FrancophonIA/ELRC3.0 huggingface dataset:
English: 44 mg (equivalent to 31.42 mg oxalic acid)
Danish: 44 mg (svarende til 31,42 mg oxalsyre)
English: Accidental ingestion may cause adverse reactions.
Danish: Utilsigtet indtagelse kan medføre uønskede virkninger.
English: Honey bees
Danish: Antal bier
English: − Personal protective equipment consisting of protective clothing, acid-resistant gloves and glasses should be worn when handling the veterinary medicinal product.
Danish: − Ved håndtering af veterinærlægemidlet bør anvendes personlige værnemidler bestående af beskyttelsesdragt, syrebestandige handsker og beskyttelsesbriller.
English: Treatment should be conducted as soon as possible in late summer/early autumn with decreasing colony population,
Danish: Behandlingen gives tidligst muligt i sensommeren/begyndelsen af efteråret ved faldende antal individer i familien, og når det naturlige nedfald
English: ROUTE(S) OF ADMINISTRATION In-hive use.
Danish: INDGIVELSESVEJ(E) Til anvendelse i bistader.
English: No of applications
Danish: INGEN ANGIVELSE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees
Danish: VETERINÆRLÆGEMIDLETS NAVN VarroMed, 5 mg/ml + 44 mg/ml, bistadedispersion
English: up to 5x possible in late summer/early autumn with decreasing colony population, and when the natural mite fall is more than 4 mites per day.
Danish: Behandlingen gives tidligst muligt i sensommeren/begyndelsen af efteråret ved faldende antal individer i familien, og når det naturlige nedfald af mider er over 4 mider pr. dag.
English: Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 10% solution of oxalic acid dihydrate in 50% sugar solution, permanent lesions in digestive and excretory organs were noted after 72 hours (h).
Danish: Ved påføring af en 10 % opløsning af oxalsyre, dihydrat, i 50 % sukkeropløsning er der bemærket blivende forandringer i fordøjelsessystem og ekskretionsorganer efter 72 timer.
English: Formic acid /oxalic acid dihydrate
Danish: Myresyre/oxalsyre, dihydrat
English: The treatment should be repeated twice more (that is to a maximum of 3 treatments), if more than 10 mites are detected on the floorboard within 6 days after the first treatment (maximum of 3 treatments).
Danish: Hvis der findes flere end 10 mider på bundbrættet inden for 6 dage efter første behandling, gentages behandlingen to gange (dvs. i alt højst 3 behandlinger).
English: Oxalic acid dihydrate
Danish: Oxalsyre, dihydrat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees
Danish: VETERINÆRLÆGEMIDLETS NAVN VarroMed, 75 mg + 660 mg, bistadedispersion
English: 4.9 Amounts to be administered and administration route In-hive use.
Danish: 4.9 Dosering og indgivelsesvej Til anvendelse i bistader.
English: Citric acid monohydrate Purified water
Danish: Citronsyremonohydrat
English: 44 mg (equivalent to 31.42 mg oxalic acid anhydrous)
Danish: 44 mg (svarende til 31,42 mg oxalsyre, vandfri)
English: No. of applications
Danish: ANVENDELSE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed bee-hive dispersion for honey bees Formic acid / oxalic acid dihydrate
Danish: VarroMed bistadedispersion Myresyre/oxalsyre, dihydrat
English: WITHDRAWAL PERIOD(S) Honey: Zero days.
Danish: 10. TILBAGEHOLDELSESTID Honning: Nul dage.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion Formic acid/oxalic acid dihydrate
Danish: VarroMed 75 mg + 660 mg bistadedispersion Myresyre/oxalsyre, dihydrat
English: 5 mg/ml Oxalic acid dihydrate 44 mg/ml
Danish: VarroMed 5 mg/ml + 44 mg/ml bistadedispersion Myresyre/oxalsyre, dihydrat
English: Opened sachets should not be stored.
Danish: Opbevares utilgængeligt for børn.
English: decreasing colony population, and when the natural mite fall is more than 4 mites per day.
Danish: sensommeren/først på efteråret ved aftagende antal individer i familien, og når det naturlige nedfald af mider er over 4 mider pr. dag.
English: PHARMACEUTICAL FORM Bee-hive dispersion
Danish: LÆGEMIDDELFORM Bistadedispersion
English: Formic acid
Danish: Myresyre
English: WITHDRAWAL PERIOD(S) Withdrawal period(s) (honey): zero days.
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid (honning): Nul dage.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG
English: Patients with cancer
Danish: Patienter med cancer
English: It may be necessary to monitor your blood.
Danish: Det kan blive nødvendigt, at kontrollere dit blod.
English: Approximately 10% of patients can be expected to experience an adverse drug reaction.
Danish: Cirka 10 % af patienterne kan forventes at opleve en utilsigtet lægemiddelreaktion.
English: PACKAGE LEAFLET - INFORMATION FOR THE USER
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: If someone else is injecting for you, they can also use the back of your arms.
Danish: Hvis en anden udfører injektionen, kan du også anvende bagsiden af dine arme.
English: If these reactions occur they require the immediate attention of a physician and intensive medical care.
Danish: Hvis disse reaktioner opstår, kræver de omgående tilsyn af en læge og intensiv medicinsk behandling.
English: If it occurs, appropriate dose adjustment should be made as provided.
Danish: Hvis det forekommer, skal hensigtsmæssig dosisjustering gennemføres som foreskrevet.
English: A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Danish: Der blev også udført en systematisk undersøgelse med mere end 9000 kræftpatienter, der deltog i 57 kliniske forsøg.
English: Pull straight.
Danish: Træk lige.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Dypeno videre til andre.
English: Your doctor will consider what is the best treatment for you during your pregnancy.
Danish: Din læge vil nøje overveje den mest egnede behandling for Dem under graviditeten.
English: The expiry date refers to the last day of the month.
Danish: Udløbsdatoen er den sidste dag i den pågældende måned.
English: Do not take a double dose to make up for a forgotten individual dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for glemte enkeltdoser.
English: Check that it is the correct dose that your doctor has prescribed.
Danish: Kontroller, at det er den korrekte dosis, som din læge har ordineret.
English: Pregnancy: Animal studies are insufficient with respect to effects on pregnancy (see section 5.3).
Danish: Graviditet: Dyreforsøg er utilstrækkelige med hensyn til virkningen ved graviditet (se pkt.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden du begynder at tage medicinen.
English: Do not warm Dynepo in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Dynepo må ikke opvarmes på nogen anden måde (den må f.eks. ikke opvarmes i mikrobølgeovn eller i varmt vand).
English: Your doctor or nurse will tell you how much Dynepo you need and how frequently it should be injected.
Danish: Din læge eller sygeplejerske vil fortælle dig, hvor meget Dynepo, du har brug for, og hvor ofte den skal injiceres.
English: An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use except that routine updates of the Risk Management Plan should be provided yearly until the start of the three-yearly PSUR cycle.
Danish: Der bør gives adgang til en opdateret Risikostyringsplan i henhold til CHMP's retningslinje for risikostyringssystemer for lægemidler til humant brug, medmindre der bør gives adgang til rutinemæssige opdateringer af Risiko-styringsplanen årligt indtil den 3-års PSUR cyklus påbegyndes.
English: Epoetin delta can then be reintroduced with a lower dosage (see section 4.2).
Danish: Derefter kan epoetin delta atter introduceres i en lavere dosis (se afsnit 4.2).
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forholdsregler vedrørende brug
English: Half life is approximately 50% shorter in healthy subjects.
Danish: Halveringstiden er ca. 50 % kortere i raske.
English: Dynepo may also cause changes in the composition of your blood.
Danish: Dynepo kan også være årsag til ændringer i dit blods sammensætning.
English: Like all medicines, Dynepo can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Dynepo have bivirkninger, selvom ikke alle får bivirkninger.
English: The target haemoglobin concentration in two studies was >13 g/dL; in the remaining three studies it was 12-14 g/dL.
Danish: Den tilsigtede hæmoglobinkoncentration i to undersøgelser var > 13 g/dl; i de resterende tre undersøgelser var den på 12-14 g/dl.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Danish: To af forsøgene rekrutterede patienter, der blev behandlet med kemoterapi.
English: No special dosage adjustments are required in elderly patients.
Danish: Dosisjustering er ikke påkrævet hos ældre patienter.
English: • Malignant diseases including multiple myeloma and myelodysplastic syndrome
Danish: • Maligne sygdomme, inklusiv multiple myelom og myelodysplastisk syndrom.
English: In case of its use during pregnancy, concomitant iron substitution should be considered in the mother.
Danish: I tilfælde af anvendelse under graviditet, bør samtidigt jerntilskud til moderen overvejes.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke forsøger at give dig selv injektionen, medmindre du har modtaget særlig oplæring hos din læge eller sygeplejerske.
English: Your doctor or nurse will show you how to inject yourself.
Danish: Din læge eller sygeplejerske vil vise dig, hvordan du selv foretager injektionen.
English: Because of the time required for erythropoiesis, an interval of approximately 4 weeks may occur between the time of a dose adjustment (initiation, increase, decrease or discontinuation) and a significant change in haemoglobin.
Danish: På grund af den tid som er nødvendig for erythropoiesis, kan der opstå et interval på ca. 4 uger mellem tidspunktet for dosisjusteringen (start, forhøjelse, nedsættelse eller ophør) og en markant ændring i hæmoglobin.
English: This may be associated with life-threatening cardiovascular complications.
Danish: Dette kan føre til livstruende, kardiovaskulære komplikationer.
English: The elimination half-life ranges from 4.7 to 13.2 hours in patients.
Danish: Elimineringshalveringstiden er i patienter fra 4,7 til 13,2 timer.
English: The most frequent side effects observed (in 1% to 10% of patients) with Dynepo are: - increase in blood pressure.
Danish: De mest almindelige bivirkninger der er observeret (hos 1 % til 10 % af patienterne) i forbindelse med Dynepo er: - en stigning i blodtrykket.
English: Dynepo should not be used by healthy persons.
Danish: Dynepo må ikke anvendes af raske personer.
English: It could be a consequence of a marked rise in your blood pressure.
Danish: Dette kan nemlig skyldes en kraftig stigning i dit blodtryk.
English: Only use each syringe for one injection.
Danish: Brug kun hver injektionssprøjte til én injektion.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Danish: I de fire placebokontrolgruppeforsøg lå hazard ratio for generel overlevelse på mellem 1,25 og 2,47, til fordel for kontrolgruppen.
English: It is recommended that a complete blood count and platelet count is performed regularly.
Danish: Det anbefales at udføre en komplet blodtælling og trombocyttælling regelmæssigt.
English: This is the most common cause of an incomplete response to an erythropoietin therapy.
Danish: Dette er den mest almene årsag til en mangelfuld respons på erytropoietinbehandling.
English: Epoetin delta is produced in human cells (HT-1080) by gene-activation technology.
Danish: Epoetin delta fremstilles i human celler (HT-1080) ved hjælp af genaktiveringsteknologi.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8167 patients).
Danish: Meta-analyse af generelle overlevelsesdata frembragte et punktestimat på 1,08 til fordel for kontrolgrupper (95 % CI: 0,99, 1,18; forsøg og 8167 patienter).
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Danish: Symptomer på anæmi og følgesygdomme kan variere efter alder, køn og den generelle sygdomsbelastning; det er nødvendigt at få en læges vurdering af den individuelle patients kliniske forløb og tilstand.
English: Dynepo contains less than 1mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
Danish: Dynepo indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er reelt "natriumfrit".
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Danish: Der blev observeret en øget relativ risiko for tromboemboliske hændelser (RR 1,67, 95 % CI: 1,35, 2,06, 35 forsøg og 6769 patienter) hos patienter, der blev behandlet med rekombinant, human erythropoietin.
English: 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
Danish: 6.6 Regler for bortskaffelse af et brugt lægemiddelprodukt eller affaldsmaterialer fra et sådant produkt samt anden håndtering af produktet
English: Your doctor will probably not make changes to your dosage more than once a month.
Danish: Din læge vil sikkert ikke ændre din dosis mere end én
English: Polycythaemia Thrombocytosis
Danish: Polycytæmi Trombocytose
English: Survival and tumour progression have been examined in five large controlled studies of epoetin alfa, beta and darbepoetin alfa involving a total of 2,833 patients, of which four were double-blind placebocontrolled studies and one was an open-label study.
Danish: Overlevelse og tumorudvikling er blevet undersøgt i fem store kontrollerede forsøg med epoetin alfa,beta og darbepoetin alfa, med 2833 involverede patienter, hvoraf fire var dobbeltblindede placebokontrollerede forsøg, og et var en ublindet forsøg.
English: You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection.
Danish: Du skal give sig selv en injektion i vævet under huden, en såkaldt subkutan injektion.
English: If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to decrease the haemoglobin level.
Danish: Hvis alvorlig polycytæmi opstår, kan konventionelle metoder (flebotomi) være indiceret for at nedsætte
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Virkninger i ikke-kliniske forsøg blev kun observeret ved eksponering, der anses for tilstrækkeligt meget højere end den maksimale, humane eksponering, hvilket indikerer ringe relevans for den kliniske anvendelse.
English: Your doctor may decide that it would be best for you to inject Dynepo yourself.
Danish: Din læge kan eventuelt beslutte, at det vil være bedst for dig at injicere Dynepo selv.
English: During Dynepo therapy, absolute or functional iron deficiency may develop.
Danish: Under Dynepo-behandling kan absolut eller funktionel jernmangel opstå.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Erythropoietinreceptorer kan udtrykkes på overfladen af tumorceller.
English: Administer the amount required..
Danish: Injicér den krævede mængde.
English: If the suggested target range is exceeded, treatment with epoetin delta should be temporarily withdrawn until the haemoglobin/haematocrit returns to the suggested target range.
Danish: Hvis det foreslåede målområde overskrides, skal behandling med epoetin delta ophøre midlertidigt, indtil hæmoglobin/hæmatokrit vender tilbage til den foreslåede målområde.
English: Your blood pressure needs to be checked closely before and during treatment with Dynepo.
Danish: Deres blodtryk skal nøje kontrolleres før og under behandling med Dynepo.
English: Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications like hypertensive encephalopathy and related complications (seizures, stroke).
Danish: Blodtrykket skal være tilstrækkeligt under kontrol inden påbegyndelse og under behandling, for at forebygge akutte komplikationer, såsom hypertensiv encefalopati og relaterede komplikationer (krampeanfald, slagtilfælde).
English: In addition, a reduction of the administered dose of Dynepo needs to be considered.
Danish: Endvidere er det nødvendigt at overveje en reduktion af den administrerede dosis Dynepo.
English: Animal studies conducted with both Dynepo and epoetin alfa in pregnant female rats and rabbits did not show any teratogenic effect, but indicated class-related reversible effects on growth and haematopoiesis in the offspring.
Danish: Dyreforsøg, der blev gennemført med både Dynepo og epoetin-alfa hos drægtige rotter og kaniner viste ingen teratogen virkning, men indikerede klasse-relateret, reversibel effekt på vækst og hæmatopoiese hos afkommet.
English: Following intravenous doses, volume of distribution approximates total blood volume and ranges from 0.063 to 0.097 l/kg.
Danish: Efter intravenøs dosering svarer fordelingsvolumen omtrentligt til den totale blodvolumen og ligger på mellem 0,063 til 0,097 l/kg.
English: Diarrhoea Nausea Pruritus
Danish: Diarré Kvalme Pruritus
English: Inform your doctor if you are pregnant or breast-feeding or think you might be pregnant.
Danish: Kontakt din læge, hvis du er gravid, ammer eller har en mistanke om, at du er gravid.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in Section 4.2.
Danish: Hos patienter med kronisk nyresvigt må den vedligeholdende hæmaglobinkoncentration ikke overskride den øvre grænse for den tilsigtede hæmoglobinkoncentration, der anbefales i afsnit 4.2.
English: Check the appearance of Dynepo.
Danish: Kontroller, hvordan Dynepo ser ud.
English: It may not be necessary to use erythropoietin during the first three months after starting peritoneal dialysis because an increase in haemoglobin often occurs during this period.
Danish: Det er ikke sikkert, at anvendelse er nødvendig de første 3 måneder efter start af peritoneal dialyse, da en stigning i hæmoglobin ofte forekommer i denne periode.
English: Other side effects that occur less frequently (in 0.1% to 1% of patients) include itching, pain, reaction at the site of injection (such as soreness and bleeding), flu-syndrome, diarrhoea, nausea.
Danish: Andre bivirkninger som forekommer mindre hyppigt (hos 0,1 % til 1 % af patienterne) kan være kløe, smerte, reaktioner på injektionsstedet (så som ømhed og blødning), influenzalignende symptomer, diarre, kvalme.
English: Change the place that you inject each time so you don't become sore in one area.
Danish: Skift injektionssted hver gang, så du ikke bliver øm i det pågældende område.
English: No accumulation of epoetin delta was observed after repeated intravenous administration three times weekly.
Danish: Ingen akkumulation af epoetin delta blev observeret efter gentagne intravenøse administreringer tre gange
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Danish: Erythropoietin er en vækstfaktor, der primært stimulerer produktionen af røde blodlegemer.
English: The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
Danish: Hæmoglobinniveauet bør bestemmes 1 gang om ugen, indtil den har stabiliseret sig i det foreslåede målområde, og vedligeholdelsesdosen er blevet etableret.
English: The biological efficacy of erythropoietin has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (rats and dogs).
Danish: Den biologiske effekt af erythropoitin er blevet demonstreret efter intravenøs og subkutan anvendelse i forskellige dyremodeller in vivo (rotter og hunde).
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Danish: Kontrollerede kliniske forsøg har ikke vist markante fordele, der kan tilskrives administrering af epoteiner, når hæmoglobinkoncentrationen forøges udover det niveau, som er nødvendigt for at kontrollere symptomer på anæmi og undgå blodtransfusion.
English: The bioavailability of subcutaneously administered epoetin delta is between 26% and 36%.
Danish: Biotilgængeligheden af subkutant administreret epoetin delta er mellem 26 % og 36 %.
English: Treatment can result in polycythaemia if the haemoglobin/haematocrit is not carefully monitored and the dose appropriately adjusted.
Danish: Behandling kan føre til polycytæmi, hvis hæmoglobin/hæmatokrit ikke overvåges nøje og dosis passende justeres derefter.
English: Even patients with normal blood pressure may have a marked rise in their blood pressure and existing high blood pressure can get worse (See 2.
Danish: Selv patienter med normalt blodtryk kan få kraftigt forhøjet blodtrykket, og patienter, som allerede har forhøjet blodtryk, kan opleve en forværring (Se afsnit 2.
English: Your doctor will manage your dosage so that haemoglobin concentrations will not consistently be above 12 g/dl which may be associated with a higher risk of cardiovascular events (e.g. heart attacks).
Danish: din læge vil justere Deres dosis således, at hæmoglobinkoncentrationen ikke konsekvent vil være over 12 g/dl, hvilket kan forbindes med en højere risiko for kardiovaskulære begivenheder (f.eks. hjerteanfald)
English: Your dose of Dynepo may vary depending on your weight and on your response to the treatment.
Danish: Din Dynepo-dosis kan variere afhængig af din vægt og din reaktion på behandlingen.
English: The most common are hypertension, access related thrombosis and headache.
Danish: Du mest almindelige er hypertension, trombose i forbindelse med anfald og hovedpine.
English: You do not have to remove the air bubble before injecting.
Danish: Det er ikke nødvendigt at fjerne luftboblen før injektionen.
English: Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/week should be investigated, including referral to a haematologist.
Danish: Anæmi hos epoetin-resistente eller hyporesponsive patienter, som ikke reagerer på 20.000 IE/uge, bør undersøges, heriblandt henvises til en hæmatolog.
English: Take your next dose at the normal time.
Danish: Tag din næste dosis til den
English: If you accidentally give yourself too large a dose, tell your doctor.
Danish: Hvis du ved et uheld tager for stor en dosis, skal du kontakte lægen.
English: Lactation: It is not known whether Dynepo is excreted in human breast milk.
Danish: Amning: Det vides ikke om Dynepo udskilles i modermælken hos mennesker.
English: If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du oplyse din læge eller apotek herom.
English: Red blood cells are very important since they contain haemoglobin, a protein which distributes oxygen in your body.
Danish: Røde blodlegemer er meget vigtige, da de indeholder hæmoglobin, som er et protein, der transporterer ilten