FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Danish: Efter administration af overdosis af vaccinen, er der ikke observeret andre bivirkninger end de under 4.6. beskrevet
English: • In very rare occasions, abscessation may be observed.
Danish: • I meget sjældne tilfælde kan der ses abscesdannelse.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Danish: Obevaringstid for veterinærlægemidlet i salgspakning: 18 måneder.
English: ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur.
Danish: ** antitoksisk antistoftiter induceret efter gentagen vaccination i marsvinesera i henhold til Ph. Eur.
English: As a consequence, these components induce immunity against equine influenza virus (H3N8).
Danish: Som følge heraf inducerer komponenterne immunitet over for influenza virus (H3N8) hos hest.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Water for injections
Danish: Dinatriumhydrogenorthophosphat Vandfrit monokaliumphosphat Vand til injektion
English: Name and address of the manufacturers of the biological active substances
Danish: Navn og adresse på fremstiller af de biologisk aktive stoffer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 10 doser: 10 hætteglas à 1 dosis
English: • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Danish: • Undtagelsesvis kan der ses hypersensitivitetsreaktion, der kan kræve korrekt symptomatisk behandling.
English: • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
Danish: • Undtagelsesvis kan der iagttages apati og nedsat ædelyst dagen efter vaccination.
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Danish: MERIAL, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
English: Special precautions for use in animals: Only healthy animals should be vaccinated.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr: Vacciner kun raske dyr.
English: The vaccine stimulates active immunity against equine influenza and tetanus.
Danish: Vaccinen stimulerer aktiv immunitet mod influenza og tetanus.
English: No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL's inactivated vaccine against rabies.
Danish: Ingen interaktion er observeret, når vaccinen anvendes samtidigt, men via et andet vaccinationssted, med MERIALs inaktiverede vacciner mod rabies.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas
English: • Store and transport refrigerated (2 °C - 8 °C).
Danish: • Opbevares og transporteres nedkølet (2 °C-8 °C).
English: • 5 months after primary vaccination course with ProteqFlu-Te.
Danish: • 5 måneder efter basisvaccination med ProteqFlu-Te.
English: Box of 10 vials of 1 dose.
Danish: Æske med 10 hætteglas à 1 dosis.
English: Tetanus component: MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex FRANCE
Danish: MERIAL Toulouse 4 Chemin du Calquet 31057 Toulouse Cedex Frankrig
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGS-TILLADELSEN
English: Carbomer ......................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Danish: Carbomer ........................................................................................................................................... 4 mg Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material.
Danish: Anvend sterilt og antiseptisk-frit og/eller desinfektionsfrit materiale ved administration af vaccinen.
English: EXP Use immediately after opening.
Danish: EXP{måned/år} Anvendes umiddelbart efter anbrud.
English: Shake the vaccine gently before use.
Danish: Vaccinen omrystes let før brug.
English: Manufacturer for the batch release: MERIAL
Danish: Fremstiller af batchfrigivelse: MERIAL
English: Pregnancy and lactation: Can be used during pregnancy and lactation.
Danish: Anvendelse under drægtighed og laktation: Kan anvendes under drægtighed og laktation.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Danish: Aktiv immunisering af heste, der er 4 måneder eller ældre, mod influenza for at nedsætte kliniske symptomer og virusudskillelse efter infektion og mod tetanus for at forebygge dødelighed.
English: Onset of immunity: 14 days after primary vaccination course.
Danish: Immunitet indsætter 14 dage efter basisvaccination.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Suspension for injection.
Danish: Suspension til injektion.
English: • Pain, local hyperthermia and muscle stiffness can occur in rare cases.
Danish: • I sjældne tilfælde kan der forekomme smerte, lokal hyperthermi og muskelstivhed.
English: Only healthy animals should be vaccinated.
Danish: Vacciner kun raske dyr.
English: • Use immediately after opening.
Danish: • Anvendes umiddelbart efter anbrud.
English: Horses
Danish: Heste.
English: Incompatibilities: Do not mix with any veterinary medicinal product.
Danish: Væsentlige uforligeligheder: Må ikke blandes med andre lægemidler til dyr.
English: Intramuscular use (preferably in the neck region).
Danish: Injiceres intramuskulært, gerne i halsregionen.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som, men ikke blandet med Merials dræbte vaccine mod rabies; dog på et andet administrationssted.
English: In rare occasions, swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks,
Danish: Hævelse på op til 15-20 cm i diameter (der kan vare i op til 2-3 uger)
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Indehaver af markedsføringstilladelsen og fremstiller af batchfrigivelse: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: For intramuscular use.
Danish: Til intramuskulær anvendelse.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Danish: I tilfælde af forøget infektionsrisiko eller utilstrækkelig colostrumoptagelse, kan der gives yderligere en injektion med ProteqFlu-Te ved 4 måneders alderen efterfulgt af det fulde vaccinationsprogram (basisvaccination ved 5-6 måneders alderen og 4-6 uger senere fulgt af revaccination).
English: Use immediately after opening.
Danish: Anvendes umiddelbart efter anbrud.
English: Duration of immunity induced by the vaccination scheme: - 5 months after the primary vaccination course; - after the primary vaccination course and the booster injection 5 months later: 1 year with regard to equine influenza and 2 years with regard to tetanus.
Danish: Varighed af immunitet opnået efter vaccinationsprogrammet: - 5 måneder efter basisvaccinationen - efter basisvaccination og revaccination 5 måneder senere er varigheden 1 år for beskyttelse mod heste influenza og 2 år for beskyttelse mod tetanus.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: B. BETINGELSER, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: • Keep out of the sight and reach of children.
Danish: • Opbevares utilgængeligt for børn.
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Danish: Vaccinestammerne vCP2242 og vCP3011 er rekombinant canarypox virus der afgiver hæmagglutinin HA genet fra hhv. influenza virusstammerne A/eq/Ohio/03 (amerikansk stamme, Florida undergruppe clade 1) og A/eq/Richmond/1/07 (amerikansk stamme, Florida undergruppe clade 2) hos hest.
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Danish: Administrer en dosis (1 ml) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: - Basisvaccination med ProteqFlu-Te: første injektion fra 5 - 6 måneders alderen, anden injektion 4-6 uger senere.
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Danish: Administrer en dosis (1 ml) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: - Basisvaccination med ProteqFlu-Te: første injektion fra 5-6 månedersalderen, anden injektion 4-6 uger senere.
English: ProteqFlu-Te Suspension for injection for horses
Danish: ProteqFlu-Te Suspension til injektion til hest.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp.
English: o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
Danish: • Efterfulgt af: o mod tetanus: injektion af 1 dosis ProteqFlu-Te med intervaller på højst 2 år o mod hesteinfluenza: årlig injektion af 1 dosis ProteqFlu eller ProteqFlu-Te, idet vaccinationsintervallet på højst 2 år skal respekteres for tetanuskomponenten.
English: Influenza A/eq/Ohio/03 [H3N8] recombinant Canarypox virus (vCP2242) ........... ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant Canarypox virus (vCP3011) ≥ 5.3 log10 FAID50* Clostridium tetani toxoid ......................................................................................................... ≥ 30 IU**
Danish: Influenza A/eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242) .............. ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinant canarypox virus (vCP3011) .. ≥ 5,3 log10 FAID50* Clostridium tetani toxoid........................................................................................................... > 30 IU**
English: Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Danish: Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt: Efter administration af overdosis af vaccinen, er der ikke observeret andre bivirkninger end de under ”Bivirkninger” beskrevet.
English: Influenza component: MERIAL
Danish: Influenza:
English: Veterinary medicinal product subject to prescription.
Danish: Lægemidlet må kun udleveres efter recept.
English: Intramuscular use
Danish: Intramuskulært.
English: Butyl elastomer closure and aluminium cap.
Danish: Butylelastomerprop med aluminiumshætte.
English: EXP
Danish: EXP{måned/år}
English: Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............ ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .
Danish: Influenza A/eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242) ............. ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinant canarypox virus (vCP3011) .. ≥ 5,3 log10 FAID50 * Clostridium tetani toxoid.......................................................................................................... .> 30 IU**
English: ProteqFlu-Te suspension for injection for horses
Danish: ProteqFlu-Te Injektionsvæske, suspension, til heste
English: PACKAGE LEAFLET FOR: ProteqFlu-Te suspension for injection for horses
Danish: INDLÆGSSEDDEL ProteqFlu-Te Injektionsvæske, suspension, til heste.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr: I tilfælde af selvinjektion ved hændeligt uheld skal De straks søge lægehjælp.
English: It is especially important to mention the following:
Danish: Det er især vigtigt, at du nævner følgende:
English: Frequency is based on annual rate.
Danish: Frekvensen er baseret på årlig rate.
English: Other side effects include: Very common
Danish: Andre bivirkninger omfatter: Meget almindelig
English: Patients at risk is the number of patients at risk at the beginning of the period.
Danish: Patienter i risiko er antallet af patienter i risiko ved periodens begyndelse.
English: Date of first authorisation: 16 January 2014 Date of latest renewal: 28 September 2018
Danish: Dato for første markedsføringstilladelse: 16. januar 2014 Dato for seneste fornyelse: 28. september 2018
English: It can also help prevent heart disease.
Danish: Det kan også hjælpe med at forebygge hjertesygdom.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Danish: Indtagelse af alkohol og lægemidler, der indeholder alkohol, skal undgås.
English: Time to first event was analysed in a Cox proportional hazards model.
Danish: Tid til første hændelse blev analyseret i en Cox proportional hazards-model.
English: • Take your tablet with food.
Danish: • Tag din tablet sammen med mad.
English: • Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner).
Danish: • Tag din tablet to gange dagligt, én gang om morgenen (morgenmad) og én gang om aftenen (aftensmad).
English: Take the medicine pack with you.
Danish: Tag lægemiddelpakningen med dig.
English: Your doctor will tell you exactly which strength of this medicine to take.
Danish: Din læge vil fortælle dig præcis hvilken styrke af dette lægemiddel, du skal tage.
English: The red blood cells most likely represent a secondary compartment of distribution.
Danish: Sandsynligvis repræsenterer de røde blodlegemer et sekundært fordelingskompartment.
English: < 30 Metformin is contraindicated.
Danish: < 30 Metformin er kontraindiceret.
English: Measure your blood sugar if possible and rest.
Danish: Mål dit blodsukker om muligt og hvil dig.
English: Your doctor may consider temporarily changing your treatment if you develop a serious infection.
Danish: Lægen kan overveje kortvarigt at ændre din behandling, hvis du udvikler en alvorlig infektion.
English: This medicine is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Danish: Dette lægemiddel frarådes til børn og unge under 18 år, da det ikke er blevet undersøgt hos disse patienter.
English: Results on primary and secondary endpoints are displayed in Figure 2.
Danish: Resultater på primære og sekundære endepunkter vises i figur 2.
English: Do not stop taking this medicine without talking to your doctor first.
Danish: Hold ikke op med at tage dette lægemiddel uden først at tale med din læge.
English: HR=Hazard ratio CI=Confidence interval.
Danish: HR=Hazard ratio CI=Konfidensinterval.
English: Similar reductions were observed at up to 104 weeks.
Danish: Tilsvarende reduktioner blev set i op til 104 uger.
English: Gastrointestinal symptoms i,§
Danish: Gastrointestinale symptomer i,§
English: Xigduo is contraindicated in patients with:
Danish: Xigduo er kontraindiceret til patienter med:
English: Diabetic ketoacidosis b,k,l
Danish: Diabetisk ketoacidose b,k,l
English: • Swallow the tablet whole with half a glass of water.
Danish: • Synk tabletten hel med et halvt glas vand.
English: • if you have ever had a diabetic coma.
Danish: - hvis du nogensinde har haft diabetisk koma.
English: To treat diabetes:
Danish: Til behandling af diabetes:
English: Dapagliflozin was rapidly and well absorbed after oral administration.
Danish: Dapagliflozin blev hurtigt og godt absorberet efter oral administration.
English: The mean age of the study population was 63.9 years, 37.4% were female.
Danish: Gennemsnitsalderen for studiepopulationen var 63,9 år, 37,4 % var kvinder.
English: • if you have a severe infection.
Danish: - hvis du har en alvorlig infektion.
English: Adverse reactions listed below are classified according to frequency and system organ class.
Danish: De nedenfor anførte bivirkninger er klassificeret efter hyppighed og systemorganklasse.
English: • This medicine is taken in combination with diet and exercise.
Danish: • Denne medicin tages i kombination med diæt og motion.
English: Do not take a double dose of this medicine to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis af dette lægemiddel som erstatning for den glemte dosis.
English: The events occurred evenly distributed over the study period.
Danish: Bivirkningerne forekom ligeligt fordelt over studieperioden.
English: The number of first events for the single components are the actual number of first events for each component and does not add up to the number of events in the composite endpoint.
Danish: Antallet af første hændelser for enkeltkomponenterne er det faktiske antal af første hændelser for hver komponent og svarer ikke til antallet af hændelser i det sammensatte endepunkt.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Danish: Efter en oral dosis er den tilsyneladende terminale eliminationshalveringstid ca. 6,5 timer.
English: This is to reduce the risk of side effects in the stomach.
Danish: Dette skal du gøre for at nedsætte risikoen for bivirkninger i maven.
English: • decreased vitamin B12 levels in the blood
Danish: • nedsatte vitamin B12-niveauer i blodet
English: In total, 22.4% had had diabetes for ≤ 5 years, mean duration of diabetes was 11.9 years.
Danish: I alt 22,4 % havde haft diabetes i ≤ 5 år, middelvarigheden af diabetes var 11,9 år.
English: • awakening from sleep at night to pass urine
Danish: • opvågning om natten for at lade vandet
English: Interaction with food
Danish: Interaktion med fødevarer
English: • if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
Danish: • hvis du har "type 1-diabetes" - den type, som sædvanligvis starter, når man er ung, og hvor kroppen overhovedet ikke producerer insulin.
English: P-values are all adjusted p-values for multiplicity.
Danish: P-værdierne er alle p-værdier justeret for multiplicitet.
English: This leads to a high level of sugar (glucose) in your blood.
Danish: Dette medfører højt indhold af sukker (glukose) i dit blod.
English: The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established.
Danish: Xigduos sikkerhed og virkning hos børn og unge i alderen 0 til < 18 år er endnu ikke klarlagt.
English: CI=confidence interval.
Danish: CI=konfidensinterval.
English: Do not use this medicine after the expiry date which is stated on the blister or carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren eller æsken efter ‘EXP'.
English: Both belong to a group of medicines called oral anti-diabetics.
Danish: Begge tilhører en gruppe medicin, der kaldes orale antidiabetika.
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke dette lægemiddel, hvis noget af ovennævnte gælder for dig.
English: Your doctor may ask you to stop taking this medicine.
Danish: Din læge kan bede dig om at stoppe med dette lægemiddel.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Danish: Den maksimale daglige dosis metformin bør helst fordeles på 2-3 daglige doser.
English: Your doctor will check your kidney function.
Danish: Lægen vil undersøge din nyrefunktion.
English: All randomised patients who took at least one dose of double-blind study medicinal product during the shortterm double-blind period.
Danish: Alle randomiserede patienter der tog mindst én dosis dobbelt-blindet studiemedicin under den kortvarige dobbelt-blinde periode.
English: Therefore, the use of this medicinal product is not recommended during the second and third trimesters of pregnancy.
Danish: Derfor anbefales det ikke at anvende dette lægemiddel i løbet af det andet og tredje trimester af graviditeten.
English: If you miss a dose, take it as soon as you remember.
Danish: Hvis du glemmer en dosis, så tag den så snart du kommer i tanker om det.
English: Do not drive or use any tools or machines, if you start to feel these symptoms.
Danish: Lad være med at køre i trafikken eller arbejde med værktøj eller maskiner, hvis du begynder at få disse symptomer.
English: If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated.
Danish: Hvis der opstår acidose af den ene eller anden form, skal behandlingen standses omgående, og der skal påbegyndes andre relevante, korrigerende forholdsregler.
English: No metabolites have been identified in humans.
Danish: Der er ikke identificeret metabolitter hos mennesker.
English: Figure 2: Treatment effects for the primary composite endpoints and their components, and the secondary endpoints and components
Danish: Figur 2: Behandlingsvirking for de primære sammensatte endepunkter og deres komponenter, og de sekundære endepunkter og komponenter
English: The most frequently reported adverse reactions across the clinical studies were genital infections.
Danish: Den hyppigste bivirkning på tværs af de kliniske studier var genitale infektioner.
English: Results at Week 24 (LOCF
Danish: Resultater ved uge 24 (LOCF
English: If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly.
Danish: Hvis du har type 2-diabetes producerer din bugspytkirtel ikke nok insulin, eller din krop er ikke i stand til at udnytte det insulin, den producerer, godt nok.
English: You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters (the last six months) of pregnancy.
Danish: Hold op med at tage dette lægemiddel, hvis du bliver gravid, da det ikke bør tages i andet og tredje trimester (de sidste seks måneder) af graviditeten.
English: (95% CI) Difference from metformin c
Danish: (95 % CI) Forskel fra metformin c
English: Diet and exercise
Danish: Diæt og motion
English: Film-coated tablet (tablet).
Danish: Filmovertrukne tabletter (tablet).
English: The mean Vd ranged between 63-276 l.
Danish: Middel-Vd varierede fra 63-276 l.
English: Xigduo should not be used to treat this condition.
Danish: Xigduo må ikke bruges til behandlling af denne sygdom.
English: LOCF: last observation (prior to rescue for rescued patients) carried forward.
Danish: LOCF: last observation carried forward (før behandling med rescue medicin).