprazole-treated patients had an overalllower incidence (25.8 %) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3 %).
Grand mal-kramper Serotoninsyndrom Taleforstyrrelser
Grand mal convulsion Serotonin syndrome Speech disorder
I kliniske forsøg havde en daglig dosis på 10-30 mg aripiprazol ingen signifikant effekt på metabolismen af CYP2D6-substrater (dextromethorphan/3-methoxymorphinan forholdet), CYP2C9 (warfarin), CYP2C19 (omeprazol) og CYP3A4 (dextromethorphan).
Potential for aripiprazole to affect other medicinal products In clinical studies, 10-30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Det er foreslået, at aripiprazols virkning på skizofreni og bipolær lidelse type 1 medieres gennem en kombination af partiel agonisme på dopamin D2- og serotonin 5-HT1a-receptorer samt antagonisme på serotonin 5-HT2a-receptorer.
It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Tics associeret med Tourettes syndrom: Aripiprazole Accords sikkerhed og virkning hos børn og unge i alderen 6-18 år er endnu ikke klarlagt.
Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents 6 to 18 years of age have not yet been established.
Aripiprazole Accord bør ikke anvendes til børn under 15 år med skizofreni på grund af utilstrækkelig dokumentation for sikkerhed og virkning (se pkt.
Aripiprazole Accord is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Sikkerheden ved og virkningen af Aripiprazole Accord ved behandling af skizofreni eller maniske episoder ved bipolær lidelse type I hos patienter i alderen 65 år og derover er ikke undersøgt.
The safety and efficacy of Aripiprazole Accord in the treatment of schizophrenia or manic episodes inBipolar I Disorder in patients aged 65 years and older has not been established.