FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been no adverse events in pigs, including suspected lack of expected efficacy reports during this period.
Danish: Der har ikke været nogen bivirkninger hos svin, herunder rapporter om formodning om manglende forventet virkning, i denne periode.
English: Data for some indications were absent, however, at the time of the Article 35 referral, there was no documented evidence in relation to suspected lack of expected efficacy of doxycycline products in chickens.
Danish: • Enteritis forårsaget af Clostridium perfringens og Clostridium colinum Der manglede data for nogle indikationer, men på tidspunktet for indbringelsen i henhold til artikel 35 var der ingen dokumentation i forbindelse med formodningen om manglende forventet virkning af doxycyclin-lægemidler hos kyllinger.
English: Applicant/ Marketing Authorisation Holder
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: A study investigated the safety of Doxycyline 50% WSP administered at dose rates of 0, 10, 50 and 150 mg doxycycline hyclate/kg body weight/day for 10 days.
Danish: I en undersøgelse af sikkerheden af Doxycyclin 50% WSP blev der givet doser på 0, 10, 50 og 150 mg doxycyclinhyclat/kg kropsvægt dagligt i 10 dage.
English: As data on calves presented in the dossier to support clinical data concern pre-ruminant calves, with a non clear rumen maturity for some studies presented in the dossier, and considering changes to the key pharmacokinetic parameters after i.v.
Danish: Da de data for kalve, der er fremlagt i dossieret til støtte for kliniske data, vedrører prædrøvtyggende kalve med en ubestemt udvikling af vommen i nogle af de undersøgelser, der blev fremlagt i dossieret, og i betragtning af ændringerne i de vigtigste farmakokinetiske parametre efter IV-indgivelse hos ikke-drøvtyggende i forhold til drøvtyggende kalve, og at der ikke er nogen klar sikkerhedsmargin, der kunne gøre det muligt at gennemgå den daglige dosis til kalve, skal den dyreart, som lægemidlet er beregnet til, tydeligt angives som præ-drøvtyggende kalve.
English: Poland Dopharma B.V. Zalmweg 24
Danish: Dopharma B.V Zalmweg 24
English: Calves, pigs, chicken
Danish: Kalve, kyllinger, svin
English: A study investigated the safety of Doxycyline 50% WSP administered at doses of 0, 25 and 75 mg doxycycline hyclate/kg body weight /day for 5 days.
Danish: En undersøgelse blev udført af sikkerheden af Doxycyclin 50% WSP givet i doser på 0,25 og 75 mg doxycyclinhyclat/kg kropsvægt dagligt i 5 dage.
English: ADVICE ON CORRECT ADMINISTRATION For the administration through the drinking water, the exact daily amount of product should be calculated, based on the recommended dose, and the number and weight of the animals to be treated, according to the following formula: mg product / kg body weight / day x
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Ved dosering gennem drikkevandet skal den præcise daglige mængde produkt beregnes baseret på den anbefalede dosis og antallet og vægten af de dyr, der skal behandles, i henhold til følgende formel:
English: There have been no adverse events in calves, including suspected lack of expected efficacy reports during this period.
Danish: Der har ikke været nogen bivirkninger hos kalve, inklusive rapporter formodning om manglende forventet virkning, i denne periode.
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the reach and sight of children.
Danish: TEKSTEN "OPBEVARES UTILGÆNGELIGT FOR BØRN" Opbevares utilgængeligt for børn.
English: 6 Pijpers A., Prophylaxis of pleuropneumonia by doxycycline in-feed medication in pigs, Feed Medication with Tetracyclines in Pigs, 125-143 (1990)
Danish: Medication with Tetracyclines in Pigs, 85-103 (1990) 6 Pijpers A., Prophylaxis of pleuropneumonia by doxycycline in-feed medication in pigs, Feed Medication with
English: • Target species;
Danish: • Doseringer;
English: Lactose
Danish: Dyreart
English: 25 mg doxycycline hyclate /kg body weight / day, corresponding to 50 mg of product per kg body weight, for 3-5 consecutive days.
Danish: 25 mg doxycyklin hyclat pr. kg legemsvægt pr. dag, svarende til 50 mg produkt pr. kg legemsvægt, 3-5 dage i træk.
English: Doxycycline hyclate 500 mg/g (equivalent to doxycycline 433 mg/g)
Danish: 500 mg/g (svarer til 433 mg/g doxycyklin)
English: Doxycycline hyclate: 500 mg (equivalent to 433 mg doxycycline) Excipients:
Danish: 500 mg (svarer til 433 mg doxycyklin)
English: 10 mg doxycycline hyclate /kg body weight / day, corresponding to 20 mg of product per kg body weight, for 3-5 consecutive days.
Danish: 10 mg doxycyklin hyclat pr. kg legemsvægt pr. dag, svarende til 20 mg produkt pr. kg legemsvægt, 3-5 dage i træk.
English: Marketing authorisation holder: Dopharma Research B.V. Zalmweg 24
Danish: Indehaver af markedsføringstilladelsen: Dopharma Research B.V.
English: Water Soluble Powder Cattle (calves), swine, birds
Danish: Kvæg (kalve), svin, fugle
English: Pre-ruminant calves: 10 mg doxycycline hyclate /kg body weight / day, corresponding to 20 mg of product per kg body weight, for 3-5 consecutive days, divided over 2 administrations.
Danish: Kalve inden den drøvtyggende alder: 10 mg doxycyklin hyclat pr. kg legemsvægt pr. dag, svarende til 20 mg produkt pr. kg legemsvægt, 3-5 dage i træk fordelt på 2 doseringer.
English: Water Soluble Powder Non-ruminating calves Pigs
Danish: Kalve inden den drøvtyggende alder, svin, ikke-æglæggende fjerkræ
English: Water Soluble Powder Calves, pigs, poultry
Danish: Pulver til oral opløsning Kalve, svin, fjerkræ
English: Calves, pigs and poultry
Danish: Kalve, svin, fjerkræ
English: Residue depletion data in chickens support a meat withdrawal period of 5 days when chicken are administered at 25 mg doxycycline hyclate/kg body weight/day for 5 days.
Danish: Restkoncentrationsdata hos kyllinger støtter en tilbageholdelsesperiode på 5 dage, når kyllinger får 25 mg doxycyclinhyclat/kg kropsvægt dagligt i 5 dage.
English: Residue depletion data in pigs support a meat withdrawal period of 8 days when pigs are administered at 10 mg doxycycline hyclate/kg body weight/day for 5 days.
Danish: Restkoncentrationsdata hos svin understøtter en tilbageholdelsesperiode på 8 dage, når svin får 10 mg doxycyclinhyclat/kg kropsvægt dagligt i 5 dage.
English: Residue depletion data in calves support a meat withdrawal period of 7 days when calves are administered at 5 mg doxycycline hyclate/kg body weight, twice a day for 5 days.
Danish: Restkoncentrationsdata hos kalve støtter en tilbageholdelsesperiode på 7 dage, når kalve får 5 mg doxycyclinhyclat/kg kropsvægt to gange dagligt i 5 dage.
English: Summary of product characteristics, labelling and package leaflet
Danish: Bilag III Produktresume og indre emballage
English: 6.5 Nature and composition of immediate packaging White polypropylene container of 1000 g, covered with a low-density polyethylene lid. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: Water Soluble Powder Calves, chicken, pigs
Danish: Pulver til oral opløsning Kalve, svin, kyllinger
English: The chicken meat residue depletion data available support a meat withdrawal period of 5 days when chicken are administered 25 mg doxycycline hyclate/kg body weight/day for 5 days.
Danish: De tilgængelige restkoncentrationsdata i kyllingekød støtter en tilbageholdelsesperiode på 5 dage, når 25 mg doxycyclinhyclat/kg kropsvægt gives dagligt til kyllinger i 5 dage.
English: The calf meat residues depletion data available support a meat withdrawal period of 7 days when calves are administered 5 mg doxycycline hyclate/kg body weight twice a day for 5 days.
Danish: De tilgængelige restkoncentrationsdata i kalvekød støtter en tilbageholdelsesperiode på 7 dage, når 5 mg doxycyclinhyclat/kg kropsvægt gives to gange dagligt til kalve i 5 dage.
English: The pig meat residue depletion data available support a meat withdrawal period of 8 days when pigs are administered 10 mg doxycycline hyclate/kg body weight/day for 5 days.
Danish: De tilgængelige restkoncentrationsdata i svinekød støtter en tilbageholdelsesperiode på 8 dage, når 10 mg doxycyclinhyclat/kg kropsvægt gives dagligt til svin i 5 dage.
English: Pre-ruminant calves, pigs, chickens.
Danish: Kyllinger (slagtekyllinger), kalve, svin
English: TARGET SPECIES Pre-ruminant calves, pigs and chickens
Danish: DYREARTER Kalve inden den drøvtyggende alder, svin og kyllinger.
English: Date of first authorisation: 15 November 2013 Date of latest renewal: 26 July 2018
Danish: Dato for første markedsføringstilladelse: 15. november 2013 Dato for seneste fornyelse: 26. juli 2018
English: * Toe and midfoot † Ankle, below knee and above knee
Danish: * Tå og mellemfod † Ankel, under knæ og over knæ
English: Figure 2: Treatment Effect for the Primary Composite Endpoint and its Components
Danish: Figur 2: Behandlingseffekt for det primære komposit endepunkt og dets komponenter
English: • if you have type 1 diabetes because Invokana should not be used to treat this condition.
Danish: • hvis du har type 1-diabetes, da Invokana ikke må anvendes til behandling af denne sygdom.
English: • about what you can do to prevent dehydration (see section 4 for signs of dehydration).
Danish: • for at få at vide, hvad du kan gøre for at forebygge dehydrering (se punkt 4 for tegn på dehydrering).
English: Figure 1: Time to First Occurrence of MACE
Danish: Tid til første forekomst af MACE
English: Your doctor may prescribe Invokana together with another glucose-lowering medicine.
Danish: Din læge kan ordinere Invokana sammen med et andet glucosesænkende lægemiddel.
English: These studies were multicenter, multi-national, randomised, double-blind, parallel group, with similar inclusion and exclusion criteria and patient populations.
Danish: Disse studier var multicenter, multinationale, randomiserede, dobbeltblinde, med parallelle grupper og med sammenlignelige kriterier for inklusion og eksklusion og patientpopulationer.
English: ATC code: A10BK02.
Danish: ATCkode: A10BK02.
English: This reduces the amount of sugar in your blood and can help prevent heart disease.
Danish: Derved nedsættes mængden af sukker i blodet, hvilket kan medvirke til at forebygge hjertesygdomme.
English: Note: Incidence is based on the number of patients with at least one amputation, and not the total number of amputation events.
Danish: : Incidens er baseret på antal patienter med mindst én amputation og ikke det samlede antal amputationer.
English: Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include:
Danish: Alvorlig allergisk reaktion (sjælden, kan berøre op til 1 ud af 1.000 personer) Mulige tegn på en alvorlig allergisk reaktion kan omfatte:
English: The racial distribution was 72% White, 16% Asian, 5% Black, and 8% other groups.
Danish: Racemæsssigt fordelte de sig med 72 % hvide, 16 % asiater, 5 % sorte og 8 % andre grupper.
English: The MACE findings in this subgroup were consistent with the overall findings.
Danish: MACE-fundene i denne undergruppe var foreneligt med de samlede fund.
English: Invokana is used in adults to treat type 2 diabetes.
Danish: Invokana anvendes hos voksne til at behandle type 2-diabetes.
English: • increased levels of “ketone bodies” in your urine or blood
Danish: • forhøjet niveau af “ketonstoffer” i urinen eller blodet
English: Stop taking Invokana and talk to a doctor or go to the nearest hospital immediately if you have any of the following serious side effects:
Danish: Stop med at tage Invokana, og kontakt din læge, eller tag øjeblikkeligt til det nærmeste hospital, hvis du får en af følgende alvorlige bivirkninger:
English: • if you have ever had serious heart disease or if you have had a stroke.
Danish: • hvis du nogensinde har lidt af alvorlig hjertesygdom eller har haft et slagtilfælde.
English: If Fournier's gangrene is suspected, Invokana should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Invokana seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: • if you have severe liver problems.
Danish: • hvis du har alvorlige leverproblemer.
English: Treatment with canagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Danish: Behandlingen med canagliflozin kan genoptages, når ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: • if you have severe kidney problems or are on dialysis.
Danish: • hvis du har alvorlige nyreproblemer eller er i dialyse.
English: As precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Danish: Som en forebyggende foranstaltning bør det overvejes at overvåge patienter med øget risiko for amputation tæt og at rådgive patienterne om vigtigheden af rutinemæssig forebyggende fodpleje og opretholdelse af passende hydrering.
English: Patients had an overall mean age of 59.5 years (range 21 years to 96 years), with 3,135 patients ≥ 65 years of age and 513 patients ≥ 75 years of age.
Danish: Patienternes samlede gennemsnitsalder var 59,5 år (interval 21 år til 96 år), med 3.135 patienter i alderen ≥ 65 år og 513 patienter ≥ 75 år.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: A total of 10,501 patients with type 2 diabetes participated in ten double-blind, controlled clinical efficacy and safety studies conducted to evaluate the effects of Invokana on glycaemic control.
Danish: I alt 10.501 patienter med type 2 diabetes deltog i ti dobbeltblinde, kontrollerede kliniske studier af sikkerhed og virkning for at evaluere Invokanas virkninger på glykæmisk kontrol.
English: - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes.
Danish: - som monoterapi når metformin ikke bør anvendes på grund af intolerans eller kontraindikationer - sammen med andre lægemidler til behandling af diabetes.
English: Diabetic ketoacidosis b,h
Danish: Diabetisk ketoacidose b,h
English: Renal Endpoints
Danish: Renale endepunkter
English: Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
Danish: Invokana er indiceret til behandling af voksne med utilstrækkeligt kontrolleret type 2-diabetes mellitus som supplement til diæt og motion:
English: If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital immediately.
Danish: Hvis du har taget mere af dette lægemiddel end du burde, kontakt da din læge eller tag øjeblikkeligt til det nærmeste hospital.
English: Invokana should not be used to treat this condition.
Danish: Invokana må ikke anvendes til behandling af denne sygdom.
English: Sixty-six percent of subjects had a history of established cardiovascular disease, with 56% having a history of coronary disease, 19% with cerebrovascular disease, and 21% with peripheral vascular disease; 14% had a history of heart failure.
Danish: Seksogtres procent af forsøgspersonerne havde en anamnese med etableret kardiovaskulær sygdom, med 56 % med en anamnese med koronar hjertesygdom, 19 % med cerebrovaskulær sygdom og 21 % med perifer vaskulær sygdom; 14 % havde en anamnese med hjertesvigt.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2):
Danish: Diabetisk ketoacidose (sjælden, kan berøre op til 1 ud af 1.000 personer) Symptomerne på diabetisk ketoacidose (se også punkt 2) er:
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dL).
Danish: I en række af disse tilfælde fremstod tilstanden atypisk med kun moderat forhøjet blodglucose, under 14 mmol/l (250 mg/dl).
English: It is also important to keep following advice about diet and exercise given by your doctor or nurse.
Danish: Det er også vigtigt, at du altid følger de råd om kost og motion, som du får af din læge eller sygeplejersken
English: Effects of canagliflozin on other medicinal products
Danish: Canagliflozins indvirken på andre lægemidler
English: Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Croscarmellosenatrium Magnesiumstearat
English: Poly(vinylalcohol) Titanium dioxide (E171) Macrogol 3350
Danish: Poly(vinylalkohol) Titandioxid (E171) Macrogol 3350
English: Before initiating Invokana, consider factors in the patient history that may increase the risk for amputation.
Danish: Før behandling med Invokana initieres, skal faktorer i patientens anamnese, som kan forøge risikoen for amputation, tages i betragtning.
English: Balanitis or balanoposthitis b,l
Danish: Balanitis eller balanopostitis b,l
English: Vulvovaginal candidiasis b,k common
Danish: Vulvovaginal candidiasis b,k
English: Consideration may also be given to stopping treatment with Invokana in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Danish: Det kan også overvejes at stoppe behandlingen med Invokana hos patienter, der udvikler lidelser, der kan være forløbere for amputation, som f.eks. sår på underekstremitet, infektion, osteomyelitis eller gangræn.
English: , Blood phosphate increased
Danish: , forhøjet phosphat i blodet
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Invokana, and during treatment:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Invokana og under behandlingen:
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Effects of other medicinal products on canagliflozin
Danish: Andre lægemidlers indvirken på canagliflozin
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N = 12,441) of patients from 13 controlled phase 3 and phase 4 studies including both doses of canagliflozin was conducted.
Danish: Til vurdering af risikofaktorerne for disse bivirkninger blev der gennemført en større puljet analyse (N = 12.441) af patienter fra 13 kontrollerede fase 3- og fase 4-studier, der omfattede begge doser canagliflozin.
English: Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe and midfoot amputations).
Danish: Visse studier peger på, at det at tage canagliflozin kan bidrage til risikoen for amputation af en underekstremitet (primært amputation af tå og mellemfod).
English: Invokana contains sodium
Danish: Invokana indeholder natrium
English: • The other ingredients are: tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose (see section 2 ‘Invokana contains lactose'), magnesium stearate, and microcrystalline cellulose film-coating: macrogol 3350, poly(vinylalcohol), talc, and titanium dioxide (E171).
Danish: • Øvrige indholdsstoffer: tabletkerne: croscarmellosenatrium, hydroxypropylcellulose, lactose (se punkt 2 ”Invokana indeholder lactose”), magnesiumstearat og mikrokrystallinsk cellulose filmovertræk: macrogol 3350, poly(vinylalkohol), talcum og titandioxid (E171).
English: Incidence rate (per 100 subject-years) 0.34 HR (95% CI) vs. placebo Minor Amputation, n (%) Major Amputation, n (%)
Danish: Incidensrate (pr. 100 forsøgspersonsår) HR (95 % CI) vs. placebo Mindre amputation, n (%) Større amputation, n (%)
English: In the dedicated cardiovascular study and the larger pooled analysis, discontinuations due to adverse reactions related to volume depletion and serious adverse reactions related to volume depletion were not increased with canagliflozin.
Danish: I det dedikerede kardiovaskulære studie og den større puljede analyse steg antallet af seponeringer på grund af bivirkninger relateret til volumendepletering og alvorlige bivirkninger relateret til volumendepletering ikke ved behandling med canagliflozin.
English: The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 83.5 litres, suggesting extensive tissue distribution.
Danish: Canagliflozins gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs infusion til raske forsøgspersoner var 83,5 liter, hvilket tyder på omfattende fordeling i væv.
English: Related to bone fracture; see description of AR below.
Danish: Relateret til knoglebrud, se beskrivelse af bivirkninger nedenfor.
English: • blood tests may show changes in blood fat (cholesterol) levels and increases in amount of red blood cells in your blood (haematocrit).
Danish: • blodprøver kan vise ændringer i blodets fedtindhold (kolesteroltal) og et øget antal røde blodlegemer i blodet (hæmatokrit).
English: • medicines used to lower your blood pressure (anti-hypertensives), including diuretics
Danish: • lægemidler til at sænke blodtrykket (antihypertensiva), herunder vanddrivende midler
English: • a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: • din ånde lugter sødligt, du har en sødlig eller metallisk smag i munden, eller din urin eller sved lugter anderledes
English: Table 2: Integrated Analysis of Amputations in CANVAS AND CANVAS-R Placebo
Danish: Tabel 2: Integreret analyse af amputationer i CANVAS OG CANVAS-R Placebo N = 4344
English: Medicinal product/Laboratory test interference
Danish: Interferens med lægemiddel/laboratorietest
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Danish: Risikoen for diabetisk ketoacidose skal overvejes i tilfælde af ikke-specifikke symptomer som f.eks. kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, forvirring samtusædvanlig træthed eller søvnighed.
English: Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Danish: Hver tablet indeholder mindre end 1 mmol natrium (23 mg) og er i det væsentlige natriumfri.
English: Use in patients at risk for adverse reactions related to volume depletion
Danish: Anvendelse til patienter med risiko for bivirkninger, der er forbundet med volumendepletering
English: Table 4: Efficacy results from active-controlled clinical studies Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Danish: Tabel 4: Effektresultater fra aktivt kontrollerede kliniske studier Sammenlignet med glimepirid som dobbeltbehandling med metformin (52 uger) Canagliflozin + metformin Glimepirid (titreret) + metformin (N = 482)
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Danish: • lavt blodsukker (hypoglykæmi) - når dette lægemiddel tages sammen med insulin eller et sulfonylurinstof (såsom glimepirid eller glipizid).