natgillin/translations-raw huggingface dataset:
- Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Varighed af immunitet: Mindst et år efter basisvaccination for alle komponenter i Versican Plus Pi/L4.
Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
Basisvaccination: To doser af Versican Plus Pi/L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen.
Primary vaccination scheme: Two doses of Versican Plus Pi/L4 3-4 weeks apart from 6 weeks of age.
Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15
Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10
Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundesygevirus, hundeparvovirus, hundeadenovirus type 1 og 2, hundeparainfluenzavirus, Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola servar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Rekonstitueret vaccine: Lyserød eller gullig farve, let opalisering.
Reconstituted vaccine: pinkish or yellowish colour with a slight opalescence.
Hyppigheden af bivirkninger er defineret som:
The visual appearance is as follows:
Revaccinationsprogram: Der anbefales en årlig vaccination med Versican Plus Pi/L4.
Re-vaccination scheme: A single dose of Versican Plus Pi/L4 to be given annually.
LÆGEMIDDELFORM Lyofilisat og suspension til injektionsvæske, suspension.
PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection
Suspension (inaktiveret): L. interrogans serovar Icterohaemorrhagiae
L. interrogans serovar Icterohaemorrhagiae
UDLØBSDATO EXP {måneder/år} Anvendes straks efter anbrud.
EXP {month/year} Once reconstituted, use immediately.
Indtræden af immunitet: - 3 uger efter basisvaccination for CPiV - 4 uger efter basisvaccination for Leptospira komponenter.
− 4 weeks after the completion of primary course for Leptospira components.
VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4 lyofilisat til hund
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate for dogs
INDLÆGSSEDDEL Versican Plus Pi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
PACKAGE LEAFLET: Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4 suspension til hund
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 suspension for dogs
4.1 Dyrearter, som lægemidlet er beregnet til Hund
CLINICAL PARTICULARS 4.1 Target species
− for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and
VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Artikel 34 i direktiv 2001/82/EF, med senere ændringer
Article 34 of Directive 2001/82/EC, as amended
Udvalget udpegede G. Johan Schefferlie som rapportør og dr. Michael Holzhauser-Alberti som medrapportør.
The Committee appointed Mr G. Johan Schefferlie as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Internationalt fællesnavn (INN): tilmicosin
International non-proprietary name (INN): tilmicosin
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 18. oktober 2013.
The final opinion was converted into a Decision by the European Commission on 18 October 2013.
Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 18. september 2012, den 11. februar 2013 og den 26. maj 2013.
Written explanations were provided by the marketing authorisation holders on 18 September 2012, 11 February 2013 and 26 May 2013.
Indbringelsesproceduren påbegyndtes den 15. maj 2012.
The referral procedure started on 15 May 2012.
Der blev afgivet mundtlige redegørelser den 11. juni 2013.
Oral explanations were given on 11 June 2013.
På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne med hensyn til tilladelserne for Micotil 300 Injectie og tilknyttede navne, indbragte Nederlandene den 24. april 2012 sagen for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF, for at få løst uoverensstemmelserne i produktoplysningerne i hele EU.
Due to divergent national decisions taken by Member States concerning the authorisations of Micotil 300 Injectie and its associated names, on 24 April 2012 the Netherlands referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve discrepancies in the product information across the European Union.
Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, og det ændrede produktresumé, etikettering og indlægsseddel findes i bilag III.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, labelling and package leaflet in Annex III.
juli 2013.
18 October 2013
Micotil 300 Injectie og tilknyttede navne er veterinærlægemidler, der er godkendt til anvendelse hos måldyrearterne kvæg, får og kaniner til behandling af forskellige infektioner forårsaget af tilmicosinfølsomme mikroorganismer.
Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
På grundlag af de tilgængelige data var CVMP af den opfattelse, at benefit/risk-forholdet for Micotil 300 Injectie og tilknyttede navne fortsat er positiv, forudsat at markedsføringstilladelserne ændres i overensstemmelse med de anbefalede produktoplysninger.
Based on the currently available data, the CVMP considered that the benefit-risk profile of Micotil 300 Injectie and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
Micotil 300 Injectie er en injektionsvæske, der indeholder tilmicosin i styrken 300 mg/ml.
Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Det har et antibakterielt spektrum svarende til tylosin med øget aktivitet over for Pasteurella multocida og Mannheimia haemolytica.
Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Udtalelse som følge af en sag indbragt i henhold til artikel 340F om Micotil 300 Injectie og tilknyttede navne
Opinion following an Article 340F referral for Micotil 300 Injectie and its associated names
Udtalelse som følge af en sag indbragt i henhold til artikel om Micotil 300 Injectie og tilknyttede navne
Opinion following an Article 341 referral for Micotil 300 Injectie and its associated names
CPMP vedtog derfor en positiv udtalelse ved konsensus den18.
The Committee adopted a positive opinion by consensus on 18 July 2013.
Posaconazole SP 40 mg/ml Oral suspension Oral anvendelse Flaske (glas)
Posaconazole SP 40 mg/ml Oral suspension Oral use
Indhold (koncentration) Pakningsstørrelse
Content (concentration) Package size
Styrke Lægemiddelform Indgivelsesvej
Invented name Strength Pharmaceutical Form
Startpakning: 63 (1 x 21 og 2 x 21) tabletter
270 capsules blister (PVC/Aclar (PCTFE)) Initiation pack: 63 (1 x 21 and 2 x 21) tablets
Startpakning: 63 (7 x 3 og 7 x 6) kapsler
Immediate Packaging Pack size blister (PVC/PE/PCTFE/alu) Initiation pack: 63 (7 x 3 and 7 x 6) capsules blister (PVC/PE/PCTFE/alu) 252 x 1 capsules (unit dose)
Denne oversigt blev sidst ajourført i 03-2019.
This overview was last updated in 03-2019
Instanyl fik en markedsføringstilladelse med gyldighed i hele EU den 20. juli 2009.
Instanyl received a marketing authorisation valid throughout the EU on 20 July 2009.
Yderligere information om Instanyl findes på agenturets websted under: ema.europa.eu/medicines/Human/EPAR/Instanyl.
Further information on Instanyl can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/Instanyl.
Andre oplysninger om Instanyl
Other information about Instanyl
Lægemidlet udleveres kun efter "særlig" recept.
The medicine can only be obtained by ‘special' prescription.
Som for alle lægemidler bliver data vedrørende brug af Instanyl løbende overvåget.
As for all medicines, data on the use of Instanyl are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Instanyl?
What measures are being taken to ensure the safe and effective use of Instanyl?
En oversigt over Instanyl, og hvorfor det er godkendt i EU
An overview of Instanyl and why it is authorised in the EU
Hvorfor blev Instanyl godkendt i EU?
Why is Instanyl authorised in the EU?
Lægen bør være opmærksom på, at Instanyl kan misbruges.
The doctor should keep in mind the potential for Instanyl to be abused.
For mere information om brug af Instanyl, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Instanyl, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Instanyl opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Instanyl's benefits are greater than its risks and it can be authorised for use in the EU.
Hvilke risici er der forbundet med Instanyl?
What are the risks associated with Instanyl?
Bivirkningerne svarer til bivirkningerne ved andre lægemidler, der indeholder fentanyl, og der er truffet foranstaltninger til at minimere risikoen for misbrug og overdosis.
Side effects are similar to those of other medicines containing fentanyl, and measures have been put in place to minimise the risk of misuse and overdose.
Patientens gennembrudssmerte blev anset for at have responderet på behandlingen, hvis der var en reduktion på mindst 2 point.
A patient's breakthrough pain was considered to have responded to treatment if there was a reduction of at least 2 points.
Hvad er Instanyl, og hvad anvendes det til?
What is Instanyl what is it used for?
Det aktive stof i Instanyl, fentanyl, er et opioid.
The active substance in Instanyl, fentanyl, is an opioid.
Bivirkninger rapporteret for Instanyl vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Instanyl are carefully evaluated and any necessary action taken to protect patients.
Det leveres i enkeltdosisbeholdere og flerdosisbeholdere.
It is available in singledose containers and in multidose containers.
Det må ikke anvendes til behandling af andre kortvarige smerter end gennembrudssmerter.
It must not be used to treat short-term pain other than breakthrough pain.
Eftersom fentanyl har været anvendt i mange år, fremlagde virksomheden data fra faglitteraturen og fra studier, den havde foretaget, som viste, at Instanyl var mere effektivt end placebo (en uvirksom behandling) til at behandle gennembrudssmerter hos kræftpatienter.
Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out, which showed that Instanyl was more effective than placebo (a dummy treatment) at treating breakthrough pain in cancer patients.
Instanyl indeholder det aktive stof fentanyl.
Instanyl contains the active substance fentanyl.
Hver patient brugte så den identificerede dosis Instanyl eller placebo til at behandle gennembrudssmerter.
Each patient then used the identified dose of Instanyl or placebo to treat breakthrough pain.
I et tredje studie, som omfattede 139 patienter og sammenlignede Instanyl med "transmukosal" fentanyl (som absorberes gennem mundslimhinden), oplevede de patienter, som fik Instanyl, hurtigere smertelindring end de patienter, der fik transmukosal fentanyl.
In a third study, which involved 139 patients and compared Instanyl with ‘transmucosal' fentanyl (absorbed through the lining of the mouth), patients who received Instanyl had faster pain relief than patients who received transmucosal fentanyl .
Når patienten sprøjter Instanyl ind i næsen, absorberes en dosis fentanyl i blodbanen via blodkarrene i næsen.
When the patient sprays Instanyl into the nose, a dose of fentanyl is absorbed into the blood stream through the blood vessels in the nose.
De hyppigste bivirkninger ved Instanyl (som kan forekomme hos op til 1 ud af 10 personer) er søvnighed, svimmelhed, hovedpine, vertigo (en følelse af, at alt kører rundt), rødmen, hedeture, irritation i halsen, kvalme, opkastning og hyperhidrose (overdreven svedtendens).
The most common side effects with Instanyl (which may affect up to 1 in 10 people) are somnolence (sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening of the skin), hot flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating).
I et hovedstudie tog 178 voksne kræftpatienter med gennembrudssmerter et pust af enten Instanyl (50, 100 eller 200 mikrogram) eller placebo, når de oplevede gennembrudssmerter.
In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl (50, 100 or 200 microgram) or placebo when they experienced breakthrough pain.
Instanyl fås som næsespray (50, 100 og 200 mikrogram pr. dosis).
Instanyl is available as a nasal spray (50, 100 and 200 micrograms per dose).
Virksomheden, der markedsfører Instanyl, skal desuden udlevere oplysningsmateriale til patienter, læger og apotekspersonale med beskrivelse af, hvordan lægemidlet anvendes korrekt og sikkert.
The company that markets Instanyl will also provide educational materials to be supplied to patients, doctors and pharmacists, explaining the correct and safe use of the medicine.
I et andet hovedstudie fik 128 patienter stigende doser af Instanyl, indtil en tilstrækkelig smertestillende dosis var opnået.
In another main study, 128 patients were given increasing doses of Instanyl until the adequate dose for pain relief was reached.
Antallet af patienter, der responderede på behandlingen, var også højere i Instanylgruppen end i placebogruppen.
The number of patients who responded to treatment was also higher in the Instanyl group than in the placebo group.
Gennembrudssmerter er, når en patient oplever yderligere, pludselig smerte på trods af igangværende behandling med smertestillende midler.
Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Instanyl er påvist at give hurtig smertelindring hos kræftpatienter.
Instanyl has been shown to provide rapid relief of pain in patients with cancer.
Før behandlingen med Instanyl indledes, skal patientens længerevarende smerter være under kontrol ved hjælp af opioide smertestillende midler, og patienterne bør ikke have over fire tilfælde af gennembrudssmerter om dagen.
Before starting treatment with Instanyl, the patient's long-term pain should be well controlled by opioid pain killers and they should have no more than 4 episodes of breakthrough pain a day.
Patienten bør få Instanyl for højst fire tilfælde af gennembrudssmerter om dagen.
The patient should be given Instanyl for a maximum of 4 episodes of breakthrough pain a day.
Hvis smertelindringen er utilstrækkelig, kan samme dosis gives igen, når der er gået mindst 10 minutter.
If there has been insufficient pain relief, the same dose can be given again at the earliest after 10 minutes.
Instanyl må ikke anvendes til patienter, som ikke i forvejen tager opioider for at holde smerterne under kontrol, som har svær respirationsdepression (åndedrætsbesvær), eller som har svære obstruktive lungesygdomme (sygdomme, der giver alvorlige vejrtrækningsproblemer).
Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Behandling med Instanyl bør indledes og løbende overvåges af en læge med erfaring i opioidbehandling af kræftpatienter.
Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients.
Instanyl anvendes hos voksne patienter, der allerede bruger opioider (en gruppe smertestillende midler, som omfatter morfin og fentanyl) for at kontrollere længerevarende kræftsmerter.
Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Hvilke fordele viser studierne, at der er ved Instanyl?
What benefits of Instanyl have been showed in studies?
De patienter, der fik Instanyl, havde lov til at tage endnu et pust 10 minutter efter den første dosis, hvis smertelindringen ikke var tilstrækkelig.
Patients taking Instanyl were allowed to take a second spray 10 minutes after the first dose if there had been insufficient pain relief.
Den højeste dosis var 200 mikrogram, der blev givet som et pust i det ene næsebor, og patienterne havde lov til at tage endnu et pust efter 10 minutter, hvis smertelindringen ikke var tilstrækkelig.
The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain relief.
Det må heller ikke anvendes til patienter, som har fået strålebehandling i ansigtet, eller som har tilbagevendende episoder af epistaxis (næseblod).
It must also not be used in patients who have had facial radiotherapy (treatment with radiation to the face) or who have recurrent episodes of epistaxis (nosebleeds).
Ændringen i smerteintensiteten efter 10 minutter lå på mellem 2,0 og 2,7 point efter indgivelse af doser af Instanyl sammenlignet med 1,3 efter indgivelse af placebo.
The change in pain intensity after 10 minutes was between 2.0 and 2.7 points after receiving doses of Instanyl compared with 1.3 after receiving placebo.
Faldet i smerteintensiteten efter 10 minutter lå på mellem 1,8 og 2,7 point på en 11-punkts-smerteskala hos de patienter, der fik Instanyl, sammenlignet med 1,4 hos de patienter, der fik placebo.
The reduction in pain intensity after 10 minutes was between 1.8 and 2.7 points on an 11-point pain scale for patients who took Instanyl, compared with 1.4 for patients who took placebo.
Instanyl er et lægemiddel, der anvendes til at behandle gennembrudssmerter hos voksne med kræft.
Instanyl is a medicine used to treat breakthrough pain in adults with cancer.
Når fentanyl er i blodbanen, virker det på receptorerne i hjernen og rygmarven og lindrer smerte.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Antallet af gennembrudssmertetilfælde, der responderede på behandlingen, var også højere blandt de patienter, der fik Instanyl end blandt dem, der fik placebo.
The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.
I Instanyl er fentanyl indeholdt i en næsespray.
In Instanyl, fentanyl is contained inside a nasal spray.
Det må ikke anvendes til patienter behandlet med lægemidler, der indeholder natriumoxybat (til behandling af narkolepsi, en søvnforstyrrelse).
It must not be used in patients treated with medicines containing sodium oxybate (used to treat narcolepsy, a sleep disorder).
Hvordan anvendes Instanyl?
How is Instanyl used?
Den fuldstændige liste over bivirkninger ved Instanyl fremgår af indlægssedlen.
For the full list of side effects with Instanyl, see the package leaflet.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Instanyl.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Instanyl have also been included in the summary of product characteristics and the package leaflet.
Hvordan virker Instanyl?
How does Instanyl work?
Den første dosis Instanyl er 50 mikrogram (et pust med den laveste styrke) i det ene næsebor.
The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is increased as necessary until reaching the dose that gives the patient adequate pain relief.
Bilag IV Betingelser for ophævelse af suspenderingen
Annex IV Conditions for lifting the suspension
Den nye formulering skal godkendes af de nationale kompetente myndigheder i de berørte medlemsstater.
The new formulation must be approved by the National Competent Authorities of the concerned Member States.
Bevis for, at lægemidlet er blevet reformuleret, at det udviser en acceptabel udløsningsprofil med samme kvalitets-, sikkerheds- og effektprofil som den aktuelt godkendte formulering, men uden den klinisk signifikante interaktion med alkohol.
Evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol.
Gælder kun lægemidler med polymethacrylat-triethylcitrat-overtræk som mekanisme til modificeret udløsning
Only applicable to products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism
Dette sammendrag blev sidst ajourført i maj 2015.
This summary was last updated in May 2015.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Innovax-ILT den 3. juli 2015.
The European Commission granted a marketing authorisation valid throughout the EU for Innovax-ILT on 3 July 2015.
Den fuldstændige EPAR for Innovax-ILT findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The full EPAR for Innovax-ILT can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Innovax-ILT.
This is a summary of the European public assessment report (EPAR) for Innovax-ILT.
Vaccinen kan gives til daggamle kyllinger som en enkelt injektion under huden i nakken.
The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck.