FrancophonIA/ELRC3.0 huggingface dataset:
English: Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have
Danish: Immunisering fra afkom af vaccinerede fugle bør derfor udsættes indtil dette antistofniveau er faldet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En dosis (0,5 ml) indeholder:
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN MED HENSYN TIL SIKKER OG EFFEKTIV BRUG
English: No information is available on the safety of this vaccine for birds in lay.
Danish: Der foreligger ingen information om sikkerheden af denne vaccine på æglæggere.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6 emulsion for injection for chickens
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobilis Influenza H5N6, injektionsvæske, emulsion, til kyllinger.
English: Allow the vaccine to reach a temperature of 15°C - 25°C and shake well before use.
Danish: Lad vaccinen opnå stuetemperatur (150C - 250C) og omryst, grundigt før brug.
English: For disposal read the package leaflet.
Danish: bortskaffelse læs indlægsseddel.
English: Liquid light paraffin 234.8 mg/0.5 ml
Danish: Paraffinolie, tynd 234,8 mg/0,5 ml.
English: BATCH NUMBER <Lot> {number}
Danish: BATCHNUMMER Batch nr. {nummer}
English: Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Danish: To uger efter en enkelt vaccination er der vist en reduktion i kliniske symptomer, dødelighed og udskillelse og overførsel af virus efter eksponering med en virulent H5N1-stamme.
English: The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H5.
Danish: Vaccinen stimulerer aktiv immunitet mod fugleinfluenza-virus type A, undertype H5.
English: SPECIAL STORAGE CONDITIONS Store refrigerated (2°C to +8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres koldt (2oC til 8oC).
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: Tryptose and NZ-Amines: The use of unspecified countries of origin of the cows providing the milk and unspecified suppliers of the tryptose and NZ-Amine is not considered acceptable.
Danish: og leverandører af trypsin og NZ-amin, som ikke er specificeret, kan ikke accepteres.
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Danish: 9 OPLYSNINGER OM KORREKT ANVENDELSE Lad vaccinen opnå stuetemperatur (150C - 250C) og omryst grundigt før brug.
English: Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Danish: Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: INDICATION(S) Active immunisation against avian influenza type A, subtype H5.
Danish: INDIKATION(ER) Aktiv immunisering mod fugleinfluenza type A, undertype H5.
English: Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35
Danish: Indehaver af markedsføringstilladelsen Intervet International B.V.
English: From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly 6 weeks and older: 0.5ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination No information is available on vaccination in the presence of maternally derived antibodies.
Danish: 6 uger og ældre: 0,5 ml subkutant eller intramuskulært Kommende æglæggere og avlsdyr bør gives en anden vaccination 4 - 6 uger efter første vaccination.
English: Adjuvant: Liquid paraffin
Danish: Adjuvans: Paraffinolie, tynd
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN MED HENSYN TIL UDLEVERING OG BRUG
English: TARGET SPECIES Chickens.
Danish: DYREARTER Kyllinger.
English: EXPIRY DATE <EXP {month/year}> Once broached, use within 8 hours.
Danish: Efter anbrud anvendes inden 8 timer.
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN MED HENSYN TIL UDLEVERING OG BRUG
English: ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection Read the package leaflet before use.
Danish: INDGIVELSESVEJ(E) Til intramuskulær eller subkutan injektion.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION For subcutaneous or intramuscular use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG> INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR
English: PHARMACOVIGILANCE ASPECTS
Danish: BIVIRKNINGSOVERVÅGNING
English: 4.8 Interactions with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON {250ml Bottle / 500ml Bottle}
Danish: {250 ml flaske/500 ml flaske}
English: Store at +2°C to +8°C.
Danish: Opbevares og transporteres koldt (2°C til 8°C).
English: This summary was last updated in 02-2012.
Danish: Dette sammendrag blev sidst ajourført i 02-2012.
English: If the solution for infusion is used, it should be given over a period of 90 minutes.
Danish: Hvis infusionsopløsningen anvendes, bør den indgives over en periode på 90 minutter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temodal on 26 January 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Temodal den 26. januar 2009.
English: The full EPAR for Temodal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Temodal findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Temodal capsules have been studied in four main studies.
Danish: Temodal kapsler er blevet undersøgt i fire hovedundersøgelser.
English: Patients may also need to take medicines to prevent vomiting before taking Temodal.
Danish: Patienterne vil muligvis også have behov for medicin til at forbygge opkastning, før de tager Temodal.
English: Temodal capsules should be taken whole without food.
Danish: Temodal kapsler bør synkes hele uden føde.
English: It is available as capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg) and as a powder to be made up into a solution for infusion (drip into a vein).
Danish: Det fås som kapsler (5 mg, 20 mg, 100 mg, 140 mg, 180 mg og 250 mg) og som et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: This is a summary of the European public assessment report (EPAR) for Temodal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temodal.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temodal.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Temodal.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Danish: • Voksne med nydiagnosticeret glioblastoma multiforme (en aggressiv form for hjernesvulst).
English: Other information about Temodal
Danish: Andre oplysninger om Temodal
English: The main measures of effectiveness were how long the patients survived or the length of time before the patient's cancer started to get worse.
Danish: De primære effektmål var, hvor lang tid patienterne overlevede, eller tidsrummet indtil patientens kræft blev værre.
English: The CHMP decided that Temodal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Temodal er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Temodal.
English: A further two studies were carried out in a total of 35 patients with brain tumours to show that the capsules and solution for infusion produce the same levels of temozolomide in the blood.
Danish: Der blev foretaget yderligere to undersøgelser af i alt 35 patienter med hjernesvulster for at vise, at kapslerne og infusionsopløsningen resulterer i den samme mængde temozolomid i blodet.
English: The other three main studies involved patients with malignant glioma that had come back or got worse after previous treatment.
Danish: De tre andre hovedundersøgelser omfattede patienter med ondartet gliom, der var vendt tilbage eller var blevet værre efter tidligere behandling.
English: The dose of Temodal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Danish: Dosis af Temodal afhænger af legemsoverfladearealet (beregnes ud fra patientens højde og vægt) og varierer fra 75 til 200 mg pr. kvadratmeter én gang dagligt.
English: For more information about treatment with Temodal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temodal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Temodal must not be used in patients with severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells).
Danish: Temodal må ikke anvendes til patienter med svær myelosuppression (en tilstand, hvor knoglemarven ikke kan producere nok blodceller).
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temodal is being used alone or with radiotherapy, and how the patient responds to treatment.
Danish: Dosen og antallet af doser afhænger af, hvilken form for svulst der behandles, om patienten er blevet behandlet tidligere, om Temodal anvendes alene eller sammen med strålebehandling, og hvordan patienten reagerer på behandlingen.
English: EPAR summary for the public temozolomide
Danish: EPAR sammendrag for offentligheden temozolomid
English: Temodal is used first with radiotherapy and then on its own;
Danish: Temodal anvendes først sammen med strålebehandling og herefter alene.
English: Patients receiving the solution for infusion may also have injection site reactions, such as pain, irritation, itching, warmth, swelling and redness, as well as bruising.
Danish: Patienter, der får infusionsopløsningen, kan også få reaktioner på injektionsstedet, såsom smerte, irritation, kløe, varmefornemmelse, hævelse og rødme samt blå mærker.
English: Treatment with Temodal should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temodal skal ordineres af en læge med erfaring i behandling af hjernetumorer.
English: The most common side effects with Temodal (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, constipation, loss of appetite, alopecia (hair loss), headache, fatigue (tiredness), convulsions (fits), rash, neutropenia or lymphopenia (low white blood cell counts), and thrombocytopenia (low blood platelet counts).
Danish: De mest almindelige bivirkninger ved Temodal (som optræder hos flere end 1 ud af 10 patienter) er kvalme, opkastning, forstoppelse, appetitløshed, alopeci (hårtab), hovedpine, træthed, kramper, udslæt, neutropeni eller lymfopeni (lavt antal hvide blodlegemer) og trombocytopeni (lavt antal blodplader).
English: Temodal is used on its own in these patients.
Danish: Til disse patienter anvendes Temodal alene.
English: Temodal is an anticancer medicine.
Danish: Temodal er et lægemiddel mod kræft.
English: Temodal must not be used in people who are hypersensitive (allergic) to temozolomide, any of the other ingredients or dacarbazine (another anticancer medicine).
Danish: Temodal må ikke anvendes til personer, som er overfølsomme (allergiske) over for temozolomid, et eller flere af de øvrige indholdsstoffer eller dacarbazin (et andet lægemiddel mod kræft).
English: The final study looked at the safety and effectiveness of Temodal in the treatment of 162 patients with anaplastic astrocytoma who were in their first relapse.
Danish: I den sidste undersøgelse så man nærmere på sikkerheden og effekten af Temodal ved behandling af 162 patienter med anaplastisk astrocytom, som havde deres første tilbagefald.
English: Temodal is a medicine that contains the active substance temozolomide.
Danish: Temodal er et lægemiddel, der indeholder det aktive stof temozolomid.
English: What is the risk associated with Temodal?
Danish: Hvilken risiko er der forbundet med Temodal?
English: The active substance in Temodal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Danish: Det aktive stof i Temodal, temozolomid, tilhører en gruppe af lægemidler mod kræft, kaldet alkylerende midler.
English: Two of these studies involved patients with glioblastoma multiforme: one looked at the effects of Temodal in 138 patients and the other compared Temodal with procarbazine (another anticancer medicine) in 225 patients.
Danish: To af disse undersøgelser omfattede patienter med glioblastoma multiforme, hvor den ene undersøgelse så på virkningen af Temodal hos 138 patienter, mens man i den anden sammenlignede Temodal med procarbazin (et andet lægemiddel mod kræft) hos 225 patienter.
English: In the study of newly diagnosed glioblastoma multiforme, patients survived for an average of 14.6 months when they received Temodal and radiotherapy, compared with 12.1 months with radiotherapy alone.
Danish: I undersøgelsen af nydiagnosticeret glioblastoma multiforme overlevede patienterne gennemsnitligt 14,6 måneder, når de fik Temodal og strålebehandling, sammenlignet med 12,1 måneder, når de fik strålebehandling alene.
English: Why has Temodal been approved?
Danish: Hvorfor blev Temodal godkendt?
English: In the comparative study of glioblastoma multiforme that had come back or got worse after previous treatment, it took an average of 2.9 months until the cancer got worse in patients taking Temodal, compared with 1.9 months in the patients taking procarbazine.
Danish: I den sammenlignende undersøgelse af glioblastoma multiforme, som var kommet tilbage eller var blevet værre efter tidligere behandling, tog det gennemsnitligt 2,9 måneder, førend kræften blev værre hos patienter, der tog Temodal, sammenlignet med 1,9 måneder hos de patienter, der fik procarbazin.
English: For the full list of all side effects reported with Temodal, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Temodal fremgår af indlægssedlen.
English: The first study compared the effectiveness of Temodal and radiotherapy with that of radiotherapy on its own in 573 patients with newly diagnosed glioblastoma multiforme.
Danish: I den første undersøgelse blev virkningen af Temodal og strålebehandling sammenlignet med virkningen af strålebehandling alene hos 573 patienter med nydiagnosticeret glioblastoma multiforme.
English: In anaplastic astrocytoma, it took an average of 5.4 months for the cancer to get worse in patients taking Temodal.
Danish: I undersøgelsen med patienter med anaplastisk astrocytom tog det gennemsnitligt 5,4 måneder, inden kræften blev værre hos de patienter, der fik Temodal.
English: What is Temodal?
Danish: Hvad er Temodal?
English: For full details, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: How has Temodal been studied?
Danish: Hvordan blev Temodal undersøgt?
English: What is Temodal used for?
Danish: Hvad anvendes Temodal til?
English: What benefit has Temodal shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Temodal?
English: How is Temodal used?
Danish: Hvordan anvendes Temodal?
English: How does Temodal work?
Danish: Hvordan virker Temodal?
English: Date of first authorisation: 19 November 2012 Date of latest renewal: 18 September 2017
Danish: Dato for første markedsføringstilladelse: 19. november 2012 Dato for seneste fornyelse: 18. september 2017
English: Do not administer the injection to yourself.
Danish: Du må ikke selv foretage injektionen.
English: General advice
Danish: Generelle råd:
English: It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Danish: Det er vigtigt at forsøge at undgå, at der udvikles ONJ, da det er en smertefuld tilstand, som kan være svær at behandle.
English: Specific studies for the 3-monthly dosing regimen have not been performed.
Danish: Der er ikke udført specifikke studier for 3-måneders regimet.
English: 500 ml over 1 hour
Danish: 500 ml over en time
English: Not known (frequency cannot be estimated from the available data) • asthma attack
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) • astmaanfald
English: • you are a smoker (as this may increase the risk of dental problems)
Danish: er ryger (da det kan forhøje risikoen for at få tandproblemer).
English: This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 2).
Danish: Det blev dokumenteret både i den primære analyse efter et år og i den bekræftende analyse af to års endpoint (tabel 2).
English: • Needles and syringes should never be reused.
Danish: • Kanyler og sprøjter må aldrig genbruges
English: Your doctor may take steps to correct such changes and may give you an injection containing these minerals.
Danish: Din læge vil måske træffe nogle forholdsregler for at korrigere ændringerne og måske give dig en injektion, som indeholder disse mineraler.
English: * Mean change from baseline to last assessment.
Danish: * Middelændring fra baseline til sidste evaluering
English: ONJ can also occur after stopping treatment.
Danish: ONJ kan også opstå, efter at behandlingen er afsluttet.
English: If you wear dentures you should make sure these fit properly.
Danish: Hvis du bruger tandprotese, skal du sikre dig, at den passer korrekt.
English: Please consult your doctor
Danish: Tal med din læge.
English: Other things that can increase the risk of fractures include:
Danish: Andre forhold, som kan øge risikoen for knoglebrud, er:
English: Serum CTX reduction was maintained over the 2 years, with more than half of the patients identified as responders in both treatment groups.
Danish: Reduktion i serum-CTX blev fastholdt i de 2 år, med over halvdelen af patienterne klassificeret som respondenter i begge behandlingsgrupper.
English: • It helps to prevent other bone problems that may need surgery or radiotherapy.
Danish: • Det hjælper med at forebygge andre knogleproblemer, som kan kræve operation eller strålebehandling
English: • smoking cigarettes, or drinking too much alcohol
Danish: • cigaretrygning eller for meget alkohol
English: The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.
Danish: Smerteniveauet var permanent under baseline gennem hele undersøgelsen og blev ledsaget af et signifikant reduceret forbrug af analgetika.
English: • you have cancer.
Danish: har kræft.
English: • If you have any disturbance of mineral metabolism (such as vitamin D deficiency)
Danish: • hvis du har problemer med mineralmetabolismen (f.eks. vitamin D mangel).
English: The vertebral fracture risk reduction was very consistent with that seen in the overall population.
Danish: Den vertebrale risikoreduktion var meget lig den, der blev set for den samlede population.
English: You should arrange an appointment to get the next injection as soon as possible.
Danish: Du skal træffe aftale om at få den næste injektion så hurtigt som muligt.
English: If you are unable to do so, you should inform your doctor
Danish: Hvis du ikke kan det, skal du kontakte din læge
English: In table 1 a complete list of known adverse reactions is presented.
Danish: Tabel 1 viser en komplet liste over kendte bivirkninger.
English: The results from this trial are summarised below.
Danish: Resultaterne fra denne undersøgelse er beskrevet i det følgende.
English: This also applies to solutions used to flush butterfly and other devices.
Danish: Det gælder også for opløsninger, som anvendes til at skylle venflonet og andet udstyr.
English: Method of administration For intravenous use over 15 - 30 seconds, every three months.
Danish: Administration Til intravenøs anvendelse over 15-30 sekunder hver tredje måned.
English: • not smoking and not drinking too much alcohol
Danish: • at undgå rygning og for meget alkohol
English: • Dispose of the full container according to local requirements or as instructed by your healthcare professional.
Danish: • Destruer den fyldte kanyleboks i henhold til lokale retningslinjer eller i følge vejledning fra din sundhedsperson.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER Lot
English: Elderly population (> 65 years)
Danish: Ældre population (>65 år)
English: Elderly population (>65 years)
Danish: Ældre population (> 65 år)
English: There is limited data available on patients of African origin.
Danish: Der er kun begrænsede tilgængelige data vedrørende patienter af afrikansk oprindelse.
English: • increased sensitivity of sound, taste or touch or changes in smell
Danish: • øget følsomhed for lyd, smag eller berøring eller ændringer i lugtesans
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Danish: Med henblik på at mindske risikoen for, at der udvikles ONJ, er der nogle forholdsregler, du skal tage.
English: Body weight gain was decreased in F1 offspring in rats.
Danish: Legemsvægten var reduceret hos F1-afkommet hos rotter.
English: Mean relative changes from baseline % [95% CI]
Danish: Gennemsnitlige relative ændringer fra baseline % [95 % konfidensinterval]
English: • serious, potentially life-threatening allergic reaction (see section 2).
Danish: • alvorlig, eventuelt livstruende, allergisk reaktion (se punkt 2).
English: • If you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys
Danish: • hvis du har eller har haft problemer med nyrerne, nyresvigt eller haft behov for dialyse, eller hvis du har andre sygdomme, som kan påvirke dine nyrer
English: Your doctor will work out how much Ibandronic acid Accord you will be given depending on your illness.
Danish: Lægen vil bedømme, hvor meget Ibandronsyre Accord du skal have afhængigt af din sygdom.
English: As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates.
Danish: Da de beregnede værdier for en stor dels vedkommende er en funktion af studiets varighed, den anvendte dosis og analysens følsomhed, er den sande terminale halveringstid sandsynligvis væsentlig længere, som for andre bisphosphonater.
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevarinsbetingelser.